[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":613},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,96,0,25,[9,48,76,103,129,158,182,211,241,262,281,299,319,344,370,398,423,444,470,490,516,533,549,572,593],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100645646","intraoperative-portable-ultrasound-for-real-time-graft-perfusion-assessment-during-cabg-a-randomized-controlled-trial-100645646",false,"NCT07700524","Intraoperative Ultrasound Assessment of Coronary Artery and Bypass Graft Blood Flow During CABG","Quantitative Assessment of Native Coronary Artery and Bypass Graft Blood Flow Using Intraoperative Ultrasound in Patients Undergoing Coronary Artery Bypass Grafting: A Single-Centre Prospective Feasibility and Safety Study","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Confirmed coronary artery disease and scheduled to undergo elective isolated coronary artery bypass grafting at Nanjing Drum Tower Hospital.\n* Able and willing to provide written informed consent before any study-specific procedures are performed.\n\nExclusion Criteria:\n\n* Urgent, emergency, or salvage coronary artery bypass grafting.\n* Prolonged preoperative fasting, as defined in the study protocol, or inability to maintain adequate oral intake without enteral or parenteral nutritional support.\n* History of malignancy.\n* Body weight below 50 kg.\n* Preoperative hemodynamic instability requiring ongoing resuscitation or mechanical circulatory support, including intra-aortic balloon pump, extracorporeal membrane oxygenation, or left ventricular assist device support.\n* Endotracheal intubation and invasive mechanical ventilation before surgery.\n* Impaired consciousness, clinically significant central nervous system dysfunction, or evidence of cerebral malperfusion after hospital admission.\n* End-stage renal disease requiring maintenance dialysis before hospital admission.\n* Severe pulmonary disease considered to preclude tolerance of elective coronary artery bypass grafting or to confer an unacceptably high perioperative risk.\n* Severe peripheral vascular disease or clinical evidence of limb malperfusion before surgery.\n* History of gastrointestinal ulceration or chronic inflammatory gastrointestinal disease.\n* Chronic inflammatory or autoimmune disease, or long-term treatment with systemic corticosteroids or non-steroidal anti-inflammatory drugs.\n* Active infection or sepsis at screening.\n* Severe uncontrolled arrhythmia requiring urgent treatment or expected to cause marked intraoperative hemodynamic instability.\n* Previous cardiac surgery requiring repeat median sternotomy.\n* Planned concomitant major cardiac or aortic surgery, including valve surgery, congenital heart defect repair, or aortic surgery.\n* Inability to understand the study information or unwillingness or inability to provide written informed consent.\n* Inability or unwillingness to complete follow-up at 30 ± 7 days after surgery.\n* Pregnancy or breastfeeding.","ALL","18 Years",{"count":20,"type":21},190,"ESTIMATED","OBSERVATIONAL","This single-centre, prospective observational feasibility and safety study will enrol 190 consecutive adults undergoing elective isolated coronary artery bypass grafting (CABG) at Nanjing Drum Tower Hospital. The study aims to evaluate the feasibility and safety of intraoperative ultrasound for the quantitative assessment of native coronary artery and bypass graft blood flow.\n\nTransit-time flow measurement will be performed as part of routine intraoperative graft assessment. Additional ultrasound measurements will be obtained from major native coronary arteries before and after revascularisation and from bypass grafts after restoration of blood flow. The ultrasound findings will be collected for research purposes and will not influence graft revision or other intraoperative clinical decisions.\n\nThe co-primary outcomes are the participant-level technical success rate of the protocol-defined intraoperative ultrasound assessment and the incidence of adverse events related to the ultrasound device or measurement procedure. Secondary outcomes include agreement between ultrasound and transit-time flow measurements, changes in native coronary artery blood flow after revascularisation, measurement repeatability, and exploratory associations between intraoperative flow parameters and postoperative cardiac function and myocardial injury biomarkers. Participants will be followed for 30 ± 7 days after surgery.",[25],"Coronary Artery Disease",[27,28,29,30,31,32,33,34],"Intraoperative ultrasound","Coronary artery bypass grafting","Native coronary artery blood flow","Bypass graft blood flow","Transit-time flow measurement","Feasibility","Safety","Prospective cohort study","NOT_YET_RECRUITING","2026-08-06",{"date":38,"type":39},"2026-08-11","ACTUAL",{"date":41,"type":21},"2027-01-01",{"date":43,"type":21},"2029-12-30",{"name":45,"class":46},"The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":47},"100650407","early-phase-1-snc116-therapy-for-refractory-systemic-lupus-erythematosus-100650407","NCT07748156","SNC116 Therapy for Refractory Systemic Lupus Erythematosus","An Exploratory Clinical Study Evaluating the Safety, Preliminary Efficacy, and Pharmacokinetic Characteristics of SNC116 in the Treatment of Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Age ≥ 18 years, ≤ 65 years, gender not restricted.\n2. For refractory systemic lupus erythematosus (SLE), the following criteria must be met:\n\n   1. Conform to the classification criteria of SLE of the European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) in 2019\n   2. Disease activity score SLEDAI-2000 ≥ 6, and at least one BILAG-2004 index of the British Isles Lupus Activity Group (severe manifestations) or two B-class (moderate manifestations) organ scores, or both; or disease activity score SLEDAI-2000 ≥ 8\n   3. Definition of recurrence\u002Frefractory: After receiving conventional treatment for at least 6 months, the disease remains active. Conventional treatment is defined as using glucocorticoids and\u002For antimalarial drugs, and any one or more of the following immunomodulatory drugs: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biological agents\u002Fmolecular targeted drugs, including CD20 monoclonal antibodies, belimumab, tepredipine, tofacitinib, baricitinib, upadacitinib, etc.\n   4. Refractory lupus nephritis (LN) requires simultaneous satisfaction of: According to the classification of the International Society of Nephrology (ISN)\u002FRenal Pathology Society (RPS), biopsy-proven type III, IV, or V, or type III\u002FIV combined with type V, activity index (AI) ≥ 1, diagnosed as active LN; Renal biopsy must be conducted within one year before screening or during the screening period; Urine protein to creatinine ratio (UPCR) ≥ 1.0 g\u002Fg, or 24-hour urine protein ≥ 1.0 g, with or without red blood cell casts in active urinary sediment;\n3. Within 7 days before SNC116 administration, the blood routine test results must meet the following requirements (excluding SLE activity caused by surgery and assessed by the investigator):\n\n   1. Absolute neutrophil count (ANC) ≥ 1.5×10\\^9\u002FL;\n   2. Absolute lymphocyte count (ALC) ≥ 0.5×10\\^9\u002FL (or lymphocyte subpopulation detection CD3+ T cells ≥ 300 cells\u002FμL);\n   3. Hemoglobin (Hb) ≥ 80 g\u002FL;\n   4. Platelet count (PLT) ≥ 50×10\\^9\u002FL.\n4. During the screening period, serum pregnancy test results of fertile female subjects must be negative (women who have undergone surgical sterilization or have been menopausal for at least 2 years are considered to have no fertility). Fertile female subjects and male subjects must use highly effective contraceptive methods throughout the clinical study and within 2 years after the last study treatment.\n5. Subjects must agree not to donate blood, organs, tissues, sperm\u002Fspirit and\u002For egg cells for at least 2 years after SNC116 treatment.\n6. Voluntarily participate in the clinical trial and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Individuals who have had any allergic reaction, hypersensitivity reaction, intolerance or contraindication to the components of SNC116 or the drugs that may be used in the study (such as tocilizumab), or who have previously experienced severe allergic reactions.\n2. Subjects who had uncontrolled active infections requiring intravenous antibiotics, antiviral or antifungal drugs, etc. within 7 days before the administration of SNC116.\n3. Subjects with a primary immunodeficiency disorder.\n4. Subjects who had malignant tumors requiring treatment or evidence of recurrence within 2 years before screening (excluding: non-melanoma skin cancer that has been fully cured, cervical carcinoma in situ, localized prostate cancer, superficial bladder cancer, breast duct carcinoma, thyroid cancer, and other localized carcinomas).\n5. Subjects who have previously received any treatment using vesicular virus G glycoprotein pseudotyped viruses.\n6. Subjects who have previously received CD19 CAR-T cell therapy or other genetically modified T cell therapy.\n7. Subjects with organ dysfunction, meeting any of the following criteria:\n\n   1. Serum ALT and AST \\> 2.5 times the upper limit of normal;\n   2. Total bilirubin \\> 1.5 times the upper limit of normal, for those with Gilbert syndrome, total bilirubin \\> 3.0 times the upper limit of normal;\n   3. Creatinine clearance rate (estimated by the Cockcroft-Gault formula) \\\u003C 30 ml\u002Fmin;\n   4. Blood oxygen saturation ≤ 91% under indoor ventilation conditions without oxygen inhalation;\n   5. Left ventricular ejection fraction \\\u003C 45%.\n8. Subjects with clinically significant major cardiovascular diseases, including any of the following:\n\n   1. Had myocardial infarction within 6 months before screening;\n   2. Had unstable angina pectoris within 3 months before screening, or had evidence of active ischemic heart disease indicated by electrocardiogram and other examinations;\n   3. Uncontrolled and clinically significant arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, torsades de pointes, severe atrioventricular block, etc.);\n   4. For male subjects, QTcF ≥ 450 milliseconds, for female subjects, QTcF ≥ 470 milliseconds and the investigator judges it to be clinically significant;\n   5. Congestive heart failure of NYHA classification ≥ 3;\n   6. Poorly controlled hypertension (systolic pressure \\> 160 mmHg and\u002For diastolic pressure \\> 100 mmHg) or with hypertensive crisis or hypertensive encephalopathy;\n   7. Had deep vein thrombosis or pulmonary embolism within 6 months before screening;\n   8. Other cardiovascular diseases assessed by the investigator as being significantly high risk and not suitable for enrollment.\n9. Meet any of the following criteria:\n\n   1. Human immunodeficiency virus (HIV) antibody positive;\n   2. Positive for hepatitis B surface antigen (HBsAg) and\u002For hepatitis B core antibody (HBcAb) and HBV-DNA above the detection limit of the testing method;\n   3. Positive for hepatitis C virus (HCV) antibody and HCV RNA above the detection limit;\n   4. Active syphilis (excluding false positives caused by the disease);\n   5. Subjects with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA detection (virus active);\n   6. Subjects who had active tuberculosis or latent tuberculosis that was not properly treated within 6 months before screening.\n10. Subjects who had a history of or symptoms of severe central nervous system diseases within 6 months before screening (excluding simple trigeminal nerve disease; except for those caused by SLE activity, as assessed by the investigator). These include but are not limited to mental disorders, cerebrovascular diseases, encephalitis, brain injury, epilepsy, convulsions, aphasia, dementia, suicidal tendencies, etc. 11. Before receiving SNC116, the following drugs\u002Ftreatments were administered:\n\n    1. Within 1 week, preventive treatment with short-acting oral antiretroviral drugs was received.\n    2. Within 1 week, small molecule drugs (such as JAK inhibitors) or iltiazumab were received.\n    3. Within 2 weeks or 3 half-lives (as determined by the investigator) received immunosuppressants, such as azathioprine (AZA), mycophenolate mofetil (MMF), methotrexate (MTX), cyclosporine (CsA), tacrolimus (FK506), cyclophosphamide (CYC), leflunomide (LEF).\n    4. Within 4 weeks received biologics (such as belimumab, tixagevimab, anifrolumab), experimental drugs\u002Ftreatments (except for clear placebo-controlled groups), or plasma exchange treatment; for belimumab and tixagevimab, baseline B cell levels need to be recorded.\n    5. Within 6 months received anti-CD20 monoclonal antibodies (such as rituximab, obinutuzumab), and the peripheral blood CD19+ B cell count at screening needs to be ≥ 50 cells\u002FμL.\n    6. Experienced major surgery within 4 weeks.\n    7. Received live vaccines within 4 weeks.\n\n12\\. Had other active autoimmune diseases and the investigator determined that they were not suitable to participate in this study.\n\n13\\. Pregnant, or lactating, or planning to become pregnant. 14. Had other serious or diagnosed medical conditions within 3 months before screening (such as severe pulmonary disease or oxygen-dependent dependence, or progressive renal function deterioration requiring dialysis treatment, or active gastrointestinal bleeding\u002Fulcer\u002Fperforation, or uncontrolled serous cavity effusion, etc.), and the investigator believed that these conditions might affect the safety or study compliance of the subjects, and were not suitable to participate in this study.\n\n15\\. Exclusion criteria for SLE:\n\na) Diagnosed as drug-induced lupus; b) At screening, had lupus crisis, or severe central nervous system involvement (neuro-psychiatric lupus) of the subjects.\n\n16\\. Other situations that the investigator believed might affect the safety or study compliance of the subjects and were not suitable to participate in the study.","65 Years",{"count":57,"type":21},28,"INTERVENTIONAL",[60],"EARLY_PHASE1","This study aims to evaluate the safety and tolerability of SNC116 in treating patients with systemic lupus erythematosus.",[63],"Systemic Lupus Erythematosus",[65,66,67],"in vivo CAR-T","CD19","SLE","2026-07-31",{"date":70,"type":39},"2026-08-05",{"date":72,"type":21},"2026-08",{"date":74,"type":21},"2030-01",{"name":45,"class":46},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":58,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":47},"100649994","phase-2-a-prospective-single-arm-multicenter-clinical-study-of-high-risk-localized-and-locally-advanced-renal-clear-cell-carcinoma-100649994","NCT07741617","A Prospective, Single-Arm, Multicenter Clinical Study of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma","A Prospective, Single-Arm, Multicenter Clinical Study of Epalolitoworelimab (a PD-1\u002FCTLA-4 Combination Antibody) Combined With Lenvatinib in the Perioperative Treatment of High-Risk Localized and Locally Advanced Renal Clear Cell Carcinoma","Inclusion Criteria:\n\n1. Ability to understand and agree to comply with the study requirements and assessment schedule, and voluntarily provide written informed consent (ICF) prior to any trial-related procedures.\n2. Age ≥ 18 years and ≤ 75 years, male or female.\n3. Histologically or cytologically confirmed localized and locally advanced clear cell renal cell carcinoma.\n4. Locally advanced renal cell carcinoma (stage III per AJCC): cT3a G3-4 cN0 M0; cT3b-T4 Gany cN0 M0; cTany cN1 Gany cM0; or high-risk localized renal cell carcinoma: cT1b G4 or with sarcomatoid features cN0 cM0; cT2 G3-4 cN0 cM0.\n5. No prior treatment with any immune checkpoint inhibitor.\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n7. Life expectancy ≥ 3 months.\n8. At least one measurable lesion according to RECIST v1.1.\n9. Planned to receive neoadjuvant therapy and surgical resection.\n10. Adequate major organ function within 7 days prior to treatment, meeting the following criteria: A. Hematology: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL; hemoglobin ≥ 80 g\u002FL; platelet count ≥ 90 × 10⁹\u002FL. B. Blood biochemistry: total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN (for subjects with liver metastases, ALT or AST ≤ 5 × ULN is permitted); serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin. C. Left ventricular ejection fraction ≥ 50%. D. Activated partial thromboplastin time (APTT), international normalized ratio (INR), and prothrombin time (PT) ≤ 1.5 × ULN. E. Normal thyroid function, defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects with total T3 (or free T3) and free T4 within the normal range are also eligible. F. Cardiac enzymes and troponin within normal limits (isolated laboratory abnormalities deemed clinically insignificant by the investigator are also allowed).\n11. Female subjects of childbearing potential must agree to use effective contraception (e.g., intrauterine device, contraceptive pill, or condom) during the study and for 6 months after study completion; serum pregnancy test must be negative within 72 hours prior to the first dose, and they must not be breastfeeding. Male subjects must agree to use effective contraception during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n1. Presence of symptomatic or untreated known brain metastases or other central nervous system (CNS) metastases. CNS metastases that have been completely resected and\u002For irradiated with documented stability or improvement are not exclusionary, provided that computed tomography (CT) shows stability for at least 4 weeks prior to screening, with no evidence of cerebral edema and no requirement for glucocorticoids or anticonvulsants\n2. Patients with advanced or metastatic renal cell carcinoma, or non-clear cell renal cell carcinoma\n3. Known hypersensitivity to the investigational product or any of its excipients; or previous allergy to Chinese hamster ovary cell products or other recombinant human or humanized antibodies.\n4. Prior discontinuation of immunotherapy due to severe and\u002For life-threatening immune-related adverse events\n5. Adverse events from prior anti-tumor therapy have not recovered to ≤ Grade 1 per NCI-CTCAE v5.0 at enrollment (except for alopecia or other toxicities deemed by the investigator to be tolerable and not clinically significant)\n6. Presence of any active autoimmune disease or history of autoimmune disease, including but not limited to: interstitial pneumonia, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism (patients on hormone replacement therapy may be considered for inclusion); patients with psoriasis or childhood asthma\u002Fallergy that has completely resolved and requires no intervention in adulthood may be considered, but those requiring bronchodilators for medical intervention are excluded\n7. History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation or allogeneic bone marrow transplantation.\n8. Presence of poorly controlled cardiac symptoms or diseases, including but not limited to: heart failure ≥ NYHA class II, unstable angina, myocardial infarction within 1 year, and clinically significant supraventricular or ventricular arrhythmias that have not been clinically intervened or remain poorly controlled after intervention\n9. Severe infection (CTCAE \\> Grade 2) within 4 weeks prior to the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; active pulmonary inflammation on baseline chest imaging; signs or symptoms of infection or need for oral or intravenous antibiotic therapy within 14 days prior to the first dose of study drug (prophylactic antibiotics are allowed).\n10. Active pulmonary tuberculosis infection identified by history or CT, or history of active pulmonary tuberculosis infection within 1 year prior to enrollment, or history of active tuberculosis infection more than 1 year ago without adequate treatment.\n11. Positive HBV DNA test; hepatitis C (positive anti-HCV antibody with HCV RNA above the lower limit of quantification of the assay).\n12. Diagnosis of another malignancy within 5 years prior to the first dose of study drug, except for malignancies with low risk of metastasis or death, such as adequately treated basal cell carcinoma or squamous cell carcinoma of the skin, or cervical carcinoma in situ, which may be considered for enrollment.\n13. Known hereditary or acquired bleeding or thrombotic tendency (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.), or currently receiving thrombolytic or anticoagulant therapy.\n14. Clinically significant bleeding symptoms or clear bleeding tendency within 3 months prior to enrollment, such as daily hemoptysis ≥ 2.5 mL, lower gastrointestinal bleeding, esophageal-gastric varices with bleeding risk, bleeding gastric ulcer, or vasculitis, etc.\n15. Arterial\u002Fvenous thrombotic events occurring within 6 months prior to enrollment, such as cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism.\n16. Pregnant or breastfeeding female patients.\n17. According to the investigator's judgment, any other factors that may compel premature termination of the study, such as other serious concomitant diseases (including psychiatric disorders) requiring concomitant treatment, alcoholism, drug abuse, family or social factors that may affect subject safety or compliance.\n18. Currently participating in another clinical study, unless it is an observational (non-interventional) clinical study or follow-up of an interventional study.","75 Years",{"count":85,"type":21},54,[87],"PHASE2","Study Design Prospective, single-arm, multicenter clinical study.\n\nStudy Drugs\n\nNeoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1\u002FCTLA-4 combination antibody) plus lenvatinib.\n\nAdjuvant phase: QL1706 monotherapy.\n\nTarget Population Patients with high-risk localized or locally advanced clear cell renal cell carcinoma (ccRCC) meeting AJCC staging criteria (e.g., cT3a G3-4 cN0M0, etc.) who are candidates for neoadjuvant therapy and surgical resection.\n\nTreatment Flow\n\nScreening (28 days): Informed consent obtained, baseline assessments completed.\n\nNeoadjuvant phase (4 cycles, 21 days\u002Fcycle):\n\nQL1706 5 mg\u002Fkg IV, Q3W; plus oral lenvatinib 12 mg QD.\n\nEfficacy evaluation every 2 cycles; surgery after 4 cycles (unless early termination).\n\nAdjuvant phase (13-17 cycles, 21 days\u002Fcycle):\n\nEligible patients continue QL1706 5 mg\u002Fkg IV, Q3W.\n\nImaging every 3 months until recurrence, new therapy, death, or completion of 21 cycles total.\n\nFollow-up: Safety follow-up (90 days after last QL1706 dose or 30 days after last other drug, whichever is longer), then survival follow-up every 90 days.\n\nEndpoints\n\nPrimary: Objective response rate (ORR) per RECIST 1.1.\n\nSecondary: Pathological complete response rate (pCR), median disease-free survival (mDFS), 12-\u002F24-month DFS rates, median overall survival (mOS), and safety.\n\nSample Size Planned enrollment: 54 subjects.",[90],"Urologic Neoplasms",[92,93,94],"high risk","locally advanced","ccECC","2026-07-30",{"date":97,"type":39},"2026-08-03",{"date":99,"type":21},"2026-08-15",{"date":101,"type":21},"2030-08-15",{"name":45,"class":46},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":58,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":123,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":47},"100640527","transcutaneous-auricular-vagus-nerve-stimulation-for-poor-weight-loss-response-to-incretin-receptor-agonists-100640527","NCT07619989","Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Incretin Receptor Agonists","Adjunctive Transcutaneous Auricular Vagus Nerve Stimulation in Overweight or Obese Patients With a Suboptimal Weight-Loss Response to Incretin Receptor Agonists: A Single-Center, Randomized, Sham-Controlled Study","Inclusion Criteria:\n\n1. Individuals with obesity, or overweight accompanied by at least one weight-related comorbidity (e.g., hypertension or fatty liver disease), who have been receiving tirzepatide therapy for at least 12 weeks and have achieved ≤10% weight loss during treatment;\n2. Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of diseases that may substantially affect body weight homeostasis, including Cushing's syndrome, uncontrolled thyroid disease (thyroid-stimulating hormone \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL), malignancy, or similar conditions;\n2. Use within the past 3 months of medications, other than incretin receptor agonists, that may significantly affect body weight, including glucocorticoids and antipsychotic agents;\n3. Skin infection or damage involving the auricular area;\n4. Women planning pregnancy in the near future;\n5. Contraindications to MRI, such as metallic prostheses or claustrophobia;\n6. Diagnosis of diabetes mellitus; Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.","50 Years",{"count":112,"type":21},24,[114],"NA","This is a single-center, randomized, participant-blinded, sham-controlled trial designed to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight or obese patients who show a suboptimal weight-loss response to incretin receptor agonist therapy. A total of 24 participants will be randomly assigned to receive either taVNS plus tirzepatide 5 mg or sham stimulation plus tirzepatide 5 mg for 12 weeks. The primary objective is to compare the percent change in body weight from baseline to week 12 between the two groups.",[117],"Obesity & Overweight",[117,119,120,121],"Transcutaneous Auricular Vagus Nerve Stimulation","Incretin Receptor Agonists","Non-responders","RECRUITING",{"date":68,"type":39},{"date":125,"type":21},"2026-08-01",{"date":127,"type":21},"2027-09-01",{"name":45,"class":46},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":12,"sex":17,"minAge":136,"maxAge":55,"enrollmentInfo":137,"targetDuration":4,"studyType":58,"phases":139,"briefSummary":140,"conditions":141,"keywords":144,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":47},"100649400","ai-assisted-remote-insulin-pump-optimization-in-t1dm-100649400","NCT07732777","AI-Assisted Remote Insulin Pump Optimization in T1DM","Evaluating AI-Assisted Remote Optimization of Insulin Pump Settings in Type 1 Diabetes Using CGM","Inclusion Criteria:\n\n1. Clinical diagnosis of T1D, meeting all three of the following criteria:\n\n   1. Clinical medical records or a certification document issued by a specialist physician confirming the diagnosis;\n   2. At least one of the following: age at disease onset \\\u003C 15 years; presentation with ketosis or diabetic ketoacidosis (DKA) at onset; no overweight or obesity at onset; highest random C-peptide \\\u003C 200 pmol\u002FL;\n   3. At least one of the following: continuous insulin therapy initiated after diagnosis; positive for any islet autoantibody.\n2. Age 14 to 65 years, inclusive, male or female.\n3. HbA1c \\\u003C 11.0% at the screening visit.\n4. At least 3 months of documented T1D duration, and at least 3 months of treatment with either multiple daily insulin injections (MDI) or insulin pump therapy.\n5. Willing to wear the study device continuously throughout the trial and to use either insulin aspart or insulin lispro.\n6. Willing to perform at least one fingerstick blood glucose measurement per day.\n7. Willing to upload data from the study device.\n8. Willing and able to provide signed informed consent (by the participant and\u002For legally authorized representative) and to learn basic diabetes management and study device operation.\n\nExclusion Criteria:\n\n1. History of severe hypoglycemia within the 6 months prior to screening, defined as an event requiring medical assistance (i.e., physician office visit, emergency room visit, or hospitalization), coma, seizure, or hypoglycemia with loss of consciousness.\n2. Unresolved acute complications of diabetes at screening, including diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state (HHS), or hyperglycemia with severe circulatory impairment.\n3. Unresolved adverse skin conditions at the intended device placement site (e.g., psoriasis, dermatitis herpetiformis, rash, staphylococcal infection) at screening.\n4. Intolerance to subcutaneous infusion sets or adhesive tapes, or presence of edema.\n5. Presence of significant acute or chronic complications, hepatorenal disease, or other systemic diseases at screening. Hyperthyroidism or hypothyroidism with unstable thyroid function at the time of screening, defined as thyroid-stimulating hormone outside the normal range with concurrent abnormal free triiodothyronine or free thyroxine levels.\n6. Prior pancreas or islet cell transplantation.\n7. Any of the following cardiovascular or cerebrovascular events within 1 year prior to screening: myocardial infarction, heart failure (NYHA Class III\u002FIV), unstable angina, coronary artery bypass grafting, coronary stent implantation, angina pectoris, congestive heart failure, ventricular arrhythmia, transient ischemic attack (TIA), cerebrovascular accident (CVA), or other thromboembolic disease.\n8. Diagnosis of any of the following: malignancy, tuberculosis or other chronic wasting disease, hematological disorder, psychiatric disorder, systemic lupus erythematosus, rheumatoid arthritis, autoimmune hemolytic anemia, or clinically significant malabsorption. Diagnosis of adrenal insufficiency, or current treatment for hyperthyroidism, or planned treatment for hyperthyroidism during the study period.\n9. History of drug abuse or alcohol abuse.\n10. Use of any oral, injectable, or intravenous glucocorticoids within 8 weeks prior to screening, or planned use during the study period.\n11. Use of any of the following non-insulin glucose-lowering agents within 8 weeks prior to screening, or planned use during the study period: thiazolidinediones (TZDs), alpha-glucosidase inhibitors, sulfonylureas (SUs), glinides, dipeptidyl peptidase-4 inhibitors (DPP-4i), sodium-glucose cotransporter-2 inhibitors (SGLT2i), or glucagon-like peptide-1 receptor agonists (GLP-1 RAs). Participants currently using any of these agents must undergo a washout period of at least 7 days prior to enrollment.\n12. Planned elective surgery requiring general anesthesia, or planned dialysis during the study period.\n13. For women of childbearing potential: pregnancy, lactation, positive pregnancy test at screening, or planned pregnancy during the study period. Women of childbearing potential who are not using an effective method of contraception (e.g., oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and who do not agree to continue using such effective contraception during the study period will be excluded.\n14. Current participation in, or treatment with an investigational drug or device within 2 weeks prior to screening (observational studies are permitted).\n15. Any other condition that, in the investigator's judgment, would make the participant unsuitable for the study, including but not limited to: history of ocular trauma or other confirmed ocular disease causing blurred vision, deafness, eating disorders, celiac disease, or being underweight (Body Mass Index \\\u003C 18 kg\u002Fm²).","14 Years",{"count":138,"type":21},50,[114],"This study evaluates an AI-assisted remote parameter optimization tool for individuals with type 1 diabetes （T1D） using insulin pump and continuous glucose monitoring (CGM). The Artificial Intelligence (AI) algorithm analyzes regularly CGM and insulin data to generate personalized recommendations for adjusting pump settings. All algorithm-generated recommendations are reviewed and approved by physicians before being transmitted to the participant's mobile application for implementation.",[142,143],"Type 1 Diabetes Mellitus","Type 1 Diabetes (T1D)",[145,146,147,148,149],"Type 1 Diabetes","Insulin Pump","Continuous Glucose Monitoring","Artificial Intelligence","Insulin Dosage Adjustment","2026-07-26",{"date":152,"type":39},"2026-07-29",{"date":154,"type":39},"2026-01-28",{"date":156,"type":21},"2028-12-31",{"name":45,"class":46},{"id":159,"slug":160,"hasResults":12,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":166,"targetDuration":4,"studyType":58,"phases":168,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":177,"startDateStruct":178,"completionDateStruct":179,"leadSponsor":181,"locationsCount":4},"100649284","phase-1-tumor-specific-t-cells-cctlgl01-for-advanced-gastrointestinal-cancer-100649284","NCT07735065","Tumor-Specific T-Cells (cCTL:GL01) for Advanced Gastrointestinal Cancer","A Single-Arm, Interventional, Exploratory Clinical Study of Tumor-Specific Cytotoxic T-Cell Injection (cCTL:GL01) for the Treatment of Advanced Gastrointestinal Tumors","cCTL","Inclusion Criteria:\n\n* Age 18 to 65 years (inclusive), male or female;\n* Ability to understand the study and has signed the written Informed Consent Form (ICF), and is willing and able to comply with all protocol-required procedures;\n* Fresh tumor tissue samples can be obtained via biopsy or surgery, and peripheral blood mononuclear cells (PBMCs) can be obtained via apheresis;\n* Histologically and\u002For cytologically confirmed advanced gastrointestinal solid tumors (e.g., esophageal cancer, gastric cancer, colon cancer, etc.), with previous receipt of at least one systemic therapy that failed or resulted in recurrence; OR previous receipt of any form of immunotherapy or cellular therapy that failed or resulted in recurrence;\n* Presence of at least one measurable lesion according to RECIST v1.1, or has an evaluable target lesion\u002Fdisease assessment method as determined by the investigator. (Note: A measurable lesion is defined as a non-nodal lesion with at least one dimension ≥ 10 mm, or a nodal lesion with a short axis ≥ 15 mm, measured by CT\u002FMRI; lesions previously treated with local therapies \\[e.g., radiotherapy\\] cannot be considered as target lesions unless clear disease progression is documented.)\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 1;\n* Life expectancy ≥ 20 weeks;\n* Hepatitis B virus (HBV) infected patients (with HBV DNA levels below the lower limit of detection \\[LLOD\\]), or cured Hepatitis C virus (HCV) infected patients;\n* Laboratory values within 14 days prior to the first dose of study drug must meet the following criteria:\n\n  1. Hematology: Absolute neutrophil count (ANC) ≥1.5×109\u002FL; Platelets (PLT) ≥100×109\u002FL; Hemoglobin (Hb) ≥90g\u002FL; Note: The above requirements must be met without receiving any transfusion of blood components or supportive therapy with cell growth factors within two weeks prior to blood collection.\n  2. Renal Function: Serum creatinine ≤1.5×upper limit of normal (ULN) OR creatinine clearance (CrCl) ≥50mL\u002Fmin (calculated using the Cockcroft-Gault formula).\n  3. Hepatic Function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.0×ULN (for patients with liver metastases, ALT and AST ≤3.0×ULN); Serum total bilirubin (TBIL) ≤1.5×ULN.\n  4. Coagulation Function: International Normalized Ratio (INR) or prothrombin time (PT) ≤1.5×ULN (for patients receiving warfarin anticoagulation, INR must be between 1.5 and 2.5); activated partial thromboplastin time (aPTT) ≤1.5×ULN.\n* Female patients of childbearing potential must have a confirmed negative serum pregnancy test within 3 days prior to the first dose of study drug, and must initiate effective contraception immediately following the negative result; patients of childbearing potential and their partners must agree to use highly effective contraception throughout the study drug treatment period and for 90 days after the last dose of study drug.\n* Adverse events (AEs) related to prior anti-cancer therapy must have resolved to Grade 0 or 1; the following AEs are permitted for enrollment: alopecia, Grade ≤2 sensory neuropathy, and endocrine disorders controlled by hormone replacement therapy.\n\nExclusion Criteria:\n\n* History of a second primary malignancy within 5 years (inclusive) prior to screening, except for cured cervical carcinoma in situ, localized skin squamous cell carcinoma, basal cell carcinoma, ductal carcinoma in situ (DCIS) of the breast, \\\u003CT1 urothelial carcinoma, or prostate cancer under active surveillance;\n* Patients with Gilbert's syndrome;\n* Patients with anorexia, nausea, or vomiting of Grade≥2;\n* History of bowel obstruction or intestinal perforation within 6 months prior to screening;\n* Patients who experienced Grade≥3 toxicity related to prior irinotecan use;\n* Symptomatic brain metastases or leptomeningeal metastases; or other evidence indicating that central nervous system (CNS) metastases or leptomeningeal metastases are uncontrolled, and the investigator deems the patient unsuitable for enrollment. Patients with asymptomatic brain metastases or those stable after treatment (receiving≤10mg\u002Fday of prednisone or equivalent systemic corticosteroids), with both imaging and neurological examinations judged to be stable following relevant treatment, are permitted to be enrolled;\n* History of cerebrovascular accident (CVA), transient ischemic attack (TIA), myocardial infarction (MI), unstable angina, or New York Heart Association (NYHA) Class III or IV heart failure within 24 weeks prior to enrollment; history of malignant arrhythmia within 12 weeks prior to enrollment; or QTcF \\> 450 ms in males or QTcF \\> 470 ms in females;\n* Active autoimmune disease, or a history of autoimmune disease requiring systemic treatment within 2 years prior to screening. The following conditions are permitted for enrollment: hypothyroidism, vitiligo, Graves' ophthalmopathy, Hashimoto's thyroiditis, Type I diabetes mellitus, childhood asthma, or allergic asthma with no acute exacerbations\u002Fattacks within 2 years prior to screening;\n* Prior history of allogeneic stem cell transplantation or solid organ transplantation;\n* History of severe allergic reactions, Grade 3-4 hypersensitivity to humanized antibody or fusion protein therapies, or known hypersensitivity to irinotecan;\n* History of Grade 3-4 immune-related adverse events (irAEs) or those leading to permanent discontinuation of treatment (except for Grade 3 endocrine abnormalities controlled by hormone replacement therapy);\n* Receipt of \\>10mg\u002Fday of prednisone (or equivalent systemic corticosteroids) or other immunosuppressants for≥5 consecutive days within 2 weeks prior to screening; however, short-course (≤1 week) of topical, ocular, intra-articular, intranasal, or inhaled administration is permitted;\n* Receipt of any live vaccine within 4 weeks prior to enrollment;\n* Presence of any of the following: Active bacterial infection requiring intravenous anti-infective therapy within 2 weeks prior to the first dose of study drug; Positive for human immunodeficiency virus (HIV) (HIV-1\u002F2 antibodies); Active tuberculosis (TB) currently receiving anti-TB treatment or having received anti-TB treatment within 1 year prior to screening;\n* Receipt of anti-cancer therapy or radiotherapy within 4 weeks or 5 half-lives (whichever is longer) prior to enrollment. Palliative radiotherapy for symptom control is permitted but must be completed at least 2 weeks prior to the first dose of study drug, and no additional radiotherapy is planned for the same lesions;\n* Patients who underwent major surgery, interventional therapy\u002Fablation therapy, experienced major trauma within 4 weeks prior to the first dose of study drug, or require elective major surgery during the study period (excluding needle biopsy, aspiration drainage, bronchoscopy, or intravenous cannulation);\n* Participation in any drug or medical device clinical trial within 4 weeks prior to the first dose of study drug;\n* Presence of psychiatric disorders, psychological illness, or familial genetic diseases that may affect the conduct of the clinical trial;\n* According to the investigator's judgment, any condition that may interfere with disease staging, treatment, and follow-up, affect patient compliance, or place the patient at high risk;\n* Any other severe underlying diseases or reasons that, in the opinion of the investigator, make the patient unsuitable for participation in the clinical trial.",{"count":167,"type":21},20,[169],"PHASE1","This clinical trial is designed to study an investigational cell therapy called cCTL-GL01 in patients with advanced gastrointestinal cancers (including cancers of the stomach, esophagus, colon, or rectum) that have not responded well to standard treatments.\n\nThe main goals of this study are to find out: If cCTL-GL01 is safe and what side effects it might cause; How well cCTL-GL01 works to control or shrink tumors.",[172],"Advanced Gastrointestinal Cancer",[174,175,176],"Tumor specific T cell","Cell Therapy","Gastrointestinal Cancer",{"date":152,"type":39},{"date":125,"type":21},{"date":180,"type":21},"2028-08-01",{"name":45,"class":46},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":190,"minAge":18,"maxAge":83,"enrollmentInfo":191,"targetDuration":4,"studyType":58,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":47},"100647590","phase-2-adjuvant-rezvilutamide-monotherapy-for-high-risk-prostate-cancer-after-radical-prostatectomy-100647590","NCT07711314","Adjuvant Rezvilutamide Monotherapy for High-Risk Prostate Cancer After Radical Prostatectomy","Rezvilutamide Monotherapy as Adjuvant Treatment for Patients With High Recurrence Risk After Radical Prostatectomy: A Prospective, Multicenter, Single-Arm Study","ARMOR","Inclusion Criteria:\n\n* Age and Diagnosis: Male patients aged ≥ 18 and ≤ 75 years with histologically or cytologically confirmed prostate adenocarcinoma.\n* Disease Stage and Surgery: Localized prostate cancer (assessed by conventional imaging such as CT and bone scan), having undergone radical prostatectomy within 12 weeks prior to enrollment.\n* Postoperative PSA: Postoperative prostate-specific antigen (PSA) level \\\u003C 0.1 ng\u002FmL within 8 weeks after surgery.\n* Risk Stratification: Postoperative CAPRA-S score ≥ 6, indicating a high risk of recurrence.\n* Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* Adequate Organ Function: Must meet the following laboratory criteria:\n\n  1. Absolute neutrophil count (ANC) ≥ 1.5 × 10\\^9\u002FL (without blood transfusion or G-CSF within 14 days).\n  2. Hemoglobin (HGB) ≥ 90 g\u002FL. Platelet count (PLT) ≥ 100 × 10\\^9\u002FL. (3) Coagulation: International Normalized Ratio (INR) or Prothrombin Time (PT) ≤ 1.5 × upper limit of normal (ULN) (without blood product transfusion within 14 days).\n\n  (4)Creatinine clearance rate ≥ 30 mL\u002Fmin. (5) Total bilirubin (TBIL) ≤ 1.5 × ULN. (6) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN.\n* Radiotherapy Intention: Patients who are unfit for or refuse to receive radiotherapy.\n* Contraception: Patients of reproductive potential must be willing to use highly effective contraceptive methods during the study and for 12 weeks after the last dose of study drug. I\n* informed Consent: Capable of understanding and providing written informed consent (ICF) and willing to comply with study requirements and evaluation schedules.\n\nExclusion Criteria:\n\n* Histology: Prostate tissue pathology showing neuroendocrine, small cell, or sarcomatoid features.\n* Metastasis: Preoperative conventional imaging (e.g., CT or bone scan) indicating pelvic lymph node metastasis (cN1) or distant metastasis (cM1).\n* Prior Therapies: Prior androgen deprivation therapy (ADT) (including medical or surgical castration), focal therapy for prostate cancer, or chemotherapy\u002Fradiotherapy for prostate cancer.\n* Prior Novel Hormonal Agents: Prior treatment with second-generation anti-androgens (e.g., abiraterone, apalutamide, enzalutamide, darolutamide, etc.). ·Recent Surgery: Major surgery requiring general anesthesia (other than radical prostatectomy) within 28 days prior to the first dose of study drug.\n* Other Malignancies: History of or concurrent other malignancies within the past 2 years, except for cured non-melanoma skin cancer and superficial bladder tumors (Ta, non-invasive; Tis, carcinoma in situ; and T1).\n* Thromboembolic Events: Arterial or venous thromboembolic events (e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism) within the past 6 months, or currently receiving therapeutic anticoagulation with warfarin or heparin.\n* Cardiovascular Conditions: Heart rate-corrected QT interval (QTc) \\> 500 ms; severe cardiovascular disease (myocardial ischemia or infarction grade ≥ II, uncontrolled arrhythmias, NYHA class III-IV heart failure, or LVEF \\\u003C 50% on echocardiogram).\n* Allergies: Known allergy to any study drug or its excipients.\n* Active Infections\u002FHepatitis: Active viral hepatitis requiring treatment (HBV DNA ≥ 500 IU\u002FmL for HBV carriers; positive HCV RNA for HCV antibody-positive patients); known human immunodeficiency virus (HIV) infection; or any other active infection.\n* Autoimmune Diseases: Active autoimmune disease or history of autoimmune disease requiring systemic treatment, known history of allogeneic organ or hematopoietic stem cell transplant, or long-term high-dose use of corticosteroids or other immunomodulators.\n* Systemic Diseases: History of interstitial lung disease or uncontrolled systemic diseases (e.g., diabetes, hypertension, acute lung disease).\n* Seizures: History of epilepsy or conditions that may induce seizures.\n* Substance Abuse\u002FCompliance: Underlying medical conditions, alcohol\u002Fdrug abuse, or dependence that would interfere with drug administration, results interpretation, or pose a high risk for complications.\n* Sperm Donation\u002FFamily Planning: Men engaging in sexual activity with women of childbearing potential unwilling to use a condom with spermicide, unwilling to abstain from sperm donation during the study and for at least 3 months after the last dose, or planning to have children during this period.\n* Concurrent Trials: Concurrent participation in another therapeutic clinical study","MALE",{"count":192,"type":21},48,[87],"Prostate cancer patients with high-risk features who undergo radical prostatectomy (RP) are at a significant risk of biochemical recurrence (BCR) and disease progression. While adjuvant androgen deprivation therapy (ADT) with or without radiotherapy is the current standard of care, long-term ADT is associated with substantial adverse effects, including metabolic syndrome, cardiovascular disease, and bone density loss, which negatively impact patients' quality of life. There is an unmet clinical need to optimize adjuvant treatment strategies to improve survival outcomes while minimizing treatment-related toxicity for this high-risk population. Rezvilutamide is a novel, potent, second-generation oral androgen receptor (AR) inhibitor. This prospective, multicenter, single-arm clinical trial aims to evaluate the efficacy and safety of rezvilutamide monotherapy as an adjuvant treatment in patients with localized prostate cancer who have a high risk of recurrence following radical prostatectomy. The study plans to enroll 48 male patients (aged 18-75 years) who have completed radical prostatectomy within 12 weeks, have achieved a postoperative prostate-specific antigen (PSA) level of \\\u003C 0.1 ng\u002FmL within 8 weeks, and possess a high recurrence risk defined by a CAPRA-S score of ≥ 6. Eligible patients will receive rezvilutamide monotherapy at a dose of 240 mg orally once daily for 12 cycles (28 days per cycle, totaling 48 weeks). The primary endpoint of the study is the 2-year biochemical progression-free survival (bPFS) rate. Secondary endpoints include event-free survival rate, 5-year bPFS, 5-year metastasis-free survival (MFS), testosterone recovery rate and time at 2 years, overall safety, and health-related quality of life assessed by the FACT-P and EPIC-26 questionnaires. By exploring this monotherapy approach, the study hopes to provide a new, effective, and better-tolerated adjuvant treatment option that can improve the prognosis of high-risk patients post-prostatectomy.",[196],"Prostate Cancer (Post Prostatectomy)",[198,199,200,201,202],"Rezvilutamide","Radical Prostatectomy","Adjuvant Therapy","Prostate Cancer","High-risk","2026-07-22",{"date":205,"type":39},"2026-07-23",{"date":207,"type":39},"2026-07-01",{"date":209,"type":21},"2030-05",{"name":45,"class":46},{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":218,"maxAge":18,"enrollmentInfo":219,"targetDuration":4,"studyType":58,"phases":221,"briefSummary":222,"conditions":223,"keywords":227,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":47},"100648494","machine-learning-guided-liv-selection-for-adolescent-idiopathic-scoliosis-100648494","NCT07723053","Machine Learning-Guided LIV Selection for Adolescent Idiopathic Scoliosis","A Prospective Randomized Controlled Trial of the Drum Tower Rule Machine Learning Model for Lowest Instrumented Vertebra Selection in Lenke Type 1 and Type 5 Adolescent Idiopathic Scoliosis","Inclusion Criteria:\n\n* Diagnosis of adolescent idiopathic scoliosis classified as Lenke type 1A or Lenke type 5C.\n* Age 10 to 18 years, inclusive.\n* Scheduled to undergo posterior spinal fusion using an all-pedicle screw instrumentation system.\n* Planned selective thoracic fusion or selective lumbar fusion, with a clinical need for lowest instrumented vertebra decision-making.\n* Availability of required preoperative standing full-spine radiographs and bending radiographs.\n* Ability and willingness to complete the planned 24-month postoperative follow-up.\n* Written informed consent provided by the participant and legal guardian.\n\nExclusion Criteria:\n\n* \\- Congenital scoliosis, neuromuscular scoliosis, syndromic scoliosis, or other non-idiopathic scoliosis.\n* History of spinal trauma, spinal tumor, spinal tuberculosis, or spinal infection.\n* Previous spinal surgery.\n* Severe sagittal spinal deformity, such as Scheuermann disease, for which the study model is not applicable.\n* Neurological symptoms or signs.\n* Leg length discrepancy greater than 10 mm.\n* The surgeon determines that there is no clinical equipoise for lowest instrumented vertebra selection because one option is clearly contraindicated for safety or anatomical reasons.\n* Inability to complete follow-up or required study assessments.","10 Years",{"count":220,"type":21},300,[114],"This study will evaluate whether a machine learning-based decision support model, called the Drum Tower Rule, can help surgeons select the lowest instrumented vertebra during corrective surgery for adolescent idiopathic scoliosis.\n\nPatients with Lenke type 1 or Lenke type 5 adolescent idiopathic scoliosis who are scheduled for posterior spinal fusion will be randomly assigned to one of two groups. In the model-guided group, surgeons will receive the model-predicted risk of postoperative distal adding-on and a recommendation for lowest instrumented vertebra selection. In the conventional-experience group, surgeons will select the lowest instrumented vertebra according to routine clinical experience and existing surgical principles, without access to the model output.\n\nAll patients will receive standard posterior spinal fusion. The main outcome is the incidence of distal adding-on at 24 months after surgery, assessed by blinded radiographic reviewers.",[224,225,226],"Adolescent Idiopathic Scoliosis","Lenke Type 1 Adolescent Idiopathic Scoliosis","Lenke Type 5 Adolescent Idiopathic Scoliosis",[228,229,230,231,232,233,234],"Lowest Instrumented Vertebra","Distal Adding-on","Machine Learning","Surgical Decision Support","Posterior Spinal Fusion","Lenke Classification","Drum Tower Rule","2026-07-19",{"date":205,"type":39},{"date":207,"type":21},{"date":239,"type":21},"2030-09",{"name":45,"class":46},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":4,"eligibilityCriteria":247,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":58,"phases":249,"briefSummary":250,"conditions":251,"keywords":253,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":255,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100647006","early-phase-1-safety-tolerability-immunogenicity-pharmacodynamic-characteristics-and-preliminary-anti-tumor-activity-of-personalized-cancer-vaccines-alone-and-in-combination-with-toripalimab-in-participants-with-resected-nsclc-100647006","NCT07683832","Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccines Alone and in Combination With Toripalimab in Participants With Resected NSCLC","A Clinical Study to Evaluate the Safety, Tolerability, Immunogenicity, Pharmacodynamic Characteristics, and Preliminary Anti-tumor Activity of Personalized Cancer Vaccine Alone and in Combination With Toripalimab in Patients With Resected NSCLC","Inclusion Criteria:\n\nKey inclusion criteria:\n\n* ≥18 years of age at time of informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1\n* Life expectancy of ≥6 months\n* Patient diagnosed with NSCLC and is receiving perioperative and\u002For adjuvant anti-cancer therapy.\n* Sufficient organ function\n* Female patients must meet both of the criteria: a) Surgically sterile, or postmenopausal for ≥2 years, or women of childbearing potential with a negative pregnancy test and willing to use effective contraception during the study and for at least 90 days after the last study dose. Use of progesterone-containing contraceptives is not permitted. b) Agree not to breastfeed during the study and for at least 90 days after the last study dose.Male patients must meet the following criteria:If not surgically sterile and potentially engaging in sexual activity that could lead to pregnancy, agree to use effective contraception during the study and for at least 90 days after the last study dose.\n\nExclusion Criteria:\n\nKey Exclusion Criteria:\n\n* For perioperative or adjuvant therapy setting, participants have received systemic anti-tumor treatment previously\n* Any other prior malignancy active within the previous 5 years, except for skin basal cell cancer that has been cured, or superficial bladder cancer, carcinoma in situ of the breast, carcinoma in situ of the cervix, thyroid cancer\n* Active or prior history of interstitial lung disease, tuberculosis, or any other condition known to compromise pulmonary function.\n* Active infections\n* History of severe cardiovascular or cerebrovascular diseases occurring within 6-month prior to study treatment\n* Known hypersensitivity to the active ingredients or excipients of ABO2109 or toripalimab\n* Positive pregnancy test or lactating women",{"count":138,"type":21},[60],"The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, as well as preliminary efficacy of a personalized cancer vaccine alone and in combination with toripalimab in patients with resected NSCLC. The study included dose escalation and dose expansion two parts.",[252],"Non-Small Cell Lung Cancer NSCLC",[254],"Nanjing Drum Tower Hospital",{"date":256,"type":39},"2026-07-06",{"date":258,"type":21},"2026-07-28",{"date":260,"type":21},"2031-04-17",{"name":45,"class":46},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":268,"targetDuration":4,"studyType":58,"phases":270,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":47},"100646546","phase-2-ptc-guided-neoadjuvant-therapy-for-muscle-invasive-bladder-cancer-100646546","NCT07690878","PTC-guided Neoadjuvant Therapy For Muscle-invasive Bladder Cancer","Inclusion Criteria:\n\n1. Histologically confirmed muscle-invasive urothelial carcinoma of the bladder, with clinical stage cT2-4aN0M0.\n2. Medically suitable for radical cystectomy as assessed by the multidisciplinary team.\n3. Expected survival of at least 18 months.\n4. Estimated glomerular filtration rate (eGFR) ≥60 mL\u002Fmin.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. No prior systemic chemotherapy, immunotherapy, targeted therapy, or antibody-drug conjugate therapy for bladder cancer.\n7. Adequate organ and marrow function, including hemoglobin ≥90 g\u002FL, absolute neutrophil count ≥1.5 × 10\\^9\u002FL, platelet count ≥100 × 10\\^9\u002FL, potassium 3.5-5.5 mmol\u002FL, ALT and AST ≤1.5 × upper limit of normal, total bilirubin ≤1.5 × upper limit of normal, and left ventricular ejection fraction ≥50%.\n8. Ability to understand and willingness to sign written informed consent.\n9. Willingness and ability to comply with study procedures and follow-up.\n10. Willingness to provide tumor tissue, urine samples, and peripheral blood samples when required for Patient-derived Tumor-like Cell Clusters (PTC) generation, urinary tumor DNA testing, and biomarker analyses.\n11. Female participants of childbearing potential and male participants with partners of childbearing potential must agree to use medically accepted contraception during study treatment and for 6 months after completion of study treatment. Female participants must not be pregnant or breastfeeding.\n\nExclusion Criteria:\n\n1. Non-urothelial carcinoma histology, or mixed histology with a predominant non-urothelial component, such as small cell carcinoma or adenocarcinoma.\n2. Evidence of distant metastatic disease on imaging.\n3. Uncontrolled or clinically significant comorbid illness, including but not limited to uncontrolled infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, clinically significant arrhythmia, interstitial lung disease, severe chronic gastrointestinal disease associated with diarrhea, or psychiatric\u002Fsocial conditions that may limit compliance or increase study risk.\n4. Known hypersensitivity or allergy to any study treatment, or history of autoimmune disease.\n5. Prior exposure to systemic immunotherapy or antibody-drug conjugate therapy, including but not limited to anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies.\n6. Receipt of a live attenuated vaccine or occurrence of severe infection within 1 month before enrollment.\n7. Use of systemic corticosteroids or other systemic immunosuppressive therapy within 2 weeks before enrollment, or expected need for systemic immunosuppressive therapy during the study.\n8. Active or symptomatic viral hepatitis or other chronic liver disease, or known human immunodeficiency virus infection.\n9. Active tuberculosis.\n10. Any other condition that, in the opinion of the investigator, makes the participant unsuitable for this study.",{"count":269,"type":21},35,[87],"This study evaluates Patient-derived Tumor-like Cell Clusters (PTC)-guided individualized neoadjuvant therapy in patients with muscle-invasive bladder cancer who are candidates for radical cystectomy.",[273],"Bladder Cancer",{"date":275,"type":39},"2026-07-08",{"date":277,"type":21},"2026-07",{"date":279,"type":21},"2028-10",{"name":45,"class":46},{"id":282,"slug":283,"hasResults":12,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":286,"eligibilityCriteria":287,"healthyVolunteers":12,"sex":190,"minAge":18,"maxAge":83,"enrollmentInfo":288,"targetDuration":4,"studyType":58,"phases":289,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":298,"locationsCount":47},"100645130","phase-4-177lu-psma-617-combined-with-darolutamide-in-neoadjuvant-treatment-of-high-risk-localized-prostate-cancer-a-prospective-single-arm-multi-center-clinical-trial-100645130","NCT07677566","177Lu-PSMA-617 Combined With Darolutamide in Neoadjuvant Treatment of High-risk Localized Prostate Cancer: a Prospective, Single-arm, Multi-center Clinical Trial","IUNU-PC-123","Inclusion Criteria:\n\n1. Patients must be ≥ 18 and ≤75 years of age\n2. All patients must have a histologically or cytologically diagnosis of prostate cancer，without distant metastasis, and suitable for radical prostatectomy\n3. All patients meet at least one of the following criteria： multi-parameter MRI or PSMA PET \u002F CT shows clinical staging of primary tumor ≥ T2c； Gleason score of primary tumor ≥ 8； prostate specific antigen (PSA) ≥20 ng\u002Fml； Radiographic assessment of regional lymph node metastases (N1)\n4. Eastern Cooperative Oncology Group (ECOG) physical condition score 0- 1\n5. Primary lesion SUVmax ≥ 20.0 as assessed by PSMA-PET examination.\n6. Adequate organ function: Complete Blood Count: White blood cell count (WBC) ≥ 3.0 × 10\\^9\u002FL, platelet count ≥ 100 × 10\\^9\u002FL, hemoglobin ≥ 9 g\u002FdL. Renal Function: Serum creatinine ≤ 2 × ULN. Liver Function: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN, total bilirubin (TBIL) ≤ 1.5 × ULN. Coagulation Function: International normalized ratio (INR) \\\u003C 1.5.\n7. Voluntary Participation: Participants must voluntarily agree to participate and sign the informed consent form (ICF), indicating their understanding of the purpose of the study and the required procedures, as well as their willingness to participate in the research. Participants must be willing to comply with the prohibitions and restrictions outlined in the study protocol.\n8. Patients of childbearing potential must be willing to take high-efficiency contraceptive measures during the study period and within 120 days after the last dose of treatment\n\nExclusion Criteria:\n\n1. Patients with prostate having neuroendocrine, small cell, or sarcoma-like features are not eligible\n2. Patients with low-risk and medium-risk, localized prostate cancer (the following conditions are met at the same time) are not eligible: prostate specific antigen (PSA) \\\u003C20 ng\u002FmL multiparameter MRI or PSMA PET \u002F CT shows clinical staging of primary tumor \\\u003C T3, Gleason score of primary tumor \\\u003C 8\n3. Patients with clinical or radiological evidence of regional or extra-regional lymph node metastases or bone metastases or visceral metastases (any M1）\n4. Primary lesion SUVmax \\\u003C 20.0 as assessed by PSMA-PET examination.\n5. Patients who have previously received androgen deprivation therapy (medical or surgical) more than 3 months or focal treatment of prostate cancer or prostate cancer radiotherapy or prostate cancer chemotherapy\n6. Patients with severe or uncontrolled concurrent infections\n7. Patients must not have New York Heart Association Class III or IV congestive heart failure at the time of screening. Patients must not have any thromboembolic event, unstable angina pectoris, myocardial infarction within 6 months prior to registration\n8. Uncontrolled severe hypertension, persistently uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection\n9. Patients with a history of other malignancies within the past 5 years, except for prostate cancer, are not eligible; however, cured basal cell carcinoma or squamous cell carcinoma of the skin may be eligible\n10. Patients with mental illness, mental disability, or inability to provide informed consent",{"count":167,"type":21},[290],"PHASE4","The goal of this clinical trial is to explore the efficacy and safety of darolutamide combined with 177Lu-PSMA-617 in treating high-risk localized prostate cancer patients who are scheduled to undergo radical prostatectomy. The main questions it aims to answer are:\n\nDoes this combination treatment improve the pathological complete response rate (pCR)? What is the minimal residual disease (MRD) rate in these patients? What are the safety profiles and any adverse effects associated with this treatment? Researchers will compare the combination of darolutamide and 177Lu-PSMA-617 to a placebo to see if the combination is effective in treating high-risk localized prostate cancer.\n\nParticipants will:\n\nReceive either darolutamide combined with 177Lu-PSMA-617 or a placebo every day for 12 weeks.\n\nVisit the clinic every 6 weeks for checkups and tests. Keep a diary of their symptoms and any side effects experienced during the treatment.\n\nUndergo imaging tests, including prostate MRI and PSMA PET\u002FCT, before surgery and during follow-up.",[201,293],"Prostate Cancer Patients","2026-06-24",{"date":207,"type":39},{"date":207,"type":21},{"date":156,"type":21},{"name":45,"class":46},{"id":300,"slug":301,"hasResults":12,"nctId":302,"briefTitle":303,"officialTitle":304,"acronym":4,"eligibilityCriteria":305,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":306,"targetDuration":4,"studyType":58,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"locationsCount":47},"100588828","early-phase-1-universal-anti-cd70-car-t-cht101-cell-therapy-for-relapsed-refractory-systemic-lupus-erythematosus-100588828","NCT06946485","Universal Anti-CD70 CAR-T (CHT101) Cell Therapy for Relapsed Refractory Systemic Lupus Erythematosus","A Clinical Study of the Safety and Efficacy of Universal Anti-CD70 CAR-T (CHT101) for the Treatment of Relapsed and Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n1. Meet the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE).\n2. SLEDAI-2000 score \\>6.\n3. Have at least one BILAG-2004 Grade A or two Grade B organ domain scores, or both.\n4. Failure to respond to conventional therapy or disease relapse after remission. Conventional therapy: Glucocorticoids (≥1 mg\u002Fkg\u002Fday) combined with cyclophosphamide and ≥1 of the following immunosuppressants for \\>6 months: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine A, and\u002For biologics (e.g., rituximab, belimumab, telitacicept).\n5. Aged 18-65 years; both genders eligible.\n6. Adequate organ function:Bone marrow function: White blood cell count ≥3×10⁹\u002FL. Absolute neutrophil count ≥1×10⁹\u002FL (without colony-stimulating factor therapy within 2 weeks prior to testing). Hemoglobin ≥60 g\u002FL; Liver function: Alanine aminotransferase (ALT) ≤3×upper limit of normal (ULN). Aspartate aminotransferase (AST) ≤3×ULN. Total bilirubin (TBIL) ≤1.5×ULN (except Gilbert's syndrome, TBIL ≤3.0×ULN); Renal function: Creatinine clearance (CrCl) ≥60 mL\u002Fmin (calculated by Cockcroft-Gault formula); Coagulation: International normalized ratio (INR) ≤1.5×ULN. Prothrombin time (PT) ≤1.5×ULN; Cardiac function: Hemodynamic stability with left ventricular ejection fraction (LVEF) ≥55%.\n7. Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication. Females of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating.\n8. Voluntarily participate in the study, provide written informed consent, and demonstrate good compliance with follow-up.\n\nExclusion Criteria:\n\n1. Presence of neuropsychiatric lupus (NPSLE).\n2. History of thrombotic thrombocytopenic purpura (TTP) or thrombotic microangiopathy (TMA).\n3. History of severe drug allergies or hypersensitivity.\n4. Active or suspected uncontrolled infections requiring treatment (including fungal, bacterial, viral, or other pathogens).\n5. Central nervous system disorders caused by autoimmune diseases (ADs) or non-ADs.\n6. Severe cardiac diseases.\n7. Congenital immunoglobulin deficiency.\n8. History of malignancy (except non-melanoma skin cancer, in situ cervical\u002Fbladder\u002Fbreast\u002Fthyroid carcinoma with disease-free survival \\>5 years).\n9. End-stage renal failure.\n10. Participants meeting any of the following: Hepatitis B surface antigen (HBsAg)-positive or hepatitis B core antibody (HBcAb)-positive with detectable HBV DNA; Hepatitis C virus (HCV) antibody-positive with detectable HCV RNA; HIV antibody-positive; Syphilis-positive (RPR and TPHA positive, or TPHA positive with RPR reconfirmed positive after 4 weeks).\n11. Psychiatric disorders or severe cognitive impairment.\n12. Participation in other clinical trials within 3 months prior to enrollment.\n13. Pregnant women or those planning pregnancy.\n14. Other conditions deemed by the investigator to preclude study participation.",{"count":307,"type":21},15,[60],"This investigator-initiated trial aims to evaluate the safety and efficacy of universal anti-CD70 CAR-T (CHT101) in patients with relapsed refractory systemic lupus erythematosus.",[311],"Systemic Lupus Erythematosus (SLE)",{"date":313,"type":39},"2026-06-29",{"date":315,"type":39},"2025-04-02",{"date":317,"type":21},"2027-03",{"name":45,"class":46},{"id":320,"slug":321,"hasResults":12,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":326,"targetDuration":4,"studyType":58,"phases":328,"briefSummary":330,"conditions":331,"keywords":334,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":47},"100590545","phase-3-study-on-ketorolac-for-improving-outcomes-and-prognosis-in-patients-with-stanford-type-a-aortic-dissection-100590545","NCT06968806","Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection","Study on Ketorolac for Improving Outcomes and Prognosis in Patients With Stanford Type A Aortic Dissection -A Single-Center, Randomized, Double-Blind, Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients with Stanford Type A aortic dissection confirmed by imaging and scheduled for emergency surgery.\n\nAged between 18 and 65 years.\n\nSigned informed consent.\n\nExclusion Criteria:\n\n* Patients who are unable to eat independently or require prolonged fasting.\n\nHistory of malignant tumors.\n\nBody weight \\\u003C50 kg.\n\nTraumatic aortic dissection.\n\nPatients with Marfan syndrome.\n\nUnstable vital signs requiring preoperative mechanical support or resuscitation (e.g., IABP \\[Intra-Aortic Balloon Pump\\], ECMO \\[Extracorporeal Membrane Oxygenation\\], LVAD \\[Left Ventricular Assist Device\\])\n\nPatients requiring preoperative endotracheal intubation.\n\nConsciousness impairment, central nervous system dysfunction, or evidence of cerebral malperfusion syndrome upon admission.\n\nPreoperative hematemesis, melena, fresh blood in stool, or symptoms of bowel dilation.\n\nClear evidence of limb malperfusion before surgery.\n\nPresence of organ malperfusion syndrome.\n\nPatients requiring interventional procedures to relieve organ malperfusion before surgery.\n\nHistory of gastrointestinal ulcers or chronic gastrointestinal inflammatory diseases.\n\nHistory of dialysis or renal insufficiency before admission.\n\nHistory of liver disease.\n\nAllergy to ketorolac tromethamine, aspirin, or other nonsteroidal anti-inflammatory drugs (NSAIDs).\n\nChronic inflammatory diseases, autoimmune diseases, or long-term use of steroids or NSAIDs for other reasons.\n\nAbsence of cerebral perfusion during deep hypothermic circulatory arrest.\n\nHistory of major surgery or acute myocardial infarction within 90 days.\n\nHistory of cardiac or major vascular surgery.\n\nPregnant or lactating women.\n\nPatients who refuse to participate in this clinical trial or decline to sign the informed consent form.\n\nAny other conditions deemed unsuitable for participation by the investigator.",{"count":327,"type":21},360,[329],"PHASE3","This multicenter, randomized, double-blind, placebo-controlled trial evaluates the efficacy and safety of ketorolac in 360 patients with Stanford Type A aortic dissection, conducted between 2025 and 2027. Participants will receive either ketorolac (60 mg intramuscularly \\[IM\\] preoperatively and 30 mg twice daily \\[BID\\] for two days postoperatively) or placebo in addition to standard care. Study outcomes include composite clinical endpoints, postoperative complications, and adverse events, which will be assessed through clinical evaluations, laboratory testing, and imaging studies at predefined intervals up to 90 days. The objective of this trial is to determine whether perioperative administration of ketorolac improves clinical outcomes in this patient population.",[332,333],"Aortic Dissection","Inflammation",[333,332,335],"Ketorolac","2026-06-19",{"date":338,"type":39},"2026-06-23",{"date":340,"type":39},"2025-10-27",{"date":342,"type":21},"2028-09-01",{"name":45,"class":46},{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":4,"eligibilityCriteria":350,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":83,"enrollmentInfo":351,"targetDuration":4,"studyType":58,"phases":353,"briefSummary":354,"conditions":355,"keywords":358,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":367,"leadSponsor":369,"locationsCount":47},"100644191","phase-1-a-study-of-metformin-to-improve-cardiac-function-after-lvad-implantation-100644191","NCT07666698","A Study of Metformin to Improve Cardiac Function After LVAD Implantation","Study on the Effect of Metformin in Improving Cardiac Function After Implantation of Left Ventricular Assist Devices","Inclusion Criteria:\n\n* Age 18-75 years\n* Receiving continuous-flow LVADs, such as HeartMate 3, HVAD, Core-Heart 6, Brio-Heart\n* Presence of insulin resistance\n* HbA1c ≤ 6.5%\n\nExclusion Criteria:\n\n* Diagnosed type 1 diabetes mellitus, or type 2 diabetes mellitus with HbA1c \\> 6.5% (patients with prior type 2 diabetes who are currently off therapy and have HbA1c ≤ 6.5% may be enrolled; such patients may still have insulin resistance but have achieved glycemic control)\n* History of diagnosed diabetic ketoacidosis or hyperosmolar hyperglycemic state\n* Currently using any glucose-lowering medications (including insulin, oral hypoglycemic agents, GLP-1 receptor agonists, SGLT2 inhibitors, etc.)\n* History of diagnosed polycystic ovary syndrome (PCOS) and currently undergoing treatment\n* Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m² (CKD-EPI equation)\n* History of acute kidney injury (KDIGO criteria) with incomplete renal recovery\n* Receiving any form of renal replacement therapy (hemodialysis, peritoneal dialysis)\n* Post-kidney transplantation or awaiting kidney transplantation\n* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3× the upper limit of normal, total bilirubin \\> 2× upper limit of normal, or Child-Pugh class B or C cirrhosis\n* Active viral hepatitis\n* History of alcoholic liver disease or drug-induced liver injury currently in the active phase\n* Concurrent right ventricular assist device (RVAD) or total artificial heart implantation\n* LVAD-related complications requiring surgical intervention within 30 days postoperatively, including but not limited to: pump thrombosis requiring LVAD exchange or thrombolysis, driveline infection requiring debridement or replacement, hemorrhagic complications requiring re-sternotomy, device malfunction requiring urgent intervention\n* Acute kidney injury requiring ongoing renal replacement therapy (CRRT) within 30 days postoperatively\n* Preoperative severe right heart failure (on echocardiography: right ventricular fractional area change \\\u003C 35%, or tricuspid annular plane systolic excursion \\\u003C 14 mm; or right heart catheterization showing central venous pressure \\> 15 mmHg and cardiac index \\\u003C 2.0 L\u002Fmin\u002Fm²)\n* Preoperative severe pulmonary arterial hypertension (mean pulmonary arterial pressure ≥ 40 mmHg and pulmonary vascular resistance ≥ 4 Wood units)\n* Within 30 days postoperatively, occurrence of severe low cardiac output syndrome requiring extracorporeal membrane oxygenation (ECMO) or intra-aortic balloon pump (IABP) support\n* Significant prosthetic valve dysfunction or severe prosthetic valve infectious endocarditis\n* Severe unrepaired valvular disease\n* Active systemic infection or sepsis requiring ongoing intravenous antibiotics or antifungal therapy\n* Active infectious endocarditis (modified Duke criteria) or high clinical suspicion\n* Human immunodeficiency virus (HIV) infection with CD4 count \\\u003C 200\u002FμL or not on regular antiretroviral therapy\n* Active tuberculosis or non-tuberculous mycobacterial infection\n* Active cytomegalovirus (CMV) or Epstein-Barr virus (EBV) infection\n* Known active inflammatory diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease) currently requiring immunosuppressive therapy\n* Platelet count \\\u003C 50 × 10⁹\u002FL, hemoglobin \\\u003C 80 g\u002FL, international normalized ratio (INR) \\> 3.0 and not reversible (unless on warfarin with INR within the target range)\n* Known bleeding disorders (e.g., hemophilia, von Willebrand disease, acquired von Willebrand syndrome)\n* Malignancy diagnosed within the past 5 years (except for cured thyroid cancer, breast cancer, lung cancer, cervical cancer, etc.) and currently receiving chemotherapy, radiotherapy, or targeted therapy\n* Prior recipients of heart transplantation or other organ transplants\n* Patients awaiting heart transplantation with an anticipated waiting time of less than 3 months\n* Pregnant or lactating women\n* Reproductive-age women who are capable of conceiving but refuse to use effective contraception during the study period (including surgical sterilization, intrauterine device, oral contraceptives, condoms, etc.)\n* Women planning pregnancy during the study\n* Known allergy to metformin or any drug excipient\n* Known history of lactic acidosis\n* Currently using medications that may significantly increase the risk of lactic acidosis, including but not limited to: carbonic anhydrase inhibitors (topiramate, acetazolamide), antiretroviral drugs (especially nucleoside reverse transcriptase inhibitors), certain chemotherapeutic agents (cisplatin)\n* Currently using medications that may affect glycemic control or insulin sensitivity and that cannot be stopped or substituted during the study, including but not limited to: systemic glucocorticoids (prednisone-equivalent dose \\> 10 mg\u002Fday for \\> 2 weeks), high-dose thiazide diuretics (hydrochlorothiazide \\> 50 mg\u002Fday), atypical antipsychotics (olanzapine, clozapine, etc.), immunosuppressants (tacrolimus, cyclosporine, etc.)\n* Unable to complete 12-month follow-up\n* Known psychiatric disorders or cognitive impairment that may affect informed consent validity or study compliance\n* History of drug or alcohol abuse (within the past year)\n* Concurrent participation in another clinical trial\n* Any other circumstance, as determined by the investigator, that would render the subject unsuitable for enrollment (including but not limited to social, psychological, or geographic factors)",{"count":352,"type":21},108,[169,87],"This study investigates whether metformin, compared with placebo, improves cardiac function in patients after Left Ventricular Assist Device (LVAD) implantation. Metformin is a widely used oral medication for type 2 diabetes, but emerging evidence suggests it may have beneficial effects on cardiac metabolism and function independent of its glucose-lowering effects. This is a prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 108patients undergoing LVAD implantation will be enrolled from 5 centers in China. Eligible participants will be randomly assigned in a 1:1 ratio to receive either metformin or placebo for 12 months.\n\nThe primary outcome is the incidence of Full Responder at 12 months post-implantation. A Full Responder is defined as meeting all of the following four criteria: (1) left ventricular ejection fraction (LVEF) ≥40% and left ventricular end-diastolic diameter (LVEDD) ≤6.0 cm (Utah-Inova Responder criteria); (2) soluble ST2 (sST2) ≤100 ng\u002FmL at both 6 months and 12 months post-implantation; (3) absolute value of left ventricular global longitudinal strain (GLS) ≥12% at 12 months post-implantation.\n\nSecondary outcomes include clinical events, cardiac function status, blood biomarker results, global functional status and quality of life, medication safety, and exploratory measures. Clinical events assessed up to 24 months post-implantation include: heart failure rehospitalization rate, all-cause mortality, LVAD explantation rate, cardiovascular mortality, major bleeding, cardiac structural damage, thromboembolic events, systemic inflammatory dissemination, sepsis, and other serious adverse events.\n\nCardiac function status is evaluated by echocardiographic parameters (LVEF, LVEDD, GLS) and hemodynamic measures. Blood biomarkers include sST2, NT-proBNP, cardiac troponin, and inflammatory cytokines. Global functional status and quality of life are measured using the 6-minute walk test (6MWT), peak oxygen consumption (VO₂max), and the Kansas City Cardiomyopathy Questionnaire (KCCQ). Safety outcomes include the incidence and severity of adverse events, serious adverse events, and adverse events of special interest. Exploratory outcomes include pre-implantation right ventricular myocardial biopsy (obtained only when clinically indicated for temporary pacemaker lead placement) to assess insulin receptor substrate (IRS)\u002FAkt phosphorylation, G6PD activity, NADPH\u002FNADP⁺ ratio, and oxidative stress markers (malondialdehyde, 4-hydroxynonenal).\n\nThe study aims to provide evidence on whether adjunctive metformin therapy can improve post-LVAD cardiac outcomes and reduce adverse clinical events.",[356,357],"Heart Failure","Left Ventricular Assist Device",[359,360,361,362,363],"Metformin","Cardiac Function","LVAD","Randomized Controlled Trial","Full Responder","2026-06-18",{"date":294,"type":39},{"date":277,"type":21},{"date":368,"type":21},"2029-09",{"name":45,"class":46},{"id":371,"slug":372,"hasResults":12,"nctId":373,"briefTitle":374,"officialTitle":375,"acronym":4,"eligibilityCriteria":376,"healthyVolunteers":12,"sex":17,"minAge":377,"maxAge":378,"enrollmentInfo":379,"targetDuration":4,"studyType":58,"phases":381,"briefSummary":382,"conditions":383,"keywords":386,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":47},"100641111","the-cognitive-protective-effect-of-vr-based-cognitive-training-in-type-2-diabetes-patients-with-mild-cognitive-impairment-100641111","NCT07650318","The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment","The Cognitive Protective Effect of VR-based Cognitive Training in Type 2 Diabetes Patients With Mild Cognitive Impairment：A Prospective, Randomized, Open-Label, Parallel-Group Pilot Study","Inclusion Criteria:\n\n1. Aged 45-80 years; gender is not restricted;\n2. Participants must meet the diagnostic criteria for diabetes outlined in the \\*Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 Edition)\\*, namely: patients exhibit typical symptoms of diabetes and meet one of the following conditions: 1) HbA1c ≥ 6.5%; 2) Fasting blood glucose ≥7.0 mmol\u002FL. Fasting is defined as no caloric intake for at least 8 hours; 3) 2-hour postprandial blood glucose ≥11.1 mmol\u002FL following an oral glucose tolerance test; 4) Random blood glucose ≥11.1 mmol\u002FL;\n3. Stable glycemic control regimen for 3 months or longer;\n4. Completed a systematic neuropsychological assessment and met the MCI diagnostic criteria outlined in the 2018 American Academy of Neurology Guidelines for Mild Cognitive Impairment, satisfying the following conditions: 1) The patient or a caregiver subjectively perceives a decline in cognitive function; 2) Assessment results indicate impairment in one or more cognitive domains; 3) There is mild impairment in complex instrumental activities of daily living, but the patient maintains independence in basic activities of daily living; 4) Does not yet meet the diagnostic criteria for dementia;\n5. Has an educational level of elementary school or higher and is able to cooperate in completing the assessment, VR training, and various examinations;\n6. Cooperate in undergoing magnetic resonance imaging (MRI) examinations;\n7. Voluntarily participates in this study, signs an informed consent form, and is able to comply with the study protocol requirements to complete follow-up.\n\nExclusion Criteria:\n\n1. Suffering from other dementia-related neurological disorders (such as Alzheimer's disease, Parkinson's disease, etc.) or severe mental illness;\n2. History of central nervous system disorders, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc.;\n3. Severe sinusitis, space-occupying lesions in the nasopharynx, or congenital disorders affecting the sense of smell,or a history of trauma;\n4. Glaucoma, severe dry eye syndrome, uncorrected strabismus, severe diabetic retinopathy,or severe motion sickness, making the user unable to tolerate VR devices;\n5. History of acute diabetic complications within the past 3 months (diabetic ketoacidosis, hyperglycemic hyperosmolar state, severe hypoglycemia, etc.);\n6. Severe impairment of vital organ function, including cardiac, hepatic, or renal dysfunction;\n7. Pregnant or breastfeeding women, or women planning to become pregnant during the study;\n8. Contraindications for MRI scans, such as the presence of metallic prostheses, pacemakers, cochlear implants, or other metallic implants, or claustrophobia;\n9. Participation in other clinical trials currently or within the past 3 months;\n10. Known or suspected history of allergy to study-related materials;\n11. Currently taking medications intended to improve cognitive function.","45 Years","80 Years",{"count":380,"type":21},40,[114],"A single-center, prospective, open-label, parallel-group randomized controlled trial is conducted to investigate the cognitive-protective efficacy of a novel, diabetes-specific virtual reality (VR)-based cognitive training system integrated with diet management modules, relative to frequency- and duration-matched traditional paper-and-pencil cognitive training, in adults aged 45-80 years with T2DM and amnestic\u002Fmixed mild cognitive impairment (MCI). A total of 40 eligible participants are randomly assigned 1:1 to either the intervention group (16 weeks of individualized VR training with dynamic difficulty, 2 sessions\u002Fweek, 30-60 minutes\u002Fsession) or the active control group (standardized paper-and-pencil cognitive tasks). All participants maintain stable glucose-lowering regimens for ≥3 months and receive standardized weekly diabetes health education. The primary endpoint is the between-group difference in the change in MoCA total score from baseline to the 16-week follow-up. Secondary endpoints include changes in individual cognitive domains (memory, executive function, attention, processing speed), olfactory threshold\u002Fidentification\u002Frecall, brain structural volumes and resting-state functional connectivity (assessed via 3.0T fMRI), glycemic control (HbA1c, fasting\u002Fpostprandial glucose), lipid profile, body composition, sleep quality, anxiety and depressive symptoms, and diabetes self-management behaviors. The safety and participant adherence to the VR intervention are also systematically monitored.",[384,385],"Type 2 Diabetes Mellitus (T2DM)","Mild Cognitive Impairment (MCI)",[387,388,389,390],"Cognition","Cognitive training","Functional MRI","Virtual reality (VR) technology","2026-06-16",{"date":364,"type":39},{"date":394,"type":39},"2026-06-01",{"date":396,"type":21},"2028-06-01",{"name":45,"class":46},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":405,"maxAge":83,"enrollmentInfo":406,"targetDuration":4,"studyType":58,"phases":408,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":4},"100642760","transcutaneous-auricular-vagus-nerve-stimulation-in-type-2-diabetes-with-mild-cognitive-impairment-100642760","NCT07642518","Transcutaneous Auricular Vagus Nerve Stimulation in Type 2 Diabetes With Mild Cognitive Impairment","Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Type 2 Diabetes and Mild Cognitive Impairment: A Single-Center, Randomized, Double-Blind, Sham-Controlled Clinical Trial","Inclusion Criteria:\n\n1. Type 2 diabetes mellitus\n2. Meets criteria for mild cognitive impairment\n3. Aged 40 to 75 years, with no gender restrictions\n4. HbA1c levels between 6.5% and 9.0%\n5. At least 6 years of formal education\n6. Able to cooperate with and complete all cognitive and functional assessments\n7. Right-handed\n8. Voluntary provision of written informed consent\n\nExclusion Criteria:\n\n1. Concomitant use of GLP-1 receptor agonists, Alzheimer's disease medications, anti-Parkinson's medications, antiepileptic drugs, or antipsychotic drugs within 3 months prior to screening\n2. Presence of dementia-related neurological disorders; current or history of clinically significant psychiatric disorders within the past 2 years (e.g., schizophrenia, bipolar disorder, major depressive disorder, generalized anxiety disorder, personality disorders)\n3. CNS diseases, including traumatic brain injury, intracranial hemorrhage, acute cerebral infarction, etc\n4. Severe sinusitis, nasal and sinus polyps, space-occupying lesions such as skull base or nasopharyngeal tumors; congenital diseases or history of trauma of the nose, maxillofacial region, or skull base that affect olfactory function; presence of upper respiratory tract infection symptoms (e.g., nasal congestion, rhinorrhea, fever) on the day of the MRI scan\n5. Acute complications of diabetes, including diabetic ketoacidosis, hyperglycemic hyperosmolar state, hypoglycemic coma, etc\n6. Severe impairment of major organ function (e.g., heart, liver, kidneys), including any of the following: ALT and\u002For AST \\> 3×ULN. eGFR \\\u003C 45 mL\u002Fmin\u002F1.72 m² (CKD-EPI). History of unstable angina, myocardial infarction, or NYHA Class II or higher heart failure within 3 months prior to screening\n7. Concurrent major illnesses, such as active or untreated malignancies, or malignancies in clinical remission for less than 5 years.\n8. Contraindications for MRI scans (e.g., implanted metallic prostheses, claustrophobia); presence of cardiac pacemakers or other implantable medical devices; severe infection or ulceration of the auricular skin\n9. Pregnant or lactating women\n10. History of alcohol abuse, defined as an average weekly alcohol consumption exceeding 21 units for males and 14 units for females (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of distilled spirits\u002Fliquor)\n11. Any other conditions or factors that, in the opinion of the investigator, may confound the efficacy or safety evaluation of the study, making the participant unsuitable for enrollment","40 Years",{"count":407,"type":21},38,[114],"This study is a 24-week, single-center, randomized, double-blind, sham-controlled, parallel-group clinical trial. A total of 38 patients with type 2 diabetes and mild cognitive impairment were enrolled and randomly assigned in a 1:1 ratio to either the treatment group (receiving active transcutaneous auricular vagus nerve stimulation) or the sham control group (receiving sham transcutaneous auricular vagus nerve stimulation). The primary objective of this study is to evaluate the potential disease-modifying effects of transcutaneous auricular vagus nerve stimulation on cognitive impairment in patients with type 2 diabetes.",[411,412],"Type 2 Diabetes","Mild Cognitive Impairment",[411,412,414,119],"Cognitive Impairment","2026-06-09",{"date":417,"type":39},"2026-06-11",{"date":419,"type":21},"2026-05-20",{"date":421,"type":21},"2027-12-31",{"name":45,"class":46},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":432,"conditions":433,"keywords":436,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":439,"startDateStruct":440,"completionDateStruct":441,"leadSponsor":443,"locationsCount":47},"100642273","effects-of-different-secukinumab-maintenance-regimens-on-long-term-outcomes-in-patients-with-psoriasis-100642273","NCT07642544","Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis","Effects of Different Secukinumab Maintenance Regimens on Long-Term Outcomes in Patients With Psoriasis: A Single-Center Real-World Cross-Sectional Retrospective Study","Inclusion Criteria:\n\n* Age ≥ 18 years, with a clinical diagnosis of moderate-to-severe plaque psoriasis.\n* Initiated secukinumab treatment at our center between January 2020 and December 2025, and completed the standard 5-week induction period.\n* Achieved PASI 75 response at the end of the induction period.\n* Had a clearly defined maintenance treatment pattern (standard or non-standard), with complete treatment records and regular efficacy assessments.\n* Complete electronic medical record data available for extraction.\n\nExclusion Criteria:\n\n* Failure to complete the induction period, or failure to achieve PASI 75 response by the end of the induction period.\n* Irregular maintenance treatment pattern, or substantial missing data.\n* Use of other targeted biologic agents or small molecule drugs during the maintenance period.\n* Permanent discontinuation of treatment for non-efficacy reasons, such as pregnancy, severe infection, or malignancy.\n* Participation in other interventional clinical trials that may confound efficacy assessment.",{"count":431,"type":21},120,"To evaluate the long-term efficacy of two maintenance treatment patterns of secukinumab-the standard maintenance group and the non-standard maintenance group-by assessing the median time to onset and incidence of secondary failure, as well as the time to regain response after dose escalation of secukinumab (including re-initiation of intensive dosing or shortening of the injection interval) in patients who experienced secondary failure.",[434,435],"Psoriasis","Psoriasis (PsO)",[437,438],"psoriasis","secukinumab",{"date":417,"type":39},{"date":394,"type":21},{"date":442,"type":21},"2027-03-01",{"name":45,"class":46},{"id":445,"slug":446,"hasResults":12,"nctId":447,"briefTitle":448,"officialTitle":449,"acronym":4,"eligibilityCriteria":450,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":453,"conditions":454,"keywords":457,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":468,"locationsCount":469},"100643538","diagnostic-value-of-the-liver-inflammation-index-for-mash-in-patients-with-t2dm-and-mafld-100643538","NCT07632677","Diagnostic Value of the Liver Inflammation Index for MASH in Patients With T2DM and MAFLD","A Multicenter Cross-Sectional Study Evaluating the Diagnostic Accuracy of the Liver Inflammation Index for Metabolic Dysfunction-Associated Steatohepatitis (MASH) in Patients With Concurrent Type 2 Diabetes Mellitus and Metabolic Dysfunction-Associated Fatty Liver Disease","Inclusion Criteria:\n\n1. Adults aged ≥18 years, with no restrictions on sex;\n2. Patients clinically diagnosed with metabolic dysfunction-associated fatty liver disease (MAFLD) according to the Chinese Society of Hepatology guideline Guidelines for the Prevention and Treatment of Metabolic Dysfunction-Associated (Nonalcoholic) Fatty Liver Disease (2024 Edition), and additionally diagnosed with type 2 diabetes mellitus (T2DM) based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes Mellitus (2024 Edition).\n\nExclusion Criteria:\n\n1. Presence of unhealed wounds, scars, or other conditions in the right upper abdominal region that are unsuitable for ultrasonographic examination;\n2. Development of other liver diseases during follow-up, including viral hepatitis, drug-induced liver injury, autoimmune liver disease, alcoholic liver disease, or other chronic liver diseases;\n3. History of hepatic decompensation;\n4. History of hepatectomy or liver transplantation;\n5. History of other malignancies;\n6. Presence of vascular liver disease, cystic fibrosis-associated liver disease, sarcoidosis, polycystic liver disease, congenital or rare hereditary liver diseases, mechanical cholestasis, secondary sclerosing cholangitis, or heart failure accompanied by hepatic venous congestion;\n7. History of transjugular intrahepatic portosystemic shunt (TIPS);\n8. Occurrence of acute hepatitis during follow-up (defined as alanine aminotransferase levels \\>5 times the upper limit of normal) or acute-on-chronic liver failure (ACLF);\n9. Clinical or subclinical hypothyroidism or hyperthyroidism.",{"count":452,"type":21},10000,"This observational study aims to evaluate a new diagnostic tool, the Liver Inflammation Index, in detecting Metabolic Dysfunction-Associated Steatohepatitis (MASH) among adults who have both Type 2 Diabetes Mellitus (T2DM) and Metabolic Dysfunction-Associated Fatty Liver Disease (MAFLD).",[384,455,456],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","Metabolic Dysfunction-associated Fatty Liver Disease",[458,459,460,461],"Type 2 Diabetes Mellitus","MASH","MAFLD","Liver inflammation index","2026-06-02",{"date":464,"type":39},"2026-06-08",{"date":466,"type":21},"2026-05-15",{"date":421,"type":21},{"name":45,"class":46},22,{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":110,"enrollmentInfo":477,"targetDuration":4,"studyType":58,"phases":478,"briefSummary":479,"conditions":480,"keywords":481,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":483,"startDateStruct":485,"completionDateStruct":487,"leadSponsor":489,"locationsCount":47},"100640987","transcutaneous-auricular-vagus-nerve-stimulation-for-poor-weight-loss-response-to-lifestyle-intervention-100640987","NCT07630597","Transcutaneous Auricular Vagus Nerve Stimulation for Poor Weight-Loss Response to Lifestyle Intervention","Transcutaneous Auricular Vagus Nerve Stimulation as an Adjunctive Treatment for Overweight\u002FObese Patients With Poor Weight Loss Response to Lifestyle Intervention: A Single-Center, Randomized, Sham-Controlled Pilot Study","Inclusion Criteria:\n\n1. Completed 12 weeks of lifestyle intervention treatment with ≤5% weight loss during the treatment period;\n2. Completed 12 weeks of lifestyle intervention, with less than 1 month since completion, and achieved ≤5% weight loss during the intervention period;\n3. Current body mass index (BMI) ≥28 kg\u002Fm², or BMI ≥24 kg\u002Fm² with at least one weight-related comorbidity (e.g., hypertension or fatty liver disease);\n4. Willingness to provide written informed consent.\n\nExclusion Criteria:\n\n1. Presence of diseases that may substantially affect body weight homeostasis, including Cushing's syndrome, uncontrolled thyroid disease (thyroid-stimulating hormone \\>6.0 mIU\u002FL or \\\u003C0.4 mIU\u002FL), malignancy, or similar conditions;\n2. Use within the past 3 months of medications that may significantly affect body weight, including glucocorticoids and antipsychotic agents;\n3. Skin infection or damage involving the auricular area;\n4. Women planning pregnancy in the near future;\n5. Inability to complete the 12-week intervention period for practical reasons, such as frequent business travel or planned travel.",{"count":112,"type":21},[114],"This single-center, randomized, single-blind, sham-controlled pilot study aims to evaluate the adjunctive effect of transcutaneous auricular vagus nerve stimulation (taVNS) in overweight\u002Fobese patients who show a poor weight loss response to lifestyle intervention. Participants who achieve no more than 5% weight loss after 12 weeks of lifestyle intervention will be randomized to receive either taVNS plus lifestyle intervention or sham stimulation plus lifestyle intervention for an additional 12 weeks. The primary objective is to compare the percent change in body weight from baseline between the two groups after 12 weeks of intervention. Secondary objectives include evaluation of changes in body composition and fat distribution, autonomic function, liver-related parameters, and glycemic and lipid-related metabolic parameters.",[117],[117,119,482,121],"Lifestyle Intervention",{"date":484,"type":39},"2026-06-05",{"date":486,"type":39},"2026-05-08",{"date":488,"type":21},"2027-03-31",{"name":45,"class":46},{"id":491,"slug":492,"hasResults":12,"nctId":493,"briefTitle":494,"officialTitle":495,"acronym":496,"eligibilityCriteria":497,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":498,"targetDuration":4,"studyType":58,"phases":500,"briefSummary":501,"conditions":502,"keywords":505,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":509,"lastUpdatePostDateStruct":510,"startDateStruct":511,"completionDateStruct":513,"leadSponsor":515,"locationsCount":47},"100638009","prophylactic-antibiotics-in-preventing-surgical-site-infection-after-hepatobiliary-surgery-in-high-resistant-settings-100638009","NCT07620223","Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings","Prophylactic Antibiotics in Preventing Surgical Site Infection After Hepatobiliary Surgery in High-Resistant Settings: A Randomized Clinical Trial","PASH","Inclusion Criteria:\n\n* Adult patients aged ≥18 years;\n* Deemed eligible for elective hepatobiliary surgery;\n* Demonstrated comprehension of the study nature and expressed willingness to comply with trial procedures;\n* Capable of providing written informed consent.\n\nExclusion Criteria:\n\n* History of β-lactam allergy or hypersensitivity\n* Uncontrolled preoperative infection;\n* Current or recent (within the preceding month) systemic corticosteroid administration;\n* Severe hepatic or renal impairment;\n* Pregnancy or lactation;\n* Concurrent enrolment in another clinical trial;\n* Any other condition deemed by the investigator to render the patient unsuitable for study participation.",{"count":499,"type":21},378,[114],"To analyse the efficacy of different preoperative prophylactic antimicrobial regimens for perioperative infection prevention in patients undergoing hepatobiliary surgery in a high antimicrobial resistance setting.",[503,504],"Hepatobiliary Surgery","Prophylactic Antibiotics",[503,506,507,508],"Antimicrobial resistance","Prophylactic antibiotic","Surgical site infection","2026-05-27",{"date":462,"type":39},{"date":512,"type":39},"2026-05-24",{"date":514,"type":21},"2029-01-31",{"name":45,"class":46},{"id":517,"slug":518,"hasResults":12,"nctId":519,"briefTitle":520,"officialTitle":521,"acronym":4,"eligibilityCriteria":522,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":532,"locationsCount":47},"100623664","diagnostic-accuracy-of-a-diquat-quantitative-detection-kit-and-a-portable-mass-spectrometry-system-for-quantifying-diquat-concentrations-in-human-blood-samples-100623664","NCT07399574","Diagnostic Accuracy of A Diquat Quantitative Detection Kit and A Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples","Accuracy, Safety, and Clinical Performance of a Diquat Quantitative Detection Kit (In-Situ Ionization Mass Spectrometry) and a Portable Mass Spectrometry System for Quantifying Diquat Concentrations in Human Blood Samples (Whole Blood\u002FPlasma)","Inclusion Criteria:\n\n1. Patients with suspected or clinically diagnosed acute diquat poisoning, providing whole blood and\u002For plasma samples, including qualified residual specimens retained after prior clinical testing when available.\n2. The participant or their legally authorized representative can fully understand the study purpose and procedures, voluntarily agrees to participate, and is willing and able to comply with the study requirements.\n3. Sample collection is performed according to routine clinical standards, with no apparent ethical concerns related to sample acquisition.\n\nExclusion Criteria:\n\n1. Abnormal sample appearance, such as visible flocculent material or other gross abnormalities.\n2. The participant is unable to provide a specimen, or the specimen does not meet testing requirements.\n3. Any participant considered inappropriate for inclusion by the investigator.",{"count":524,"type":21},60,"This is an observational, non-interventional diagnostic accuracy study designed to evaluate a diquat quantitative detection kit (ambient ionization mass spectrometry method) and a portable mass spectrometry analysis system for measuring diquat concentrations in human blood samples (whole blood\u002Fplasma), using LC-MS\u002FMS as the clinical gold standard for comparison.",[527],"Diquat Poisoning",{"date":509,"type":39},{"date":530,"type":21},"2026-09-01",{"date":156,"type":21},{"name":45,"class":46},{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":538,"acronym":4,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":540,"targetDuration":4,"studyType":58,"phases":541,"briefSummary":542,"conditions":543,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":544,"startDateStruct":545,"completionDateStruct":546,"leadSponsor":548,"locationsCount":4},"100610961","phase-1-accelerated-hemodiafiltration-in-severe-acute-diquat-ahead-poisoning-100610961","NCT07234383","Accelerated HEmodiafiltration in Severe Acute Diquat (AHEAD) Poisoning","Accelerated HEmodiafiltration in Severe Acute Diquat (AHEAD) Poisoning: a Single-center, Single-arm, Open-label, Clinical Trial","Inclusion criteria:\n\n1. Age ≥ 18 years; and\n2. A history of oral exposure to diquat solution, reported by patient(s) or their legal proxies; and\n3. An exposure time (time form exposure to presentation at ED) ≤ 48 hours, reported by patient(s) or their legal proxies; and\n4. Plasma diquat concentration measured upon ED presentation ≥ 1,000 ng\u002FmL.\n\nExclusion criteria:\n\n1. Evidence of co-ingestion of other toxic substances alongside diquat; and\u002For\n2. Withholding of CVVHDF due to limitations on the escalation of life-sustaining therapies; and\u002For\n3. Any CKRT within the previous 2 months; and\u002For\n4. Kidney transplant within the past 365 days; and\u002For\n5. Known pre-hospitalization advanced chronic kidney disease, defined by an estimated glomerular filtration rate calculated using serum creatine (eGFRer) of less than 30 mL\u002Fmin\u002F1.73 m2 by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, if pre-hospitalization serum creatine is available; and\u002For (6) Treating clinician(s) believe(s) that either immediate or deferral of CVVHDF initiation is mandated; and\u002For (7) Pregnant or breast feeding.",{"count":112,"type":21},[169],"Diquat (1,1'-ethylene-2,2'-bipyridinium) is a bipyridine herbicide that shares a similar physicochemical structure and redox cycling mechanism with paraquat. Upon ingestion, it is rapidly absorbed and distributes widely, including gastrointestinal tract, kidneys, liver, skeletal muscle, lungs, myocardium, and central nervous system. Severe diquat poisoning commonly causes toxic encephalopathy, circulatory collapse, and multiorgan dysfunction. Extracorporeal treatments, including hemoperfusion, hemodialysis, and continuous kidney replacement therapy, are frequently used in management. Continuous veno-venous hemodiafiltration (CVVHDF), the most frequently used continuous kidney replacement therapy modality, is primarily indicated for acute kidney injury. Acute kidney injury occurs in up to 73.3% of patients with acute diquat poisoning, and nearly all patients with severe acute diquat poisoning are at risk of developing acute kidney injury. In clinical practice, patients with severe acute diquat poisoning are typically defined as those with a plasma diquat concentration of ≥1000 ng\u002FmL measured at the time of presentation to the emergency department. However, the Extracorporeal Treatments in Poisoning (EXTRIP) workgroup has not issued any definitive recommendations on initiating extracorporeal treatments for diquat poisoning, and the optimal timing for starting CVVHDF has not been evaluated in clinical trials. Current practice typically delays CVVHDF until acute kidney injury occurs. A preliminary retrospective cohort study suggested that, among severe acute diquat poisoning patients treated with combined hemoperfusion and CVVHDF, an interval of \\\u003C30 minutes between hemoperfusion and CVVHDF was associated with a significantly lower risk of death compared with longer intervals (≥30 minutes). Accordingly, this study proposes a single-arm trial (SAT) to determine whether accelerated initiation of CVVHDF immediately following hemoperfusion improves outcomes in patients with severe acute diquat poisoning.",[527],{"date":509,"type":39},{"date":41,"type":21},{"date":547,"type":21},"2030-12-31",{"name":45,"class":46},{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":568,"completionDateStruct":569,"leadSponsor":570,"locationsCount":571},"100638206","multicenter-validation-of-a-risk-prediction-model-for-mdrgnb-infection-100638206","NCT07603128","Multicenter Validation of a Risk Prediction Model for MDRGNB Infection","Prospective Validation of a Risk Prediction Model for MDRGNB Infection: A Multicenter Real-World Prospective Study","PRIOR","Inclusion Criteria:\n\n* Age ≥18 years;\n* ICU stay ≥48 hours;\n* At least one clinical microbiological specimen collected and submitted for testing within 48 hours of ICU admission, with the first submission time designated as the index time;\n* Core predictive variables of the model extractable from electronic medical records or laboratory information systems.\n\nExclusion Criteria:\n\n* For patients with multiple ICU admissions, only the first ICU stay was retained;\n* Missing or indeterminate primary outcome;\n* Missing key predictive variables that could not be handled according to prespecified rules.",{"count":558,"type":21},1000,"This prospective multicenter validation study aimed to evaluate the predictive performance of a previously developed model for MDRGNB infection in ICU patients.",[561],"Infection",[563,564,565,561],"Prediction model","MDRGNB","ICU","2026-05-22",{"date":509,"type":39},{"date":566,"type":39},{"date":156,"type":21},{"name":45,"class":46},11,{"id":573,"slug":574,"hasResults":12,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":4,"eligibilityCriteria":578,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":579,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":592,"locationsCount":47},"100639557","clinical-efficacy-and-population-pharmacokinetics-of--lactams-in-cirrhotic-patients-100639557","NCT07612163","Clinical Efficacy and Population Pharmacokinetics of β-lactams in Cirrhotic Patients","Clinical Efficacy and Population Pharmacokinetics of β-lactams in Patients With Liver Cirrhosis: A Retro-prospective Observational Study","Inclusion Criteria:\n\nAge over 18 years Chinese patient: male or female Liver cirrhosis Diagnosed as bacterial infection Treated by β-lactams Serum concentration determined during therapy\n\nExclusion Criteria:\n\nDuration of β-lactams treatment less than 48 hours Patients renal or liver function not tested before treatment started Using more than two kinds of β-lactams",{"count":558,"type":21},"Patients may benefit from the personalized β-lactams dosing strategy based on pharmacokinetics. The objective of this study is to retrospectively review, prospective observe and analyze the clinical outcomes of patients with liver cirrhosis, and to build a population pharmacokinetics model in the population mentioned above.",[582],"Bacterial Infections",[584,582,585],"β-lactam","Liver cirrhosis","2026-05-21",{"date":588,"type":39},"2026-05-28",{"date":590,"type":39},"2023-12-31",{"date":421,"type":21},{"name":45,"class":46},{"id":594,"slug":595,"hasResults":12,"nctId":596,"briefTitle":597,"officialTitle":598,"acronym":4,"eligibilityCriteria":599,"healthyVolunteers":12,"sex":17,"minAge":600,"maxAge":83,"enrollmentInfo":601,"targetDuration":4,"studyType":58,"phases":603,"briefSummary":604,"conditions":605,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":612,"locationsCount":4},"100638598","structural-mechanisms-of-dual-target-tdcs-in-stroke-hemiparetic-hand-100638598","NCT07605039","Structural Mechanisms of Dual-Target tDCS in Stroke Hemiparetic Hand","Multimodal MRI-Based Study of the Structural Mechanisms Underlying Interhemispheric Network Reorganization Induced by Dual-Target tDCS in Stroke Hemiparetic Hand","Inclusion Criteria:\n\n1. Diagnosed with stroke according to the \"Diagnostic Criteria for Major Cerebrovascular Diseases in China, 2019\", confirmed by cranial CT or MRI.\n2. First-ever unilateral subcortical stroke (involving the corona radiata, basal ganglia, thalamus, internal capsule, etc.).\n3. Age 30-75 years.\n4. Right-handed prior to stroke onset.\n5. Stroke onset ≥ 2 weeks.\n6. Hemiplegic hand function at Brunnstrom Stage I-III.\n7. Written informed consent provided by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Any contraindications to MRI.\n2. History of other neurological disorders or substance abuse.\n3. Unstable conditions or rapidly progressive\u002Fmalignant diseases, e.g., severe atrial fibrillation.\n4. Severe skin allergies.\n5. Inability to cooperate with basic communication or assessments, such as severe aphasia.","30 Years",{"count":602,"type":21},56,[114],"This is a single-center, randomized, single-blind study investigating the effects of dual-target transcranial direct current stimulation (tDCS) combined with task-oriented functional electrical stimulation on upper limb recovery in patients with non-acute post-stroke hemiplegia. A total of 56 participants will be recruited and randomly assigned (1:1) to the dual M1 tDCS group or sham stimulation group. The intervention is delivered five times per week for four weeks, with 20 sessions in total. Multimodal MRI (T1W, T2W, and DTI) will be used to assess structural and network-level reorganization of sensorimotor pathways, including the corticospinal tract, in response to tDCS.\n\nThe primary outcome is the Broetz hand function score, evaluated at baseline, post-intervention, and six-month follow-up. Secondary outcomes include Fugl-Meyer Assessment of the upper extremity (FMA-UE) and multimodal MRI-derived measures of white matter integrity. This study aims to elucidate the structural constraints underlying sensorimotor network lateralization and to identify responder and non-responder profiles based on corticospinal tract damage, providing mechanistic insight into individualized tDCS-based neurorehabilitation after stroke.",[606],"Stroke","2026-05-17",{"date":566,"type":39},{"date":610,"type":21},"2026-05-06",{"date":156,"type":21},{"name":45,"class":46},""]