Clinical nodal staging of N or N disease
Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
Clinical or radiologic suspicion of residual MCC at the time of enrollment
Patients who are not appropriate candidates for participation in this clinical study for any other reason as deemed by the investigator
Lack of availability for immunological and clinical follow-up assessment.
Clinical Laboratories:
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Nodal disease as detected by clinical exam or CT
Parts A-C only: Patients must have biopsy proven MF, clinical stage I, II, or III (excluding visceral or nodal involvement), and must be refractory to or intolerant of established therapies for their condition
Patients with known leptomeningeal or brain metastases should be excluded from this clinical trial; imaging or spinal fluid analysis to exclude central nervous system (CNS) involvement is not required, unless there is clinical suspicion by the treating investigator
Pathologically confirmed squamous cell carcinoma of the oral cavity; clinical stage >= T (primary tumor greater than cm in size) and/or evidence of regional nodal involvement by clinical exam or imaging
Is currently receiving tazemetostat as either monotherapy or in combination with other approved drug(s) or investigational agent(s) on an Epizyme-sponsored clinical trial or any other clinical trial being conducted with tazemetostat that is not sponsored by Epizyme (including but not limited to, Investigator initiated trials). For subjects on combination therapy, the other therapeutic(s) must have been completed or will be provided by a source other than Epizyme
Has had an interruption of tazemetostat dosing of > days from the antecedent clinical study to starting the rollover study.
Clinical evidence of extra-capsular extension on scans.
PID deemed to be of sufficient past severity to warrant allo BMT, by meeting the two criteria below:\r\n* PID as defined by monogenetic mutation or, in the absence of a PID-associated genetic mutation, patients with an immune defect potentially amenable to allo BMT who meet the clinical history criteria below may be eligible upon discussion with the principal investigator (PI)\r\n** Mutations should be confirmed in a Clinical Laboratory Improvement Act (CLIA)-certified laboratory, if such testing is available\r\n** Patients without a mutation must be deemed eligible and appropriate for allo BMT by the PI; some patients may meet the clinical history criteria listed below, but will not be eligible if it is thought that their clinical history is due to a condition apart from an immune defect; in addition, patients with a PID of mild severity, such as those with selective immunoglobulin A (IgA) deficiency, may meet at least two of the clinical history criteria, but may be deemed inappropriate for allo BMT by the PI if it is felt that the risks of the procedure outweigh the severity of the disease\r\n** All mutation testing will be performed on National Institute of Allergy and Infectious Diseases (NIAID) protocols (such as -I- Detection and Characterization of Infections and Infection Susceptibility; PI: Steve Holland, with genetic counseling and education through these established protocols)\r\n* Clinical history of at least two of the following:\r\n** Life-threatening, organ-threatening, or severely disfiguring infection\r\n** Protracted or recurrent infections requiring unusually long or repeated courses of antibiotics\r\n** Infection with an opportunistic organism\r\n** Chronic elevation in the blood (>= documented elevations over a period of months or longer) of a latent virus (EBV, CMV, human herpesvirus [HHV], HHV, etc.)\r\n** Evidence of immune dysregulation, as manifested by autoimmune disease, atopy, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, granulomas, splenomegaly, or lymphadenopathy\r\n*** Patients with hemophagocytic lymphohistiocytosis or macrophage activation syndrome related to an underlying lymphoma with no other clinical history suggestive of a primary immunodeficiency will not be eligible\r\n** Hypogammaglobulinemia, dysglobulinemia, or impaired response to vaccination\r\n** Hematologic malignancy or lymphoproliferative disorder\r\n*** Tissue diagnosis should be confirmed by National Cancer Institute (NCI) Department of Pathology, if prior biopsies are available\r\n** Virus-associated solid tumor malignancy or pre-cancerous lesion\r\n*** Tissue diagnosis should be confirmed by NCI Department of Pathology, if prior biopsies are available
History or clinical suspicion of neurofibromatosis
Histologic diagnosis of malignant melanoma, stages IIB-IV is radiologically confirmed complete clinical remission (cCR) without clinical evidence of disease
Lack of availability of a patient for immunological and clinical follow-up assessment
Meets clinical diagnostic criteria for NF or genetically conformed NF
Current participation in any other interventional clinical study (except survival follow up).
Patient agrees to allow access to or provide clinical, imaging, and laboratory follow-up information for until time of death or data analysis, whether or not obtained from Johns Hopkins providers
RAPID EXPANSION PROTOCOL (REP) ELIGIBILITY: Clinical performance status equivalent to ECOG - at the last calendar clinical visit
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Clinical performance status equivalent to ECOG - at the clinical visit prior to lymphodepletion
Must have medical assessment consistent with prognosis for an expected survival of at least months and be clinically appropriate to receive a week hiatus from any cytotoxic treatment according to the best clinical judgement of the treating investigator.
Patients at risk of brain perfusion problems, e.g., carotid stenosis Uncontrolled hypertension requiring clinical intervention
Lack of availability of a patient for immunological and clinical follow up assessment
Clinical stage T (invasion into rectum or ureters) significantly increases the morbidity of the surgery\r\n* Patients with rectal or ureteral invasion will be considered to have unresectable disease
Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam
Clinical suspicion of active carcinoma in situ (CIS)
Lack of availability of a patient for immunological and clinical follow-up assessment
Baseline clinical stage of TN or inoperable T (unequivocal organ involvement) are to be excluded
Patient must have cholangiocarcinoma, gallbladder cancer or adenocarcinoma on liver biopsy with clinical features consistent with biliary primary/cholangiocarcinoma
Enrollment in any other clinical study from screening up to day ; enrollment in another clinical study not interfering with the endpoints of this study after day according to the judgment of the PI (or PI designee) will be allowed, but will be clearly documented in the case report form (CRF) and in the patients medical file
PHASE I STUDY ELIGIBILITY CRITERIA:\r\nConcurrent enrollment in another clinical study, unless it is an observational non-interventional clinical study or the follow-up of an interventional study
Insufficient breast imaging to judge clinical stage
Insufficient breast imaging to judge clinical stage
Patients must agree to appropriate clinical monitoring to receive the study regimens
Clinical T-classification T-
Clinical T disease
Clinical T tumor
Diagnosis of intrahepatic malignancy including but not limited to HCC; the histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers such as alpha-fetoprotein (AFP) and clinical findings
The patient must have documented disease limited to the peritoneal surface, amenable to complete cytoreduction indicated by:\r\n* Disease confined to the peritoneal surfaces\r\n* No parenchymal liver metastases\r\n* No evidence of clinical, biochemical or radiological biliary obstruction\r\n* Small volume of disease in the gastro-hepatic ligament defined by a < cm mass in the epigastric region on cross-sectional imaging\r\n* No clinical or radiological evidence of hematogenous or distant nodal metastasis
Patients must have at least one lesion which can be biopsied with acceptable clinical risk as judged by the clinical services who perform the biopsy
HAPLOIDENTICAL RELATED DONOR: No mutation in GATA, or in the case where the mutation in GATA has not been identified, but the recipient has the clinical syndrome of MonoMAC, the donor is required to have no clinical evidence of MonoMAC
Patients with resectable primary NSCLC who are undergoing surgery to resect T to T lesions OR any patients with clinical NI or N disease regardless of T-stage
Hematologic, renal, and liver function as determined by hematology and clinical chemistry tests will be acceptable if within +/- x of normal reference range as defined by the local hospital clinical laboratory; final decision on inclusion will be made by physician, concerning suitability of patient for surgery
Evidence of other significant disease including hematologic, renal or liver disease that is not explained by the patients current medical condition or concomitant disease, (i.e. levels of absolute neutrophil count [ANC], hemoglobin, platelets, clotting time, serum creatinine, etc); lab values, as determined by hematology and clinical chemistry tests, will be unacceptable if greater than +/- x of normal reference range as defined by the local hospital clinical laboratory; final decision on inclusion will be made by physician, concerning suitability of patient for surgery
Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
Acute IA defined as duration of clinical syndrome of < days.
Patients with clinical or radiological evidence of bone (>= sites, or predominantly lytic if < ) or other extranodal metastasis
Able to access ruxolitinib and/or background cancer therapy outside of the clinical study.
Any clinical event that would make TRC therapy inappropriate under the parent protocol
Subjects with the presence of a deep-seated intravascular source of infection (eg, endocarditis [as evidenced by vegetations on an echocardiogram or clinical suspicion] or septic thrombosis);
Patients must be co-enrolled on the companion protocol HCC - (Cell Harvest and Preparation to Support Adoptive Cell Therapy Clinical Protocols and Pre-Clinical Studies) and have available TIL cultures for therapy
Tis-T Urothelial cancer; patients will be stratified according to clinical stage
Lack of ability of a patient for immunological and clinical follow-up assessment
Inability to travel to the National Institutes of Health (NIH) Clinical Center
A diagnosis of CD established by referring physician(s) and confirmed by our review of the clinical presentation, clinical course, endoscopic and imaging findings, and histology of mucosal tissue specimens
Clinical performance status equivalent to ECOG - at the clinical visit prior to apheresis
Patients must have the ability and willingness to come to Clinical Center for bi-weekly follow-up appointments
Clinical stage Tis or Tmi N M
Availability of >= clinical vials of HSPPC-
No clinical deterioration at the time of registration/randomization
Documented clinical prostatitis requiring therapy within months prior to Treatment
allow bilirubin up to . times ULN if elevation is not associated with other signs of liver toxicity or can be explained by mechanical obstruction - requires clinical research physician approval.
Prior participation in an afatinib clinical study, even if not assigned to afatinib treatment
Have a clinical indication for treatment as determined by the investigator
Patients must not have clinical evidence of leptomeningeal disease (a spinal tap does not need to be performed)
A clinical indication for treatment as determined by the investigator
Patients (at institutions listed) must be offered the opportunity to participate in the optional S Co-Clinical PDX Model trial; participating patients must have a fresh tissue biopsy for the Co-Clinical PDX Model Trial completed within days of Step Randomization
Patient must not have obvious clinical progression of lymphoma after PBSCT as determined by the treating physician; NOTE: Restaging imaging studies are NOT required for eligibility if there is no clinical suspicion of progressive disease
Completed anastomosis must be at a location where a WCE can be performed to evaluate for a sub-clinical leak
Clinical stage T or less (pelvic MRI shows no rectal and ureteral invasion)
Clinical stage T (pelvic MRI shows rectal and/or ureteral invasion)
Lack of availability for immunological and clinical follow-up assessment.
Patients should have no significant worsening in clinical status for a minimum of days prior to enrollment
Circulating atypical cells of clinical significance
The patient was informed about the positive survival results of the RTOG - clinical trial, and has elected to forgo treatment with high-dose bicalutamide
Intrathoracic disease should be encompassable in acceptable radiation fields per investigator clinical judgement.
Clinical evidence of nephrotic syndrome prior to enrollment
No clinical ileus or subileus
PART A: Able (physically and financially) to travel to University of Colorado for clinical trial treatment
Prior randomization into this clinical study.
Lack of availability of a patient for immunological and clinical follow-up assessment
Patients with clinical evidence of disease beyond the uterus, including presence of suspicious aortic or inguinal nodes on imaging or clinical exam
a documented NTRK fusion and a clinical history of relapse following a response to a prior TRK inhibitor
Unifocal primary tumor based on imaging and clinical assessment; microscopic multifocality is allowed
Evidence of any other primary cancers or metastases; evidence of deep soft-tissue or bony invasion, which would preclude transoral minimally invasive surgery (TMIS) by clinical and/or radiographic exam
Subject with clinical or laboratory evidence of active DIC
Must have a confirmed diagnosis of WM as defined by the Second International Workshop, with a clinical indication for treatment.
Clinical diagnosis of acquired TTP (initial or recurrent), which includes thrombocytopenia and microscopic evidence of red blood cell fragmentation (e.g., schistocytes).
PRE-REGISTRATION INCLUSION CRITERIA: Diagnosis or clinical signs of urothelial carcinoma with clinical stage T or greater disease without lymph node involvement where neoadjuvant chemotherapy of cisplatin and gemcitabine are indicated
Subjects who have clinical evidence of carcinoid-induced heart disease
Able to safely complete the six minute walk test (MWT) as per attending physician's clinical judgement
No clinical indication for a peritoneal port
Clinical Laboratories:
Diastolic dysfunction felt to contribute to any clinical sign or symptom.
Has a significant clinical disease or condition
Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
There is clinical support for non-septic shock
Lack of availability of a patient for immunological and clinical follow-up assessment
Nodal disease as detected by clinical exam or CT
Have evidence of at least mild clinical depression on a standardized screening questionnaire
Subject must currently be participating in an ibrutinib clinical trial, deriving clinical benefit from treatment with ibrutinib in the opinion of the treating physician and do not have access to commercial ibrutinib within their region.
RT delivered by clinical setup only (no CT simulation)
PATIENTS AND PARTNERS: Not oriented to time, place, or person as deemed by the clinical team
Participants must have documentation of a plexiform neurofibroma (PN), based on either clinical exam or imaging
Clinical evidence of left heart failure as the main etiology for respiratory compromise
Follow-up either here at University of Southern California (USC) or centers that are available to transfer the requested clinical and radiological data
Clinical indication for a therapeutic liver resection
Have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation
No clinical or radiological evidence of hematogenous or distant nodal (retroperitoneal, pelvic, mediastinal, peri-portal or peri-aortic) metastasis
Participating in another clinical study with competing study outcomes
Clinical diagnosis of insomnia as identified through the screening Insomnia Severity Index score >
Have a clinical diagnosis of sleep apnea or restless leg syndrome
Clinical diagnosis of BRONJ subsequent to oral surgery as established by standard clinical protocol per American Association of Oral and Maxillofacial Surgeons (AAOMS) diagnostic criteria
CLINICAL PROCOTOL USED AS REFERENCE FOR THIS STUDY:
Patients deemed otherwise clinically unfit for clinical trial per investigators discretion
Patient not already seen by UKanQuit staff as part of the hospital based clinical service
Patients with ulcerative colitis in clinical remission (UCDAI) =< for at least months, regardless of how long ago they were diagnosed for UC
Any clinical worsening from pre-injectable HMA (HYPOMETHYLATING AGENT) baseline condition, including:
Subject has middle ear effusion upon clinical examination.
Sigmoidoscopy finding requiring clinical intervention
Occurrence of a varicella or HZ episode by clinical history within the months preceding the first dose of study vaccine/placebo.
Patients with operable focal or multifocal (T-T, stage II and IIIA invasive ductal carcinoma [all receptor phenotypes]), and who have completed neoadjuvant chemotherapy with a clinical complete response (by clinical examination)
Sufficient leukemia or MDS specimen available for profiling from diagnosis or recurrence OR bone marrow aspirate or blood draw planned for clinical care anticipated to allow collection of minimum specimen for testing; OR clinical tumor profiling using rapid heme panel available in the medical record
Patients receiving NAC and having a nodal complete clinical response as assessed by physical exam
For patients highly suspected to have aGVHD and requiring systemic therapy, informed consent should be signed after biopsy taken to support clinical diagnosis.
Normal tone on clinical exam
Adults with a suspected or confirmed lymphoma diagnosis and:\r\n* Who will undergo clinically indicated procedure potentially allowing for excess or discarded clinical specimens\r\n* Who must be able to understand and sign an informed consent
Agrees to allow access to clinical records regarding response to treatment and long term follow up
Clinical instability
Participants must have clinical characteristics consistent with IBC, characterized by a rapid onset of clinical findings exemplified as diffuse edema and erythema of the breast, often without a palpable mass
INR > . that cannot be corrected with fresh frozen plasma \r\n* For patients on Coumadin general clinical guidelines for IR ablation will be followed
Patient has participated in a clinical study of an investigational drug or device within months prior to screening CDU that may have an impact on clinical outcomes; and,
Patients must agree to allow access to clinical records regarding response to treatment and long term follow up
Neurofibromatosis type (NF) status will be determined by clinical exam or genetic testing
Patients must be clinical candidates for radioembolization with either SIR-spheres or TheraSphere due to metastatic or primary malignancies of the liver
Paraneoplastic syndrome of autoimmune nature, requiring systemic treatment or clinical symptomatology suggesting worsening of PNS
Negative nodal basin clinical exam
Patient must have surgical resection followed by systemic adjuvant therapy with an aromatase inhibitor (AIs) as part of planned treatment; any approved AI at standard clinical dosing may be used; in pre-menopausal patients, ovarian suppression with a gonadotropin-releasing hormone (GnRH) agonist will be started prior to initiation of the AI on a separate clinical trial in parallel with the imaging study
DYNAMIC COHORT: No clinical plan for biopsy or surgical procedure of known or suspected cancer
For clinical provider participants: Clinical provider at a Houston Area Location of MD Anderson assigned to the intervention
Inability to determine the QT interval on ECG, except for patients with evidence of measurable QT interval at the time of CML diagnosis (e.g. prior to first start of TKI treatment) and who have no documented clinical signs of cardiovascular disease and/or clinical signs of conduction abnormality.
Subjects participating in another clinical investigation at the time of signature of the informed consent.