[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Children's Hospital of Zhejiang University School of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":630},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,48,0,25,[9,47,80,101,128,161,189,214,240,258,279,300,326,351,381,407,433,456,478,503,522,544,564,584,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100644814","early-phase-1-rd06-05-universal-cd19bcma-car-t-for-refractory-pediatric-autoimmune-diseases-100644814",false,"NCT07674147","RD06-05 Universal CD19\u002FBCMA CAR-T for Refractory Pediatric Autoimmune Diseases","A Clinical Study of the Safety, Efficacy, and Pharmacokinetics of Universal CD19\u002FBCMA-Targeted CAR-T Cell Injection for the Treatment of Autoimmune Diseases in Children and Adolescents","Inclusion Criteria:\n\n1. Voluntary participation with signed informed consent from patient or legal guardian.\n2. Age \\>=5 to \\\u003C20 years, male or female.\n3. Important organ function meeting the following requirements (excluding abnormalities related to autoimmune disease activity): a) Bone marrow: ANC \\>=1.0x10\\^9\u002FL, hemoglobin \\>=60 g\u002FL, platelets \\>=30x10\\^9\u002FL; b) Liver: ALT \\\u003C=3xULN (except IIM-related elevation), AST \\\u003C=3xULN, total bilirubin \\\u003C=2xULN (\\\u003C=3xULN for Gilbert syndrome); c) Kidney: eGFR \\>=30 mL\u002Fmin\u002F1.73m\\^2 (lower eGFR or on renal replacement may be allowed if benefit \\> risk by investigator judgment); d) Cardiac: LVEF \\>=55% by echocardiogram; e) Pulmonary: No severe lung disease, SpO2 \\>=92%.\n4. Negative serum or urine pregnancy test for females of childbearing potential at screening.\n5. Females of childbearing potential must use highly effective contraception from at least 28 days before lymphodepletion through 12 months post-infusion. Males must use effective barrier contraception and not donate sperm from start of lymphodepletion through 12 months post-infusion.\n\n   Disease-Specific Inclusion Criteria for SLE\u002FLN:\n6. Diagnosis of SLE by 2019 EULAR\u002FACR or 2012 SLICC criteria.\n7. If renal involvement: kidney biopsy within 2 years showing active nephritis (class III, IV, V, or combination). Renal involvement defined as proteinuria \\>0.15g\u002F24h, or hematuria, or eGFR \\\u003C90.Inadequate response to standard therapy: high-dose glucocorticoid (\\>=1 mg\u002Fkg\u002Fd prednisone equivalent) + hydroxychloroquine + at least 2 DMARDs for 3 months, or intolerance, or unable to taper steroid to \\\u003C=5 mg\u002Fday at 6 months.\n8. Positive ANA, anti-dsDNA, or anti-Smith antibody.\n9. SLEDAI-2K \\>=8 and clinical SLEDAI-2K \\>=4 (renal proteinuria \\>0.5g\u002F24h or UPCR \\>500 mg\u002Fg or active urinary sediment may waive the clinical SLEDAI-2K requirement).\n10. Physician Global Assessment (PGA) \\>=1.0 (0-3 VAS).\n\n    Disease-Specific Inclusion Criteria for SSc:\n11. Diagnosis of SSc by 2013 ACR\u002FEULAR criteria.\n12. Diffuse cutaneous SSc.\n13. Evidence of active disease (e.g., new SSc within 2 years, new skin involvement or worsening mRSS within 6 months, tendon friction rubs, lung function decline, ILD progression).\n14. FVC \\>=50% and DLCO \\>=45% predicted.\n15. Failed or relapsed on conventional therapy (glucocorticoid \\>0.5 mg\u002Fkg\u002Fd prednisone equivalent + at least two immunomodulators for \\>6 months).\n\n    Disease-Specific Inclusion Criteria for IIM:\n16. Diagnosis of IIM (dermatomyositis, antisynthetase syndrome, IMNM) by 2017 ACR\u002FEULAR criteria (probability \\>=55%).\n17. Active disease: at least 2 of 6 core set abnormalities (MMT-8\\\u003C142, PhGA \\>=2 cm, PtGA \\>=2 cm, extra-muscular MDAAT \\>=2 cm, PedsQL \\>=60, CK \\>=1.5xULN).\n18. Positive myositis-specific autoantibody.\n19. Failed or relapsed on conventional therapy (glucocorticoid \\>1 mg\u002Fkg\u002Fd prednisone equivalent + at least 2 immunomodulators for \\>=6 months).\n\n    Disease-Specific Inclusion Criteria for IgAN:\n20. Biopsy-confirmed IgA nephropathy.\n21. On ACEi\u002FARB for \\>=3 months, and at least one of: a) proteinuria \\>=500 mg\u002F24h or UPCR \\>=0.5 mg\u002Fmg after \\>=3 months of steroid + at least one immunosuppressant\u002Fbiologic; b) eGFR decline \\>50% within 3 months; c) 22.intolerance to conventional therapy with benefit \\> risk.\n\nDisease-Specific Inclusion Criteria for MDR-NS:\n\n23.Meets 2025 KDIGO definition of steroid-resistant nephrotic syndrome. 24.At least one of: a) failed to achieve remission after 12 months of two different mechanism steroid-sparing agents (at least one calcineurin inhibitor); b) no remission after 3-6 months of one CNI with benefit \\> risk; c) intolerance to conventional therapy; d) coexisting systemic disease requiring long-term immunosuppression.\n\n25.Prior kidney biopsy showing minimal change disease (MCD) or focal segmental glomerulosclerosis (FSGS).\n\nExclusion Criteria:\n\n1. Co-existing autoimmune disease that may interfere with disease activity attribution or add safety risk (unless stable \\>=3 months and approved).\n2. Prior B-cell\u002FASC depletion therapy: a) Anti-CD20 or T-cell engager within 3 months (allowed if \\>3-6 months and CD19+ B-cells \\> LLN); b) Prior CD19 and BCMA dual-targeted therapy, or CD19 or BCMA targeted therapy within 6 months (allowed if \\>6 months and B-cells \\> LLN); c) Other B-cell\u002FASC targeted therapies require approval.\n3. Rapidly progressive glomerulonephritis (RPGN): \\>=50% crescents on biopsy, or doubling of serum creatinine within 2 months, or investigator judgment.\n4. Cardiac disease: NYHA class III\u002FIV heart failure, MI, angioplasty\u002Fstent, unstable angina, or other severe cardiac disease within 12 months.\n5. Severe CNS disease (traumatic brain injury, impaired consciousness, epilepsy, cerebrovascular ischemia\u002Fhemorrhage) that may affect compliance or assessment.\n6. Malignancy history except cured non-melanoma skin cancer or carcinoma in situ, unless disease-free for \\>=3 years.\n7. Primary immunodeficiency.\n8. Uncontrolled infection (simple UTI or upper respiratory infection allowed).\n9. Known history of HIV, hepatitis C, or syphilis infection.\n10. Active or latent hepatitis B infection.\n11. Positive EBV or CMV DNA or IgM at screening.\n12. History of recurrent tuberculosis.\n13. Prior CAR-T or other transgenic immune cell therapy.\n14. Live attenuated vaccine within 4 weeks before enrollment.\n15. Allergy to any component of the cell therapy product.\n16. Hypersensitivity to tacrolimus or prior grade \\>=3 tacrolimus-related toxicity requiring hospitalization (exceptions may be approved).\n17. Participation in another clinical trial within 30 days before screening.\n18. Pregnancy, breastfeeding, or unwillingness to use effective contraception.\n19. Any other condition judged by investigator as unsuitable for study.\n\n    Disease-Specific Exclusion Criteria for SLE:\n20. Active\u002Funstable neuropsychiatric lupus (seizures, psychosis, organic brain syndrome, CVA, encephalitis, CNS vasculitis) within 90 days requiring intervention.\n21. Prior treatments: belimumab\u002Ftelitacicept within 4 weeks; ianalumab within 8 weeks unless B-cells \\> LLN; \\>1 systemic NSAID within 14 days; inability to wash out NSAID before disease activity assessment; intra-articular\u002FIM glucocorticoid within 6 weeks; immunosuppressant doses above specified limits; initiation or dose change of hydroxychloroquine within 8 weeks; ACEi\u002FARB\u002FSGLT2 inhibitor dose change within 4 weeks.\n22. Disease flare requiring increased corticosteroids (\\>20 mg\u002Fday prednisone equivalent) or new immunosuppression during screening.\n\n    Disease-Specific Exclusion Criteria for IIM:\n23. Severe rhabdomyolysis or CK \\>=20xULN.\n24. FVC \\\u003C=60% predicted, or DLCO \\\u003C=70% predicted, or worsening lung function compared to prior 3-12 months.\n\n    Disease-Specific Exclusion Criteria for SSc:\n25. Anti-centromere antibody positive without ATA or anti-RNAP3.\n26. Clinically significant respiratory disease other than ILD (severe COPD, severe asthma, recent severe respiratory infection, smoking).\n27. FVC \\\u003C50% or DLCO \\\u003C40% predicted.\n28. On lung transplant list or expected within 12 months.\n29. History of scleroderma renal crisis within 6 months.\n30. SSc-like disorders (morphea, eosinophilic fasciitis, etc.).\n31. Antifibrotic drugs within 4 weeks (colchicine, D-penicillamine, pirfenidone, tyrosine kinase inhibitors).\n32. Prior chlorambucil, bone marrow transplant, or total lymphoid irradiation.\n\n    Disease-Specific Exclusion Criteria for IgAN:\n33. Secondary IgAN (cirrhosis, celiac disease, HIV, malignancy).\n34. Other cause of chronic kidney disease (diabetic nephropathy, other primary glomerulopathy) that may interfere.\n35. Uncontrolled blood pressure.\n36. Prior treatments: hydroxychloroquine dose change within 8 weeks; biologics (infliximab, eculizumab, canakinumab) within 4 weeks; prednisone \\>30 mg\u002Fday or unstable dose; endothelin receptor antagonist within 4 weeks before lymphodepletion.\n\n    Disease-Specific Exclusion Criteria for MDR-NS:\n37. Secondary nephrotic syndrome\u002Fproteinuria (infection-related, drug-related, systemic disease) that may interfere.\n38. On maintenance dialysis, need for immediate renal replacement, or expected dialysis\u002Ftransplant within 12 months.\n39. Prior treatments: ACEi\u002FARB dose change within 4 weeks; glucocorticoid dose adjustment within 2 weeks or need for \\>10 mg\u002Fday prednisone equivalent; 40.disease flare requiring increased steroids (\\>10 mg\u002Fday) or new immunosuppression during screening.","ALL","5 Years","20 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This is a single-arm, open-label, phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05, a universal CD19\u002FBCMA dual-targeting chimeric antigen receptor T-cell (CAR-T), in pediatric and adolescent patients with refractory autoimmune diseases, including systemic lupus erythematosus\u002Flupus nephritis (SLE\u002FLN), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), multidrug-resistant nephrotic syndrome (MDR-NS), and refractory IgA nephropathy (IgAN).\n\nApproximately 30 eligible patients will be enrolled and receive a single intravenous infusion of RD06-05 at an initial dose of 6×10⁶ CAR+ T cells\u002Fkg, with a potential dose escalation to 10×10⁶ CAR+ T cells\u002Fkg following review by a Safety Review Committee (SRC).",[28,29,30,31,32,33],"Autoimmune Diseases","SLE - Systemic Lupus Erythematosus","SSc-Systemic Sclerosis","IIM- Idiopathic Inflammatory Myopathies","IgAN - IgA Nephropathy","Multi-Drug Resistant Nephrotic Syndrome","NOT_YET_RECRUITING","2026-06-23",{"date":37,"type":38},"2026-06-29","ACTUAL",{"date":40,"type":22},"2026-07",{"date":42,"type":22},"2030-07",{"name":44,"class":45},"The Children's Hospital of Zhejiang University School of Medicine","OTHER",2,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":59,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100627610","symptom-cluster-heterogeneity-and-gut-microbiota-mechanisms-in-childhood-cancer-survivors-100627610","NCT07450872","Symptom Cluster Heterogeneity and Gut Microbiota Mechanisms in Childhood Cancer Survivors","A Multicenter Study on the Heterogeneity of Symptom Clusters and the Underlying Mechanisms of Gut Microbiota and Metabolites Among Childhood Cancer Survivors","SC-Het-GM-CCS","Inclusion Criteria for Children:\n\n* Aged 8-18 years;\n* Clinically and pathologically confirmed diagnosis of cancer (including leukemia, lymphoma, central nervous system tumors, or other common solid tumors);\n* Currently in the rehabilitation\u002Fmaintenance phase or completed treatment ≥6 months prior to enrollment;\n* No cognitive impairment; able to understand, communicate, and complete questionnaires independently;\n* Written informed consent\u002Fassent obtained from participants and their legal guardians.\n\nExclusion Criteria for Children:\n\n* Presence of severe treatment-related sequelae (e.g., significant organ dysfunction or neurological impairment) that may interfere with symptom assessment;\n* Poor compliance or inability to independently complete interviews\u002Fquestionnaires;\n* Concurrent participation in other interventional clinical trials that may influence study outcomes;\n* Planned major surgery or initiation of new chemotherapy\u002Fradiotherapy during the study period.\n\nInclusion Criteria for Caregivers:\n\n* Primary caregiver of an eligible CCS participant;\n* Aged ≥20 years;\n* Able to understand study content and complete questionnaires, with adequate literacy and communication ability;\n* Written informed consent provided prior to participation.\n\nExclusion Criteria for Caregivers:\n\n* Experience of major adverse life events within the past 6 months (e.g., bereavement, divorce) that may affect psychological assessment\n* Presence of severe cognitive impairment;\n* Presence of severe aphasia, psychiatric disorders, or other conditions preventing independent completion of assessments.","8 Years","18 Years",{"count":58,"type":22},600,"6 Months","OBSERVATIONAL","Advances in medical care have significantly improved survival among children with cancer. In China, the 5-year survival rate has reached 71.9%. Despite these improvements, many survivors continue to experience multiple co-occurring symptoms, such as fatigue, pain, sleep disturbance, and depression, which may adversely affect their quality of life.\n\nThese symptoms often occur together as symptom clusters and may reflect shared underlying biological mechanisms. This study aims to characterize symptom clusters among childhood cancer survivors and to explore their potential biological basis.\n\nParticipants will complete questionnaire assessments at multiple time points to evaluate symptom patterns and changes over time. In addition, stool samples will be collected to analyze gut microbiota composition and metabolite profiles. The study will examine the associations between symptom clusters and gut microbiota-metabolite features.\n\nFindings from this study are expected to improve understanding of symptom burden in childhood cancer survivors and to provide evidence for the development of targeted symptom management strategies.",[63,64,65],"Cancer","Glioma","Leukemia (Both ALL and AML)",[67,68,69],"symptom cluster","childhood cancer survivors","gut microbiat","RECRUITING","2026-06-03",{"date":73,"type":38},"2026-06-05",{"date":75,"type":38},"2026-01-01",{"date":77,"type":22},"2028-12-31",{"name":44,"class":45},1,{"id":81,"slug":82,"hasResults":12,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":86,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100637211","study-on-influencing-factors-of-skin-complications-related-to-insulin-injection-in-children-with-type-1-diabetes-mellitus-100637211","NCT07615803","Study on Influencing Factors of Skin Complications Related to Insulin Injection in Children With Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n* Patient meets the diagnostic criteria for T1DM recommended by WHO and is diagnosed with T1DM.\n* Patient was diagnosed with T1DM for \\>= 6 months.\n* Patient has no cognitive or awareness disorders and has the ability to read.\n* Patient agrees to participate in this study.\n* Patient's family caregiver has a certain level of comprehension ability, is conscious and clear-minded during the survey, and can answer freely.\n* Patient's family caregiver voluntarily participates in the survey.\n* Patient's family caregiver provides an average daily care time for the child of \\>= 6 hours.\n\nExclusion Criteria:\n\n* Patient has acute or chronic complications of diabetes and is unable to cooperate, requiring urgent treatment.\n* Patient is in a state of disease stress, such as acute infection, surgery, trauma, etc., and is difficult to cooperate with the research.\n* Patient's family caregiver has unconsciousness or abnormal mental state.\n* Patient's family caregiver has hearing or language disorders.\n* Patient or patient's family caregiver has already participated in this survey.",true,{"count":88,"type":22},199,"This study was a cross-sectional, observational design without involving random grouping or intervention. From July 2026 to June 2027, 199 children with type 1 diabetes who had received insulin treatment for at least 6 months and their main family caregivers were recruited by a continuous enrollment method from the endocrinology department of a tertiary children's hospital in Zhejiang Province. Qualified investigators conducted on-site distribution and collection of structured questionnaires, collecting general information of the children, the occurrence of skin complications, and the insulin injection behaviors of the caregivers. At the same time, personnel with ultrasound qualifications used a wireless handheld ultrasound combined with a skin lipid caliper to uniformly measure the subcutaneous fat thickness at 8 sites including the abdomen, buttocks, arms, and thighs.",[91,92],"Diabetes (Insulin-requiring, Type 1 or Type 2)","Skin Abnormalities","2026-05-28",{"date":95,"type":38},"2026-05-29",{"date":97,"type":22},"2026-12-01",{"date":99,"type":22},"2027-12-01",{"name":44,"class":45},{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":23,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":127,"locationsCount":79},"100638595","phase-3-efficacy-and-safety-of-ruxolitinib-cream-in-chinese-children-aged-2-11-years-with-non-segmental-vitiligo-100638595","NCT07595939","Efficacy and Safety of Ruxolitinib Cream in Chinese Children Aged 2-11 Years With Non-segmental Vitiligo","Efficacy and Safety of Ruxolitinib Cream in Children Aged 2-11 Years With Non-segmental Vitiligo: A Single-Center, Real-World Study","Inclusion Criteria:\n\n* Children aged 2 to 11 years, regardless of sex.\n* Clinical diagnosis of non-segmental vitiligo, with affected Body Surface Area (BSA) ≥0.1%, T-VASI score ≥0.1, and total depigmented area not exceeding 10% BSA.\n* Legal guardian voluntarily provides signed informed consent and agrees to scheduled follow-ups.\n\nExclusion Criteria:\n\n* Diagnosis of other forms of vitiligo (e.g., segmental vitiligo).\n* Presence of other hypopigmentary or depigmentary disorders that could interfere with efficacy assessment (e.g., pityriasis alba, leprosy, post-inflammatory hypopigmentation, progressive macular hypomelanosis, nevus depigmentosus, and tinea versicolor).\n* Prior or current use of any treatment for depigmentation.\n* History of failure with any systemic or topical JAK inhibitor therapy for vitiligo or any other inflammatory condition.\n* Known hypersensitivity to the study drug or its excipients.\n* Concurrent participation in another clinical trial.\n* Considered by the investigator to be unsuitable for the study for any other reason.","2 Years","11 Years",{"count":111,"type":22},20,[113],"PHASE3","The goal of this clinical trial is to evaluate the efficacy and safety of Ruxolitinib Phosphate Cream in treating non-segmental vitiligo in children aged 2 to 11 years under real-world conditions. The main question\\[s\\] it aims to answer are:\n\nPrimary Efficacy: What is the improvement rate (e.g., proportion of participants achieving F-VASI75) after 24 weeks of treatment with Ruxolitinib Phosphate Cream in this population? Safety Profile: What is the safety profile of the treatment over 24 weeks, specifically regarding the incidence of Application Site Acne, Application Site Pruritus, and other adverse events?\n\nParticipants will:\n\nApply Ruxolitinib Phosphate Cream topically to vitiligo lesions as prescribed by the investigator.\n\nAttend scheduled clinic visits at Weeks 4, 8, 12, and 24 for efficacy and safety assessments.\n\nUndergo standardized clinical photography and severity scoring of their vitiligo lesions at each visit.\n\nReport any adverse events or skin reactions experienced during the study period to the research team.",[116],"Vitiligo",[118,119,120],"vitiligo","Ruxolitinib","children","2026-05-18",{"date":123,"type":38},"2026-05-19",{"date":125,"type":22},"2026-06-01",{"date":77,"type":22},{"name":44,"class":45},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":134,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":55,"maxAge":56,"enrollmentInfo":136,"targetDuration":4,"studyType":23,"phases":138,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":79},"100637735","exergame-based-physical-activity-promotion-for-children-and-adolescents-with-congenital-heart-disease-100637735","NCT07593118","Exergame-Based Physical Activity Promotion for Children and Adolescents With Congenital Heart Disease","An Exergame-Based Physical Activity Promotion Intervention for Children and Adolescents With Congenital Heart Disease: A Multiple-Baseline Single-Case Experimental Design Study","ExPACE-CHD","Inclusion Criteria:\n\n1. aged 8-18 years, with a confirmed diagnosis of congenital heart disease and a history of cardiac surgery or catheter-based intervention;\n2. at least 3 months since the most recent surgery or intervention, with a clinically stable condition and no planned reintervention in the near future;\n3. deemed by a pediatric cardiologist to be suitable for regular physical activity or low-to-moderate to moderate-to-vigorous physical activity;\n4. presenting with insufficient physical activity and\u002For impaired exercise capacity, defined by at least one of the following: failure to meet the recommended physical activity level for children and adolescents (ie, an average of 60 minutes of moderate-to-vigorous physical activity per day), objectively impaired exercise capacity (eg, peak oxygen uptake \\\u003C80% of predicted and\u002For anaerobic threshold \\\u003C55% of predicted), or reduced exercise tolerance indicated by the 6-minute walk test, physical fitness assessment, or clinical exercise evaluation;\n5. having basic cognitive and communication abilities sufficient to understand instructions and complete questionnaires, trial sessions, and training tasks;\n6. willingness of both the child and the guardian to participate, with written informed consent obtained;\n7. availability of basic family conditions to support intervention delivery, including access to smart devices and\u002For game equipment, internet access, and at least one caregiver able to provide support.\n\nExclusion Criteria:\n\n1. clear contraindications to exercise, such as uncontrolled arrhythmia, overt heart failure, severe pulmonary hypertension, or recent hemodynamic instability;\n2. severe comorbidities that substantially interfere with exercise performance, such as serious neurological disorders, severe musculoskeletal disorders, or other conditions markedly limiting physical activity;\n3. participation within the previous 3 months in another systematic intervention likely to substantially influence physical activity or exercise capacity;\n4. any condition, as comprehensively judged by the research team, that may affect participant safety, intervention implementation, the quality of physical activity monitoring data, or completion of questionnaires or follow-up, including refusal to wear the monitoring device, refusal to complete follow-up, or evident risk of poor adherence.",{"count":137,"type":22},13,[139],"NA","The goal of this clinical trial is to learn whether a Nintendo Switch-based exergame physical activity program can help children and adolescents with congenital heart disease increase their physical activity. It will also learn about the safety, acceptability, and feasibility of this program. The study will include children and adolescents aged 8 to 18 years who have congenital heart disease, have received surgical or interventional treatment, and are clinically stable.\n\nThe main questions it aims to answer are:\n\nDoes the exergame-based program increase the amount of time participants spend in moderate-to-vigorous physical activity each day? Is the exergame-based program safe, acceptable, and feasible for children and adolescents with congenital heart disease?\n\nAll participants will receive the same exergame-based physical activity program. Researchers will use different baseline observation periods to help understand whether changes in physical activity happen after the program starts.\n\nParticipants will:\n\nWear an activity monitor to measure daily physical activity. Complete a baseline observation period lasting 7, 14, or 21 days. Take part in a 12-week Nintendo Switch-based exergame physical activity program with guidance, goal setting, self-monitoring, feedback, and caregiver support.\n\nComplete a 2-week observation period after the program to see whether physical activity changes are maintained.\n\nComplete study assessments at screening, the end of baseline, week 4, week 8, week 12, and the end of the observation period.\n\nResearchers will also collect information on step counts, energy expenditure, self-reported physical activity, exercise capacity, quality of life, adherence, acceptability, and adverse events.",[142,143],"Congenital Heart Disease","Physical Inactivity",[145,146,147,148,149,150,151,152,142,153],"Exergame","Physical Activity","Moderate-to-Vigorous Physical Activity","Children","Adolescents","Single-Case Experimental Design","Multiple-Baseline Design","Nintendo Switch","Accelerometer","2026-05-15",{"date":121,"type":38},{"date":157,"type":22},"2026-07-01",{"date":159,"type":22},"2027-09-01",{"name":44,"class":45},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":23,"phases":171,"briefSummary":172,"conditions":173,"keywords":178,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":79},"100639684","early-phase-1-cd19bcma-ucar-t-for-b-cell-related-autoimmune-disease-100639684","NCT07586267","CD19\u002FBCMA UCAR-T for B Cell-Related Autoimmune Disease","An Exploratory Clinical Study Evaluate the Safety and Efficacy of Universal Universal Allogeneic CAR-T Cells Targeting CD19 and BCMA in the Treatment of B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n\n  1. Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n  2. Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n  3. Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n  4. Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n  5. Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n\n  1. Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n  2. Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n  3. SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both)；Patients with severe refractory SLE-ITP, characterized by a platelet count of \\\u003C30×10⁹\u002FL or \\\u003C50×10⁹\u002FL accompanied by bleeding tendency, regardless of the SLEDAI-2K score.\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Telitacicept or rituximab).\n  2. if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n  3. Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n  4. Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n\n  1. Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n  2. \\>50% decline in eGFR within 3 months;\n  3. Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n\n  1. Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n  2. Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n  3. Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ;or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.","3 Years",{"count":170,"type":22},15,[25],"This is an exploratory, open-label, single-arm clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219CX. QT-219CX is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219CX .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[28,174,33,175,176,177],"Systemic Lupus Erthematosus (SLE)","IgA Nephropathy (IgAN)","Systemic Sclerosis (SSc)","ANCA Associated Systemic Vasculitis",[179,33,174,175,176,180],"UCART","ANCA associated systemic vasculitis","2026-05-12",{"date":183,"type":38},"2026-05-14",{"date":185,"type":22},"2026-05-08",{"date":187,"type":22},"2030-12-31",{"name":44,"class":45},{"id":190,"slug":191,"hasResults":12,"nctId":192,"briefTitle":193,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":12,"sex":17,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":23,"phases":200,"briefSummary":201,"conditions":202,"keywords":205,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":209,"completionDateStruct":211,"leadSponsor":213,"locationsCount":79},"100639548","adaptive-digital-exercise-rehabilitation-for-children-after-chd-surgery-100639548","NCT07574463","Adaptive Digital Exercise Rehabilitation for Children After CHD Surgery","Development and Evaluation of a Just-in-Time Adaptive Digital Exercise Rehabilitation Program for Children After Congenital Heart Disease Surgery","Inclusion Criteria:\n\n* Children aged 6 to 12 years\n* Diagnosed with congenital heart disease (CHD) and have undergone cardiac surgery\n* Clinically stable after transfer to the general ward, with stable circulatory, respiratory, musculoskeletal, and neurological status, and assessed by the clinician as suitable to begin active exercise rehabilitation\n* Able to understand and cooperate with basic exercise training requirements\n* Written informed consent provided by the child and the legally authorized guardian\n\nExclusion Criteria:\n\n* Absolute contraindications to exercise rehabilitation, including uncontrolled arrhythmia, acute heart failure, hemodynamic instability, severe aortic stenosis, acute myocarditis, or acute pericarditis\n* Severe comorbid conditions that could interfere with rehabilitation, including severe hepatic or renal dysfunction, malignancy, or acute infection\n* Musculoskeletal or neuromuscular disorders that would prevent participation in or completion of the rehabilitation training","6 Years","12 Years",{"count":199,"type":22},130,[139],"The goal of this clinical trial is to evaluate whether a Just-in-Time Adaptive Intervention (JITAI)-based digital exercise rehabilitation program can improve postoperative recovery in children after congenital heart disease (CHD) surgery. The study will examine whether this system can:\n\nImprove cardiopulmonary endurance, cardiac function, and muscle strength Increase rehabilitation adherence and enhance training experience while reducing exercise-related fear Researchers will compare children receiving the adaptive digital exercise rehabilitation program with those receiving standard postoperative rehabilitation to determine whether the digital program provides additional clinical and behavioral benefits.\n\nParticipants will:\n\nWear non-invasive monitoring devices to collect real-time physiological data Engage in daily structured exercise rehabilitation sessions guided by the digital system Receive adaptive adjustments in exercise intensity based on real-time physiological feedback Complete questionnaires on recovery, emotional status, and rehabilitation experience",[203,204],"Congenital Heart Disease (CHD)","Congenital Heart Disease in Children",[206],"Just-in-Time Adaptive Intervention","2026-05-05",{"date":185,"type":38},{"date":210,"type":22},"2026-12-30",{"date":212,"type":22},"2029-02-28",{"name":44,"class":45},{"id":215,"slug":216,"hasResults":12,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":4,"eligibilityCriteria":220,"healthyVolunteers":86,"sex":221,"minAge":222,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100636230","a-bio-psycho-social-medical-model-based-study-on-adolescent-female-hpv-vaccination-behavior-and-comprehensive-intervention-100636230","NCT07562984","A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention","A Bio-Psycho-Social Medical Model-Based Study on Adolescent Female HPV Vaccination Behavior and Comprehensive Intervention: An International Multicenter Randomized Controlled Trial","Inclusion Criteria:\n\n1. Female, aged 9-17 years (inclusive of 9 and 17 years old).\n2. Attending pediatric \\& adolescent gynecology, adolescent health clinics, or related pediatric\u002Fchild healthcare clinics at the research centers; or attending vaccination clinics for non-HPV vaccinations (e.g., influenza, tetanus).\n3. Has not received any dose of HPV vaccine and has no definitive plan for HPV vaccination on the day of the visit (confirmed by investigator inquiry).\n4. Accompanied by at least one primary caregiver (parent or legal guardian) who can comprehend the study content and is willing to participate in shared decision-making interventions.\n5. Plans to reside mostly in the region where the research center is located for the next 12 months to facilitate follow-up.\n6. Caregiver provides written informed consent; adolescent provides informed consent\u002Fassent per local ethical requirements.\n\nExclusion Criteria:\n\n1. Previous completion of or initiation of any HPV vaccine series.\n2. History of severe allergic reaction to any HPV vaccine or its main components, or assessed by a vaccinating physician as currently unsuitable for HPV vaccination.\n3. Comorbid severe physical illness (e.g., severe cardiopulmonary disease, active malignancy) or severe mental disorder, judged by the investigator as unsuitable for participation or likely unable to complete follow-up.\n4. Participation in other clinical studies highly related to HPV vaccination behavior intervention within the past year, which may interfere with the evaluation of this study's intervention effect.\n5. Currently receiving treatment for HPV-related diseases (e.g., genital warts) where the physician considers vaccination currently inadvisable.\n6. History of autoimmune diseases or tumors.\n7. Other situations deemed by the investigator to affect study adherence or interpretation of results (e.g., families with extremely high mobility).","FEMALE","9 Years","17 Years",{"count":225,"type":22},300,[139],"Based on the biopsychosocial (BPS) medical model, this study focuses on HPV vaccination behavior among adolescent females. It aims to explore the influence of multidimensional factors-including biological characteristics, psychological factors, and family and social environments-on vaccination behavior, and to evaluate the effectiveness of a comprehensive HPV vaccination intervention program designed for joint participation by adolescents and their parents.\n\nThis study employs a prospective, multicenter, randomized, open-label, parallel-group design. Participants-girls and adolescents aged 9-17 who are scheduled to receive or have not yet completed HPV vaccination, along with their primary caregivers-were recruited from our hospital and collaborating pediatric\u002Fmaternal and child health institutions both domestically and internationally. Participants were randomly assigned in a 1:1 ratio to an intervention group and a control group.\n\nIn addition to routine vaccination clinic counseling, the intervention group received a comprehensive HPV vaccination intervention program based on the BPS model, including: structured health education materials (illustrated booklets\u002Fshort videos); structured communication and shared decision-making support in the clinic setting; continuous information dissemination and vaccination reminders via platforms such as WeChat; and personalized follow-up and Q\\&A sessions for families with high vaccine hesitancy; The control group received standard routine education and vaccination services.\n\nThe primary outcome was the proportion of adolescents who completed the first dose of the HPV vaccine within 3 months of enrollment; secondary outcomes included the proportion completing the full vaccination series within 6 months, changes in vaccine hesitancy levels and HPV-related knowledge, changes in anxiety\u002Fdepression levels among adolescents and caregivers, and changes in the quality of parent-child communication regarding health and vaccination as well as family decision-making patterns.\n\nThis study is expected to identify key bio-psycho-social determinants of HPV vaccination behavior among adolescent females, validate the effectiveness of the comprehensive BPS intervention in increasing vaccination rates and improving decision-making experiences and psychosocial outcomes, and provide evidence-based guidance and scalable practical pathways for pediatric and related specialty clinics to implement adolescent vaccination health promotion and family shared decision-making services.",[229,230,231],"HPV","Vaccination Hesitancy","Biopsychosocial Model","2026-04-28",{"date":234,"type":38},"2026-05-01",{"date":236,"type":22},"2026-04-30",{"date":238,"type":22},"2028-11-30",{"name":44,"class":45},{"id":241,"slug":242,"hasResults":12,"nctId":243,"briefTitle":244,"officialTitle":244,"acronym":4,"eligibilityCriteria":245,"healthyVolunteers":12,"sex":17,"minAge":196,"maxAge":197,"enrollmentInfo":246,"targetDuration":4,"studyType":23,"phases":248,"briefSummary":249,"conditions":250,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":255,"leadSponsor":257,"locationsCount":4},"100635920","application-construction-and-effect-evaluation-of-family-empowered-pulmonary-rehabilitation-in-school-age-children-with-asthma-100635920","NCT07558954","Application Construction and Effect Evaluation of Family-empowered Pulmonary Rehabilitation in School-age Children With Asthma","Inclusion Criteria:(All must be met)\n\n* School-aged children aged 6 to 12 years.\n* Meet the diagnostic criteria for asthma according to the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2025 Edition).\n* Received regular inhaled asthma medications for at least 3 months, with moderate or better medication adherence (score ≥6 on the Morisky Medication Adherence Scale).\n* Pulmonary function test shows obstructive ventilatory dysfunction or small airway dysfunction.\n* The primary caregiver has good communication and literacy skills, can use smartphone applications (e.g., WeChat) proficiently, and is willing to participate in the study.\n* Written informed consent has been obtained from the participant and their legal guardian.\n\nExclusion Criteria:(Any one leads to exclusion)\n\n* Children in acute asthma exacerbation.\n* Presence of other severe chronic diseases (e.g., congenital heart disease, neuromuscular disease, immunodeficiency disease, etc.).\n* Children with mental or psychological disorders who cannot cooperate.\n* Other conditions judged by the investigator to be unsuitable for participation in this study.",{"count":247,"type":22},92,[139],"Study Purpose: To develop a pulmonary rehabilitation intervention program suitable for school-age children with asthma, and to evaluate its effectiveness in improving asthma control in children through a prospective randomized controlled trial.\n\nStudy Methods: This is a single-center, prospective, randomized, open-label, parallel-controlled trial. Eligible subjects who meet all inclusion criteria and none of the exclusion criteria, together with their families, will be randomly assigned in a 1:1 ratio to either the intervention group (family-empowered pulmonary rehabilitation intervention) or the control group (conventional pulmonary rehabilitation care) after signing the informed consent form.\n\nBoth groups will receive a 12-week core intervention period, with follow-up assessments conducted at baseline, end of intervention (12 weeks), and at 24 and 48 weeks after intervention.",[251],"Asthma Childhood","2026-04-26",{"date":236,"type":38},{"date":234,"type":22},{"date":256,"type":22},"2027-12-31",{"name":44,"class":45},{"id":259,"slug":260,"hasResults":12,"nctId":261,"briefTitle":262,"officialTitle":166,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":265,"briefSummary":266,"conditions":267,"keywords":268,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":271,"lastUpdatePostDateStruct":272,"startDateStruct":274,"completionDateStruct":276,"leadSponsor":278,"locationsCount":79},"100631939","early-phase-1-allogeneic-cd19bcma-car-t-for-b-cell-related-autoimmune-disease-100631939","NCT07507201","Allogeneic CD19\u002FBCMA CAR-T for B Cell-Related Autoimmune Disease","Inclusion Criteria:\n\n* Common Inclusion Criteria:\n* 1.Major organ function must meet the following criteria (exceptions allowed for abnormalities related to autoimmune disease activity):\n* 1)Bone Marrow Function: a. Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL; b. Hemoglobin ≥ 60 g\u002FL; c. Platelet count ≥ 30 × 10⁹\u002FL.\n* 2)Hepatic Function: ALT ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); AST ≤ 3 × ULN (except when elevation is attributable to inflammatory myopathy); Total bilirubin ≤ 2.0 × ULN (≤ 3.0 × ULN allowed for Gilbert syndrome).\n* 3)Renal Function: eGFR ≥ 30 mL\u002Fmin\u002F1.73 m².(Participants with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m² and\u002For those receiving renal replacement therapy may be considered eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant or guardian provides fully informed consent.)\n* 4)Cardiac Function: Echocardiography shows no significant structural abnormalities and left ventricular ejection fraction (LVEF) ≥ 55%.\n* 5)Pulmonary Function: No severe pulmonary disease, and SpO₂ ≥ 92%.\n* 2.Women of childbearing potential must use medically acceptable contraception or practice abstinence during the study treatment period and for at least 12 months after the end of study treatment.\n* 3.Informed consent: The participant (and guardian if the participant is a minor) must provide written informed consent, indicating understanding of the study purpose and procedures and willingness to participate.\n* Disease-Specific Inclusion Criteria\n* SLE:\n* 1.Age ≥ 5 years.\n* 2.Meets the 2012 SLICC or 2019 EULAR\u002FACR classification criteria for SLE.\n* 3.Must meet at least one of the following adequate treatment conditions:\n* 1)Active disease persists despite adequate treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent dose of other corticosteroids) in combination with at least two immunosuppressants or biologic agents for at least 3 months, or affected organ function has failed to improve; or inability to taper glucocorticoid dosage to ≤5 mg\u002Fday after 6 months of conventional treatment;\n* 2)Patients who have developed intolerable drug toxicity during conventional therapy, or have contraindications precluding standard treatment, or have experienced multiple treatment failures-may be considered for enrollment following full informed consent by the investigator and the patient or legal guardian;\n* 3)SLEDAI-2K Criteria: SLEDAI-2K score ≥8; or SLEDAI-2K score ≥6 combined with at least one BILAG-2004 Category A or two Category B organ system involvements (or both).\n* 4.No occurrence of macrophage activation syndrome within 1 month prior to screening.\n* 5.Occurrence of CNS lupus symptoms requiring intervention within 60 days prior to screening, including seizures, psychosis, cerebrovascular events, etc.\n* MDR-SRNS\n* 1.Age ≥3 years old, gender unlimited.\n* 2.Diagnosed with SRNS according to the 2021 Kidney Disease: Improving Global Outcomes #KDIGO# Guidelines;\n* 3\\. Must meet at least one of the following adequate treatment conditions:\n* a) have not achieved a complete response after 12 months of treatment with two standard doses of hormone replacement drugs with different mechanisms of action or relapse of disease activity after remission(at least one of the two drugs is a calcineurin inhibitor such as cyclosporine or tacrolimus, Other replacement drugs include Mycophenolate Mofetil, cyclophosphamide, Taitacept or rituximab).\n* b) if no remission has been achieved after 3 to 6 months of adequate treatment with one calcineurin- inhibitor. The researcher judges that the benefits outweigh the risks and the patient or guardian has fully informed consent, the patient can be considered for inclusion.\n* c) Patients unable to tolerate conventional therapy may be eligible if, in the investigator's judgment, the potential benefit outweighs the risk and the participant (or guardian if minor) provides fully informed consent.\n* d) Patients with other diseases, such as systemic lupus erythematosus, requiring long-term systemic treatment with glucocorticoids or immunosuppressants, may be considered for inclusion after the investigator determines that the benefits outweigh the risks, and the patient or guardian has fully informed consent.\n* 4.Renal biopsy was performed and the pathological type was determined to be minimal lesion nephropathy(MCD) or focal segmental glomerulosclerosis (FSGS);\n* IgA nephropathy\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. IgA nephropathy pathologically confirmed by renal biopsy;\n* 3\\. Angiotensin-Converting Enzyme Inhibitors (ACEI) or angiotensin receptor blocker (ARB) treated for at least 3 months and meet at least one of the following requirements:\n* a) Combination or sequential treatment with steroids and at least one immunosuppressant or biologic for ≥ 3 months; and 24-hour urine protein quantification ≥500mg or UPCR≥0.5mg\u002Fmg;\n* b) \\>50% decline in eGFR within 3 months;\n* c) Patients who are unable to tolerate conventional treatment and for whom the investigator determines the benefits outweigh the risks and who have obtained fully informed consent from the patient or guardian may be considered for inclusion;\n* 4\\. Exclude subjects with other secondary causes; exclude patients with uncontrolled blood pressure.\n* Systemic Sclerosis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Scleroderma fulfilling the 2013 ACR classification criteria\n* 3\\. Positive scleroderma-related antibodies.\n* 4\\. Modified Rodnan Skin Score (mRSS) ≥ 15 (total score 51).\n* 5\\. Must meet at least one of the following adequate treatment conditions:\n* a) Treated with glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) plus at least one immunomodulatory agent (including antimalarials, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, or biologics such as rituximab, belimumab, thalidomide) for more than 3 months without significant improvement.\n* b) Meets criteria for rapidly progressive disease and is unresponsive to standard therapy; participant may be enrolled if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* c) Patients unable to tolerate conventional therapy may be eligible if the investigator determines that potential benefit outweighs risk and informed consent is obtained.\n* 6\\. Presence of severe pulmonary arterial hypertension (PAH), defined as a mean pulmonary arterial pressure \\>45 mmHg, or other severe involvement of major organs will be exclude.\n* Refractory\u002FRelapsed ANCA-Associated Vasculitis:\n* 1\\. Age: ≥ 5 years old, gender unlimited;\n* 2\\. Meets the diagnostic criteria for ANCA-associated vasculitis according to the 2007 European Medicines Agency (EMA) algorithm or the 2022 ACR\u002FEULAR classification criteria, including microscopic polyangiitis (MPA) and granulomatosis with polyangiitis (GPA).\n* 3\\. Refractory AAV is defined as: a reduction in the Birmingham Vasculitis Activity Score (BVAS) of less than 50%, a persistent score of ≥ 3, or the occurrence of new organ involvement following ≥3 months of standard induction therapy (including glucocorticoids in combination with Rituximab \\[RTX\\] or Cyclophosphamide \\[CYC\\]) ; or a worsening of the disease during maintenance therapy or after treatment discontinuation following the achievement of remission (BVAS = 0), which necessitates the re-initiation of induction therapy;\n* 4\\. Or meets the criteria for severe vasculitis, with inadequate response to standard-of-care therapy, and may be considered for enrollment if the investigator determines that the potential benefits outweigh the risks and the patient or legal guardian provides fully informed consent.\n* 5\\. Evidence of active vasculitis meeting the following criteria: For participants \\\u003C18 years of age: Pediatric Vasculitis Activity Score (PVAS) ≥10 (total score 63); For participants ≥18 years of age: Birmingham Vasculitis Activity Score (BVAS) ≥10 (total score 63); indicating active vasculitis.\n* 6\\. Exclusion Criterion: Presence of alveolar hemorrhage requiring ventilatory support for more than one week.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, tocilizumab), or subjects with a history of severe allergic reactions.\n* 2.Subjects with grade III or IV heart failure (NYHA classification).\n* 3.Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs.\n* 4\\. Uncontrollable infection, or active infection that requires systemic treatment at screening.\n* 5\\. Had active pulmonary tuberculosis at screening.\n* 6\\. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive.\n* 7\\. History of severe herpes infection prior to screening, such as herpetic encephalitis, ocular herpes, or disseminated herpes; Signs of herpes or varicella-zoster virus infection (especially chickenpox, shingles) within 12 weeks prior to screening.\n* 8\\. Patients had active central nervous system disease.\n* 9\\. Patients with malignant diseases such as tumors before screening.\n* 10\\. Secondary or congenital immunodeficiency.\n* 11\\. History of any cardiac, endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal disease or other major medical condition that would prevent the administration of QT-019B, except for lupus.\n* 12\\. Received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; Acute graft-versus host disease (GVHD) of grade 2 or above was present within 2 weeks prior to screening.\n* 13\\. Received live vaccine within 4 weeks before screening.\n* 14\\. Tested positive in Blood pregnancy test.\n* 15\\. Patients who had participated in other clinical trials and received any intervention within 3 months before enrollment.\n* 16\\. Any abnormal laboratory test results judged by the investigator to be clinically significant and prevent the subject from participating in the study. Laboratory test values that are out of range and not of clinical significance will not be considered as exclusion criteria.\n* 17\\. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome.",{"count":170,"type":22},[25],"This is an exploratory, open-label, single-arm Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of QT-219C. QT-219C is a universal allogeneic chimeric antigen receptor T-cell (CAR-T) product targeting both CD19 and BCMA. The study targets subjects with refractory B-cell-related autoimmune diseases, including systemic lupus erythematosus (SLE), multi-drug resistant nephrotic syndrome (NS), IgA nephropathy (IgAN), systemic sclerosis (SSc), and ANCA-associated vasculitis (AAV) .The research is divided into two phases: a dose-escalation phase and a dose-expansion phase. Dose Escalation: Utilizes a standard \"3+3\" design to evaluate potential recommended dose(RD) and identify dose-limiting toxicities (DLTs) .Treatment Procedure: Eligible subjects will receive a lymphodepleting conditioning regimen followed by a single intravenous infusion of QT-219C .Primary Objectives: The primary goals are to evaluate the safety profile, including the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS), and to assess clinical response rates at 90 days post-infusion .Follow-up: Subjects will be monitored for pharmacokinetics (cell expansion), pharmacodynamics (B-cell depletion), and long-term safety for up to two years .",[28,174,33,175,176,177],[179,33,269,32,176,270],"Systemic Lupus Erthematosus","ANCA-Associated Vasculitis (AAV)","2026-03-30",{"date":273,"type":38},"2026-04-02",{"date":275,"type":22},"2026-04-01",{"date":277,"type":22},"2029-12",{"name":44,"class":45},{"id":280,"slug":281,"hasResults":12,"nctId":282,"briefTitle":283,"officialTitle":283,"acronym":4,"eligibilityCriteria":284,"healthyVolunteers":86,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":285,"targetDuration":287,"studyType":60,"phases":4,"briefSummary":288,"conditions":289,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100631120","serum-copeptin-as-biomarker-for-diagnosis-and-classification-of-polyuric-primary-monosymptomatic-nocturnal-enuresis-100631120","NCT07496541","Serum Copeptin as Biomarker for Diagnosis and Classification of Polyuric Primary Monosymptomatic Nocturnal Enuresis","Inclusion Criteria:\n\n* 1.Age 5-18 years old. 2. No treatment has been received within 1 month prior to the trial. 3. Able to complete a 7-night urine diary and relevant research questionnaires for 2 days. 4. Guardians and the child themselves have agreed to participate in the study and have signed the informed consent form. 5. Meet the diagnostic criteria for PMNE as defined in the 2025 nocturnal enuresis guidelines: Age ≥ 5 years old, at least 1 episode of involuntary nocturnal urination per month for more than 3 months, without daytime lower urinary tract symptoms and organic urinary system disorders.\n\nExclusion Criteria:\n\n* 1\\. Patients under the age of 5; 2. Patients with daytime lower urinary tract symptoms or history of bladder dysfunction; 3. Patients with secondary nocturnal enuresis who have experienced at least 6 months of dry bed period; 4. Patients with chronic diseases.",{"count":286,"type":22},180,"1 Day","Primary monosymptomatic nocturnal enuresis (PMNE) is one of the most common urinary system problems in childhood. The exact pathological mechanism has not been fully elucidated yet, but excessive nocturnal urination is considered one of the core pathogenic mechanisms. Studies have found that a considerable number of PMNE patients have abnormal secretion of arginine vasopressin (AVP) at night. Currently, the \"gold standard\" for diagnosing nocturnal polyuria is through a voiding diary, which is cumbersome and the records may contain errors, and there are many inconveniences in clinical implementation. Therefore, finding objective and simple biomarkers to assist in diagnosis and classification is a current clinical research hotspot. Copeptin is the C-terminal fragment of the precursor protein of AVP and is released into the blood simultaneously at the same molar ratio as AVP, making it an ideal alternative biomarker for AVP. This study aims to systematically and deeply explore the diagnostic value of serum copeptin in PMNE, especially in its different subtypes (NP-PMNE vs. NNP-PMNE), analyze its correlation with clinical severity, and explore more precise detection strategies, in order to provide new and objective biological tools for the clinical management of PMNE.",[290,291],"Primary Monosymptomatic Nocturnal Enuresis","Copeptin","2026-03-23",{"date":294,"type":38},"2026-03-27",{"date":296,"type":22},"2026-03-17",{"date":298,"type":22},"2029-01-31",{"name":44,"class":45},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":324,"leadSponsor":325,"locationsCount":79},"100631321","phase-4-perioperative-lidocaine-for-lung-protection-in-infants-undergoing-cardiac-surgery-100631321","NCT07499154","Perioperative Lidocaine for Lung Protection in Infants Undergoing Cardiac Surgery","Evaluation of the Effect of Perioperative Lidocaine Administration on Reducing Pulmonary Injury in Infants Following Cardiac Surgery: A Randomized, Placebo-Controlled, Double-Blind, Multi-center Superiority Trial.","PLICS","Inclusion Criteria:\n\n1. Infants aged 0 to 12 months.\n2. Congenital heart disease requiring corrective, non-palliative cardiac surgery with cardiopulmonary bypass.\n3. American Society of Anesthesiologists (ASA) physical status I to III.\n4. Written informed consent provided by parent(s) or legal guardian(s).\n\nExclusion Criteria:\n\n1. Multiple malformations, chromosomal abnormalities, or immunodeficiency.\n2. Known or suspected allergy to lidocaine.\n3. Concomitant continuous infusion of another local anesthetic.\n4. Conditions associated with increased risk of lidocaine accumulation or toxicity, including severe conduction block or severe bradycardia.\n5. ASA physical status IV or higher.\n6. Severe malnutrition expected to substantially impair postoperative recovery.\n7. Severe hepatic or renal dysfunction.\n8. Significant pre-existing pulmonary disease or markedly impaired preoperative pulmonary function.\n9. Central nervous system disorders that may increase susceptibility to lidocaine neurotoxicity, including epilepsy or prior central nervous system infection.\n10. Use of medications that may interact with lidocaine or constitute an exclusion, including class I or class III antiarrhythmic agents, cimetidine, or antiviral drugs, as determined by the clinical team.\n11. Current or recent participation in another interventional clinical trial in its active intervention phase.","12 Months",{"count":310,"type":22},320,[312],"PHASE4","Cardiopulmonary bypass-associated pulmonary injury is a common complication after infant cardiac surgery and may contribute to impaired oxygenation, prolonged mechanical ventilation, and longer intensive care stay. Lidocaine has anti-inflammatory and membrane-stabilizing properties and may attenuate perioperative lung injury. This investigator-initiated, randomized, placebo-controlled, double-blind trial will evaluate whether perioperative intravenous lidocaine reduces postoperative pulmonary injury in infants undergoing corrective non-palliative congenital cardiac surgery with cardiopulmonary bypass.",[142,315,316],"Postoperative Pulmonary Complications","Acute Lung Injury",[318,319,320,321],"Lidocaine","Lung injury","Infant cardiac surgery","Cardiopulmonary bypass",{"date":271,"type":38},{"date":275,"type":22},{"date":256,"type":22},{"name":44,"class":45},{"id":327,"slug":328,"hasResults":12,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":23,"phases":336,"briefSummary":337,"conditions":338,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":79},"100630620","early-phase-1-exploratory-clinical-study-on-the-safety-and-efficacy-of-anti--cd19bcma-car-nk-cell-injection-for-the-treatment-of-refractory-pediatric-rheumatic-diseases-100630620","NCT07490041","Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19\u002FBCMA CAR-NK Cell Injection for the Treatment of Refractory Pediatric Rheumatic Diseases","Exploratory Clinical Study on the Safety and Efficacy of Anti- CD19\u002FBCMA CAR-NK Cell Injection for the Treatment of Relapsed\u002FRefractory Pediatric Rheumatic Diseases","Cell therapy","Common Inclusion Criteria:\n\n1. . Gender unrestricted, age ≥5 years;\n2. . The patient or their legal guardian agrees to participate in this clinical trial and signs the informed consent form, indicating their understanding of the trial's purpose and procedures and willingness to participate;\n3. . Peripheral blood B cells confirmed by flow cytometry to express CD19, with a B cell count \\>5 cells\u002FuL;\n4. . If previously treated with B cell-targeted therapy, peripheral blood B cell count at screening has returned to normal or above the pre-treatment level;\n5. . Echocardiography indicates basically normal cardiac structure and left ventricular ejection fraction (LVEF) ≥55%; electrocardiogram shows no significant abnormalities;\n6. . Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3.0×ULN, total bilirubin (TBIL) ≤2.0×ULN;\n7. . Renal function: estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73m²; (If eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² and\u002For undergoing renal replacement therapy, the subject may be considered for enrollment after the investigator's assessment that the benefit outweighs the risk and with full informed consent from the patient\u002Fguardian);\n8. . Pulmonary function: No severe pulmonary lesions, blood oxygen saturation (SpO₂) ≥92%;\n9. . Female subjects of childbearing potential must have a negative urine pregnancy test and agree to use effective contraception during the trial until 1 year after infusion.\n\nPolyarticular Juvenile Idiopathic Arthritis (pJIA):\n\n1. . Onset before age 16, disease duration ≥6 weeks, diagnosed as polyarticular JIA according to the 2001 International League of Associations for Rheumatology (ILAR) classification criteria, and positive for rheumatoid factor (RF) and\u002For anti-citrullinated peptide\u002Fprotein antibody (ACPA): positive on ≥2 occasions at least 3 months apart during the first 6 months of illness;\n2. . Judged by the investigator to have active disease despite adequate standard-dose treatment prior to screening, meeting the following adequacy of treatment conditions: a. Treatment with conventional disease-modifying antirheumatic drugs (DMARDs) for at least 6 months, with stable doses of 2 DMARDs for ≥12 weeks; b. Treatment with at least 2 biologic agents, with stable doses for ≥12 weeks;\n3. . Juvenile Arthritis Disease Activity Score-27 (JADAS-27) \\>8.5;\n4. . Must have at least 5 active joints (defined as the presence of joint swelling; or in the absence of swelling, the presence of limited range of motion accompanied by pain on motion and\u002For tenderness) as per the American College of Rheumatology (ACR) definition at both screening and baseline;\n5. . No occurrence of macrophage activation syndrome within 1 month prior to screening.\n\nSjögren's Syndrome (SS):\n\n1. . Diagnosed with childhood-onset primary SS at least 24 weeks prior to signing the ICF, according to the 2002 American-European Consensus Group (AECG) classification criteria \u002F 2016 EULAR\u002FACR classification criteria and the 2021 Japanese classification criteria for childhood primary SS;\n2. . Meet the classification criteria for SS, and Intolerance or inadequate response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent doses of other corticosteroids) and at least 2 immunosuppressants, with a duration of glucocorticoid treatment of at least 6 months;\n3. . EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5 in at least 1 of the following 8 domains at screening: constitutional, lymphadenopathy, glandular, articular, cutaneous, renal, hematological, and serological;\n4. . EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) score ≥5 at screening;\n5. . Positive for anti-SSA\u002FRo antibody.\n\n   Juvenile Dermatomyositis (JDM):\n6. . Diagnosed with JDM at least 24 weeks prior to signing the ICF according to the 2017 EULAR\u002FACR classification criteria;\n7. . Meet the classification criteria for Refractory JDM (RJDM), and had Intolerance or inadequate response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent doses of other corticosteroids) and at least 2 immunosuppressants, with a duration of glucocorticoid treatment of at least 6 months;\n8. . Patients with anti-synthetase syndrome who are anti-synthetase antibody positive and meet the criteria for RJDM can be directly enrolled;\n9. . Patients with immune-mediated necrotizing myopathy who are signal recognition particle (SRP) or 3-hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR) antibody positive and meet the criteria for RJDM can be directly enrolled.\n\nSystemic Sclerosis (SSc):\n\n1. . Meet the 2013 ACR\u002FEULAR classification criteria for SSc, with first non-Raynaud's phenomenon occurring at age \\\u003C18 years and disease duration ≤60 months;\n2. . Positive for antinuclear antibody (ANA) or any SSc-specific antibody;\n3. . Modified Rodnan Skin Score (mRSS) ≥15 (total score 51);\n4. . Meet the definition of treatment-refractory disease: inadequate response to glucocorticoids (≥0.5 mg\u002Fkg\u002Fday) and cyclophosphamide and at least 1 other immunomodulatory drug for over 3 months;\n5. . Diagnosed with refractory UCTD-ILD: UCTD typically refers to patients with symptoms and signs suggestive of CTD and serologic evidence of autoimmunity, but not fulfilling classification criteria for any defined CTD. Presence of ILD-related clinical manifestations: e.g., dry cough, exertional dyspnea, bibasral crackles, clubbing, OR chest high-resolution CT consistent with ILD features (often symmetric, subpleural), OR pulmonary function tests showing impaired diffusion capacity and restrictive ventilatory defect. All patients must have no improvement in symptoms like dyspnea or cough after at least 1 month of glucocorticoid therapy (prednisone ≥1 mg\u002Fkg\u002Fday or equivalent).\n\nSystemic Lupus Erythematosus (SLE):\n\n(1. Diagnosed with childhood-onset SLE according to the 2012 Systemic Lupus International Collaborating Clinics (SLICC) or 2019 EULAR\u002FACR classification criteria for SLE; (2). Must meet one of the following adequacy of treatment conditions:\n\n* After treatment with glucocorticoids (≥1 mg\u002Fkg\u002Fday prednisone or equivalent) and one or more immunomodulators (including cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, telitacicept, belimumab, and rituximab) for 3 months (3M);\n* Patients intolerant to conventional therapy may be considered for enrollment after the investigator judges benefit outweighs risk and with full informed consent from the patient\u002Fguardian;\n* OR inability to taper glucocorticoids to ≤5 mg\u002Fday after 6 months (6M) of conventional therapy; (3). Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score \\>6; (4). No occurrence of macrophage activation syndrome within 1 month prior to screening.\n\nMixed Connective Tissue Disease (MCTD):\n\n(5). Diagnosed with childhood-onset primary MCTD at least 24 weeks prior to signing the ICF according to the Sharp 1986 MCTD classification criteria adapted for children; (6). Meet the above childhood MCTD classification criteria, and also had Intolerance or inadequate response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent doses of other corticosteroids) and at least 2 conventional immunosuppressants, with a duration of standardized glucocorticoid treatment of at least 6 months; (7). Childhood version of the Mixed Connective Tissue Disease Activity Index (MDAI) score ≥8 at screening; (8). Patient-reported outcome (PRO) score for MCTD characteristic involvement dimensions ≥5 at screening; (9). High-titer positive for anti-U1-RNP antibody (titer ≥1:1000), and negative for anti-Sm antibody.\n\nExclusion Criteria:\n\n1. . History of malignancy (except for basal cell or squamous cell skin cancer or carcinoma in situof the cervix that has been excised and cured for at least 5 years), or current malignancy.\n2. . Known allergy, hypersensitivity, intolerance, or contraindication to CD19\u002FBCMA CAR-NK cells or any component of the drugs that may be used in the study (including fludarabine, cyclophosphamide, and tocilizumab), or subjects who have experienced a severe allergic reaction in the past.\n3. . Evidence of severe active viral or bacterial infection, or uncontrolled systemic fungal infection at screening or baseline visits, or subjects with active or uncontrolled infection requiring parenteral antimicrobial therapy.\n4. . Subjects with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) functional classification (see Appendix).\n5. . Subjects with congenital heart disease, or history of acute myocardial infarction within 6 months prior to screening, or severe arrhythmia (including multifrequent ventricular premature beats, supraventricular tachycardia, ventricular tachycardia, etc.); or combined with moderate to large pericardial effusion, severe myocarditis, etc.; or unstable vital signs requiring vasopressors to maintain blood pressure.\n6. . Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA levels above the normal reference range in peripheral blood at screening; OR positive hepatitis C virus (HCV) antibody with detectable HCV RNA levels above the normal reference range; OR positive human immunodeficiency virus (HIV) antibody; OR positive syphilis test; OR positive cytomegalovirus (CMV) DNA test.\n7. . History of severe herpes infection, such as herpes encephalitis, ocular herpes, or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella, herpes zoster) within 12 weeks prior to screening.\n8. . Current active tuberculosis or history of active tuberculosis, or subjects whose interferon-gamma release assay for tuberculosis infection cannot yield a negative result during the screening period.\n9. . Subjects with interstitial lung disease (ILD), meeting any of the following conditions are excluded: Forced vital capacity (FVC) \\\u003C50% of predicted value at screening, OR diffusing capacity of the lungs for carbon monoxide (DLCO) \\\u003C40% of predicted value; Requiring long-term oxygen therapy or non-invasive ventilation; Acute exacerbation of interstitial pneumonia\u002Facute respiratory failure within the past 6 months, or hospitalization due to ILD requiring intravenous pulse corticosteroid therapy; Rapidly progressive ILD as judged by the investigator.\n10. . Subjects with pulmonary arterial hypertension (PAH), meeting any of the following conditions are excluded: Results from right heart catheterization or echocardiography (non-invasive estimation) meeting any of the following: a. Estimated systolic pulmonary artery pressure (sPAP) \\>50 mmHg (assessed in conjunction with tricuspid regurgitation velocity); b. Diagnosis of WHO functional class III or IV PAH.\n\n    Hospitalization within the past 6 months due to acute exacerbation of PAH or right heart failure; Requiring intravenous prostacyclin analog therapy during the screening period; Presence of signs of right ventricular dysfunction, including but not limited to ascites, hepatic congestion, peripheral edema, accompanied by significantly elevated BNP\u002FNT-proBNP levels and clinically unstable symptoms.\n11. . History of epilepsy or other active central nervous system diseases.\n12. . Subjects with acquired or congenital immunodeficiency diseases.\n13. . History of any clinically significant cardiac, endocrine, hematological, hepatic, immunological, metabolic, urological, pulmonary, neurological, dermatological, psychiatric, renal disease, or other major condition that, in the investigator's judgment, precludes the administration of KN5601.\n14. . Solid organ or hematopoietic stem cell transplantation within 3 months prior to screening; OR acute graft-versus-host disease (GVHD) of grade 2 or higher within 2 weeks prior to screening.\n15. . Vaccination with a live vaccine within 4 weeks prior to screening.\n16. . Having received the following treatments within the specified time frames prior to the baseline visit: B cell depletion therapy within 26 weeks; Within 24 weeks prior to randomization: Anti-CD40 monoclonal antibody, belimumab, abatacept, anti-tumor necrosis factor alpha (anti-TNFα) biologics, immunoglobulin, plasmapheresis; Within 12 weeks prior to randomization: JAK inhibitors or other kinase inhibitors, unless explicitly permitted by the protocol; Use of traditional Chinese medicines, proprietary Chinese medicines, or health products containing Tripterygium wilfordii(Lei Gong Teng), Tripterygium hypoglaucum(Kunming Shan Hai Tang), Colquhounia coccineavar. mollis(Huo Ba Hua Gen), or white peony root (Paeonia lactiflora, Bai Shao) within 4 weeks; Within 3 half-lives of prior therapy, OR within 4 weeks, OR until the expected pharmacodynamic effects have returned to baseline levels (whichever is longer); B cell count below the lower limit of normal or baseline value (whichever is lower) following prior B cell depletion therapy.\n17. . Participation in any clinical trial within three months.\n18. . Any other condition that, in the opinion of the investigator, may increase the risk to the subject or interfere with the trial results.",{"count":335,"type":22},36,[25],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19\u002FBCMA CAR-NK cell injection in patients with refractory pediatric rheumatic diseases.",[339,340,341,342],"Rheumatic Diseases","Pediatric Rheumatological Condition (i.e., Arthritis, SLE, Kawasaki's Disaese)","Systemic Lupus Erythematosus (SLE)","Connective Tissue Disease-associated Interstitial Lung Disease","2026-03-18",{"date":345,"type":38},"2026-03-24",{"date":347,"type":22},"2026-03-19",{"date":349,"type":22},"2027-12-19",{"name":44,"class":45},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":362,"conditions":363,"keywords":369,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":296,"lastUpdatePostDateStruct":374,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":380},"100630136","hem-survive-structuralized-follow-up-for-childhood-hematological-malignancy-survivors-100630136","NCT07483749","HEM-SURVIVE: Structuralized Follow-up for Childhood Hematological Malignancy Survivors","A Multicenter Prospective Study on Structuralized Follow-up Model Construction and Late Effect Burden of Childhood Hematological Malignancy Survivors (HEM-SURVIVE)","Inclusion Criteria:\n\n* Diagnosed with childhood hematological malignancies (ALL, AML, Lymphoma, etc.), Completed primary treatment for ≥12 months.\n* Age 1-21 years.\n* Capable of completing follow-up and data collection.\n* Informed consent signed.\n\nExclusion Criteria:\n\n* Severe organ failure preventing follow-up.\n* Major genetic or systemic diseases affecting growth\u002Forgan function.\n* Expected poor compliance or refusal to participate.","1 Year","21 Years",{"count":361,"type":22},400,"This study aims to construct a structuralized follow-up model for survivors of childhood hematological malignancies in China. Using a multicenter prospective cohort design, it will identify the burden and risk factors of late effects. The study hypothesizes that a standardized follow-up path managed by an electronic platform will improve follow-up compliance and reduce the missed diagnosis rate of late effects.",[364,365,366,367,368],"Acute Lymphoblastic Leukemia","Acute Myeloid Leukemia","Lymphoma","Leukemia","Pediatric",[370,371,372,373],"Survivorship","Late Effects","Follow-up Model,","Risk Stratification",{"date":347,"type":38},{"date":376,"type":22},"2026-03-25",{"date":378,"type":22},"2028-12",{"name":44,"class":45},3,{"id":382,"slug":383,"hasResults":12,"nctId":384,"briefTitle":385,"officialTitle":386,"acronym":4,"eligibilityCriteria":387,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":56,"enrollmentInfo":388,"targetDuration":4,"studyType":23,"phases":390,"briefSummary":391,"conditions":392,"keywords":394,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":406,"locationsCount":79},"100628489","nudt15tpmt-multi-gene-guided-6-mp-dosing-in-childhood-all-maintenance-therapy-100628489","NCT07462299","NUDT15\u002FTPMT Multi-gene Guided 6-MP Dosing in Childhood ALL Maintenance Therapy","A Prospective Study of NUDT15\u002FTPMT Multi-gene Combined Guidance on 6-MP Dosage During Maintenance Therapy in Childhood Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\nDiagnosed with ALL and scheduled for maintenance therapy. Plan to receive oral 6-MP. NUDT15 and TPMT genotyping results available. Baseline liver and kidney function within acceptable limits (ALT\u002FAST ≤ 2.5xULN, etc.).\n\nSigned informed consent. -\n\nExclusion Criteria:\n\nDown syndrome. Relapsed\u002Frefractory disease before maintenance. Prior hematopoietic stem cell transplantation. Severe organ dysfunction or uncontrolled infection.\n\n\\-",{"count":389,"type":22},110,[139],"This is a prospective, single-center clinical study to evaluate the safety and efficacy of a personalized 6-mercaptopurine (6-MP) dosing strategy guided by NUDT15 and TPMT genotypes in children with Acute Lymphoblastic Leukemia (ALL) during maintenance therapy. The study compares this gene-guided strategy with historical controls to assess if it reduces the incidence of Grade ≥3 neutropenia and infection events.",[393],"Childhood Acute Lymphoblastic Leukemia",[395,396,397,398,399],"NUDT15","TPMT","6-MP","Pharmacogenetics","Maintenance Therapy","2026-03-05",{"date":402,"type":38},"2026-03-10",{"date":404,"type":22},"2026-02-20",{"date":77,"type":22},{"name":44,"class":45},{"id":408,"slug":409,"hasResults":12,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":56,"enrollmentInfo":414,"targetDuration":168,"studyType":60,"phases":4,"briefSummary":416,"conditions":417,"keywords":419,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":79},"100627726","the-efficacy-of-specific-immunotherapy-guided-by-component-resolved-diagnosis-for-dust-mite-allergens-in-chinese-pediatric-patients-with-rhinitis-andor-asthma-100627726","NCT07452380","The Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and\u002For Asthma","A Multicenter Registry Study Examining the Efficacy of Specific Immunotherapy Guided by Component-Resolved Diagnosis for Dust Mite Allergens in Chinese Pediatric Patients With Rhinitis and\u002For Asthma（EXPLORER STUDY）","Inclusion Criteria:\n\n-(1) Age: 5 years ≤ age \\\u003C 18 years; (2) 1) Allergic rhinitis caused by Dermatophagoides pteronyssinus and\u002For Dermatophagoides farinae; 2) Or serum specific IgE ≥ 0.70 (kU\u002FL) (for D. pteronyssinus and\u002For D. farinae); (3) Children meeting criteria (2) must undergo allergen component testing; (4) If accompanied by bronchial asthma, asthma must be diagnosed according to the Guidelines for the Diagnosis and Prevention of Childhood Bronchial Asthma (2025 edition) and the patient's asthma symptoms must be confirmed as well-controlled.\n\n(5) Receiving treatment with dual-mite (Dermatophagoides pteronyssinus and farinae) subcutaneous immunotherapy (SCIT).\n\nExclusion Criteria:\n\n* (1) Participants and\u002For their parents\u002Flegal guardians are judged by the investigator to be unable to fully understand the study requirements, or to adhere to long-term treatment and identify adverse reactions (including but not limited to conditions such as cognitive impairment or mental illness); (2) Children with severe or uncontrolled asthma (FEV1 \\\u003C 70% of predicted value) or with irreversible airflow obstruction; (3) Children using beta-blockers or angiotensin-converting enzyme inhibitors (ACEI); (4) Children with severe autoimmune diseases or immunodeficiencies, including AIDS, inflammatory bowel disease, etc., as well as those currently using immunosuppressants; (5) Children with severe cardiovascular diseases or malignant tumors; (6) Children with incomplete clinical data.",{"count":415,"type":22},1000,"This study is a Study to Understand How to Better Match Allergy Shots to a Child's Unique Mite Allergy Profile\n\n1. Why is this study being done? For many children, tiny house dust mites are a major cause of persistent allergies, leading to uncomfortable symptoms like a stuffy nose, sneezing, and even asthma. A common long-term treatment is allergy shots, also known as allergen immunotherapy (AIT). These shots work like a vaccine, slowly training the body's immune system to stop overreacting to mites. However, not every child responds to this treatment in the same way. The investigators now know that children can be allergic to different parts of the dust mite. While most treatments focus on the most common parts (called \"major allergens\"), some children are allergic to other, less common parts (called \"intermediate or minor allergens\").\n\n   The EXPLORER study wants to find out if a child's unique allergy profile-meaning which specific mite proteins they are allergic to-affects how well they respond to allergy shots. Our goal is to move away from a \"one-size-fits-all\" approach and toward more personalized care for children with dust mite allergies.\n2. Who is this study for? The investigators are looking for children and teenagers (ages 5 to 18) in China who have a confirmed dust mite allergy and are planning to start allergy shots.\n3. What will happen during the study? This is an \"observational\" study, which means the investigators will simply observe and track the progress of children who are already receiving a standard, approved allergy shot treatment as part of their regular medical care. The investigators won't be testing a new drug.\n\n   Here's what participation involves:\n\n   A Detailed Allergy Test: At the beginning, participants will have a special blood test. This test will look for allergies to nine different specific parts of the dust mite, giving us a very detailed map of their allergy.\n\n   Grouping: Based on the results of this test, participants will be placed into different groups according to their specific allergy patterns.\n\n   Tracking Progress: The investigators will follow their treatment journey for three years. The investigators will collect information at regular check-ups (at 0, 3, 6, 12, 24, and 36 months) on:\n\n   How well their symptoms are controlled. How much allergy medication they need. Their overall quality of life. Any side effects from the shots. Annual Blood Tests: Once a year, the investigators will repeat the detailed blood test to see how their immune system is changing in response to the treatment.\n4. What do the investigators hope to learn? The investigators have a main theory, or hypothesis: Children who are allergic to many different parts of the dust mite (including the minor ones) will show greater improvement from the allergy shots, compared to children who are only allergic to the most common parts.\n\n   By studying a large group of 1,000 children, the investigators hope to provide clear evidence that can help doctors choose the right treatment for the right child. This will help fill a current gap in medical guidelines and bring us closer to truly personalized treatment for pediatric allergies.\n5. Why is this study important? This is the first large-scale study of its kind in a real-world setting. The results could change how doctors diagnose and treat dust mite allergies in children. Instead of just knowing a child is allergic to mites, the investigators will be able to see the full picture of how they are allergic. This knowledge will help ensure that every child receives the treatment that gives them the best chance for long-term relief.",[418],"Allergic Rhinitis Due to House Dust Mite",[420,421,422,423,424,425],"House dust mite","allergic rhinitis","Component-Resolved Diagnosis","Allergen Immunotherapy","subcutaneous immunotherapy","asthma",{"date":427,"type":38},"2026-03-09",{"date":429,"type":38},"2025-11-01",{"date":431,"type":22},"2028-11-01",{"name":44,"class":45},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":56,"enrollmentInfo":440,"targetDuration":4,"studyType":23,"phases":441,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":454,"leadSponsor":455,"locationsCount":380},"100615924","a-study-on-the-efficacy-and-safety-of-telitacicept-in-the-treatment-of-children-ocular-myasthenia-gravis-100615924","NCT07298928","A Study on the Efficacy and Safety of Telitacicept in the Treatment of Children Ocular Myasthenia Gravis","The Children's Hospital, Zhejiang University School of Medicine, National Clinical Research Center for Child Health","Inclusion Criteria:\n\n1. The patient and their legal guardian voluntarily sign the informed consent form.\n2. Age \\\u003C 18 years, male or female.\n3. Diagnosis of OMG according to the Chinese Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (2025 Edition).\n4. Stable administration of any one or combination of the following standard treatments prior to enrollment:\n\n   1. Cholinesterase inhibitors\n   2. Glucocorticoids\n\nExclusion Criteria:\n\n1. Active infection under treatment： Patients who are HBsAg positive must be excluded. Patients who are HBsAg negative but HBcAb positive must undergo quantitative HBV-DNA testing. Patients with a positive quantitative HBV-DNA result must be excluded; those with a negative result may be enrolled.\n2. Severe hepatic or renal insufficiency.\n3. Patients with malignant tumors other than thymoma.\n4. Patients within 3 months post-thymectomy.\n5. Hypogammaglobulinemia (IgG \\\u003C 400 mg\u002FdL) or IgA deficiency (IgA \\\u003C 10 mg\u002FdL).\n6. History of allergy to human-derived biological products.\n7. Participation in any other clinical trial within 28 days prior to enrollment or within 5 times the half-life of the investigational drug from the previous trial (whichever is longer).\n8. Patients deemed unsuitable for participation by the investigator (e.g., patients with severe psychiatric disorders).",{"count":21,"type":22},[139],"Under conventional treatment regimens, pediatric ocular myasthenia gravis (OMG) is prone to relapse and is associated with corticosteroid-related adverse effects, indicating an unmet clinical need. In May 2025, the targeted B-cell biologic agent Telitacicept was approved for use in adult patients with acetylcholine receptor (AChR) antibody-positive generalized myasthenia gravis (GMG) and subsequently initiated in national multicenter clinical trials for adult OMG. Our center published a retrospective study in the Chinese Journal of Evidence-Based Pediatrics in August 2025, which was the first report both domestically and internationally on the efficacy and safety of Telitacicept in four pediatric OMG patients. This study plans to conduct a prospective, multicenter, open-label, single-arm clinical trial aimed at evaluating the effectiveness and safety of Telitacicept in pediatric OMG.",[444],"Effectiveness",[446,447,448,148,449,450],"long-term follow-up","Ocular myasthenia gravis","Telitacicept","Biological agent","Targeted treatment",{"date":452,"type":38},"2026-03-06",{"date":402,"type":22},{"date":378,"type":22},{"name":44,"class":45},{"id":457,"slug":458,"hasResults":12,"nctId":459,"briefTitle":460,"officialTitle":461,"acronym":4,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":463,"maxAge":4,"enrollmentInfo":464,"targetDuration":4,"studyType":23,"phases":466,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":470,"lastUpdatePostDateStruct":471,"startDateStruct":473,"completionDateStruct":475,"leadSponsor":477,"locationsCount":46},"100557554","evaluate-the-safety-and-preliminary-efficacy-of-exg110-in-subjects-with-fabry-disease-100557554","NCT06539624","Evaluate the Safety and Preliminary Efficacy of EXG110 in Subjects With Fabry Disease","A Multicenter, Non-randomized, Open-label, Dose-finding Study to Evaluate the Safety and Preliminary Efficacy of Gene Therapy With EXG110 in Subjects With Fabry Disease","Inclusion Criteria:\n\n1. At the time of signing the informed consent, age ≥7, male or female\n2. Clinical symptoms (at least one Fabry disease related symptom) and genetic diagnosis of Fabry disease,\n3. Prior or no prior ERT treatment\n4. Have renal or cardiac involvement (adults only)\n5. All subjects of reproductive age voluntarily took effective contraception and prohibited sperm donation from entering the screening period until 52 weeks after dosing (main study period)\n6. The subjects voluntarily participate and are fully informed, fully understand the research, can comply with the requirements of the research protocol, and are willing to complete the research as planned, and voluntarily provide biological samples for testing according to the requirements of the protocol\n\nExclusion Criteria:\n\n1. Screening period laboratory test results: a) aspartate aminotransferase or alanine aminotransferase \\> 1.5× upper limit of normal (ULN);b) Total bilirubin \\> 1.5× upper limit of normal (ULN);c) Alkaline phosphatase \\> 2× upper limit of normal (ULN);d) Albumin \\\u003C lower limit of normal (LLN)\n2. There was a clinically significant increase in AFP during the screening period\n3. Serum virology test: a) Hepatitis B: Hepatitis B virus surface antigen (HBsAg) positive, and hepatitis B virus-deoxyribonucleic acid (HBV-DNA) higher than the upper limit of normal detection;b) Hepatitis C: if the hepatitis C virus (HCV) antibody is positive, and the hepatitis C virus-ribonucleic acid (HCV-RNA) is higher than the upper limit of normal test value;c) Syphilis: positive for syphilis screening (Tp-Ab) and positive for syphile-specific antibodies;d) HIV: Known human immunodeficiency virus (HIV) positive history or HIV screening positive\n4. AVT917 (\\>1:50), anti-AGA antibody positive(\\>1:2560)\n5. C3 lower than the normal range, C5b-9 higher than the normal range, anti-AVT917 IgM positive\n6. Current or have a history of serious cardiovascular disease and surgical history\n7. Current underlying liver disease or history of liver disease, as assessed by the investigator, that may affect the safety assessment of the drug\n8. Renal disease in adult and the slope of kidney \\>5 mL\u002Fmin\u002F1.73m²\u002Fyear\n9. Subjects with poorly controlled diabetes after drug treatment (e.g., HbA1c≥8%);\n10. Acute\u002Fchronic infection or other chronic disease that the investigator determines will increase the risk of participants participating in the study\n11. Patients with a history of malignant tumor or currently suffering from any malignant tumor (except for the following tumor diseases: skin basal cell carcinoma, cervical carcinoma in situ, breast carcinoma in situ, skin squamous cell carcinoma has been controlled after treatment);\n12. Have malignancy cancer\n13. Patients with active autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, multiple sclerosis, immune vasculitis, inflammatory bowel disease, etc.);\n14. known history of allergy to the components of the investigational products\n15. Patients with a history of drug use or drug abuse or alcoholism\n16. Use of systemic (intravenous or oral) immunomodulators within the past 6 months or currently\n17. Initiation of treatment with blood pressure lowering drugs that affect proteinuria levels (such as angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, or angiotensin-receptor\u002Fenkephalin inhibitors) within 4 weeks prior to screening, or changes in the therapeutic dose of these drugs within 4 weeks prior to screening;\n18. Has received, or is currently receiving, a clinical trial of another investigational drug\u002Fmedical device or treatment (other than vitamins and minerals) within 3 months prior to signing the informed consent (or within 5 half-lives of the investigational drug, whichever is longer)\n19. Previous treatment with gene therapy products\n20. Those who had received live attenuated vaccine\u002Fvaccine within 12 weeks prior to screening or planned to receive it during the study\n21. Other clinical conditions that the investigators felt needed to be ruled out","7 Years",{"count":465,"type":22},12,[139],"Objective: To explore the safety and tolerability of different doses of EXG110 with Fabre disease",[469],"Fabry Disease","2026-02-25",{"date":472,"type":38},"2026-02-27",{"date":474,"type":38},"2024-10-16",{"date":476,"type":22},"2027-04-09",{"name":44,"class":45},{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":483,"acronym":484,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":17,"minAge":486,"maxAge":56,"enrollmentInfo":487,"targetDuration":4,"studyType":23,"phases":489,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":496,"lastUpdatePostDateStruct":497,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":79},"100626397","phase-1-xenon-therapy-for-children-with-autism-spectrum-disorder-100626397","NCT07435103","Xenon Therapy for Children With Autism Spectrum Disorder","Efficacy of Xenon in Children With Autism Spectrum Disorder: a Multicenter, Randomized, Controlled Study","ASD; Xe","Inclusion Criteria:\n\n* Aged 4-18 years, with no gender restriction.\n* Meeting the diagnostic criteria for Autism Spectrum Disorder (ASD) as specified in the Diagnostic and Statistical Manual of Mental Disorders (5th Edition) (DSM-5), with the diagnosis confirmed by assessment using the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).\n* The total T-score on the Social Responsiveness Scale, Second Edition (SRS-2) is ≥90.\n* No treatment such as neuromodulation (transcranial magnetic stimulation, transcranial electrical stimulation) has been received for at least 1 month prior to randomization.\n* For participants who have previously taken psychotropic medications prior to randomization, it is required that the medications have been discontinued for a minimum of 5 half-lives or 4 weeks, whichever is longer.\n* The participants and their legal guardians confirm that they will not add new or alter the existing established treatment regimens such as behavioral rehabilitation during the study period.\n* The legal guardians of the participants have a full understanding of the study content, participate voluntarily, and sign a written informed consent form.\n\nExclusion Criteria:\n\n* Having other major neurological diseases (e.g., epilepsy, cerebral palsy), severe physical illnesses, or genetic syndromes.\n* Having severe auditory or visual impairments that prevent the completion of assessments with cooperation.\n* A history of anaphylaxis or adverse reactions to Xenon.\n* Currently participating in or having participated in other interventional clinical trials within the recent 3 months.\n* The investigator judges that there is any condition that may increase the risk to the participant or interfere with the conduct of the trial and the assessment of its results.","4 Years",{"count":488,"type":22},72,[490,491],"PHASE1","PHASE2","This study aims to evaluate the efficacy and safety of inhaled xenon for the treatment of children with autism spectrum disorder (ASD). The primary objective is to determine whether short-term inhalational xenon therapy can improve social functioning in children with ASD, as measured by changes in the Social Responsiveness Scale (SRS). Safety and tolerability of xenon inhalation in the pediatric population will also be assessed.\n\nIn this randomized, placebo-controlled trial, participants will receive either inhaled xenon or a placebo gas (medical air without xenon) to compare treatment effects.\n\nParticipants will:\n\nInhale 25% xenon or placebo for 10 minutes per day for 10 consecutive days Attend two clinical visits: one immediately after completion of the intervention and one at 3 months post-intervention for follow-up assessments and safety evaluations",[494,495],"Autism Spectrum Disorder (ASD)","Autism","2026-02-24",{"date":472,"type":38},{"date":499,"type":22},"2026-03-01",{"date":501,"type":22},"2027-06-30",{"name":44,"class":45},{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":17,"minAge":509,"maxAge":510,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":521,"locationsCount":4},"100626557","a-multicenter-clinical-study-on-the-optimization-of-timing-and-efficacy-evaluation-of-bronchoscopic-intervention-in-pediatric-severe-pneumonia-100626557","NCT07437183","A Multicenter Clinical Study on the Optimization of Timing and Efficacy Evaluation of Bronchoscopic Intervention in Pediatric Severe Pneumonia","Inclusion Criteria:\n\n1. According to the on Clinical Warning and Early Decision-making for Severe Pneumonia in Children, severe pneumonia is diagnosed when any of the following symptoms are present: poor general condition; refusal to eat or dehydration; altered consciousness; significantly increased respiratory rate (RR) (RR \\> 70 breaths per minute for infants or RR \\> 50 breaths per minute for older children); central cyanosis; respiratory distress (including groaning, nasal flaring, and use of accessory muscles indicated by three concave signs), involvement of multiple lung lobes or ≥ 2\u002F3 of one lung; pleural effusion; pulse oxygen saturation ≤ 0.92 at sea level; or any extrapulmonary complications. The presence of any of these conditions qualifies as severe pneumonia.\n2. The time from onset to enrollment was ≤ 72 hours, and the patient had not received bronchoscopic lavage treatment.\n\nExclusion Criteria:\n\n1. Having severe underlying diseases: congenital heart disease, bronchopulmonary dysplasia, malignant tumors, severe immunodeficiency diseases, etc.\n2. There are contraindications for performing a bronchoscopy examination.\n3. Respiratory tract foreign bodies, airway developmental malformations, etc.","1 Month","14 Years",{"count":512,"type":22},3168,[139],"1. Main objectives: ① To determine the optimal timing for bronchoscopic lung lavage in treating severe pneumonia in children, providing evidence-based guidance for the standardized clinical implementation of this technique. ② To establish a multidimensional efficacy evaluation system encompassing clinical symptoms, blood gas analysis, and inflammatory markers.\n2. Secondary objectives: ① To assess the impact of different intervention timings on clinical outcomes, including the time to temperature normalization, resolution of lung rales, length of hospital stay, hospitalization costs, and mortality rate. ② To evaluate the therapeutic effects at the pathophysiological level by measuring inflammatory factors (e.g., IL-6, IL-8), epithelial\u002Fendothelial injury biomarkers (e.g., SP-D, angiopoietin-2), and indicators of pathogen clearance, thereby clarifying the treatment's effects on inflammation control, lung injury repair, and pathogen elimination. ③ To enhance the accumulation of safety data by calculating the incidence of adverse events related to bronchoscopic procedures (such as airway bleeding and hypoxemia) and further defining the safety profile of this technique in the pediatric population.",[516],"Pediatric Sever Pneumonia","2026-02-22",{"date":472,"type":38},{"date":499,"type":22},{"date":77,"type":22},{"name":44,"class":45},{"id":523,"slug":524,"hasResults":12,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":4,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":17,"minAge":287,"maxAge":529,"enrollmentInfo":530,"targetDuration":4,"studyType":23,"phases":532,"briefSummary":533,"conditions":534,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":537,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":543},"100596467","effects-of-enteral-feeding-regimens-on-nec-mortality-and-neurodevelopment-in-very-preterm-infants-100596467","NCT07045844","Effects of Enteral Feeding Regimens on NEC, Mortality, and Neurodevelopment in Very Preterm Infants","The Effects of Different Enteral Feeding Regimens on Necrotizing Enterocolitis, Mortality, and Neurodevelopment in Very Preterm Infants: A Multicenter Double-Randomized Trial","Inclusion Criteria:\n\n* Gestational age at birth less than 29 weeks;\n* No contraindications to enteral feeding;\n* Mother is willing to breastfeed.\n\nExclusion Criteria:\n\n* For Randomization Group 1: If the infant has already received pasteurized human donor milk (pHDM), preterm formula (PTF), or nutritional fortifiers;\n* For Randomization Group 2: If the infant is exclusively fed with preterm formula and the mother has no intention to express breast milk;","14 Days",{"count":531,"type":22},2324,[139],"The goal of this clinical trial is to evaluate whether supplementing with pasteurized donor human milk (pHDM) or preterm formula (PTF) when own mother's milk (OMM) is insufficient can improve outcomes in very preterm infants born before 29 weeks of gestation. It also aims to assess whether routine use of human milk fortifiers benefits this population. The main questions it aims to answer are:\n\nDoes supplementing OMM with pHDM or PTF improve survival without surgery-requiring necrotizing enterocolitis (NEC) by 34 weeks corrected gestational age? Is routine fortification of human milk better than selective fortification based on growth faltering?\n\nResearchers will compare:\n\npHDM vs. PTF to see which better supports survival without severe NEC. Routine fortification vs. selective fortification to assess the impact on growth and long-term neurodevelopment.\n\nParticipants will:\n\nBe randomized twice:\n\n* First, within the first week of life to receive either pHDM or PTF when OMM is insufficient\n* Second, in the second week of life to receive either routine fortification or selective fortification only if growth faltering occurs Receive feeding and care as per standard clinical practice Complete neurodevelopmental assessment at 2 years corrected age using the PARCA-R tool (no additional study visits required) This multicenter, double-randomized, open-label randomized controlled trial is embedded in routine neonatal care and uses real-world data to assess both short- and long-term outcomes.\n\nCOLLABORATE-China is being run in partnership with the UK-wide COLLABORATE trial sponsored by Imperial College London.",[535,536],"Very Preterm Infant","Necrotizing Enterocolitis (NEC)",{"date":496,"type":38},{"date":539,"type":22},"2026-03-02",{"date":541,"type":22},"2030-07-31",{"name":44,"class":45},22,{"id":545,"slug":546,"hasResults":12,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":4,"eligibilityCriteria":550,"healthyVolunteers":12,"sex":17,"minAge":196,"maxAge":56,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":561,"leadSponsor":562,"locationsCount":563},"100625546","the-efficacy-and-safety-of-infliximab-combination-with-azathioprine-in-crohns-disease-in-children-100625546","NCT07424040","The Efficacy and Safety of Infliximab Combination With Azathioprine in Crohn's Disease in Children","Study on the Efficacy and Safety of Infliximab Monotherapy or in Combination With Azathioprine in the Treatment of Crohn's Disease in Children","Inclusion Criteria:\n\n* Diagnose Crohn's disease based on the 2019 Expert Consensus for the Diagnosis and Treatment of Pediatric Inflammatory Bowel Disease.\n* The baseline Pediatric Crohn's Disease Activity Index (PCDAI) value is ≥ 30.\n* None of the patients had received treatment with azathioprine, 6-mercaptopurine, or anti-TNF biological agents before.\n* Patients who received the following adjunctive treatments also meet the participation criteria: acid-suppressing drugs (if the dose was stable for at least 2 weeks before enrollment, it is applicable), enteral nutrition (with a stable plan for 2 weeks). Rectal, intravenous, or oral corticosteroids are not allowed, and they must be discontinued at least 2 weeks before enrollment.\n\nExclusion Criteria:\n\n* Suffering from short bowel syndrome, ostomy surgery, symptomatic stenosis, abscess, or a recent history of abdominal surgery (within 6 months)\n* History of tuberculosis or other granulomatous infections, positive chest imaging or positive tuberculin skin test\n* Recent opportunistic infection history (within 6 months), active hepatitis B or C infection, human immunodeficiency virus infection\n* Multiple sclerosis, cancer\n* Homozygous mutations in NUDT15 or TPMT genes, or heterozygous mutations in at least one of the above genes",{"count":552,"type":22},154,[139],"The goal of this clinical trial is to investigate whether there are significant differences in the efficacy of infliximab monotherapy and combined azathioprine therapy in treating pediatric Crohn's disease, as well as whether there are differences in the safety of these two treatment regimens during long-term use. The main questions it aims to answer are:\n\nIs infliximab combined with azathioprine superior to monotherapy in inducing and maintaining remission of Crohn's disease in children? In long-term treatment, can infliximab combined with azathioprine more effectively reduce disease activity and the occurrence of complications, but the incidence of adverse reactions is not higher than that of monotherapy? Researchers will compare the treatment of infliximab combined with azioprine with that of infliximab monotherapy to assess the efficacy and safety of both in inducing and maintaining remission of Crohn's disease in children.\n\nParticipants will:\n\nTake drug ABC or a placebo every day for 4 months Experimental group: Infliximab, administered intravenously at 5mg\u002Fkg every 8 weeks at weeks 0, 2, 6 and thereafter, along with azathioprine, taken orally at 1.5-2.5mg\u002Fkg daily.\n\nControl group: Infliximab (Remicade), administered intravenously at 5mg\u002Fkg every 8 weeks at weeks 0, 2, 6 and thereafter.\n\nA comprehensive disease assessment will be conducted at the hospital in the 14th and 54th weeks.\n\nRecord their symptoms, signs and test results.",[556,557],"Crohn's Diseases","Crohn's Disease in Pediatric Patient","2026-02-15",{"date":404,"type":38},{"date":499,"type":22},{"date":238,"type":22},{"name":44,"class":45},4,{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":86,"sex":17,"minAge":168,"maxAge":196,"enrollmentInfo":571,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":577,"lastUpdatePostDateStruct":578,"startDateStruct":580,"completionDateStruct":581,"leadSponsor":583,"locationsCount":4},"100618755","construction-of-a-multidimensional-risk-prediction-model-for-severe-early-childhood-caries-100618755","NCT07335744","Construction of a Multidimensional Risk Prediction Model for Severe Early Childhood Caries","Construction of a Multidimensional Risk Prediction Model for Severe Early Childhood Caries Based on the \"Bio-psy-social\" Medical Model","Inclusion Criteria:\n\n* Age range: 3-6 years old (36 months ≤ months \\\u003C 72 months);\n* Good overall health condition (ASA classification I-II);\n* Parents have given informed consent and are willing to participate in this study.\n\nExclusion Criteria:\n\n* Suffering from severe systemic diseases (such as congenital heart disease, blood disorders, immune deficiencies, etc.);\n* Having congenital craniofacial deformities (such as cleft lip and palate, facial clefts, etc.);\n* Undergoing orthodontic treatment for the mouth;\n* Having a history of long-term use of drugs that affect saliva secretion;\n* Refusing to undergo oral clinical examination or unable to cooperate.",{"count":572,"type":22},1200,"This study aims to address the high prevalence and recurrence rate of severe early childhood caries (S-ECC) by breaking away from the traditional single biological factor perspective and introducing the theories of \"24-hour activity behavior\" and \"family psychological stress\". By collecting clinical and behavioral data from 1,200 preschool children and their parents, it explores the association pathways between parental burnout, children's executive function, sleep\u002Fdietary behaviors and S-ECC, and builds a high-precision risk prediction model to provide evidence-based support for the clinical development of personalized prevention strategies.",[575,576],"Severe Early Childhood Caries","Caries","2026-02-10",{"date":579,"type":38},"2026-02-12",{"date":499,"type":22},{"date":582,"type":22},"2028-05-30",{"name":44,"class":45},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":591,"minAge":59,"maxAge":510,"enrollmentInfo":592,"targetDuration":4,"studyType":23,"phases":594,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":79},"100624060","urethral-plate-flap-vs-tunica-vaginalis-flap-for-residual-severe-ventral-curvature-in-hypospadias-100624060","NCT07404722","Urethral Plate Flap vs. Tunica Vaginalis Flap for Residual Severe Ventral Curvature in Hypospadias","Urethral Plate Flap Versus Tunica Vaginalis Flap Corporoplasty for the Correction of Residual Severe Ventral Curvature After Urethral Plate Transection in Hypospadias Repair: A Single-Center, Randomized, Controlled, Non-Inferiority Study","Inclusion Criteria:\n\n* Age: 6 months to 14 years.\n* Diagnosis: Primary hypospadias (no history of prior hypospadias repair).\n* Intraoperative Condition: Residual ventral curvature ≥ 30° confirmed by artificial erection test after transection of the urethral plate.\n* Consent: Signed informed consent provided by the participant's legal guardian.\n\nExclusion Criteria:\n\n① Glans diameter \\\u003C 1 cm; ② Combined with cryptorchidism; ③ Combined with severe bleeding disorders or coagulation dysfunction.","MALE",{"count":593,"type":22},90,[139],"The correction of ventral curvature in hypospadias follows a stepwise principle. Clinically, in some cases of hypospadias, residual severe ventral curvature (VC ≥ 30°) persists even after thorough skin degloving and transection of the urethral plate, due to the unbalanced development of the ventral and dorsal tunica albuginea of the corpus cavernosum. In such cases, ventral tunica albuginea incision and corporoplasty with a graft are mandatory.\n\nAlthough the currently commonly used pedicled Tunica Vaginalis Flap (TVF) corporoplasty can effectively correct the curvature, it requires additional dissection of the scrotum and tunica vaginalis sac. This prolongs the operative time and poses risks of donor-site complications, such as testicular retraction and scrotal hematoma.\n\nThe novel Urethral Plate Flap (UPF) corporoplasty utilizes local pedicled urethral plate tissue for homologous repair. This study adopts a prospective, single-center, randomized, controlled, double-blind, non-inferiority trial design, enrolling 90 subjects. The aim is to verify that the therapeutic efficacy of the UPF technique in correcting such residual severe ventral curvature is non-inferior to that of TVF, while demonstrating significant advantages in surgical efficiency and donor-site safety.\n\nThis study aims, through a single-center, double-blind, RCT design, and under the strict indication of \"residual severe ventral curvature after urethral plate transection,\" to verify efficacy via a \"non-inferiority\" hypothesis, and to verify safety and efficiency via a \"superiority\" hypothesis. The goal is to provide Level I evidence for the update of hypospadias guidelines, while simultaneously exploring the establishment of postoperative imaging evaluation standards.",[597,598,599,600,601,602],"Residual Severe Ventral Curvature","Transection of the Urethral Plate","Corporoplasty","Pedicled Tunica Vaginalis Flap (TVF)","Novel Urethral Plate Flap (UPF)","Hypospadias","2026-02-08",{"date":605,"type":38},"2026-02-11",{"date":607,"type":22},"2026-02-23",{"date":609,"type":22},"2029-02-22",{"name":44,"class":45},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":4,"eligibilityCriteria":617,"healthyVolunteers":12,"sex":17,"minAge":618,"maxAge":59,"enrollmentInfo":619,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":626,"startDateStruct":627,"completionDateStruct":628,"leadSponsor":629,"locationsCount":79},"100622357","natural-course-of-congenital-hydronephrosis-in-infants-aged-0-6-months-100622357","NCT07382570","Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months","Multicenter Prospective Cohort Study Protocol on the Natural Course of Congenital Hydronephrosis in Infants Aged 0-6 Months (3-Year Cycle)","Inclusion Criteria:\n\n* Diagnostic Criteria: Congenital hydronephrosis is diagnosed by abdominal ultrasound examination and meets the UTD grading system criteria (Grades I-III). This is defined as an anterior-posterior renal pelvis diameter (APD) ≥4 mm during the fetal period or ≥7 mm after birth, or accompanied by calyceal dilation, renal parenchymal changes, and other manifestations.\n* Informed Consent: The legal guardian voluntarily agrees to participate in the study and provides written informed consent.\n* Follow-up Feasibility: The guardian commits to cooperating with the complete 3-year follow-up period, including attending regular examinations at the research center, and maintains stable contact information.\n\nExclusion Criteria:\n\n* Presence of other severe congenital malformations that may affect follow-up or prognosis assessment, such as congenital heart disease, biliary atresia, spina bifida, etc.\n* Secondary hydronephrosis caused by acquired factors (e.g., urinary system tumors, stones, trauma) or well-defined genetic metabolic diseases.\n* Having received interventional treatments prior to enrollment, such as surgical procedures related to hydronephrosis (e.g., pyeloplasty) or pharmacological interventions (e.g., long-term use of diuretics).\n* Severe underlying diseases that preclude tolerance for long-term follow-up, such as severe infections, respiratory failure, or renal failure (e.g., glomerular filtration rate \\\u003C 30 ml\u002Fmin\u002F1.73m²).\n* Inability of the legal guardian to cooperate due to mental illness, cognitive impairment, or refusal to comply with follow-up schedules and data collection requirements.","0 Months",{"count":620,"type":22},330,"This project aims to systematically delineate the natural progression of congenital hydronephrosis diagnosed within the critical window of 0-6 months through a prospective, multicenter, observational cohort study. The focus will be on analyzing the resolution rates, progression rates, and influencing factors of hydronephrosis of varying severities based on the UTD grading system.\n\nCongenital hydronephrosis is one of the most common congenital urinary system abnormalities in children, with a high prenatal detection rate. However, its postnatal natural course is highly heterogeneous, leading to significant controversy in clinical management regarding follow-up intensity and intervention timing. Currently, there is a lack of prospective, large-sample, multicenter natural history data in China. By establishing a standardized follow-up system and collecting high-quality clinical and imaging data, this study aims to provide high-level evidence-based medical support for developing individualized and precise clinical management strategies, thereby reducing unnecessary interventions and delayed treatment. Consequently, conducting this multicenter study holds significant clinical and scientific value.",[623,624,625,368],"Congenital Hydronephrosis","UTD Grading System","Natural Progression",{"date":605,"type":38},{"date":499,"type":22},{"date":238,"type":22},{"name":44,"class":45},""]