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+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis [with the exception of diverticulosis]; sarcoidosis syndrome, or other serious gastrointestinal [GI] chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves disease; rheumatoid arthritis; hypophysitis; uveitis, sarcoidosis syndrome, etc.) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: \r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet alone
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n• Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patients with active autoimmune disease or history of autoimmune disease that might recur should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ?12 months prior to randomization
+Chronic inflammatory bowel disease (Crohn's disease or ulcerative colitis)
+No history of serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet
+Patients must not have any prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, immune-mediated alopecia, Grave’s disease, or psoriasis requiring systemic treatment within the past 2 years are not eligible; patients with hypothyroidism (e.g. post Hashimoto syndrome) who are stable on hormone replacement therapy are eligible
+No active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease; human immunodeficiency virus (HIV) (+) patients are eligible as long as they have: cd4 > 200, undetectable viral load and on highly active antiretroviral therapy (HAART) therapy
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), should be evaluated for the presence of target organ involvement and potential need for systemic treatment; if no systemic immune suppression is deemed necessary they can be eligible
+No gastrointestinal disorders associated with a high risk of perforation or fistula formation within 3 months prior to registration:\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n* Known malabsorption syndrome\r\n* Bowel obstruction or gastric outlet obstruction\r\n* Percutaneous endoscopic gastrostomy (PEG) tube placement
+No patients with known active autoimmune disease or known history of autoimmune disease for which recurrence may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis; patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including type I diabetes mellitus or thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+No active known autoimmune disease, including colitis, inflammatory bowel disease (i.e. ulcerative colitis or Crohn’s disease), rheumatoid arthritis, panhypopituitarism, adrenal insufficiency
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen, or type 2 diabetes mellitus are eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; however,\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, lichen sclerosis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patient has any concurrent autoimmune disease or has a history of chronic or recurrent autoimmune disease; these include but are not limited to: multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura
+Active small or large intestine inflammation such as Crohn’s disease or ulcerative colitis
+Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn’s disease, ulcerative colitis)
+History of chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, uveitis, etc) with symptomatic disease within the last 3 years; Note: active vitiligo or alopecia or a history of vitiligo or alopecia will not be a basis for exclusion
+Active or history of inflammatory bowel disease (eg, colitis, Crohn’s), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis
+Patients with clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding are NOT eligible for participation; these may include (but are not limited to):\r\n* Active peptic ulcer disease\r\n* Known intraluminal metastatic lesion/s with risk of bleeding \r\n* Inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease)\r\n* Other gastrointestinal conditions with increased risk of perforation
+History of inflammatory bowel disease (Crohn's or ulcerative colitis)
+13. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis);
+Known history of colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
+Presence of a bowel obstruction, history or presence of inflammatory enteropathy, or extensive intestinal resection, Crohn disease, ulcerative colitis, or chronic diarrhea;
+Active or history of any autoimmune disease including colitis and inflammatory bowel disease (subjects with diabetes Type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible) or immunodeficiencies.
+Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis, (non-infectious) pneumonitis.
+Have inflammatory bowel disease for which the participant has used immunosuppressive agents within the last 2 years.
+Active diarrhea or inflammatory bowel disease
+Active or documented inflammatory disease.
+Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
+Patients with history of and/or active inflammatory bowel disease.
+Subject with a history of autoimmune disease (e.g., ulcerative colitis, Crohn's disease, rheumatoid arthritis, Addison's syndrome, multiple sclerosis, uveitis, systemic lupus erythematosus or Wegener's granulomatosis). Subjects with vitiligo, endocrinopathies, and alopecia are allowed. Subjects with psoriasis not requiring systemic treatment within the past 6 months are allowed;
+History or risk of autoimmune disease that threatens vital organ function, including, but not limited to, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis\r\n* Patients with a prior history of immune related events to anti-CTLA-4 may be eligible after discussion with the sponsor; however, patients with a history of grade 3 and 4 pulmonary, CNS and renal events attributed to anti-CTLA-4 agents will be excluded\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History of symptomatic autoimmune disease (such as lupus, scleroderma, Crohn’s disease, ulcerative colitis) requiring systemic treatment (for example corticosteroids or immunosuppressants); replacement therapy (for example, thyroxine, insulin) is not considered a systemic treatment
+Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.
+Patients with active autoimmune diseases or history of autoimmune diseases should be excluded; these include but are not limited to patients with a history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematous (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's ulcerative colitis, hepatitis, toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome. Note: Patient are permitted to enroll if they have controlled celiac disease, vitiligo, eczema, psoriasis, controlled Type I diabetes mellitus, endocrine deficiencies (including hypothyroidism) managed with replacement hormones including low-dose (?10 mg/day prednisone equivalents) corticosteroids. Patients with rheumatological autoimmune diseases that are frequently limited in severity such as rheumatoid arthritis and Sjogren's syndrome are permitted to enroll if they do not require treatment with a non-biologic or biologic disease modifying anti-rheumatic drug (DMARDs), e.g. cyclophosphamide or adalimumab. All patients with an autoimmune rheumatological disease require evaluation for severity and target organ involvement.
+Participants with inflammatory bowel disease
+Active inflammatory or other gastrointestinal disease,
+History of bowel obstruction, inflammatory enteropathy or extensive intestinal resection.
+Active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus) requiring active systemic treatment; hypothyroidism without evidence of Grave’s disease or Hashimoto’s thyroiditis is permitted
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease) or who are receiving systemic therapy for an autoimmune disease; exceptions include vitiligo, hypothyroidism controlled on hormone replacement, type I diabetes, Grave’s disease,\r\nadrenal insufficiency on stable replacement doses of steroids (prednisone =< 10 mg/day or equivalent), or with principal investigator approval
+Active or history of autoimmune disease or immune deficiency, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis for a more comprehensive list of autoimmune diseases and immune deficiencies) with the following exceptions:
+Active or prior documented autoimmune or inflammatory disorders including but not limited to inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
+Known history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis.
+May not have primary immunodeficiency or history of systemic autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
+Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn’s disease, ulcerative colitis, or chronic diarrhea
+Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis), or any other chronic, serious GI condition associated with diarrhea; NOTE: Subjects with known diverticulosis are permitted to enroll
+Bilateral hip prostheses, inflammatory bowel disease or connective tissue disorder such as active scleroderma or lupus (radiotherapy contraindications)
+Inflammatory or chronic functional bowel disorder such as Crohn's Disease, inflammatory bowel disease, chronic diarrhea, or constipation
+History of inflammatory bowel disease (e.g., Crohn disease and ulcerative colitis), active bowel inflammation (e.g., diverticulitis)
+Current acute or chronic colitis, inflammatory bowel disease, pneumonitis or pulmonary fibrosis.
+Any history of active or severe autoimmune disease: inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, rheumatoid arthritis, systemic progressive scleroderma, systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis), CNS or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome, myasthenia gravis, multiple sclerosis); patients with hypothyroidism with stable hormone replacement therapy dosing are allowed on study
+History of inflammatory bowel disease
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematous, Wegner's syndrome, myasthenia gravis, Grave's disease, rheumatoid arthritis, hypophysitis, uveitis, autoimmune pneumonitis, autoimmune nephritis or nephropathy, etc.) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
+Active autoimmune disease including active diverticulitis, symptomatic peptic ulcer disease, colitis, or inflammatory bowel disease that has required systemic treatment in past 2 years
+Unresolved diarrhea ? CTCAE grade 2 or presence of medical condition associated with chronic diarrhea (such as irritable bowel syndrome, inflammatory bowel disease)
+Inflammatory eye disease requiring steroid treatment
+History of autoimmune disease including rheumatoid arthritis, systemic lupus and sarcoidosis
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegner’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vacuities, or glomerulonephritis\r\n* Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study\r\n* Patients with controlled type I diabetes mellitus on a stable dose of insulin regimen are eligible for this study
+Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus (SLE), and Sjogren’s syndrome, sarcoidosis; asthma or chronic obstructive pulmonary disease (COPD) that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegner syndrome; Hashimoto syndrome; Graves’ disease; rheumatoid arthritis, hypophysitis, uveitis, etc.) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Requirement for intermittent use of bronchodilators or local steroid injections\r\n* Subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement, or psoriasis not requiring systemic treatment
+Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis
+Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis)
+History of autoimmune disease including, but not limited to:\r\n* Systemic lupus erythematosus (SLE), scleroderma, calcinosis, Raynaud phenomenon, esophageal dysmotility, sclerodactyly, and telangiectasia (CREST) syndrome, rheumatoid arthritis\r\n* Inflammatory bowel disease, celiac disease, primary biliary cirrhosis, autoimmune hepatitis\r\n* Dermatomyositis, polymyositis, giant cell arteritis\r\n* Autoimmune hemolytic anemia (AIHA), cryoglobulinemia, antiphospholipid antibody syndrome (APLS)\r\n* Diabetes mellitus type I, myasthenia gravis, Grave’s disease\r\n* Wegener’s granulomatosis or other vasculitis\r\n* A history of Hashimoto’s thyroiditis, psoriasis, or eczema, any of which has been inactive for at least one year, or isolated Raynaud’s phenomenon is acceptable
+History of inflammatory bowel disease or other serious autoimmune disease; (not including thyroiditis and rheumatoid arthritis); patients already on hydroxychloroquine for such disorders are not eligible
+History of or active inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.
+EXCLUSION - DURVALUMAB DRUG-SPECIFIC: Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion:\r\n* Participants with vitiligo or alopecia\r\n* Participants with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement \r\n* Any chronic skin condition that does not require systemic therapy\r\n* Participants without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Participants with celiac disease controlled by diet alone
+Has an active autoimmune disease (or inflammatory disorders) requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or a syndrome that requires systemic steroids or immunosuppressive agents. Subjects with inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia or resolved childhood asthma/atopy\r\n* Subjects that require intermittent use of bronchodilators or local steroid injections would not be excluded from the study\r\n* Subjects with hypothyroidism stable on hormone replacement or Sjorgen’s syndrome will not be excluded from the study\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Subjects without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Subjects with celiac disease controlled by diet alone.
+Active or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis).
+Subjects with a history of autoimmune disease (active or past), such as but not restricted to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; autoimmune-related thyroid disease, type I diabetes and vitiligo are permitted if the condition is well controlled
+Auto-immune disease including inflammatory bowel disease, lupus, rheumatoid arthritis, but not including hypothyroidism or psoriasis if condition has been stable for 2 months or greater
+History of autoimmune disease (i.e. rheumatoid arthritis, systemic lupus erythematosus) with requirement of immunosuppressive medication within 6 months.
+Subjects with active, known, or suspected autoimmune disease including patients with a history of inflammatory bowel disease (ulcerative colitis or Crohn’s disease); patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis), and central nervous system or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome, myasthenia gravis, multiple sclerosis). Subjects with vitiligo, type I diabetes mellitus, Grave’s disease, Hashimoto thyroiditis, psoriasis, and other mild autoimmune disease not requiring systemic treatment are permitted to enroll at the discretion of the investigator.
+Has active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+History of active autoimmune diseases such as but not limited to Crohn’s disease, ulcerative colitis, Sjogren’s syndrome, requiring active immune suppression; patient may have hay fever or controlled asthma
+GENERAL: History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible.\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).
+Known contraindications to radiation such as inflammatory bowel disease, active systemic lupus or scleroderma, or radiation hypersensitivity syndrome (ataxia telangiectasia or Fanconi’s anemia)
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
+History of inflammatory bowel disease
+History of inflammatory bowel disease, autoimmune disease, or other connective tissue diseases
+Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjoogren’s syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions:\r\n* Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study\r\n* Patients with controlled type 1 diabetes mellitus who are on a stable insulin regimen are eligible for the study
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis.\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone, controlled type 1 diabetes mellitus on a stable insulin regimen are eligible.\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations.\r\n** Rash must cover less than 10% of body surface area (BSA).\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%).\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids).
+Patients with history or current diagnosis of inflammatory bowel disease are not eligible
+Any condition or history of active rectal inflammatory bowel disease or other factors which might increase the risk of fistula formation;
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, vascular thrombosis associated with antiphospholipid syndrome, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, systemic vasculitis, or glomerulonephritis
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded\r\n* Of note, patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis with the exception of diverticulosis, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea), systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome (granulomatosis with polyangiitis), Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia,\r\n* Grave’s disease,\r\n* Hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement,\r\n* Psoriasis not requiring systemic treatment (within the past 2 years),\r\n* Any chronic skin condition that does not require systemic therapy, patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet alone
+Known or suspected autoimmune disease. Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study. Patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate.
+Active inflammatory bowel disease, other bowel disease causing chronic diarrhea (defined as > 4 loose stools per day), or bowel obstruction
+Patients with a history of autoimmune disease (e.g., rheumatoid arthritis, Addison's syndrome, multiple sclerosis, uveitis, systemic lupus erythematosus or Wegener's granulomatosis). Patients with vitiligo or alopecia are allowed. Patients with Graves disease or psoriasis not requiring systemic treatment within the past 2 years are allowed.
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]); the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormonal replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Subjects without active disease in the last 5 years may be included but only after consultation with the principal investigator\r\n* Subjects with celiac disease controlled by diet alone
+Inflammatory bowel disease
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+May not have primary immunodeficiency or history of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/systemic disease modifying agents within the last 2 years
+Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])
+Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+Autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus; Note: vitiligo, mild psoriasis (topical therapy only) or hypothyroidism are allowed
+History of chronic autoimmune disease (e.g. systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, hypophysitis, etc.) with symptomatic disease within the 3 years before enrollment; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity e.g. rheumatoid arthritis or thyroiditis may be allowed per principal investigator (PI) discretion provided it has been quiescent for a minimum of three years; the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included\r\n* Patients with celiac disease controlled by diet alone\r\n* Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: 1) Patients with vitiligo or alopecia; 2) Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; 3) Any chronic skin condition that does not require systemic therapy; 4) Patients without active disease in the last 5 years may be included but only after consultation with the study physician; 5) Patients with celiac disease controlled by diet alone. Subjects with history of diverticulitis may be included only after consultation and approval of the study physician.
+Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exception: a. patients with a history of autoimmune hypothyroidism who are on thyroid replacement hormone are eligible for the study; b. patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study; c. patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: i. rash must cover < 10% of body surface area.; ii. disease is well controlled at baseline and requires only low-potency topical corticosteroids; iii. no occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]); the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Subjects without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Subjects with celiac disease controlled by diet alone
+History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis a) Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. b) Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible. c) Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations; rash must cover less than 10% of body surface area (BSA)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 2 years prior to the start of treatment\r\nNOTE: Subjects with vitiligo, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded. These include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded\r\n* Of note, patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible; however, patients with vitiligo, diabetes mellitus, and Hashimoto thyroiditis on appropriate replacement therapy may be enrolled
+Patients with inflammatory bowel disease
+Have an active autoimmune disease (e.g., rheumatoid arthritis, SLE, ulcerative colitis, Crohn's Disease, MS, ankylosing spondylitis) requiring continuing immune suppressive therapy.
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment
+Current severe acute or chronic colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis
+History of automimmune disease including myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis), vascular thrombosis associated with antiphospholipid syndrome, Wegner’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, or glomerulonephritis\r\n* Note: Patients with type 1 diabetes mellitus, vitiligo, alopecia, hypothyroidism requiring hormone replacement, Graves disease, or skin disorders not requiring systemic treatment are permitted to enroll
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis) or pneumonitis
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, granulomatosis with polyangiitis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\r\n* Subjects with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study\r\n* Subjects with controlled type I diabetes mellitus on a stable dose of insulin regimen may be eligible for this study\r\n* Subjects with a history of celiac disease may be eligible if controlled with diet
+Patients with inflammatory bowel disease
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Active or prior documented inflammatory bowel disease
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
+Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis a. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. b. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. c. Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations \r\n* Rash must cover less than 10% of body surface area (BSA)\r\n* Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n* No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History of active or known autoimmune disease that can cause diarrhea like (but not limited to) Addison's disease, celiac disease/gluten intolerance/irritable bowel syndrome, scleroderma
+Active/uncontrolled autoimmune disease: patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.
+History of or active autoimmune disorders (including but not limited to: Crohn’s disease, rheumatoid arthritis, scleroderma, systemic lupus erythematosus, Grave’s disease) and other conditions that compromise or impair the immune system
+Autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+History of inflammatory bowel disease;
+Severe (requiring active treatment) acute or chronic medical conditions including: colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis
+Active auto-immune disease including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy
+Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia Gravis, multiple sclerosis); history of Grave’s disease on stable thyroid hormone replacement for at least 1 year is allowed
+All other significant diseases (for example, colitis, pneumonitis, pulmonary fibrosis, inflammatory bowel disease, uncontrolled asthma)
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis).
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Any of the following within 28 days before the first dose of study treatment\r\n* Intra-abdominal tumor/metastases invading gastrointestinal (GI) mucosa\r\n* Active peptic ulcer disease\r\n* Inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis\r\n* Malabsorption syndrome
+Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis); patients with Hashimoto’s thyroiditis are eligible to go on study
+History of autoimmune disease, such as, but not restricted to: rheumatoid arthritis, inflammatory bowel disease, systemic lupus erythematous, ankylosing spondylitis, scleroderma, or multiple sclerosis requiring treatment within the last two years; patients with vitiligo or diabetes are not excluded; replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; patients with recent history of thyroiditis; subjects with remote history (greater than 5 years) of thyroiditis are not excluded
+Any active or recent history (within 6 months of first study dose) of autoimmune disease or syndrome that requires systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; subjects with vitiligo, controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy are permitted to enroll
+malabsorption syndromes such as celiac disease, cystic fibrosis, inflammatory bowel disease, systemic sclerosis, and carcinoid syndrome
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Known or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study; patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+Any symptomatic autoimmune disease (such as lupus, scleroderma, Crohn's disease, ulcerative colitis) that requires administration of >10mg of prednisone equivalent. Lower dose steroids for conditions such as hypophysitis are allowed.
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Has active or prior documented inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis)
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+History or presence of autoimmune disease requiring systemic immunosuppression (including but not limited to: inflammatory bowel disease, systemic lupus erythematosus, vasculitis, rheumatoid arthritis, scleroderma, multiple sclerosis, hemolytic anemia, Sjogren syndrome, and sarcoidosis)
+Patients are excluded if they have a history of autoimmune disease, as follows: Patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). Patients with a history of Guillain-Barre Syndrome are excluded but myasthenia gravis or psoriasis is acceptable.
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Patient with other co-morbidities that in the opinion of the treating physician would be a contra-indication to protocol participation (e.g. inflammatory bowel disease)
+History of Crohn’s disease or ulcerative colitis
+Active or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis) or a history of primary immunodeficiency
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Serious autoimmune disease: Patients with a history of active serious inflammatory bowel disease (including Crohn's disease and ulcerative colitis) or autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic Lupus Erythematosus or autoimmune vasculitis [e.g. Wegener's Granulomatosis] are excluded from this study.
+Active or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener's granulomatosis
+History of hemorrhagic diarrhea, inflammatory bowel disease or active uncontrolled peptic ulcer disease; (concomitant therapy with ranitidine or its equivalent and/or omeprazole or its equivalent is acceptable); history of ileus or other significant gastrointestinal disorder known to predispose to ileus or chronic bowel hypomotility
+Patients with risk factors for bowel obstruction or bowel perforation (e.g., acute diverticulitis) will be excluded
+Patients with active autoimmune diseases are excluded: Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as well as patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
+Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis; currently receiving immunosuppressive doses of steroids or other immunosuppressive medications (inhaled and topical steroids are permitted)
+Active or prior documented autoimmune disease (including inflammatory bowel disease, celiac disease, Wegener syndrome) within the past 2 years; subjects with childhood atopy or asthma, vitiligo, alopecia, Hashimoto syndrome, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Have active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy
+Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea.
+Inflammatory bowel disease that is uncontrolled or on active treatment (Crohn’s disease, ulcerative colitis)
+History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
+History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin
+Active autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) in which possible progression during treatment would be considered unacceptable by the investigators
+Inflammatory bowel disease
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]); the following are exceptions to this criterion: a) patients with vitiligo or alopecia; b) patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; c) any chronic skin condition that does not require systemic therapy; d) patients without active disease in the last 5 years may be included but only after consultation with the study physician; d) patients with celiac disease controlled by diet alone
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn’s disease], celiac disease, or other serious chronic gastrointestinal conditions associated with diarrhea; autoimmune vasculitis; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis, hypophysitis, uveitis, etc.) within 3 years prior to the planned start of treatment; the following are exceptions to this criterion:\r\n* Vitiligo\r\n* Alopecia\r\n* Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Psoriasis not requiring systemic treatment\r\n* Other conditions considered to be low risk of serious deterioration by the principal investigator (PI)
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Patients with complete bowel obstruction or who are at high risk for gastrointestinal (GI) perforation or severe hemorrhage and patients with inflammatory bowel disease
+Severe autoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic Lupus Erythematosus or autoimmune vasculitis (e.g. Wegener’s Granulomatosis) are excluded from this study; patients with history of mild autoimmune disorders, including but not limited to mild psoriasis or Hashimoto’s hyperthyroidism may be included at the discretion of the principle investigator
+History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin
+History of any autoimmune disease, including any history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, as well as history of symptomatic disease (e.g. rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the principal investigator
+Active or prior documented autoimmune disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease, Wegner syndrome, Hashimoto syndrome) within the past 3 years; subjects with vitiligo, alopecia, Grave’s disease, or psoriasis not requiring systemic treatment (within the past 3 years) are not excluded; patients with hypothyroidism stable on thyroid replacement therapy for the previous 3 months are not excluded
+Clinical contraindication to stereotactic body radiotherapy as determined by the investigator (e.g., active systemic sclerosis, active inflammatory bowel disease if bowel is within radiation field)
+Poorly controlled inflammatory bowel disease
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies, should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Active autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) whose possible progression during treatment would be considered unacceptable by the investigators
+Any active autoimmune disease or a documented history of autoimmune disease, or history of syndrome that required systemic steroids or immunosuppressants (excluding vitiligo, type 1 diabetes mellitus, Graves or Hashimoto’s disease, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, resolved childhood asthma/atopy and patients with asthma requiring intermittent bronchodilator therapy)\r\n* Examples include, but are not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system [CNS] or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis).
+Subjects must not have active auto-immune disease, including connective tissue disease, uveitis, sarcoidosis, inflammatory bowel disease, or multiple sclerosis, or have a history of severe (as judged by the principal investigator) autoimmune disease requiring prolonged immunosuppressive therapy
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician and/or PI\r\n* Patients with celiac disease controlled by diet alone
+Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])
+Patients with a history of inflammatory bowel disease such as Crohn’s disease and ulcerative colitis
+Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible; patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions: patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations, rash must cover less than 10% of body surface area (BSA), disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%), no acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])
+Patients with a history of inflammatory bowel disease such as Crohn’s disease and ulcerative colitis
+Clinically significant ulcerative colitis, inflammatory bowel disease, or partial or complete small bowel obstruction are to be excluded
+History of inflammatory bowel disease
+Active autoimmune disease (excluding autoimmune thyroid disease on a stable thyroid regimen); such conditions include but are not limited to systemic lupus erythematous, rheumatoid arthritis, ulcerative colitis, Crohn’s disease and temporal arteritis
+No prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease including Addison’s disease, Grave’s disease, Hashimoto’s thyroiditis, hypophysitis, uveitis); asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; active vitiligo or alopecia, or a history of vitiligo or alopecia is acceptable
+PHASE I STUDY ELIGIBILITY CRITERIA:\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
+PHASE II STUDY COHORT 1 OVARIAN CANCER ELIGIBILITY CRITERIA (MEDI+O, MEDI+C AND MEDI+O+C):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
+PHASE II STUDY COHORT 5 TRIPLE NEGATIVE BREAST CANCER ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn`s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
+PHASE II STUDY METASTATIC CASTRATE-RESISTANT PROSTATE CANCER COHORT 4 ELIGIBILITY CRITERIA (MEDI+O ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
+PHASE II COLORECTAL CANCER COHORT 6 (MEDI+C ONLY):\r\nActive or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis); eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis
+History or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or Crohn’s disease) or other symptomatic autoimmune disease including, inflammatory bowel disease, or history of any poorly controlled or severe systemic autoimmune disease (i.e., rheumatoid arthritis, systemic lupus erythematosus, scleroderma, type I diabetes, or autoimmune vasculitis)
+Have a history of any autoimmune disease; patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s Disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, or autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre Syndrome and Myasthenia Gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the protocol chair
+History of any autoimmune disease, including but not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with Graves or Hashimoto’s disease, vitiligo, and type I diabetes mellitus will be allowed
+ADDITIONAL CRITERIA FOR STUDY CONTINUATION: History of any autoimmune disease, including but not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with Graves or Hashimoto’s disease, vitiligo, and type I diabetes mellitus will be allowed
+Patients who have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's disease, multiple sclerosis (MS), ankylosing spondylitis)
+Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjorgen’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligible
+Patients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)
+History of autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
+Patients with a known history of any of the following autoimmune diseases are excluded: \r\n* Patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) \r\n* Patients with a history of rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis (e.g., Wegener’s granulomatosis)
+Serious intercurrent medical illness which would interfere with the ability of the patient to carry out the treatment program, including, but not limited to, inflammatory bowel disease, Crohn's disease, ulcerative colitis, or active diverticulitis
+Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the PI to determine if eligible
+Uncontrolled inflammatory bowel disease
+Autoimmune disease such as scleroderma, lupus, or inflammatory bowel disease
+History of collagen vascular disease or inflammatory bowel disease (Crohn’s or ulcerative colitis)
+History of Crohn’s disease or Ulcerative colitis
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's disease and/or psoriasis not requiring systemic therapy within the last two years from randomization and patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement are not excluded.
+Serious autoimmune disease at the discretion of the treating attending: patients with a history of active serious inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, irritable bowel syndrome, ulcerative colitis)
+Known or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]) are excluded from this study; any condition requiring systemic treatment with corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to first dose of study drug; inhaled steroids and adrenal replacement steroids doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease
+Prior or currently active autoimmune disease requiring management with immunosuppression; this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren's syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication (e.g., corticosteroids) which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable; any patients receiving steroids should be discussed with the principal investigator (PI) to determine if eligible
+Systemic collagen vascular disease including scleroderma or systemic lupus erythematosus (SLE); rheumatoid arthritis is eligible
+History of rheumatoid arthritis, inflammatory bowel disease, or psoriatic arthritis
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and myasthenia gravis)
+History of autoimmune disease such as scleroderma, lupus, and inflammatory bowel disease
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis); history of Grave’s disease on stable thyroid hormone replacement for at least 1 year is allowed
+Patients with active inflammatory bowel disease
+Patients with inflammatory bowel disease
+History of (H/o) Crohn’s disease/ulcerative colitis/scleroderma
+Patients with a history of autoimmune disease, such as but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis
+History of inflammatory bowel disease
+Presence of other known significant autoimmune or inflammatory disease; examples include major chronic infectious/inflammatory/immunologic diseases such as systemic lupus erythematosus, rheumatoid arthritis, Sjogren's syndrome and periodic fever syndromes
+Known autoimmune conditions including but not limited to rheumatoid arthritis, multiple sclerosis, lupus, scleroderma, sarcoidosis, vitiligo, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves’ disease, or Hashimoto’s thyroiditis
+Autoimmune disease: Patients with a history of inflammatory bowel disease (including Crohn's disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus or autoimmune vasculitis [e.g., Wegener's Granulomatosis] are excluded from this study.
+History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison's disease, multiple sclerosis, Graves disease, Hashimoto's thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (example [e.x.]: fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
+History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin
+Prior diagnosis of Crohn's disease or ulcerative colitis
+Active autoimmune disease including but not limited to: rheumatoid arthritis (RA), inflammatory bowel disease (IBD), celiac disease, systemic lupus erythematosus (SLE), scleroderma or multiple sclerosis; patients with autoimmune hypothyroidism or type I diabetes mellitus will be eligible; patients who are seropositive only without clinical symptoms will not be excluded
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with a history of autoimmune disease (specifically including: diabetes mellitus, vitiligo, Hashimoto’s thyroiditis) who are asymptomatic, do not require immune suppression or steroids, and do not have threatened vital organ function from these conditions may be considered after discussion with the principal investigator (PI)
+A documented history of inflammatory bowel disease (ulcerative colitis or Crohn's disease, within three years)
+Has active or prior inflammatory bowel disease or primary immunodeficiency
+Patients with active autoimmune diseases including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, polymyositis dermato-myositis, or a vasculitic syndrome; at the discretion of the treating physician patients who show disease control for at least 6 months may be enrolled
+Documented history of certain autoimmune diseases such as systemic lupus erythematosus, sarcoidosis, rheumatoid arthritis, glomerulonephritis, or vasculitis
+There are no exclusions due to co-morbid disease or illnesses except for patients who carry a diagnosis of Inflammatory Bowel Disease that has been active within the last year
+Active rectal diverticulitis, Crohn’s disease, or ulcerative colitis
+Patients who have an active autoimmune disease or history of autoimmune disease requiring medical treatment with systemic immunosuppressants, including: inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemic, or immune thrombocytopenia, rheumatoid arthritis, SLE, and Sjogren's syndrome, sarcoidosis. Asthma or COPD that does not require systemic corticosteroids or routine use of inhaled steroids is acceptable
+No prior or currently active autoimmune disease requiring management with systemic immunosuppression; this includes inflammatory bowel disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia or immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease; asthma or chronic obstructive pulmonary disease that does not require daily systemic corticosteroids is acceptable
+History of inflammatory bowel disease
+Any patient with active Crohn’s disease or active ulcerative colitis
+History of or active inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
+Active or prior documented autoimmune or inflammatory disorders; patients without active disease in the last 5 years may be included after consultation with the study physician; this includes: inflammatory bowel disease, such as Crohn’s disease or ulcerative colitis, and diverticulitis with the exception of diverticulosis; sarcoidosis syndrome, or other serious GI chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome (granulomatosis with polyangiitis); myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis; or uveitis; the following are exceptions to this criterion:\r\n* Vitiligo or alopecia\r\n* Hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Celiac disease controlled by diet alone
+Ongoing acute or chronic inflammatory skin disease.
+Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
+Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
+History of or ongoing inflammatory bowel disease
+Active autoimmune disease, including, but not limited to, Systemic Lupus Erythematosus (SLE), Multiple Sclerosis (MS), Ankylosing Spondylitis (AS), and Rheumatoid Arthritis (RA).
+Prior autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s Granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre Syndrome and Myasthenia Gravis); note: patients with other immune disorders should not be enrolled without discussion with the principal investigator
+Pre-existing Familial adenomatous polyposis, inflammatory bowel disease or ulcerative colitis
+Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis;
+Known history of immune-mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
+Patient who have a history or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded because of the risk of recurrence or exacerbation of disease; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjögren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA) \r\n** Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%) \r\n** No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes but is not limited to: history of immune-related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome. Patients with vitiligo or endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible. Patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome, and psoriasis controlled with topical medication, and patients with positive serology, such as antinuclear antibodies (ANA) or anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible. Patients with type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, or conditions not expected to recur in the absence of an external trigger (precipitating event) are eligible
+Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., Crohns disease], diverticulitis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener syndrome; myasthenia gravis; Grave's disease; rheumatoid arthritis; hypophysitis, uveitis, etc) within the past 3 years prior to the start of treatment; the following are exceptions:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto's disease) stable on hormone replacement\r\n* Psoriasis not requiring systemic treatment
+Inclusion Criteria:\n\n          -  Scheduled to undergo an elective (non-emergent) bowel resection with or without a\n             planned stoma via laparotomy or minimally invasive technique. This includes any\n             subject in which a resection of the small intestine, colon, or rectum is performed for\n             any elected indication.\n\n          -  Has been informed of the nature of the study (either the subject or their legal\n             representative), agrees to its provisions, and has provided written informed consent.\n\n        Exclusion Criteria:\n\n        Subjects will not be eligible for participation in the study if they meet ANY of the\n        following exclusion criteria:\n\n          -  <18 or >80 years of age.\n\n          -  Requires emergency bowel surgery.\n\n          -  Has had 1 or more abdominal surgeries, excluding the current, for inflammatory bowel\n             disease, including, but not limited to, inflammatory bowel disease (IBD), Crohn's\n             Disease, or ulcerative colitis. Note: This does not apply to previous surgery such as\n             hernia repair unrelated to IBD.\n\n          -  American Society of Anesthesiologists (ASA) Class 4 or 5.\n\n          -  Insulin dependent diabetes mellitus.\n\n          -  Known inability to take the study drug orally (i.e. complete small bowel obstruction).\n\n          -  Has contraindications or potential risk factors to taking TXA. These include subjects\n             with:\n\n               1. Known sensitivity to TXA;\n\n               2. Recent craniotomy (past 30 days);\n\n               3. Active cerebrovascular bleed;\n\n               4. Active thromboembolic disease (such as deep vein thrombosis, pulmonary embolism,\n                  cerebral thrombosis, ischemic stroke, or acute coronary syndrome);\n\n               5. Acute promyelocytic leukemia taking all-trans retinoic acid for remission\n                  induction, or\n\n               6. Continuing use of a combined hormonal contraceptive and or combined hormonal\n                  replacement therapy (including combined hormonal pill, patch, or vaginal ring).\n\n          -  Has the following risk factors for thromboembolic disease:\n\n               1. Known medical history of congenital or acquired thrombophilia such as, but not\n                  limited to patients with:\n\n                    -  Sickle cell disease;\n\n                    -  Nephrotic syndrome;\n\n                    -  Factor V Leiden;\n\n                    -  Prothrombin gene mutation;\n\n                    -  Protein C or S deficiency;\n\n                    -  Antithrombin III deficiency;\n\n                    -  Antiphospholipid syndrome.\n\n               2. Stage IV malignant neoplasm;\n\n               3. Neurologic paresis, partial paralysis, or paralysis;\n\n               4. Pacemaker;\n\n               5. History of pulmonary embolism, deep vein thrombosis, cerebrovascular accident, or\n                  rental venous/arterial occlusion;\n\n          -  History of or current seizure disorder.\n\n          -  Patients with myeloproliferative disorders.\n\n          -  Body Mass Index (BMI) >40.\n\n          -  Any other condition that, in the opinion of the Investigator, would preclude the\n             subject from being an appropriate candidate for the study, including severe renal or\n             hepatic impairment.\n\n          -  Planned treatment with alvimopan (Entereg®) during study participation period.\n\n          -  Received any other investigational therapy within 4 weeks prior to Randomization\n\n          -  Chronic opioid usage, defined by the American Pain Society as daily or near-daily use\n             of opioids for at least 90 days.\n\n          -  Female subjects of childbearing potential with a positive urine or serum pregnancy\n             test or who are not taking (or not willing to take) acceptable birth control measures\n             (abstinence, intrauterine devices, contraceptive implants or barrier methods) through\n             Day 30. Additionally, those women who are lactating and insist on breast feeding\n             within 5 days of the last dose of study drug.\n\n          -  Known history of radiation enteritis.
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible.
+History of Crohn’s disease, ulcerative colitis, or ataxia telangiectasia
+History of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease), or any other known autoimmune diseases including rheumatoid arthritis, scleroderma, systemic lupus erythematosus, and autoimmune vasculitis
+Any medical condition that would be a contra-indication to radiation therapy, such as inflammatory bowel disease
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included, but only after consultation with the PI\r\n* Patients with celiac disease controlled by diet alone
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Note:\r\n** Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone are eligible\r\n** Patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible\r\n** Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n*** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n*** Rash must cover less than 10% of body surface area (BSA)\r\n*** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n*** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia;\r\n* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; \r\n* Any chronic skin condition that does not require systemic therapy; \r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician; \r\n* Patients with celiac disease controlled by diet alone
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable.
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g. colitis, ulcerative colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.]). The following are exceptions to this criterion: patients with vitiligo or alopecia, patients with hypothyroidism (e.g. following Hashimoto syndrome) stable on hormone replacement, any chronic skin condition that does not require systemic therapy, patients without active disease in the last 5 years may be included but only after consultation with the study physician, and patients with celiac disease controlled by diet alone.
+History of pre-existing immunodeficiency disorder or autoimmune condition requiring immunosuppressive therapy. This includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease\r\nor any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines.
+History of active or prior documented autoimmune disease within the past 2 years including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, auto-immune Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis, with the following caveats:\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with Grave’s disease, vitiligo, autoimmune alopecia, or psoriasis not requiring systemic treatment (within the past 2 years) are eligible upon consultation with the study chairs\r\n* Patients with questionable diagnosis of autoimmune disease who have never been treated with immunosuppressive regimen and have no ongoing symptoms at the time of enrollment may be eligible after discussion with medical monitor and principle investigator
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the Investigator to be unacceptable.
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable
+Autoimmune disease including, but not limited to, rheumatoid arthritis, systemic lupus erythematous, multiple sclerosis, or ankylosing spondylitis
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (i.e. not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patients with Crohn's disease or ulcerative colitis
+Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc.])\r\n* The following are exceptions to this criterion:\r\n** Patients with vitiligo or alopecia;\r\n** Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement;\r\n** Any chronic skin condition that does not require systemic therapy;\r\n** Patients without active disease in the last 5 years may be included but only after consultation with the medical oncology study chair;\r\n** Patients with celiac disease controlled by diet alone
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled Type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Active or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)
+Patients with active autoimmune disease or documented autoimmune disease within 2 years, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
+Active or prior documented inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
+DOSE ESCALATION COHORT: Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving systemic therapy for an autoimmune or inflammatory disease\r\n* Exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, Hashimoto's disease, or with PI approval
+DOSE EXPANSION COHORT: Subjects with any active or inactive autoimmune process (eg, rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who are receiving systemic therapy for an autoimmune or inflammatory disease; exceptions include subjects with vitiligo, hypothyroidism stable on hormone replacement, controlled asthma, type I diabetes, Graves' disease, Hashimoto's disease, or with PI approval
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+No standard contraindications to radiation therapy including prior significant radiation therapy, inflammatory bowel disease, irritable bowel syndrome or collagen vascular disease
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, are excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Patients with significantly diseased or obstructed gastrointestinal tract that could interfere with absorption of oral medication, including inflammatory or chronic functional bowel disorder, such as Crohn disease, inflammatory bowel disease, chronic diarrhea, or constipation
+Active autoimmune process (eg rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) or who have been receiving therapy for an autoimmune or inflammatory disease; vitiligo, thyroiditis, or eczema is permitted if patient is otherwise eligible
+History of inflammatory bowel disease requiring ongoing therapy
+DONOR: History of or symptoms consistent with inflammatory bowel disease or a serious autoimmune disorder
+Patients must not have active or a history of small or large intestine inflammation such as Crohn’s disease or ulcerative colitis
+Patients must not have a documented history of inflammatory bowel disease (including ulcerative colitis and Crohn’s disease) or diverticulitis (history of diverticulosis is allowed)
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis); patients with thyroid disease will be allowed; autoimmune diagnoses not listed here must be approved by the protocol chair, following discussion with the study sponsor and Cancer Therapy Evaluation Program (CTEP)
+Any autoimmune disease such as inflammatory bowel disease, including but not limited to:\r\n* Ulcerative colitis\r\n* Crohn's disease\r\n* Rheumatoid arthritis\r\n* Systemic sclerosis\r\n* Systemic lupus erythematosus\r\n* Autoimmune hepatitis\r\n* Other autoimmune disease not listed above\r\n* NOTE: Subjects with autoimmune thyroid disease and diabetes mellitus type I will be allowed
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis \r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations \r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids)
+Inflammatory bowel disease
+Autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
+History of autoimmune disorders requiring cytotoxic or immunosuppressive therapy, or autoimmune disorders with visceral involvement; active or inactive auto-immune disorders (e.g., rheumatoid arthritis, moderate or severe psoriasis, multiple sclerosis, systemic lupus erythematosus, inflammatory bowel disease, etc.) requiring treatment\r\n* The following will not be exclusionary:\r\n** Vitiligo, thyroiditis or eczema requiring systemic steroids at a dose =< 7.5 mg/day of prednisone or equivalent; individual cases can be discussed with the principal investigator
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic non-gastrointestinal autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)
+Active inflammatory bowel disease
+Patients with history of inflammatory bowel disease, or who require steroid or cytotoxic therapy for collagen vascular disease
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)
+Patients must not have a history of inflammatory bowel disease or diverticulitis (history of diverticulosis is allowed)
+Patients with active inflammatory bowel disease
+Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus
+Any condition (e.g., gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous [IV] alimentation, prior surgical procedures affecting absorption, ulcerative colitis, inflammatory bowel disease, a partial or complete small bowel obstruction, or active peptic ulcer disease) that impairs their ability to swallow and retain MK-2206 or hydroxychloroquine tablets
+History of immunodeficiency (e.g., human immunodeficiency virus [HIV]) or autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, vasculitis, polymyositis-dermatomyositis, scleroderma, multiple sclerosis, or juvenile-onset insulin-dependent diabetes) that may be exacerbated by immunotherapy
+The participant has a history of inflammatory bowel disease or Crohn's disease requiring medical intervention within 12 months.
+Patient must not have a history of inflammatory bowel disease requiring pharmacological and/or surgical intervention within the 12 months prior to randomization
+Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), diverticulitis or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding
+Prior diagnosis of Crohn's disease or ulcerative colitis
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
+Patient must have no active inflammatory bowel disease
+Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease.
+Active inflammatory disease requiring immunosuppressants, including small or large intestinal inflammation such as Crohn's disease or ulcerative colitis
+Patients must not have any active or prior documented autoimmune or inflammatory disease (including inflammatory bowel disease, diverticulitis with the exception of diverticulosis, celiac disease, irritable bowel disease; Wegener syndrome; Hashimoto syndrome) within 3 years prior to sub-study registration; patients with vitiligo, alopecia, Grave's disease, or psoriasis requiring systemic treatment within the past 3 years are not eligible
+Subjects who have a history of inflammatory bowel disease, Crohn's disease, ulcerative colitis, or Wegener's granulomatosis;
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease (eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis); myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
+Have current or recent gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.
+Ongoing inflammatory bowel disease
+History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect
+History of inflammatory bowel disease
+Intraluminal metastatic lesion with suspected bleeding, inflammatory bowel disease, ulcerative colitis or other GI condition associated with increased risk of perforation
+Subject has active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease [exclude only if active within the last 6 months prior to signing the ICF], or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
+Patients are ineligible if they have a history of autoimmune disease, as follows: patients with a history of inflammatory bowel disease are excluded from this study as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); patients with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded; patients with a history of autoimmune thyroiditis are eligible if their current thyroid disorder is treated and stable with replacement or other medical therapy
+History or risk of autoimmune disease (for example, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis
+History of inflammatory bowel disease (e.g., Crohnis disease, ulcerative colitis),celiac disease (i.e., sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with absorption, distribution, metabolism, or excretion of the IP and/or predispose the subject to an increased risk of gastrointestinal toxicity.
+History of inflammatory bowel disease or active bowel inflammation
+History of inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis), celiac disease, prior gastrectomy, gastric bypass, upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption of the study drug and/or predispose the subject to an increased risk of gastrointestinal toxicity.
+History of inflammatory bowel disease, prior bowel surgeries (or colostomy) for any reason, or prior partial/radical cystectomy for any reason
+Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, or multiple sclerosis, with the following exceptions: patients with a history of autoimmune-related hypothyroidism who are on thyroid replacement hormone are eligible for the study; patients with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study; patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:\r\n* Rash must cover < 10% of body surface area\r\n* Disease is well controlled at baseline and requires only low-potency topical corticosteroids\r\n* No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high potency or oral corticosteroids within the previous 12 months
+History of or active autoimmune disease including, but not limited to, systemic lupus erythematous, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, and vasculitis or glomerulonephritis; patients with autoimmune thyroid disease on a stable thyroid replacement regimen; controlled vitiligo, eczema, psoriasis, or seborrhoic dermatitis with only dermatologic manifestations; or controlled type I diabetes on a stable insulin regimen may be eligible for the study with approval by the medical monitor
+Active or history of inflammatory bowel disease (colitis, Crohn's), celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis.
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Known or suspected autoimmune disease; patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus or autoimmune vasculitis [e.g., Wegener’s granulomatosis] are excluded from this study; patients with a history of Hashimoto’s thyroiditis only requiring hormone replacement, type I diabetes, or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are allowed to participate
+Autoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study
+History of Crohn's Disease or Ulcerative Colitis
+History of pre-existing immunodeficiency disorder, autoimmune condition requiring immunosuppressive therapy, or chronic infection (i.e. hepatitis B, hepatitis C, human immunodeficiency syndrome virus [HIV]); this includes inflammatory bowel disease, ulcerative colitis, Crohn’s disease, systemic vasculitis, scleroderma, psoriasis, multiple sclerosis, hemolytic anemia, immune-mediated thrombocytopenia, rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, or other rheumatologic disease or any other medical condition or use of medication which might make it difficult for the patient to complete the full course of treatments or to generate an immune response to vaccines
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease, Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patient with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Active autoimmune disease which requires treatment with systemic immunosuppressive agents, e.g. inflammatory bowel disease, multiple sclerosis, sarcoidosis, psoriasis, autoimmune hemolytic anemia, rheumatoid arthritis, systemic lupus erythematosus (SLE), vasculitis, Sjögren's syndrome, scleroderma, autoimmune hepatitis, and other rheumatological diseases
+Inflammatory bowel disease
+Rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, autoimmune vasculitis
+Patients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis)
+Patients with a known history of any of the following autoimmune diseases are excluded: (a) patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) (b) patients with a history of rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])
+Inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
+Have a history of inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ?12 months prior to randomization.
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome or chronic inflammatory demyelinating polyneuropathy (CIDP), myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded \r\n* Of note, patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+Active autoimmune disease (including but not limited to: systemic lupus erythromatosis, Sjogren’s syndrome, rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, etc.) requiring immunosuppressive therapy within 4 weeks prior to the screening visit, with the exception of thyroid replacement
+Active peptic ulcer disease, inflammatory bowel disease (e.g. ulcerative colitis, Crohn’s disease), or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding
+History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves' disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.x. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
+History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin
+Inflammatory bowel disease including Crohn's disease and colitis ulcerosa.
+Ongoing acute or chronic inflammatory skin disease.
+Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
+Autoimmune- or antibody (Ab)-mediated disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, temporal arteritis, and thyroiditis
+History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg, Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders, etc.); patients will be eligible if prior autoimmune disease is not deemed to be active (e.g. fibrotic damage of the thyroid after thyroiditis or its treatment, with stable thyroid hormone replacement therapy); vitiligo will not be a basis for exclusion
+History of inflammatory bowel disease, celiac disease, or other chronic gastrointestinal conditions associated with diarrhea or bleeding, or current acute colitis of any origin
+History of active autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, Wegener's granulomatosis, vascular thrombosis associated with antiphospholipid syndrome, Sjogren's syndrome, Guillain-Barre syndrome, multiple sclerosis, systemic vasculitis, or glomerulonephritis\r\n* Patients with history of autoimmune related hypothyroidism on stable dose of thyroid replacement hormone may be eligible for this study\r\n* Patients with controlled type I diabetes mellitus on a stable dose of insulin may be eligible for this study
+History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) =< 12 months prior to randomization
+Autoimmune disease: Patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable. Acceptable exclusions include: Hashimoto’s thyroiditis, type 1 diabetes mellitus, and other localized or inactive conditions with approval of the PI.
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis or glomerulonephritis\r\n* Patients with history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study\r\n* Patients with controlled type I diabetes mellitus on a stable dose of insulin regimen for more than a month may be eligible for this study\r\n* Patients with auto immune disease that does not recur unless patient is exposed to an external trigger (i.e. gluten and celiac disease) may also be eligible
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune pneumonitis, autoimmune vasculitis [eg, Wegener’s granulomatosis]) and motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia, Gravis); patients with Hashimoto’s thyroiditis are eligible to go on study
+Active inflammatory bowel disease
+History of diverticulitis, chronic ulcerative lower GI disease such as Crohn’s disease or ulcerative colitis, or other symptomatic lower GI conditions that might predispose to perforations
+History of autoimmune disease including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; Note: patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone may be eligible for this study
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis, Crohn’s disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener’s syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves’ disease; rheumatoid arthritis; hypophysitis, uveitis; etc.) within the past 3 years prior to the start of treatment\r\n* The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment
+Active or history of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, polymyositis, sarcoidosis, etc.) with symptomatic disease within the 2 years before randomization; Note: subjects with vitiligo, Graves' disease or psoriasis not requiring systemic treatment within the past 2 years will not be excluded
+Active or history of inflammatory bowel disease (colitis, Crohn’s disease), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea
+Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection (hemicolectomy or extensive small intestine resection with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea.
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+Active autoimmune disease, defined as any autoimmune condition currently requiring therapy (e.g., systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease, rheumatoid arthritis)
+Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis])
+Patients with a history of Inflammatory bowel disease such as Crohn’s disease and ulcerative colitis
+History of autoimmune disorder, including type 1 diabetes mellitus, pemphigus vulgaris, systemic mastocytosis, systemic lupus erythromatosis, dermatomyositis/polymyositis, rheumatoid arthritis, systemic sclerosis, Sjörgen’s syndrome, vasculitis/arteritis, Behcet’s syndrome, autoimmune thyroiditis, multiple sclerosis, or uveitis; (vitiligo is allowed)
+Active or history of autoimmune or inflammatory disorders, including inflammatory bowel disease (e.g., colitis, Crohn’s), diverticulitis (with the exception of diverticulosis), irritable bowel disease, celiac disease or other serious gastrointestinal chronic conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis, Sarcoidosis syndrome, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, uveitis, etc; patients without active disease in the last 5 years may be included but only after consultation with the study physician; Note: the following are exceptions to this criterion: vitiligo or alopecia; patients with hypothyroidism (i.e. following Hashimoto syndrome) stable on hormone replacement; any chronic skin condition that does not require systemic therapy; patients with celiac disease controlled by diet alone
+Participant has a history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism, or excretion of the IP and/or predispose the participant to an increased risk of gastrointestinal toxicity.
+Systemic autoimmune disease (e.g., systemic lupus erythematosus, active rheumatoid arthritis, Marfan Syndrome, etc.).
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis; patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible; patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible; patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations \r\n* Rash must cover less than 10% of body surface area (BSA)\r\n* Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n* No acute exacerbations of underlying condition within the last 12 months (not requiring PUVA [psoralen plus ultraviolet A radiation], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, high potency or oral steroids)
+Patients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)
+Patients receiving treatment for active autoimmune disease. \Active\ refers to any condition currently requiring therapy. Examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis.
+Active autoimmune disease (e.g., systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) in which possible progression during treatment would be considered unacceptable by the investigators
+Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
+Active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids; NOTE: these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including chronic prolonged systemic corticosteroids (defined as corticosteroid use of duration one month or greater), should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or anti-phospholipid syndrome should be excluded
+Inflammatory bowel disease
+Medical history of autoimmune disease (e.g., Crohn's disease, ulcerative colitis) or other diseases requiring systemic glucocorticoid or immunosuppressive therapy.
+History of any autoimmune disease, including but not limited to: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s Granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis); patients with Graves or Hashimoto’s disease, vitiligo, and type I diabetes mellitus will be allowed
+History of inflammatory bowel disease (e.g., Crohn’s, ulcerative colitis) - note patients with irritable bowel syndrome are eligible
+Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis).
+Autoimmune disease: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) and autoimmune disorders such as rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus or autoimmune vasculitis (e.g., Wegener’s granulomatosis) are excluded from this study
+Diagnosis of autoimmune disease, including, but not limited to:\r\n* Systemic lupus erythematosus (lupus)\r\n* Multiple sclerosis (MS)\r\n* Rheumatoid arthritis (RA)\r\n* Ankylosing spondylitis\r\n* Other autoimmune disease (specify)
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)
+Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
+Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
+Uncontrolled inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+Patients with active inflammatory bowel disease or collagen vascular disease –systemic lupus erythematosus (SLE), scleroderma
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease) whose possible progression during treatment would be considered by the investigator to be unacceptable
+COHORT A: Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis)
+COHORT B: Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis or Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis)
+Active or history of inflammatory bowel disease (colitis, Crohn's), diverticulitis, irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea. Active or history of systemic lupus erythematosus or Wegener's granulomatosis.
+Patients with an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus [SLE], ulcerative colitis, Crohn's disease, multiple sclerosis [MS], ankylosing spondylitis)
+Inflammatory bowel disease or connective tissue disease requiring medical management
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible.\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with inactive inflammatory bowel disease, not currently receiving therapy, may be eligible
+Known history of immune mediated colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
+History of bowel obstruction, refractory ascites, or bowel perforation due to advanced disease within the past 3 months from start of study treatment
+Active immune-mediated diseases including: connective tissue diseases, uveitis, sarcoidosis, inflammatory bowel disease, multiple sclerosis.
+History of chronic autoimmune disease (e.g., Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, rheumatoid arthritis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; Note: active vitiligo or a history of vitiligo will not be a basis for exclusion
+Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea; active or history of systemic lupus erythematosus or Wegener’s granulomatosis
+Autoimmune disease; patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis)
+Any uncontrolled systemic inflammatory disease or infection requiring antibiotics, non-steroidal, or steroidal anti-inflammatory agents on a daily basis
+Patients with any active autoimmune disease (i.e. psoriasis, extensive atopic dermatitis, asthma, inflammatory bowel disease (IBD), multiple sclerosis (M.S.), uveitis, vasculitis), chronic inflammatory condition, or any condition requiring concurrent use of any systemic immunosuppressants or steroids for any reason would be excluded from the study. Any patient with an allo-transplant of any kind would be excluded as well. This would include those with a xenograft heart valve to avoid the potential risk of any immune reaction causing valvular degeneration. Mild-intermittent asthma requiring only occasional beta-agonist inhaler use or mild localized eczema will not be excluded.
+History of autoimmune disease, including inflammatory bowel disease
+Known active autoimmune disease will be excluded. (For example, Grave's disease; systemic lupus erythematosus; rheumatoid arthritis; Crohn's disease; psoriasis).
+The patient has uncontrolled or significant medical condition other than cancer, that would prevent the participation in the study or make this protocol unreasonably hazardous, in the opinion of the investigator, including but not limited to:\r\n* Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn's disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g. Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)\r\n* Known or suspected brain metastasis, or untreated leptomeningeal disease\r\n* Active infection or other medical condition that would make prednisone use contraindicated\r\n* Active or symptomatic viral hepatitis or chronic liver disease
+Have a history of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
+Inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
+History of inflammatory bowel disease
+Prior history of scleroderma or inflammatory bowel disease
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome)
+History of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; prior history of autoimmune thyroiditis or vitiligo is permitted
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. myasthenia gravis, Guillain-Barre syndrome); those with immune-mediated skin toxicity (i.e. toxic epidermal necrolysis, Stevens-Johnson syndrome) will also be excluded
+Clinical contraindication to stereotactic body radiotherapy (e.g. active systemic sclerosis, active inflammatory bowel disease if bowel is within target field, etc)
+Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)
+At the time of screening, active peptic ulcer disease or active inflammatory bowel disease (including ulcerative colitis or Crohn’s disease), diverticulitis, cholecystitis, symptomatic cholangitis, or appendicitis
+Autoimmune disease: subjects with a documented history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease are excluded from this study as are subjects with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); subjects with motor neuropathy considered of autoimmune origin (e.g., Guillain-Barre syndrome and myasthenia gravis) are excluded from this study
+Any chronic inflammatory bowel disease and/or chronic bowl obstruction
+Any patient currently requiring or anticipated to require tumor necrosis factor (TNF) blocking agent (e.g., infliximab) therapy for diagnosis of rheumatologic disease or inflammatory bowel disease (e.g., ankylosing spondylitis, Crohn disease, plaque psoriasis, psoriatic arthritis, rheumatoid arthritis or ulcerative colitis)
+History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with diverticulosis\r\n* Patients with celiac disease controlled by diet alone
+Known history of colitis, inflammatory bowel disease, pneumonitis, or pulmonary fibrosis
+Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's Palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
+Diagnosis of inflammatory bowel disease (Crohn's disease or Ulcerative Colitis).
+Patients with Crohn’s disease or ulcerative colitis
+Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves‘ disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
+Active or prior documented inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis)
+Active inflammatory bowel disease (i.e., Crohn's disease or ulcerative colitis)
+Patients with a history of auto-immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis; patients receiving replacement thyroid hormone would be eligible
+Active autoimmune disease requiring active therapy with any form of steroid or immunosuppressive therapy or a documented history of any of the following: inflammatory bowel disease; regional enteritis systemic lupus erythematosus; Sjogren's syndrome; inflammatory neurologic disorder such as multiple sclerosis; or any immune mediated disease that can cause life-threatening symptoms or severe organ/tissue damage in the opinion of the principle investigator
+history of inflammatory bowel disease of the rectum;
+Pre-existing autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis) requiring anti-inflammatory therapy
+Ongoing inflammatory bowel disease
+History of autoimmune disease or known inflammatory bowel disease.
+History of inflammatory bowel disease
+Patients with a history of inflammatory bowel disease
+Uncontrolled inflammatory bowel disease, peptic ulcer disease or history of significant gastro intestinal bleeding within 6 months of enrollment.
+Ongoing inflammatory bowel disease
+History of Crohn’s disease or ulcerative colitis
+Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
+Have a bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection or chronic diarrhea
+Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
+Patients with history of inflammatory bowel disease or major bowel surgery
+Patients on treatment for rheumatoid arthritis or systemic lupus erythematosus
+History of inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), celiac disease, or other chronic gastrointestinal conditions associated with diarrhea, or current acute colitis of any origin
+Active peptic ulcer disease, inflammatory bowel disease (eg, ulcerative colitis, Crohn's disease), diverticulitis, or other gastrointestinal conditions with increased risk of perforation or gastrointestinal bleeding.
+Ongoing gastrointestinal medical condition such as Crohn's disease, Inflammatory bowel disease, chronic diarrhea, or constipation
+Ongoing inflammatory bowel disease
+Active autoimmune disease (e.g. systemic lupus erythematosus, vasculitis, infiltrating lung disease, inflammatory bowel disease) whose possible progression during treatment would be considered unacceptable by the investigators
+Autoimmune disease: Patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (eg, rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [eg, Wegener’s granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis)
+Active autoimmune disease such as Crohn’s disease, rheumatoid arthritis, Sjogrens' disease, systemic lupus erythematosis, or similar conditions
+Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)
+History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Bell’s palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis\r\n* Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible\r\n* Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible\r\n* Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:\r\n** Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations\r\n** Rash must cover less than 10% of body surface area (BSA)\r\n** Disease is well controlled at baseline and only requiring low potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, fluocinolone 0.01%, desonide 0.05%, alclometasone dipropionate 0.05%)\r\n** No acute exacerbations of underlying condition within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Autoimmune or antibody-mediated disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, ulcerative colitis, Crohn's disease, and temporal arteritis (patients with a history of hypothyroidism will not be excluded)
+Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
+Active or prior documented autoimmune, or inflammatory bowel disease, or inflammatory bowel disease. or systemic treatment for psoriasis within the past 5 years.;
+Known history of autoimmune conditions including, but not limited to: rheumatoid arthritis, multiple sclerosis, lupus erythematosus, scleroderma, sarcoidosis, inflammatory bowel disease, idiopathic thrombocytopenia purpura, Graves' disease, or Hashimoto's thyroiditis;
+Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
+Patient has an autoimmune condition, including, but not limited to, multiple sclerosis, Grave's disease, vasculitis, systemic lupus erythematosus, rheumatoid arthritis, systemic sclerosis, myasthenia gravis, ankylosing spondylitis, Wegener's granulomatosis, ulcerative colitis, Crohn's disease, psoriasis requiring systemic therapy, pemphigus, temporal arteritis, dermatomyositis, Sjögren's syndrome, Goodpasture's syndrome, interstitial pneumonitis, interstitial nephritis, or Henoch-Schönlein purpura.
+Inflammatory bowel disease including Crohn's disease and colitis ulcerosa.
+Ongoing acute or chronic inflammatory skin disease.
+Ongoing inflammatory bowel disease
+Active inflammatory bowel disease
+History of chronic autoimmune disease (e.g., systemic lupus erythematosus or Wegener’s granulomatosis, Addison’s disease, multiple sclerosis, Graves’ disease, Hashimoto’s thyroiditis, hypophysitis, etc.) with symptomatic disease within the 3 years before randomization; note: active vitiligo or a history of vitiligo will not be a basis for exclusion; in addition, a past history of certain autoimmunity eg rheumatoid arthritis or thyroiditis may be allowed per Principal Investigator (PI) discretion provided it has been quiescent for a minimum of three years
+Active or history of inflammatory bowel disease (colitis, Crohn’s), irritable bowel disease, celiac disease, or other serious, chronic, gastrointestinal conditions associated with diarrhea
+Subjects with known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
+Patients with active autoimmune disease; “active” refers to any condition currently requiring therapy; examples of autoimmune disease include systemic lupus erythematosus, multiple sclerosis, inflammatory bowel disease and rheumatoid arthritis
+Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
+Patients with active inflammatory bowel disease
+Known history of autoimmune disease, arteritis, or vasculitis, including, but not limited to: lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease (including ulcerative colitis and Crohn's disease), Grave's disease, Hashimoto's thyroiditis, Wegener's granulomatosis, temporal arteritis, and polyarteritis nodosa
+Known clinically significant gastrointestinal disease including, but not limited to, inflammatory bowel disease
+Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
+Pre-existing diarrhea uncontrolled with supportive care; prior hemorrhagic diarrhea due to ulcerative colitis, inflammatory bowel disease or other cause; active, uncontrolled peptic ulcer disease even in the setting of proton-pump inhibitor or histamine2-blocker use
+Prior history of inflammatory bowel disease.
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); CNS or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and Myasthenia Gravis, multiple sclerosis)
+Patients with inflammatory bowel disease or other autoimmune conditions which might affect the radiated colon or rectum
+Autoimmune disease: patients with a history of inflammatory bowel disease, including ulcerative colitis and Crohn’s disease, are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener’s granulomatosis]); central nervous system (CNS) or motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome and myasthenia gravis, multiple sclerosis)
+Gastrointestinal (GI) disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
+Gastrointestinal diseases that could alter the assessment of safety, including irritable bowel syndrome, ulcerative colitis, Crohn's disease, or hemorrhagic coloproctitis.
+History of or active inflammatory bowel disease or active bowel inflammation
+Participants with active gastrointestinal conditions (Crohn's disease, ulcerative colitis, diverticulosis associated colitis, and Behçet's disease)
+History of inflammatory bowel disease
+Gastro-intestinal disease with increased risk of diarrhea (e.g. inflammatory bowel disease)
+Autoimmune disease: patients with a history of inflammatory bowel disease are excluded from this study, as are patients with a history of symptomatic disease (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis]); motor neuropathy considered of autoimmune origin (e.g. Guillain-Barre syndrome)
+Gastrointestinal (GI) disease with increased risk of diarrhea [e.g. inflammatory bowel disease (IBD)]
+The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease. Patients with vitiligo are not excluded.
+The patient has symptomatic autoimmune disease such as, but not limited to multiple sclerosis, lupus, and in-flammatory bowel disease.
+Prior history of uveitis or autoimmune inflammatory eye disease
+Active inflammatory bowel disease or other bowel disease causing chronic diarrhea.
+History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis (RA), inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn's disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]); the following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with celiac disease controlled by diet alone
+Active or prior documented inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)
+Patients with inflammatory or chronic functional bowel disorder, such as Crohn disease, inflammatory bowel disease, or gastrointestinal graft versus host disease that in the opinion of the investigator may interfere with absorption of ponatinib or increase the risk of serious complications
+Patients with autoimmune diseases are excluded: patients with a history of inflammatory bowel disease (including Crohn’s disease and ulcerative colitis) are excluded from this study as are patients with a history of autoimmune disease (e.g., rheumatoid arthritis, systemic progressive sclerosis, systemic lupus erythematosus, Wegener’s granulomatosis)
+Have a history (within 3 years) of inflammatory bowel disease,
+Inflammatory arthritis that requires disease modifying drugs (e.g. rheumatoid arthritis)
+History of inflammatory bowel disease
+History of or active inflammatory disease or active bowel inflammation
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease; systemic lupus erythematosus; Wegener syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis, hypophysitis, uveitis) within the past 3 years prior to the start of treatment; the following are exceptions to this criterion:\r\n* Subjects with vitiligo or alopecia\r\n* Subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement or psoriasis not requiring systemic treatment
+Severe gastrointestinal conditions such as clinical or radiological evidence of bowel obstruction within 4 weeks prior to study entry, uncontrolled diarrhea in the last 4 weeks prior to enrollment, or history of inflammatory bowel disease
+Patients with gastrointestinal disease or disorder that could interfere with absorption of CUDC-907, such as bowel obstruction or inflammatory bowel disease
+History of autoimmune disease including: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, type I diabetes mellitus, vasculitis, or glomerulonephritis; patients with a history of autoimmune-related hypothyroidism on thyroid replacement hormone or those with autoimmune dermatologic conditions not requiring the use of prednisone > 10 mg or equivalent are eligible
+Subjects may be excluded if they have known autoimmune inflammatory disease. (e.g. rheumatoid arthritis, ulcerative colitis, gout, chronic steroids).
+Rheumatoid arthritis and other types of autoimmune and inflammatory joint disease
+Bowel obstruction
+A prior history of any other malignancy except basal or squamous cell skin cancers, strokes, diabetes, current heart disease or uncontrolled hypertension, peripheral vascular disease, liver disease, autoimmune and/or inflammatory diseases including rheumatoid arthritis and ulcerative colitis, and other medical conditions that would limit participation in the assessments (e.g., pulmonary disease, orthopedic problems, major psychiatric illness, major cognitive dysfunction, or an acute medical problem)
+History of clinically significant Crohn’s disease or inflammatory bowel disease (IBD)
+Patients with clinical symptoms or signs of gastrointestinal obstruction and/ or those who require parenteral hydration and/or nutrition; patients with history or current diagnosis of inflammatory bowel disease are not eligible
+Patients with a history of or who currently have evidence of autoimmune disease (other than autoimmune thyroid disease managed with thyroid hormone replacement or vitiligo) including: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn’s disease, autoimmune hepatitis, Wegener’s etc., are ineligible
+Chronic inflammatory conditions
+Inflammatory bowel disease (e.g. Crohn’s disease, ulcerative colitis)
+Any history of inflammatory bowel disease
+Participants with inflammatory bowel disease (e.g., ulcerative colitis, Crohn’s)
+Patients with a diagnosis of inflammatory bowel disease, i.e. Crohn’s disease or ulcerative colitis
+Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids, should be excluded; these include but are not limited to patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn’s, ulcerative colitis, autoimmune hepatitis, and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome should be excluded; patients with vitiligo, endocrine deficiencies including thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible; patients with rheumatoid arthritis and other arthropathies, Sjogren’s syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible
+Bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection.
+Prior history of inflammatory bowel disease or other chronic diarrheal illness
+Patients with autoimmune disorders (for example, systemic lupus erythematosus or rheumatoid arthritis), who have been treated in the last 3 years
+Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn’s disease, bowel surgery such as gastric bypass, and celiac disease
+Clinically significant systemic infection or uncontrolled chronic inflammatory disease (eg, rheumatoid arthritis, inflammatory bowel disease) as determined by the investigator during screening.
+History of medial or arthritic disease that could confound or interfere with evaluation of activity level, including but not limited to inflammatory arthritis (rheumatoid arthritis, systemic lupus spondyloarthropathy, psoriatic arthritis, polymyalgia rheumatica), Parkinson’s disease and cancer involving the bone
+Inflammatory bowel disease (IBD)/Crohn's
+Patients with a history of gastric bypass surgery or inflammatory bowel disease
+Prior colorectal surgery or history of inflammatory bowel disease
+History of diverticulitis, Crohn’s disease or ulcerative colitis
+Any history of inflammatory bowel disease
+Patient with Crohn's colitis or ulcerative colitis
+Have a personal history of inflammatory bowel disease (Crohn’s disease or colitis), colon polyps, or a history of cancer except non-melanoma skin cancer
+Prior diagnosis of cancer (except non-melanoma skin cancer), Crohn’s disease, inflammatory bowel disease or colitis
+Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, or inflammatory bowel disease
+CONTROL (HEALTHY) GROUP: Inflammatory conditions, such as rheumatoid arthritis, systemic lupus or inflammatory bowel disease
+Ongoing irritable bowel syndrome (IBS) or colitis (including but not limited to ulcerative colitis, Crohn’s disease, microscopic colitis, etc.)
+Patients with inflammatory bowel disease
+Diagnosis of inflammatory bowel disease, liver or kidney disease, bleeding diathesis
+Has a diagnosis of an inflammatory, autoimmune, or chronic infectious disease (including rheumatoid arthritis, lupus, chronic liver disease, multiple sclerosis, fibromyalgia, inflammatory bowel disease, psoriasis, human immunodeficiency virus [HIV])
+Patient has a history of severe GI tract insult including but not limited to previous bowel perforation, grade 4 neutropenic colitis or typhlitis, inflammatory bowel syndrome, short small bowel syndrome (Crohn’s disease, ulcerative colitis) or history of bowel resection
+No history of Inflammatory bowel disease
+Individuals with inflammatory bowel disease
+Participants with dysplasia-associated mass or lesion (DALM) due to longstanding idiopathic inflammatory bowel disease will be excluded
+Inflammatory bowel disease
+Known diagnosis of colon heritable cancer syndrome (familial adenomatous polyposis [FAP], hereditary nonpolyposis colorectal cancer [HNPCC]) or inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
+Has severe colitis of any etiology or a history of inflammatory bowel disease (IBD)
+No previous diagnoses of ulcerative colitis, Crohn’s disease or irritable bowel disease
+History of auto?immune disease such as, but not restricted to, inflammatory bowel disease, systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, scleroderma, multiple sclerosis, Hashimoto’s thyroiditis, or Grave’s disease
+History of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis), celiac disease (ie, sprue), prior gastrectomy or upper bowel removal, or any other gastrointestinal disorder or defect that would interfere with the absorption, distribution, metabolism or excretion of the IP (INVESTIGATIONAL PRODUCT) and/or predispose the subject to an increased risk of gastrointestinal toxicity
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis, Crohn's disease], diverticulitis with the exception of a prior episode that has resolved or diverticulosis, celiac disease, irritable bowel disease, or other serious gastrointestinal chronic conditions associated with diarrhea; systemic lupus erythematosus; Wegener's syndrome [granulomatosis with polyangiitis]; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis, uveitis; etc) within the past 3 years prior to the start of treatment. The following are exceptions to this criterion:
+Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis, celiac disease, systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:\r\n* Patients with vitiligo or alopecia\r\n* Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement\r\n* Any chronic skin condition that does not require systemic therapy\r\n* Patients without active autoimmune disease in the last 5 years may be included but only after consultation with the study physician\r\n* Patients with diverticulosis\r\n* Patients with celiac disease controlled by diet alone
+Any active or recent history (within 6 months of first study dose) of autoimmune disease or syndrome that requires systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications including but not limited to: myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with anti-phospholipid syndrome, Wegner’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; subjects with vitiligo, controlled type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement therapy are permitted to enroll
+Diagnosis of inflammatory bowel disease
+Serious digestive and/or absorptive problems, including inflammatory bowel disease and chronic diarrhea that preclude adherence to the study diet.
+Personal history of inflammatory bowel disease
+History of CRC, bowel resection, polyposis syndrome, or inflammatory bowel disease
+Inflammatory bowel disease (Crohn’s disease, ulcerative colitis)
+Contraindications to radiotherapy (including active inflammatory bowel disease).
+Active inflammatory bowel disease within the last 6 months
+Patients with active inflammatory bowel disease
+Active inflammatory bowel disease within the last 6 months
+History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjogren’s syndrome, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis; patients with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone are eligible for this study; patients with controlled type 1 diabetes mellitus on a stable insulin regimen are eligible for this study
+Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:\r\n* Gastrointestinal (GI) disorders: (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn’s disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea\r\n* Systemic lupus erythematosus\r\n* Wegener’s syndrome (granulomatosis with polyangiitis)\r\n* Myasthenia gravis\r\n* Graves’ disease\r\n* Rheumatoid arthritis\r\n* Hypophysitis\r\n* Uveitis\r\n* The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment
+Active or prior documented autoimmune or inflammatory disorders including but not limited to the following:\r\n* GI disorders: (including inflammatory bowel disease [e.g., ulcerative colitis, Crohn’s disease], diverticulitis (with the exception of a prior episode that has resolved), celiac disease, or other serious gastrointestinal chronic conditions associated with diarrhea\r\n* Systemic lupus erythematosus\r\n* Wegener’s syndrome (granulomatosis with polyangiitis)\r\n* Myasthenia gravis\r\n* Graves’ disease\r\n* Rheumatoid arthritis\r\n* Hypophysitis\r\n* Uveitis\r\n* The following are exceptions to this criterion: subjects with vitiligo or alopecia; subjects with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement; or subjects with psoriasis not requiring systemic treatment
+Unable to swallow capsules or malabsorption syndrome, symptomatic inflammatory bowel disease or ulcerative colitis, or partial or complete bowel obstruction at time of screening
+Patients with various autoimmune disorders (including rheumatoid arthritis?RA, Crohn’s disease, systemic lupus erythematosus–SLE, Takayasu arthritis)
+Any active cancer, history of gastrointestinal cancer, or chronic disease such as peptic ulcer, irritable bowel syndrome, inflammatory bowel disease, intestinal malabsorption syndrome or other gastrointestinal disorder
+Self-reported inflammatory bowel disease
+No history of inflammatory bowel disease
+History of inflammatory bowel disease
+Patients with known history of an autoimmune disease- including but not limited to: celiac disease, Crohn's disease, dermatomyositis, Grave's disease, systemic lupus erythematosus, myasthenia gravis, psoriasis, and rheumatoid arthritis.
+Inflammatory bowel disease, active rectal diverticulitis, Crohn's disease affecting the rectum, anal stenosis or ulcerative colitis. (Nonactive diverticulitis and Crohn's disease not affecting the rectum are allowed)
+Has a history of inflammatory bowel disease or history of scleroderma
+History of or active autoimmune disorders (including but not limited to: myasthenia gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic lupus erythematosus, scleroderma) and other conditions that disorganize or alter the immune system.
+History of inflammatory bowel disease.