[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiang Gao\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":92},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,68],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100620985","epidemiological-characteristics-and-efficacy-evaluation-of-difficult-to-treat-crohns-disease-100620985",false,"NCT07364734","Epidemiological Characteristics and Efficacy Evaluation of Difficult-To-Treat Crohn's Disease","Epidemiological Characteristics and Efficacy Evaluation of Refractory Crohn's Disease: a Multicenter, Prospective and Observational Cohort Study","Inclusion Criteria:\n\n* The diagnosis of Crohn's disease was confirmed;\n* Patients aged 18-65;\n* Informed consent was obtained voluntarily.\n\nExclusion Criteria:\n\n* The diagnosis of CD was unclear;\n* The clinical baseline data were missing seriously;\n* Patients currently enrolled in clinical trials or receiving experimental drugs;\n* Other contraindications to biologics or small molecule drugs (including active infection, pregnancy, etc.);\n* Patients with short bowel syndrome;\n* Patients with a small bowel or colostomy.","ALL","18 Years","65 Years",{"count":20,"type":21},1400,"ESTIMATED","1 Year","OBSERVATIONAL","Difficult to treat Crohn's disease (DTT-CD) was defined by the International Organization for the Study of Inflammatory Bowel Diseases (IOIBD) in 2023, which refers to CD patients with poor response to drug treatment and poor prognosis. Foreign epidemiological studies have shown that DTT-CD accounts for 24.8% of all CD patients, and most of them are patients with advanced treatment failure according to more than two different mechanisms. Our previous retrospective data suggested that compared with foreign DTT-CD patients, there was no significant difference in the proportion of patients with advanced treatment failure due to more than two different mechanisms, but the proportion of patients with recurrence after two intestinal resection and complex anal fistula was increased. Therefore, this project aims to determine the current prevalence and epidemiological status of DTT-CD in China; To clarify the difference in efficacy and prognosis between DTT-CD patients and non DTT-CD patients using advanced treatment (including biological agents and small molecule drugs); Objective to evaluate the incidence and risk factors of non DTT-CD patients progressing to DTT-CD within 1 year. To further verify whether the domestic DTT-CD population is significantly different from the foreign population, and provide theoretical support for the selection of subsequent treatment options.",[26],"Crohn Disease",[28,29,30],"Difficult-To-Treat Crohn's Disease","Epidemiological Characteristics","Efficacy Evaluation","RECRUITING","2026-01-16",{"date":34,"type":35},"2026-01-23","ACTUAL",{"date":37,"type":35},"2025-11-01",{"date":39,"type":21},"2027-11-30",{"name":41,"class":42},"Xiang Gao","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":43},"100586241","ustekinumab-with-semi-en-vs-exclusive-en-for-preoperative-crohns-disease-optimization-100586241","NCT06912815","Ustekinumab With Semi-EN vs Exclusive EN for Preoperative Crohn's Disease Optimization.","Comparative Analysis of Curative Effect Ustekinumab Combined With Semi Enteral Nutrition and Exclusive Enteral Nutrition in Preoperative Optimization of Crohn's Disease: A Multicenter, Prospective, Randomized, Controlled Study","USE-OPT CD","Inclusion Criteria:\n\n* CD patients with surgical indications, who are scheduled for partial intestinal resection and anastomosis;\n* CD patients diagnosed prior to surgery;\n* Patients aged 18-65;\n* CDAI score of \\>150;\n* For patients with peritoneal abscess, they must receive adequate antibiotics and drainage prior to enrollment, and be confirmed to be free of infection before enrolling in the study;\n* The patients agree to participate in the study and sign an informed consent form;\n* Patients who have not used ustekinumab prior to surgery;\n* Patients who have tried other treatments and found them ineffective, and plan to stop using them and schedule surgery.\n\nExclusion Criteria:\n\n* Emergency surgery;\n* Had received exclusive enteral nutrition support within 3 months prior to surgery;\n* Unable to tolerate enteral nutrition;\n* Failed with UST;\n* Pregnant or with co-existing intestinal outside organ dysfunction, tumor, rheumatological or immunological diseases, etc.",{"count":53,"type":21},184,"INTERVENTIONAL",[56],"NA","Ustekinumab (UST) is a novel biologic agent that targets and binds to Interleukin-12 (IL-12) and Interleukin-23 (IL-23), and is approved for inducing and maintaining remission in Crohn Disease(CD). Currently, it is believed that the use of UST for the preoperative treatment of CD patients is generally safe and does not increase surgical complications, and it can be used for preoperative treatment of CD. However, there is still a lack of literature reporting the role of UST in preoperative optimization for CD. Semi-enteral nutrition refers to the provision of more than 50% of the energy required by the human body through enteral nutrition preparations. Semi-enteral nutrition can improve the nutritional status of patients with CD, but it does not induce remission of active disease. The treatment method of UST combined with semi-enteral nutrition can not only induce disease remission, but also improve the nutritional status of patients. Therefore, can the combined treatment regimen replace Exclusive Enteral nutrition (EEN) as a new therapy for preoperative optimization of CD? At present, there is a lack of relevant research, so this study intends to conduct a multi-center, prospective, randomized controlled trial to compare the efficacy differences between UST+semi-enteral nutrition and EEN in preoperative optimization for CD, and to clarify the preoperative optimization effect of UST combined with semi-enteral nutrition therapy.",[59],"Crohn Disease (CD)","2025-04-02",{"date":62,"type":35},"2025-04-06",{"date":64,"type":35},"2024-08-01",{"date":66,"type":21},"2026-09",{"name":41,"class":42},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":76,"targetDuration":22,"studyType":23,"phases":4,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},"100576084","efficacy-and-safety-of-upadacitinib-in-inflammatory-bowel-disease-100576084","NCT06780683","Efficacy and Safety of Upadacitinib in Inflammatory Bowel Disease","Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study","EaseUpIBD","Inclusion Criteria:\n\n* Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent.\n\nExclusion Criteria:\n\n* Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.",{"count":77,"type":21},174,"Inflammatory Bowel Disease (IBD), which encompasses ulcerative Colitis (UC) and Crohn's Disease (CD), has seen significant improvements in patient outcomes with biologic treatments. However, nearly half of the patients are either primary or secondary non-responders to the existing biologics. Upadacitinib is the only oral small molecule targeted drug approved for IBD in China. There is a paucity of research on the efficacy and safety of upadacitinib in treating Chinese patients with UC and CD, and a lack of study data on the Chinese IBD population. This study aims to conduct a multicenter, single-arm, prospective, observational real-world study to analyze the efficacy and safety of upadacitinib in the treatment of Chinese patients with IBD, providing a basis for clinical decision-making.",[80,81,82],"Inflammatory Bowel Disease","Crohn's Disease","Ulcerative Colitis","2025-01-13",{"date":85,"type":35},"2025-01-17",{"date":87,"type":35},"2024-01-01",{"date":89,"type":21},"2028-12-31",{"name":41,"class":42},6,""]