Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe and/or symptomatic refractory concurrent infection other than EBV
Severe infections within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe organ dysfunction unrelated to underlying GVHD, including:
Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients with known hepatic cirrhosis or severe pre-existing hepatic impairment are not eligible
No history of psychiatric disorders that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder) or prevent the patient from giving informed consent
Patients must not have had history of severe toxicity and intolerance to or hypersensitivity to irinotecan or any other study drug; patients must not have had a severe infusion-related reaction during any prior therapy with pertuzumab or trastuzumab
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients with septicemia or severe infection
Patients with septicemia or severe infection
Severe infections within 28 days prior to randomization, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
Patients must not have severe infections within 28 days prior to registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients must not have severe infections within 28 days prior to step 1 registration, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
History of severe asthma or absolute requirement for chronic inhaled corticosteroid medications.
Moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation.
Patients currently being treated for severe infections or who are recovering from major surgery or other intercurrent illnesses are ineligible until recovery is deemed complete by the investigator
Known prior history of mania or major psychiatric illness (schizophrenia, bipolar disorder, severe major depression requiring hospitalization, etc.)
Severe or moderate hepatic impairment
Severe infection within 4 weeks prior to randomization
Prior severe reaction to treatment with a human antibody that cannot be managed with standard supportive measures.
Severe infection within 4 weeks prior to initiation of study treatment;
Known Childs class B or C hepatic cirrhosis or severe pre-existing hepatic impairment
Procurement: Patients with severe intercurrent infection
Patients with severe intercurrent infection
Severe infection within 4 weeks before initiation of study treatment
Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
Chronic renal failure or current evidence of moderate to severe renal impairment.
History of severe adverse events, in the investigator's opinion, related to ramucirumab.
Severe dyspnea at rest, due to complications of advanced malignancy, or requiring supplementary oxygen therapy.
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Known severe congenital or acquired cellular or humoral immunodeficient or immunocompromised patients
Intractable, severe diarrhea, defined as > 1.500 cc diarrheal fluid per day, or diarrhea causing persistent severe electrolyte abnormalities, or hypoalbuminemia
Severe infection within 4 weeks prior to randomization
Severe valvular heart disease
Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
Severe peripheral vascular disease (i.e., severe claudication [pain occurring after less than 200 meters of walking], rest pain, ischemic ulceration or gangrene) in subjects whose Injectable Lesions are located in an extremity.
Severe infection considered by the local site investigator to be unsafe for study participation.
PROCUREMENT: Patients with severe intercurrent infection
TREATMENT: Patients with severe intercurrent infection
Severe dyspnea at rest due to complications of advanced malignancy or current requirement for continuous oxygen therapy
Patients must satisfy the criteria for a diagnosis of one of the severe neurological autoimmune disorders outlined
Patients with a severe intercurrent infection
Moderate or severe persistent asthma, or a history of asthma within the last 2 years, or currently has uncontrolled asthma of any classification
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe dyspnea at rest due to complications of advanced malignancy, or requiring supplementary oxygen therapy.
Severe infection within 28 days prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Contraindication to hepatic arteriography (e.g. hepatic artery dissection and/or thrombosis, uncorrectable coagulopathy, severe allergy to iodinated contrast, severe vascular disease precluding safe hepatic artery catheterization)
Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels (eg, carotid artery) should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
Patients with severe intercurrent infection
Severe comorbidities:
Severe infection within 4 weeks prior to initiation of study treatment
Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis.
Participants with clinically diagnosed moderate to severe cGvHD according to NIH Consensus Criteria prior to randomization:
Significant valvular disease, severe regurgitation, or stenosis by imaging independent of symptom control with medical intervention or history of valve replacement
Severe comorbidities:
EXCLUSION - INFUSION: Severe active intercurrent infection
Severe pre-existing ototoxicity or neuropathy that would, in the opinion of the investigator, preclude the use of cisplatin chemotherapy
Severe underlying cardiac or renal diseases
Patient may not have severe hepatic disease (direct bilirubin greater than 3 mg/dl OR aspartate aminotransferase [AST] greater than 500 IU/L), unless hepatic injury is due to LCH
Patients undergoing allogeneic HSCT for correction of a primary immunodeficiency disorder (e.g. severe combined immunodeficiency [SCID])
Severe infection within 4 weeks prior to enrollment
Patients who have had any prior bevacizumab, due to case reports suggesting a possible risk of severe toxicity in combination with radiotherapy
Severe medical comorbidities precluding endoscopy
Severe intercurrent infection
Severe intercurrent infection
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to Cycle 1, Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe intercurrent infection
Severe acute infection
Patients with severe intercurrent infection
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease and acquired immunodeficiency syndrome [AIDS])
Severe intercurrent infection
Patients must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of study enrollment\r\n* A fever above 38.2 celsius (C) AND clinical signs of infection within 48 hours of study enrollment
RETREATMENT WITH MODIFIED T-CELLS EXCLUSION CRITERIA: Patients has an active severe infection defined as:\r\n* A positive blood culture within 48 hours of scheduled T cell infusion OR\r\n* A fever above 38.2 C AND clinical signs of infection within 48 hours of T cell infusion
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
EXCLUSION - TREATMENT: Severe intercurrent infection
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration or severe diabetic retinopathy are ineligible because of the potential for greater HCQ toxicity
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease and acquired immune deficiency syndrome [AIDS])
T-LGL judged by the investigator to require therapy based upon:  \r\n*Severe neutropenia (absolute neutrophil count < 500/microL)\r\n*Moderate neutropenia (absolute neutrophil count < 1000/microL) with recurrent infections\r\n*Symptomatic or transfusion dependent anemia\r\n*Severe thrombocytopenia (< 50,000/microL)\r\n*Hepatic infiltration resulting in abnormal liver function tests\r\n*Symptomatic splenomegaly
Patients with evidence of synthetic dysfunction or severe cirrhosis requiring deferral of conditioning as recommended by a gastroenterology specialist
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease).
Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible.
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Severe symptomatic depression and or anxiety (study physician discretion)
Severe gastrointestinal disorder
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease and acquired immunodeficiency syndrome [AIDS])
GENERAL: Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Severe infections within 4 weeks prior to Day 1 of Cycle 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Immediate life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation
Other severe acute or chronic medical condition
New onset moderate or severe cGVHD as defined by the 2014 NIH Consensus Development Project Criteria
Severe hip disease precluding the use of dorsolithotomy position
Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to start of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 556 mL/m2/day, or severe abdominal pain with or without ileus) within 7 days prior to Day 1
Severe infection within 4 weeks prior to initiation of study treatment
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant staphylococcus aureus infection
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Subjects must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of study enrollment\r\n* A fever above 38.2 Celsius (C) AND clinical signs of infection within 48 hours of study enrollment
Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the Investigator.
Severe asthma.
Any evidence of mucositis/stomatitis or previous history of severe (?Grade 3) mucositis from prior therapy.
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Moderate or severe ascites
Severe constipation or condition where exacerbation of constipation is not advisable (e.g. small bowel obstruction history)
Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)
Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
Has known hepatic cirrhosis or severe preexisting hepatic impairment.
Uncontrolled thromboembolic events or recent severe hemorrhage
Severe infections within 4 weeks prior to the first study treatment, including but not limited to hospitalization for complications of infection, bacteremia or severe pneumonia
Subjects with severe claustrophobia that is unresponsive to oral anxiolytics
Subjects must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of study enrollment\r\n* A fever above 38.2 Celsius (C) AND clinical signs of infection within 48 hours of study enrollment
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Severe infection within 4 weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
History of severe eczema (as determined by the investigator) requiring medical treatment
Patients who experienced a severe systemic reaction or side-effect as a result of a previous vaccination with vaccinia
Severe infections within 4 weeks prior to study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Patients with known moderate or severe hepatic impairment, active hepatitis A, B, and/or C infection, due to the difficulty that would be faced in assessing the attribution of any events of hepatic toxicity while on cabozantinib therapy
Any form of systemic immunodeficiency, including acquired deficiency such as HIV or primary immunodeficiency such as severe combined immunodeficiency disease
Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
Subject has tolerated prior dose of modified CAR T cell infusion without experiencing a severe toxicity; OR if patient did have a severe toxicity, they have fully recovered to baseline
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe active co-morbidity as determined by the investigator or principal investigator
No preexisting condition that would deter radiotherapy, eg, fistulas, severe ulcerative colitis (particularly participants currently taking sulphasalazine), Crohn's disease, prior adhesions
Patients with severe intolerance to glucocorticoids
Severe infections within 4 weeks prior to cycle 1 day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Evidence of severe portal hypertension with evidence of decompensation either with bleeding varices, large volume ascites, or hepatic encephalopathy
Active tuberculosis or severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin; severe reactions include anaphylaxis and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
Patients with severe psychiatric (i.e. schizophrenia, bipolar, or borderline personality disorder) or other clinically progressive major medical problems, unless approved by the PI.
History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Patients with unstable or severe intercurrent medical conditions such as severe heart (New York Heart Association class 3 or 4) or lung (forced expiratory volume in 1 second [FEV1] < 50%) disease, uncontrolled diabetes mellitus
Severe infections =< 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past
Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral medication.
Severe infections within 4 weeks of first study treatment including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement.
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Pregnant or lactating subjects. * Note: Major surgery defined as requiring a general anesthesia or respiratory assistance; involving openings into the great cavities of the body, organs removed, or normal anatomy altered; implying risks of severe hemorrhage; implying risk for life of the patient or severe disability.
Known severe congenital or acquired cellular or humoral immunodeficiency such as common variable immunodeficiency.
Severe psychiatric illness or mental deficiency making compliance to treatment unlikely and/or informed consent impossible
DONOR: Severe psychiatric illness or mental deficiency making compliance with donation unlikely and/or informed consent impossible
Severe, active co-morbidity, defined as follows:
Patients with severe, active co-morbidity, defined as follow:\r\n* Patients with an active infection requiring intravenous treatment or having an unexplained febrile illness (maximum temperature [Tmax] > 99.5 degrees Fahrenheit [F]/37.5 degrees Celsius [C])\r\n* Patients with known immunosuppressive disease or known human immunodeficiency virus infection\r\n* Patients with unstable or severe intercurrent medical conditions such as severe heart disease (New York Heart Association class 3 or 4)\r\n* Patients with known lung (forced expiratory volume in 1 second [FEV1] < 50%) disease or uncontrolled diabetes mellitus\r\n* Patients with albumin allergy\r\n* Patients with gadolinium allergy
Any evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic impairment) or current unstable or uncompensated respiratory or cardiac conditions which makes it undesirable for the patient to participate in the study or which could jeopardize compliance with the protocol
Psychiatric disorder or a mental deficiency of the patient that is sufficiently severe to make compliance with the treatment unlikely, and making informed consent impossible
Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Evidence of severe concurrent disease requiring treatment
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Severe active comorbidities which would make the patient an unacceptable candidate for this clinical trial per physician discretion
Have major abnormalities documented by ECHO with Doppler (for example, moderate or severe heart valve function defect including moderate or severe valve stenosis or regurgitation, left ventricular ejection fraction <50%, evaluation based on the institutional lower limit of normal, septal aneurysm or other heart aneurysm, any aneurysm of the major vessels or any condition that results in increased risk of aneurysm (eg, Marfan syndrome, patent foramen ovale [PFO]).
Prior severe skin reaction (toxic epidermal necrosis) with immunomodulating agents
Patients with severe co-extensive comorbidities or significant psychiatric illness
Patients must have undergone hematopoietic stem cell transplantation and have moderate to severe chronic GVHD as defined by the National Institute of Health (NIH) consensus criteria
Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Subject has history of severe infusion reactions related to prior biologics or antibody-based treatments
Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Unstable or severe intercurrent medical conditions such as severe heart (New York Association class 3 or 4) or lung (forced expiratory volume in 1 second [FEV1] < 50%) disease, uncontrolled diabetes mellitus
Patients with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or places them at an unacceptable risk for participation in the study
Symptomatic cognitive or emotive disorder such as untreated schizophrenia, severe untreated depression, anxiety; this is determined by clinical assessment
Severe/unstable angina
Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
History of inflammatory colitis or other active severe comorbidities
AT THE TIME OF INFUSION: Severe intercurrent infection
MRI MONITORING SUB-STUDY: Known history of severe renal insufficiency, asthma, allergic conditions, sickle cell anemia, chronic hemolytic anemia, and gastrointestinal disorders
Severe infection within 4 weeks prior to enrollment
Prior severe infusion reaction (bronchospasm, stridor, urticaria and/or hypotension) to a taxane therapy
TREATMENT: Severe intercurrent infection
Intolerance of protocol agents as follows:\r\n* Known or presumed intolerance of gemcitabine, vorinostat or sorafenib\r\n* Experienced any of the following toxicities with prior gemcitabine administration (if given): capillary leak syndrome, posterior reversible encephalopathy, hemolytic uremic syndrome, thrombotic thrombocytopenic purpura, unexplained dyspnea or other evidence of severe pulmonary toxicity, or severe hepatic toxicity
Intrinsic lung disease resulting in moderate to severe dyspnea
Patient must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of study enrollment\r\n* A fever above 38.2 Celsius (C) AND clinical signs of infection within 48 hours of study enrollment
ELIGIBILITY CRITERIA AT THE TIME OF APHERESIS: Patients must NOT have an active severe infection defined as:\r\n* A positive blood culture within 48 hours of blood draw OR\r\n* A fever above 38.2 C AND clinical signs of infection within 48 hours of blood draw
RETREATMENT WITH MODIFIED T CELLS: Patient has an active severe infection defined as:\r\n* A positive blood culture within 48 hours of scheduled T cell infusion\r\n* A fever above 38.2 C AND clinical signs of infection within 48 hours of T cell infusion
PROCUREMENT: Patients with severe active infection
Severe psychiatric illness or mental deficiency sufficiently severe as to make compliance with the transplant treatment unlikely and informed consent impossible
Research participants being treated for severe infection or who are recovering from major surgery are ineligible until recovery is deemed complete by the investigator
Subjects with moderate-severe renal disease
Severe, active co-morbidity, defined as follows:
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Subject with current skin diseases that the investigator feels is not safe for study participation including but not limited to severe atopic dermatitis, cutaneous T-cell lymphoma, erythroderma
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Any contraindications to angiography and hepatic artery catheterization such as:\r\n* History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated\r\n* Bleeding diathesis, not correctable by usual forms of therapy\r\n* Severe peripheral vascular disease that would preclude catheterization
Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery)
Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy or radiologic studies
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Individuals with severe or uncontrolled recurrent cutaneous infections who are considered at elevated risk for serious infection on anakinra therapy will be excluded per physician discretion
Clinical evidence of severe hepatic impairment
Patients should have an indication for therapy for their disease such as transfusion dependence or morbidity associated with their cytopenia(s) such as bleeding, severe fatigue, or frequent/multiple infections (eg. neutropenia)
Severe alloimmunization with inability to guarantee a supply of adequate PRBC donors
Severe intercurrent infection
Patients with severe comorbidities, not related to their EBV-associated malignancy, that would be expected to preclude their survival for the 6 weeks required to assess response of T cell therapy
Severe hypertension (diastolic BP > 100 on medication).
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Patients with prior history of severe (grade III or IV) acute GVHD even if resolved if post-transplant
History of severe eczema (as determined by the Investigator) requiring medical treatment
Patients in Part E or Part F: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab
Severe renal disease (creatinine > x 3 normal for age)
Severe hepatic disease (direct bilirubin > 3 mg/dl or serum glutamic oxaloacetic transaminase [SGOT] > 500)
Severe life, threatening infection
Severe life, threatening infection
Any contraindications to angiography and hepatic artery catheterization such as: History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine that cannot be corrected or premedicated; Bleeding diathesis, not correctable by usual forms of therapy; Severe peripheral vascular disease that would preclude catheterization.
History of grade 3 or higher radiation induced pneumonitis (severe, limiting self care activities of daily living [ADL], requiring oxygen)
Other concurrent severe and/or uncontrolled medical, psychiatric or social conditions that could compromise the safety or compliance of treatment as so judged by treating physician\r\n* Examples include but are not limited to:\r\n** History of severely impaired lung function defined as spirometry and diffusion capacity of carbon monoxide (DLCO) that is =< 50% of the normal predicted value and/or 02 saturation that is =< 88% at rest on room air\r\n** Uncontrolled diabetes mellitus consistent fasting blood glucose readings > 160 mg/dL or < 50 mg/dL); use of diabetic medications is permitted\r\n** Hyperlipidemia (total cholesterol > 300-400; triglycerides > 300); use of lipid lower lowering agents is permitted\r\n** Other: e.g. severe infection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, severe chronic liver or renal disease, active upper GI tract ulceration
Severe intercurrent infection
Patients with severe renal disease (i.e., creatinine clearance less than 40 cc/1.73 m^2)
Patients with severe personality disorder or mental illness that would preclude compliance with the study
Patients with a severe infection that on evaluation by the Principal Investigator precludes ablative chemotherapy or successful transplantation
Serious underlying medical condition or infection other than HIV that would contraindicate SC-EPOCH-R; examples include, but are not limited to:\r\n* Severe AIDS-related wasting\r\n* Severe intractable diarrhea\r\n* Active inadequately treated opportunistic infection of the central nervous system (CNS)\r\n* Primary CNS lymphoma
Current severe urinary incontinence, hydronephrosis, severe voiding dysfunction, any level of urinary obstruction requiring indwelling/condom catheters
Known moderate or severe persistent asthma within the past 2 years, or uncontrolled asthma of any classification
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia that require IV antibiotics within 2 weeks of starting study treatment
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Criteria 6 Known moderate or severe persistent asthma within the past 2 years
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Patient has untreated severe hypothyroidism
The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease).
Severe infection within 4 weeks prior to Day 1 of Cycle 1
Moderate to severe hepatic impairment.
Severe, active co-morbidity
Bone lesions: lytic lesions, severe osteopenia or pathologic fractures
Severe hypertension (diastolic BP > 100 on medication)
Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Subjects who have history of severe hypersensitive reaction to the active ingredient or any excipients of DHP107 or IV paclitaxel.
Patients who have severe infections within 4 weeks before initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia;\r\n* Exception: uncomplicated urinary tract infection will not be considered as a severe infection in these patients
Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe, active comorbidity, including any of the following:
Severe organ failures or diseases, including: clinically relevant coronary disease, myocardial infarction or any other relevant cardiovascular disorder within 12 months before study entry, severe psychiatric illness and severe infection.
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia.
Evidence of severe concurrent disease requiring treatment.
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Active uncontrolled infection or severe infection disease (e.g., severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection)
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Severe infections =< 4 weeks prior to registration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to week 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia\r\n* Any course of oral or IV antibiotics must have been completed at least 2 weeks prior to the first dose of study medications
History of severe asthma and currently on systemic chronic medications (mild asthma requiring inhaled steroids only is eligible)
28 or more reported moderate-to-very severe hot flashes per week
Severe increased intracranial pressure, status epilepticus, or other serious complications from the brain tumor, requiring emergency or urgent intervention
Severe or uncontrolled intercurrent illness/infection
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Have immediate, life-threatening, severe complications of leukemia, such as uncontrolled bleeding, pneumonia with hypoxia or sepsis, and/or disseminated intravascular coagulation.
Have severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study treatment that would preclude administration of oral/enteral medication.
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe uncontrolled malabsorption condition or disease (i.e. grade II/III diarrhea, severe malnutrition, short gut syndrome)
Patients who have severe hypersensitivity to irinotecan hydrochloride (HCl)
Patients with severe hepatic disease (direct bilirubin greater than 3 mg/dl or aspartate aminotransferase [AST] greater than 500 IU/L)
Severe infections within 4 weeks prior to cycle 1, day 1 including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
AIDS-related syndromes, infectious or otherwise, if perceived to cause excessive risk for morbidity post-HSPC infusion, as determined by the PI; examples include, but not limited to:\r\n* Severe AIDS-related wasting\r\n* Severe intractable diarrhea\r\n* Active inadequately treated opportunistic infection of the central nervous system (CNS)\r\n* Primary CNS lymphoma
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Uncorrected severe electrolyte disorder, including severe potassium (< 3.0 mEq/L) or magnesium (< 1.0 mEq/L) deficiency
With hepatic dysfunction as evidenced by total bilirubin > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
With hepatic dysfunction as evidenced by aspartate aminotransferase (AST) > 2.0 x upper limit of normal or evidence of synthetic dysfunction or severe cirrhosis
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Moderate or severe symptomatic metastatic disease, defined as a requirement for treatment with opioid analgesics for cancer-related pain within 21 days prior to registration
Patient with severe hepatic disease (direct bilirubin greater than 3 mg/dl or aspartate aminotransferase [AST] greater than 500 IU/L)
Unstable or severe intercurrent medical or psychiatric conditions as determined by the Investigator
History of cutaneous or mucocutaneous reactions, or diseases in the past, due to any cause, severe enough to cause hospitalization or an inability to eat or drink for > 2 days; this exclusion relates to the long-term possibility of severe cutaneous or mucocutaneous reactions to rituximab that might occur at increased frequency in participants who have had severe skin disease or reactions in the past
Severe intercurrent infection
Known moderate or severe persistent asthma within the past 2 years or currently has uncontrolled asthma of any classification
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy
Subjects with an active severe infection or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled).
Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
Severe organ dysfunction unrelated to underlying GVHD, including:
Patients with severe hepatic sinusoidal obstruction syndrome who in the judgment of the treating physician are not expected to have normalized bilirubin by Day 56 after enrollment.
Moderate or severe ascites.
Any clinically significant pre-existing severe renal disease (eg, glomerulonephritis, nephritic syndrome, Fanconi Syndrome or renal tubular acidosis) or high risk of developing severe renal impairment.
Has moderate or severe persistent asthma within the past 2 years or uncontrolled asthma of any classification.
Subjects with other concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study, or places them at an unacceptable risk for participation in the study
Severe infection within 4 weeks prior to initiation of study treatment
Severe neurogenic bladder
Severe infection within 4 weeks prior to D1 of C1
Coagulation function tests not suggestive of severe liver dysfunction
Participants with severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
PHASE I: History of intolerance to capecitabine at doses =< 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome, documented severe diarrhea requiring hospitalization, or other documented severe adverse events (AEs) attributable to capecitabine
PHASE II: History of intolerance to capecitabine at doses below 1000 mg/m^2 BID, as defined by documented >= grade 3 hand-foot syndrome; documented severe diarrhea requiring hospitalization; or other documented severe AEs attributable to capecitabine
Severe psychological illness such as major psychosis (e.g. schizophrenia), major bipolar depression, or suicidal situational depression
Patients with severe, active co-morbidity, defined as follows:
Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Signs or symptoms of serious active infection requiring oral or i.v. antibiotics within 2 weeks prior to cycle 1 day 1 and/or hospitalization at study entry including, but not limited to, hospitalization for complications of infection, bacteremia, active tuberculosis or severe pneumonia
Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention; or history of valve replacement;
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
Known hepatic cirrhosis or severe pre existing hepatic impairment.
Severe, active co-morbidity
Moderate or severe hepatic impairment
Inability to lie still for the entire imaging time (due to cough, severe arthritis, etc.)
Known bleeding disorders (e.g., severe von Willebrand’s disease) or severe hemophilia
Severe infection within 4 weeks prior to randomization
Patients with moderate to severe renal impairment.
Subjects with known history of keratitis, ulcerative keratitis or severe dry eye.
Subjects with any known severe allergies (e.g. anaphylaxis) to any active or inactive ingredients in the study drugs.
Severe intercurrent infection
Severe hypertension (diastolic BP > 100 on medication)
Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Severe, active co-morbidity, defined as follows:
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Immediately life-threatening, severe complications of leukemia.
Severe underlying chronic illness or disease
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Subject has a documented severe congenital or acquired immunodeficiency;
Severe claustrophobia
Patients with moderate or severe cardiac disease:
Severe infections within 4 weeks prior to cycle 1, day 1 including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Has severe voiding symptoms (International Prognostic Scoring System [IPSS] > 20) or urinary retention requiring a catheter
Patients with concurrent severe medical problems unrelated to the malignancy that would significantly limit full compliance with the study or expose the patient to extreme risk or decreased life expectancy.
Concurrent illness, including severe infection that might jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety a. Human Immunodeficiency Virus (HIV)-infection is not an exclusion criterion if it is controlled with anti-retroviral drugs that are unaffected by concomitant enzalutamide.
The patient has concurrent severe and/or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes, severe infection requiring active treatment, severe malnutrition, chronic severe liver or renal disease)
Subjects with an active severe infection that required anti-infective therapy or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled).
AT THE TIME OF INFUSION: Severe intercurrent infection
Patients must not have a severe psychiatric illness, including major depression or any previous suicide attempts
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Moderate or severe ascites
Moderate to severe steroid-refractory cGVHD as defined by all following criteria:
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Subjects with an active severe infection that required anti-infective therapy or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled).
Subjects with immediately life-threatening, severe complications of leukemia such as uncontrolled bleeding, pneumonia with hypoxia or shock, and/or disseminated intravascular coagulation.
Severe acute infection
Have any other severe concurrent disease, or have a history of serious organ dysfunction (e.g. uncontrolled or severe cardiovascular disease, diabetes, pulmonary disease, infection, psychiatric illness) that may in the judgment of the treating physician/ principal investigator place the patient at undue risk to undergo treatment
History of severe motor or sensory neuropathy, or any other autoimmune disorder which is deemed to be significant
Subjects with severe renal impairment requiring dialysis.
Patients who have previously had a severe side effect, such as agranulocytosis and neutropenia, in conjunction with previous mebendazole or benzimidazole class drug for a parasitic infection
Moderate or severe cGvHD diagnosed and staged per National Institutes of Health (NIH) criteria
Diagnosis of severe aplastic anemia: eligibility to be discussed with principal investigator (PI) and service chief; such patients will be assessed in Arm B
Severe active viral infection, especially hepatitis B; severe infection (such as sepsis, pneumonia, etc.) should be clinically controlled at the time of randomization; contact the national co-investigator for further advice if necessary
Moderate to end-stage kidney disease and a history of severe asthma or allergies
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Subjects with severe hepatic impairment\r\n* Bilirubin > 3 x ULN, regardless of any level of ALT
Patients with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the Medical Monitor, excess risk associated with study participation or study agent administration
Have moderate or severe cardiac disease:
Severe infections within 4 weeks prior to cycle 1, day 1, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Bleeding or thrombotic disorders or subjects at risk for severe hemorrhage. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Severe or life-threatening infection within 2 weeks of entry onto the study
Severe intercurrent infection
Any other concurrent severe known disease (except carcinoma in-situ) concurrent severe and/or uncontrolled medical condition including congestive heart failure grade III or IV according to the NYHA classification or with ejection fraction < 50%, etc.
Patients with unstable or severe intercurrent medical conditions such as severe heart or lung disease
Severe liver or renal insufficiency
Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
The donor currently has or had a history of any clinically relevant gastrointestinal, hematologic, respiratory, psychiatric, renal, hepatic, cardiac, metabolic (eg, fructose intolerance), neurological, or any other disease or condition which may influence the physiological metabolic turnover (eg, severe endocrine diseases, febrile condition, severe infections
Any active, severe local or systemic infection at the screening visit
History of severe side effects toimmunotherapy
Severe illness requiring hospitalization
Symptomatic moderate or severe chronic GVHD patients in need of a change of systemic immunosuppressant (IS) therapy
HIV infection (due to increased risk of severe infection and unknown interaction of moxetumomab pasudotox with antiretroviral drugs)
Severe renal impairment.
Severe hepatic impairment.
Severe, active co-morbidity: (e.g. cardiac disease; respiratory disease; chronic hepatitis; hemtological and bone marrow diseases; severe malabsoprtion; human immunodeficiency virus).
Severe psoriasis
History of severe reactions to cetuximab and/or panitumumab (except for G3 rash and G3 hypomagnesaemia)
Severe systemic infection (i.e., sepsis)
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Involvement of one or more of the following organ systems (renal, neurologic, hematologic, cardiac, pulmonary, gastrointestinal) of moderate-to-severe severity as indicated by an “A” or 2 B score on the British Isles Lupus Assessment Group (BILAG), a 2 or higher on the Physician Global Assessment, or severe enough to require hospitalization if the organ involvement was not “captured” on either the BILAG or Systemic Lupus Erythematosus Activity Measure (SLAM) instruments
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Severe cerebrovascular disease (multiple cerebrovascular accidents [CVAs] or CVA within 6 months)
Have other severe concurrent disease or serious organ dysfunction involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo treatment
Patients who have contraindications to radiotherapy, such as scleroderma, dermatomyositis, or severe cutaneous manifestations of systemic lupus erythematosus (SLE)
Moderate to severe hepatic impairment
Severe, active co-morbidity (e.g. cardiac disease; respiratory disease; chronic hepatitis; hematological and bone marrow diseases; severe malabsorption)
Central nervous system injury or severe neurological impairment
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Severe infections within 4 weeks prior to cycle 1, day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe organ dysfunction manifested during screening period:
Patient shows evidence of severe hepatic veno-occlusive disease (VOD) or sinusoidal obstruction.
Have a primary or other severe immunodeficiency which predisposes to rapid progression to disseminated AdV disease
Patients with sepsis or severe infection
Open fractures with severe contamination.
Patients with known severe macular degeneration, uncontrolled glaucoma, or markedly decreased visual acuity
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Active severe infection that required anti-infective therapy or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, subjects with tumor fever may be enrolled)
Active uncontrolled infection or severe infectious disease, such as pneumonia, meningitis, septicemia, or methicillin-resistant Staphylococcus aureus infection.
Moderate to severe aortic or mitral stenosis or other valvulopathy (ongoing).
Prior intolerance to fluorouracil (5-FU) or oxaliplatin, excluding severe neuropathy that reversed to grade 2 or less
Known hepatic impairment including cirrhosis, known renal impairment including renal insufficiency or glomerulonephritis and severe cerebral or peripheral vascular disease;
Any active, severe local or systemic infection at the screening visit
Known severe ulcer disease
Severe conduction disturbance
History of severe intolerance to cytotoxic agent(s) given in the assigned arm
Severe dyspnea at rest due to complications of advanced malignancy or requiring current continuous oxygen therapy
Known hepatic cirrhosis or severe pre-existing hepatic impairment
Severe diarrhea (? grade 3) not controllable with medication or that requires total parenteral nutrition
Severe conduction disturbances
Any other evidence of severe iron overload that, in the Investigator's opinion, warrants exclusion.
Prior unanticipated severe reaction to fluoropyrimidine therapy
Subjects with severe renal impairment (GFR <50 mL/min/1.73 m²) or on dialysis.
Patients must have provided informed consent, be willing to have blood specimens taken, and exhibit no severe other medical or psychiatric problems
Patients with severe medical or psychiatric diseases are INELIGIBLE (patients with stable chronic diseases such as high cholesterol or hypertension ARE eligible); examples of problems that would make patients INELIGIBLE include severe heart failure, or hypoxia due to severe lung disease
Severe renal impairment (stage 3B) defined as eGFR < 45 cc/min/1.73 m^2 as measured by the CKD-EPI calculation
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease and acquired immune deficiency syndrome [AIDS])
Severe concurrent disease;
Concurrent severe, intercurrent illness.
Pre-existing neuropathy or severe fluid retention
Patients must not have serious infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment; these need not be specified in the history and physical and can be documented through signature on the eligibility checklist; severe, active co-morbidity, defined as follows:
The patient has other concurrent severe medical prob-lems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Subject has severe granulocytopenia
Serious illnesses, such as: cardiovascular disease (uncontrolled congestive heart failure, hypertension, cardiac ischemia, myocardial infarction, severe cardiac arrhythmia), bleeding disorders, autoimmune diseases, severe obstructive or restrictive pulmonary diseases, active systemic infections, inflammatory bowel disorders, severe renal disease
The patient has other concurrent severe medical prob-lems, unrelated to the malignancy, that would significantly limit full compliance with the study or expose the patient to unacceptable risk.
Severe hepatic impairment
Patients with severe psychological or medical illness
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Uncontrolled, severe infective processes
Any form of primary immunodeficiency (such as severe combined immunodeficiency disease)
Have severe hepatic impairment, severe renal impairment, or end-stage renal disease as determined by the treating physician
Traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia
Untreated current severe depression; currently treated depression is permitted if treatment is stable
Patients with severe hepatic impairment
Severe cognitive or hearing impairment that is documented in the medical record (one that would make it difficult to comprehend and remember the material covered during study phone sessions)
Unable to provide meaningful consent (e.g., severe cognitive impairment)
History of major psychiatric condition (e.g. psychosis) in parent or child; severe neurodevelopmental disorder in child (e.g. Down's syndrome)
Severe hypertension (diastolic BP > 100 on medication)
Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Severe anemia (hemoglobin < 8 g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have chemotherapy within past 2 weeks).
Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0–10 NRS scale
Severe sleep disorders (e.g., narcolepsy)
Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
Other medical or psychological conditions that would make participation unsafe or inhibit our ability to test our primary hypothesis, e.g. Parkinson’s disease, severe dementia
Report severe depressive mood (Center for Epidemiological Studies Depression Scale [CES-D] > 24)
People who self-report having a severe mental illness
Severe visual or auditory impairment
Severe sleep disorders (e.g., Narcolepsy)
Severe psychological impairment (e.g., hospitalization for depressive episode in the past 12 months)
Have a psychiatric diagnosis that would require significant study modification to meet their needs such as uncontrolled severe mental illness, substance abuse, or active suicidal ideation
Severe active anemia (a hemoglobin < 8 documented by labs drawn within 3 months of first study treatment)
Severe renal impairment as measured eGFR less than 30 per institutional laboratory
Patients with sepsis or severe infection
Have moderate to severe levels of fatigue
No evidence of moderate to severe depression as determined by a HADS depression score of =< 13
History of any cardiovascular disease (CVD) or any other medical conditions (e.g. severe osteoarthritis) that will prevent him from walking
Having a psychotic disorder or the presence of another psychiatric condition (e.g., severe depression [i.e., > 19 on the Patient Health Questionnaire-9 [PHQ-9]], suicidal ideation) or cognitive impairment (e.g., severe dyslexia, traumatic brain injury) limiting ability to give consent and/or participate fully in the study
Contraindications to arteriography and selective visceral catheterization:\r\n* Severe allergy or intolerance to contrast media, narcotics, sedatives, or atropine\r\n* Bleeding diathesis not correctable by usual forms of therapy\r\n* Severe peripheral vascular disease precluding catheterization
Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
Patient has severe disabilities limiting moderate physical activity, such as severe orthopedic conditions
Severe musculoskeletal disease: severe muscle or joint disorders due to disease or trauma, amputations, or any condition that significantly impair physical capabilities, as defined by the physician
Unable to provide meaningful consent (e.g., women with severe cognitive impairment such that the descriptions of the research are not clearly understood will be excluded)
Average dyspnea Borg Scale >= 4 of 10 with severe exertion over the past week
Severe or symptomatic heart disease
Patients not felt be a safe surgical candidate by pain management physician for placement of and intrathecal drug delivery system (IDDS) due to the presence of severe medical comorbidities
Severe or untreated psychiatric disease
Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
Medical record documentation of severe mental illness (i.e., schizophrenia or bipolar disorder), active suicidal ideation, or active substance use disorder
Severe co-existing morbidities having a life expectancy of less than 30 days
Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g., untreated major depression or psychosis, substance abuse, severe personality disorder)
Severe concurrent illness other than neoplasia
Parents of ALL or AML survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
Existing history of severe cognitive impairment in the child as reported by the parents or documented in the child's City of Hope medical records
Parent/Caregiver: parents with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
Child: survivors with a history of a major psychiatric condition that precludes participation (e.g., psychosis, severe depression, active substance abuse)
Active or unstable metabolic conditions such as brittle diabetes or severe anemia (hemoglobin < 8 g/dl)
Severe cognitive impairment
Severe depression as determined by the investigator
Uncorrected primary obstructive or severe regurgitative valvular disease, nondilated (restrictive) or hypertrophic cardiomyopathy, or significant systemic ventricular outflow obstruction
Serious psychiatric disease including schizophrenia, bipolar disorder and severe depression
Severe illness at the time of the clinic visit
Severe cognitive, visual, or hearing impairment that would preclude DA viewing
Received treatment for serious psychiatric illness (e.g., schizophrenia, severe depression) in the past 6 months
Megacolon or moderate to severe ileus
Patients with sepsis or severe infection
Patients with severe symptom distress as assessed by nursing staff.
Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, substance abuse, severe personality disorder)
Patients with history of primary idiopathic myelofibrosis or any severe marrow fibrosis
Severe depression (Patient Health Questionnaire [PHQ]-8 >= 20)
Report moderate-severe fatigue in past week (Fatigue Symptom Inventory [FSI] average rating >= 4 of 0-10)
Patients with end-stage disease, severe dementia and/or life expectancy of less than one year
Significant cardiopulmonary disease, severe arthritis, glaucoma, or any other medical conditions that make yoga practice unsafe as determined by a study investigator
Moderate to severe fatigue (>= 4 on BFI)
Moderate or severe ascites
Satisfactory cardiopulmonary function (no history of severe congestive heart failure or severe pulmonary disease, as indicated by clinically acceptable risks to undergo major abdominal - cytoreductive surgery)
Severe infection within 4 weeks prior to randomization
Participants who, in the judgment the study principal investigator (PI), have severe or unstable mental illness which could interfere with participation in the trial
Severe anemia (hemoglobin [Hb] < 7g/L) not corrected prior to study enrollment (bloodwork is not required if patient did not have recent chemotherapy within the last 2 weeks)
Moderate or severe acute illness with or without fever
Pre-registration screen of cognition is \severe\ or lower
Severe marital maladjustment that prevents a patient from benefiting from the proposed intervention (< 85 on the Locke-Wallace Marital Adjustment Test)
Grade III lymphedema or lymphedema considered severe by the treating clinician
Severe hearing impairment that limits the ability to use audio-based guided imagery modules
Have confirmed diagnosis of chronic fatigue syndrome or other diagnosis known to cause severe fatigue
No history of prior inpatient psychiatric treatment for severe mental illness within 1 year (e.g., psychosis)
History of prior inpatient psychiatric treatment for severe mental illness within the past year (e.g., psychosis),
Subject answers item #1 of muscle spasms questionnaire as moderate or severe intensity at time of screening
Severe concomitant illnesses
Patients with severe organ dysfunction\r\n* On dialysis\r\n* Requiring oxygen (O2) at more than 2 l/min\r\n* Uncontrolled arrhythmia or heart failure\r\n* Veno-occlusive disease (sinusoidal obstruction syndrome)
Clinical history of severe psychiatric disorders
Subject has moderate or severe overlap chronic (c)GVHD according to National Institutes of Health (NIH) criteria
Grade III lymphedema or lymphedema considered severe by the treating clinician
Any condition that causes severe pain with exertion
Patients with known severe esophagitis
Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrhythmia, or severe cardiomyopathy. These underlying medical conditions may make the participant more likely to develop a contrast reaction. This is based on the American College of Radiology (ACR) contrast manual version 10.3 and hospital policy.
Participants with the following underlying medical conditions: multiple myeloma, myasthenia gravis, dysproteinemias, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, cardiac arrhythmia, or severe cardiomyopathy
Previous documented history of moderate to severe hypersensitivity to Gd contrast agents
Subjects with severe, symptomatic dysphagia (unable to pass solids)
Uncorrected primary obstructive or severe regurgitative valvular disease:\r\n* Nondilated (restrictive); or\r\n* Hypertrophic cardiomyopathy; or\r\n* Significant systemic ventricular outflow obstruction
History of severe osteoporosis (T score =< -4 either spine or hip), or presence of vertebral fracture
Severe organ dysfunction.
DONOR: Severe psychiatric illness. Mental deficiency sufficiently severe as to make compliance with the donation procedure unlikely, and making informed consent impossible
Severe osteoporosis
Severe neuromusculoskeletal conditions that limit their ability to perform walking exercise (including ataxia, peripheral or sensory neuropathy, unstable bone lesion, severe arthritis, lower limb fractures within 6 months, lower limb amputation)
Patient aged < 2 years with known hepatic impairment (any grade), or patient aged 2 years with known severe hepatic impairment.
Patient aged < 2 years with known renal impairment (any grade), or patient aged 2 years with known severe renal impairment.
History of severe food intolerance to broccoli
Moderate to severe sun damage
Unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
Patient has a history of severe renal or hepatic impairment, severe bone marrow suppression, or systemic infection
History of severe asthma and currently on chronic systemic medications (mild asthma requiring inhaled steroids only is eligible)
Recent or severe mental illness (uncontrolled severe depression or mood symptoms, active hallucinations, or hospitalization in the past month for a psychiatric condition); night and/or ‘swing’ shift work (which complicates EMA schedules);
For nicotine replacement therapy (NRT) (patch, gum, lozenge):\r\n* History of severe eczema or any serious skin problem if requested nicotine patch\r\n* History of severe allergic reaction to the nicotine patch or other skin adhesives\r\n* History of heart attack in the last 2 months\r\n* Currently experiencing frequent angina or chest pain related to heart\r\n* Currently experiencing signs and symptoms of peptic ulcer\r\n* Currently receiving medications for rapid or irregular heart beat\r\n* Currently experiencing signs and symptoms of severe, uncontrolled high blood pressure
Patients with a history of severe allergy including eczema or other exfoliative skin disorder or active skin diseases such as psoriasis, lichen planus, severe acneiform rash, impetigo, varicella zoster, or sepsis among patients or among close social, sexual or domestic contacts; patients with burns or other traumatic or pruritic skin conditions or open wounds should not receive the vaccine until the condition has resolved; surgical scars must be healed
Participants with oral leukoplakia or erythroplakia with mild, moderate, or severe histologic dysplasia, or hyperplasia not associated with mechanical factors such as ill-fitted dentures
Participants who exhibit severe psychological distress that prohibits them from participating in our intervention or long-term research program
Prior history of severe reactions to oxaliplatin as characterized by the presence of hemodynamic instability, significant respiratory symptoms or potential airway compromise
Severe hypertension (diastolic BP > 100 on medication)
Severe cerebrovascular disease (multiple CVA or CVA within 6 months)
Patients with severe intercurrent infection
History of severe brain-injury or stroke.
Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD).
Have a history of severe claustrophobia
Severe concomitant illnesses
Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation
Has severe hepatic insufficiency within 5 days before randomization
Patients with severe metabolic disorders that would preclude administration of calcitriol
symptomatic severe aortic stenosis,
History of significant tachyarrhythmia, severe angina, or myocardial ischemia
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Severe/uncontrolled inter current illness within the previous 28 days prior to PET scan
Have severe claustrophobia
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Severe claustrophobia not relieved by oral anxiolytics per institutional standard practice
Known history of severe claustrophobia
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Dementia or other severe cognitive impairment causing inability to understand or consent to the procedure and study
Patients with evidence of moderate or severe cardiac valvular disease on echocardiogram
Severe emphysema or COPD: additional testing and PI consent is required
Any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or ATV tunneling, for example:
severe cachexia
severe respiratory insufficiency or hypoxia
Are not free of unstable angina, arrhythmia, or severe systemic disease that would make moderate intensity exercise participation unsafe
Severe acute illness
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Moderate or severe depression as measured on the Beck Depression Inventory (BDI) - Short Form; the cut-off score for the BDI will be 8/9
Participants who have any contraindication to iodinated contrast for routine computed tomography (CT) scans including: sickle cell disease, pheochromocystosis, multiple myeloma, severe cardiac disease, aortic stenosis, primary pulmonary hypertension, or severe cardiomyopathy
Moderate or severe aortic stenosis
Exposure to gadolinium-based contrast agents increases the risk for nephrogenic systemic fibrosis (NSF) in patients with acute or severe renal dysfunction; therefore, patients with the following conditions are excluded from the study:\r\n* Acute or chronic severe renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m^2)\r\n* Acute renal dysfunction due to the hepato-renal syndrome or in the perioperative liver transplantation period
History of moderate or severe reaction to contrast agent injection
Has history of herpetic infection, recurrent aphthous ulcer, or other ulcer forming diseases, abscesses, granulomas, or severe gingivitis
Any patient with a history of a severe reaction (Common Toxicity Criteria [CTC] version [v.]4 grade >= 2) to gadolinium or other contrast agents
Known history of severe claustrophobia
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g. severe claustrophobia)
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.); although at Mission Bay Hospital pediatric patients may be sedated per clinical protocol
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Severe claustrophobia
Severe infection requiring systemic treatment within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
Severe renal insufficiency (GFR ? 29).
Inability to lie still for the entire imaging time (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Participants with severe claustrophobia unresponsive to oral anxiolytics
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Subjects with severe claustrophobia unresponsive to oral anxiolytics
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
Have a history of severe claustrophobia
NORMAL VOLUNTEERS: Have a history of severe claustrophobia
Severe cardiac rhythm disorders within the last 7 days
Women who have had a moderate or severe contrast reaction to intravenous gadolinium-diethylenetriamine pentaacetic acid (DTPA)
Inability to tolerate scanning (e.g. - claustrophobia, severe pain)
Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (severe claustrophobia, radiation phobia, etc.)
Severe respiratory disease
Severe psychiatric illnesses (current schizophrenia, major depression with suicidal ideation, or substance abuse within two years)
Severe infections within 28 days prior to Day 1, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia or active tuberculosis
Inability to participate in physical activity because of severe disability (e.g., severe arthritic conditions)
Patients with sepsis or severe infection
Have moderate or severe cardiac disease:
Patients suffering from a severe psychiatric disorder or condition that would significantly interfere with study participation
Patients who are experiencing severe symptom distress, including severe emotional distress and cognitive dysfunction, which may interfere with study participation; this will be determined by the principle investigator and/or attending physician who is caring for the patient during that visit
Severe psychiatric disorders that may interfere with study procedures (though volunteers will not be otherwise screened for psychopathology or drug use, which are prevalent among smokers)
Known moderate to severe aortic stenosis, moderate to severe mitral stenosis, or other valvulopathy (ongoing).
Severe, active co-morbidity, defined as follows:
has a substantial risk to progress and cause severe complications.