[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fit\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fit":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,48,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":23,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100601498","dynamic-uc-early-qfit-and-calprotectin-change-predicting-relapse-in-biologic-naive-ulcerative-colitis-100601498",false,"NCT07111273","DYNAMIC-UC: Early qFIT and Calprotectin Change Predicting Relapse in Biologic-Naive Ulcerative Colitis","Diagnostic Value of Quantitative Fecal Immunochemical Test (qFIT) and Calprotectin (FC) Dynamic Changes at 2 Weeks for Predicting 52-Week Relapse or Treatment Escalation in Biologic-Naive Ulcerative Colitis: A Multicenter, Prospective Cohort Study (DYNAMIC-UC)","DYNAMIC-UC","Inclusion Criteria:\n\n* Age 18-75 years.\n* Established diagnosis of Ulcerative Colitis (UC) confirmed by clinical, endoscopic, and histopathological criteria.\n* Endoscopic disease activity (Mayo Endoscopic Subscore ≥ 2) confirmed by colonoscopy during screening.\n* Biologic-naive (no prior exposure to any biologic agent \\[e.g., infliximab, adalimumab, vedolizumab, ustekinumab\\] or JAK inhibitor).\n* No use of systemic corticosteroids (oral or intravenous) within 4 weeks prior to Baseline (Week 0) visit.\n* If using oral or rectal mesalazine\u002F5-ASA preparations, dose must have been stable for ≥2 weeks prior to Baseline (Week 0).\n\nWilling and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Diagnosis or high suspicion of Crohn's disease, ischemic colitis, infectious colitis, radiation colitis, intestinal tuberculosis, or other types of colitis.\n\nPresence of other conditions clearly causing intestinal bleeding (e.g., acute hemorrhoidal bleeding, colorectal cancer, large colorectal polyps \\>1cm, intestinal vascular malformations).\n\n* Untreated systemic conditions that may cause intestinal bleeding (e.g., thrombocytopenia \\[PLT \\\u003C50 x 10\\^9\u002FL\\], severe coagulopathy).\n* Regular use of antiplatelet agents (e.g., aspirin, clopidogrel) or anticoagulants (e.g., warfarin, rivaroxaban).\n* Pregnancy or lactation.\n* Any other condition deemed by the investigator to make the patient unsuitable for study participation.","ALL","18 Years","75 Years",{"count":21,"type":22},100,"ESTIMATED","14 Weeks","OBSERVATIONAL","This multicenter prospective cohort study aims to evaluate whether a \\>50% decrease or normalization of both quantitative fecal immunochemical test (qFIT) and fecal calprotectin (FC) levels at 2 weeks after starting conventional therapy (mesalazine or corticosteroids) can predict clinical relapse or need for biologic\u002FJAK inhibitor therapy escalation by 52 weeks in biologic-naive patients with active ulcerative colitis (UC). Secondary objectives include assessing predictive value at 4 weeks, building dynamic prediction models, conducting health economic evaluation (Number Needed to Test, NNT), and exploring baseline predictors of early biomarker response. Patients will be observed during standard care with stool samples collected at Weeks 0, 2, and 4. Biomarker results will be blinded to clinicians\u002Fpatients until study completion.",[27,28,29,30],"Ulcerative Colitis (UC)","Fecal Calprotetin","FIT","Biomarker",[32,33,29,34],"ulcerative colitis","fecal calprotectin","biologic-naive","NOT_YET_RECRUITING","2025-08-06",{"date":38,"type":39},"2025-08-08","ACTUAL",{"date":41,"type":22},"2025-08-01",{"date":43,"type":22},"2026-12-30",{"name":45,"class":46},"Qilu Hospital of Shandong University","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":56,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":57,"conditions":58,"keywords":59,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100601521","fecal-biomarker-response-evaluation-for-super-early-efficacy-in-ulcerative-colitis-100601521","NCT07111572","Fecal biOmarker Response Evaluation for Super-Early Efficacy in Ulcerative Colitis","Dynamic Changes of Fecal Calprotectin and Fecal Immunochemical Test for Early Prediction of Biologic Treatment Efficacy in Ulcerative Colitis: A Multicenter, Prospective Cohort Study","FORESEE-UC","Inclusion Criteria:\\*\\*\n\n* Age 18-75 years, UC diagnosis with endoscopic Mayo score (MES) ≥2\n* Moderate-to-severe activity (Full Mayo Score ≥6)\n* Initiating vedolizumab or infliximab within 7 days after baseline\n* Biologic-naïve or prior exposure to only one TNF-α inhibitor\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Pregnancy\u002Flactation\n* Contraindications to biologics (e.g., active TB, severe infection)\n* Experimental drug use within 4 weeks prior to baseline",{"count":21,"type":22},"This multicenter prospective cohort aims to evaluate whether combined changes in fecal calprotectin (FC) and fecal immunochemical test (FIT) at \\*\\*Week 2 and Week 4\\*\\* after initiating biologic therapy (vedolizumab or infliximab) can predict clinical response at \\*\\*Week 14\\*\\* and mucosal healing at \\*\\*Week 52\\*\\* in moderate-to-severe ulcerative colitis (UC) patients. Primary outcome: clinical remission rate at Week 14.",[27,28,29],[60,33,29],"UC",{"date":38,"type":39},{"date":41,"type":22},{"date":64,"type":22},"2026-12-01",{"name":45,"class":46},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":76,"conditions":77,"keywords":4,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":47},"100505006","nationwide-uniform-scientific-evaluation-of-flexible-and-integrated-treatment-projects-from-2022-onwards-100505006","NCT05855720","Nationwide Uniform Scientific Evaluation of Flexible and Integrated Treatment Projects From 2022 Onwards","Bundesweit Einheitliche Wissenschaftliche Evaluation Von Modellvorhaben Nach § 64b SGB V ab 2022","EVA64_2","Inclusion Criteria:\n\n* treatment in any of the participating hospitals or control hospitals within recruitment phase (number of hospitals will be fix until June 2026)\n* being insured with any of the participating SHI funds\n\nExclusion Criteria:\n\n* less than one year follow-up data available",{"count":75,"type":22},30000,"This study is an evaluation of flexible and integrated psychiatric care models (according to § 64b of the German Social Code Book V (SGB V)) (FIT) including new FIT projects starting after 2022 and the prolongation of any of 19 already established FIT projects (mainly at German psychiatric hospitals). The central concern of this evaluation is to answer the question whether FIT care offers advantages over standard care. The orientation of model care is a more cross-sectoral provision of services through more flexible psychiatric treatment intensities. However, FIT program structures depend on the individual situation and organization of the FIT hospital together with the participating statutory health insurance (SHI) funds.",[78,79,80,29,81,82,83],"Mental Health","Cross-sectoral Treatment","Flexible and Integrated Treatment","Psychiatry","Evaluation Study","Cohort Studies","RECRUITING","2024-08-06",{"date":87,"type":39},"2024-08-07",{"date":89,"type":39},"2019-01-01",{"date":91,"type":22},"2041-07",{"name":93,"class":46},"Technische Universität Dresden"]