4867 lines (4866 with data), 799.8 kB

Patients must have had histologic verification of juvenile myelomonocytic leukemia (JMML) at original diagnosis and currently have relapsed or refractory disease; the diagnosis is made based on the following criteria\r\n* JMML category  (all of the following): the diagnostic criteria must include all features in category  and EITHER (i) one of the features in category  OR (ii) two features from category  to make the diagnosis\r\n** Splenomegaly\r\n** >  ( x ^/uL) circulating monocytes\r\n** < % blasts in the bone marrow or peripheral blood\r\n** Absence of the t(;) or BCR/ABL fusion gene\r\n* JMML category  (at least one of the following if at least two category  criteria are not present):\r\n** Somatic mutation in RAS or PTPN\r\n** Clinical diagnosis of NF or NF gene mutation\r\n** Homozygous mutation in CBL\r\n** Monosomy \r\n* JMML category  (at least two of the following if no category  criteria are met):\r\n** Circulating myeloid precursors\r\n** White blood cell count, >   ( x ^/ uL)\r\n** Increased hemoglobin F for age\r\n** Clonal cytogenetic abnormality\r\n** GM-CSF hypersensitivity
Radiographic findings consistent with non-small cell lung cancer, including lesions with ground glass opacities with a solid component of % or greater; those with ground glass opacities and < % solid component will be excluded
Patients must have biopsy-proven newly diagnosed polymorphic or monomorphic PTLD using the World Health Organization (WHO) classification and that is:\r\n* CD positive\r\n* EBV positive by Epstein-Barr virus early ribonucleic acid (RNA) (EBER) in situ hybridization (preferred) and/or LMP immunoperoxidase staining
Fulminant PTLD defined as: fever >  degrees Celsius (C), hypotension, and evidence of multi-organ involvement/failure including two or more of the following: \r\n* Bone marrow (including pancytopenia without any detectable B-cell proliferation) \r\n* Liver (coagulopathy, transaminitis and/or hyperbilirubinemia)\r\n* Lungs (interstitial pneumonitis with or without pleural effusions)\r\n* Gastrointestinal hemorrhage
Karnofsky performance status > % (given the aggressiveness of this disease and the often severely debilitated nature of the patients at initial presentation)
Unsuitable for or refractory to transarterial hepatic chemo-embolization (TACE) or drug eluting beads (DEB) for any of the following reasons, as described by Raoul et al ():\r\n* Technical contraindications: arteriovenous fistula, including surgical portosystemic shunt or spontaneous portosystemic shunt\r\n* Severe reduction in portal vein flow: due to tumor portal vein, IVC or atrial invasion or bland portal vein occlusion\r\n* Medical contraindications including congestive heart failure, angina, severe peripheral vascular disease\r\n* Presence of extrahepatic disease\r\n* No response post TACE (or DEB) or progressive HCC despite TACE; prior TACE or DEB is allowed but must be >  days from study entry\r\n* Serious toxicity following prior TACE (or DEB); prior TACE or DEB must be >  days from study entry\r\n* Other medical comorbidities making TACE (or DEB) unsafe and/or risky (e.g. combination of relative contraindications including age >  years, tumor >  cm, > % replacement of the liver by HCC, extensive multinodular bilobar HCC, biliary drainage)
No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Radical or partial nephrectomy with lymphadenectomy in select participants
Refractory anemia with ringed sideroblasts (RARS)
Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >=  days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
Known p/q co deletion
Multi focal (defined as  separate areas of contrast enhancement measuring at least  cm in  planes that are not contiguous on either fluid attenuated inversion recovery (FLAIR) or T sequences);
Associated with either diffuse subependymal or leptomeningeal dissemination; or
Thrombolytic use (except to maintain i.v. catheters) within  days prior to randomization
Presence of tumor(s) invading into the heart or great vessels (including carotid artery) or another location where bleeding is associated with high morbidity including patients with primary cardiac or great vessel angiosarcoma
NEUROCOGNITIVE REMEDIATION INTERVENTION
Uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution despite adequate electrolyte supplementation
Patients with known cardiopulmonary disease are not eligible; cardiopulmonary disease is defined as:\r\n* Cardiomyopathy other than chemotherapy related changes in cardiac function that meet the eligibility requirements\r\n* Clinically significant arrhythmia:\r\n** History of polymorphic ventricular fibrillation or torsade de pointes,\r\n** Permanent atrial fibrillation (a fib), defined as continuous a fib for >=  months,\r\n** Persistent a fib, defined as sustained a fib lasting >  days and/or requiring cardioversion in the  weeks before screening,\r\n** Grade  a fib defined as symptomatic and incompletely controlled medically, or controlled with device (e.g. pacemaker), or ablation and\r\n** Patients with paroxysmal a fib or < grade (Gr)  a fib for period of at least  months are permitted to enroll provided that their rate is controlled on a stable regimen\r\n* Implantable cardioverter defibrillator;\r\n* Moderate to severe aortic and/or mitral stenosis or other valvulopathy (ongoing);\r\n* Pulmonary hypertension\r\n* Congestive heart failure class III or IV
Patients who are receiving any investigational agent other than pevonedistat, including but not limited to androgens, supraphysiologic doses of corticosteroids, erythropoietin, eltrombopag, or romiplostim
Absence of invasion or microinvasion
Amenable to follow up examinations
Bloody nipple discharge
Documented history of prior tamoxifen, aromatase inhibitor, or raloxifene in last  months
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A) trial prior to randomization
Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed
Patients must have been assigned to SF
Patients are eligible under ONE of the following criteria:\r\n* Patients must have histologically confirmed rare cancer and must be able to submit specimens; NOTE: Subsequent to sites Institutional Review Board (IRB) approval of revision , patients are NOT required to participate in EAY National Cancer Institute (NCI)-Molecular Analysis for Therapy Choice (MATCH) to register to this study\r\n* FOR PATIENTS ENROLLED IN EAY NCI-MATCH PRIOR TO EAY ADDENDUM  ONLY: Patients must have histologically confirmed rare cancer that did not have a match to a molecularly-guided therapy on EAY NCI-MATCH protocol or who are off protocol treatment on EAY, NCI-MATCH and have no further molecularly-matched treatment recommendations per EAY, NCI-MATCH or who are otherwise unable to receive EAY, NCI-MATCH therapy
Patients must have adequate adrenal axis function, as evidenced by adrenocorticotropic hormone (ACTH) values within the institutional normal ranges OR cortisol levels within institutional normal ranges (ante meridiem [AM] cortisol preferred), within  days prior to registration
Primary surgeon indicates need for abdominoperineal (APR) at baseline
Patients must be registered to the ALCHEMIST-SCREEN (ALLIANCE A) trial prior to randomization
United States (U.S.) patients who can complete the survey and the interview by telephone or email in English must be offered participation in the SGEN survey ancillary study; NOTE: Patients enrolled to S prior to revision # are not eligible for the SGEN survey ancillary study; study physicians will provide participants with a hard copy of the survey (at the time of informed consent) to improve tracking and comprehension during the interview
Results of central PD-L testing available; Q Solutions will forward the PD-L results to the statistical center and the statistical center will notify the site that the result is available; the notification from the Alliance registration/randomization office will serve as a confirmation of this eligibility criteria; after sites receive the confirmation e-mail from Alliance they can register the patient
Patients with new symptoms of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), or exposure to cardiotoxic medications must have a cardiology consultation, creatinine phosphokinase (CPK), and troponin testing at prestudy and as clinically indicated
Albumin, alkaline phosphatase, bicarbonate, blood urea (BUN), chloride, glucose, phosphorus, and total protein must be assessed within  days of registration
Patients must have a Ki- proliferative index of -% OR at least  mitotic figures per  high powered fields
No ongoing major illness or psychosocial issues that would limit compliance with the protocol
Presence of deficient (d) DNA mismatch repair (dMMR); MMR status must be assessed by immunohistochemistry (IHC) for MMR protein expression (MLH, MSH, MSH, PMS) where loss of one or more proteins indicates dMMR; dMMR may be determined either locally or by site-selected reference lab; Note: loss of MLH and PMS commonly occur together; formalin-fixed paraffin-embedded (FFPE) tumor tissue is required for subsequent retrospective central confirmation of dMMR status
Patients who are known to have Lynch syndrome and have been found to carry a specific germline mutation in an MMR gene (MLH, MSH, MSH, PMS) are eligible to participate
SR and SR patients:
Patients must not be registered to step  until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L testing; patients must be registered within  days of receiving the e-mail notification confirming submission was evaluable for PD-L status
Patients with postoperative fistula
Cytogenetic analysis must be performed from diagnostic bone marrow (preferred) or if adequate number of circulating blasts from peripheral blood; FISH testing for common B-lineage ALL abnormalities including t(;) (BCR/ABL), t(;) (ETS-variant gene  [ETV]/runt-related transcription factor  [RUNX]), t(;) (pre-B-cell leukemia homeobox  [PBX]/transcription factor  [TCF]), +,+,+, (centromeric [Cen]/Cen/Cen), t(q;var), (myeloid/lymphoid or mixed lineage leukemia [MLL]), deletion (del)(p) (cyclin-dependent kinase inhibitor A [CDKNA]/Cen), and t(;var) (immunoglobulin heavy chain [IGH] is encouraged); if there are few or no circulating blasts and an adequate marrow sample cannot be obtained for cytogenetic analysis, the patient may still enroll on the trial
ELIGIBLE SITES:\r\n* Extremities: upper (including shoulder) and lower (including hip)\r\n* Trunk: body wall
Within  days prior to registration: Complete dental exam; complete elimination of dental and periodontal pathology including crowns on teeth susceptible to fracture, extraction of non-restorable or periodontally uncorrectable teeth; creation of an oral environment that the patient can efficiently maintain in a high state of health; and oral hygiene instruction to maintain excellent oral health
RMS types included under embryonal rhabdomyosarcoma (ERMS) include those classified in the  International Classification of Rhabdomyosarcoma (ICR) as ERMS (classic, spindle cell, and botryoid variants), which are reclassified in the  World Health Organization (WHO) classification as ERMS (classic, dense and botryoid variants) and spindle cell/sclerosing RMS (encompassing the historical spindle cell ERMS variant and the newly recognized sclerosing RMS variant); classification of alveolar rhabdomyosarcoma (ARMS) in the  WHO classification is the same as in the ICR and includes classic and solid variants\r\n* ERMS\r\n** Stage , group III (non-orbit)\r\n** Stage , group I/II\r\n** Stage /, group III\r\n** Stage , group IV, <  years old\r\n* ARMS:\r\n** Stages -, groups I-III
Patients with uncontrolled hyperglycemia
Patients with uncontrolled hyperlipidemia
It is recommended that the starting and maintenance dose of rosuvastatin (due to BCRP inhibition by osimertinib) should be as low as possible and should be guided by the statin label; monitoring of low-density lipoprotein (LDL) cholesterol levels is advised; if the subject experiences any potentially relevant adverse events suggestive of muscle toxicity including unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever, the statin should be stopped, creatine kinase (CK) levels should be checked, and any appropriate further management should be taken
Surgical formalin-fixed paraffin-embedded (FFPE) specimen must be available for submission to GenomeDx for genomic analysis on DECIPHER GRID platform\r\n* Please note: If a patient already has a Decipher risk score and meets all of the other eligibility criteria, the patient is eligible to be registered; however, the Decipher risk report will need to be submitted to GenomeDx for validation
Eligibility criteria for the Longitudinal, Computerized Assessment of Neurocognitive Functioning study \r\n* Patients must be aged  to  years at time of B-ALL diagnosis, enrolled on AALL\r\n* Patients must be English-, French- or Spanish-speaking (languages in which the assessment is available)\r\n* Patients must have no known history of neurodevelopmental disorder prior to diagnosis of B-ALL (e.g., Down syndrome, Fragile X, Williams Syndrome, mental retardation)\r\n* Patients must have no significant visual impairment that would prevent computer use and recognition of the visual test stimuli
Effective Amendment , patients enrolled on AALL, without Down syndrome, meeting the following criteria will NOT be eligible to continue on AALL or the VHR stratum of AALL: \r\n* Intrachromosomal amplification of chromosome  (iAMP)\r\n* Mixed-lineage leukemia (MLL) rearrangement\r\n* Hypodiploidy (n <  chromosomes and/or a deoxyribonucleic acid [DNA] index < .) \r\n* Induction failure (M BM at day )\r\n* Without favorable cytogenetics (no ETV-RUNX or double trisomies +), with day  BM MRD >= .%
Patients must have newly diagnosed v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) non-amplified neuroblastoma (International Classification of Diseases for Oncology [ICD-O] morphology /) or MYCN non-amplified ganglioneuroblastoma verified by histology
Patients must meet the specified criteria for one of the treatment groups defined below; genomic features include MYCN gene amplification, segmental chromosome aberrations (somatic copy number loss at p, p, p, or q or somatic copy number gain at q, p, or q) and deoxyribonucleic acid (DNA) index\r\n* Favorable genomic features are defined by one or more whole-chromosome gains or hyperdiploid tumor (DNA index > ) in the absence of segmental chromosome aberrations as defined above\r\n* Unfavorable genomic features are defined by the presence of any segmental chromosome aberration (somatic copy number loss at p, p, p, or q or somatic copy number gain at q, p, or q) or diploid tumor (DNA index = ); this includes copy neutral loss of heterozygosity (LOH)\r\n* Only patients with MYCN non-amplified tumors are eligible for this study
Institution has received results from Adaptive Biotechnologies as defined by one of the following criteria:\r\n* Patients are MRD Indeterminate: ClonoSEQ ID molecular marker assessment did not identify any unique clonal immunoglobulin DNA sequence OR\r\n* ClonoSEQ ID molecular marker assessment identified unique clonal immunoglobulin DNA sequence and MRD assessment is completed
If the RQ-PCR results are known at the time of study enrollment, the patient must demonstrate the PML-RARalpha transcript by RQ-PCR to be eligible
Determination of activated B-celllike (ABC) subtype by pre-registration central review
For de novo stage IV NSCLC patients (patients with metastatic disease at first presentation), primary disease must be treatable with local therapy in the form of SBRT or hypofractionated radiation. If the primary disease is found in the peripheral or central lung parenchyma without nodal disease, for instance, SBRT may be employed at the discretion of the treating institution. If primary disease is more advanced with involvement of the mediastinum (T tumor, N-N disease, etc.), these volumes should be technically treatable with hypofractionated radiation; surgery should only be used for metastatic tumors that can be completely resected by lobectomy, segmentectomy, or wide wedge resection.
Patients judged capable of tolerating a radical course of chemoradiation therapy
Patients with vulvar melanomas or sarcomas
There are no restrictions on distance between the metastases
pN or pNx
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-) questionnaire
Patients must be PPD negative within  days prior to registration; PPD negativity is defined as <  mm diameter induration (palpable, raised hardened area) in the volar forearm at - hours following injection with standard tuberculin dose ( units, . ml); for PPD readings done outside of - hour window, patients must have PPD test and reading repeated to confirm eligibility
Patient must have stage I-III malignant pleural mesothelioma that is deemed resectable and must be planning to undergo pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP)
Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy within  days prior to step  registration; patients must undergo the diagnostic laparoscopy to rule out peritoneal disease spread
Prior WBRT
Patients must have a body surface area >= . m^ at enrollment while the  mg strength tablet supply is available; patients < . m^ must follow the dosing nomogram; patients >= . m^ at enrollment must follow the dosing nomogram
Must have evidence of progressive or recurrent GCT (measurable or non-measurable) following one line of cisplatin-based chemotherapy, defined as meeting at least one of the following criteria:\r\n* Tumor biopsy of new or growing or unresectable lesions demonstrating viable non-teratomatous GCT (enrollment on this study for adjuvant treatment after macroscopically complete resection of viable GCT is not allowed); in the event of an incomplete gross resection where viable GCT is found, patients will be considered eligible for the study\r\n* Consecutive elevated serum tumor markers (HCG or AFP) that are increasing; increase of an elevated lactate dehydrogenase (LDH) alone does not constitute progressive disease\r\n* Development of new or enlarging lesions in the setting of persistently elevated HCG or AFP, even if the HCG and AFP are not continuing to increase
No secondary somatic malignancy arising from teratoma (e.g., teratoma with malignant transformation) when it is actively part of the disease recurrence or progression
CYPA isoenzymes within  days of randomization.
Cutaneous T cell lymphomas except transformed mycosis fungoides (MF)
Presence of grade >  peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Treatment with clinically significant enzyme-inducing drugs, including known P-glycoprotein inducers (including St. Johns Wort and rifampicin) should be used only if absolutely necessary and considered to be the best available choice for the patient; if possible, it is recommended that alternatives to known substrates, inhibitors or inducers of P-glycoprotein be considered; cases should be discussed with the principal investigator, and may be allowed as per his/her discretion
Diagnosis: Subjects must have a diagnosis of neuroblastoma or ganglioneuroblastoma (nodular or intermixed) verified by histology or demonstration of clumps of tumor cells in bone marrow with elevated urinary catecholamine metabolites. Subjects with the following disease stages at diagnosis are eligible, if they meet the other specified criteria: a) Subjects with newly diagnosed neuroblastoma with INSS Stage  are eligible with the following: i. Age >  months (>  days) regardless of biologic features or ii. Age - months (- days) with any of the following  unfavorable biologic features (MYCN amplification, unfavorable pathology and/or DNA index = ) or iii. MYCN amplification (> -fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features. b) Subjects with newly diagnosed neuroblastoma with INSS Stage  are eligible with the following: i. MYCN amplification (> -fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features or ii. Age >  months (>  days) with unfavorable pathology, regardless of MYCN status. c) Subjects with newly diagnosed neuroblastoma with INSS Stage A/B with MYCN amplification (> -fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features.
Ability to tolerate PBSC collection: No known contraindication to PBSC collection. Examples of contraindications would include a weight or size less than that determined to be feasible at the collecting institution, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure.
Hormonal-acting agents (including DES, aldosterone, and spironolactone but not including gonadotropin-releasing hormone [GnRH] agonists or antagonists) are forbidden during the trial and must be stopped prior to treatment start; no washout period will be required for any of these agents
Margins of the resected specimen or re-excision specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the pathologist\r\n* Notes: Additional operative procedures may be performed to obtain clear margins; focally positive margins are acceptable based on technical feasibility of additional surgery and/or the potential for benefit with further surgery based on the extent and location of the positive margin (eg, focally positive deep margin at the pectoralis fascia); also, patients with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection
Pathologic nodal staging of Nb, Nc, or N disease
For hepatitis B participants, must be on a nucleoside analog reverse transcriptase inhibitor (lamivudine, telbivudine, adefovir, tenofovir, or entecavir).
Subject must be referred for treatment with ibrutinib.\r\n* Since ibrutinib will not be supplied as part of the study, the subjects ability to obtain ibrutinib from a commercial supplier must be confirmed prior to enrollment
Parts B, B, and C: During prior platinum therapy, requirement for dose reduction or discontinuation of carboplatin or cisplatin for toxicity or lack of tolerability
History of malignancy with confirmed activating RAS mutation at any time; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility
Patient is non-responsive to, refractory to, or intolerant of ESAs, or ESAs are contraindicated or unavailable, or a documented serum erythropoietin level of >  U/L.
For patients with non-castrate levels of circulating androgen levels (testosterone >=  g/dl)\r\n* PSA levels should be increasing on at least two occasions >=  week apart\r\n* Patients should not be considered candidates for radiation therapy
leukemia in st relapse following ?  unsuccessful salvage attempts,
Active history of diverticulitis; note that diverticulosis is permitted
Prior treatment with angiopoietin inhibitors, or inhibitors of tyrosine kinase with immunoglobulin-like and epidermal growth factor (EGF)-like domains (Tie)  or Tie including, but not limited to, AMG, CVX-, XL, and XL
Concomitant use either of warfarin and/or -hydroxy--methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors (statins).
Ability to hold their breath for >  seconds for  times
Patients with bronchiectasis in the region of the intended implantation sites
Posterior lesions that would be >  cm distance from Calypso detector plate; patients may be treated in the prone position in order to meet the required minimum distance
Patients must have received at least two lines of HER-directed therapy in the inoperable locally advanced and/or metastatic setting; prior therapy for inoperable locally advanced/metastatic disease should include trastuzumab plus pertuzumab as well as ado-trastuzumab; pertuzumab and ado-trastuzumab should have been previously used, unless for reasons that include, but are not limited, to the following: intolerance to pertuzumab and/or ado-trastuzumab, medical contraindication, regimen declined by patient, treating investigator discretion, or medical insurance coverage issues which prevented administration of pertuzumab or ado-trastuzumab; these reasons must be reviewed with the study chairs and documented in the medical record and care report form; patients who relapse within  months of completing neoadjuvant/adjuvant pertuzumab or ado-trastuzumab would be considered as having progressed on that regimen
Tumours that are known to have genomic alterations in PTEN or PIKCB by local test results may also be eligible. Part B - Tumour amenable to taking of paired biopsies in opinion of the investigator.Patients with TNBC or mCRPC: PTEN-deficient tumours Parts A,B or D(mCRPC)
Prospectively determined eligible PTEN alteration determined by next generation sequencing, protein deficient determined by IHC or PIKCB mutation/amplification. Part D
-  INCLUSION CRITERIA:\n\n          -  Patients of any age or either gender with indications for receipt of investigational\n             HPC-CORD BLOOD who are participating in an NIH-IRB approved clinical trial for\n             unrelated hematopoietic stem cell transplantation.\n\n          -  Signed informed consent (and assent when applicable).\n\n        EXCLUSION CRITERIA:\n\n          -  Patients who are receiving licensed CB products (only)\n\n          -  Patients who are receiving unlicensed CB products from other CB banks (i.e. NMDP)
Pathology slides from tumor tissue obtained by surgical excision or core biopsy must be reviewed by the designated site pathologist, or backup pathologist, prior to study entry; confirmation of the diagnosis must be documented by the AMC-approved pathologist prior to study entry; please reference the AMC- Manual of Procedures (MOP) for further instructions on documenting the diagnosis; the site pathologist for non-Hodgkin lymphoma (NHL) must be approved through the AMC's external quality assurance (EQA) process
Based on surgeon's assessment, patient is recommended to undergo cytoreduction surgery via laparotomy with the operative goal of this procedure to achieve optimal cytoreduction to less than  cm of residual disease
Plan for exploratory laparoscopy prior to laparotomy for assessment of disease resectability
Surgeon has high suspicion (> % chance) that cytoreduction surgery will be aborted due to inability to achieve optional cytoreduction to <  cm residual disease
Patients with any disease that will obscure toxicity or dangerously alter drug metabolism
For the diagnosis of pure germinoma, HCGbeta (serum and CSF) must be =<  mIU/ml, serum AFP must be =<  IU/l (ng/ml) and =< institutional norm and initial CSF AFP =<  IU/l (ng/ml) and =< institutional norm with histologically proven diagnosis of germinoma at diagnosis or subsequent relapse
For histologically unconfirmed MMGCT, serum and/or CSF tumor markers of HCGbeta >  mIU/ml or any elevation of above AFP >  IU/L (ng/ml) and/or above institutional norm in the serum and CSF AFP >=  IU/L (ng/ml) and/or institutional norm
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than  month
PARTICIPANTS FROM ST. JUDE AND COLLABORATING SITES PARTICIPATING IN THERAPEUTIC AND BIOLOGICAL OBJECTIVES:
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN THERAPEUTIC AND BIOLOGICAL OBJECTIVES:
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN BIOLOGICAL OBJECTIVES ONLY:
First generation: AR antagonists (e.g., bicalutamide, nilutamide, flutamide),  alpha reductase inhibitors, ketoconazole, estrogens (including diethylstilbesterol [DES]), or progesterones
Patients treated with prior interleukin- (IL-).
Need for vasopressor or ventilatory support
Patients with a history of Grade - capillary leak syndrome, or non-cardiac Grade edema are ineligible, e.g., related to SL- or other etiology
Angioimmunoblastic T-cell lymphomas (AITL);
Serum total bilirubin within normal range for the institution (biliary drainage is allowed for biliary obstruction) (within  days of treatment initiation)
Any of the following:\r\n* Individuals/or persons who are nursing\r\n* Individual/or persons who are pregnant\r\n* Individuals/or persons of childbearing potential who are unwilling to employ adequate contraception
Prior history of receiving pazopanib treatments
ER+ breast cancer patients harboring the AKT EK mutation (patient population tested in MSK IRB# -, study DC part E, ClinicalTrials.gov NCT)
Requirement for insulin for routine diabetic management and control
Have BSA involvement corresponding to stages IA, IB or IIA CTCL with at least  distinct lesions
Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for  months
Metastatic meningiomas (as defined by extracranial meningiomas) and meningioma with extra-cranial spread are allowed
Patients whose apheresis product were to be further selected and purified
Combination/multi-agent cyto-reductive therapy
Eltrombopag, romiplostim or platelet stimulating agents:  days
O saturation < % (on room air). . History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death.
Patient has a history of clinically significant dry eye (xerophthalmia) or other corneal abnormality, or if a contact lens wearer, does not agree to abstain from contact lens use from baseline through the last TVB- dose
Known history of myelodysplasia.
Evidence or history of other significant, hepatic, renal, ophthalmologic, psychiatric, or gastrointestinal disease which would likely increase the risks of participating in the study.
Must be able to take antithrombotic prophylaxis.
Patients with GBMs located in the following anatomical regions known to have magnetic susceptibility or poor signal will be excluded: mesial temporal lobe, orbitofrontal cortex, prefrontal cortex, medial frontal gyrus, brainstem, and cerebellum
Subjects with symptomatic bradycardia
Abnormal cardiac rhythm not controlled with medication; Hx of stroke within  year; Hx of coronary events and/or heart failure within  year.
Hx of drug-induced acute tubular necrosis.
Unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographically involves the carotid arteries, nerves)
Acetaminophen use within  hours before a dose of gedatolisib (PF-)
Recovery from ASCT toxicity as defined as outpatient status, able to drink, eat normally, and do not need intravenous hydration prior to day  of therapy
fluoropyrimidine (IV -FU capecitabine, or S-),
trastuzumab in case of HER-positive
ramucirumab
Total abstinence from sexual intercourse
Total abstinence from sexual intercourse
Subjects with leptomeningial disease or neoplasms in the last  years
Recurrence of BCG unresponsive Ta/T disease >  months after last BCG instillation or BCG unresponsive CIS >  months after last BCG instillation.
Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions
Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible.
Deletion of chromosome , or del(p)
Known deficiencies or suspected defect in the urea cycle
Active skin or soft tissue infection including cellulitis, erysipelas, impetigo, furuncle,carbuncle, abscess, or fasciitis.
Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
Participants who are receiving other concurrent chemotherapies or immunotherapies for their cancer (except for patients who will receive letrozole, anastrozole, exemestane, tamoxifen, fulvestrant, trastuzumab, bisphosphonates, or ovarian suppression therapy)
Uncontrolled electrolyte disorders that can compound the effects of QTc-prolonging drug (e.g. hypocalcemia, hypokalemia, hypomagnesemia)
Agreement of both the Chow et al. and type of cancer, ECOG performance status, age, prior palliative chemotherapy, prior hospitalizations, and hepatic metastases (TEACHH) models, indicating a median life expectancy of >  months
Subject is a female who is pregnant or breast-feeding, or intends to become pregnant during their participation in the study (including up to  months after the last dose of IMP) or is a male who intends to father a child during their participation in the study (including up to  months after the last dose of IMP);
Subject with any prior Grade ?  irAE to other therapeutic proteins or immunotherapy, and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, -hydroxytryptamine antagonists, or corticosteroids;
AGSP
L-Histidine base
L-Histidine HCl
?, ? -Trehalose Dihydrate
Active treatment with medications that lower the seizure threshold which cannot be held: \r\n* Aminophylline/theophylline\r\n* Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone)\r\n* Bupropion\r\n* Lithium\r\n* Pethidine\r\n* Phenothiazine antipsychotics (e.g., chlorpromazine, mesoridazine, thioridazine)\r\n* Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
Common variable immunodeficiency
Patients with symptomatic cholelithiasis
Must be unresponsive or refractory to erythropoiesis-stimulating agents (ESA), based on one of the following:
Subjects who have exhibited allergic reactions to tipifarnib, or structural compounds similar to tipifarnib or to its excipients.
Brain metastasis must not be impending herniation or other significant vasogenic edema requiring increasing steroid doses; lesions must not have frank hemorrhage
An echocardiographic finding of tricuspid valve regurgitant jet (TRJ) velocity ? . m/sec.
SAFETY RUN-IN: Patients known to be carriers of hepatitis virus B and C
Halabi Nomogram score <
Successfully pass the screening CPET by achieving: o Volitional exhaustion (RPE ?  using the - RPE scale) after  (or more) minutes, in the absence of any cardiorespiratory abnormalities.
Note: To assist practitioners with delivering valid CPET assessments, patients nearing exhaustion should achieve a respiratory exchange ratio (RER) of ?..
Men who do not complete the baseline lifestyle and quality-of-life questionnaires and -days of diet diaries or Food Frequency Questionnaire (FFQ) (TBD) will not be eligible
Patients with pure seminoma
Patients with pure teratoma
Use of T cell depletion either ex vivo or in vivo (i.e. ATG, alemtuzumab) is prohibited.
Patients who have had more than  months of prior therapy; patients outside of this window may be considered for inclusion; please contact the sponsors representative in Poland or the lead primary investigator as appropriate on a case-by-case basis
Unresolved irAEs following prior biological therapy, except that stable and managed irAEs may be acceptable (e.g., hypothyroidism or hypopituitarism on appropriate replacement).
Subjects who have lesions within  cm of central structures, will be eligible on a case-by-case basis \r\n* Tumor within or touching the zone of the proximal bronchial tree, defined as a volume  cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
The AZD plus olaparib and AZD plus olaparib additional inclusion criteria will be added as addendums to the protocol and opened once the recommended phase II doses are available
The use of cannabis oil is prohibited during the first  cycles of this protocol; patients must be off of cannabis oil for  days prior to enrollment
Retinoblastoma protein (RB) positivity as defined by RB expression (score of . or ) with concurrent pina loss (score of -)
Subjects may not be on other therapies that affect hormone levels, such as estrogens, testosterones, ketoconazole during this study; however, megestrol for hot flashes is permitted
NOTE: exceptions can be granted from PI for instances of Gilberts disease, and/or primarily indirect bilirubinemia, if due to recent transfusion and/or hemolysis
cMET amplification by FISH (GCN ? ),
Crizotinib, or any other cMET inhibitor or HGF-targeting inhibitor.
Suitable for treatment with nivolumab per package insert
Must have histologic demonstration of metastatic or surgically unresectable urothelial cancer. Minor components of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Responders who cease responding
Never responded
Patient has hypersensitivity to boron, mannitol sucrose, histidine (as base and hydrochloride salt) and polysorbate  or any of the components of study therapy including required prophylactic medications
BRAFV mutation positive
NRAS codon , , or  mutation
DONOR: ABO compatibility (in order of priority)\r\n* Compatible or minor ABO incompatibility\r\n* Major ABO incompatibility
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
Nottingham grade -. Specifically, nuclear and mitotic scores must be less than or equal to .
Subjects with gastric mucosa-associated lymphoid tissue (MALT) lymphoma must be Helicobacter pylori (HP)-negative
Vasopressor requirement
Biopsy proven MLS (including the reciprocal chromosomal translocation t(;)(q;p); A the primary sarcoma in case of non-metastatic disease for management is with curative intent (regimen to be chosen =  x  GY) B in case of oligometastatic patients, the metastasis may also be irradiated to a dose of  GY in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in  times  Gy, for convenience purposes (see paragraph  for radiobiological considerations).
Intraoperative frozen section suggesting hepatobiliary, pancreatic, adrenal, or urinary tract cancer
Participants may have either extensive or limited cGVHD requiring systemic treatment
Diagnosis of extranodal NK/T lymphoma, per WHO classification, th ed., which must include EBV tumor positivity, measured either by EBV encoded RNA (EBER) or LMP immunostaining.
Hemophagocytic lymphohistiocytosis.
Prior vismodegib or other antagonists of the hedgehog (Hh) pathway
Patients must be considered to have an acceptable risk of early mortality with intensive chemotherapy as determined by the attending physician at the time of the initial visit; since the specific therapy within each arm will be determined after randomization, there is no threshold of organ dysfunction or performance status for inclusion
Patients must have a histologically confirmed CD+ lymphoproliferative disease that is related to an immunosuppressed state (e.g., post-transplant lymphoproliferative disorder [PTLD], diffuse large B-cell lymphoma [DLBCL] of the elderly, iatrogenic immunodeficiency-associated lymphoproliferative disorder [LPD]) and for which rituximab monotherapy would be considered to be appropriate frontline therapy
Pregnancy or active nursing of an infant is not permitted
Treatment with a somatostatin analog (e.g., octreotide acetate) is required for all participants; octreotide naive patients may initiate this during the screening period or at start of study
Participants with an Inventory of Depressive Symptomatology (IDS) score >  or IDS # score  >= will be referred to Dr. Andrew Miller
Adverse event requiring discontinuation of vemurafenib in the antecedent protocol
PIKCA WILD TYPE AND MUTANT COHORT (closed //): Patients who were pre-registered to National Cancer Institute (NCI)  trial (Phase II Trial of Neoadjuvant MK- in Combination with either Anastrozole if Postmenopausal or Anastrozole and Goserelin if Premenopausal in Women with Clinical Stage  or  PIKCA Mutant Estrogen Receptor Positive and HER Negative Invasive Breast Cancer), started anastrozole (or anastrozole plus goserelin if premenopausal) =<  weeks, and were found negative for PIKCA hotspot mutations are eligible to be screened for the wild type cohort; in institutions without NCI  open, or after completion of enrollment to NCI  in institutions where it is open, patients will be pre-registered to this trial and those with PIKCA mutations will be enrolled to the PIKCA mutant cohort
PIKCA WILD TYPE COHORT (closed //): tumor PIKCA mutation present\r\n* Note that if a patient did not have sufficient research tissue for PIKCA sequencing at pre-registration or if PIKCA sequencing result is delayed, she could be registered and enrolled on the PD trial without assigning to a particular cohort at the time of enrollment; PIKCA sequencing will be performed in the future on tumors collected at subsequent time points to assign the treatment cohort or when the PIKCA sequencing data is available
Syncope without known aetiology within  months
Baseline (pre-treatment) electrocardiogram (EKG) with any of the following changes consistent with cardiac ischemia:\r\n*Significant ST depression (ST depression of >=  mm, measured from isoelectric line to the ST segment at a point  msec from the end of the QRS complex)\r\n* Significant ST elevation (> mm in limb lead or  mm in precordial lead measured at a point . sec [ mm] after the J-point [the end of the QRS complex] and compared to baseline [line drawn from P start to T end])\r\n* Investigators are encouraged to consult with cardiologists locally and with the study chair should any questions arise
Other\r\n* Diffuse metastatic spread confined to one organ system is ineligible; examples of this include leptomeningeal spread in the CNS and peritoneal carcinomatosis. \r\n* Metastatic disease sites must be treatable with stereotactic radiosurgery (at discretion of treating physician); patients with oligometastatic sites not amenable to SRS treatment, either through size or locations, are ineligible for this trial
Patients unable to have SRS/SBRT through insurance coverage or ability to pay for SRS/SBRT
Patients unable to have SRS/SBRT through insurance coverage or ability to pay for SRS/SBRT
Patients known to have germ-line adenomatous polyposis coli (APC) mutations or clinical manifestations of Familial Adenomatous Polyposis(FAP)/Gardner's syndrome can be included
Freckling in the axilla and/or inguinal region
Plexiform neurofibroma
Two or more Lisch nodules
A first-degree relative with NF
Antibiotics: clarithromycin, erythromycin, troleandomycin
Antidepressants: nefazodone, fluvoxamine
Miscellaneous: amiodarone
If requires pheresis to collect blood, creatinine (Cre) < . upper limit of normal
Other serious illness(es) involving the cardiac, respiratory, CNS, renal, hepatic or hematological organ systems which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.
AEs leading to single-agent trastuzumab emtansine or combination trastuzumab emtansine treatment discontinuation in the parent study
Ongoing SAEs from the parent study
History of hypersensitivity with previous trastuzumab emtansine or any agent used with trastuzumab emtansine in the parent study, precluding further dosing
Pregnancy or expressed plans to become pregnant within  year of the procedure
Receiving erythroid stimulating agents (erythropoietin [EPO]: Procrit, Aranesp)
Recursive partitioning analysis (RPA) class III patients (expected to be treated less than  years from first course of therapy and have a tracheostomy or percutaneous endoscopic gastrostomy [PEG] tube at presentation)
Subjects exhibiting idiosyncratic reactions to psoralen compounds.
Subjects treated, or anticipated to be treated, with delavirdine (due to potential for loss of virologic response and possible resistance to delavirdine or to the class of non-nucleoside reverse transcriptase inhibitors caused by phenytoin).
Other acute leukemias that are of ambiguous lineage or of other types
CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
Have received treatment with a therapeutic antibody less than  weeks before the first dose of AG-. A minimum -week period between the last treatment with a therapeutic antibody and the first dose of AG- may be permitted in subjects with rapidly progressive or aggressive subtypes of lymphoma following discussion with the medical monitor.
Are unable to take no food or liquids other than water for  hours before and  hours after each dose of AG-.
ALL PHASES:
Inclusion of women, minorities, and other underrepresented populations: this protocol is open to males and females of all races
CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
Meets one of the sets of the following criteria:
Evidence of electrolyte imbalance
TNBC is defined as:
Human papillomavirus-negative HNSCC
Has a ROS translocation
Females with a histologically proven CAH/EIN or grade I endometrial carcinoma (EC) for which surgery is planned; the pathologic report from the referring facility will be used to determine pathologic eligibility; this report must be within  days of their baseline (pre-surgical) clinic visit
Use hormone replacement therapy (including systemic or topical estrogen, progesterone, or testosterone based medication) or/and phytoestrogen supplements (i.e. black cohosh) or has been on progestin (including progestin containing IUD), tamoxifen or aromatase inhibitor within the prior  months
Life expectance of >=  months
All subjects must:
Agree not to share IP with another person
Nodal status - negative (Imaging of the axilla is negative; Imaging is suspicious or abnormal but the FNA or core biopsy of the questionable node[s] on imaging is negative)
A serum TSH and AM cortisol must be obtained within  days prior to randomization to obtain a baseline value.
All patients must have locoregional staging determined by endoscopic ultrasound (EUS) if technically feasible; endoscopy reports or subsequent gastrointestinal (GI) clinic note should clearly state both the T and N stage
Patients highly unlikely to undergo PD according to the surgeons judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc
Prior therapy with any known inhibitor of MNK- or MNK-.
Disease measurability:
Documented cardiomyopathy;
Women with an abnormal mammogram (BI-RADS final assessment category -probably benign, -suspicious, or -malignant findings). Women with BI-RADS  assessment (needs additional imaging evaluation) that are subsequently found to have negative (BI-RADS ) or benign findings (BI-RADS ), are NOT excluded.
Any patient receiving treatment with short-acting octreotide, which cannot be interrupted for  hours before and  hours after the administration of yttrium Y -edotreotide (Y-DOTA-TOC), or any patient receiving treatment with octreotide LAR or lanreotide, which cannot be interrupted for at least  weeks before the administration of Y-DOTA-TOC\r\n* Concurrent somatostatin receptor analog (SSA) allowed if progression has been documented and the SSA dose has been stable for at least two months; long-acting SSA cannot be given within four weeks of treatment and short-acting SSA cannot be given with  hours of treatment; SSA therapy can restart one day after treatment
Uncontrolled infection; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Participants with symptomatic hyperviscosity or serum IgM > , mg/dL to undergo plasmapheresis prior to treatment initiation
Hemosiderosis/hemochromatosis
Disease status requirement:
Acute leukemias of ambiguous lineage
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
more than one sequential second generation AR-directed therapy
Baseline peripheral neuropathy >= grade  or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
History of thrombocytopenia with complications
Hepatopulmonary shunting < % as documented via hepatic artery perfusion study
Patients with a condition related to their cancer or leptomeningeal disease requiring urgent intervention that has not been clinically managed or stabilized prior to the time of consent
Diagnostic biopsy reveals perineural invasion (PNI) and/or lymphovascular invasion (LVI)
Trismus or compromised airway
Patients must not be on active anti-androgen therapy or -alpha reductase inhibitors; patients on stable dose of -alpha reductase inhibitors for benign prostatic hypertrophy for at least  months may continue; they must withdraw from the study if this is stopped while on study
Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability
Patients must weigh ?  kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
History of orthotopic liver transplantation, hepatic vasculature incompatible with perfusion, hepatofugal flow in the portal vein or known unresolved venous shunting. Prior Whipple procedure is permitted provided the anatomy is still compatible for perfusion with the Melphalan/HDS system.
Patients with biliary stents.
Surgical fixation of bone lesion to be irradiated is required and indicated to provide mechanical stability
EXCLUSION - PROCUREMENT: Clinically significant viral infection or uncontrolled viral reactivation of Epstein Barr virus (EBV), cytomegalovirus (CMV), adenovirus (Adv), BK-virus, or human herpesvirus  (HHV-)
All hormonal-acting agents (including diethylstilbestrol/DES, aldosterone, and spironolactone) must be discontinued before registration; no washout period will be required for any of these agents
Additional criteria for cohort D (anti-PD combo) will be supplied in an appendix at a later date.
Additional criteria for cohort D (anti-PD combo) will be supplied in an appendix at a later date.
Spinal Instability Neoplastic score >=  unless lesion reviewed by a neurosurgical service and considered stable
Adequate oral intake/nutritional status without the need for enteral or parenteral feeding during chemoradiation or preoperative period
Esophagogastrectomies will be performed via a laparotomy and a right thoracotomy with en-bloc removal of perigastric, celiac, periesophageal and subcarinal lymph nodes; esophagogastric reconstruction will be performed above the level of the azygo-caval junction using an end-to-end (EEA) stapling device
Meets laboratory criteria for the following parameters: ANC, platelets, hemoglobin, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, BUN and creatinine.
Treatment with the following medications are contraindicated with DSF: metronidazole, isoniazid, dronabinol, carbocisteine, lopinavir, paraldehyde, ritonavir, sertraline, tindazole, tizanidine, atazanavir.
History of Wilson's disease.
At Massachusetts General Hospital (MGH), samples will be tested using a multiplex polymerase chain reaction (PCR) technology called anchored multiplex PCR (AMP) for single nucleotide variant (SNV) and insertion/deletion (indel) detection in genomic DNA using next generation sequencing (NGS); briefly, genomic DNA was isolated from a formalin-fixed paraffin embedded tumor specimen is sheared with the Covaris M instrument, followed by end-repair, adenylation, and ligation with an adapter; a sequencing library targeting hotspots and exons in  genes (including BRAF, exons  and ) is generated using two hemi-nested PCR reactions; Illumina MiSeq  x  base paired-end sequencing results are aligned to the hg human genome reference using BWA-MEM; MuTect and a laboratory-developed insertion/deletion analysis algorithm are used for SNV and indel variant detection, respectively; this assay has been validated to detect SNV and indel variants at % allelic frequency or higher in target regions with sufficient read coverage; this test was developed, and its performance characteristics were determined by the MGH Center for integrated diagnostics
All Arms:
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Patients with significant edema leading to risk of brain herniation
Patients with midline shift > mm
Any anticoagulation drug/strategy may be used to treat the index VTE; protocol treatment will begin <= days after the index VTE diagnosis date
estrogen-gestagen based contraceptives associated with inhibition of ovulation (oral, intravaginal, transdermal),
gestagen-only based contraceptives associated with inhibition of ovulation (oral, injectable, implantable),
intra-uterine devices (IUDs),
sexual abstinence in accordance with an individual's lifestyle
For participants treated with prior neoadjuvant chemotherapy: tumor stage of ypT-a or ypN+ (ypT- or ypN+ for participants with upper urinary tract UC) and M
Eligible for another actively accruing Roche/Genentech-sponsored interventional clinical trial Study-Drug Specific Exclusion Criteria: Trastuzumab plus Pertuzumab
Patients must have available two UCB units fulfilling the following criteria:
Each unit must have a minimum of . x ^/kg pre-cryopreserved total nucleated cell dose. For non-red blood cell depleted units, the minimum pre-cryopreserved total nucleated cell dose of each unit must be at least . x^/kg.
Participants currently receiving systemic or topical corticosteroids for the treatment of cGvHD for a duration of <  months prior to Cycle  Day  (if applicable), and have a confirmed diagnosis of steroid-refractory cGvHD defined per  NIH consensus criteria irrespective of the concomitant use of a calcineurin inhibitor (CNI), as follows:
Participant must accept to be treated with only one of the following BAT options on Cycle  Day  (additions and changes are allowed during the course of the study, but only with BAT from the following BAT options): extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), infliximab, rituximab, pentostatin, imatinib, ibrutinib
Use of -alpha reductase inhibitor within  days prior to randomization
The study is open to all participants regardless of gender or ethnicity; efforts will be made to extend the accrual to a representative population; if differences in outcome that correlate to gender, racial, or ethnic identity are noted, accrual may be expanded or additional studies may be performed to investigate those differences more fully
Radioactive iodine (RAI)-refractory disease defined as  or more of the following:\r\n* Patients who have received greater than  mCi of radioactive iodine in their lifetime OR\r\n* RAI-avid metastatic lesion which remained stable in size or progressed despite RAI treatment within  months of RAI treatment OR\r\n* % or more increase in serum thyroglobulin (on thyroid-stimulating hormone [TSH]-suppression) within  months of RAI treatment OR\r\n* Index metastatic lesion non-RAI avid on a diagnostic RAI scan OR\r\n* Presence of fluorodeoxyglucose (FDG) avid metastatic lesions on positron emission tomography (PET)/CT scan (standardized uptake values [SUV]max >  of any single lesion)
Patients requiring biliary stent placement must have biliary stent placed >  days prior to screening.
Biliary Adenocarcinoma (gallbladder or biliary tree (intrahepatic or extrahepatic cholangiocarcinoma) except Ampulla of Vater cancers)
Mesothelioma
OR
Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement well documented to be due to prostate cancer or benign prostatic hyperplasia (BPH)
Cohort A: Histologically confirmed locally advanced or metastatic solid tumor malignancy other than clear cell renal cell carcinoma with progression on at least one prior systemic therapy and presence of biallelic loss of SETD detected in tumor tissue detected using a Clinical Laboratory Improvement Act (CLIA)-certified next generation sequencing panel (e.g. UCSF, FoundationOne); biallelic loss will be defined by one or more of the following:\r\n* Pathogenic or likely pathogenic loss-of-function SETD mutation with mutant allele frequency (MAF) > %\r\n* Pathogenic or likely pathogenic loss-of-function SETD mutation with MAF >  times the MAF of other oncogenic mutations detected in the tumor sample\r\n* Pathogenic or likely pathogenic loss-of-function SETD mutation with concomitant loss of chromosome p\r\n* Pathogenic or likely pathogenic loss-of-function SETD mutation with copy-neutral loss of heterozygosity
Cohort B: Patients with histologically confirmed locally advanced or metastatic clear cell renal cell caricnoma (with clear cell component on pathology), who have been treated with at least one prior systemic therapy for locally advanced or metastatic disease, including either tyrosine kinase inhibitor and/or immune checkpoint inhibitor, with evidence of SETD mutation on CLIA-certified next generation sequencing panel\r\n* All next generation sequencing (NGS) sequencing reports including information pertaining to mutant allele frequency and chromosome p loss will be reviewed by the University of California at San Francisco (UCSF) Molecular Tumor Board to verify bi-allelic loss of SETD
PMF, PPV-MF, or PET-MF (as defined by Tefferi and Vardiman )
For enrollment into the China extension cohort, residence in the People's Republic of China Disease-specific Inclusion Criteria:
Participant consents to allow access to diagnostic BM aspirate or PB sample and/or the DNA derived from that sample, if available, that may be used to validate a companion diagnostic that is being developed in parallel with gilteritinib.
For United Kingdom sites:
Consistent and correct usage of established hormonal contraceptives that inhibit ovulation
For United Kingdom sites:
Consistent and correct usage of established hormonal contraceptives that inhibit ovulation
Established IUD or IUS
Required used of folate-containing supplements (e.g. folate deficiency)
History of pericarditis
Admitted to an institution by administrative or court order
Current use of metformin, or strong antioxidants (extracts from grape seed, milk thistle; pine bark, green tea, saw palmetto; resveratrol; flavonoids; catechins; ellagic acid), large quantities of red grapes, white button mushrooms, red wine
Compliant on combined anti-retrovirals (cART) if HIV infected
No risk factors for microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage)
FAZ in combination with PDR: NSCLC/TNBC / Selected indication(s) in dose expansion group QW dosing regimen
Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
Use of any of the following concurrent treatment or medications:\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Interferon (e.g. IntronA)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Participants enrolling into the NTRK cohort must have an NTRK, , or  rearrangement as confirmed by targeted NextGen sequencing using the DFCI/BWH OncoPanel or another CLIA-certified method
Participants enrolling to the NTRK cohort who have received a prior NTRK inhibitor may not be on anticoagulant therapy unless the investigator has deemed it safe to temporarily hold to facilitate the baseline tumor biopsy
Known life-threatening reaction (i.e., anaphylaxis) to Thymoglobulin that would prohibit use for the patient as this study requires use of the Thymoglobulin preparation of ATG.
Participant has taken any of the following medications within the past  months:\r\n* A thiazolidinedione (e.g. pioglitazone [Actos] or rosiglitazone [Avandia]),\r\n* A biguanide (e.g. metformin [Glucophage, Glumetza, Fortamet, Riomet] or proguanil [Paludrine])\r\n* A combination drug containing one of the agents above (brand names include: ACTOplus Met, Avandamet, Avandaryl, Duetact, Glucovance, Invokamet, Janumet, Jentadueto, Komboglyze, Metaglip, PrandiMet, Synjardy, Xigudo)
Participant is currently taking an enzyme inducer of CYPC (carbamazepine [Carbatrol, Epitol, Equetro, Tegretol] cortisol [Hydrocortisone]; dexamethasone [Decadron]; phenobarbital [Luminal Sodium]; phenytoin [Dilantin, Phenytek, Novaplus Phenytoin Sodium]; primidone [Mysoline]; rifampin [Rifadin, Rimactane]; rifapentine [Priftin]; secobarbital [Seconal])
Participant is currently taking a cationic drug or multidrug and toxin extrusion [MATE] inhibitor (e.g. amiloride [Midamor]; cimetidine [Tagamet]; digoxin [Lanoxin, Digitek, Digox]; dolutegravir [Tivicay]; morphine [Roxanol, Duramorph, Kadian, MS Contin]; procainamide [Pronestyl, Procanbid]; quinidine [Quinidex, Cardioquin, Quin-G, Quinora]; quinine [Qualaquin, Quinamm, Quiphile]; ranitidine [Zantac, Deprizine, Gabitidine]; ranolazine [Ranexa]; triamterene [Dyrenium)] trimethoprim [Proloprim, Trimpex, Primsol]; vancomycin [Vancocin, Vancoled]; or vandetanib [Calpresa])
Participant has > Common Terminology Criteria for Adverse Events (CTCAE) grade  limb edema ( - % inter-limb discrepancy in volume or circumference at point of greatest visible difference; swelling or obscuration of anatomic architecture on close inspection)
TREATMENT INCLUSION: Electrocardiography (EKG) shows no significant arrhythmias
Coexisting ophthalmic disease likely to require slit-lamp examination within the next  days
Pregnant or intend to become pregnant, breastfeeding or intend to breastfeed during the study
Anthracyclines within  days before first ZW dosing or lifetime load exceeding  mg/m adriamycin or equivalent
Trastuzumab, pertuzumab, lapatinib, or T?DM within  weeks before first ZW dosing
Patients requiring prolonged treatment with fluconazole, voriconazole, or posaconazole; use of isavuconazonium sulfate, liposomal amphotericin, are echinocandins are permitted
Prior treatment with clofarabine within  months or history of clofarabine-induced liver dysfunction
Have never used tamoxifen, raloxifene, or other antiestrogen compounds
Participant who has started or increased dosage of lipid-lowering agents in the last  days of enrollment; or are taking fibric acid (fenofibrate, gemfibrozil) lipid lowering agents.
Presence of a hip prosthesis
Pregnant or breastfeeding females; the potential effects of prexasertib use during pregnancy and breastfeeding are not known and prexasertib has the potential for teratogenic or abortifacient effects.
Active cardiomyopathy
Unresectable HCC, defined by imaging criteria or cytohistologic assessment; TACE as a preferred method of treatment is determined by a multidisciplinary Brigham and Womens Hospital (BWH)/Dana Farber Cancer Institute (DFCI) Liver Tumor Board
Patients with known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Patients will have close margins
FOLFIRINOX
Known underlying collagen vascular disease or intrinsic lung disease that could complicate expected sequelae of radiation (idiopathic pulmonary fibrosis, Wegeners granulomatosis)
Have persistent active cGVHD manifestations, as defined by  NIH Consensus Development Project on Criteria for Clinical trials in cGVHD, after at least  months of steroid therapy.
Known cerebral/meningeal disease
Must meet criteria for high risk disease\r\n* Patients with International Neuroblastoma Staging System (INSS) stage  disease are eligible with the following\r\n** MYCN amplification (greater than four-fold increase in MYCN signals as compared to reference signals), regardless of age or additional biologic features\r\n** Age > months (>  days) regardless of biologic features\r\n** Age - months (- days) with any of the following unfavorable biologic features (unfavorable pathology and/or deoxyribonucleic acid [DNA] index =) or any biologic feature that is indeterminate/unsatisfactory/unknown
Recent history of thyroiditis
Able to complete all mandatory tests
DLBCL, regardless of cell of origin or underlying molecular genetics
PMBCL
alemtuzumab within  months of enrollment
fludarabine, cladribine, or clofarabine within  months of enrollment
Bulky disease
Extrahepatic metastases
Allow biopsies
Patients must have disease that is suitable for repeated measurement, either
Hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement
Have received vaccination against Neisseria meningitidis at least  weeks prior to beginning study protocol (only for cohorts where patients receive eculizumab treatment) in accordance with the most current Advisory Committee on Immunization Practices (ACIP) recommendations
Have baseline anti-vaccinia antibody titers < 
Be receiving concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin, imatinib, ST-) during the course of study
Documented MAPK pathway alteration
The presence of extra capsular, seminal vesicle invasion or metastatic disease.
High grade B-cell lymphoma (HGBL), with MYC and BCL and/or BCL rearrangements or DLBCL, NOS per the  revision of the WHO classification of lymphoid neoplasms (Swerdlow et al, ).
Patient may not have disease limited to a single skin or bone site, with the following exceptions:\r\n* Central nervous system (CNS) risk lesions/special site disease: patients with single bone sites that are CNS-risk (sphenoid, mastoid, orbital, zygomatic, ethmoid, maxillary, or temporal bones, the cranial fossa, pituitary gland or neurodegenerative disease) or are special sites (odontoid peg, vertebral lesion with intraspinal soft tissue extension) require systemic therapy as standard of care and thus ARE eligible for the study\r\n* Functionally critical lesions: a single lesion not described above which may cause functionally critical anatomic abnormality wherein attempts at local therapy (such as surgical curettage or radiation) would cause unacceptable morbidity; these patients may be enrolled with approval of the principal investigator (PI) and documentation of the rationale justifying systemic therapy
Age >=  years old and toilet-trained; participants must be able to deposit stool samples directly into stool collection containers
Appropriate staging imaging.
The following baseline neurocognitive assessments must be completed and uploaded within  calendar days after or at the time of Step  registration: HVLT-R (recall, delayed recall, and recognition), TMT (parts A and B), and COWA; the neurocognitive assessments will be uploaded into the National Surgical Adjuvant Breast and Bowel Project, Radiation Therapy Oncology Group, and Gynecologic Oncology Group (NRG) Oncology RAVE system for evaluation by Dr. Wefel; once the upload is complete, within  business days, a notification will be sent to the site to proceed to Step  registration; at minimum, the HVLT-R delayed recall must be able to be scored (i.e. completed without error) in order to be eligible
Patients must have a baseline raw score greater than  on the HVLT-R delayed recall. as determined by central assessment by the Neurocognitive Co-Chair, Dr. Wefel
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Patient may not have had therapy modulating testosterone levels (such as luteinizing hormone, releasing-hormone agonists/antagonists and antiandrogens) within  months prior to randomization; agents such as  alpha reductase inhibitors, ketoconazole, abiraterone, systemic steroids, or herbal supplements known to decrease PSA levels including any dose of megestrol acetate, finasteride (e.g., saw palmetto and prostate cancer [PC]-SPES, African pygeum extract, lycopene, alanine, glutamic acid and glycine, beta-sitosterol, lycopene, nettle root extract, quercetin, Belizian Man Vine extract, muira puama extract and epimedium extract campesterol, stigmasterol, sitostanol and brassicasterol) are not permitted at any time during the period that the PSA values are being collected
Mesothelioma.
Myopathy or any clinical situation that causes significant and persistent elevation of CPK (> .  ULN in two different determinations performed one week apart).
Documented MAPK alteration
Consensus among the PI, key assistant investigators (AIs), and consultants (as necessary) that correction of the patients immune system through BMT has the potential to improve the patients health, quality of life, and/or life expectancy, after taking into consideration the patients existing non-hematopoietic, potentially irreversible organ dysfunction
Human immunodeficiency virus (HIV) positive or other acquired immunodeficiency that, as determined by the PI, interferes with the assessment of PID severity and/or the attribution of clinical manifestations of immunodeficiency to a PID
Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
Use of any of the following concurrent treatment or medications:\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Patients with any psychiatric or social condition that leads them to be unlikely to adhere to the study schedule and contribute to the primary objectives
Two oncologists disagree on prognosis or resectability
Patients with LCH must require systemic therapy according to the Histiocyte Society LCH Evaluation and Treatment Guidelines OR patients with HS requiring systemic treatment as defined by disease that cannot be surgically resected and/or encompassed in a single radiation field
+ yrs (US), + yrs (Singapore)
Symptomatic vertebral fragility fractures or fragility fracture of hip, pelvis, wrist, or other location (fragility fracture - any fracture w/out trauma or as a result of a fall from ?standing height)
Moderate (%-% decrease vertebral ht.) or severe (>% decrease vertebral ht.) morphometric vertebral fractures
?-CTX serum level > pg/mL (morning after ?hrs fasting)
Thiazolidinedione peroxisome proliferator-activated receptor gamma agonist (e.g. Actos [pioglitazone] and Avandia [rosiglitazone]) w/in  wks prior to study drug
Hyperparathyroidism, Paget's disease or osteomalacia
Low- or high-grade non-nodular, previously untreated (\treatment nave\) dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ? weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
Operable per institution's standards
Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ? weeks prior to planned treatment under this protocol.
Prior distal esophagectomy
Patients must have histologically confirmed adenocarcinoma of the prostate without previous therapy for PC\r\n* Treatment-naive AND\r\n* Undergoing RP as initial, locally definitive therapy for PC AND\r\n* Eligible for RP in a  month timeframe AND\r\n* Consentable for RP
Subject has prior use of any anti-cancer treatment or product, such as PC-SPES (or any other PC-x product: PC-HOPE, PC-CARE, PC-PLUS, etc)
Patients receiving antithymocyte globulin (ATG) or campath within  days of infusion
Aggressive clinical behavior requiring previous treatment with chemotherapy even if histologic features such as the Ki index or mitotic rate corresponds with low or intermediate grade.
myelodysplasia
Recurrent disease that presents > days after, or minimal residual disease (MRD) that presents >  days after either:
Patients receiving anti-thymocyte globulin (ATG) or Campath within  days of infusion
Asymptomatic or minimally symptomatic disease (no narcotic analgesic; other analgesics use is allowed)
Uncontrolled fecal incontinence
Use of antidepressants such as sertraline within  weeks OR use of paroxetine, fluoxetine, or citalopram within  months prior to registration
Active cases (within the past  months) of depressive disorder, manic episodes, and/or anxiety requiring active treatment with a selective serotonin reuptake inhibitor (SSRI); patients being treated with an SSRI for non-psychiatric indications (such as hot flashes) are allowed and should go through the appropriate washout
Known history of splenomegaly
For subjects with NMIBC, failure or intolerance of prior BCG therapy; failure is defined as evidence of TCC on cystoscopic examination and biopsy or cystoscopic examination and urine cytology at least  weeks from completion of last BCG or intravesical treatment
Part :
The presence of or imminent occurrence of airway obstruction, unless tracheostomy in place.
Patients must have at least one measurable PN, defined as a lesion of at least  cm measured in one dimension; patients who underwent surgery for resection of a PN are eligible provided the PN was incompletely resected and is measurable as per criteria above; measurability and suitability for volumetric MRI analysis of the target PN must be confirmed with the National Cancer Institute (NCI) Pediatric Oncology Branch (POB) prior to enrolling a patient; the target PN will be defined as the clinically most relevant PN, which has to be amenable to volumetric MRI analysis; PN will be classified as typical PN or nodular PN versus \solitary nodular PN\ prior to enrollment
Monocular vision or has media opacities or any other condition that precludes monitoring of the retina or the fundus, or has a history of ophthalmology exam with retina or cornea abnormalities
diagnosis of HGG, DIPG, low grade astrocytoma, medulloblastoma/PNET, ependymoma, neuroblastoma, RMS and tumours with ErbB deregulation
Study participants will be women who have gone through a bi-lateral oophorectomy procedure
Must have anti-measles immunity as demonstrated by serum immunoglobulin (Ig)G anti-measles antibody levels of >= . EU/ml as determined by BioPlex Measles IgG multiplex flow immunoassay
Resistant to all of the following: DOXIL, gemcitabine hydrochloride (GEM), topotecan hydrochloride (TOPA), and weekly paclitaxel (TAXOL); (NOTE: resistance is defined as either ) less than a complete response to any chemotherapy regimen containing the agent in question [consider weekly TAXOL as a separate agent from every-three-week TAXOL], ) serum CA- >=  x ULN within  days of last dose of chemotherapy containing the agent in question, confirmed by a second CA- [the second CA- does not have to be within  days of chemotherapy], or ) CT or PET/CT evidence of cancer recurrence/progression within  days of last dose of chemotherapy containing the agent in question; [for example, if a patient previously received carboplatin and GEM, had a complete response, and had initial evidence of relapse >  days after the last dose of GEM, that patient would not be considered resistant to GEM])
ibritumomab tiuxetan (biologic half-life in NHL = . days [based upon measurement of radioactivity from administered [In]-ibritumomab tiuxetan]; required washout =  days (. weeks)
Subject is undergoing one of the following elective procedures: Cardiac procedure (Epicardium); Cardiac procedure (Aortic Anastomosis or Aortotomy suture line); Liver resection; Total splenectomy; On-clamp partial nephrectomy; or Radical nephrectomy.
Subject in whom the bleeding flux from the identified lesion is > .[g/(cms)] and ?.[g/(cms)].
Subject undergoing a cardiac procedure in which there is no aortic anastomosis or aortotomy suture line to evaluate using the bleeding severity scale (i.e., not for treatment at the distal coronary artery bypass graft anastomosis);
Patients who are immunocompetent
Patients who are not pregnant; committed to using adequate contraception through week  if of childbearing age; condom use will be encouraged
LOW GRADE B-NHL PATIENTS ONLY
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay
Complete documentation of the details of the initial therapy before randomization including cytogenetics and International Staging System (ISS) is available.
Prior use of ibrutinib
Patients with markedly decreased visual acuity
Patients with sinonasal SCCAs
ELIGIBILITY FOR SCREENING: Any patient with diagnosis of either:\r\n* EBV positive Hodgkins lymphoma\r\n* EBV positive non-Hodgkins lymphoma (regardless of histologic subtype)\r\n* EBV (associated)-T/NK-lymphoproliferative disease\r\n* Severe chronic active EBV (CAEBV)** AND\r\n* In first or subsequent relapse (Group A)\r\n* With active disease persisting despite therapy (Group B)\r\n* With active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of chronic lymphocytic leukemia (CLL) (Group C)\r\n** CAEBV is defined as patients with high EBV viral load in plasma or peripheral blood mononuclear cell (PBMC) (>  genomes per ug PBMC deoxyribonucleic acid [DNA]) and/or biopsy tissue positive for EBV
ELIGIBILITY CRITERIA AT TIME OF TREATMENT: Any patient with diagnosis# of either:\r\n* EBV positive Hodgkins lymphoma\r\n* EBV positive non-Hodgkins lymphoma (regardless of histologic subtype)\r\n* EBV (associated)-T/NK-lymphoproliferative disease\r\n* Severe chronic active EBV (CAEBV)** AND#\r\n* In first or subsequent relapse (Group A)\r\n* With active disease persist despite therapy (Group B)\r\n* With active disease if immunosuppressive chemotherapy is contraindicated e.g. patients who develop Hodgkin disease after solid organ transplantation or if the lymphoma is a second malignancy e.g. a Richter's transformation of CLL (Group C)\r\n** CAEBV is defined as patients with high EBV viral load in plasma or PBMC (>  genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV\r\n# The disease diagnosis and the group must be noted on the eligibility checklist
Principal Inclusion criteria:\n\n          -  Aged at least \n\n          -  The presence of a solid malignant tumour that is not considered appropriate for\n             further standard treatment\n\n          -  Module  and  Part B study expansions, and Module : patients must have a tumour at\n             least  cm in size that can be measured using a CT or MRI scan\n\n          -  Module  Part B Study expansion: second line lung adenocarcinoma with ATM deficient\n             tumours.\n\n          -  Module  Part B All - No previous treatment with PARP inhibitor.\n\n          -  Module  Part B Study expansion: advanced gastric adenocarcinoma (including GEJ)\n             patients with ATM deficient tumours\n\n          -  Module  Part B Study expansion: advanced gastric adenocarcinoma (including GEJ)\n             patients with ATM proficient tumours\n\n          -  Module Part B Study expansion: Second or thrid line HER negative breast cancer\n\n          -  Module  Part B Study expansion: Second or third line triple negative breast cancer\n             (TNBC) Module : advanced recurrent or metastatic non-small cell lung cancer, or head\n             and neck squamous cell carcinoma\n\n        Principal exclusion criteria\n\n          -  A diagnosis of ataxia telangiectasia\n\n          -  Prior exposure to an ATR inhibitor\n\n          -  Bad reaction to AZD\n\n          -  Module : Contra-indicated for treatment with carboplatin\n\n          -  Module : Contra-indicated for treatment with olaparib\n\n          -  Module : Contra-indicated for treatment with MEDI
Patients with cataracts on ophthalmologic examination
Have a history of thrombocytopenia with complications
Known uncompensated hypothyroidism (defined as greater than x upper limit of normal not treated with replacement hormone)
Patients with uncontrolled infections for whom myeloablative HCT is considered contraindicated by the consulting infectious disease physician (upper respiratory tract viral infection does not constitute an uncontrolled infection in this context)
Donors who fail eligibility requirements for donation of cells or tissue for donation of a Human Cell and Tissue Products (HCT/P) will be excluded unless use of the cells complies urgent medical need or allogeneic use in a first-degree or second-degree relative
AD worse in risk organs after week  (after Initial Course ), or AD worse or AD intermediate in risk organs after week  (after Initial Course ).
Albumin < g/L or substitution dependency (at least one of the two criteria to be fulfilled)
AD worse in risk organs after week  (after Initial Course ), or AD worse or AD intermediate in risk organs after week  (after Initial Course ) of Stratum I OR
AD worse after the nd and rd -CdA/Ara-C course, and those AD worse or AD intermediate after the th -CdA/Ara-C course of Stratum III AND
LCH-related permanent consequences (e.g. vertebra plana, sclerosing cholangitis, lung fibrosis, etc.) in the absence of active disease
Permanent consequences (e.g. sclerosing cholangitis, lung fibrosis, etc.) without evidence of active LCH in the same organ or in any other locations
Isolated liver sclerosis or pulmonary fibrosis, without active LCH.
Gamma-glutamyl transpeptidase (GGT): - U/L
Patients must have disease limited to the hemithorax
Patients must have measurable contrast-enhancing supratentorial tumor (>= . cc [current resolution of MRSI is . cc]) in a region amenable to MRSI
Patients taking any of the following category I drugs that are generally accepted to have a risk of causing Torsades de Pointes =<  days prior to registration (for cohort a and b [belinostat cohort] only)\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Patients may have had multiple primary melanomas.
Patients must be able to avoid direct contact with pregnant or nursing women, infants and immunocompromised individuals during the days of reolysin treatment and for two days after
Medical contraindications to stopping aspirin, Coumadin or other anticoagulants prior to image-guided tumor biopsies; follow institutional guidelines when determining drugs to avoid and length of washout
International Prognostic Index must be documented:\r\n* ECOG performance status >=  ( point)\r\n* Age >=  ( point)\r\n* >=  extranodal sites ( point)\r\n* Lactate dehydrogenase (LDH) > upper limit of normal ( point)\r\n* Ann Arbor stage III or IV ( point)
Patients who are reported to be of direct Asian-Pacific (China, Japan, Taiwan, Singapore, Republic of Korea, and Thailand) ancestry
Have Q-T intervals greater than  ms unless treated with an Accysync model  synchronization system controlling the NanoKnife systems output pulses
Receive non-conventional fractionation schedules, such as stereotactic radiation ( fractions or less) or received higher than  gray (Gy) delivered conventionally
PHASE I: For the post allo-HCT cohort, chimerism analysis must demonstrate > % either donor or recipient in peripheral blood CD cells, must be done within  month of enrollment (no mixed chimerism are eligible)
RETREATMENT WITH MODIFIED T-CELLS INCLUSION CRITERIA: Subject has tolerated prior dose of modified \r\nT cell infusion without experiencing a dose limiting toxicity OR if patient did have a dose limiting toxicity (DLT), they have fully recovered back to baseline
History of vesicoureteral reflux or an indwelling urinary stent
Previous immunization against CT, MAGE-A, other cancer-testis antigens, or WT
Patients must have had histologic verification of an extracranial germ cell tumor that is not a pure teratoma (mature or immature), pure germinoma, or pure seminoma
INCLUSION - TREATMENT: Available autologous transduced cytotoxic T lymphocytes with ? % expression of GD CAR and killing of GD-positive targets ? % in cytotoxicity assay
Subjects must either have a CA - value > the institutional upper limit of normal (ULN) on two separate checks at least  weeks apart OR have had an R resection margin OR N nodal disease regardless of CA - level
Patients that have been prescribed sipuleucel-T and have not started treatment
V-Ki-ras Kirsten rat sarcoma viral oncogene homolog (KRAS) or neuroblastoma (N) RAS mutant tumors
Patients who have required toxicity related dose reductions of greater than % of the original dose of infusional -FU and/or irinotecan during the administration of FOLFIRI/bevacizumab
History of sarcoidosis
PART I: Naive to trastuzumab (Herceptin), pertuzumab (Perjeta) and lapatinib (Tykerb), ado-trastuzumab emtansine (Kadcyla) or other HER-directed therapies
Leukemia participants aged  to  years with induction failure and favorable cytogenetics (i.e., ETV-RUNX or hyperdiploidy defined as deoxyribonucleic acid [DNA] index >= . or modal chromosome number >= )
COHORT B, GROUP : GALLBLADDER CANCER OR CHOLANGIOCARCINOMA: If the patient has had decompression of the biliary tree within the last  days, stability of the bilirubin level needs to be confirmed with two measurements that are within  to  days of each other; (the second measurement must be obtained within  days prior to registration); both the first and second measurement must be < . x institutional ULN (IULN); stability is defined as the second measurement being no more than one point higher than the first
Metastatic or unresectable measurable cancers that express mesothelin; as in other protocols conducted by Dr. Hassan in the National Cancer Institute (NCI), epithelial mesotheliomas and pancreatic cancers do not need to be assessed for mesothelin expression since all of these tumors have been shown to express mesothelin; other metastatic or unresectable cancers must be shown to expresses mesothelin as assessed by reverse transcriptase-polymerase chain reaction (RT-PCR) or immunohistochemistry on tumor tissue; bi-phasic mesotheliomas must express mesothelin on greater than % of the cells in the epithelial component; diagnosis will be confirmed by the Laboratory of Pathology, NCI
Patients with sarcomatoid mesothelioma as mesothelin is not expressed in this type of mesothelioma
Patients with diabetic retinopathy
An artificial implant that cannot be easily removed (e.g., heart valves, prosthetic hips or knees, or other devices), which could allow a nidus of infection.
Patients with indwelling catheters (other than Portacath, Hickman or PICC lines)
Patients with any of the following cardiovascular conditions: patent foramen ovale, prior history of bacterial endocarditis, any existing thrombus (either arterial or venous) as well as known history of DVT, permanent pacemakers, AICDs, LVADs, or other intravascular cardiac device, known AV malformations.
-FC
-FU
Appropriate contraception in both genders
Creatinine =< . mg/dL is recommended; however, institutional norms are acceptable
Hypokalemia or hypomagnesemia if it cannot be corrected
Evidence of uncontrolled extrathoracic metastases
Must be willing to have an Ommaya reservoir placed and a candidate for an Ommaya reservoir placement
Cannot be on systemic agents (chemotherapy) that have central nervous system (CNS) penetration (temozolomide, carmustine [BCNU], lomustine [CCNU], etoposide, Xeloda, carboplatin, Navelbine, bevacizumab, CPT- and topotecan; note: please check with study principal investigator [PI] [Dr. Raizer] to clarify other agents not listed) unless they develop or have progressive or persistent leptomeningeal metastases while on these agent(s) and have controlled systemic disease\r\n* NOTE: may continue on intravenous (IV) trastuzumab, pertuzumab, TDM-, lapatinib or hormonal agents if controlling systemic disease and developed LM while on therapy \r\n* NOTE: patients requiring systemic agents (such as those listed above) are eligible but will not be able to start treatment until after the first assessment by imaging and cytology
Neurotropism is identified pathologically by the presence of melanoma cells around nerve sheaths (perineural invasion) or within nerves (intraneural invasion).
Occasionally, the tumour itself may form neuroid structures (termed 'neural transformation'; this is also regarded as neurotropism)
\normal\-looking nerves that appear to be \entrapped\ within the tumour should not be regarded as neurotropism
Albinism
Any patient or tumor/anatomical factors that may prevent brachytherapy apparatus from being properly and safely inserted and positioned and from radiation therapy being administered per American Brachytherapy Society (ABS) guidelines
BMBx consistent with HCL, reviewed by Laboratory of Pathology, NCI; BMBx may be negative in HCLv in patients with increasing peripheral blood HCLv cells and spleen size
Symptomatic splenomegaly
Active or recent (prior  month) invasive fungal infection without interdisciplinary (ID) consult and approval
Patients must be treated with a standard accepted chemotherapy regimen for rhabdomyosarcoma (for example, according to Intergroup Rhabdomyosarcoma Study [IRS]-IV, IRS-V, or future IRS study)
Patients with co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease
Performed within  business days of treatment initiation with the exception of beta- HCG ( hours), if applicable: Platelets >= , / uL.
Eribulin dose modification necessary in patients with hepatic insufficiency according to United Surgical Partners International (USPI).
Symptomatic nodal disease (i.e., scrotal, penile, or leg edema)
History of neurological conditions that would confound assessment of treatment-emergent neuropathy
Required used of folate-containing supplements (e.g. folate deficiency)
At time of registration and within  weeks prior to initiating on-protocol treatment: Absolute neutrophil count (ANC) >= . x ^ /L\r\n* May be waived on a case-by-case basis for patient populations recognized to have normal baseline values below this level.
Blood sample submitted for additional testing within  days of TIL harvest per national blood banking standards (e.g., anti-human T-cell lymphotropic [HTLV]-I/II virus, anti-T. cruzi, West Nile virus nucleic acid testing [NAT], anti-cytomegalovirus [CMV], rapid plasma reagin [RPR]), for purposes of proper handling and storage.
BM with increased fibrosis (reticulin stain > /).
Urothelial cancer (UC) in the upper genitourinary tract (kidneys, renal collecting systems, ureters) within  months of enrollment
Pathologically confirmed diagnosis of IDH-mutant acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML)\r\n* IDH mutations will include any IDH R or R alterations\r\n* Eligibility and enrollment will be based on local IDH mutational testing performed at any center. The presence of an IDH mutation at the time of initial diagnosis or any other time thereafter is necessary and sufficient. The presence of an IDH mutation at time of enrollment is not necessary for the purposes of eligibility
Patients who are pregnant or breast-feeding. The anti-proliferative activity of this experimental drug and temozolomide may be harmful to the developing fetus or nursing infant
Subject has  first-degree relative (FDR; defined as parents, offspring or siblings) with TD AND AC value > .% or
Subject has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
>  hospital admission for infection in prior  months
Parkinsons disease
Kyphoplasty or vertebroplasty within  week of enrollment
Subjects must be deemed to be potential surgical candidates by an evaluating surgeon
Patients with significant edema leading to risk of brain herniation
Agree to be evaluated at the transplant center or by local provider every  months for  months after randomization
Known hypersensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Biliary obstruction, biliary stent or prior biliary surgery except cholecystectomy
Significant arteriovenous shunt identified on angiography of the hepatic artery
Expired breath carbon monoxide < 
Positive urine toxicology- screen (methamphetamine, cocaine, opiates, benzodiazepines, tetrahydrocannabinol [THC])
Patients with history of more than one symptomatic oxalate stone
Electrocardiogram (EKG) showing ischemic changes or abnormal rhythm and/or an echocardiogram or MUGA scan showing abnormal wall motion or ejection fraction < %
Outpatients with MPE undergoing IPC placement
Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
Patients who are known to be both V-kit Hardy-Zuckerman  feline sarcoma viral oncogene homolog (KIT) and platelet-derived growth factor receptor alpha (PDGRF?) wild type.
Non-GCB of origin by standard immunohistochemical classification
Baseline serum B-type natriuretic peptide (BNP) above the age-adjusted upper limit of normal
Mitral and/or tricuspid valvopathy or valvular prosthesis; angina; severe arterial hypertension; chronic and/or paroxysmal atrial fibrillation; previous myocardial infarction
Histopathologically confirmed, well-differentiated metastatic NETs
Receiving stable-dose somatostatin analog (long-acting release [LAR], depot) for >  months before enrollment
Somatic alteration in one of the following DDR genes as determined by genomic sequencing performed in a Clinical Laboratory Improvement Amendments (CLIA) laboratory. Somatic alterations will include nonsense, frameshift, splice-site or missense mutations or homozygous deletions. Subjects with alterations in DDR genes not included in the list below will be considered on a case by case basis after discussion with the Principal Investigator(s). Subjects with germline alterations in DDR genes will be considered on a case by case basis and will be reviewed by the principal investigator(s). At least  subjects will have BRCA or ATM alterations.\r\n* Nucleotide excision repair: ERCC, ERCC, ERCC, ERCC, ERCC\r\n* Homologous recombination: BRCA, BRCA, RAD, RAD, RADB, RADC, RAD, RADL, NBN, MREA, RADD, CTIP\r\n* DNA Sensor: ATM, ATR, MDC, ATRX, CHEK, CHEK\r\n* Fanconi anemia pathway: PALB, BRIP, FANCA, FANCB, FANCC, FANCD, FANCE, FANCF, FANCG, BLM\r\n* Base excision repair: XRCC, XRCC, XRCC, XRCC, XRCC\r\n* Other: MUTYH, RECQL, POLQ, POLE, WRN
Symptomatic hypothyroidism without replacement\r\n* Patients may be rescreened after initiating adequate replacement therapy
HTN with need for  or more anti-hypertensives to control it at baseline (because there isnt room to\tadd more antihypertensives if axitinib causes increased blood pressure [BP])
Subjects with arterial thrombotic events in the prior  months (axitinib has never been studied in this population)
Subjects who have had venous thrombotic events in the prior  months (axitinib has never been studied in this population)
Patients with prior pneumonectomy
Other acute leukemias: leukemias of ambiguous lineage or of other types e.g. blastic plasmacytoid dendritic cell neoplasm with less than % blasts. Persistent/relapsed disease with cytogenetic, flow cytometric or molecular aberrations in >= % of cells are eligible.
Histologically confirmed myelodysplastic syndrome with positive TET mutations (we will test all MDS patients for TET mutations using next generation sequencing and only patients with TET mutations will be included in our study)
Uncontrolled hyponatremia, syndrome of inappropriate antidiuretic hormone secretion (SIADH), hypokalemia, hyperkalemia, hypomagnesemia or hypermagnesemia
Participants may not concomitantly use statins while on study; however, a patient using statins for over  months prior to study drug administration and in stable status without CK rise may be permitted to enroll
Prior ipsilateral thoracotomy (the likely presence of adhesions will limit ability to perform a precise block guided by thoracoscopy). Note: previous VATS or robotic surgery is permissible.
Off all mycosis fungoides (MF)-directed therapy at the time of enrollment, with the exception of ruxolitinib
COHORT I ONLY: Patients that are on ruxolitinib may enroll in study as long as they are willing to remain on ruxolitinib during the study and have not lost response to ruxolitinib defined as an increase in >  cm in spleen size from nadir. There is no minimum or maximum time requirement for time on ruxolitinib
COHORT I ONLY: Participants must have splenomegaly (defined by ultrasound or computed tomography [CT] scan of the abdomen) or symptoms (demonstrated by the presence of  symptom score >  or  symptom scores > ) related to myelofibrosis as measured by the myeloproliferative neoplasm symptom assessment form MPN-SAF and platelets > /uL and hemoglobin > /dL
COHORT II ONLY: Participants are ineligible for ruxolitinib  do not have splenomegaly or symptoms of myelofibrosis as defined by the MPN-SAF. Or participants failed ruxolitinib as defined by loss of response to therapy and no allergy to ruxolitinib in the past
Ongoing Grade > proliferative or nonproliferative retinopathy.
A response of at least  on a  point scale (with  = not tired at all and  = extremely tired) to the question how tired did you feel in the past week?
Obstructive renal failure that is not relieved with stents or nephrostomy tube/s
Uncontrolled hematuria
Patients with inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., ataxia-telangiectasia, Nijmegen breakage syndrome)
Active or recent thrombolic events
Asymptomatic or minimally symptomatic disease.
Arrhythmias requiring class Ia and III antiarrhythmics and/or grade >=  bradycardia
Prior elotuzumab
Invasive malignancy that require active systemic chemotherapy or biologics that may cause significant drug-drug interaction with either vemurafenib or obinutuzumab
Subjects must be deemed unfit for RC due to comorbid conditions with a risk of mortality.
Presence of any bladder or urethral anatomic feature that in the opinion of the Investigator may prevent the safe placement, indwelling use, or removal of TAR-.
Pyeloureteral tube externalized to the skin (ureteral stent or unilateral nephrostomy tube is allowed).
Has a diagnosis of von Hippel Lindau disease, based on a germline VHL alteration
Patients must have a confirmed heterozygous TET mutations identified by next generation targeted deep sequencing
Have locally confirmed MSS or pMMR CRC; MSS is defined as - allelic shifts among - tumor microsatellite loci using a PCR-based assay; pMMR is defined as presence of protein expression of  MMR enzymes (MLH, MSH, MSH and PMS) by immunohistochemistry
Hx or condition related to thrombosis, embolism or vascular occlusion/ischemia, including but not limited to: TIA, stroke, MI, stent placement, valve replacement and/or repair
History of any inherited coagulation or platelet function, disorder or ITP, TTP, or HUS
Subjects may receive radiotherapy for symptomatic metastases prior to enrollment provided that there is at least one other non-irradiated lesion amenable to LCT at the time of enrollment. When feasible, stereotactic body radiation therapy (SBRT) or other hypofractionated techniques are strongly encouraged.
Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components ( less than [<]  percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Research participants with new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications must have a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre -study and as clinically indicated
If the research participants has new symptoms of CHF, cardiomyopathy, myocarditis, MI, or exposure to cardiotoxic medications they already had a cardiac consultation, creatinine phosphokinase (CPK), and troponin testing at pre study deeming them fit for study participation
Less than  months from the completion of last trastuzumab infusion
Prior olaratumab therapy must have been received with doxorubicin as indicated on the olaratumab label.
Prior olaratumab therapy must have included at least  full cycles of olaratumab/doxorubicin (that is, a minimum of  doses of olaratumab).
Participants, who completed at least  cycles of combination olaratumab/doxorubicin therapy then discontinued doxorubicin due to toxicity or maximum dosing and proceeded to olaratumab monotherapy, are eligible.
Subjects receiving systemic steroids, nitrogen mustard, psoralen UVA radiation therapy (PUVA), narrow band UVB light therapy (NB-UVB) or carmustine (BCNU) or other systemic therapies for CTCL within  weeks of enrollment.
Monocularity
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled or evolving retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder
Willingness and ability of patients to report selected study outcomes (e.g., GHS and HRQoL) using an electronic device or paper backup questionnaires.
M NED RCC participants who present not only with the primary kidney tumor but also solid, isolated, soft tissue metastases that can be completely resected at one of the following: the time of nephrectomy (synchronous) or, ? year from nephrectomy (metachronous).
Combo C :Existing periorbital edema.
Ascites requiring non-pharmacologic intervention or escalation in pharmacologic intervention to maintain symptom control, within  months prior to the first scheduled dose
Drugs with known renal toxicity (e.g. vancomycin, amphotericin B, acyclovir, cyclosporin, methotrexate, tacrolimus) should be avoided to the extent possible during the  days of clofarabine treatment in each cycle or, if required, administered cautiously and with close monitoring
Biomarker-positive for deoxyribonucleic acid (DNA)-repair anomalies
Women  years of age or older, who are either: Postmenopausal or Pre/perimenopausal women with medically-induced menopause by treatment with agents to induce chemical menopause.
Locally-advanced or metastatic malignancy with an NTRK, NTRK or NTRK gene fusion, identified through molecular assays as routinely performed at CLIA or other similarly-certified laboratories.
Biopsy-proven HSIL (anal intraepithelial neoplasia  [AIN] with a positive p stain, AIN -, or AIN) of the anal canal at either the squamocolumnar junction or distal anus, documented within  days prior to enrollment, but not less than  days prior to randomization
HSIL comprising  or more lesions, or anal HSIL in at least  octants, or anal HSIL that has recurred or is persistent after prior ablative treatment\r\nNote: HSIL should be in the anal canal at either the squamocolumnar junction or distal anus on HRA at screening or randomization; the extent of HSIL should be based on available biopsy results and visual appearance
Prior intra-anal use of topical -fluorouracil % or imiquimod .%, .% or % for treatment of HSIL at any point, use of intra-anal or topical -fluorouracil % or imiquimod .%, .% or % for treatment of condyloma within  months prior to randomization or perianal imiquimod .%, .% or % or topical -fluorouracil % within  months prior to randomization
Condyloma occupying more than % of the circumference of the anal canal or that obscures a satisfactory exam
Treatment for anal or perianal HSIL, low-grade squamous intraepithelial lesion (LSIL) or condyloma within  months of randomization; please note that infrared coagulation (IRC) or electrocautery of a biopsy site to stop bleeding does not constitute treatment
Childs Pugh A (- points)
Severe cardiopulmonary disease precluding the use of the minimally invasive technique as deemed by Internal Medicine Preoperative Assessment, Consultant and Treatment (IMPACT)
Phosphorus WNL
Histological confirmation of adrenocortical carcinoma (ACC) based on either: i). Weiss Score of >=  in patients who had earlier surgical resection OR ii). biopsy results compatible with ACC in the context of clinical setting highly suggestive of ACC (adrenal mass >  cm invading surrounding organs or associated with distant metastases).
For mitotane treated patients, mitotane should have been stopped at least  days prior to study enrollment AND to have mitotane serum level of <  mg/L.
Prior radium Ra  dichloride
Metastases that in the judgment of investigator-radiologist are not amenable to SBRT
Presence of metastatic disease that can be biopsied by any methodology applicable
Have used or plan to use from  days prior to enrollment (day  visit) through the end of the study the following medications known to lower the seizure threshold: \r\n* Aminophylline/theophylline\r\n* Atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone)\r\n* Bupropion\r\n* Insulin\r\n* Lithium\r\n* Pethidine\r\n* Phenothiazine antipsychotics (e.g., prochlorperazine [compazine], chlorpromazine, mesoridazine, thioridazine)\r\n* Tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
Able to complete the quality of recovery (QoR)  questionnaire.
Brain natriuretic peptide (BNP) =< ULN
Subjects who have hypersensitivity to decitabine, CDX-, poly-ICLC or nivolumab
p and q deletion status known
IDH  &  mutations status known
MGMT status known
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Confirmed diagnosis of primary cold agglutinin disease (CAgD) based on the following criteria: a) Chronic hemolysis, b) Polyspecific direct antiglobulin test (DAT) positive, c) Monospecific DAT strongly positive for Cd, d) Cold agglutinin titer >=  at  degree Celsius, and e) Immunoglobulin G (IgG) DAT less than or equal to (<=) +, and, f) No overt malignant disease
Negative inked histologic margins from lumpectomy, with the exception of a focus of positive margin at the pectoralis fascia
Significant post lumpectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation or nodal evaluation is acceptable
Gamma-glutamyltransferase =< . x ULN
Concomitant use of high dose systemic steroids and other drugs such as calcitonin preparations, active vitamin D preparations, estrogen preparations, selective estrogen receptor modulators, vitamin K preparations, parathyroid hormones, phosphorus absorbers; Note, inhaled, topical steroids and low tapering doses of steroid especially in patients treated recently for brain metastases will be included
Partial thromboplastin time (PTT) WNL+/-  % unless on active anticoagulation (suggested to be drawn peripherally to prevent port drawn elevation due to routine heparin flush of ports) obtained ?  days prior to randomization
Consent to receive FMT administered endoscopically (colonoscopically) and undergo necessary bowel preparation pre-procedure\r\n* Understand infectious risks associated with FMT administration; although FMT infusate has been screened for bacteria, viruses, fungi and parasites there is a risk of transmission of known and unknown infectious organisms contained in the donor stool; post-FMT bacteremia (e.g. E. coli), sepsis and fatal events may rarely occur\r\n* Understand non-infectious risks associated with FMT administration\r\n** Possible allergy and/or anaphylaxis to antigens in donor stool\r\n** Theoretical risk of developing disease possibly related to donor gut microbiota including but not limited to: obesity, metabolic syndrome, cardiovascular disease, autoimmune conditions, allergic/atopic disorders, neurologic disorders, psychiatric conditions and malignancy\r\n* Understand risks associated with colonoscopy including risk of infection transmission, colonic perforation, aspiration pneumonia, and death\r\n* Understand that data regarding the long-term safety risk of FMT are lacking
Presence of absolute contra-indications to FMT administration\r\n* Toxic megacolon\r\n* Severe dietary allergies (e.g. shellfish, nuts, seafood)\r\n* Inflammatory bowel disease\r\n* Anatomic contra-indications to colonoscopy
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to <= mm.
AdV DNA plasma viremia of ? , copies/mL and rising, defined as two consecutive results ? , copies/mL from the designated central virology laboratory, with the second result being greater than the first.
>  hospital admission for infection in prior  months
Completion of the OPN-- study
Plan to be included into another interventional investigational study.
Lack of available therapist/clinic,
Acute facial infection (e.g., facial or parotid gland abscess).
Any condition in which increased venous and lymphatic return is undesirable.
Distant metastatic disease of peritoneum: \r\n* Positive peritoneal cytology.\r\n* Carcinomatosis on diagnostic laparoscopy or laparotomy.
Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity.
Gamma-glutamyl transpeptidase (GGT) must be =< . x institutional upper limit of normal (grade  or less per CTCAE )
The hepatic requirements may be waived for patients with grade  or  elevations of hepatic transaminases clearly due to leukemic infiltration after consultation with a study co-chair
BUN > in conjunction with a creatinine >.
Patients who require anticoagulation or systemic steroids at doses > mg daily of prednisone or equivalent or any immunosuppressive drugs. Beta-blocker therapy, while not exclusionary, is discouraged and alternatives should be sought if possible. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis.
Patients must have the HA-(H) genotype (RS_: A/G, A/A)
A specific performance status score is not required for enrolling on the protocol; a delay in infusion of the HA- TCR T cells may be required for patients with low performance status
The presence of organ toxicities will not necessarily exclude patients from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA- TCR T cells may be required
Unrelated donor residing outside of the United States of America (USA)
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons
Patient has history of or currently has non-peritoneal surface macroscopic metastatic disease in addition to peritoneal surface malignancy such as macroscopic pulmonary disease or other macroscopic disease outside of the peritoneal cavity
Patients must have undergone stem cell mobilization with the combination of G-CSF and plerixafor as per TJUH BMT SOP guidelines
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV
Any surgical intervention for benign prostatic hypertrophy;
Subjects in custody and or residing in a nursing home or rehabilitation facility;
Condition requiring medication with potential photosensitizing effects (tetracyclines, quinolones, sulphonamides, phenothiazines, sulfonylurea hypoglycaemic agents, thiazide diuretics, griseofulvin, and amiodarone) if these treatments could not be stopped at least  days before and for  days after the VTP procedure or replaced by treatments without photosensitizing properties;
Diagnosis of BOS by one of the following criteria\r\n* Transbronchial or surgical lung biopsy demonstrating the obliterative bronchiolitis lesion\r\n* Volumetric computed tomography (CT) scan with lung density analysis with ? % air trapping\r\n* National Institutes of Health (NIH)-based PFT criteria for the diagnosis of BOS: FEV/FVC < . and FEV < % \r\n* Evidence of clinical improvement after treatment for BOS initiated
There are no gender or race-ethnicity-based restrictions
The following medications may significantly increase the level of pirfenidone and should not be taken concurrently including: fluvoxamine, ciprofloxacin >  mg twice daily, systemically administered aminolevulinic acid, vemurafenib and enoxacin, any other strong inhibitors of P isozymes CYPA, CYPC, C, D, and E should be avoided
Vaginal stenosis which would not allow vaginal probe to be placed (based on physician exam)
Patients must agree to be randomly assigned to either intervention or control group
Significant mental or emotional problems that would interfere with study participation (as assessed by the National Comprehensive Cancer Network [NCCN] Distress Thermometer); any value higher than  will trigger further intervention, but ultimately enrollment into the clinical trial will be determined by the enrolling physician
Men with >  bony metastases
Fecal incontinence
Metastatic melanoma or epithelial cancer with at least one lesion that is resectable or in selected cases, available peripheral blood mononuclear cells (PBMCs)
Patients must have undergone puberty at the time of study entry to allow pre-transplant fertility preservation to occur, if desired; puberty will be defined as Tanner III or more in male patients (typically age >=  years) and menarche in female patients
In patients who have received chronic transfusion therapy for >=  year and who have clinical evidence of iron overload by serum ferritin or magnetic resonance imaging (MRI), evaluation by liver biopsy is required; histological examination of the liver must document the absence of cirrhosis, bridging fibrosis and active hepatitis; the absence of bridging fibrosis will be determined using the histological grading and staging scale as described by Ishak and colleagues
Tumors with known IDH (isocitrate dehydrogenase ) or known IDH mutations as determined by immunohistochemistry for the IDH RH variant or by direct sequencing
Active tuberculosis or bacille Calmette-Guerin (BCG) infection
Urinary N-telopeptide level above  nM bone collagen equivalent (BCE)/mM creatinine measured at ARUP
Any atrophic macular condition including intermediate or advanced age-related macular degeneration
Active gout or inflammatory arthritis requiring treatment
Use within  days of registration of calcitonin, recombinant parathyroid hormone-related peptides, mithramycin, radium, strontium ranelate, or gallium nitrate
Patients may not plan to receive any other approved or investigational agents to treat their glioblastoma besides temozolomide prior to the evaluation visit  weeks after the initiation of radiotherapy and temozolomide; Note: Exceptions may be made for non-therapeutic intervention at the discretion of the principal investigator; the recently Food and Drug Administration (FDA) approved NovoTTF electric field therapy begins after the study period and is therefore permitted
Prior use of clofarabine or fludarabine
Subjects must be followed at the Cleveland clinic for AS
Subjects not followed by the Cleveland clinic.
SSA therapy is recommended by physician for disease management, and has not yet begun
Myopathy > grade  or any clinical situation that causes significant and persistent elevation of CPK (>. x ULN in two different determinations performed one week apart);
Patients must agree to consent to the companion genomic profiling study MSK IRB -
Willingness to travel to the CTSC at WCMC weekly
History of gout
History of nephrolithiasis or nephrolithiasis including that incidentally discovered during computed tomography (CT) screening
Vegetarian or vegan eating habits
History of muscle cramps or restless legs
Gum chewing habit
Have received prior treatment with olaratumab, doxorubicin, or ifosfamide, or have participated in other trials investigating olaratumab.
Have known urinary outflow obstruction, or inflammation of the urinary bladder (cystitis).
Patients receiving medications known to lower the seizure threshold are ineligible unless discontinued or substituted at least  weeks prior to study entry. These include: ) aminophylline/theophylline; ) atypical antipsychotics (e.g., clozapine, olanzapine, risperidone, ziprasidone); ) bupropion; ) lithium; ) pethidine; ) phenothiazine antipsychotics (e.g., prochlorperazine (compazine), chlorpromazine, mesoridazine, thioridazine); ) tricyclic and tetracyclic antidepressants (e.g., amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine).
Estrogens, progestational agents such as megestrol, medroxyprogesterone, diethylstilbestrol (DES), cyproterone, spironolactone >  mg/kg, etc. unless discontinued at least two weeks prior to randomization.
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception for at least  months after the last dose of the study drug
Patients of any gender, race or ethnicity
Have a CAR T cell product likely to meet release criteria based on available in-process testing, as reviewed and acknowledged by the individual(s) listed on the protocols delegation of authority log who are authorized to make this determination
A pathologically confirmed (histology or cytology) malignant neoplasm with at least one target lesion that is confirmed by conventional imaging and is determined to express somatostatin receptors by Ga-DOTATOC (TATE) PET within  months prior to treatment with Y-DOTATOC
Completion of Norfolk Quality of Life Questionnaire
Prior PRRT with Y-DOTATOC (TATE) or Lu-DOTATOC (TATE) or I-MIBG therapy for this malignancy
Any subject for whom, in the opinion of their physician, a -hour discontinuation of somatostatin analogue therapy represents a health risk; also subjects who have received sandostatin long-acting release (LAR) in the past  days or long-acting lanreotide within the past  weeks are excluded; subjects may be maintained on short acting octreotide during the time from last injection of long-acting somatostatin analogue until  hours (hrs) prior to injection of study drug; known antibodies to octreotide, lanreotide, or DOTATOC or history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-DOTATOC
Alpha , galactose IgE (alpha gal) < . IU/ml or negative within  days prior to on study status
Comorbidities.
Has prothrombin time (PT) or aPTT >. upper limit of normal (ULN) or active uncontrolled coagulopathy or bleeding disorder. Participants therapeutically anticoagulated with warfarin, direct thrombin inhibitors, direct factor Xa inhibitors, or heparin are excluded from enrollment.
>=  osseous and/or extra-osseous lesion that can be radiated
Solitary plasmacytoma
Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN)
Confirmed diagnosis of sickle cell disease by hemoglobin electrophoresis or high-performance liquid chromatography (HPLC) [performed locally]. All sickle cell disease genotypes are eligible.
Has received prior immunotherapy including antiPD-, antiPD-L, or antiPD-L agents, or if the subject has previously participated in Merck pembrolizumab clinical trials
Prior treatment: Previously untreated or has received a maximum of one cycle of any combination chemotherapy (e.g. cyclophosphamide/hydroxydaunorubicin/oncovin/prednisone [CHOP], cyclophosphamide/hydroxydaunorubicin/oncovin/etoposide/prednisone, [CHOEP], dose-adjusted etoposide/vincristine/doxorubicin/cyclophosphamide/prednisone [DA-EPOCH], cyclophosphamide/oncovin/doxorubicin/methotrexate-ifosfamide/VePesid/AraC [CODOX-M/IVAC], hyper cyclophosphamide/dexamethasone/doxorubicin/vincristine [CVAD]) within  weeks of study entry; additionally, a patient may have taken antiretroviral therapy (e.g. zidovudine [AZT] and/or interferon [IFN]) at any time prior to study enrollment
History of keratitis;
Patients between ages  and 
Patients with evidence of significant arterial insufficiency or microangiopathy in any organ due to any reason, which could lead to distal extremity hypoxia, as evidenced by any gangrenous change in distal limbs or requiring resection for this reason.
Patients with extrahepatic metastases
Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta, or T by more than  years) and diagnostic evaluation at screening shows no evidence of tumor causing the hydronephrosis
Subjects must have histologically or cytologically confirmed EBV-positive LPD or an EBV-positive NHL confirmed by the Laboratory of Pathology, National Cancer Institute (NCI)\r\n* Cohort : EBV-positive B-cell LPD; subjects may be previously untreated or relapsed from prior therapy\r\n** Lymphomatoid granulomatosis (LYG), grades I-II\r\n** Chronic active EBV disease (CAEBV)\r\n** EBV-positive post-transplantation lymphoproliferative disorder (PTLD); NOTE: PTLD after solid organ transplantation is excluded; patients who, at the discretion of the investigator, need urgent therapy with standard agents will not be eligible\r\n* Cohort : EBV-positive B-cell NHL subjects must have relapsed from previous treatment with an anthracycline and rituximab-based regimen or be considered not eligible for the same\r\n** Lymphomatoid granulomatosis (LYG), grade III\r\n** EBV-positive immunodeficiency-associated diffuse large B-cell lymphoma (DLBCL)\r\n** EBV-positive DLBCL
Females of Childbearing Potential (FCBP) and male subjects who have reached puberty (and when applicable, with parental/legal representative) must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction.
Treatment with Somatostatin analogs injections (octreotide or lanreotide) for at least  months with a stable dose for at least the last three months of therapy
Biochemically controlled
Symptomatic cholelithiasis
Metastatic lesions targeted for treatment must be located in the thoracic and/or lumbar vertebral body(ies), periacetabulum, iliac crest, and/or sacrum OR benign bone tumors (Europe and Canada only) - no restrictions on location of lesion
Use of OsteoCool in vertebral body levels C-C
Fractures due to prostatic cancer or other osteoblastic metastases to the spine
If group  is not filled, patients may proceed onto treatment without the completion of tests for DNA repair status; once group  is filled, patients cannot be enrolled onto the study or start treatment until DNA damage repair status is successfully determined for study group placement\r\n* Patients will be replaced if:\r\n** They have tissues that are not evaluable for mutations or the expression signatures\r\n** They do not have mutations associated with DNA repair and their expression signature is not evaluable
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than  month
Have either:
Known mutation in KRAS at position G, G, or Q
Ability to discriminate intensity of thermal stimuli using QST.
Had prior lumbar spine surgical procedures that could impair the ability to perform the injection.
Presence of an IT shunt.
Patients, who require urgent initiation of chemotherapy (other than debulking agent such as hydroxyurea or cyclophosphamide) due to leukemia-related emergencies such as leukostasis, or disseminated intravascular coagulopathy; patients will not be excluded solely based on prior use of debulking agent; prior or current use of leukapheresis will be allowed
Systolic >= 
Prior WBRT
MMSE < 
Participants with local conditions or systemic illnesses that would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc
Measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v). that will not undergo SRT and that is amenable to monitoring\r\n* Note: All brain metastases will receive SRT; therefore, a patient with brain metastases that will be treated with SRT must also have extracranial disease that will not undergo SRT and that is amenable to monitoring
PHARMACODYNAMIC EXPANSION COHORT: Consent to allow mandatory paired (pre- and on- treatment) fresh tissue biopsies if deemed safe to do so for quantitation of Akt pathway signaling proteins
Subjects must give informed consent according to the rules and regulations of the individual participating sites.
Must have had a diagnostic mammogram performed within the last  months
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Patients must have adequate TIL available as per Moffitt Cell Therapies current standard operating procedures (SOP)
Agrees to the placement of an intraperitoneal port before the start of chemotherapy and remains in place through day  or longer
Disease outside of the peritoneal cavity
Active smoker
Overweight or obese
Priority for members of a minority group
Participants with a history of variceal bleed within  months prior to enrollment
Any other ongoing serious medical problem unrelated to cancer or its treatment that is not covered by the detailed exclusion criteria and which is expected to interfere with the anti-tumor effect of infused EA-NK cells or the action of hu.-IL or to significantly increase the severity of the toxicities experienced from this immunotherapy regimen
Currently on therapy for active chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); prophylactic therapy is allowed
Patients with grade >=  neuropathy will be evaluated on a case-by-case basis
PHEO/PGL that is associated with the SDHx mutations or is not associated with any known susceptibility genetic mutations for PHEO/PGL (a.k.a. apparent sporadic), based on documented genetic testing results obtained prior to study enrollment; PHEO/PGL that is associated with non-SDHx mutations such as VHL, NF, and RET will not be eligible for this study
History of hypersensitivity to alectinib or any of its excipients; in addition, subjects who are unable to tolerate the  mg twice daily BID dose of alectinib will not be permitted to enroll unless doses of alectinib below the entry level are being investigated (e.g. dose level - and -) and they have previously tolerated alectinib monotherapy at the dose being investigated
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception
Consented for genome sequencing and dbGAP-based data sharing
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds  mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Have been treated on any Merck-sponsored pembrolizumab-containing gastric cancer pivotal trial will require prior authorization by Merck in order to enroll in this study
Platelets > ,/L. Patients with ? , platelet count may be allowed into the study on a case-by-case basis after consultation with the Medical Monitor.
alemtuzumab within  months of enrollment
fludarabine, cladribine, or clofarabine within  months of enrollment
Urine protein (dipstick): negative or trace; in case of trace, a urinalysis has to be performed in the local laboratory and have to confirm that such abnormality is not to be considered clinically significant, according to the investigator's judgement
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), or herpes zoster (VZV) at screening
History of major implant(s) or device(s), including but not limited to:\r\n* Prosthetic heart valve(s).\r\n* Artificial joints and prosthetics placed =<  months prior to treatment initiation.\r\n* Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed.
Uncontrolled hyper- or hypothyroidism
Patients with known contraindications to radiotherapy including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., ataxia telangiectasia, Nijmegen breakage syndrome)
Recognized immunodeficiency condition including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have acquired, hereditary, or congenital immunodeficiencies, including HIV infection or have been splenectomized.
Patients with fistula documented radiographically or by EDG/EUS, endobronchial ultrasound (EBUS)
No prior exposure to colony stimulating factor  receptor (CSFR) antagonists such as but not limited to emactuzumab (RG) (Roche), PLX (Plexicon), JNJ (Johnson & Johnson), including both anti-CSFR and small molecule inhibitors and prostaglandin E receptor  (EP) antagonists
Active hydronephrosis
Consent to a saliva sample collection for a germline comparator, unless prohibited by local regulations or ethics committee (EC) decision.
Patients must have histologically or cytologically confirmed metastatic/recurrent adenoid cystic carcinoma (ACC) or non-adenoid cystic carcinomas (non-ACC) of major or minor salivary glands
Platelets (plts) >  x ^/L
FOR ALL PHASES (Ib AND II):
Histologically proven adrenocortical carcinoma (ACC) with the majority of disease confined to the peritoneal cavity and resectable or amenable to radiofrequency ablation; or disease that in the opinion of the investigators can be managed medically or surgically and does not present an immediate threat to the patients life
Patients who have had a stent placed for biliary obstruction can be included in the study provided serum bilirubin at time of enrollment is within protocol limits
History of syncopal or vasovagal episode as determined by medical record and history in the  month period prior to first vaccination administration
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds  mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
MVT- and MVT- administered as part of a different protocol
Tumour sites amenable to repeated biopsies.
Must be functionally and technically fit for partial laryngectomy. Subsite study candidates will be evaluated by enrolling physician. The assessment checklist will be submitted at time of enrollment and evaluated by Dr. Gross or Dr. Phan.
Patients requiring treatment with one or more medications known to interact adversely with digoxin, namely thiazide and/or loop diuretics, quinidine, ritonavir, amiodarone, cyclosporine, itraconazole, propafenone, spironolactone, verapamil
Patients with a diagnosis of NF and GIST who do not meet other eligibility criteria may enroll on the NF natural history study, and will be followed on this study; should they require therapy for GIST based on evidence of progression, they may then enroll on study
Patients who anticipate the need for surgical intervention within the first three cycles ( months), as surgical intervention during the period of dose limiting toxicity (DLT) evaluation may affect analysis of adherence and/or make the subject inevaluable
Must be able to complete an acceptable cardiopulmonary exercise test (CPET) at baseline defined as at least one of the following:\r\n* Achieving a plateau in oxygen consumption concurrent with an increase in power output;\r\n* Respiratory exchange ratio >= . (RER);\r\n* Volitional exhaustion with a rating of perceived exertion >=  (RPE)
History of neurological conditions that would confound assessment of treatment-emergent neuropathy
Required used of folate-containing supplements (e.g. folate deficiency)
History of VOD
Successful collection of T cells for huJCAR manufacturing
Colorectal, hepatocellular, gallbladder, cholangiocarcinoma, neuroendocrine, melanomas, hematological and central nervous system (CNS) malignancies;
Patients with known sensitivities to either cyclophosphamide and/or sirolimus
Frequent vomiting.
Current (within  week of Screening) or regular use of any medication (including over-the-counter (OTC), herbal or homeopathic preparations) that could improve or worsen the cancer being studied, or could affect the action or disposition of IT-, or its clinical or laboratory assessment; e.g. Coumadin therapy, due to high competitive protein binding. Subjects taking ANY supplemental IRON, i.e., therapeutic or as part of a multivitamin regimen, are excluded from this study, whether prescribed or self-medicated.
Evidence or history of veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS)
Deferral of donors that:\r\n* Have traveled to active Zika virus zones \r\n* Are at potential risk of transmissible spongiform encephalopathy (TSE), including CreutzfeldtJakob disease (CJD), based on family and travel history
Must have had a nephrectomy (radical or partial) and must provide the cell block from the nephrectomy
Subradiographic and/or cytopathologic evidence of peritoneal carcinomatosis found at staging laparoscopy\r\n* Documentation of cytopathologic diagnosis of malignant peritoneal cytology in the absence of disseminated peritoneal disease must be obtained; if cytologic analysis reveals atypical cells of undetermined significance, a repeat lavage with cytopathologic analysis will be performed and must demonstrate evidence of malignancy\r\n* Limited peritoneal involvement (=< P or peritoneal cancer index [PCI] < ) found at staging laparoscopy or on final pathology that is deemed completely resectable is permitted
Physiologically able to undergo HIPEC and gastrectomy
Previous exploratory laparotomy or laparoscopy with tissue biopsy or peritoneal lavage is permitted (prior surgical score, PSS, of  or )
Disseminated extra-peritoneal or solid organ metastases\r\n* Includes carcinomatosis associated with clinically or radiographically evident ascites (greater than  cc)\r\n* Excludes greater omentum and ovarian metastases
The primary lesion must be accessible for endoscopic biopsy and injection as evaluated by a gastroenterologist at New York-Presbyterian (NYP)-Columbia; further, the patient must be deemed able to tolerate repeated endoscopy procedures by an anesthesiologist and/or gastroenterologist at NYP-Columbia
Nursing patients are not allowed on the study and women must commit to no lactation during the course of the study
Participant with a history of cirrhosis or other indication of significant possible hepatic dysfunction. Note: Those with non-alcoholic steatohepatitis (NASH) should be discussed with the AbbVie TA MD before enrollment.
For male subjects, the digital rectal examination must not be suspicious for carcinoma of the prostate.
Able to retain bladder instillations for up to  minutes (  minutes).
History of vesicoureteral reflux.
An indwelling ureteral stent.
Acute leukemias of ambiguous lineage
Patients known to be colonized with multi-drug resistant organisms or with history of infection with multi-drug resistant organisms; patients with history of infection with extended-spectrum beta-lactamase producing organism
Febrile patients
In the opinion of the investigator, EUS directed implantation posing undue subject risk e.g. previous EUS-FNA was considered technically too difficult to perform, or imaging demonstrates multiple collateral vessels surrounding or adjacent to the target tumor
Evidence of radiographic invasion into stomach, duodenum or peritoneum (if not certain confirmation must be obtained prior to enrolment)
All primary cutaneous T-cell lymphomas
All patients must have radiographically assessable disease
Patients must have a serum creatinine less than or equal to . mg/dL and total bilirubin less than or equal to . mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of a biliary stent or percutaneous transhepatic drainage is acceptable; once biliary drainage has been established, institution of protocol therapy may proceed when the total bilirubin falls to . mg/dL or lower)
Patients must have elevated calcitonin levels greater than  pg/mL
Agrees to take measures to avoid becoming pregnant during the study and
Patients who require anticoagulation, systemic steroids, statin therapy or beta-blocker therapy. The beta-blocker might compromise use of epinephrine for the rare possibility of anaphylaxis. Hypertension controlled by other agents does not disqualify, provided other criteria are met.
Only for subjects enrolled in Arm  - Neratinib and trametinib: all skin rash (dermatitis acneiform, erythema, xeroderma, eczema) should be at grade  when starting trametinib treatment.
Only for subjects enrolled in Arm  - Neratinib and trametinib: history of retinal disorder, dry eye syndrome, or blurry vision need to be evaluated by ophthalmology prior to starting treatment.
TP mutant relapsed/refractory AML following + (or similar cytarabine containing induction chemotherapy for AML) disease detected by one of the following methods:\r\n* Bone marrow blasts > %, or\r\n* Hematologics flow cytometry assay (threshold > .%) (alternative equivalent assay may be substituted), or\r\n* Persistent cytogenetic abnormality (e.g. del, delp, etc) by fluorescence in situ hybridization (FISH) or conventional karyotyping, or\r\n* Persistent TP mutation (at least  variant reads with at least x coverage)
The presence of a TP mutation should be determined by Genoptix (or institutional preferred equivalent assay) for all patients; detection of a TP mutation at the time of initial diagnosis is sufficient for enrollment; detection of a TP mutation in either the peripheral blood or bone marrow is adequate for enrollment
Signed consent to long-term follow-up protocol PA-.
Willingness to sign medical records release form and tissue release form
Acute leukemias of ambiguous lineage
Patients receiving anti-retroviral therapy or other agents that are contra-indicated with nelfinavir due to drug-drug interactions
Subjects for whom, in the opinion of their physician, a -hour discontinuation of somatostatin analogue therapy represents a health risk
Patients with a diagnosis of agammaglobulinemia, that is:\r\n* Undetectable anti-tetanus toxoid immunoglobulin G (IgG)\r\n* Known history of agammaglobulinemia
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Poor health literacy
Did not discontinue because of tolerability concerns.
Hospitalized for sickle cell crisis or other vaso-occlusive event within  days of signing the ICF (i.e., a vaso-occlusive event cannot be within  days prior to signing the ICF)
Patients who occasionally or regularly use medications that impact dopamine receptor signaling and can cause side effects in people with neuroendocrine tumors including PC-PG such as metoclopromide, chloropromazine, prochlorperazine, droperidol, ephedrine, pseudoephedrine, fenfluramine, methylphenidate, phentermine, amitryptaline, imipramine, tranciproamine, moclobemide, phenelzine, paroexetine, and fluoxetine
All patients must have no more than  contiguous vertebral body levels treated at a single site, and no more than  discontiguous vertebral body levels treated
All patients must have received prior conventional external-beam radiation therapy (cEBRT) to the site of interest to no more than a critical neural tissue dose equivalent dose (EQD)/ of  Gy in a single session or  Gy cumulative over multiple sessions and cauda equina dose EQD/ of  Gy in a single session or  Gy cumulative over multiple session
No prior use of ketoconazole for greater than  days
As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles)
Patients must have stable cardiovascular, neurovascular and neurological status, and be considered surgical candidates, as determined by any relevant pre-operative assessments, at the neurosurgeons discretion.
Demyelinating form of Charcot-Marie-Tooth disease
Histopathological diagnosis of amyloidosis based on detection by immunohistochemistry and polarizing light microscopy of green bi-refringent material in congo red stained tissue specimens (in an organ other than bone marrow) or characteristic electron microscopy appearance
Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least  weeks after completion of antiviral therapy)
Patients must be positive for the RARA super-enhancer associated biomarker or RARA pathway associated biomarker at the time of study screening.
Patients with equivocal HER in situ hybridization results according to current ASCO/CAP guidelines are allowed, as long as the clinician has determined that they should be treated as HER negative
Pure seminoma after orchiectomy presenting with isolated retroperitoneal lymphadenopathy OR stage I pure seminoma with isolated retroperitoneal relapse; relapse should be within  years
Serum alpha-fetoprotein (AFP) not greater than . times the upper limit of the local laboratory assay within  days of RPLND
Dental braces or prosthesis that interferes with volumetric analysis of the neurofibroma(s)
GROUP : \r\n* Patients must have ) both a and b below; and ) either c, or d\r\n** a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows and knees and/or involving the torso in addition to distal extremity involvement; a skin score will be obtained but not used to determine eligibility\r\n** b) Duration of systemic sclerosis =<  years from the onset of first non-Raynaud's symptom; for those patients with disease activity between - years from the onset of first non-Raynaud's symptom, recent progression or activity of disease must be documented\r\n** c) Presence of SSc-related pulmonary disease with forced vital capacity (FVC) < % or hemoglobin-adjusted diffusing capacity for carbon monoxide (DLCO) < % of predicted AND evidence of alveolitis or SSc-related interstitial lung disease by high-resolution chest computed tomography (CT) scan and/or by bronchoalveolar lavage (BAL) (interstitial lung disease may be nonspecific interstitial pneumonia [NSIP] or usual interstitial pneumonia [UIP]; a bronchoalveolar lavage [BAL] should be done to confirm the findings of alveolitis only if the high resolution CT scan [HRCT] fails to show findings typically associated with systemic sclerosis changes [ground glass NSIP, UIP, SSc related interstitial lung disease]); alveolitis by BAL cell count will be defined based on a BAL cell differential count (> % neutrophils and/or > % eosinophils) from any lavaged lobe\r\n** d) History of SSc-related renal disease that may not be active at the time of screening; stable serum creatinine must be documented for a minimum of  months post-renal crisis at the time of the baseline visit; history of scleroderma hypertensive renal crisis is included in this criterion and is defined as follows:\r\n*** History of new-onset hypertension based on any of the following (measurements must be repeated and confirmed at least  hours apart within  days of first event-associated observation, with a change from baseline):\r\n**** Systolic blood pressure (SBP) >=  mmHg\r\n**** Diastolic blood pressure (DBP) >=  mmHg\r\n**** Rise in SBP >=  mmHg compared to baseline\r\n**** Rise in DBP >=  mmHg compared to baseline\r\n***AND one of the following  laboratory criteria: \r\n**** Increase of >=  % above baseline in serum creatinine\r\n***** Proteinuria: >= + by dipstick confirmed by protein:creatinine ratio > .\r\n***** Hematuria: >= + by dipstick or >  red blood cell (RBC)s/hematopoietic-promoting factor (HPF) (without menstruation)\r\n***** Thrombocytopenia: < , platelets/mm^\r\n***** Hemolysis: by blood smear or increased reticulocyte count\r\n*** The above definition of SSc hypertensive renal crisis is independent of whether concomitant anti-hypertensive medications are used\r\n*** Subjects who present with solely skin and renal disease in the absence of other organ involvement, except classic SSc renal crisis as described above and including non-hypertensive renal crisis, must see a nephrologist to confirm that their renal disease is secondary to only SSc\r\n*** Note: Subjects may be re-screened if they fail to meet inclusion criteria on initial evaluation
GROUP :\r\n* Progressive pulmonary disease as defined by a decrease in the FVC or DLCO-adjusted by  or  percent or greater, respectively, from a prior FVC or DLCO-adjusted in the previous -month period\r\n* Patients will have diffuse cutaneous disease and may have both FVC and DLCOcorr >= % at screening for the study\r\n* Patients must also have evidence of alveolitis as defined by abnormal chest computed tomography (CT) or bronchoalveolar lavage (BAL)
GROUP : Diffuse scleroderma with disease duration =<  years since development of first sign of skin thickening plus modified Rodnan skin score >=  plus either\r\n* Erythrocyte sedimentation rate (ESR) >  mm/st hour and/or hemoglobin (Hb) <  g/dL, not explained by causes other than active scleroderma\r\n* Lung involvement (either FVC or DLCO < % and evidence of interstitial lung disease by CT scan or alveolitis by BAL)
Prior treatment with enfortumab vedotin or other monomethyl auristatin E (MMAE)-based antibody-drug conjugates (ADCs).
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot undergo MRI assessments c) PCNSL patients with systemic disease
Consistent and correct usage of established oral contraception.
active gastrointestinal bleeding, unrelated to cancer, as evidenced by hematemesis, hematochezia or melena in the past  months without evidence of resolution documented by endoscopy or colonoscopy;
Monocularity
Visual acuity of / or worse in both eyes
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled or active ocular problems (e.g., retinopathy, macular edema, active uveitis, wet macular degeneration) requiring surgery, laser treatment, or intravitreal injections
Inlyta (axitinib) and/or,
CELL PROCUREMENT: Subjects with relapsed fulminant CD+ ALL that is rapidly progressing who cannot safely delay definitive treatment for their ALL by at least  weeks in the opinion of the investigator
iC-CAR CELL INFUSION: Corticosteroid use is contraindicated following iC-CAR infusion unless medically necessary e.g., to treat CRS)
Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye exam; examples of disqualifying baseline conditions include macular degeneration and other retinal disease such as cataracts that would interfere with required funduscopic examinations, or severe baseline visual impairment, retinopathy or visual field changes, or having only one functional eye; all patients must undergo a screening eye exam prior to enrollment
Score greater than  on the Insomnia Severity Index and meet the criteria for insomnia disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, th Edition (DSM-) as assessed by the insomnia interview schedule
Measurable disease per modified severity weighted assessment tool (mSWAT) and/or Sezary count
Consent to undergo mandatory prostatic core biopsies at the time of fiducial marker placement and  days (+/-  days) after with or without SD- therapy, depending on study arm
Estrogen containing compounds for >  months prior to enrollment
Failure to satisfy minimum criteria of lung shunting (> %) or presence of extrahepatic gastrointestinal activity on microaggregated albumin (MAA) scan or angiogram that preclude SIR-Spheres
M
A concomitant medical condition requiring receipt of a therapeutic anticoagulant that in the opinion of the treating physician cannot safely allow for therapeutic injection of ONCOS- and tumor biopsies. Local clinical practice can be followed with regard to holding a therapeutic anticoagulant during invasive procedures such as biopsies.
Histologically confirmed adenocarcinoma of the small intestine that is advanced (not amenable to surgery) or metastatic (clinical stage IV); for the purposes of this study, ampullary tumors are considered a part of the duodenum and are classified as adenocarcinomas of the small intestine
Active infection at time of hospital admission of haploidentical (Haplo) BMT
Any NSAIDs or omega- free fatty acid supplementation within the last  days
History of syncope within the last  months
Patients with undetectable anti-tetanus toxoid IgG
Patients with known history of agammaglobulinemia
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Concurrent use of an angiotensin-converting enzyme (ACE) inhibitor (increased risk of angioedema with ACE inhibitors administered in combination with everolimus, seen in approximately .% of patients)
A history of anaphylaxis to peginterferon alfa-b or interferon alfa-b
Subjects must have no prior history of veno-occlusive disease (VOD)
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX vaccine
Have an Eastern Cooperative Oncology Group (ECOG) performance status of  (fully active, able to carry out all pre-disease activities without restriction) or  (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature)
Patient has history of clinically significant dry eye (xerophthalmia) or other corneal abnormality or, if a contact lens wearer, does not agree to abstain from contact lens use from day  through the last study drug dose
Unlikely to cooperate in the study.
Patients must be in a major molecular remission (MMR) on a TKI (imatinib, dasatinib, nilotinib, or bosutinib) for a minimum of  year leading up to enrollment; major molecular remission is defined as BCR-ABL transcripts =< .% by quantitative real time polymerase chain reaction (QPCR) (International Scale [IS]) or >= -log reduction in BCR-ABL messenger ribonucleic acid (mRNA) from the standardized baseline, if QPCR (IS) is not available\r\n* MMR must be documented on at least  occasions, at least  months apart, in the  to  months leading up to enrollment
Patients in complete molecular remission (CMR) on a TKI (imatinib, dasatinib, nilotinib, or bosutinib); CMR is defined as no detectable BCR-ABL mRNA by QPCR (IS) using as assay with a sensitivity >= . logs below the standardized baseline
Atypical BCR-ABL mRNA transcripts that cannot be monitored with QPCR
Patients with previously documented BCR-ABL Kinase Domain mutations that confer resistance to nilotinib; this includes, but is not limited to, the TI mutation
History of developing any condition during prior treatment with ramucirumab for which ramucirumab must be permanently discontinued according to the ramucirumab label.
Patients must be considered appropriate candidates for LITT
Geriatric assessment score of >= 
Uncontrolled HTN  days prior to enrollment
The following are not counted as medical therapies: nephrectomy, radiation therapy, other energy-ablative techniques, or metastasectomy
Patients undergoing an extrapleural pneumonectomy (EPP); lung sparing surgeries, such as pleurectomy/decortication, are acceptable
Patients who have received pleurectomy with decortication (P/D) or EPP for mesothelioma
Patients with inherited syndromes associated with hypersensitivity to ionizing radiation, specifically patients with known history of ataxia-telengiectasia, Nijmegen breakage syndrome
Has undergone a surgical procedure involving general anesthesia within  weeks of starting trial treatment, or has inadequate healing or recovery from complications of surgery prior to starting trial treatment; this does not apply to low-risk procedures such as thoracentesis; paracentesis; chest tube/pleurX catheter placement; line placement; needle biopsy of tumor; and bronchoscopy
Candidate for fulvestrant therapy  patients who have started fulvestrant may enter this trial if within  months of starting fulvestrant
Patients may agree to provide optional paired biopsies.
Has evidence of immune- mediated hepatitis, nephritis, or thyroiditis
History of non-transfusional hemosiderosis
In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.
The recombinant vaccinia vaccine should not be administered if the following apply to either recipients or, for at least  weeks after vaccination, their close household contacts (close household contacts are those who share housing or have close physical contact):\r\n* Persons with active or a history of eczema or other eczematoid skin disorders\r\n* Those with other acute, chronic or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne or other open rashes or wounds) until condition resolves\r\n* Pregnant or nursing women; children under  years of age
In subjects requiring biliary decompression, biliary stent or drainage using percutaneous transhepatic cholangiogram (PTC) are allowed
Has received prior immunotherapy including antiPD-, antiPD-L, or antiPD-L agents, or if the subject has previously participated in Merck pembrolizumab clinical trials
PB or BM basophils ?%
Subjects who within  hours of randomization have used an anti-Factor IIa agent such as dabigatran or an anti-FXa agent such as rivaroxaban, apixaban, or edoxaban;
Creatinine ? . xULN
Progressing based on organ assessment after at least  days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR
Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria:
Inadequate renal function, defined as calculated or estimated creatinine clearance <  mL/min unless lymphoma, KSHV-MCD, or KSHV-associated inflammatory cytokines syndrome (KICS)-related
Platelets < ,/mm^ unless lymphoma, KSHV-MCD, or KICS-related
Indeterminate or negative HER status
The use of natural or synthetic cannabinoids
Prior thermal ablative therapy for prostate cancer (e.g. high-intensity focused ultrasound [HIFU] or cryoablation)
Any prior use of Revlimid or Velcade
The Hepatobiliary Multidisciplinary Committee (HDMC) must approve of this intervention
The Hepatobiliary Multidisciplinary Committee (HDMC) disapproves of this intervention
Insurance will not cover the procedure
Histologically confirmed residual ovarian cancer at time of second-look surgery; patients with cytological evidence of malignant cells in washings obtained as part of the second look procedure are eligible even if biopsies are negative
History of gastrointestinal or urinary fistulae, non-healed or chronic wound, or other conditions that, in the investigators view, would contraindicate or significantly increase the risks of bevacizumab therapy
Active uncontrolled infection; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Mutational testing of patient samples for KIT and platelet-derived growth factor receptor (PDGFR) mutations; (this will not hold up starting therapy, but will be done for all patients lacking up front mutational testing)
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to =<  mm
Not adhering to pregnancy prevention recommendations
Allergic or unable to tolerate TMZ for any reason; any patient that successfully completed at least  weeks of Temodar during standard of care XRT/TMZ and whose blood counts meet the eligibility requirements within  weeks post XRT/TMZ is eligible
Concomitant treatment with the following drugs that may interact with S-: Sorivudine, brivudine, uracil, eniluracil, folinate/folinic acid, Cimetidine, dipyridamole, and nitroimidazoles, including metronidazole and misonidazoleMethotrexate, Clozapine,Allopurinol,Phenytoin,Flucytosine, a fluorinated pyrimidine antifungal agent,Coumarin-derivative anticoagulant
Patients must have a bone marrow biopsy available, or one scheduled to be performed for a clinical indication so that survivin expression could be determined (note: survivin staining in tumor need not be resulted prior to enrollment or treatment as it is obtained for correlative science)
Common variable immunodeficiency
Prior taxanes for CRPC
Tumor must be mismatch repair (MMR) proficient as determined by microsatellite instability or immunohistochemistry for MMR proteins\r\n* Microsatellite instability testing must be microsatellite instability (MSI)-stable or MSI-low\r\n* Or immunohistochemistry (IHC) for MMR proteins must demonstrate intact MMR proteins
History of oxalate nephrolithiasis or urine oxalate > mg/dL
Decision impaired patients
Any of the disease stages listed below\r\n* Stage IB disease that meets ALL of the following criteria:\r\n** Plaque disease (ie,Tb staging)\r\n** Diffuse skin involvement with indication for TSEB (plaque disease with or without patches)\r\n** Not appropriate for treatment with focal therapies\r\n** One prior course of low-dose TSEB or one prior course of systemic chemotherapy regimens (excluding brentuximab)\r\n* Stage IIA, IIB, or IIIA that meets ONE or BOTH of the following criteria:\r\n** Patient is a candidate for treatment with low-dose TSEB\r\n** Patient is a candidate for systemic therapy\r\n* IIIB or IVA disease requiring systemic therapy\r\n* Transformed cutaneous T-cell lymphoma (CTCL)
Demyelinating form of Charcot-Marie-Tooth syndrome
History of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility, for example, gastroparesis, history of extensive abdominal surgery
Moribund patients not expected to survive up to  hours
Patients with ARDS resulting from trauma
Patients with prior pneumonectomy
Patients willing to be treated with frame-based gamma knife SRS at MD Anderson main campus or MD Anderson at the Woodlands
Patients with exposed carotid artery preoperatively requiring sacrifice or bypass intra-operatively
met the screening criteria for CI through a positive response to at least  of  scaled questions from the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC-QLQ) i.e. Please rate on a scale from  to , the difficulty level you have in concentrating on things, like reading a newspaper or watching television? \\ means no difficulty and \\ means very difficult. Please rate on a scale from  to , the difficulty level you have in remembering things. \\ means no difficulty and \\ means very difficult, will be included.
Presence of donor specific antibodies (DSA) with mean fluorescence intensity (MFI) of >  as assessed by the single antigen bead assay, <  weeks prior to starting transplant conditioning
Confirmation of resectability by surgical oncology consultation
Short removable metal stents rather than plastic stents are strongly encouraged but not required for palliation of initial obstructive jaundice
PART  EXCLUSION CRITERIA: Potential subjects and/or parents/guardians who, in the opinion of the investigative team, are likely to be non-compliant with study schedules or procedures
PART  GROUP  EXCLUSION CRITERIA: Potential subjects and/or parents/guardians who, in the opinion of the investigative team, are likely to be non-compliant with study schedules or procedures
PART  GROUP A EXCLUSION CRITERIA: Potential subjects and/or parents/guardians who, in the opinion of the investigative team, are likely to be non-compliant with study schedules or procedures
PART  GROUP  EXCLUSION CRITERIA: Potential subjects and/or parents/guardians who, in the opinion of the investigative team, are likely to be non-compliant with study schedules or procedures
Patient with known active herpes simplex virus infections (prior uncomplicated oral herpes simplex virus [HSV] lesions are not an exclusion), prior complications from HSV infections such as encephalitis, or who require systemic antiviral therapy at the time of study enrollment should be excluded
Patients should not be prescribed concomitant medications that may contribute to prolonged QTc without consultation with the chemotherapy pharmacist; additional ECGs should be done at the investigators discretion to ensure the subjects safety; drugs that are generally accepted to increase the risk of Torsades de Pointes, include (but not limited to):\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, ibutilide, dofetilide, sotalol\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Patients with a diagnosis of spinal cord ependymoma, myxopapillary ependymoma, subependymoma, ependymoblastoma, supratentorial ependymoma, or mixed glioma are NOT eligible for either Stratum
Additionally, patients treated in stage , cohort # must be EBV seropositive, given the inclusion of T cells derived from an EBV-specific subset in this group
Treatment with alemtuzumab or other T cell-depleting antibodies within  months of T cell therapy
Serious cardiopulmonary comorbidities
Ileus
Gastroparesis
Presence of MRD (defined as < % blasts in the bone marrow by morphologic assessment and no clinically-apparent extramedullary disease but with quantifiably-measurable disease as assessed by either MFC or PCR) under any of the following circumstances:\r\n* MRD persistence >=  weeks after the start of initial therapy\r\n* MRD persistence >=  weeks after the start of salvage therapy, or \r\n* MRD reappearance at any time
Eligible for:\r\n* Cohort A: Robot-assisted radical cystectomy (RARC) as per the attending urologist\r\n* Cohort B: Robot-assisted radical Nephrectomy (RARN)/robot-assisted partial nephrectomy (RAPN) as per the attending urologist\r\n* Cohort C: RAPN as per the attending urologist
Subject has a known allergic/hypersensitivity to investigational components or excipients (doxorubicin, trehalose, monoclonal antibody therapy, penicillin class of antibiotics, gentamicin (or other aminoglycosides), or ciprofloxacin hydrochloride (or other quinolones)).
Patients with a relapsed/refractory peripheral T cell lymphoma; patients must have received at least one prior standard cytotoxic regimen such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (CHOP), or etoposide phosphate, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (EPOCH) OR
Patients at Washington University must be enrolled in HRPO#  (Tissue Acquisition for Analysis of Genetic Progression Factors in Hematologic Diseases); this is not a requirement for secondary sites; however, secondary sites must provide informed consent forms that document that permission for whole genome, whole exome, and/or genome wide sequencing, and data sharing among institutions, was obtained; because the study will also be sequencing non-diseased (normal) tissue, the informed consent forms must explicitly ask if patients wish to be informed, (or in the case of their death, their next-of-kin) if a deleterious mutation is identified in their non-diseased tissue, as this may be heritable
Willing to comply with the treatment assignment:\r\n* Intent to proceed with high-dose cytarabine (HiDAC) consolidation for LAM VAF < .%\r\n* Intent to proceed with either HiDAC consolidation or allogeneic stem cell transplantation, at the discretion of the treating physician, for LAM >= .%
Caregiver capable of providing post-HCT care, who will be present once induction therapy with filgrastim, cladribine, cytarabine, mitoxantrone hydrochloride (GCLAM) begins
DLCOc < % or FEV < %
Known non-synonymous mutation in the following genes: Raf, PDGFR, VEGFR, Flt-, KIT, JAK, STAT, RAS, MEK, or ERK; genomic sample preferably from relapse, but may be from other stage of treatment if relapse sample is not reasonably obtainable; genetic analysis for determination of eligibility occurs as part of routine care and is not being performed specifically for the purposes of this study
Lung metastases will be unresectable due to anatomic location, distribution, or patients comorbidities, as determined by review of imaging by a faculty member in the Department of Thoracic & Cardiovascular Surgery
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan syndrome, PFO, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computerized tomography [CT] scan with contrast or magnetic resonance imaging [MRI]).
Adequate oral intake and nutritional status without current or likely need for enteral or parenteral feeding during chemoradiation or the preoperative period
Inadequate caloric or fluid intake whereby there is a current or likely future need for enteral or parenteral feeding during chemoradiation or the preoperative period
Patient requiring anti-diabetic medications to manage hyperglycemia are eligible; adjustments of other anti-diabetic agents will be made with close monitoring of blood glucose
Known loss of complete cytogenetic response (CCyR) by marrow cytogenetic or blood fluorescence in situ hybridization (FISH) for breakpoint cluster region (BCR)- v-abl Abelson murine leukemia viral oncogene homolog  (ABL)
Known history of macular edema
Use of thiazolidinedione (TZD) within  days prior to enrollment
Uncontrolled peripheral edema (+ or more) of any etiology
Known cerebral/meningeal disease
Prior use of ARN- (apalutamide)
The use of drugs known to lower the seizure threshold, including: atypical antipsychotics (e.g. clozapine, olanzapine, risperidone, ziprasidone), bupropion, lithium, meperidine, pethidine, phenothiazine antipsychotics (e.g. chlorpromazine, mesoridazine, thioridazine), and tricyclic antidepressants (e.g. amitriptyline, desipramine, doxepin, imipramine, maprotiline, mirtazapine)
invasive mediastinal staging requirement will be based on current American College of Chest Physicians (ACCP) lung cancer staging criteria and will be performed by any of the following tests, in appropriate patients, alone or in combination based on study site preference in accordance with ACCP guidelines - mediastinoscopy, mediastinotomy, VATS, endobronchial ultrasound, endoscopic ultrasound.
Patients having prior therapy with Laser Induced Thermal Therapy (LITT) is allowed, but at least  days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade  or less and subsequent histologic documentation of recurrence
No more than  contiguous or discontiguous vertebral levels involved with metastasis in the spine to be irradiated in a single session or  sessions
Patients with hydronephrosis that has not been addressed with a documented assessment (i.e. normal GFR, no intervention necessary) or an intervention such as placement of a stent or nephrostomy tube
Has favorable risk AML as defined by the presence of isolated t(;) or inv() or t(;)(p.;q) on a standard karyotype or mutated NPM with concurrent wild-type FLT on molecular testing
Disease amenable to maximal surgical debulking via extended pleurectomy/decortication as determined by a surgeon specializing in mesothelioma
Arterial blood gas partial pressure carbon dioxide (pCO) <  mmHg
Have no extrathoracic disease by best surgical staging
History and/or current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc unless the lead investigator obtains approval from Novartis
Successful collection of T cells for JCAR manufacturing
Current exposure to household contacts =<  months old or household contact with known immunodeficiency; NOTE: patient must avoid contact during documented viral shedding; participants with continuous viral shedding will be given recommendations for restricted activities to avoid contact with immunocompromised persons
Patients with smoldering and lymphomatous ATL
Relapsed, recurrent, or refractory malignancy; all solid tumor diagnoses will be eligible\r\n* Pathologic confirmation of the diagnosis either at original diagnosis or recurrence\r\n* Known non-synonymous mutation in the following genes: EGFR, ERBB, or JAKVF (JAK); genomic sample preferably from relapse, but may be from other stage of treatment if relapse sample is not reasonably obtainable; genetic analysis for determination of eligibility occurs as part of routine care and is not being performed specifically for the purposes of this study
Evidence by physical examination or mammography of other suspicious masses, densities, or microcalcifications in either breast, unless biopsied and found to be benign
Use of any anti-leukemic agents after relapse is documented (note that the use of these anti-leukemic agents given as post-transplant maintenance therapy is allowed in this study, e.g., subcutaneous or oral -azacytidine or FLT inhibitors for maintenance) for cohorts  and 
Disease-related exclusions
Known androgen receptor (AR) positive breast cancer (AR staining > % by immunohistochemistry is considered positive); if the AR status is unknown, the patient can go on study
Patient must have been evaluated by a University of California Los Angeles (UCLA) thoracic surgeon, and deemed medically and technically suitable for a pleurectomy/decortication procedure
Known history of plasma cortisol and adrenocorticotropic hormone (ACTH) levels consistent with adrenal failure
Myeloproliferative syndromes
Group II: KS (no prior therapy required):\r\n*Concurrent KSHV-associated multicentric Castleman disease (MCD)\r\n*KSHV Inflammatory Cytokine Syndrome (KICS), including those also meeting clinical criteria for KS immune reconstitution syndrome (KS IRIS)
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation
intravaginal
transdermal
Progestogen-only hormonal contraception associated with inhibition of ovulation
injectable
Vasectomised partner
Current evidence of endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc
Acute renal failure due solely to readily reversible causes such as hypercalcemia, hyperuricemia, dehydration, hyperviscosity, or acute tubular necrosis from nephrotoxic drugs
Prior cerebrovascular event with persistent neurologic deficit
Kyphoplasty or vertebroplasty within  week prior to event 
Albuminemia > g/L
A recognized immunodeficiency disease including human immunodeficiency virus (HIV) infection (and other cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; subjects who have hereditary, congenital or acquired immunodeficiencies).
Vulnerable population groups, i.e., prisoners, those lacking consent capacity, non-English speaking, illiterate, pregnant females
DONOR: Vulnerable population groups, i.e., prisoners, those lacking consent capacity, non-English speaking, illiterate, pregnant females
Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics
For cohorts ,  and  only: Patient's tumor must be positive by histological or molecular assay for NY-ESO-, according to the screening algorithm; historical results may be used\r\n* For cohort , NY-ESO- results will be noted but NY-ESO- positivity is not required for eligibility
The risk factor for RVO are listed below; exclusion should be considered by clinical discretion if they have the following conditions:\r\n* Uncontrolled glaucoma with intra-ocular pressures >  mmHg\r\n* Serum cholesterol >= grade \r\n* Hypertriglyceridemia >= grade \r\n* Hyperglycemia >= grade 
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV
Patients must not have been treated with CHK/ inhibitors
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine or CRS- (e.g., glycerol)
Histopathologically confirmed diagnosis of previously untreated DLBCL of the non-GCB DLBCL subtype
Confirmed PDGFRA amplification in the tumor tissue at the time of diagnosis or time of recurrence. Central confirmation of PDGFRA amplification will be performed by FISH in CLIA certified lab (ProPath). Signal quantitation will be used to generate a PDGFRA/centromere  ratio. PDGFRA to Centromere  ratios will be interpreted as follows: . to ., borderline for amplification; . to ., low-level amplification; and greater than . or clustered signals that are too numerous to count would be considered highly amplified. Tumor samples with PDGFRA to Centromere  ratios of . or higher will be considered amplified and therefore eligible for this trial. For patients with local CLIA testing demonstrating PDGFRA amplification by Next Generation Sequencing (Foundation Medicine, CMS), central testing will not be required.
Diagnosis of colorectal carcinoma with intrahepatic metastases; limited extrahepatic metastasis is allowed as long as the overall metastatic burden is hepatic dominant
If extrahepatic disease is present, it must be asymptomatic
Contraindications to angiography and selective visceral catheterization\r\n* Any bleeding diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device)\r\n* Severe allergy or intolerance to contrast agents, narcotics, or sedatives that cannot be managed medically
Any intervention for, or compromise of the ampulla of Vater
N nodal disease
Male who is expecting to father a child during the treatment period
ENTRECTINIB EXCLUSION CRITERIA: History of other previous cancer that would interfere with the determination of safety or efficacy of entrectinib in melanoma
AZD is an inhibitor of breast cancer resistance protein (BCRP); the use of statins including atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP inhibitor alternatives
No prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
Subjects must be fully informed about their illness and the investigational nature of the study protocol (including foreseeable risks and possible side effects)
Patient must have previously undergone standard chemoradiation- . Gy (. Gy/fraction) or  Gy (. Gy/fraction) with concurrent and adjuvant Temodar (temozolomide)
Willingness to fill out IPSS, SHIM, and EPIC quality of life forms
IPSS (American Urological Association [AUA]) score =< 
Inability to have gold fiducial markers placed in the prostate, or fiducial markers already placed, that are not in accordance with the protocol
History or presence of cardia arrest or unexplained syncope
Hypokalemia
Patients who have received alemtuzumab or antithymocyte globulin within  weeks of the transplant admission; the absence of these therapies in the medical record will serve as documentation that they were not given
.
For women on estrogen based contraceptives, family history of venous thromboembolism (VTE) and/or risk factors predisposing for VTE and other medical conditions known to be associated with VTE.
Any condition contraindicating fulvestrant administration:
Poor nutritional state (as determined by clinician)
Prior treatment with EGFR-targeted therapy, including, but not limited to, the following examples: Gilotrif (afatinib),Tarceva (erlotinib), Erbitux (cetuximab), Iressa (gefitinib), Vectibix (panitumumab), Caprelsa (vandetanib), Tykerb (lapatinib), CDX, DC-immunotoxin)
Eastern Cooperative Oncology Group (ECOG) performance status of  (fully active, able to carry on all pre-disease performance without restriction),  (restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, such as light housework or office work) or  (ambulatory and capable of all self-care but unable to carry out any work activities; up and about more than % of waking hours)
Pharmacologic therapy with agents reported to produce adverse drug-drug interactions. (Table )
Patients with electronic pacemakers or defibrillators.
Classified as having insufficient tumor shrinkage by imaging (< % shrinkage after  cycles of anthracycline-based chemotherapy based upon diagnostic imaging)
Uncontrolled infection at the time of enrollment; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Tracheo-esophageal (TE) fistula or direct invasion into the tracheo-bronchial mucosa; a bronchoscopy (biopsy and cytology should be performed) is required to exclude TE fistula or tracheo-bronchial involvement in patients with a tumor located at <  cm from the incisors
Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia or hypokalemia defined as less than the lower limit of normal for the institution, despite adequate electrolyte supplementation
Favorable candidates for surgical decompression by prior documented criteria
Spine instability as determined by Spinal Instability Neoplastic Score (SINS) score > 
> % loss of vertebral body height
Bony retropulsion causing neurologic abnormality
Tumor infiltrating into large vessels or infiltrating into the proximal tracheobronchial network, visible on medical imaging; the investigator or radiologist must rule out tumors that conjoin, surround or extend into the immediate area of a large vessel (e.g.: pulmonary artery, superior vena cava)
Pre- or perimenopausal status or menopausal status that cannot be accurately assessed (e.g. equivocal measurements of estradiol and FSH)
Subjects where more than % of the total esophagus volume receives more than % of the prescribed RT dose Main exclusion criteria for cPoP
Moribund status or status epilepticus
AZD is an inhibitor of breast cancer resistance protein (BCRP); the use of statins including Atorvastatin which are substrates for BCRP are therefore prohibited and patients should be moved on to non-BCRP alternatives
Pre-certification for the Y TARE should be performed prior to enrollment on this study
Patients who have had only segmentectomies or wedge resections
Cohort : Pre-treated patients with cMET mutations regardless of cMET GCN, or
Cohort : Pre-treated patients with either cMET GCN ?  without cMET mutations or cMET mutations regardless of cMET GCN
In accordance with French Regulatory Authorities: Patients with French Social Security in compliance with the French law relating to biomedical research (Huriet Law - and related decrees)
Documented mutation in gBRCA or gBRCA that is predicted to be deleterious or suspected deleterious
gBRCA and/or gBRCA mutations that are considered to be non detrimental (eg, \Variants of uncertain clinical significance\ or \Variant of unknown significance\ or \Variant, favour polymorphism\ or \benign polymorphism\ etc.)
Patients requiring ventilator support
Patients with documentation of well differentiated liposarcoma only (of the well differentiated/dedifferentiated liposarcoma family) are specifically excluded, owing to its characteristically slow growth. If high grade areas are suspected (dedifferentiation), but not proved by pathology analysis (e.g. after primary resection of a well-differentiated liposarcoma), a biopsy must be performed to demonstrate the high-grade dedifferentiated disease
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole and butylated hydroxytoluene
Receiving erythroid stimulating agents (epoetin alfa [EPO]: Procrit, Aranesp)
Any history or evidence of opportunistic infection within  months of screening including tuberculosis, severe cytomegalovirus (CMV) or herpetic infections (such as disseminated herpes, herpes encephalitis, ophthalmic herpes)
Any revascularization procedure, including the placement of a stent
Patients presenting for orthopaedic evaluation with a painful impending pathologic femur fracture or displaced pathologic femur fracture in the intertrochanteric, pertrochanteric, or subtrochanteric region of the proximal femur; the anatomic region of interest is defined by a line drawn from the base of the femoral neck to  cm below the base of the lesser trochanter or  diaphyseal shaft widths, whichever is greater
Radiographic evidence of an intramedullary occlusion by blastic metastases that would necessitate an alternative method of treatment, such as a plate/screw construct
Patients with advanced hip arthritis on radiographic imaging
Histologic diagnosis of AT/RT or MRT as documented by institutional pathologist with loss of INI or BRG expression in tumor cells confirmed by immunohistochemistry, or by molecular confirmation of tumor-specific biallelic SMARCB loss/mutation or SMARCA loss/mutation if INI/BRG immunohistochemistry is not available; patients with synchronous extraneural AT/RT are eligible; for Stratum A participants, histologic confirmation of the diagnosis of AT/RT or MRT may be from the original diagnosis or at the time of recurrence/progression\r\n* Whereas testing of INI expression by immunohistochemistry is widely available, Clinical Laboratory Improvement Amendments (CLIA)-certified sequencing of SMARCB in tumor samples is only done in limited institutions; therefore, we expect that the vast majority of patients will have confirmation of their diagnoses by immunohistochemistry only; exceptional cases may require gene sequencing\r\n* Of note, occasional patients with histologic diagnosis suggestive of AT/RT or MRT may display immunohistochemical and/or molecular characteristics which are equivocal (e.g., patchy loss of INI expression by immunohistochemistry, proof of monoallelic loss of SMARCB without confirmation of second hit by sequencing of exons only); these cases may be confirmed unequivocally to represent AT/RT or MRT only by research studies (e.g., whole genome sequencing); therefore, we propose that such patients be candidates for the current study but their outcomes be described separately
Evidence of extensive intraperitoneal adhesions at the time of surgery, as determined by the operating surgeon which prohibits intraperitoneal therapy
Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable
Invasion or ulceration of inguinal nodal disease into the overlying skin
Hydroxyurea that is ongoing (hydroxyurea is permitted up to the first dose)
Rectal cancer located within  cm from the anal verge based on proctoscopy and digital rectal examination (DRE)
Fecal incontinence at baseline
Patients with carcinosarcoma.
Willingness to take bupropion
Carbon monoxide (CO) test under  parts per million (ppm)
Unexplained febrile illness
ARM C COHORT : Patients who have had decompression of the biliary tree within the last  days, must have a stable bilirubin level as confirmed by two measurements that are within  to  days of each other; (the second measurement must be obtained within  days prior to registration); both the first and second measurement must be =<  X IULN; stability is defined as the second measurement being no more than one point higher than the first
Relapsed Ph+ ALL, with no prior exposure to dasatinib and without known ABL kinase mutations predicted to be resistant to dasatinib (e.g. LR, LV, QH, EK, VL, TA, TI, FC, FI, FL, FS, FV)
Relapsed or refractory Ph-like ALL without prior exposure to dasatinib and with mutations or rearrangements of genes conferring sensitivity to dasatinib (ABL, CSFR, PDGFRB) or ruxolitinib (CRLF, JAK, EPOR, TSLP)
Patients with dominant leukemic clone bearing documented bcr-abl mutations enabling bcr-abl TKI resistance at diagnosis
Mature B-cell (Burkitts) ALL
Patients with untreated MCL should be asymptomatic or minimally symptomatic from their MCL and without aggressive clinicopathological features that would otherwise warrant immediate intensive therapy; these will generally be patients who qualify for an initial period of watch and wait per clinical discretion
Active or history of diverticulitis; diverticulosis is permitted
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nPatients are allowed to have received prior PARP inhibitors (PARPi), and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics; however, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible; for this study, BSI- (iniparib) is not considered as PARPi
Has not had a coma or long or multiple seizures within  days after a dose of DTP or Tdap unless a cause other than the vaccine was indicated
Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement
 years of age or older or - with a low (-) oncotype score; oncotype is not required for women diagnosed with DCIS
Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement
Documented/locally determined AKT or PIKCA mutation
Anastrozole defined by the Investigator based on institutional SOC, scientific evidence, expert medical judgment, or published literature
Ki score/proliferative index =< % or low to intermediate mitotic index
Confirmation that insurance will cover SBRT through normal hospital authorization process
Significant urinary obstruction in spite of alpha blocker use (i.e. AUA symptom score > )
Contraindications to sildenafil including:\r\n* Known retinitis pigmentosa\r\n* History of priapism related to PDE inhibitors (eg, sildenafil, vardenafil, tadalafil)\r\n* Presence of nonmalignant hematologic disorders, such as sickle cell disease, that may increase the risk of priapism
BM cellularity < % and
< % for patients ? yrs.
FOR THE PILOT PORTION
Undergone molecular testing for integral biomarkers including immunohistochemical staining for vimentin
Scheduled for curative or palliative major cancer surgery; patient must be scheduled for at least one of the following procedures (i.e., Common Procedural Terminology [CPT codes]), and may be scheduled for more than one of these procedures within or across each of the following procedure types (e.g., glossectomy, pharyngectomy, etc.) or procedure families (e.g., head and neck surgery, thoracic surgery, etc.)\r\n* Head and neck surgery\r\n** Glossectomy (CPT codes ,,,,,)\r\n** Pharyngectomy (CPT codes ,,,,,)\r\n** Laryngectomy (CPT codes ,,, , , , , , , )\r\n** Neck dissection (CPT codes , )\r\n* Thoracic Surgery\r\n** Esophagectomy (CPT codes , , , , , , , , , , , )\r\n** Lung resection (CPT codes , , , , , , , , , , , , , , , , , , , , , )\r\n* Upper gastrointestinal/hepatico-pancreatico-biliary surgery\r\n** Gastrectomy (CPT codes , , , , , , )\r\n** Pancreatectomy (CPT codes , , , , , , , , , , )\r\n** Hepatectomy (CPT codes , , , )\r\n* Colorectal surgery\r\n** Colectomy (CPT codes , , , , , , , , , , , , , , , )\r\n** Proctectomy (CPT codes , , , , , , , , , , , , , , , , , , , , , , , )\r\n* Gynecologic surgery\r\n** Hysterectomy/Myomectomy (CPT codes , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , )\r\n** Gynecologic reconstruction (CPT codes , , , , , , , )\r\n* Urologic Surgery\r\n** Prostatectomy (CPT codes , , , , , , , , , )\r\n** Nephrectomy (CPT codes , , , , , , , , , )\r\n** Cystectomy (CPT codes , , , , , , , , , , )\r\n* Soft tissue/plastic surgery\r\n** Breast reconstruction (CPT codes , , , , , , , , , , )\r\n** Flap reconstruction (CPT codes , , , , , , , , , )
These procedures are commonly performed in patients with malignant neoplasms, malignant neuroendocrine tumors, or carcinomas in situ, and are commonly tracked by hospitals and cancer centers participating in the ACS NSQIP Procedure Targeted option because they are often associated with higher rates of postoperative morbidity and mortality (compared to other, less complex cancer procedures)
Donor cellular engraftment of at least .% from the reduced intensity/non-ablative procedure
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: ECOG performance -
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine
Has completed the baseline HRQOL questionnaires UNLESS is unable to complete because of literacy or limited vision
Use of LHRHA (with or without anti-androgens) for less than  days prior to randomisation in the trial.
No active infection: patients should be afebrile; if present, pulmonary infiltrates or other sites of infection must be improving on antibiotics; patients should not require oxygen; study chair will be the arbiter of this criterion
MRI MONITORING SUB-STUDY: Engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities
Clinical assessment score will be obtained, at baseline\r\n* Visual assessment (VA) in affected eye of at least / - /\r\n* Ocular motility intact - /\r\n* No diplopia - /\r\n* Binocularity (fusion) +/- prism - /\r\n* Normal tear lake, no complaint of persistent tearing - /\r\n* Intact lacrimal system by probing/irrigation (both canaliculi to nasolacrimal duct [NLD]) - /\r\n* Patient assessment of visual function on the affected side (good, fair, poor) - //\r\n* Score maximum - 
Prior to enrollment, the CA should have been elevated to at least double the level seen at the nadir value following the first complete response and measurable intraperitoneal disease that can be identified radiologically and accessed by laparoscopy/laparotomy for a biopsy and peritoneal catheter placement
Patients with a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia; patients who have acquired, hereditary, or congenital immunodeficiencies
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Hb ?  g/dL (independent of transfusions or erythropoiesis-stimulating agents [ESA]).
Ability to understand and complete the European Organization for Research and Treatment of Cancer (EORTC) quality of life (QOL) instruments
Note: Patients positive for hepatitis B and C will be evaluated on a case by case basis
Have had complete (CC- or CC-) CRS with HIPEC open or minimally invasive (laparoscopic or robotic)
Able to perform  minute walk test
History of familial cardiomyopathy
Recent documented myocarditis within  months of consent
History of infiltrative cardiomyopathy or restrictive cardiomyopathy
Mechanical or bioprosthetic heart valve
Cardiogenic shock
ITP that has persisted for ?  months. ITP must be diagnosed in accordance The American Society of Hematology  Evidence-based Practice Guideline for Immune Thrombocytopenia (Neunert et al. ) or the International Consensus Report on The Investigation and Management of Primary Immune Thrombocytopenia (Provan et al. ), as locally applicable.
Patients must meet the diagnostic criteria for HPS (at least  of the following):\r\n* Fever\r\n* Splenomegaly\r\n* Cytopenia involving >=  cell lines\r\n* Hypertriglyceridemia or hypofibrinogenemia\r\n* Tissue demonstration of hemophagocytosis\r\n* Hepatitis\r\n* Low or absent natural killer (NK) cell activity\r\n* Serum ferritin >=  ug/L\r\n* Soluble interleukin (IL)- receptor (cluster of differentiation [CD]) >  U/mL
Inability to complete the survey instrumentation accurately
Current or previous treatment with an -hydroxy--methyl-glutaryl-coenzyme A reductase (HMG CoA) reductase inhibitor (any statin)
Category I drugs that are generally accepted to have a risk of causing torsades de pointes including: (patients must discontinue drug at least  days prior to starting dasatinib)\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, sparfloxacin, lidoflazine
A documentation of diagnosis of hemophagocytic lymphocytosis, either newly diagnosed or relapsed/refractory by the treating physician and the principal investigator (PI) in the patients chart; it must be noted that no diagnostic criteria have been established for diagnosis of HLH in adult patients as this was a hitherto poorly identified and considered to be a very rare disease in adults; adult HLH seems to occur more frequently post malignancy and has a more fulminant course than pediatric HLH; in the absence of standard diagnostic guidelines if the patient's symptoms are highly suspicious for HLH and after an adequate work-up to rule out alternate potential alternate etiologies is performed we will treat the patient for HLH as missing the diagnosis is associated with high mortality; these patients will be discussed with the PI (Dr. Daver) prior to enrollment in all such cases
Platelets >=  K/cumm (must be within  days of MLA)
Evaluable myelofibrosis by IWG-MRT criteria including one or more of the following:\r\n* Spleen >=  cm below the left costal margin\r\n* MPN-SAF total symptom score (TSS) >  at baseline\r\n* Hemoglobin <  g/dL
at least  grade  CIRS-G comorbidities OR
Absence of any autoimmune syndrome typically associated with thymomas but not thymic carcinomas (myasthenia gravis, pure red cell aplasia, etc.)
Concurrent treatment or medications (must be off for at least  week) including:\r\n*Interferon (e.g. Intron-A)\r\n*Allergy desensitization injections\r\n*Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n*Interleukins (e.g. Proleukin)\r\n*Any investigational therapeutic medication
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds  mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Fecal incontinence
American Urological Association Symptom Index (AUA SI) =< 
Patients who are on warfarin and cannot have a drug substitution or who decline the drug substitution
Known human immunodeficiency virus (HIV)-positive individuals; high-dose ascorbate acid is a known CYP A inducer, which results in lower serum levels of antiretroviral drugs; a clinical trial designed to address these interaction issues is more appropriate than this phase  study
Prior use of pegylated interferon or interferon
Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia is excluded; this includes, but is not limited to, del(), del(), del()
Patients with jaundice or clinical cholangitis, with new elevation of alkaline phosphatase, total bilirubin, and imaging findings supportive of stent occlusion (loss of stent patency, debris within stent, loss of or excessive pneumobilia)
Have altered gastro-duodenal or hepatobiliary anatomy such that endoscopic retrograde cholangiopancreatogram (ERCP) is felt to be unacceptably technically difficult or unsafe
Have additional sites of biliary strictures (intrahepatic/hilar) such that ERCP stenting is felt to be unlikely to provide adequate clinical benefit
Are unsuitable for endoscopy (either because of hemodynamic instability, respiratory distress or unsafe hematological parameters such as refractory anemia <  g/dL, thrombocytopenia <  K/mcL, or coagulopathy with international normalized ratio [INR] > .)
Have biliary strictures not technically amenable to endoscopic therapy
If the patient has been treated with non-steroidal anti-androgens (flutamide, bicalutamide or nilutamide) or other hormonal treatment (such as ketoconazole), these agents must have been stopped at least  days prior to enrollment for flutamide or ketoconazole, and at least  days prior to enrollment for bicalutamide or nilutamide; and the patients must have demonstrated progression of disease since the agents were suspended
Patients with persistent grade  or higher prior vincristine (VCR) (vincristine sulfate)-related neuropathy
Chemotherapy, immunotherapy, radiotherapy, radiosurgery, interferon (e.g. Intron-A), allergy desensitization injections, growth factors (e.g. Procrit, Aranesp, Neulasta), interleukins (e.g. Proleukin) or any investigational therapeutic medication within  weeks of study entry
EUS evidence of vessel interfering with path of fiducial marker
Use or consumption of any of the following substances:
Either resectable or borderline resectable as determined on staging imaging (as defined by National Comprehensive Cancer Network [NCCN])
ELIGIBILITY CRITERIA FOR T-CELL PRODUCT INFUSION: Patient has not received immunotherapy (for example- murine, chimeric or humanized monoclonal antibodies), T cell growth factors (such as IL-, IL- or IL-), interferons, vaccines, and other cellular products), pentoxifylline within the  days prior to the infusion of the T cell product
RETREATMENT WITH MODIFIED T CELLS: Subject has tolerated prior dose of modified T cell infusion without experiencing a dose limiting toxicity
RETREATMENT WITH MODIFIED T CELLS: Normal serum creatinine based on age/gender
RETREATMENT WITH MODIFIED T CELLS: Normal serum sodium level without need for supplementation
We will carefully consider the inclusion of patients with severe artifacts in D CT images, which deteriorate the accuracy of ventilation computation
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Prior cryosurgery, high intensity focused ultrasound (HIFU) or brachytherapy of the prostate
Phosphorus before the first dose of ceritinib
Inability to perform y TARE due to: () inability to catheterize the hepatic artery, () portal vein thrombosis/occlusion without the ability to perform selective infusion, () technetium Tc m-labeled macroaggregated albumin (Tc-m MAA) hepatic artery perfusion scintigraphy shows unfavorable shunt fraction between the liver and the pulmonary parenchyma as determined by the interventional radiologist, or () other contraindication to TARE identified by interventional radiologist
Subjects on any immunomodulatory drug
Patients must have radiographic evidence of malignancy in the spine or cauda equina region (L to sacrum) which is suitable for radiation therapy
Patients with paraspinal extension of disease with visceral involvement, exclusive of patients with cauda equina and sacral disease extension
Subjects who have received at least one vaccine under protocol University of Pennsylvania Cancer Center (UPCC)- or UPCC-
Subjects who are positive for serum anti-Yo (cerebellar degeneration-related protein  [cdr]) antibodies are not eligible; (Yo antibody does not need to be repeated if performed in the past)
Hemodynamic instability requiring continuous infusions of inotropes or vasopressors
History (last  months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
Individuals rated as moderate (-) to high ( or greater) on suicidality as assessed by Module B of the MINI
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or tetrahydrocannabinol (THC); a. participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; b. participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return
Extra-cranial metastasis
Extensive disease, disease location, and/or co-morbid condition that the PI or designee considers unsafe for surgical intervention of NK cell infusion
Patients with history of pneumonectomy
Willingness to take everolimus orally and maintain a pill diary
DONOR: Non-inherited maternal antigen (NIMA), inhibition of platelet aggregation (IPA), and natural killer cell (NK) reactivity will not be included in selection criteria
Masses located close to the hilar vessels or at locations that cannot be accessed with the HIFU probe
Patients with myelodysplastic syndromes refractory (primary or acquired resistance) to hypomethylating agents; at least  -month cycles of prior decitabine or SGI- (guadecitabine) OR  -month cycles of -azacytidine (intravenous [IV], subcutaneous, or oral) is required unless the patient has progressive disease prior to completing the required number of cycles
Patients with another active malignancy; asymptomatic sites of disease are not considered active; treated or untreated sites of disease may be considered inactive if they are stable for at least  months and are not expected to require therapy for  months
Produce an expired carbon monoxide (CO) level greater than or equal to  parts per million (ppm) or a NicAlert reading of > 
Have a history of neurological illness or closed head injury
Report uncorrected vision problems
Have STEC-HUS
Have a positive direct Coombs test
Satisfactory (adequate) colposcopy
Lives within  miles of the University of Alabama at Birmingham
Cervical lesion incompletely visualized (e.g., extending into the endocervical canal)
Relief of biliary obstruction if present (percutaneous transhepatic cholangiography [PTC] tube or endobiliary stent)
Presence of Tb disease, precluding organ preservation
Patients receiving the following drugs that are contraindicated with NFV will be excluded:\r\n* Antiarrhythmics: amiodarone, quinidine\r\n* Antimycobacterial: rifampin\r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine\r\n* Herbal products: St. Johns wort (hypericum perforatum)\r\n* -hydroxy--methyl-glutaryl-coenzyme A (HMG-CoA) reductase potential  inhibitors: lovastatin, simvastatin\r\n* Neuroleptic: pimozide\r\n* Proton pump inhibitors\r\n* Sedative/hypnotics: midazolam, triazolam
Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study:\r\n* Anti-convulsants: carbamazepine, phenobarbital, phenytoin\r\n* Anti-mycobacterial: rifabutin\r\n* Phosphodiesterase type  (PDE) inhibitors: sildenafil, vardenafil, tadalafil\r\n* HMG-CoA reductase inhibitors: atorvastatin, rosuvastatin\r\n* Immunosuppressants: cyclosporine, tacrolimus, sirolimus\r\n* Narcotic analgesic: methadone\r\n* Oral contraceptive: ethinyl estradiol\r\n* Macrolide antibiotic: azithromycin\r\n* Inhaled/nasal steroid: fluticasone\r\n* Antidepressant: trazodone
Subjects with a strong likelihood of non-adherence such as difficulties in adhering to follow-up schedule due to geographic distance from the Siteman Cancer Center should not knowingly be registered
Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for the eligible injection sites (left and right medial deltoid region) exceeds  mm
Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art
Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region
Nutrition evaluation with consideration of percutaneous endoscopic gastrostomy (PEG) tube placement
T/ or N
TN disease
If the patient has received pre-operative neoadjuvant chemotherapy, evidence of response must be documented by at least one of the following: decline in serum carcinoma antigen (CA) level, at least a % decrease in the sum of the longest diameter of target lesions on radiographic imaging, or resolution of ascites or pleural effusion(s)
Patients receiving neo-adjuvant chemotherapy whose disease has progressed following at least  cycles, defined by at least one of the following: clinical deterioration (new or worsening of existing ascites, carcinomatous ileus, malignant bowel obstruction, declining performance status), new lesion(s) or increase in maximal diameter of > % of the two largest target lesions, rising CA- (an increase of at least % of baseline value that increases over  values obtained every  days)
Female patients of any ethnic group; female patients must be surgically sterile, postmenopausal (no menses for at least one year), or using medically approved method of contraception (excluding rhythm, withdraw or abstinence)
Homozygous negative for the UDP glucuronosyltransferase  family, polypeptide A (UGT A)* allele
One prior single fraction radiosurgical procedure within the treatment field is acceptable if V <  cc (V is the volume of normal brain [outside gross tumor volume (GTV)] receiving  or more Gy); additional radiosurgical procedures outside of the treatment area are acceptable
Prior therapy with fenretinide, or fenretinide + ketoconazole, if DLT's were experienced
Concurrent use of the selective serotonin reuptake inhibitor (SSRI) antidepressant fluvoxamine (Luvox)
Having a tattoo on the back that is too large to permit PVB injections (as determined by the provider performing the procedure)
Pathologic T or T disease, resected with negative margins (>= mm)
Pathologic Na, Nb, or Nc disease
Presence of close (<  mm) or positive margins
ARM  - BPDCN: Research participants with a diagnosis of BPDCN, according to World Health Organization (WHO) classification by hematopathology, who underwent at least  line of systemic therapy for BPDCN and who have persistent or recurrent disease in at least one of the following are eligible: peripheral blood, bone marrow, lymph nodes, spleen, cutaneous lesions or other sites OR participant who are at high risk for disease recurrence
Patients with histologically confirmed peritoneal surface malignancies, including malignant peritoneal mesothelioma and peritoneal carcinomatosis (PC) from presumed appendiceal and colorectal primary tumors; most patients will have received extensive prior treatments, due to the recurrent nature of PC; prior therapies involve previous CRS, local and systemic chemotherapy, and their different numbers; none of these prior treatments disqualifies the patient from receiving the protocol-mandated experimental treatment
Any contra-indication to angiography
Males must agree to take appropriate precautions to avoid fathering a child (with at least % certainty) from screening through  months after the last dose of rituximab; (Note: permitted methods that are at least % effective in preventing pregnancy should be communicated to the participants and their understanding confirmed)
Chronic neurologic condition which affects voice or swallow (for instance, multiple sclerosis or Parkinson disease)
Patients who are moribund
Subjects on cisapride, oral midazolam, nisoldipine, felodipine, pimozide, quinidine, dofetilide, triazolam, methadone, levacetylmethadol (levomethadyl), lovastatin, simvastatin, dihydroergotamine, ergometrine (ergonovine), ergotamine and methylergometrine (methylergonovine), cisapride, pimozide, methadone, levacetylmethadol (levomethadyl), quinidine
Subjects with a history of keloids or excessive scarring
Expected ablation volume > % of total liver volume or removal of  hepatic segments
Baseline Chemistry
EBV: For treatment of persistent EBV infection despite standard therapy; for EBV infection, standard therapy is defined as rituximab given at  mg/m^ in patients for - doses with a cluster of differentiation (CD)+ tumor\r\n* EBV infection: defined as\r\n** Biopsy proven lymphoma with EBV genomes detected in tumor cells by immunocytochemistry or in situ PCR\r\n** Or clinical or imaging findings consistent with EBV lymphoma and/or elevated EBV viral load in peripheral blood\r\n* Failure of therapy is defined as\r\n** Increase or less than % response at sites of disease for EBV lymphoma OR\r\n** Increase or a fall of less than % in EBV viral load in peripheral blood or any site of disease after st dose of rituximab
BK virus: Treatment of persistent BK virus infection or BK virus disease despite antiviral treatment with cidofovir or leflunomide; no clear standard treatment is defined; cidofovir has been administered in low doses as well as high doses to HSCT patients with BK infections but no randomized trials are available proving its clinical efficacy; in small trials leflunomide had activity against BK virus, therefore we will consider this agent an acceptable alternative to cidofovir, given the absence of a clear first line option\r\n* BK virus infection is defined as the presence of BK virus positivity as detected by PCR or culture in one site such as blood or urine\r\n* BK virus disease is defined as the presence of BK virus detectable by culture or PCR in blood or urine or other body fluids and symptoms of disease including, but not limited to persistent microscopic or macroscopic hematuria or detectable BK virus in more than one site\r\n* Failure of therapy is defined as a rise or a fall of less than % in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) or worsening hematuria after  days of antiviral therapy
HHV: Treatment of persistent HHV infection or disease despite antiviral treatment with ganciclovir, cidofovir and foscarnet; no clear standard treatment is defined; ganciclovir, cidofovir and foscarnet all have variable in vitro activity against HHV-, and may have a role in treating HHV--associated disease  therefore antiviral treatment with one or more of these agents will we acceptable initial therapy\r\n* HHV virus infection is defined as the presence of elevated HHV- levels as detected by PCR or positive culture in one site such as cerebrospinal fluid (CSF) or blood\r\n* HHV disease is defined as defined as the presence of HHV detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of HHV encephalitis OR detectable HHV by PCR or culture in more than one site\r\n* Failure of therapy is defined as a rise or a fall of less than % in viral load in peripheral blood or any site of disease (as measured by PCR or any other quantitative assay) after  days of antiviral therapy
JC virus: Treatment of progressive or persistent JC virus infection or disease without suitable alternative treatment option; pepmixes specific for antigens on adenovirus, EBV, CMV, HHV and BK virus are used to generate multivirus-specific VSTs; no pepmix specific for the rare JC virus is used for generation of these cytotoxic T lymphocytes (CTLs), however given the high homology (> %) between JC and BK and the fact that BK virus-specific T cells targeting polyomavirus capsid protein (VP) and large T (as targeted in multivirus VSTs) have been administered to treat JCV-progressive multifocal leukoencephalopathy (PML), resulting in viral clearance from the cerebrospinal fluid it is likely that VSTs are efficacious against JC virus; given the current lack of treatment options for JC virus infection or reactivation after HSCT and the risk of progression to PML, which is almost uniformly fatal, and the apparent activity of BK virus-directed T cells against JC virus infected cells, this trial proposes including patients with progressive or persistent JC virus on this study, unless a suitable alternative therapy is available\r\n* JC virus infection is defined as the presence of elevated JC virus levels as detected by PCR or positive culture in one site such as CSF or blood\r\n* JC virus disease is defined as defined as the presence of JC virus detectable by culture or PCR in one or more sites such as blood or CSF and symptoms of disease including symptoms of PML OR detectable JC virus by PCR or culture in more than one site
Adequate blood cell counts (i.e. absolute neutrophil count [ANC] > ) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and epoetin
Patients are in CR/VGPR or have primary refractory NB in BM - i.e., NB resistant to standard therapy, as evidenced by persistence of NB in the BM by histology or metaiodobenzylguanidine (MIBG) scan, but all other findings in scans show VGPR
Electrocardiogram (EKG) showing no ischemic changes and no abnormal rhythm
Requires urinary catheterization for voiding due to obstruction secondary to prostatic enlargement thought to be due to prostate cancer or benign prostatic hyperplasia
No prior attempt at mobilizing PBSC
Patients must not have received radiation therapy to more than % of hematopoiesis forming bones (spine, pelvis and proximal long bones) during lifetime
Active epilepsy or convulsive conditions that require continuous use of anticonvulsants
Focally positive surgical margins are permitted
Patients with a history of gallbladder problems or gall stones or biliary obstruction, unless patient had cholecystectomy
Prior treatment with the following agents known to have endocrine effects on prostate cancer: GnRH agonist, GnRH antagonist, anti-androgen (bicalutamide, nilutamide, flutamide), ketoconazole, diethylstilbestrol, estrogen, abiraterone acetate; concurrent use of -alpha-reductase inhibitors finasteride or dutasteride is permitted for patients who have been already receiving either of these treatments for at least  month at the time of study enrollment; baseline PSA must have been obtained in such patients after at least  month on -alpha-reductase treatment; initiation of treatment with -alpha-reductase inhibitors is not permitted within the first  months of study participation
Patients with sickle-cell anemia or thalassemia major.
Fractional shortening (FS) > %
The patient who has not previously received hyperthermic intraperitoneal chemotherapy must have histopathologically or cytologically confirmed cancer from peritoneal mesothelioma, pseudomyxoma, or gastrointestinal malignancies (excluding pancreatic and hepatobiliary) with known synchronous or metachronous disease dissemination limited to the peritoneal surfaces
Sickle cell disease - patients with sickle cell disease at high risk for disease related morbidity or mortality, defined by having irreversible end-organ damage (A, B, C, D, or E) or potentially reversible complication(s) not ameliorated by hydroxyurea (F):\r\n* A. Stroke defined as a clinically significant neurologic event that is accompanied by an infarct on cerebral magnetic resonance imaging (MRI) or an abnormal trans-cranial Doppler examination (>=  m/s); or\r\n* B. Sickle cell related renal insufficiency defined by a creatinine level >= . times the upper limit of normal and kidney biopsy consistent with sickle cell nephropathy or nephrotic syndrome or creatinine clearance <  mL/min or requiring peritoneal or hemodialysis; or\r\n* C. Pulmonary hypertension as defined by tricuspid regurgitant jet velocity (TRV) of >= . m/s at least  weeks after a vaso-occlusive crisis; or\r\n* D. Recurrent tricorporal priapism defined as at least two episodes of an erection lasting >=  hours involving the corpora cavernosa and corpus spongiosa; or\r\n* E. Sickle hepatopathy defined as either ferritin >  mcg/L or direct bilirubin > . mg/dL at baseline; or
Thalassemia - patients with thalassemia who have grade  or  iron overload, determined by the presence of  or more of the following:\r\n* Portal fibrosis by liver biopsy \r\n* Inadequate chelation history (defined as failure to maintain adequate compliance with chelation with desferroxamine initiated within  months of the first transfusion and administered subcutaneously for - hours at least  days each week)\r\n* Hepatomegaly of greater than  cm below the costochondral margin
Major ABO mismatch
Total bilirubin =< , (with relief of biliary obstruction if present [percutaneous transhepatic cholangiography (PTC) tube or endobiliary stent])
Isolated extra-medullary disease relapse
Results of ATRX and/or p/q chromosomal status: if ATRX is lost, p/q status is not required; if ATRX is intact, p/q chromosomal status must be available to permit treatment selection
Results of pRAS testing
Multi-focal disease
The extrathoracic disease must be controlled
Positive test results for human T-lymphotropic  (HTLV ) virus; HTLV testing is required in patients from endemic countries (Japan, countries in the Caribbean basin, South America, Central America, Sub Saharan Africa, and Melanesia)
Patients with a history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors, such as schwannoma, acoustic neuroma, or ependymoma only if those lesions have been stable for the past  months
Histologically documented uterine leiomyosarcoma with no visible residual disease
Patients must have histological evidence of a metastatic well differentiated or moderately differentiated mucinous appendiceal epithelial neoplasm (AEN)
Radiographic images demonstrating the presence of mucinous peritoneal carcinomatosis (PMP)
Patients must be able to understand and provide answers to the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core- (QLQ-C)/ovarian (OV)- QOL questionnaires in order to participate in the trial
Patients who are receiving an emergency colonoscopy
History and physical including neurological exam, height, weight, cranial skin exam, and Karnofsky performance status >= % within  days prior to registration
History of central nervous system (CNS) radiotherapy: radiation of  gray (Gy) in  fractions, . Gy in . Gy fractions,  Gy in  fractions or equivalent or lower doses
Known sensitivity or allergy to conductive hydrogels (like the gel used on electrocardiogram [ECG] stickers or TENS [transcutaneous electrical nerve stimulation] electrodes)
Childs class A or B
Prior use of duloxetine or milnacipran
History or behavior that would, in the investigators judgment, prohibit compliance for the duration of the study
Presenting with anti-erythrocyte antibodies leading to the unavailability of phenotype compatible red blood cells.
Infratentorial disease
Patient receiving or planning to receive trastuzumab, trastuzumab with pertuzumab or ado-trastuzumab emtansine, for at least  months, alone or in combination with other systemic treatment or radiation
Anergic, defined by the inability to make a Delayed-type Hypersensitivity (DTH) to at least one of the following: candida, mumps, tetanus or trichophyton (based upon availability)
No irreversible coagulopathies
Inability to deliver target dose with CyberKnife due to normal tissue dose constraints
Decreased platelet count and/or anticoagulation parameters that would preclude transcutaneous placement of fiducials
Must not have taken a hypomethylating agent
Patients who have received prior therapies will be allowed to enroll after a wash-out period as follows assuming they have recovered from the side effects of such therapies:\r\n* Chemotherapy   week wash-out period\r\n* Oral agents   week wash-out period (except vemurafenib, which will require no wash-out period)\r\n* Investigational agents   week wash-out period\r\n* Immunotherapy   week wash-out period\r\n* Palliative radiation therapy to bone/brain   week wash-out period\r\n* Major radiation or surgical procedure   week wash-out period
MATCHED RELATED DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
HAPLOIDENTICAL RELATED DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
Children with INSS  disease, age <  months with all  favorable biologic features (non-amplified MYCN, favorable pathology and deoxyribonucleic acid [DNA] index > )
Subjects will be recruited from patients who are potential candidates for SRS treatment at Dartmouth Hitchcock Medical Center (DHMC) for brain metastases
Invasive ductal, medullary, papillary, colloid (mucinous) or tubular histologies
All tumors (invasive and non-invasive disease) must be excised with a minimum margin width of >=  mm; re-excision of surgical margins is permitted; focally close (<  mm) or positive (tumor cells at the inked edge of the specimen) margins determined to be at an anatomic boundary of resection by the surgeon, such as posterior fascia for posterior margins or skin for anterior margins, are also acceptable
Patients presenting with abnormal microcalcifications on a screening mammogram must have radiographically confirmed excision of the suspicious microcalcifications, either by specimen radiograph or post-biopsy mammograms
Subject presents an increased surgical risk including abnormally positioned carotid artery or an inability to obtain adequate exposure for transoral surgery
Use of any of the following within the past  days: megestrol acetate (Megace), diethyl stilbestrol (DES), or cyproterone acetate, ketoconazole, high dose calcitriol [,(OH)VitD] (i.e., > . ug/week)
Primary HLH patients
History of priapism
Known history of retinitis pigmentosa
Known mitochondrial disorder caused by mutations in mitochondrial deoxyribonucleic acid (DNA) polymerase gamma
Failure to obtain insurance/payment authorization for Zevalin, unless the subject agrees to cover the cost
Positive leukocytotoxic crossmatch
DONOR: Positive infectious disease test as dictated by blood collection centers standard operating procedure (SOP)
Concurrent treatment or medications (must be off for at least  week) including:\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Patient has participated in a Novartis sponsored combination trial where pasireotide was dispensed in combination with another study medication and is still receiving combination therapy. (only patients receiving pasireotide monotherapy can be included)
Sexually active males unless they use a condom during intercourse while taking drug and for  months after pasireotide s.c. last dose and  months after pasireotide LAR last dose and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid If a study patient or partner becomes pregnant or suspects being pregnant during the study or within  month after the final dose of pasireotide s.c. or  months after the final dose of pasireotide LAR, the Study Doctor needs to be informed immediately and ongoing study treatment with pasireotide has to be stopped immediately For patients taking pasireotide LAR, the future dose injections will be cancelled.
Patients must demonstrate active noninfectious inflammatory pustular skin lesions resembling pustular psoriasis and involving >= % total body surface area, or palmoplantar involvement; conditions may include, but are not be limited to, pustular psoriasis, Sneddon-Wilkinson disease, subcorneal pustular dermatosis, reactive arthritis, palmoplantar pustulosis, acrodermatitis continua of Hallopeau and palmoplantar pustular psoriasis
Patients must have histopathologic confirmation of epidermal neutrophilic pustular skin disease
Quantiferon tuberculosis (TB) gold must be performed for screening for mycobacterium tuberculosis infection; however, a tuberculin skin test may be placed if the Quantiferon TB gold test is indeterminate; patients must have a negative Quantiferon TB Gold (or tuberculin skin test) or evidence of appropriate treatment prior to study entry
History of anakinra use
Subjects who experience a significant flare after discontinuation of a tumor necrosis factor (TNF) inhibitor as part of this study that requires urgent medical management or hospitalization, or in the estimation of the principal investigator poses excessive risk to the patient to enter the study
Other defined dermatologic conditions which may include pustules as part of the clinical presentation, but which clinically and/or histologically do not resemble pustular psoriasis; examples include, but are not limited to acute generalized exanthematous pustulosis (AGEP, a drug-induced pustular dermatosis typically caused by beta-lactam antibiotics, tetracyclines, oral antifungals and other drugs), bacterial or fungal folliculitis, cutaneous candidiasis, tinea pedis, tinea corporis, neutrophilic eccrine hidradenitis or eosinophilic pustular folliculitis (Ofuji syndrome)
Chest x-ray (if Quantiferon TB Gold is positive) demonstrating pleural scarring and/or calcified granuloma consistent with prior or current untreated TB
Individuals with life-threatening or disabling inflammation of the eyes, gut or joints requiring urgent or immediate medical attention, or at the physician's discretion
Subjects for whom there is concern about compliance with the protocol procedures
Have a haploidentical family peripheral blood donor selected for best possible killer cell immunoglobulin-like receptor (KIR) reactivity; KIR typing will not be indicated if there is only one haploidentical donor; KIR typing is advised to be done if feasible and does not delay transplant
Newly diagnosed, untreated intraocular retinoblastoma; participants previously diagnosed with unilateral retinoblastoma treated surgically, with focal therapy or needing chemotherapy who develop asynchronous involvement of the contralateral eye, or patients with unilateral retinoblastoma treated only with enucleation or focal therapy who develop asynchronous involvement of the contralateral eye, will be eligible for study
Chronic (> month duration) IA, relapsed/recurrent IA, or refractory IA which has not responded to antifungal therapy.
Known hereditary problem of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
On artificial ventilation or receiving acute Continuous Positive Airway Pressure (CPAP)/Bilevel Positive Airway Pressure (BPAP) at the time of randomization.
Distal biliary obstruction consistent with pancreatic cancer, distal CBD cholangiocarcinoma or other periampullary malignancy
Location of distal biliary obstruction is such that it would allow the proximal end of a stent to be positioned at least cm from the hilum
Endoscopic and surgical treatment to be provided by same team
Surgically altered biliary tract anatomy, not including prior cholecystectomy
Patients for whom endoscopic techniques are contraindicated
If image guidance with daily cone beam CT with direct physician visual assessment is used for treatment positioning, the presence of markers or clips in the surgical bed is recommended but not required. If cone beam CT imaging will NOT be used for image guidance, then the patient must be prepared to have  fiducial markers minimum,  preferred, placed prior to treatment (if not previously done).
Paget's disease of the nipple.
Histologically and cytologically proven bile duct cancer of any type (including intrahepatic cholangiocarcinomas, extrahepatic primary cholangiocarcinomas, hilar cholangiocarcinomas, cholangiocarcinomas located in the gall bladder or hepatic capsule effraction, and carcinoma of the Ampulla of Vater, etc.) that is not amenable to surgery, radiation, or combined modality therapy with curative intent, and has failed or is not eligible for available chemotherapies such as gemcitabine with or without platinum
Patients who relapse after receiving a one or more courses of fludarabine, bendamustine, cytoxan, rituxan, chlorambucil, or campath based therapy
Patients should have findings of relapse by one or both of the following:\r\n* ALC >  on  consecutive occasions and increasing\r\n* Any increase in lymphadenopathy over best response that has persisted for more than  months
Must not have nonmyeloablative conditioning as defined below:\r\n* TBI =<  Gy +/- purine analog\r\n* Flu + Cy +/- antithymocyte globulin (ATG)\r\n* Flu + cytarabine (AraC) + idarubicin (Ida)\r\n* Cladribine + AraC\r\n* Total lymphoid irradiation + ATG
Must not receive antithymocyte globulin as part of pre-transplant conditioning regimens
Prior sotatercept
No restriction based on prior treatments
Patients who are receiving antiarrhythmic medications with action on repolarization times (with prolongation of the QTc interval such as amiodarone, disopyramide, dofetilide, flecainide, ibutilide, quinidine, sotalol, dronedarone etc.)
Have a target tumor that is accessible for intratumoral administration by PTA (Percutaneous transluminal approach) or EUS (Endoscopic Ultrasound) guidance as determined by the radiologist/gastroenterologist performing the PTA/EUS injection.
History of biliary colic attack
Established refractoriness to CMC-
Patients must be deemed to have borderline resectable disease (adapted from National Comprehensive Cancer Network [NCCN] Practice Guidelines in Oncology - v..) with no radiologic evidence of distant metastatic disease prior to registration; specifically, patients must have at least one designation of borderline resectable and no designation of unresectable disease
Total bilirubin < . mg/dl with relief of biliary obstruction if present (percutaneous transhepatic cholangiography [PTC] tube or endobiliary stent)
COHORTS  AND : HEALTHY VOLUNTEERS: Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as clinics, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
Disease amenable to biopsy via percutaneous approach or other minimally invasive procedures such as thoracoscopy, bronchoscopy, laparoscopy, or gastrointestinal (GI) endoscopy
Normal phosphorus (can be on oral supplementation)
Patients with ATP-binding cassette, sub-family B (MDR/TAP) (ABCB) and ABCB genotypes associated with mithramycin-mediated hepatotoxicity
Certain scores on an anxiety and depression mood questionnaires
Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is < % of T cell population
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (patients must discontinue drug  days prior to starting dasatinib):\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Other rare lethal disorders of hematopoiesis and lymphohistiocytosis for which a T-cell depleted transplant is indicated (e.g., hemophagocytic lymphohistiocytosis; refractory; non-severe combined immunodeficiency [SCID] lethal genetic immunodeficiencies such as Wiskott Aldrich syndrome, CD ligand deficiency, autoimmune lymphoproliferative syndrome [ALPS])
Patients must be willing to forego other drug therapy against the tumor while being treated with pulse dosing of lapatinib and temozolomide and radiation and subsequently pulse dosing lapatinib and temozolomide
Patients who have any disease that will obscure toxicity or dangerously alter drug metabolism
Exclusion criteria (PET specific):\r\n* Pregnant or nursing women; extreme claustrophobia; weight near or greater than  pounds
Must have clinically severe SCD (SS, SC or SBeta Thal) or thalassemia major and be eligible for myeloablative SCT
Sufficient physiological reserves
Patients with biopsy proven locally advanced sinus, nasal cavity, hard palate, soft palate, major or minor salivary gland tumors, or lacrimal apparatus, with nasal cavity, sinus, auditory canal, or skull base involvement are eligible
Patients assessed at presentation as requiring interstitial brachytherapy treatment
Patients with a hypersensitivity to halichondrin B and/or halichondrin B chemical derivative
Colorectal cancer patients with known v-Ki-ras Kirsten rat sarcoma viral oncogene homolog (KRAS) mutation (for the arm combining bevacizumab, temsirolimus and cetuximab)
Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma or other EBV-associated malignancy, OR
EBV-specific T-cells are available for adoptive immune cell therapy from a consenting third party donor; the third party EBV CTLs to be administered will be selected on the basis of two criteria: ) that they are matched for at least  HLA antigens and ) that they are restricted by an allele shared with the EBV+ malignancy (if known), or with the donor in HSCT recipients, or patient in organ transplant or immunodeficient patients
Patients who develop EBV lymphomas or lymphoproliferative diseases or other EBV-associated malignancy as a consequence of profound immunodeficiencies associated with a congenital immune deficit or acquired as a sequela of anti-neoplastic or immunosuppressive therapy; for these patients, normal, EBV specific T-cells from third party seropositive donors who are HLA compatible in ) at least  HLA antigens and ) one restricted allele shared by the patient will be used; again, selection of T cells known to be restricted by an allele shared by the patient will be given priority
Patients who develop other EBV-associated malignancies without pre-existing immune deficiency, including: EBV+ Hodgkin's and non-Hodgkin's disease, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma; normal, EBV specific T-cells from third party seropositive donors who are HLA compatible in ) at least  HLA antigens and ) one restricted allele shared by the patient will be used; again, selection of T cells known to be restricted by an HLA allele shared by the patient will be given priority
For subjects with HIV-associated entered after a tolerable dose has been determined, KS lesions must be either:\r\n* Increasing despite HAART and HIV suppression below the limit of detection ( copies/mL) in the two months prior to screening or\r\n* Stable despite HAART for at least three months; stable disease must be symptomatic (examples of symptomatic disease include disease associated with pain, edema, psychological distress and/or social withdrawal)
Any abnormality that would be scored as a >= grade  toxicity by CTCAE, except:\r\n* Obesity is not considered an abnormality for the purposes of eligibility assessment unless in the opinion of the principal investigator or lead associate investigator its clinical consequences in a particular subject places the subject at unacceptable risk if they were to participate in the study or confounds the ability to interpret data from the study\r\n* Lymphopenia\r\n* Asymptomatic hyperuricemia, hypophosphatemia, or creatine kinase (CK) elevations\r\n* Direct manifestations of KS\r\n* Direct manifestations of HIV infection, except for neurologic or cardiac manifestations\r\n* Direct manifestations of HIV therapy, except for neurologic or cardiac manifestations
ABT- is primarily excreted in the urine, and is not even metabolized by the liver; thus such degree of hepatic impairment is not expected to affect the dosing of ABT-
Any cytogenetic abnormality in the bone marrow that is known to be associated with or predictive of myelodysplasia is excluded; this includes, but is not limited to, del(), del(), del()
Patient must present with indications for diagnostic or therapeutic approaches for benign and/or malignant diseases of the oral cavity or laryngopharynx (including the neoplastic lesions of the tongue, tongue base, retromolar trigone, tonsils, palate, posterior and lateral pharynx, glottic, supraglottic and subglottic larynx)
Inability to adequately visualize anatomy to perform the diagnostic or therapeutic surgical approach transorally
Containing calcifications in the focused ultrasound sonication beam path in the event system tools cannot tailor the treatment around these calcification spots
More than % of the skull area traversed by the sonication pathway is covered by scars, scalp disorders (e.g., eczema), or atrophy of the scalp.
Unstable hemodynamic status including:
At least  months from completion of temozolomide (to be consistent with the rechallenge group from Perry et al. JCO )
Any abnormality that would be scored as NCI Common Toxicity Criteria (CTC) grade  toxicity that is unrelated to HIV, its treatment, or to MCD that would preclude protocol treatment; exceptions include:\r\n* Lymphopenia\r\n* Direct manifestations of Kaposi sarcoma or MCD\r\n* Direct manifestation of HIV (i.e. low cluster of differentiation [CD] count)\r\n* Direct manifestation of HIV therapy (i.e. hyperbilirubinemia associated with protease inhibitors)\r\n* Asymptomatic hyperuricemia\r\n* Hypophosphatemia\r\n* Elevated creatinine kinase (CK) attributed to exercise
Subjects must not be candidates for intensive high-dose chemotherapy, with or without an autologous stem cell transplant (ASCT), due to one or more of the following factors:\r\n* Age >=  years: Patients <  years of age must be ineligible for high-dose chemotherapy (HDT)/ASCT on the basis of comorbidity, organ dysfunction or patients refusal for HDT/ASCT\r\n* Comorbid disease, such as coronary artery disease (CAD), congestive heart failure (CHF), pulmonary dysfunction, liver or kidney dysfunction, precluding high dose therapy secondary to expected increased morbidity and mortality: poor performance status (Karnofsky performance scale [KPS] % or less); ejection fraction < %; impaired pulmonary function test with diffusing capacity of lung for carbon monoxide (DLCO) < % expected\r\n* Patient refusal\r\n* Medical conditions which in the opinion of the treating physician and DMT preclude HDT/ASCT
Patients with mixed chimerism (present of more than % recipient chimerism) at  months post transplant will not be started on the protocol until the chimerism changes back to > %
DONOR: Evidence of prior sensitization to EBV by EBV serology testing (seropositive)
Preceding and/or ongoing organ dysfunction or other co-morbidity including but not limited to uncontrolled infection that would impair the patients ability to endure known side effects of cytokine release syndrome or neurological toxicity
Patients with foreign body intracranially, such as bullet fragments, are not allowed, with the exception of VP-shunts (non-programmable) and Ommaya catheters
Immunohistochemically negative for IDH RH mutation
Subjects with active Epstein-Barr virus (EBV) unrelated to underlying lymphoma (positive serology for anti-EBV virus capsid antigen [VCA] IgM antibody and negative for anti-EBV Epstein-Barr nuclear antigen [EBNA] IgG antibody, or clinical manifestations and positive EBV PCR consistent with active EBV infection)
An activating point mutation in HER including, but not limited to, LS, GV, and VL.
An activating point mutation in HER including, but not limited to, LS, GV, and VL.
Histologic evidence of Well differentiated Neuroendocrine tumors (NETs) of the lung (typical and atypical according to the World Health Organisation (WHO criteria), evaluated locally)
Has a mitotic index < mitoses/ mm for typical carcinoid (TC) and < mitoses/ mm and/or foci of necrosis for atypical carcinoid (AC)
Positive Somatostatin receptors (SSTR) imaging
Has been treated with an Somatostatin analogs (SSA) at any time prior to randomization, except if that treatment was for less than  days (e.g. peri-operatively) of short acting SSA or one dose of long acting SSA and the treatment was received more than  weeks prior to randomization
Patients must weigh ?  kg (due to possible size limitations with respect to percutaneous catheterization of the femoral artery and vein using the Delcath Hepatic Delivery System).
Patients with prior Whipple's procedure.
Parts  and :
Parts  and :
Part :  or 
Parts ,  and : , , or 
Recent (<  months) active diverticulitis
For patients with non-measurable, structural disease the following must apply:\r\n* Undetectable thyroglobulin antibody AND\r\n* A serum thyroglobulin of  ng/ml or greater in the context of suppressed thyroid-stimulating hormone (TSH) (TSH =< . mcU/ml) =<  days prior to study registration; use of any thyroglobulin assay is allowed, though all serum thyroglobulin measurements for study purposes must be conducted with the same thyroglobulin assay
Patients with del(p) confirmed by FISH in >= % of cells or on stimulated karyotype
Patients with unmutated IGHV who also have a complex karyotype on a stimulated karyotype
Tumors will be deemed Wnt positive if, at the time of central analysis, there is:\r\n* Monosomy  as determined by array comparative genomic hybridization (CGH)\r\n* Gene transcript detection by NanoString supporting Wnt+ medulloblastoma\r\n* Absence of large-cell, anaplastic histology\r\n* Nuclear b-catenin immunohistochemistry (IHC) result will be determined, but not required for the diagnosis
Patients of Asian descent
A reasonable suspicion of ovarian cancer by the treating oncologist is required, evidenced by abdominal carcinomatosis, omental caking, pleural effusions or ascites AND an elevated CA >  OR CA:carcinoembryonic antigen (CEA) ratio >  OR CA =<  with no evidence of gastrointestinal (GI) cancer
ELIGIBILITY CRITERIA FOR REGISTRATION: subjects for whom neoadjuvant chemotherapy followed by interval cytoreductive surgery is planned must have fine needle aspirate (FNA) or other cytology showing adenocarcinoma OR core biopsies OR surgically directed biopsies showing adenocarcinoma AND CA over  OR CA:CEA ratio >  OR CA =<  with no evidence of GI cancer; they should have presumed stage III or IV disease, generally based on abdominal carcinomatosis, omental caking, pleural effusions or ascites
Fibrinogen > 
Para-aortic or inguinal metastasis
Patients undergoing preoperative chemoradiotherapy
Patients with any disease that would obscure toxicity or dangerously alter drug metabolism
Bulky disease in the fissure preventing lung-sparing pleural IMRT
Patients undergoing extrapleural pneumonectomy
Patients treated on this study will have:\r\n* Acute leukemia in st or nd complete remission (CR)\r\n* MDS (myelodysplastic syndrome), specific subtypes of RA (refractory anemia) or RARS (refractory anemia with ringed sideroblasts) subtypes\r\n* Hodgkin or indolent non-Hodgkins lymphoma with chemosensitive disease\r\n* Myeloma without morphological evidence of disease, or a PR to the most recent therapy\r\n* Myeloproliferative disorders with at least a PR to current therapy\r\n* Aplastic anemia\r\n* A hematological or oncological disease (not listed) that meets the criteria reviewed above
Patients who have developed anaphylactic responses to other vaccines
Histologically documented uterine carcinosarcoma with no visible residual disease
Patients can have extra-hepatic disease, provided the hepatic disease is the highest burden, the extra-hepatic disease is low burden and potentially treatable with surgery, ablative radiation therapy, or United States (US) Food and Drug Administrationapproved first- or second-line systemic therapy regimens
Other baseline neurocognitive or emotional disorders or deficits, including but not limited to head injury, cardiovascular accident (CVA), transient ischemic attack (TIA), or other cerebral insults with residual neuropsychiatric deficits, psychiatric disorders, learning disabilities, human immunodeficiency virus (HIV) positivity or other medical conditions at high risk of causing neurocognitive decline or emotional instability
Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and ampullary carcinomas are not eligible
Diagnosis of NF by National Institutes of Health (NIH) criteria () with evidence of either:\r\n* Bilateral vestibular schwannomas, or\r\n* First-degree family relative with NF and either unilateral vestibular schwannomas (VS) or any  of: meningioma, schwannoma, glioma, neurofibroma, or juvenile posterior subcapsular lens opacity
Patients must have at least one unresected VS
FA complementation group A as determined by somatic cell hybrids, molecular characterization, western blot analysis, acquisition of mitomycin C resistance after in vitro lentiviral transduction with a vector bearing the complementary deoxyribonucleic acid (cDNA) for Fanconi complementation group A, or other clinically certified method of complementation group analysis
Physical or emotional status that would prevent informed consent, protocol compliance, or adequate follow-up
Total abstinence or
For the diagnosis of pure germinoma, HCGB (serum and CSF) must be =<  mIU/ml, serum AFP must be =<  IU/l (ng/ml) and =< institutional norm and CSF AFP =<  IU/l (ng/ml) and =< institutional norm with histologically proven diagnosis of germinoma at diagnosis or relapse
For histologically unconfirmed MMGCT, serum and/or CSF tumor markers of HCG? >  mIU/ml or any elevation of AFP >  IU/L (ng/ml) and/or institutional norm in the serum and CSF AFP >  IU/L (ng/ml) and/or institutional norm
Paget's disease of the nipple
MATCHED RELATED DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
Concurrent treatment or medications (must be off for at least  week) including:\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections \r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Other rare lethal disorders of hematopoiesis and lymphopoiesis for which a T-cell depleted transplant is indicated (e.g. hemophagocytic lymphohistiocytosis; refractory aplastic anemia or congenital cytopenias; non-severe combined immunodeficiency [SCID] lethal genetic immunodeficiencies such as Wiskott Aldrich syndrome, CD ligand deficiency or, autoimmune lymphoproliferative syndrome [ALPS], as well as refractory autoimmune cytopenias, paroxysmal nocturnal hemoglobinuria [PNH], metabolic storage diseases or heavily transfused congenital hemoglobinopathies)
All other patients, including those with treatment related malignancies and/or those who have AML derived from MDS, will have received extensive prior chemo/radiotherapy and, therefore, will be considered to be at poor risk of conditioning and transplant related morbidities, and potentially transplant related mortality; patients with life threatening non-malignant genetic and acquired disorders will also, by virtue of their history of, optional transfusions and/or infection be considered poor risk; stopping rules for non-relapse related mortality in these heavily treated patients are, therefore, slightly less stringent than patients in the poor risk transplant groups; stopping rules for the principal endpoints of graft failure and GvHD are the same for all groups
Patients with clinically suspected dense intraperitoneal adhesions preventing adequate IP distribution
Histologic proof of phyllodes tumor of borderline or malignant grade, as first defined by Pietruszka and modified by Azzopardi and adopted by the World Health Organization:\r\n * Borderline malignant: - mitoses/ high-power fields (HPF), pushing or infiltrating margins, + (moderate) stromal cellularity and atypia\r\n * Malignant:  or more mitoses/ HPF, predominantly infiltrating margins, usually + (severe) stromal cellularity and atypia but occasionally +
HSV- Seropositive
Known existing uncontrolled coagulopathy, hemorrhagic disorder, or inability to discontinue Coumadin or Plavix for  days prior to each treatment (except for prophylaxis against portacath-associated thrombosis, which does not require cessation of therapy)
Intraperitoneal ports may be placed during or at any time separate from surgical debulking; provided the patient has been allowed at least  weeks to recover from surgical debulking, no additional recovery time is required for port placement
Patients must undergo a peritoneal scan documenting at least one working intraperitoneal port prior to receiving chemotherapy
One of the following:\r\n* At least  prior courses of purine analog\r\n*  prior course of purine analog plus >=  course of rituximab if the response to the course of purine analog lasted <  year\r\n* Diagnosis of HCL variant (HCLv)\r\n* Unmutated (> % homology to germline) IGHV-+expressing HCL/HCLv
Patients with fungal infection and radiological progression after receipt of amphotericin B or active triazole for greater than  month
patients who are immunocompetent
patients who are not pregnant, committed to using adequate contraception if of childbearing age
Patients with a history of keloid formation ( ID delivery group only)
Prostate volume: =<  cc\r\n* Determined using: volume = ?/ x length x height x width\r\n* Measurement from CT or ultrasound =<  days prior to registration
Subjects whose physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from  days prior to being administered HSV to  days following administration should not be in the study
PART II; Subjects must have been enrolled in Part  of this study and have received  dose of HSV and have completed at a minimum the day  follow-up; subjects must have been categorized at a minimum as having stable disease thought to be attributable to the virus; subjects who were minimally characterized as having stable disease are also eligible if their lesion re-occurs or re-grows; the same criteria will be applied to determine eligibility for a third dose, and again for a fourth dose
American Joint Committee on Cancer (AJCC) stage -IIIa (pathologic stage Tis, TN, TN, TNa, TNa, TNa, TNa, M) histologically confirmed ductal carcinoma in-situ or invasive carcinoma of the breast with a lesion =<  cm treated with lumpectomy and either sentinel node biopsy or axillary dissection (if invasive carcinoma is present)
Negative inked histologic margins of lumpectomy (no invasive cells at margin) or negative re-excision specimen to be confirmed prior to radiation
History of malabsorption syndrome e.g., pancreatic insufficiency, celiac disease, tropical sprue
Prior radioimmunotherapy
Admission for UCBT must be within an acceptable time period after the pre-allograft chemotherapy
Units with attached segments for confirmatory typing will be given preference
Myeloproliferative syndromes
Willingness to undergo MDACC Audiology and Ophthalmology Assessment
Patients must be consulted to avoid impregnating partner
Must not be taking a drug specifically known to interact with VPA for at least  weeks prior to initiating the trial; including but not limited to: Aspirin, Felbamate, Rifampin, Amitriptyline/Nortriptyline, Carbamazepine, Clonazepam, Diazepam, Ethosuximide, Lamotrigine, Phenobarbital, Primidone, Phenytoin, Tolbutamide, Warfarin, Zidovudine
Subjects must have an indication for treatment as defined by the NCI Working Group Guidelines
Three lumens of central vascular access will be required for all patients entered on protocol due to the need for a dedicated line for continuous infusion cyclosporine
Verified by morphology and confirmed by cytochemistry and immunophenotyping
MLL status unknown
MLL rearranged AND age >  months
Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(;) and breakpoint as in B-ALL
DONOR: ABO compatibility (in order of priority) \r\n- Compatible\r\n- Major incompatibility\r\n- Minor incompatibility\r\n- Major and minor incompatibility
Poor mouth opening, with maximal opening less than . cm
Hemophagocytic lymphohistiocytosis (HLH), familial hemophagocytic lymphohistiocytosis (FLH), viral-associated hemophagocytic syndrome (VAHS), X-linked lymphoproliferative disease (XLP), severe chronic active Epstein Barr virus infection (SCAEBV) with predilection for T- or natural killer (NK)-cell malignancy
Patients with severe hepatic disease (direct bilirubin greater than  ug/dl or serum glutamic pyruvate transaminase [SGPT] greater than  ug/dl)
Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy; MRD will be defined by either flow cytometry (> .% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (polymerase chain reaction [PCR] or fluorescent in situ hybridization [FISH]) or conventional cytogenetics (g-banding)\r\n* New leukemia subtypes: if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee
Patients must be receiving a v-raf murine sarcoma viral oncogene homolog B (B-RAF) inhibitor and failed to achieve PR or CR or have progressive disease in response to B-RAF treatment (Cohort C)
Myeloproliferative syndromes
All diseases are advanced hematologic malignancies not curable by conventional chemotherapy; responses to conventional treatment range from zero to % but are typically short lived
Myeloproliferative syndromes
Alpha feto protein (AFP) <  ug/L (for non-hepatitis B or C patients); alpha fetoprotein >  ug/L is allowed for patients with hepatitis B or C cirrhosis
Patients must demonstrate the ability and willingness to eat solid food and SV/placebo.
Active acute infection, except for Herpes viruses (cytomegalovirus [CMV], Epstein Barr virus [EBV], herpes zoster virus [HZV], herpes simplex virus  [HSV ]).
A known allergy to one or more components of SV, namely soy beans, mushrooms, mung beans, red dates, scallion, garlic, lentil beans, leek, hawthorn fruit, onions, ginseng, angelica root, Chinese licorice, dandelion root, Senegal root, ginger, olives, sesame seed and parsley.
Patients must have no rapidly progressing or deteriorating neurologic examination
Patients with obstructive or symptomatic communicating hydrocephalus
Non-Hodgkin lymphoma (NHL) previously untreated with cytotoxic chemotherapy; however, patients may be entered if they have had prior cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome) and/or a single dose of intrathecal methotrexate (MTX) at the time of the pre-treatment diagnostic lumbar puncture
Inclusion Criteria:\n\n          -  Pathologically documented EBV antigen positive lymphoproliferative disease, lymphoma,\n             or other EBV-associated malignancy OR\n\n          -  Severely immunocompromised patients who develop blood levels of EBV DNA exceeding \n             copies/ml DNA, and are therefore at high risk for developing an EBV LPD\n\n        It is expected that five types of patients afflicted with EBV-associated lymphomas or\n        lymphoproliferative diseases will be referred and will consent to participate in this\n        trial. These are:\n\n          . Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders\n             following an allogeneic marrow transplant.\n\n          . Patients developing or at risk for EBV lymphomas or lymphoproliferative disorders\n             following an allogeneic organ transplant.\n\n          . Patients with AIDS developing EBV lymphomas or lymphoproliferative diseases as a\n             consequence of the profound acquired immunodeficiency induced by HIV.\n\n          . Patients who develop EBV lymphomas or lymphoproliferative diseases as a consequence of\n             profound immunodeficiencies associated with a congenital immune deficit or acquired as\n             a sequela of anti-neoplastic or immunosuppressive therapy.\n\n          . Patients who develop other EBV-associated malignancies without pre-existing immune\n             deficiency, including: EBV+ Hodgkin's and Non- Hodgkin's disease, EBV+ nasopharyngeal\n             carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma.\n\n        Exclusion Criteria:\n\n        The following patients will be excluded from this study:\n\n          -  Moribund patients who, by virtue of heart, kidney, liver, lung, or neurologic\n             dysfunction not related to lymphoma, are unlikely to survive the - weeks required\n             for in vitro generation and expansion of the EBV-specific T cells to be used for\n             therapy and the subsequent  weeks required to achieve an initial assessment of the\n             effects of infusions of EBV-specific T cells.\n\n          -  Pregnancy does not constitute a contraindication to infusions of EBV-specific T cells.
No prior systemic chemotherapy; patients may be entered if they have had prior limited-field radiotherapy, a short course of glucocorticoids and/or cyclophosphamide for an urgent problem at diagnosis (e.g. epidural cord compression, superior vena cava syndrome)
Platelets ? ,/mcL OR ? . if thrombocytopenia due to iBCL
Be in urgent need of therapy for lymphoma related complications (such as hyperviscosity syndrome) and those with bulky disease
Histologic demonstration of transitional cell carcinoma of the urothelium. Minor components (less than [<]  percent [%] overall) of variant histology such as glandular or squamous differentiation, or evolution to more aggressive phenotypes such as sarcomatoid or micropapillary change are acceptable
Presence of lesions that are amenable for injections as determined by interventional radiology\r\n* NOTE: Nodal or extranodal sites must be palpable and easily accessible; sites such as mediastinum, retroperitoneum, within solid organs, spinal sites, central nervous system (CNS) sites, etc., are NOT allowed
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception
Must have determination of biomarker (BM) status (either BM positive [+] or BM negative [-]) by the sponsor's blood based assay
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception
Patients with uncontrolled or symptomatic kidney stones; NOTE: Patients with calcium oxalate crystals on baseline urinalysis or a history of symptomatic calcium oxalate stones must be seen by the Nephrology Stone Clinic and placed on a low oxalate diet (<  mg oxalate/day) prior to enrollment
Known paroxysmal nocturnal hemoglobinuria (PNH)
Current evidence of endocrine alteration of calcium Phosphate homeostasis (e.g. parathyroid disorder, history of parathyroidectomy, tumor lysis, tumoral calcinosis, paraneoplastic hypercalcemia)
Confirmed diagnosis of primary cold agglutinin disease (CAgD) based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for Cd; d) Cold agglutinin titer >=  at  degree celsius; e) Immunoglobulin G (IgG) DAT less than or equal to (<=) +, and f) No overt malignant disease
Patients must have erythematous manifestations of cutaneous aGvHD. Characteristics of the rash must indicate active inflammation (red coloration) as distinct from resolving inflammation (brown coloration).
Patients known to have CMV, adenovirus, human herpes virus  (HHV), Epstein Barr virus (EBV) or any hepatitis viremia from screening according to institutional standard practice
IA involving sites other than lungs and sinuses
Other leukemia subtypes: A major effort in the field of hematology is to identify patients who are of high risk for treatment failure so that patients can be appropriately stratified to either more (or less) intensive therapy; this effort is continually ongoing and retrospective studies identify new disease features or characteristics that are associated with treatment outcomes; therefore, if new features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee
Practice total abstinence from sexual intercourse (minimum  complete menstrual cycle)
Prior treatment of chronic HCV infection with a direct acting antiviral agent(s): telaprevir, boceprevir, sofosbuvir, simeprevir, or other direct acting antiviral
Chronic ITP (ITP lasting for greator than or equal to ([>=]  months) as defined in the protocol
cTN- tumour invasion into submucosa, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
cTN - tumour invasion into muscularis propria, no radiographic evidence of mesorectal nodal metastasis, tumour deposits or vascular invasion.
cTa,bN- tumour invasion through the muscularis propria no more than  mm into the subserosa/perirectal tissue and clear of the circumferential radial margin (CRM). Absence of radiographic evidence of mesorectal nodal metastasis, tumour deposits or lymphovascular invasion.
Mid to low-lying tumour eligible for local tumour excision in the opinion of the treating surgeon.
Mismatch repair deficiency as identified by immunohistochemistry or other institutional standard, or Epstein-Barr virus positivity as determined by in situ hybridization or other institutional standard
completed the base trial and have shown a clinical benefit of SD or better and have never met any withdrawal criteria as defined in the tisotumab vedotin base protocol, or
Following receipt of verbal and written information about the trial, patients must provide signed informed consent before any trial-related activity is carried out.
ANC >=  K/CUMM
Platelets >= , K/CUMM
Patients able to complete study and within geographical proximity allowing for adequate follow up
Planned to receive IMRT with daily fractions of . Gy to . Gy to a cumulative dose of at least  Gy and a maximum of  Gy
Radiation fields to include at least two mucositis sites at risk (buccal mucosa, floor of mouth, ventral and lateral tongue, soft palate) in which both sites receive a minimum cumulative dose of  Gy
Subjects with a history of hepatitis of any etiology or hepatic insufficiency
History of narcolepsy or any neurological condition which may impair consciousness
Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery;
thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
indication for anticoagulant treatment for a disease other than the index VTE episode; Related to bleeding risk:
bacterial endocarditis;
Late-Gadolinum enhancement (LGE) on CMR indicative of cardiac amyloidosis
Subjects with a diagnosis of hereditary ATTR amyloidosis should have a known amyloidogenic transthyretin (TTR) mutation demonstrated by genotyping AND is recognised to be primarily associated with cardiomyopathy AND one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis. Or Scintigraphy: m^Tc-DPD with Grade  cardiac uptake or m^Tc-PYP with either Grade  or  cardiac uptake.
Subjects with a diagnosis of wild type ATTR-CM must be negative by genotyping and have one of the following: Definite histochemical identification of amyloid by Congo red staining and green birefringence in crossed polarised light in cardiac or other tissue biopsy and identification of TTR as the amyloid fibril protein either by immunohistochemistry or proteomic analysis OR Scintigraphy m^Technetium-dicarboxypropane diphosphonate (m^Tc-DPD) with Grade  cardiac uptake or m^ Technetium-pyrophosphate (m^Tc-PYP) with Grade  or  cardiac uptake.
Cardiomyopathy primarily caused by non-amyloid diseases (e.g. ischemic heart disease; valvular heart disease)
Sustained / symptomatic monomorphic ventricular tachycardia (VT), or rapid polymorphic VT, at screening
Any active and persistent dermatological condition
Inability to fit inside scanner due to body size (girth)
History of claustrophobia m^TC-PYP OR mTC-DPD BONE TRACER RADIOSCINTOGRAPHY
TTR polyneuropathy and / or intracranial TTR involvement including ophthalmological disease
For Cohort A:\n\n          . Prior history of diagnosis of SAA\n\n          . Diagnosis of relapsed/refractory SAA or recurrent AA following IST for SAA at the time\n             of enrollment. Patients with recurrent AA (e.g., losing their response) are exempt\n             from meeting the diagnostic criteria for relapsed SAA at the time of enrollment, but\n             must have been previously diagnosed with SAA.\n\n          . Agree to concurrent eltrombopag treatment with appropriate, investigator-selected IST\n             with either hATG + CsA or CsA.\n\n             For Cohort B:\n\n          . Diagnosis of SAA at the time of enrollment\n\n          . Patients must not have been previously treated for SAA\n\n          . Patients must agree to treatment with hATG + CsA concurrent with eltrombopag.\n\n             For all patients, regardless of cohort:\n\n          . Age  to < years\n\n          . Where appropriate, assessments to rule out congenital/inherited bone marrow failure\n             syndromes and other causes of immune-mediated pancytopenia, which may be treated with\n             transplant, must be completed prior to enrollment.\n\n          . Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a\n             treatment option or has been refused by the patient. (Candidacy for HSCT will be\n             determined as per local practice.)\n\n         . Bone marrow aspirate and biopsy at any time during the  weeks prior to first dose of\n             eltrombopag\n\n         . Normal karyotype with FISH for chromosomes  and \n\n         . Performance status score: Karnofsky ? or Lansky ? (depending on age)\n\n         . Serum creatinine ?.  ULN\n\n         . Total bilirubin ?.  ULN\n\n         . Written informed consent signed by a parent or legal guardian prior to initiation of\n             any study specific procedure.\n\n        Exclusion Criteria:\n\n          . Prior and/or active medical history of:\n\n               -  Fanconi anemia (via chromosomal breakage test or growth arrest by flow cytometry)\n\n               -  Other known underlying congenital/inherited marrow failure syndromes\n\n               -  Symptomatic Paroxysmal Nocturnal Hemoglobinuria (PNH) and/or PNH clones >% of\n                  PMN or RBC at time of enrollment\n\n               -  Any cytogenetic abnormalities, including but not limited to chromosome  or\n                  myelodysplasia, in bone marrow within  weeks of study enrollment\n\n               -  Myelodysplastic syndrome (MDS)\n\n               -  Other known or suspected underlying primary immunodeficiency\n\n               -  Any malignancy\n\n          . Active infection not responding to appropriate therapy\n\n          . Prior eltrombopag or other thrombopoietin receptor (TPO-R) agonist treatment for at\n             least  months and a lack of response.\n\n          . Any out of range lab values Creatinine >.  upper limit of normal (ULN), Total\n             bilirubin >.  ULN Aspartate aminotransferase (AST) or alanine aminotransferase\n             (ALT) >.  ULN
Symptomatic cardiomyopathy
Patients with Portal-caval shunts
Prior treatment with an antibody-drug conjugate (ADC) which consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-)
Prior use of trametinib or other MAPK inhibitor in any context
Histologically or cytologically documented locally advanced recurrent or metastatic HCC or for patients with cirrhosis according to the American Association for the Study of Liver Diseases (AASLD) and Asian Pacific Association for the study of the liver (APASL) criteria. Current cirrhotic status of Child Pugh Class A (- points), with no encephalopathy and/or clinically significant ascites (defined as requiring the use of diuretics or paracentesis treatment).
Prior use of any experimental or approved C-C chemokine receptor type  (CCR) modulators including maraviroc and PRO 
Hypersensitivity to the active pharmaceutical ingredient or any of the excipients of the IMPs, including Labrasol, butylated hydroxyanisole, and butylated Hydroxytoluene
Symptomatic lymphadenopathy
Bothersome cutaneous disease
? weeks for systemic retinoids, interferons, vorinostat, romidepsin, fusion proteins
Have significant baseline neuropathies
Recent use of photosensitizing agents such as fluoroquinolones and retinoids or patients undergoing phototherapy.
Participation in any other intraoperative margin assessment protocol that would affect data acquisition.
Patients receiving any statin except pravastatin or rosuvastatin
Patients with markedly decreased visual acuity in the opinion of the treating investigator after completion of screening ophthalmologic exam
Patients who have received at least  transfusion per year in the last  years and who are expected to have a continuing requirement (based on Investigator's judgement) during the duration of the trial
Thalassemia syndromes;
Prior history of receiving pazopanib treatments
Patients with MF/SS must have failed at least  prior topical therapy (including steroids, nitrogen mustard, retinoids, phototherapy, photochemotherapy, radiation, and total skin electron beam); there is no upper limit for prior therapies
Able to take acetaminophen
Patients without access to the duodenum or ampulla are not candidates for ERCP and stenting
Patient with contra-indication to high dose of steroids (including ongoing active infection, use of live vaccines, virosis such as hepatitis, herpes, varicella, herpes zoster)
Prior treatment with a taxane or other tubulin-targeted agent (eg, indibulin) other than a vinca alkaloid
Targeted tumor(s) are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L - L), Sacral vertebra (S - S)
Need surgical stabilization of the affected weight bearing bony structure (> fracture risk score, see Section .) OR
Patients must meet all the University of Alabama at Birmingham (UAB) diagnosis and disease status criteria for clinical appropriateness for allogeneic HSCT derived from American Society for Blood and Marrow Transplantation (ASBMT) and National Comprehensive Cancer Network (NCCN) guidelines and updated annually
Patients must not have any significant organ system compromise except hematopoiesis as defined in the UAB eligibility checklist including, a Karnofsky performance status > % and a life expectancy assuming control of primary disease >  weeks
Infections requiring administration of ganciclovir, valganciclovir or acyclovir at the time of infusion: HSV-Tk cells can be administered after a -hour discontinuation interval of antiviral therapy
Castleman's disease (multi-centric disease)
Patient with one of the following documented mastocytosis as per WHO classification: Smouldering Systemic Mastocytosis, Indolent Systemic Mastocytosis, Cutaneous Mastocytosis
Handicapped status defined as at least two of the following handicaps, including at least one among pruritus, flushes, depression and asthenia: pruritus score ? , number of flushes per week ? , Hamilton rating scale (depression) ? , number of stools per day ? , number of mictions per day ? , Fatigue Impact Scale total score (asthenia) ? 
Patients with OPA >  (moderate to intolerable general handicap)
Patient with one of the following mastocytosis: Systemic Mastocytosis with an Associated clonal Hematologic Non Mast cell lineage Disease (SM-AHNMD), Mast cell leukemia (MCL), Aggressive systemic mastocytosis (ASM)
C-Kit (CD) positive tumours detected immuno-histochemically or PDGF positive if c-kit negative
Ki  < %
Presence of autonomous adrenocortical hormone secretion despite the absence of disease detectable with imaging techniques
Patients who require or are likely to require any strong modifier of CYP activity to be taken prior to milataxel administration
Poor nutritional state (as determined by clinician)
Patients who will require APR or hand-sewn colo-anal anastomosis
Patients having additional surgical procedures which may have affect recovery
Patients, who are participating in a previous Bayer/Onyx sponsored study that has reached its endpoint (statistical and regulatory or study end), and who are, in the opinion of the Investigator, expected to continue to have an overall positive benefit/risk from continuing treatment.
Satisfactory haematological or biochemical functions (tests should be carried out within  weeks prior to randomisation): Results of clinical investigations carried out within  weeks prior to randomisation can be used in place of the required screening investigations. Patients with mild laboratory abnormalities can be included at the discretion by the site principal investigator, and after approval by ASCOLT Trial Management Group
History of erosive GERD or active erosive GERD on gastroscopy.
Patients with a history of uncontrolled seizures or who are not on anti seizure medication (e.g., Phenytoin  mg PO t.i.d. or Keppra  mg po bid) before the procedure
Has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.
Hepatitis B and C negative, unless the result is consistent with prior vaccination or prior infection with full recovery
Unable to receive prophylactic treatment for pneumocystis and herpes simplex virus (HSV)
Pre-pectoral implant placement
Undergoing delayed reconstruction
Participation in a TRACON Pharmaceuticals sponsored parent TRC study and, thought to have potential to derive clinical benefit from continued treatment with TRC in the opinion of the parent study investigator.
ability to begin TRC dosing on this protocol within  weeks from the subjects last dose of TRC in the parent TRC study
exclude use of acetaminophen or acetaminophen-containing medications from  day before to  day after completion of treatment. The active metabolite of acetaminophen, N-acetyl-p-benzoquinone imine (NAPQI), is known to block effects of cenersen & use of acetaminophen during treatment with study regimen has been associated with a failure to achieve a response in a past clinical trial of cenersen.
Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within  months prior to screening Visit ;
History of pathologically confirmed CIN by colposcopically-directed punch biopsy, within  weeks prior to administration of first study vaccination (CIN / subjects will not be eligible);
For the diagnosis of CIN, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;
Current recognized immunodeficiency disease, including infection with HIV, cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, or hereditary or congenital immunodeficiencies.
Erythropoietin and darbopoietin-? are permitted;
Patients with M+ disease (defined as neuraxis dissemination either by imaging or by cytology)
Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use, or removal of TAR .
Pyeloureteral tube externalized to the skin is exclusionary. Unilateral nephrostomy tube or ureteral stent is permitted as long as it does not interfere with placement or retention of TAR- in the bladder.
Indwelling catheters are not permitted.
tubal sterilization, or
Subjects eligible for the Observation Arm must have had their central line removed and replaced within  hours of the qualifying blood culture ( hours with Medical Monitor approval);
Subjects with septic shock that requires inotropic support or is unresponsive to fluid resuscitation;
Subjects with short-term CVCs indwelling less than  days;
The total sum of Ad-p Injection Doses (mL) based upon the tumor volumes shown in Table  should be less than or equal to  mL as the MTD of Ad-p is . x vp/treatment day.
Unresectable gallbladder cancer at the time of enrollment based on high-quality, preoperative, cross-sectional imaging of the C/A/P
Patients with bladder CIS, or completely resected high grade Ta/T lesions that are BCG unresponsive; unresponsive is BCG refractory and/or BCG relapsing\r\n* BCG refractory: persistent high-grade disease at  months despite receiving at least - induction instillations and at least one maintenance (two of three instillations) in a  month period\r\n* BCG relapsing: recurrence of high-grade disease after achieving a disease-free state at  months after receiving at least - induction instillations and at least one maintenance (two of three instillations) in a  month period
Patients who cannot hold instillation for  hours
Has reached the age of majority in their country
A lesion that either:\r\n* Is intended to be accessed bronchoscopically OR\r\n* Is intended to be accessed with computed tomography (CT) guided transthoracic injection and in the estimation of the radiologist performing the procedure will not require transversing a bullae that significantly increases the risk of pneumothorax.
A history of prior significant toxicity, other than thrombocytopenia, from another Bcl- family protein inhibitor
The study will require that % of enrolled subjects have homozygous deletions, deleterious mutations, or both in one or more of the DNA damage response (DDR) genes; the other % of patients must have an intact DDR pathway
Tumor causing urinary outlet obstruction that requires catheterization for voiding; patients that require catheterization to void secondary to benign strictures or other non-cancer causes will be permitted to enroll
Presence of a known ibrutinib resistance mutation at ? % variant allele frequency OR < % with two separate measurements at least  weeks apart with increasing variant allele frequency
Evidence of EWS translocation by FISH or RT-PCR or Next Generation Sequencing (NGS). If available, NGS sequencing report should be submitted to Gradalis.
Active retinal pigment epithelium (RPE)/photoreceptor disorders such as; retinitis pigmentosa, cone-rod dystrophies, Bests dystrophy, Stargardt disease (STGD), macular degeneration.
Patient's tumor must express specified biomarkers. Note: Patients who were previously screened for participation in other Immatics' sponsored clinical trials and whose biomarkers are positive for IMA- based on IMA_Detect may enter IMA- screening
Available IMA product passed all required release tests
Patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation.
Urgent need of treatment to prevent acute neurologic deterioration, including urgent neurosurgery or radiotherapy
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of study agent dosing
Predicted time to first treatment of ? years according to MDACC nomogram.
Willingness to receive all outpatient treatment, all laboratory monitoring, and all radiological evaluations at the institution that administers study drug for the entire study
Prior use of SERM
Inability to stop anticoagulants/antiplatelet therapy peri-operatively
Derived clinical benefit from IGN, defined as CR, PR, or SD, in another Valor-sponsored IGN- study (e.g., IGN-)
Tolerated IGN therapy in the other Valor-sponsored IGN study
Discontinued from another Valor IGN study due to an AE considered by the Investigator to be related to IGN treatment
Positive infectious disease test as dictated by blood collection centers standard operating procedure (SOP)
A diagnosis of basal cell nevus syndrome (BCNS) as defined in the Consensus Statement (Bree et al, American Journal of Medical Genetics [Am J Med Genet] Part A :-)\r\n* Major criteria are: \r\n** BCC prior to age  years, or excessive number of BCCs out of proportion to prior sun exposure and skin type\r\n** Keratocyst of the jaw prior to age \r\n** Palmar or plantar pitting\r\n** Lamellar calcification of the falx cerebri\r\n** Medulloblastoma\r\n** First degree relative with BCNS\r\n* Minor criteria are: \r\n** Rib anomalies, or other specific skeletal malformations including kyphoscoliosis and short th metacarpals\r\n** Macrocephaly\r\n** Cleft/lip or palate\r\n** Fibroma of the heart or ovary\r\n** Ocular abnormalities\r\n** Other rare abnormalities listed in the article by Bree et al\r\n* For diagnosis of BCNS, the patient must have either  major criteria, one major and two minor criteria, or one major criterion plus molecular confirmation of a patched  (PTCH) gene mutation
Laboratory requirements: \r\n* If the patient has never had a skin biopsy to establish the histological diagnosis of BCC as part of his/her syndrome, then one lesion must be biopsied prior to entry into the trial\r\n* Any suspected BCC lesion of >  mm in diameter must be biopsied at the start of the trial, to establish the histological subtype of the BCC\r\n* Any presumed BCC lesion that fails to respond by the end of the trial must be biopsied to rule out an incorrect diagnosis as a reason for the lack of response\r\n* If a female patient suspects she is pregnant during the course of the trial, a serum pregnancy test will be administered and if positive, any further PDT treatments will be halted
Patients with a coexisting skin condition such as scleroderma, psoriasis, or eczema in the skin areas to be treated with PDT, that might interfere with response assessment
Patients with CEA plasma levels >  ng/mL must be approved in advance by the Sponsor.
PREREGISTRATION (STEP ): Peripheral blood must be collected for submission to Fred Hutchinson Cancer Research Center for central assessment of the establishment of BCR/ABL status to confirm patients eligibility for registration to Step ; Fred Hutchinson will forward results within - business days of receipt of the peripheral blood to the submitting institution
REGISTRATION TO TREATMENT (STEP ): Institution has received central BCR-ABL test results confirming MRD positive status
Histologically or cytologically confirmed germ cell tumour (non-seminoma or seminoma); or exceptionally raised tumour markers (alpha-fetoprotein [AFP] >= ng/mL and/or human chorionic gonadotropin [HCG] >=  IU/L) without histologic or cytologic confirmation in the rare case where pattern of metastases consistent with germ cell tumor (GCT), high tumour burden, and a need to start therapy urgently
Primary arising in testis, ovary, retro-peritoneum, or mediastinum
Intermediate or poor prognosis as defined by International Germ Cell Cancer Consensus Classification (IGCCC) classification (modified with different lactate dehydrogenase [LDH] criteria for intermediate risk non-seminoma, and inclusion of ovarian primaries); see below\r\n* Primary site: Testis or retro-peritoneum or mediastinum\r\n** Histology: Non-seminoma\r\n*** Prognostic category: Intermediate\r\n**** Clinical Factors: Testes/retroperitoneal primary and no liver, bone, brain or other non-pulmonary visceral metastases and intermediate markers  any of:\r\n***** AFP >=  ng/mL and =<   ng/mL\r\n***** HCG >=  IU/L and =<   IU/L\r\n***** LDH >= . x upper limit of normal (ULN) and =<  x ULN\r\n*** Prognostic category: Poor\r\n**** Clinical Factors: Mediastinal primary or liver, bone, brain or other non-pulmonary visceral metastases or poor markers  any of:\r\n***** AFP >   ng/mL or\r\n***** HCG >   IU/L or\r\n***** LDH >  x ULN\r\n** Histology: Seminoma\r\n*** Prognostic category: Intermediate\r\n**** Clinical factors: Any primary site and liver, bone, brain or other non-pulmonary visceral metastases and normal AFP, any HCG, any LDH\r\n* Primary site: Ovary\r\n** Histology: Malignant germ cell tumour histology (any of yolk sac, choriocarcinoma, embryonal carcinoma, mixed malignant GCT)\r\n*** Prognostic category: Federation of Gynecology and Obstetrics (FIGO)/Children's Oncology Group (COG) stage IV\r\n**** Distant metastases involving liver/spleen parenchyma and/or extra-abdominal organs (including but not limited to inguinal lymph nodes and lymph nodes outside abdominal cavity, lungs, bone, brain) and/or pleural effusion with positive cytology
Significant co-morbid respiratory disease that contraindicates the use of bleomycin
Immuno-magnetically purged PBSCs are permitted, however a special exception protocol must be filed with the FDA and local IRB where patient will be infused to allow infusion of immunomagnetically purged PBSC; CD+ selected cells are not permitted
Patients and/or families who are physically and psychologically unable to cooperate with the radiation safety isolation
Signed consent to long-term follow- up protocol PA- 
Prior cryosurgery, high-intensity focused ultrasound ablation (HIFU) or brachytherapy of the prostate
Pre/perimenopausal women must be amenable to be treated with goserelin. All patients will be rendered post-menopausal secondary to concomitant administration of goserelin.
Part : presence of fatigue as defined FACIT-F subscale of ?  on a  to  scale (in which  = no fatigue and  =worst possible fatigue)
Part : able to complete the baseline assessment forms
Patients may not be receiving any other investigational agents or have received any definitive prostate cancer (PCa)-specific treatment (en-bloc resection of bladder tumors [EBRT], Brachytherapy etc) prior
Patients with convincing evidence of extraprostatic extension or T disease on digital rectal examination (DRE)
History of peritonitis or diverticulitis
At least one but no more than  discrete PSMA-avid metastases on baseline PSMA-PET scan; all PSMA-avid lesions must be amenable to SBRT in judgment of treating radiation oncologist; there are no restrictions on site of metastasis (e.g. bone, lymph node, visceral); equivocal lesions on PSMA PET scan that are not definitive for metastasis will not count towards the limit of metastases and will not undergo SBRT
Requires hospitalization for IV empiric antibiotic therapy
Confirmed fungal infection (eg, Pneumocystis jirovecii etiology in patients with pneumonia) that justifies adding additional empiric antimicrobial therapy (eg, antifungals)
Confirmed viral infection that justifies adding additional empiric antiviral therapy (eg, ganciclovir, foscarnet)
Patient has developed a rash or symptoms of a rash (cutaneous burning) characteristic of an EGFR inhibitor (health-care provider report of the rash with no other documentation is permitted)
Patients with risk of broncho-aspiration based on documented swallowing test by a speech pathologist (if available)
Confirmed MGMT-promoter unmethylated status
Has known gliomatous meningitis, extracranial disease, or multifocal disease.
Use of valproate in any of its indications (epilepsy, mood disorder). Valproate, due to its HDAC inhibiting activity is contraindicated. For those patients on valproate, valproate will need to be discontinued and switched to a different anti-epileptic agent or psychotropic agent. A washout period of  days from valproate acid will be allowed prior to enrolling into the trial.
Prior administration of other NY-ESO- targeting immunotherapeutics.
At sites in the Southeastern U.S., subject must have negative serum test for galactose-alpha-,-galactose IgE (Note: positive test result is predictive of immediate-onset anaphylaxis reaction during first exposure to cetuximab, which is prevalent predominantly in limited geographic region of the Southeastern U.S.
Patient has no significant valvular heart disease (trace or mild valvular stenosis or regurgitation is allowed)
Asplenia
Glasgow Coma Score of less than 
Consented to genome sequencing and the database of genotypes and phenotypes (dbGaP)-based data sharing and has provided or will provide germline (PBMC) and tumor DNA/ribonucleic acid (RNA) samples of adequate quality for sequencing. (Acquisition of specimens for sequencing and the sequencing itself may be done as part of routine care or another research project.)
As this study aims to assess the immunogenicity of various vaccine plus adjuvant combinations, no prior immunotherapy will be permitted.
ENROLLMENT: Patients where the burden of pulmonary metastasis, location, or bulkiness of disease may cause high morbidity if localized swelling such as causing uncontrolled symptoms, oxygen dependence, or location near a major bronchi as determined by investigator.
Active or recent (prior  month) invasive fungal infection unless cleared by innovation and development (ID) consult
DONOR: The CB unit selected for transplant must have a MINIMUM of . x ^ TNC/kg
DONOR: A domestic backup unit must be identified and reserved prior to the start of the treatment plan for possible infusion in the unlikely event of poor post-thaw viability of the primary CB unit
Current peripheral neuropathy >= grade  or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
Other non-malignant hematologic disorders\r\n* Transfusion dependent or involve other potential life-threatening cytopenias, including but not limited to paroxysmal nocturnal hemoglobinuria, Glanzmanns thrombasthenia, severe congenital neutropenia and Shwachman-Diamond syndrome
Cerebral adrenoleukodystrophy (cALD)\r\n* Diagnosis of adrenoleukodystrophy (ALD) by abnormal plasma very long chain fatty acid (VLCFA) profile or ABCD gene mutation\r\n* Cerebral disease on MRI\r\n* Absence of a major functional disability (cortical blindness, loss of communication, wheelchair dependence) on the ALD Neurologic Function Scale\r\n* Performance intelligence quotient (IQ) of  or higher
Acute leukemias of ambiguous lineage
Presence of distant metastases; intra-abdominal (regional) spread is allowable if meets inclusion criterial indeterminate or small volume pulmonary nodules may be eligible, if the treating physicians recommend curative-intent resection of the primary tumor despite the presence of possible lung metastases
Prior eribulin
Monocytes >= /uL
Any of the following\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception
Men must have osseous metastases, but the presence of visceral metastases will not exclude patients from participation\r\n* Prior external beam radiation therapy (>  weeks prior to enrollment) for palliation of osseous metastatic disease is allowed, provided there is at least one osseous metastasis which has not been irradiated and which can be biopsied
Ki- >= %.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART ): Patients must have relapsed/progressed after any therapy for MCL.
FOR TISSUE COLLECTION TO ESTABLISH PDX (PART ): Reasonable expectation that the patient can wait - months for generation of data for subsequent treatment selection.
If participant is on a selective serotonin reuptake inhibitor (SSRI), serotonin-norepinephrine reuptake inhibitor (SNRI) or membrane stabilizer (pregabalin, gabapentin, for example), it must be a stable, unchanged dose for previous  months
Conditions that preclude SGB or sham intervention (e.g., anatomic abnormalities of the anterior neck or cervical spine; goiter, cardiac/pulmonary compromise; acute illness/infection; coagulopathy or bleeding disorder; allergic reactions/contraindications to a local anesthetic or contrast dye); pregnancy
Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes but is not limited to, sepsis, liver failure, renal failure, cardiovascular failure, pulmonary failure
Patients must have consented to the MD Anderson ATTACC protocol prior to inclusion
History of familial cardiomyopathy
Documented myocarditis within  months of enrollment
History of infiltrative cardiomyopathy or restrictive cardiomyopathy
Presence of left ventricular thrombus as documented by echocardiography or left ventriculogram
Mechanical or bioprosthetic heart valve
AICD firing within the last  days
Patients who are on warfarin and cannot have a drug substitution or who decline the drug substitution
After the T cell infusion, patients may not be on any other treatments for their cancer aside from those included in the treatment section of the protocol
Participants must have an image guided biopsy performed to yield fresh tissue for the in vitro organoid bio-assay and two biomarker testing (western blot and immunohistochemistry)
Participants with a history of cranial nerve palsy
All types of urinary diversions
Receiving potassium wasting diuretics or amphotericin must be noted to have theoretically increased arrhythmia risks with arsenic trioxide (potassium wasting diuretics or amphotericin are not excluded)
Has known serious hypersensitivity reactions to peg-interferon alfa-b or interferon alfa-b
Subjects with carcinosarcoma
As patients with ALL frequently have cytopenias, no hematologic parameters will be required for enrollment or to receive the first cycle of treatment; however, adequate recovery of blood counts will be required to receive subsequent cycles
Per good clinical practice, any toxicity related to prior therapies that, in the opinion of the investigator, would potentially be worsened with DA-EPOCH-A +/- imatinib (imatinib mesylate) +/- rituximab, should be resolved to grade  or less
Patient agrees to undergo a baseline and a follow-up C-alpha-methyl-L-tryptophan (AMT)-PET scan during immunotherapy (IMT)
No other investigational agents, immunomodulating agents, or cancer chemotherapy are permitted for the duration and  months following the study IMT unless there is disease progression; radiotherapy is not permitted; appropriate antibiotics, blood products, antiemetics, fluids, electrolytes and general supportive care are to be used as necessary
Patients with extracranial metastases
Prior therapy with an Abelson murine leukemia viral oncogene homolog (ABL) kinase inhibitor such as nilotinib, ponatinib, dasatinib, or imatinib
Minor surgical procedures must be completed >=  days prior to randomization with documentation of adequate recovery from associated complications to grade =< ; these include (but are not limited to) laparoscopy, thoracoscopy, bronchoscopy, mediastinoscopy, endoscopic ultrasonography, skin biopsy, percutaneous needle biopsy, and routine dental procedures; as a precautionary measure, it is recommended, but not strictly required, that placement of a central venous access device, thoracentesis, or paracentesis be done  days before the initiation of protocol directed chemotherapy with documentation of adequate recovery from associated complications to grade =< 
Subjects must have at least one positive DTH skin response (more than  mm) to test item challenge prior to randomization.
Current use of certain concomitant medications due to mechanistic-based platelet toxicities from navitoclax: clopidogrel, ibuprofen, tirofiban and other anticoagulants, drugs or herbal supplements that effect platelet function; NOTE: antiplatelet use is prohibited during the use of navitoclax; subjects who have previously received aspirin therapy for thrombosis prevention may resume a low dose (i.e., maximum  mg QD) of aspirin if platelet counts are stable (>= ,/mm^) through  weeks of navitoclax administration; all decisions regarding treatment with aspirin therapy will be determined by the principal investigator in conjunction with the medical monitor
Confirmation of radiographic stage as borderline resectable disease by real-time Alliance central radiographic review
Unable to obtain confirmation of payment coverage (insurance or other) for either possible treatment
Have an isocitrate dehydrogenase  (IDH) mutation
Part  patients must show evidence of wild-type (WT) p as assessed by central deoxyribonucleic acid (DNA) sequencing
Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
Participants who have ever previously received any anti-neoplastic agent, including methotrexate, -mercaptopurine, -thioguanine, vincristine cyclophosphamide, cytarabine (except for IT cytarabine), or any anthracycline, for any reason (e.g., rheumatologic or autoimmune condition) are not eligible
Signs of leukostasis requiring urgent therapy
Subjects must have at least  cutaneous, subcutaneous, or nodal lesion that is suitable for intralesional injection, with or without the use of ultrasound; lesions in mucosal surfaces (periocular, nasal, etc) are not eligible for injection because the area cannot be properly contained with an occlusive dressing
Anti-measles virus immunity as demonstrated by IgG anti-measles antibody per institutional guidelines (within  days prior to study registration)
PRRT administered within  months of the first dose.
Adenocarcinoma originating in the ampulla or appendix; (duodenal tumors that involve the ampulla but originate in the duodenum are eligible)
Patients with prosthetic heart valves
Subject had disease progression prior to Cycle  defined as ?% increase in bone marrow blasts from pretreatment levels to >%, or ? g/dL reduction of Hgb from pretreatment levels with transfusion dependence after at least  cycles of HMA. Other prior treatments for MDS such as lenalidomide, cytarabine, intensive chemotherapy, hydroxyurea, erythropoietin and other growth factors, or hematopoietic cell transplant (HCT) are allowed.
Subjects must have either:
Pre-study evaluation must include an ophthalmologic exam by an ophthalmologist (not optometrist) and should minimally include visual acuity testing, slit lamp examination, and funduscopic examination; follow up eye-exams will only be performed if subjects develop/report any visual impairment; visual impairment may include peripheral flashes (photopsia), blurred or double vision, floaters, color distortion and dimness, difficulties with light/dark accommodation, tunnel vision or other field defects, halos, apparent movement of stationary objects, and complex disturbances; follow up eye-exams will minimally include visual acuity testing, slit lamp examination, and funduscopic examination; additional testing will be based on symptoms, what is observed and ophthalmologist recommendations
Prior use of steroidal antiandrogens (megestrol acetate, cyproterone acetate), AR partial agonists, ketoconazole, chemotherapy, immunotherapy, estrogens, radiopharmaceuticals within  months before registration and during administration of study treatment
Inability to have fiducial markers placed
The trial is open to both genders
Histologically proven advanced MPM of biphasic or sarcomatoid histology. Biphasic MPM is defined using the World Health Organization's international histological classification of tumors as containing an epithelial and a sarcomatoid component with each component comprising at least % of the tumor
Heme: Plt Ct ?  x /L, ANC ? . x /L, and Hemoglobin ?  g/dL
Phase : Birth through  years of age at CD with a locally advanced or metastatic solid tumor or primary CNS tumor that has relapsed, progressed or was nonresponsive to available therapies and for which no standard or available systemic curative therapy exists, or infants from birth and older with a diagnosis of malignancy and with a documented NTRK fusion that has progressed or was nonresponsive to available therapies, and for which no standard or available curative therapy exists, or patients with locally advanced infantile fibrosarcoma who would require, in the opinion of the Investigator, disfiguring surgery or limb amputation to achieve a complete surgical resection. The Phase I dose escalation cohorts are closed to enrollment. In addition to the above stated Inclusion Criteria, patients eligible for enrollment into this cohort must have a malignancy with a documented NTRK gene fusion with the exception of patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer. Patients with infantile fibrosarcoma, congenital mesoblastic nephroma or secretory breast cancer may enroll into this cohort with documentation of an ETV rearrangement by FISH or RT-PCR or a documented NTRK fusion by NGS.
Patient history:\r\n* Patients with history of neurofibromatosis (NF) may have other stable central nervous system (CNS) tumors (schwannoma, acoustic neuroma or ependymoma) if lesions have been stable for  months\r\n* No metastatic meningiomas (as defined by extracranial meningiomas) allowed\r\n* No history of allergic reactions attributed to compounds of similar or biologic composition to assigned study drug\r\n* No known active hepatitis B or C\r\n* No current Child Pugh class B or C liver disease\r\n* No uncontrolled gastric ulcer disease (grade  gastric ulcer disease within  days of registration)\r\n* No uncontrolled diabetes defined as a known diabetic with hemoglobin AC (HBAC) > . OR fasting glucose > \r\n* No uncontrolled hypertension defined as blood pressure (BP) > /\r\n* No abdominal fistula, gastrointestinal (GI) perforation, or intra-abdominal abscess within  days prior to registration
CONSOLIDATION CRITERIA:
Patients with any prior history of SOS irrespective of severity
AGSE
L-Histidine
?-trehalose dihydrate or
Phase II temporarily suspended as requested by the FDA due to IND Safety Report of  October 
oral, intra-vaginal or transdermal combined (estrogen and progestogen containing) hormonal contraception associated with inhibition for ovulation
oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation.
vasectomised partner
It is deemed ethical to provide an experimental drug (e.g., Mylotarg) that is associated with hepatotoxicity (veno-occlusive disease [VOD]) and myelosuppression
Patients who require anti-arrhythmic treatment with Amiodarone or any drug with a quinidine-like effect on the heart or who have history of a malignant ventricular arrhythmia unless they have a functioning Automatic Implantable Cardio Defibrillator (AICD) implanted
Patients must not be in status, coma, or assisted ventilation prior to study enrollment
Anti-measles immunity as demonstrated by serum immunoglobulin (Ig)G anti-measles antibody levels of >= . EU/ml as determined by BioPlex Measles IgG multiplex flow immunoassay
CT imaging review submission to confirm unilateral pleural involvement; this review for CT imaging is mandatory prior to registration to confirm eligibility; it should be initiated as soon as possible after pre-registration
For patients with a recently placed biliary stent, patients should have consistent results within a hepatic group from two laboratory readings within  days apart, taken at least  days following biliary stent placement; for patients with a biliary stent placed over  months ago, no obstruction or blockage can have occurred within the last  months
Prior treatment with a TORC, dual TORC/ inhibitor, or BCL-/xL inhibitor
Patients with known contraindications to radiotherapy, including inherited syndromes associated with hypersensitivity to ionizing radiation (e.g., ataxia-telangiectasia, Nijmegen breakage syndrome)
Patients with solitary plasmacytoma
Previous treatment with tocilizumab or other cytokine-targeted biologic disease modifying antirheumatic drugs (including adalimumab, certolizumab, etanercept, golimumab, infliximab, anakinra) within  months of enrollment
History of partial or total gastrectomy
Germline ABCB (CC) and ABCB (GG or GC) genotypes determined by pharmacogenomics analysis of peripheral blood mononuclear cells
Disease amenable to biopsy via percutaneous approach or other minimally invasive procedures such as thoracoscopy, bronchoscopy, laparoscopy, or gastrointestinal (GI) endoscopy
Patients - years of age with good risk AML defined as the presence of t(;), inv(), or t(;) as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or fluorescence in situ hybridization (FISH) (patients with t(;), inv(), t(;) who are unable to receive anthracycline based induction will be allowed to enroll provided the medical reason they are unable to receive anthracyclines is clearly documented and provided they fulfill all other eligibility and criteria)
ADDITIONAL CRITERIA FOR COHORTS A AND B PARTICIPANTS ONLY: Cohort b: MGMT promoter methylated, partially methylated, indeterminate or unknown
All patients will be previously or simultaneously enrolled in the natural history ECD protocol #-HG-, Clinical and Basic Investigations into Erdheim Chester disease; eligible patients must have been diagnosed with Erdheim Chester disease, confirmed by pathological evaluation of the affected tissue with adequate staining; affected tissue must harbor the BRAF VE or VK mutation
Residual adverse events due to previously administered agents (except alopecia, stable residual neuropathy, and residual hand, foot syndrome) that have not recovered to Grade  or below in severity level (based on NCI CTCAE) before Screening
Refractory to - to -week course of ESA (erythropoiesis stimulating agent) administered within the past  years before enrollment, or erythropoietin (EPO) level ?  mU/mL and off ESA for at least  weeks before Screening.
Recursive partitioning analysis (RPA) class I-II/Karnofsky performance status >= %
Myeloproliferative syndromes
Must have a baseline American Urological Association (AUA)/International Prostate Symptom Score (IPSS) score of < 
Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogrens syndrome), congenital abnormality (e.g., Fuchs' dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
Gylcated hemoglobin (HgbAc) < .%
DONOR: Determination of histocompatibility will be made by deoxyribonucleic acid (DNA) oligotyping (low resolution for class I antigens and high resolution for class II antigens)
Within or touching the zone of proximal bronchial tree defined as a volume  cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
CYP A stimulators or inhibitors should be avoided or used with great caution when taking cyclophosphamide; aprepitant should also be used with caution with etoposide or vincristine chemotherapy
Cisplatin should be used with caution with nephrotoxic drug; aminoglycoside should be avoided or used with caution during or shortly after cisplatin administration and concomitant use with amphotericin B should probably also be avoided; patients receiving cisplatin and other potentially ototoxic drugs such as aminoglycoside or loop diuretics concomitantly should be closely monitored for signs of ototoxicity\r\n* Plasma levels of anticonvulsant agents should be monitored and doses adjusted during therapy with cisplatin
Anti-measles virus immunity as demonstrated by immunoglobulin G (IgG) anti-measles antibody levels of >= . EU/ml as determined by enzyme immunoassay
Hemoglobin >= . (may transfuse)
Sinusoidal obstruction syndrome (SOS) if present, must be stable or improving clinically
=< grade  hypercalcemia (applicable only for dose levels that include cis retinoic acid [RA])
Patient declines participation in NANT -; unless the institution has been granted special exemption from mandatory enrollment on NANT - by the NANT Operations Center
For the purpose of obtaining a RECIST v. baseline scan, participants must have a\n             radiological evaluation conducted no more than  days prior to beginning study\n             therapy (PLD).  NOTE: For participants with a history of CNS metastasis, baseline\n             radiological imaging must include an evaluation of the head.
Prior exposure to FR-targeted therapy (eg, EC, EC, EC, farletuzumab).
Inclusion of ECP in the treatment of any patient is contraindicated with any of the following:\r\n* Unstable hemodynamics requiring vasopressors or other support measures not amenable to or medically appropriate for continuation during the procedure\r\n* Uncontrolled infection\r\n* Inability to maintain acceptable venous access\r\n* Uncontrolled or uncorrectable coagulopathy
History of a light-sensitive cutaneous disease
Subjects with aphakia
Patients receiving the following drugs that are contraindicated with NFV will be excluded: antiarrhythmics amiodarone, quinidine), antimycobacterial (rifampin), ergot derivatives (dihydroergotamine, ergonovine, ergotamine, methylergonovine), herbal products (St. Johns wort), -hydroxy--methyl-glutaryl-coenzyme A (HMG-CoA) reductase inhibitors (lovastatin, simvastatin), neuroleptic (pimozide), proton pump inhibitors, sedatives/hypnotics (midazolam, triazolam)
Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: anti-convulsants (carbamazepine, phenobarbital, phenytoin), anti-mycobacterial (rifabutin), PDE inhibitors (sildenafil, vardenafil, tadalafil), HMG-CoA reductase inhibitor (atorvastatin, rosuvastatin), immunosuppressants (cyclosporine, tacrolimus, sirolimus), narcotic analgesic (methadone), oral contraceptive (ethinyl estradiol), macrolide antibiotic (azithromycin), Inhaled/nasal steroid (fluticasone), antidepressant (trazodone)
Pretreatment electrocardiography (EKG).
For the Diabetes Expansion Cohort - Subjects who currently require insulin,\n             thiazolidinediones, dual proliferator-activated receptors (PPAR) agonists,\n             glucagon-like peptide (GLP-) analogues, dipeptidyl peptidase (DPP-IV) inhibitors or\n             have received the same in the  weeks prior to screening.
Subjects with known complications of diabetes like diabetic nephropathy or diabetic\n             retinopathy
Fasting plasma glucose (FPG) =<  mg/dL (. mmol/L) and glycosylated hemoglobin (HbAc) =< .% (both criteria have to be met)\r\n* For patients with FPG >=  mg/dL and/or HbAc >= .% (i.e. threshold for pre-diabetes) at screening, recommend lifestyle changes according to American Diabetes Association (ADA) guidelines, i.e. dietary advice (e.g. small frequent meals, low carbohydrate content, high fiber, balancing carbohydrate intake over the course of the day, three small meals and  small snacks rather than one large meal) and exercise; a consultation with a diabetologist is highly recommended
Presence of vestibular schwannomas
Evidence of progressive increase in vestibular schwannoma size or worsening hearing\n             loss due to vestibular schwannoma
Surgical margins that cannot be microscopically assessed or that are positive
Patients must be assigned to SB
Patients should be carefully screened for depression at baseline and if there are indications or a history of depression it is strongly recommended that these patients be closely followed together with behavioral health or psychiatric medical support; patients with an established diagnosis of depression that, in the assessment of the investigator may make the administration of interferon (IFN)-alfa or ipilimumab hazardous, should not be enrolled on this protocol; the risks and benefits of being treated with standard adjuvant IFN-alfa should be weighed very carefully in consultation with behavioral health or psychiatry
Patients must not have had any infectious disease vaccination (e.g., standard influenza, HN influenza, pneumococcal, meningococcal, or tetanus toxoid) within  weeks prior to randomization
Confirmation of N status by frozen section examination; right sided tumors require that node levels , , and  be sampled and diagnosed as negative on frozen section; left sided tumors require that node levels  or ,  and  be sampled and diagnosed as negative on frozen section; levels  and  nodes may be sampled by mediastinoscopy, endobronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS), or at the time of thoracotomy or VATS exploration; nodes previously sampled by mediastinoscopy (or EBUS and/or EUS) either immediately prior to or within  weeks of the definitive surgical procedure (thoracotomy or VATS) do not need to be resampled
Hold trimethoprim/sulfamethoxazole (Bactrim) on the day of high-dose methotrexate (HDMTX) infusion and continue to hold until the methotrexate level is less than . micromolar ( x - M)
In the opinion of the investigator do not require rapid cytoreduction due to bulky disease (e.g. painful lymphadenopathy or organomegaly, or impending end-organ dysfunction
Extrahepatic disease
Any contraindications to treatment with LC Bead device (e.g. patients with large diameter arteriovenous shunts or patients with a right-to-left shunt)
Total bilirubin =< . x the upper limits of normal (ULN) (biliary stenting or percutaneous biliary drainage are allowed for cancer related biliary obstruction)
Tumor must be HER-positive and retinoblastoma (RB)-proficient; RB-proficiency is determined by tumor biopsy demonstrating RB normal and cyclin-dependent kinase inhibitor A (pina) low by immunohistochemistry; RB proficiency means that there is an intact RB pathway indicative of responsiveness to PD-; RB staining is scored on an absent (no nuclear staining), weak (nuclear staining less than observed in endothelial cells and stromal cells surrounding the tumor), positive (nuclear staining at or above surrounding tissue) (, .,  respectively); pinka is a routine clinical stain that is scored using absent, weak, positive, strong (, , ,  respectively); tumors will be scored using (p)/(RB), where a score of less than  is required for inclusion; RB loss is expected to occur in less than % of cases; RB  proficiency will be done locally as standard of care and made available for central review at later time points in the study
Patients who have adenocarcinomas of the ampulla, distal bile duct, and duodenum
Patients with a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide (DMSO), fetal bovine serum, or trypsin (porcine origin)
Consensus following presentation of the case at the multidisciplinary Pediatric Neuro-Oncology conference, which includes participation of neuro-oncology, neurosurgery, radiation oncology, interventional neuroradiology and neurology
Patients must have histologic or cytologic verification of extra-ocular retinoblastoma; extra-ocular disease includes orbital disease, optic nerve involvement at the surgical margin, regional nodal disease, and/or overt distant metastatic disease (at sites such as bone, bone marrow, liver and/or the central nervous system); patients with trilateral retinoblastoma will also be included in this protocol\r\n* Patients with a CNS lesion consistent with trilateral or stage b disease may be enrolled without tissue confirmation if () unequivocal leptomeningeal disease is present on brain or spine magnetic resonance imaging (MRI) scan and/or () the primary tumor is at least  cm in diameter, predominantly solid, and demonstrates enhancement on the post-gadolinium images; however, even in such cases surgery should be given serious consideration
Any of the following:\r\n* Pregnant persons\r\n* Nursing persons\r\n* Persons of childbearing potential who are unwilling to employ adequate contraception
Patients must be assigned to SD
Patients must be assigned to SC
HCV treatment experienced or naive\r\n* HCV treatment naive: no prior exposure to any IFN, ribavirin (RBV), or other approved or experimental HCV-specific direct acting antivirals (DAA)\r\n* HCV treatment-experienced: virologic failure after treatment with polyethylene glycol (PEG)- IFN + RBV, NS protease inhibitor plus PEG-IFN + RBV, or regimen of sofosbuvir (SOF) +/- RBV +/- PEG-IFN regimen
Any HCV treatment which uses pegylated interferon
Lymphomas of other histologies other than the ones listed in inclusion above
Breastfeeding mothers must agree to discontinue nursing if the mother is treated with selinexor
Presence of distance metastases (M)
Signed informed consent for the focal laser ablation (FLA) treatment through the  month follow up visit
Rectal fissure, fibrosis, stenosis, or other anatomic abnormality precluding insertion of transrectal device
Urinary tract or rectal fistula
Patients AML must carry mutations in isocitrate dehydrogenase  (IDH) or IDH
Mammogram or ultrasonography (USG) performed
Significant dermatological disease including but not limited to, skin drying and fissuring, paronychial inflammation, infectious sequelae (eg. blepharitis, cheilitis, cellulitis, cyst)
Clear BCMA expression must be detected on greater than % of malignant plasma cells from either bone marrow or a plasmacytoma by flow cytometry or immunohistochemistry; these assays must be performed at the National Institutes of Health; it is not required that the specimen used for BCMA determination comes from a sample that was obtained after the patients most recent treatment; BCMA expression will need to be documented on the majority of malignant plasma cells at some time after the original anti-BCMA CAR T-cell infusion in all patients undergoing a second anti-BCMA CAR T-cell infusion; if paraffin embedded unstained samples of bone marrow involved with MM or a plasmacytoma are available, these can be shipped to the National Institutes of Health (NIH) for BCMA staining, otherwise new biopsies will need to be performed for determination of BCMA expression
Diagnosis: \r\n* Patients with refractory or recurrent solid tumors (excluding central nervous system [CNS] tumors) and patients with unresectable translocation positive renal cell carcinoma (tRCC) are eligible; patients must have had histologic verification of malignancy at original diagnosis or relapse\r\n* The diagnosis of translocation morphology or transcription factor E (TFE) renal cell carcinoma is established by having characteristic morphology AND either a) strong nuclear TFE or TFEb staining on immunohistochemistry OR b) cytogenetic studies of the tumor demonstrating a TFE translocation OR c) fluorescent in situ hybridization (FISH) demonstrating a TFE translocation
Significant ST depression of >= . mm in  or more leads and/or T wave inversions in >=  leads
Requirement of inotropic support (excluding digoxin)
Patients must be candidates for SRS and planning to undergo SRS
Creatinine < . milligrams per deciliter
History of spontaneous pneumothorax
History of sinus or ear surgery, excluding myringotomy or ear tubes
Prior history of SCCHN
Patients must have progressed on, be ineligible for, or have declined participation in GOG- provided that protocol is actively accruing patients
PROCEEDING TO TREATMENT WITH -FC:
Urgent need of treatment to prevent acute neurologic deterioration
Patients have failed at least one previous induction course of intravesical BCG, defined as histologically confirmed persistent or relapsing tumor present on post-BCG endoscopic evaluation; all BCG failures will be considered for inclusion into the study, including BCG-refractory, -resistant, and -relapsing; for the purposes of the study, BCG-refractory and BCG-resistant subjects will be considered to have BCG-persistent disease
Patients unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczematoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV)
Patients currently taking drugs that are generally accepted to have a high risk of causing torsades de pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine, ranolazine, and St. Johns wort
Patients who have mucinous, squamous, sarcomas, or carcinosarcomas
Cancer antigen - (CA-); NOTE: in the event that a stent has been placed and biliary obstruction has been relieved, the CA- should be drawn post stent placement
Re-enrollment: Received at least  intravenous doses of ALT- with no dose-limiting toxicity (DLT)
All patients must have a psychosocial evaluation prior to transplant as per COH SOP
Patients with myeloproliferative neoplasms
Patients must have elevated calcitonin levels, greater than  pg/mL in females and  pg/mL in males
Symptomatic disease, as defined by the IWWM, includes the following criteria:\n             Hemoglobin less than  g/dL, platelet count less than , uL, bulky adenopathy\n             or organomegaly, symptomatic hyperviscosity syndrome, severe neuropathy, amyloidosis,\n             cryoglobulinemia, cold agglutinin disease, or evidence of transformation high-grade\n             non-Hodgkin's lymphoma.
Patients on warfarin (patients on injectable blood thinners, such as Lovenox, are able to continue those)
Pathologic assessment of the mediastinum to document involved nodal stations
Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics
Vasopressor requirement
Patients with known antibodies to immunoglobulin (Ig)A
Willingness and ability to complete the bowel and urinary domains of the EPIC prior to registration
Patients with antibiotic allergies per se are not excluded; although the production of TIL for adoptive transfer includes antibiotics, extensive washing after harvest will minimize systemic exposure to antibiotics
Patients must have adequate TIL available as described in the Moffitt Cell Therapy Core standard operating procedures (SOP)
Adequate absolute CD count estimated to be required to obtain target cell dose based on discussion with Department of Transfusion Medicine (DTM) apheresis and Cell Processing Section, DTM
History of prior IPHC/HIPEC
History of prior HIPEC
< Grade  hypo/hyperkalemia
< Grade  hypo/hyperphosphatemia
< Grade  hypo/hypermagnesemia
Receiving mitotane within  months of enrolling on the study
-
Approval for hydroxychloroquine treatment by an eye doctor, based on a screening eye exam; examples of disqualifying baseline conditions may include macular degeneration and other retinal disease such as cataracts that would interfere with required funduscopic examinations, or severe baseline visual impairment, retinopathy or visual field changes; all patients must undergo a screening eye exam prior to enrollment
Must not have retinal or visual field changes from prior -aminoquinoline compound use
Tamoxifen or other preventive measures within  months
History of cholecystitis without cholecystectomy
Electrolyte abnormalities (particularly hypokalemia or hypomagnesemia)
History of syncope or family history of idiopathic sudden death
Concomitant disease(s) that could prolong QT such as autonomic neuropathy (caused by diabetes, or Parkinson's disease), human immunodeficiency virus (HIV), cirrhosis, uncontrolled hypothyroidism or cardiac failure
Hemoglobin >=  g/dl (per manufacturer recommendation)
DONOR: History of medical illness that in the estimation of the PI or DTM/NMDP physician poses prohibitive risk to donation including, but not limited to, stroke, hypertension that is not controlled with medication, or heart disease; individuals with symptomatic angina or a history of coronary bypass grafting or angioplasty will not be eligible
In subjects between  and  years of age, physiologic age and co-morbidity will be thoroughly evaluated before enrolling; specifically, any history of cardio-vascular pathology or symptoms, not clearly fitting the exclusion criteria will prompt an evaluation by a Clinical Center Cardiologist and eligibility will be considered on a case-by-case basis
Histological confirmation of a high-grade malignant glioma is required; histologic diagnoses include, but are not limited to, anaplastic astrocytoma and glioblastoma multiforme; patients with DIPG are exempt from histologic verification if they have typical MRI findings of DIPG (i.e. hypo- or isointense on T-weighted imaging, hyperintense on fluid-attenuated inversion recovery [FLAIR] or T-weighted imaging, epicenter in the pons, > % of pons involved) in the face of a typical clinical presentation
Patients with an HGG that was completely resected with good margins
Recursive partitioning analysis (RPA) class I (KPS >= , primary cancer controlled, age < , metastases in brain only) or class II (lack of one or more of class I criteria)
HER expressing adenocarcinoma of the esophagus centrally
Evidence of tracheoesophageal fistula or invasion into the trachea or major bronchi
Patients must not have collecting duct or medullary carcinoma
Childs score of A or B
Neutralizing antibodies less than or equal to % neutralization of  ng/ml of LMB-
Patients who are not candidates for HDR brachytherapy
EBV seropositive
EBV-seropositive
OR non-measurable disease only, with rising serum cancer antigen (CA)- or CA . or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least  days apart with the most recent measurement being within  days prior to registration; the second CA - or CA . or CEA value must have at least a % increase over the first and for CA - or CA . be greater than or equal to  units/mL or for CEA be greater than or equal to  ng/mL
Creatinine =< . mg/dL is recommended; however, institutional norms are acceptable
Patients should be found unresectable by a preliminary Ear, Nose, and Throat (ENT) evaluation or have refused surgery
Previous treatment with or inability to receive BL or HA recombinant immunotoxin; patients must have had at least  prior systemic therapies, including  courses of a purine nucleoside analog (PNA), or  course of either rituximab or B-RAF proto-oncogene, serine/threonine kinase gene (BRAF) inhibitor following a single prior course of PNA
Serum that neutralizes =< % of the activity of  ug/mL of LMB- using a bioassay
Chronic Epstein-Barr virus (EBV)-associated lymphoproliferative disease\r\n* At any point after diagnosis, including upfront therapy
A diagnosis of ET or PV shall be made in accordance with the World Health Organization (WHO) () criteria as shown below (Values below are at the time of diagnosis, not study entry):\r\n* Polycythemia Vera ( major criteria required)\r\n** Hemoglobin (Hb) > .g/dl (male) or .g/dl (female) or \r\n** Hematocrit (HCT) >  percentile reference range or \r\n** Elevated red cell mass (> % above mean predicted value) or \r\n** Hb > g/dl (male) or g/dl (female) if associated with a sustained rise from baseline with no apparent cause (e.g. treated iron deficiency)\r\n** Presence of JAKVF\r\n* Essential Thrombocythemia (all  major criteria required)\r\n** Platelets count >=  x ^/L\r\n** Megakaryocyte proliferation with large and mature morphology; no significant increase or left shift of neutrophil granulopoiesis or erythropoiesis\r\n** Not meeting WHO criteria for chronic myelogenous leukemia (CML), PV, myelodysplastic syndromes (MDS) or other myeloid neoplasms\r\n** Demonstration of JAKVF, clonal cytogenetic marker or no evidence of reactive thrombocytosis\r\n** May participate in study without presence of JAKVF
In addition patients must EITHER be intolerant or resistant to hydroxyurea according to previously modified established criteria as follows:\r\n* Any ONE of the following:\r\n** Platelet count >  x ^/L after  months of at least g/day of hydroxyurea or maximally tolerated dose (MTD) of hydroxyurea (. g/day in patients with a body weight greater than  kg)\r\n** White blood cell (WBC) < . x ^/L or Hgb < g/dl at any dose of hydroxyurea not to exceed g/day (for a period of at least  months)\r\n** Progressive splenomegaly or hepatomegaly (> cm from initiation of hydroxyurea) or the appearance of new splenomegaly or hepatomegaly while on maximum tolerated dose (MTD) of hydroxyurea\r\n** Not achieving a Hct < % in order to eliminate the need for supplemental phlebotomies after  months of at least g/day MTD of hydroxyurea\r\n** Not achieving a WBC of <  x ^/L after  months of at least g/day MTD of hydroxyurea\r\n** Having a platelet count <  x ^/L on hydroxyurea at any dose without eliminating the need for supplemental phlebotomy or having progressive splenomegaly as defined above\r\n** Development of a major thrombotic episode (cerebral vascular accident [CVA], myocardial infarction, severe migraines requiring medication, abdominal vein thrombosis, deep vein thrombosis) while being treated with maximal tolerated doses of hydroxyurea\r\n** Presence of leg ulcers or other unacceptable hydroxyurea-related-nonhematological toxicities, such as unacceptable mucocutaneous manifestations, gastrointestinal symptoms, pneumonitis or fever at any dose of hydroxyurea\r\n* OR have Splanchnic Vein Thrombosis (SVT) (includes Budd-Chiari, abdominal vein thrombosis, portal vein thrombosis, splenic vein thrombosis); for these patients the following additional inclusion/exclusion criteria apply:\r\n** >  months since onset of SVT\r\n** SVT treated with oral anticoagulants but no aspirin\r\n** Liver enzymes not >  times the normal value\r\n** Absence of encephalopathy, refractory or infected ascites, esophageal varicose of grade >  at time of trial entry\r\n** Bone marrow biopsy confirmed diagnosis of PV or ET\r\n** JAK-VF present\r\n** These patients may have a normal blood count at trial entry
No detectable PNH (paroxysmal nocturnal hemoglobinuria) clone where tested
Registration of patients who have not yet undergone Oncotype DX screening must occur no later than  days after definitive surgery; (for all patients, Step  Registration must occur within  days after definitive surgery); if the Oncotype DX Breast Cancer Assay has not been performed, patients must be willing to submit tissue samples for testing to determine the Recurrence Score value; a representative block or unstained sections from the representative block are sent directly to Genomic Health for Oncotype DX Breast Cancer Assay which will be performed according to the standard commercial process\r\n* If the Oncotype DX Recurrence Score is already known and is  or less, the patient must be registered to Step  immediately following Step  registration; if the Oncotype DX Recurrence Score is already known and is greater than , the patient is ineligible
The Quality of Life and Economic Substudy is permanently closed to accrual effective //; patients who consented to QOL prior to // should continue to complete QOL forms per their expectation report; patients who are able to complete a questionnaire in English must be offered the opportunity to participate in the Quality of Life and Economic Substudy; (The Quality of Life and Economic Substudy is available to U.S. INSTITUTIONS ONLY); patients who are not able to complete a questionnaire in English are registered to S without participating in the Quality of Life and Economic Substudy\r\n* Patients who consent to participate in the Quality of Life and Economic Substudy and who do not yet know the results of their Oncotype DX screening must agree to complete the S Health-Related Quality of Life Questionnaire: Enrollment between  days prior to and  days after Step  Registration\r\n* Patients who consent to participate in the Quality of Life and Economic Substudy and who do already know their Oncotype DX Recurrence Score (and it is  or less) will proceed to Step  Registration without completing the S Health-Related Quality of Life Questionnaire Enrollment Form (but will complete the S Health-Related Quality of Life Questionnaire: Randomized Study Form)
The Quality of Life and Economic Substudy is permanently closed to accrual effective //; patients at U.S. INSTITUTIONS who consent to participate in the Quality of Life and Economic Substudy must agree to complete the S Health-Related Quality of Life Questionnaire: Randomized Study Form after Recurrence Score results and randomized treatment status are known but before treatment has been initiated
Essential Thrombocythemia (all  major criteria required)\r\n* Platelets count >=  x ^/L\r\n* Megakaryocyte proliferation with large and mature morphology; no significant increase or left shift of neutrophil granulopoiesis or erythropoiesis\r\n* Not meeting WHO criteria for chronic myelogenous leukemia (CML), PV, myelodysplastic syndromes (MDS) or other myeloid neoplasms\r\n* Demonstration of clonal cytogenetic marker or no evidence of reactive thrombocytosis\r\n* May participate in study without presence of JAKVF
No known PNH (paroxysmal nocturnal hemoglobinuria) clone
Must have full activity or, if limited, must be able to walk and carry out activities such as light house work or office work
Are \BCG Unresponsive\ which refers to patients with high-grade NMIBC who are unlikely to benefit from and who will not receiving further intravesical BCG. The term \BCG unresponsive\ includes patients who did not respond to BCG treatment and have a persistent high-grade recurrence within  months after BCG was initiated, and those who despite an initial complete response (CR) to BCG, relapse with high-grade CIS within  months of their last intravesical treatment with BCG or relapse with high-grade Ta/T NMIBC within  months of their last intravesical treatment with BCG. The following criteria define the patients who may be included in the study:
No maximum limit to the amount of BCG administered
All visible papillary tumors must be resected and those with persistent T disease on transurethral resection of bladder tumor (TURBT) should undergo an additional re-TURBT within  to  days prior to beginning study treatment. Obvious areas of CIS should also be fulgurated.
Symptomatic urinary tract infection or bacterial cystitis (once satisfactorily treated, patients can enter the study)
Patients who cannot hold instillation for  hour
cytotoxic agents (e.g. Mitomycin C, doxorubicin and epirubicin) when administered as a single instillation immediately following a TURBT procedure which is permitted between  to  days prior to beginning study treatment
Use of alemtuzumab
Use of direct acting antivirals for hepatitis C virus (HCV) recurrence, with the exception of sofosbuvir and ledipasvir/sofosbuvir
Clinically active serious infection documented by positive cultures or an incomplete course of treatment for bacteremia or fungemia
Use of direct acting antivirals for HCV recurrence\r\n* Sofosbuvir and ledipasvir/sofosbuvir are not excluded therapies
Use of alemtuzumab
Patients who can complete PRO forms in English are required to complete a pre-study SI Patient Reported Outcomes (PRO) Questionnaire and a pre-study SI EQ-D Questionnaire within  days prior to registration; NOTE: Patients enrolled to SI prior to // are not eligible for the PRO study
For subjects with CNS involvement: Subjects must have deficits that are stable for a minimum of  days prior to enrollment, or seizures that are stable, not increasing in frequency or severity and controlled on current anti-seizure medication(s) for a minimum of  days prior to enrollment NOTE: Subjects with leptomeningeal disease or brian tumors with positive cerebral spinal fluid cytology are eligible for this study. Subjects may receive glucocorticoids (at stable or tapering dose) to control CNS symptoms prior to enrollment; however, subjects should receive a stable or tapering dose for at least  days prior to enrollment.
ATRT
MRT
RTK
Extraskeletal myxoid chondrosarcoma
Extraskeletal myxoid chondrosarcoma
Chordoma (poorly differentiated or de-differentiated)
Cytogenetics or FISH and/or molecular confirmation (e.g., deoxyribonucleic acid [DNA] sequencing) of SS rearrangement t(X;)(p;q)
A dual-energy X-ray absorptiometry (DEXA) scan must be obtained within  years prior to registration
Specimen Submission Criteria:
Regulatory Criteria:
Patients undergoing pre-treatment surgery for purposes other than cytoreduction may also participate provided they meet eligibility; patients randomized to arms containing bevacizumab must wait a minimum of  days since that procedure to begin protocol treatment; patients who undergo an uncomplicated port placement must wait a minimum of  days to begin protocol treatment
Unmanageable fecal incontinence
In a heterosexually active woman of childbearing potential, unwillingness or inability to use a highly effective contraceptive method for the entire study treatment period and for at least  months after study treatment completion. Additionally, for women randomized to chemotherapy, unwillingness to adhere to the restrictions in the respective locally established guidelines and local approved label (prescribing information, Summary of Product Characteristics, or US product insert) from the manufacturer and the Patient Information Leaflet (package insert) as instructed by the Investigator.
For subjects in the UK only: Refusal of permission to allow the subject's General Practitioner to be notified of their participation in the study.
Or known cases of hepatobiliary diseases (e.g., primary biliary cholangitis, primary sclerosing cholangitis, history of immune-mediated cholangitis);
Subjects with cholangitis attributed to infectious etiology (e.g., ascending cholangitis, bacterial cholangitis) are eligible if the infection has been fully resolved prior to the screening visit.
Diagnosis of PMF according to the revised WHO criteria; or PET-MF or PPV-MF according to the IWG-MRT criteria
Subjects with phenotypes that are non-microsatellite instability high (non-MSI-H) will enroll in the non- MSI-H Safety Cohort and the C, C Cohorts.
Cancer arising from one of the following primary sites: paranasal sinus, nasopharynx, salivary gland, skin
Any non-squamous subtype
Each block of chemotherapy is a separate reinduction attempt.
Physiologic dosing of hydrocortisone is permitted.
CIS (with or without papillary disease) OR
Any grade T papillary disease OR
Subjects with hydronephrosis, except for those subjects where hydronephrosis has been longstanding (i.e., predates the diagnosis of the CIS, Ta or T by more than  years) and diagnostic evaluation at Screening shows no evidence of tumor. Subjects with hydronephrosis that is unequivocally unrelated to upper tract malignancy may be considered eligible with Sponsor approval.
Subjects on -alpha reductase inhibitors such as finasteride (PROSCAR, PROPECIA), or dutasteride (AVODART) within  days of study drug initiation.
Active diverticulitis.
Females must abstain from breastfeeding during study participation and  months after IP discontinuation.
Parts  and :  or 
Parts  and : , , or 
PMBCL:
RS:
Prior treatment with other immune modulating agents within fewer than  weeks prior to the first dose of REGN. Examples of immune modulating agents include blockers of CTLA-, -BB (CD), OX-, therapeutic vaccines, or cytokine treatments.
Subjects with histologically or cytologically confirmed NSCLC, MEL (including I/O relapsed MEL or I/O refractory MEL), CRC, SCCHN, ovarian cancer, recurrent B cell NHL or HL, or glioblastoma
The following are excluded: Subjects with liver transplants, clear invasion of the bile duct or main portal branch(es), or hepatorenal syndrome, or subjects who have required esophageal variceal ablation within  days of starting study treatment.
A minimum genotypic identical match of / is required.
They can't cooperate with the special precautions that are needed for this trial.
Key
Patients assessed at presentation as requiring interstitial brachytherapy treatment
Patients of all ages.
Relapsed, progressing or persistent malignancy requiring withdrawal of systemic immune suppression.
Active or recent (within  days) episode of transplant associated microangiopathy.
Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating gastric/GEJ cancer; previously received trastuzumab as part of a regimen in the metastatic setting with evidence of progression; Zr-trastuzumab use as imaging agent for Zr-trastuzumab PET permitted
Prior administration of other NY-ESO--targeting immunotherapeutics.
Unwillingness to discontinue ado-trastuzumab emtansine or lapatinib use
Patients must not be registered until receiving confirmation from the Southwest Oncology Group (SWOG) Statistical Center that the patient's tissue specimen was adequate for PD-L testing; patients must be registered within  working days of receiving the e-mail notification
Patients who received an investigational agent (including AG- or AG-) < days prior to their first day of study drug administration. In addition, the first dose of AG- should not occur before a period ? half-lives of the investigational agent (other than AG- or AG-) has elapsed.
Isolated extra-medullary disease relapse
The following drugs must be stopped >  week prior to CTL infusion and should not be administered concomitantly or following lymphodepleting chemotherapy: vincristine, -mercaptopurine, -thioguanine, methotrexate <  mg/m, cytosine arabinoside <  mg/m/day, asparaginase (non-pegylated)
Pegylated-asparaginase must be stopped >  weeks prior to CTL infusion e. CNS disease prophylaxis:
CNS directed radiation must be completed >  weeks prior to CTL infusion g. Anti T-cell Antibodies: Administration of any T cell lytic or toxic antibody (e.g. alemtuzumab) within  weeks prior to CTL is prohibited since residual lytic levels may destroy the infused CTL cells and/or prevent their in vivo expansion. If such an agent has been administered within  weeks prior to CTL, contact the Sponsor, consider consultation with an pharmacology expert, and consider measuring residual drug levels, if feasible, prior to CTL infusion Women of child-bearing potential (defined as all women physiologically capable of becoming pregnant) and all male participants, unless they are using highly effective methods of contraception for a period of  year after the CTL infusion. Highly effective contraception methods include:
Discharge summary
Subject has favorable risk cytogenetics as categorized by the National Comprehensive Cancer Network Guidelines Version ,  for AML.
Any significant ophthalmologic abnormality. The use of contact lenses is not recommended during the study.
If a subject has de novo DLBCL, the diagnosis is confirmed by biopsy and is immunohistologically characterized as de novo germinal center B-cell-like (GCB) DLBCL or de novo non-GCB DLBCL.
Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.
Subject received intra-operative sealant, glue or any buttressing material other than the LifeSeal Surgical Sealant.
A score higher than  on the Cumulative Illness Rating Scale-Geriatric.
Must have an apheresis product of non-mobilized cells accepted for manufacturing
Prior administration of other NY-ESO--targeting immunotherapeutics
WBCs ? /uL,
Kaposi sarcoma (KS) (following prior KS-specific therapy (Cohorts -)\r\n* (KS) impacting physical and/or psychological wellbeing and not amenable to local therapy and one or more of the following: \r\n** Stable KS despite  or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine [vincristine sulfate], vinblastine); or\r\n** Progressive disease despite  or more cycles of liposomal doxorubicin or paclitaxel or other active cytotoxic agents (i.e. etoposide, bleomycin, anthracyclines, vincristine, vinblastine); or\r\n** Patient who received a cumulative lifetime dose of anthracycline of >=  mg/m^; or\r\n** Recurrent or progressive KS after completion of prior first line chemotherapy\r\n** Intolerant of or refuses further cytotoxic chemotherapy\r\n** No KSHV-associated multicentric Castleman disease in past  years\r\n** For KS patients, the following laboratory values supersede values below:\r\n*** Platelets > lower limit of normal\r\n*** Hemoglobin >  g/dL
Treatment naive Kaposi sarcoma impacting physical and/or psychological wellbeing and not amenable to local therapy. (Cohort )\r\n* On antiretroviral therapy (ART) with suppressed HIV viral load for >  months (Note: an extended washout period is needed to avoid treatment during the period of risk for the highly toxic and often fatal Immune Reconstitution Inflammatory Syndrome (IRIS)\r\n* No KSHV-associated multicentric Castleman disease in past  years\r\n* No prior systemic chemotherapy \r\n* No symptomatic pulmonary KS or chest X-rays positive for un-evaluated abnormalities \r\n* Disease evaluable by AIDS Clinical Trial Group (ACTG) KS response criteria\r\n* CD+ T-cell count >=  cells/uL \r\n* For KS patients, the following laboratory values supersede values below:\r\n** Platelets > lower limit of normal\r\n** Hemoglobin >  g/dL
Life expectance of greater than two months to allow completion of study treatment and assessment of dose-limiting toxicity
Unstable cardiac disease including angina or hypertension as defined by the need for overnight hospital admission within the last  months ( days).
Patients must have completed a course of prior adjuvant trastuzumab or experienced side effects that resulted in early discontinuation of trastuzumab that have since resolved
Pure verrucous carcinoma of the penis
WT TP status
Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia)
Evidence of extensive intraperitoneal adhesions at the time of surgery which prohibits intraperitoneal therapy, as determined by the operating surgeon
Histochemical diagnosis of amyloidosis, as based on tissue specimens with Congo red staining with exhibition of an apple-green birefringence
Must have baseline efficacy images with measurable target tumors in the liver according to RECIST . using standard imaging techniques taken within  days prior to randomization. Images must be taken after, or at the time of completion of first line chemotherapy
Intervention for, or compromise of, the Ampulla of Vater
Patients must complete all required pretreatment evaluations
Has high risk bone metastases that are asymptomatic or minimally symptomatic (not requiring opioids). High risks metastases are defined as: . bulkiest sites of osseous disease >=  cm, . disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints . disease in long bones with /-/ cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpus, phalanges) . disease in junctional spine (C-T, T-L, L-S) and/or disease with posterior element involvement
Total abstinence from sexual intercourse (?  complete menstrual cycle before the baseline/randomization visit).
Patients must be able to receive weekly cisplatin
Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least  months after treatment;\r\n* NOTE: patient with <  moths of life expectancy will be treated with palliative QUAD shot radiotherapy and those with >  moths of life expectancy will be treated with conventionally fractionated full dose re-irradiation approach; additional other factors determining which patients will be treated with Quad shot therapy rather than full dose are if the patients have poor performance status, bulky or diffuse disease, significant medical co-morbidities, and significant metastatic disease burden
Karnofsky functional status rating >= 
Subjects with HNSCC:
Prior intracerebral agent.
Need for urgent palliative intervention for primary disease (e.g., rapidly increasing intracranial pressure, impending herniation, uncontrolled seizures).
Used any prescription medication during the prior  weeks that the investigator judges is likely to interfere with the study or to pose an additional risk to the patient in participating, specifically inhibitors or inducers of cytochrome P (CYP)A (refer to Appendix ). A stable regimen (?  weeks) of antidepressants of the selective serotonin re-uptake inhibitor (SSRI) class is allowed (common SSRIs include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline, and fluoxetine).
History of intracranial abscess within  months prior to study enrolment.
Use of -alpha reductase inhibitors (-ARIs) or hormone therapy within  months prior to the baseline visit. Baseline PSA must be established after a minimum of  months following -ARIs discontinuation. Additionally, use of -ARIs is not permitted following treatment during the study follow-up period.
Interest in future fertility
Patients with artificial urinary sphincter or any penile implant
Obstructing median lobe enlarged out of proportion to the rest of the prostate and protruding significantly into the bladder, sometimes referred to as \ball valve\ median lobe, determined on Baseline MRI
History of Parkinson's disease or multiple sclerosis
Patients in the USA: Glucagon
Patients in Canada and Europe: Buscopan (Hyoscine)
Patients must have been assigned to SA
Cytogenetic abnormalities finding in malignant myeloma clone with t(; ); and / or del(p); and / or q amplification; and / or t(:);or
Cytogenetic abnormalities finding in malignant myeloma clone with t(; ); and / or del(p); and / or q amplification; and / or t(; ); or
Serum LDH >  x ULN; c. Minimal residual disease (MRD) positive (defined as more than  malignant cell in  cells) measured by ClonoSIGHT NGS assay of a BMA sample) at the time of enrollment to this study; BMA sample collected at the time of multiple myeloma diagnosis, prior to induction therapy available for central MRD assessment by ClonoSIGHT NGS assay
Differentiated thyroid carcinoma (DTC) with focus loci of ATC is allowed. If a participant has pathology showing a small focus of ATC arising out of DTC and the measurable disease is not fully consistent with ATC, confirmation of ATC by biopsy is required.
Differentiated thyroid cancer (DTC) or MTC. However, ATC arising out of DTC is allowed, as long as the measurable disease is clinically consistent with ATC i.e., rapidly progressive and/or F fluorodeoxyglucose (FDG)-avid.
Are currently totally abstinent (as their preferred and usual lifestyle), and who do not agree to be totally abstinent during the study period and for  days after study drug discontinuation.
Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
CT scans or MRIs used to assess disease at baseline must be submitted for central review
Are at least:
Isolated extra-medullary disease relapse
Anti T-cell therapy: Administration of any T cell or toxic agent is strongly discouraged since residual lytic levels may destroy the infused CTL cell or prevent their in vivo expansion.
Solid tumors with documented ROS, NTRK, NTRK, or NTRK rearrangement
NSCLC with documented ROS, NTRK, NTRK, or NTRK rearrangement
k-RAS wild-type CRC with documented NTRK, NTRK, or NTRK rearrangement
Other solid tumors with documented ROS, NTRK, NTRK, or NTRK rearrangement
Prior administration of other NY-ESO--targeting immunotherapeutics.
For patients enrolled in Part SA who are receiving anti-PD- mAb therapy, marrow and hepatic function as defined in criteria a and b may be up to CTCAE Grade  if first reviewed, found to be within acceptable safety parameters for treatment with pembrolizumab, and approved by the Sponsor Medical Monitor.
Confirmed diagnosis of advanced malignancies that may be controlled with pSK or Akt inhibition based on already identified molecular alteration known to affect the PAM pathway, such as:: such as: such as: phosphate and tensin homolog (PTEN), phosphoinositide -Kinase catalytic subunit alpha isoform (PIKCA), protein kinase B  (Akt ), Akt , mammalian target of rapamycin (mTOR), tumor sclerosis complex  (TSC), tumor sclerosis complex  (TSC), in subjects who have received at least all treatment options considered to be standard therapy, unless some available treatment are not acceptable to the subject. For the dose escalation portion of the trial, subjects must have received the standard therapy unless intolerant or contraindicated.
Part , Cohort : For subjects with only PAM pathway alterations, subjects must have only PAM alterations, excluding Akt activating mutations or amplifications, and no other genomic alterations.
Part , Cohort : Histologically confirmed local laboratory testing (immunohistochemistry + staining and/or fluorescence in situ hybridization ratio >= .) HER+ metastatic breast cancer subjects who are resistant to trastuzumab-containing treatment and progressed on trastuzumab, pertuzumab, a taxane, and/or trastuzumab emtansine. There is no limit regarding the number of prior lines of therapy. Subjects may be enrolled regardless of whether or not their tumor harbors a PAM pathway alteration (documentation of PAM pathway alteration for this cohort is not required).
Monocularity
Contact lens dependent (if using contact lens, must be able to switch to glasses during the entire study duration)
Uncontrolled or evolving retinopathy, wet macular degeneration, uveitis, papilledema, or optic disc disorder
Have acquired, hereditary or congenital immunodeficiencies including cellular immunodeficiencies, hypogammaglobulinemia and dysgammaglobulinemia.
Have a prior history of a documented hemolytic event.
Extensive prior RT.
Impending need for immediate RT for symptomatic relief.
Patients managed with a total pancreatectomy, a distal pancreatectomy, or central pancreatectomy
Acute paronychia developing during the course of their monotherapy or combination chemotherapy
Involvement of at least one nail with a Paronychia Severity Grading score of  or higher
Patients with paronychia requiring surgical intervention at baseline
Ineligible for intensification treatment due to failure to mobilize an acceptable number of hematopoietic stem cells
Refused intensification treatment and/or ASCT
Transformed disease is permitted
Progesterone only oral contraception, where inhibition of ovulation is not the primary mode of action.
Active GI bleeding, as evidenced by hematemesis, hematochezia or melena in the past  months without evidence of resolution documented by endoscopy or colonoscopy
has achieved menarche at some point
Thrombopoiesis-stimulating agents (eg, romiplostim, eltrombopag, Interleukin-)
Other investigational mAbs within  months prior to first dose of IP.
Serum total bilirubin > .  ULN. Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > % with either a positive Coombs' test or over % of indirect bilirubin
night sweats for >  month without evidence of infection
Active hepatitis B or C as evidenced by detection of virus specific Deoxyribonucleic Acid (DNA) or Ribonucleic Acid (RNA).
Anti-nuclear antibody (ANA) negative or low-positive institutional range, as determined within  days from registration. Intermediate values (usually defined by a titer of ?:, or as indicated by institutional range) are acceptable if there are, in the opinion of the Investigator, no early signs of an autoimmune disease.
Prior administration of other intratumoral immunotherapeutics
Prior treatment with: second generation androgen receptor (AR) inhibitors, other investigational AR inhibitors, or CYP enzyme inhibitor.
Prior eribulin use
Hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene;
Patients must not be receiving erythroid stimulating agents (EPO: Procrit, Aranesp)
Site has received notification from Mayo Clinic  Rochester Division of Hematopathology of the central confirmation of diagnosis and tissue adequacy for mandatory research studies
International Prognostic Index (IPI) of  or greater
Cohort : Participants must have a mature T cell, B cell, or natural killer (NK) cell neoplasm.
For Part E: Participants must have adenoid cystic carcinoma (ACC).
For Part F dose confirmation: Participants must have leiomyosarcoma and prescreened alterations in a defined pathway.
Besylate Sub-Study only: unable or unwilling to eat the FDA recommended high-fat high-calorie breakfast (two eggs fried in butter, two strips of bacon,  ounce [oz]) of hash brown potatoes and  oz of whole milk) within the recommended  minutes.
Tumors must have been completely resected; in patients with tumor adherent to adjacent structures, en bloc R resection must be documented in the operative report or otherwise confirmed by the surgeon; near or positive radial margin are NOT exclusions as long as en bloc resection was performed; positive proximal margin or distal margin is an exclusion
Thymic carcinoid
Patients must not have a history of thrombo-embolic events within  years prior to study randomization
History of allergic reactions attributed to the following: \r\n* Camptothecin derivatives (e.g., topotecan [topotecan hydrochloride], irinotecan, or exatecan [exatecan mesylate]) \r\n* Any ingredients contained within the liquid irinotecan solution (e.g., sorbitol) or\r\n* Any antiemetics or antidiarrheals appropriate for administration with study therapy (e.g., loperamide or dexamethasone)
MDS: MDS classifiable by the World Health Organization (WHO) system as RA, RARS, refractory cytopenia with multilineage dysplasia (RCMD), RCMD and ringed sideroblasts (RCMD-RS) or RAEB
Fungal infections with radiological progression after receipt of amphotericin product or active triazole for >  month
The trial is open to both genders
Known history of positive serum human ADA.
Gastroduodenal ulcer(s) determined by endoscopy to be active.
Prior formal search was instituted
Patients on anti-platelet agents including clopidogrel and glycoprotein IIb/IIIa inhibitors; aspirin is allowed, but should be held before surgery according to standard practices
No history of uncontrollable supraventricular arrhythmias
Blood sample sent for free IGF- testing
be able to understand the reason for complying with the special conditions of the pregnancy prevention risk management plan and give written acknowledgement of this.
a history of \double/triple hit\ genetics
Primary mediastinal DLBCL.
A valid cobas PIKCA mutation result by central testing is required
Patients with biliary or gastro-duodenal obstruction must have drainage or surgical bypass prior to starting chemotherapy.
Patients may begin BBI on a date determined by the investigator and medical monitor for the sponsor after a minimum of  days since last receiving anti-cancer treatment which did not include BBI, provided that all treatment-related adverse events have resolved or have been deemed irreversible (except for alopecia).
Patients who previously received BBI for treatment of PDAC on the BBI- (BBI-PANC) study may continue with BBI in monotherapy between discontinuation of the first chemotherapy backbone and start of the second chemotherapy backbone. Patients may begin chemotherapy backbone on a date determined by the investigator and medical monitor for the sponsor after a minimum of  days and a maximum of  days since last receiving anti-cancer treatment which included BBI, provided that all treatment-related adverse events have resolved or have been deemed irreversible (except for alopecia).
Known hypersensitivity to the components of the study therapy. (Please reference Section , Formulation of EC and EC, in the respective Pharmacy Manuals)
No history of known human anti-chimeric antibody (HACA) positivity; this does not have to be checked prior to enrollment unless clinically indicated
Subjects must not be candidates for ruxolitinib based on EITHER:
Patients with ventricular tachycardia or supraventricular tachycardia that requires treatment with a class Ia antiarrhythmic drug or class III antiarrhythmic drug
EXCLUSION FOR COLLECTION OF T CELLS/PBMCS: Females who are pregnant
EXCLUSION FOR TREATMENT: Preceding and/or ongoing organ dysfunction or other co-morbidity including but not limited to uncontrolled infection that would impair the patients ability to endure known side effects of cytokine release syndrome or neurologic toxicity
Documented cardiomyopathy
Sufficient physiological reserves
Patients who have recovered from exploratory thoracotomy
Intervention for, or compromise of, the Ampulla of Vater
Patients who meet International Federation of Gynecology and Obstetrics (FIGO) stage I, II, or III criteria for low-risk gestational trophoblastic neoplasia (GTN): post molar GTN or choriocarcinoma (as defined below); patients may have had a second curettage but must still meet GTN criteria below:\r\n* Post molar GTN\r\n** For the purposes of this study, patients must have undergone evacuation of a complete or partial hydatidiform mole and then meet the criteria for GTN defined as:\r\n*** A < % decrease in the hCG level using as a reference the first value in the series of  values taken over a period of  weeks (>  mIU/ml minimum) OR\r\n*** A > % sustained rise in the hCG taking as a reference the first value in the series of  values taken over a period of  weeks (>  mIU/ml minimum) OR\r\n*** A persistently elevated hCG level a period of  months or more following the initial curettage (>  mIU/ml minimum)\r\n* Choriocarcinoma\r\n** Histologically proven non-metastatic choriocarcinoma OR\r\n** Histologically proven metastatic choriocarcinoma if the metastatic site(s) is restricted to one (or more) of the following: vagina, parametrium, or lung
Patients who do not have GTN
Patients with non-gestational choriocarcinoma
Plts > ,/mcL
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than  month
Willingness and ability to complete the Expanded Prostate Cancer Index Composite (EPIC-) questionnaire
Use of -alpha reductase inhibitor within the  months prior to dosing.
Neuroendocrine tumors, pancreatic basket\r\n* Grade  or grade  (or described as low grade, intermediate grade, well differentiated, or moderately differentiated) according to reviewing pathologist\r\n* Progressive disease over the preceding  months\r\n* Any number of prior therapies, including \r\n* Patients using a somatostatin analogue for symptom control must be on stable doses for  days prior to enrollment
Neuroendocrine tumors, extrapancreatic basket\r\n* Grade  or grade  (or described as low grade, intermediate grade, well differentiated, or moderately differentiated; typical or atypical carcinoid if originating in lung) according to reviewing pathologist\r\n* Progressive disease over the preceding  months\r\n* Any number of prior therapies, including \r\n* Patients using a somatostatin analogue for symptom control must be on stable doses for  days prior to enrollment
Peritoneal mesothelioma basket:\r\n* None
Myopathy > grade  or any clinical situation that causes significant and persistent elevation of CPK (> .  ULN in two different determinations performed one week apart).
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Hypersensitivity to dexamethasone, sucrose histidine (as base and hydrochloride salt), and polysorbate  or any of the components of study therapy that are not amenable to premedication with steroids, or H blockers that would prohibit further treatment with these agents.
malignant biliary obstruction unless the bile flow to the gastrointestinal tract is maintained by a fully operational biliary stent
Poor CYPD metabolizers based on the screening test for genetic polymorphisms in CYPD metabolizing capacity
All Study Arms:
All Arms:
Arms C only: bendamustine
Have adequate biliary drainage.
Requires open spinal procedure or a percutaneous procedure without the use of image guidance
pterygoid plate erosion;
direct extension to involve prevertebral fascia;
extension to superior nasopharynx or Eustachian tube;
suspected invasion (encasement) of the common or internal carotid arteries. Encasement will be assessed radiographically and will be defined as tumor surrounding the carotid artery  or greater;
direct extension to mediastinal structures;
RB status
Diffuse Intrinsic Pontine Glioma (DIPG) Patients with newly diagnosed diffuse intrinsic pontine gliomas (DIPGs), defined on neuroimaging as tumors with a pontine epicenter and diffuse intrinsic involvement of the pons, are eligible without histologic confirmation.
Patients with brainstem tumors that do not meet these criteria or not considered to be typical intrinsic pontine gliomas will only be eligible if the tumors are biopsied and proven to have + RB and be the following according to the  World Health Organization classification of tumors of the central nervous system: an anaplastic astrocytoma (IDH mutant, IDH wildtype, or NOS), glioblastoma (IDH mutant, IDH wildtype or NOS), diffuse midline glioma, H KM mutant or H KM negative, diffuse astrocytoma (IDH mutant, IDH wildtype or NOS).
Patients must have had histologically verified the following according to the  World Health Organization classification of tumors of the central nervous system: anaplastic astrocytoma (IDH mutant, IDH wildtype, or NOS), glioblastoma multiforme (IDH mutant, IDH wildtype, or NOS), diffuse astrocytoma (IDH mutant, IDH wildtype or NOS)
AND RB positive noted on immunohistochemistry.
Documented cardiomyopathy
Subjects must fall into one of the two populations below:
CLL/SLL cells must demonstrate one or more of the following high-risk genomic features:\r\n* Delp.(tumor protein p [TP]) as detected by fluorescence in-situ hybridization (FISH)\r\n* Delq.(ataxia telangiectasia mutated [ATM]) as detected by FISH\r\n* Complex karyotype (>=  cytogenetic abnormalities on stimulated karyotype)\r\n* Unmutated immunoglobulin variable region heavy chain (IgVH) ( >= % sequence homology compared with germline sequence)\r\n* Zeta-chain (TCR) associated protein kinase kDa (ZAP-) gene promoter hypomethylation < %
Consented to genome sequencing and database of genotypes and phenotypes (dbGaP)-based data sharing and has provided or will provide germline (peripheral blood mononuclear cell [PBMC]) and tumor DNA/ribonucleic acid (RNA) samples of adequate quality for sequencing; (acquisition of specimens for sequencing and the sequencing itself may be done under this study or as part of routine care or another research project)
Prior cancer immunotherapy, specifically indoleamine ,-dioxygenase (IDO) or tryptophan ,-dioxygenase (TDO) inhibitors, T-cell costimulatory receptor agonist antibodies, or checkpoint inhibitors among certain participants
A pathologically confirmed (histology or cytology) malignant neoplasm with at least one target lesion that is confirmed by conventional imaging and is determined to express somatostatin receptors by Ga-DOTATOC (TATE) PET within  days prior to treatment with Y-DOTATOC
Completion of Norfolk Quality of Life Questionnaire
Prior PRRT with Y-DOTATOC (tyr-octreotate [TATE]) or Lu-DOTATOC (TATE) or I-metaiodobenzylguanidine (MIBG) therapy for this malignancy
Any subject for whom, in the opinion of their physician, a -hour discontinuation of somatostatin analogue therapy represents a health risk; also subjects who have received long-acting somatostatin analogue in the past  days or long-acting lanreotide within the past  weeks are excluded; subjects may be maintained on short acting octreotide during the time from last injection of long-acting somatostatin analogue until  hours (hrs) prior to injection of study drug; known antibodies to octreotide, lanreotide, or DOTATOC or history of allergic reactions attributed to compounds of similar chemical or biologic composition to Y-DOTATOC
Subject weighs more than  pounds; (subjects who weigh more than  pounds will not be able to fit inside the imaging machines)
B-Leukocyte count ?. xe/L
ECOG performance status > after optimization of analgesics
Any congenital or acquired condition leading to compromised ability to generate an immune response
Requirement for continual immune suppression
Subjects HCV-positive after successful treatment (defined as sustained virologic response [SVR]  or SVR ) are allowed as long as  weeks have passed between completion of HCV therapy and start of study drug
Patients can have either failed BCG induction therapy within a six-month period or have been successfully treated with BCG, but subsequently found to have recurrence. The first standard course of intravesical BCG therapy must include at least six weekly treatments (allowable range of instillations per course is -). The second course of BCG therapy must include at least two weekly treatments.
Cannot achieve acceptable stereotactic ablative radiation therapy (SABR) planning to meet minimal requirement of target coverage and dose-volume constraints of critical structures
Have baseline clinical and laboratory parameters that are consistent with the requirements prescribed in respective labels and are suitable for consideration of treatment with capecitabine (or -FU) and cisplatin (for example, dihydropyrimidine dehydrogenase deficiency).
Patients must be registered within  days of completion of chemoradiation
Prior placement of Gliadel wafer or local brachytherapy
History of meningococcal disease
History and/or current evidence of uncontrolled endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis, etc
Contraindications to behavioral counseling, nicotine gum, patch, or lozenge and unable to complete study procedures as determined by eligibility screening
Caution should be taken with the use of hydroxychloroquine and any drugs known to interact with it; it is important to regularly consult a frequently-updated list; medical reference texts such as the Physicians Desk Reference may also provide this information
Lipid panel:
Total abstinence or;
body piercing or tattoos,
body piercing or tattoos. At the discretion of the investigator, additional patients may also be tested for hepatitis C.
For patients with LM and/or BM, CNS complications that require urgent neurosurgical intervention
Known intracranial haemorrhage which is unrelated to tumour
Prostate volume by transrectal ultrasonography (TRUS) <  cc
History of immunization with LL
All metastases not resected must be amenable to SBRT
The patient must meet ONE of the three following criteria:\r\n* - radiographically distinct metastases of any distribution in the allowed anatomical sites OR\r\n*  radiographically distinct metastases that must be anatomically close (i.e., with less than or equal to  cm of normal tissue between them) OR\r\n*  or  distinct metastasis,  or  to be treated with SBRT and the other (s) having been surgically removed
Metastases with indistinct borders making targeting not feasible
Patients who are not euthyroid as judged by the investigator.
SPECIMEN SUBMISSION CRITERIA:
REGULATORY CRITERIA:
Patients must have BRAFVE mutation
Agree to follow a low lycopene and phytoene diet
Is intolerant to VELCADE (ie, discontinued due to any adverse event while on VELCADE treatment)
Subjects with known history of keratitis, ulcerative keratitis or severe dry eye.
Paget's disease of the nipple
Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation
No restriction based on prior treatments
Subjects with coagulopathies, including thrombocytopenia
Has had prior gastrectomy
Radiographic evidence of cavitary or necrotic tumours or local invasion of major blood vessels by MPM
Patients must have one of the following: elevated beta (b)-microglobulin levels (defined as  times compared to normal), carry a Janus kinase  (JAK) mutation, or presence of phosphorylated p nuclear factor kappa-light-chain-enhancer of activated B cells (NF-kB) component in at least % of bone marrow cells
Patients with documented c-v-kit Hardy-Zuckerman  feline sarcoma viral oncogene homolog (KIT) mutations
Patients currently taking one or more of the following drugs that are generally accepted to have a risk of causing Torsades de Pointes:\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycins, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
No patients being decisionally impaired
Decisionally impaired patients
Patients with the FIPL-PDGFRalpha fusion even with resistance to imatinib (such patients are no longer defined as systemic mastocytosis by the WHO)
Commercially available, molecularly targeted therapies (e.g., dabrafenib, trametinib, vemurafenib, imatinib) taken within  days prior to lymphodepletion
For the purposes of this study, aggressive multidrug chemotherapy is defined as chemotherapy including  or more agents that must include an alkylating agent and a platinum-containing compound; patients must have ONE of the following:\r\n* First episode of recurrent disease following completion of aggressive multi-drug frontline therapy\r\n* First episode of progressive disease during aggressive multi-drug frontline therapy\r\n* Primary resistant/refractory disease (less than partial response by INRC) detected at the conclusion of at least  cycles of aggressive multidrug induction chemotherapy on or according to a high-risk neuroblastoma protocol (examples include A, ANBL, ANBLP, etc.)
Concurrent antiviral agent active against vaccinia virus (e.g., cidofovir, vaccinia immunoglobulin) during the study
Injectable disease (ie, suitable for direct injection or through the use of ultrasound [US] guidance) defined as follows:
Patients treated with TNF antagonists.
Platelets < ,/ mm for any reason, PT prolongation or thrombocytopenia that is not due to sepsis.
History of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within  months prior to consent.
Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection.
Currently tolerating imatinib mg QD. Patients with prior imatinib treatment interruption or dose reductions are required to be on treatment with  mg imatinib for two weeks immediately prior to randomization to ensure tolerance to imatinib
Subjects with less than CHR after  months of imatinib treatment or lost CHR after initial achievement
However, if a change in hormonal therapy is indicated, e.g. due to intolerable adverse effects, the regimen may be modified but change should be minimized thereafter.
Plasmacytomas >  cm in marrow areas measured by magnetic resonance imaging (MRI) or extramedullary plasmacytomas (radiated lesions are exempt from this criteria); patients may receive cytoreductive therapy, including allogeneic stem cell transplant (ASCT) (if high risk) or second ASCT (if failed a prior ASCT) to achieve disease control, but may not receive any cytoreductive therapy within  days of the dosimetry infusion and must have bone marrow cellularity meeting inclusion criteria obtained at least  days after any cytoreductive/myelosuppressive chemotherapy was last administered
Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g. uninterrupted long car or plane trips)
Ways to minimize risk of DVT should be discussed with patients, including, but not limited to, avoiding smoking, minimizing pro-thrombotic hormone replacement, avoiding prolonged periods of inactivity (e.g uninterrupted long car or plane trips)
Patient with low-intermediate risk, early-stage organ-confined prostate cancer (cTc and cTa, N, M), diagnosed with TRUS guided transperineal biopsy (TPBx) and voluntarily chooses MRgFUS as the non-invasive treatment, who may currently be on watchful waiting or active surveillance and not in need of imminent radical therapy.
Positive TRUS-guided transperineal biopsy (TPBx) cores, detected in a maximum of four () sectors, ( for each cancerous focus) out of  sectors (or out of  sectors in prostates with volume < cc)
Any rectal pathology, anomaly or previous treatment, which can change acoustic properties of rectal wall or prevent safe probe insertion (e.g., fistula, stenosis, fibrosis).
Identified calcification of  mm or more in largest diameter neighboring the rectal wall (in a distance of less than  mm) and interfering with the acoustic beam path.
Lower limb musculo-skeletal fixed deformities.
Active UTI
Prostatitis NIH categories I, II and III
Interest in future fertility
Patients must not be pregnant or lactating as chemotherapy is thought to present substantial risk to the fetus/infant
Patient has a rare hereditary problem of galactose intolerance, severe lactase deficiency or of glucose-galactose malabsorption
Patients with any disease that will obscure toxicity or dangerously alter drug metabolism
Patient with electrolyte abnormality deemed clinically significant by the investigator (e.g., hypokalemia, hypomagnesemia, hypophosphatemia, hyperkalemia, hypocalcemia, hyponatremia) unless the level can be corrected to normal levels prior to initiating study drug
The following medications within four weeks prior to start of study treatment (week ): systemically administered radiopharmaceuticals such as bone seeking isotopes (e.g., samarium- lexidronam); hematopoietic growth factors other than erythropoietin; medroxyprogesterone as an appetite stimulant; or alternative medicine treatments for prostate cancer, including Prostasol (formerly: PC-Plus), saw palmetto, or Zyflamend
Patients with pN+ or > T disease or who have not had a visibly complete TURBT
Patients with Gleason score >= ; PSA > ; OR clinical stage >= T are ineligible for this trial\r\n* Should findings of extracapsular extension or seminal vesicle invasion be noted on prostate MRI, this study, if used, will not render patients ineligible for accrual to this protocol; primary tumor staging for eligibility purposes is to be based on palpable or core biopsy evidence only with respect to extracapsular extension or seminal vesicle involvement
No restriction based on prior treatments
HAMA titer >  Elisa units/ml
Absence of rectum or other anatomic features which would preclude transperineal needle insertion into the prostate
American Urologic Association Obstructive Symptom Index Score > 
Subjects with >  renal/genitourinary toxicity: \r\n* Bladder spasms\r\n* Creatine > . x UNL\r\n* Dysuria (painful urination)\r\n* Genitourinary fistula\r\n* Hemoglobinuria (> +)\r\n* Operative injury to bladder and/or ureter\r\n* Proteinuria\r\n* Renal failure\r\n* Ureteral obstruction\r\n* Urinary retention\r\n* Urine color change (not related to other dietary or physiologic cause e.g. bilirubin, concentrated urine, hematuria)
Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone .%, hydrocortisone butyrate .%, fluocinolone .%, desonide .%, alcometasone dipropionate .%)
Patients with known TP mutations or chromosome  or p deletions
Active tuberculosis or bacillus Calmette-Guerin (BCG) infection
SCCHN
Non-resectable disease
Cataract of Grade ? for posterior subcapsular cataract, cortical cataract, nuclear opalescence, or nuclear color based on the LOCS III.
Prior treatment with compounds with the same mode of action as proposed for HDM, i.e. an inhibition of the interaction of TP with HDM, e.g. RG or CGM
Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
Female subjects of childbearing potential should be willing to use two methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through  days after the last dose of study medication; subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for >  year\r\n* Cohort  (accrual to  patients) is for patients who had ongoing stable disease (SD) on letrozole + palbociclib, enrolled on prior version of eligibility criteria to receive pembrolizumab after obtaining stable disease on letrozole + palbociclib; these patients must have been on treatment with letrozole and palbociclib for  months with SD per RECIST .; received up to  lies of previous therapy including endocrine and/or chemotherapy in advanced setting prior to initiation of letrozole and palbociclib; no grade  toxicities except alopecia
Phase : activated B-cell or unclassifiable subtypes confirmed by immunohistochemistry using the Hans algorithm
Fluorodeoxyglucose-avid disease (based on local evaluation) per the Lugano Classification. Fluorodeoxyglucose-avid disease is defined as disease with a -point scale score of  or .
Be of nonchildbearing potential:
Hydroxyurea for ?  days
Uncontrolled infection within one week of the first dose; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines are acceptable
Have abnormal QTcF (>milliseconds) after electrolytes have been corrected (at least two different ECG readings and at least  minutes between readings)
Prior ipilimumab is permitted.
Previous treatment with either a PD- inhibitor (for patients enrolling on the IMO- + pembrolizumab combination) or CTLA- inhibitor (for patients enrolling on the IMO- + ipilimumab combination if applicable) should not have been accompanied by DLT for which permanent discontinuation is recommended (per USPI).
Ages  to  at the time of Assent or Consent per IRB guidelines
All patients with a diagnosis of complex atypical hyperplasia OR grade  endometrioid endometrial carcinoma on endometrial biopsy or dilation and curettage (D & C) within three months of study enrollment
Congenital or acquired uterine anomaly which distorts the uterine cavity
Genital actinomycosis
Part :  or 
Part  and : , , or 
Participants must begin study treatment no later than  days from the post-ASCT discharge; additionally, they must have recovered from ASCT toxicities at the time of first study treatment; recovery from ASCT toxicity is defined using the eligibility criteria in this section, as well as outpatient status, ability to drink and eat normally, without the need for intravenous hydration; participants must be no later than  days from stem cell reinfusion; exceptions to these time frames may be made in discussion with the overall principal investigator (PI) and will not constitute study violations
Timing of radiation may be according to a concurrent protocol (such as a Childrens Oncology Group [COG] study) or according to physician discretion
Patients with co-morbidities that would make the use of radiation too toxic to deliver safely, such as serious local injury or collagen vascular disease
Primary tumor must be arising in one of the following central chest locations:\r\n* Within or touching the zone of the proximal bronchial tree (a volume  cm in all directions around the proximal bronchial tree [carina, right (R) & left (L) main bronchi, R & L upper lobe bronchi, intermedius bronchus, R middle lobe bronchus, lingular bronchus, R & L lower lobe bronchi])\r\n* Adjacent to (within  mm) or invading the mediastinal pleura\r\n* Adjacent to (within  mm) or invading the parietal pericardium
Diagnosis of precursor B-cell or precursor T-cell ALL by immunophenotyping
Childs class C
In the dose expansion portion of the phase I study, patients must have locally advanced, unresectable or metastatic GIST that is resistant to imatinib; this population includes patients who have not been treated with imatinib (imatinib naive) but considered to have primary resistance to imatinib, i.e. KIT/PDGFRA wild-type GIST, and patients with imatinib-refractory disease, i.e. has had prior treatment with imatinib
Prior therapy with Laser-Induced Thermal Therapy (LITT) is allowed but at least  days must have elapsed from last LITT, with recovery from all LITT-related toxicities to Grade  or less and subsequent histologic documentation of recurrence.
Presence of hemosiderin.
Patients with steroid myopathy.
Eligibility for T-cell infusion (includes cyclophosphamide, T cell, anti-CTLA infusions and s.c. IL-) (Turnstile ) (Note: evaluate at least  week before T-cell infusion): ECOG/Zubrod performance status of -.
Prior to cyclophosphamide and T cell infusions: platelets =< ,
Inadequate response to eculizumab defined as having received eculizumab for at least  months plus a documented LDH level ? . x the upper limit of normal (ULN) and/or the presence of a known C mutation conferring resistance to eculizumab
History of meningococcal disease
Investigator considers R-CHOP immunochemotherapy appropriate.
Wolff-Parkinson White syndrome or the presence of an intra-cardiac defibrillator
Presence of TI mutation by ABL sequencing
Vaccination with a live or attenuated vaccine =<  days prior to randomization; Note: other types of vaccines, including inactivated/killed, toxoid (inactivated toxoid), and subunit/conjugate are all permitted at any time
Colonoscopy, sigmoidoscopy, or proctoscopy =<  days prior to randomization
Resectable, borderline resectable or metastatic disease
May have had intervening therapy since completion of initial UC- dosing, but excluding the following:\r\n* Within  days of UC- restart, or  half-lives (if known), whichever is shorter: small molecular tyrosine kinase inhibitor (e.g.: ibrutinib, idelalisib, AVL-, IPI-); \r\n* Within  days of UC- restart: chemotherapy (e.g., purine analogues, alkylating agents), corticosteroids, radiation therapy, or participation in any other investigational drug treatment (besides UC-) \r\n* Within  days UC- restart: previous UC- dosing\r\n* Within  days of UC- restart: monoclonal antibody therapy directed against CLL (eg. rituximab, ofatumumab, obinutuzumab, alemtuzumab)
At time of surgery, has a completed anastomosis that is able to be visualized and is accessible to allow for circumferential sealant application with minimal bowel manipulation (?%)
Patients must have a confirmed diagnosis of neurofibromatosis  by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the neurofibromatosis  (NF) gene\r\n* The NIH criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF and EITHER unilateral eighth nerve mass OR two of the\r\nfollowing: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity\r\n* The Manchester criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR any two of: schwannoma, glioma, neurofibroma, cataract
Able to receive ibrutinib through commercial supply, i.e., insured patients meeting Food and Drug Administration (FDA)-approved indications
other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide).
Prior use of lenvatinib
Patients who have developed any evidence of clinical or radiologic pneumonitis, cryptogenic organizing pneumonia (COP)/bronchiolitis obliterans organizing pneumonia (BOOP), or other lung injury, during treatment with prior FRalpha-targeting therapy, such as mirvetuximab soravtansine (IMGN), or with any prior cancer immunotherapy
Creatinine < . mg/dL is recommended; however, institutional norms are acceptable
The subjects must have at least four BCCs in non-cosmetically sensitive sites
Hypersensitivity to pegfilgrastim or Escherichia (E.) coli derived proteins
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV
History of Raynauds disease, cryoglobulinemia
At least one metastasis must show uptake of In-DTPA-octreotide (indium In- pentetreotide) on SPECT that is higher than the physiologic radiotracer uptake by the liver
Non ductal adenocarcinomas, neuroendocrine neoplasms, cystic tumors of the pancreas such as cystadenomas, cystadenocarcinomas and solid pseudopapillary neoplasms; in addition, adenocarcinomas arising from duodenum, distal bile duct, and ampulla will also be excluded
Motivated to change their marijuana use (>=  on a -point Likert-type scale)
CNS complications for whom urgent neurosurgical intervention is indicated (e.g., resection, shunt placement)
Neuroimaging evidence of midline shift
History of median sternotomy
Patients must have negative tests (antibody and/or antigen) for hepatitis viruses B and C unless the result is consistent with prior vaccination or prior infection with full recovery.
have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography (CT) scan with contrast).
Pregnant or nursing women, due to the unknown effects ofLY on the developing fetus or newborn infant.
Any National Comprehensive Cancer Network (NCCN)-International Prognostic Index (IPI) score; a calculated score required for enrollment
Performance status <  (unless previous performance status was  or  and deterioration is due to lymphoma which treating medical doctor [MD] expects to reverse with therapy)
Systemic androgens and estrogens (vaginal estrogen creams are allowed)
Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the enzalutamide capsule components, including caprylocaproyl polyoxylglycerides (Labrasol), butylated hydroxyanisole and butylated hydroxytoluene.
Received double-blind placebo during the main study.
The expanded cohort will consist of predominantly (> %) p mutated HNSCC patients at the MTD
Willingness to use a medically acceptable method of contraception throughout the study period and for  weeks after the final administration of AZD or longer if needed as per chemotherapies product information (all subjects)
Biliary stents (plastic or metallic) are allowed; however, those patients with metallic stents will not undergo the functional MRI correlative component of this study
Patients with any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration including: abdominal surgery within  weeks of study entry (for reasons other than IP port placement), intestinal dysfunction, or suspected extensive adhesions from prior history or finding at laparoscopy.
Locally confirmed MMR deficient or MSI-H status.
No evidence of true progressive disease from the postoperative period to the post-chemoradiation period, based on changes in the neurologic exam, steroid use, or evident radiographic progression, according to RANO criteria; patients with increased or new gadolinium enhancement may continue on protocol if in the investigators judgment that enhancement is likely due to pseuodoprogression; the use of correlative imaging studies (including perfusion-weighted imaging [PWI]) and repeat or diffusion weighted imaging (DWI), and repeat imaging after an interval of - weeks is strongly encouraged to help distinguish between pseudoprogression and true progression
Surgical margins that cannot be microscopically assessed or that are positive
Known myopathy or persistent CPK elevations > . ULN in two different determinations performed one week apart
Has completed baseline Health-Related Quality of Life (HRQL) questionnaires UNLESS is unable to complete because of limited literacy or vision
Must be able to avoid direct contact with pregnant women, infants <  months of age and immunocompromised individuals while on study and for >=  weeks following the last dose of study agent administration; direct contact is defined as household contact, i.e., anyone living with the patient
Other anti-platelet agents (such as clopidogrel, ticlopidine, dipyridamole, or anagrelide). Aspirin use at doses up to  milligrams (mg)/day is permitted.
History of a prior significant toxicity, other than thrombocytopenia, from another Bcl- family protein inhibitor
Bacterial peritonitis within  days
Family history consistent with thrombophilia or hypofibrinolysis
Esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS) +/- biopsy at M.D. Anderson are required to confirm staging
Microsatellitosis as per AJCC  definition
Patient has already undergone a local flap reconstruction of the defect after excision of the primary and determination of an accurate excision margin is impossible.
Melanoma located distal to the metacarpophalangeal joint, on the tip of the nose, the eyelids or on the ear, mucous membranes or internal viscera.
A diagnosis of PVNS or GCT-TS (i) that has been histologically confirmed either by a pathologist at the treating institution or a central pathologist, and (ii) where surgical resection would be associated with potentially worsening functional limitation or severe morbidity (locally advanced disease), with morbidity determined consensually by qualified personnel (eg, two surgeons or a multi-disciplinary tumor board).
Symptomatic disease because of active PVNS or GCT-TS, defined as one or more of the following:
a worst stiffness of at least  at any time during the week preceding the Screening Visit (based on a scale of  to , with  representing \stiffness as bad as you can imagine\).
Willingness and ability to use an electronic diary.
Known metastatic PVNS/GCT-TS.
Transformed disease (assessed by investigator):
Patients unable to ambulate or who have amputations or paralysis of any extremity
Study population:
Unstable hyperthyroidism or hypothyroidism
Has received prior interstitial brachytherapy, implanted chemotherapy, or therapeutics delivered by local injection or convection enhanced delivery
Patient has an ECOG performance status of  (fully active, able to carry out all pre-disease activities without restriction) or  (unable to perform physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature), as assessed on CD, before the first dose of PBI .
Confirmed PD-L-negative SCCHN by Ventana SP;
Endorse persistent CRCI subjective complaints
Has a metastatic deposit that can be biopsied
Histologically documented PCNSL or SCNSL; patients with SCNSL need to have cytology or tissue biopsy documenting lymphomatous involvement of the central nervous system (CNS)
Presence of a RAS mutation in exons , , or  of KRAS or NRAS (patients with mutations in exons , , or  of KRAS and/or NRAS are excluded)
Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled as indicated by baseline pattern of >  loose stools daily in subjects without a colostomy or ileostomy; subjects with a colostomy or ileostomy may be entered at investigator discretion
Patients are to be treated with hypofractionated RT
Participants must have a baseline mammographic density >= % based upon the Breast Imaging Reporting and Data System (BIRADS) density score of , , or  ( = -%, scattered fibroglandular densities;  = -%, heterogeneously dense breasts;  = > %, extremely dense breasts); women with a baseline mammographic density of < % ( = .-%, breasts are almost entirely fat) will not be eligible
Willingness to abstain from all omega- fish oil supplements for  days prior to baseline evaluation and during the study intervention
Unexplained febrile illness
In the dose-finding phase, patients may be cetuximab-exposed or cetuximab-nave; if the most recent line of therapy included cetuximab, a two-week washout period without cetuximab dosing is required
In the dose-expansion phase, patients must be cetuximab-resistant by fulfilling at least one of the criteria defined below:\r\n* Disease recurrence within  months of completing definitive radiotherapy for locally advanced disease; radiation must have included concurrent cetuximab; induction chemotherapy, if given, may or may not have included cetuximab\r\n* Disease progression during, or within  months, of cetuximab treatment in the recurrent/metastatic setting; prior cetuximab exposure may have occurred in first, second and/or third line\r\n* If the most recent line of therapy included cetuximab, a two-week washout period without cetuximab dosing is required
Patients with target tumors that could potentially invade a major vascular structure (e.g., innominate artery, carotid artery), based on unequivocal imaging findings.
Documented BCR-ABL <.% (>MR i.e. > log reduction) or undetectable BCR-ABL by PCR for at least  years according to the patient's local lab
Documented BCR-ABL <.% (>MR i.e. > log reduction) or undetectable BCR-ABL at least  times prior to screening according to the patient's local lab
Patients are allowed to have received prior treatment with mFOLFOX; if patients are currently receiving treatment with mFOLFOX, the subject must have documented disease progression; patients must also be able to tolerate standard mFOLFOX; reduced dosing of mFOLFOX at enrollment is exclusionary
Participants must be candidates for RP and considered surgically resectable by urologic evaluation
History of abdominoperineal resection for rectal cancer, rectal stenosis, or other major rectal pathology
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine or CRS- (e.g., glycerol)
Patient is unable to avoid intimate contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) ) for at least  days after receiving CRS- infusion
Total Cumulative Illness Rating Scale (CIRS score) greater than (>) 
An individual organ/ system impairment score of  as assessed by the CIRS definition limiting the ability to receive the treatment regimen of this trial with the exception of eyes, ears, nose, throat organ system
Patients may not smoke or plan to smoke tobacco or marijuana during study therapy
Patients must be questioned for a past medical history of gout; patients must not have a history of gout which can be exacerbated by perifosine
Known TI or VL mutation.
CTCL with histologic evidence of folliculotropic variant or large cell transformed CTCL
Note: Discontinuation of Trastuzumab is not necessary.
The QTc should be based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period.
Confirmed PD-L-positive SCCHN by Ventana SP assay
Documented history of vesicoureteral reflux
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Double (tandem) ASCT.
AGSE
L-Histidine
?-trehalose dihydrate or
Serum alkaline phosphatase less than . times the upper limits of normal; note: if hepatic function is abnormal, the decision to initiate temozolomide treatment should carefully consider the benefits and risks for the individual patient
History of oxalate nephrolithiasis or urine oxalate >  mg/dL
This must be the patients FIRST mobilization attempt
For bilateral retinoblastoma\r\n* Group A and Group A eyes that have failed local therapy\r\n* Group A and Group B eyes that have failed local therapy\r\n* Group A and Group C eyes\r\n* Group A and Group D eyes\r\n* Group A and Group E eyes in which the Group E eye is not planned for enucleation after first cycle of chemotherapy\r\n* Group B and Group B eyes that have failed local therapy\r\n* Group B and Group C eyes\r\n* Group B and Group D eyes\r\n* Group B and Group E eyes in which the Group E eye is not planned for enucleation after first cycle of chemotherapy\r\n* Group C and Group C eyes\r\n* Group C and Group D eyes\r\n* Group C and Group E eyes even if early enucleation is planned for the Group E eye\r\n* Group D and Group D eyes\r\n* Group D and Group E eyes even if early enucleation is planned for the Group E eye\r\n* Group E and Group E eyes if at least one eye is not planned for enucleation
Any technical factor that would prohibit use of catheterization of the ophthalmic artery (e.g., small for age infant, untreatable allergy to contrast)
Asymptomatic or minimally symptomatic
Monocytes >= . x ^/L
Known myopathy or history of rhabdomyolysis
Uncontrolled hypothyroidism
Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacity
Patient's tumour sample must be PD-L positive (?%of tumour cells with membrane staining (Cohort  and ) or PD-L positive with ?% of tumour cells with membrane staining (Cohort ))
Patients with Trisomy 
Subject must have available at least  prior full sets of scans (not including screening), each separated by at least  months with less than or equal to  mm slice thickness and up to  mm interslice gap on either D T weighted image, D T weighted image, or FLAIR.
Patients must have confirmation of DT/DF by local pathologist prior to registration
Chronic daily NSAID use as treatment for controlling desmoid tumors is not allowed, and should be stopped >=  days prior to registration; NSAIDS are allowed when used for desmoid tumor-related pain or for symptoms that are unrelated to desmoid disease (eg. headache, arthritis)
Patient has documented evidence of PrR negative endometrial cancer. PrR negativity can be determined by immunohistochemistry. The tumor is considered PrR negative if the number of PrR positive cells is less than % determined by immunohistochemistry;
History of use of progestins for a period of longer than  months for any indication, including endometriosis;
Subjects in whom everolimus is contraindicated.
Have hormone-sensitive metastatic disease (M) as evidenced by soft tissue and/or bony metastases
Treatment with concurrent -alpha reductase inhibitors (finasteride, dutasteride), estrogens, and/or cyproterone
Patients must have adequate EGFR greater than  mL/min per . m (per VA formula and adjusted for gender and race)
Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on body wall
Morning cortisol >= institutional normal
Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.
Patients with sickle-cell anemia or thalassemia major.
Treatment Naive only: and a) do not want to receive chemoimmunotherapy or b) have comorbidities that would preclude chemoimmunotherapy.
Receiving concurrent androgens, anti-androgens, estrogens, or progestational agents, or received any of these agents within the  months prior to enrollment or having taken finasteride or dutasteride within  days of registration
Ongoing participation in a Phase  (LX.--CS, LX.--CS) or Phase  (LX.--CS, LX.--CS) study
Major protocol violations or tolerability concerns in a Phase  (eg, LX.--CS, LX.--CS) or Phase  (eg, LX.--CS, LX.--CS) study
Hepatocellular carcinoma for which treatment with FOLFOX or CAPOX would be acceptable as determined by the Investigator.
Cholangiocarcinoma for which treatment with FOLFOX or CAPOX would be acceptable as determined by the Investigator.
Abnormal glucuronidation of bilirubin
History of RPLS
Participants who are >=  years of age or Legally Authorized Representative (LAR) of participants who are younger than  years must sign an informed consent for the Pediatric Oncology Branch (POB) Screening Protocol (-C-: Eligibility Screening and Tissue Procurement for the National Cancer Institute [NCI], Pediatric Oncology Branch [POB] Clinical Research Protocols) prior to participating in studies required to determine eligibility for this trial; after confirmation of eligibility, participants who are >=  years of age or LAR of minor participants must sign an informed consent document for this trial, indicating that they are aware of the investigational nature of the proposed treatment, the risks and benefits of participating and the alternatives to participating, prior to the conduct of any study procedures
Have some types of eye problems or impairments
With historically documented Ph+ cells
Known Abl-kinase mutation resistant to Dasatinib (e.g. TI or TA)
Phase Ib only:\r\n* Patients with metastatic rectal cancer are allowed if their primary site meets other eligibility criteria and chemoradiotherapy is recommended as initial therapy for symptom palliation by the multidisciplinary treating team\r\n* Patients with locally advanced unresectable rectal cancer are allow provided:\r\n** There is no evidence of recto-vaginal, recto-vesicular, recto-intestinal fisutalization\r\n** Standard dose and schedule chemoradiotherapy is recommended as initial therapy by the multidisciplinary treating team
Refractory to ofatumumab (progression or relapse < months of receiving ofatumumab therapy or < months of receiving an ofatumumab- containing regimen)
Unable to receive prophylactic treatment for pneumocystis or herpes simplex virus (HSV)
History of myocardial infarctions or cardiac stent placement less than  year before recruitment into the study
Direct laryngoscopy showing no evidence of greater than stage II true glottic larynx cancer
Anti-thymocyte globulin (ATG) level of >=  ugm/ml
Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
Information available or pending regarding possible genetic alterations that can explain the patients pheochromocytoma/paraganglioma (mutations in succinate dehydrogenase subunit B [SDHB], SDHV or von Hippel-Lindau [VHL] genes)
Patients who have large abdominal masses impinging on bowel or pulmonary masses with encroached vessels and a potential to bleed will be considered on case by case basis after careful consultation with multiple disciplines such as radiologists and surgeons with main intent being patient safety
Minimum weight  kilograms is required to be eligible for the study since the minimum injection volume of SYLATRON is . ml,  mcg, subcutaneously (SQ) as suggested by Merck
Patients with resected primary must be active participants of the NSABP Patient Registry and Biospecimen Profiling Repository (MPR-) study. Patients with intact primary and metastatic KRAS wild-type disease at presentation (treatment naive), must have signed consent for quadruple wild-type central testing for treatment-naive tumor sample submission
All patients must have radiographically assessable disease
Total bilirubin less than or equal to . mg/dL in the absence of biliary obstruction; if the patient has biliary obstruction, biliary decompression will be required; either endoscopic placement of biliary stent ( French or greater) or percutaneous transhepatic drainage are acceptable; once biliary drainage has been established, institution of gemcitabine therapy may proceed when the total bilirubin falls to =< . mg/dL; patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
Patients who cannot undergo staging laparoscopy; for example, this may include patients with a prior history of multiple abdominal operations in which laparoscopy may not be technically feasible or potentially harmful; the patient is eligible if they have a common bile duct stent adjacent to the tumor that may be used as an internal marker, or if the patient has already had a staging laparoscopy without marker implantation and the markers can be implanted (by interventional radiology) prior to the beginning of radiation therapy
Patients with a recognized acquired, hereditary, or congenital immunodeficiency disease including cellular immunodeficiencys, hypogammaglobulinemia or dysgammaglobulinemia
Patients receiving the following drugs that are contraindicated with nelfinavir (NFV) (VIRACEPT) will be excluded if they cannot be change or discontinued; drugs that should not be coadministered with Viracept:\r\n* Antiarrhythmics: amiodarone, quinidine\r\n* Antimycobacterial: rifampin\r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine\r\n* Herbal products: St. John's wort (hypericum perforatum)\r\n* -hydroxy--methyl-glutaryl (HMG)-acetyl coenzyme A (CoA) reductase inhibitors: lovastatin, simvastatin\r\n* Neuroleptic: pimozide\r\n* Sedative/hypnotics: midazolam, triazolam
Patients receiving the following drugs will be clinically evaluated as to whether dosage/medication can be changed to permit patient on study: \r\n* Anti-convulsants: carbamazepine, phenobarbital\r\n* Anti-convulsant: phenytoin; phenytoin plasma/serum concentrations should be monitored; phenytoin dose may require adjustment to compensate for altered phenytoin concentration\r\n* Anti-mycobacterial: rifabutin; it is recommended that the dose of rifabutin be reduced to one-half the usual dose when administered with VIRACEPT;  mg BID is the preferred dose of VIRACEPT when coadministered with rifabutin\r\n* Erectile dysfunction agent: sildenafil; sildenafil shall not exceed a maximum single dose of  mg in a  hour period\r\n* HMG-CoA reductase inhibitor: atorvastatin; use lowest possible dose of atorvastatin with careful monitoring, or consider other HMG-CoA reductase inhibitors such as pravastatin or fluvastatin in combination with VIRACEPT\r\n* Immunosuppressants: cyclosporine, tacrolimus, sirolimus\r\n* Narcotic analgesic: methadone; dosage of methadone may need to be increased when coadministered with VIRACEPT\r\n* Oral contraceptive: ethinyl estradiol; alternative or additional contraceptive measures should be used when oral contraceptives and VIRACEPT are coadministered\r\n* Macrolide antibiotic: azithromycin; dose adjustment of azithromycin is not recommended, but close monitoring for known side effects such as liver enzyme abnormalities and hearing impairment is warranted
Documented cardiomyopathy
The target index tumor(s) is determined (by CT images) to be in a location where cryoablation is technically achievable based on the proximity of adjacent organs/ structures and is greater than . cm from any critical organ/structure (possibly achieved with additional maneuvers such as iatrogenic pneumothorax or hydrodissection).
Patients who are curable by conventional multidisciplinary management.
Emergency treatment for hyperleukocytosis with hydroxyurea for ?  days;
Patients must have pathological Gleason (pG) sum -; or pG sum  and either pT or R disease (i.e. positive margins)
BCC/SCC adjacent to or overlapping with burn or scar
BCC/SCC within  cm of another treated or untreated BCC/SCC
Genetic disorder predisposing patient to skin cancers or radiation sensitivity (basal cell nevus syndrome, xeroderma pigmentosum, ataxia telangiectasia mutans)
Subjects must be able to discontinue any drug treatment aimed at lowering disease burden in CNL or aCML; subjects should discontinue hydroxyurea to treat underlying CNL or aCML disease no later than day - (one week before starting ruxolitinib); for drugs that have more long-lasting effects on the marrow, such as thalidomide and its analogs, and interferon, subjects should discontinue these no later than day -
Columbia Suicide Severity Rating Scale (C-SRSS) baseline/screening: patient response of yes to any question except question 
History of malignancy with confirmed activating RAS mutation at any time. Prospective RAS testing is not required. However, if the results of previous RAS testing are known, then those results must be used in assessing eligibility.
Patient must have a medical oncology consult with the recommendation of chemotherapy; recommended regimens are as follows: cyclophosphamide and doxorubicin (AC); Taxotere, doxorubicin and cyclophosphamide (TAC); Taxotere and cyclophosphamide (TC); or Taxotere, carboplatin and trastuzumab (TCH) prior to registration; the use of additional chemotherapy, hormonal therapy or trastuzumab after the initial regimen is at the discretion of the medical oncologist; other primary regimens are possible but the principal investigator (PI) must be notified prior to enrollment
Previously received trastuzumab as part of a regimen in the perioperative or metastatic setting with evidence of progression; Zr-trastuzumab use as imaging agent for Zr-trastuzumab PET permitted
Patients receiving any concurrent anticancer therapy or investigational agents with the intention of treating esophagogastric cancer; Zr-trastuzumab uses as imaging agent for Zr-trastuzumab PET permitted
No lymphovascular space invasion (LVSI) present on biopsy or previous cone
Cone margins and endocervical curettage (ECC) specimen negative for invasive cancer, cervical intraepithelial neoplasia (CIN) II, CIN III or adenocarcinoma-in-situ; (a negative margin is defined as no invasive cancer within . mm of both the endocervical and ectocervical margins and no adenocarcinoma in situ [AIS] or CIN II or CIN III at the inked or cauterized margin; one repeat cone and ECC permitted)
Patients are eligible for the study when a cone and ECC are performed prior to pre-enrollment in the study, and pathologic eligibility criteria are met; the cone and ECC must be performed within  weeks prior to pre-enrollment in the study; if the cone and ECC performed prior to pre-enrollment do not meet the pathologic criteria, patients may be pre-enrolled and are allowed  repeat cone & ECC after pre-enrollment in order to meet pathologic eligibility criteria
Presence of LVSI
Cone margins or ECC specimen positive for invasive cancer, CIN II, CIN III or adenocarcinoma-in-situ (one repeat cone permitted)
Prior lenvatinib
Patients who have borderline resectable disease using National Comprehensive Cancer Network (NCCN) definition
Inadequately controlled arterial hypertension
Key
Treatment with T-cell depleting, B-cell depleting or IL- signaling targeted medication (eg, ATG, alemtuzumab, basiliximab, denileukin diftitox, IL-, rituximab within wks prior to starting AMG .
Treatment with T regulatory cell expanding therapies (ie ECP, PUVA, UVB, adoptively transferred T regulatory cells) within  wks prior to starting dose of AMG .
Laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Transverse laparotomy incisions
Laparotomy incisions left open due to a case classification as contaminated or dirty
receiving ibrutinib and progressing at the time of study enrollment
Is the age of majority in country of residence
tenosynovial giant cell tumor (TGCT), which is associated with severe morbidity or functional limitations and for whom surgery is not an option (prior pexidartinib is permitted for TGCT patients unless ineffective or not tolerated and there has been a washout period of at least  weeks)
intra-uterine device (nonhormonal or hormonal)
No prior use of ketoconazole for greater than  days
Thromboembolism within  months of enrollment
Extrahepatic metastases including nodal disease
PART B: Any history of myocardial infarction or embolic/occlusive cerebro-vascular accident (stroke)
Have access via central line (e.g., portacath)-double lumen due to CPI- administration requirements
Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
PSA value that is undetectable can be enrolled if pathology from prostatectomy demonstrates one or more of the following: positive margin, extracapsular extension, or seminal vesicle invasion
Patients must be at least  days from use of any mushroom supplements (examples: turkey tail, reishi, maitake, shiitake) and agree to withhold them for the entire study period (one year)
Subjects in second or later relapse;
Treatment with clinically significant cytochromes P enzyme inducers, such as phenytoin, phenobarbital, chlordiazepoxide, diazepam, isoniazid, metronidazole, warfarin, amitriptyline within  days prior to the first dose of disulfiram; of note, lorazepam and oxazepam are not affected by the P system and are not contraindicated with disulfiram
Patients must be willing to submit blood for pharmacokinetics; sites must order S pharmacokinetic (PK) kit immediately after registration; the Southwest Oncology Group (SWOG) patient identification (ID) number must be provided on the S PK Kit request form
Any prior intervention for, or ongoing compromise of, the ampulla of Vater or biliary-enteric anastomosis
Patients must not have evidence of extensive or matted/fixed pathologic adenopathy on preoperative imaging
Pregnant or breast-feeding because there are no adequate and well-controlled studies of eltrombopag use in pregnancy and it is unknown whether eltrombopag is excreted in human milk.
Infratentorial meningioma (patients may have infratentorial meningioma if there is concurrent growing supratentorial meningioma that serves as the target lesion)
Presence of a foreign body intracranially such as a bullet fragment
Patients who are pregnant or breast-feeding; the anti-proliferative activity of this experimental drug may be harmful to the developing fetus or nursing infant
Subject must be known to be RET positive (known KIFB-RET translocation, or other confirmed RET translocations (e.g., CCDC-RET)) or have an available tumor sample for local or central testing obtained prior to consent (Screen ). Subjects whose samples need to be submitted for central laboratory testing must be current non-smokers and not known to have mutation in EGFR, KRAS, or ALK.
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV
Patients must have completed all planned/elective surgeries >  weeks and must have recovered from surgery before registration; participants should try to avoid any additional elective surgeries during the study period; particular instances may be discussed with Protocol Chair/designee
History of toxicity to the most recent AI (letrozole or exemestane) that warrants cessation of the AI
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with human immunodeficiency virus (HIV)
More than  prior relapses
Subjects with active hepatitis B or C on anti-viremic compounds may remain on such treatment, except for interferon
T-cell depletion with anti-thymocyte globulin (ATG) (rabbit or horse) or at least  mg of alemtuzumab total in the conditioning regimen; acceptable conditioning regimens include but are not limited to fludarabine/melphalan/alemtuzumab; fludarabine/busulfan/alemtuzumab; fludarabine/melphalan/ATG; fludarabine/busulfan/ATG
Prior use of any hypomethylating agent or cytarabine
Must meet one of the following three criteria\r\n* <  cigarettes smoked lifetime\r\n* Known to harbor a RET rearrangement; importantly, at least  patients out of the first  and  patients overall must harbor RET rearrangements in their lung cancers (note that screening for RET rearrangements will not be done as part of this study and must be done separately, prior to screening)\r\n* Known to harbor another potentially targetable genomic alteration in RET, cKIT, PDGFRa, or PDGFRb; eligible genomic alterations include rearrangements, high level amplifications, insertions or deletions in the kinase domain, or point mutations that are known to be oncogenic
Total bilirubin =<  mg/dl; patients with biliary obstruction can join if bilirubin corrects to required limit after adequate biliary drainage
Subjects with a hypersensitivity to halichondrin B or halichondrin B chemical derivative
Patients cannot be already treated on angiotensin-converting enzyme inhibitor (ACE) or angiotensin II receptor blocker (ARB) therapy for hypertension or renal protection (with diabetes) at the time of enrollment
History of sarcoidosis
Clinical stage IIA (TN), IIB (TN, TN) or stage IIIA (TN, TN, TN, TN), IIIB, or IIIC breast cancer with no prior treatment
Inability to swallow BKM capsules; (in the future a different formulation of BKM may become available and may be approved by Novartis for other routes of administration, which would then supersede this exclusion criteria)
Suitable and interested to proceed to ASCT
Willing to return to consenting Mayo Clinic (Mayo Clinics campus in Rochester, Mayo Clinics campus in Arizona, or Mayo Clinics campus in Florida) institution for follow-up during the active monitoring phase of the study
Patients who have hypoglycemia with a value of =<  mg/dL
Known HIV-positive patients and those with other acquired/inherited immunodeficiencies are ineligible due to the possibility of affecting the response to indoximod and the higher risk of active opportunistic infections.
Patients must receive RT at the participating institution.
Patients with known hypersensitivity to Escherichia coli (E.coli)-derived proteins, filgrastim, or any component of filgrastim are not eligible
REGISTRATION EXCLUSION CRITERIA: Uncontrolled hypocalcemia, hypomagnesemia, hyponatremia, or hypokalemia defined as less than the lower limit of normal for the institution despite adequate electrolyte supplementation
Pregnant or nursing women due to the unknown effects of immunization on the developing fetus or newborn infant.
Patients must have a confirmed diagnosis of neurofibromatosis  by fulfilling National Institute of Health (NIH) criteria or Manchester criteria, or by detection of a causative mutation in the NF gene\r\n* The NIH criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity.\r\n* The Manchester criteria includes presence of:\r\n** Bilateral vestibular schwannomas, OR\r\n** First-degree relative with NF and EITHER unilateral eighth nerve mass OR two of the following: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Unilateral vestibular schwannoma AND any two of: neurofibroma, meningioma, glioma, schwannoma, juvenile posterior subcapsular lenticular opacity, OR\r\n** Multiple meningiomas (two or more) AND unilateral vestibular schwannoma OR any two of: schwannoma, glioma, neurofibroma, cataract
Known human immunodeficiency virus (HIV)-positive individuals; high-dose ascorbate acid is a known cytochrome P A (CYP A) inducer, which results in lower serum levels of antiretroviral drugs; a clinical trial designed to address these interaction issues is more appropriate than this phase  study
History of angioedema
Participants must be determined by an expert sarcoma surgeon to have resectable disease located on the upper extremity (including shoulder), lower extremity (including hip), trunk, retroperitoneum, or pelvis
Treated with at least  year of imatinib
Bcr-Abl level by PCR must be less than or equal to .% and greater than .% by PCR reported on the International scale. This will be confirmed during screening
TI mutation
Patients who are new visits to Female Sexual Medicine Program or patients who are not consistently using any vulvovaginal health promotion strategies (e.g., pelvic floor exercises, dilator therapy, moisturizers) recommended by the Female Sexual Medicine Program
Males must agree to take appropriate precautions to avoid fathering a child (with at least % certainty) from screening through follow-up; permitted methods for preventing pregnancy should be communicated to the subjects and their understanding confirmed
More than three relapses
Patients who are taking metronidazole and cannot be safely moved to a different antibiotic greater than  days prior to starting mebendazole therapy; metronidazole and mebendazole have been reported to be associated with Stevens-Johnson Syndrome/Toxic Epidermal Necrolysis
Subjects with mycosis fungoides (MF) and a known history of non-complicated staphylococcus infection/colonization are eligible provided they continue to receive stable doses of prophylactic antibiotics
Patient is taking concurrent drugs that are contraindicated with nelfinavir, including any of the following:\r\n* Alfuzosin\r\n* Cisapride\r\n* Sildenafil (Revatio)\r\n* Amiodarone\r\n* Quinidine\r\n* Rifampin\r\n* Dihydroergotamine\r\n* Ergonovine\r\n* Ergotamine\r\n* Methylergonovine\r\n* Hypericum perforatum (St. John's wort)\r\n* Lovastatin\r\n* Simvastatin\r\n* Pimozide\r\n* Midazolam\r\n* Triazolam\r\n* Oral Midazolam
N-Terminal ProB-type natriuretic peptide (NTproBNP) <  pg/mL
History of malignancy with confirmed activating RAS mutation at any time; Note: prospective RAS testing is not required; however, if the results of previous RAS testing are known, they must be used in assessing eligibility
STEPS  AND  AND RANDOMIZATION
Inclusion Criteria:\n\n          . Randomized in the parent study, PCYC--CA\n\n          . Informed consent for Study PCYC--CA\n\n          . IRC-confirmed PD in the parent study PCYC--CA or closure of the parent study\n\n        Exclusion Criteria:
Creatinine equal or less than . mg/dl based on University of Iowa Hospitals and Clinics (UIHC) values/tests
Histologically confirmed classical HCL with one of the following:\r\n* Intolerance to purine analogs or considered to be poor candidates for purine analog-based therapy\r\n* Failure to achieve any response (CR or PR) to the initial purine analog-based therapy\r\n* Relapse =<  years of purine analog-based therapy\r\n* >=  Relapses\r\n* Histological confirmation of diagnosis will be performed at Memorial Sloan Kettering Cancer Center (MSKCC) or a participating site
Patients with known atypical transcript
History of hypotension and/or blindness during prior treatment with tadalafil or other PDE- inhibitors
History of significant hypotensive episode requiring hospitalization
Prior use or participation in a clinical trial of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, TAK-, TAK-, TAK-), chemotherapy, or immunological agents (e.g., immune modulators, cytokines, vaccines, or antibody-delivered chemotherapy); the use of denosumab for bone metastasis is permitted
Patients with recent excisional node biopsies/neck dissections are included if material is evaluable for extracapsular spread
Patient must not have a true unknown primary in which permanent section results are negative for malignancy in completely excised ipsilateral oropharyngeal tissue (palatine and lingual tonsil)
DLBCL
Other indolent NHL (eg, MZL/MALT)
Graft:\r\n* Cryopreserved dose will be >= . x ^ total nucleated cells (TNC)/kilogram in each unit for double unit CB grafts; this will be the CB graft for the majority of patients\r\n* In select patients with access to CB units that have high TNC (> . x ^/kg), and are from good quality CB banks a single unit could be considered with a back-up CB unit on standby\r\n* In select patients who have a very poor search and only have one suitable CB unit available, this unit could be given as a single unit; this unit must have a TNC >= . x ^ TNC/kilogram and a cluster of differentiation (CD)+ cell dose >= . x ^ CD+/kilogram\r\n* Haplo-identical donors who are / or better but not HLA-identical will be used
Patients must have clear margins after wide local excision; patients with nodes that are palpable or detectable on radiologic imaging must have an adequate lymphadenectomy
Presence of gliomatosis cerebri, cranial or spinal leptomeningeal metastatic disease
Requiring any of the following concurrent treatment or medications:\r\n* Radiation therapy\r\n* Chemotherapy\r\n* Interferon (e.g. Intron-A)\r\n* Allergy desensitization injections\r\n* Growth factors (e.g. Procrit, Aranesp, Neulasta)\r\n* Interleukins (e.g. Proleukin)\r\n* Any investigational therapeutic medication
Previous treatment with at least one standard therapy used to treat stage IA, IB or IIA CTCL including but not limited to oral corticosteroids, high-potency topical corticosteroids, topical mechlorethamine, topical bexarotene, psoralen and ultraviolet A (PUVA), ultraviolet B (UVB), total body electron beam radiation, biological response or oral methotrexate
Use more than  g/d of acetaminophen
An artificial (prosthetic) joint or other artificial implant or device that cannot be easily removed (with some exceptions for dental and breast implants and biliary stents and mediports)
Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS- treatment until completion of antibiotic regimen
Chronic GVHD manifestations that can be followed on physical or laboratory exam\r\n* Skin changes\r\n* Oral mucosa changes\r\n* Hepatic dysfunction\r\n* Diarrhea
No prior treatment with bortezomib for cGVHD; participants may have received bortezomib for other reasons besides cGVHD (such as leukemia or solid tumor); any other previous treatments for cGVHD are allowed
No extrapancreatic disease
Confirmation of resectability by surgical oncology consultation.
Presentation at a multidisciplinary conference at either University of Chicago or NorthShore University
Short removable metal stents rather than plastic stents are preferred but not required for palliation of initial obstructive jaundice
Indolent NHL:
Aggressive NHL:
For Part B:
Known cerebral or meningeal disease
Patients must be able to fit into either the Civco stereotactic immobilization or the Elekta Stereotactic BodyFix immobilization device
GROUP A MONOTHERAPY
ONLY APPLIES TO PATIENTS IN GROUP B
Participants must consent to collection of blood, ascites fluid and tumor tissue samples prior to first dose of CRLX and at least one additional sample collection after the second dose (archived material is acceptable for collection prior to first dose of CRLX)
Irradiation: interval from the last dose of local RT, craniospinal RT, and palliative RT for symptomatic disease >=  months, >=  months, and >=  weeks before study enrollment, respectively
Completion of local RT with or without concomitant chemotherapy including temozolomide and radiosensitizing agents (e.g., carboplatin, vorinostat) outside the context of a clinical trial; any agent administered during RT should have a short half-life so that it should already be completely eliminated by the start of this therapy; if other agents were used concurrently with RT, they will need to be discussed with the principal investigator to assess eligibility
Presence of LGL clone prior to enrollment will not be an exclusion criterion if the LGL clone is < % of T cell population
Subjects must have a confirmed diagnosis of beta-thalassemia major and have been enrolled in a hypertransfusion program with a confirmed annual transfusion of >=  mL/kg/yr but <  mL/kg/yr, AND >=  transfusions of blood per year over a minimum of two years
Same as above and patients undergoing single fraction spinal SBRT
Spinal hardware at either a) the vertebral body to be treated or b) one vertebra (VB) above and below
Prior kyphoplasty at either a) the vertebral body to be treated or b) one VB above and below
Extensive (> %) height loss of the involved vertebral body
Patients with primary disease arising in the posterior elements of the VB in question
Sodium levels =< grade 
Patients who, for any reason, are not able to comply with the national legislation
Relapsed or refractory TCL status including diagnoses of peripheral TCL-NOS, angioimmunoblastic TCL, anaplastic large cell lymphoma, hepatosplenic TCL, enteropathy-associated TCL, or mycosis fungoides(MF)/cutaneous TCL with transformation to systemic TCL.
Achieved at least a PR (and not progressed) after ABVD therapy
Ki index ? % (to be centrally confirmed).
Any patient receiving treatment with short-acting Octreotide, which cannot be interrupted for  h before and  h after the administration of Lu-DOTA-Tyr-Octreotate, or any patient receiving treatment with Octreotide LAR, which cannot be interrupted for at least  weeks before the administration of Lu-DOTA-Tyr-Octreotate, unless the tumour uptake on target lesions observed by OctreoScan imaging during continued Octreotide LAR treatment is at least as high as normal liver uptake observed by planar imaging.
Additional exclusions for the  pazopanib containing arms (crizotinib plus pazopanib) and (pazopanib plus pemetrexed) and (crizotinib plus pazopanib plus pemetrexed):\r\n* History of stroke or transient ischemic attack within  months prior to study enrollment\r\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within  months prior to study enrollment\r\n* Urine for proteinuria >= + (patients discovered to have >= + proteinuria on urinalysis at baseline should undergo a  hour urine collection and must demonstrate =<  g of protein in  hours to be eligible)
Persistent neurotoxicity from intraventricular methotrexate, cytarabine, thiotepa
Saw palmetto administered with the intent to treat the patients malignancy within  week of degarelix injection for Cohorts , , and , and for within  week of surgery for Cohort 
Two pretreatment CA values (documented on two occasions taken at least one week apart) must be at least twice the upper limit of normal, or twice the nadir value if pretreatment CA values never normalized
Is currently participating in a GSK study (monotherapy or in combination with an approved anti-cancer agent) sponsored by GSK or by another research organization working on behalf of GSK.
Local access to commercially available GSK.
Patients must have histologically confirmed pancreatic neuroendocrine tumors that are considered low or intermediate grade as defined by Klimstra et al (to include proliferation-related Ki- antigen [Ki-] and mitotic index)
Individuals with a known t(;)/breakpoint cluster region-Abelson (BCR-ABL) fusion based on testing at either initial diagnosis or at relapse
Individuals with a history of allergic reactions to any of the agents being used in this trial, with the exception of PEG asparaginase; participants with a history of allergy to PEG asparaginase are allowed on study but should receive Erwinia asparaginase instead of PEG asparaginase; individuals with a history of allergy to both PEG and Erwinia asparaginase are excluded from the study
Patients who, for any reason, are not able to comply with the national legislation.
Predisposing colonic or small bowel disorders in which the symptoms are uncontrolled, as indicated by a baseline pattern of >  watery or soft stools daily in patients without a colostomy or ileostomy; patients with a colostomy or ileostomy may be entered at investigator discretion
Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to alternative anti-hypertensive agent
AST (GOT) ?  IU/L
Patients for whom completion of this study and/or follow-up is deemed inappropriate for any reason
Use of systemic glucocorticoids such as prednisone or Decadron in the last month
Cardiogenic shock
Tumors in the body or tail of the pancreas (to the left of the portal-SMV confluence) are not eligible; location at the portalSMV confluence is allowed
Patients cannot have hepatic or peritoneal metastases detected by imaging or laparoscopy prior to chemoradiation
History of grade  (Gr. ) or greater retinopathy or keratitis
A history of neurological complications due to poliovirus infection
Patients with worsening steroid myopathy (history of gradual progression of bilateral proximal muscle weakness, and atrophy of proximal muscle groups)
Genotype: APC mutation (with or without family history) required
Classical FAP Phenotype: 's to ,'s of colorectal adenomatous polyps, usually appearing in teenage years
UGI endoscopy/LGI endoscopy (proctoscopy/colonoscopy) performed within  days of randomization.
For all subjects, any rectal/pouch polyps >  mm must be excised at \baseline\.
No concurrent warfarin, fluconazole, lithium, Pradaxa or other direct thrombin inhibitors, Plavix, cyclosporine, other NSAIDs (such as ibuprofen, aspirin, diflunisal), diuretics (furosemide and thiazides), DMSO, methotrexate, probenecid, propoxyphene hydrochloride, Tylenol (acetaminophen) preparations containing aspirin or cytotoxic chemotherapy drugs.
obscured by other structures or artifacts on the images)
Women who are morbidly obese (> lbs)
Known cerebral/meningeal disease
Significant shunting to the lung (> %) identified on macroaggregated albumin (MAA) scan
Unsuccessful closure of collateral blood flows from the hepatic artery to non-targeted organs such as the gastrointestinal (GI) tract
A solitary liver metastasis that is amenable to surgical removal for potential cure
Biliary obstruction, biliary stent, or prior biliary surgery including sphincterotomy but excluding cholecystectomy
Asymptomatic carriers of hepatitis B virus can be considered for study if they agree to and comply with close monitoring and suppressive therapy with lamivudine during treatment and for additional six months after coming off study.
Patients with neurofibromatosis 
Patients must be ineligible to receive IL- based on evidence that may include ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (< %), or respiratory compromise (forced expiratory volume in one second [FEV] < %), or prolonged smoking history, or clinically significant patient history which in the judgment of the investigator would compromise the patients ability to tolerate aldesleukin
No evidence of cerebral edema
Sarcoma located on upper (includes shoulder) or lower (includes hip) extremities or on the body wall
Patients must not be pregnant or breast feeding. Patients must not be pregnant because lacosamide produced developmental toxicity in rats following administration during pregnancy. There is insufficient information to determine if lacosamide is safe during lactation.
Patients must not have any disease that will obscure toxicity or dangerously alter Drug metabolism
Perioperative anticonvulsants should be tapered as indicated in the protocol.
Patients who do not have hypo- or hyperthyroidism
History of any major disease that might interfere with safe protocol participation
Patients must fall into Radiation Therapy Oncology Group (RTOG) recursive partitioning analysis (RPA) class I or II
T-cell depletion (including ATG or alemtuzumab) is not allowed.
Patients should not be taking drugs that are generally accepted to have a risk of causing Torsades de Pointes; the following must be discontinued at least  days prior to enrollment to be eligible: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
For patients with MPN: Tolerating ruxolitinib but with persistent manifestations of disease (i.e. persistent splenomegaly, abnormal blood counts, persistent constitutional symptoms residual fibrosis in bone marrow [+ or greater], or measurable allele burden as evidenced of clonal JAK or MPL mutation)
Suspected or documented radionecrosis
Women with neuroendocrine histologies, or histologies other than squamous, adenosquamous or adenocarcinoma
Ability to read and follow instructions
pc-ALCL and MF patients must have progressed or relapsed after treatment with local radiation therapy, phototherapy, topical chemotherapy, or have failed systemic therapy of at least one single agent (e.g., methotrexate or bexarotene or other non-CD antibody) or one multi-agent chemotherapy (e.g. CHOP: cyclophosphamide, doxorubicin, vincristine, and prednisone); pc-ALCL classified patients are required to have one or more cutaneous tumors that by history have been present for at least  months
Pathological diagnosis of chondrosarcoma of the spine or sacrum or chordoma of the spine, or sacrum
Subjects who received a tetanus- diphtheria (Td) or diphtheria toxoid/tetanus toxoid vaccine adsorbed (Tdap) immunization in the previous  years
At NIH: age >=  years old and/or >=  years old and pubertal and =<  years for recipient; pubertal is defined by: prior menses at any time (females), documentation of clinical Tanner stage greater than  at some point pre-chemotherapy or at the current visit; (at this point, sex steroids have been produced for a few years which has driven initial pubertal development); Tanner  is defined as: breast buds for females with coarse pubic hair, and coarse pubic hair and testes > . cm for males
Bronchiolitis obliterans as the sole indication of ECP
Patients with a prior history of marked intolerance to -fluoropyrimidines (-FU, floxuridine, capecitabine, -fluorocytosine [flucytosine]), since such patients may have deficiency of dihydropyrimidine dehydrogenase, which places them at risk for severe and life-threatening toxicity with -FU
Patients requiring treatment with any other systemic glucocorticoid; NOTE: this restriction regarding choice of glucocorticoid does not apply should patient need <  week course of glucocorticoid for treatment of non-infectious pneumonitis during study
Grade > retinopathy
Hematopoietic stem cell transplant (HSCT) patients with symptomatic hemorrhagic cystitis (minimal grade  symptoms of HC per NCI criteria) and positive BKV in urine >  x ^ deoxyribonucleic acid (DNA) copies/ml
Patients of East Asian ancestry
History of treatment with eltrombopag, romiplostim or other thrombopoietin receptor (TPO-R) agonists
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption
Hydronephrosis (either bilateral or involving a solitary kidney) that has not been addressed by means of a nephrostomy or indwelling stent; EXCEPTION: non-obstructive hydronephrosis in setting of prior urinary diversion is consistent with eligibility
Unwillingness to maintain adequate contraception measures for the entire course of the study
Caution should be exercised in patients who are regularly taking narcotic analgesics, particularly higher doses; the doses of narcotic analgesics may need to be reduced, patients may need to be monitored closely for drug interactions, and the risks and benefits of participation in the study should be considered; clinical judgment should be exercised to manage this potential drug interaction
Patients must have had FISH evaluation of leukemia cells within  months without intervening treatment demonstrating deletion q-
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress
Patients are offered registration to the correlative study CALGB-
Successful completion of three -hour dietary recalls during the run-in period
Has demonstrated compliance with study drug(s), treatment visit schedules, and the requirements and restrictions listed in the consent form
Local access to commercially available GSK
Fungal infections with radiological progression after receipt of amphotericin B or active triazole for greater than  month
Surgery must be planned to be performed by a pre-approved, study-specific credentialed surgeon; the registering physician MUST be the pre-approved, credentialed surgeon intended to perform the assigned procedure
Patients must not have undergone a prior partial cystectomy for invasive bladder cancer; patients must not have received any prior pelvic surgery that would obviate a complete extended lymphadenectomy (e.g. aorto-femoral/iliac bypass) or for whom the surgeon feels that their ability to perform a standard or extended pelvic node dissection would be compromised
Existing cortical bone destruction, where orthopedic stabilization would be required
Histopathology of amyloidosis or light chain deposition disease based on detection by polarizing microscopy of green bi-refringent material in Congo red-stained tissue specimens or characteristic electron microscopy appearance or immunohistochemical stain with anti-light chain anti-sera
Patients with positive antinuclear antibody (ANA) and/or anti-double strand (ds) DNA antibodies
Must be able to anticipate achieving SBRT/RT dosimetry guidelines
Other prohibited medications: \r\n* Oral hypoglycemics: tolbutamide, chlorpropamide; \r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine; \r\n* Neuroleptics: pimozide; \r\n* Antiarrhythmics: amiodarone, bepridil, flecainide, lidocaine, mexiletine, quinidine, propafenone; \r\n* Immune modulators: cyclosporine, tacrolimus, sirolimus; \r\n* Miscellaneous: theophylline, quetiapine, risperidone, tacrine, clozapine, atomoxetine
EXPANSION COHORT ONLY: Other prohibited medications: \r\n* Oral hypoglycemics: tolbutamide, chlorpropamide; \r\n* Ergot derivatives: dihydroergotamine, ergonovine, ergotamine, methylergonovine; \r\n* Neuroleptics: pimozide; \r\n* Antiarrhythmics: amiodarone, bepridil, flecainide, lidocaine, mexiletine, quinidine, propafenone; \r\n* Immune modulators: cyclosporine, tacrolimus, sirolimus; \r\n* Miscellaneous: theophylline, quetiapine, risperidone, tacrine, clozapine, atomoxetine
Advanced/poorly differentiated thyroid cancers of follicular cell origin that have no uptake (< %) on radioiodine scan or are unresponsive to radioiodine therapy; unresponsiveness to radioiodine therapy is defined as a patients thyroglobulin not falling to less than  ng/ml within  months after previous radioiodine ablative treatment
Thyroglobulin (Tg) levels greater than or equal to  ng/ml in the absence of Tg antibodies; patients who are Tg-antibody (Tg-Ab) positive may be included despite a lower Tg level if they have detectable disease on cross sectional imaging; (the presence of Tg-Ab may lead to falsely low Tg levels and therefore render the Tg a less sensitive marker of disease; however, Tg-Ab has been shown to also act as a tumor marker, and will be used as an endpoint for the study in patients who are Tg-Ab positive)
There are other criteria--please discuss with your doctor.
There are other criteria--please discuss with your doctor.
Negative margins after lumpectomy (re-excision for initial positive margins is allowed-negative margins defined as >=  mm clear of tumor in all directions); histological negative margins closer than  mm are permitted in the circumstance where the margin of excision is limited by adjacent tissues such as pectoral muscle or skin, but in the opinion of the surgeon and radiation oncologist an oncologically adequate excision was achieved
Patients must complete appropriate pretreatment evaluation including post-lumpectomy mammogram if microcalcifications were initially present to confirm complete removal
PB or BM basophils ?%
Patients must not have any disease that will obscure toxicity or dangerously alter drug metabolism
a documented NTRK fusion unresponsive to a prior TRK inhibitor
AML-associated inv()/t(;)/del(q), t(;) (i.e. promyelocytic leukemia) with/without secondary aberrations; t(;) lacking del (q) or complex karyotypes
Hydroxyurea for cytoreduction
Presence of leg ulcers or other unacceptable mucocutaneous manifestations at any dose of hydroxyurea.
Any unresolved toxicity (CTCAE grade > ) from previous anti-cancer systemic therapy unless approved by one of the principal investigators (Drs. Lee or Sherman); rare exceptions that would not affect the study (e.g., radiation induced dysphagia) allowed with the consent of either principal investigators (Drs. Lee or Sherman)
Histologically confirmed diagnosis of grade  or  out of  UPS or dedifferentiated/pleomorphic LPS of the extremity (including limb girdle, i.e. shoulder or hip) that measures greater than  cm in any direction as assessed by imaging; Alternative terms for UPS meeting inclusion criteria include but are not limited to the following
Tc, N-N
T, N-N
T, N-N
h. History of psychotropic drug abuse and inability to quit
Documented lymphoid or myeloid neoplasm with p rearrangement known to lead to FGFR activation, based on standard diagnostic cytogenetic evaluation performed locally, before signing informed consent for this study.
Meets one or more Groupe d'Etude des Lymphomes Folliculaire (GELF) criteria.
combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Patients with a tracheoesophageal (TE) fistula or direct invasion into the mucosa of the trachea or major bronchi; bronchoscopy is encouraged if a TE fistula is suspected; the presence of a fistula will exclude a patient from this study
Absence of macroscopic disease after upfront surgery (i.e., TxNx and TxN; TxN+ and T-Nx are eligible if the T/N stage categories meet the criteria above)
Clinically (medically) indicated procedure (i.e. biopsy of lesions of recurrent disease, palliative management via resection, thoracentesis, etc.) to collect tumor in sufficient quantity (\golf ball size\ estimated weight - grams, pleural, and/or ascites fluid estimated volume ?  mL) for vaccine processing.
Patients with microscopic and/or gross extra thyroidal disease extension without RAI uptake but with a) FDG-PET positive disease or b) suppressed thyroglobulin > ng/mL or c) stimulated thyroglobulin > ng/L.
Patients with tracheal/esophageal involvement. High mitotic activity or necrosis in pathology does not exclude from the study. Note: in Categories a and b, patients can be followed using US locally in addition to standard diagnostic followup menu but, if US only is positive, a FDG-PET or MRI will be obtained. If negative, a rising thyroglobulin titer is required in which case response will be monitored by continued US and suppressed and/or stimulated thyroglobulin. Thyroglobulin titer cannot be used if anti-thyroglobulin antibodies are present).
Erythropoietin stimulating agents (ESA) and blood transfusions are allowed as medically indicated, ESA use should be consistent with American Society of Clinical Oncology (ASCO) guidelines
Patients shall not receive any herbal/alternative therapies such as flaxseed or soy products or black cohosh
Grade > retinopathy
HLA-A* positive (to enable immunization with the HLA class I restricted gp[g-M] peptide); stage IIB or IIC patients will be enrolled after review and approval by the principal investigator (PI); (a tool to determine the projected survival at  years, like, but not limited to, the nomogram at www.melanomaprognosis.org; if the projected survival is less than % at  years, then the patient is considered for enrollment; this is with the recognition that the adjuvant, if effective offers a significant impact in that group of stage II patients)
More than  months of cumulative iron-chelation therapy (such as daily deferasirox (Exjade) or deferiprone or x/week deferosamine). intermittent deferoxamine doses in association with blood transfusions are not exclusionary regardless of duration of such treatment. -- More than  years since patient began receiving regular transfusions ( units per  weeks or  units received in a  month period).
Evaluable KS involving the skin and/or viscera, including at least one of the following:\r\n* KS of the skin with >=  KS lesions that are evaluable by non-invasive methods that have not been treated with local therapeutic modalities\r\n* Pulmonary KS evaluable by computed tomography (CT) scan\r\n* Gastrointestinal KS evaluable by direct visualization or fiberoptic instrumentation\r\n* Biopsy proven lymph node involvement measurable by CT scan
Patients with any other abnormality that would be scored as a grade  or greater toxicity, except:\r\n* Lymphopenia\r\n* Direct manifestations of KS\r\n* Direct manifestation of HIV\r\n* Direct manifestation of HIV therapy (i.e. hyperbilirubinemia associated with protease inhibitors)\r\n* Asymptomatic hyperuricemia\r\n* Hypophosphatemia
Uncontrolled hyperthyroidism or hypothyroidism
Patients with known splenomegaly
Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to dasatinib administration
Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes or prolonged QT interval including: (Patients must discontinue drug  days prior to starting dasatinib)\r\n* Quinidine, procainamide, disopyramide\r\n* Amiodarone, sotalol, ibutilide, dofetilide\r\n* Erythromycin, clarithromycin\r\n* Chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide\r\n* Cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Hepatitis A, B and C status will be tested prior to therapy, but results will not exclude patients from participation (if positive, patients will be told they are at higher risk of adverse effects from allogeneic transplantation)
Patients must have at least one of the following for inclusion into protocol:\r\n* Lupus nephritis, defined as renal biopsy (biopsy within  months of transplant decision) showing glomerulonephritis, with active diffuse proliferative lesion (World Health Organization [WHO] stage IV or Vd, with biopsy classified by WHO criteria)\r\n* Refractory and severe seizures or encephalopathy attributed to SLE\r\n* Severe pulmonary involvement with recurrent pulmonary hemorrhage; and/or refractory pulmonary infiltrate not attributed to infection; and/or interstitial lung disease- defined by presence of alveolitis or pneumonitis on high-resolution computed tomography (CT) scan or documentation of DLCO < % at least twice\r\n* Transfusion-dependent cytopenias that are unresponsive to standard treatment\r\n* Catastrophic antiphospholipid syndrome, which is defined as an antiphospholipid titer greater than  standard deviations above the mean and two or more antiphospholipid related manifestations, including either cytopenias or vascular thrombosis that failed to respond to anticoagulant therapy\r\n* Vasculitis and/or immune complex deposition causing end-organ signs or symptoms, e.g. cerebritis, cardiac failure, or renal failure, refractory to standard treatment
Diagnosis of SSc as defined by American College of Rheumatology and at high-risk for fatal outcome based on the following prognostic factors; patients must have () both a and b below and () at least one of c, d, e, or f\r\n* a) Diffuse cutaneous scleroderma as defined by skin thickening proximal to the elbows or knees and/or torso, in addition to distal extremity involvement\r\n* b) Duration of systemic sclerosis =<  years from the onset of first non-Raynauds symptom\r\n* c) Presence of interstitial or pulmonary vascular lung involvement (forced vital capacity [FVC] or DLCO < % of predicted) especially with evidence of alveolitis (abnormal bronchoalveolar lavage or high-resolution chest CT scan)\r\n* d) Presence of SSc-related pulmonary disease and alveolitis (abnormal bronchoalveolar lavage or high-resolution chest CT scan) with FVC or DLCO between % and % predicted, AND a drop in FVC > % predicted within the preceding  months\r\n* e) Presence of myocardial disease (arrhythmia needing therapy, cardiomegaly, presence of moderate or large pericardial effusion, or left axis deviation on electrocardiogram [EKG])\r\n* f) History of SSc renal crisis
A Kurtzke extended disability status scale (EDSS) of . to .
All patients with a diagnosis of complex atypical hyperplasia or endometrial biopsy within three months of study enrollment OR patients with a diagnosis of grade  endometrioid endometrial carcinoma on endometrial biopsy within three months of study enrollment in the presence of one or more of the following: ) desire for future fertility ) morbid obesity (body mass index > ) ) multiple co-morbidities (American Society of Anesthesiology [ASA] class  or )
Diagnosis of grade  endometrioid endometrial carcinoma or higher on endometrial biopsy or on dilation and curettage specimen
Congenital or acquired uterine anomaly which distorts the uterine cavity
Genital actinomycosis
Breastfeeding mothers
Confirmed diagnosis of aggressive systemic mastocytosis (ASM) or mast cell leukemia (MCL) according to WHO criteria for SM and established criteria for ASM and MCL (Valent et al ), presenting with at least one measurable C-Finding.
Prior use of Herceptin (trastuzumab), and a taxane
All subjects must:
Evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
Uncontrolled hyperthyroidism or hypothyroidism
intra-prostatic calcifications >. cm (single or continuous grouping) on  or more consecutive images along the same plane by either the TRUS or Sonablate  measurement will not be enrolled;
interest in future fertility;
urinary tract or rectal fistula;
rectal fibrosis/stenosis; anoscopy or proctoscopy may be performed at the investigator's discretion;
anomaly of the rectal anatomy or mucus membrane; anoscopy or proctoscopy may be performed at the investigator's discretion;
fully active at a minimum or fully capable of selfcare and up and about more than % of waking hours
Curran Group status of I-IV at the time of enrollment
The patient's hematopoietic cell transplant donor must consent to a  volume leukapheresis or whole blood donations obtained at one phlebotomy which will total approximately  ml from which the WT- specific T cells to be used for adoptive transfer will be generated
DONOR EXCLUSION: New health conditions which would exclude a transplant donor from a second blood donation are limited, but include:\r\n* New onset of an human immunodeficiency virus (HIV) infection\r\n* Other uncontrolled infection which could be transmitted to the patient by blood cells and would place the patient at significant increased risk of severe morbidity or death\r\n* Significant anemia with hemoglobin (Hgb) =<  gm/dl, persisting since the time of the original transplant donation\r\n* History of myocardial infarction or stroke since the time of hematopoietic stem cell transplant (HSCT) donation which might increase the risk of blood donation
Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
Medulloblastoma patients >=  and <  years old at diagnosis who have non-metastatic disease with no more than  cm^ of residual tumor are also eligible; medulloblastoma patients in the >=  and <  years old age group with anaplastic or large cell histology or with v-myc avian myelocytomatosis viral oncogene homolog (MYC) or v-myc avian myelocytomatosis viral oncogene neuroblastoma derived homolog (MYCN) amplification are excluded; pathology from collaborating institutions must be centrally reviewed prior to enrollment for confirmation
Histologic diagnosis of nodular desmoplastic medulloblastoma (includes medulloblastoma with extensive nodularity); patients with focal areas of anaplasia or other atypical features suggesting a more aggressive phenotype in a tumor which would otherwise be considered nodular desmoplastic should be treated on the intermediate risk arm; in such unusual cases, final risk stratification will be at the discretion of the principal investigator and study pathologist
Patients may have had up to  prior relapses.
Prior treatment with isotretinoin is allowed because the trial is based on the hypothesis that HDAC inhibition will potentially overcome resistance to retinoids.
Group A: Pathologic fracture or impending pathologic fracture of the femur;
Group A: Intramedullary rod, plating, cementation, hip arthroplasty, or knee arthroplasty.
Surgical drain output >  cc of bloody fluid during first  hours
Patients who have fragmented mechanical heart valves
Patients must have a family member who is matched at , , or  HLA antigens typed as described above and willing to donate - ml or bone marrow for mesenchymal stem cell (MSC) generation or the angioblast mesenchymal precursor cells will be used for the cord blood co-cultures; patients that are high risk for relapse are eligible to use the angioblast \off-the-shelf\ mesenchymal precursor cells
Measles antibody titer on the BioRad Multiplex assay less than or equal to .
Patients with obstructive or symptomatic communicating hydrocephalus
Patients must have no rapidly progressing or deteriorating neurologic examination
Patients who fulfil the diagnostic criteria of HLH.
Prior administration of interferon alfa-b or PEG-Intron
Patients must have a direct bilirubin < . x upper limit of normal (ULN) for age or normal; these criteria may be waived for patients with known or suspected liver involvement by leukemia following review and approval by the study chair or vice chair
Patients must have an alanine transaminase (ALT) <  x ULN for age; these criteria may be waived for patients with known or suspected liver involvement by leukemia following review and approval by the study chair or vice chair
History of severe allergy to any of the components of NEOD such as histidine/L-Histidine, Trehalose, or Polysorbate 
Cardio or cerebral vascular event within  months
Active diverticulitis.
Undergoing ileoanal reconstruction, total colectomy or proctocolectomy, abdominoperineal resection, Hartmann's procedure, Hartmann's reversal or multiple synchronous colon resections (e.g., LAR and concomitant right colectomy).
Has a diagnosis of locally advanced rectal or rectosigmoid cancer undergoing extended en bloc operations.
Subjects must have histological or serological proof of metastatic germ cell neoplasm (gonadal or extragonadal primary) with disease not amenable to cure with either surgery or chemotherapy; subjects with seminoma and non-seminoma are eligible, as are women with ovarian GCTs
Subjects must have received initial cisplatin based combination therapy, such as bleomycin-etoposide-cisplatin (BEP), cisplatin-etoposide (EP), etoposide-ifosfamide-cisplatin (VIP), or similar regimens AND demonstrated progression following the administration of at least one salvage regimen for advanced germ cell neoplasm, such as high dose chemotherapy, paclitaxel-ifosfamide-cisplatin (TIP), or vinblastine-ifosfamide-cisplatin (VeIP)
Major immunologic reaction to any IgG containing agent or auristatin based agent
Estrogens
History of major immunologic reaction to any IgG containing agent.
Use of nasogastric or gastronomy (G)-tube administration
Subjects with relapsed/persistent malignancy requiring rapid immune suppression withdrawal.
Group : Patients must have ) both a and b below; and ) at least one of c, d or e:\r\n* a. diffuse cutaneous scleroderma with skin score of greater than or equal to  (modified Rodnan scale [mRSS])\r\n* b. duration of systemic sclerosis less than or equal to  years from the onset of first non-Raynauds symptom\r\n* c. presence of interstitial lung disease (either forced vital capacity [FVC] or corrected diffusing capacity of the lung for carbon monoxide [DLCOcorr] less than  % of predicted) and evidence of alveolitis (abnormal bronchoalveolar lavage (BAL) or high resolution chest computed tomography [CT] scan) after treatment with intravenous cyclophosphamide greater than or equal  grams given over at least a  month period; for patients not able to adequately complete pulmonary function tests (PFT), there must be evidence of progressive disease on chest CT\r\n* d. left heart failure with left ventricular ejection fraction (LVEF) < % (that has responded to treatment targeted to scleroderma); nd or rd atrioventricular (AV) block with other evidence of cardiomyopathy related to SSc; myocardial disease not secondary to SSc must be excluded by a cardiologist \r\n* e. history of SSc-related renal disease that is not active at the time of screening; history of scleroderma hypertensive renal crisis is included in this criterion
Group : Progressive pulmonary disease as defined by a decrease in the FVC or DLCOcorr by  percent or greater compared to a prior FVC or DLCOcorr in the previous twelve month period; in addition, patients may have either less skin involvement than group  (mRSS less than ) and the FVC or DLCOcorr is less than % or both FVC and DLCOcorr greater than or equal to % if they have diffuse cutaneous disease (mRSS greater than ) at screening for the study; patients must also have evidence of alveolitis as defined by abnormal chest CT or BAL; for patients not able to adequately complete PFT, there must be evidence of progressive disease on chest CT
Group : Diffuse scleroderma with disease duration less than or equal to  years since development of first sign of skin thickening plus modified Rodnan skin score greater than or equal to  plus erythrocyte sedimentation rate (ESR) >  mm/st hour and/or hemoglobin (Hb) <  g/dL, not explained by causes other than active scleroderma
Unless patients have a DLCO-adjusted less than %, patients in all groups must have failed either oral or intravenous cyclophosphamide regimen defined as: IV cyclophosphamide administration for at least >  months between first and last cyclophosphamide dose at a total cumulative IV dose of at least  grams, oral cyclophosphamide administration for >  months regardless of dose, or combination of oral and IV cyclophosphamide for at least >  months independent of dose
Known history of positive serum human ADA to trastuzumab.
Mature B cell (Burkitts) ALL
Asymptomatic or mildly symptomatic
Prior therapy with any known inhibitor of MNK or MNK.
Presence of extra-hepatic spread of disease.
All subjects must:
Agree not to share either study drug with another person.
Patients with the following TNM stages are eligible: \r\n* pTaN- (pN;pN;pN) provided less than  nodes dissected and/or positive surgical margins\r\n* pTbN- (pN;pN;pN)\r\n* pTaN- (pN;pN;pN)\r\n* pTbN- (pN;pN;pN)
Diagnosis of primary MF (PMF) or secondary MF (PET-MF and PPV-MF) as per WHO  criteria.
Aspartate aminotransferase and alanine aminotransferase values . x ULN (or x ULN in the case of patients with MF accompanied by hepatic extramedullary hematopoiesis, as manifested by any degree of hepatomegaly).
One to two painful vertebrae (T-L) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imaging and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
Compromise in the posterior column of the vertebral body or walls of pedicles.
Additional non-kyphoplasty/vertebroplasty surgical treatment is required for the index vertebra(e),
Bedridden due to paralysis or neurological decline,
Modified Glasgow Prognostic Score (mGPS) of  or  as defined below:
Cumulative Illness Rating Scale score > , by assessment of the investigator
All sites of metastasis must be measured in  planes, in millimeters and stored in Pediatric Oncology Network Database (POND) (a web-based data network, secure, independent and password protected)
Patients must have had  or more prior therapeutic attempts defined as:
Evidence of immunodeficiency or immune suppression
Patients with a history of prior veno-occlusive disease (VOD) or findings consistent with a diagnosis of VOD, defined as: conjugated serum bilirubin >. mg/dL AND unexplained weight gain greater than % of baseline weight or ascites AND hepatomegaly or right upper quadrant pain without another explanation, OR reversal of portal vein flow on ultrasound, OR pathological confirmation of VOD on liver biopsy.
Patients must suspend the use of P inducing or P suppressing agents for a minimum of  days prior to starting lapatinib
Known hypersensitivity to filgrastim or to Escherichia coli (E. coli) derived proteins
Be of nonchildbearing potential:
Consistent and correct usage of established hormonal contraceptives that inhibit ovulation,
Mutation load determined by FoundationOne of >=  mutations/MB tested on archival tumor sample; the mutation load metric will be displayed on the FoundationOne report for all participating sites or may be obtained from Foundation Medicine from older reports using the Insights Portal, which will be available to all participating sites, or by emailing Foundation Medicine
Patients with monocular vision or have media opacities or any other condition that precludes monitoring of the retina or fundus.
Any prior history of treatment with maytansine (DM or DM)-based ADC
Refuses to complete quality of life questionnaires either alone or with assistance from study staff despite adequate fluency
Schistocytes on peripheral blood smear (> per HPF) OR histologic evidence of microangiopathy
Able to receive antibiotic prophylaxis against N. meningitides for the duration of the study.
Positive HIV (ELISA and Western blot) test result (checked at screening). Historical local data will be acceptable if it the test was done within one month before start of HSCT conditioning and not more than  months before study visit .
Patients with known or suspected hereditary complement pathway deficiency. This exclusion criterion is not applicable to patients with complement pathway abnormalities/upregulation known to be associated with increased risk of transplant associated microangiopathy
Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone .%, hydrocortisone butyrate .%, flucinolone .%, desonide .%, aclometasone dipropionate .%)
Prior treatment with antiPD-, or antiPD-L therapeutic antibody or pathway targeting agents
Requires hospitalization for intravenous (IV) empiric antibiotic therapy
Mercury (Hg) >  gr/dL
Patients with obstructed gastrointestinal tract or uncontrolled vomiting
Uncontrolled symptomatic orthostatic hypotension
Confirmed solid or hematological TP null type cancer.
Biliary obstruction or presence of a percutaneous biliary drain. Note: Subjects with endobiliary stents may participate as long the enrollment criterion relating to serum bilirubin concentration is met.
Evidence of active hair loss
Evidence of diffuse, spontaneous terminal hair regrowth
Active joint inflammation or other immune disorder involving joints (osteoarthritis is not exclusionary)
Be of nonchildbearing potential:
Minor changes from the required initial laboratory data guidelines will be allowed at the discretion of the attending team under special circumstances; the reasons for exceptions must be documented prior to enrollment
Known grade  or  neurotoxicity
Shunt
Bullet fragments
Patients receiving any disease-modifying anti-rheumatic drug (DMARD)
Patients must not have prior visual field changes from prior -aminoquinoline compound use
Active diverticulitis
This study will be limited to enrollment of Caucasian males only
Active diverticulitis.
Prior radioimmunotherapy
Persistent cytopenia requiring growth factors and/or blood products AND evidence of hypocellular BM (< %); persistent cytopenia (at least  week period) is defined by presence of TWO of the following:\r\n* Absolute neutrophil count (ANC) < . x ^/L without filgrastim support or any ANC value that requires recurrent support by filgrastim (administered at least once a week)\r\n* Platelets (Plt) <  x ^/L\r\n* Hemoglobin (Hb) <  or packed red blood cell (PRBC) transfusion dependent (once every  weeks or more) with reticulocyte count of <  x ^\r\n* This criteria for persistent cytopenia and hypocellular bone marrow does not apply to patients with auto-immune cytopenia ONLY PGF patients
Full donor myeloid chimerism; patients after T cell depletion transplant can have a significant mixed T cell chimerism and this can affect the testing of marrow chimerism; in this case, the neutrophil chimerism will be used to determine eligibility for this trial; patients will be excluded if neutrophils are less than % donor cells; a higher percentage of host cells could be due to relapse or impending relapse
Evidence of relapsed disease by morphologic, cytogenetic or molecular diagnostic tools
In the opinion of the HCT center will be ready to begin pre-transplant conditioning within  weeks of trial enrollment from a medical and psychosocial standpoint
History of known congenital hypercoagulable condition
Patients with extrapleural pneumonectomy (EPP)
Refractory to obinutuzumab (defined as progression or relapse < months of receiving obinutuzumab monotherapy or < months of receiving an obinutuzumab-containing regimen)
For those patients who had a biliary stent inserted,  stable bilirubin readings within  to  hours of each other taken at least  days and not more than  days post-stenting must be obtained. In addition, there should be no complications (eg, infection) present and bilirubin levels should have stabilized ( readings with total bilirubin within % of each other) before administering first treatment.
A history of uveitis and/or scleritis
Active thyroiditis
History of uveitis
History of prior crizotinib use
Patients may enroll in this study if they are thought to have no residual disease after TURBT
Urethral strictures that would prevent endoscopic procedures and repeated catheterization
Upper urinary tract disease (eg, vesicoureteral reflux or urinary-tract stones) that would make multiple transurethral procedures a risk
Patients with mycosis fungoides or Sezary syndrome must have stage IIb-IV disease (by International Society of Cutaneous Lymphoma [ISCL]/European Organization for Research and Treatment of Cancer [EORTC] criteria)
History of treatment with eltrombopag, romiplostim or other thrombopoietin receptor (TPO-R) agonists
Must have included trastuzumab, pertuzumab, and trastuzumab emtansine. Subjects starting initial systemic therapy for HER-positive breast cancer prior to June  are not required to have had pertuzumab
History of cranial nerve palsy.
Inability or unwillingness to take supportive medications including a centrally acting appetite stimulant (e.g., mirtazapine or olanzapine) and a peripherally acting appetite stimulant (e.g., low dose glucocorticoids or megesterol acetate).
Patients must be appropriate candidates for RFA, with platelets >= ,/mm^
Concurrent, acute, active opportunistic infection other than oral thrush or genital herpes within  days of enrollment
Acute treatment for an infection (other than oral thrush or genital herpes) or other serious medical illness within  days of enrollment
Participants for whom front-line cytotoxic therapy is indicated (i.e., symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status); all participants must have a chest X-ray to rule out pulmonary KS within  days of study enrollment
Participants should not have significant abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogrens syndrome), congenital abnormality (e.g., Fuchs dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal-Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
For any surgery or invasive procedure requiring sutures or staples for closure, ibrutinib should be held at least  days prior to the intervention and should be held at least  days after the procedure, and restarted at the discretion of the investigator when the surgical site is reasonably healed without serosanguineous drainage or the need for drainage tubes
An mGPS of  or  as defined below:
An modified Glasgow Prognostic Score (mGPS) of  or  as defined below:
An modified Glasgow Prognostic Score (mGPS) of  or  as defined below:
Assessment by the attending thoracic surgeon that radical pleurectomy can be safely achieved in pts with malignant pleural mesothelioma
Pts of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, then appropriate measures will be undertaken to attempt to increase participation of pts of that minority or gender group
External biliary drain
Solid tumors that meet the following criteria: Measurable disease by Response Evaluation Criteria In Solid Tumors . (RECIST) in at least  site. For Castrate Resistant Prostate Cancer (CRPC) measurable disease can also include Prostate Specific Antigen (PSA) level. Disease progression with the last line of therapy and at least one prior standard of care regimens, or tumor for which there is no approved therapy, or for which standard therapy is unsuitable or refused. Mutation Status: Solid tumor types, other than prostate, must have a one of the following EZH inhibitor sensitizing mutations as determined via local testing: An activating mutation in EZH (YF/C/S/H/N, AV/G, and/or AV; Loss of a component of the SWI/SNF complex, including, but not limited to, ARIDA, SMARCB (aka SNF/INI/BAF), SMARCA (aka BRG), or PBRM (aka PB) as determined by molecular testing (bi-allelic loss or mutation) or immunohistochemistry; Loss of BAP (ubiquitin carboxy-terminal hydrolase) as determined by molecular testing (bi-allelic loss or mutation) or immunohistochemistry
Pregnant or intend to become pregnant, breastfeeding or intend to breast-feed during this study
Biopsy proven EBV(+) or KSHV(+) malignancy, including but not limited to:\r\n* EBV(+) non-Hodgkin lymphoma or lymphoproliferative disease\r\n* EBV(+) Hodgkin lymphoma\r\n* KSHV(+) Kaposi sarcoma involving skin, with or without visceral involvement\r\n* KSHV(+) primary effusion lymphoma\r\n* EBV(+) gastric cancer\r\n* EBV(+) nasopharyngeal cancer\r\n* EBV(+) leiomyosarcoma\r\n* KSHV(+) Castleman disease\r\n* Chronic active EBV
Four or more American College of Rheumatology (ACR) criteria as revised by Hochberg for the classification of SLE or  or more of the Systemic Lupus International Collaborating Clinics (SLICC) criteria
Total Symptom Score ?  on the MPN-SAF TSS ., not including the inactivity question
Radiosensitizing doses of -fluorouracil;
An intraoperative MRI upon resection will confirm the distance of the planned injection sites from the ventricular system prior to the HSV injection; intra-operatively, the neurosurgeon may decide to not inject the HSV or may revise the sites of HSV injection if injection cannot be guaranteed >=  cm from the ventricular system; patient will removed from the study if there are not sufficient areas in the tumor cavity to guarantee injection of HSV >=  cm from the ventricular system
Patients with history of prior HSV encephalitis or encephalitis due to other etiologies
There is no available information regarding human fetal or teratogenic toxicities
Subjects whose primary physicians determine that anti-HSV antiviral therapy (such as acyclovir, ganciclovir, foscarnet, etc.) cannot be safely discontinued from  days prior to the injection to  days following the injection are excluded from this study
Male or female patients and no race-ethnic restrictions
Patients with sickle cell disease and sickle cell crisis
Subject's overall Beck Depression Inventory II Score is >  or has a score of  on question  relating to suicidal thoughts or wishes at the baseline visit
Sexual Health Inventory for Men (SHIM) score >= 
Carcinoembryonic antigen (CEA)</= times the ULN
Have extra-hepatic metastatic disease. Suspicious lesions should be rigorously evaluated with other imaging techniques and/or biopsy to exclude extra-hepatic metastatic disease prior to submitting for central radiology review.
Willing to refrain from the concurrent use of high-dose ( mg or higher per day) of vitamins, antioxidants, Proscar, Avodart, and anti-inflammatory agents
EUS clinically indicated for staging, and/or celiac neurolysis
Phase Ib: Documented evidence of PTEN mutations, homozygous deletion of PTEN or PTEN negative (H Score <) by IHC confirmed by local or central assessment.
. Have completed baseline quality of life evaluation as assessed by LCSS modified for mesothelioma
Meets the requirements for HD IL- therapy per Institutional guidelines
Uncontrolled hypertriglyceridemia (>  mg/dL)
Unresectable stage IIIA or IIIB disease; patients must be surgically staged to confirm N or N disease; patients may have invasive mediastinal staging by mediastinoscopy, mediastinotomy, endobronchial ultrasound transbronchial aspiration (EBUS-TBNA), endoscopic ultrasound (EUS), or video-assisted thoracoscopic surgery (VATS)
Patients with unresectable or metastatic melanoma, for whom treatment with ipilimumab is indicated as per ipilimumab/Yervoy package insert (applicable for US sites) or product information (applicable for Australia site).
Any contraindications for ipilimumab/Yervoy as per package insert(applicable for US sites) or product information (applicable for Australia site).
Anticipated treatment of the index tumor that would require iceball formation within . cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava (IVC), bowel, or bladder
Mechanical obstruction that would prevent adequate oral nutritional intake.
Evidence of Gilbert's Syndrome or homozygosity for the Uridine -diphospho-glucuronosyltransferase (UGT) A* allele
Presence of megakaryocyte proliferation and atypia, usually accompanied by either reticulin and/or collagen fibrosis, or, in the absence of significant reticulin fibrosis, the megakaryocyte changes must be accompanied by an increased bone marrow cellularity characterized by granulocytic proliferation and often decreased erythropoiesis (ie. prefibrotic cellular-phase disease)
Leukoerythroblastosis
Palpable splenomegaly
Platelets ? ,//microL
History of depression or active treatment for depression
History of hypothyroidism or hyperthyroidism
At least  weeks must have passed since any of the following: systemic corticosteroids, immunotherapy (for example, interleukins, MCC vaccines, intravenous immunoglobulin, expanded polyclonal tumor infiltrating lymphocyte [TIL] or lymphokine-activated killer [LAK] therapy), pentoxifylline, other small molecule or chemotherapy cancer treatment, other investigational agents or other agents that target merkel cell carcinoma
MMSE score  or above
Vagus nerve stimulator
Programmable shunt
Radiological suspicion of pseudoprogression or radionecrosis
>  days after reduced intensity conditioning (RIC) allogeneic transplant for lymphoma
Mixed (-%) or complete (> %) chimerism
Karnofsky performance status >=  (Radiation Therapy Oncology Group [RTOG] recursive partitioning analysis [RPA] class I & II)
Any regular use of cyclooxygenase- (COX-) inhibitors as defined by - times per week
CHEMORADIATION:
HgbAc of ? %
History of orthostatic hypotension
Hypertriglyceridemia >= Grade 
Subjects are receiving ongoing treatment with AGS- in protocol AGS- - or AGS--.
Obesity from a genetic cause (e.g., Prader-Willi)
Angioimmunoblastic TCL
PTCL-unspecified
Hepatosplenic TCL
Subcutaneous panniculitis TCL
Transformed mycosis fungoides (tMF)
Primary cutaneous gamma-delta TCL
CHOP 
CHOP 
CHOP + etoposide
Men who are sexually active, including those with a pregnant partner, must agree to practice a medically acceptable barrier method contraceptive regimen (eg, condoms) while receiving pralatrexate and for  days after the last administration of pralatrexate.
Precursor T/NK neoplasms
Mycosis fungoides, except tMF
Have had prior radioimmunotherapy
Platelets count ? xE/L
Serum neutralization antibody assay shows >= % neutralization of the SS (dsFv) PE activity at  ng/ml
Concomitant chemotherapy and radiotherapy while on protocol is prohibited; prednisone therapy will not be permitted with the exception of brief courses (=<  days) used for inflammatory conditions unrelated to CLL; patients may receive intravenous immunoglobulin (IVIG) while on protocol; patients may receive erythropoietin, darbepoetin, filgrastim, peg filgrastim, or sargramostim while on protocol; patients with cellular immune cytopenias may receive cyclosporine (pure red cell aplasia, etc.) while on study but consultation with principal investigator (P.I.) (or designee) is required
Other serious medical problem that in the view of the investigator makes therapy difficult to comply with or difficult to interpret toxicity
Other serious medical problem that in the view of the investigator makes therapy difficult to comply with or difficult to interpret toxicity
Must be KRAS WT;
INITIAL ENROLLMENT:
Patients with advanced cancer must meet one of the following criteria (does not apply to first-degree relatives or individuals with pre-invasive histology enrolling only for EGFR germline mutation testing):\r\n* Patients must have biopsiable disease and be willing to undergo biopsy for molecular profiling or\r\n* Patients must have enough and adequate archival material from a previous biopsy to perform molecular profiling analyses; the adequacy of the material provided will be determined by the principal investigator in conjunction with the laboratories performing the molecular profiling analyses or\r\n* Patients must have previously undergone a successful molecular profiling of their tumor with mutation analysis of any of the genes described or anaplastic lymphoma receptor tyrosine kinase (ALK) break apart fluorescence in situ hybridization, as part of this protocol (crossover patients) or other molecular profiling protocols such as the Lung Cancer Mutation Consortium protocol among others
LAPATINIB DITOSYLATE ARM: Previous lapatinib (lapatinib ditosylate) therapy
SUNITINIB MALATE ARM: Previous sunitinib (sunitinib malate) therapy
Patients with known syndromes that alter radiosensitivity
Has been withdrawn from the CS trial.
Patients with diabetic retinopathy
Participants for whom front-line cytotoxic therapy is indicated (i.e. symptomatic visceral or pulmonary KS or symptomatic KS impairing functional status)
For BCG-unresponsive and BCG-relapsing NMIBC, participants must have received an adequate course of BCG
Any major operation must have occurred at least  days before study enrollment
Patients scheduled for elective thoracic surgery (segmentectomy, lobectomy or bi-lobectomy, pneumonectomy or esophagectomy) and meeting one of the four following risk criteria:\r\n* Female and B-type natriuretic peptide (BNP) >=  pg/ml (no age limit) \r\n* Male gender <  and BNP >=  pg/ml\r\n* Male- age >=  (No BNP limit)\r\n* History of prior AF
Patients in sinus rhythm
Patients with stable respiratory status (no respiratory distress)
Sufficient physiological reserves
Insurance approval for SBRT should be obtained prior to randomization
Cohort : Has received prior aromatase inhibitor therapy and is deemed to be resistant to all three (anastrozole, letrozole, exemestane) approved AIs; resistance is defined as progression within  months or while on an AI
Ability to understand and follow the breathing instructions involved in the respiratory gating procedure or to tolerate compression sufficient to reduce fiducial motion to =<  mm
Metastatic or locally recurrent EBV-positive, non-keratinizing and/ or undifferentiated NPC* who do not have curative options such as chemo-radiation or surgery *Subjects will be enrolled based on confirmed histology diagnosis of the NPC
Treated with ado-trastuzumab emtansine (T-DM) Part b:
Treated with ado-trastuzumab emtansine (T-DM) (patients with HER overexpression only)
Abnormalities of the cornea based on history (e.g., dry eye syndrome, Sjogrens syndrome), congenital abnormality (e.g., Fuchs dystrophy), abnormal slit-lamp examination using a vital dye (e.g., fluorescein, Bengal Rose), and/or an abnormal corneal sensitivity test (Schirmer test or similar tear production test)
Platelets >= ,/microliters
Must have undergone first-line treatment with a high-dose methotrexate-based chemotherapy regimen with or without brain radiotherapy; high-dose methotrexate is defined as >=  grams/m^; methotrexate dose reduction for creatinine clearance <  ml/min is permitted
Patients with MPD
has p- and/or TP mutation; or
No evidence of TLS per the Cairo-Bishop definition of laboratory TLS (subjects may be enrolled upon correction of electrolyte abnormalities).
All subjects must:
Agree not to share IP with another person.
Known or demonstrated wild type KIT or PDGF-R, or known or demonstrated mutations of PDGF R, SDH, or NF  that are causative for the observed malignancy.
Parts a and d: Patients with known or presumed pathogenic KIT exon  or  resistance mutations. (However, such patients are permitted on the combination arms of Parts b, c, e, or f.)
All subjects or legally appointed representatives/caregivers, must personally sign and date the IRB/IEC approved consent form before initiating any study specific procedures or activities.
NHL SUBJECTS:
ALL SUBJECTS:
NOTE: If both serum and urine m-components are present, both must be followed in order to evaluate response.
Diagnosed with relapsed or refractory NHL limited to subtypes listed below; the subject must have histologic confirmation of diagnosis according to review at the Cleveland Clinic Foundation, either at initial diagnosis or at any subsequent relapse; (biopsy is not required at relapse, but is suggested; biopsy at outside institution, reviewed at the Cleveland Clinic, is acceptable)
Patients must have an expected minimum life span of  days
Moderate to severe cGVHD as assessed by NIH cGVHD Diagnosis and Staging Criteria (NCDSC) with at least three organ systems involved OR one organ system with a score of  OR lung organ score = 
B cell depleting biologic agents
Prior history of a pathologic fracture
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos (pioglitazone) and Avandia (rosiglitzone)
Fasting ?-CTX of > pg/mL
Patient shows evidence of diffuse alveolar hemorrhage or other active pulmonary disease, which is likely to require more than L of oxygen via face mask or an estimated FiO() of % via other delivery methods in order to sustain an O() saturation of %.
Patients whose AML is classified as favorable according to the European LeukemiaNet (ELN) disease risk assessment.
Patient has no significant valvular heart disease (trace or mild valvular stenosis or regurgitation is allowed).
Glasgow Coma Score (GCS) of less than .
Asplenia.
Known other causes of thrombocytopenia
Symptomatic pericarditis.
Prior treatment with a monomethyl auristatin E (MMAE)-containing antibody-drug conjugate (ADC)
Serum phosphorus > .; electrolyte repletion is allowed to reach these values
Patients must have demonstrated either disease progression or intolerance to imatinib mesylate, have non-mutant Stem Cell Factor Receptor gene (KIT) GIST, or cannot obtain imatinib in their country
Required used of folate-containing supplements (e.g. for folate deficiency)
Verification received from Argos Therapeutics that ribonucleic acid (RNA) successfully collected from TURBT procedure
Part B
For Part B only:
Subjects with uterine carcinosarcoma
Basal cell carcinomas of aggressive subtypes (infiltrative, morpheaform, micronodular)
Patients who have previously received CDX- (CR-vc monomethyl auristatin E [MMAE]; CDX-) or other MMAE-containing agents
No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays
Serum magnesium, calcium, and phosphorus must be within normal reference ranges as per local tests. [If initial screening results are outside of normal reference range, the Investigator may initiate appropriate measures to correct. However administration of FS may not proceed until the specified electrolytes have normalized.]
Hypersensitivity/infusion reaction to monoclonal antibodies, other therapeutic proteins, or allergy to any component/excipient of FS finished drug product (arginine, glycine, phosphoric acid, or polysorbate ) and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as anti-histamines, -HT antagonists, or corticosteroids.
Subjects with negative nodal status (N)
Oral kinase inhibitors approved by local regulatory authorities may be used within  weeks prior to initiation of DLYEA, provided that any clinically relevant drug-related toxicity has completely resolved and prior approval is obtained from the Medical Monitor
Prior history of a pathologic fracture
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos (pioglitazone) and Avandia (rosiglitazone)
Fasting ?-CTX of > pg/mL
Neurologically stable
Complex/combined procedures (coronary artery bypass graft [CABG] plus valve), double/triple valve repair/replacements, ascending aorta/aortic arch surgeries (without baseline AT level restriction or preoperative heparin requirement). OR
Infective endocarditis.
There are no known contra-indications to any of the planned agents used in this protocol; etoposide may be substituted by etoposide phosphate (Etopophos) if the patient has a history of hypersensitivity reaction to etoposide
Endogenous erythropoietin levels <  units/L
B and folate deficient patients with and without clinical symptoms (patients could be rescreened after successful therapy of B and folate deficiency)
Wash-out period:
Concomitant diseases/conditions: Unstable angina, myocardial infarction, valvular heart disease, encephalopathy, ischemic attacks, hemorrhagic or ischemic cerebrovascular accident (CVA) or ongoing pulmonary embolism within last year, arrhythmia, hepatopathy, uncontrolled infection, hemoptysis or oxygen requiring dyspnea, known HIV infection, bleeding risk, muscular problems, peripheral neuropathy, Symptomatic or progressive brain metastases or leptomeningeal disease.
Platelet count ? .x(to the th power)/?l (? . x (to th power)/?l after stem cell transplant)
Platelet count ? . x (to the th power)/?l (? . x (to the th power)/?l after stem cell transplant)
Scarring or significant skin disease on both upper arms.
Persistent grade  fatigue at Baseline.
Inclusion:\n\n          . Received prior treatment with NKTR-\n\n          . Free of disease progression since receiving NKTR-\n\n          . Adequate bone marrow and organ function\n\n          . Treatment with NKTR- in the extension study to begin within  weeks after receipt\n             of their of last dose of NKTR-\n\n          . Agree to use adequate contraception\n\n        Exclusion:\n\n          . Treatment with other anti-cancer therapy between the last dose of NKTR- in the\n             prior study and before first dose of NKTR- in the extension study\n\n          . A toxicity that requires a rd dose reduction after taking NKTR- or are scheduled\n             to receive a dose <  mg/m upon entry into this study\n\n          . Pregnancy or lactation
Untreated SCCHN of oral cavity/soft palate, categories TN-M,TN-M,TN-M,TN-M (T allowed only if invasion of mandible is negligible) scheduled for SOC
no immunosuppressives with  year
Subjects to be treated with other than SOC
Tumor classifications TN, TN, TN, any TN classification with M
Inclusion Criteria:\n\n        Entry criteria include the following:\n\n          . Clinical diagnosis of VOD, made by Baltimore Criteria, Modified Seattle Criteria, or\n             biopsy proven:\n\n             . Baltimore Criteria- Bilirubin ? mg/dL and at least  of the following clinical\n             findings:\n\n               -  Ascites (radiographic or physical exam)\n\n               -  Weight gain of ?% compared to the day of conditioning-- if this value is not\n                  available, the weight on the date of admission to the SCT unit may be used)\n\n               -  Hepatomegaly; increased over baseline.\n\n             . Modified Seattle Criteria: At least two of the following\n\n               -  Bilirubin ? mg/dL\n\n               -  Ascites (radiographic or physical exam) and/or weight gain ?% above baseline\n                  weight (defined as weight on the first day of conditioning- if this value is not\n                  available, the weight on the date of admission to the SCT unit may be used)\n\n               -  hepatomegaly increased over baseline\n\n             . Patients that do not meet the Baltimore Criteria or Modified Seattle Criteria and\n             have biopsy proven VOD are eligible.\n\n          . Patient must also provide written informed consent.\n\n        Exclusion Criteria:\n\n          -  Use of any medication which increases the risk of hemorrhage is disallowed. Use of\n             heparin or other anticoagulants is disallowed within  hours unless being used for\n             routine central venous line management, fibrinolytic instillation for central venous\n             line occlusion, intermittent dialysis or ultrafiltration of CVVH.\n\n          -  Clinically significant uncontrolled acute bleeding, defined as hemorrhage requiring >\n              cc/kg of packed red blood cells (e.g., a pediatric patient weighing  kg and\n             requiring > cc of packed red blood cells/ hours, or an adult patient weighing \n             kg and requiring > units of packed red blood cells/ hours) to replace blood loss,\n             OR bleeding from a site which in the Investigator's opinion constitutes a potential\n             life-threatening source (e.g. pulmonary hemorrhage or CNS bleeding), irrespective of\n             amount of blood loss, at any point from the date of SCT through the date of severe VOD\n             diagnosis.\n\n          -  Hemodynamic instability as defined by a requirement for multiple pressors, or\n             inability to maintain mean arterial pressure (for children: to maintain mean arterial\n             pressure within  standard deviation of age-adjusted levels) with single pressor\n             support.\n\n          -  Woman who are pregnant.
Prisoner
The complete set of baseline radiographic images must be available before treatment initiation.
Participants with evidence of electrolyte imbalance
Failure to enroll and comply with Alliance A
Ejection fraction equal or > % before admission for transplant as per institutional standards; patients with coronary heart disease (recent myocardial infarctions, angina, cardiac stent, or bypass surgery in the last  months or arrhythmia) need to be cleared by cardiology as per Emory bone marrow transplant (BMT) standards
Intention or plans for cyclophosphamide mobilization
On a gluten-free diet for at least  months
Tumors with HER activating or other mutations including GA, DH, DY, VL, Pins, VI, RC, HER in-frame deletion , LS, GA, SF, SY, VE, RQ, LS, LP, EA, DH, DY, A_GinsYVMA, GV, GC, G insertions, VL, G_SinsCPG, P_insGSP, LV, VI, LR, RC, and any others identified where there is reported activity with neratinib
Patients must have a comprehensive geriatric assessment and chemotherapy toxicity assessment score between -
Mitoxantrone > mg/m and idarubicin >  mg/m.
The two most recent measurements of serum testosterone prior to enrollment must fulfill the following criteria:
The two measurements are spaced at least  days apart;
Both must be measured within  months of enrollment;
CBC (except platelets and hemoglobin), serum chemistry, liver panel, and CPK values ? Grade  abnormality as defined in CTCAE v . dated June , 
Contraindication to placement of endorectal MRI coil, biopsy device or ultrasound probe (e.g., severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection)
Member of vulnerable population including prisoners or mentally disabled patients, in accordance with U.S. Department of Health and Human Services (DHHS) definitions
Volume difference of at least  mL between the normal and lymphedematous limb based on perometry evaluation
Recent history of cellulitis in the affected extremity (within last  months)
Palbociclib can be started at week , if indicated
Statin use in the last  months
Uncorrected coagulopathy:\r\n* Plavix usage at the time of vertebroplasty or history of taking Plavix less than  days prior to procedure (in selected cases, radiation treatment can be initiated, the antiplatelet agent stopped, and vertebroplasty performed after  days)
Asymptomatic vertebral fracture and low risk for biomechanical instability and collapse
Procedures prescribed within one week of discharge of a hospitalization.
Experienced a Grade  or higher hypersensitivity reaction to monoclonal antibodies or other therapeutic proteins, and the reaction could not be controlled or prevented on subsequent infusion with standard therapies such as antihistamines, -hydroxytryptamine (-HT) receptor antagonists, or corticosteroids;
Known sensitivity to conductive hydrogels like the gel used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes
Impending or actual pathological fracture of the humerus, secondary to metastatic bone disease.
In the investigator's judgment, functional deficit in the target humerus with an etiology other than bone metastases (e.g. due to vascular insufficiency).
Extremely comminuted fractures where insufficient holding power of the balloon on the intramedullary canal is probable.
Any condition that will put the patient at undue risk or discomfort as a result of adherence to study procedures. For example, consider requirement to take mocetinostat with water and recommendation to avoid agents that increase gastric pH
Pathologic mediastinal staging to include endobronchial ultrasound with or without endoscopic ultrasound (endobronchial ultrasound [EBUS] +/- endoscopic ultrasound [EUS]) including evaluation of N nodes
Drug induced thrombocytopenia
Mediastinoscopy and/or endoscopic bronchial ultrasound (EBUS) and/or endoscopic ultrasound (EUS) for complete surgical staging when clinically indicated
Has recognized immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia, and/or other hereditary congenital immunodeficiencies
Embryonal or alveolar rhabdomyosarcoma
Dermatofibrosarcoma protuberans
Extraskeletal myxoid chondrosarcoma
Sarcomas arising from bone or cartilage, e.g. chondrosarcoma, osteosarcoma, chordoma.
Local conditions or systemic illnesses which would reduce the local tolerance to radiation treatment, such as serious local injuries, active collagen vascular disease, etc.
DLBCL of GCB subtype
Disease is confined to locoregional site as confirmed by the CT and/or diagnostic staging laparoscopy to avoid occult peritoneal deposits; diagnostic laparoscopy will be only if absolutely required
Ineligible histology including non-adenocarcinomas, adenosquamous carcinoma, islet cell carcinomas, cystadenomas, cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct and ampullary carcinomas
Abnormal T wave morphology (other than slight flattening)
Other QRS or T/U morphology preventing accurate determination of QT interval
Primary resistance or acquired resistance (i.e., acquired resistance will be defined as disease progression following a period of response defined as >= % decline in PSA within  weeks of starting therapy and not otherwise meeting criteria for primary resistance) to any of the following agents/combinations of therapy:
Male participants, even if surgically sterilized (ie, status postvasectomy), who:
Participants with biliary obstruction for which a stent had been placed are eligible provided that the stent has been in place for more than  days before the first dose of alisertib and liver function has stabilized.
No use of PPIs within  days before the first dose of alisertib.
Patient has a suitable MSD, volunteer MURD, or killer-cell immunoglobulin-like receptor (KIR) mismatched haploidentical donor available in the necessary time for stem cell donation
Patient must have been pre-identified as having a tumor with CDK amplification or mutation, CDK amplification or mutation, Cyclin D (CCND) amplification, Cyclin D (CCND) amplification, or p (CDKNA) mutation
Any cardiac pre-excitation syndromes (such as Wolff-Parkinson-White);
- fluoropyrimidine
- cetuximab or panitumumab for patients with K-Ras wt or Ras wt tumours
Colonic prosthesis (stent) implant in place
Biopsy-proven well-differentiated, low-to-intermediate-grade PNET or GI-NET with elevated (> ULN) biomarkers (serotonin, -hydroxyindoleacetic acid (-HIAA), chromogranin A (CgA), neurokinin A, and neuron-specific enolase (NSE))
Prior history of HNC
Male participants, even if surgically sterilized (that is, status postvasectomy), who:
Participants with a cardiac pacer whose heart rate is set at a fixed rate and participants on concomitant medication that may limit increase in heart rate in response to hypotension (example, high-dose beta blocker).
Note, unlike pharmaceutical company sponsored protocols eligibility is not conditioned on bilirubin, creatinine, or absence of other malignancy within the past - years; the TRM score incorporates creatinine and thus a high creatinine can in principle be offset by favorable values for the other covariates in the TRM score; bilirubin was not a covariate in the TRM; furthermore, in the doses we are using, dose adjustment of decitabine or ara-C is not indicated in the presence of renal or hepatic abnormalities; our broad eligibility criteria may increase the likelihood that our results will be generalizable; the inability to reproduce results of early phase AML studies has been a problem in the past
Patients who are on a somatostatin analogue for control of hormonal syndromes must be on a stable dose (no change in mg dose of long acting octreotide or lanreotide, changes in dosing interval of +/-  week is allowed) for  months prior to date of study entry
Rapid central review confirmation of group D disease based on RetCam images from diagnostic EUA must be obtained before starting treatment
Unilateral retinoblastoma with group A, B, C, or E eyes
Abnormal cardiac valve morphology (>=grade ) documented by echocardiogram (subjects with grade  abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study.
Subjects with COPD or subjects with increased risk of respiratory depression
Multi-focal (defined as two separate areas of contrast enhancement measuring at least  cm in  planes that are not contiguous on either fluid-attenuated inversion recovery (FLAIR) or T sequences);
Associated with either diffuse subependymal or leptomeningeal dissemination; or
Progressed (> % increase in evaluable disease) or non-response on Revlimid or within  days of stopping Revlimid
Prior history of a pathologic fracture
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos (pioglitazone) and Avandia (rosiglitzone)
Fasting ?-CTX of > pg/mL
BRAFV mutation positive.
Immunosuppressed patients
Sensitive substrates for cytochrome P C or A (e.g., repaglinide, midazolam, sildenafil);
Substrates for p-glycoprotein transporter (e.g., ambrisentan, digoxin), OCT transporter (e.g., metformin), OAT transporter (e.g., captopril, furosemide, methotrexate), and OATPB transporter (e.g., atorvastatin, rosuvastatin, valsartan);
Donor-specific antibodies (DSA) will be assessed by the local laboratory  days or less prior to transplant using solid phase micro particle technology (by Luminex phenotype panel or Luminex single antigen bead test); the following criteria apply:\r\n* Participants without detectable DSA will be deemed eligible if they meet other entry criteria\r\n* Participants with detectable DSA and a positive flow cytometric crossmatch may undergo de-sensitization per standard of care if they are cytotoxic crossmatch negative; such participants must demonstrate a negative flow cytometric crossmatch by day - in order to receive the first dose of study therapy (ATG); participants who do not demonstrate an acceptable response to de-sensitization by day - will be considered screen failures and will be terminated from the study\r\n* Participants with a positive cytotoxicity crossmatch will be excluded
Serological evidence of prior Epstein-Barr virus (EBV) infection as documented by positive immunoglobulin G (IgG) and negative immunoglobulin M (IgM) antibodies against EBV
DONOR: Serologic evidence of prior EBV infection as documented by positive IgG and negative IgM antibodies against EBV
Calculated panel reactive antibody (PRA) greater than %
Laboratory values: screening serum creatinine > .xULN, ALT > .xULN, total bilirubin > .xULN, ANC < /mm, platelet concentrations < ,/mm, absolute lymphocyte count < /mm, hematocrit level < % for females or < % for males, serum albumin ? . g/dL, PT/INR .xULN or >xULN on anticoagulant with no evidence of active bleeding.
Have prosthetic heart valves, major implant or device placed in the last  months or history of infection with implant/device that cannot be easily removed
Rapidly progressing disease
Valvular heart disease that requires antibiotic prophylaxis for prevention of endocarditis
Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS- treatment until completion of antibiotic regimen
Lack of metabolic complications
Presence of amyloid deposits in biopsy tissue and presence of a variant TTR genotype and/or TTR precursor protein identification by immunohistochemistry, scintigraphy or mass spectrometry
Prior history of myositis or rhabdomyolysis.
Subject with a diagnosis of mild-moderate or severe CDAD (first occurrence or first recurrence within  months) with: Diarrhea: a change in bowel habits with >  liquid or unformed bowel movements (UBM) within  hours prior to randomization, AND Positive C. difficile toxin test on a stool sample produced within  hours prior to randomization.
Likelihood of death within  hours from any cause.
Not removed from trametinib treatment due to the development of unacceptable toxicity that is not manageable with dose reduction
experienced no dose limiting toxicity (DLT)
Patients enrolling on the retreatment cohort must have locally and systemically stable disease following the definite local treatment.
Known immunodeficiency disease, including cellular immunodeficiencies, hypogammaglobulinemia, or dysgammaglobulinemia; and/or other hereditary or congenital immunodeficiencies
Abnormal cardiac valve morphology (>= Grade ) documented by echocardiogram (ECHO)
Prior history of a pathologic fracture
Treatment with a thiazolidinedione PPAR gamma inhibitor; e.g. Actos (pioglitazone), and Avandia (rosiglitzone)
Fasting ?-CTX of > pg/mL
Planned treatment with NovoTTF therapy alone per Food and Drug Administration (FDA)-approved indication; NovoTTF therapy must start within  days of registration, but not less than  days or more than  days from stereotactic biopsy (if applicable) and not less than  days or more than  days from open resection (if applicable)
For patients enrolling in this trial at Washington University School of Medicine (WUSM), it is required that WUSM patients must also enroll in Human Research Protection Office (HRPO)# ; the genetic analyses for University of Florida (UF) patients will take place at WUSM under the auspices of this protocol
Paraneoplastic syndromes
ASS deficiency (defined as <% ASS expression) demonstrated on tissue specimen by Immunohistochemistry (IHC). Cytology and fine need aspirate specimens are not acceptable for ASS testing.
Has had either partial or total gastrectomy
Patients with any gastrointestinal dysfunctions that could interfere with the interpretation of the food effect data
Sickle Cell Disease (HbSS, HbSC, HbS??-thalassemia, or HbS??-thalassemia)
If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least  months, with the dose stable for at least  months
Grade >= hypercholesterolemia or hypertriglyceridemia
PART I: History of oxalate renal calculi; urine oxalate level >  mg/d at baseline
PART II: ECOG performance status -\r\n* Eastern Cooperative Oncology Group performance status\r\n* Grade  = Fully active, able to carry on all pre-disease activities without restriction\r\n* Grade  = Restricted in physical strenuous activity but ambulatory and able to carry out work of a light or sedentary nature e.g. light housework, office work\r\n* Grade  = Ambulatory and capable of all self care but unable to carry out any work activities; up and about more than % of waking hours
PART II: History of oxalate renal calculi; urine oxalate level >  mg/d at baseline
Respiratory functions clinically stable for the preceding  months and expected to be stable for the next  months as determined by project principal investigators (PIs) and other pulmonary medicine faculty
Hypersensitivity to -aminoquinoline compounds, including hydroxychloroquine sulfate, chloroquine phosphate and amodiaquine
Retinal or visual field changes from prior -aminoquinoline compound use such as hydroxychloroquine sulfate, chloroquine phosphate and amodiaquine
For the -% of patients without splenomegaly, the diagnostic entry criteria must include all other features described above and at least  of the following criteria: \r\n* Circulating myeloid precursors \r\n* White blood cell (WBC) > ,/uL\r\n* Increased fetal hemoglobin (HgbF) for age\r\n* Sargramostim (GM-CSF) hypersensitivity\r\nOR, patients must have been previously diagnosed with JMML
Non-smoker
Any prior ado-trastuzumab emtansine
One of the following known rare hereditary conditions: galactose intolerance, primary hypolactasia or glucose-galactose malabsorption
Patients must have histologically confirmed HR+ breast cancer; HR+ is defined as either ERa or PgR being positive, or both; positivity is defined for the purposes of this protocol as:\r\n* Allred >= \r\n* IHC +, +, +\r\n* Percentage of positive staining > %\r\n** When there is discrepancy between the metastatic and primary tumor results with respect to ERA or PgR status, the metastatic results will hold precedence; when there is discrepancy between the local and University of Wisconsin (UW) pathology results with respect to ER? or PgR status, the UW results will hold precedence
Bilirubin < . mg/mL x upper limit of normal; this requirement reflects the excretion of CPX- by the liver
Intubated and mechanically-ventilated
Presence of Gram-negative organism(s) by either Gram stain or culture of respiratory secretions, or suspected Gram-negative pathogen
Impaired oxygenation
Presence of a multi-drug resistant (MDR) organism in a pre-therapy respiratory specimen OR at least two risk factors for MDR organisms
Known or suspected bacteremia secondary to Staphylococcus aureus
Patients receiving veno-venous extracorporeal circulation membrane oxygenation (V-V ECMO)
Aromatase Inhibitor (AI) resistant, defined as:
For the dose expansion cohorts: in addition to the above, there must be a difference between the amyloidogenic (i.e. clonal) and non-amyloidogenic light chain (dFLC) of at least mg/L (mg/dL)
Adults
Abnormal cardiac valve morphology (>=grade ) documented by echocardiogram (subjects with grade  abnormalities [i.e., mild regurgitation/stenosis] can be entered on study). Subjects with moderate valvular thickening should not be entered on study
Require elective (non-emergency), open (non-laparoscopic), hepatic resection (anatomic or non-anatomic resections of at least one anatomical hepatic segment, or equivalent tissue volume).
Application of any topical haemostatic material on the resection surface of the liver prior to application of study treatment.
Diagnosis of ?-thalassemia major and a history of at least  mL/kg/year of pRBCs or ? transfusions of pRBCs per year for the prior  years.
Treated and followed for at least the past  years in a specialized center that maintained detailed medical records, including transfusion history.
Patients should receive concomitant therapy with bisphosphonates, regardless of the presence of bony lesions, although study physicians may use their discretion based on presence of renal insufficiency or other mitigating factors
Allergic to fosaprepitant, aprepitant, ondansetron, or any other -HT antagonist
Prior radioimmunotherapy
Participants must meet the inclusion criteria outlined in the respective parent protocols: NO (NCT), NO (NCT), NP (NCT), NP (NCT) or NP (NCT)
Participants must have completed one of the following clinical study protocols and have been determined to have clinical benefit on treatment at the conclusion of required study analyses as defined in the respective parent protocols: NO (NCT), NO (NCT), NP (NCT), NP (NCT) or NP (NCT)
Participants must meet the exclusion criteria outlined in the respective parent protocols: NO (NCT), NO (NCT), NP (NCT), NP (NCT) or NP (NCT)
Participants continuing to require dose modifications
Inclusion Criteria:\n\n        Patients are eligible if they:\n\n          . have undergone noncardiac surgery;\n\n          . are ? years of age;\n\n          . have suffered MINS based upon fulfilling one of the following criteria: A. Elevated\n             troponin or CK-MB measurement with one or more of the following defining features i.\n             ischemic signs or symptoms (i.e., chest, arm, neck, or jaw discomfort; shortness of\n             breath, pulmonary edema); ii. development of pathologic Q waves present in any two\n             contiguous leads that are ? milliseconds; iii. electrocardiogram (ECG) changes\n             indicative of ischemia (i.e., ST segment elevation [? mm in leads V, V, or V OR ?\n             mm in the other leads], ST segment depression [? mm], OR symmetric inversion of T\n             waves ? mm) in at least two contiguous leads; iv. new LBBB; or v. new or presumed new\n             cardiac wall motion abnormality on echocardiography or new or presumed new fixed\n             defect on radionuclide imaging B. Elevated troponin measurement after surgery with no\n             alternative explanation (e.g., pulmonary embolism, sepsis) to myocardial injury; AND\n\n          . provide written informed consent to participate within  days of suffering their\n             MINS.\n\n        Exclusion Criteria:\n\n        Patients meeting any of the following criteria will be excluded:\n\n          . hypersensitivity or known allergy to dabigatran;\n\n          . history of intracranial, intraocular, or spinal bleeding;\n\n          . hemorrhagic disorder or bleeding diathesis;\n\n          . known hepatic impairment or liver disease expected to have an impact on survival;\n\n          . condition that requires therapeutic dose anticoagulation (e.g., prosthetic heart\n             valve, venous thromboembolism, atrial fibrillation);\n\n          . currently using or plan to initiate rifampicin, cyclosporine, itraconazole,\n             tacrolimus, ketoconazole, or dronedarone;\n\n          . women who are pregnant, breastfeeding, or of childbearing potential who refuse to use\n             a medically acceptable form of contraception throughout the study;\n\n          . investigator considers the patient unreliable regarding requirement for study\n             follow-up or study drug compliance; OR\n\n          . previously enrolled in the MANAGE Trial.\n\n        Also excluded will be patients in whom any of the following criteria persist beyond  days\n        of their suffering MINS:\n\n          . the attending surgeon believes it is not safe to initiate therapeutic dose\n             anticoagulation therapy;\n\n          . the attending physician believes ASA, intermittent pneumatic compression, or elastic\n             stockings are not sufficient for venous thromboembolism (VTE) prophylaxis and that the\n             patient requires a prophylactic-dose anticoagulant;\n\n          . the patient has an indwelling epidural or spinal catheter that cannot be removed, or\n             the first dose of dabigatran will occur within  hours of epidural catheter removal;\n             OR\n\n          . estimated glomerular filtration rate (eGFR) < ml/min as estimated by calculated\n             creatinine clearance.\n\n          . it is expected that the patient will undergo cardiac catheterization for MINS.\n\n        Exclusion Criteria Specific to Patients in the Omeprazole Factorial Component of the Trial:\n\n        Patients meeting any of the following criteria:\n\n          . hypersensitivity or known allergy to omeprazole;\n\n          . requirement for a proton pump inhibitor, an H-receptor antagonist, sucralfate,\n             atazanavir, clopidogrel, or misoprostol;\n\n          . esophageal or gastric variceal disease; OR\n\n          . patient declines participation in the omeprazole arm of MANAGE.
Patients must have histologically confirmed thyroid carcinoma with the PAX-PPARgamma translocation; refractory to radioactive iodine (RAI) as defined by: the tumor does not concentrate RAI; or the patient has had RAI within the last  months and has had progression despite that RAI; or the last RAI treatment was >  months ago and the patient progressed after at least two RAI treatments; or the patient has received RAI treatments with a cumulative RAI dose of >= . GBq ( mCi) \r\n* Not a candidate for surgery or RAI therapy with curative intent \r\n* Lesions that would be treated by external beam radiation therapy (EBRT) based on standard of care can be so treated, but then cannot be used as target lesions unless there has been progression of the lesion since treatment
Confirmed parainfluenza at screening by one of the following methods using any sample type: Respiratory Virus Panel, Direct fluorescent antibody (DFA), Qualitative/quantitative RT-PCR test for parainfluenza virus performed at the local laboratory (a confirmatory PCR test will be done at the central lab but is not required to start the patient on study).
Confirmed PIV lower tract disease for subjects on mechanical ventilation will be defined as PIV detection in bronchoalveolar lavage (BAL) or biopsy within last  days of screening
Confirmed PIV lower tract disease for subjects on non-invasive positive pressure ventilation or supplemental oxygen will be defined as all of the following within the last  days of screening: New pulmonary infiltrate on chest imaging and at least one PIV sign and/or symptom as defined in section ..
Subjects treated with oral, aerosolized or intravenous (IV) ribavirin for the treatment of PIV. A forty-eight hour ( hr) wash out period prior to randomization is allowed.
Subjects with a history of RSV or MPV
Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
Require therapeutic doses of any anti-coagulant.
. If patient is in irPD (unconfirmed) status, they must not have had a decrease in their Karnofsky Performances Scale (KPS) score >  points and to be judged to not have \rapid clinical deterioration\ by the investigator since the subject's last tumor measurement leading to irPD assessment.
. Currently in status of irPD (confirmed) or irPD (unconfirmed) without evidence of tumor inflammatory response, or with rapid clinical deterioration, or with a decrease of  points or more on their KPS score since their last assessment before irPD (unconfirmed) assessment.
Subjects with calculated BSA < . m are not eligible for study participation as Sorafenib dosing for this study cannot accommodate subjects of this size utilizing commercially available drug formulation.
To define DHL, patients must have evidence of C-myc (defined as: cytogenetic evidence [fluorescence in situ hybridization (FISH) or karyotype] of C-myc breaks [increased copy number in itself is not considered positivity for C-myc] OR positive IHC defined as >= % of the lymphoma cells staining for C-myc) PLUS either:\r\n* Breaks in BCL- via cytogenetic studies or\r\n* BCL- immunopositivity in >= % of lymphoma cells during phase I portion of the trial and >= % of lymphoma cells during the phase II portion of the trial
Subjects with a history of NF- related cerebral vascular anomaly (such as Moyamoya).
Prior use of or participation in a clinical trial evaluating and agent that either blocks androgen synthesis (e.g. abiraterone acetate, TAK-, TAK-, TAK-) or targets the AR (e.g., bicalutamide, BMS-) (patients who are known to have only received placebo in these studies are eligible)
INTRATUMORAL DRUG DISTRIBUTION STUDY PATIENTS:
Continuation of trastuzumab and pertuzumab are allowed for those patients already on trastuzumab and pertuzumab therapy
Has leukaemia.
Subjects with abnormal cardiac valve morphology (>=grade ) documented by echocardiogram (NOTE: subjects with grade  abnormalities [i.e., mild regurgitation/stenosis] can be entered on study).
Documented presence\r\n* GROUP A: kinesin family member B (KIFB)-RET or related variant RET fusions\r\n* GROUP B: any of the following aberrations\r\n** NTRK fusion\r\n** MET overexpression, amplification, or mutation\r\n** AXL overexpression, amplification, or mutation\r\n* GROUP C: ROS fusion
PHASE II: Measurability and suitability for volumetric MRI analysis of the target PN must be confirmed with the NCI Pediatric Oncology Branch (POB) prior to enrolling a patient; the target PN will be defined as the clinically most relevant PN, which has to be amenable to volumetric MRI analysis; PN will be classified as typical PN versus nodular PN versus solitary nodular PN prior to enrollment
PHASE I: Patients who anticipate the need for surgical intervention within the first three cycles ( months), as surgical intervention during the period of dose limiting toxicity (DLT) evaluation may affect analysis of adherence and/or make the subject inevaluable
Patients must have an Oncotype DX recurrence score < \r\n* If the patient does not already have Oncotype DX recurrence score, specimen (unstained blocks or slides) must be sent to the Genomic Health centralized laboratory in Redwood City, California; please see MA. trial specific website for instructions on ordering Oncotype DX test
NET subjects must have progressed on or been ineligible for treatment with somatostatin analogues (SSA) and at least one other FDA-approved targeted therapy (everolimus or sunitinib).
Circulating hepatitis C virus on qPCR
Active adenovirus viremia
Need for vasopressor or ventilatory support
Have central confirmation of primarily non-enhancing disease by MRI with less than or equal to  mm slice thickness and up to  mm interslice gap on either D T weighted image, D T weighted image, or FLAIR, with at least  non-enhancing tumor measuring  cm.
Have received prior systemic anti-cancer therapy within  month of the first dose of AG- or AG- or have received an investigational agent < days prior to their first dose of AG- or AG-. In addition, the first dose of AG- or AG- should not occur before a period of ? half-lives of the investigational agent has elapsed.
Patients must have either CA- in the normal range or CA- decrease by more than % during front-line therapy that is stable for at least  days (ie, no increase > % from nadir).
Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-negative severe combined immunodeficiency [SCID]) or combined T- and B-cell immunodeficiencies (e.g., T- and B-negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency)
Prior treatment with immunomodulators, including toll-like receptor (TLR) agonists, inhibitors of indoleamine ,-dioxygenase (IDO)/ tryptophan-,-dioxygenase (TDO), or agonists of OX, is allowed provided that at least  half-lives of the drug or a minimum of  weeks have elapsed between the last dose of the prior treatment and the proposed Cycle , Day , with the exception as specified in protocol
Requires ongoing hydroxyurea (hydroxyurea permitted up to first dose)
Only lucid patients qualified to consent to neurosurgical procedure will be approached for participation in this study
Patients that have clinically indicated intraoperative sensorimotor, or language mapping, will also have simultaneous (or tandem) iDOS for functional brain mapping;  patients from each cortical mapping area will be imaged; optical maps will be compared to electrophysiological maps
ARQ  is a sensitive substrate for C and A, a strong inhibitor for C and moderate inhibitor by in vitro data only for A; temsirolimus is a sensitive substrate for CYP A and a weak inhibitor of CYPD and CYPA/; per the UWinRx Drug Interaction Policy, the following medications are contraindicated or must be used with caution
Does not have active acute bronchiolitis obliterans or bronchiolitis obliterans organizing pneumonia
Combined major surgical cases that include a partial nephrectomy
Ongoing treatment with iniparib at time of parental study completion/closure and meet criteria to initiate a subsequent cycle of therapy, as described in the parental study protocol.
This includes but is not limited to cetuximab, panitumumab, erlotinib, geftinib, and lapatinib
For immunoglobulin (Ig) A patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ?  mg/dL (. g/dL).
Patients participating in the study must have metastatic (m)CRPC
Recovered or stabilized from prior treatments.
The primary tumor of any T-stage\r\n* Is within or touching the zone of the proximal bronchial tree defined as a volume  cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), or\r\n* Within  cm of the mediastinal pleura but outside the proximal bronchial tree
Requirement for anticoagulant therapy other than low intensity treatment to maintain patency of central venous catheters.
Centrally located, defined as located within  cm of the central bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi), major vessels (aorta, pulmonary artery trunk, left/right pulmonary artery/vein main branches, superior/inferior vena cava, brachiocephalic artery trunk or left/right brachiocephalic vein, left/right subclavian artery/vein), esophagus, heart, tracheal, pericardium, mediastinal pleural and brachial plexus, chest wall and vertebral body, but no direct invasion, stage I (T-Ta =<  cm without main bronchus involvement), selective stage II (selective T with involvement of mediastinal pleura, parietal pericardium), based upon the following minimum diagnostic workup:\r\n* History/physical examination including weight and assessment of Zubrod performance status within  months prior to registration\r\n* Evaluation by an experienced thoracic cancer clinician within  months prior to registration\r\n* Computed tomography (CT) scan with intravenous contrast (unless medically contraindicated) of the entirety of both lungs and the mediastinum, most part of liver, and adrenal glands acquired within  months prior to registration must be available; the primary tumor dimension will be measured on the CT in lung window; if positron emission tomography (PET)/CT scan is performed within  months prior to registration, CT of chest is recommended but not required; whole body fluorodeoxyglucose (FDG)-PET within  months prior to registration with adequate visualization of the primary tumor and draining lymph node basins in the hilar and mediastinal regions and adrenal glands; pulmonary function tests (PFTs): routine spirometry, lung volumes, diffusion capacity (within  months prior to registration)\r\n* Patients with hilar or mediastinal lymph nodes =<  cm and no abnormal hilar or mediastinal uptake on PET will be considered N; patients with >  cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but non-diagnostic uptake) may still be eligible if directed tissue biopsy of all abnormally identified areas are negative for cancer; the primary tumor should be considered medically inoperable by an experienced thoracic cancer clinician for a standard lobectomy and mediastinal lymph node dissection/sampling procedure or patient refuses surgery; the patient may have underlying physiological medical problems that would prohibit a surgery due to a low probability of tolerating general anesthesia, the operation, the postoperative recovery period, or the removal of adjacent functioning lung; these types of patients with severe underlying health problems are deemed \medically inoperable;\ standard justification for deeming a patient medically inoperable based on pulmonary function for surgical resection of NSCLC may include any of the following: Baseline forced expiratory volume of the lung in  second (FEV) < % predicted, postoperative FEV < % predicted, severely reduced diffusion capacity, baseline hypoxemia and/or hypercapnia, exercise oxygen consumption < % predicted, severe pulmonary hypertension, diabetes mellitus with severe end organ damage, severe cerebral, cardiac, or peripheral vascular disease, or severe chronic heart disease; if the patient has medically resectable/operable disease but declines surgery after consulting with a thoracic surgeon, he/she will be considered eligible
History of lobectomy involving > % of lobe
Patients currently taking drugs that are generally accepted to have a risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide, amiodarone, sotalol, ibutilide, dofetilide, erythromycins, clarithromycin, chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide, cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
Active severe personality disorders (defined according to DSM-IV). Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous  weeks prior to start of study drug.
Grade  or worse hypercholesterolemia or hypertriglyceridemia or >% glycated Hb (HbAC)
Patients with primary mediastinal DLBCL
Any inflammatory changes of the surface of the eye
Greater than three prior recurrences
Hyperuricemia, history of gout, high uric acid, and/or kidney disease
Hyperuricemia, history of gout, high uric acid, and/or kidney disease
Use more than  g/d of acetaminophen
Prosthetic joint or other artificial implant or device that cannot be easily removed (there are some exceptions)
Unable to avoid close contact with another individual known to be at high risk of listeriosis (e.g., newborn infant, pregnant woman, HIV-positive individual) during the course of CRS- treatment until completion of antibiotic regimen
Subjects may be on a biphosphonate provided it had not been initiated within  days prior to receiving the first injection of DPX-Survivac
Subjects with recent history of thyroiditis
Recipient must have available the successful collection of a POL mobilized product.
Subject discontinued ABT- orln ABT- (ABT-i) administration before completing the prior study (due to disease progression, toxicity, withdrawn consent, other).
Adequate bone marrow, renal, hepatic, and metabolic function (tests within normal limits or only minimally altered as assessed ?  days before inclusion in the study)Recovery to asymptomatic or minimally altered or to baseline from any adverse event (AE) derived from previous treatment (mild alteration for alopecia, skin toxicity or fatigue are allowed).
Has multicentric Castleman's disease
Recursive partitioning analysis (RPA) class I (Karnofsky performance status [KPS] >= %, primary cancer controlled, age < , metastases in brain only) or class II
Patients cannot have had a second line salvage treatment (chemotherapy, biologic agents, investigational drugs, or radiation) or have had an autologous or allogeneic hematopoietic stem cell transplantation; patients can have had mixed frontline therapy such as - cycles of ABVD (doxorubicin, bleomycin, vinblastine and dacarbazine) followed by - cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP) as long as the induction chemotherapy is not more than  cycles in total length
Mesenchymal, dedifferentiated, and extraskeletal myxoid chondrosarcoma subtypes.
Dedifferentiated
Myxoid
Round Cell
Pleomorphic - Leiomyosarcoma
Hypersensitivity to the active substance, or any of the excipients of the eribulin drug product, or dacarbazine, (please refer to the dacarbazine prescribing information).
Previous radioimmunotherapy (RIT) within  months of study entry. Subjects who have received RIT must have attained a PR or CR lasting at least  months, and must have recovered from any hematologic or other toxicity.
Positive immunohistochemical staining for WT- (greater than % of cells)
History of clinically significant gastrointestinal bleeding requiring procedural intervention (e.g., variceal banding, transjugular intrahepatic portosystemic shunt procedure, arterial embolization, topical coagulation therapy) within  weeks before enrollment.
Patients with symptomatic cholelithiasis
Since zidovudine and stavudine have potential for severe hematological toxicity potentially overlapping with toxicities of the study therapy, treatment with these agents will be disallowed
Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie or Tie including, but not limited to, AMG, CVX-, XL, and XL
Participants in whom the required program of oral (PO) and IV fluid hydration is contraindicated
Prior history of a hypersensitivity reaction to PLD, doxorubicin, bortezomib, carfilzomib, or liposomal drug formulations other than PLD
Does not have:
Respiration rate > breaths per minute. For those subjects who require ventilatory support or oxygen supplementation, this requirement is waived.
Subjects who require Extra Corporeal Membrane Oxygenation (ECMO) at Baseline
ALT or AST xULN and bilirubin xULN
ALT xULN
French and Korean subjects: the French or Korean subject has participated in any study using an investigational drug during the previous  days.
b. ? prior therapy and one of the following abnormalities: p del, p, q amp, p del, t(;)
Can take oral med
Cytopenias
No known contraindication to peripheral blood stem cell (PBSC) collection; examples of contraindications might be a weight or size less than the collecting institution finds feasible, or a physical condition that would limit the ability of the child to undergo apheresis catheter placement (if necessary) and/or the apheresis procedure
Patients must have failed (relapsed or refractory) front-line standard anthracycline-containing regimen, such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, and dacarbazine (ABVD), vinblastine, doxorubicin hydrochloride, vincristine sulfate, bleomycin sulfate, mechlorethamine hydrochloride, etoposide, and prednisone (Stanford V), or bleomycin sulfate, etoposide, doxorubicin hydrochloride, cyclophosphamide, procarbazine hydrochloride, and prednisone (BEACOPP)
Subjects with organ transplants
Traumatic catheterization within  month
Patients may receive estrogen +/- progestin replacement
Patients with a CA: carcinoembryonic antigen (CEA) ratio of < 
Unable to attend to nd study visit at Stanford for Mohs surgical excision
Any female that is trying to get pregnant
For IgA patients whose disease can only be reliably measured by serum quantitative immunoglobulin (qIgA) ?  mg/dL (. g/dL)
Abnormal cardiac valve morphology (subjects with minimal abnormalities can be entered on study with approval from the medical monitor.
Tumor within or touching the zone of the proximal bronchial tree defined as a volume of  cm in all directions around the proximal bronchial tree (carina, right and left mainstem bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Gender is not a criterion.
Hypotension requiring vasopressor support
Inability to achieve or maintain a minimum mean arterial pressure (MAP) of mmHg
Patients must not have retinal or visual field changes from prior -aminoquinoline compound use
Intubated, mechanically ventilated, with respiratory failure secondary to diffuse, bilateral parenchymal lung disease (as judged by chest x-ray).
Glasgow Coma Score <  (prior to respiratory failure).
Patients with impending death from another disease.
Patients moribund or with other organ failure at possible randomization:
hypotension unresponsive to treatment (mean BP <  or < th % for age),
hyperkalemia, serum K+ > . plus widening of QRS complex on EKG (QRS complex corresponds to the depolarization of the right and left ventricles of the heart).
Paraplegia
DONOR: History of prior malignancy; however, cancer survivors who have undergone potentially curative therapy may be considered for stem cell donation on a case-by-case basis; the risk/benefit of the transplant and the possibility of transmitting viable tumor cells at the time of transplantation will be discussed with the patient
Patients may receive transfusion if necessary to reach the pre-apheresis hematology parameters; if elevated PT is concluded to be due to a circulating anticoagulant then patient may enroll despite the abnormal laboratory finding
Patients must be judged as being in a state of no evidence of disease at the time of enrollment; there is sometimes difficulty in definitively determining whether previously irradiated or surgerized sites are truly sterile, but the judgement should be based on standard imaging using the best judgment of the referring physician and Principal Investigator or her designee
Emotional limitations
night sweats
Known cerebral/meningeal disease.
Known structural heart disease.
Patients must be registered in the University of California at San Francisco (UCSF) Neuro-Oncology database prior to treatment with study drug
History of hypersensitivity to doxil, doxorubicin, hydrochloride (HCL), temsirolimus or its metabolites (including sirolimus), polysorbate , bevacizumab or murine products
At the time of the second bronchoscopy (if clinically necessary), all patients will undergo routine laboratory tests including a CBC, chemistry  panel and coagulation profile
Paget's disease.
Patients who have completed preceding gefitinib therapy from either the IL/ (mg dosing) study or IL/ (mg dosing) study and in the opinion of the investigator may benefit from further gefitinib treatment.
Withdrawal, at any time, from the preceding gefitinib study.
Adults or skeletally mature adolescents (ie, radiographic evidence of at least  mature long bone [eg, humerus with closed growth epiphyseal plate]) equal or greater than  years of age
Has a suspected mechanical gastrointestinal obstruction, fecal impaction, or clinically important active diverticular disease as determined by the investigator.
Patients with familial adenomatous polyposis who have undergone subtotal colectomy with ileorectal anastomosis, total colectomy with ileo-anal pull through (reservoir), and patients with intact colons with  or more adenomas in the rectum-sigmoid or reservoir
Patients with familial adenomatous polyposis (FAP) and duodenal adenomatous polyposis without current lower tract adenomatous polyposis i.e. status/post (s/p) ileostomy
Patients must have a normal echocardiogram (EF > % normal) without any evidence of cardiac chamber hypertrophy, dilatation or hypokinesis. The Sponsor must be provided with copies of these tests BEFORE Sponsor will approve enrollment. In addition, the sponsor must receive a list of current medications taken by the patient before Sponsor will approve enrollment.
The PI and the Clinical Coordinator will be asked to verify that their referred patients do not have these exclusionary histories listed in . and a copy of this verification must be sent to the Sponsor before the Sponsor will approve of enrollment. Referring physicians will not need to sign. (Template for verification letter Appendix C).
Rapid diagnostic test, PCR, or viral culture positive for influenza in the  hours prior to first dose
Keratoconjunctivitis sicca or incompletely treated eye infection.
Have at least one of the following symptoms affecting sleep: a) not feeling refreshed on awakening b) difficulty falling asleep c) waking up during the night d) have difficulty falling back asleep at night after awakening e) waking up too early in the morning f) excessive sleepiness during the day
Diagnosis of other \congenital\ aplastic anemias such as: Diamond-Blackfan; Shwachman-Diamond; congenital amegakaryocytosis
Veno-occlusive disease, if present, should be stable or improving
Completion of PD-L testing\r\n* Patients will be stratified as PD-L >= % versus (vs) < % OR inevaluable; baseline tumor will be utilized; if this returns inevaluable, efforts should be made to utilize the resected specimen
Randomization within  days of completion of surgical \r\n* The primary region must be included on cross-sectional imaging (e.g. sinus/neck if arising from sinonasal primary; pelvis if genitourinary); radiographic changes considered nonspecific or possibly due to surgery or radiation are not considered evidence of disease
Subjects allergic to infliximab, inactive components of infliximab, murine proteins and methylprednisolone
MELD Score < 
History of orthotopic liver transplantation, clinical symptoms of portal hypertension, Whipple's procedure, hepatic artery anatomy incompatible with perfusion or known unresolved venous shunting
Failure of prior intravesical treatment(s), one of which must include a course of BCG; failure is defined as evidence of TCC on cystoscopic examination and biopsy or cystoscopic examination and urine cytology at least  weeks from completion of last treatment
Any subjects with muscle-invasive TCC (stages T - T) OR any known TCC of the ureter or renal pelvis are not allowed
The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) is allowed Exclusion Criteria Specific to Obinutuzumab-Containing Cohorts: Hypersensitivity to obinutuzumab
Exclusion of people that do not understand the risks, such as decisionally-impaired individuals, prisoners, and vulnerable populations
Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
Absolute contraindications: venous injury at the level of the femoral veins or proximally; known or suspected thrombosis of the femoral or iliac veins on the proposed side of venous cannulation, ambulatory patient
Patients must have - intrahepatic foci of HCC and may not be candidates for refuse hepatic resection; patients who are on the organ wait list for orthotopic liver transplantation (OLT) will be considered for this trial as a bridge to transplant
Intrahepatic cholangiocarcinoma; a histological diagnosis is mandated; a diagnosis of adenocarcinoma with staining pattern consistent with cholangiocarcinoma and with a clinical presentation consistent with cholangiocarcinoma will be acceptable for enrollment as this is a typical intrahepatic cholangiocarcinoma presentation
History of biliary stent, internal biliary drain, or prior procedure compromising the ampulla of Vater (diagnostic endoscopic retrograde cholangiopancreatography [ERCP] is permissible)
History of major implant(s) or device(s), including but not limited to: \r\n* Prosthetic heart valve(s) \r\n* Artificial joints and prosthetics placed =<  months prior to treatment initiation \r\n* Current or prior history of infection or other clinically significant adverse event associated with an exogenous implant or device that cannot be removed
Microsatellite instability as determined by MSI-plus assay
Patients must have a minimum of two metastases per hemithorax
Patients with a positive fecal occult blood test excluding hemorrhoids
Patients must have progressed on octreotide therapy and/or radioactive isotopes linked to octreotide or its congeners if they had a positive octreotide scan; patients who have negative or mildly positive octreotide scans are exempt from this requirement
Prior chemotherapy with combination of capecitabine (or -flourouracil [-FU]) and temozolomide (or dacarbazine [DTIC]) will be excluded; patients can have had prior therapies up to  prior chemotherapy regimens such as streptozocin, anthracyclines, irinotecan, etoposide, or a platinum agent including single agent capecitabine (or FU) or temozolomide (or DTIC).
Uncontrolled infection at the time of enrollment; infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable
Requirement for constant administration of H antagonist
Corticosteroids should not be used as anti-emetic therapy; corticosteroid therapy is not permissible except for the following indications: \r\n* As treatment or prophylaxis for anaphylactic reactions\r\n* As a treatment for symptoms of cytarabine (Ara-C) syndrome (including fever, rash, or conjunctivitis)\r\n* Physiologic replacement stress-dosing as indicated for suspected or confirmed adrenal insufficiency
Inability to obtain Foundation One testing on archival tissue, or, lack of previous Next Generation Sequencing incorporating testing for NOTCH -, -, -, and -
Is allergic to aminoglycoside antibiotics (such as gentamicin and/or streptomycin)
Have undergone clearance after baseline ophthalmologic exam (at least fundoscopic exam, visual acuity, intraocular pressure, assessment of visual fields and measurement of color vision)
Inorganic phosphorus =< ULN
Patients with both variant alleles (*/*)
Patients with MF who are eligible for enrollment in the pacritinib PERSIST- study at Washington University School of Medicine (WUSM) (NCT) Human Research Protection Office (HRPO) 
Patients with markedly decreased visual acuity
Significant (presumed) risk factors for toxicity due to IASA therapy including, but not limited to: major uncorrectable coagulopathy, bowel perforation, ongoing bacteremia, mesenteric insufficiency, are exclusionary; in these or any questionable cases, discussion with the PI is required
Subjects assessed by consultant anesthetist as unsuitable for general anesthetic
TSER genotype */*
Receiving erythroid stimulating agents (erythropoietin [EPO]: Procrit, Aranesp)
Tumor located peripherally within the lung (peripheral defined as not touching any surface within  cm of the proximal bronchial tree in all directions) and not touching the mediastinal pleura
Oral, implantable, or injectable hormone contraceptives are not considered effective for this study
Prostate size on trans-rectal ultrasound (TRUS) measurement less than  grams
Patients must have NY-ESO- specific cells already produced or in production; these cells may be either in the process of their final expansion (for fresh infusion) or expanded and frozen at the time of enrollment
Able to visualize prostate gland adequately on transrectal ultrasound imaging during enrollment evaluation,
Has no prostate calcification greater than  mm in the treatment zone, as noted by TRUS,
Are interested in future fertility,
Prior history of rhabdomyolysis
Plan to treat with anastrozole for at least  months
No significant post mastectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable
Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)
Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< . mcg) and it has been used for at least  days with no plans to stop or alter use during the course of the study
Antidepressants for mood and hot flashes, including selective serotonin reuptake inhibitors (SSRIs) will be allowed if patients have been on a stable dose for the last  days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed, not antidepressants that have been titrated up to the highest doses for depression management (i.e. Effexor . - mg or Lexapro - mg or Celexa    mg)
History of Parkinsons disease, multiple sclerosis or fibromyalgia
Have had treatment with an antipsychotic agent such as risperidone, quetiapine, clozapine, a phenothiazine, or a butyrophenone within  days before enrollment or plans for such treatment during the study period; NOTE: participants could have received prochlorperazine and other phenothiazines as antiemetic therapy on a short term basis (i.e., =<  days)
>=  score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question ); it is not required for the patient to complete the entire BFI to meet this criterion
No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic disease
A diagnosis of radionecrosis will be based on a clinical onset of symptoms and radiological findings of radionecrosis at - months following radiosurgery, with or without pathological confirmation
Symptomatic brain radionecrosis to at least one lesion following radiosurgery treatment for brain metastases where symptomatic is defined as:\r\n* New or increasing headache associated with mass effect, sensory or motor abnormality, cognitive changes, speech difficulty, balance or coordination difficulty, cranial nerve deficits\r\n* Symptoms are persistent or worsening despite administration of at least dexamethasone  mg daily for  week
Able to participate in patient-report outcomes (MDASI-BT, DSQ-C, LASA) questionnaires; assistance by research personnel is acceptable if participant has disabilities that make reading or writing difficult
Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia
Have a confirmed diagnosis of sleep apnea or restless leg syndrome
Residency in a rural zip code defined as below by the Rural-Urban Commuting Areas (RUCA) version .; residential zip codes are assigned a RUCA code based on size of its largest population center and commuting patterns; a spreadsheet with eligibility by zip code will be provided to all participating sites\r\n* Rural: ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., ., and .
Residency in one of the following states: Georgia, Illinois, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, and Wisconsin
Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study
Receiving continuous oral MP during the maintenance phase of therapy for ALL (held only for toxicity or illness), and will be returning to the clinic every  weeks for scheduled appointments while enrolled on COG ACCL (between days  and )
All patients must have undergone a cone biopsy or loop electrosurgical excision procedure (LEEP); depth of invasion must be =<  mm
Patients with depth of invasion >  mm on first cone biopsy (or LEEP)
Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Patients must not be registered to step  until receiving confirmation from the ECHO Core Lab that the patients LVEF by echocardiogram was >= % by central review; patients must be registered within  calendar days of receiving the e-mail notification
Current use (previous  days) of a tobacco dependence treatment including bupropion, varenicline, and nicotine replacement because the person is trying to quit; use of bupropion for depression does not exclude the patient from participating; the occasional use of tobacco dependence treatment (e.g., nicotine replacement therapy [NRT]) to avoid using tobacco in public spaces is not considered to be an exclusion criteria
KEY INFORMANT: Agrees to have the interview taped, transcribed and qualitatively analyzed
The following baseline neurocognitive assessments must be completed and uploaded prior to step  registration: HVLT-R (recall, delayed recall, and recognition), TMT parts A and B, and COWA; the neurocognitive assessment will be uploaded into a folder in the NRG Medidiata RAVE System for evaluation by Dr. Wefel; once the upload and scoring of the tools are complete, a notification will be sent within  business days to the research associate (RA) to proceed to step ; in order for the patient to be eligible, at least  of the  neurocognitive assessments must be able to be scored (i.e. free of any errors)
Completion of all items on the following baseline quality of life forms: MDASI-BT, LASA QOL, WPAI-GH and Employment Questionnaire; these quality of life forms will be required and data entered at step  registration
Women who are morbidly obese (BMI >= ) undergoing laparotomy for any indication
Women with laparotomy incisions left open due to case classification as \contaminated\ or \dirty\
Women with laparotomy incisions unable to be closed primarily due to tissue or fascial damage
Women undergoing panniculectomy at the time of laparotomy
Live within one hour commuting distance to the center where they were recruited
Flap coverage or skin graft
Repeat surgeries for oncologic reasons (positive margins)
Known inherited predisposition to thrombosis
Use of bolus is permitted, but not required
After completion of all three screening questionnaires, participant must score accordingly on at least one questionnaire to be eligible:\r\n* Score >=  on the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)-Anxiety/Depression Scale OR\r\n* Score >=  on the Distress Thermometer OR\r\n* Score >  on the Modified Cancer Acceptance Scale
Paid employment (full time or part time) at time of consent
Able to use and read a smartphone (iPhone or Android)
Has a smartphone (iPhone or Android)
Patients having any immediate reconstructive procedure
Requirement of assistive devices (e.g., cane) for ambulation
Not in a committed relationship for at least  months
Patients with painful metastases to hands and feet that need to be radiated on protocol
Salvage RC
Bedridden, or physical debilitation such that study participation would not be feasible or would create undue hardship
A text messaging plan that includes a minimum of  text messages a month at no additional cost
Use of the following treatments for erectile dysfunction (ED): penile implants, vacuum pump devices, intra-cavernosal injections
Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale
Consented to enroll in a trial with a toxicity endpoint
TEMPLATE MODIFICATION:
Undergoing surgical procedures of expected length =<  hours requiring NMB
Use of toremifene
Myasthenia gravis or other neuromuscular disease
Treated and followed at one of the study sites (including affiliated network sites) and for whom treatment and surveillance data are available, for at least  year of follow up after date of diagnosis
Incarcerated individuals or individuals detained within the legal system
Life expectance of at least three months
Score in the range of 'very low' or 'low' food security status on the United States Department of Agriculture (USDA) Household Food Security Module (score of  or higher)
Living independently (no patient in an assisted living facility) in New York City (NYC)
CLINICIAN: Has a Doctor of Medicine (MD) or Doctor of Osteopathic Medicine (DO) degree
Has physical limitations that would prevent participation (e.g. blindness)
Have basic proficiency in the use of a computer, including word processing and email
Commit to the STOP Program by completing the online course and sharing lessons learned with other CCPs at the monthly virtual meetings that will take place during the  months following course completion
Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the\r\nfollowing criteria:\r\n* PSA test at diagnosis =<  ng/ml\r\n* Localized PCa (cT/T,N,M)\r\n* Biopsy Gleason grade - OR (or + AND <=% cores are positive for adenocarcinoma)\r\n** A minimum of  diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or magnetic resonance imaging (MRI) imaging.\r\n* No treatment yet\r\n** No previous radiation or simultaneous use of androgen deprivation\r\n** Prior use of -alpha reductase inhibitor is allowed if they have been stopped for  or more months and biopsy performed when patient was not\r\ntaking the drug\r\n* English language proficient and ability to provide informed consent form (ICF)\r\n* Managing urologist considers them a candidate for active surveillance
Women who receive Oncotype Dx testing
AIM : Patients needing immediate medical intervention, for example, conditions such as; hypercalcemia causing lethargy and confusion, acute respiratory distress, dehydration, and/or hypotension
Symptomatic nodal disease, i.e. scrotal, penile or leg edema
Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L - L), Sacral vertebra (S - S)
Need surgical stabilization of the affected bony structure (> fracture risk score, see Section .) OR
Platelets (plts) > ,
Significant food allergies which would make the subject unable to consume the food provided (soy or nut allergy)
Reside in a non-metro county of the United States according to the United States Department of Agriculture (USDA) Rural-Urban Continuum Codes ( -) (RUCC) or at a rural zip-code by the USDA Rural Urban Commuting Area (RUCA) codes (.X)
Have an email address at which to receive CaringGuidance prompts
Have a baseline Distress Thermometer score of >= , or an Impact of Events Scale score of >= , or Center for Epidemiological Studies Depression Scale score of >=  (i.e. clinically meaningful thresholds)
Megestrol use at the time of study enrollment.
High anxiety score (>=/) on the Hospital Anxiety and Depression Scale (HADS).
Newly diagnosed patients with stage  through a BC scheduled to receive a -week, -week, -week, - week, or -week chemotherapy regimen, adjuvant or neoadjuvant
Eye diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
Lives outside of the United States throughout duration of study
Has private insurance, or covered by Medicare or Medicaid
Actively practicing mindfulness meditation
Be a resident of the United States of America
Fibrinogen ?  mg/dL
This study was designed to include women and minorities, but was not designed to measure differences between them; males and females will be recruited with no preference to gender; minorities will actively be recruited to participate; no exclusion to this study will be based on race
Patients must be >=  months from craniotomy
Patients who, based on the physicians opinion, are unable to participate in neurocognitive testing and/or neurocognitive rehab secondary to significant neurologic deficit
Race: African-Americans and non-Hispanic whites
Able to hear normal conversation
Reporting a severity of  or higher on fatigue using a - standardized scale at intake.
Residing in a nursing home
Bedridden
Being evaluated or likely to be evaluated for a medical cause of fatigue (e.g., anemia, hypothyroidism) during the study; (per provider report)
Have diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated (as assessed by screening questions)
Are receiving, or are likely to receive another intervention for the treatment of fatigue during the study period; (per provider report)
Has subjective sleep disturbance (i.e., a self-rated score of fairly bad or very bad on question  of the Pittsburgh Sleep Quality Index [during the past month, how would you rate your sleep quality overall? =very good; =fairly good; =fairly bad; =very bad])
Have a diagnosed sleep disorder (i.e., obstructive sleep apnea or narcolepsy)
Already have an ongoing regular yoga practice within  months of study enrollment
Patients already meeting the criteria for metabolic syndrome as defined by the Adult Treatment Panel III criteria which requires / parameters encompassing glucose control, blood pressure, lipids and waist circumference; patients with  of the parameters at baseline will be allowed enrollment provided that one of those risk factors is hypertension (>= />=  mm Hg)
Must be able to complete an acceptable cardiopulmonary exercise test (CPET) at baseline, defined as at least one of the following:\r\n* Achieving a plateau in oxygen consumption concurrent with an increase in power output\r\n* Respiratory exchange ratio >= . (RER)\r\n* Volitional exhaustion with a rating of perceived exertion >=  (RPE)
Subjects who have had treatments with GnRH agonists/antagonists and/or anti-androgens within  year of randomization
History of unexplained syncope or family history of idiopathic sudden death
Patients must have confirmed and measurable sickle cell disease, defined by sickle cell anemia (SS) or sickle beta (SB) thalassemia confirmed by hemoglobin fractionation
Patients with type I hypersensitivity reactions to chemotherapy agents including, but not exclusive to, platins, taxanes, or monoclonal agents as evidenced by typical immunoglobulin (Ig)E-mediated symptoms (ie. flushing, hives, dyspnea, wheezing, nausea, itchy eyes, nasal congestion, hypotension, angioedema) or tryptase level elevated above baseline during an infusion reaction\r\n* For various reasons, some, but not all, patients enrolled in the desensitization program may not have positive skin test data to confirm an IgE-mediated reaction; these reasons include ) cutaneous toxicity of the drug precluding testing, ) limited sensitivity of skin testing for the drug being tested, ) lack of adequate testing reagent and controls
Patients with breakthrough reactions requiring multiple desensitization interventions including failed -step protocols or intervention with additional antihistamine (requiring >  mg of short-acting st-generation antihistamine  i.e. diphenhydramine or hydroxyzine -or >  mg of long-acting nd generation antihistamine  i.e. cetirizine or loratadine)
Patients with known diagnosis of a primary mast cell disease (ie. mastocytosis)
Clinically significant fractures as defined by International Society for Clinical Densitometry (ISCD) (a long bone fracture of the lower extremities, vertebral compression fracture, or two or more long bone fractures of the upper extremities) indicated by a cast or a spine x-ray within the last  weeks
Acute thrombocytopenia in patients with hematological malignancies who are in remission and are receiving myelosuppressive consolidation chemotherapy that is expected to induce marrow aplasia for at least  weeks or;
Subjects receiving procoagulant agent including desmopressin acetate (DDAVP), recombinant human antihemophilic factor (FVII) or prothrombin complex concentrate within  hours of enrollment
Patients with known lupus anticoagulant or positive antiphospholipid antibody
-MMP:-TGN ratio >=  within  days prior to enrollment
Absolute neutrophil count (ANC) persistently >= /mm^ (as measured by  complete blood counts [CBCs] done over  weeks or  successive monthly CBCs) despite ?MP>= % of Childrens Oncology Group (COG) dosing
Meeting any requirement in the parent protocol to permanently discontinue ibrutinib treatment.
Have high grade squamous intraepithelial lesion (HSIL) of the vulva (VIN or VIN) caused by infection with HPV types  and/or  confirmed at screening visit;
Allergy to imiquimod % cream or to an inactive ingredient in imiquimod % cream;
Must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL. a. High-grade B-cell lymphoma (BCL) with MYC and BCL- and/or BCL- translocations (double-hit DLBCL under DLBCL, not otherwise specified [NOS], based on the  World Health Organization [WHO] classification criteria) is not eligible for this study.
Others:
History of cerebellar toxicity or cerebellar neurological findings on exam
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study
History of endometrial neoplasia
Subject has advanced (metastatic or inoperable) high grade myxoid liposarcoma / myxoid round cell liposarcoma. Inoperable refers to a tumor lesion in which clear margins cannot be obtained without leading to significant functional compromise
Others:
Known hypersensitivity (example, anaphylactic and anaphylactoid reactions) to any particular combination drug will result in a participant being ineligible for inclusion in that particular cohort.
Permanently discontinued from any Medivation sponsored study with talazoparib alone or in combination with another agent.
Participants must be classified into one of two cohorts of recurrent or persistent endometrial cancer of any histology:\r\n* The first cohort (MSI/POLE cohort) includes endometrial cancers that are: MSI-H as determined by immunohistochemical complete loss of expression (absence of nuclear immunoreactivity) of at least one of the mismatch repair genes MSH, MSH, MLH and PMS; this test is now done routinely for every newly diagnosed endometrial cancer patient in most centers in the United States (US); and/OR: POLE-mutated, i.e. endometrial cancers known to harbor mutations in the exonuclease domain (amino acid residues ) of polymerase e (POLE) as determined by targeted sequencing or other next generation sequencing assay; any Clinical Laboratory Improvement Amendments (CLIA)-approved genomic test documenting mutations in the exonuclease domain of POLE gene (amino acid residues ) in the tumor will be accepted as proof of presence of POLE mutations and will lead to classification into this patient cohort\r\n* The second cohort (MSS cohort) includes: endometrial cancers that are MSS as determined by normal immunohistochemical nuclear expression of all the mismatch repair genes MSH, MSH, MLH and PMS; tumors which have not been sequenced for POLE mutations (i.e. their POLE mutations status is unknown) but are MSS, will be included in this cohort
Participants must be candidates for RP and considered surgically resectable by urologic evaluation
Prior adverse reaction to tetanus toxoid-containing vaccines
Have previously completed or withdrawn from this study or any other study investigating prexasertib or a checkpoint kinase I (CHK) inhibitor or have shown hypersensitivity to any of the components of the prexasertib formulation
Infection or abscess anywhere in the body
Anatomic or physiologic abnormality that could lead to significant postoperative adverse events
Anticipated need for use of ADM/mesh at the time of implant or implant exchange
Works for Mentor or the study doctor or is directly related to anyone who works for Mentor or the study doctor
Documented MSI-H or dMMR-positive tumor as determined by local laboratory for Part B and Part B pembrolizumab combination MSI-H/dMMR expansion cohorts only.
Vulnerable populations (adults unable to consent, individuals who are not yet adults, wards of the state, prisoners)
Patients with partial or complete limb amputations
Estimated intelligence at least  (standard score)
Demonstrated attention difficulties (T-score of at least  on attention questionnaire or  or more standard deviations below mean on direct attention measures)
Computer capability at home or provided a departmental iPad Mini to borrow for study purposes
Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
Sighted
Are engaged in shift work or travel across more than three time zones within  weeks prior to study
Take prescribed sedative hypnotics or steroids; individuals who have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g., migraine), or take photosensitizing medications (e.g., some porphyrin drugs, antipsychotics, antiarrhythmic agents) will be excluded for safety of using bright light
A history of at least moderate CRF over the past month as defined by a CRF score of  or more on a - numerical rating scale
Participants who are deemed qualified for yoga movements according to the Yoga Qualifying Movements Screening Checklist (a checklist developed by researchers at the University of California, Los Angeles to promote yoga safety through assessing the eligibility of each patient)
Subjects currently admitted to an inpatient unit at Michigan Medicine
Has a minimum appointment time of  minutes
Able to engage using at least one of the intervention formats
Significant insomnia as evidenced by an Insomnia Severity Index score >= 
Prior attempt(s) to treat insomnia using cognitive-behavioral treatment for insomnia
Diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated, or other sleep disorder
Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
Currently treated with any of the following contraindicated medications:\r\n* Saquinavir, Lopinavir, Amprenavir, Atazanavir, Delavirdine \r\n* Mexiletine (and other types of sodium-channel blocker antiarrhythmics)\r\n* Phenytoin, Carbamazepine, Oxcarbazepine, Lamotrigine\r\n* Amiodarone \r\n* Dronedarone \r\n* Dihydroergotamine \r\n* Cimetidine
Have confirmed LE based on bioimpedance measurements with an LDex score of > . (which corresponds to a bioimpedance resistance ratio of  standard deviations [SD] above normative values)
Be able to attend the sessions at the University of California, San Francisco (UCSF) Parnassus campus
Have a condition that precludes measurement of LE using bioelectrical impedance spectroscopy (BIS), including pregnancy
Compromised immunity
Who underwent or who will undergo lung resection at Brigham and Womens Hospital (BWH)
Patients with baseline immobility (i.e. wheelchair-bound, use of any walking assistance device, or gait alterations)
Anaphylaxis to local anesthetics or narcotics
Patients with previous ventral hernia repair, cosmetic abdominoplasty or anterior abdominal wall reconstruction
All races and ethnicities will be included.
Eye Diseases which limit the ability of light to be processed (e.g., untreated cataracts, severe glaucoma, macular degeneration, blindness, pupil dilation problems or retina damage)
Focus groups consisting of men who live, work, or worship in the  predetermined neighborhoods
Brief Fatigue Inventory (BFI) score > 
Inability to lay supine for one hour at a time, given the nature of the massage intervention
Subjects who have massages on a regular basis; regular massage usage will be operationally defined as receiving  or more massages/year for the last  years
Subjects currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem; however, since past experience with CAM therapies should not confound any of the analyses of the experiments proposed in this study, we will not exclude individuals who have engaged in a CAM manual therapy in the past, nor will we exclude individuals who practice yoga or meditation for well-being, take vitamins or use nicotine
People unable to read and understand the informed consent document because of language difficulties
Phase I: Having a non-hematologic malignancy reason for undergoing transplantation (e.g. aplastic anemia)
Baseline erectile dysfunction, as defined by the use of medications or devices to assist erection, lack of baseline erections, or a SHIM/IIEF-  or lower, which is collected as part of routine care.
Lack of successful intraoperative nerve sparing.
Patients who are able to follow-up in person during the trial
History of interstitial cystitis
History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis
Intractable vomiting
No vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
Vascular invasion or resection/repair/reconstruction that results in decreased perfusion of the extremity
The following exclusion criteria will avoid the possibility of preexisting muscle impairment: history of congenital myopathies; neurologic disorder involving sequelae of spinal derangement; disk disease; tremor and rigidity
Reports moderate fatigue on most days within the past week (i.e., at least  out of the last  days), rated as >=  on a  (no fatigue) to  (worst fatigue) scale
Depression or anxiety as defined either by ongoing pharmacological treatment for depression or anxiety or a Hospital Anxiety and Depression Scale (HADS) score >=  on initial screening; those individuals taking psychoactive medications for treatment of hot flashes are eligible if they have been on a stable dose for at least three months
Skin conditions involving open sores on the scalp that would prevent proper application of the electrodes
Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks, braids or other hair accessories that cannot be removed
Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
Does not complete baseline patient-reported outcome (PRO) assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
PATIENTS: Diagnosed with a primary HNC and going to receive at least  weeks of RT with at least  fractions.
Live within a  hour commuting distance from Rutgers Cancer Institute of New Jersey
Subjects with a diagnosis of differentiated thyroid cancer who have undergone total or near-total thyroidectomy and are candidates for iodine I- (I-) treatment at Thomas Jefferson University Hospital (TJUH) are eligible to participate
No history of celiac disease or non-celiac gluten sensitivity
Physical handicap that would prevent participation in program
Subjects on strong CYP A inducers or inhibitors who are unable to have those agents replaced with clinical alternatives prior to beginning the study; length of washout period will be  days; notably, in the case of allogeneic transplant recipients requiring cyclosporine or tacrolimus, no empiric dose adjustments will be required due to close level monitoring and adjustments, which are standard in Oregon Health & Science University (OHSU) protocols
Be first-generation immigrants
Required laboratory parameters: Patients able to adequately perform pulmonary function testing per American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines, as determined by the enrolling investigator and trained respiratory therapists
PROVIDER ELIGIBILITY: The participant is a healthcare provider at Columbia University Medical Center with a high-risk patient identified in the research database (IRB-AAAO or IRB-AAAP)
Willingness and ability to complete the entire workshop, including the interviews and questionnaires (there is no predetermined qualification with regard to the ability to hold an artist tool; accommodations and creative solutions will be made to facilitate participation)
Parent must live at least % of the time in the home and have a child - years old living at home who has been told their parents cancer diagnosis
If a biological parent lives in the home, and is physically well themselves, this person must be the co-parent
If a biological parent does not live in the home (or has died), the co-parent does not have to be a biological parent; therefore, co-parents may be step-parents, lesbian, gay, bi-sexual or transgender (LGBT) partners, grandparents, aunts, uncles, etc if they otherwise meet eligibility criteria
Participants must live within  miles of the University of Washington, Seattle, WA to receive the in-person version of the intervention
Parents and co-parents selecting the telephone version of the intervention may live any distance from the University of Washington
The child will be excluded if he or she has learning challenges as assessed by the patient or co-parent; patients and co-parents will be instructed to consider any formal diagnoses of a learning disability of the presence of an Individual Education Plan (IEP) when making this assessment
Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device [IUD] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)\r\n* Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study
Expected to use other HT antagonists or NK antagonists during the study
Travel distance greater than  miles
Presence of fatigue on FACIT-F subscale of =<  on a  to  scale (in which  = no fatigue and  = worst possible fatigue)
CRP must be >=  mg/l in the absence of any other more likely cause of increased CRP like an infection or an autoimmune disorder
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
Phase II: Not adherent to sun protection recommendations (i.e., mean score <  [which corresponds to often] on a -point scale [from  = never to  = always] that assesses the frequency of engaging in four sun protection behaviors)
Women who will be treated at the Johns Hopkins Hospital, Sibley Memorial Hospital or who will be treated by oncologists in the community as long as we will have access to treatment records
The presence of more than mild valvular stenosis or regurgitation, prosthetic valves or pacemaker on their baseline echocardiogram
Poor image quality on baseline echocardiogram or anatomic limitations that preclude the acquisition of good quality images such as recent mastectomy or surgery
Patients who are unwilling to wear the Under Armour (UA) health band
Rhythms other than sinus rhythm
Patients unwilling to come to the Johns Hopkins campus to have the required testing performed
Patients who plan to receive chemotherapy at Dana-Farber Cancer Institute (DFCI) to treat recurrent, incurable gynecologic cancers (i.e., ovarian, uterine, and cervical that has recurred despite >=  prior treatments)
Capable of downloading and running the study application (app)
Patients will be ineligible if they are participating in an investigational drug treatment trial that requires structured symptom or toxicity reporting at the time of enrollment
Positive  dimensional computed tomography (D CT) for single gland (adenoma) primary hyperparathyroidism
Planning on remaining in New York City (NYC) for at least  months
Licensed taxi driver for at least three months
Part-time driver (fewer than  shifts/week, totaling less than  hours per week)
Must have refractory CINV defined as nausea and/or vomiting that occurs after the first cycle of cancer targeted therapy despite guideline-based prophylaxis and after first-line rescue medication with either a dopamine receptor antagonist, steroid, and/or benzodiazepine
CLINICIANS: Oncology nurses and oncologists practicing at participating clinics.
Have reliable transportation to the testing facilities
Subjects must have a personal mobile device compatible for the activity monitor
Have had a distal, anterograde fasciocutaneous flap
Subjects who have had an osteocutaneous or musculocutaneous flap
Subjects who have a radial forearm flap with a proximal skin flap or subjects that receive a reverse radial forearm flap
Presence of a health problem that precludes safe participation in the intervention
Able to travel to University of Kansas Medical Center (KUMC) for data collection
Not able to travel to KUMC for data collection
Patients who have a history of gastrointestinal dysmotility or functional gastroparesis, including diabetic gastroparesis, central and peripheral nervous system disorders, renal failure, medication side effects, including chronic dependence of promotility agents, anticholinergic antispasmodic agents, or daily narcotic use
Patients who have a history of duodenal ulcer or duodenal fibrosis
Documented consent to participation to include the following study specific procedures:\r\n* Be able to provide up to six serial stool collections at home and deliver to FedEx location that day as per standard operating procedure\r\n* Have three -ml blood samples taken during a routine clinic visit\r\n* To not take probiotic supplements except as oriented\r\n* If randomized to the probiotic-supplemented group (the yogurt-based supplement Activia), be willing to comply with daily intake and record this intake as a component of a dietary log; the patient will be asked not to take any yogurt or yogurt-containing foods beyond this\r\n* If randomized to the probiotic-restricted group, agree not to consume yogurt or yogurt-containing foods\r\n* Maintain a dietary log and stool frequency log
Other factors that at the discretion of the investigators would adversely affect study participation
Hemodynamic instability
Admission to the MSKCC Adult BMT service for an outpatient HSCT for a hematologic malignancy
Must have two breasts
Active yoga practice <  months
Not actively trying to quit
During the first in-person session (phase ), a smoker must have elevated carbon monoxide (CO) to confirm final eligibility (CO >=  ppm)
Have impaired quality of life (report a score of  or less on question  of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ C] How would you rate your overall quality of life during the past week? [Answers range from   very poor to   excellent]).
Patients must be able to understand and operate the mobile device independently; therefore we will exclude those the provider team considers unable to do so
Preoperative surgical plan: immediate placement subpectoral tissue expander with ADM
Oncology Clinician: Current Massachusetts General Hospital (MGH) Cancer Center oncology clinician (board-certified physicians or mid-level practitioners)
Geriatrics Clinician: Current MGH Geriatric Medicine clinician (board-certified physicians or mid-level practitioners)
Women diagnosed with breast cancer stages I-III initiating first line adjuvant aromatase inhibitor (AI) therapy with any of the Food and Drug Administration (FDA)-approved AIs (anastrozole, exemestane, letrozole)
AI use >  days prior to study enrollment
Subjects must have a Single Item Screening Scale for Fatigue score of >=  (out of  points,  being no fatigue and  being severe, incapacitating fatigue) to be eligible for the trial
Any use of an assisted walking device
Recent history of falls or balance problems
EXCLUSION - STUDY : Lower extremity major amputation
Abilitytoprovideinformedconsent
Abilitytoprovideawrittenphysician'sclearance
PatientsmustbenewtotheSurvivorshipClinic(withinmonthsoffirstvisit).
Dysphagia or requirement for artificial feeding
The subject has a surgical indication for pancreatectomy (pancreaticoduodenectomy, distal pancreatectomy, total pancreatectomy)
Significant insomnia as evidenced by an Insomnia Severity Index score >= 
Have diagnosed, untreated sleep apnea or sleep apnea suspected by a physician but which has not been unevaluated or other sleep disorder
Employment that involves irregular sleep patterns, such as shift-work or frequent long-distance travel that involves adjusting to different time zones, or employment in a position that could impact public safety (such as operating heavy machinery)
Patients with hypersensitivity to ropivacaine/amide-type anesthetics
Patient has taken the anti-emetic agents within the last  hours prior to the start of treatment with study drug: () -hydroxytryptamine (HT) antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within  days prior to administration of investigational product; () phenothiazines (prochlorperazine, fluphenazine, perphenazine, thiethylperazine, chlorpromazine, etc.); () benzamides (metoclopramide, alizapride, etc.); () domperidone; () cannabinoids; () neurokinin (NK) antagonist (aprepitant); () benzodiazepines (lorazepam, alprazolam, etc); () herbal medications or preparations in doses designed to ameliorate nausea or emesis
Self-reported new onset since initiation of treatment cognitive dysfunction as determined by telephone screen using the brief ( questions) assessment established by Ercoli et al. (endorsement on all three questions):\r\n* Do you think or feel that your memory or mental ability has gotten worse since you completed your breast cancer treatment? \r\n* Do you think that your mind isn't as sharp now as it was before your breast cancer treatments?\r\n* Do you feel like these problems have made it harder to function on your job or take care of things around the home?
Able to bite upper lip via Upper Lip Bite Test (ULBT)
Liquid only diet <  hrs and/or solids <  hrs
Unable to bite upper lip via Upper Lip Bite Test (ULBT)
Choledochoenteric anastomosis; transpapillary biliary stent, or sphincterotomy of duodenal papilla
Patients who have difficulty walking or may not be able to complete the physical therapy measures
Both cavernous nerves fully resected as per surgery report (nerve sparing score of  in MSKCC surgeon note), or documented in the progress note that the nerves were fully resected
Sedentary lifestyle, as engaging in less than  minutes structured aerobic walking, cycling or swimming per week
PHASE : PROVIDER ELIGIBILITY: Health professional who works with childhood cancer survivors ages  to 
Eligible treatment sites are:\r\n*Weight bearing sites\r\n** Pelvis (excluding pubis) \r\n** Femur\r\n** Sacrum and/or sacroiliac joints\r\n** Tibia\r\n** Up to  consecutive cervical, thoracic or lumbar vertebral bodies\r\n** Lumbosacral spine\r\n*Non-weight bearing sites\r\n** Up to  consecutive ribs\r\n** Humerus\r\n** Fibula\r\n** Radius +/- ulna\r\n** Clavicle\r\n** Sternum\r\n** Scapula\r\n** Pubis\r\nIf multiple sites are treated, the treatment site is included as weight-bearing if any of the sites include the pelvis, sacrum, femur or tibia
A score of >=  on the Distress Thermometer (DT) and indication that this distress is related in some way to the caregiving role; potential participants will be asked whether or not their distress is in any way related to their caregiving experience; individuals who answer \no\ will be asked whether or not their distress started or has gotten worse since the patient began treatment or was diagnosed
Either a score of >  on the Brief Penn State Worry Questionnaire OR a score >=  on the Brooding Subscale of the Rumination Response Scale
AYA Inclusion Criteria:\n\n          -  Ever diagnosed with cancer;\n\n          -  Knows his or her cancer status;\n\n          -  Ages of  up to  years;\n\n          -  Ability to speak English;\n\n          -  Consent from the legal guardian for adolescents aged -;\n\n          -  Consent from a surrogate for adolescents aged -;\n\n          -  Assent from adolescent aged -;\n\n          -  Consent from adolescent aged -;\n\n        Inclusion Criteria for Legal Guardians of Adolescents Age -:\n\n          -  Legal guardian of assenting adolescent participant;\n\n          -  Knows cancer status of adolescent;\n\n          -  Adolescent willingness to discuss problems related to cancer with them;\n\n          -  Age  or older;\n\n          -  Ability to speak English;\n\n          -  Consent to participate; Consent for his/her adolescent to participate;\n\n        Inclusion Criteria for Surrogates of AYAs Age -:\n\n          -  Selected by adolescent aged  to ;\n\n          -  Knows cancer status of adolescent;\n\n          -  Age  or older;\n\n          -  Ability to speak English;\n\n          -  Willingness to discuss problems related to cancer and EOL;\n\n          -  Consent to participate;\n\n        Exclusion Criteria - for AYA or surrogate decision-maker:\n\n        Developmental delay; foster care; active homicidality or suicidality, depression in the\n        severe range
Creatinine value greater than . for men and . for women
Diet restrictions including vegetarianism, veganism, soy-free diet
CRITERIA FOR SURVIVORS:
Appropriate homebound setting as defined by one of the following:\r\n* Lodging at Memorial Sloan-Kettering (MSK) residence\r\n* Staying at home or a \home equivalent\ in any one of the zip codes; home equivalent is defined as a residence which may or may not be the primary residence of the patient\r\n* \Home equivalent\ must pass the \Home Environment Screening Tool\ for homebound stem cell transplantation (not required for MSK recognized lodging facility)
Have Wi-Fi connection
YBCS: Able to consent to the study
HCP: HCP of breast cancer patients/HCP designated by a YBCS study participant: oncologists and their advanced nurse practitioners; and primary care providers in family medicine, internal medicine and gynecology
HCP: Able to consent to the study
To be randomized, participants must have the presence of at least  reproductive health issue (e.g., birth control practices, fertility concerns, hot flashes, or sexual dysfunction/vaginal discomfort) and % adherence on reporting daily hot flashes through text messages during the -week run in period
Taking a third-generation AI (e.g., anastrozole [Arimidex], letrozole [Femara], or exemestane [Aromasin]) for at least  months with sufficient time left in their AI prescription to complete all study assessments (e.g., at least one year left on AIs)
Inflammatory, metabolic or neuropathic arthropathies at the time of recruitment; this includes international classification of diseases (ICD)  codes M-M
Fibromyalgia (ICD  code M.)
Regular use of narcotics
The child does not have learning challenges
Parents will be ineligible if their child lives in the home less than % of the time
Incarceration
Scheduled for major pancreatectomy (i.e., pancreaticoduodenectomy, total pancreatectomy, or a distal pancreatectomy)
Men who do not complete the baseline lifestyle and quality-of-life questionnaires and food frequency questionnaire (FFQ) will not be eligible
Registration >=  days after placement of a new stent or >=  days after a stent exchange
Active cholecystitis
Taking any of the following drugs at the time of study participation: epidermal growth factor receptor inhibitor, topoisomerase  inhibitor (camptothecin, irinotecan); buspirone, benzodiazepines, zolpidem, calcium channel blockers (such as felodipine, nifedipine, verapamil); digoxin or quinidine; codeine or fentanyl; phenytoin, propranolol, rifampin, or theophylline
Contraindication to epidural catheter placement including bleeding diathesis (essential thrombocythemia, idiopathic thrombocytopenic purpura, von Willebrand disease, and hemophilia A or B), neurological dysfunction (multiple sclerosis, subacute myelo-opticoneuropathy or preexisting lower limb neurological deficit), prior extensive spinal surgery or major spinal deformity, pre-operative use of anti-coagulant with planned use of therapeutic dose of anti-coagulant in post-operatively, documented pre-operative coagulopathy (international normalized ratio [INR] greater than . not on Coumadin or partial thromboplastin time [PTT] greater than ), platelets less than ,/uL, or evidence of infection at potential epidural site
Patients with poor performance status preoperatively such that they are unable to walk up two flights of stairs
Practicing mindfulness meditation for an average of more than  hour/week or have taken mindfulness training in the past
Normal cognition
No evidence of significant anxiety or depression as determined by a total HADS scores of < 
Prior non-tolerance of gabapentin
Inability to travel to the NIH, for example, due to physical limitations, for the in-person evaluation(s)
Sedentary lifestyle, as engaging in less than  minutes structured aerobic walking, cycling or swimming per week
Evidence of active intrathoracic malignancy (primary or metastatic) in the lungs or pleural space that is a significant cause of respiratory insufficiency
Evidence of accessory respiratory muscle use with breathing
Shock (need for vasopressor therapy or mean arterial pressure [MAP] <  despite fluid administration)
pH < . or partial pressure of carbon dioxide (pCO) >  (if available)
Airway or facial trauma that would hinder the use of a NIPPV mask
Glasgow Coma Scale (GCS) <  or inadequate airway protective reflexes
Undrained pneumothorax/pneumomediastinum
Copious secretions (>  cc/hr sputum production or >  cc's hemoptysis/ hrs)
Respiratory arrest
ALS PATIENTS: Already on a stable dose of riluzole for at least one month
ALS PATIENTS: Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) with < or equal to  point decline in last month
TECHNOLOGY REQUIREMENT: Patients will need a home computer or adaptor with universal serial bus (USB) port to charge the Jawbone Up 
Phase : Signed consent forms and completed surveys that will be returned to the study team by mail
Undergoing or initiating active surveillance
Able to achieve and complete an acceptable cardiopulmonary exercise test defined as follows: achieving peak or plateau in oxygen consumption concurrent with increased power output; a respiratory exchange ratio >= . or volitional exhaustion-rating of perceived exertion > 
NON-RANDOMIZED OBSERVATIONAL COMPONENT ELIGIBILITY:\r\nBiopsy prior to study enrollment that is obtainable AND has sufficient residual tumor tissue from such biopsy is obtainable and donated for the research
Anemia (defined as having a hemoglobin level less than . g/dL for white women, following the Ohio State University (OSU) hospitals criteria, and . for African American women, based on data from Beutler and Waalen)
Individuals who routinely take fish oil, krill oil, or flaxseed (oil, pills, or powder) or consume more than two portions of oily fish per week
Caregiver (age  years or older) of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Childrens Hospital Pediatric BMT Unit
Patients who have been readmitted to Pediatric BMT unit after initial transplant (not already in the study)
CIPN that may be associated with previous treatment with a vinca alkaloid (e.g. vincristine, vinblastine), or current treatment with a vinca alkaloid
All patients must have no more than  contiguous vertebral body levels treated at a single site, and no more than  discontiguous vertebral body levels treated
All patients must be deemed at \high risk\ of developing vertebral body fracture by having at least one of the following characteristics: \r\n* Spine Instability Neoplastic Score classification of \Indeterminate\ deemed as a score from  to \r\n* Pre-existing vertebral body fracture\r\n* Planned radiation dose of  Gy
Patients who have > % vertebral body collapse
Patients must be diagnosed with a primary glioma and have refractory partial onset seizure activity (defined as  or more seizures in a -day period) on non-enzyme inducing anti-epileptic regimen that can include, but not limited to the following: levetiracetam (Keppra) or Keppra XR, lamotrigine (Lamictal) or Lamictal XR, gabapentin (Neurontin), tiagabine (Gabitril), topiramate (Topamax), valproic acid (Depakene)/valproate (Depacon), zonisamide (Zonegran), lacosamide (Vimpat), and clonazepam (Klonopin)
Insurance information will be reviewed to ensure geriatric referral is covered for all potential participants
Thrombosis of lower extremities in the last week
Acute myocarditis, pericarditis, or endocarditis in the last week
Suspected dissecting aneurysm
Able to walk without an assistive device
Able to complete a minimum of  days of in-home activity monitoring before operation
Open, hybrid, robotic, laparoscopic, or laparoscopic-assisted procedure exceeding  hours
Fatigue brought on by conditions other than cancer such as (the indicated tests are required only if that mechanism of fatigue is suspected):\r\n* Uncontrolled hypothyroidism (thyroid-stimulating hormone [TSH] >  IU)\r\n* Hypercalcemia (calcium >  mg/dL) calcium (Ca)=SerumCA + .* (Normal/Albumin PatientAlbumin)\r\n* Decompensated congestive heart failure\r\n* Chronic obstructive pulmonary disease requiring oxygen replacement
There are no exceptions to exclusion; the Data and Safety Monitoring Committee (DSMC) will not approve exceptions
History of serious mood disorder or attempted suicide as determined by patients history and physical and by using the Depression Screening; subjects with a score of greater than  or those answering # with scores greater than a \\ will be deemed ineligible to be enrolled on study
History of angioedema
Receiving or anticipated need for methadone as co-administration with voriconazole potentially increases methadone exposure
First craniotomy
Emergency case
Report sleep disturbance of  or greater on the Insomnia Severity Index (ISI), and report insomnia that began or got worse with diagnosis of cancer or treatment with chemotherapy
Sleep apnea or restless leg syndrome (RLS)
Patients must be able to walk unassisted without oxygen
Able to fast for  hours for blood work and basal metabolic rate (BMR) measurement
SUBJECT: Have parent-reported or documented difficulties in attention, processing speed, memory, or learning as assessed by the screening questions (a score of at least  on any one of the  questions or the participant having >= / standard deviation [SD] decline in test scores, scores < , or special education services or accommodations).
Loss of a child at least  months ago who had been diagnosed with cancer as reported in the child's medical record or by parent report
Loss of a child  years old or younger as reported in the child's medical record or by parent report
Biological or adoptive parent or stepparent as reported in the child's medical record or by parent report
Residing in New York, New Jersey, Connecticut, or Pennsylvania for part  step  (PS); residing in New York for PS; and residing in New York or New Jersey or ability to complete sessions in New York or New Jersey for part , as reported in the child's medical record or by parent report
SUPPORT PROVIDER: Must reside in New York or New Jersey or ability to complete sessions in New York or New Jersey
Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses
Available email address
Lack of email address
Participants must be oriented to person, place, and time
Patients with extreme mobility issues (e.g. unable to get in and out of a chair unassisted)
Prior history of treatment with recombinant thrombopoietin (TPO) or TPO-receptor (R) agonists
PHASE II: Patient is within the recruitment window of discharge home to  weeks post-discharge home date
Have vaginal dryness, dyspareunia, or >=  urinary tract infections per year since starting AI therapy
Patients must agree not to use any additional estrogen during the five year study period; however, use of non-estrogen containing lubricants prior to sexual intercourse, or otherwise, is allowed
Patients receiving preoperative enteral nutrition
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\r\n* Achieving a plateau in oxygen consumption, concurrent with an increase in power output\r\n* A respiratory exchange ratio >= .\r\n* Attainment of maximal predicted heart rate (HR max) (i.e., within  beats per minute [bpm] of age-predicted HR max [HR max = -Age[years])\r\n* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) >=  on the BORG scale
Patients of east Asian ancestry (Chinese, Japanese, or Korean origin)
Be chronically fatigued as defined by having a >=  on the Brief Fatigue Inventory
Cannot supplement with fish oil and other omega--fatty acids
Inability to conceive after  months of unprotected intercourse with male
Patients with a history of enfuvirtide resistance
A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a -minute driving distance of Duke Adult Bone Marrow Transplant (ABMT) clinic
Experiencing disability as indicated by a score of >=  on the Vulnerable Elder survey
Has a Hamilton Rating Scale for Depression (HAM-D) -item score of more than 
Recurring seizures resulting from the head injury
Dysfunctions of lungs, liver, gastrointestinal tract, hematopoietic and central nervous systems will not affect eligibility for this protocol
Patients must meet the following clinical criteria to receive CMVpp-CTL infusions\r\n* Stable blood pressure and circulation, not requiring pressor support\r\n* Evidence of adequate cardiac function as demonstrated by electrocardiogram (EKG) and/or echocardiography\r\n* A life expectancy of at least  weeks, even if requiring artificial ventilation\r\n* There are no age restrictions
Patients who are moribund
Received any drug with potential anti-emetic effect within  hours prior to the start of study-designated chemotherapeutic agent: -hydroxytryptamine type  (HT) receptor or substance P/neurokinin (NK) receptor antagonists; dopamine receptor antagonists (metoclopramide); phenothiazine anti-emetics (prochlorperazine, thiethylperazine and perphenazine); diphenhydramine, scopolamine, chlorpheniramine maleate, trimethobenzamide; haloperidol, droperidol, tetrahydrocannabinol, or nabilone
Ongoing vomiting from any organic etiology
Case review by the study chair, or designate, as a case where treatment should be tried
Patients with implantable drug delivery systems, e.g. Medtronic Synchromed
Skin conditions such as open sores that would prevent proper application of the electrodes
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\r\n* Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\r\n* A respiratory exchange ratio >= .;\r\n* Attainment of maximal predicted heart rate (HRmax) (i.e., within  beats per minute [bpm] of age-predicted HRmax);\r\n* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) >=  on the BORG scale
Have a Distress Thermometer score of  or greater or a score of >=  on the Depression or Anxiety subscale of the Hospital Anxiety and Depression Scale (HADS)
Asplenia
Use of Erbitux
Smoker
Location of pain is outside the distribution of the ICBN, can be directly attributable to trauma to a nerve other than the ICBN, or is consistent with trauma during breast surgery to a nerve other than the ICNB (e.g. medial and lateral pectoral nerve; long thoracic nerve; thoracodorsal nerve; other intercostal nerves)
Any prisoner and.or other vulnerable person
Patients who underwent a linear closure on the face at University Hospitals (UH) Mohs clinic
Presence of fatigue on a numerical scale during the last  hours of more or equal to  on a  to  scale on which  equals no fatigue and  worst possible fatigue
Currently on methylphenidate or has been on methylphenidate within the last  days
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
CAGE questionnaire score is  or above on a  to  scale
Separate episode of VTE or arterial thrombosis within  months of enrollment
Major bleed (WHO grade  or ) within  months of enrollment
History of alloimmunization (defined as platelet refractoriness with panel reactive antibody [PRA] > %) at the time of or prior to enrollment
Cognitively able to complete interviews as judged by the study team
Subjects are experiencing bothersome hot flashes per the study questionnaires.
Subjects already receiving other treatment for hot flashes.
Patients who are local and able to follow-up in the SCC within  days if necessary
Patients receiving methadone or transdermal fentanyl due to reasons such as long and variable half-life and transdermal rather than oral route for delivery of opioids
Meet the screening criteria for psychological distress (National Comprehensive Cancer Network (NCCN) distress > ).
Among patients treated in the urban centers, we will specifically target patients who live more than  miles away from the clinic as they are more likely to experience problems with access to care.
Admitted to the hospital
Patients receiving myeloablation (MA) or reduced intensity conditioning (RIC) are allowed
Medically indicated subunit (Engerix-B for HBV, Gardasil for HPV) or killed vaccine (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
Hormonal (e.g., tamoxifen or arimidex, etc.) and targeted (tarceva and avastin, etc.) therapies allowed as long as they will be continued during the course of the study.
Live within a  mile radius of MD Andersons main campus.
Men or women with a history of CRF as defined by a score >=  on the numeric analogue scale (  ) (Eligibility Question Fatigue Scale)
Use of ginseng capsules for fatigue, within the last  months
Currently using any other pharmacologic agent to specifically treat fatigue including psychostimulants, antidepressants, etc., although antidepressants used to treat items other than fatigue (such as hot flashes) are allowed if the patient has been on a stable dose for >=  days prior to registration and plans to continue for >=  days after registration; erythropoietin agents to treat anemia are allowed
Able to eat by mouth
Estimated length of hospital stay is  days or more
Emergency craniotomies
Patients who need intraoperative evoked potential monitoring which precludes the scalp block
Age >=  (to reduce the likelihood of enrolling patients with obstruction due to primary sclerosing cholangitis).
Radiographic evidence of a biliary hilar stricture OR intrahepatic but no extrahepatic biliary ductal dilation.
Known diagnosis of primary sclerosing cholangitis without suspicion of dominant hilar stricture.
Known IgG-mediated cholangiopathy.
Significant liver metastatic disease interfering with safe/effective percutaneous transhepatic biliary drainage (PTBD).
Prior endoscopic retrograde cholangiopancreatography (ERCP) or PTBD for hilar obstruction.
Surgically altered luminal anatomy other than prior Billroth reconstruction.
All gynecologic laparoscopic/robotic surgeries EXCEPT diagnostic laparoscopies
Patients undergoing diagnostic laparoscopy
Patients planning to undergo hand-assisted laparoscopy
FCGs: Find conversations around religion or spirituality emotionally upsetting
No allergic reactivity has been associated with olfactory training and thus there is no need for any exclusion criteria related to this
No other agents have any possible potentiation or decreased activity related to olfactory training and thus there is no need for any exclusion criteria related to this
Patients will be excluded if they have any of the following medical conditions that would prohibit the safe implementation of self-care of LEF: recurrent or metastatic cancer; any other active cancer; acute infection; congestive heart failure; renal failure; cardiac or pulmonary edema; sensitive carotid sinus; severe carotid blockage; and uncontrolled hypertension
Subnormal intellectual potential (intelligence quotient [IQ] below )
Allergy or adverse reaction to ropivacaine (ropivacaine hydrochloride) or any amide type of local anesthesia
Positive screen for sexual dysfunction that is causing distress based on the National Comprehensive Cancer Network (NCCN) survivorship guidelines
Admitted to Lunder at Massachusetts General Hospital
Admitted electively
Be receiving hospital-based treatment so that acupressure treatments and parents can be trained and monitored
Study materials will be available in English or Spanish; if families would like to be part of the trial, but do not speak either of these two languages, arrangements can be made to include them using University of California at San Francisco (UCSF)'s translation services
Receiving treatment at UCSF Benioff Childrens Hospital San Francisco or Oakland
Participants with evidence of diarrhea as defined by three or more loose or liquid stools per day or loose watery stool (greater volume of stool), that occurs more frequently than usual and lasting for more than three days prior to admission, history of inflammatory bowel disease, irritable bowel syndrome, colectomy or bariatric surgery, celiac disease
Patients who are known to be hypersensitive to aprepitant, granisetron or any of the components of the patch or to dexamethasone
Reside in Southern California
Neurological examination within  week prior to registration to rule out rapid neurologic decline; patients with mild to moderate neurological signs are eligible; these neurological signs include radiculopathy, dermatomal sensory change, and muscle strength of involved extremity / (lower extremity for ambulation or upper extremity for raising arms and/or arm function)
Spine instability due to a compression fracture
> % loss of vertebral body height
Patients with rapid neurologic decline
Bony retropulsion causing neurologic abnormality
Patients who are diabetic
Use of estrogens (oral, dermal or vaginal), progesterone (oral or topical), or androgens during the previous  months
Use of another antiemetic agent (HT antagonists, phenothiazines, butyrophenones, cannabinoids, metoclopramide, or corticosteroids) within  hours prior to day  of the study
Lactating patients must agree not to nurse a child while on this trial
Caregiver of a patient who will be hospitalized to undergo first-time autologous (self) or allogeneic (alternative donor) BMT in the University of Michigan Mott Childrens Hospital BMT Unit
Patients who will be hospitalized to undergo first-time autologous or allogeneic BMT will be given the opportunity to assent/consent and participate in the study; with his/her permission, the patient will also be provided with their own iPad BMT Roadmap information system to use; qualitative interviews will be conducted in patients with their assent/consent
Have a permanent ostomy or anastomosis
At least a fifth grade education
Any significant comorbid conditions that would interfere with or preclude participation in an exercise intervention, including orthopedic conditions such as advanced osteoarthritis, mobility-limiting amputations or chronic injuries, or mobility-limiting acute orthopedic injuries
Child: existing history of severe cognitive impairment (intelligence quotient [IQ] =< ) as reported by the parents or the child's City of Hope medical records, or by the child's performance score on the Wechsler Intelligence Scale for Children (WISC) Working Memory and Processing Speed index measures administered in this study
Are able to move from sitting to standing without difficulty and to walk  block
Medically indicated subunit (Engerix-B for HBV; Gardasil for human papillomavirus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
Alemtuzumab or any equivalent in vivo T-cell depleting agent
Minorities will be recruited; no exclusion to this study will be based on race
Participants must not be actively receiving physical therapy in a relevant area (e.g. leg strengthening, balance and gait training), at time of enrollment, or participating in intensive ( min per day) aerobic program three times per week
Hemiplegia or lower limb amputation
Significant orthopedic or muscluloskeletal condition that does not allow weight bearing
Unable to maintain safe stance and walk, either with or without an assistive device
Received a referral letter for GC from their MCC physician
Of Ashkenazi Jewish descent
Has at least one functional deficit as defined by GA screen
Preferentially, patients should have active refractory-cGvHD; any degree of severity (as per NIH criteria) and/or pattern of organ involvement may be considered; (that said, patients with more severe and/or extensive chronic GvHD are expected to be the usual candidates for LD-TLI protocol therapy)
Ideally, patients' refractory cGvHD should be controlled to a degree that would potentially permit no additional requirement for systemic IST before and following TLI =< d - and >= d +, respectively (NOTE: Relatively minor dose modifications of ongoing medications and topical therapies will be exempt)
Have been using a Wii Fit
Subjects with cold agglutinin disease or cold urticaria
Personal history of migraine, cluster or tension headaches
Subjects who have lichen planus or lupus
Living within a  mile radius of the City of Hope
Neuropsychological tests will be performed by a trained examiner
Long-term follow up must be possible
Patients may not take memantine
Communication difficulties to include\r\n* Uncorrected or uncompensated hearing and/or vision impairment\r\n* Uncorrected or uncompensated speech defects
Use of growth hormone, megestrol, Marinol, or any other anabolic agents, appetite stimulants (including corticosteroids other than dexamethasone at the time of IV chemotherapy administrations), tube feeding, or parenteral nutrition during the  month prior to entering the study
PEER NAVIGATORS:
Owns an operational vehicle
Presence of psychiatric or psychological symptoms which in the judgment of the principal or associate investigators would compromise the donors ability to engage in the intervention or is likely to interfere with the study procedures or results
Inability to perform the testing procedure (for example, because of aphasia, motor deficits affecting the dominant hand, or intelligence quotient [IQ] < )
Artificial joints in the upper quadrants
Unwillingness or inability to cooperate, or, for the parents or guardians of minors, to give consent, or for the child to give assent, or any condition of sufficient severity to impair cooperation with the study
Women who report themselves to be of Latino or Hispanic ethnic background (defined as Spanish, Mexican, Central or South American, Cuban, Puerto Rican, Dominican, or other Hispanic origin)
Women who are under- or uninsured and come from low-income communities
Craniotomy or intracranial biopsy site must be adequately healed, free of drainage or cellulitis, and the underlying cranioplasty must appear intact at the time of study entry
Inadequately controlled hypertension (defined as the normal published range for age and height)
Have at least one geriatric assessment domain meet the cut-off score for impairment other than polypharmacy
Undergoing an exploratory laparotomy for suspected gynecologic cancer, which includes metastatic disease from neoplasia originating in other organs
Requirement for significantly modified diet (liquids and/or solids) due to compromised oral/pharyngeal function at baseline
Radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, including placement of external ventricular drain or ventriculoperitoneal shunt
Patients must have aromatase inhibitor (AI)-associated musculoskeletal symptoms that began or increased after starting AI therapy; new musculoskeletal pain must not be due specifically to fracture or traumatic injury
Patients must not require selective serotonin reuptake inhibitors (SSRIs) or tricyclic antidepressants during study participation; patients must have been able to taper and discontinue treatment with these medications at least  days prior to registration ( days for fluoxetine), and must not be experiencing antidepressant withdrawal symptoms (e.g., dizziness, nausea, sleep disturbance, or other sensory disturbances); patients must not have previously taken the serotonin norepinephrine reuptake inhibitors (SNRI) duloxetine or milnacipran; prior venlafaxine is allowed as long as it was not taken concurrently with AI therapy and was not taken for treatment of pain (e.g., prior treatment for hot flashes is permitted)\r\n* NOTE: Patients requiring antidepressants for management of depression are not appropriate candidates for this placebo-controlled study, but those who are on antidepressants for other indications, such as hot flash management, may be able to tolerate a time off of antidepressant therapy
Individuals who are not willing to stop fish or krill oil supplements during the study; (note that there is no limit to fish intake or omega- fatty acid [FA] in food)
Functionally appropriate to participate in the intervention, as assessed by  functional assessment items from the European Quality of Life- dimension (EQ-D)
Endorsement of at least one sexual symptom
PATIENTS WITH CIN:
PATIENTS WITHOUT CIN:
Patients without CIN will be matched on cancer diagnosis and CTX agents administered (i.e., only a platinum compound, only a taxane, or both) to the patients with CIN but will not have any of the changes in sensation or pain listed above for patients with CIN
Patients report a history of peripheral vascular disease, diabetes, vitamin B deficiency, thyroid dysfunction, human immunodeficiency virus (HIV) neuropathy, cervical or lumbar pain with radiculopathy, or another painful condition that is difficult for them to distinguish from their CIN
Currently practicing mindfulness-based interventions (yoga, meditation, deep breathing)
Require psychotherapy within the last three months
Expect to relocate from Northeast Ohio within  months
Wake Forest University student
Case review by the study chair, or designate, as a case where treatment should be tried
Existing operational implantable drug delivery systems, e.g. Medtronic Synchromed
Skin conditions such as open sores that would prevent proper application of the electrodes
Referral to pulmonary or interventional radiology services for large-volume thoracentesis
Study subject has any disease or condition that interferes with safe completion of the study including:\r\n* Coagulopathy, with criteria left at the discretion of the operator\r\n* Hemodynamic instability with systolic blood pressure <  mmHg or heart rate >  beats/min, unless deemed to be stable with these values by the attending physicians
Referral is for diagnostic thoracentesis only
Inability to assume or maintain a seated position for the procedure
Presence of multiple loculations on bedside pre-procedure ultrasound
Elective minimally invasive operation
Absence of dysphagia
Participants may be on anti-depressants and/or anxiolytics as long as the dosing has remained stable over the preceding  weeks
Verification of a functioning email address and access to electronic device(s) capable of charging and syncing the FitBit
Pancreaticoduodenectomy
Firm gland texture
Poor preoperative performance status as defined by: timed get up and go (<  seconds)
Failure to extubate at the conclusion of the case
No active gallbladder disease
No active gout
No active diverticulitis
Agree to complete study surveys
Surgeons opinion at the time of dissection that the subjects well-being (e.g. bleeding or other independent acute health problems) would be compromised
Vocal fold paralysis
Symptomatic patients with a BFI symptom scale of  points or greater
CIPN neuropathy: received neurotoxic chemotherapy in any setting as cancer treatment; including taxanes-such as paclitaxel or docetaxel; platinum-based compounds such as carboplatin or cis-platinum or oxaliplatin; or, vinca alkaloids such as vincristine, vinblastine, or vinorelbine, or proteasome inhibitors such as bortezomib\r\n* NOTE: patients should no longer be receiving the therapy that caused the CIPN, or have recently started a new treatment that may worsen CIPN; patients on a treatment that may cause CIPN for a period of time where CIPN does not appear to be worsening may be allowed at discretion at the principal investigator
Patients with implantable drug delivery systems, e.g. Medtronic SynchroMed
Skin conditions such as open sores that would prevent proper application of the electrodes
st episode of CDI
Admitted in the hospital at the time of enrollment
Hypotension or shock
History of multiple CDI
Patients with vaginal stenosis
Chronic GVHD manifestations that can be followed on physical or laboratory exam; these include but are not necessarily limited to:\r\n* Skin changes \r\n* Oral mucosa changes\r\n* Bronchiolitis obliterans\r\n* Ocular changes
A score above  on the Wender Utah Rating Scale for attention deficit disorder (ADD) (WURS)
Patients with extreme mobility issues (e.g., unable to get in and out of a chair unassisted)
Patients who have practiced yoga or taken yoga classes in the year prior to study enrollment or who are currently engaged in a regular mind-body practice
Profess extreme dislike of music.
Wait time is longer than  min.
Prospective study: Physically capable of using a tablet computer (no severe visual, hearing, or hand motor deficits)
Vulnerable populations: cognitively impaired; prisoners; terminally ill; elderly and infirm; drug addicts
Have daily use of an iPhone or iPad that meets the following technical specifications: at least iOS ; for iPhones, must be iPhone  or above
Men and women with literacy as demonstrated by reading and signing informed consent form
Patients admitted to the acute inpatient rehabilitation unit and those seen in the Physical Medicine and Rehabilitation outpatient clinic
Bothersome hot flashes (defined by their occurrence of >=  times per week and of sufficient severity to prompt the patient to seek therapeutic intervention)
Currently on fish oil or has been on fish oil within the last  days
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
Followed in the Adult Long Term Follow Up Program
Recent history of attending regular QMBE or similar classes (e.g. yoga or tai chi classes i.e.  or more classes in the past  months)
Resistance training on > or =  days/week accounting for more than  minutes of strength training per week
Autologous transplant recipients with multiple myeloma or lymphoma (both Hodgkins and Non-Hodgkins types) receiving the most common autologous regimens, melphalan and cyclophosphamide, carmustine, and etoposide (CBV)/carmustine, etoposide, cytarabine, and melphalan (BEAM)
Confirmed acute lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis
Thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) that will be continued on study
Use of a Factor Xa inhibitor (e.g. apixaban, rivaroxaban, or edoxaban) =<  months prior to randomization
Mechanical heart valve
Bacterial endocarditis
Access to smartphone device compatible to sync with PAM device
Recent injury which may result in impaired mobility
Cognitively intact, as evidenced by orientation to person, place, and time
African-Americans and non-Hispanic Whites
Latino
A current resident of either King, Snohomish or Pierce counties in Washington State with the intent of remaining a resident for at least  months following study enrollment
Cut-annoyed-guilty-eye (CAGE) positivity (>= /)
Patients with normal saliva production (no salivary gland changes; no xerostomia)
Patients who are on pilocarpine for ophthalmic or non-ophthalmic indications
Men with prostate cancer managed at University of California, San Francisco (UCSF)
Be able to walk unassisted
Patients may or may not report any of symptoms related to lymphedema (i.e. swelling, heaviness, tightness, firmness, numbness, tingling, stiffness, limb fatigue, limb weakness, and impaired limb mobility of shoulder, arm, elbow, wrist, and fingers)
Ability to give informed consent before any trial-related activities (Trial-related activities are any procedure that would not have been performed during normal management of the subject)
Has taken oral immediate release opioids within  hours prior to arrival
Blindness or severity of visual impairment that precludes ones ability to view images/text
Patients with known difficult airways
Patients where other lung isolation devices may be warranted (tracheostomy, nasal intubation)
Patients requiring a right sided VDLT or DLT
Agree to receive text messages on their smartphone over a -month period
Prior lumpectomy
Patients requiring treatment in supine position
ONCOLOGIST: Care for oncology patients at the Indiana University (IU) Simon Cancer Center or an affiliated clinic (e.g., Spring Mill Clinic, Eskenazi Health, IU Health North, IU Health West)
ONCOLOGY NURSE: Be a registered nurse or advanced practice nurse who provides care to patients seen by an enrolled oncologist
Resident of Oahu, Hawaii (HI)
Possession of smartphone to have a Fitbit synced to
Long term survivor of ALL
History of executive dysfunction, documented by SJLIFE neurocognitive testing, and defined as having an age-adjusted standard score < th percentile on Trail Making Test Part B, Verbal Fluency, or Digit Span Backward
History of self-reported executive dysfunction in daily life, defined as having a standardized score < th percentile on Behavior Rating Inventory of Executive Function (BRIEF) Initiate, Shift, or Working Memory domains OR having scored < th percentile on the Childhood Cancer Survivor Study Neurocognitive Questionnaire Task Efficiency or Memory domains
Any survivor with full scale intelligence quotient (IQ) < 
Unlikely to be compliant with the study intervention
Anatomically intact parotid and submandibular glands
Must be right-handed
Suspected or confirmed physical closure of salivary gland ducts on either side
Report clinically significant anxiety symptoms (i.e., Hospital Anxiety and Depression Scale Questionnaire [HADS]-anxiety subscale >= )
RCT: Participants will come from urban and rural regions of the country
Needle path without transgression of pleural fissure, bleb, or bulla is possible
INDIVIDUAL INTERVIEWS:
Are within traveling distance to FCCC, MSMC, Rutgers Cancer Institute of New Jersey, or Temple University Hospital (TUH)
Patients who have regularly practiced yoga in the year prior to recruitment
Treated at one of the Survivorship Centers of Excellence or their community affiliates
Have BFI =< 
Patients with external biliary drains
Presence of any bladder or urethral anatomic feature that in the opinion of the investigator may prevent the safe placement, indwelling use or removal of TAR-.
Documented history of vesicoureteral reflux or the presence of an indwelling ureteral stent or nephrostomy tube at the time of screening.
All patients who do not have a documented NF mutation must meet the clinical diagnosis of NF using the National Institutes of Health (NIH) Consensus Conference criteria; in addition to tibial pseudarthrosis, one or more of the following diagnostic criteria for NF must be present:\r\n* Six or more cafe-au-lait spots (>= .cm prepubertal; >= .cm postpubertal)\r\n* Freckling in the axilla or groin\r\n* Optic pathway glioma\r\n* Two or more iris Lisch nodules\r\n* Two or more neurofibromas or one plexiform neurofibroma\r\n* A first-degree relative with NF
Patients must have tibial pseudarthrosis that has the potential to cause significant morbidity; radiographic findings (anterior-posterior [AP] & lateral leg radiographs) must support the diagnosis of tibial pseudarthrosis with chronic non-union
Plexiform neurofibroma of any size, or nodular neurofibroma of >  cm diameter involving the ipsilateral leg, including the hip\r\n* If presence of plexiform is suspected but not certain on physical exam, MRI of the leg may be indicated to rule this out
Precocious puberty from any cause
Inadequate neurovascular status in the involved limb that may jeopardize healing
Two or more prior surgeries for tibial pseudarthrosis
Selection of a surgical approach that does not include prescribed surgical intervention, which must include removal of pseudarthrosis tissue, placement of an intramedullary rod using the Williams approach, and autogenous bone graft from the iliac crest distributed at the osteotomy site
A CXR shows hydropneumothorax.
A CXR shows ?% of the affected hemithorax to be free of the expected lung parenchymal markings and there is no suggestion of pleural fluid.
Have poor-risk prognostic factors defined as antecedent hematologic disorder, prior chemotherapy or XRT, abnormal karyotype other than t(;), inv, or t(;), any karyotype with FLT-ITD, or presenting WBC>K, or
Group : Patients must have a confirmed diagnosis of unresectable GIST that has progressed following imatinib and at least  of the following: sunitinib, regorafenib, sorafenib, dasatinib, pazopanib, or an experimental kinase-inhibitor agent, and the patient does not have a DV mutation in PDGFR?.
Group : Patients must have a confirmed diagnosis of unresectable GIST that has progressed and/or patients must have experienced intolerance to imatinib and not received additional kinase-inhibitor therapy. Patients must not have a known DV mutation in PDGFR?.
The surgical cavity is clearly visible on CT images
Evidence of low-volume peritoneal disease defined by a peritoneal carcinomatosis index (PCI) =<  based on cross-sectional imaging and/or diagnostic laparoscopy findings
Peritoneal carcinomatosis index (PCI) >= 
Concurrent anal canal or perianal HSIL or condyloma that in the judgment of the clinician cannot be cleared or can only be cleared with undue morbidity to the participant
Baseline AFP ? nanograms/milliliter.
Patients must give informed consent according to the rules and regulations of the individual participating sites
Unresectable disease (e.g. immobile node on physical exam, nodal disease that radiographically involves the carotid arteries, nerves)
Right handed (quantitative EEG [qEEG] database comparison is specific to handedness; by requiring all participants be right handed, we will be consistent across EEG analysis)
Factors contraindicated to fMRI
Any extreme mobility issues (e.g. unable to get in or out of a chair unassisted, extremity issues such as neuropathy that limits physical manipulation of objects
Regularly practiced meditation (greater than once per week) in the year prior to study enrollment
Phase : Clinician participants must be oncology clinicians (i.e. physicians and nurse practitioners) who maintain at least % clinical practice at the MGH Cancer Center or one of its community affiliates at the North Shore, Emerson Hospital and MGH West
Phase : For this proposed study, four groups of stakeholders will provide ongoing feedback about the study design, methods, and results; to be eligible as a stakeholder, the participant must be able to represent the interests and perspective of at least one of the following stakeholder groups: ) oncology patient or family member; ) oncology physician; ) cancer practice setting administrator; and ) health system, community, and society
Active Clostridium difficile infection or on prophylactic or tapering antibiotics for Clostridium difficile infection
Receiving radiation therapy of any type at Dana-Farber Cancer Institute (DFCI), Brigham and Women's Hospital (BWH), Massachusetts General Hospital (MGH), or affiliated network sites (including but not limited to partial breast irradiation, two-field, three-field, and four-field plans)
Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) subscale score >=  pre-radiation therapy and decrease in FACIT-F of  points or more as compared to prior FACIT
Have sufficient sensory acuity (i.e., auditory, visual) and manual dexterity to use a computer game as per judgment of clinician or consenting professional
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\r\n* Achieving a plateau in oxygen consumption, concurrent with an increase in power output\r\n* A respiratory exchange ratio >= .\r\n* Attainment of maximal predicted heart rate (maximum heart rate [HRmax])\r\n* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) >=  on the BORG scale
Baseline presence of oral ulcers
Patients on warfarin (patients on injectable blood thinners, such as Lovenox, are able to continue those)
Presumed ampullary or duodenal cancer based on preoperative work-up or intraoperative findings
Caregiver has a T score >=  (at least one half standard deviation above the population mean) on either the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety or Depression measure or a Distress Thermometer score of  or higher
Patients who currently practice yoga or have taken a yoga class regularly within the last  months
Prisoner
Prior history of hernia repair with mesh, or multiple (> ) prior hernia repairs, or plan to use mesh for hernia closure in current surgical procedure
Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately  mL in - min)
Aspartate aminotransferase (AST) <  x upper limit of normal (ULN), unless hepatic dysfunction is a manifestation of presumed cGVHD; for patients with abnormal LFTs as the sole manifestation of active cGVHD, documented cGVHD on liver biopsy will be required prior to enrollment; abnormal LFTs in the context of active cGVHD involving other organ systems may also be permitted if the treating physician documents the abnormal LFTs as being consistent with active hepatic cGVHD, and a liver biopsy will not be mandated in this situation
Post-transplant exposure to T-cell or IL- targeted medication (e.g. anti-thymocyte globulin [ATG], alemtuzumab, basiliximab, denileukin diftitox) within  days prior
Severe anemia (hemoglobin [Hb] <  g/L) if documented in the last month and not corrected prior to study enrollment; extra blood work will not be drawn unless the patient already has the lab abnormalities documented and need to be corrected
Bilirubin >  x upper limit of normal if documented in the last month and not lowered to <  x normal prior to study enrollment; extra blood work will not be drawn unless the patient already has the lab abnormalities documented and need to be corrected
Patients will be recruited through - surgeons located in  surgical practice sites within Michigan, Georgia, California, and Tennessee; patients will also be recruited at the University of Michigan (UM) Comprehensive Cancer Center
Patients who are not able to use telephone-based interactive voice response software due to physical limitations (e.g., impaired hearing)
Patients must have the ability to use audio media in their home and read and understand study manual provided
PHASE II: A score of >=  on the Distress Thermometer (DT) and indication that this distress is related in some way to the patient's breast cancer or survivorship
Symptomatic carotid stenosis
Unavailability for follow-up
CLINICIAN: Has an doctor of medicine (MD) or doctor of osteopathic medicine (DO) degree
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\r\n* Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\r\n* A respiratory exchange ratio >= .;\r\n* Attainment of maximal predicted heart rate (HRmax) (i.e., within  beats per minute (bpm) of age-predicted HRmax;\r\n* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) >=  on the Borg scale
Cohort  participant: \r\n* Has neurocognitive impairment defined as performance on at least one measure of attention, memory, and/or executive functioning =< th percentile\r\n* Is absent of delayed sleep onset latency defined as an inability to fall asleep within  minutes < once a week during the past month
Participant has known sleep apnea or medically treated sleep disorder (e.g. restless leg syndrome)
Patient must receive any one of the following conditioning regimens: total body radiation (single or fractionated dose)/cyclophosphamide, busulfan/cyclophosphamide, or fludarabine/busulfan/lymphocyte immune globulin (ATGAM/thymoglobulin [thymo])
Megestrol use at the time of study enrollment
The planned procedure is a clean-contaminated (class II) case (includes gastric, small bowel, and colorectal resections, as well as bile or pancreatic duct transections)
Emergent cases will not be included in the study
The planned procedure involves foreign material (such as mesh or subcutaneous drains) being left in the subcutaneous space at the time of surgery (for example, a ventral hernia repair); surgical drains that are placed to drain an intraabdominal space and exit the abdominal wall remote from the incision are allowed in the study
Patients with a diagnosis of polysomnographically confirmed obstructive sleep apnea or narcolepsy
Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately  mL in - min)
Vasopressor requirement
Cancers not usually occurring in childhood/adolescent or young adult populations, such as lung or prostate cancer
Cognitive impairments that would make it difficult for AYA/parents to participate in the intervention or complete questionnaires (determination in consultation with attending physician, oncologist, and, for adolescents below age , the parents)
Patients must be willing to submit blood and urine samples for serum hormones (estradiol, FSH, LH), inflammatory biomarkers (serum TNFalpha, IL-, IL-, CRP and urine CTX-II),urine AI metabolites, and deoxyribonucleic acid (DNA) analysis (CYPA), and must be given the option to consent to use of remaining specimens for future translational medicine studies; baseline samples must be obtained prior to beginning intervention
HSCT patients with either moderate or severe immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within  hours (therapeutic arms)
HSCT patients with mild immunodeficiency based on immunodeficiency scoring system would be eligible for entry on study if a nasopharyngeal wash or throat swab specimen is positive by rapid RSV antigen testing and/or on culture within  hours but will not be randomized to therapeutic arms and will be followed as per standard of care (control arm)
Patients with RSV infection limited to the URT as documented by negative chest radiographic findings within the last  hours of enrollment and pulse oxygenation of more than  mm of Hg on room air
Patients with evidence of RSV LRI as documented by a positive rapid RSV antigen testing and/or culture on nasal washes AND new or progressive infiltrates on chest radiographic studies suggestive of viral etiology and/or pulse oxygen less than  mm of Hg on room air
Patients with positive RSV by rapid antigen testing and/or culture in bronchoalveolar lavage regardless of the chest radiographic findings
Subjects must agree to not use any over-the-counter or prescription vaginal preparations (lubricants, creams, gels, ointments, solutions) during the four weeks of treatment with topical fluocinonide cream
Use of any vaginal preparations within one week prior to study enrollment (exception: subjects currently using a vaginal preparation can enroll after discontinuing treatment for  days)
Patients must not be planning to receive any of the following concomitant medications that can cause skin rash or other dermatologic reactions that could interfere with the EGFRI-induced skin toxicity assessments, for the duration of the study: allopurinol, systemic corticosteroids, topical retinoids (Retin-A, Tretinoin), oral retinoids (Amnesteem, Claravis, Sotret)
Rate fatigue at least  or higher on a scale of -
Have a major contraindication to methylphenidate hydrochloride (MP) (e.g., allergy/hypersensitivity to study medications or their constituents), exercise (e.g., cardiac disease), cognitive behavioral therapy (e.g., schizophrenia), or conditions making adherence difficult as determined by the attending physician
Significant psychiatric or other co-morbid disease, which the treating clinician believes prohibits informed consent or participation in the study
Rate fatigue on a numerical scale during the previous  hours as >=  on a  to  scale ( = no fatigue and  = worst possible fatigue)
Inability to complete the baseline assessment forms or to understand the recommendations for participation in the study
Patients with airway stents undergoing bronchoscopy
Patients with no stent lumen occlusion from mucus impaction as determined at the time of the initial visual bronchoscopic assessment
Patients are not required to be registered on a COG therapeutic trial
Patients needing anti-emetic treatment for breakthrough nausea/vomiting may also receive anti-emetic agents on an as needed (PRN) basis
Anatomically intact parotid and submandibular glands
Suspected or confirmed physical closure of salivary gland ducts on either side
Current acknowledged use of amifostine trihydrate, cholinergic agonist medications (pilocarpine hydrochloride, cevimeline hydrochloride), certain beta adrenergic antagonists, anticholinergic agents, or any saliva substitute or other medication/herbal preparation known to affect salivary function
Subjects must have HL, NHL, or MM requiring PBSCT
Subjects must have a psychological and emotional state that, in the view of the investigators, allows adherence to the protocol
Female subjects capable of reproduction, and male subjects who have partners capable of reproduction, must agree to the following:
No hereditary or idiopathic angioedema
Karnofsky performance status >=  (Radiation Therapy Oncology Group [RTOG] recursive partitioning analysis [RPA] class I & II)
Able to walk  minutes at a time (use of a cane is acceptable)
PEER MENTORS
PEER MENTORS:
This study is open to patients of all races and ethnicities
All patients undergoing planned open pancreaticoduodenectomy (PD) at Johns Hopkins Hospital (except pregnant women, adults lacking capacity to consent, non-English-speakers, and prisoners), irrespective of diagnosis, comorbidities, or administration of neoadjuvant therapy are eligible for this study
History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
History of pure red cell aplasia
Ability to operate the accelerometer (Actiwatch Spectrum Pro)
Second or third shift workers or others with non-traditional sleep schedules
Outpatients with MPE undergoing IPC placement
Patients undergoing pleurodesis for benign disease (e.g., spontaneous pneumothorax)
Chronic insomnia has been defined in previous research:as the presence of () three or more episodes of insomnia (i.e., ? minuteSOL, ? minute wake after sleep onset (WASO), or ? . hour total sleep time (TST) per night) of per week and () daytime effects of insomnia, such as irritability, difficulty concentrating, or fatigue for at least one month.
interested in behavioral sleep treatment
untreated sleep disorders such as sleep apnea
Normal cognition and willingness to complete fatigue and quality of life forms at each designated time point along with a patient observation form and pill diary
Active psychosis
Patients using carbonic anhydrase inhibitors (acetazolamide [Diamox], brinzolamide [Azopt], methazolamide [Neptazane], dorzolamide [Trusopt], pomegranate ellagitannins), cimetidine, or topiramate
History of polycythemia
Patient who have reported fatigue moderate or higher fatigue (based on the - Fatigue scale, a fatigue score of  or higher) while on radiation treatment
No patients being decisionally impaired
Patient who have reported less than moderate fatigue (based on the - Fatigue scale, a fatigue score less than )
Decisionally impaired patients
BFI score must meet at least one of the below criteria:\r\n* Total BFI < \r\n* Dietary subscale < \r\n* Frequency subscale < \r\n* Urgency subscale < 
Rectal prolapse
Active anal/rectal abscess
Patients must be able to ambulate a minimum of  feet prior to enrollment in pulmonary rehab
Inmates
Patients with a history of left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis)
Patients with retinitis pigmentosa
Patients with active thrombophlebitis
Patients with a history of existing hypercalcemia, hypocalcemia, hypermagnesemia or hypomagnesemia that is not corrected despite supplementation
Known hypersensitivity to VPA, valproate sodium, disodium valproate, or any ingredient in the respective formulation
Any of the following interventions on the affected hemithorax: prior IPC, prior chest tube placement, history of chemical or mechanical pleurodesis, history of thoracotomy within  weeks and incompletely healed surgical incision before randomization
Evidence of empyema or history of empyema of the affected hemithorax
The following drugs will not be administered concurrently with VPA: carbapenem antibiotics; clonazepam; topiramate; felbamate; lorazepam; barbiturates; carbamazepine; chlorpromazine; ethosuximide; guanfacine; lamotrigine; methylfolate oxcarbazepine; paliperidone; phenytoin; primidone; protease inhibitors; rifampin; risperidone; rufinamide; salicylates; temozolomide; tricyclic antidepressants; vorinostat; zidovudine
Began adjuvant therapy with an aromatase inhibitor  to  months before survey sent out (Benchmark Survey only)
Patients of East Asian ancestry (i.e., Chinese, Japanese, Taiwanese, or Korean)
undergoing a procedure other than laparotomy
All patients who currently use a urinary drainage bag for a period of at least  days prior to signing consent for the study and who are expected to use the urinary drainage bag for an additional period of  weeks or more based on the diagnosis
Report sleep disturbance of  (sum total of all  items) or greater on the Insomnia Severity Index\r\n* (Note: this measure will be repeated again at baseline assessment)
Patients who are shift workers are excluded; shift worker is defined as someone who has irregular work and sleep hours (such as working a non-traditional schedule: e.g., pm-midnight or pm-am; a rotating schedule e.g., alternating between day and night shifts, or starting work between am and am)
+: Standard-dose cytarabine - mg per meter squared continuous infusion for  days with idarubicin  mg per meter squared or daunarubicin - mg per meter squared for  days
High-dose cytarabine-based (HIDAC) chemotherapy administering a total cytarabine dose of ?  g per meter squared alone or in combination with other anti-leukemic agents (for example, anthracyclines, purine nucleoside inhibitors, etoposide, etc.)
Plan to be treated with cetuximab (Erbitux)
No restrictions or requirements will be placed on race
INCLUSION CRITERIA FOR FAMILY MEMBERS: No significant auditory or visual deficits with corrective devices
Spouses and patients must be married or cohabiting and in intimate relationship for at least  months
Fitzpatrick skin types V, VI
Sufficient auditory acuity
Intra-operative injuries (for example: rectal injury)
Any prisoner and/or other vulnerable persons as defined by NIH ( CFR , Subpart B, C, and D)
Of any ethnicity
Endorse a moderate level of anxiety (e.g., greater than or equal to  on the Hospital Anxiety and Depression Scale [HADS-A])
Baseline gabapentin use
Any musculoskeletal problems that would interfere with the NET therapy
Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for - in person assessments over the - weeks of the study
Visual impairments such as uncorrected vision or color blindness
Anticipate moving from the region in the next  months
Inability to use a mouse or computer keys to navigate around the computer screen
Experiencing disrupted sleep (determined by Pittsburgh Sleep Quality Index)
Patients engage in shift work or travel across more than three time zones within three months prior to study
Patients who have eye conditions (glaucoma or retinal disease), problems triggered by bright light (e.g. migraine), or take photosensitizing medications (e.g. some porphyrin drugs, antipsychotics, antiarrhythmic agents) will be excluded for safety of using bright light
Ownership of smartphone with following specifications: wireless capability, running on iPhone operating system (iOS) or Android operating system, current software (. Android; . iOS or later), and, adequate memory to run the AMT program ( megabyte[M] Android; .M iOS)
Unfamiliar with mobile phones/tablets, including ability to download and register the Headspace app
Subjects receiving the short-course fractionation radiation therapy (i.e.,  sessions or  sessions at . to . Gy fractions per session, with or without boost)
No diagnosis of sleep apnea or restless leg syndrome that is currently interfering with sleep
Ability to come to standing from seated position without assistance
Adolescent gives assent
Have a distress level of >=  on the National Comprehensive Cancer Network (NCCN) Distress Thermometer (DT); this is required for intervention group participants only to be able to show improvement in mood/quality of life (QOL)
Patients with a DT level >  will be considered on a case-by-case basis
Immobility as defined by inability to ambulate unassisted
Must have cancer-related fatigue, as indicated by a response of  or greater when asked to rate their level of fatigue at its worst in the past week on an -point scale anchored by  = no fatigue and  = as bad as you can imagine
Tumor abutting main stem bronchus, main pulmonary artery branches, esophagus and/or trachea.
No active suicidality;
Active suicidality;
Score below  on a distress thermometer and an adapted thermometer of stress;
EXPERT PANEL:
A convenience sample of - experts (at least three lymphedema therapists and a varying number of HNC medical, radiation, and surgical oncologists, HNC nurse practitioners, speech and language pathologists, and nursing and informatics scientists) will be recruited to inform development of videos, protocol, and educational manual
Subsequent to the development of the materials, five additional therapists will be recruited to conduct an unbiased test of the therapists training video and protocol
A convenience sample of - HNC survivors (based on data saturation) will be recruited and interviewed about their status/needs for conducting lymphedema self-care; then, an additional  HNC survivors will be recruited to undergo a training session with the study therapist and test the patient video and educational manual
Using the same inclusion criteria as Stage  a convenience sample of  different HNC survivors will be recruited
Patients with medical conditions (e.g., acute infection, congestive heart failure, renal failure, cardiac or pulmonary edema, sensitive carotid sinus, severe carotid blockage, and uncontrolled hypertension) that would prohibit the safe implementation of home-based self-care of lymphedema will be excluded
Patients must regularly consume a diet with a glycemic load >  as estimated through the  day food recall
Inoperable malignant neoplasm causing biliary obstruction or stricture that requires a fully covered metal stent
Undergone or is planning to undergo brachytherapy with transpapillary or percutaneous implantation of intracavitary radiation sources
Endoscopic procedures are contraindicated
Current anatomy upstream of intended stent placement compromising the flow of bile from the liver such that stent placement may not alleviate the biliary obstruction symptoms
Presence of a metal biliary stent
Patients plan to have primary surgery at either the University of Chicago Hospital or the University of Wisconsin Hospital
Patients with a suspected benign gynecologic process
Active disease relapse
Concurrent use of adjuvant medication such as but not limited to: gabapentin, pregabalin or duloxetine etc.; NOTE: patients on gabapentin or pregabalin can be considered if they can be tapered off before enrolling on the study
Patients with baseline (at start leukemia treatment) infection, defined as patients with fever and known positive cultures at the time of registration; or chest or sinus computed tomography with findings suggestive of pneumonia or sinusitis; or one positive galactomannan test >=  or two positive galactomannan test >= . to 
Patients with pre-existing dermatologic condition affecting the face and chest that would impair assessment of papulopustular rash, including dense and/or long facial hair (per investigator discretion)
Brief Fatigue Inventory (BFI) score of > 
Inability to lay supine for one hour at a time, given the nature of the massage intervention
Subjects who have massages on a regular basis; regular massage usage will be operationally defined as receiving  or more massages/year for the last  years
Subjects currently employing any other complementary and alternative medicine (CAM) manual therapy and/or holistic therapies to treat a perceived health problem; however, since past experience with CAM therapies should not confound any of the analyses of the experiments proposed in this study, we will not exclude individuals who have engaged in a CAM manual therapy in the past, nor will we exclude individuals who practice yoga or meditation for well-being, take vitamins or use nicotine
People unable to read and understand the informed consent document because of language difficulties
Patients unable to use audio or video media due to auditory or ocular dysfunction
Muscle spasms onset after starting vismodegib
Presence of muscle spasms or active neurologic disease prior to start of vismodegib
Any topical treatment for neuropathy or other serious skin condition on the hands or feet
Patients who have any confounding medical or neurological conditions that have the potential to affect cognition, speech or swallowing function; i.e. stroke, neurodegenerative disease, neuromuscular movement disorders, head injury, etcetera
Undergoing a procedure other than laparotomy
Have a response of >  or greater on a question assessing expected nausea as assessed on a -point Likert-scale anchored at one end by  = \I am certain I WILL NOT have this,\ and at the other end by  = \I am certain I WILL have this.\
Cognitive difficulties that preclude answering the survey questions, participating in the exercise classes or performance tests, or providing informed consent (confirmed by the professional opinion of the Principal Investigator, Dr. Kerri Winters-Stone)
Received a transplant at a consortium center for a hematologic malignancy or myelodysplasia
Does not have internet and email access; note that survivors otherwise eligible, but excluded from full study participation because of this exclusion, will be asked to fill out a mailed copy of the baseline assessment for use in secondary aims analyses; they will be sent an information form and a copy of the tailored My Health Action Plan health care guideline for transplant survivors also provided to randomized participants
Has received treatment for a recurrent or nd cancer that required > surgical excision in the past  years or did not have a hematologic malignancy or myelodysplasia diagnosis or did not receive a first transplant between - years before approach for the study; (these participants will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment)
Scores  or above on the patient health questionnaire (PHQ)- depression measure (indicating severe depression); these participants will be contacted by a study psychologist to evaluate and provide resources to address their needs (% of enrollees in our previous study); they will be ineligible for randomization, but will have intervention site access if they complete baseline PRO assessment
Residing in an institution or other living situation where health care decisions are not made by the participant (e.g., hospitalized, prisoners, living in a rehabilitation facility)
Does not complete baseline PRO assessment items required to determine stratification or whether the survivor meets inclusion and exclusion criteria
Has medical or health issues prohibiting computer use (e.g., vision-impaired, cognitively impaired, illness or accident impairing computer function)
Participant has symptoms of NP/PN with onset within  days after one of the following vincristine doses +/-  days: protocol week  or week  (induction), week  (reinduction I), or week  (reinduction II)
Cryoablation should be performed within  days of baseline evaluations
Anticipated treatment of the index tumor that would require iceball formation within . cm of the spinal cord, brain, other critical nerve structure, large abdominal vessel such as the aorta or inferior vena cava, bowel, or bladder
Anaphylaxis to local anesthetics or narcotics
Patients who cannot be effectively reconstructed without the use of bioprosthetic mesh
Able to ambulate
Cognitively intact
May include patients undergoing ileostomy or colostomy reversal
Adequate visual accuracy allowing eye testing
All ABO blood group combinations of the donor/recipient are acceptable since even major ABO compatibilities can be dealt with by various techniques (red cell exchange or plasma exchange)
Patients who may have insufficient renal capacity for clearance of Progel polyethylene glycol load
Able to be accompanied by their spouse or significant other partner/friend (spouse, significant other, partner, or friend)
Must be right handed
N
M
Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD
Neurological conditions that affect balance and, or muscle strength
All cancer patients >  years of any ethnicity who have been treated with intravenous zoledronate (zoledronic acid) for >= year duration
Consent for sample collection for urine, hematology, histopathology and microbial profiling
Willingness to provide consent for sample collection for blood, urine and saliva
Patients who actively decline participation or who are judged to be in distress before the interview
Bothersome hot flashes (defined by their occurrence >=  times per week [about  per day]) and of sufficient severity to make the patient desire therapeutic intervention
Have a smartphone
Have at least one ovary
Have a valid United States mailing address for receipt of saliva kit
Patients with a prior history of colonic surgeries
CESM is an imaging exam that uses radiation and is not typically employed in women younger than age  due to potentially negative biologic effects on glandular breast tissue.
Participants will be undergoing surgical excision to remove the ADH.
CESM studies will include at least four low energy and four recombined images (left craniocaudal [LCC], left mediolateral oblique view [LMLO], right craniocaudal [RCC], right mediolateral oblique [RMLO])
Rural Appalachian resident
Palpable nodule in both lobes of the prostate or evidence of extra-prostatic disease
History of finasteride or dutasteride use in the last  months
Pediatric patients, as pediatric cirrhosis is uncommon
Patients will be excluded from functional magnetic resonance imaging (fMRI) testing if they are left-handed, claustrophobic, have a pacemaker, or have metal implants; patients not fMRI testing may still enroll in clinical trial, including the event related potentials (ERP) testing, if all other eligibility criteria are met
Participants from Franklin County or from Appalachia Ohio (depending on program location)
OneormoreSYHC visitsinthelastyear
Notup-to-datewithscreening (up to date with screening will be defined by Healthcare Effectiveness Data and Information Set [HEDIS] and Uniform Data System [UDS] criteria, which require presence of guaiac fecal occult blood test [gFOBT]/fecal occult blood test [FIT] in the last year, sigmoidoscopy in the last  years, or colonoscopy in the last  years)
InsuredbyMediCal,Medicare,orprivatehealthinsurance
Uninsured
Patients declining oral biopsies
Reside in one of  rural counties in Indiana (IN) or Ohio (OH)
Plan to move outside of the country within the next year
Reside in a nursing home or other institution
Subjects are scheduled for colposcopy clinic based on screening with abnormal pap smear or have repeat colposcopy indicated for specific clinical indications, based off of the most recent American Society of Colposcopy and Cytology guidelines
Uninsured or on public Medicaid insurance
Women with heterogeneously dense or extremely dense parenchyma by prior digital mammography report (i.e., \dense breasts\), presenting for routine annual mammography with digital breast tomosynthesis
For women who have not had any prior mammography (i.e. this is their first, baseline, mammogram), the breast tissue must be dense (heterogeneously dense or extremely dense) on the current mammogram
Patients with active esophagitis
Patients must also have a treatment plan that includes liver function assessment with indocyanine green (IC-GREEN)
Participant will not or cannot provide medical records of past/present clinical exams (including but not limited to palpation, mammograms, biopsies, and ultrasound) if needed
INHALATION: Are a smoker
Should generally be between the ages of  and ; can be older or younger than this range depending on family history, genetic mutation status, or other factors; or as specified by separate protocols for approved intervention trials
If undergoing regular screening, subject must have a mammogram performed at the University of Kansas Medical Center or other accredited facility within  year prior to their RPFNA procedure; mammograms must be read as not suspicious for breast cancer (American College of Radiology [ACR] class I-III) unless issue resolved with other procedures
Metastatic malignancy to other organs, excluding Hodgkins or non-Hodgkins lymphoma
Willingness to undergo surgical evaluation for abnormal EUS/FNA finding
Prior partial or total gastrectomy with Billroth II or Roux-en-Y anastomosis
Significant damage or deformity to the feet that would alter blood flow or make it impossible to measure/interpret findings;
Diagnosis of restless leg syndrome or other movement disorders that would prevent accurate data from being able to be collected.
PRELIMINARY TEST: Ages -
PRELIMINARY TEST: No history of hysterectomy
No Pap test in the last  years
Resident of an Ohio Appalachia county
Currently prescribed anti-coagulation medications (ReoPro [abciximab], Aggrenox [aspirin plus dipryridamole], Persantine [dipyridamole], Integrillin [eptifibatide], Ticlid [ticlopidine], Aggrastat [terofiban], Heparin, Coumadin [warfarin], Pradaxa [dabigatran], Xarelto [rivaroxaban])
Have cardiomyopathy
Have cystic fibrosis
Are insured by the Colorado indigent care program (CICP) or Medicaid-Old age pension, American Association of Retired Persons (AARP) Medicare/Secure Horizons (except private fee-for-service [PFFS]), Denver Health Managed Medicaid, Evercare; Kaiser (not the prescriber of origin), Medicare Complete, New Medicaid, New CICP
Haitian, Hispanic, or African American
Report not having had a pap smear in the last three years
Live in the cities of Miami/Little Haiti, Hialeah or unincorporated southern Miami-Dade
Plan to move outside of Miami-Dade county during the next six months
Community physicians, colorectal cancer survivors, family advocates, researchers, and representatives of community-based organizations
Patients who have no plans to move out of the region in the next  months
Patients who are scheduled for a routine appointment with participating providers, who would utilize a guide to aid in decision making for prostate cancer screening, specifically men ages -
Patients are undergoing clinically indicated EGD
Patients are not undergoing clinically indicated EGD
Acknowledge sex with men in lifetime
Reside in Harris County, Texas
Have not had a clinician-provided digital rectal exam in the prior  months
Women with pacemakers
Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection); the definition of resection does not include endomucosal resection (EMR); patients that have received total proctocolectomy are ineligible\r\n* In addition to segmental resections, the following types of procedures are allowed: polypectomy: for Tis (stage ) or pT patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met:\r\n** Single specimen, completely removed\r\n** Clear margins\r\n** None of the following must be present:\r\n*** Moderate or poor differentiation\r\n*** Lymphovascular invasion\r\n*** Perineural invasion\r\n* Transanal excision is allowed for pT rectal cancer patients with well or moderately differentiated tumors if National Comprehensive Cancer Network (NCCN) criteria for transanal excision are met, as stipulated here:\r\n** < % circumference of bowel\r\n** <  cm in size\r\n** Margin clear (>  mm)\r\n** Mobile, nonfixed\r\n** Within cm of anal verge\r\n** T only\r\n** Endoscopically removed polyp with cancer\r\n** No lymphovascular invasion or perineural invasion\r\n** Well to moderately differentiated\r\n** No evidence of lymphadenopathy on pretreatment imaging\r\n***When the lesion can be adequately identified in the rectum, transanal endoscopic microsurgery (TEM) may be used; TEM for more proximal lesions may be technically feasible
Patients must have a pure tone audiometry evaluation to document air conduction within  days prior to registration; patients with hearing loss >  dB in any of the five tested frequencies ( Hertz [Hz],  Hz, , Hz, , Hz, , Hz) are not eligible; patients with active ear infections should be tested only after the acute phase of infection has resolved; for optimal results, it is recommended that testing be conducted by an audiologist, in a hearing test room, with insert earphones; Note: sites should not order audiometry evaluation until the potential participant has met all other eligibility criteria required for this study
SPECIMEN SUBMISSION AND SUBSTUDY CRITERIA
REGULATORY CRITERIA
Vegan vegetarians
Able to hold breath for  seconds
Biopsy-proven anal HSIL at baseline (anal intraepithelial neoplasia [AIN] with a positive cyclin-dependent kinase inhibitor A [p] stain, AIN-, or AIN)
At least one focus of HSIL must be identified that is not within a condyloma that may be treated after enrollment into the study
Warts so extensive that they preclude the clinician from determining the extent and location of HSIL
Receiving pyrimethamine, cimetidine, rifampin or cephalexin
Qualifying cytological atypia in RPFNA, Masood score of -; the qualifying RPFNA (of one or both breasts) must be send to Dr. Seewaldt's laboratory for cytological scoring and proteomic analysis; score results must be received from Dr. Seewaldts lab prior to patient registration/randomization; test must be done =<  days prior to registration/randomization\r\n* Note: Only the contralateral breast can be aspirated in women with DCIS and those undergoing surgery for an atypical lesion; the decision to aspirate the contralateral breast is at the discretion of the womans surgeon
Women eligible to take tamoxifen must be offered tamoxifen prevention as part of their clinical care and have refused tamoxifen treatment
Confirmed acute index (original venous thrombotic) event: lower extremity or upper extremity (jugular, innominate, subclavian, axillary, brachial) DVT, PE, splanchnic (hepatic, portal, splenic, mesenteric, renal, gonadal), or cerebral vein thrombosis for which the patient has received >=  days (but =<  days) of anticoagulant therapy prior to registration; the date, imaging modality, and location of index event will be required; the date of initiation and specific type of anticoagulants used will also be required
Mechanical heart valve
Bacterial endocarditis
primary bone malignancies or aggressive benign bone tumors of the femur or tibia, soft-tissue sarcomas which have invaded the femur or tibia, or oligometastatic bone disease of the femur or tibia in a patient expected to live at least one year post-operatively; and
treatment by surgical excision and endoprosthetic replacement of the femur or tibia.
documented anaphylaxis or angioedema to penicillin or cefazolin (Ancef);
prior local infection within the surgical field of the affected limb;
History of any upper gastrointestinal (GI) surgery that does not permit access to or evaluation of a  cm segment of the duodenum that includes the duodenal bulb, i.e. whipple procedure or similar
Spigelman ?
Statin use or statin use is indicated based on guidelines
Patients must understand that they will be permanently sterilized
Women with elevated levels of CA (> ) or transvaginal ultrasound suggesting cancer, unless findings are consistent with endometriosis; CA and transvaginal ultrasounds must be the most recent, but no older than  year from the date of enrollment
Anticipated desensitization treatment; this decision to exclude will be based on the site clinicians judgement; desensitization procedures vary somewhat among the five participating transplant centers, which does not permit proposing uniform criteria across all study sites for determining exclusion due to desensitization; in general, women who have received a prior transplant, have unsuitable scores on Calculated Panel Reactive Antibody (PRA) percentage (institution-specific thresholds), or an ABO incompatible donor are likely to undergo desensitization at one or more of the study centers; these factors, among others, will be used by the study clinician to determine exclusion due to anticipated desensitization in the study
Participants who cannot have their warfarin, Lovenox, Plavix, or other comparable medications held for percutaneous or transjugular liver biopsy and surgery if so indicated
Mammographically dense breast (heterogeneously dense [C] or extremely dense [D], based on American College of Radiology [ACR] BIRADS fifth edition classification or heterogeneously dense [] or extremely dense [], based on ACR BIRADS fourth edition classification) in either breast
Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study
Documented evidence of fibrosis or cirrhosis (Metavir , , and ) and subjects with significant extrahepatic manifestations of hepatitis C (such as cryoglobulinemia with symptoms or evidence of end-organ manifestations, renal disease, type  diabetes, or porphyria cutanea tarda
History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
Reports conducting at least  new initial screenings per month
Presence of gallstones and hypertriglyceridemia (level greater than  mg/dl) that requires medical or surgical intervention; note: we will include patients who had an independent episode of pancreatitis after a cholecystectomy, but exclude patients who are candidates for cholecystectomy
Recurrent pancreatitis episode is iatrogenic (endoscopic retrograde cholangiopancreatography [ERCP] induced)
Participants may have a history of indeterminate pulmonary nodule(s) by chest imaging if nodule follow-up has been completed or the study procedures would not interfere with nodule follow-up
Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolves to ? Grade  within screening timeframe)
Positive FOBT during the study period
Positive antinuclear antibody (ANA) result
FOCUS GROUP: Not able to speak and read English; not able to physically attend the focus group location and time, women who do not wish to be contacted or involved in research, women who have died between mammogram and recruitment data pull date, and women who have disenrolled from Group Health between mammogram and pull date
BETA/USABILITY TESTING AND THE TRIAL: who have disenrolled from Group Health between her mammogram and the record pull date, who have died, and those who have indicated that they do not want to be contacted for research, if they participated in our previous intervention development activities, or if they died or disenrolled from health plan between mammogram and start of recruitment
Self-described betel nut chewer (chewed betel nut for at least  years, and at a rate of at least  days per week); must be class  betel nut chewers: that is, must chew a quid consisting of areca nut, slaked lime, betel leaf, tobacco, and other optional ingredients, and not swallow the quid
Chews betel nut alone (i.e., without quid)
One or more Padua-based risk factor:\r\n* History of previous venous thromboembolic event (excluding superficial vein thrombosis)\r\n* Reduced mobility (Eastern Cooperative Oncology Group [ECOG] performance status  or )\r\n* Established hereditary thrombophilia (e.g. Factor V Leiden, G prothrombin mutation, protein C or S deficiency, antithrombin deficiency)\r\n* Recent surgery within the last  days\r\n* Age >=  years\r\n* Congestive heart failure (New York Heart Association [NYHA] class III or IV)\r\n* Complicated respiratory insufficiency (defined as an increased requirement for supplementary oxygen of at least L)\r\n* Acute myocardial infarction or ischemic stroke\r\n* Obesity (body mass index [BMI] >= )\r\n* Receiving hormonal agents (e.g. tamoxifen, estrogen, testosterone)\r\n* Acute infection (i.e. requiring antimicrobial therapy)
Bacterial endocarditis
RECIPIENT: Medically indicated subunit (Engerix?B for HBV; Gardasil for human papillomavirus [HPV]) or killed vaccines (e.g. influenza, pneumococcal, or allergy treatment with antigen injections)
RECIPIENT: Alemtuzumab or any equivalent in vivo T?cell depleting agent
Ability to take digital time stamped photos.
Reported use of oral antidiabetic agents (OADs).
Subjects considered by the investigator as unsuitable for the study for reasons not otherwise stated.
WHITE, NON-HISPANIC: Study participants will not have had a skin examination within the last year and will be of European ancestry. The study sample will be limited to non-Hispanic whites because i) skin type is the overwhelming risk factor for cutaneous melanoma resulting in very low incidence of this disease among persons who are black, Asian, Native American or Pacific Islander, and ii) the prior genetic investigation upon which this application is based was undertaken in a non-Hispanic white population. Thus at this time, inference of genetic risk attributable to MCR variants is unknown for individuals not identifying as non-Hispanic white eliminating any direct inference of the proposed intervention to a non-Hispanic white population.
WHITE, NON-HISPANIC: Participants reporting sun-sensitive phenotypes.
H/L: Participants with a personal history of melanoma and/or more personal history of more than one SCC and/or BCC.
Participants must have Lynch syndrome defined as meeting any of the following: () Mutation-positive Lynch syndrome: carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the deoxyribonucleic acid (DNA) mismatch repair (MMR) genes (i.e. MLH, MSH/EPCAM, MSH, or PMS) or () Mutation-negative Lynch syndrome: patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e. polyp) or a non sporadic MMR deficient malignant tumor (where non-sporadic MMR deficient is defined by: microsatellite instability high by either immunohistochemistry or microsatellite instability (MSI) testing or both, but no evidence of MLH promoter methylation in cases with loss of both MLH and PMS, and/or no evidence of BRAF mutation in cases with loss of both MLH and PMS) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic testing.
Patients already on AED(s)
Expired carbon monoxide reading >= .
Motivated to quit within the next  days.
At least marginal health literacy.
Physically unable to wear equipment and provide a good reading of physiological measures.
Under active surveillance
Not compliant with recommended sun protection, as determined by at least one of the following criteria:\r\n* Any intentional sunbathing, artificial tanning or a sunburn in the past  years\r\n* Having a moderate to light complexion (Fitzpatrick skin types I-IV) and not using sunscreen >= % of the time during incidental sun exposure
Answers no to all questions on the PA Readiness Questionnaire (PAR-Q) or is cleared in writing by a physician
Does not have schizophrenia
All newly referred patients to colposcopy clinic at Siteman Cancer Center at Washington University (SIUM) and Washington University School of Medicine (WUSM)
Prior treatment for cervical HSIL\r\n* Note: Cervical scarring that occurs after treatment with cryotherapy or LEEP may impact future visual evaluation of the cervix, making visual inspection with acetic acid (VIA) or colposcopy more challenging
Planned allogeneic HCT using fludarabine phosphate (FLU)/melphalan hydrochloride (MEL) or FLU/busulfan (BU) conditioning
Subjects will be eligible if their planned post grafting immunosuppression consists of one of the two following regimens:\r\n* TAC/MTX: tacrolimus (oral or intravenous) and intravenous methotrexate administered according to institutional standard practice.\r\n* TAC/SRL: tacrolimus (oral or intravenous) and oral sirolimus, administered according to institutional standards of care
Interest and willingness to commit to the  week Getting Ahead training program that will occur over  sessions occurring twice a week
If the patient is female, she shall: a) not have attained menarche yet or b) have attained menarche and have a negative pregnancy test at the screening visit and at Day
Patient who received any drug with potential anti-emetic effect within  h prior to the start of reference chemotherapy, including but not limited to: NK- receptor antagonists (e.g., aprepitant or any other new drug of this class); -HT receptor antagonists (e.g., ondansetron, granisetron, dolasetron, tropisetron, ramosetron); Benzamides (e.g., metoclopramide, alizapride); Phenothiazines (e.g., prochlorperazine, promethazine, perphenazine, fluphenazine, chlorpromazine, thiethylperazine); Benzodiazepines initiated  h prior to study drug administration or expected to be received within  h following initiation of chemotherapy, except for single doses of midazolam, temazepam or triazolam; Butyrophenones (e.g., droperidol, haloperidol); Anticholinergics (e.g., scopolamine, with the exception of inhaled anticholinergics for respiratory disorders e.g., ipratropium bromide); Antihistamines (e.g., diphenhydramine, cyclizine, hydroxyzine, chlorpheniramine, dimenhydrinate, meclizine); Domperidone; Mirtazapine; Olanzapine; Prescribed cannabinoids (e.g., tetrahydrocannabinol, nabilone); Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications; Herbal preparations containing ephedra or ginger.
Current and former tobacco users are eligible; the tobacco use assessment form must be completed following consent, to assure eligibility; patients must have >=  pack-year cumulative tobacco exposure or its equivalent to be eligible; this is defined as follows:\r\n* Cigarette exposure: >=  pack-years OR\r\n* Cigar exposure: >=  cigar-years, where  cigar year is defined as having smoked on average >=  cigar/day for a year OR\r\n* Chewing tobacco: >=  snuff-years, where  snuff year is defined as using on average >=  pinch (dip) of chewing tobacco/day for a year
Individuals who are willing to limit sun exposure to the body during the study period, and who agree to wear protective clothing and sun protection factor (SPF)  broad spectrum sunscreen or sunblock on exposed skin when they are outdoors
A subgroup of Individuals with  benign melanocytic nevi (BN) measuring at least  mm in diameter and with evidence of benign features by epiluminescence microscopy (ELM) will be included in the study; these criteria will be considered optional and applicable when the  BN are present in surgically accessible areas
Individuals must not take mega-doses of vitamins; mega-doses are defined as more than  capsules of standard multivitamins daily or more than the Tolerable Upper Intake Levels of Vitamins, as defined by the Institute of Medicine, National Academy of Sciences; such vitamin therapy must be discontinued at least  days prior to study entry
Proven or probable aspergillosis or other mold infection or deep mycoses including hepatosplenic candidiasis less than  days from first dose of isavuconazole (ISA)
Time interval of at least  days duration where complications such as rejection episodes, viral infections, surgical interventions and therapies with mono or polyclonal antibodies are ruled out by the transplant team
No history of celiac disease or non-celiac gluten sensitivity
Their vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
Their vision should be normal or corrected-to-normal (to ensure that they can accurately see the images on the screen and select the appropriate response)
No quit attempts or attempts to cut back in the last month ( days)
Permanent contact information
Laparoscopic or robotic pancreaticoduodenectomy
Karnofsky performance status: Full intensity conditioning, -%; reduced intensity conditioning, -%
Co-medications that may interact with rolapitant (e.g. metoprolol/beta blocker, codeine, pimozide thioridazine) as reviewed by Duke Preston Robert Tisch Brain Tumor investigator pharmacist
Ongoing vomiting from any organic etiology
Patient has taken the following agents within the last  hours prior to the start of treatment with study drug:\r\n* -hydroxytryptamine (HT) antagonists (ondansetron, granisetron, dolasetron, tropisetron, etc.); palonosetron is not permitted within  days prior to administration of investigational product\r\n* Benzamides (metoclopramide, alizapride, etc.)\r\n* Domperidone\r\n* Cannabinoids\r\n* Neurokinin- (NK) antagonist (aprepitant)\r\n* Benzodiazepines (lorazepam, alprazolam, etc.)\r\n* Herbal medications or preparations in doses designed to ameliorate nausea or emesis
Participants that are unable to provide a mailing address within the mainland United States or Puerto Rico, or are unable to provide a mailing address (i.e., do not have one), will be excluded from participating in the study
Not be allergic to soy or soy related products
Oriented to person, place, and time
Women with a prior history of cardiovascular disease, defined as a  or more positive responses on the Heart Questionnaire
Uses a walker or wheelchair/scooter
Use of anti-diarrheal agents (including but not limited to loperamide, octreotide, bismuth, tincture of opium, atropine, probiotics in any form other than food) within the past  days
Total colectomy
Fecal incontinence
Prior otologic surgery beyond tympanostomy tubes, including, but not limited to, tympanomastoidectomy, cochlear implant, endolymphatic shunt, mastoidectomy, osseous-integrated hearing device
Baseline asymmetric hearing loss (defined by ) >= -dB interaural threshold difference at -octave frequencies (-, Hz), ) >= -dB difference at -octave frequencies, and ) > -dB difference at -octave frequency)
Active carcinomas or melanomas of the skin of the face, scalp, ear, and neck
Prior melanomas of the skin of the face, scalp, ear, and neck, which are less than  years from surgical excision
Have at least one child under age  who is living in the same household
Have personally received genetic testing for the CDKNA/p genetic mutation and/or has one or more family members who received CDKNA/p testing
Expired-air carbon monoxide (CO) >  ppm (if =<  ppm, then NicAlert Strip > )
Positive urine screen for cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP) (NOTES: tetrahydrocannabinol [THC] will be tested but will not be an exclusionary criterion; participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; participants failing the toxicology screen will be allowed to re-screen once)
Ever used reduced nicotine cigarettes
Smoke roll your own cigarettes exclusively
Actively trying to quit
Currently taking the following medications:\r\n* Phenytoin (brand name: Dilantin)\r\n* Carbamazepine (brand name: Tegretol, Carbatrol, Equetro, Epitol)\r\n* Oxcarbazepine (brand name: Trileptal)\r\n* Primidone (brand name: Mysoline)\r\n* Phenobarbital\r\n* Bendamustine (Treanda)\r\n* Clopidogrel (Plavix)\r\n* Clozapine (Clozaril, FazaClo)\r\n* Erlotinib (Tarceva)\r\n* Flecainide (Tambocor)\r\n* Fluvoxamine (Luvox)\r\n* Irinotecan (Camptosar)\r\n* Olanzapine (Zyprexa)\r\n* Ropinirole (Requip)\r\n* Tacrine (Cognex)\r\n* Theophylline (Theo Dur, etc.)
Helicobacter pylori negative, defined as negative stool antigen testing and negative histological examination
Patients who are premenopausal defined as an individual with at least six menstrual cycles in the past year\r\n* Women with hysterectomy with intact functioning ovaries who are not having menstrual cycles need to be  years of age and under
Patients with a history of hypocalcemia
Radiographically-demonstrable metastases at any time prior to the time of enrollment
Use of systemic immunosuppressant agents including anti-metabolites, glucocorticoids, tumor necrosis factor (TNF) alpha antagonists, antibodies to interleukin (IL)  or IL receptor (R), calcineurin inhibitors, mammalian target of rapamycin (mTOR) antagonists
Prior history of serious toxicity or a systemic reaction to vaccinia immunization such as myopericarditis progressive vaccinia infection, or eczema vaccinatum
Inflammatory or exfoliative skin diseases such as eczema, psoriasis that disrupt epidermis
Inability to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination or until the vaccination site heals completely: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, or (d) immunocompromised individuals, such as those with HIV
Patients with active Clostridium difficile infection at the time of study enrollment; active infection is defined as a stool sample positive for Clostridium difficile toxin via enzyme immunoassay (EIA) and either symptoms (frequent loose stools) OR imaging findings consistent with toxic megacolon
If previously on oral contraceptives or hormone replacement, off for  weeks or more prior to baseline RPFNA; the exception is low dose vaginal hormones (estring, vagifem, or . gram or less of conjugated estrogen vaginal cream twice weekly or less often); these vaginal preparations may be continued at the same dose
An RPFNA performed less than six months prior to enrollment on study that exhibits at least  cells on the cytology or Ki- slide, and a Ki- positivity measured on at least  cells that is less than %
RPFNA criteria:\r\n* Cells suspicious for malignancy
Planning on remaining in New York City (NYC) for at least  months (with no vacations or trips to exceed two months)
Licensed taxi driver for at least  months
Part-time driver (drives fewer than  hours per week); although it is highly unlikely for NYC taxi drivers to work for multiple garages at study baseline, drivers may switch jobs and/or their garage base affiliation while participating in this study; new jobs and/or garage base affiliations will be tracked during follow-up assessments and noted for potential limitations with study retention and intervention contamination; drivers will be allowed to continue the study even if they are no longer working with the initial garage base
Individuals rated as moderate (-) to high ( or greater) on suicidality as assessed by module B of the MINI
Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, or phencyclidine (PCP)\r\n* Participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded\r\n* Participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return for  days
Patients with symptomatic cholelithiasis
Direct bili =<  x ULN
Patients with documented contraindications for bupropion (bupropion hydrochloride), including: bulimia nervosa, anorexia nervosa; use of monoamine oxidase inhibitors in the past two weeks; documented seizure disorders or predisposition to seizure (ie stroke, brain metastases); abrupt withdrawal from alcohol, benzodiazepines, or other sedatives; closed-angle glaucoma
Parents whose child is a pregnant adolescent
Able to achieve an acceptable peak baseline CPET, as defined by any of the following criteria:\r\n* Achieving a plateau in oxygen consumption, concurrent with an increase in power output;\r\n* A respiratory exchange ratio of >= .;\r\n* Attainment of maximal predicted heart rate (HRmax) (i.e., within  beats per minute [bpm] of age-predicted HRmax);\r\n* Volitional exhaustion, as measured by a rating of perceived exertion (RPE) >=  on the BORG scale
Have an active metabolic or digestive illness that impact phytochemical absorption and metabolism, including: diabetes, malabsorptive disorders (Crohns disease, documented celiac disease, etc.), renal insufficiency (creatinine [Cr] > .), hepatic insufficiency (nonalcoholic steatohepatitis [NASH], cirrhosis, active viral hepatitis), hyper- or hypothyroidism, or short bowel syndrome
Willingness to accept randomization to each of the three arms
Ability to send and receive emails
Ability to complete online forms
Known diagnosis of familial adenomatous polyposis (FAP) or hereditary non-polyposis colorectal cancer (HNPCC, Lynch syndrome)
Engaging in three or more intercourse events (defined as having penile-vaginal intercourse) per month; subjects must consent not to douche or use any vaginal products, including tampons, for  hours before enrollment and study visits
Active genital ulcers
Full-time New York City cab drivers
No immediate plans (within the next  months) to leave the city for vacation or for trips back to their home country
Driver for at least  years
Driving schedule does not include overnight shifts, nor does driver have an additional job overnight
Has a sleep disorder (including insomnia, delayed sleep phase syndrome [DSPS], narcolepsy, night terror, sleep apnea, sleep walking)
Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitor (SNRIs) (common anti-depressant therapies)
With prosthetic heart valves
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
Participants must have the ability to safely undergo bronchoscopy in the judgment of the investigators
Participants must not have used any other investigation agent within the last six months
PILOT III: Less than  days of  minutes or more of resistance training per week
PILOTS I, II AND III: Unable to walk without crutches, walker, cane, or other assistive device
If continuing in the Control Group portion, agree to not consume fish oil during the duration of the study
Smoke at least weekly
Regular use of any form of tobacco other than cigarettes;
History (last  months) of abnormal heart rhythms, cardiovascular disease (stroke, angina, heart attack) may result in ineligibility; these conditions will be evaluated on a case by case basis by the study physician
Individuals rated as moderate (-) to high ( or greater) on suicidality as assessed by module B of the MINI
Positive toxicology screen for any of the following drugs: cocaine, opiates, methadone, benzodiazepines, barbiturates, amphetamines, methamphetamines, phencyclidine (PCP), or delta--tetrahydrocannabinol (THC); A: participants with valid prescriptions for opiates, benzodiazepines, barbiturates, amphetamines or methadone will not be excluded; B: participants failing the toxicology screen will be allowed to re-screen once; if they test positive again, they will not be allowed to return
Unwilling to change hairstyle or remove a wig as necessary for the appointment to accommodate the net that is required to be worn on the scalp during the study procedure
Baseline mammographic density > % based upon the classification system ( = -%, \scattered fibroglandular densities\;  = -%, heterogeneously dense;  = >%, extremely dense). Women with a baseline mammographic density of ? % ( = ?%, breasts are almost entirely fat) will not be eligible
Mammograms that are reported as suspicious.
Approval for the use of this treatment protocol by the individual institutions Human Rights Committee must be obtained, in accordance with the institutional assurance policies of the U.S. Department of Health and Human Services
Planning to leave the college within next  months
Patient is enrolled on an investigational nonmyeloablative HCT protocol or a nonmyeloablative treatment plan with postgrafting CSP that does not use acute GVHD as its primary endpoint (protocol  serves as adjunct protocol); OR
Patients with fungal pneumonia with radiological progression after receipt of amphotericin formulation or mold-active azoles for greater than  month
Patients who are immunocompetent
Patients with active eczema during the last  months
Patients who are in close social/domestic contact with a pregnant woman
Able to complete all mandatory tests
Fair, good or excellent cosmesis, as determined by trained nurse assessment using the Harvard Cosmetic Scale
Physiological Model for End-Stage Liver Disease (MELD) >=  at screening visit\r\n* If the patient has been dialyzed at least twice within the last  days, then the factor used for serum creatinine should be .; any value less than one is given a value of  (i.e., if bilirubin is . a value of . is used) to prevent the occurrence of scores below  (because any positive value below  the natural logarithm would yield a negative result); the upper limit of serum creatinine is capped at .; the lower limit of serum sodium (Na) is capped at , and the upper limit is capped at ; after enrollment, if a patients MELD increases to  or greater, they can still be eligible
At screening has suspected or confirmed CDI, and is receiving or is planning to receive a - to -day course of antibacterial drug treatment for CDI
At study infusion has a diagnosis of CDI confirmed by a diagnostic assay which detects the presence of C. difficile toxin in stool, and is still receiving antibacterial drug treatment for CDI.
ENROLLMENT HAS ENDED
Patients must have started on anastrozole and plan to continue on anastrozole therapy for a minimum of  months
Hair that covers the scalp and is at least / inch in length
scalp metastases or scalp wounds
use of hair dyes
Subjects should have no serious physical activity, diet, or nutrition restrictions that could interfere with changes brought about as a result of the intervention; restrictions that will be screened for are untreated exercise-induced asthma, orthopedic or neurological problems, and medical conditions affecting nutritional status, intestinal absorption, or response to nutritional intervention (e.g. inflammatory bowel disease)
Be a permanent resident of the state of Kansas or Missouri
Has been admitted to the hospital greater than three days
Pre-existing ischemic heart disease (includes angina if documented in electronic medical record [EMR]) or ongoing cardiomyopathy.
Participants must have a dental examination within  months of enrolling in the study
HSCT recipients who underwent ex vivo T-cell depletion of the graft, or a mismatched, or cord or haplo identical blood transplantation
Extreme orthopedic or mobility issues (e.g., unable to get in and out of a chair unassisted)
Hyperplastic polyp or/and adenoma cases
Polyps free participants with any of the following high risk of colorectal polyps or cancer: () family history of colorectal cancer or polyps; () current cigarette smoker; () obesity (body mass index [BMI] >=  kg/m^); () low intake of fiber (lowest fiber intake quartile: daily intake < . g); () high intake of red meat and well-done or processed meat (mutagenicity index >= )
Participants with known genotype for ThrIle polymorphism in TRPM
Use of digoxin and licorice
Current use of blood anticoagulant drugs such as dicumarol (Warfarin), clopidogrel (Plavix), prasugrel hydrochloride (HCl) (Effient), ticlopidine (Ticlid), Lovenox (Enoxaparin), Fragmin (Dalteparin), Innohep (Tinzaparin), eptifibatide (Integrilin), tirofiban (Aggrastat), and abciximab (ReoPro)
Current use of lithium carbonate therapy (Eskalith, Lithobid, Lithonate, Lithotabs, Apo-Lithium carbonate, Apo-Lithium carbonate SR, Carbolith, Duralith, PMS-Lithium carbonate, PMS-Lithium citrate)
Biopsies performed at outside institutions should have Gleason score confirmed at the study site by a genitourinary (GU) pathologist to ensure eligibility
Unable to avoid close contact or household contact with the following high-risk individuals for three weeks after the day  vaccination or until the vaccination site heals completely: (a) children =<  years of age, (b) pregnant or nursing women, (c) individuals with prior or concurrent extensive eczema or other eczemoid skin disorders, (d) individuals with other acute, chronic, or exfoliative skin condition, or (e) immunocompromised or immunosuppressed persons (by disease or therapy)
Lives in the United States (US)
History of diabetic ketoacidosis
Consumes + servings of fruits and vegetables and is active for at least  minutes + days per week
History of  alpha reductase inhibitors prior  months
Expired-air carbon monoxide (CO) >  parts per million (ppm)
Have ever used varenicline
Participants must have Lynch syndrome defined as meeting any of the following:\r\n* Mutation-positive Lynch syndrome: carriers or obligate carriers (by pedigree) of a pathogenic mutation in one of the DNA mismatch repair (MMR) genes (i.e. mutL homolog  [MLH], mutS homolog  [MSH]/epithelial cell adhesion molecule [EPCAM], mutS homolog  [MSH], or PMS postmeiotic segregation increased  [S. cerevisiae] [PMS]) or\r\n* Mutation-negative Lynch syndrome: patients with a personal history of a non-sporadic MMR deficient premalignant lesion (i.e. polyp) or a non-sporadic MMR deficient malignant tumor (where non-sporadic MMR deficient is defined by: microsatellite-instability high by either immunohistochemistry or microsatellite instability [MSI] testing or both, but no evidence of MLH promoter methylation in cases with loss of both MLH and PMS, and/or no evidence of v-raf murine sarcoma viral oncogene homolog B [BRAF] mutation in cases with loss of both MLH and PMS) but germline MMR genetic testing showed either a variant of unknown significance or mutation negative result or had declined germline MMR genetic testing
Individuals who received scheduled aspirin, NSAIDs, or COX-inhibitors of any kind for more than  days (>  days) during anytime within the  weeks preceding baseline eligibility screening visit; individuals on cardio-protective aspirin will not be eligible
Individuals taking the drugs listed below may not be randomized unless they are willing to stop the medications (and possibly change to alternative non-excluded medications to treat the same conditions) no less than  days prior to starting naproxen or placebo on this study; consultation with the participants primary care provider may be obtained but is not required; the use of the following drugs or drug classes is prohibited during naproxen/placebo treatment:\r\n* Investigational agents\r\n* NSAIDs: such as aspirin, ketorolac and others NSAIDs\r\n* COX- inhibitors: such as celecoxib, rofecoxib and other COX-\r\n* Antiplatelet agents: such as aspirin, clopidogrel, ticlopidine, dipyridamole, abciximab, tirofiban, eptifibatide and prasugrel\r\n* Anticoagulants:\r\n** Heparin\r\n** Heparinoids: such as fondaparinux, danaparoid and other heparinoids\r\n** Low-molecular weight heparins: such as enoxaparin, dalteparin, parnaparin, reviparin, tinzaparin, ardeparin, certoparin, lepirudin, bivalirudin\r\n** Other anticoagulants: argatroban, apixaban, dabigatran, rivaroxaban, warfarin, acenocoumarol, dicumarol, phenindione and other anticoagulants\r\n* Lithium\r\n* Selective serotonin and norepinephrine reuptake inhibitors: milnacipran, fluoxetine, paroxetine, nefazodone, citalopram, clovoxamine, escitalopram, flesinoxan, femoxetine, duloxetine, venlafaxine, vilazodone, sibutramine, desvenlafaxine\r\n* Anticonvulsants: phenytoin, paraldehyde, valproic acid, carbamazepine, trimethadione, phenobarbital, diazepam, chlormethiazole, mephenytoin, ethotoin, paramethadione, phenacemide, mephobarbital, oxcarbazepine, zonisamide, piracetam, vigabatrin, felbamate, gabapentin, beclamide, fosphenytoin, stiripentol, tiagabine, topiramate, pregabalin, lacosamide, rufinamide, caramiphen\r\n* Antibiotics and antifungals:\r\n** Fluoroquinolones : such as ofloxacin, norfloxacin, levofloxacin\r\n* Other agents: teriflunomide, cyclosporine, tacrolimus, ginkgo, gossypol, meadowsweet, feverfew, beta glucan, pentosan, pentoxifylline, cilostazol, erlotinib, pemetrexed, methotrexate, pralatrexate
Celiac sprue
The subject agrees to stop consuming tea or tea-containing products and quercetin supplements throughout the entire intervention period except for the green tea extract and quercetin provided during study intervention
Prior sensitivity or allergic reaction to tea, tea products or tea and quercetin supplements
FOCUS GROUPS AND SURVEYS: Healthy volunteers currently living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, Los Angeles, New York City, Minneapolis or Duluth, Minnesota (MN) who attend bars or nightclubs; both current (past  day) smokers and nonsmokers will be included in the focus groups and surveys
QUALITATIVE INTERVIEWS WITH KEY INFORMANTS FROM SOCIAL BRANDING CAMPAIGN: Participants are key informants from the Social Branding bar intervention (i.e. facilitators, brand managers, or cessation counselors) who may be young adults or slightly older
Not living in San Diego, Portland, Albuquerque, Oklahoma, San Francisco/Bay Area, Nashville, Tucson, Los Angeles, New York City, Minneapolis or Duluth MN or currently attending college outside of the target cities
Known diagnosis of short-segment or long-segment Barretts esophagus as previously made by upper endoscopy showing salmon-colored distal esophageal mucosa and biopsies revealing intestinal metaplasia with goblet cells; potential study subjects may be contacted by mailings or phone calls or may be approached in clinic; additionally, potential study subjects may be approached using a web-based recruitment tool; informed consent will be obtained by a research coordinator or study investigator
% or higher estimated mammographic density on visual inspection
Timing of follicular phase of menstrual cycle:\r\n* For women who are actively menstruating, at least  menstrual periods in past  months such that there is a reasonable expectation of being able to perform the aspiration in the follicular phase of the cycle (sometime between day  and day  inclusive, with day one being the first day of bleeding); very light periods and spotting count OR\r\n* Women who have not had  menstrual periods in the past year due to Mirena type intrauterine devices (IUDs) or endometrial ablation may be screened, but hormone levels must be assayed - weeks prior to RPFNA in order to predict when to perform RPFNA so as to be in the follicular phase; lab results and institutional normal ranges must be reviewed by the protocol chair, who will provide an acceptable time window within which to conduct the RPFNA; women who have had their uterus removed, but still have at least one functioning ovary may be screened using the same hormone level check; must be willing to have same assessment of hormones and prediction of follicular phase repeated for the off-study RPFNA
Considered to be perimenopausal and/or entering the menopause transition
Consumption of systemic antibiotics or commercial supplements containing SDG (e.g. flaxseed or sesame seed supplements) during the  weeks prior to baseline RPFNA; consumption of foods containing flaxseed or sesame seed are permitted
Regular consumption of non-prescription anticoagulants, such as aspirin, NSAIDS or fish oil during the  weeks prior to baseline RPFNA is strongly discouraged, but occasional use will not exclude subject from participation
RPFNA specimen exhibits hyperplasia +/- atypia; Masood score of >=  with >=  cells on the cytology slide
Ki- >= % positivity (>=  cells)
Consumption of green tea or supplements containing green tea or tea extract within  days prior to enrollment
Advanced adenomas are defined as subject with polyps >=  cm, tubulovillous adenomas (- percent villous features), villous adenomas (>  percent villous), or high-grade dysplasia
Colonoscopy =<  days prior to randomization with removal of all adenomas or polyps >=  mm in size
History of gastroduodenal ulcers documented =<  year
Total colectomy
Patients with a colostomy
Able to hold breathe for  seconds
 to  years of age with diabetes per American College of Cardiology (ACC)/American Heart Association (AHA) ACC/AHA  guidelines
Uncontrolled hypothyroidism
Women who will have at least one fallopian tube removed for risk-reducing reasons (with or without removal of ovar[ries])
Women using non-hormonal forms of contraception\r\n*(Note: If a copper IUD is being used, the IUD must be removed prior to or at time of Mirena insertion)
All participants must score  out of  or above on the place attachment scale (i.e., measuring adolescents feeling of attachment to their after-school program)
Adequate visualization of entire cervix, cervical lesion(s) and squamous-columnar junction
The standard criteria for prospective clinical trials of medications developed by Drug-Induced Liver Injury Network (established by The National Institute of Diabetes and Digestive and Kidney Diseases) will be used to assess the laboratory test abnormalities. Normal range for these labs will typically be  -  IU/L for AST;  -  IU/L for ALT; . - . mg/dL for bilirubin. Subjects will be excluded if values are x -x . the upper limit
Evidence of hematopoietic, cardiovascular, hepatic, renal, neurologic, psychiatric, dermatologic, immune disorder, or other disease that may interfere with assessment of safety or efficacy of vaccine activity as indicated in study objectives
Positive viral test for HIV-, HIV-, HBV, HCV, Treponema pallidum, HTLV  (if tested), HTLV- (if tested), or WNV (if tested)
Is not expected to receive a minimum of  days of POS IV solution
As determined by the study investigators or consenting professionals, recent prolonged antibiotic treatment as prevention or suppression of an ongoing infection, where treatment involves gut-perturbing antianaerobic antibiotics
The ethnic and racial composition of the subject population will reflect the composition of subjects seeking care at The Ohio State University and James Cancer Hospital and Solove Research Institute; no special groups such as prisoners, children, the mentally disabled, or groups whose ability to give voluntary informed consent may be in question will be used for this study
Dietary intake of large amounts of curry, turmeric spices or black pepper on a regular basis
Physically able to engage in low-to-moderate PA
Valid home address in the Houston neighborhoods of Gulfton, the East End/Magnolia, or near Northside, or adjacent neighborhoods
Bilingual Latina
Live in the community
Latina
Reside in the Dan River region of southern Virginia
Hispanic
Have no plans to move in the next six months
Interested in making a serious quit attempt in the next  days
Non-Hispanic
Non-smoker
Not interested in making a serious quit attempt in the next  days
Recipients with donor sensitive antibodies (DSA), defined by  or higher median fluorescence intensity (MFI) against one or more class I or II antigens
Patients who only have a port are ineligible
Known diagnosis of histologically-confirmed BE with or without dysplasia (as defined by the presence of specialized columnar epithelium anywhere in the tubular esophagus with >=  cm of circumferential involvement or non-circumferential involvement of specialized columnar epithelium) requiring radiofrequency ablation
Inability to abstain from, NSAID (including aspirin), and selective COX- inhibitor therapy at the time of randomization through the completion of the study (the study period is defined as baseline to exit endoscopy at  months after randomization which defines the completion of the study); participants may take Tylenol and non-NSAID pain relievers
Surveillance biopsies demonstrating residual BE at qualifying exam
Have an address in a rural census tract defined by a Rural-Urban Commuting Areas (RUCA) code of -
Have general knowledge of text messaging
Reside in a rural location as defined by Rural-Urban Commuting Area (RUCA) Codes, Urban Influence Codes, amount of agricultural income, and/or individual commuting patterns
One individual per household will be permitted to enroll in the study
Subjects with pre-operative urinary incontinence defined as use of pads or adult diapers;
Creatinine < . mg/ld
Presumptive evidence that all adenomatous lesions, including qualifying advanced adenoma, have been completely removed
Diagnosis of nonalcoholic steatohepatitis (NASH) and a NAFLD (nonalcoholic fatty liver disease) activity score (NAS) >= ; NOTES and EXCEPTIONS: NAS is based on findings from a liver biopsy; participants with NAS of =<  are eligible for enrollment; participants with NAS of - must be discussed with the principal investigator and Division of Cancer Prevention (DCP) before enrollment to consider other risk factors (i.e., obesity, alcohol intake); participants with a prior diagnosis of NASH and no available NAS must be discussed with the principal investigator and DCP before enrollment to considered risk factors (i.e., obesity, alcohol intake)
Antinuclear antibody (ANA) test result excludes overt autoimmune disease; note: test result may be reported in any of the following formats: =< :, negative, or < .
African American
Participants in each component (focus groups, surveys and educational programs) will be  years of age and over; these men and women are generally healthy, ambulatory and able to participate in events in their community; no women, men, or children of any ethnic or social background will be excluded from the educational program
EDUCATIONAL INTERVENTION:
Aim : Director/leader or program manager/coordinator of organization or organization representative who has been nominated to be interviewed by the organizations director/leader or manager/coordinator
worsening granulocytes should be ? % decrease from pre-injectable HMA (HYPOMETHYLATING AGENT) baseline value
worsening platelets should be ? % decrease from pre-injectable HMA (HYPOMETHYLATING AGENT) baseline value (untransfused)
thrombopoiesis-stimulating agents ([TSAs]; eg, Romiplostim, Eltrombopag, Interleukin-)
hydroxyurea
Serum total bilirubin > . x ULN (upper limit of normal). Higher levels are acceptable if these can be attributed to active red blood cell precursor destruction within the bone marrow (ie, ineffective erythropoiesis). Subjects are excluded if there is evidence of autoimmune hemolytic anemia manifested as a corrected reticulocyte count of > % with either a positive Coombs' test or over % of indirect bilirubin
Presence of any contra-indication for a neurosurgical procedure
Any participant must obtain prior approval from insurance to reimburse for oral temozolomide for the duration of the study or agree to self-pay for oral temozolomide or obtain institutional commitment from the study site to provide temozolomide
Already consuming a carbohydrate-restricted or vegetarian diet
Largest imaging dimension of cancerous finding < -mm
Any rectal pathology, anomaly or previous treatment, which could change acoustic properties of rectal wall or prevent safe probe insertion (e.g., stenosis, fibrosis, inflammatory bowel disease, etc).
Identified calcification of  mm or more in largest diameter neighboring the rectal wall (in a distance of less than  mm) and interfering with the acoustic beam path.
Lower limb musculoskeletal fixed deformities preventing probe insertion or patient positioning during procedure.
Active UTI
Prostatitis NIH categories I, II and III.
Interest in future fertility
Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for  months prior to IORT.
Thiazolidinedione agents such as rosiglitazone and pioglitazone are not permitted
cN or cN disease
Largest single focus of disease >  centimeters by either mammogram or MRI or both; Note: measurement of the largest single focus should include any satellite lesions within  centimeter of the index lesion
cNX, cN, or cN disease
Must have received bilateral radiation therapy, and subsequently developed grade  or  xerostomia, according to modified Radiation Therapy Oncology Group (RTOG) scale:\r\n* Grade   None\r\n* Grade   Slight dryness of mouth (good response on stimulation and no significant dietary alterations necessary)\r\n* Grade   Moderate dryness of mouth (poor response on stimulation and altered oral intake required such as frequent water, oral lubricants, or soft-moist foods)\r\n* Grade   Complete dryness of mouth (no response on stimulation and difficult oral alimentation; intravenous (IV) fluids, pureed diet or tube feedings may be required)\r\n* Grade   Fibrosis
Suspected or known closure of salivary gland ducts on either side
Epstein-Barr virus (EBV) positive DLBCL, NOS
Clonal BMPC percentage >=%
Participants must be designated to undergo reduced intensity allogeneic peripheral blood hematopoietic stem cell transplantation (HSCT); consent will be obtained prior to admission for HSCT; the following HSCT conditions must be planned:\r\n* Donors must be / HLA-matched (at the allele level) as defined by matching at HLA-A, -B, -DR and C who pass institutional standard to serve as a peripheral blood stem cell donor\r\n* Donor grafts must be granulocyte colony-stimulating factor (G-CSF) mobilized peripheral blood stem cells with dose and apheresis logistics at the discretion of institutional standard\r\n* Conditioning therapy will be one of the following  options:\r\n** Fludarabine/melphalan where fludarabine is >=  mg/m^ intravenously (IV) total dose and melphalan is - mg/m^ IV total dose; exact logistics of administration are at the discretion of institutional standard\r\n** Fludarabine/busulfan where fludarabine is >=  mg/m^ IV total dose and busulfan = . mg/kg IV total dose; exact logistics of administration are at the discretion of institutional standard\r\n** Fludarabine/busulfan where fludarabine is >=  mg/m^ IV total dose and busulfan is dosed to achieve area under the curve (AUC) of  umol/min based on a pharmacokinetics determined from a test dose; exact logistics are at the discretion of institutional standard\r\n* GVHD prophylaxis is comprised of tacrolimus/short course methotrexate as defined by tacrolimus started prior to day  of HSCT and methotrexate given after HSCT on days +, + and + +/- + at a dose of - mg/m^ IV; exact logistics are at the discretion of the treating institution
Women whose most recent CA or transvaginal ultrasound is abnormal; a history of abnormal CA or ultrasound is allowed, as long as the most recent testing is normal
History of  or more adenomatous polyps
Participants with known genotype for rs in fatty acid desaturase  (FADS)
Patients with a preexisting tracheostomy
Clinically apparent bleeding diathesis (meaning bleeding that is spontaneous, excessive, or delayed in onset following tissue injury results from a localized pathologic process or a disorder of the hemostatic process, involving a complex interplay among vascular integrity, platelet number and function, coagulation factors, and fibrinolysis)
Lymphovascular invasion
History of malabsorption syndrome (e.g., pancreatic insufficiency, celiac disease, or tropical sprue)
Is currently taking, or has taken within  hours of Treatment Day  the following drugs with antiemetic properties: -hydroxytryptamine  (-HT) antagonists (e.g., ondansetron), benzamides (e.g., haloperidol), cyclizine, domperidone, herbal therapies with potential antiemetic properties, olanzapine, phenothiazines (e.g., prochlorpenzine), scopolamine (this is not an exhaustive list)
Is allergic to fosaprepitant, aprepitant (MK-), ondansetron, or any other -HT antagonist
Personal history of polyps
Pregnancy complications (Diabetes, Anomaly, Fetal growth restriction, HTN, Hx of > miscarriages)
Identify as being of Latino heritage, ethnicity, or ancestry
The CVC consists of a . French size, Bard, dual-lumen, PowerPICC catheter
Patients in whom the lock solution application will interfere with routine treatment of the underlying disease
Patients receiving phosphodiesterase type  (PDE-) inhibitors (such as sildenafil, tadalafil, vardenafil)
Patients who have a minocycline-rifampin coated CVC
Non-African-Americans
BMI ?  percentile for age and sex (overweight or obese) OR at risk for obesity (BMI between the th and th percentile and at least one overweight parent (BMI ?  kg/m)
Comorbidities of obesity that require immediate subspecialist referral
Smoked at least  cigarettes in lifetime
Colonoscopy within the last three years that found >=  adenoma
Dietary restrictions substantially limiting compliance or vegetarian or vegan diet
Received the following within  days before screening or plans to receive during the study: ganciclovir, valganciclovir, foscarnet, acyclovir, valacyclovir, or famciclovir
Participants may have a history of indeterminate pulmonary nodule(s) by chest imaging if nodule follow-up has been completed or the study procedures would not interfere with nodule follow-up
Patient has been assessed by treating physician to be appropriate candidate for everolimus plus exemestane therapy as treatment of advanced or metastatic breast cancer and plans to prescribe everolimus mg PO QD in combination with exemestane mg PO QD
Patients with confirmed symptomatic PE and/or DVT who have been treated for  to  months and did not interrupt anticoagulation for longer than  week
Legal lower age limitations (country specific) Indication for therapeutic-dosed anticoagulants Indication for antiplatelet therapy or a conventional non-steroid anti-inflammatory drug (NSAID) Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk Calculated creatinine clearance <  mL/min
History of gastroparesis
Use of laxatives more than  times per week
Ability to complete questionnaire(s) and dietary food logs
Willingness to consume meals/snacks provided for  consecutive days
Drink less than or equal to one alcoholic drink/day
Have a history of gallstones
Non-Hispanic African American or non-Hispanic White
Use of pharmacotherapy in the month prior to enrollment, including prior use of varenicline
has agreed to continue adequate contraception during the entire treatment period and for  months after completion of the vaccination series.
Have no evidence of alopecia or mild alopecia (NCI CTCAE grade  alopecia defined as hair loss of <% of normal for that individual that is not obvious from a distance but only on close inspection; a different hair style may be required to cover the hair loss but it does not require a wig or hair piece to camouflage). Female/male-pattern baldness or age-related hair loss are allowed if not greater than grade , per NCI-CTCAE v. .. Subjects that have previously lost their hair may enroll if they currently have Grade  or  alopecia
Patients receiving thiazides or furosemide diuretics, with the exception of subjects who have stable doses and have been on therapy for over six months
Patients that indicate they have significant hair breakage or hair damage and associated hair loss from hair over-processing within the last  days due to peroxide applications, permanent hair coloring, bleaches, streaking, perms, relaxers and/or hair oxidative dyes.
anticipated to be severely immobilized for at least  hours after randomization
acute ischemic stroke with lower extremity hemiparesis or hemi paralysis
Subjects must agree to abstain from dietary sources of glucosinolates and isothiocyanates beginning three days prior to study and throughout duration of the active study ( days); participants will be asked to keep a food diary; patients will be asked to record instances of accidental ingestion of these foods, with patients being removed from the study if this occurs  or more times
Subject must not be a tobacco user or quit at least  months prior to the first administration of the BSE-SFN as tobacco has been found to interfere with the measurement of sulforaphane (SFN) metabolites
Chlorine (Cl) within  x ULN
Carbon dioxide (CO) within  x ULN
able to eat at least soft solids
able to perform oral rinse
Normal anal cytological result, low-grade intraepithelial lesions (LSIL)/condyloma or atypical squamous cells of undetermined significance (ASCUS) result within  days prior to entry, and no by high-grade anal intraepithelial neoplasia (HGAIN) on biopsy
Anal cytological result of HSIL, atypical squamous cells suggestive of HSIL (ASC-H), or suggestive of invasive carcinoma at screening; or history of these results
HGAIN (e.g., anal intraepithelial neoplasia [AIN]  or , or perianal intraepithelial neoplasia grade  or ) or invasive carcinoma at pre-entry on biopsy, or participant has a history of invasive carcinoma or any prior anal cytology result of HSIL or ASC-H
Expected use of any systemic antineoplastic or immunomodulatory treatment, systemic corticosteroids used for greater than  days, investigational vaccines, interleukins, interferons, growth factors, or IVIG during study followup; hepatitis C co-infected subjects should not enroll in this study if they expect to initiate treatment for hepatitis C (e.g., interferons) during this trial
has agreed to continue adequate contraception during the entire treatment period and for  months after completion of the vaccination series.
Must meet Eastern Cooperative Oncology Group (ECOG) performance status criteria of - ( = fully active, must be able to carry out all pre-disease activities without restriction;  = restricted in physically strenuous activity, but ambulatory and able to carry out work of a light or sedentary nature)
pericarditis,
dissecting aneurism,
Hyperparathyroidism (parathyroid hormone [PTH] >  pg/mL)
Has moderate to severe depression according to Quick Inventory of Depressive Symptomatology-Self Rated  (QIDS-SR-) scores of >=  AND a Hospital Anxiety and Depression Scale (HADS) Depression subscale score of >= 
Korean American immigrant women
Residence in Minnesota
Possession of active email account
For patients with intratumoral hemorrhage (acute, subacute, or chronic) seen on hemosiderin-sensitive (gradient-echo) MRI, there must be at least  x  x  mm \measurable enhancement\ that is not obscured or distorted by magnetic susceptibility blooming artifact
Pathologic nipple discharge associated with IPWA (spontaneous bloody or clear persistent single duct discharge)
Patient has already had molecular profiling and patient has not yet started matched targeted therapy based on the report; approved molecular profiling include: \r\n* Foundation Medicine FoundationOne\r\n* University of California, San Francisco (UCSF)  Cancer Gene Panel\r\n* University of Washington OncoPlex Cancer Gene Panel\r\n* Children's Hospital of Philadelphia (CHOP) Comprehensive Solid Tumor Next Generation Sequencing (NGS) Panel\r\n* Other pre-approved molecular profiling test by study principal investigator (PI)
Capable of making informed decisions regarding his/her treatment
Patients who have received an investigational drug in the  days before CEUS, or will receive one within  hour after their CEUS exam
Patients undergoing cervicography OR colposcopy OR visual inspection with acetic acid (VIA) OR patients undergoing loop electrosurgical excision procedure (LEEP) for the treatment of cervical cancer
Patients of all ethnicities will be included
Cancer located on a site that may not be convenient or accessible for imaging with the current version of the RCM device (gingivobuccal region, back of the oral cavity, back of the tongue, floor of the mouth, deep under the tongue, etc.)
Surgical staging with retroperitoneal staging and lymphadenectomy is permitted
ADULTS
ADULTS
For cohort C, patients with GBM who have completed standard temozolomide + radiation and have suspected pseudoprogression can enroll; there is no time frame from completion of chemoradiation as pseudoprogression is increasingly recognized at later time points
High or mixed affinity binders (alanine [Ala]/Ala or Ala/threonine [Thr]) based on genotyping result from PBR affinity test; this blood test will be performed as part of the screening process after consent has been obtained
The patients DCT-ventilation image meets the heterogeneity criteria
Patients with suspected or histologically documented new non-small cell carcinoma that have agreed to undergo a thoracotomy for segmentectomy, lobectomy, bilobectomy or pneumonectomy as recommended by their thoracic surgeon for treatment
There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients with a nodule within SPiNPerc range (i.e. The patient would not go on for a CT guided TTNA), OR There is a predetermined plan to pursue stereotactic body radiation therapy (SBRT) in the event of a nondiagnostic study procedure in patients where the target nodule is within a region considered to be not accessible to a percutaneous approach as determined by the radiology core lab and thus would prevent a confirmatory tissue diagnosis before SBRT.
Participants must have a pre-operative standard mammogram with or without ultrasound; these may be performed at outside institutions but must be reviewed at Brigham and Women's Hospital/Dana-Farber Cancer Institute (BWH/DFCI)
Participants with a known Li-Fraumeni or Cowdens disease
Able to produce mL of urine
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
History of bone fracture after the conclusion of chemotherapy\r\n* History of bone fracture will be based on patient/parent report of fracture occurrence and will be confirmed in review of the medical record whenever feasible
Participants must have a pre-operative standard mammogram with or without ultrasound; these may be performed at outside institutions
Participants with known Li-Fraumeni or Cowdens disease
Presence of biliary-enteric anastomosis
Hemosiderosis/hemochromatosis
Patients undergoing a reduction mammoplasty OR
Patients of all ethnic and gender groups will be included; protocol accrual will be reviewed annually to include a determination of minority and gender representation; if accrual demonstrates under-representation of any group with comparison to disease incidence in that group, appropriate measures will be undertaken to increase participation of patients of that minority or gender group
Patients considered in vulnerable populations
Symptomatic osteonecrosis (ON) of the femur or proximal tibia with MR signal abnormalities that involve more than % of the respective joint surface, but no evidence of epiphyseal collapse
There will be no gender/race-ethnic restrictions
Hemosiderosis/hemochromatosis (patients can still be included in the nd branch without receiving ferumoxytol)
Location: supratentorial
Patients undergoing :\r\n* Surgical laryngeal, esophageal, and tracheal endoscopy (panendoscopy)\r\n* Fiberoptic esophagoscopy\r\n* Intubation\r\n* Office-based nasal or laryngeal endoscopy
Have CT scans within  days suitable for use with the virtual bronchoscopic system
Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Patients with minimal FDG-avidity localized to the planned treatment target (e.g. maximum standardized uptake value [SUV] < .)
Patients who are claustrophobic
Presence of erosive esophagitis
Prisoner
Cannot receive furosemide
Cannot receive furosemide
Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
Be capable of understanding the investigational nature of the study and all pertinent aspects of the study
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs; (Note: This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device)
Patients with known or suspected right-to-left, bi-directional, or transient right-to-left cardiac shunts
Patients with a history of anaphylactic allergy to Definity, manifested by one or more of the following symptoms: generalized urticaria, difficulty in breathing, swelling of the mouth and throat, hypotension, or shock
Patients with known or suspected pancreatic or ovarian carcinoma who will be undergoing clinically appropriate laparoscopic evaluation or treatment; patients will not undergo laparoscopy solely for the purpose of participation in this trial
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Pathologically confirmed, well differentiated functioning or non-functioning metastatic GEP-NET (Grade I and II as per World Health Organisation classification )
Subject who have received treatment of any somatostatin analogue, including Somatuline Autogel /Depot, Sandostatin LAR within  days, and Sandostatin within  hours prior to first Ga-OPS administration
Patients must have confirmation of prostate cancer with identifiable metastatic disease on at least  clinically indicated imaging modality; if there is only soft tissue metastasis, one lesion must measure at least  mm or greater
Localized SCCHN.
For patients with reproductive potential must undergo counseling to understand unknown risks to resultant progeny.
Definitive findings of systemic metastasis on conventional imaging
TOBACCO PRODUCT USERS
Must not have had an injection of a radioisotope  hours prior to exam
Mitotic rate >= /mm^
Deep positive margin
Risk of poor cosmetic outcome after initial lumpectomy and possible additional excision, as assessed by Dr. Sharma
Patients that have complex DCIS as indicated on radiology, which would require excising a large tissue volume
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
PART B ONLY
Cases without prior biopsy will be chosen based upon consensus of a MD Anderson faculty neuroradiologist and neurosurgeon for high probability of representing a glioblastoma
History of high grade anal intraepithelial neoplasia (AIN  or )
Highly suspicious pulmonary nodule(s), defined as distinct nodule with a diameter of ?mm in its largest dimension
Active prostatitis
pT (seminal vesicle invasion or extraprostatic extension), or
Patients presenting with a pituitary nodule presumed to be resectable on pre-operative assessment
Patients with significant neurological motor deficits of the upper extremities, which would preclude them from performing the while awake intra-operative tasks
Individuals who are considered to be mentally disabled will not be recruited for this study
Subjects who have difficulty lying flat on their back for extended periods of time
Individuals who are considered to be mentally disabled will not be recruited for this study
Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials (e.g. iron), or have embedded metal fragments from military activities
Have received orthodontic work involving ferromagnetic materials
Claustrophobic (i.e. feeling very anxious in a confined small space)
Patients not capable of getting PET study due to weight, claustrophobia, or inability to lay still for the duration of the exam
Confirmed diagnosis of Erdheim-Chester disease or Langerhans cell histiocytosis or other histiocytic disorder and requiring additional diagnostic imaging and biopsy to determine mutational status in order to determine therapeutic options
Investigator precludes participation for scientific reasons, for reasons of compliance, or for reasons of the patients safety
Patients deemed not surgical candidates due to prohibitive co-morbidities
Patients who cannot tolerate or have contra-indications to endorectal coil insertion; for example, patients with a prior abdominoperineal resection of the rectum or latex allergy
Able to breathe regularly for gated treatment, as measured with the Varian Real-time Position Management (RPM) system
Bronchiectasis in the region of the intended implantation
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [carbon C  (- C)] pyruvate injection)
Patients with excessive dental restorations and amalgam
Patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field
Both sporadic desmoid tumors and those associated with familial adenomatous polyposis (FAP) syndromes will be included
Any race
Patients must have tumors that produce CEA as documented by a current or past history of an elevated serum CEA above the institutional limit of normal, or by immunohistochemical methods; NOTE: Patients with colorectal cancer are exempt from this requirement since > % are CEA positive
Patients must agree to fill out the longitudinal psychosocial questionnaires assessing health related quality of life
Patients receiving T cell depletion or thymoglobulin as part of their transplant
Women undergoing cold knife cone (CKC) of the cervix at MD Anderson
Patients consented for the trial that on the baseline -dimensional (D) study have poor acoustic echo windows (i.e. a reader is unable to see in definition  or more segments from the apical views) will not be eligible to continue in the trial and peak hyperemia images will not be obtained
The study population may include illiterate persons and University Hospital (UH)/Case employees if they meet other inclusion criteria; the consent process for these potential participants will be conducted according to Institutional Review Board (IRB) guidelines
Inflammatory disease (for example fever of unknown origin, vasculitis, osteomyelitis)
Pregnant women are excluded from this study because there is an unknown, but potential risk, for adverse events, as small animal trials have linked ferumoxytol administration (at very high doses) to birth defects (e.g., soft-tissue malformations and decreased fetal weights); it is not known whether ferumoxytol is present in human milk; breastfeeding, however, should be discontinued if the mother receives ferumoxytol while nursing
Patients with known sensitivity or contraindication to any of the component of Zr-DFO-trastuzumab (Zr or desferrioxamine [DFO] or trastuzumab)
Patients who have received trastuzumab must have at least a washout period for trastuzumab of  days, this will not apply to Zr-DFO-trastuzumab repeat, post treatment assessment where patients may be receiving trastuzumab
Ultrasound showing accessible abnormal ipsilateral axillary lymph node (cortical thickness >=  mm, eccentric cortical thickening, or rounded morphology with effacement of fatty hilum)
Ability to hold the breath for  seconds
Ventilator
Mentally/physically impaired/unresponsive
 consecutive consenting patients presenting to The Ohio State University James Cancer Hospital Otolaryngology Department with a suspicious oral lesion or prior biopsy-confirmed epithelial dysplasia (mild, moderate, severe), carcinoma in situ (CIS), or squamous cell carcinoma (SCC) will be recruited; adult patients presenting for initial evaluation for treatment planning and/or presenting for follow-up appointments monitoring for recurrence will be eligible to participate
Females with tattoos on either or both breasts
Females with nipple piercings on either or both breasts
Females with skin piercings (aka microdermal anchor surface or microdermal piercings) in either or both breasts
Symptomatic distal rectal stenosis
Patients who have received and/or are scheduled to receive a combination of the following cardiotoxic chemotherapy agents:\r\n* Anthracyclines (doxorubicin, daunorubicin, epirubicin, idarubicin); antimetabolites (-fluorouracil); alkylating agents (busulfan, cisplatin, cyclophosphamide, ifosfamide); anthraquinones (mitoxantrone); antimicrotubules (paclitaxel, vinca alkaloids [vinblastine, vincristine]); biological agents (interferon-alpha, interleukin-); hormone-modifying therapy (androgen-deprivation therapy, aromatase inhibitors); tyrosine-kinase inhibitors (bevacizumab, imatinib, lapatinib, sorafenib, sunitinib, trastuzumab); rituximab; docetaxel (Taxotere); any other potentially cardiotoxic treatment
Breast size per visual inspection to fit within the ultrasound tomography (UST) ring array
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of [  F] -L-Fluoroglutamine (S,R) injection and blood draws)
Subjects with any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.)
Subjects with any type of ferromagnetic bioimplant that could potentially be displaced or damaged
Subjects with permanent tattoo eye liner (may contain metallic coloring)
Known right to left cardiac shunt, bidirectional or transient
Willingness to comply with required follow up perometer and BIS measurements and completion of LEFT-BC questionnaire
Primary or secondary brain tumor (enhancing mass lesion +/- nonenhancing abnormality), known or suspected, located near (<  cm) any portion of the motor cortex, motor pathway, language cortex, or language pathway, or other clinically relevant brain areas, as determined on anatomical images
Less than  mm distance to a structure (gastrointestinal [GI] or biliary tract), that cannot be protected from the ablation injury with technical modifications such as hydro or air dissection\r\n* This will not be considered exclusion when IRE is used
Known hyperthyroidism
Patients must document their willingness to be followed until death or time of progression; time on study for purposes of adverse event reporting however will be from the time of injection of FMISO to  hours after the FMISO injection (completion of drawing of second set of laboratory studies in initial  patients); by signing informed consent, the patients are documenting their agreement to have clinical and radiographic endpoints and the results of histopathologic tissue analysis and other laboratory information entered into a research database
Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the MR
Patients must be able to lie still for the tests; their girth and weight must be suitable to enter the gantry, which varies per tomograph
Patients with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to each set of multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness
Known reaction to gadopentetate dimeglumine (Gd-DTPA)
Non-smoker
Plan to receive dental treatment during the study dates
Metals or any conditions (e.g. hip prosthesis) that can distort the local magnetic field
African-American or white men (Hispanic or non-Hispanic)
Have a condition or impediment (i.e., insect bites, poison ivy, open sores, chafing of the skin, scar, tattoos, moles, etc.); that could interfere with the intended field of view (within one probe length or  cm of the nodule),
Subjects with prior complete or partial hysterectomy involving removal of the cervix
Evidence of calcifications on mammogram
Patients with injection of other radioactive material within  days
neurostimulator,
have engaged in occupations or received orthodontic work which may have caused lodging of ferromagnetic materials in the body;
are claustrophobic;
are diabetic;
Must have surgically curable disease as evaluated by initial imaging by our UNC surgeons
Incarcerated or otherwise institutionalized at time of enrollment
Gamma-glutamyltransferase (GGT) > . x ULN
Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Hypersensitivity to dextran and/or modified form thereof
Has a known hypersensitivity to indocyanine green (ICG), methylene blue and Technetium TC-m colloid (mTc-colloid)
Patient with right-to-left, bi-direction, or transient right-to-left cardiac shunts
Off Sandostatin (octreotide acetate)-long acting release (LAR) >  weeks and off immediate release (subcutaneous) for  hrs prior to Ga-DOTATOC PET-CT
No therapy other than Sandostatin since last Octreoscan + diagnostic CT
=<  total cores positive
Conditions which make repeat TRUS biopsies not feasible
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Subjects who lack fitness for flexible bronchoscopy as determined by the physician performing the bronchoscopy before the procedure
Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Surgical absence of a rectum or the presence of a rectal fistula
Actively taking blood thinning agents (with the exception of low dose aspirin [ mg] Plavix, Coumadin, etc.) or severe comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g., coagulopathy
Patients with a pure ground-glass opacity identified on chest CT
Lack fitness to undergo flexible bronchoscopy as determined by the bronchoscopist prior to procedure
Presence of altered anatomy (Billroth II or Roux-en-Y reconstruction)
Intrahepatic biliary strictures or strictures within  cm of the ampulla
Patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm
Inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of F SKI- injection and blood draws)
Participants with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Clinically unstable, severely ill, or moribund
Contraindication to furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs; (Note: This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction is available for the used PET device)
Able to remain still for duration of each imaging procedure (about one hour)
Patients must have their echocardiograms performed such that strain may be calculated using either GE or Tomtec software
Off Sandostatin (octreotide acetate)-long acting release (LAR) >  weeks and off immediate release (subcutaneous) for at least  hours (hrs) prior to Ga-DOTATOC PET-CT imaging
Participants who are not considered candidates for ado-trastuzumab-emtansine
Patients who are claustrophobic
Patients unlikely to be optimally debulked at surgery (tumor implants in difficult to reach places [i.e. falciform ligament or porta hepatitis], suprarenal retroperitoneal lymphadenopathy)
Patients who undergo intra-arterial hepatic mTc MAA evaluation in anticipation of Y microsphere radioembolization
Subjects who have difficulty lying flat on their back for extended periods of time
Patients who have a serious reaction with the test/loading cetuximab dose for which they were not able to receive the full dose
Patients receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Determination by the surgeon that the neoplasm is non-palpable; a patient with a palpable hematoma from core biopsy, but a non-palpable neoplasm, will be eligible for study
History of median sternotomy
Enrollment will not be restrictive and will encompass patients who are women, minorities and other underrepresented populations
Normal subjects could be recruited from the population of patients routinely undergoing PET CT for assessment of a pulmonary nodule (presumed unlikely to have marrow disease); alternatively, normal subjects could be recruited from the cohort of myeloma patients termed asymptomatic who are assumed not to have marrow involvement
UNC patients must co-enroll into LCCC for collection of tissue samples
Prior use of radiosensitizers, Gliadel wafers, or other interstitial intracranial treatments
Prior treatment with an antibody-drug conjugate (ADC) that consists of an exatecan derivative that is a topoisomerase I inhibitor (eg, DS-a)
Prior treatment with CD or signal regulatory protein alpha (SIRP?) targeting agents (with exception of HuF-G for patients in the Rollover cohort).
Must be:
Histopathologically confirmed mycosis fungoides or Szary syndrome (CTCL stage IIB or greater according to the European Organization for Research and Treatment of Cancer/International Society for Cutaneous Lymphomas [EORTC-ISCL] consensus classification) at study entry with progressive, persistent, or recurrent disease who have no available remaining standard therapeutic options (i.e., Refractory) as determined by the Investigator.
Acyclovir resistant mucocutaneous HSV infection based on clinical failure (no improvement after at least  days with FDA approved high doses with acyclovir, valacyclovir or famciclovir) requiring switch to foscarnet treatment.
the use of one of the following: diaphragm, Lea's shield, FemCap, sponge, and
ACV-resistant and foscarnet-resistant/intolerant mucocutaneous HSV infection based on clinical failure (no improvement after at least  days of foscarnet therapy or intolerance to foscarnet requiring cessation of foscarnet treatment) or result from genotypic/phenotypic testing.
Exposure to specific substrates of the drug transporters OATPB, OATPB, MATE and MATEK within the appropriate wash-out period (a minimum of  x reported elimination half-life) before the first dose of study treatment
Previous meningioma progression during treatment with other mTORC/ inhibitors (but not mTORC inhibitors such as everolimus or other rapalogs)
Unable to receive prophylactic treatment for pneumocystis, herpes simplex virus (HSV), and herpes zoster (varicella zoster virus [VZV]) at start of treatment
Sustained platelet count ?,/L, and/or sustained Hgb ? g/dL and/or sustained ANC ?/mm, which is considered by the Investigator as related to the nature of the graft (higher transient levels following occasional blood product transfusions are allowed).
Histopathological evidence of glioblastoma (WHO grade IV) on a progressive tumor specimen after treatment with temozolomide or PCV chemotherapy; the diagnosis of glioblastoma must be confirmed on central review by a study-designated neuropathologist at New York University Langone Medical Center (NYULMC) at screening; exceptions to this eligibility include the following:\r\n* Any progressive glioma with IDH or IDH mutation, regardless of WHO grade, histopathological diagnosis, or prior therapy, will be eligible if the progressive tumor specimen is found to have one of the genetic alterations below:\r\n** >=  somatic mutations per Mb by whole-exome sequencing\r\n** High mutation burden or microsatellite instability (MSI) identified by Foundation Medicine panel next-generation sequencing (FoundationOne, FoundationOne CDx); Foundation Medicine's threshold for high mutation burden (HMB) in their panel next generation sequencing (NGS) assays is >=  somatic mutations per megabase (Mb); Foundation Medicine's panel NGS assay has been validated by whole-exome and whole-genome sequencing to correlate tightly with tumor mutation burden (R^ = .)\r\n** Mutation in a mismatch repair gene or other genes known to be associated with hypermutator phenotypes or microsatellite instability, including but not limited to MSH, MSH, MLH, POLE, PMS, POLD as determined by validated methods\r\n** Microsatellite instability as identified by polymerase chain reaction (PCR) or other validated methods\r\n* Progressive oligodendroglioma (with p/q codeletion) that has hallmark histopathological features of glioblastoma (i.e. necrosis, pseudopalisading necrosis, or microvascular proliferation) is eligible as IDH/ mutant, p/q codeleted oligodendrogliomas that have progressed after chemotherapy have been shown to develop hypermutation phenotype
Advanced low or intermediate grade gastroenteropancreatic or lung or thymus neuroendocrine tumor (NET), or NET of unknown primary, progressed after at least  line of anticancer therapy (unless no standard treatments available or such treatments are deemed not appropriate)
Prior use of lorlatinib (PF-)
Be of nonchildbearing potential:
Able to remain still for duration of each imaging procedure (about one hour)
Patients meeting the criteria for enrollment on research protocol - to receive DSTPS antibody drug conjugate (ADC) (the therapeutic ADC based on MSTPA) will be preferred patients for this study; patients that are to receive DSTPS will not be injected with DSTPS until imaging with Zr-DFO-MSTPA is finished, approximately  week
TREATMENT GROUP: Premenopausal or peri-menopausal, defined by having regular menstrual cycles that are regular but may have >  days variability in the length of consecutive cycles (irregularity caused by hormonal contraceptive use is acceptable if the subject is  years of age or younger)
TREATMENT GROUP: Elect to undergo, but have not yet started tamoxifen therapy
NORMAL GROUP: Premenopausal or peri-menopausal, defined by having regular menstrual cycles that are regular but may have >  days variability in the length of consecutive cycles (irregularity caused by hormonal contraceptive use is acceptable if the subject is  years of age or younger)
Have engaged in occupations or activities which may cause accidental lodging of ferromagnetic materials, or have imbedded metal fragments from military activities
Have received orthodontic work involving ferromagnetic materials
Are claustrophobic
Patients who have gynecologic malignancies involving the upper, middle and/or lower third of the vagina or are undergoing pelvic exenteration
Subject weighs more than  pounds; (subjects who weigh more than  pounds will not be able to fit inside the imaging machines)
Uncontrolled or unstable hyperthyroidism or Graves disease
Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc)
Must have been listed on the regional OPTN/UNOS liver transplant wait list with HCC-exception Model for End Stage Liver Disease (MELD) points prior to enrollment in this trial OR \r\n* Site principal investigator (PI) or designated site co-investigator determines whether patient is likely to meet all criteria for being listed on the regional OPTN/UNOS liver transplant waitlist with HCC-exception MELD points, but has not yet been listed with UNOS UNet\r\n* Investigator has completed and signed the Declaration of Intent to List source document declaring that the patient will likely meet all wait list criteria\r\n* Participants listed with the intent to undergo either deceased donor transplant or live donor adult liver transplantation (LDALT) are eligible for this trial
Renal insufficiency at the time of enrollment, as determined by eGFR  to  mL/min/. m^ by the MDRD model based on a serum creatinine level obtained within  days prior to enrollment, unless permitted by the institutions policy and/or American College of Radiology (ACR) guidance for risk reduction strategies
Patients must have previously responded to a molecularly-targeted therapy and subsequently developed resistance, or have an analogous clinical situation in which determining their molecular genotype is of interest clinically and/or scientifically
Patients who have upper tract TCC
Subjects with clinically significant signs of uncal herniation, such as acute pupillary enlargement, rapidly developing motor changes (over hours), or rapidly decreasing level of consciousness, are not eligible
Has the following International Federation of Gynecology and Obstetrics (FIGO) IA-IIAstaging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.
Subjects who have a serious reaction with the test/loading cetuximab dose for which they were not able to receive the full dose
Subjects receiving class IA (quinidine, procainamide) or class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents
Diagnosed with mCRPC and painful bone metastases, referred for Xofigo (radium Ra  dichloride)
Able to remain still for duration of the imaging procedure (about one hour)
evaluation of F-FSPG safety and tolerability will not be confounded by the other investigational PET or SPECT tracer
a minimum of two days (or longer as necessary based on radiological half-life) have elapsed between investigational PET or SPECT tracer administrations to allow acceptable clearance of the tracer
Patients who are pregnant or lactating or who suspect they might be pregnant; serum pregnancy tests will be obtained prior to the baseline and subsequent multi-tracer PET scans in female patients that are not postmenopausal or surgically sterile
Able to remain still for duration of each imaging procedure (about  minutes)
Subjects who have undergone prior radioembolization
Subjects who exhibit noticeable anxiety, claustrophobia, or vertigo when moved into the scanner
Patients who have any type of ferromagnetic bioimplant that could potentially be displaced
Patients who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix
Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced
Subjects who exhibit noticeable anxiety and/or claustrophobia or who exhibit severe vertigo when they are moved into the magnet bore
No significant esophagitis (LA grade < B, C and D).
Patients without visible BE at time of study EGD.
Patients for whom use of the NvisionVLE device would be in conflict with the Instructions for Use (IFU).
Patients must be assessed by surgeons and are considered surgically resectable
Previous hip replacement surgery, metallic hip replacement or extensive pelvic orthopaedic metal work
Known bleeding disorder that cannot be sufficiently corrected with co-fact or fresh frozen plasma (FFP)
Primary tumor of any T-stage within or touching the zone of the proximal bronchial tree, defined as a volume  cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, bronchus intermedius, right middle lobe bronchus, lingular bronchus, right and left lower lobe bronchi)
Prior diagnosis of cancer treatment induced left ventricular dysfunction (CILVD) with recovered LVEF (i.e. improved to > %) for at least  months with recommended HF medications (ACE-I or ARB and/or beta [B]-blocker)
Absence of other causes of cardiomyopathy (e.g. ischemia, hypertension, amyloidosis, or hemochromatosis) per chart review of the clinicians documentation
Residence within the United States
Able to remain still for duration of each imaging procedure (about one hour)
Hemosiderosis/hemochromatosis
Be using more than one antihypertensive drug
Prior SLN dissection
Heart rate <  prior to propranolol
Referred to University Hospitals Case Medical Center (UHCMC) Nuclear Medicine for methylene diphosphonate (MDP) bone scintigraphy
For salvage setting patients, lack of documented treatment or management recommendation on file
Patients with (any one of the following):\r\n* Suspicion of NET on axial imaging (CT/magnetic resonance imaging [MRI]/fludeoxyglucose [FDG] PET) and/or\r\n* Biochemical evidence of neuroendocrine tumor (serum/urinary) based on elevated levels of chromogranin A, pancreatic polypeptide, neuron-specific enolase, vasoactive intestinal polypeptide, serotonin (urinary -hydroxyindoleacetic acid [HIAA]), gastrin, somatostatin, catecholamines, metanephrines, calcitonin, fasting insulin, C-peptide (proinsulin), glucagon and/or\r\n* Familial predisposition to NET in patients with multiple endocrine neoplasia type  (MEN) and Von Hippel-Lindau (VHL) (symptomatic and/or asymptomatic cases; with biochemical or anatomic imaging evidence of disease)
Patients must be able to perform ABC procedures
Able to remain still for duration of each imaging procedure (about  minutes)
Patients with hypermetabolic activity and uptake in the neck, axilla, breast and inguinal region on scan, defined visually as significant lesion suspicious for malignancy by a nuclear medicine physician or trainee; (we will include a subset of patients with normal lymph nodes during screening; this subset of patients will be imaged as a negative control for this study)
Patients imaged for Cerenkov luminescence are going to be required to be in a darkened enclosure for at least  minutes and sit still during image acquisition, potentially covered by a dark cloth in case that the ambient light level remains too high for the ultra-sensitive camera; any conditions that would prevent this will exclude the patients
Right-hand dominance
Planned treatment with standard agents or investigational agents that can potentially activate herpesvirus TK, including but not limited to the following; concurrent radiation therapy is permissible:\r\n* Platinum compounds (for example, cisplatin, carboplatin)\r\n* Anthracyclines (for example, doxorubicin or pegylated doxorubicin)\r\n* Tubulin disrupting agents (for example, vincristine, vinblastine)\r\n* Rituximab\r\n* Gemcitabine\r\n* Cytarabine\r\n* Histone deacetylase inhibitors\r\n* Bortezomib; Note: patients who would not receive bortezomib as part of their usual care may receive a one-time dose of bortezomib for the purpose of imaging with I-FIAU and FIAU-PET-CT
Patient has contraindication to either endobronchial ultrasound or mediastinoscopy such as: history of bleeding diathesis, latex allergy, mediastinoscopy, mediastinal nodal resection, tracheostomy
An intact cervix.
Known history of ablative or excisional therapy to the cervix within the preceding  months.
Patient who presents to clinic with a history of hoarseness and voice changes and are noted to have changes to their vocal folds that are concerning for the possibility of dysplasia or early stage malignancy
Require more than one localization needle for localization of the surgical target (bracket localization)
Urine culture positive for significant urinary tract infection (UTI)
Extremely poor intravenous access, prohibiting the placement of a peripheral IV line for injection of radiotracer
Corrected vision is worse than / unless due to cataracts.
Previous treatment with a selective FGF-FGFR targeted therapy and/or selective pan-FGFR inhibitor . Use of any vaccines against infectious diseases (eg, influenza, varicella) within  weeks ( days) of initiation of study therapy . Presence of gastric or esophageal varices requiring active treatment . A clinically significant ECG abnormality, including a marked baseline prolonged QTc interval (eg, a repeated demonstration of a QTc interval > ms) . Significant cardiovascular impairment or any other major illness, medical condition . Males who have not had a successful vasectomy (confirmed azoospermia) or they and their female partners do not meet the criteria . Hypersensitivity to the study drug or to any of the excipients . Intolerance or hypersensitivity to both CT and MRI contrast material that would preclude the ability to acquire the triphasic liver imaging required by the protocol . Participants with inorganic phosphorus > upper limit of normal for the institution . Participants with total or ionized serum calcium > upper limit of normal for the institution . Participants with endocrine changes that may result in increases in calcium or phosphate, including but not limited to hyperparathyroidism and tumoral calcinosis . Participants with past medical history and/or current evidence of tumoral calcinosis or tissue calcification . Participants who take calcium, vitamin D or systemic corticosteroids
Active infection, with the exception of resolving cholangitis, will preclude enrollment on the study; preoperative interventions can only be initiated when acute cholangitis has resolved*
Regular use of thiazide diuretics (i.e., hydrochlorothiazide), which can lead to hypercalcemia, and unwillingness or inability to discontinue or switch to an alternative anti-hypertensive agent
History of reactive hypoglycemia
History of  alpha reductase inhibitors prior  months
Vegetarians
Use of metronidazole or antabuse during the study
Participants not capable of keeping moderately still for the imaging portion of the study session (~ hour for imaging)
Pregnancy or active nursing of an infant
Have a confirmed diagnosis of type I endometrial cancer (endometrioid) based on pre-operative endometrial biopsy or dilation and curettage (D&C)
Uncontrolled hypothyroidism
Regular use of laxatives (e.g. Ex-lax, Dulcolax, Miralax) that may affect the microbiome >=  days a week
Able to remain still for duration of each imaging procedure (about one hour)
Maintain a consistent general diet without significant variation
Able to deliver four fresh (within  hours) stool samples to Mayo Clinic Rochester over a four month period
Only individuals who can understand and give informed consent will be eligible to participate in this study; individuals who are considered to be mentally disabled will not be recruited for this study; all subjects must understand and be able to give informed consent; we will not be using specific methods to assess decisional capacity; all individuals will be told that their choice regarding study participation will in no way change their access to clinical care; this should negate any undue influence or coercion; children, fetuses, neonates, or prisoners are not included in this research study; women of child-bearing potential will have a urine pregnancy test at the time of screening
Able to read adequately to complete the survey and related study documents or give consent
Unable to read for comprehension or completion of study documents
Patients who have too much esterase as determined by a pre-screen dose, with a conversion rate yielding concentration of CPT >  ng/ml in vitro.
Cachexia
Any NSAIDs or omega- free fatty acid supplementation within the last  days
Cancer/testis antigen B (NY-ESO-) specific T cell therapy within  year of starting on the trial
Known prosthetic devices that would prohibit imaging of lesion of interest due to radiographic artifact
Participants cannot be taking the following medications because of major pharmacokinetic interactions with celecoxib while being enrolled in the study: abciximab, argatroban, bivalirudin, cilostazol, dabigatran, etexilate, dipyridamole, fondaparinux, heparin, lepirudin, pemetrexed, protein C, rivaroxaban, sibutramine, Ticlopidine, tirofiban, vilazodone and warfarin
Use of > % of cigarettes in the form of roll-your-own cigarettes unless they are machine rolled and include a filter
If is neither a citizen of the United State nor a Permanent Resident Alien (Green Card holder) (to facilitate compensation of participants)
All patients with transdermal patches (e.g.; fentanyl, Lidoderm, scopolamine, etc)
Any evidence of lymphatic or hematogenous metastases
Hospitalization within  days of enrollment
Non-diabetic and obese
Capable of performing a simple test for assessing cardiopulmonary fitness
Patients availability to check their weight twice per week, during the study duration
Known sarcomatous histologies
Willingness to take kava supplement as instructed
A rise in prostate-specific antigen (minimal value  ng/milliliter (mL); ? consecutive rising values)
May continue ongoing antiestrogen
Patients found to require sternocleidomastoid muscle or internal jugular vein excision
No restrictions based on gender or racial/ethnic background
Have predisposing conditions that are consistent with development of aneurysms of the ascending aorta or aortic stress (for example, family history of aneurysms, Marfan-Syndrome, bicuspid aortic valve, evidence of damage to the large vessels of the heart documented by computed tomography (CT) scan with contrast).
Biliary obstruction for whom a biliary drain or stent has been placed are eligible, provided that the drain or stent have been in place for at least  days prior to the first dose of crizotinib, and the liver function has stabilized as defined by  measurements at least  days apart that put the patient in the same hepatic dysfunction stratum as defined in Section .
Be colorblind
Patients must not have any known contraindication to CSFs prior to registration, including prior hypersensitivity to Escherichia coli-derived proteins, filgrastim, pegfilgrastim, or tbo-filgrastim
Site Coordinator identification and contact with as many as possible of the sites relevant healthcare providers and staff regarding participation in the study intervention; relevant providers may include physicians, nurse practitioners, physician assistants, patient navigators, nurses and other staff who interact directly with breast cancer patients
Received HBOC genetic counseling or mutation testing prior to diagnosis; if the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/multisite  or comprehensive sequencing) and documentation is provided, they remain eligible
Radiographic confirmation of MBO is required prior to registration; scans may have been done before or after admission; scans done prior to admission must have been completed within  days prior to admission; computed tomography (CT) scans are preferred
Patients must consent and provide both their contact information and that of their representative for a monthly -hour dietary recall phone call to be conducted by the Arizona Diet, Behavior and Quality of Life Assessment Lab
African American or Black race
Scheduled prostate cancer consultation to be the first consultation after diagnosis (i.e. not a second-opinion or a consultation following previous discussions of treatment options)
Scheduled to receive an allogeneic HCT at the Dana-Farber Inpatient Hospital or Brigham and Women's Hospital (BWH) under the care of a DFCI physician
Residence in New York, Maine, New Hampshire, Vermont, Connecticut, Rhode Island, or Massachusetts
Does not live in New York, Maine, New Hampshire, Vermont, Connecticut, Rhode Island, or Massachusetts
Registered Nurse (RN) or Doctor of Medicine (MD) degree.
Signed informed consent for patients participating in the paper based survey
CLINICIAN: MSK medical oncology HCPs - specifically identified as attendings, fellows, or advance practice professional (APP)  either a nurse practitioner (NP) or physician assistant (PA) from gastrointestinal (GI), genitourinary (GU) oncology, lymphoma, or bone marrow transplant (four services with a large number of geriatric patients)
AIM : Difficulty reading due to poor eyesight (i.e., reporting more than only a little difficulty)
At risk for cancer-related infertility, as assessed by their clinician(s), including the oncofertility specialist
PROVIDER TRAINING
Patients who meet this criteria will be referred to OHSU Health Promotion Sports Medicine researcher, Carol DeFrancesco, to complete assessment using stages of change tobacco use readiness ruler and question set
PATIENTS: A prognosis of  months or less based on the treating oncologists assessment
Prior allogeneic BMT
Board-certified oncologists who practice in any setting in the United States and have a smartphone
Dana Farber Cancer Institute (DFCI) oncologists are excluded from this study; this includes DFCI satellite sites, non-DFCI Dana Farber (DF)/Harvard Cancer Center (HCC) sites, and other non- DF/HCC sites that are under the DFCI Institutional Review Board (IRB)
Pennsylvania or New Jersey residents\r\n* Telehealth visits for New Jersey residents will only be performed by physicians with a current medical license issued by the state of New Jersey
Decisionally impaired patients
Patients not residing in Pennsylvania or New Jersey
Staff of the Department of General Internal Medicine (usability test)
Adequate cognitive status as determined by a research coordinator at recruitment; to assess the participants capacity to take part in the interview, the interviewer will note and comment on the participant's spontaneous speech and capacity to write date at the time of consent; participants should be oriented to person, place, date, time, and events (RCT)
Living in the community (not institutionalized, etc) (RCT)
Disease duration  years or less (RCT)
Familiarity with and participation in social media (e.g. Facebook) (usability test and RCT)
Hospitalized (RCT)
Agreed to receive home healthcare
Located in the New York City (NYC) Borough of Manhattan, Queens, Brooklyn, or the Bronx
Has a roster of at least  drivers
Planning on remaining in NYC for at least  year, (with no vacations or trips to exceed two months)
Licensed taxi driver for at least three months
Affiliated with a NYC garage
Has not seen a doctor for an annual physical within the last year, not including an annual required physical for work, at baseline
TIPs INCLUSION: Planning on remaining in NYC for at least  year, (with no vacations or trips to exceed one month)
TIPs INCLUSION: Licensed taxi driver for at least two years
TIPs INCLUSION: Affiliated with a NYC garage
TIPs INCLUSION: As per study team judgment, based upon the TIPs screening tool, is socially active among fellow taxi drivers, cares about health issues, and wants to help others improve their health
Does not agree to holding screening health fairs on location (e.g. does not sign enrollment form, or send email confirming agreement, or verbally agree to study team management)
Part-time driver (drives fewer than  hours per week); although it is highly unlikely for NYC taxi drivers to work for multiple garages at study baseline, drivers may switch jobs and/or their garage base affiliation while participating in this study; new jobs and/or garage base affiliations will be tracked during follow-up assessments and noted for potential limitations with study retention and intervention contamination; drivers will be allowed to continue the study even if they are no longer working with the initial garage base
Newly diagnosed with colorectal adenocarcinoma at Ohio State University (OSU) (or a participating Ohio hospital) with sufficient tumor available to perform the microsatellite instability (MSI) test, regardless of age at diagnosis or family history
First-degree relatives of the cases who test positive for LS
First-degree relatives of the cases who test negative for LS
Individuals who are cognitively impaired
Orthopedic, neurologic, or musculoskeletal disability that would interfere with the functional task of standing on a weight scale (Pre-pilot phase, Arm )
No home WiFi connection (PCS study)
Have at least one of  pre-defined anatomic mucosal subsites on view
Must be able to perform oral rinse
physiologic condition that precludes the use of an oral rinse
Presence of mucosal ulceration at baseline
Oncology providers and staff at Moses Cone Health System (MCHS)
Oncology providers and staff at the University of Pittsburgh Medical Center (UPMC)
African American or White patients who reside in Guilford County, NC or Allegheny County, Pennsylvania (PA)
Uninsured or Underinsured
Fecal Occult Blood Test (FOBT) or fecal immunochemical test (FIT) not completed in the last year
Complete contact information on file
Insured but not underinsured
Recruit for at least  months at the point of enrollment
Missouri residents
Calling for themselves
Interested in trying to quit in the next  months
RETROSPECTIVE STUDY POPULATION
Admitted to Seidman th floor of the Seidman Cancer Center
PROSPECTIVE STUDY POPULATION
Residents covering the gynecologic oncology service
Part  only: did not complete part  of the study
Patients have never done the ESAS before
Inclusion and exclusion criteria for the ETRIC randomized study will be the same as the\n        eligibility criteria for the BMT CTN parent studies. Please refer to BMTCTN\n        (NCT) Reduced Intensity Regimen vs Myeloablative Regimen for Myeloid Leukemia or\n        Myelodysplastic Syndrome, BMTCTN (NCT) Double Cord Versus Haploidentical,\n        BMTCTN (NCT) Novel Approaches for Graft-versus-Host Disease Prevention Compared\n        to Contemporary Controls, and BMTCTN (NCT) Calcineurin Inhibitor-Free\n        Interventions for Prevention of Graft-versus-Host Disease for detailed eligibility\n        criteria.\n\n        Notes: Enrollment on the BMT CTN  trial (NCT) was closed to further accrual on\n        April , . Enrollment on the BMT CTN  trial (NCT) completed accrual on May\n        , .\n\n        Additional inclusion criteria specific for the ETRIC study will include:\n\n          . Adult patients (?  years)\n\n          . Speaking and reading proficiency in English (as most of this study's instruments have\n             not been translated and validated in languages other than English)\n\n          . Willing and able to provide informed consent\n\n          . Stated willingness to comply with study procedures and reporting requirements\n\n        Exclusion Criteria: N/A
Charts eligible for audit after completion of the educational initiative will be for those CRC and NSCLC survivors presenting for follow-up after the initiative has been completed by site health care providers
Participants will be patients scheduled to visit the Barnes-Jewish Hospital (BJH)/Washington University (WU) Department of Otolaryngology clinic for management of thyroid disorders (ranging from benign to cancerous nodules or masses) that will involve surgical interventions of complete or partial thyroidectomies
CLINICIANS:
Ability to understand and the willingness to use the PMSA on the patients personal smartphone
Patients who do not own smartphones or who do not use them for more than email, texting and calling
Patients who are unable to successfully respond to the PMSA alarm and properly enter their data
Willingness to try novel cigarettes
Active plans to quit or actively seeking smoking cessation treatment in the next  months. (Subjects are permitted to quit during the study, and this will be assessed and analyzed, but those with stated active intention to quit at the time of screening will not be included.)
Current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report (e-cigarette users will be excluded if their average monthly use exceeds half of their average monthly use of conventional tobacco cigarettes)
Other household members are participating or have participated
Active plans to leave the country in the next . months
Thrombocytopenia <  x ()/L (< ,/L) at baseline evaluation.
Current treatment with lithium. Drug interactions between filgrastim and lithium, which may potentiate the release of neutrophils, have not been fully evaluated.
Evidence of uncontrolled infection (oral/oropharyngeal or systemic), including oral herpes or unexplained febrile illness (? .F /.C) requiring systemic anti-infectives, within d of treatment Day .
Cardiac pacemaker with heart rate (HR) set at a fixed rate and treatment with concomitant medication that may limit increase in HR in response to hypotension (example, high-dose beta blocker).
Fatigue or lethargy
Cachexia or edema
Cough, dyspnea, airway hyperreactivity, or nasal inflammation
Arthralgia or myalgia
For Part B only, participants must have advanced or metastatic CRC expressing either low or high levels of GCC, for whom standard treatment is no longer effective or does not offer curative or life-prolonging benefit. A portion of participants should have tumors amenable for serial biopsy and a willingness to provide consent for pharmacodynamic assessment.
Access to a device capable of receiving plain text messages
A personal email address
Use or consumption of:
Photosensitizing drugs, medications which might generate fluorescence or according to label, might generate photochemical reaction. These include hematoporphyrin derivatives and purified fractions; Photofrin; and precursors of protoporphyrin IX (-Aminolevulinic acid) used in Gliolan or Hexvix
Patient dosed with UCART who completed or discontinued early from a sponsored or from any investigator-initiated study that tested UCART, or patients who were administered UCART under a special access scheme (compassionate use);
Individual test orders; defined as single biomarker assessment
Due to the complexity of state and federal requirements governing the participation\n             of prisoners in research, prisoner-patients shall not be approached for participation\n             in the Registry.
The patient must be able to communicate and understand/complete forms/instructions, and be able to provide informed written consent prior to enrollment; patients may have the assistance of an interpreter or surrogate when completing forms/surveys as needed
Unable to read for comprehension or completion of study documents.
Patients who have not achieved a -log reduction in BCR-ABL transcript levels compared with baseline as determined by local standards or > % IS [International Standard]) documented at .-. months since the initial start of dasatinib therapy.
Minimum of  calendar years of nilotinib treatment with at least the last  months of nilotinib treatment prior to pre-screening at approved total dialy dose of  mg BID or at a reduced dose of  mg QD if required from the perspective of tolerance for BCR-ABL positive CML in documented chronic phase at the time of diagnosis
Evidence of typical BCR-ABL transcripts (ba and/or ba) at the time of CML-CP diagnosis i.e. prior to first start of TKI treatment which are amenable to standardized RT-PCR quantification\
Potassium (suggested keep to prevent issues with QT and/or rhythm abnormalities)
Magnesium (suggested keep to prevent issues with QT and/or rhythm abnormalities)
poor cytogenetics
SCLC or PAC that is advanced or has spread to other parts of the body
Subjects who will have administration of methylene blue or any blue dye used for sentinel node mapping procedures.
able to stand independently
Use of any ongoing medications which might generate fluorescence or, according to the medication label, might generate a photochemical reaction. These include haematoporphyrin derivatives and purified fractions, Photofrin, and the precursors of protoporphyrin IX (-Aminolevulinic acid) used in Gliolan or Hexvix.
Heart rhythm disturbances
Inclusion Criteria:\n\n        Ostomy patients who:\n\n          -  Have healthy peristomal skin\n\n          -  Are within  weeks post op\n\n        Exclusion Criteria:\n\n        Ostomy patients who:\n\n          -  Have a fistula, wound, lesion or suspected infection in the peristomal area\n\n          -  Are in-patient in healthcare facility
Patients with bronchiectasis in the lobe of the intended implantation sites.
Inclusion Criteria:\n\n          . age  or older\n\n          . former smoker who quit during pregnancy as assessed via self-report\n\n          . smoked an average of greater than or equal to  cigarette per day during the year\n             prior to the current pregnancy\n\n          . gestational age <  weeks and ability to attend an in-person visit at University of\n             Texas MD Anderson Cancer Center (UTMDACC) between - weeks of gestational age\n\n          . can speak, read and write in English.\n\n          . must have a functioning home or personal cell phone\n\n        Exclusion Criteria:\n\n        ) high-risk pregnancy or known negative birth outcome
Inclusion Criteria:\n\n          . age  or older\n\n          . former smoker who quit during pregnancy as assessed via self-report\n\n          . smoked an average of greater than or equal to  cigarette per day during the year\n             prior to the current pregnancy\n\n          . gestational age <  weeks and ability to attend an in-person visit at University of\n             Texas MD Anderson Cancer Center (UTMDACC) between - weeks of gestational age\n\n          . can speak, read and write in English.\n\n          . must have a functioning home or personal cell phone\n\n        Exclusion Criteria:\n\n        ) high-risk pregnancy or known negative birth outcome
Use or consumption of any of the following substances:
Patients who are at least  years old, who have been identified by the BMT social worker as having a cancer or pre-cancer diagnosis and are Minnesota residents with potential legal needs (see the list below), expected to proceed to transplant, considered the primary client for legal services or are at least  years old and have a legal-designate.
The patient or legal designate must be able to complete study tools by the BMT social workers. Interpreters will be provided by UMMC for non-English speaking pt's and BMT social workers will assist patients who cannot read.
Patients must have interest in a legal consultation as specified by the I-Help model to receive free legal consultation.
Patients who do not have any identified any potential legal needs, or whose legal needs are beyond those covered in the I-Help model.
Patients who are not residents of Minnesota as CALL attorneys are only licensed to practice law in Minnesota.
Permanent or temporary housing available within a  minute (min) commute from the SCCA
Patients who are not candidates for RT/CRT treatment
Major physical disability which would prevent subject from transferring from a chair to a bed and sitting in an upright position
All subjects or legally appointed representatives/caregivers, must personally sign and date the IRB/IEC approved consent form before initiating any study specific procedures or activities.
Indication of systemic treatment for the relapsed EOC, FTC or PPC.
Agree to follow the CC- Pregnancy Prevention Plan (PPP)
Use or consumption of any of the following substances:
Subjects with congenital long QT syndrome or subjects taking Class IA, Class III or Class IC anti-arrhythmic medications will require a cardiologist's evaluation prior to eligibility assessment. subjects with cardiovascular diseases can be included as long as the benefits of androgen deprivation therapy outweigh the potential risk of cardiovascular events
Tissue must be available for genotyping or biopsy planned to obtain tissue for genotyping; biopsy requirement may be waived if not technically feasible and plasma genotyping reveals an eligible EGFR mutation (exon  del/LR); determination of technical feasibility must be made independently of plasma genotyping results
History or evidence of giant congenital melanocytic nevi, dysplastic nevis syndrome or xeroderma pigmentosum.
BPDCN
Hurthle cell
Insular
One or more measurable lesions that have progressed according to RECIST . within  months (an additional month will be allowed to accommodate actual dates of performance of screening scans, ie, within ? months) after Iodine- therapy, despite demonstration of radioiodine avidity at the time of that treatment by pre- or posttreatment scanning. These participants must not be eligible for possible curative surgery.
Unexplained/undiagnosed abnormal uterine bleeding (concern for undiagnosed endometrial cancer)
Had inadequate home environment or social support to safely complete the trial procedures
Has responded (achieved a CR or PR) to BV or BV-containing regimens, if previously treated with BV.
Known history of positive serum human ADA.
Elevated serum hCG (in cases of choriocarcinoma); elevated hCG or measurable disease (in cases of PSTT or ETT)
has a substantial probability to cause an irreversible injury to any tissue and/or
Positive HBs Ag or positive HBV viremia, Positive HCV viremia.
Has inadequate home environment or social support to safely complete the trial procedures