[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ulcerative-colitis-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ulcerative-colitis-acute":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100643065","phase-1-a-phase-i-study-to-evaluate-the-safetytolerability-of-bdhk-2009-tablets-in-healthy-adult-100643065",false,"NCT07632573","A Phase I Study to Evaluate the Safety\u002FTolerability of BDHK-2009 Tablets in Healthy Adult","A Phase I Clinical Study to Evaluate the Safety\u002FTolerability, Pharmacokinetics\u002FPharmacodynamics of BDHK-2009 Tablets in Healthy Adult Participants: a Randomized, Double-blind, Placebo-controlled, Single-dose\u002FMultiple-dose Escalation Study.","Inclusion Criteria:\n\n\\- 1. Participants who are able to communicate effectively with the investigator, understand and comply with the trial requirements, voluntarily participate in the trial, and understand and sign the informed consent form.\n\n2\\. Healthy participants aged 18 to 55 years (inclusive), regardless of gender. 3. Weight ≥ 50 kg (for males) and ≥ 45 kg (for females), with a body mass index (BMI) of 18-26 kg\u002Fm².\n\n4\\. At screening, physical examination, vital signs, 12-lead electrocardiogram (ECG), and laboratory tests (including complete blood count, blood biochemistry, urinalysis, coagulation function, serological virology, thyroid function, etc.) results are either within normal limits or, if abnormal, not clinically significant.\n\n5\\. Women of childbearing potential (WOCBP) must have negative pregnancy test results at screening and baseline, and must not be pregnant, lactating, or planning pregnancy during the study period. WOCBP must agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product (whichever is longer).\n\n1. WOCBP is defined as any female who has experienced menarche and has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) and is not postmenopausal;\n2. Non-childbearing potential females are defined as postmenopausal females and premenopausal females who have undergone sterilization surgery. Postmenopausal is defined as the absence of menstruation for ≥ 12 months without alternative medical intervention. Follicle-stimulating hormone (FSH) testing will be performed for subjects with uncertain status, and FSH \\> 40 mIU\u002FmL can confirm menopause.\n\n   6\\. Male participants with partners of childbearing potential are eligible for the study only if they agree to use acceptable contraceptive measures during the treatment period and for at least 90 days after the last dose of the investigational product, and agree not to donate sperm during this period. In addition, male participants with partners of childbearing potential must use condoms continuously until at least 90 days after the last dose of the investigational product (whichever is longer).\n\n   Exclusion Criteria:\n   * 1\\. As determined by the investigator, known or persistent psychiatric disorders requiring pharmacological intervention that may interfere with the participant's participation in the study, including but not limited to schizophrenia, bipolar disorder, or major depressive disorder.\n\n     2\\. Participants with clinically significant abnormalities in any disease or condition, including but not limited to metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, urinary, endocrine, neurological, psychiatric, thyroid, or other disorders, as determined by the investigator to be unsuitable for participation in this study.\n\n     3\\. Presence or suspected presence of active viral, bacterial, fungal, or parasitic infection.\n\n     4\\. History of recurrent or chronic infections.\n\n     5\\. Participants with acute illness within 2 weeks prior to screening; participants with clinically significant infections (e.g., upper respiratory tract infection, nasopharyngitis, urinary tract infection, etc.) within 3 months prior to screening; participants with evidence of any infection within 7 days prior to screening; participants with a history of herpes simplex infection or recurrent (\\>1 episode) herpes zoster or disseminated herpes zoster.\n\n     6\\. History of epidemic meningococcal infection.\n\n     7\\. History of splenectomy or functional asplenia.\n\n     8\\. Participants with positive test results for hepatitis B surface antigen (HBsAg), hepatitis C antibody (anti-HCV), HIV antibody (anti-HIV), or Treponema pallidum antibody.\n\n     9\\. Participants with a history of active tuberculosis or evidence of active or latent tuberculosis infection at screening.\n\n     10\\. Participants with a history of allergic tendencies, such as asthma, atopic dermatitis, chronic urticaria, or allergic rhinitis, or with allergies to two or more medications, foods, or pollens; participants with a history of hypersensitivity to the investigational drug or any of its components or to drugs with the same mechanism of action, or with clinically significant allergy history as determined by the investigator to be ineligible for enrollment.\n\n     11\\. Participants who have participated in another interventional clinical study and received an interventional treatment (including investigational drugs and investigational medical devices) within 30 days prior to the first dose of the study drug, or within 5 half-lives of the study drug (whichever is longer).\n\n     12\\. Participants with a history of drug abuse within 12 months prior to screening, or participants with positive urine drug screening results.\n\n     13\\. Participants who have used any strong inducers or strong inhibitors of the hepatic metabolic enzyme CYP3A within 14 days or 5 half-lives prior to administration of the investigational drug (whichever is longer).\n\n     14\\. Participants who have used any prescription medications within 14 days prior to administration of the investigational drug, or any over-the-counter medications, herbal medicines, or dietary supplements within 7 days prior to administration of the investigational drug, unless the investigator determines that the medication is not clinically significant.\n\n     15\\. Participants who have consumed any foods or beverages containing substances that may induce or inhibit hepatic metabolic enzymes (such as grapefruit, Seville orange, or star fruit, etc.) within 7 days prior to administration of the investigational drug, or who are unable to avoid consumption of foods or beverages containing caffeine within 48 hours prior to administration of the investigational drug and throughout the inpatient study period.\n\n     16\\. Participants who consumed more than 14 units of alcohol per week within 1 month prior to screening (1 unit of alcohol is approximately equivalent to 360 mL of beer, or 45 mL of spirits with 40% alcohol content, or 150 mL of wine), or who consumed any alcohol products within 24 hours prior to dosing, or who have positive alcohol screening test results.\n\n     17\\. Heavy smokers or participants who smoked more than 5 cigarettes per day within 3 months prior to dosing, and who are unable to abstain from using more than 5 tobacco or nicotine-containing products (including nicotine patches) per week from screening through the end of the study.\n\n     18\\. Participants who donated blood or experienced blood loss ≥ 200 mL within 1 month prior to screening or dosing, or who donated blood or experienced blood loss ≥ 400 mL within 3 months prior to dosing, or who have difficult venous access or are unable to tolerate blood sampling.\n\n     19\\. At screening or baseline, 12-lead electrocardiogram (ECG) findings showing clinically significant abnormalities, including but not limited to: QTcF \\> 450 ms, or other arrhythmias or morphological abnormalities as determined by the investigator that may increase participant risk or interfere with data interpretation.\n\n     20\\. Participants with dysphagia or special dietary requirements who are unable to accept a standardized diet (e.g., severe food allergies).\n\n     21\\. Participants who have undergone major surgical procedures within 3 months prior to screening or who are planning to undergo surgery during the trial period.\n\n     22\\. Participants who have received vaccination within 8 weeks prior to screening, or who plan to receive vaccination during the study or within 8 weeks after administration of the study drug.\n\n     23\\. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for participation in the study.",true,"ALL","18 Years","55 Years",{"count":21,"type":22},68,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase 1, 2-part, randomised, double-blind, placebo-controlled, FIH study to determine the safety, tolerability, and PK of single, ascending oral doses (SAD) of BDHK-2009 (Part 1) and multiple oral doses (Part 2) of BDHK-200 in healthy adult participants.",[28,29,30,31,32],"Ulcerative Colitis (UC)","Ulcerative Colitis (Disorder)","Ulcerative Colitis Acute","IBD (Inflammatory Bowel Disease)","CD - Crohn's Disease",[34,35,36,37,38,39],"Crohn's disease","Ulcerative Colitis","Inflammatory Bowel Disease","IBD","CD","UC","RECRUITING","2026-06-02",{"date":43,"type":44},"2026-06-08","ACTUAL",{"date":46,"type":44},"2026-05-18",{"date":48,"type":22},"2027-02-28",{"name":50,"class":51},"Benethera (Shaoxing) Biotechnology Co., Ltd.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":23,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":52},"100612837","phase-4-upadacitinib-combined-with-corticosteroids-vs-corticosteroid-monotherapy-induction-for-inpatients-and-outpatients-with-acute-severe-ulcerative-colitis-100612837","NCT07258771","Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction for Inpatients and Outpatients With Acute Severe Ulcerative Colitis","Acute Severe Ulcerative Colitis- Upadacitinib Combined With Corticosteroids vs Corticosteroid Monotherapy Induction While Transitioning Away From the Emergency Setting (ACUTE): A Phase IV, Single Center, Partially Blinded, Randomized Study","ACUTE","Inclusion Criteria:\n\n* Patient ≥ 18 to 75 years of age at the time of consent\n* Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)\n* Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 6 bowel movements per day with visible blood in the 7 days prior to Day 0 plus at least one of the following:\n\n  i. Temperature \\> 37.8 Celsius(C) per patient report or documented in Electronic Health Record (EHR) in the 7 days prior to Day 0.\n\nii. Pulse ≥ 90 beats per minute (BPM) per patient report or documented in EHR iin the 7 days prior to Day 0 iii. Hemoglobin ≤ 10.5 grams per deciliter (g\u002FdL) in the 7 days prior to Day 0 iv. Erythrocyte sedimentation rate ≥ 30 millimeters per hour (mm\u002Fh) in the 7 days prior to Day 0 v. C-reactive protein ≥ 3.0mg\u002FdL in the 7 days prior to Day 0 vi. Fecal calprotectin \\>782 Milligrams per kilogram (mg\u002Fkg) in the 7 days prior to consent.\n\nvii. Oral corticosteroid use for ≥ 7 days in the month prior to consent at a dose equivalent to ≥ 20 milligrams per day (mg\u002Fday)\n\n* For a person of reproductive\u002Fchildbearing potential (i.e., presence of intact ovaries and fallopian tubes and are considered premenopausal by standard assessment), a negative lab-based (serum\u002Furine) pregnancy test is required.\n* For a person of reproductive potential (i.e., presence of intact ovaries and fallopian tubes) and has childbearing potential, intent to use at least one effective method of birth control from study Day 0 through the end of blinding or at least 30 days after the last dose of upadacitinib or week 48, whichever occurs most recently. A person without reproductive or childbearing potential does not require an intent to use effective birth control.\n* Participants enrolled in the outpatient cohort must be under the care of an outpatient gastroenterologist affiliated with the University of Michigan.\n* Ability to take oral medication and be willing to adhere to the study intervention regimen.\n* Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures.\n* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study.\n\nExclusion Criteria:\n\n* On IV corticosteroids for \\> 72 hours immediately prior to enrollment continuously (at any institution) which is equivalent to a cumulative dose of 180mg of IV Methylprednisolone in the 3 days prior to enrollment.\n* Patients with a prior exposure upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (e.g., tofacitinib, baricitinib, or filgotinib) are permissible.\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months prior to Baseline. (Note: A Urine Drug Screen does not need to be performed).\n* A history of two or more prior episodes of herpes zoster, or one or more episodes of disseminated herpes zoster.\n* Patients with ongoing severe active infection (as determined by the study team) per investigator. Patients with active serious infection(s) requiring treatment with intravenous anti-infectives or oral\u002Fintramuscular anti-infectives may consider infectious disease clearance.\n* Active tuberculosis (TB) or untreated latent TB as described in the protocol.\n* In participants that tested positive for Coronavirus disease 2019 (COVID-19), at least 5 days must have passed between a COVID-19 positive test result and the baseline visit of asymptomatic participants. Participants with mild\u002Fmoderate COVID-19 infection can be enrolled if fever is resolved without use of antipyretics for 24 hours and other symptoms improved, or if 5 days have passed since the COVID-19 positive test result (whichever comes last). Participants may be rescreened if deemed appropriate by the investigator based upon the participant's health status.\n* Recent (within past 6 months) cerebrovascular accident, myocardial infarction, coronary stenting, or aorto-coronary bypass surgery.\n* Known hypersensitivity to the following drugs or constituents (and its excipients): methylprednisolone, prednisone, upadacitinib, or upadacitinib placebo. The following ingredients can be found in upadacitinib and upadacitinib placebo: colloidal silicon dioxide, hypromellose, iron oxide yellow and iron oxide red, magnesium stearate, mannitol, microcrystalline cellulose, polyvinyl alcohol, polyethylene glycol, talc, tartaric acid and titanium dioxide. This includes a known or suspected hypersensitivity to cow's milk for patients expected to be in the inpatient cohort (component of methylprednisolone).\n* Participants that are currently pregnant or breastfeeding. Participants with a borderline serum pregnancy test at Screening must have absence of clinical suspicion of pregnancy or other pathological causes of borderline results and a serum pregnancy test ≥ 3 days later to document continued lack of a positive result. Participants with a urine pregnancy test at Baseline that is borderline or ambiguous must have a serum pregnancy test performed. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.\n* Participants that have received any live vaccine with replicating potential within 30 days prior to the first dose of study drug or are expected to need a live vaccination with any replicating potential during study participation or within 30 days of study completion.\n* Patients that meet diagnostic criteria for toxic megacolon as determined by the study and treatment team. Patients are expected to have dilation of the transverse colon \\> 6 centimeters (cm) or cecum\u002Fright colon \\> 9cm and three of the following signs of systemic toxicity (Temperature \\> 38◦C, Heart rate (HR) \\> 120 beats per minute (BPM), white blood cells (WBC) \\> 10500\u002Fmicroliter (µL), Hemoglobin \\\u003C 10.5mg\u002FdL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, or hypotension)\n* Patients with active Cytomegalovirus (CMV) colitis as defined as having \\> 5 CMV inclusion bodies per high powered field in any one ulcer at baseline. If CMV colitis is confirmed, the patient can remain in the trial if permissible by the infectious disease and primary treatment team and if concomitant anti-viral therapy is initiated.\n* Patients that had received any investigational agent or procedure within 30 days or five half-lives prior to baseline, whichever is longer, or were enrolled in an interventional study.\n* Patients with an active malignancy with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.\n* Patients that had a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery (partial colectomy is permissible)\n* Patients with certain laboratory abnormalities suggestive of moderate or severe renal, hematological, or gastrointestinal\u002Fliver impairment (per protocol).\n* History of or clinical evidence of liver cirrhosis\n* History of inherited or acquired conditions that predispose to hypercoagulability (per protocol). Please note, that patients with a remote history of provoked thromboembolic event or recent thromboembolic event on systemic anticoagulation are NOT exclusionary.\n* Active Hepatitis B Infection: Hepatitis B surface antigen (HBsAg) positive with detectable deoxyribonucleic acid (DNA) not on therapy. Patients with serologic evidence of a resolved prior hepatitis B virus (HBV) infection (i.e., HBsAg-negative and anti-HB Core-positive) or patients with HBsAg positive on suppressive HBV therapy with low DNA (\\\u003C105 copies\u002Fmilliliter (mL) or \\\u003C104 IU\u002FmL negative) are not exclusionary.\n* Active Hepatitis C Infection: Hepatitis C Virus (HCV) ribonucleic acid detectable in any patient with anti-HCV antibody.\n* Acquired Immunodeficiency Syndrome: Confirmed positive anti-human immunodeficiency virus (HIV) antibody with cluster of differentiation 4 (CD4) counts \\\u003C350 cells\u002Fmicroliter (uL) or Acquired Immune Deficiency Syndrome (AIDS)- defining opportunist infection.\n* Solid organ or bone marrow transplant within 1 year or expected transplant within 6 months of randomization.\n* Patients that had a history of spontaneous GI perforation (other than appendicitis or mechanical injury) or are at significantly increased risk of GI perforation per investigator's judgment.\n* Actively receiving strong CYP3A4 inducers or inhibitors prior to the first dose of study drug or are expected to receive any of these medications during the study period. This includes grapefruit and grapefruit juice.\n* The presence of any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery) as determined by the investigator. Procedures such as gastric banding that simply divide the stomach into separate chambers are not exclusionary.\n* Patients that had a history of a clinically significant medical condition per protocol.","75 Years",{"count":63,"type":22},110,[65],"PHASE4","This trial is being conducted to learn more about the optimal sequence of various medications in the management of acute severe ulcerative colitis (ASUC).\n\nThis research is studying multiple drugs already approved by the Food and Drug Administration (FDA). The goal of this study is to test the early efficacy and safety of upadacitinib (Rinvoq) and corticosteroids compared to corticosteroids alone as induction therapy for both inpatients and outpatients with ASUC.",[30],[69,70,71,72,73,74],"Acute Severe Ulcerative Colitis","Inpatient","Outpatient","Optimal sequence","Upadacitinib","Corticosteroids","2026-01-29",{"date":77,"type":44},"2026-02-02",{"date":79,"type":44},"2026-01-16",{"date":81,"type":22},"2030-12",{"name":83,"class":84},"Berinstein, Jeffrey","OTHER",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":18,"maxAge":61,"enrollmentInfo":93,"targetDuration":4,"studyType":23,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":52},"100505895","phase-4-feasibility-pilot-sequential-multiple-assignment-randomized-trial-smart-for-acute-severe-ulcerative-colitis-100505895","NCT05867329","Feasibility Pilot Sequential Multiple Assignment Randomized Trial (SMART) for Acute Severe Ulcerative Colitis","A Sequential Multiple Assignment Randomized Trial (SMART) Feasibility Pilot Developing and Optimizing Patient-Tailored Adaptive Treatment Strategies (ATS) for Acute Severe Ulcerative Colitis (ASUC)","Inclusion Criteria for Clinical trial patients:\n\n1. Patient ≥ 18 to 75 years of age at baseline\n2. Diagnosis of ulcerative colitis (verified by a typical clinical history as well as characteristic appearance on endoscopy and histology)\n3. Current hospital admission for ulcerative colitis treatment (expecting IV corticosteroid initiation)\n4. Meeting the following definition of acute severe ulcerative colitis as defined as having ≥ 4 bowel movements per day with visible blood and one of the following:\n\n   1. Temperature \\> 37.5C\n   2. Pulse \\> 90 BPM\n   3. Hemoglobin \\\u003C 10.5g\u002FdL\n   4. Erythrocyte sedimentation rate ≥ 30mm\u002Fh\n   5. Weight loss \\> 5 lbs over 3 months\n   6. C-reactive protein ≥ 3.0mg\u002FdL\n   7. Fecal calprotectin \\>782 mg\u002Fkg (within 4 weeks)\n   8. Oral corticosteroid use for ≥ 14 days at a dose equivalent to ≥ 30mg\u002Fday\n5. Prior history of receiving at least one dose of adalimumab, certolizumab, infliximab, or golimumab originator or biosimilars\n6. Participants who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, daily bowel movement symptoms surveys, and other study procedures\n7. Evidence of a personally signed and dated informed consent document indicating that the participant (or a legal representative) has been informed of all pertinent aspects of the study\n8. Ability to take oral medication and be willing to adhere to the study intervention regimen\n9. For females of reproductive potential (i.e., females \\\u003C55 years of age with intact ovaries and fallopian tubes): A negative pregnancy test on admission and intent to use highly effective contraception during 3-month follow-up period which include the following.\n\n   1. Combined (estrogen and progestogen containing) hormonal contraception (oral, intravaginal, transdermal, injectable) associated with the inhibition of ovulation, initiated at least 30 days prior to study baseline\n   2. Progestogen-only hormonal contraception (oral, injectable, implantable) associated with inhibition of ovulation, initiated at least 30 days prior to study baseline\n   3. Bilateral tubal occlusion\u002Fligation (could be via hysteroscopy, provided a hysterosalpingogram confirmed success of the procedure)\n   4. Vasectomized partner(s) provided the vasectomized partner had received medical confirmation of the surgical success and was the sole sexual partner of the trial participant\n   5. Intrauterine device or intrauterine hormone-releasing system\n   6. Lifestyle abstinence (refraining from heterosexual intercourse when this is in line with the preferred and usual lifestyle of the patient)\n   7. Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods)\n   8. Consistent use of barrier contraception\n\nExclusion Criteria for Clinical trial patients:\n\n1. Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease\n2. On IV corticosteroids for ≥ 72 hours prior to enrollment continuously (at any institution)\n3. Currently pregnant or breastfeeding\n4. Patients who meet diagnostic criteria for toxic megacolon during this current admission. This will be determined by the study team and inpatient treatment team according to the following supportive criteria: Having dilation of the colon \\> 6m and three of the following (Temperature\\>38C, HR \\>120 BPM, WBC\\>10500\u002FµL, Hemoglobin \\\u003C 10.5mg\u002FdL) and one of the following (dehydration, altered mental status, severe electrolyte disturbances, and hypotension)\n5. Known hypersensitivity to any of the following drugs or constituents: methylprednisolone, cyclosporine, tofacitinib, or upadacitinib\n6. Patients who had previous exposure to upadacitinib. Previous exposure to other Janus kinase (JAK) inhibitors (eg, tofacitinib, baricitinib, or filgotinib) are permissible.\n7. Patients with ongoing severe infection (as determined by the study team), including untreated or inadequately treated latent or active tuberculosis (TB)\n\n   1. Active CMV colitis is defined as having \\> 5 CMV inclusion bodies per high powered field in any one ulcer at baseline. If CMV colitis is confirmed, the patient can remain in the trial if permissible by the infectious disease and primary treatment team and if concomitant anti-viral therapy is initiated.\n   2. Patients with a positive stool exam for enteric pathogens can remain in the trial. Initiation of treatment at the discretion of the treatment team and infectious disease team if needed.\n8. Patients who had received any investigational agent or procedure within 30 days or five half-lives prior to baseline, whichever is longer, or were enrolled in an interventional study\n9. Current malignancy with the exception of non-metastatic basal cell or squamous cell carcinoma of the skin.\n10. Patients who had a history of colectomy (total or subtotal), ileoanal pouch, Kock pouch, or ileostomy or were planning bowel surgery\n11. Moderate or severe renal, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or psychiatric condition including the following:\n\n    1. Neutropenia - ANC \\\u003C1200 cells\u002Fmm3 or Total white blood cell count \\\u003C2500\u002FµL\n    2. Hemoglobin \\\u003C 8mg\u002FdL\n    3. Platelet count \\\u003C80,000\u002FµL\n    4. Moderate\u002Fsevere renal impairment with eGFR \\\u003C30mL\u002Fmin\u002F1.73m2 (by simplified four-variable Modification of Diet in Renal)\n    5. ALT and AST liver biochemistry levels that are ≥ 2 times the upper limit of normal (ULN)\n12. Cirrhosis with mild to severe hepatic impairment (defined as a Child-Pugh score ≥5)\n13. History of uncontrolled hypertension (systolic blood pressure \\>160mmHg or diastolic blood pressure \\> 100mmHg despite anti-hypertensives)\n14. Any of the following cardiovascular conditions:\n\n    1. Recent (within previous 6 months) cerebrovascular accident, myocardial infarction, or coronary stenting\n    2. Recent (within previous 6 months) moderate-to-severe congestive heart failure (New York Heart Association class III or IV)\n15. History of inherited or acquired conditions that predispose to hypercoagulability including the following. Please note, that patients with a remote history of provoked thrombotic event or recent thrombotic event on systemic anticoagulation are NOT exclusionary.\n\n    1. Antiphospholipid syndrome\n    2. Factor V Leiden mutation\n    3. Prothrombin G20210A mutations\n    4. Deficiencies of antithrombin\n\n    f. Deficiency of protein C g. Deficiency of protein S h. Heparin cofactor II deficiency i. Plasminogen and plasminogen activator inhibitor-1 j. Dysfibrinogenemia k. Factor XII deficiency\n16. Patients with total cholesterol \\\u003C80 mg\u002FdL at baseline\n17. Patients who had a history of an allergic reaction or significant sensitivity to constituents of the treatment (and its excipients) and\u002For other products in the same class of medication (ex., tofacitinib)\n18. Patients who had hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV) infection defined as:\n\n    1. HBV: hepatitis B surface antigen (HBsAg) positive with detectable deoxyribonucleic acid (DNA) not on therapy. Patients with serologic evidence of a resolved prior HBV infection (i.e., HBsAg-negative and anti-HB Core-positive) or patients with HBsAg positive on suppressive HBV therapy with low DNA (\\\u003C105 copies\u002FmL or \\\u003C104 IU\u002FmL negative) are not exclusionary\n    2. HCV: HCV ribonucleic acid detectable in any patient with anti-HCV antibody\n    3. HIV: Confirmed positive anti-HIV antibody with CD4 counts \\\u003C350 cells\u002FuL or acquired immunodeficiency syndrome (AIDS)- defining opportunist infection\n19. Solid organ or bone marrow transplant within 1 year or expected transplant within 6 months\n20. History of more than one episode of herpes zoster, a history of disseminated herpes zoster or disseminated herpes simplex\n21. Current use of medications which significantly increase the risk of venous thromboembolic event as determined by the investigator including:\n\n    1. Hormone replacement therapy\n    2. Testosterone\n    3. Tamoxifen\n22. Vaccination with live or attenuated live vaccines within 6 weeks of baseline or scheduled to receive these vaccines during study period or within 140 days (20 weeks) after last dose of study medication.\n23. History of any lymphoproliferative disorder (such as EBV-related lymphoproliferative disorder), history of lymphoma, leukemia, myeloproliferative disorders, multiple myeloma, or signs and symptoms suggestive of current hematologic disease.\n24. Patients who had a history of spontaneous GI perforation (other than appendicitis or mechanical injury), diverticulitis, or significantly increased risk of GI perforation per investigator's judgement\n25. Actively receiving strong CYP3A4 inducers or inhibitors prior to the first dose of study drug or are expected to receive any of these medications during the study period. This includes grapefruit and grapefruit juice.\n26. The presence of any condition possibly affecting oral drug absorption (e.g., gastrectomy, clinically significant diabetic gastroenteropathy, or certain types of bariatric surgery such as gastric bypass). Procedures such as gastric banding that simply divide the stomach into separate chambers are NOT exclusionary.\n27. Patients who had a history of a clinically significant medical condition or any other reason which, in the opinion of the investigator, would have interfered with the patient's participation in this study, would have made the patient an unsuitable candidate to receive treatment, or would have put the patient at risk by participating in the protocol\n\nInclusion criteria for Physicians:\n\n1\\. Clinicians (Internal medicine residents, gastroenterology fellows, and attending gastroenterologists or colorectal surgeons) caring for the patients enrolled in the clinical trial\n\nExclusion criteria for Physicians:\n\n1\\. Non-clinicians not caring for the enrolled patient","FEMALE",{"count":94,"type":22},162,[65],"The goal of this trial is to create personalized treatments for each patient admitted to the hospital with acute severe ulcerative colitis (ASUC). The study will test the feasibility and acceptability of these treatment strategies among patients and physicians so that the study team can later do a larger trial to test whether the medication treatment pathways help patients avoid colectomy while ensuring patient's are safe.",[30],[69,99],"Ulcerative colitis flare","2025-04-10",{"date":102,"type":44},"2025-04-15",{"date":104,"type":44},"2023-09-30",{"date":106,"type":22},"2026-05",{"name":83,"class":84}]