[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xijing Hospital of Digestive Diseases\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":469},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,79,100,129,151,166,187,205,229,243,262,283,304,335,359,378,400,425,446],{"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":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100635283","phase-4-upadacitinib-versus-infliximab-as-second-line-treatment-for-acute-severe-ulcerative-colitisuprise-100635283",false,"NCT07550673","Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis（UPRISE）","Upadacitinib Versus Infliximab as Second-Line Treatment for Acute Severe Ulcerative Colitis: Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients diagnosed with ASUC\n* Aged 18 years or older.\n* No gender restriction.\n\nExclusion Criteria:\n\n* Presence of contraindications, allergy, or intolerance to upadacitinib or infliximab.\n* Patients requiring immediate colectomy; diagnosis of Crohn's disease; confirmed intestinal infection; hemodynamic instability; clinically significant cytomegalovirus infection; current malignancy.\n* Presence of severe underlying systemic diseases involving the heart, lungs, liver, kidneys, hematologic system, or other organ systems.\n* Pregnant or breastfeeding women.\n* Unwilling to participate in the clinical study.","ALL","18 Years","85 Years",{"count":20,"type":21},226,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","This clinical trial aims to evaluate the comparative efficacy and safety of upadacitinib versus infliximab as second-line treatments for acute severe ulcerative colitis, addressing the following key questions: (1) Can upadacitinib as a second-line therapy effectively induce remission in acute severe ulcerative colitis with efficacy non-inferior to infliximab? (2) What adverse reactions may occur with upadacitinib in the treatment of acute severe ulcerative colitis? Researchers will also compare the efficacy of upadacitinib with that of corticosteroids to assess its therapeutic effect. Participants will be assigned to either the upadacitinib group (receiving upadacitinib extended-release tablets 45 mg once daily for 8 weeks, followed by 30 mg once daily) or the infliximab group (receiving an initial dose of 5 mg\u002Fkg, with additional doses at week 2, week 6, and every 8 weeks thereafter at the same dose). The treatment duration is 3 months, with outpatient visits for examinations and tests every two weeks. Patients will record their bowel movements and symptoms such as abdominal pain, and undergo colonoscopy, ultrasound examinations, and blood tests at specified time points.",[27],"Acute Severe Ulcerative Colitis",[29,30,31,32,33],"Acute severe ulcerative colitis","Upadacitinib","second-line treatments","infliximab","Randomized Controlled Trial","RECRUITING","2026-04-21",{"date":37,"type":38},"2026-04-24","ACTUAL",{"date":40,"type":38},"2026-04-20",{"date":42,"type":21},"2028-11-01",{"name":44,"class":45},"Xijing Hospital of Digestive Diseases","OTHER",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":59,"conditions":60,"keywords":62,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},"100623797","full-time-rdi-for-esd-impact-on-major-adverse-events-and-procedure-time-100623797","NCT07401303","Full-time RDI for ESD: Impact on Major Adverse Events and Procedure Time","The Effect of Full-time RDI on the Incidence of Major Adverse Intraoperative or Delayed Events and the Proportion of ESD Procedures With Prolonged Procedure Time: A Multicenter Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n* scheduled to undergo ESD for an early gastric cancer (the indication for ESD under current guidelines)\n* both genders aged 18-75 years\n* no pretreatment (ESD, surgery, radiation therapy, or chemotherapy) performed on the stomach to be examined\n* platelet count of \\>10×10\\^9\u002FL and hemoglobin count of \\>8.0 g\u002FL in blood tests performed in the 3 months before the ESD\n* \"antithrombotic drugs\" have been withdrawn for the period recommended by current guidelines\n* written consent provided at the patient's discretion\n\nExclusion Criteria:\n\n* scheduled for hybrid ESD\n* scheduled for ESD due to multiple lesions\n* scheduled for treatment of lesions with residual recurrence\n* presence of submucosal tumors\n* unable to discontinue an antithrombotic drugs at the time of informed consent\n* inherited or acquired coagulopathy likely to affect the risk of bleeding\n* receiving maintenance dialysis\n* deemed unsuitable for participation in this study by the principal investigator or other investigators\n* unable to provide informed consent","75 Years",{"count":56,"type":21},640,[58],"NA","Gastric cancer remains a major global health burden, ranking fifth in incidence worldwide and disproportionately affecting Asia, with China accounting for a significant share of cases and deaths. Early detection and minimally invasive treatment are critical to improving outcomes. Endoscopic submucosal dissection (ESD) is the preferred curative approach for early gastric cancer, enabling precise, en bloc tumor resection while preserving gastric function. However, ESD is technically complex, time-consuming, and associated with risks such as intraoperative and delayed bleeding and perforation. These complications limit its widespread adoption, particularly outside East Asia.\n\nTraditional ESD relies on white light imaging (WLI), which offers limited visualization of submucosal vessels and bleeding sources. Red Dichromatic Imaging (RDI) is an emerging image-enhanced endoscopy technology that uses specific narrow-band wavelengths to enhance the contrast of deep blood vessels and active bleeding sites by exploiting hemoglobin's optical absorption characteristics. Preliminary studies indicate that RDI improves bleeding point identification, facilitates hemostasis, and reduces endoscopists' procedural stress. However, prior research applied RDI only intermittently during bleeding events, leaving its potential benefits throughout the entire ESD procedure unexplored.\n\nThe \"full-time RDI\" concept proposes continuous use of RDI during all ESD stages-including submucosal injection, mucosal incision, dissection, and wound management-to enhance visualization of high-risk vessels, improve layer differentiation, and potentially reduce adverse events and operation time. Despite promising retrospective data, robust prospective evidence from large randomized controlled trials is lacking.\n\nThis multicenter, prospective randomized controlled trial aims to evaluate whether full-course RDI reduces major intraoperative and delayed complications and decreases unexpectedly prolonged operation times compared to conventional WLI-guided ESD in early gastric cancer. Secondary endpoints include procedural efficiency, safety across lesion locations, and operator stress.\n\nBy rigorously assessing full-time RDI's clinical value, this study addresses an urgent unmet need to improve ESD safety and efficiency, potentially broadening its application and enhancing patient outcomes. The innovation lies in integrating continuous advanced imaging throughout ESD, representing a significant advancement in endoscopic oncology and minimally invasive gastric cancer treatment.",[61],"Early Gastric Cancer or Gastric Adenoma",[63,64,65,66,67,68],"endoscopic submucosal dissection","ESD","red dichromatic imaging","RDI","bleeding","perforation","NOT_YET_RECRUITING","2026-02-23",{"date":72,"type":38},"2026-02-27",{"date":74,"type":21},"2026-03-01",{"date":76,"type":21},"2028-01-31",{"name":44,"class":45},1,{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":88,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":78},"100619421","optimization-of-tavns-intervention-strategies-for-refractory-constipation-100619421","NCT07344402","Optimization of taVNS Intervention Strategies for Refractory Constipation","A Prospective, Randomized, Controlled Trial Investigating Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention Strategies and Neurophysiological Mechanisms in Patients With Refractory Constipation","Inclusion Criteria (Revised) Diagnosis of Functional Constipation (FC): Meets Rome IV criteria for functional constipation.\n\nLow CSBM frequency during screening: During the 2-week screening\u002Frun-in period, has ≤2 complete spontaneous bowel movements (CSBMs) per week, based on daily diary.\n\nInadequate response to prior therapy: History of ≥3 months of prior constipation treatment (e.g., laxatives and\u002For prokinetic agents) with inadequate response (persistent constipation symptoms and\u002For persistently low CSBM frequency) as documented by medical history and\u002For records.\n\nAge: 18 to 80 years. Ability to comply: Able and willing to comply with study procedures (including stimulation sessions and diary completion).\n\nNo concurrent clinical trial participation: Not participating in another interventional clinical trial during the study period.\n\nInformed consent: Provides written informed consent. Exclusion Criteria (Revised) Organic\u002Fsecondary causes of constipation: Evidence or history of gastrointestinal organic disease (e.g., inflammatory bowel disease, colorectal tumor, congenital megacolon) or other conditions likely to cause secondary constipation, including endocrine\u002Fmetabolic disorders (e.g., uncontrolled hypothyroidism, uncontrolled diabetes) or neurological disorders (e.g., Parkinson's disease, spinal cord disorders).\n\nMedications causing constipation (unless stable): Current use of medications known to cause constipation (e.g., opioids, anticholinergics) that cannot be discontinued or kept stable during the study, in the investigator's judgment.\n\nOpioid use disorder or chronic opioid use: History of substance abuse or chronic opioid use that may affect bowel function.\n\nSevere psychiatric conditions or safety risk: Current severe psychiatric disorder requiring urgent intervention, or risk of self-harm\u002Fsuicide as assessed by a qualified clinician.\n\nContraindications to taVNS or ear stimulation: Significant ear disease or skin lesions\u002Finfection at the stimulation site, or other contraindications to the study device\u002Fprocedure.\n\nImplanted electronic medical devices: Presence of implanted electrical devices (e.g., pacemaker, implantable cardioverter-defibrillator) or other conditions where electrical stimulation is contraindicated.\n\nPregnancy or lactation: Pregnant or breastfeeding women. Serious comorbidities that may interfere: Severe or unstable medical conditions that could interfere with participation or outcome assessment (e.g., significant cardiovascular disease\u002Farrhythmia, coagulation disorders or regular anticoagulant therapy, severe hepatic\u002Frenal impairment, organ failure).\n\nCognitive\u002Fcommunication impairment: Cognitive impairment, aphasia, or other conditions preventing valid consent or reliable diary completion.\n\nInvestigator discretion: Any condition that, in the investigator's opinion, makes the participant unsuitable for the study.",{"count":87,"type":21},100,[58],"The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) works to treat refractory constipation in adults. It will also learn about the safety and tolerability of taVNS. The main questions it aims to answer are:\n\nDoes taVNS improve constipation symptoms, as measured by the change in complete spontaneous bowel movements per week (ΔCSBMs\u002Fweek) from baseline to post-treatment? What medical problems or side effects do participants have when receiving taVNS? Does taVNS reduce the need for rescue laxatives? Researchers will compare active taVNS to sham taVNS to see if taVNS works to treat refractory constipation.\n\nParticipants will:\n\nBe randomly assigned (double-blind) to receive active taVNS or sham taVNS for 20 days Receive stimulation twice daily, 30 minutes per session, with a 12-hour interval between sessions Receive stimulation at 30 Hz with 200 μs pulse width, delivered to the left cymba conchae Keep a daily diary of bowel habits and symptoms, including CSBMs, and rescue laxative use (bowel movements occurring within 24 hours after rescue laxative use will not be counted as CSBMs)",[91],"Refractory Constipation","2026-01-07",{"date":94,"type":38},"2026-01-15",{"date":96,"type":38},"2025-09-01",{"date":98,"type":21},"2026-01-20",{"name":44,"class":45},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":116,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100617806","transcranial-alternating-current-stimulation-for-refractory-constipation-with-somatic-symptom-disorder-100617806","NCT07323407","Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder","A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder","RELIEF-tACS","Inclusion Criteria:\n\n1. Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.\n2. Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week.\n3. Poor Response to Previous Treatment: Subjects must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).\n4. Diagnosis of Somatic Symptom Disorder (SSD): Subjects must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All subjects will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.\n\n   * Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.\n   * Criterion B: At least one of the following must be met:\n\n     1. Excessive and persistent thoughts about the severity of symptoms;\n     2. Persistently high levels of anxiety about health or symptoms;\n     3. Excessive time and energy devoted to health concerns or symptoms.\n   * Criterion C: Symptoms must persist for at least 6 months.\n5. Age Range: Subjects must be between 18 and 80 years old.\n6. No Concurrent Clinical Trials: Subjects must not participate in any other clinical trials during the study period.\n7. Informed Consent: Subjects must voluntarily agree to participate and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease);\n2. Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial, participants are only allowed to take prescribed emergency medications, with detailed records of usage required);\n3. History of chronic pain or substance abuse, such as opioids;\n4. Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;\n5. Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;\n6. History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver\u002Fkidney impairment or prolonged Q-T interval on ECG;\n7. Pregnant or breastfeeding women;\n8. Patients with benign or malignant tumors or autoimmune diseases;\n9. Chronic conditions requiring long-term medication that may affect quality of life or interfere with examinations\u002Ftreatment, including cardiovascular diseases, coagulation disorders or regular anticoagulant use (warfarin\u002Fheparin), liver\u002Fkidney diseases, organ failure, cognitive impairment, aphasia, etc.","80 Years",{"count":110,"type":21},60,[58],"The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.\n\nThe study focuses on three primary domains:\n\nEfficacy - Bowel Function:\n\n• Assessment of whether a 4-week course of tACS improves bowel activity, measured by changes in Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency over the treatment and follow-up period.\n\nEfficacy - Symptom and Quality of Life Burden:\n\n• Evaluation of the effect of tACS on constipation-related severity and patient-reported outcomes, including the Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL).\n\nSafety and Tolerability:\n\n• Documentation of adverse events associated with tACS, with particular attention to incidence, intensity, and overall patient tolerability compared with sham stimulation.",[114,115,91],"Functional Constipation (FC)","Somatic Symptom Disorder (DSM-5)",[117,118,119,120],"Functional Constipation","Somatic Symptom Disorder","refractory constipation","transcranial alternating current stimulation",{"date":122,"type":38},"2026-01-09",{"date":124,"type":38},"2025-08-20",{"date":126,"type":21},"2026-12-01",{"name":44,"class":45},2,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":136,"targetDuration":4,"studyType":22,"phases":138,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":78},"100574120","phase-3-fenofibrate-in-primary-biliary-cholangitis-a-real-world-study-100574120","NCT06755151","Fenofibrate in Primary Biliary Cholangitis: a Real World Study","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis (PBC)","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated)\n2. Completed in a PBC study with fenofibrate(NCT05749822,NCT06174402)\n3. ALP\\> 1\\*ULN\n4. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n\nExclusion Criteria:\n\n1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar\n2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results",{"count":137,"type":21},300,[139],"PHASE3","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Combination with Ursodeoxycholic Acid in Subjects with Primary Biliary Cholangitis (PBC)",[142],"Primary Biliary Cholangitis (PBC)","2026-01-06",{"date":145,"type":38},"2026-01-08",{"date":147,"type":38},"2024-01-17",{"date":149,"type":21},"2035-12",{"name":44,"class":45},{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":134,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":157,"targetDuration":4,"studyType":22,"phases":159,"briefSummary":140,"conditions":160,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":161,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":165,"locationsCount":78},"100574150","phase-3-fenofibrate-in-combination-with-ursodeoxycholic-acid-in-primary-biliary-cholangitis-a-real-world-study-100574150","NCT06755541","Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cholangitis: a Real World Study","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated)\n2. Completed in a PBC study with fenofibrate(NCT05751967)\n3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n\nExclusion Criteria:\n\n1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar\n2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results",{"count":158,"type":21},150,[139],[142],{"date":145,"type":38},{"date":163,"type":38},"2024-01-30",{"date":149,"type":21},{"name":44,"class":45},{"id":167,"slug":168,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":4,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":173,"targetDuration":4,"studyType":22,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":180,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":186},"100496867","phase-2-fenofibrate-for-compensated-cirrhosis-patients-with-primary-biliary-cholangitis-100496867","NCT05749822","Fenofibrate for Compensated Cirrhosis Patients With Primary Biliary Cholangitis","Fenofibrate Combined With Ursodeoxycholic Acid in Compensated Cirrhosis Patients With Primary Biliary Cholangitis Who Had an Inadequate Response to Ursodeoxycholic Acid","Inclusion Criteria:\n\n* Must have provided written informed consent\n* Age 18-75 years;\n* BMI 17-28 kg\u002Fm2\n* Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n  1. History of AP above ULN for at least six months;\n  2. Positive AMA titers (\\>1\u002F40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n  3. Documented liver biopsy result consistent with PBC.\n* Diagnosis of compensated cirrhosis, as demonstrated by the presence of ≥ 1 of the following 4 diagnostic factor\n\n  1. The histology was consistent with the diagnosis of liver cirrhosi;\n  2. Endoscopy shows esophageal and gastric varices or ectopic varices of digestive tract, excluding non cirrhotic portal hypertension;\n  3. Ultrasound or CT and other imaging examinations indicate the characteristics of liver cirrhosis or portal hypertension, such as splenomegaly, portal vein ≥ 1.3 cm, or liver stiffness measured by transient elastography\\>16.9 kPa;\n  4. Abnormal laboratory inspection indicators (2 out of 4): 1) PLT \\\u003C 100 × 109\u002FL, and no other reason can be explained; 2) Serum albumin\\\u003C35 g\u002FL, excluding malnutrition or kidney disease and other causes; 3) INR \\> 1.3 or PT prolongation (stop thrombolytic or anticoagulant drugs for more than 7 days); 4) AST\u002FPLT (APRI)\\>2）\n* Incomplete response to UDCA defined by ALP \\> 1.67 x ULN\n* Taking UDCA for at least 6 months (stable dose for ≥ 3 months) prior to Day 0\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT or AST \\> 5×ULN, TBIL \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).\n* Creatinine \\>1.5×ULN and creatinine clearance \\\u003C60 ml\u002Fmin.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise",{"count":174,"type":21},104,[176,139],"PHASE2","The main objectives of the study were to assess the effects of fenofibrate on serum alkaline phosphatase, as a composite endpoint and on safety in participants with primary biliary cholangitis (PBC).",[179],"Primary Biliary Cholangitis",{"date":145,"type":38},{"date":182,"type":38},"2023-02-17",{"date":184,"type":21},"2027-12-31",{"name":44,"class":45},12,{"id":188,"slug":189,"hasResults":11,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":194,"targetDuration":4,"studyType":22,"phases":195,"briefSummary":196,"conditions":197,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},"100497032","phase-3-fenofibrate-combined-with-ursodeoxycholic-acid-in-subjects-with-primary-biliary-cholangitis-100497032","NCT05751967","Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis","A Prospective, Multi-center, Randomized, Double-blind, Placebo-controlled Study: Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis and an Inadequate Response to Ursodeoxycholic Acid","Inclusion Criteria:\n\n* Must have provided written informed consent;\n* Age 18-75 years;\n* BMI 17-28 kg\u002Fm2\n* Male or female with a diagnosis of PBC, by at least two of the following criteria:\n\n  * History of AP above ULN for at least six months;\n  * Positive AMA titers (\\>1\u002F40 on immunofluorescence or M2 positive by enzyme linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies;\n  * Documented liver biopsy result consistent with PBC.\n* Incomplete response to UDCA defined by Xi'an criteria (ALP \\>2.5× ULN, AST\\>2×ULN or TBIL\\>1×ULN) after UDCA treatment for 4-6 weeks with at least one abnormal test in ALP or TBIL.\n\nExclusion Criteria:\n\n* History or presence of other concomitant liver diseases.\n* ALT\u002FAST \\> 5×ULN, TBIL \\> 3×ULN.\n* If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating.\n* Allergic to fenofibrate or ursodeoxycholic acid.\n* Taking hepatotoxic drugs (e.g., dapsone, erythromycin, fluconazole, ketoconazole, rifampicin) for more than 2 weeks within 6 months, and long-term hormonal users.\n* Recurrent variceal bleeding, poorly controlled hepatic encephalopathy or refractory ascites.\n* Patients with a history of severe cardiac, cerebrovascular, renal, respiratory disease or functional failure, and psychiatric disorders (including those due to alcohol and drug abuse).\n* Creatinine \\>1.5×ULN and creatinine clearance \\\u003C60 ml\u002Fmin.\n* Currently using statins (such as pravastatin, fluvastatin, and simvastatin), other fibrates (such as gemfibrozil and bezafibrate), and drugs structurally similar to fenofibrate (like ketoprofen).\n* Planned to receive an organ transplant or an organ transplant recipient.\n* Needing Liver transplantation within 1 year according to the Mayo Rick score.\n* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator.",{"count":158,"type":21},[139],"Current treatment guidelines recommend ursodeoxycholic acid (UDCA) as the first-line treatment for new-diagnosed primary biliary cholangitis (PBC) patients. However, up to 40% patients are insensitive to UDCA monotherapy, and evaluation of UDCA response at 12 months may result in long period of ineffective treatment. We aimed to develop a new criterion to reliably identify non-response patients much earlier. Recently, our team designed and validated a new early criterion for distinguishing high-risk PBC patients in a Chinese population for the first time. Our data indicated that PBC patients with ALP ≤ 2.5 × ULN, AST ≤ 2 × ULN, and TBIL ≤ 1 × ULN (Xi'an criterion) after 1 month UDCA treatment were likely to have better prognosis. It can be readily applied in the rapid identification of PBC patients who require additional therapeutic approaches. However, whether it is reasonable to apply it to the response definition of clinical research, and the guidance of PBC management and choice of second-line treatment, further research is needed.",[179],{"date":145,"type":38},{"date":200,"type":38},"2023-02-22",{"date":202,"type":21},"2027-12-01",{"name":44,"class":45},7,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":210,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":212,"targetDuration":4,"studyType":22,"phases":214,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":78},"100607356","phase-4-efficacy-of-bacillus-coagulans-in-alleviating-anxiety-and-depression-in-patients-with-functional-dyspepsia-100607356","NCT07187492","Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia","Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.\n* Aged 18 to 80 years, regardless of gender.\n* Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.\n\nExclusion Criteria:\n\n* Use of probiotics or antibiotics within one month prior to the trial.\n* Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.\n* Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.\n* Participation in any other clinical trial within one month prior to the study.\n* Positive test for Helicobacter pylori (Hp) infection.\n* Long-term use of traditional Chinese herbal medicine.\n* Pregnancy or lactation.\n* History of drug abuse.\n* Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc.\n* History of major surgery or diagnosis of diabetes mellitus.\n* Refusal to provide written informed consent.",{"count":213,"type":21},180,[24],"Objective: This study aims to evaluate the effectiveness of Bacillus coagulans in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.\n\nMethods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Bacillus coagulans, while the control group received a placebo with the same appearance and odor.\n\nThe treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.",[217,218,219,220],"Functional Dyspepsia","Probiotics","Depression","Anxiety","2025-12-29",{"date":223,"type":38},"2026-01-05",{"date":225,"type":38},"2025-09-20",{"date":227,"type":21},"2027-05-31",{"name":44,"class":45},{"id":230,"slug":231,"hasResults":11,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":235,"targetDuration":4,"studyType":22,"phases":236,"briefSummary":237,"conditions":238,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":239,"startDateStruct":240,"completionDateStruct":241,"leadSponsor":242,"locationsCount":78},"100607002","phase-4-efficacy-of-clostridium-butyricum-in-alleviating-anxiety-and-depression-in-patients-with-functional-dyspepsia-100607002","NCT07182890","Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia","Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial",{"count":213,"type":21},[24],"Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.\n\nMethods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor.\n\nThe treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.",[217,218,219,220],{"date":223,"type":38},{"date":225,"type":38},{"date":227,"type":21},{"name":44,"class":45},{"id":244,"slug":245,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":250,"targetDuration":4,"studyType":22,"phases":252,"briefSummary":253,"conditions":254,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":78},"100615734","phase-3-firefly-trial-fenofibrate-intervention---randomized-evaluation-in-first-line-pbc-therapy-100615734","NCT07296458","FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy","A Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Clinical Trial of Fenofibrate in Treatment-Naïve Patients With Primary Biliary Cholangitis","Inclusion Criteria:\n\n1. Voluntarily join the group and be able to understand and sign the informed consent form;\n2. Age: 18 years old or above and below 75 years old;\n3. The diagnosis of primary biliary cholangitis follows the AASLD international diagnostic and treatment guidelines (meeting two of the following three criteria: positive AMA or gp210, sp100; elevated serum ALP; pathological manifestations of non-suppurative cholangitis and interlobular bile duct destruction);\n4. The patient did not receive UDCA and fenofibrate treatment in the 6 months before enrollment, and ALP was greater than the upper limit of normal (ULN).\n\nExclusion Criteria:\n\n1. Combined liver diseases caused by other factors: including viral hepatitis, chronic alcoholic hepatitis, steatohepatitis, drug-induced hepatitis, autoimmune hepatitis, primary sclerosing cholangitis, etc;\n2. Pregnant women, lactating women, or those who plan to give birth during the study period;\n3. Individuals who are allergic to fenofibrate or ursodeoxycholic acid;\n4. At the time of diagnosis or in the past, there have been variceal bleeding, hepatic encephalopathy, ascites, spontaneous bacterial peritonitis, hepatocellular carcinoma, and hepatorenal syndrome;\n5. Individuals with a history of severe diseases or functional failures in the heart, cerebrovascular system, kidneys, respiratory system, as well as mental illnesses (including those caused by alcohol and drug abuse);\n6. Transaminase greater than 5×ULN, or total bilirubin greater than 3×ULN;\n7. Creatinine level greater than 1.5×ULN;\n8. Glomerular filtration rate (GFR) ≤ 45 mL\u002Fmin\u002F1.73 m2;\n9. International normalized ratio (INR) ≥ 1.5 (for patients undergoing anticoagulant therapy, an INR value within the therapeutic target range is sufficient);\n10. Subjects who have received treatment with obeticholic acid and other fibrates (such as gemfibrozil, bezafibrate, pemafibrate, Elafibranor, Seladelpar, Lanifibranor, Saroglitizar, etc.) within the previous 6 weeks prior to screening;\n11. Screening for individuals who have taken colchicine, methotrexate, azathioprine, or undergone systemic hormone therapy for more than 2 weeks within the previous 2 months;\n12. Is currently undergoing treatment with immunosuppressants (such as cyclosporine, tacrolimus, and related biologics);\n13. Plan to receive organ transplantation or have already undergone organ transplantation;\n14. Clear history of HIV infection or HIV antibody positive during the screening period;\n15. Screen for individuals with a clear history of malignant tumor or anti-tumor treatment within the previous 2 years;\n16. Other situations that researchers judge as unsuitable for enrollment.",{"count":251,"type":21},132,[139],"The goal of this clinical trial is to learn if the drug Fenofibrate works to treat adults with a liver disease called Primary Biliary Cholangitis (PBC) who have not received previous treatment. It will also learn about the safety of Fenofibrate. The main questions it aims to answer are:\n\nIs Fenofibrate better at helping the liver return to normal function (measured by a blood test called ALP) than the standard medication, Ursodeoxycholic What kind of medical problems do participants have when taking Fenofibrate compared to those taking UDCA?\n\nResearchers will compare Fenofibrate to the active drug UDCA (the current standard treatment) to see which one works better.\\*\\*\n\nParticipants will:\n\nBe randomly assigned to take either Fenofibrate plus a UDCA placebo, or UDCA plus a Fenofibrate placebo, every day for 12 months. (Neither they nor their doctor will know which group they are in.) Visit the clinic 5 times over the year (at 1, 3, 6, 9, and 12 months) for check-ups, blood tests, and questionnaires.\n\nUndergo a special scan (like FibroScan) to measure liver stiffness at some visits.\n\nBe encouraged to have a liver biopsy at the start and end of the study to provide detailed information about liver health (this is optional).",[142],"2025-12-20",{"date":221,"type":38},{"date":258,"type":38},"2025-12-15",{"date":260,"type":21},"2028-12-31",{"name":44,"class":45},{"id":263,"slug":264,"hasResults":11,"nctId":265,"briefTitle":266,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":4},"100602895","phase-4-efficacy-and-safety-of-berberine-for-gastric-intestinal-metaplasia-100602895","NCT07129460","Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia","Efficacy and Safety of Berberine for Gastric Intestinal Metaplasia: a Prospective, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* patients aged from 18 to 75 years old.\n* patients with OLGIM stage Ⅱ-Ⅳ diagnosed by upper gastrointestinal endoscopy and histopathological examination within the last 3 months.\n* patients without Helicobacter pylori infection, including patients who had successful Helicobacter pylori eradication before enrollment.\n\nExclusion Criteria:\n\n* a history of regular use (defined as at least once per week) of non-steroidal anti-inflammatory drugs (NSAIDs) and\u002For statins\u002For Metformin.\n* a history of stomach surgery (including endoscopic submucosal dissection and endoscopic mucosal resection) or previously diagnosed malignant tumor.\n* a history of heart failure, renal failure, liver cirrhosis or chronic hepatic failure; patients with contraindications or allergies to the drugs in this study.\n* breastfeeding or pregnancy.\n* a history of substance abuse or alcohol abuse within the past one year.\n* patients with severe mental illness.\n* refusal to undergo drug treatment.\n* refusal to sign informed consent.",{"count":270,"type":21},204,[24],"The goal of this clinical trial is to investigate the efficacy of Berberine in treating gastric intestinal metaplasia in Helicobacter pylori-negative adults. It will also learn about the safety of Berberine. The main questions it aims to answer are:\n\nDoes Berberine promote the regression of IM in individuals without Helicobacter pylori infection? What medical problems do participants experience when taking Berberine? Researchers will compare Berberine to a placebo (a look-alike substance that contains no drug) to see if uBerberine is effective in treating gastric intestinal metaplasia.\n\nParticipants will:\n\nTakeBerberine or a placebo every day for 6 months. Visit the clinic once every 4 weeks for checkups and tests.",[274],"Gastric Intestinal Metaplasia","2025-08-26",{"date":277,"type":38},"2025-09-04",{"date":279,"type":21},"2025-10-01",{"date":281,"type":21},"2027-05-01",{"name":44,"class":45},{"id":284,"slug":285,"hasResults":11,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":290,"targetDuration":4,"studyType":22,"phases":292,"briefSummary":294,"conditions":295,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":297,"startDateStruct":299,"completionDateStruct":301,"leadSponsor":303,"locationsCount":78},"100600954","early-phase-1-fenofibrate-in-subjects-with-primary-biliary-cholangitis-pbc-100600954","NCT07104201","Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)","Inclusion Criteria:\n\n1. Must have given written informed consent (signed and dated)\n2. Completed in a PBC study with fenofibrate(NCT06591455)\n3. Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n\nExclusion Criteria:\n\n1. Treatment-related adverse event (AE) leading to study drug discontinuation in a previous PBC study with seladelpar\n2. A medical condition, other than PBC, that in the Investigator's opinion would preclude full participation in the study or confound its results",{"count":291,"type":21},15,[293],"EARLY_PHASE1","An Open Label Long-Term Study to Evaluate the Safety and Tolerability of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)",[142],"2025-08-03",{"date":298,"type":38},"2025-08-05",{"date":300,"type":38},"2025-03-13",{"date":302,"type":21},"2035-03",{"name":44,"class":45},{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":311,"sex":16,"minAge":17,"maxAge":312,"enrollmentInfo":313,"targetDuration":4,"studyType":314,"phases":4,"briefSummary":315,"conditions":316,"keywords":324,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":326,"lastUpdatePostDateStruct":327,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":334},"100533123","predicting-treatment-outcomes-in-refractory-constipation-through-brain-connectivity-evaluation-100533123","NCT06221722","Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation","Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study","Inclusion Criteria:\n\n* 18≤ age ≤ 45 years old\n* Right-handed\n* Patients diagnosed as functional constipation according to the Rome IV criteria\n* Informed consent of patients\n\nExclusion Criteria:\n\n* Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)\n* Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)\n* No history of chronic pain, no recent major trauma\n* Drug abuse or tobacco dependence (half a pack or more per day)\n* Combined hypothyroidism and Parkinson's disease\n* Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones\n* History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)\n* Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)\n* Pregnant or lactating women with constipation after delivery\n* Patients with other benign and malignant tumors and autoimmune diseases\n* Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.\n* Heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life",true,"45 Years",{"count":158,"type":21},"OBSERVATIONAL","The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:\n\n* Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients\n* Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.\n\nParticipants will receive:\n\n* Standard physiological and psychological assessments of constipation\n* BOLD-fMRI tests\n* Standard protocol and fluoxetine treatment\n\nIf there is a comparison group: Researchers will compare:\n\nRefractory group\u002FFluoxetine sensitive group to see the specific brain alterations.",[317,91,318,319,320,321,322,323],"Constipation - Functional","Fluoxetine","fMRI","Brain Connectivity","Treatment Efficacy","Somatic Symptom","Mental Symptom",[319,325,119],"functional connectivity","2025-07-22",{"date":328,"type":38},"2025-07-24",{"date":330,"type":38},"2023-11-01",{"date":332,"type":21},"2026-09-01",{"name":44,"class":45},3,{"id":336,"slug":337,"hasResults":11,"nctId":338,"briefTitle":339,"officialTitle":340,"acronym":4,"eligibilityCriteria":341,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":343,"targetDuration":4,"studyType":314,"phases":4,"briefSummary":345,"conditions":346,"keywords":348,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":78},"100590023","selection-and-efficacy-influencing-factors-of-first-line-biologic-agents-in-moderate-to-severe-ulcerative-colitis-100590023","NCT06962020","Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis","Selection and Efficacy-Influencing Factors of First-Line Biologic Agents in Moderate-to-Severe Ulcerative Colitis: A Prospective, Multi-Center, Real-World Study","Inclusion Criteria:\n\n* Age range of 18-70 years old, gender not limited;\n* According to international guidelines and consensus, patients with ulcerative colitis should be diagnosed to exclude radiation enteritis, infectious enteritis, tumor related diseases, etc;\n* Patients assessed as moderate to severe ulcerative colitis based on the Mayo score;\n* During the follow-up period, no relevant treatments (drugs and surgery) were used that could affect the assessment of the efficacy of biologics\n\nExclusion Criteria:\n\n* Patients with hemodynamic instability;\n* Patients with obvious liver and kidney function injury: bilirubin, aminotransferase (ALT, AST) exceeded the upper limit of normal by 2 times; eGFR\\\u003C60ml\u002Fmin or dialysis patients;\n* Patients allergic to IFX or VDZ;\n* Patients whose primary disease was gastrointestinal malignancy;\n* Patients currently suffering from serious or uncontrolled underlying diseases of the blood, digestive tract, metabolism, endocrine, lung, heart, nervous system, mental system, etc.;\n* Female patients during pregnancy and breastfeeding (including patients with reproductive needs);\n* Patients with current infection with infectious diseases (hepatitis B, hepatitis C, syphilis, AIDS, tuberculosis, etc.);\n* Patients who cannot cooperate with regular follow-up and review of laboratory indicators;\n* Any other circumstances which, in the opinion of the investigator, would render the subject unfit for study inclusion.","70 Years",{"count":344,"type":21},400,"The purpose of this prospective, multicenter, real-world study is to compare the efficacy differences and influencing factors of different first-line biologics in patients with moderate to severe ulcerative colitis. The question that this study aims to answer is: When treating patients with moderate to severe ulcerative colitis, should IFX or VDZ be prioritized as the first-line choice for biologics?, Which biological agent has better therapeutic effect?. Researchers will observe and follow up with patients with moderate to severe ulcerative colitis treated with different biologics on the front line, evaluate their condition changes, eliminate relevant interfering factors, and draw the final conclusion.",[347],"Ulcerative Colitis (UC)",[349,350],"biologics","ulcerative colitis","2025-07-01",{"date":353,"type":38},"2025-07-03",{"date":355,"type":38},"2025-04-30",{"date":357,"type":21},"2025-11-20",{"name":44,"class":45},{"id":360,"slug":361,"hasResults":11,"nctId":362,"briefTitle":363,"officialTitle":364,"acronym":4,"eligibilityCriteria":365,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":78},"100544172","phase-2-fenofibrate-in-patients-with-primary-biliary-cholangitis-pbc-100544172","NCT06365424","Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)","An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects With Primary Biliary Cholangitis (PBC)","Inclusion Criteria:\n\n* Must have given written informed consent (signed and dated)\n* Participated in the PBC study with fenofibrate (NCT02823353)\n* Females of reproductive potential must use at least one barrier contraceptive and a second effective birth control method during the study and for at least 90 days after the last dose. Male subjects who are sexually active with female partners of reproductive potential must use barrier contraception and their female partners must use a second effective birth control method during the study and for at least 90 days after the last dose\n\nExclusion Criteria:\n\n* Treatment-related adverse event (AE) leading to fenofibrate discontinuation\n* A medical condition, other than PBC, that in the investigator's opinion would preclude full participation in the study or confound its results (e.g., cancer)\n* Known history of other liver diseases\n* For females, pregnancy or breast-feeding\n* Long-term use of immunosuppressive agents\n* Any other condition(s) that would compromise the safety of the subject or compromise the quality of the clinical study, as judged by the Investigator",{"count":367,"type":21},117,[176,139],"An Open Label Long-Term Study to Evaluate the Safety and Effectiveness of Fenofibrate in Subjects with Primary Biliary Cholangitis (PBC)",[179],{"date":372,"type":38},"2025-07-02",{"date":374,"type":38},"2017-04-08",{"date":376,"type":21},"2027-04",{"name":44,"class":45},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":4,"eligibilityCriteria":384,"healthyVolunteers":311,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":4},"100587138","advanced-adenoma-detection-with-3d-imaging-device-during-colonoscopy-100587138","NCT06924489","Advanced Adenoma Detection With 3D Imaging Device During Colonoscopy","Effect of 3-Dimensional Imaging Device on Advanced Adenoma Detection During Colonoscopy: A Multi-center Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18-75 years;\n* Patients with indications for colonoscopy and receiving diagnostic colonoscopy, without history of inflammatory bowel disease, colorectal cancer, polypectomy or polyposis syndromes;\n* Signing the written informed consent;\n\nExclusion Criteria:\n\n* Patients with polyposis syndromes (e.g., Peutz-Jeghers syndrome, Cronkhite-Canada syndrome, familial adenomatous polyposis \\[FAP\\], Lynch syndrome, etc.);\n* Patients with a history of colorectal polypectomy and pathological diagnosed as adenoma;\n* Patients with a history of colorectal adenocarcinoma or alarming symptoms;\n* Patients with a history of inflammatory bowel disease;\n* Patients with mental illness or severe functional disorder who cannot cooperate with colonoscopy;\n* Patients with severe cardiopulmonary insufficiency;\n* Patients with severe coagulation disorders or high bleeding risk (platelets \\\u003C50×10⁹\u002FL, INR \\>1.5; discontinuation of antithrombotic drugs should follow the 2012 Japanese Guidelines for Gastroenterological Endoscopy in Patients Undergoing Antithrombotic Treatment and the2017 Appendix on Anticoagulants Including Direct Oral Anticoagulants;\n* Patients with severe electrolyte imbalances;\n* Patients with acute peritonitis or suspected intestinal perforation;\n* Patients with toxic megacolon;\n* Patients with stage 3 or higher hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg);\n* Patients with untreated severe abdominal hernia, intestinal obstruction;\n* Patients with intestinal strictures of any cause;\n* Pregnancy and lactation.",{"count":386,"type":21},1566,[58],"The goal of this clinical trial is to learn if 3-dimensional (3D) imaging device works to identify patients with high risk adenomas during colonoscopy to guide proper follow-up strategy. It will also learn about the safety of 3-dimensional (3D) imaging device. The main questions it aims to answer are:\n\nDoes 3-dimensional (3D) imaging device improve the identification of patients with high risk adenomas? What adverse events do participants experience during colonoscopy? Researchers will compare 3-dimensional (3D) imaging device to traditional 2-dimensional (2D) imaging device to see if 3-dimensional (3D) imaging device works to improve high risk adenoma identification.\n\nParticipants will:\n\nUndertake colonoscopy examination using 3-dimensional (3D) imaging device or 2-dimensional (2D) imaging device. Be followed-up to 30 days to record potential colonoscopy-relevant adverse events.",[390,391],"Colorectal Adenoma","Colorectal Polyps","2025-04-04",{"date":394,"type":38},"2025-04-11",{"date":396,"type":21},"2025-06-01",{"date":398,"type":21},"2026-07-01",{"name":44,"class":45},{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":108,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":417,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":78},"100523181","effect-of-questionnaires-and-feedback-on-the-patient-compliance-for-endoscopic-surveillance-after-esd-100523181","NCT06092281","Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After ESD","Effect of Questionnaires and Feedback on the Patient Compliance for Endoscopic Surveillance After Endoscopic Submucosal Dissection: a Prospective, Randomized Controlled, Superiority Trial.","Inclusion Criteria:\n\n* Adult patients (≥18 years) after ESD for mucosal lesions.\n\nExclusion Criteria:\n\n* Patients after ESD for submucosal tumors, e.g. stromal tumors, neuroendocrine tumors;\n* Additional radical surgery after ESD procedure;\n* Past history of ESD procedure or local recurrence;\n* Severe comorbidities with a life expectancy of \\\u003C6 months as judged by the investigator;\n* Unable to cooperate with information collection due to mental disorders, severe neurosis, or dysgnosia;\n* Unable to understand or unwilling to sign a written informed consent.",{"count":408,"type":21},500,[58],"Endoscopic submucosal dissection (ESD) is now considered the standard treatment for early gastrointestinal neoplasms. However, there is still a possibility of developing local recurrence or metachronous neoplasia after ESD. Regular endoscopic surveillance after ESD can identify and remove local recurrences and metachronous lesions early, improving patient prognosis. However, the patient compliance with post-ESD endoscopic surveillance is currently unclear, and many patients fail to adhere to the scheduled follow-up. A prospective, randomized controlled, superiority trial was designed to evaluate whether completing a questionnaire and receiving feedback on compliance-related education can improve patient compliance with post-ESD endoscopic surveillance, in comparison to those who did not complete the compliance-related education questionnaire. Additionally, the investigators intend to investigate the factors that influence patient compliance.\n\nThis study will consist of two parts.\n\nPart 1 will assess whether the completion of questionnaire and feedback on compliance-related education can improve short-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing short-term patient compliance.\n\nPart 2 will assess whether the completion of questionnaire and feedback on compliance-related education can improve long-term patient compliance with post-ESD endoscopic surveillance, and investigate factors influencing patient compliance.",[412],"Patient Compliance",[414,63,415,416],"compliance","surveillance","post-ESD","2025-04-03",{"date":419,"type":38},"2025-04-08",{"date":421,"type":38},"2023-10-01",{"date":423,"type":21},"2029-12",{"name":44,"class":45},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":78},"100466652","comparison-of-different-operations-for-siewert-type-ii-adenocarcinoma-of-esophagogastric-junction-100466652","NCT05356520","Comparison of Different Operations for Siewert Type II Adenocarcinoma of Esophagogastric Junction","A Multicenter Randomized Controlled Study of Siewert II Esophagogastric Junction Adenocarcinoma With Endoscopic Ivor-Lewis Approach Versus Laparoscopic Transabdominal Extended Gastrectomy","Inclusion Criteria:\n\n* Histologically confirmed EGJ type II adenocarcinoma\n\n  ··The tumor can be removed by laparoscopy through the gastrodiaphragmatic esophageal hiatus or by endoscopic Ivor Lewis operation\n* Pretreatment stage CT1-4A, N0-3, M0\n* For cT4a stage patients, their resectable properties must be clearly verified before randomization\n* For locally advanced tumors (CT3-T4 or N+), all 4 cycles of chemotherapy (FLOT) were completed before surgery.\n* 18 to 75 years old\n* ECOG score 0-2\n* ASA \\\u003C4\n* Good bone marrow function (leukocyte \\> x 10 \\^ 9 \u002F l; Hemoglobin\\> 9 g\u002Fdl. ·Platelet\\>100×10\\^9\u002F L), renal function (glomerular filtration rate \\& GT; 60ml\u002Fmin) and liver function (total bilirubin \\< 1.5 times normal (ULN), aspartate aminotransferase (AST\\\u003C 2.5x ULN, Alanine aminotransferase (ALT)\\\u003C3 x ULN)\n* Patients and their family members voluntarily sign written informed consent\n\nExclusion Criteria:\n\n* Histologically confirmed EGJ type I and III adenocarcinoma\n* Tumor spread over 5 cm proximal to EGJ\n* Clinically significant (active) heart disease (i.e. symptomatic coronary artery disease or myocardial infarction within the last 12 months) resulting in left ventricular ejection fraction\\\u003C50%(determined by echocardiography)\n* Clinically significant lung diseases (forced expiratory volume in 1 second (FEV1)\\\u003C1.5 l\u002Fs)\n* Pregnant women and nursing mothers\n* Stump gastric cancer\n* Borrmann Type 4 (Leather stomach)\n* Simultaneous or heterochronous malignant tumors of other organs except carcinoma in situ of the cervix and adenoma and focal colorectal carcinoma\n* Right thoracotomy or history of right pleural adhesion\n* Cirrhosis, or indocyanine green test ≥15% of chronic liver disease\n* No seizure control, central nervous system diseases or mental disorders\n* History of upper abdominal surgery (except laparoscopic cholecystectomy)\n* The patient has coagulation dysfunction and cannot be corrected\n* Patients with heart, lung, liver, brain, kidney and other important organ failure\n* Patients with metabolic diseases such as diabetes\n* Immunosuppressive therapy, such as organ transplantation, SLE, etc\n* Seriously out of control recurrent infections or other seriously out of control concomitant diseases\n* Other diseases requiring simultaneous surgery\n* Diseases requiring emergency surgery due to tumor emergencies (e.g. hemorrhage, perforation, obstruction)",{"count":433,"type":21},212,[58],"The incidence of esophagogastric junction has been increasing in recent years, and surgery is an important method for the treatment of adenoma at the esophagogastric junction. Currently, there is a great controversy about the surgical method of Siewert II, mainly choosing the right chest or the left chest for thoracic surgery. Therefore, it is of great significance to further study the surgical methods of Siewert II esophagogastric junction adenoma. Objective: To compare the safety, feasibility, and clinical efficacy of endoscopic Ivor-Lewis versus laparoscopic extended abdominal gastrectomy for Siewert type Ⅱadenocarcinoma at the resectable esophagogastric junction.",[437],"Siewert Type II Adenocarcinoma of Esophagogastric Junction","2024-11-06",{"date":440,"type":38},"2024-11-08",{"date":442,"type":38},"2022-05-01",{"date":444,"type":21},"2028-05-31",{"name":44,"class":45},{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":311,"sex":16,"minAge":17,"maxAge":342,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":78},"100529010","phase-4-standard-or-short-course-vonoprazan-non-bismuth-triple-therapy-or-high-dose-dual-therapy-versus-rabeprazole-bismuth-quadruple-therapy-for-primary-helicobacter-pylori-eradication-100529010","NCT06168214","Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication","Standard or Short-course Vonoprazan Non-bismuth Triple Therapy or High-dose Dual Therapy Versus Rabeprazole-bismuth Quadruple Therapy for Primary Helicobacter Pylori Eradication: A Single-center, Randomised, Controlled Trial.","Inclusion Criteria:\n\n* Age 18-70 years, regardless of sex; chronic gastritis, peptic ulcer or dyspeptic symptoms, clear Hp infection (positive 13C-urea breath test); voluntary Hp eradication treatment; women of childbearing age are required to use a medically desirable form of contraception during the trial and for 1 month after the trial.\n\nExclusion Criteria:\n\n* Have contraindications to the study drug or are allergic to the study drug; have taken a PPI within 2 weeks and an antibiotic or bismuth within 4 weeks; pregnant and lactating women; and Have undergone upper gastrointestinal surgery; refluse to sign the informed consent document.",{"count":454,"type":21},1404,[24],"The goal of this clinical trial is to compare eradication rates of Helicobacter pylori in patients aged 18-70 years with first infection. The main questions it aims to answer are:\n\n* Main indicators: the eradication rate of Helicobacter pylori for eradication.\n* Secondary indicators: symptomatic relief rate at 2 weeks after treatment and 4 weeks after the end of treatment; compliance and adverse reactions during treatment.",[458],"the Eradication Rates of Helicobacter Pylori",[460],"Helicobacter pylori ; Vonoprazan","2024-08-09",{"date":463,"type":38},"2024-08-13",{"date":465,"type":38},"2023-09-04",{"date":467,"type":21},"2024-12-25",{"name":44,"class":45},""]