--- a
+++ b/clusters/3009knumclusters/clust_264.txt
@@ -0,0 +1,606 @@
+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.