[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"First Affiliated Hospital of Wenzhou Medical University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":632},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,36,0,25,[9,41,70,95,118,140,161,184,205,226,255,275,296,323,351,383,423,440,459,481,502,534,557,579,608],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100641420","phase-4-the-impact-of-initiating-dotinurad-urate-lowering-therapy-at-different-time-windows-on-gout-flare-resolution-time-100641420",false,"NCT07661030","The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time","The Impact of Initiating Dotinurad Urate-Lowering Therapy at Different Time Windows on Gout Flare Resolution Time: A Multicenter, Randomized, Parallel-Controlled Study","Inclusion Criteria:\n\n* Male or female individuals aged 18-70 years old.\n* Meet the 2015 ACR\u002FEULAR diagnostic criteria of gout.\n* With an onset of acute gout flares within 7 days.\n* With gout experiencing gout flares ≥2 times; or with gout experiencing gout flares 1 time and is younger than 40 years old; or with gout experiencing gout flares 1 time and has a serum uric acid level greater than 480 μmol\u002FL and\u002For has co-morbidities (renal function impairment, hypertension,).\n* Provide a signed written informed consent form.\n\nExclusion Criteria:\n\n* Has secondary hyperuricemia.\n* Serum uric acid level \\\u003C 360 μmol\u002FL.\n* Used IL-1β inhibitors within 6 months before screening.\n* Used uric acid-lowering drugs within 1 month before screening.\n* Used anti-inflammatory drugs within 14 days before screening.\n* Comorbidities with nephrolithiasis or clinical urinary calculi\n* History of kidney transplantation or dialysis.\n* Estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m².\n* AST or ALT \\> 2 times the upper limit of normal.\n* Systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period.\n* White blood cell count \\\u003C 3.5 × 10⁹\u002FL, or platelet count \\\u003C 100 × 10⁹\u002FL, or hemoglobin \\\u003C 90 g\u002FL.\n* Currently in the treatment period of malignant tumors, or within 6 months after the end of the treatment period.\n* Congestive heart failure (New York Heart Association \\[NYHA\\] cardiac function classification II-IV), confirmed ischemic heart disease, peripheral artery disease and\u002For cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).\n* Hypersensitivity to the study drugs or their excipients, or all of urine alkalinizer (potassium citrate\u002Fsodium citrate hydrate compound preparations).\n* Have active gastrointestinal ulcers\u002Fbleeding, or have had a recurrence of ulcers\u002Fbleeding in the past.","ALL","18 Years","70 Years",{"count":21,"type":22},142,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","To confirm that initiating Dotinurad for uric acid uric acid lowering during the acute phase of gout is non-inferior to initiating it after the acute phase of gout has subsided, and to analyze whether initiating Dotinurad treatment during the acute phase will increase the pain level, the recurrence rate of gout, and the inflammatory level of patients.",[28],"Gout","NOT_YET_RECRUITING","2026-06-16",{"date":32,"type":33},"2026-06-22","ACTUAL",{"date":35,"type":22},"2026-07-30",{"date":37,"type":22},"2027-07-30",{"name":39,"class":40},"First Affiliated Hospital of Wenzhou Medical University","OTHER",{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100639078","phase-3-edaravone-dexborneol-for-post-stroke-epilepsy-100639078","NCT07604350","Edaravone Dexborneol for Post-Stroke Epilepsy","A Randomized, Double-blind, Placebo-controlled, Multicenter Clinical Study of Edaravone Dexborneol Sublingual Tablets for the Prevention of Post-Stroke Epilepsy","EDEN-PSE","Inclusion criteria: 1. Adults aged 18 to 80 years, of either sex.\n\n2\\. Diagnosis of acute ischemic stroke confirmed by clinical presentation and neuroimaging (MRI or CT).\n\n3\\. Time from stroke onset to screening\u002Frandomization ≤48 hours.\n\n4\\. High risk of post-stroke epilepsy, defined as a SeLECT-EEG score ≥7, including: stroke severity (Se, 0-2 points), large-artery atherosclerosis etiology (L, 0-1 point), cortical involvement (C, 0-2 points), middle cerebral artery territory infarction (T, 0-1 point), and EEG findings (EEG, 0-2 points).\n\n5\\. No prior history of epilepsy before the index stroke, and no history of other central nervous system disorders (e.g., traumatic brain injury, brain tumor) associated with seizures.\n\n6\\. Conscious at enrollment or with recovered consciousness after treatment, and able to cooperate with sublingual medication administration and follow-up assessments.\n\n7\\. Provision of written informed consent by the patient or a legally authorized representative.\n\nExclusion criteria: 1. History of epilepsy or occurrence of any seizure prior to screening.\n\n2\\. History of ischemic or hemorrhagic stroke within 12 months prior to the index stroke.\n\n3\\. Large cerebral infarction with severe intracranial hypertension on imaging after stroke, with limited life expectancy or inability to complete follow-up.\n\n4\\. Severe renal impairment (significantly reduced eGFR according to contraindications of edaravone dexborneol) or a history of edaravone-related renal injury.\n\n5\\. Severe hepatic dysfunction (ALT or AST \\>3 times the upper limit of normal) or severe heart failure (New York Heart Association class III-IV) that may preclude tolerance to the study drug.\n\n6\\. Known hypersensitivity to edaravone or borneol, or a history of severe drug allergy.\n\n7\\. Pregnant or breastfeeding women; women of childbearing potential unwilling to use effective contraception.\n\n8\\. Presence of other serious diseases (e.g., advanced malignancy) that may affect survival or study compliance.\n\n9\\. Any other condition that, in the investigator's judgment, makes the patient unsuitable for participation in the study.","80 Years",{"count":51,"type":22},160,[53],"PHASE3","This is a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial designed to evaluate the efficacy and safety of Edaravone Dexborneol sublingual tablets in preventing late-onset epilepsy in patients with acute ischemic stroke at high risk.\n\nEligible participants are adults aged 18-80 years with a confirmed diagnosis of acute ischemic stroke by clinical and imaging criteria (MRI or CT), enrolled within 48 hours of stroke onset. High risk for post-stroke epilepsy is defined as a SeLECT-EEG score ≥7. Patients must have no prior history of epilepsy or other central nervous system disorders associated with seizures. Key exclusion criteria include prior seizures before enrollment, recent stroke within the past 12 months, severe renal or hepatic dysfunction, significant cardiac insufficiency, drug hypersensitivity, pregnancy or lactation, and other conditions deemed unsuitable by investigators.\n\nA total of approximately 160 participants will be randomized in a 1:1 ratio to receive either Edaravone Dexborneol sublingual tablets or matching placebo.\n\nThe primary endpoint is a composite outcome assessed within 2 years, defined as the occurrence of either: (1) definite clinical epileptic seizures, or (2) new-onset or worsening epileptiform EEG abnormalities (including IEDs, PDs, LRDAs) or electrographic seizures.\n\nSecondary endpoints include: incidence of individual components of the primary outcome; time to first seizure; characteristics, severity, and frequency of seizures; longitudinal changes and resolution rate of epileptiform EEG activity; cognitive function assessed by MoCA and MMSE; neurological outcomes evaluated by mRS and NIHSS; quality of life and functional independence measured by SSQOL and Barthel Index; recurrence of stroke and all-cause mortality; changes in inflammatory biomarkers (TNF-α, IL-1β, COX-2, iNOS); and safety outcomes including treatment-emergent adverse events, serious adverse events, laboratory abnormalities, and treatment discontinuation due to adverse events.\n\nAll efficacy and safety outcomes will be independently reviewed by a blinded adjudication committee. Statistical analyses will include chi-square or Fisher's exact tests for categorical outcomes, Kaplan-Meier survival analysis with log-rank tests for time-to-event data, and Cox proportional hazards models to adjust for potential confounders.\n\nThe study period is planned from June 2026 to June 2030.",[56,57],"Post-stroke Epilepsy","Post-stroke Seizure",[59,60],"post-stroke epilepsy","edaravone dexborneol","2026-05-20",{"date":63,"type":33},"2026-05-22",{"date":65,"type":22},"2026-06",{"date":67,"type":22},"2030-12",{"name":39,"class":40},1,{"id":71,"slug":72,"hasResults":12,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":69},"100640973","phase-4-evaluating-the-efficacy-and-safety-of-lecanemab-in-alzheimers-disease-through-multi-omics-approachs-100640973","NCT07604896","Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs","Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs","Inclusion Criteria:\n\n* Age: 50 to 90 years old.\n* No gender restrictions.\n* Patients with MCI and mild AD.\n* The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point.\n* Positive Amyloid protein confirmed by amyloid-PET or CSF.\n* There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial.\n* Agree to participate in the research and sign the informed consent form.\n\nExclusion Criteria:\n\n* Patients with cognitive impairment caused by reasons other than AD.\n* There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening.\n* A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects.\n* Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study.\n* There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment.\n* There are contraindications for MRI scans, including the installation of cardiac pacemakers\u002Fdefibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans).\n* There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening.\n* Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group.\n* Surgical operations under general anesthesia are planned to be performed during the research period.\n* Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.","50 Years","90 Years",{"count":80,"type":22},200,[25],"This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment.\n\nThe primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT\u002FOCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.",[84,85,86],"Alzheimer s Disease","Alzheimer Dementia (AD)","MCI-AD, Early Stage Alzheimer's Disease","RECRUITING","2026-05-17",{"date":63,"type":33},{"date":91,"type":33},"2026-01-01",{"date":93,"type":22},"2028-12-31",{"name":39,"class":40},{"id":96,"slug":97,"hasResults":12,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":23,"phases":105,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":4},"100640523","phase-2-nintedanib-with-or-without-dextromethorphan-in-patients-with-idiopathic-pulmonary-fibrosis-ipf-100640523","NCT07583589","Nintedanib With or Without Dextromethorphan in Patients With Idiopathic Pulmonary Fibrosis (IPF)","A Multicenter, Randomized, Double Blind, Placebo-controlled Clinical Study to Evaluate the Treatment of Nidanib With or Without Dextromethorphan in Idiopathic Pulmonary Fibrosis (IPF) Patients.","Inclusion Criteria:\n\n1. Age ≥40 years old, regardless of gender;\n2. According to \"2022 ATS\u002FERS\u002FJRS\u002FALAT Guidelines\", it was diagnosed as idiopathic pulmonary fibrosis (IPF);\n3. Lung function meets the following conditions during screening: forced vital capacity (FVC) ≥45% predicted value; The dispersion of carbon monoxide (DLco, corrected Hb) in a single breath is between 30% and 80% of the predicted value.\n4. HRCT images completed within 12 months before screening can be used to determine UIP mode;\n5. It is expected to complete the whole research plan, including 12 weeks of treatment and 1 week of follow-up;\n6. Willing to follow all the requirements of drug use, visit and data collection during the study period;\n7. Be able to understand the research content and sign the written informed consent;\n8. Women of childbearing age provide negative pregnancy test results, and agree to take effective contraceptive measures during the study period and within 3 months after the last administration; Male subjects with fertility also need to take effective contraception at the same time.\n\nExclusion Criteria:\n\n1. Suffering from other interstitial lung diseases caused by non-IPF reasons (such as connective tissue disease-related ILD, chronic allergic pneumonia, pneumoconiosis, drug-induced pneumonia, radiation lung disease, etc.);\n2. One or more Acute Exacerbation)； of IPF occurred within 3 months before screening;\n3. Have received a lung transplant;\n4. Complicated with severe COPD(GOLD III and above), severe asthma or other airway diseases that may interfere with FVC determination;\n5. The following systemic immunosuppressive treatments were used within 4 weeks before screening: \\> 15 mg\u002Fd prednisone (or equivalent dose), cyclophosphamide, methotrexate, tuzumab, rituximab, mycophenolate mofetil, etc.\n6. Currently or in the past, allergic to Nidanib, dextromethorphan or any of its auxiliary ingredients;\n7. The following laboratory abnormalities exist: ALT or AST \\>3×ULN；; eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²；\n8. Have a history of uncontrolled mental illness, epilepsy, central nervous system dysfunction, or may induce adverse reactions after using dextromethorphan;\n9. Being receiving drugs that may have serious drug interaction with dextromethorphan, such as monoamine oxidase inhibitor (MAOI) and selective serotonin reuptake inhibitor (SSRI), and unable to stop taking drugs;\n10. Pregnant or lactating women;\n11. At the time of screening, there are other major diseases or medical conditions that researchers think will significantly increase the risk and affect the treatment compliance or data interpretation;\n12. Interventional treatment of other clinical trials within 4 weeks before screening.\n13. Use Nidanib or pirfenidone for anti-fibrosis treatment within 8 weeks before screening;","40 Years",{"count":104,"type":22},60,[106],"PHASE2","Nintedanib combined with or without Dextromethorphan for the treatment of IPF, with FVC as the primary efficacy endpoint to evaluate its effectivenes.",[109],"Idiopathic Pulmonary Fibrosis (IPF)","2026-05-08",{"date":112,"type":33},"2026-05-13",{"date":114,"type":22},"2026-05-12",{"date":116,"type":22},"2027-06-01",{"name":39,"class":40},{"id":119,"slug":120,"hasResults":12,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":4,"eligibilityCriteria":124,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":125,"targetDuration":4,"studyType":23,"phases":127,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":69},"100640321","single-port-versus-conventional-laparoscopic-surgery-for-radical-proximal-gastric-cancer-a-randomized-controlled-trial-100640321","NCT07586384","Single-port Versus Conventional Laparoscopic Surgery for Radical Proximal Gastric Cancer: A Randomized Controlled Trial","A Prospective, Single-center, Randomized Control Led Study of Laparoscopic Single-port Surgery System Versus Traditional Laparoscopic Surgery in Radical Proximal Gastric Cancer","Inclusion Criteria:\n\n* Age between 18 and 75 years inclusive.\n\nECOG performance status ≤ 2.\n\nHistologically confirmed proximal gastric cancer or Siewert type II adenocarcinoma of the esophagogastric junction.\n\nClinical stage cT1-T3, N0-N+, M0.\n\nTumor maximum diameter ≤ 4 cm and esophageal invasion ≤ 2 cm.\n\nCandidates for radical proximal gastrectomy (PG) with feasibility of R0 resection and functional anastomosis.\n\nAssessed by a Multidisciplinary Team (MDT) as suitable for PG rather than total gastrectomy, with no requirement for neoadjuvant therapy.\n\nRadiographic evidence of localized disease (no distant metastasis to liver, lung, or peritoneum via enhanced CT or MRI).\n\nASA physical status classification ≤ III.\n\nAdequate bone marrow, hepatic, renal, cardiac, and pulmonary function.\n\nAbility to understand and provide written informed consent.\n\nWillingness and ability to comply with the 12-month postoperative follow-up schedule.\n\nExclusion Criteria:\n\n* Clinical stage T4 or presence of distant metastasis.\n\nEsophageal invasion exceeding 2 cm.\n\nHistory of previous major gastric surgery (e.g., partial or total gastrectomy).\n\nOther malignant tumors within the last 5 years.\n\nSevere organic diseases that preclude safe anesthesia or surgery (e.g., severe heart failure, pulmonary fibrosis).\n\nRequirement for emergency surgery due to active gastric bleeding, perforation, or acute obstruction.\n\nPregnant or lactating women.\n\nSerious psychiatric disorders or cognitive impairment that interferes with study compliance.\n\nAny other condition that, in the opinion of the investigator, would make the participant unsuitable for the study.",{"count":126,"type":22},90,[128],"NA","To evaluate the safety and efficacy of SP1000 and conventional laparoscopy in radical gastrectomy for proximal gastric cancer.",[131,132],"Stomach Neoplasms","Robotic Surgical Procedures",{"date":134,"type":33},"2026-05-14",{"date":136,"type":33},"2025-11-05",{"date":138,"type":22},"2027-09-30",{"name":39,"class":40},{"id":141,"slug":142,"hasResults":12,"nctId":143,"briefTitle":144,"officialTitle":144,"acronym":4,"eligibilityCriteria":145,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":146,"targetDuration":4,"studyType":148,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":4},"100631058","intelligence-system-for-predicting-atezolizumab-bevacizumab-response-and-clinical-outcomes-in-unresectable-hepatocellular-carcinoma-100631058","NCT07495735","Intelligence System for Predicting Atezolizumab-Bevacizumab Response and Clinical Outcomes in Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n* (i) Clinical or pathological diagnosis of HCC;\n* (ii) Administration of atezolizumab-bevacizumab treatment;\n* (iii) At least 18 years old.\n\nExclusion Criteria:\n\n* (i) Lack of key clinical data (laboratory test results), or lack of enhanced CT images taken within one month before treatment;\n* (ii) Comorbid with other malignant tumors;\n* (iii) PS score \\> 2 or Child-Pugh score \\> 7;\n* (iv) Unable to evaluate tumor response;\n* (v) Loss to follow-up.",{"count":147,"type":22},400,"OBSERVATIONAL","This study is a multicenter retrospective clinical research, led by the First Affiliated Hospital of Wenzhou Medical University, and jointly conducted by other sub-centers. The aim is to develop an non-invasive artificial intelligence system for predicting the response and clinical outcomes of patients with unresectable hepatocellular carcinoma (uHCC) to the treatment with atezolizumab combined with bevacizumab (T+A). In response to the clinical situation where approximately half of uHCC patients do not respond to the standard T+A therapy and traditional invasive biopsy is unable to fully reflect the heterogeneity of the tumor microenvironment, this study plans to retrospectively collect the data of 400 patients who met the inclusion and exclusion criteria from January 2020 to November 2025. The study will systematically summarize multi-dimensional data such as enhanced CT images within one month before treatment, baseline characteristics, serum markers, liver disease factors, and tumor stage. By integrating these clinical features with deep learning imageomics features extracted from images, the research team is dedicated to constructing and validating a safe, non-invasive, and reproducible prediction model, with the aim of achieving precise identification of the benefit population before implementing immunotherapy combined with anti-angiogenic treatment, and providing a powerful intelligent tool support for optimizing clinical treatment decisions and improving patient survival prognosis.",[151,152],"HCC - Hepatocellular Carcinoma","Atezolizumab and Bevacizumab in Hepatocellular Carcinoma","2026-03-24",{"date":155,"type":33},"2026-03-27",{"date":157,"type":22},"2026-03-22",{"date":159,"type":22},"2026-12-30",{"name":39,"class":40},{"id":162,"slug":163,"hasResults":12,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":168,"targetDuration":4,"studyType":23,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":69},"100606391","phase-2-ssri-antidepressant-fluoxetine-improving-immunotherapy-efficacy-in-advanced-hepatobiliary-malignancy-patients-with-depression-and-anxiety-100606391","NCT07174947","SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety","SSRI Antidepressant Fluoxetine Improving Immunotherapy Efficacy in Advanced Hepatobiliary Malignancy Patients With Depression and Anxiety: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Age: 18 to 80 years old, both male and female are acceptable.\n* The histopathological\u002Fcytological diagnosis is hepatocellular carcinoma or cholangiocarcinoma. Hepatocellular carcinoma can be diagnosed by imaging.\n* Patients with metastatic advanced or locally advanced liver and gallbladder malignancies;\n* No treatment has been received and a first-line treatment regimen including PD-1 inhibitors \u002FPD-L1 inhibitors is planned to be carried out;\n* Patients with a PHQ-9 score of ≥10 or a GAD-7 score of ≥8, that is, those with positive screening for depression or anxiety;\n* At least one lesion measurable by CT or MRI (with a maximum diameter of ≥0.5cm);\n* ECOG: 0-2;\n* Child-Pugh score ≤7 points;\n* The expected survival period is ≥12 weeks.\n* Baseline blood cell count tests and blood biochemistry must meet the following standards:1) White blood cell count ≥3.0×10\\^9\u002FL; Hemoglobin ≥90 g\u002FL;2) Absolute neutrophil count ≥1.5×10\\^9\u002FL;3) Platelet count ≥100×10\\^9\u002FL;4) Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of the normal upper limit (ULN);5) Total bilirubin ≤ twice ULN;6) Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g\u002FL;\n* The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n\nExclusion Criteria:\n\n* Those with uncorrectable coagulation dysfunction and a distinct bleeding tendency;\n* Patients who currently have unstable or active ulcers or gastrointestinal bleeding;\n* Severe functional insufficiency of vital organs, such as severe cardiopulmonary insufficiency, etc;\n* Patients with hepatic encephalopathy or intractable ascites requiring treatment;\n* A history of mental disorders such as bipolar disorder, schizophrenia, and active suicidal ideation;\n* Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (active is defined as a viral load \\> 20,000 IU\u002FmL), or those who are positive for HBV or HCV and refuse to receive standardized antiviral treatment;\n* Unable to swallow oral medication;\n* Patients allergic to fluoxetine;\n* Currently using drugs that may have serious interactions with fluoxetine;\n* The researchers assessed that the patient was unable or unwilling to comply with the requirements of the research protocol.",{"count":169,"type":22},240,[106],"Advanced liver and gallbladder malignancies (including liver cancer, cholangiocarcinoma and gallbladder cancer) are a type of disease that is difficult to treat, and most patients have a short survival period. In recent years, immunotherapy (such as PD-1\u002FPD-L1 inhibitors) has brought new hope to these patients, but still only a small number of patients can benefit.\n\nResearch has found that approximately 40% of patients with liver and gallbladder tumors have symptoms of depression and anxiety, which not only affect their quality of life but may also reduce the therapeutic effect by influencing immune function. Fluoxetine is a commonly used antidepressant. The latest research shows that in addition to improving mood, it may also enhance the anti-tumor effect of immunotherapy. This study aims to explore whether fluoxetine combined with immunotherapy can better control tumors than immunotherapy alone, prolong the survival period of patients, and at the same time improve the depressive and anxious symptoms and quality of life of patients.",[173,174,175,176],"Hepatobiliary Malignancy","Fluoxetine","Anxiety Disorders","Depression Disorders","2026-03-20",{"date":153,"type":33},{"date":180,"type":33},"2025-10-01",{"date":182,"type":22},"2027-12-01",{"name":39,"class":40},{"id":185,"slug":186,"hasResults":12,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":4,"eligibilityCriteria":190,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":191,"targetDuration":4,"studyType":23,"phases":193,"briefSummary":194,"conditions":195,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":202,"leadSponsor":204,"locationsCount":4},"100622285","phase-2-the-safety-and-efficacy-of-ondansetron-in-reducing-immune-checkpoint-inhibitor-related-toxicities-100622285","NCT07381634","The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities","The Safety and Efficacy of Ondansetron in Reducing Immune Checkpoint Inhibitor-Related Toxicities: A Single-Center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age: 18 to 80 years old, both male and female are acceptable.\n2. The imaging or pathological diagnosis is hepatocellular carcinoma;\n3. It is planned to carry out standard treatment for liver cancer, specifically including lenvatinib + tislelizumab or lenvatinib + pembrolizumab or atezolizumab + bevacizumab.\n4. ECOG score: 0 to 2 points;\n5. Expected survival period ≥12 weeks;\n6. Baseline blood cell count tests and blood biochemistry must meet the following standards:\n\n   White blood cell count ≥3.0×10\\^9\u002FL; Hemoglobin ≥90 g\u002FL; The absolute neutrophil count is ≥1.5×10\\^9\u002FL; Platelet count ≥100×10\\^9\u002FL; Alanine aminotransferase (ALT), aspartate aminotransferase (AST) ≤ 2.5 times the upper limit of normal (ULN). Total bilirubin ≤ twice ULN; Serum creatinine ≤ 1.5 times ULN; Albumin ≥30 g\u002FL;\n7. The subjects voluntarily joined this study, signed the informed consent form, had good compliance and cooperated with the follow-up.\n\nExclusion Criteria:\n\n1. Those who have received treatment with ondansetron within 14 days;\n2. Patients with autoimmune diseases;\n3. Use of systemic glucocorticoids or other immunosuppressants within 14 days;\n4. Those who have previously discontinued ICI treatment due to irAEs;\n5. Those with severe liver dysfunction (Child-Pugh grade C);\n6. Those with contraindications to ondansetron such as serotonin syndrome or phenylketonuria;\n7. Patients allergic to ondansetron;\n8. Those who are currently using drugs that may have serious interactions with ondansetron, such as apopmorphine;\n9. The researcher evaluated that the patient was unable or unwilling to comply with the requirements of the research protocol.",{"count":192,"type":22},134,[106],"This study is a prospective, randomized, single-center randomized controlled clinical trial to investigate the safety and efficacy of ondansetron in reducing the toxicity associated with immune checkpoint inhibitor treatment. This study plans to enroll 134 patients with hepatocellular carcinoma who are scheduled to receive standard ICI treatment. This study will adopt the 2023 CSCO Guidelines for the Management of Immune checkpoint inhibitor-related toxicity as the main assessment criterion, and take the incidence and severity of irAEs as the main observation indicators to evaluate the effectiveness of ondansetron in reducing the toxicity related to immune checkpoint inhibitor treatment in patients with hepatocellular carcinoma.",[196,197],"Hepatocellular Carcinoma (HCC)","IrAE","2026-03-09",{"date":200,"type":33},"2026-03-11",{"date":177,"type":22},{"date":203,"type":22},"2027-06-20",{"name":39,"class":40},{"id":206,"slug":207,"hasResults":12,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":211,"targetDuration":4,"studyType":23,"phases":213,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":69},"100623251","early-phase-1-clinical-study-of-cbg131-car-t-cell-injection-for-the-treatment-of-cldn182-positive-advanced-gastric-and-pancreatic-cancer-100623251","NCT07394205","Clinical Study of CBG131 CAR-T Cell Injection for the Treatment of CLDN18.2-Positive Advanced Gastric and Pancreatic Cancer","Inclusion Criteria:\n\n1. Age 18-70 years (inclusive) at the time of informed consent; sex unrestricted.\n2. Voluntary participation: the subject (or legally authorized representative) must provide written informed consent (ICF, Informed Consent Form).\n3. Histologically confirmed advanced gastric or gastroesophageal junction adenocarcinoma that has progressed after ≥ 2 prior systemic regimens, OR histologically confirmed advanced pancreatic adenocarcinoma that has progressed after ≥ 1 prior systemic regimen.\n4. CLDN18.2 positivity in archival or fresh tumor tissue by immunohistochemistry (IHC): ≥ 40% of tumor cells staining ≥ 2+.\n5. At least one measurable lesion per RECIST 1.1 (longest diameter ≥ 10 mm).\n6. Estimated life expectancy \\> 12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n8. Adequate organ function within 14 days prior to leukapheresis, defined by all of the following:\n\n(1) Total bilirubin ≤ 2 × ULN (Upper Limit of Normal); (2) ALT and AST ≤ 2.5 × ULN (≤ 5 × ULN if liver or bone metastases are present); (3) Calculated creatinine clearance (Cockcroft-Gault) ≥ 50 mL\u002Fmin; (4) Hemoglobin ≥ 90 g\u002FL; (5) White blood cell (WBC) count ≥ 1.5 × 10⁹\u002FL, with documented suitable venous access for leukapheresis and no contraindications to leukapheresis; (6) Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL without Granulocyte Colony-Stimulating Factor (G-CSF) or other myeloid growth factors within 7 days of screening labs; (7) Absolute lymphocyte count ≥ 0.5 × 10⁹\u002FL; (8) Platelet count ≥ 80 × 10⁹\u002FL without transfusion within 7 days of screening labs; (9) Prothrombin time (PT) prolongation ≤ 4 s above ULN; (10) Oxygen saturation ≥ 95% on room air. 9: Contraception and pregnancy requirements: Women of childbearing potential (WOCBP) must have a negative serum pregnancy test at screening and again before lymphodepleting chemotherapy; must not be breastfeeding. WOCBP and fertile men must use a highly effective contraceptive method from screening until 12 months after CBG131 infusion or study discontinuation, whichever is later.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women.\n2. Active bacterial or fungal infection within 72 h before lymphodepletion. Subjects receiving prophylactic antibiotics, antifungals or antivirals are allowed if there is no evidence of active infection and the agents are not on the prohibited-medication list.\n3. Systemic corticosteroids equivalent to \\> 15 mg\u002Fday prednisone within 2 weeks before leukapheresis (inhaled or topical steroids permitted). Any systemic glucocorticoids within 7 days before leukapheresis, except inhaled or topical preparations.\n4. Live-attenuated vaccine within 4 weeks before leukapheresis or planned during the study.\n5. Positive HBsAg or HBcAb with HBV-DNA ≥ ULN; positive HCV antibody with detectable HCV RNA; positive HIV antibody; positive syphilis serology.\n6. Prior hypersensitivity to immunotherapy, cyclophosphamide, fludarabine, albumin-bound paclitaxel, tocilizumab, or any component of CBG131 (e.g. DMSO), or other significant allergic history.\n7. Anti-cancer therapy within 2 weeks before leukapheresis (or 5 half-lives, whichever is shorter), including surgery, systemic chemotherapy, radiotherapy, interventional procedures, or anti-PD-1\u002FPD-L1 monoclonal antibody (mAb)\u002FClaudin18.2-targeted agents\u002Fother investigational drugs within 4 weeks (or 5 half-lives).\n8. Prior gene-engineered cellular therapy (e.g. CAR-T, TCR-T, TIL).\n9. Major surgery within 4 weeks before leukapheresis or significant trauma, or anticipated major surgery during the study (except cataract or local-anaesthetic procedures).\n10. Known or suspected brain metastases.\n11. Portal-vein tumor thrombus or tumor thrombus in mesenteric\u002Finferior vena cava on imaging.\n12. Central or extensive pulmonary metastases, extensive liver metastases, or widespread bone metastases.\n13. History of organ transplantation or on transplant waiting list.\n14. Uncontrolled or serious illnesses that could limit participation, including: Diabetes with HbA1c \\> 8%, uncontrolled hypertension (\\> 160\u002F100 mmHg), Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%, congestive heart failure, acute MI, severe arrhythmia, unstable angina within 6 months, pulmonary embolism, COPD, ILD, clinically significant pulmonary-function abnormalities; Active peptic ulcer, active GI bleeding, bleeding diathesis, major GI bleed within 3 months, prior immunotherapy-related bleeding, hypotension requiring vasopressors.\n15. Deep ulceration of primary tumor, full-thickness infiltration at anastomotic recurrence, or tumor encasing\u002Finvading major vessels on CT\u002FMRI ± endoscopy, carrying high risk of bleeding or perforation.\n16. Requirement for warfarin or heparin anticoagulation.\n17. Chronic antiplatelet therapy at doses exceeding aspirin 100 mg\u002Fday or clopidogrel 75 mg\u002Fday.\n18. Toxicities from prior therapies not resolved to ≤ Grade 1 or baseline (except alopecia, pigmentation, or laboratory abnormalities allowed by protocol) at informed-consent signature.\n19. Clinically significant CNS disease, abnormal neurologic findings, or psychiatric disorder.\n20. Other malignancies within 5 years (except adequately treated cervical carcinoma in situ or basal-cell skin cancer).\n21. Clinically relevant thyroid dysfunction (TT4, TT3, FT3, FT4, TSH outside normal limits per investigator).\n22. Active autoimmune disease (e.g. psoriasis, RA) or any condition requiring chronic immunosuppressive therapy.\n23. Known or suspected CNS metastases.\n24. Single target lesion \\> 4 cm in longest diameter (or \\> 4 cm short axis for lymph nodes) before leukapheresis.\n25. Symptomatic ascites or ascites requiring repeated paracentesis or intraperitoneal therapy; small-volume radiologic ascites permitted if asymptomatic.\n26. Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation.",{"count":212,"type":22},18,[214],"EARLY_PHASE1","The goal of this clinical trial is to learn if CBG131 works to treat advanced gastric cancer or pancreatic cancer in adults whose tumors are CLDN18.2-positive. It will also learn about the safety of CBG131 and find the best dose to use.\n\nThe main questions it aims to answer are:\n\nIs CBG131 safe, and what medical problems do participants have when receiving it? Does CBG131 shrink tumors in participants with CLDN18.2-positive cancers? How long do the CAR-T cells stay and work in the body? Researchers will test different doses of CBG131 to see which dose is safest and most effective. This is an early-stage trial, so there is no placebo group-everyone who joins will receive the actual treatment.\n\nParticipants will:\n\nHave their blood cells collected through a procedure called leukapheresis (so the CAR-T cells can be made).\n\nReceive chemotherapy for 3 days to prepare their body for the CAR-T cells Get a single infusion of CBG131 CAR-T cells through an IV. Visit the clinic frequently for the first month, then regularly for 2 years for checkups, blood tests, and tumor assessments.\n\nKeep track of their symptoms and any side effects they experience.",[217],"Advanced Gastric and Pancreatic Cancer","2026-02-01",{"date":220,"type":33},"2026-02-06",{"date":222,"type":22},"2026-09-30",{"date":224,"type":22},"2030-01-31",{"name":39,"class":40},{"id":227,"slug":228,"hasResults":12,"nctId":229,"briefTitle":230,"officialTitle":231,"acronym":4,"eligibilityCriteria":232,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":233,"enrollmentInfo":234,"targetDuration":4,"studyType":23,"phases":236,"briefSummary":237,"conditions":238,"keywords":240,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":247,"lastUpdatePostDateStruct":248,"startDateStruct":250,"completionDateStruct":252,"leadSponsor":254,"locationsCount":69},"100619694","phase-2-a-single-center-phase-ii-study-on-efficacy--safety-of-scrtcapoxserplulimabbevacizumab-for-mss-rectal-cancer-100619694","NCT07347951","A Single-center, Phase II Study on Efficacy & Safety of SCRT+CAPOX+Serplulimab+Bevacizumab for MSS Rectal Cancer","A Single-Center, Prospective, Phase II Clinical Study to Evaluate the Preliminary Efficacy and Safety of Short-Course Radiotherapy Followed by CAPOX Chemotherapy Combined With Serplulimab and Bevacizumab as Total Neoadjuvant Therapy for MSS-Type, Mid-Low Locally Advanced Rectal Cancer","Inclusion Criteria:\n\n* Patients who have a desire to preserve the anus and are willing to receive the entire course of neoadjuvant therapy.\n\n  * Aged between 18 and 75 years, with no gender restrictions.\n\n    * Diagnosed via pelvic MRI and rectoscopy with a tumor located ≤10 cm from the anal verge, with a clinical stage of cT3-4N0\u002F+M0, and lymph nodes confined within the mesorectum.\n\n      * Histologically diagnosed with rectal adenocarcinoma; genetic testing indicates MSS or MSI-L, or immunohistochemistry of tumor biopsy indicates pMMR (positive for MSH1, MSH2, MSH6, and PMS2 proteins).\n\n        * ECOG performance status score of 0-1.\n\n          ⑥ No prior antitumor therapy, immunotherapy, anti-angiogenic therapy, or pelvic radiotherapy before inclusion.\n\n          ⑦ Laboratory tests must meet the following criteria: i. White blood cell count ≥3.5×10⁹\u002FL, absolute neutrophil count ≥1.8×10⁹\u002FL, platelet count ≥100×10⁹\u002FL, and hemoglobin ≥100 g\u002FL; ii. INR ≤1.5, and APTT ≤1.5 times the upper limit of normal, or partial thromboplastin time (PTT) ≤1.5 times the upper limit of normal; iii. Total bilirubin ≤1.25 times the upper limit of normal; ALT and AST ≤3 times the upper limit of normal; serum albumin ≥28 g\u002FL; iv. 24-hour creatinine clearance rate ≥50 mL\u002Fmin or serum creatinine ≤1.5 times the upper limit of normal.\n\n          ⑧ Willing to participate in this study voluntarily, sign the informed consent form, and comply with the scheduled outpatient visits and related procedural requirements to complete follow-up.\n\nExclusion Criteria:\n\n* In addition to a confirmed diagnosis of rectal cancer, there is a current or past history of active malignant tumors.\n\n  * Patients with metastases to other sites indicated by preoperative staging.\n\n    * Patients with suspicious positive lymph nodes in non-draining areas of the rectum, such as the internal and external iliac lymph nodes, as assessed by preoperative MRI or CT.\n\n      * Patients requiring emergency surgery due to complications such as intestinal obstruction, intestinal perforation, or intestinal hemorrhage.\n\n        * Patients with severe comorbid conditions and an estimated life expectancy of ≤5 years.\n\n          * Patients with known allergies to any components in the study.\n\n            ⑦ Patients who have received immunosuppressive or systemic corticosteroid therapy for immunosuppressive purposes within 30 days prior to the initiation of study treatment.\n\n            ⑧ Patients who have received any other investigational drug treatment (including immunotherapy) or participated in another interventional clinical trial within 30 days prior to screening.\n\n            ⑨ Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other severe diseases requiring combined treatment (including psychiatric disorders), and severe laboratory abnormalities.\n\n            ⑩ Patients with congenital or acquired immunodeficiency (such as HIV infection).\n\n            ⑪ Vulnerable populations, including individuals with psychiatric disorders, cognitive impairments, critically ill patients, minors, pregnant women, illiterate individuals, etc.\n\n            ⑫ Other circumstances where, in the investigator's judgment, the patient is deemed unsuitable to participate in the clinical trial.","75 Years",{"count":235,"type":22},30,[106],"In a single-center, prospective, phase II study (ClinicalTrials registration number: \\[to be filled in\\]) initiated by our center to evaluate the safety and preliminary efficacy of short-course radiotherapy followed by sequential CAPOX chemotherapy combined with serplulimab and bevacizumab as total neoadjuvant therapy for MSS-type mid-low locally advanced rectal cancer, patients with mid-low MSS-type locally advanced rectal adenocarcinoma were enrolled. They received short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy. It is anticipated that 30 subjects with locally advanced rectal cancer will be enrolled between September 2025 and September 2027.\n\nThis phase II exploratory study targets patients with locally advanced mid-low MSS\u002FpMMR rectal cancer. It employs short-course radiotherapy combined with CAPEOX, serplulimab, and bevacizumab as preoperative total neoadjuvant therapy, aiming to clarify the efficacy and safety of this new combined radiotherapy, chemotherapy, targeted therapy, and immunotherapy approach, while also assessing the rectal\u002Fanal preservation rate and quality of life of patients. After neoadjuvant therapy, patients will undergo imaging and endoscopic evaluations to determine subsequent treatment strategies. Radical surgical resection will be performed on patients after neoadjuvant immunotherapy, followed by further analysis of the pathological complete response (pCR) rate. The primary study endpoint is the pCR rate, and secondary study endpoints include the objective response rate, organ preservation rate, 3-year disease-free survival (DFS), 3-year overall survival (OS), incidence of adverse events, and quality of life scores (EORTC QLQ-C30, EORTC QLQ-CR29, Wexner).",[239],"Locally Advanced Rectal Cancer (LARC)",[241,242,243,244,245,246],"Rectal cancer","MSS","neoadjuvant immunotherapy","neoadjuvant chemoradiotherapy","Target therapy","locally advanced","2026-01-11",{"date":249,"type":33},"2026-01-16",{"date":251,"type":33},"2025-12-01",{"date":253,"type":22},"2030-12-01",{"name":39,"class":40},{"id":256,"slug":257,"hasResults":12,"nctId":258,"briefTitle":259,"officialTitle":260,"acronym":4,"eligibilityCriteria":261,"healthyVolunteers":12,"sex":17,"minAge":102,"maxAge":19,"enrollmentInfo":262,"targetDuration":4,"studyType":23,"phases":264,"briefSummary":265,"conditions":266,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":272,"leadSponsor":274,"locationsCount":69},"100614817","intelligent-precision-knee-preservation-system-for-knee-osteoarthritis-100614817","NCT07284524","Intelligent Precision Knee Preservation System for Knee Osteoarthritis","The Dynamic Dual-Mode Alignment Optimization and Intelligent Precision Knee Preservation System for Knee Osteoarthritis","Inclusion Criteria:\n\n1. Age between 40 and 70 years;\n2. Unilateral medial compartment knee osteoarthritis (mild to moderate pain);\n3. Mild to moderate varus deformity (5°-15°);\n4. Coronal MRI showing medial meniscus extrusion (MME) \\>3 mm and flexion contracture \\\u003C10°;\n5. Intact lateral meniscus and articular cartilage;\n\nExclusion Criteria:\n\n1. Patients with concomitant inflammatory arthritis (e.g., rheumatoid arthritis) or systemic inflammatory diseases;\n2. Patients with severe varus deformity (\\>10°) or flexion contracture \\>10°;\n3. Patients with lateral meniscus pathology (tear, discoid meniscus) or knee joint instability;\n4. Patients with a history of major knee trauma, infection, or prior knee surgery;\n5. Patients with severe patellofemoral osteoarthritis;\n6. Patients with advanced medial compartment osteoarthritis (bone-on-bone contact or knee subluxation);\n7. Patients who refuse second-look arthroscopy or participation in the study;\n8. Patients unable to complete at least 12 months of follow-up;\n9. Patients with severe osteoporosis;\n10. Patients with cognitive impairment.",{"count":263,"type":22},150,[128],"The goal of this clinical trial is to verify whether the \"dynamic dual-mode alignment optimization + intelligent precision knee-preserving system\" (integrating static\u002Fkinematic target alignment, CT-based preoperative three-dimensional \\[3D\\] planning, 3D-printed guide plates, and intraoperative augmented reality \\[AR\\] real-time feedback) achieves a greater relative reduction in peak knee adduction moment (KAM) at 12 months postoperatively, while maintaining or improving knee clinical function and without increasing perioperative or long-term complication rates, compared with traditional knee-preserving strategies. The target population is patients aged 40-70 years with knee osteoarthritis (KOA; Kellgren-Lawrence grade II-III) who require high tibial osteotomy (HTO) for unilateral medial-compartment disease with mild-to-moderate varus deformity and who meet the inclusion and exclusion criteria.\n\nThe main questions are:\n\n* Can the dynamic dual-mode alignment + intelligent precision system achieve a greater relative reduction in peak KAM at 12 months postoperatively than traditional knee-preserving strategies?\n* Can this system improve static alignment accuracy, dynamic load parameters (e.g., KAM impulse and varus thrust), and patient-reported outcome (PRO) scores without increasing complication rates?\n* Can 3D-printed patient-specific instrumentation (PSI) guide plates and real-time AR feedback reduce intraoperative radiation exposure and shorten operative time compared with traditional methods?\n\nResearchers will compare:\n\nKinematic alignment (KA), traditional mechanical alignment (MA), and dynamic dual-mode alignment (DA) to evaluate the relative performance of alignment strategies;\n\n3D-printed PSI-guided HTO versus traditional fluoroscopy-guided HTO to assess the efficacy of PSI; and\n\nAR-assisted intraoperative adjustment versus traditional fluoroscopy-based adjustment to evaluate the precision of AR navigation.\n\nParticipants will:\n\n* Complete preoperative assessments, including laboratory tests (complete blood count, biochemistry, coagulation), imaging (full-length, weight-bearing lower-limb radiographs; knee CT and\u002For MRI as indicated), 3D gait analysis (to measure KAM, KAM impulse, and varus thrust), and PRO assessments (KOOS, WOMAC, and Lysholm scores)\n* Receive assigned surgical interventions: the DA group will undergo HTO guided by dual-mode alignment plus 3D-printed PSI and intraoperative AR feedback; the MA and KA groups will undergo HTO based on traditional or kinematic alignment, respectively; the traditional HTO group will undergo surgery relying on intraoperative fluoroscopy and surgeon experience.\n* Attend follow-up visits at 6 weeks, 3 months, 6 months, and 12 months postoperatively, including imaging to assess alignment accuracy and bone healing, gait analysis, PRO assessments, and complication monitoring.\n* Record medication use and rehabilitation compliance throughout the study period.",[267],"Knee Osteoarthritis (Knee OA)","2025-12-02",{"date":270,"type":33},"2025-12-16",{"date":91,"type":22},{"date":273,"type":22},"2027-06-30",{"name":39,"class":40},{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":233,"enrollmentInfo":283,"targetDuration":4,"studyType":23,"phases":285,"briefSummary":286,"conditions":287,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":293,"leadSponsor":295,"locationsCount":4},"100612967","the-efficacy-and-safety-of-laparoscopic-proximal-gastrectomy-with-lpg-tbrosf-versus-ltg-for-localized-proximal-gastric-cancer-100612967","NCT07260461","The Efficacy and Safety of Laparoscopic Proximal Gastrectomy With LPG-tbROSF Versus LTG for Localized Proximal Gastric Cancer.","A Multicenter, Prospective, Randomized Controlled Clinical Trial on the Efficacy and Safety of Laparoscopic Proximal Gastrectomy With Tubular Stomach-Based Right-Opening Single Flap Valvuloplasty (LPG-tbROSF) Versus Laparoscopic Total Gastrectomy for Localized Proximal Gastric Cancer.","Inclusion Criteria:\n\n1. Aged from 18 to 75 years old;\n2. Histologically confirmed proximal gastric adenocarcinoma, CT1-2N0M0 stage;\n3. The tumor was located in the proximal third of the stomach.\n4. ECOG score of 0 or 1;\n5. D1+ or D2 dissection according to guidelines (depending on tumor location and intraoperative evaluation).\n6. ASA grade I to III;\n7. The preoperative nutritional status of the patients was good without severe malnutrition.\n8. Voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. Concurrent with other active malignant tumors, or a history of other malignant tumors within 5 years (excluding basal cell carcinoma of the skin and carcinoma in situ of the cervix);\n2. Severe cardiovascular diseases: such as NYHA class Ⅲ and above cardiac dysfunction, recent myocardial infarction (within 6 months), refractory hypertension or arrhythmia;\n3. Severe respiratory diseases: severe impairment of lung function (FEV1%\\\u003C50%) or chronic respiratory failure;\n4. Severe liver and kidney dysfunction: ALT\u002FAST \\> 3 times the upper limit of normal, or eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m²;\n5. patients complicated with other major chronic diseases, such as active tuberculosis, rheumatoid, systemic lupus erythematosus and other autoimmune diseases that affect surgical tolerance;\n6. Tumor imaging suggested the presence of distant metastasis (M1) or regional lymph node involvement, and the tumor was unresectable.\n7. Complicated with other upper gastrointestinal diseases, such as active gastric ulcer, pyloric obstruction, persistent bleeding, which seriously affect the operation;\n8. Previous major gastric or upper abdominal surgery (such as subtotal gastrectomy, esophagogastric anastomosis, etc.) affecting the reconstruction method;\n9. Received preoperative neoadjuvant chemoradiotherapy or targeted therapy (unless specifically permitted by the study design);\n10. Pregnant or lactating women;\n11. Patients with mental disorders, cognitive impairment, poor compliance, inability to understand the study content, or inability to cooperate with the follow-up;\n12. Severe malnutrition before surgery: BMI \\\u003C 16 kg\u002Fm² or albumin \\\u003C 25 g\u002FL;\n13. Other individual conditions deemed unsuitable for enrollment by the investigator (e.g., poor willingness to cooperate, high risk of loss to follow-up, etc.).","15 Years",{"count":284,"type":22},120,[128],"This clinical trial is evaluating a new, function-preserving surgical technique for patients with early-stage cancer in the upper part of the stomach.\n\nThe current standard treatment is a Laparoscopic Total Gastrectomy (LTG), which involves the complete removal of the stomach. This study compares the standard LTG with an innovative procedure called Laparoscopic Proximal Gastrectomy combined with a novel anti-reflux reconstruction (LPG-tbROSF). This new technique removes only the cancerous upper portion of the stomach, aiming to preserve digestive functions and reduce post-surgery complications like acid reflux.\n\nThe main goal is to see if patients who receive the new, stomach-preserving surgery experience less body weight loss one year after the procedure compared to those who undergo the standard total gastrectomy. The research will also compare the two surgeries in terms of post-operative quality of life, nutritional status, acid reflux symptoms, safety, and long-term cancer outcomes.\n\nThe study is a multi-center, prospective, randomized controlled trial that plans to enroll 120 patients with localized cancer in the upper stomach.",[131,288,289],"Adenocarcinoma - Gastroesophageal Junction (GEJ)","Gastroesophageal Junction Cancer",{"date":291,"type":33},"2025-12-03",{"date":91,"type":22},{"date":294,"type":22},"2028-09-01",{"name":39,"class":40},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":304,"minAge":18,"maxAge":233,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":308,"conditions":309,"keywords":311,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":69},"100612536","phase-2-combined-chemo-immunotherapy-plus-sbrt-in-neoadjuvant-treatment-for-luminal-subtype-breast-cancer-100612536","NCT07254858","Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer","Combined Chemo-immunotherapy Plus SBRT in Neoadjuvant Treatment for Luminal Subtype Breast Cancer: A Prospective Multicenter Randomized Controlled Trial","CISN-L","Inclusion Criteria:\n\n1. Newly diagnosed, untreated breast cancer;\n2. Age: 18 years ≤ age ≤ 75 years;\n3. Histologically confirmed hormone receptor-positive (HR+) tumor specimen (estrogen receptor \\[ER\\] ≥ 10%);\n4. Human epidermal growth factor receptor-2 immunohistochemistry (HER2-IHC) result of 0\u002F1+ or 2+ with negative fluorescence in situ hybridization (FISH) test;\n5. Histologically confirmed cell proliferation index (Ki67) ≥ 20%;\n6. Programmed death-ligand 1 combined positive score (PD-L1 CPS) evaluable (i.e., availability of fresh\u002Farchived specimens);\n7. Good pulmonary function;\n8. Adequate hepatic and renal function;\n9. Histological grade ≥ 2;\n10. cN0, cT ≥ 3 cm or cN1-3, cT ≥ 2 cm (cT: clinically assessed maximum diameter of primary tumor; cN: clinically assessed regional lymph node status);\n11. Eastern Cooperative Oncology Group Performance Status (ECOG score) 0-1. Exclusion Criteria:\n\n1.Pregnancy; 2.Tumor \\> 8 cm with skin ulceration; 3.History of thoracic radiotherapy or contraindications to radiotherapy; 4.Active autoimmune disease; 5.Prior use of PD-L1 antibody therapy; 6.De novo breast cancer; 7.There are factors that may significantly increase the risk of lung or cardiac toxicity related to radiotherapy, such as (1) maximum lung depth(MLD) \\>3.2cm； (2) maximum heart distance(MHD) \\\u003C2.4cm。","FEMALE",{"count":306,"type":22},302,[106],"This study is a prospective, randomized controlled clinical trial designed to evaluate the efficacy and safety of combining radiotherapy, chemotherapy, and immunotherapy in the neoadjuvant treatment of high-risk HR+\u002FHER2- breast cancer patients.\n\nThe study plans to enroll treatment-naïve HR+\u002FHER2- breast cancer patients aged 18-75 with high-risk features (e.g., tumor size ≥3 cm or lymph node positivity, Ki-67 ≥20%). Eligible subjects will be randomized in a 1:1 ratio into two groups: the control group will receive neoadjuvant chemotherapy (nab-paclitaxel followed by epirubicin + cyclophosphamide) in combination with sintilimab immunotherapy; the experimental group will receive the same chemotherapy and immunotherapy regimen with the addition of stereotactic body radiotherapy (SBRT) administered early during treatment, at a prescribed dose of 8 Gy per fraction for 3 fractions, with one fraction per day.\n\nThe study has dual primary endpoints: pathological complete response (pCR,) and objective response rate (ORR ). Secondary endpoints include 3-year event-free survival (EFS), incidence of adverse events (CTCAE v5.0), and postoperative cosmetic outcomes of the breast. The study design incorporates hierarchical testing to control for multiplicity, and long-term follow-up is planned to evaluate survival benefits.\n\nThe study has been approved by the ethics committee, and all participants are required to provide written informed consent. The results are expected to offer a novel neoadjuvant treatment strategy for high-risk HR+\u002FHER2- breast cancer patients and improve their therapeutic outcomes.",[310],"HR+\u002FHER2- Breast Cancer",[312,313,314],"Breast Cancer","Radiotherapy","Immunotherapy","2025-11-20",{"date":317,"type":33},"2025-11-28",{"date":319,"type":22},"2025-12",{"date":321,"type":22},"2029-12-30",{"name":39,"class":40},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":233,"enrollmentInfo":330,"targetDuration":4,"studyType":23,"phases":332,"briefSummary":334,"conditions":335,"keywords":337,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100607551","phase-1-immunodynamics-guided-optimization-of-individualized-immunochemotherapy-in-advanced-driver-negative-nsclc-a-randomized-trial-100607551","NCT07190027","Immunodynamics-Guided Optimization of Individualized Immunochemotherapy in Advanced Driver-Negative NSCLC: A Randomized Trial","Prospective Randomized Controlled Trial of Immunodynamics-Guided Optimization of Individualized Immunochemotherapy Infusion Timing in Driver Gene-Negative Advanced Non-Small Cell Lung Cancer","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\nVoluntarily agree to participate, sign the informed consent form (ICF), and be able to comply with the study procedures.\n\nAge ≥18 years and ≤75 years at enrollment, both male and female participants are eligible.\n\nHistologically or cytologically confirmed stage IV non-small cell lung cancer (NSCLC) based on the AJCC 8th edition; if mixed histology exists, classification must be based on the predominant histologic component. Presence of small-cell histology excludes eligibility.\n\nNegative for actionable driver mutations: no EGFR mutations, ALK rearrangements, or ROS1 fusions. For other targetable alterations (e.g., BRAF V600E, NTRK1\u002F2\u002F3 fusions, MET exon 14 skipping, RET rearrangements), patients are excluded if FDA- or NMPA-approved targeted therapies are available.\n\nNote: Genetic testing can be conducted locally or via a central laboratory. Pre-existing valid reports are acceptable.\n\nEstimated life expectancy ≥3 months. At least one measurable lesion per RECIST v1.1 confirmed by IRC; irradiated lesions are not considered measurable unless unequivocal progression is demonstrated.\n\nECOG performance status of 0 or 1. No prior systemic therapy for advanced\u002Fmetastatic NSCLC, except adjuvant or neoadjuvant chemotherapy if the last dose was ≥6 months before recurrence.\n\nAdequate organ and bone marrow function within 14 days prior to randomization:\n\nANC ≥ 1.5 × 10⁹\u002FL Platelets ≥ 100 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula) Total bilirubin ≤ 1.5 × ULN (≤3 × ULN for Gilbert's syndrome) AST\u002FALT ≤ 2.5 × ULN (≤5 × ULN if liver metastases) INR and APTT ≤ 1.5 × ULN unless on therapeutic anticoagulation LVEF ≥ 50% by echocardiography or MUGA Female patients of childbearing potential must test negative for pregnancy within 14 days before enrollment and agree to use effective contraception from ICF signing until 180 days after the last dose. Male participants must also agree to effective contraception during the same period.\n\nExclusion Criteria:\n\nParticipants meeting any of the following are excluded:\n\nPrior thoracic radiotherapy \\>30 Gy within 6 months before first dose. Palliative radiotherapy within 7 days before first dose. Requirement for concurrent anti-tumor therapy during the study. Uncontrolled or symptomatic pleural, pericardial, or peritoneal effusions requiring repeated drainage.\n\nBrainstem, leptomeningeal, spinal cord metastases, or cord compression.\n\nActive CNS metastases or carcinomatous meningitis. Treated, stable brain metastases are allowed if:\n\nClinically stable ≥2 weeks, No evidence of progression, Off corticosteroids ≥3 days prior to treatment initiation. Previous treatment with immune checkpoint inhibitors (PD-1\u002FPD-L1, CTLA-4, etc.), immune agonists, or cellular immunotherapies.\n\nUse of traditional Chinese medicines or immunomodulatory drugs with anti-cancer activity within 2 weeks before first dose.\n\nSystemic corticosteroids (\\>10 mg prednisone equivalent\u002Fday) or other immunosuppressants within 2 weeks prior to first dose.\n\nUncontrolled systemic infection, unexplained fever \\>38.5°C, or IV antibiotic use \\>7 days within 2 weeks prior to first dose.\n\nHistory of other malignancies within the past 5 years, except adequately treated cervical carcinoma in situ, basal\u002Fsquamous cell skin cancer, localized thyroid papillary carcinoma, prostate cancer in remission, or DCIS after curative surgery.\n\nActive or history of autoimmune disease, including but not limited to: autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.\n\nControlled hypothyroidism with hormone replacement is eligible. Vitiligo, alopecia, type 1 diabetes, resolved childhood asthma, or mild psoriasis without systemic therapy are allowed.\n\nClinically significant pulmonary diseases: e.g., steroid-requiring pneumonitis, drug-induced pneumonitis, or moderate-to-severe COPD.\n\nMajor surgery within 4 weeks prior to first dose or unresolved surgical wounds.\n\nSignificant cardiovascular diseases, including:\n\nMI, unstable angina, stroke, or TIA within 6 months Arterial thromboembolism within 6 months DVT, PE, or severe thrombosis within 3 months Uncontrolled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) Myocarditis or NYHA III-IV heart failure History of allogeneic HSCT or organ transplantation (except corneal).\n\n≥ Grade 2 peripheral neuropathy per CTCAE v5.0. Active tuberculosis or suspected TB not ruled out. Positive HIV antibody; active syphilis or untreated positive non-treponemal antibody; uncontrolled HBV\u002FHCV infection per protocol definition.\n\nLive vaccine administration within 30 days before first dose or planned during study.\n\nHistory of severe hypersensitivity to monoclonal antibodies, PD-1 agents, pemetrexed, carboplatin, or premedications.\n\nConcurrent participation in another interventional clinical trial or use of other investigational products\u002Fdevices within 4 weeks prior to first dose.\n\nHistory of drug\u002Falcohol abuse or uncontrolled psychiatric disorders interfering with compliance.\n\nAny other condition judged by the investigator as inappropriate for study participation.",{"count":331,"type":22},246,[333,106],"PHASE1","The goal of this clinical trial is to evaluate whether individualized sequencing of immunotherapy and chemotherapy based on immune dynamics can improve treatment outcomes in adults with advanced non-small cell lung cancer (NSCLC) without driver gene mutations. This study will also assess the safety and feasibility of different infusion strategies.\n\nThe main questions it aims to answer are:\n\nDoes optimizing the timing of PD-1 inhibitor infusion relative to chemotherapy improve the objective response rate (ORR)?\n\nDoes individualized infusion sequencing enhance progression-free survival (PFS) compared to standard or fixed-delay administration?\n\nWhat safety concerns or immune-related adverse events occur with different infusion timing strategies?\n\nResearchers will compare three treatment strategies:\n\nGroup A (Standard Concurrent Group): Immunotherapy and chemotherapy administered on the same day (D1).\n\nGroup B (Fixed Delay Group): Chemotherapy on D1, followed by PD-1 inhibitor infusion on Day 3.\n\nGroup C (Individualized Delay Group): Chemotherapy on D1, and PD-1 inhibitor infusion scheduled on D2-D6 based on daily immune monitoring.\n\nParticipants will:\n\nReceive a PD-1 inhibitor (e.g., sintilimab, pembrolizumab, camrelizumab) combined with platinum-based chemotherapy.\n\nAttend clinic visits for regular immune monitoring, imaging assessments, and safety checks during each treatment cycle.\n\nUndergo blood tests to evaluate immune biomarkers (e.g., CD8⁺PD-1⁺ T cells, MDSC, Treg、IFN-γ、NLR、ALC、CRP) to guide individualized treatment decisions.",[336],"Advanced Non-Small Cell Lung Cancer (NSCLC)",[338,339,340,341,342],"Non-Small Cell Lung Cancer (NSCLC)","Driver Gene-Negative NSCLC","Immunochemotherapy Sequencing","Individualized Infusion Timing","Immune Dynamics","2025-09-22",{"date":345,"type":33},"2025-09-24",{"date":347,"type":22},"2025-11",{"date":349,"type":22},"2028-11",{"name":39,"class":40},{"id":352,"slug":353,"hasResults":12,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":12,"sex":17,"minAge":358,"maxAge":359,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":367,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":376,"lastUpdatePostDateStruct":377,"startDateStruct":379,"completionDateStruct":381,"leadSponsor":382,"locationsCount":69},"100607801","phase-4-butylphthalide-for-cognitive-impairment-in-elderly-patients-with-focal-epilepsy-100607801","NCT07193277","Butylphthalide for Cognitive Impairment in Elderly Patients With Focal Epilepsy","Safety and Efficacy of Butylphthalide Soft Capsules for Cognitive Impairment Comorbid With Focal Epilepsy in Elderly Patients: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Age 60-85 years (inclusive)\n* Diagnosed with focal epilepsy according to ILAE 2025 latest classification standards, with disease duration ≥2 years\n* Currently receiving stable anti-seizure medication (ASM) treatment for ≥3 months, with good seizure control (monthly seizure frequency ≤4 times in the past 3 months)\n* Cognitive impairment: Montreal Cognitive Assessment (MoCA) score 18-25 points (inclusive)\n* Basic Chinese language comprehension and expression ability, able to cooperate with neuropsychological testing\n* Voluntary participation and signed informed consent\n\nExclusion Criteria:\n\n* Diagnosed with various types of dementia (including Alzheimer's disease, vascular dementia, etc.)\n* Clear history of stroke with corresponding lesions on neuroimaging, or severe white matter lesions on brain MRI\n* Other neurological diseases that may cause cognitive impairment (traumatic brain injury, encephalitis, hydrocephalus, etc.)\n* Systemic diseases that may cause cognitive impairment (severe cardiac, hepatic, renal dysfunction, endocrine diseases, etc.)\n* Current severe depression or other psychiatric diseases affecting cognitive assessment\n* History of alcohol dependence, drug abuse, or other substance use affecting cognitive function\n* Allergy to butylphthalide or its excipients\n* Participation in other drug clinical trials within 30 days\n* Other conditions deemed inappropriate for participation by investigators","60 Years","85 Years",{"count":361,"type":22},220,[25],"This is a multicenter, randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of butylphthalide soft capsules for treating cognitive impairment in elderly patients with focal epilepsy.\n\nStudy Population: 220 elderly patients (60-85 years) with focal epilepsy and mild to moderate cognitive impairment (Montreal Cognitive Assessment score 18-25).\n\nIntervention: Participants will be randomly assigned 1:1 to receive either butylphthalide soft capsules (0.2g three times daily) or matching placebo for 48 weeks, while continuing their stable anti-seizure medication regimen.\n\nPrimary Outcome: Change in Montreal Cognitive Assessment (MoCA) total score from baseline to 48 weeks.\n\nSecondary Outcomes: Changes in neuropsychological tests (Trail Making Test, Digit Span, Rey Auditory Verbal Learning Test), seizure control measures, functional status (Activities of Daily Living, Quality of Life in Epilepsy), and exploratory neurobiological markers.\n\nThis study addresses an important unmet medical need, as current epilepsy treatments focus primarily on seizure control but lack effective interventions for epilepsy-associated cognitive impairment. Butylphthalide, a neuroprotective agent approved for acute ischemic stroke in China, has shown promise in other cognitive disorders and may benefit this patient population through its multiple neuroprotective mechanisms.",[365,366],"Focal Epilepsy","Cognitive Impairment",[368,365,366,369,370,371,372,373,374,375],"Butylphthalide","Elderly","MoCA","Neuroprotection","Randomized Controlled Trial","Double-blind","Placebo-controlled","Multicenter","2025-09-18",{"date":378,"type":33},"2025-09-25",{"date":380,"type":33},"2025-09-01",{"date":294,"type":22},{"name":39,"class":40},{"id":384,"slug":385,"hasResults":12,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":400,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":69},"100607533","phase-2-toripalimab--sequential-intravesical-gemcitabine-mitomycin-c-for-bcg-unresponsive-intolerant-high-risk-nmibc-open-label-randomized-phase-2-study-100607533","NCT07189793","Toripalimab ± Sequential Intravesical Gemcitabine-Mitomycin C for BCG-Unresponsive\u002F-Intolerant High-Risk NMIBC: Open-Label Randomized Phase 2 Study","Toripalimab With Sequential Intravesical Gemcitabine-Mitomycin C Versus Toripalimab Alone for the Treatment of BCG-Unresponsive\u002F-Intolerant High-Risk Non-Muscle-Invasive Bladder Cancer: An Open-Label, Randomized, Multicenter, Phase 2 Study","OHAI-NMIBC-01","Inclusion Criteria:\n\n1. Age ≥18 years; sex: all; signed written informed consent by the participant or legally authorised representative.\n2. Histologically confirmed high-risk non-muscle-invasive bladder cancer (HR-NMIBC), defined as any T1, high-grade Ta, and\u002For carcinoma in situ (CIS).\n3. BCG-intolerant (unable to continue BCG because of severe adverse reactions) or meeting at least one definition of BCG treatment failure:\n\n   1. Persistent or recurrent CIS within 12 months after completion of adequate BCG (with or without concomitant NMIBC);\n   2. Recurrent high-grade Ta\u002FT1 within 6 months after completion of adequate BCG;\n   3. High-grade T1 at the first evaluation after BCG induction (\\~3 months);\n   4. Ta high-grade and\u002For CIS present or recurrent at \\~3 months after receiving ≥5 BCG instillations.\n\n   Adequate BCG, for the purposes of this protocol, is defined as receipt of at least 5 of 6 induction instillations (maintenance not required).\n4. ECOG performance status 0-2.\n5. Adequate organ function per protocol laboratory criteria.\n6. No intravesical chemotherapy or immunotherapy between the most recent cystoscopy\u002FTURBT and study start; a single immediate postoperative intravesical chemotherapy at the time of the most recent cystoscopy\u002FTURBT is allowed during screening per local practice.\n7. Willing and able to comply with study procedures.\n\nExclusion Criteria:\n\n1. Muscle-invasive bladder cancer (T2-T4).\n2. Low-grade (LG) recurrence during or after BCG therapy.\n3. Concomitant upper tract urothelial carcinoma, or lymph-node\u002Fdistant metastasis.\n4. Indwelling ureteral stent or known vesicoureteral reflux.\n5. Contraindications to intravesical instillation, including within 2 weeks after TURBT, bladder perforation, symptomatic urinary tract infection, or gross haematuria.\n6. Known hypersensitivity or contraindication to gemcitabine, mitomycin C, or toripalimab.\n7. Systemic chemotherapy, small-molecule targeted therapy, or radiotherapy within 2 weeks before first study treatment.\n8. Prior immune checkpoint inhibitor therapy.\n9. Pregnant, planning pregnancy, or breastfeeding women.\n10. Ongoing acute or chronic systemic infection, or history of active tuberculosis.\n11. Other malignancy requiring active treatment.\n12. Any condition that, in the investigator's judgment, makes participation not in the patient's best interest or could confound study results.\n\nStudy Population Adults with BCG-unresponsive or BCG-intolerant HR-NMIBC treated at participating centres in China.",{"count":392,"type":22},106,[106],"This open-label, randomised, multicentre, phase 2 study (OHAI-NMIBC-01) compares toripalimab plus sequential intravesical gemcitabine followed by mitomycin C (GEM→MMC) with toripalimab alone in adults with BCG-unresponsive or BCG-intolerant high-risk non-muscle-invasive bladder cancer (HR-NMIBC). Two prespecified cohorts are analysed: (1) CIS cohort (CIS with\u002Fwithout Ta\u002FT1) and (2) non-CIS cohort (high-risk Ta\u002FT1 without CIS). In the combination arm, intravesical GEM→MMC is given weekly for 6 weeks (induction) and, for patients without recurrence at the first tumour assessment (\\~month 3), monthly maintenance continues up to 24 months or until progression\u002Funacceptable toxicity; toripalimab IV every 3 weeks starts during the first intravesical cycle and continues up to 24 months or until progression\u002Funacceptable toxicity. The monotherapy arm receives toripalimab IV every 3 weeks up to 24 months or until progression\u002Funacceptable toxicity. Cystoscopy and urine cytology are performed every 3 months; imaging every 24 weeks. Primary endpoints are 3-month complete response (CR) rate in the CIS cohort and median recurrence-free survival (RFS) in the non-CIS cohort. Secondary endpoints include landmark CR, PFS and OS, RFS\u002FHG-RFS landmarks in the non-CIS cohort, and safety (CTCAE v5.0). Exploratory analyses will assess outcomes by protocol-defined PD-L1 status. Approximately 106 participants will be enrolled at multiple sites in China.",[396,397,398,399],"Urinary Bladder Neoplasms","Carcinoma, Transitional Cell","Carcinoma in Situ of Bladder","Non-Muscle-Invasive Bladder Cancer",[401,402,403,404,405,406,407,408,409,410,411,412,413,414,415],"NMIBC","High-Risk NMIBC","BCG-Unresponsive","BCG-Intolerant","BCG Failure","Carcinoma in Situ (CIS)","Intravesical Therapy","Ta","T1","Gemcitabine","Mitomycin C","GEM-MMC","Toripalimab","PD-1 Inhibitor","Bladder-Sparing","2025-09-17",{"date":345,"type":33},{"date":419,"type":22},"2025-10",{"date":421,"type":22},"2028-10",{"name":39,"class":40},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":304,"minAge":4,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":435,"startDateStruct":436,"completionDateStruct":437,"leadSponsor":439,"locationsCount":4},"100607532","comparison-of-different-surgical-approaches-in-female-rectal-cancer-100607532","NCT07189780","Comparison of Different Surgical Approaches in Female Rectal Cancer.","Impact of Two Different Anterior Rectal Wall Mobilization Techniques on Postoperative Outcomes in Female Patients With Mid-low Rectal Cancer: a Multicenter, Prospective, Randomized Controlled Clinical Trial.","Inclusion Criteria:\n\n1. Pathologically confirmed rectal adenocarcinoma.\n2. Female patients scheduled to undergo laparoscopic total mesorectal excision (TME).\n3. Body mass index (BMI) ≤ 30 kg\u002Fm².\n4. Tumors with the distal margin located ≤ 10 cm from the anal verge.\n5. Absence of distant metastases (e.g., to the liver, lungs, or other organs).\n\nExclusion Criteria:\n\n1. Presence of severe pre-existing comorbidities (e.g., significant hepatic, renal, cardiac, pulmonary, or coagulation dysfunction).\n2. History of malignancy in other organs.\n3. Patients requiring emergency surgery due to conditions such as acute perforation or obstruction.\n4. Intraoperative findings of tumor invasion into adjacent organs necessitating multivisceral resection or palliative resection.\n5. Previous history of anorectal or rectal surgery. 6Preoperative magnetic resonance imaging (MRI) indicating invasion of the anterior rectal wall.",{"count":80,"type":22},[128],"Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects.\n\nIn our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion.\n\nSince our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.",[434],"Rectal Cancer Surgery",{"date":345,"type":33},{"date":180,"type":22},{"date":438,"type":22},"2030-08-01",{"name":39,"class":40},{"id":441,"slug":442,"hasResults":12,"nctId":443,"briefTitle":444,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":49,"enrollmentInfo":447,"targetDuration":4,"studyType":23,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":455,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100607168","evaluation-of-the-clinical-efficacy-and-feasibility-of-digital-foot-care-intervention-strategies-with-different-intensities-in-the-prevention-of-diabetic-foot-ulcers-100607168","NCT07185048","Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.","Clinical AI-powered Remote Engagement for Diabetic Foot Ulcer Prevention","Inclusion Criteria:\n\n1. Age ≥ 50 years but \\\u003C 80 years;\n2. Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3);\n3. Capable of using a smartphone to take photos and operate apps, or able to do so after simple training;\n4. Willing to participate in the study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Currently has an open foot wound or an unresolved foot ulcer;\n2. History of major lower limb amputation above the ankle joint;\n3. Pregnancy or breastfeeding;\n4. Currently suffering from poorly controlled malignant tumors;\n5. Receiving glucocorticoid or immunosuppressive therapy;\n6. Diagnosed with vascular occlusive vasculitis;\n7. Presence of foot fracture;\n8. Significant visual impairment affecting image acquisition or operation;\n9. Other conditions deemed inappropriate for participation in this study by the research team.",{"count":448,"type":22},1512,[128],"For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ulcers and easier to use.",[452],"Diabetic Foot Ulcers (DFUs)","2025-09-15",{"date":343,"type":33},{"date":419,"type":22},{"date":457,"type":22},"2028-09",{"name":39,"class":40},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":467,"targetDuration":4,"studyType":23,"phases":469,"briefSummary":470,"conditions":471,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":478,"leadSponsor":480,"locationsCount":69},"100606462","preoperative-vs-postoperative-revascularization-in-coronary-heart-disease-patients-undergoing-time-sensitive-non-cardiac-surgery-chronos-pci-100606462","NCT07175870","Preoperative vs Postoperative Revascularization in Coronary Heart Disease Patients Undergoing Time-Sensitive Non-Cardiac Surgery (CHRONOS-PCI)","Comparison of Clinical Outcomes Between Preoperative and Postoperative Revascularization in Coronary Heart Disease Patients With Time-Sensitive NOn-Cardiac Surgery: A Multicenter Pragmatic Randomized Controlled Trial (CHRONOS-PCI)","CHRONOS-PCI","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosis of coronary heart disease with non-emergent indication for PCI confirmed by coronary angiography：\n\n  * Non-ST-elevation acute coronary syndrome (NSTE-ACS) at low or intermediate ischemic risk\n  * Chronic coronary syndrome (CCS) with one of the following anatomical characteristics (see Appendix 1 for definition):\n\n    1. Moderate or severe stenosis of the left main coronary artery\n    2. Multivessel disease involving the ostium of the left anterior descending artery\n    3. Three-vessel disease with ≥70% stenosis in each major epicardial vessel\n* Indication for time-sensitive non-cardiac surgery\n* Planned non-cardiac surgery under general anesthesia in the following surgical departments: thoracic surgery, gastrointestinal surgery, colorectal surgery, hepatobiliary and pancreatic surgery, or gynecology\n* For patients with malignant tumors requiring time-sensitive surgery: written informed consent confirming understanding and acceptance that, if randomized to the \"PCI-first\" group, their tumor surgery will be delayed until 90±14 days after PCI, with acknowledgement of potential risks (e.g., tumor progression, change in resectability)\n* Ability to understand the study requirements and sign written informed consent in the language provided by the research team\n\nExclusion Criteria:\n\n* Age \\>80 years\n* Severe thrombocytopenia (platelet count \\\u003C50×10⁹\u002FL)\n* Cardiogenic shock, severe heart failure (NYHA class IV, Killip class IV, or LVEF ≤35%), malignant arrhythmias (including cardiac arrest, asystole, ventricular fibrillation, or sustained ventricular tachycardia), or other life-threatening conditions requiring resuscitation\n* Moderate-to-severe valvular heart disease, high-grade atrioventricular block, or other severe cardiac\u002Fpulmonary dysfunction incompatible with the planned surgery\n* Planned surgery with extremely high bleeding risk (e.g., intracranial surgery, spinal surgery, retinal surgery)\n* Patients with malignant tumors undergoing non-palliative surgery who are in poor general condition, defined as meeting any of the following:\n\n  1. Karnofsky performance score \\\u003C60\n  2. Eastern Cooperative Oncology Group (ECOG) performance status \\>2\n* Disease stage beyond surgical indications or estimated life expectancy \\\u003C1 year\n* Patients requiring emergency or urgent surgery due to critical illness\n* Severe renal dysfunction: serum creatinine \\>442 μmol\u002FL, GFR ≤30 mL\u002Fmin\u002F1.73 m², or currently on renal replacement therapy\n* Severe hepatic dysfunction: Child-Pugh class C or higher\n* Severe uncontrolled systemic infection\n* Advanced dementia with significant decline in quality of life requiring full-time care and support\n* Systemic thromboembolic disease (e.g., pulmonary embolism) making surgery unsuitable\n* Women who are pregnant, breastfeeding, or planning pregnancy during the study period\n* Severe, uncontrolled comorbid conditions continuously impairing physiological or psychological function\n* Participation in another clinical study within 3 months prior to enrollment\n* Any condition judged by the investigator to interfere with participation or study conduct",{"count":468,"type":22},140,[128],"To compare the safety and efficacy of preoperative versus postoperative revascularization strategies in patients with coronary heart disease undergoing time-sensitive non-cardiac surgery.",[472,473],"Coronary Artery Disease","Noncardiac Surgery","2025-09-14",{"date":476,"type":33},"2025-09-16",{"date":419,"type":22},{"date":479,"type":22},"2029-08",{"name":39,"class":40},{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":4,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":488,"targetDuration":4,"studyType":23,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":501,"locationsCount":4},"100606558","phase-3-risankizumab-for-fibrostenotic-crohns-disease-treatment-100606558","NCT07177118","Risankizumab for Fibrostenotic Crohn's Disease Treatment","A Prospective, Open-Label, Randomized Controlled Study of Risankizumab (an IL-23 Inhibitor) for the Treatment of Fibrostenotic Crohn's Disease","Inclusion Criteria:\n\n\\- Here's the translation of the provided criteria into English:\n\n1. Age between 18 and 80 years old, with no gender restrictions.\n2. Voluntarily sign an informed consent form.\n3. Diagnosed with fibrostenosing Crohn's disease by endoscopy and histology, and meet the following criteria:\n\n   * Presence of symptoms indicating fibrostenosis, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain;\n   * Endoscopic or radiological confirmation of new fibrotic stenosis (not caused by previous dilation\u002Fstenting);\n   * The length of stenosis is less than 10 cm, and there are no more than 2 stenoses in a single intestinal segment;\n4. Clinical manifestations of intestinal obstruction or sub-obstruction.\n5. Insufficient efficacy, intolerance, or contraindications to conventional or biological agents (azathioprine, 6-mercaptopurine, methotrexate, TNF-α inhibitors, etc.).\n6. Plan to receive treatment with risankizumab or ustekinumab for the first time.\n7. Have not previously used risankizumab or ustekinumab; if other biological agents have been used, they have been discontinued for at least the specified washout period (TNF-α inhibitors ≥8 weeks).\n\nExclusion Criteria:\n\n* Here is the translation of the exclusion criteria into English:\n\n  1. Age less than 18 or greater than 80 years old.\n  2. Refusal or inability to sign the informed consent form.\n  3. Absence of symptoms of fibrostenotic Crohn's disease, such as cramping, dietary restrictions or changes, postprandial vomiting, and abdominal pain.\n  4. Prior stenting and\u002For dilation treatment for stenosis (within less than 1 year).\n  5. Pregnancy, lactation, or planning to conceive.\n  6. Inaccessible endoscopy or presence of clinical conditions incompatible with endoscopy.\n  7. Presence of abscesses, fistulas, or active complex strictures (not limited to the strictured segment).\n  8. Stenosis length of 10 cm or greater, or more than 2 strictures in a single intestinal segment.\n  9. Severe coagulation dysfunction (platelet count \\\u003C 50,000; INR \\> 1.5).\n  10. Presence of end-stage organ failure, positive for Human Immunodeficiency Virus, uncontrolled infections, or a history of malignant tumors within the past 5 years.\n  11. Having received or started treatment with risankizumab or ustekinumab.\n  12. Investigator determines other conditions that make participation in this clinical study unsuitable.",{"count":489,"type":22},260,[53],"This study, titled \"IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study,\" is conducted by researchers from the First Affiliated Hospital of Wenzhou Medical University. The primary aim of this research is to evaluate the efficacy and safety of ustekinumab, an IL-23 inhibitor, for patients with fibrostenotic Crohn's disease (CD) who have failed standard treatments.\n\nThe study is a prospective, open-label, randomized controlled trial involving 260 participants across three major hospitals: the First Affiliated Hospital of Wenzhou Medical University, Taizhou Hospital of Zhejiang Province, and the Second Affiliated Hospital of Wenzhou Medical University. The participants are divided into two groups: one receiving ustekinumab and the other receiving a placebo. The study is designed to assess whether ustekinumab can improve clinical outcomes and reduce fibrosis progression in patients with fibrotic CD.\n\nThe study involves a comprehensive assessment of participants, including clinical history, physical examination, laboratory tests, and imaging studies. Key inclusion criteria include age between 18-80 years, confirmed diagnosis of fibrostenic CD, and failure of conventional or biological therapies. Participants are excluded if they are under 18, pregnant, breastfeeding, or have certain medical conditions that could interfere with the study.\n\nThe primary endpoint of the study is a clinical-imaging composite endpoint, which includes imaging assessment of bowel wall thickness and clinical symptoms. Secondary endpoints include safety, tolerability, and various functional and quality of life indicators. The study also explores the potential of ustekinumab to modulate immune responses and fibrosis-related biomarkers.\n\nThe study is expected to run from October 2025 to October 2028, with follow-up visits scheduled at regular intervals. The results will provide valuable insights into the potential of ustekinumab as a novel treatment for fibrotic CD, offering a new therapeutic option for patients who do not respond to existing treatments.\n\nThis research is crucial because fibrotic CD is a severe and progressive disease with limited treatment options. Ustekinumab, by targeting the IL-23 pathway, may offer a more effective and targeted approach to manage this condition. The study's findings could significantly impact clinical practice and improve patient outcomes.\n\nFor more detailed information, please refer to the study protocol document titled \"IL-23 Inhibitor Ustekinumab for the Treatment of Fibrotic Crohn's Disease: A Prospective, Open-Label, Randomized Controlled Study\" dated September 2, 2025. For further inquiries, contact the principal investigators Dr. Wu Fang or Dr. Wu Xiaoli at the First Affiliated Hospital of Wenzhou Medical University.",[493,494],"Crohn Disease","Crohn Disease and Ulcerative Colitis","2025-09-12",{"date":476,"type":33},{"date":498,"type":22},"2025-10-20",{"date":500,"type":22},"2028-10-20",{"name":39,"class":40},{"id":503,"slug":504,"hasResults":12,"nctId":505,"briefTitle":506,"officialTitle":507,"acronym":4,"eligibilityCriteria":508,"healthyVolunteers":12,"sex":509,"minAge":510,"maxAge":511,"enrollmentInfo":512,"targetDuration":4,"studyType":23,"phases":514,"briefSummary":515,"conditions":516,"keywords":518,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":529,"completionDateStruct":531,"leadSponsor":533,"locationsCount":4},"100606712","phase-2-can-fat-burning-shots-boost-fertility-comparing-weight-loss-injections-vs-healthy-habits-for-obese-men-with-low-sperm-health-100606712","NCT07179120","Can Fat-Burning Shots Boost Fertility? Comparing Weight-Loss Injections vs. Healthy Habits for Obese Men With Low Sperm Health","Male Fertility Preservation: Efficacy Evaluation of GLP-1Receptor Agonist Therapy for Infertility in Obese Males - A Multicenter Clinical Randomized Controlled Trial","Inclusion Criteria:\n\n* (1) Married men aged 20-45 (considering childbearing age and ensuring fertility requirements), with female spouses \\\u003C40 years old and no significant infertility factors.\n\n  (2) Meeting China's adult obesity criteria: BMI ≥28 kg\u002Fm² or meeting central obesity criteria (waist circumference ≥90 cm).\n\n  (3) Meeting WHO diagnostic criteria for male infertility: Failure to achieve pregnancy after ≥1 year of unprotected normal sexual activity, diagnosed as male-factor infertility after basic evaluation (e.g., oligospermia, asthenospermia, or high sperm deformity rate; excluding azoospermia), with essentially normal fertility function in the female spouse.\n\n  (4) Abnormal semen analysis: Baseline semen testing shows low sperm concentration or motility (e.g., sperm concentration \\\u003C15×10⁶\u002FmL or progressive motility \\\u003C32%).\n\n  (5) Willing to undergo randomization and corresponding interventions, able to attend regular follow-ups, and provide semen and blood samples.\n\n  (6) Informed consent to participate in the study and signing of the informed consent form.\n\nExclusion Criteria:\n\n* (1) Other clear causes affecting male fertility: e.g., obstructive azoospermia, severe oligospermia (sperm concentration \\\u003C5×10⁶\u002FmL), history of bilateral cryptorchidism surgery, genetic abnormalities (chromosomal anomalies such as Klinefelter syndrome, Y-chromosome microdeletions), severe reproductive tract damage, or infection history.\n\n  (2) Spouse has significant infertility factors (e.g., bilateral tubal blockage, severe ovulation disorders) without effective treatment, which may severely impact pregnancy outcomes.\n\n  (3) Previous bariatric surgery (e.g., gastric bypass, sleeve gastrectomy) or current use of other weight-loss medications (e.g., orlistat), or weight fluctuation \\>5% within 3 months before enrollment.\n\n  (4) Endocrine diseases affecting reproduction or sexual function: e.g., uncontrolled diabetes (HbA1c \\>9%) or insulin-treated diabetes, clinically significant thyroid dysfunction, hyperprolactinemia.\n\n  (5) Severe systemic diseases: Including significant cardiovascular diseases (unstable angina, class III-IV heart failure, etc.), active liver disease (transaminases \\>2× upper limit of normal), severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²), etc., making participation in clinical trials inappropriate.\n\n  (6) History of acute pancreatitis; personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN2) (GLP-1RA is contraindicated in these cases)\n\n  ; or conditions unsuitable for weight-loss medications, such as severe hepatic\u002Frenal impairment or gallstones.\n\n  (7) Use of GLP-1 receptor agonist therapy within the past 6 months. (8) Received other fertility-improving treatments within the past 6 months that cannot be discontinued (e.g., gonadotropins, clomiphene, testosterone preparations, or other drugs affecting semen such as exogenous testosterone or 5-alpha-reductase inhibitors).\n\n  (9) Alcohol or drug abuse. (10) Psychiatric or cognitive disorders preventing cooperation with follow-up. (11) Any other condition deemed by the investigator to interfere with trial results or increase participant risk.","MALE","20 Years","45 Years",{"count":513,"type":22},180,[106],"Why is this study being done? Obesity can harm men's fertility by lowering sperm quality and hormone levels, making it harder to have children. Weight loss through diet and exercise helps, but it's often hard to stick with. New medicines called GLP-1 receptor agonists, like semaglutide (Ozempic) and tirzepatide (Mounjaro), help people lose weight and improve health. Early studies suggest these drugs might also boost sperm health in obese men, but more proof is needed. This study tests if these drugs can safely improve fertility in obese men who are having trouble conceiving.\n\nWhat will happen in this study?\n\nThis is a 48-week study at several hospitals in China. About 180 men will be randomly assigned to one of three groups:\n\nGroup 1: Standard lifestyle changes, like a healthy diet and exercise, guided by experts.\n\nGroup 2: Weekly injections of semaglutide, starting low and increasing as tolerated.\n\nGroup 3: Weekly injections of tirzepatide, starting low and increasing as tolerated.\n\nAll men will have regular check-ups, including blood tests, semen analysis, and weight measurements. We will track sperm quality, hormone levels, weight loss, and whether their partners get pregnant naturally. The study includes an 8-week adjustment period, 24 weeks of treatment, and 16 weeks of follow-up.\n\nWho can join this study? Men aged 20-45 who are married, obese (BMI 28 or higher or waist size 90 cm or more), and have been trying to have a baby for at least a year without success due to low sperm count or poor sperm movement. Their female partners must be under 40 and have no major fertility issues. Men must be willing to attend visits and provide samples. People with serious health problems, recent use of similar drugs, or other causes of infertility (like genetic issues) cannot join.\n\nHow long will this study last? The full study lasts 48 weeks (about 11 months), with visits every 4-8 weeks, plus monthly phone check-ins for pregnancy updates.\n\nWhat are the possible benefits and risks? Benefits: If the drugs work, men may lose weight, improve sperm quality, and have a better chance of their partners getting pregnant naturally. They might also feel healthier overall. Risks: Common side effects include nausea, vomiting, or diarrhea from the drugs, which usually improve over time. Rare risks include pancreas inflammation or gallbladder issues. Lifestyle changes might cause minor injuries from exercise. All side effects will be monitored closely, and participants can quit anytime. Insurance covers any study-related harm.",[517],"Obesity-related Male Infertility",[519,520,521,522,523,524,525,372,526],"Obesity","Male Infertility","GLP-1 Receptor Agonists","Semaglutide","Tirzepatide","Fertility Preservation","Semen Quality","Multicenter Study","2025-09-11",{"date":416,"type":33},{"date":530,"type":22},"2026-05-01",{"date":532,"type":22},"2027-01-02",{"name":39,"class":40},{"id":535,"slug":536,"hasResults":12,"nctId":537,"briefTitle":538,"officialTitle":539,"acronym":4,"eligibilityCriteria":540,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":23,"phases":543,"briefSummary":544,"conditions":545,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":4},"100605236","inectolizumab-with-steroid-optimization-in-newly-treated-nmosd-100605236","NCT07159893","Inectolizumab With Steroid Optimization in Newly Treated NMOSD","Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease","Inclusion Criteria:\n\n* Patients who meet the 2015 International Consensus Diagnostic Criteria for Neuromyelitis Optica Spectrum Disorder (NMOSD) and are AQP4-IgG positive, with a first-attack episode;\n* Male or female,age \\>=18 and \\\u003C=65 years old;\n* EDSS score ≤ 7.5;\n* Female subjects of childbearing potential must have a negative pregnancy test result during the screening period and must use effective contraception throughout the study period;\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Laboratory abnormalities include: (white blood cell count \\\u003C 3×10⁹\u002FL), (neutrophils \\\u003C 1.5×10⁹\u002FL), (hemoglobin \\\u003C 85 g\u002FL), (platelet count \\\u003C 80×10⁹\u002FL), (serum creatinine \\> 1.5×ULN), (total bilirubin \\> 1.5×ULN), (AST (GOT) \\> 3×ULN), (ALT (GPT) \\> 3×ULN), (alkaline phosphatase \\> 2×ULN).\n* Patients currently suffering from active hepatitis or with a history of severe liver disease are ineligible. Based on the following serological test results for HBsAg, anti-HBc antibodies, and anti-HBs antibodies, there is evidence of hepatitis B virus (HBV) infection: Patients with positive HBsAg should be excluded. For patients with negative HBsAg but positive anti-HBc antibodies, regardless of whether anti-HBs antibodies are positive or negative, HBV-DNA testing is required to determine their status: If HBV-DNA is positive, the patient should be excluded; if HBV-DNA is negative, the patient may be eligible for the trial.\n* Patients with other chronic active immune system diseases, or those with stable conditions but requiring glucocorticoid therapy, are excluded, except for neuromyelitis optica spectrum disorder (NMOSD). Examples include rheumatoid arthritis, scleroderma, Sjögren's syndrome, ulcerative colitis, AIDS, genetic immunodeficiency, or drug-induced immunodeficiency. Patients with only positive autoantibodies but without clinical manifestations may be eligible for the trial.\n* Pregnant women, breastfeeding women, and patients who plan to conceive during the trial period.\n* Allergic reactions: Patients with a history of allergies to contrast agents administered via the parenteral route or to human-derived biological products.\n* Patients who received a live vaccine, except for the herpes zoster vaccine, within 28 days prior to randomization.\n* Patients who have used rituximab or other monoclonal antibodies within 6 months prior to randomization\n* Patients who have received intravenous immunoglobulin (IVIG) within 28 days prior to randomization.\n* Patients who have undergone hematopoietic stem cell transplantation or lymphocyte irradiation before randomization.\n* Patients who have used immunosuppressive agents such as azathioprine (Azathioprine, AZA, half-life t1\u002F2 = 6 hrs), mycophenolate mofetil (Mycophenolate Mofetil, t1\u002F2 = 16 hrs), leflunomide (Leflunomide, LEF, t1\u002F2 = 14.7 hrs), tacrolimus (Tacrolimus, t1\u002F2 = 43 hrs), teriflunomide (Teriflunomide, t1\u002F2 = 18 days), cyclosporine (Cyclosporin, CsA, t1\u002F2 = 27 hrs), methotrexate (Methotrexate, MTX, t1\u002F2 = 14 hrs), mitoxantrone (Mitoxantrone, NVT, t1\u002F2 = 37 hrs), and cyclophosphamide (Cyclophosphamide, CTX, t1\u002F2 = 6 hrs) before randomization are excluded. Except for leflunomide and teriflunomide, patients can be enrolled if the washout period exceeds five half-lives. For leflunomide and teriflunomide, patients need to undergo cholestyramine washout as follows: take 8 grams of cholestyramine orally three times daily for 11 days. If the 8-gram dose is not tolerated, it can be changed to 4 grams per dose, with the same frequency and duration.\n* Patients who have received any investigational drug within 28 days or five half-lives of the trial drug (whichever is shorter) before randomization.\n* Patients with symptoms of severe mental illness who are clinically unable to co-operate;\n* Patients with malignant tumours.\n* Patients who have experienced any of the following events within 12 weeks prior to randomization: myocardial infarction, unstable ischemic heart disease, stroke, or New York Heart Association (NYHA) Class IV heart failure.\n* Patients with herpes zoster infection, positive for HCV antibodies, or positive for HIV antibodies during the screening period.\n* Patients who are unable to undergo magnetic resonance imaging (MRI) during the trial period.\n* Patients whom the investigator deems unsuitable for participation in the trial.","65 Years",{"count":7,"type":22},[128],"Title: Study of Inectolizumab Combined With Steroid Hormone Adjustment Strategies in Treatment-naive Patients With Neuromyelitis Optica Spectrum Disease Objective:This study aims to evaluate the steroid-sparing effect and safety of inebilizumab in treatment-naïve AQP4-IgG seropositive neuromyelitis optica spectrum disorder (NMOSD) patients, while assessing its impact on EDSS score improvement during acute-phase treatment. The study will further explore treatment-related biomarkers, including dynamic changes in: immunoglobulin levels, lymphocyte subset profiles, serum AQP4-IgG titers, glial fibrillary acidic protein (GFAP), and neurofilament light chain (NFL) levels.\n\nStudy Design:This is a single-center, randomized, open-label, prospective clinical study planning to enroll 25 treatment-naïve, anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) patients.",[546,547,548],"Neuromyelitis Optica","Autoimmune Diseases","Demyelinating Autoimmune Diseases, CNS","2025-09-04",{"date":551,"type":33},"2025-09-08",{"date":553,"type":22},"2025-09",{"date":555,"type":22},"2026-09",{"name":39,"class":40},{"id":558,"slug":559,"hasResults":12,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":12,"sex":17,"minAge":564,"maxAge":4,"enrollmentInfo":565,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":571,"lastUpdatePostDateStruct":572,"startDateStruct":574,"completionDateStruct":576,"leadSponsor":578,"locationsCount":69},"100604587","phase-4-short-term-glucocorticoid-in-adult-steroid-sensitive-nephrotic-syndrome-the-coco-asteroid-study-100604587","NCT07151456","Short-term gluCOCOrticoid in Adult STEROID-sensitive Nephrotic Syndrome: The COCO-ASTEROID Study","Short-term vs Conventional Glucocorticoid Therapy for the Treatment of the Initial Episode of Adult Patient With Steroid-sensitive Idiopathic Nephrotic Syndrome","Inclusion Criteria:\n\n* Urine protein: creatinine ratio ≥3000mg\u002Fg (300mg\u002Fmmol)\n* Serum\u002Fplasma albumin level \\\u003C 30g\u002FL\n* Age ≥ 16 years at the time of diagnosis\n* No prior therapy with steroids, immunosuppressive or cytotoxic agents for any form of renal disease (other than the 28 days of prednisolone therapy given initially as routine clinical practice)\n* No evidence of underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome\n* Informed consent\n* SSNS defined as Complete remission within 4 weeks of prednisone or prednisolone at standard dose\n\nExclusion Criteria:\n\n* Secondary nephrotic syndrome\n* Contradictions for glucocorticoids\n* SRNS: Lack of complete remission within 4 weeks of therapy with daily prednisone or prednisolone at standard dose\n* anti-PLA2R positive\n* Adults with histological changes other than minimal lesion or focal segmental glomerular sclerosis (FSGS) glomerulonephritis where renal biopsy has been undertaken\n* Adults with a prior history of poor compliance with medical therapy Known allergy to glucocorticoid therapy\n* Other situations where the researcher deems it inappropriate to participate in the study","16 Years",{"count":566,"type":22},224,[25],"This study will compare a short-term course (12 week) glucocorticoid regimen with the Conventional 24-week regimen as originally proposed by KDIGO. The purpose of the study is to determine a short-term course (12 week) of glucocorticoid decreases the time to first relapse in adults presenting with steroid sensitive nephrotic syndrome.",[570],"Idiopathic Nephrotic Syndrome","2025-08-25",{"date":573,"type":33},"2025-09-03",{"date":575,"type":22},"2026-01",{"date":577,"type":22},"2029-12",{"name":39,"class":40},{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":304,"minAge":18,"maxAge":541,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":588,"briefSummary":589,"conditions":590,"keywords":595,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":600,"lastUpdatePostDateStruct":601,"startDateStruct":603,"completionDateStruct":605,"leadSponsor":607,"locationsCount":69},"100520089","comparison-of-5-ala-photodynamic-therapy-and-co2-laser-for-treating-persistent-low-grade-cervical-lesions-with-high-risk-hpv-infection-100520089","NCT06052033","Comparison of 5-ALA Photodynamic Therapy and CO2 Laser for Treating Persistent Low-Grade Cervical Lesions With High-Risk HPV Infection","The Effect of 5-aminolaevulinic Acid Photodynamic Therapy Versus C02 Laser in the Treatment of Persistent Cervical Low-grade Squamous Intraepithelial Lesions With High-risk HPV Infection:A Non-randomized Controlled Trail Study","Inclusion Criteria:\n\n1. Aged 18-65 years old with a history of sexual activity.\n2. Subclinical infected individuals who have been confirmed as HR-HPV positive (if there is the same positive type in the typing test) for more than 1 year using HPV typing test, HPV E6\u002FE7 mRNA test, HPV DNA test, and cervical triple step diagnostic procedure (cytology colposcopy histopathology).\n3. Patients diagnosed with LSIL by pathological examination of cervical biopsy under colposcopy with an interval of more than 1 year.\n4. No fundamental diseases of important organs.\n5. Agree to receive treatment and\u002For follow-up according to regulations and sign an informed consent form.\n6. There has been no history of using other drugs related to HPV infection in the past 3 months.\n\nExclusion Criteria:\n\n1. HR-HPV persistent infection.\n2. A total hysterectomy has been performed.\n3. Concomitant endometrial cancer, ovarian cancer, and other reproductive tract tumors.\n4. Complicated with abnormal heart, liver, and kidney functions, immune dysfunction, or immune system diseases such as systemic lupus erythematosus (SLE).\n5. Using drugs such as immunosuppressants, antiviral agents, and glucocorticoids.\n6. Pregnant and lactating women.\n7. Acute reproductive tract inflammation.\n8. Diabetes patients with uncontrolled blood sugar.\n9. Patients who do not receive full treatment and follow-up.\n10. Those who fail to sign the informed consent form.",{"count":587,"type":22},40,[128],"Non-RCT clinical trial comparing 5-ALA photodynamic therapy and CO2 laser for persistent high-risk HPV-related low-grade cervical lesions.",[591,592,593,594],"HPV-Related Cervical Carcinoma","Low-Grade Squamous Intraepithelial Lesions","HPV Infection","Photodynamic Therapy",[596,597,598,599],"high-risk hpv infection","hpv persistent","Lsil","cervical lesions","2025-05-12",{"date":602,"type":33},"2025-05-13",{"date":604,"type":33},"2023-09-11",{"date":606,"type":22},"2025-06-30",{"name":39,"class":40},{"id":609,"slug":610,"hasResults":12,"nctId":611,"briefTitle":612,"officialTitle":613,"acronym":4,"eligibilityCriteria":614,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":615,"targetDuration":4,"studyType":23,"phases":617,"briefSummary":618,"conditions":619,"keywords":621,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":4},"100584393","lcar-m61sq-in-treatment-of-relapsedrefractory-multiple-myeloma-100584393","NCT06888752","LCAR-M61SQ in Treatment of Relapsed\u002FRefractory Multiple Myeloma","A Clinical Study to Evaluate the Safety, Tolerance and Efficacy of LCAR-M61SQ Cell in Patients with Relapsed\u002FRefractory Multiple Myeloma.","Inclusion Criteria:\n\n* Subjects voluntarily participate in clinical research;\n* Age ≥18 years old;\n* Eastern Cooperative Oncology Group (ECOG) score 0-2;\n* Examination evidence of initial diagnosis of MM according to IMWG diagnostic criteria;\n* Measurable lesions were present;\n* Subjects have received at least three previous lines of multiple myeloma therapy, each with at least one complete therapy cycle, unless the best response to the therapeutic regimen was documented as disease progression (PD confirmed according to IMWG criteria);\n* Expected survival ≥3 months;\n* Clinical laboratory values in the screening period meet criteria;\n\nExclusion Criteria:\n\n* Received previous therapy targeting GPRC5D targets;\n* Prior antineoplastic therapy and meet exclusion criteria (before apheresis);\n* Subjects had Waldenstrom macroglobulinemia, POEMS syndrome, or primary AL amyloidosis at the time of screening.\n* Subjects who were positive for any of HBsAg, HBV DNA, HCV-Ab, HCV RNA, and HIV-Ab;\n* Life-threatening allergic reactions, hypersensitivity reactions, or intolerance to CAR-T cell formulations or their excipients, including DMSO, are known.\n* Serious underlying diseases were present;\n* Female subjects who were pregnant, breastfeeding, or planning to become pregnant while participating in this study or within 1 year of receiving study treatment.\n* Also enrolled in other clinical studies.",{"count":616,"type":22},35,[128],"A prospective, open-label dose-exploration and expansion study to evaluate the safety, tolerability, pharmacokinetics, and antitumor efficacy characteristics of LCAR-M61SQ in patients with relapsed\u002Frefractory multiple myeloma.",[620],"Relapsed\u002FRefractory Multiple Myeloma",[622,623],"multiple myeloma","Relapsed\u002FRefractory multiple myeloma","2025-03-17",{"date":626,"type":33},"2025-03-21",{"date":628,"type":22},"2025-03-20",{"date":630,"type":22},"2030-12-30",{"name":39,"class":40},""]