Severe and/or symptomatic refractory concurrent infection other than EBV
Patients with septicemia or severe infection
Patients with septicemia or severe infection
Patients with evidence of active septicemia, severe infection, gastrointestinal bleeding or severe gastrointestinal symptoms requiring medical or surgical therapy
Current severe, uncontrolled systemic disease other than cancer
Current severe, uncontrolled systemic disease
Severe valvular heart disease
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (i.e., uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper GI tract ulceration)
Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
Severe comorbidities:
Severe comorbidities:
Severe medical comorbidities precluding endoscopy
Patients with known G6PD deficiency, severe psoriasis, porphyria, macular degeneration or severe diabetic retinopathy are ineligible because of the potential for greater HCQ toxicity
Severe hip disease precluding the use of dorsolithotomy position
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant staphylococcus aureus infection
Has active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
Severe, uncontrolled systemic disease at screening;
Severe active co-morbidity as determined by the investigator or principal investigator
Patients with severe intolerance to glucocorticoids
Patients with severe allergies to piperacillin-tazobactam, cefepime, aztreonam or vancomycin; severe reactions include anaphylaxis and Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN)
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.
Other concurrent severe and/or uncontrolled medical disease which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration)
GROUP 6: Progressive gastrointestinal disease as defined by all of the following items:\r\n* Disease duration of scleroderma =< 2 years.\r\n* Documented severe malabsorption syndrome requiring nutritional support; severe malabsorption syndrome is > 10% weight loss and on total parenteral nutrition (TPN) or enteral feedings\r\n* High score on distention/ bloating scale (>= 1.60 out of 3.00) on gastrointestinal (GI) questionnaire
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection
Severe or uncontrolled concurrent disease, infection or comorbidity.
Severe, active co-morbidity, defined as follows:
Current severe or uncontrolled systemic disease
Evidence of severe concurrent disease requiring treatment
Current severe, uncontrolled systemic disease
Severe, active co-morbidity, defined as follows:
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/uncontrolled concurrent illness/infection
Patients in Part E or Part F: history of severe immune-mediated adverse reactions or severe hypersensitivity to pembrolizumab
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
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
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, active co-morbidity
Concurrent severe or uncontrolled medical disease.
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Concurrent severe or uncontrolled medical disease.
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 liver disease
Severe liver disease
Evidence of severe concurrent disease requiring treatment.
Active uncontrolled infection or severe infection disease (e.g., severe pneumonia, meningitis, septicemia, or methicillin resistant Staphylococcus aureus infection)
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 uncontrolled malabsorption condition or disease (i.e. grade II/III diarrhea, severe malnutrition, short gut syndrome)
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
Concomitant severe or uncontrolled medical disease
Current severe, uncontrolled systemic disease
Severe or uncontrolled concurrent disease, infection or co-morbidity.
Patients with severe, active co-morbidity, defined as follows:
Active uncontrolled infection or severe infectious disease, such as severe pneumonia, meningitis, or septicemia.
Severe, active co-morbidity
Severe, active co-morbidity, defined as follows:
Severe underlying chronic illness or disease
Severe or uncontrolled hypertension, history of congestive heart failure, acute myocardial infarction, or severe coronary arterial disease
Other concurrent severe and/or uncontrolled medical disease, psychiatric illness, or social situation, which could compromise safety of treatment as so judged by the treating physician; Note: this includes but is not limited to: severely impaired lung function, uncontrolled diabetes (history of consistent blood glucose readings above 300 mg/dL or less than 50 mg/dL), severe\r\ninfection, severe malnutrition, ventricular arrhythmias, known active vasculitis of any cause, tumor invasion of any major blood vessel, chronic liver or renal disease, and active upper GI tract ulceration
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, uncontrolled systemic disease
Other concurrent severe and/or uncontrolled medical disease, which could compromise participation in the study (e.g. uncontrolled diabetes, uncontrolled hypertension, severe infection, severe malnutrition, chronic liver or renal disease, active upper gastrointestinal [GI] tract ulceration, congestive heart failure, etc.)
Severe or uncontrolled medical issues
Current severe, uncontrolled systemic disease
Severe systemic diseases or active uncontrolled illnesses.
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
Evidence of severe or uncontrolled systemic disease or HIV infection
Severe and uncontrolled disease, including:
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 severe and/or uncontrolled medial disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection [persistent fever and worsening clinical condition])
Severe valvular stenosis (e.g., aortic or mitral stenosis with a valve area <1.0 cm2) or severe congenital heart disease
History of severe side effects toimmunotherapy
Severe illness requiring hospitalization
Severe, active co-morbidity: (e.g. cardiac disease; respiratory disease; chronic hepatitis; hemtological and bone marrow diseases; severe malabsoprtion; human immunodeficiency virus).
Severe psoriasis
Patients with severe hematologic, neurologic, or other uncontrolled disease
Severe, active co-morbidity (e.g. cardiac disease; respiratory disease; chronic hepatitis; hematological and bone marrow diseases; severe malabsorption)
Subjects with severe hemorrhage, or history of severe hemorrhage
Current severe, uncontrolled systemic disease
Open fractures with severe contamination.
Active uncontrolled infection or severe infectious disease, such as pneumonia, meningitis, septicemia, or methicillin-resistant Staphylococcus aureus infection.
Known severe ulcer disease
Current severe, uncontrolled systemic disease
Severe conduction disturbance
Active uncontrolled infection or severe infectious disease
Active uncontrolled infection or severe infectious disease
Severe or uncontrolled systemic infection
Severe conduction disturbances
Subjects with psoriasis or other severe skin disease (eg, autoimmune skin disease, active erythematous skin lesions, etc.)
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
Concomitant severe or uncontrolled medical disease
Severe concurrent disease;
History of severe cardiac disease.
Concurrent severe uncontrolled illness not related to cancer
Current severe, uncontrolled systemic disease
Current severe, uncontrolled systemic disease
liver, pancreatic or severe renal disease unrelated to disease under study
Subject has severe granulocytopenia
Uncontrolled, severe infective processes
Current severe, uncontrolled systemic disease
Patients with an active infection or severe hematological, neurological, or other uncontrolled disease.
Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver surgery
Patients with history of severe liver disease, defined as and confirmed by albumin less than 3.
Presence of severe cardiac disease
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
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
Severe or symptomatic heart disease
Severe or untreated psychiatric disease
Severe cachexia, dizziness, bone pain, or severe nausea (as judged by the investigator)
Severe co-existing morbidities having a life expectancy of less than 30 days
Severe concurrent illness other than neoplasia
Severe depression as determined by the investigator
Within 48 hours of receiving either metronidazole for mild-moderate disease or vancomycin for severe uncomplicated disease
Severe cardiac disease
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)
Evidence of severe uncontrolled systemic disease or other comorbidity that precludes liver or pancreatic surgery
Patients with known severe esophagitis
Severe osteoporosis
History of severe food intolerance to broccoli
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);
Concurrent severe and/or uncontrolled medical condition (e.g., severe COPD).
severe cachexia
severe respiratory insufficiency or hypoxia
Severe acute illness
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
Severe allergic disease
Severe coexisting or terminal systemic disease that may interfere with the conduct of the study
Severe cardiac disease
Severe respiratory disease
Severe underlying chronic illness or disease (other than breast cancer)
Inability to participate in physical activity because of severe disability (e.g., severe arthritic conditions)
Active, uncontrolled infection or severe infectious disease.
Current severe, uncontrolled systemic disease
Severe, active co-morbidity, defined as follows: