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+History of active primary immunodeficiency
+History of leptomeningeal disease
+Patients with history of John Cunningham (JC) virus identified in the cerebrospinal fluid (CSF) or previous history of PML will be excluded from the study
+Known history of acute or chronic pancreatitis
+Participants may not have had any prior history of hypertensive crisis or hypertensive encephalopathy
+History of other previous cancer that would interfere with the determination of safety or efficacy
+History of additional risk factors for torsade de pointes
+Patients with a history of, or current grade 4 depression are not eligible
+History or evidence of cirrhosis
+History of more than 2 prior recurrences (including this recurrence) of GBM or AA
+History of hypertensive crisis or hypertensive encephalopathy within 3 years
+History of ventricular arrhythmia requiring medication
+Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 75% or greater
+No history of any prior stroke (hemorrhagic or ischemic)
+Patients must not have any history of primary immunodeficiency
+No history of cornea abnormalities
+Patients must be willing to provide prior smoking history as required on the S1400 Onstudy Form
+Patients must not have a history of immune-mediated pneumonitis or colitis that required interruption of therapy or treatment of steroids
+Patients with a known history of congestive heart failure (CHF), cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications, or with a clinical history suggestive of the above must have an electrocardiography (EKG) and echocardiogram (ECHO) performed within 42 days prior to registration and as clinically indicated while on treatment
+History of adrenal insufficiency or hypoaldosteronism
+Patient must have no prior history of RCC that was resected with curative intent within the past 5 years
+Patients with pre-existing significant central nervous system pathology that would preclude treatment with blinatumomab, including: history of severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination/movement disorder, or autoimmune disease with CNS involvement are not eligible; patients with a history of cerebrovascular ischemia/hemorrhage with residual deficits are not eligible; (patients with a history of cerebrovascular ischemia/hemorrhage remain eligible provided all neurologic deficits have resolved)
+Patients with a history or presence of significant ventricular or atrial tachyarrhythmia are excluded
+History of progressive multifocal leukoencephalopathy (PML)
+History of lymphedema involving the ipsilateral or contralateral arm at present or at any time in the past
+Subject has a history of seizures within 12 months of Cycle 1 Day-2 or diagnosed neurological condition placing subject at the increased risk of seizures.
+Active history of diverticulitis; note that diverticulosis is permitted
+History of cerebrovascular disease
+History or presence of sustained ventricular tachycardia
+14. History of primary immunodeficiency;
+History of exposure to the protocol specified doses of anthracyclines
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Patients with history of positive dihydropyrimidine dehydrogenase (DPD) deficiency
+Prior history of receiving pazopanib treatments
+History of calcium oxalate stones
+History of iron overload
+History of infusion reactions to any component/excipient of PRS-343.
+Significant history of medical conditions as listed in the protocol.
+History of exposure to certain cumulative doses of anthracyclines
+History of leptomeningeal disease;
+Previous history of autologous or allogeneic-HCT
+O2 saturation < 92% (on room air). 19. History of unexplained syncope, syncope from an uncorrected cardiac etiology, or family history of sudden death.
+Patients with a history of LVEF decline to below 50% during or after prior trastuzumab or other HER2 directed therapy
+Patients with a history of intolerance to trastuzumab (i.e. a grade 3 or 4 infusion reaction) are excluded; Note: patients with a history of mild infusion reaction to trastuzumab who have previously been successfully re-challenged after an infusion reaction with or without prophylactic medication are allowed
+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.
+Participant has a history of cholecystitis (subject with history of cholecystectomy will not be excluded), or has active gallbladder disease.
+Patients with a known history of seizures must have well-controlled seizures and may not be receiving enzyme-inducing anti-convulsants
+History of or high suspicion of Gilbert’s disease (safety run-in, Part B only)
+History of progressive multifocal leukoencephalopathy (PML)
+History of progressive multifocal leukoencephalopathy (PML)
+Concurrent febrile illness, active urinary tract infection, active tuberculosis, a history of hypotension or anaphylactic reactions
+History of known risks factors for bowel perforation
+Subject who has a history of second primary cancer within the past 5 years, with the exception of:
+Known history of acute or chronic pancreatitis
+Any history of HIV-1 associated encephalopathy
+History of grade III hemorrhagic cystitis due to prior cyclophosphamide chemotherapy
+Bone metastases with prior history of pathologic fracture, lytic lesions requiring an orthopedic intervention, or not receiving bisphosphonates or denosumab
+History of carcinomatous meningitis
+History of acute pancreatitis within 1 year of study treatment or a history of chronic pancreatitis
+History of gross hemoptysis.
+Prior history of anaphylaxis with this product type
+History of seizures
+History of thromboembolism within the past 5 years, history of catheter-related thrombophlebitis or other clinically significant thrombophlebitis are excluded.
+History of unprovoked venous thrombosis/thromboembolism
+A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
+History of acute pancreatitis within 1 year of study entry or history of chronic pancreatitis
+Patients with a prior history of documented pancreatitis are not eligible
+History of proximal urethral stricture requiring dilatation.
+History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
+History of any drug allergies or significant adverse reactions to any of the components of SM-88.
+Subjects with a history of hypersensitivity to phenytoin, its inactive ingredients, or other hydantoins; or a history of prior acute hepatotoxicity attributable to phenytoin.
+Known history of HBV or HCV infection.
+History of any major disease that might interfere with safe protocol participation, as determined by the investigator
+Have a history of prior radiotherapy to the whole pelvis.
+Must have RAS mutation and microsatellite stability status results as part of medical history
+Has a history of vasculitis.
+Known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
+History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
+HLA A2+ by deoxyribonucleic acid (DNA) sequence analysis (by history with documentation or as part of this study)
+Subjects with history of osteoporosis
+History of progressive multifocal leukoencephalopathy (PML).
+History of progressive multifocal leukoencephalopathy (PML)
+History of thrombocytopenia with complications
+Patients with a history of external percutaneous transhepatic cholangiography catheter placement.
+History of primary immunodeficiency
+History of Wilson's disease.
+History of hemochromatosis.
+A history of renal failure (unless recovered for at least 6 months), lactic acidosis, recurrent or severe hypoglycemia, or significant chronic obstructive lung disease; patients will not be excluded for reversible episodes of elevated creatinine due to hypovolemia
+A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
+Has a history of vasculitis.
+Patients with a history of hypertensive crisis or hypertensive encephalopathy within 6 months of study enrollment are not eligible
+History of carcinomatous meningitis
+Participants with known history of pancreatitis or progressive multifocal leukoencephalopathy (PML)
+History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
+History of splenectomy or planning to undergo splenectomy
+History of pituitary or adrenal dysfunction
+History of chronic pancreatitis.
+History of pericarditis
+History of receiving more than 2 classes of ADT
+History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+Recent history of thyroiditis
+Primary immunodeficiency
+History of prior allogeneic HSCT
+Known history of primary immunodeficiency
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+Presence or history of carcinomatous meningitis
+History of uveal melanoma
+History of allergies to any active or inactive ingredients of atezolizumab.
+History of high grade disease
+Subjects with a history of connective tissue disorders.
+Subjects with a history of depression, anxiety, or psychotic disorders (due to tolcapone adverse event profile).
+History of progressive multifocal leukoencephalopathy (PML)
+Prior history of lactic acidosis
+Any history of hemorrhagic stroke
+History or clinical suspicion of neurofibromatosis
+History of esophageal varices
+Known history of splenomegaly
+History of personal psoriasis.
+History of tuberculosis or history of purified protein derivative (PPD) positivity
+Patients with a known history of drug abuse or any chronic neurologic, psychiatric, endocrine, metabolic, immunologic, hepatic or renal disease (including a history of hemolytic uremic syndrome) that in the opinion of the Investigator would adversely affect study participation.
+A history of chronic diarrhea, colitis, or intestinal perforation that in the opinion of the investigator precludes utilization of idelalisib
+No other history of or ongoing malignancy that would potentially interfere with the interpretation of the pharmacodynamic or efficacy assay
+Patients who have a history of another primary malignancy from which the patient has been disease free for < 3 years at the time of enrollment, with the exceptions of: a patient with a familial cancer syndrome-associated NETs including MEN1, VHL, NF-1, and thymidylate synthetase (TS)
+Diverticulitis (either active or history of) within the past 2 years; Note that diverticulosis is permitted
+Have a history of thrombocytopenia with complications
+Known family history of hereditary heart disease
+No active tobacco use (> 10 years tobacco free interval, < 20 pack/year [pk/yr.] history)
+History of vesicoureteral reflux or an indwelling urinary stent
+History of coronary revascularization or ischemic symptoms
+No history of bleeding problems; not taking aspirin or any medication that may affect erythrocyte biochemistry
+History of sarcoidosis
+History of hypercalcemia
+History of coronary revascularization or ischemic symptoms
+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.
+Individuals with known history of glucose 6 phosphate deficiency are excluded from the trial (possible issue with HCQ tolerance)
+History of proximal urethral stricture requiring dilatation.
+History of coronary revascularization or ischemic symptoms
+History of proximal urethral stricture requiring dilatation
+Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded
+Patients with a prior history of pulmonary toxicity due to medications (Ex: history of carmustine [BCNU] toxicity).
+History of leptomeningeal carcinomatosis
+History of neurological conditions that would confound assessment of treatment-emergent neuropathy
+History of coronary revascularization or ischemic symptoms.
+History of leptomeningeal carcinomatosis.
+Subject has known or suspected history of retinitis pigmentosa or known or suspected familial history of retinitis pigmentosa.
+Patient has a history of pancreatitis
+History of primary immunodeficiency.
+History of refractory systemic infection.
+Patients with history of more than one symptomatic oxalate stone
+History of hypertriglyceridemia or hypercholesterolemia and currently on medication(s)
+Prior history of hypertensive crisis, hypertensive encephalopathy, reversible posterior leukoencephalopathy syndrome (RPLS).
+Primary immunodeficiency.
+History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias
+History of previous enrollment in Studies NCT02993523 or NCT03069352.
+History of any renal calculi or hyperoxaluria or any other preexisting renal disorder
+History of G6PD deficiency, hereditary spherocytosis or hemochromatosis
+History of confirmed, corneal ulceration
+History of active primary immunodeficiency.
+History of Richter’s or prolymphocytic transformation
+Has a history of primary immunodeficiency
+Known history of cardiac arrhythmias including atrial fibrillation, tachyarrhythmias or bradycardia, unless arrhythmia is controlled and after Cardiology has cleared patient to receive ONC201. Receiving therapeutic agents known to prolong QT interval will be excluded History of CHF, or MI or stroke in the last 3 months will be excluded.
+History of coronary revascularization or ischemic symptoms
+Known history of pituitary and/or adrenal disease (or dysfunction)
+Present or history of progressive multifocal leukoencephalopathy (PML)
+Has a known history of hypertensive crisis or hypertensive encephalopathy within 6 months prior to planned start of study drug
+History of any inherited coagulation or platelet function, disorder or ITP, TTP, or HUS
+Primary immunodeficiency
+History of cirrhosis
+Research participants does NOT have any known history of congestive heart failure (CHF) or cardiac symptoms consistent with NYHA classification III-IV within 6 months prior to Day 1 of protocol treatment, cardiomyopathy, myocarditis, myocardial infarction (MI), exposure to cardiotoxic medications or with clinical history suggestive of the above must have an EKG and echocardiogram (ECHO) performed within 42 days prior to registration and as\r\nclinical indicated while on treatment
+History of severe asthma or absolute requirement for chronic inhaled corticosteroid medications (subjects with a history of mild asthma that are on or can be switched to noncorticosteroid bronchodilator regimens are eligible)
+Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
+History of hypertensive crisis or hypertensive encephalopathy within 3 years of the randomization
+Has a history of, or is currently on, dialysis.
+Primary immunodeficiency
+Patients with a history of prior hematopoietic stem cell transplantation (HSCT), elevated conjugated serum bilirubin at study entry, uncontrolled systemic fungal, bacterial, or other infection, a history of hepatitis B or C infection or a history of cirrhosis
+Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
+Patients with a confirmed history of encephalitis, meningitis, or uncontrolled seizures in the year prior to signing informed consent are ineligible
+History of immune-mediated pneumonitis
+Autoimmune disease or history of primary immunodeficiency (excluding Hashimoto’s thyroiditis, vitiligo, or DM type I)
+History of leptomeningeal carcinomatosis
+History of known active primary immunodeficiency
+History of leptomeningeal disease
+Known history of pituitary or adrenal dysfunction
+History of auto-immune disease (e.g., thyroiditis, lupus), except vitiligo
+History and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
+History of multiple drug allergies or intolerance to subcutaneous injections
+History of recurrent pancreatitis
+History of leptomeningeal disease
+Patients with a history of colitis.
+History of prior immunotherapy within the last 3 years (immunotherapy allowed for lead-in cohort in castration resistant disease)
+History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
+History of urethral stricture disease;
+History of diseases with influence on bone metabolism, such as Paget’s disease, osteogenesis imperfecta, active primary or secondary hyperparathyroidism, and primary or secondary hyperthyroidism within 12 months prior to study entry
+History of osteonecrosis of the jaw
+History of treatment with known kinase inhibiting agents
+History of gout
+History of muscle cramps or restless legs
+Known history of pituitary or adrenal dysfunction.
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of allergic response to BV-CHEP or its components or to any of the required prophylactic medications or reasonable alternatives
+History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
+History of keratitis;
+No characteristics suggesting a potential higher risk of infection with intraprostatic injections:\r\n* Recurrent urinary tract infections or history of prostatitis within 3 months prior to enrollment into the study\r\n* Urine analysis positive for nitrites and leucocyte esterase; such patients could be considered for the study after treatment and resolution of the infection\r\n* Active proctitis\r\n* History of prostatic abscess\r\n* Taking immunosuppressive medication including systemic corticosteroids\r\n* Active hematologic malignancy
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+Subject has a history of non-central line related thrombosis (arterial or venous), more than one prior central-line related thrombosis or known coagulopathy.
+Has a known prior history of viral hepatitis (B or C) as demonstrated by positive serology (presence of antigens) or have an uncontrolled infection requiring treatment
+No history of medical condition resulting in nephrotic range proteinuria.
+Patient has a history of interstitial cystitis
+Lifetime pack-year history of < 10 years, currently non-smoking for at least 5 years.
+History of claustrophobia.
+History of leptomeningeal metastases
+History of primary immunodeficiency
+Patients must provide their personal smoking history prior to registration; patients cannot have a cumulative personal smoking history that exceeds 10 pack-years\r\n* Number of pack-years = (frequency of smoking [number of cigarettes per day] x duration of cigarette smoking [years]) / 20\r\n* Note: Twenty cigarettes is considered equivalent to one pack; cigar and pipe tobacco consumption is not included in calculating lifetime pack-years
+History of seizures
+History of primary immunodeficiency
+History of ventilator support related to lung injury (e.g., pneumonia, hemorrhagic pneumonitis, capillary leakage)
+Any history of allografts
+History of pre-existing immunodeficiency disorder, autoimmune condition, or chronic infection
+History of active primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of primary immunodeficiency.
+History of leptomeningeal carcinomatosis.
+History of active primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of coronary revascularization or ischemic symptoms
+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 =< 12 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.
+(Bevacizumab-related exclusion) Prior history of hypertensive crisis or hypertensive encephalopathy
+History of primary immunodeficiency
+Creatinine > 1.5 or history of renal disease preventing use of ZA
+History of primary immunodeficiency
+Has history of osteonecrosis of the jaw
+Subject has a history of coagulopathies or hematological disorders
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of acute pancreatitis within 1 year of study or history of chronic pancreatitis.
+History of primary immunodeficiency
+Subjects must not have history of scleroderma or lupus erythematosus with either cutaneous manifestation or requiring active treatment
+Prior history of esophageal perforation
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+Patients with known history of serous retinopathy will not be eligible
+Patient with a history of genetic prothrombotic state
+Patients who are known to have a history of or a finding of corneal epitheliopathy at pre-study are excluded
+History of primary immunodeficiency
+History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+Patients with prior or current history of digoxin exposure
+Patient with history of prior exposure to decitabine
+Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
+History of neurological conditions that would confound assessment of treatment-emergent neuropathy
+History of VOD
+Patients who have a history of ataxia telangiectasia or other documented history of radiation hypersensitivity
+Patients who have a history scleroderma or other active connective tissue disease
+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 Creutzfeldt–Jakob disease (CJD), based on family and travel history
+History of primary immunodeficiency
+History of vesicoureteral reflux.
+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
+Patients with history of lactic or any other metabolic acidosis
+History of pancreatitis
+No history of seizures, encephalitis, or multiple sclerosis
+No known prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
+Known previous history of sensitivity to talimogene laherparepvec or any of its components to be administered during dosing (e.g. sorbitol, myo-inositol)
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of intolerance to somatostatin analogues
+Subjects who have unknown transfusion history
+History of primary immunodeficiency.
+Prior history of hypertensive crisis or hypertensive encephalopathy
+PRE-SCREENING: No history of keratitis or corneal disease
+History of clinically severe (e.g., requires chronic immunosuppressive therapy, [e.g., cyclosporine A, tacrolimus]) autoimmune disease (e.g., ulcerative colitis, lupus), or history of organ transplant
+History of severe asthma, presently on chronic medications (a history of mild asthma requiring inhaled steroids only is eligible)
+History of anti-CD19 or CAR-T therapy or history of prior randomization in ZUMA-7
+Participants with a history of progressive multifocal leukoencephalopathy
+Participants with a history of sustained ventricular tachycardia or aborted ventricular fibrillation or with a history of atrioventricular (AV) nodal or sinoatrial (SA) nodal dysfunction for which a pacemaker/implantable cardioverter-defibrillators [ICD] is indicated but not placed (participants who do have a pacemaker/ICD are allowed on study)
+History or presence of a 2nd autoimmune disease requiring immunosuppressive therapy that has substantial risk of immunosuppressive treatment beyond transplant with the following exceptions:\r\n* History and/or presence of Sjogren's Syndrome is allowed\r\n* Stable myositis (A history of myositis that is clinically stable as defined by lack of progressive proximal muscle weakness and a stable or decreasing creatine phosphokinase [CPK] < 3 x ULN) is allowed\r\n* The presence of anti-double stranded (ds)-deoxyribonucleic acid (DNA) without clinical systemic lupus erythematosus in a patient with a diagnosis of otherwise \pure\ SSc is allowed\r\n* Concomitant rheumatoid arthritis without extra-articular disease characteristic of rheumatoid arthritis is allowed
+Evidence of myelodysplasia (MDS); subjects with history of receiving any prior chemotherapy and/or radiotherapy for the treatment of malignant disease, history of greater than 2 months total prior cyclophosphamide for any condition (regardless of dose and route) and/or subjects presenting with abnormal peripheral blood counts require unilateral bone marrow aspiration for pathology, flow cytometry, cytogenetics, and fluorescence in situ hybridization (FISH) MDS panel (per institutional profile) to rule out MDS
+No known history of dihydropyrimidine dehydrogenase deficiency
+Patients with a history of immune-mediated neurological disorders such as multiple sclerosis, Guillain-Barré or inflammatory CNS/PNS disorders
+History of hypertensive crisis or hypertensive encephalopathy within 3 years prior to registration
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of primary immunodeficiency
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of treatment with ibrutinib or blinatumomab
+A history of metal in the head or eyes
+Patients with a previous history of neurological complications due to polyoma virus (PV) infection
+Patients with known history of agammaglobulinemia
+Has a history of primary immunodeficiency
+History of acute diverticulitis within the last 6 months, or current chronic diarrhea
+A history of anaphylaxis to peginterferon alfa-2b or interferon alfa-2b
+Has history of bipolar disorder or major depression
+Has history of not tolerating interferon treatment
+Subjects must have no prior history of veno-occlusive disease (VOD)
+Gastrointestinal tract disease or defect or previous history of colitis.
+Known history of Wilson’s disease or a copper deficiency
+History of or current relevant central nervous system pathology such as epilepsy, recurrent seizures, paresis, aphasia, apoplexia, severe brain injuries, cerebellar disease, organic brain syndrome or psychosis.
+History of seizures
+History of seizures
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+Active smoking or a cumulative pack year history of > 20 pack years, active smoking is (defined as >= 1 cigarette per day) within the last 5 years
+History of non-transfusional hemosiderosis
+History of radiation proctitis (for lead-in CRPC cohort only)
+Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash
+Patients with a history of intolerance to Das or for whom Das might not be appropriate
+History or presence of sustained bradycardia (less than or equal to 60 beats per minute [BPM]) or history of symptomatic bradycardia, left bundle branch block, cardiac pacemaker or significant atrial tachyarrhythmias, as defined by the need for treatment
+Previous history of grade 3 or worse drug-induced QTc prolongation requiring treatment withdrawal
+History of refractory systemic infection
+History of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
+History of primary immunodeficiency
+History of seizures in the past 3 years
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician.
+Patients with history of lactic or any other metabolic acidosis
+History of coronary revascularization or ischemic symptoms
+History of stroke within the last 5-years
+History of peptic ulcer disease requiring treatment within the last 5-years
+History of glucose-6-phosphate dehydrogenase deficiency
+History of coronary revascularization or ischemic symptoms
+History of primary immunodeficiency
+History of impaired adrenal gland function (eg, Addison's disease, Cushing's syndrome).
+Previous history of difficulty swallowing capsules.
+History of progressive multifocal leukoencephalopathy
+Diverticulitis either active or history of within the past 2 years; note that diverticulosis is permitted
+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
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
+History of coronary revascularization or ischemic symptoms
+Pulmonary function testing in patients with:\r\n* A prolonged history of cigarette smoking (20 pk/yr of smoking within the past two years)\r\n* Symptoms of respiratory dysfunction
+Have a known history of pituitary or adrenal dysfunction
+History of hemoptysis (defined as > 1/2 tablespoon [tsp] of bright red blood per day)
+History of active primary immunodeficiency
+Prior history of pseudoprogression or radionecrosis from cranial radiotherapy
+The patient has a history of uncontrolled hereditary or acquired thrombotic disorder
+Known history of osteoporosis
+Known history of macular edema
+Known history of ABL1-domain mutation that predicts resistance to the discontinued TKI
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+The subject has a history of anaphylaxis or other serious adverse reactions relating to administration of any components of the investigational product
+History of hemochromatosis or family member with hemochromatosis
+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
+History or presence of clinically relevant CNS pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, or psychosis; history of other organic brain syndrome that in the opinion of the PI or designee is a contraindication to lymphodepleting chemotherapy, JCAR014 infusion or durvalumab infusion
+Has a history of any of conditions that would contraindicate administration of an OC
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of prior irradiation to the area to be treated
+History of tuberculosis or history of purified protein derivative (PPD) positivity
+History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma not requiring corticosteroid therapy are eligible)
+Known history of plasma cortisol and adrenocorticotropic hormone (ACTH) levels consistent with adrenal failure
+Patients with previous history of radiosurgery, brachytherapy, Gliadel implantation, or radiolabeled monoclonal antibodies
+history of acute coronary syndromes (including unstable angina)
+History of grade 4 rash associated with thalidomide treatment
+History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
+Patients with history of splenectomy
+History of renal or hepatic disease, including history of hepatitis B or C
+Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
+History of coronary revascularization or ischemic symptoms
+Patients with a history of PR prolongation or atrioventricular (AV) block
+Patients with a history of prior therapy with paclitaxel and/or carboplatin
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of pneumonitis requiring hospitalization or systemic immune suppressive therapy
+Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
+No history of prior radiotherapy overlapping with high dose region of planned SABR course
+No prior history of lung resection on ipsilateral side
+No prior history of multifocal adenocarcinoma in situ (ie, classic or pure bronchioloalveolar carcinoma)
+History or presence of bradydysrhythmia or conduction abnormalities
+History or presence of cardia arrest or unexplained syncope
+History of Paget’s disease
+Subjects must not have a history of neurodegenerative or central nervous system movement disorder
+Patients with history of previous immunomodulatory therapy (not including lenalidomide or thalidomide)
+Confirmed history of CD19 positivity by flow cytometry for malignant cells
+History of carcinomatous meningitis
+History of or current diagnosis of progressive multifocal leukoencephalopathy (PML)
+History of primary immunodeficiency
+Subject has history of major immunologic reaction to any Immunoglobulin G (IgG) containing agent.
+Patients with a history of coronary artery disease may be included if they have had a normal stress test within 30 days of enrollment
+History of cerebrovascular disease
+Prior history of rectal resection
+History of active connective tissue disease (scleroderma)
+Patients with a history of prior radiation to the orbit if re-treatment would exceed known orbital tolerance
+History of seizures
+Active or history of diverticulitis; diverticulosis is permitted
+History of arterial thromboembolic event
+History of prior or current splenectomy or splenic irradiation
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+History of
+Subjects with a history of seizures
+History of familial cardiomyopathy
+History of infiltrative cardiomyopathy or restrictive cardiomyopathy
+Medical history of vasculitis or lupus erythematosus
+Prior history of receiving afatinib
+History of rectal fistula
+If history of depression or psychiatric illness, has to be well controlled with antidepressants and/or under psychiatrist/ psychologist care
+A history of prior radiotherapy that precludes delivery of hypofractionated radiotherapy
+History of carcinomatous meningitis
+Patients with a history of other malignancies, except:
+History of primary immunodeficiency, history of allogenic organ transplant that requires therapeutic immunosuppression and the use of immunosuppressive agents within 28 days of randomization* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
+History of acute pancreatitis within one year of study or history of chronic pancreatitis
+Patients with history of atrial arrhythmia (requiring any anti-arrhythmic therapy) or patients with any history of ventricular arrhythmia are excluded
+Patients with history of pneumonectomy
+History of or current immunodeficiency disease or prior treatment compromising immune function at the discretion of the treating physician
+History of seizures, movement disorders or cerebrovascular accident within the past 1 year prior to cycle 1 day 1
+Known history of confirmed primary immunodeficiency
+Have a history of neurological illness or closed head injury
+A known history of intolerance to ketoconazole
+A known history of intolerance to vincristine
+History of non-compliance
+City of Hope (COH) pathology review confirms that research participant’s diagnostic material is consistent with history of ALL with history of recurrence/progression/minimal residual disease (MRD) following prior therapy; additionally, CD19 positivity must be documented in a pathology report; however, it is not a requirement that the CD19 testing be performed by a COH pathologist; patients in second complete remission (CR2) or higher with history of CD19+ ALL on previous bone marrow biopsy are also eligible for the study
+Subjects on chronic immunosuppression, or who have a history of compromised immune function (e.g. history of or current malignancy other than BCC/squamous cell skin cancers)
+Subjects with a history of keloids or excessive scarring
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Less than or equal to 10 pack years of tobacco history
+Prior history of a thromboembolic event within the last two years and not currently on systemic anticoagulation
+Patients with a history of asthma will be excluded
+History of gastric or duodenal ulcers or untreated hyperacidity syndromes
+No history of chronic diarrhea
+Significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
+Patients who have a history of listeriosis prior ADXS11-001 therapy
+History of kidney stones
+History of either symptomatic hypercalcemia or hyperparathyroidism, at the treating investigator’s discretion
+History of coronary revascularization or ischemic symptoms
+Any medical history, concurrent disease or concomitant medication which could reasonably predispose the patient to renal insufficiency while on study treatment
+History or behavior that would, in the investigator’s judgment, prohibit compliance for the duration of the study
+History of arrhythmia requiring pharmacological or electrical treatment
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+History of sustained ventricular tachycardia
+Prior myocardial infraction (MI) ascertained from medical history and review of systems
+Patients with a history of hepatitis C, but have a negative viral load, are eligible
+History of priapism
+Known history of retinitis pigmentosa
+Subjects must not have a history of any significant renal or hepatic disease requiring ongoing medical therapy or clinical intervention
+Patients must not have a history of any immune system disorder, or laboratory abnormality or any condition that could potentially alter immune function
+History of anakinra use
+Previous history of splenectomy or whole spleen radiation
+Any of the following concurrent severe and/or uncontrolled medical conditions:\r\n* Hypertension, labile hypertension, or history of poor compliance with antihypertensive medication\r\n* Angina pectoris\r\n* History of congestive heart failure =< 3 months, unless ejection fraction > 40%\r\n* Myocardial infarction =< 6 months prior to registration\r\n* Cardiac arrhythmia\r\n* Poorly controlled diabetes\r\n* Interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung\r\n* Active or recent history of hemoptysis; if hemoptysis has resolved with measures such as palliative radiation therapy (e.g. 3000 cGy over 10 fractions), arteriographic embolization or endobronchial interventions (e.g. photodynamic therapy, brachytherapy), etc. for > 14 days, patients may be considered for participation in this study\r\n* >= Grade 2 hypertriglyceridemia\r\n* >= Grade 2 hypercholesterolemia\r\n* Any illness that in the opinion of the investigator would compromise the ability of the patient to participate safely in the clinical trial
+Patients with a history of documented human anti-globulin antibodies.
+History of biliary colic attack
+COHORTS 1 AND 2: HEALTHY VOLUNTEERS: Family history of toxic epidermal necrolysis
+COHORTS 1 AND 2: HEALTHY VOLUNTEERS: History of AD and asthma
+COHORT 3: ATOPIC DERMATITIS PATIENTS: Family history of toxic epidermal necrolysis
+Patients with history of bleeding disorder or with history of spontaneous haemorrhage tumour
+History of coronary revascularization or ischemic symptoms
+Patients must have a bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
+History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
+History of pituitary or adrenal dysfunction
+Any history of ventricular arrhythmia; or
+Current or past history of cardiovascular disease (e.g.. past history of myocardial infarction, ischemic cardiomyopathy) unless cardiology consultation and clearance has been obtained for study participation
+Prior history of hypertensive encephalopathy
+History of sensitivity to, or history of conditions that are known to cause sensitivity to, radiation therapy
+Overt psychosis, mental disability, otherwise incompetent to give informed consent, or history of non-compliance
+A history of variceal bleeding where the varices have not been eradicated or decompressed by shunt placement
+History of an active connective tissue disorder
+DONOR: History of hypertension that is not controlled by medication, stroke, or severe heart disease (donors with symptomatic angina will be excluded); donors with a history of coronary artery bypass grafting or angioplasty who are symptom free will receive a cardiology evaluation and be considered on a case-by-case basis
+History of seizures
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+History of proximal urethral stricture requiring dilatation
+History or evidence of a physician-diagnosed chronic or recurrent inflammatory skin disease (e.g. psoriasis, eczema, atopic dermatitis, hypersensitivity) at the proposed site of administration in the past 5 years.
+Patients with a history of keloid formation ( ID delivery group only)
+A history of syncope with calorie restriction in the past or other medical comorbidity, which would make fasting potentially dangerous
+Documented history of nephrolithiasis within the past 5 years
+History and/or clinical evidence of distant metastases (M1)
+History of pancreatitis
+History of valproic acid (VPA) use
+Patients with a history of embolic events (e.g. TIA) from arrhythmia or peripheral arterial disease or of recent MI whether or not treated with anti-platelet drugs
+Patients with a history of coronary artery disease with angina pectoris, or a history of congestive heart failure will not be eligible to receive DA-EPOCH-R chemotherapy
+History or presence of an abnormal ECG, ECHO, or MUGA that is clinically meaningful.
+History of primary immunodeficiency
+History of active primary immunodeficiency
+No history of a coagulation disorder
+Subjects with a history of hepatitis of any etiology or hepatic insufficiency
+History of splenectomy
+History of narcolepsy or any neurological condition which may impair consciousness
+History of sensitivity to any of the study medications, or metabolite thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation CARDIAC MAGNETIC RESONANCE (CMR) SCANNING
+History of claustrophobia 99m^TC-PYP OR 99mTC-DPD BONE TRACER RADIOSCINTOGRAPHY
+Presence or history of a malignant disease other than the study related cancer
+Clinical evidence or known history of cardiopulmonary disease
+Subject has a history of thromboembolic event within the past 4 weeks prior to enrollment.
+A history of biopsy-confirmed exclusive radionecrosis after initial GBM therapy
+Prior history of receiving pazopanib treatments
+History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
+History of significant neurologic or psychiatric disorders including dementia or seizures
+Patients who have a smoking history of > 10 pack-years
+History of seizures or extrapyramidal symptoms
+History of continuous daily use of PPI more than 1 year prior to consent
+History of bipolar disorder.
+History of diagnosis of neurogenic bladder requiring intermittent catheterization.
+History of asymptomatic LVEF decline to < 40% during or after prior HER2-targeted therapy
+History of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years (exceptions described in the protocol).
+Known history of allergies or sensitivities to gentamicin.
+History of or current immunodeficiency disease or prior treatment compromising immune function
+Subject has history of primary immunodeficiency
+A history of thromboembolic disorder
+History of prior mastectomy
+Patients with history of a photosensitivity disease, such as porphyria cutanea tarda
+Confirmed history of CD19-positivity by flow cytometry for malignant cells.
+Part 2: history of glaucoma
+History of peritonitis or diverticulitis
+History of and or medical condition (e.g. diverticular disease; aneurysm) that predisposes to risk of major hemorrhage
+History of leptomeningeal carcinomatosis
+History of active primary immunodeficiency
+Exclusion criteria based on organ function or medical history:\r\n* History of clinically significant cardiac or pulmonary dysfunction including the following:\r\n** Inadequately controlled hypertension (that is defined as systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg that is treated or untreated)\r\n** History of myocardial infarction within 6 months prior to first dose of study drug in cycle\r\n** Prior history of hypertensive crisis or hypertensive encephalopathy\r\n** History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, evidence of active pneumonitis on screening chest computed tomography (CT) scan or non-infectious pneuomonitis requiring steroids\r\n* Significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of cycle 1 day 1\r\n* History of stroke or transient ischemic attack within 6 months prior to cycle 1 day 1\r\n* Serious non-healing wound, active ulcer or untreated bone fracture\r\n* History of abdominal fistula or gastrointestinal perforation within 6 months prior to cycle 1 day 1\r\n* History of hemoptysis (?one teaspoon of bright red blood per episode), or any other serious hemorrhage or at risk of bleeding (gastrointestinal history of bleeds, gastrointestinal ulcers, etc.). INR > 1.5 and aPTT > 1.5 x ULN within 7 days prior to cycle 1 day 1. History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding\r\n* Life expectancy of < 12 weeks\r\n* Any previous venous thromboembolism >= grade 3\r\n* Proteinuria at screening as demonstrated by urine dipstick >= 2+ or 24-hour. proteinuria > 1.0 g\r\n* Left ventricular ejection fraction (LVEF) below institutional lower limit of normal\r\n* Uncontrolled serious medical or psychiatric illness\r\n* Pregnant or lactating, or intending to become pregnant during the study. Women who are not post-menopausal (>= 12 continuous months of amenorrhea with no identified cause other than menopause) or surgically sterile must have a negative serum pregnancy test within 14 days prior to cycle 1 day 1
+Patients with known history of G6PD deficiency
+History of active coronary or ischemic symptoms
+History of prior bowel fistula, ulcerations, or perforations
+History of primary immunodeficiency.
+History of progressive multifocal leukoencephalopathy (PML)
+History of tuberculosis or positive purified protein derivative (PPD) test
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis or uncontrolled seizures
+Suicidal ideation or history of suicide attempt
+History of familial cardiomyopathy
+History of infiltrative cardiomyopathy or restrictive cardiomyopathy
+Participants with a history of cranial nerve palsy
+History or current evidence of hyperthyroidism that would increase metabolism of itraconazole
+History of arterial thromboembolic events
+History of acute pancreatitis within 1 year of screening or past medical history of pancreatitis
+History of auto-immune disease per physician discretion
+Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
+Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
+History of pituitary or adrenal dysfunction
+Known history of pancreatitis
+History or presence of an abnormal electrocardiogram (ECG)
+History of leptomeningeal disease
+Patients with any prior history of SOS irrespective of severity
+History of primary immunodeficiency
+History of tuberculosis or history of tuberculin purified protein derivative (PPD) positivity
+Patients who have a history of noninfectious (toxic, autoimmune) hepatitis or alcoholism
+Patients with a lifetime history of porphyria or psoriasis
+TREATMENT: Patients with a history of seizures are not eligible to receive veliparib, but patients with a history of CNS metastases who have received treatment and who either have not had seizures or have been on stable doses of anti-seizure medicine and had no seizures for >= 4 weeks will be eligible for other study agents; enzyme inducing anticonvulsants are contraindicated
+History of tuberculosis or purified protein derivative (PPD) skin test positivity
+Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
+Known history of acute or chronic pancreatitis
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of partial or total gastrectomy
+Patients with a history of platelet alloimmunization
+History of diverticulitis or pancreatitis within 12 weeks of registration
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of progressive multifocal leukoencephalopathy
+History of tuberculosis or history of purified protein derivative (PPD) positivity
+Patients with a history of venous or arterial thrombosis personally before the age of 40 years unless associated with a central line
+History of a light-sensitive cutaneous disease
+For participants on the BKM120 cohort only: \r\n* Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment will not qualify for study participation\r\n* >= CTCAE grade 3 anxiety at the time of study entry regardless of whether the anxiety is being treated with medications\r\n* Patients with the following mood disorders as judged by the investigator or a psychiatrist, or as a result of patient’s mood assessment questionnaire:\r\n** Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)\r\n** >= CTCAE grade 3 anxiety\r\n** Meets the cut-off score of >= 10 in the Patient Health Questionnaire (PHQ)-9 or a cut-off of >= 15 in the Generalized Anxiety Disorder (GAD)-7 mood scale, respectively, or selects a positive response of “1, 2, or 3” to question number 9 regarding potential for suicidal thoughts in the PHQ-9 (independent of the total score of the PHQ-9)
+Previous history of intravesical therapy allowed
+Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others); ), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders [DSM]- IV) are not eligible; patients who have a history of major depression that is controlled with chronic oral therapy are eligible provided they have no history of inpatient hospitalization, history of documented suicide attempt or ideations, and are managed with one anti-depressant which has not required dose adjustment in 6 weeks; patients with a history of depression who would otherwise be eligible should be evaluated by a mental health professional prior to enrollment if there is any uncertainty regarding the status of their mental health; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
+Subject with history of acute within one year of study entry or past medical history of chronic pancreatitis
+History of pancreatitis
+Patients must provide their personal smoking history prior to registration; the lifetime cumulative history cannot exceed 10 pack-years; the following formula is used to calculate the pack-years during the periods of smoking in the patient’s life; the cumulative total of the number of pack-years during each period of active smoking is the lifetime cumulative history\r\n* Number of pack-years = (frequency of smoking [number of cigarettes per day] x duration of cigarette smoking [years])/20 \r\n* Note: twenty cigarettes is considered equivalent to one pack; the effect of non-cigarette tobacco products on the survival of patients with p16-positive oropharyngeal cancers is undefined; cigar and pipe tobacco consumption is therefore not included in calculating the lifetime pack-years; marijuana consumption is likewise not considered in this calculation; there is no clear scientific evidence regarding the role of chewing tobacco-containing products in this disease; investigators are discouraged from enrolling patients with a history of very sustained use (such as several years or more) of non-cigarette tobacco products alone
+Patients with a history of chronic kidney disease or lactic acidosis
+History of spontaneous pneumothorax
+History of seizures
+Prior history of SCCHN
+Altered immune function, including immunodeficiency or history of immunodeficiency; eczema; history of eczema, or other eczematoid skin disorders; or those with acute, chronic or exfoliative skin conditions (e.g. atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
+History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
+History of >= 10 pack-years of smoking cigarettes
+A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
+Patients with a history of pancreatitis, cholelithiasis, alcoholism, or fasting hypertriglyceridemia (> 2 x ULN)
+History of prior IPHC/HIPEC
+History of prior HIPEC
+Any patients with a history of tamoxifen or raloxifene use within two years of current DCIS diagnosis are not eligible
+History of cholecystitis without cholecystectomy
+History of syncope or family history of idiopathic sudden death
+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
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+History of psychiatric disorder (e.g. depression; suicidal ideation; psychosis)
+History of psychiatric disorder (e.g. depression)
+History of uveal melanoma
+Subjects must not have primary uveal or mucosal melanoma, history or evidence of melanoma associated with immunodeficiency states or history of other malignancy within the past 3 years.
+History of progressive multifocal leukoencephalopathy (PML)
+History of known leptomeningeal involvement (lumbar puncture not required)
+Patients with a known history of primary and secondary adrenal insufficiency are not eligible
+This criterion applies only to the patients enrolled before August 29, 2011 and those enrolled after this date electing to receive bevacizumab; patients with a history or evidence upon physical examination of central nervous system (CNS) disease, including primary brain tumor, seizures not controlled with standard medical therapy, any brain metastases or a history of stroke within 5 years of the first date of treatment on this study
+History of:
+Subject has a prior history of malignancies other than AML unless the subject has been free of the disease for ? 5 years from first dose of lenalidomide.
+Subject has a history of well-documented prior veno-occlusive disease (VOD).
+They have a history of a venous or arterial thrombosis that was not associated to a central line.
+Known history of hereditary hemorrhagic telangiectasia (HHT).
+History of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to first dose of pazopanib
+Subject has history of Myeloproliferative Neoplasm (MPN).
+Subject has a history of other malignancies .prior to study entry, with the exception of:
+History of lung inflammation or disease.
+Patient must have no history of venous thrombosis within 12 weeks of randomization
+Patient must not have history of hemoptysis in excess of 2.5 mL (1/2 teaspoon) within 8 weeks prior to randomization
+Documented history of a cerebral vascular event
+History of progressive multifocal leukoencephalopathy (PML)
+Patient has a history of acute pancreatitis within 1 year of screening or a past medical history of chronic pancreatitis
+cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis
+Patients with a history of ipsilateral DCIS are eligible
+History of coagulopathy, platelet disorder or history of non-drug induced thrombocytopenia
+History of cerebrovascular disease that would limit study compliance or place the patient at unacceptable risk for participation in the study
+History of hepatic encephalopathy
+Inclusion Criteria:\n\n        Eligibility is determined prior to leukapheresis. Subjects must satisfy the following\n        criteria to be enrolled in the study:\n\n          1. Subject is ? 18 years of age at the time of signing the informed consent form (ICF).\n\n          2. Documented diagnosis of multiple myeloma\n\n               -  Must have received at least 3 prior MM treatment regimens. Note: induction with\n                  or without hematopoietic stem cell transplant and with or without maintenance\n                  therapy is considered a single regimen.\n\n               -  Must have undergone at least 2 consecutive cycles of treatment for each regimen,\n                  unless PD was the best response to the regimen.\n\n               -  Must have received a proteasome inhibitor, an immunomodulatory agent and an\n                  anti-CD38 antibody.\n\n               -  Must be refractory to the last treatment regimen.\n\n          3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n\n          4. Subjects must have measurable disease, including at least one of the criteria below:\n\n               -  Serum M-protein greater or equal to 1.0 g/dL\n\n               -  Urine M-protein greater or equal to 200 mg/24 h\n\n               -  Serum free light chain (FLC) assay: involved FLC level greater or equal to 10\n                  mg/dL (100 mg/L) provided serum FLC ratio is abnormal\n\n        Exclusion Criteria:\n\n        The presence of any of the following will exclude a subject from enrollment:\n\n          1. Subjects with known central nervous system involvement with myeloma.\n\n          2. History or presence of clinically relevant central nervous system (CNS) pathology.\n\n          3. Subjects with active or history of plasma cell leukemia.\n\n          4. Subjects with solitary plasmacytomas or non-secretory myeloma without other evidence\n             of measurable disease\n\n          5. Inadequate organ function\n\n          6. Ongoing treatment with chronic immunosuppressants\n\n          7. Previous history of an allogeneic hematopoietic stem cell transplantation or treatment\n             with any gene therapy-based therapeutic for cancer or investigational cellular therapy\n             for cancer or BCMA targeted therapy\n\n          8. Evidence of human immunodeficiency virus (HIV) infection.\n\n          9. Seropositive for and with evidence of active viral infection with hepatitis B virus\n             (HBV)\n\n         10. Seropositive for and with evidence of active viral infection with hepatitis B virus\n             (HBV) and Hepatitis C virus (HCV)\n\n         11. Subjects with a history of class III or IV congestive heart failure (CHF) or severe\n             non-ischemic cardiomyopathy, history of stroke, unstable angina, myocardial\n             infarction, or ventricular arrhythmia within the previous 6 months.\n\n         12. Subjects with second malignancies in addition to myeloma if the second malignancy has\n             required therapy in the last 3 years or is not in complete remission\n\n         13. Pregnant or lactating women.\n\n         14. Subject with known hypersensitivity to any component of bb2121 productThe presence of\n             any of the following will exclude a subject from enrollment:\n\n        1. Subjects with known central nervous system involvement with myeloma. 2. History or\n        presence of clinically relevant central nervous system (CNS) pathology.\n\n        3. Subjects with active or history of plasma cell leukemia. 4. Subjects with solitary\n        plasmacytomas or non-secretory myeloma without other evidence of measurable disease 5.\n        Inadequate organ function 6. Ongoing treatment with chronic immunosuppressants 7. Previous\n        history of an allogeneic hematopoietic stem cell transplantation or treatment with any gene\n        therapy-based therapeutic for cancer or investigational cellular therapy for cancer or BCMA\n        targeted therapy 8. Evidence of human immunodeficiency virus (HIV) infection. 9.\n        Seropositive for and with evidence of active viral infection with hepatitis B virus (HBV)\n        and Hepatitis C virus (HCV) 10. Subjects with a history of class III or IV congestive heart\n        failure (CHF) or severe non-ischemic cardiomyopathy, history of stroke, unstable angina,\n        myocardial infarction, or ventricular arrhythmia within the previous 6 months. 11. Subjects\n        with second malignancies in addition to myeloma if the second malignancy has required\n        therapy in the last 3 years or is not in complete remission 12. Pregnant or lactating\n        women. 13 Subject with known hypersensitivity to any component of bb2121 product,\n        cyclophosphamide, fludarabine, or tocilizumab.
+History of leptomeningeal disease
+Known history of MDS.
+No evidence of any systemic autoimmune disease (e.g. Hashimoto’s thyroiditis) and/or any history of primary or secondary immunodeficiency, and no immunosuppressant therapy (with the exception of dexamethasone as noted below) for any reason
+Appropriate treatment history for histological entity.
+Patients must not have a history of seizures
+History of ulcerative colitis or other chronic inflammatory conditions affecting rectum (includes rectal fistula, anal stenosis)
+History of Parkinson's disease or multiple sclerosis
+Patients must not have any history of primary immunodeficiency
+Any history of hepatic encephalopathy
+History of primary immunodeficiency
+History of high grade esophageal or gastric varices
+History of listeriosis or previous treatment with a listeria-based immunotherapy
+History of leptomeningeal disease
+Subject must not have primary ocular or mucosal melanoma, or history or evidence of melanoma associated with immunodeficiency states (eg, hereditary immune deficiency, organ transplant, or leukemia).
+History of cerebral vascular accident or stroke within the previous 2 years
+Have a prior history of a documented hemolytic event.
+History of exposure to the cumulative doses of anthracyclines
+Prior history of malignancies, (except MDS for AML subjects), unless the subject has been free of the disease for ? 2 years. However, subjects with the following history/concurrent conditions are allowed:
+History of primary immunodeficiency.
+Has active cerebral/meningeal disease, active cytomegalovirus (CMV) colitis, or signs and symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML.
+Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)
+Patients are excluded if they have any prior history of hypertensive crisis or hypertensive encephalopathy
+History of histologically documented r/r Grades 1 to 3a FL, or r/r DLBCL
+Any history of hepatic encephalopathy
+Patients with history and/or current evidence of endocrine alteration of calcium-phosphate homeostasis
+Patients must not have prior history of desquamating rash from thalidomide at time of study entry
+Patients must not have a history of thrombo-embolic events within 3 years prior to study randomization
+History of progressive multifocal leukoencephalopathy
+Known history of positive serum human ADA.
+Prior history of invasive adenocarcinoma of colon or rectum.
+Know history of allografts (including corneal transplant).
+SUB-PROTOCOL AIM A: Patients with a history of alcoholism, drug addiction or psychotic disorders
+History of resistance to lenalidomide or response duration of <1 year
+History of progressive multifocal leukoencephalopathy
+No history of uncontrollable supraventricular arrhythmias
+a history of \double/triple hit\ genetics
+Prior history of malignancies other than DLBCL, unless the patient has been free of the disease for ?5 years prior to screening.
+History of carcinomatosis meningitis
+History of auto-immune disease
+Any prior history of hypertensive crisis or hypertensive encephalopathy.
+History of other active malignancies.
+No history of known human anti-chimeric antibody (HACA) positivity; this does not have to be checked prior to enrollment unless clinically indicated
+Present or history of progressive multifocal leukoencephalopathy (PML)
+History of pancreatitis or chronic pancreatitis.
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Patients with history of thrombophlebitis within the past 2 years or ongoing thromboembolic disorders
+History of high grade esophageal or gastric varices
+Presence of 1 or more of the following PNH-related signs or symptoms within 3 months of Screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin <10 g/dL), history of a major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction; or history of pRBC transfusion due to PNH.
+History or current evidence of
+Have a history of uncontrolled hereditary or acquired thrombotic disorder.
+History of prior immunodeficiency
+Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia.
+History of progressive multifocal leukoencephalopathy
+No prior history of immune checkpoint modulator therapy
+Echocardiogram (ECHO) cardiogram and cardiology consultation required within 7 days prior to registration for patients with a history of congestive heart failure or cardiovascular disease or history of exposure to cardiotoxic agents who are not already excluded
+History of Wilson’s disease or other copper-metabolism disorder
+History of or current immunodeficiency disease, splenectomy or splenic irradiation
+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
+Prior history of whole brain radiotherapy (only applicable for AZD3759 BM expansion)
+History of immunization with LL37
+History of or suspected Gilbert’s disease (testing not required if presence is not suspected)
+History of acute diverticulitis, or current chronic diarrhea
+History of adrenal insufficiency (including subjects using replacement therapy)
+Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
+Patient must not have active systemic lupus erythematosus, or any history of active scleroderma, or dermatomyositis with active rash
+Active systemic lupus erythematosus, or any history of active scleroderma, dermatomyositis with active rash
+History of or plan for splenectomy or splenic irradiation
+There is no specific platelet and absolute neutrophil count that will exclude patients from this study given the natural history of AML
+History of limb perfusion therapy
+History of radiotherapy for the treatment of melanoma
+Family history of inherited colon cancer syndromes
+Known personal history of >3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) >2 centimeters (cm) in size
+History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
+History of local and/or regional and/or distant melanoma recurrence
+History or current radiographic or pathologic evidence of distant metastases
+Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system.
+History of splenectomy
+History of salvage prostatectomy
+The patient has a history of pancreatitis.
+For NSCLC, patients must have a minimum of a 10 pack-year smoking history.
+History of primary idiopathic myelofibrosis
+History of known risks factors for bowel perforation
+Primary immunodeficiency
+History of a calcium/phosphate homeostasis disorder
+History and/or current evidence of ectopic mineralization/calcification
+Known history of acute or chronic pancreatitis
+Current history of neoplasm other than the entry diagnosis. Exceptions are:
+Eligibility for pheresis: (Turnstile 1) Histopathologic documentation of melanoma concurrent with the diagnosis of metastatic disease. A diagnosis of uveal melanoma can be made clinically without primary tissue evaluation, based on history and records. A prior history of brachytherapy to the eye is sufficient clinical support for a diagnosis of uveal melanoma.
+History of meningococcal disease
+History of other malignancies, unless disease-free for ? 5 years.
+Any patient with a history of major depressive episode, bipolar disorder, obsessive/compulsive disorder, schizophrenia, a history of suicide attempt or ideation, or homicide/homicidal ideation as judged by the investigator and/or based on recent psychiatric assessment may not participate in this study without discussion with and agreement of the study principal investigator (PI)
+History of hypertensive crisis or hypertensive encephalopathy
+History or recent diagnosis of demyelinating disease
+History of other carcinoma =< 3 years; exception: if risk of recurrence is known to be under 5% at time of randomization
+Primary or secondary immunodeficiency (history of or currently active) unless related to primary disease under investigation
+History of primary immunodeficiency
+Diverticulitis (either active or history of) within the past 2 years; note that diverticulosis is permitted
+History of primary immunodeficiency
+Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, homicidal ideation (e.g. risk of doing harm to self or others)
+History of transformation of indolent disease to DLBCL
+History of prior immunotherapy within the last 3 years
+History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
+History of Raynaud’s disease, cryoglobulinemia
+Subjects who have a history or current evidence of malignant biliary obstruction requiring biliary stent.
+History of leptomeningeal carcinomatosis
+History of leptomeningeal carcinomatosis
+Patient has a history of interstitial cystitis.
+History of median sternotomy
+Patients with a remote history of asthma or active mild asthma may participate.
+History of topotecan treatment for SCLC
+History of adrenal insufficiency
+Presence or history of ILD, drug-induced ILD, or presence of radiation pneumonitis
+Has a history of epilepsy, depression or other psychiatric disorders.
+History of active primary immunodeficiency
+History of needing to permanently discontinue prior gemcitabine/ cisplatin regimen for reasons other than progression (i.e. toxicity)
+History of
+Known prior history of tuberculosis or positive purified protein derivative (PPD) test result
+Prior history of any viral-based therapy
+Prior history of lactic acidosis or metabolic acidosis
+Family history consistent with thrombophilia or hypofibrinolysis
+History of or current amyloidosis
+History of previous or concurrent (i.e., second primary) invasive melanoma.
+History of or current pheochromocytoma
+History of contact dermatitis to clobetasol propionate or similarly fluorinated steroids or other steroids with the propionate ester
+Participants may not have had any prior history of hypertensive crisis or hypertensive encephalopathy
+Has a history of hypertensive crisis or hypertensive encephalopathy
+Any history of second- or third-degree heart block. (Patients with pacemakers may be eligible.)
+History of active primary immunodeficiency;
+Any active neurologic and/or psychiatric disease, history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities
+History of hemolytic anemia or thalassemia
+Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others)
+Risk factors for Torsades de Pointe (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
+Patient has a history of lactic acidosis, chronic kidney disease or a creatinine >= 1.2 mg/dl
+Prior history of chronic prostatitis or urethral stricture
+Patients with history of erosive esophagitis should be excluded from the study
+Known history of cardiomyopathy
+History of pituitary or adrenal dysfunction
+Individuals with a history of a different malignancy are ineligible except for the following circumstances: 1) individuals with a history of other malignancies are eligible as long as there is no evidence of metastases and life expectancy deemed > 2 years
+History of prior >= G 3 hypersensitivity (HSR) or any toxicity to trastuzumab or pertuzumab that warranted permanent cessation of this agent
+No history of sustained ventricular tachycardia (lasting longer than 30 sec) or cardiac arrest
+Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
+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
+Patients with history of proteinuria grade >= 2
+History of congestive heart failure or systolic dysfunction (LVEF <50%)
+History of active primary immunodeficiency
+Documented history of vesicoureteral reflux
+History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
+History of glucose-6-phosphate dehydrogenase deficiency
+History of seizures, movement disorders or cerebrovascular accident within the past 5 years
+Known myopathy or history of rhabdomyolysis
+Any history of ventricular arrhythmia
+History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
+Patients with any malignancy who will receive HDMTX given as a 5 g/m^2 infusion over 24 hours and a history of >= 1 of the following:\r\n* Documented decreased renal function, as defined as creatinine greater than 1.5 x baseline or glomerular filtration rate (GFR) < 65 ml/min/1.73m^2\r\n* History of prior nephrotoxicity with HDMTX as evidence by increased creatinine to 1.5 x baseline or need for dialysis or carboxypeptidase\r\n* History of grade 3 adverse event (AE) related to HDMTX (mucositis, myelosuppression, nephrotoxicity, hepatotoxicity) based on the National Institutes of Health (NIH) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0\r\n* Provider concern patient is at risk for MTX toxicity, such as a prior history of treatment with nephrotoxic chemotherapy, history of HDMTX-related neurotoxicity, or antimicrobial/antifungal therapy
+Subjects with a history of Grade 4 astrocytoma.
+Subjects with a history of calcium oxalate nephrolithiasis are excluded
+History of allogeneic HSCT or prior autologous HSCT
+History of pituitary or adrenal dysfunction
+History of seizures (taking/not taking anticonvulsants), arteriovenous malformation in the brain, head trauma with loss of consciousness
+History of pituitary or adrenal dysfunction
+History of RPLS
+Known history of Wilson's disease or other copper-related disorders
+History of venous thrombosis currently requiring anti-coagulation therapy
+Prior history of bowel perforation
+Recent history of myocardial infarct (less than 3 months) or history of active angina or arrhythmia
+history of arteriovenous malformations of the brain,
+history of brain infection (i.e., abscess, meningitis, or encephalitis),
+Subject with a history of exposure to enzalutamide.
+History of radiation to the chest wall or breast being studied
+Inclusion Criteria:\n\n          1. Histologically confirmed resected ductal pancreatic adenocarcinoma with macroscopic\n             complete resection (R0 and R1). Subjects with neuroendocrine (and mixed type) tumors\n             are excluded.\n\n          2. Pancreatic cancer surgical staging: T 1-3, N0-1, M0.\n\n          3. Subject should be able to start treatment no later than 12 weeks postsurgery.\n\n          4. ?18 years of age at the time of signing the informed consent form (ICF).\n\n          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\n          6. Acceptable hematology parameters:\n\n               -  Absolute neutrophil count ?1500 cell/mm3\n\n               -  Platelet count ?100,000/mm3\n\n               -  Hemoglobin (Hgb) ?9 g/dL\n\n          7. Acceptable blood chemistry levels:\n\n               -  Aspartate aminotransferase (AST)/ Serum glutamic oxaloacetic transaminase (SGOT)\n                  and Alanine transaminase (ALT)/ Serum glutamic -pyruvic transaminase (SGPT) ?2.5\n                  × upper limit of normal range (ULN)\n\n               -  Total bilirubin ? Upper Limit of Normal (ULN) (subjects with Gilbert's syndrome\n                  can have bilirubin of up to 1.5 x ULN)\n\n               -  Alkaline phosphatase ? 2.5 x ULN\n\n               -  Serum creatinine within upper limits of normal or calculated clearance ?50\n                  mL/min/1.73 m2. If using creatinine clearance, actual body weight should be used\n                  for calculating creatinine clearance (eg, using the Cockroft-Gault formula). For\n                  subjects with a Body Mass Index (BMI) >30 kg/m2, lean body weight should be used\n                  instead\n\n          8. Cancer antigen (CA)19-9 <100 U/mL assessed within 14 days of randomization\n\n          9. Acceptable coagulation studies as demonstrated by Prothrombin Time (PT) and Partial\n             Thromboplastin Time (PTT) within normal limits (±15%)\n\n        Exclusion Criteria:\n\n        A subject will not be eligible for inclusion in this study if any of the following criteria\n        apply:\n\n          1. Prior neo-adjuvant treatment or radiation therapy for pancreatic adenocarcinoma\n\n          2. Presence of or history of metastatic pancreatic adenocarcinoma\n\n          3. Any other malignancy within 5 years prior to randomization, with the exception of\n             adequately treated in-situ carcinoma of the cervix, uteri, or nonmelanomatous skin\n             cancer (all treatment of which should have been completed 6 months prior to\n             randomization)\n\n          4. Active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic\n             therapy, defined as ongoing signs/symptoms related to the infection without\n             improvement despite appropriate antibiotics, antiviral therapy, and/or other treatment\n\n          5. Known infection with hepatitis B or C, or history of human immunodeficiency virus\n             (HIV) infection, or subject receiving immunosuppressive or myelosuppressive\n             medications that would in the opinion of the investigator, increase the risk of\n             serious neutropenic complications\n\n          6. History of allergy or hypersensitivity to nab-paclitaxel or gemcitabine or any of\n             their excipients\n\n          7. Serious medical risk factors involving any of the major organ systems, or serious\n             psychiatric disorders, which could compromise the subject's safety or the study data\n             integrity. These include, but are not limited to:\n\n               1. History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa)\n\n               2. History of interstitial lung disease, slowly progressive dyspnea and unproductive\n                  cough, sarcoidosis, silicosis, idiopathic pulmonary fibrosis, pulmonary\n                  hypersensitivity pneumonitis or multiple allergies\n\n               3. History of the following within 6 months prior to Cycle 1 Day 1: a myocardial\n                  infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass\n                  graft, New York Heart Association (NYHA) Class III-IV heart failure, uncontrolled\n                  hypertension, clinically significant cardiac dysrhythmia or ECG abnormality,\n                  cerebrovascular accident, transient ischemic attack, or seizure disorder
+History of pituitary or adrenal dysfunction
+History of tuberculosis or positive purified protein derivative (PPD) test
+History of ? Grade 2 pancreatitis
+Having at least a 10-pack year history of cigarette smoking
+History of suicide attempt or preparation for attempt within the past 10 years
+History of bipolar disorder
+History of eating disorder such as anorexia or bulimia
+History of leptomeningeal disease
+History of hepatic encephalopathy
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Has a history of acute or chronic pancreatitis
+Patients have prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
+History of pituitary or adrenal dysfunction
+Patients who have radiographic evidence of esophageal varices or history of variceal hemorrhage
+PART B: History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
+PART B: Any history of venous or arterial thrombo-embolism, or previous revascularization procedure
+Patients with oropharynx carcinoma with a smoking history of ? 10 pack-year or equivalent 10 year history of tobacco product use and no recent history (within last 5 years) of tobacco use
+Smoking history < 10 pack years or equivalent 10 year history of tobacco product use
+Any significant tobacco history within the past five years
+History of connective tissue disorders such as rheumatoid arthritis, lupus, or Sjogren’s disease
+History of leptomeningeal metastases
+History of venous thrombosis currently requiring anti-coagulation therapy
+History of prior immunotherapy within the last 3 years
+History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
+History of atopic dermatitis or active skin condition (acute, chronic, exfoliative) that disrupts the epidermis
+Patients with a history of ipsilateral DCIS are eligible if they were treated with wide-excision alone, without radiation therapy; patients with a history of contralateral DCIS are not eligible
+Diverticulitis (either active or history of) within the past 2 years; note that diverticulosis is permitted
+History of asthma
+Previous or current history of a myeloproliferative disease
+Any history of allergies to grapes or grape seed
+History of sarcoidosis
+History of hypercalcemia
+History of pituitary dysfunction
+History of adrenal dysfunction
+History of pituitary or adrenal dysfunction
+History of progressive multifocal leukoencephalopathy (PML)
+History of arterial/myocardial disease
+Seizures or history of seizures
+History and/or current evidence of clinically relevant ectopic mineralization/calcification
+History of angioedema
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
+Inadequately controlled hypertension or prior history of hypertensive crisis or hypertensive encephalopathy.
+Active smoking within the past 20 years with a cumulative pack year history of > 20 pack years or active smoking (defined as >= 1 cigarette per day) within the last 5 years
+History of unstable angina within 1 year prior to study entry
+History of acute pancreatitis within 1 year prior to study entry or past medical history of chronic pancreatitis
+Prior history of non-arterial ischemic optic retinopathy
+History of significant hypotensive episode requiring hospitalization
+Except for CMMoL, patients with history of myeloproliferative neoplasms (MPN) (defined as a history of essential thrombocytosis or polycythemia vera, or idiopathic myelofibrosis prior to the diagnosis of AML) or combined MDS/MPN are not eligible.
+History of Wilson's disease or other copper-metabolism disorder
+History of primary immunodeficiency
+Have a history of vitamin B12 deficiency
+A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
+Patient must not have a history of gastric resection (MTD expansion cohort only)
+Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
+Patients with elevated troponin T and/or CK levels (> 1.5 x ULN for the laboratory) or with history of myositis, rhabdomyolysis or other myopathic disease.
+For patients with history of anthracycline exposure or coronary artery disease co-management by cardiology to optimize cardioprotective medications will be required prior to Tosedostat initiation.
+History of Barrett's esophagus, esophageal webbing, stricture, or fistula
+Patients with history of active seizures are not eligible
+History of severe asthma or presently on chronic inhaled corticosteroid medications (patients with a history of mild asthma controlled with inhaled bronchodilators are eligible)
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Individuals with a history of asparaginase-associated pancreatitis
+History of symptomatic genitourinary stones within the past year
+History of grade 3 (Gr. 3) or greater retinopathy or keratitis
+Prior history of hypertensive crisis or hypertensive encephalopathy
+A history of neurological complications due to poliovirus infection
+Genotype: APC mutation (with or without family history) required
+Patients with a prior history of documented pancreatitis
+History of any disease that could lead to impaired absorption of drugs
+History of serious chronic mental disorder or drug-abuse accompanied by documented problems of compliance with therapeutic programs
+A history of ataxia telangiectasia or other documented history of radiation hypersensitivity
+Patients must be ineligible to receive IL-2 based on evidence that may include ischemic heart disease, or arrhythmias, or poor ventricular ejection fraction (< 50%), or respiratory compromise (forced expiratory volume in one second [FEV1] < 60%), or prolonged smoking history, or clinically significant patient history which in the judgment of the investigator would compromise the patient’s ability to tolerate aldesleukin
+History or presence of sustained ventricular tachyarrhythmia; (patients with a history of atrial arrhythmia are eligible but should be discussed with Novartis prior to enrollment)
+A history of AEs with prior interleukin (IL)-2 or Interferon will not preclude subjects from entering the current study
+History of any major disease that might interfere with safe protocol participation
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
+Splenomegaly or history of proliferative hematologic disease
+History of hemoptysis
+Patients with previous history or current presence of neurological disorders (with the exception of myasthenia gravis), including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes.
+Patients with a prior history of a splenectomy and/or sickle cell trait/disease
+Patient has a history of listeriosis or prior ADXS11-001 therapy
+History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the study principal investigator [PI] prior to enrollment)
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of intolerance or resistance to lenalidomide
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of primary immunodeficiency
+Known history of previous clinical diagnosis of active tuberculosis (this does not include a history of being purified protein derivative [PPD] positive)
+History of lupus or scleroderma
+h. History of psychotropic drug abuse and inability to quit
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of seizures.
+Has a history of ocular melanoma
+History of any other active malignancies
+No history of distant metastases.
+History of primary immunodeficiency
+Any prior history of hypertensive crisis or hypertensive encephalopathy
+Patients with > 10 pack years of smoking history and/or currently a smoker at the time of treatment
+History of histologically documented, B-lymphocyte antigen cluster of differentiation 20 plus (CD20+), iNHL
+History of sensitivity to mannitol
+Participants with a history of confirmed progressive multifocal leukoencephalopathy (PML)
+History of life threatening or recurrent thrombosis/embolism; subjects may participate if they are adequately anticoagulated during the treatment
+Patients with previous history or current presence of neurological disorders, including epilepsy (although controlled by anticonvulsant therapy), Parkinson's disease and extra-pyramidal syndromes
+History of immunization with gp100(g209-2M)
+History of 15 to 75 PRBC transfusions
+History of HIV positivity by (ELISA or Western blot)
+History of scleroderma and systemic lupus erythematosus which increases the risk of toxicity from radiation treatment
+History of cumulative doxorubicin or liposomal doxorubicin dose > 430 mg/m^2
+History of heart disease
+History of renal failure requiring dialysis.
+History of heart disease.
+History of gastrointestinal disease with diarrhea as the major symptom.
+History of renal failure requiring dialysis.
+History of hypertensive or diabetic retinopathy
+History of/or current evidence of hemoptysis (bright red blood of ½ teaspoon or more)
+Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose)
+Pre-existing severe psychiatric condition or a history of a psychiatric disorder requiring hospitalization or a history of suicidal ideation or attempt
+Patients with a history of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis
+History of impaired adrenal gland function
+Patient has a history of autoimmune disorder or immune deficiency disorder
+History of one of the following myeloproliferative neoplasms: essential thrombocythemia, polycythemia vera, and primary myelofibrosis.
+History of major immunologic reaction to any IgG containing agent.
+History of pre-existing post-traumatic stress disorder (PTSD)
+Known history of positive serum human ADA to trastuzumab.
+The donor has existence or recent history of persistent pulmonary infiltrates, recent pneumonia, recent bronchitis, recurrent lung infections, or history or evidence of any lung disease including asthma, or current symptoms of upper respiratory tract infection
+Patients with a history of LVEF decline to below 50% during or after prior trastuzumab/lapatinib or other HER2 directed therapy.
+History of splenectomy
+Prior history or current evidence of osteomyelitis/osteonecrosis of the jaw
+For Post-allo Part B:History of veno-occlusive disease requiring defibrotide
+For Post-allo Part B: History of Grade 2 or higher hepatic GVHD
+History of Grade ?3 infusion-associated adverse events (AEs) or hypersensitivities to NEOD001 or any of its excipients
+History of intolerance to irinotecan at dose-intensity of 125 mg/m^2/2 weeks or lower
+History of intolerance to 5-FU at dose-intensity of 1800 mg/m^2/2 weeks or lower
+Active joint inflammation or history of inflammatory arthritis or other immune disorder involving joints
+History of prior therapy with belinostat or AZD1775
+History of other malignancies, except:
+History of known congenital hypercoagulable condition
+History of connective tissue disorders (eg, lupus, scleroderma, arteritis nodosa).
+A history of uveitis and/or scleritis
+Medical history of orthostatic hypotension.
+History of uveitis
+History of prior crizotinib use
+History of acute or chronic pancreatitis
+A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
+Evidence or history of congenital or acquired hypocoagulability disorders
+History of pancreatitis of any grade
+History of pancreatitis
+History of cranial nerve palsy.
+History of corneal disease
+History of any disease that could lead to impaired absorption of drugs
+History of coronary revascularization or ischemic symptoms
+History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity
+A history of resected pancreatic adenocarcinoma
+History of coronary revascularization or ischemic symptoms
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of noninfectious pneumonitis
+Patients with history of prior HSV encephalitis or encephalitis due to other etiologies
+Subject has documented history of allergic response to titanium or silicone
+Have a history of a primary adenocarcinoma of the colon and / or rectum
+History of exposure to pseudomonas exotoxin containing molecule
+Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to DSM- IV).
+Personal or family history of established Brugada syndrome; if pre-enrollment electrocardiogram (ECG) demonstrates abnormal findings (ST elevation in precordial leads), cardiology consultation should be obtained to rule out presence of this inherited syndrome; patients with family history of unexplained sudden death before the age 45 years; personal history of unexplained syncope or history of unexplained ventricular tachycardia or fibrillation should have a cardiology evaluation to rule out the diagnosis of Brugada syndrome
+History of tuberculosis (latent or active) or positive Interferon-gamma release assay (IGRA).
+History of depression or active treatment for depression
+History of hypothyroidism or hyperthyroidism
+History of significant neurologic or psychiatric disorders, including dementia or seizures that would impede consent, treatment, or follow up
+History of suspected history, or presence of heparin induced toxicity (w/ or w/o thrombosis)
+Patients with a history of thrombotic or hemorrhagic disorders
+Active corneal erosions or history of abnormal corneal sensitivity test
+History of orthostatic hypotension
+Patients with smoking history of less than or equal to 10 pack years and with primary tumour site of base of tongue and/or tonsil
+Patients with leptomeningeal disease (LMD) or with a history of LMD will be excluded
+History of coronary revascularization or ischemic symptoms
+History of prior systemic BCG infection
+History of immunosuppression, or conditions associated with congenital or acquired immune deficiency
+Patients with no smoking history
+History of transformation of indolent disease to DLBCL
+Known history of hepatitis C and recovery status has not been determined at time of screening
+History of myocardial infarction (MI) documented by elevated cardiac enzymes with persistent regional wall motion abnormality on assessment of left ventricular (LV) function (patients with history of MI must have an echocardiogram (echo) instead of/in addition to a MUGA to evaluate LV wall motion)
+History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the Novartis prior to enrollment)
+History of kidney, ureteral, or bladder stones within the last 5 years
+History of or current immunodeficiency disease (e.g. splenectomy or splenic irradiation)
+Prior history of a pathologic fracture
+History of pituitary or adrenal dysfunction (note: the use of daily steroids does not exclude someone from participating in this study)
+History of ventricular tachyarrhythmia within the past 5 years
+History of acute pancreatitis within 1 year of study entry
+Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others).
+Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
+Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders.
+History of progressive multifocal leukoencephalopathy (PML).
+History of glaucoma
+No other history of or ongoing malignancy that would potentially interfere with the interpretation of the Pharmacodynamic (PD) or efficacy assays
+Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events, and/or heart failure within 1 year of AVB-620 administration
+History of sensitivity to any component of SD-101
+Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
+Prior history of a pathologic fracture
+History or suspicion of a congenital or acquired coagulation disorder.
+History of other malignancies, except
+History of transfusions < 10 RBC units and must not be RBC transfusion dependent
+History of adrenal insufficiency
+History of or known carcinomatous meningitis
+History or presence of sustained ventricular tachyarrhythmia. (Patients with a history of atrial arrhythmia are eligible but should be discussed with the study chair prior to enrollment).
+Prior history of hypertensive crisis or hypertensive encephalopathy
+History of asthma
+Any history of leptomeningeal disease
+Patients with carcinomatosis meningitis or a history of ocular/uveal melanoma are excluded.
+Participants with known coagulopathy, platelet disorder or history of non-drug-induced thrombocytopenia
+Known current or a history of hepatitis B or C virus, including chronic and dormant states, unless disease has been treated and confirmed cleared
+Any history of intracerebral arteriovenous malformation, cerebral aneurysm, brain metastases or stroke.
+History of prior seizures
+Known history of mineralocorticoid excess or deficiency (not applicable to patients who have already been treated with abiraterone acetate in first line before inclusion).
+History of second primary cancer within the past 5 years, with the exception of:
+History of seizures, movement disorders or cerebrovascular accident within the past 5 years prior to cycle 1 day 1
+History of thrombosis due to a known inherited hypercoagulable state
+Have a history of tuberculosis and/or received BCG percutaneous vaccination
+Patients with a history of proven myocarditis, pericarditis, or endocarditis
+History of seizures, movement disorders or cerebrovascular accident within the past 3 years prior to cycle 1 day 1
+History of leptomeningeal disease.
+History of coronary revascularization or ischemic symptoms
+Past history of radiotherapy within the projected treatment field of any of the disease sites to be treated by MRI-guided, online adaptive SBRT
+History of Wilson's disease or other copper-related metabolic disorder
+History of non-healing wounds or ulcers.
+History of previous therapeutic HPV vaccination;
+Patients with known history of Trisomy 21 (Down Syndrome), history of congenital immunodeficiency or inherited marrow failure disorder.
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Prior history of HNC
+History of progressive multifocal leukoencephalopathy (PML)
+Prior history of a pathologic fracture
+History or signs of active coronary artery disease with or without angina pectoris.
+Inadequately controlled hypertension or history of hypertensive crisis or encephalopathy.
+Prior history of myositis or rhabdomyolysis.
+Recent history of acute pancreatitis.
+History of inflammatory colitides, chronic abdominal pain, or chronic diarrhea.
+History of a prior symptomatic stroke, dementia, or other significant central neurologic condition (i.e. multiple sclerosis)
+A history of known glucose-6-phosphate dehydrogenase (G6PD) deficiency
+History of additional risk factors for Torsade de Pointes
+Prior history of a pathologic fracture
+The subject has a history of delayed healing/open wounds or diabetic ulcers.
+Known history of resistance to thalidomide
+Previous history of exposure to an anthracycline compound.
+History of treatment with an asparaginase agent
+Presence or history of hemoptysis (>1/2 teaspoon of red blood) 2 weeks prior to the first dose of GSK3052230
+History of pituitary or adrenal dysfunction
+Prior history of cardiomyopathy.
+PART I: History of iron overload or hemochromatosis
+PART I: Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
+PART II: History of iron overload or hemochromatosis
+PART II: Participants with evidence of a significant psychiatric disorder by history/examination that would prevent completion of the study will not be allowed to participate
+Prior history of psoriasis
+History of chronic corticosteroid use
+History of a decrease in LVEF to < 40% or symptomatic CHF with previous trastuzumab treatment
+Known history of sustained (> 30 second) ventricular tachycardia or cardiac syncope. Known history of recurrent non-sustained ventricular tachycardia (> 3 beats) despite anti-arrhythmic therapy
+History or presence of ventricular tachyarrhythmia
+A history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
+Active joint inflammation or history of inflammatory arthritis or other immune disorder involving the joints
+Treated and followed for at least the past 2 years in a specialized center that maintained detailed medical records, including transfusion history.
+The subject has a history of immunologic reaction to any Immunoglobulin G (IgG) containing agent.
+History of pituitary dysfunction
+Known history of pituitary or adrenal dysfunction
+History of acute coronary syndromes.
+History of hypertensive crisis or hypertensive encephalopathy
+Subjects with a history of RSV or MPV
+Subjects with a history of documented Pseudomonas aeruginosa pneumonia confirmed radiographically and by culture from BAL.
+Recent (3 months) history of acute pancreatitis.
+History of transformation of indolent disease to DLBCL
+Subjects with a history of NF-1 related cerebral vascular anomaly (such as Moyamoya).
+History of heparin-induced thrombocytopenia.
+Prior history of chronic prostatitis
+Prior history of urethral stricture
+Patients with history or evidence of lactic acidosis or metabolic acidosis will be excluded
+History of coronary revascularization or ischemic symptoms
+History of coronary revascularization or ischemic symptoms
+A history of metabolic acidosis, including ketoacidosis or increased risk of lactic acidosis
+Patients with a history of renal disease
+Lifetime history of any DSM-IV-TR mood or psychotic disorder (e.g., major depressive disorder, bipolar disorder, schizophrenia)
+History of pituitary or adrenal dysfunction
+History of lobectomy involving > 50% of lobe
+Known active cerebral/meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy (PML) or any history of PML
+History of cirrhosis
+History of active current coronary artery disease or unstable angina
+Medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (immediate risk of doing harm to others)
+Hyperuricemia, history of gout, high uric acid, and/or kidney disease
+Hyperuricemia, history of gout, high uric acid, and/or kidney disease
+Currently have or have history of certain study-specified heart, liver, kidney, lung, neurological, immune or other medical conditions
+Subjects with recent history of thyroiditis
+Patients with a history of D835 mutations
+Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy
+Prior history of malignancy other than chronic lymphocytic leukaemia (exceptions to this rule are defined in the clinical trial protocol).
+History or presence of ventricular tachyarrhythmia
+cirrhosis (any degree) and a history of hepatic encephalopathy or ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis
+Has an acute/subacute bowel obstruction or history of chronic diarrhea requiring ongoing medical intervention
+History of significant neurological or psychiatric disorders
+History or current symptoms of congestive heart failure (shortness of breath, ankle swelling)
+History or current evidence of hyperthyroidism that would increase metabolism of Itraconazole
+History of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks.
+History of porphyria.
+History of known Glucose-6-Phosphate Dehydrogenase (G-6-PD) deficiency.
+History of epilepsy or seizures in the past 20 years.
+History of severe asthma, presently on chronic medications (a history of mild asthma not requiring therapy is eligible)
+History of medical or psychiatric disease, active substance abuse or social circumstances which in the view of the principal investigator, would preclude safe treatment
+Patients with history of autoimmune disease (excluding thyroiditis on chronic thyroid replacement therapy) or active auto-immune disease, due to a risk of exacerbation of autoimmunity with r-hIL7; patients with a history of B cell malignancy due to a risk for growth with rhIL7 therapy
+History of:
+Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
+Patients with a history of peptic ulcer disease
+Patients with recent history of kidney stones.
+Patients with recent history of pancreatitis
+History of Wilson's disease or other copper-related metabolic disorder
+Any history of metastatic TCC; subjects with suspected malignant lymphadenopathy in the abdomen or pelvis are not allowed
+History of sensitivity to mannitol
+Patients with history of confirmed progressive multifocal leukoencephalopathy
+History of main or lobar portal vein thrombosis
+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 =< 12 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
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+History of primary immunodeficiency
+History of acute pancreatitis within 1 year of study or history of chronic pancreatitis
+History or current evidence of:\r\n* Tissue calcification including, but not limited to, the soft tissue, kidneys, intestines, myocardium and lung with the exception of calcified lymph nodes and asymptomatic coronary calcification\r\n* Endocrine alterations of calcium/phosphate homeostasis, e.g., parathyroid disorders, history of parathyroidectomy, tumor lysis, tumoral calcinosis etc
+Known homozygous for UGT1A1*28 mutation from prior testing or family history
+History of coronary revascularization or ischemic symptoms
+History of coronary revascularization or ischemic symptoms
+History of life threatening or recurrent thrombosis/embolism; patients may participate if they are on anticoagulation during the treatment
+History of leptomeningeal metastases
+Patients with a known history of proven myocarditis, pericarditis, and/ or endocarditis
+Patient has a medically documented history of or active major depressive episode, bipolar disorder (I or II), obsessive-compulsive disorder, schizophrenia, a history of suicidal attempt or ideation, or homicidal ideation (e.g. risk of doing harm to self or others), or patients with active severe personality disorders (defined according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM-IV]) are not eligible; Note: for patients with psychotropic treatments ongoing at baseline, the dose and the schedule should not be modified within the previous 6 weeks prior to start of study drug
+Prior history of rhabdomyolysis
+Prior history of lactic acidosis
+Any history of second or third degree heart block;
+Current or history of anorexia or bulimia in the past 5 years
+History of Parkinson’s disease, multiple sclerosis or fibromyalgia
+History of steroid psychosis
+History of or active glaucoma
+No history of seizures
+Not currently on renal dialysis or has a history of significant renal impairment
+Patients with a history of prior (ipsilateral [ipsi]- and/or contralateral) invasive BC
+Prior history of neurologic or psychiatric disease believed to impact cognitive function
+Patient is a current or ex-smoker with a smoking history of >= 10 pack years
+DCIS prior to index lesion or history of progressive/recurrent DCIS after treatment
+Participants with a documented history of genetic predisposition for thrombosis (anti-phospholipid antibody syndrome, antithrombin [AT]-III deficiency, etc.), platelet disorder or bleeding disorder
+Self-reported history of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
+History or diagnosis of a disease affecting hemostasis
+A history of orchiectomy
+History of unexplained syncope or family history of idiopathic sudden death
+History of blood clot;
+History of cerebellar toxicity or cerebellar neurological findings on exam
+History of immune-mediated pneumonitis
+History of leptomeningeal disease
+Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis
+History of endometrial neoplasia
+History of thromboembolic disease (history of varicose veins and superficial phlebitis is allowed)
+History of primary immunodeficiency
+History of pituitary or adrenal dysfunction
+Prior history of hypertensive crisis or hypertensive encephalopathy within the previous 3 months of first study treatment
+Patient must not have a history of Raynaud’s disease
+No history of cognitive disorder
+No history of mood disorder
+History of intolerance of oxycodone.
+History of bipolar disorder diagnosis
+History of eating disorder (ever uncontrolled or any within the last two years)
+History of previous experience with smoking or marijuana
+History of bipolar disorder or manic episodes (which is a contra-indication for light treatment)
+History of uncontrolled depression or other psychiatric comorbidity with psychosis
+History of interstitial cystitis
+History of nasal or sinus anomalies or dysfunction e.g. allergic or infectious rhinitis
+Documented history of medication abuse/misuse (e.g. unsanctioned dose escalation, broken opioid agreement etc.)
+Patients with a confirmed history of calcium oxalate nephrolithiasis are excluded; patients with a significant history of malabsorption (e.g. celiac sprue, short bowel syndrome, inflammatory bowel disease [IBD] or other, as determined by the treating physician) are excluded; patients will not be eligible if actively receiving treatment for vitamin D deficiency and have had recent (3 month) history of vitamin D supplementation (> 1000 IU)
+Is known or suspected to have a (family) history of malignant hyperthermia
+Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
+No history of celiac disease or non-celiac gluten sensitivity
+Subjects with a history of anxiety-induced (“anticipatory”) nausea and vomiting
+No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
+History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
+Male patients with a history of untreated hypogonadism
+PATIENTS: History of myasthenia gravis or acute narrow angle glaucoma
+PATIENTS: History of Parkinson’s disease or Alzheimer’s dementia
+Patients who have a history of duodenal ulcer or duodenal fibrosis
+Subjects with a current or past history of schizophrenia will also be excluded
+History of neurologic illness such as stroke, multiple sclerosis, multi-infarct dementia, or Parkinson’s disease or history of dementia or chronic fatigue syndrome
+Recent history of falls or balance problems
+As per self-report and/or medical record history of diagnosed neurological illness including seizure disorder, a dementing condition, or other neurological illness (multiple sclerosis, history of cerebrovascular accident, etc.)
+Participants with untreated depression or anxiety as assessed by self-report and review of medical history
+Participants with a history of treated or untreated schizophrenia or bipolar disorder as assessed by self-report and review of medical history
+As per self-report, a lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder
+History of pre-existing neuropathic pain conditions
+Known medical history of significant psychiatric or cognitive impairment
+History of recurrent or second primary H&N, central nervous system, or thoracic cancer at time of modified barium swallow (MBS) study
+A history of gastric or duodenal ulcers or hyperacidity syndromes
+Smoking history of 30 pack-years or greater
+Documented history of Alzheimer’s disease, dementia, or other neurologic deficit that could impact decision-making
+History of patient reported PONV, chemotherapy-induced nausea and vomiting (CINV) or motion sickness
+History of cerebral vascular accident (CVA) or other central nervous system disorder resulting in residual weakness or paresis of extremity contralateral to the site of disease
+Medical history of coronary heart or artery disease, chronic or acute congestive heart failure or history of systolic or diastolic insufficiencies
+Active hemoptysis or history of clinically relevant hemoptysis as determined by the treating physician; patients who had history of transient minor hemoptysis after bronchoscopic biopsy are eligible unless deemed otherwise by the treating physician
+Blind or having a history of eye disease including, but not limited to, macular degeneration, or other diagnosed retinal problems
+History of serious mood disorder or attempted suicide as determined by patient’s history and physical and by using the Depression Screening; subjects with a score of greater than 10 or those answering #5 with scores greater than a \0\ will be deemed ineligible to be enrolled on study
+History of angioedema
+Platelets < 150 mg/dL or history of thrombocytopenia
+Lower extremity neuropathy per patient report attributable to oxaliplatin, docetaxel or paclitaxel (neurotoxic chemotherapeutic agent) as determined by patient history of neurotoxic agent administration and no history of other attributable causes such as diabetic neuropathy
+Patients with a history of enfuvirtide resistance
+History of marked anxiety disorder, or history of substance abuse
+Unable to provide medical history
+Psychiatric disorder such as severe depression, manic depressive disorder, obsessive compulsive disorder or schizophrenia; (defined per medical history)
+Co-morbid disease or incurrent illness such as:\r\n* History of head trauma \r\n* History of nasal surgery other than biopsy (before cancer was diagnosed)\r\n* History of sinus surgery other than biopsy (before cancer was diagnosed)\r\n* Chronic rhinosinusitis with or without polyp \r\n* Pregnancy \r\n* Cognitive dysfunction \r\n* History of brain surgery \r\n* Psychiatric or neurologic diseases interfering with sense of smell \r\n* Congenital disorders of olfactory dysfunction \r\n* Olfactory loss prior to onset of nasopharyngeal carcinoma
+Known history of a neurological and/or psychological disorder that in the physician’s opinion may interfere with the patient’s ability to cooperate with study procedures
+History of bipolar affective disorder or psychosis
+History of chronic pain and/or daily opioid use
+History of intolerance to negative pressure wound therapy
+Medical history of concussions
+Patients with a documented history of invasive fungal infection (IFI) within the previous 30 days are not eligible
+Personal history of migraine, cluster or tension headaches
+Prior history of hypertensive crisis or hypertensive encephalopathy
+Patients must not have any contraindicated concurrent illnesses listed on the duloxetine package insert including:\r\n* Current primary psychiatric diagnosis (schizophrenia, psychosis) or suicidal ideation, history of bipolar disorder, or seizure disorder\r\n* History of alcohol or other substance abuse or dependence within 365 days prior to registration\r\n* Chronic liver disease\r\n* End-stage renal disease\r\n* Uncontrolled narrow-angle glaucoma\r\n* Clinically significant coagulation disorder
+Have a history of dementia or major neurological illness
+Known re-expandable lung:\r\n* History of recurrent transudative (by Light’s criteria) pleural effusions of known etiology, AND\r\n* Has undergone multiple prior thoracenteses, without history of significant chest discomfort, AND\r\n* Strong clinical suspicion that the current effusion is uncomplicated and due to the known underlying etiology
+Strong, self-reported history of postoperative nausea and vomiting
+Participants will have no previous history of clinical trial research participation
+No history of hemorrhagic stroke
+Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
+Subjects who have unknown transfusion history for at least the 12 weeks prior to screening
+Personal history of an eating disorder
+History of multiple CDI
+History of gastrointestinal or genitourinary obstruction or porphyria
+Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
+History of a chronic medical condition that has the potential to significantly impact upper extremity function (e.g. stroke, Parkinson’s disease, multiple sclerosis)
+Have no clinical history of disease (e.g., multiple sclerosis, fibromyalgia) that could account for their fatigue presentation
+History of heparin induced thrombocytopenia
+Patients may or may not have a history of lymphedema or have been treated for lymphedema
+History of seizures
+At least a 30 pack-year smoking history
+No history of untreated narrow angle glaucoma within 6 weeks prior to registration
+Patients with prior history of HSCT
+History of diagnosis of neurogenic bladder.
+History of second (Mobitz II) or third degree heart block (subjects with pacemakers are eligible if they have no history of fainting or clinically relevant arrhythmias while using the pacemaker);
+Subject is pregnant, planning to become pregnant, or is lactating. 4. Subject has a history of empyema. 5. Subject has a history of chylothorax. 6. Subject has an uncorrected coagulopathy. 7. Subject has a hypersensitivity to new or existing pleural catheter or it's components.
+Has history of calcium oxalate stones
+Has history of iron overload
+No significant history of a medical problem or co-morbidity that would preclude the patient from undergoing a major abdominal operation such as a history of severe congestive heart failure or active ischemic heart disease
+History of or current hepatic encephalopathy or clinically meaningful ascites.
+=< 10 pack-years smoking history or =< 30 pack-years smoking history WITH >= 5 years abstinence from smoking
+PILOT PARTICIPANTS AND HEALTHY CONTROLS ONLY: Women with no history of cancer
+History of Sjogren’s, lupus or scleroderma
+History of myasthenia gravis or acute narrow angle glaucoma
+History of Parkinson’s disease or dementia
+Patient must not have history of prior cranial radiotherapy
+Prior history of acupressure use
+Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw
+No history of bronchial asthma or related bronchospastic conditions
+History of Guillain-Barre within 6 weeks of previous influenza vaccination
+History of neutralizing antibody activity to recombinant human erythropoietin (rHuEPO) or darbepoetin alfa.
+History of pure red cell aplasia
+No history of Paget’s disease
+No history of epilepsy/seizures
+History of phenylketonuria (PKU)
+History of polycythemia
+Patients with a history of severely impaired autonomic control of blood pressure
+Patients with a history of existing hypercalcemia, hypocalcemia, hypermagnesemia or hypomagnesemia that is not corrected despite supplementation
+Known urea cycle disorders based on history
+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 4 weeks and incompletely healed surgical incision before randomization
+Evidence of empyema or history of empyema of the affected hemithorax
+History of seizures
+Patients with a history of or current bowel obstruction
+Patients will be excluded from the trial if they have had a history of allergies or intolerance to fructooligosaccharides or the components of FOS including fructose and glucose
+History of Post-traumatic Stress Disorder
+History of multiple cancers
+Patients have a known history of seasonal affective disorder or substance abuse
+Medical history of atrial fibrillation or arrhythmia
+Presence or recent history of any systemic disorder or conditions, such as:
+Prior history of hearing impairment
+History of seizures
+History of primary (congenital) lymphedema
+Patients who have a history of breast tissue expander or implant placement
+Known history of glucose-6-phosphate dehydrogenase (G6PD) deficiency
+Known history of hemolysis and/or methemoglobinemia
+Subjects with history of presumed or proven invasive fungal infection within 30 days of randomization
+History of demyelinating disorder
+History of bone fractures
+History of gastrointestinal or genitourinary obstruction or porphyria
+Diagnosis of/problems with chronic diarrhea or history of bowel obstruction or esophageal stricture
+Patients with a prior history of colonic surgeries
+No history of CRC
+Women who report no history of Pap screening within the last four years
+Women who report no history of co-testing (Pap and HPV) within the last five years
+Must be willing to complete demographic, family history, personal health and medication history, and informed consent
+Personal history of pancreatic adenocarcinoma
+PRELIMINARY TEST: No history of hysterectomy
+Individuals that have a personal or family history of CRC (previous adenomatous polyp), and/or, have a signs and symptoms colonoscopy order from their primary care physician
+Patients determined to be at risk for esophageal cancer:\r\n* Subjects with a history of Barrett’s esophagus\r\n* Subjects with a history of low or high grade dysplasia\r\n* Subjects with a history of gastroesophageal reflux disease (GERD)\r\n* Subjects with a history of esophagitis\r\n* Subjects with symptoms of esophageal cancer (EC) referred for endoscopy (new onset dysphagia, weight loss, etc)
+Previous medical history of, or suspected hypersensitivity to, the PEG based bowel cleansing preparation and/or bowel cleansing formulations' ingredients.
+Patients have no known coagulopathy and no known history of esophageal varices
+Patients have known coagulopathies or history of esophageal varices
+Personal or family history (1st degree relative) of colon cancer
+History of significant adverse reaction or major bleeding related adverse reaction to other anticoagulant or antiplatelet agents
+Prior history of documented venous thromboembolic event within the last 5 years (excluding central line associated events whereby patients completed anticoagulation)
+History of receiving 2016-2017 influenza vaccine
+History of proven influenza disease after September 1, 2016
+FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: History of receiving current year seasonal influenza vaccine influenza vaccine
+FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: History of proven influenza disease after September 1, 2017
+Survey response indicated no prior history of HPV vaccination
+History of receiving 2017-2018 influenza vaccine
+History of proven influenza disease after September 1, 2017
+Current diagnosis or history of cardiac pre-excitation syndromes (e.g. Wolff-Parkinson-White)
+Current or ex-smoker with at least 10 pack-year history
+History of known thyroid disease
+History of known sarcoid disease
+History of known abnormalities in calcium metabolism
+History of known renal dysfunction
+History of known nephrolithiasis (kidney stones)
+Have at least a 30 pack-year history of smoking
+History of chronic myopathy
+History of pancreatic adenocarcinoma (at any time)
+History of chronic sinusitis or recent nasal polyps
+History or presence of sustained ventricular tachycardia
+History of chronic myopathy
+History of heparin induced thrombocytopenia
+WHITE, NON-HISPANIC: Without a personal history of melanoma.
+H/L: Participants with a personal history of melanoma and/or more personal history of more than one SCC and/or BCC.
+A history of adverse reaction to IV thiamine
+For patient with known history or predisposition to cardiac abnormalities: in the Investigator's opinion the history/predisposition should not jeopardize patient's safety during the study.
+Individuals with a history of any skin cancer, melanocytic lesions, actinic keratoses or actinic damage in the test area are ineligible; history of such conditions at a body site other than the test area is not exclusionary if in the opinion of the study physician it will not pose a risk to the subject
+Individuals with a history of natural or artificial sun exposure to the buttocks within 30 days of study participation are not eligible
+No history of celiac disease or non-celiac gluten sensitivity
+Women with a prior history of cardiovascular disease, defined as a 1 or more positive responses on the Heart Questionnaire
+History of disordered eating as indicated by the Eating Disorder Examination Questionnaire (EDEQ)
+Have a personal history of melanoma and/or family history of melanoma (see definition under child eligibility criteria below)
+Are at risk for melanoma due to having a first degree relative with a history of melanoma and/or at least 3 second or third degree relatives on the same side of the family with a history of melanoma and/or
+Patients with a history of hypocalcemia
+History of myocardial disease, such as myocarditis, cardiomyopathy, congestive heart failure, ischemic cardiomyopathy
+Patients with a history of pancreatitis
+>= 1 year history of smoking, and smoking >= 5 cigarettes per week
+Have a prior history of lactic acidosis by self-report
+History of panic disorder, psychosis, bipolar disorder, or eating disorders
+Eligible participants for focus groups include current or former smokers who are between 55-80 with a 30 pack­-year history
+Participants must have a smoking history of 20 pack-years or greater
+History of chronic myopathy
+History of GI ulcers, chronic GERD, or GI bleeding in the past 5 years
+History of claustrophobia
+Women with known osteoporosis or history of osteoporotic (fragility) fracture of the spine
+Current smokers or subjects with any history of smoking
+Those with a family history, previous history of removing polyps, inflammatory bowel disease, or diagnosis of colorectal cancer
+Individuals with a history of colon resection or colectomy due to any reason
+Individual with history of gastric bypass due to any reason
+History of diabetic ketoacidosis
+History of renal disease
+Healthy on the basis of medical history
+Individuals with history of myocardial infarction, stroke, coronary-artery bypass draft, invasive coronary revascularization in the preceding 5 years
+Subjects may be taking calcium supplements or have previous history of hypercalcemia
+History of lactic acidosis
+History of B12 deficiency
+Patients with a documented history of coagulopathy such as hemophilia or von Willebrand’s disease or inherited thrombophilia
+Participants who exhibit confusion, disorientation, or have a history of major psychiatric illness which may impair their understanding of the informed consent
+History of gastroduodenal ulcers documented =< 1 year
+Current or history of hepatic dysfunction
+A subject with a history or expectation of noncompliance with medications or treatment protocol
+Has a history of anaphylaxis attributed to the azole class of antifungal agents
+PHASE I: Individuals at risk for lung cancer based on a smoking history of 20 or more pack/years of cigarette smoking
+STUDY I: >= 1 year history of weekly smoking
+Generally good health as determined by medical history
+Prior history of malignancies, other than MDS (MYELODYSPLASTIC SYNDROMES), unless the subject has been free of the disease for ? 3 years. However, subjects with the following history/concurrent conditions are allowed:
+History of primary immunodeficiency
+Subjects with a history of primary idiopathic myelofibrosis.
+History of primary immunodeficiency
+History of leptomeningeal carcinomatosis
+No history of uncontrolled seizures after surgery for primary GBM (despite adequate antiepileptic therapy) or with need for concurrent administration of more than 2 antiepileptic drugs.
+Have a history of lactic acidosis or risk factors for lactic acidosis
+Have a history of alcoholism or high alcohol consumption (average of > 3 standard drinks/day)
+History of autoimmune disorder or any illness that requires therapy with chronic steroids or immunomodulators
+History of 1 or more adenomatous polyps
+Current or ex-smoker with at least a 10-year pack history
+History of known thyroid disease
+History of known sarcoid disease
+History of known abnormalities in calcium metabolism
+History of known renal dysfunction
+History of known nephrolithiasis (kidney stones)
+Personal history of polyps
+Personal history of CRC
+History of: Thrombophelitis, Deep vein thrombosis, Pulmonary embolus, Clotting disorder, Bleeding disorder, Heart disease, Diabetes, Stroke, Peanut allergy, Liver dysfunction, Hypersensitivity to progesterone
+History of relapse of ALL
+Positive history of a medical condition that precludes use of the nicotine patch
+History of chronic sinusitis or recent nasal polyps
+History of gastroparesis
+History of celiac disease
+History of difficulty with sigmoidoscopy or abnormal colorectal anatomy
+History of food allergies and/or major dietary restrictions
+Have a history of gallstones
+History of panic disorder, psychosis, bipolar disorder, or eating disorders
+Current or history of anal or peri-anal carcinoma
+Free of obvious health problems as established by medical history and clinical examination before entering into the study.
+History of any neurological disorders or seizures.
+History of radical prostatectomy
+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
+Individuals with history of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
+With history of a neurological disorder, neurodegenerative disease, or traumatic brain injury with loss of consciousness (> 60 minutes), as per medical records or patient report
+History or diagnosis of Paget’s disease
+Subject has history of primary immunodeficiency
+Self-reported or documented history of pre-existing peripheral neuropathy prior to initiation of taxane chemotherapy
+Unable to provide history
+History of anaphylactoid reaction to iodinated contrast material
+History of previous administration of GBCA
+History of renal disease, hypertension, diabetes, congestive heart failure or emphysema
+History of reaction to ICG, iodides, or technetium radiocolloid
+No prior history of breast reconstruction, reduction, or augmentation
+History of pneumonitis requiring hospitalization or systemic immune suppressive therapy
+Subjects with a history of low or high grade dysplasia
+Known history of cerebrovascular disease, dementia or prior non-mild traumatic brain injury
+History of high grade anal intraepithelial neoplasia (AIN 2 or 3)
+History of allergies to iodides
+History of hemibody external radiotherapy as assessed by medical record review
+Subjects with a history of iodide allergies
+Have known history of kidney diseases
+History of claustrophobia or other preventing condition that has previously or would interfere with completion of protocol specified imaging sessions
+History of progression or recurrence of disease while on an endocrine targeted therapy containing regimen as assessed by medical record review of breast cancer history at screening
+History of cardiovascular disease that may adversely affect patient participation at the discretion of the primary investigator
+History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
+At the discretion of the operating surgeon, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert’s)
+Known history of claustrophobia
+In order to identify subjects at risk for the development of NSF, the American College of Radiology (http://acr.org) recommends obtaining a medical history and a glomerular filtration rate (GFR) assessment within six weeks of MR imaging in the following patients: \r\n* Renal disease (including solitary kidney, renal transplant, renal tumor)\r\n* Age > 60\r\n* History of hypertension\r\n* History of diabetes\r\n* History of severe hepatic disease/liver transplant/pending liver transplant
+History of primary lymphedema
+At the discretion of the physician, bilirubin level of < 2.0 mg/dl in the absence of a history of Gilbert's disease (or pattern consistent with Gilbert's)
+Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
+History of chronic asthma
+Patients with either pre-malignant or a history of oral cancer based on patient history and clinical presentations
+History or currently taking immunosuppression
+Contraindications for MRS (e.g. history of abdomino-perineal resection of rectum)
+or have a history of kidney disease.
+The protocol nurse will check with the patient that there is no history of (h/o) kidney disease
+History of Meniere’s disease
+History of pituitary or adrenal dysfunction
+History of seizures
+Participants that have a known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
+History of median sternotomy
+History of or currently active primary or secondary immunodeficiency.
+Subjects must not have a history of primary immunodeficiency.
+Primary immunodeficiency
+History of leptomeningeal metastases
+Patients in Canada may not have a history or evidence of latent or active tuberculosis infection.
+History of secondary hyperparathyroidism
+Personal or family history of porphyrias
+History of having undergone any local ablative therapy to liver prior to enrollment on the trial
+Subjects with known or suspected iron overload (genetic hemochromatosis or history of multiple transfusions)
+Has a history of:\r\n* Neuropathy or numbness/tingling suspicious for neuropathy prior to the first dose of chemotherapy for ovarian cancer\r\n* History of prior treatment for other cancers that includes drugs known to cause neuropathy; these drugs include but are not limited to vinca-alkaloids, platinums, taxanes, bortizomib.\r\n* B12 deficiency\r\n* Known peripheral vascular disease\r\n* Chronic daily headache or headache more than 14 days of the month
+Prior history of prostatectomy
+Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)
+Personal or family history of porphyrias
+History of bilateral orchidectomy
+Personal or family history of porphyrias
+A known history of contrast sensitivity
+History of symptomatic genitourinary stones within the past year
+History of reactive hypoglycemia
+Active or history of lactic acidosis, metabolic acidosis, or diabetic ketoacidosis
+Patients with a known history of psychiatric issues
+EXCLUSION CRITERIA - FOR NORMAL HEALTHY FEMALE COHORT: History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure
+Have a history of alcoholism
+Patients with a history of coronary artery disease must have had a normal stress test within 180 days of starting IFN gamma
+Inclusion criteria (for all subjects)\n\n          -  Male and/or female subjects 18-75 years of age\n\n          -  Females must be of non-childbearing potential . All non-postmenopausal females must\n             have a confirmed negative serum pregnancy\n\n          -  Subjects in good health condition as determined by no clinically significant findings\n             from medical history and physical examination.\n\n          -  Body mass index (BMI) between ?18.0 and ?38.0 kg/m2, with body weight ? 50 kg and no\n             more than 140 kg\n\n          -  Laboratory values must be within normal limits (correction allowed) or considered\n             clinically insignificant\n\n          -  Do not participate in any other clinical trials with a BRAF or other RAF inhibitors\n\n        Additional inclusion criteria for patients with normal hepatic function (Control group):\n\n          -  Absence of clinically significant deviation from normal in medical history, physical\n             examination, vital signs, electrocardiograms and clinical laboratory determinations.\n\n          -  Must match to at least one hepatic impairment subject by age, gender and bodyweight\n\n        Additional inclusion criteria for hepatic impaired subjects:\n\n          -  Confirmed hepatic disease\n\n          -  Stable Child-Pugh status within 28 days prior to dosing.\n\n        Exclusion criteria for all subjects\n\n          -  Participation in any clinical investigation within 4 weeks prior to dosing\n\n          -  Significant acute illness within the two weeks prior to dosing\n\n          -  History of immunodeficiency diseases, including a positive HIV\n\n          -  History of malignancy of any organ system, treated or untreated, within 5 years\n\n          -  Any prior history of keratoacanthoma and/or cutaneous squamous cell carcinoma\n\n          -  A known diagnosis of any of the RASopathies, such as NF-1, Noonan syndrome, or related\n             conditions.\n\n          -  History of drug or alcohol abuse within the 6 months prior to dosing\n\n          -  Smoking: urine cotinine levels below 500 ng/mL on Day -1.\n\n          -  Use of drugs known to affect CYP3A4 and/or CYP2C8 including both (strong or moderate)\n             inhibitors and inducers, within 7 days prior to dosing\n\n          -  Administration of medications that prolong the QT interval within 4 weeks prior to\n             dosing and until EOT.\n\n          -  History or current diagnosis of cardiac disease indicating significant risk of safety\n\n          -  Any surgical or medical condition which might significantly alter the absorption,\n             distribution, metabolism or excretion of drugs.\n\n        Additional exclusion criteria for healthy subjects (control group):\n\n          -  Clinical evidence of liver disease or liver injury\n\n          -  History or presence of renal impairment as indicated by abnormal creatinine or BUN\n             values\n\n          -  A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody\n\n        Additional exclusion criteria for subjects with hepatic impairment:\n\n          -  Alcohol or drug abuse within one month prior to dosing or evidence of such\n\n          -  History of liver transplantation at any time in the past and is on immunosuppressant\n             therapy.\n\n          -  Encephalopathy Grade 3 or worse within 28 days of dosing.\n\n          -  History of surgical portosystemic shunt.\n\n          -  Life expectancy ?3 months\n\n        Other protocol-defined inclusion/exclusion may apply.
+History of lactic acidosis as per prior medical records or provided by the patient
+Patients with plasma bicarbonate less than 22 mEq/L or history of lactic or any other metabolic acidosis
+history of idiopathic urinary calcium stone disease, chronic hypercalcemia, or gastrointestinal malabsorptive conditions
+Have a history of peptic ulcer disease within the last 12 months unless adequately treated as assessed by the participant’s primary care physician or medical oncologist
+History of head injury or dementia.
+History of cognitive impairment.
+No history of colon cancer or colon resection
+History of colon cancer or colon resection
+Current smoker, or former smoker who has less than a 16-year quit history
+Have at least a 30-pack year smoking history (average packs per day x years smoking)
+A personal history of CRC
+History of autoimmune disorders, including rheumatic diseases and thyroid disorders. Exception: As with bone marrow donations, donors with a history of thyroid disease who have undergone successful therapy may be suitable.
+History of iritis or episcleritis.
+Patients with a history of non-compliance to CML treatment and monitoring requirements
+History of re-irradiation to a field which includes the carotid arteries
+History of unstable angina within 1 year of study entry
+History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
+Has a history of any major neurological disorders, including stroke, multiple sclerosis, or neurodegenerative disease.
+History of carcinomatous meningitis.
+History of parathyroid disorder or history or malignancy-associated hypercalcemia requiring therapy in the past 6 months
+History of glaucoma
+Previous history of a swallowing disorder, such as scleroderma, achalasia, esophageal stricture or esophageal diverticulum
+Suspicion or known history of gastrointestinal obstruction
+History of stroke with the past year
+History or evidence of giant congenital melanocytic nevi, dysplastic nevis syndrome or xeroderma pigmentosum.
+History of heart disease
+Known history of positive serum human ADA.
+Patient has a history of other malignancies within the last 5 years
+History of Richter’s or prolymphocytic transformation