[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Peking Union Medical College Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":633},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,322,0,25,[9,45,69,88,111,141,162,187,212,231,250,273,300,330,358,387,414,441,464,496,521,543,567,589,609],{"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":27,"conditions":28,"keywords":30,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100650961","golidocitinib-and-chidamide-for-cutaneous-t-cell-lymphoma-phase-iii-trial-100650961",false,"NCT07754890","Golidocitinib and Chidamide for Cutaneous T-Cell Lymphoma","A Prospective Single-Center Phase I\u002FII Clinical Study of Golidocitinib Combined With Chidamide in Patients With Systemically-Treated Cutaneous T-Cell Lymphoma","Inclusion Criteria:\n\n* Histopathologically confirmed cutaneous T-cell lymphoma.\n* Patients with measurable disease, with or without extracutaneous lesions, and clinical stage IB-IVB.\n* Disease that has not responded to or has relapsed after at least one prior systemic therapy (including, but not limited to, total skin electron beam therapy, bexarotene, retinoids, interferon, extracorporeal photopheresis, methotrexate, or chidamide).\n* An ECOG performance status of 0 to 2.\n* Adequate bone marrow function: Absolute Neutrophil Count (ANC) ≥1.5×10⁹\u002FL, Platelet count (PLT) ≥80×10⁹\u002FL, Hemoglobin (HGB) ≥90 g\u002FL.\n* Adequate organ function: Cardiac function Class 1-2 (NYHA), Left Ventricular Ejection Fraction (LVEF) ≥50%, Alanine Aminotransferase (ALT) \\\u003C 2.5 × Upper Limit of Normal (ULN), Total Bilirubin (TBil) \\\u003C 1.5 × ULN, Oxygen Saturation (SpO₂) \\> 93% on Room Air, estimated Glomerular Filtration Rate (eGFR) based on serum creatinine (sCr) \\> 60 mL\u002Fmin\u002F1.73m².\n\nExclusion Criteria:\n\n* Acute myocardial infarction, unstable angina, congestive heart failure, symptomatic arrhythmia within the past 6 months, or significant QT interval prolongation (corrected QT interval \\>450 ms in males or \\>470 ms in females).\n* Uncontrolled active infection.\n* Active tuberculosis infection.\n* Active Hepatitis B (HBV DNA \\> 1×10³ copies\u002FmL) or Hepatitis C (HCV RNA \\> 1×10³ copies\u002FmL) infection.\n* Pregnancy or lactation.\n* Any other condition deemed by the investigator as unsuitable for participation in this study.","ALL","18 Years","75 Years",{"count":21,"type":22},65,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a prospective, single-center phase I\u002FII study, with the purpose of evaluating the efficiency of golidocitinib combined with chidamide in patients with systemically-treated cutaneous T-cell lymphoma. The primary endpoint of the phase I study was to determine the recommended phase II dose (RP2D), while the primary endpoint of the phase II study was the objective response rate (ORR). Secondary endpoints included the complete response (CR) rate, progression-free survival (PFS), duration of response (DOR), overall survival (OS), and safety profile.",[29],"Cutaneous T-cell Lymphoma (CTCL)",[31],"cutaneous T-cell lymphoma","RECRUITING","2026-08-10",{"date":35,"type":36},"2026-08-12","ACTUAL",{"date":38,"type":36},"2025-08-26",{"date":40,"type":22},"2030-12-31",{"name":42,"class":43},"Peking Union Medical College Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":12,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":44},"100651333","cognitive-outcomes-in-bad-related-stroke-100651333","NCT07761182","Cognitive Outcomes in BAD-related Stroke","Cognitive Outcomes in Patients With Branch Atheromatous Disease-Related Stroke: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Age: 18-80 years.\n2. Time from onset to enrollment: 8-14 days; if onset time is unknown, time from last known normal to enrollment must be 8-14 days.\n3. Meet the following imaging inclusion criteria:\n\n3\\. 1 DWI infarct: single (isolated) deep (subcortical) infarct 3.2 The culprit vessel is the lenticulostriate artery, and the DWI lesion meets at least one of the following criteria (A\u002FB): A. comma-shaped infarct expanding fan-wise from bottom to top on coronal view; or B. involvement of ≥3 axial slices (slice thickness 5-7 mm) 3.3 No ≥50% stenosis of the ipsilateral middle cerebral artery (confirmed by MRA, CTA, or DSA) 4. Informed consent form signed by the patient or their legally authorized representative.\n\nExclusion Criteria:\n\n1. Baseline imaging showing intracranial hemorrhagic disease, vascular malformation, space-occupying lesion, or other non-ischemic intracranial pathology.\n2. Transient ischemic attack or stroke mimics.\n3. Cardioembolic causes: including atrial fibrillation, valvular heart disease, infective endocarditis, etc.\n4. Tandem extracranial vascular stenosis ≥50% ipsilateral to the infarct lesion.\n5. Prior diagnosis of dementia (Alzheimer's disease, frontotemporal dementia, or Lewy body dementia) or significant cognitive decline (IQCODE \\> 3.38).\n6. Contraindications to photon-counting CT or 5T-MRI.\n7. Pregnancy or lactation.\n8. Life expectancy \\\u003C 1 year.","80 Years",{"count":54,"type":22},60,"OBSERVATIONAL","Branch atheromatous disease (BAD) is a distinct subtype of ischemic stroke that is particularly prevalent among Chinese and other Asian populations. Patients with BAD are prone to early neurological deterioration and poor functional outcomes, and BAD is increasingly recognized as an independent disease entity. However, the association between BAD and cognitive impairment remains unclear. This nationwide, multicenter, prospective observational study will prospectively collect epidemiological, clinical, neuroimaging, functional, and cognitive outcome data from patients with BAD. The study aims to investigate the occurrence of cognitive impairment after BAD and identify the clinical and neuroimaging characteristics associated with cognitive impairment. In particular, the relationship between early neurological deterioration (END) and cognitive impairment will be investigated. As an exploratory objective, this study will further explore the potential brain network mechanisms underlying cognitive impairment associated with END events.",[58,59,60],"Branch Atheromatous Disease","Cognitive","Deterioration, Clinical","NOT_YET_RECRUITING","2026-08-07",{"date":35,"type":36},{"date":65,"type":22},"2026-09-01",{"date":67,"type":22},"2028-10-01",{"name":42,"class":43},{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":75,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":82,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":4},"100651330","randomized-controlled-trial-of-the-surgdiff-model-for-predicting-surgical-difficulty-to-help-choose-approach-in-mid-low-rectal-cancer-100651330","NCT07761169","Randomized Controlled Trial of the SurgDiff Model for Predicting Surgical Difficulty to Help Choose Approach in Mid-Low Rectal Cancer","Inclusion Criteria:\n\n1. Pathological examination confirmed a diagnosis of rectal adenocarcinoma; radical surgery is recommended.\n2. The inferior border of the tumor is ≥1 cm from the dentate line and ≤7 cm from the anal verge;\n3. Preoperative staging was assessed in a stage of c\u002FycT1-3N0-2M0;\n4. The cardiac, pulmonary, hepatic, renal, and other organ functions are adequate, and the patient can tolerate laparoscopic surgery.\n\nExclusion Criteria:\n\n1. Intraoperative exploration is unable to achieve R0 resection or preservation of the anus;\n2. Lateral lymph node dissection is required;\n3. Patients with a history of severe mental illness, immune disorders, or those taking hormonal medications;\n4. Any other circumstances in which the investigator deems it inappropriate for inclusion.",{"count":76,"type":22},68,[78],"NA","This study aims to investigate the feasibility of utilizing the SurgDiff surgical difficulty prediction model to assist surgeons in formulating precise surgical plans.",[81],"Rectal Cancer",{"date":35,"type":36},{"date":84,"type":22},"2026-08-30",{"date":86,"type":22},"2030-09-30",{"name":42,"class":43},{"id":89,"slug":90,"hasResults":12,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":44},"100590929","phase-2-zr-mtx-for-piol-phase-ii-trial-100590929","NCT06973811","ZR-MTX for PIOL Phase II Trial","A Prospective, Phase II Clinical Trial Using the Combination of Zanubrutinib, Rituximab and High-dose Intravenous Methotrexate With Intravitreal Methotrexate Injection Therapy for the Treatment of Primary Intraocular Lymphoma","ZR-MTX","Inclusion Criteria:\n\n* • Newly-diagnosed primary vitreoretinal lymphoma\n\n  * ECOG≤2\n  * creatinine clearance rate (CCR) ≥ 60ml\u002Fh, according to Cockcroft-Gault\n  * Total bilirubin # 2 upper limits of normal, alanine aminotransferase#ALT# \\\u003C 3 upper limits of normal\n  * Sign the Informed consent\n  * Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.\n  * Male subjects must agree to use condoms throughout study drug therapy.\n\nExclusion Criteria:\n\n* • primary central nervous system lymphoma involved eyes and brain\n\n  * systemic B cell lymphoma involved eyes\n  * Pre-existing uncontrolled active infection\n  * Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria\n  * Pregnancy or active lactation\n  * Co-existing tumors\n  * HIV or HBV or HCV infection",{"count":97,"type":22},47,[26],"This is a prospective single-arm phase II study, with the purpose of evaluating the efficiency of ZR-MTX regimen (Rituximab, Zanubrutinib and methotrexate) combined with intravitreal methotrexate, then followed by minimal residual disease directed Zanubrutinib maintenance in newly-diagnosed primary intraocular lymphoma. The primary endpoint of this study is progression-free survival (PFS).",[101],"Primary Intraocular Lymphoma",[103],"primary intraocular lymphoma","2026-08-04",{"date":62,"type":36},{"date":107,"type":36},"2025-05-21",{"date":109,"type":22},"2029-10-30",{"name":42,"class":43},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":118,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":140},"100641815","ai-assisted-rare-disease-diagnosis-100641815","NCT07650799","AI-assisted Rare Disease Diagnosis","A Multicentre Randomised Controlled Trial of LLM-Assisted Diagnostic Support in Patients With Suspected Rare or Diagnostically Unresolved Disease","Patient Inclusion Criteria:\n\n* Any age. Legal guardian co-signs consent for minors or individuals lacking legal capacity.\n* Diagnostically unresolved or suspected rare disease, with at least one prior complete clinical evaluation at a secondary-level or higher institution yielding no confirmed explanatory diagnosis.\n* First presentation to the enrolling institution for the current condition, with no prior records in the institutional HIS or outpatient system.\n* No prior genetic testing related to the current condition; no results or reports available.\n* Written informed consent provided voluntarily by patient or legal guardian, with commitment and ability to complete structured follow-up.\n\nPatient Exclusion Criteria:\n\n* Confirmed diagnosis (clinical, pathological, or molecular) explaining the primary symptoms.\n* Emergency presentation, critical illness, or any condition incompatible with trial participation.\n* Neither patient nor legally authorised proxy able to complete follow-up.\n* Concurrent enrollment in another interventional study with diagnostic accuracy or genetic testing yield as a primary endpoint.\n* Prior use of another AI system has already yielded a confirmed diagnosis for the current condition.\n\nPhysician Inclusion Criteria\n\n* Licensed physician in internal medicine, neurology, pediatrics, general medicine, rare disease, or a related specialty.\n* ≥2 years of clinical practice; competent to manage rare disease patients; stratified into junior or senior tier.\n* Voluntary participation with written informed consent.\n\nPhysician Exclusion Criteria\n\n* No longer in clinical practice, or unable to fulfill required outpatient duties during the study period.\n* Unwilling to provide informed consent or to permit protocol-required collection of consultation and questionnaire data.\n* Currently enrolled in another AI-assisted clinical workflow, or expected to be unable to comply with the procedures.","0 Years",{"count":120,"type":22},1056,[78],"A multicentre randomised controlled trial evaluating whether a rare-disease diagnostic large language model can improve diagnostic quality, efficiency, and health-economic outcomes for physicians managing patients with suspected rare or diagnostically unresolved disease.",[124,125],"Rare Disorders","Rare Diseases",[127,128,129,130,131],"rare diseases","AI","LLM","diagnosis","cost-effectiveness","2026-07-30",{"date":134,"type":36},"2026-07-31",{"date":136,"type":22},"2026-08-01",{"date":138,"type":22},"2027-12-01",{"name":42,"class":43},13,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":4,"eligibilityCriteria":147,"healthyVolunteers":12,"sex":148,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":23,"phases":151,"briefSummary":152,"conditions":153,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":157,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},"100649783","phase-2-skb264-plus-kl-a167-in-msi-hdmmr-advanced-gynecological-malignancies-100649783","NCT07738757","SKB264 Plus KL-A167 in MSI-H\u002FdMMR Advanced Gynecological Malignancies","A Phase II Study of Sacituzumab Tirumotecan (Sac-TMT\u002FSKB264) in Combination With Tagitanlimab (KL-A167) as Second-Line or Later Therapy for MSI-H\u002FdMMR Advanced Gynecological Malignancies: An Open-Label, Single-Arm, Multicenter Exploratory Trial","Inclusion Criteria:\n\n* 1\\. Age ≥18 years.\n* 2\\. Histologically or cytologically confirmed recurrent or metastatic ovarian cancer, endometrial cancer, or cervical cancer.\n* 3\\. dMMR or MSI-H subtype (defined as: deficiency\u002Floss of mismatch repair (MMR) proteins MLH1, PMS2, MSH2, or MSH6 expression detected by immunohistochemistry (IHC), or identified as MSI-H by polymerase chain reaction (PCR)\u002Fnext-generation sequencing (NGS)).\n* 4\\. Received at least 1 prior systemic regimen (prior anti-PD-1\u002FL1 allowed) for recurrent or metastatic ovarian cancer, endometrial cancer, or cervical cancer.\n* 5\\. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n* 6\\. Life expectancy more than 12 weeks.\n* 7\\. At least one measurable lesion per RECIST 1.1 criteria.\n* 8\\. Subjects must have recovered from all toxicities related to prior therapies, except for toxicities not considered a safety risk.\n* 9\\. Adequate function of the important organs.\n* 10\\. For female subjects of childbearing potential effective medical contraception must be used from the time of signing the informed consent form until 6 months after the last dose of the drug.\n\n  11\\. Participants must voluntarily participate in the study, sign an informed consent form, exhibit good compliance, and cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n* 1\\. Subjects with known other malignant tumors that are progressing or require active treatment within the past 3 years.\n* 2\\. Subjects with known meningeal metastases, brainstem metastases, spinal cord metastases and\u002For compression, or other active CNS metastases. Subjects with locally treated brain metastases may participate provided they are clinically stable for at least 4 weeks, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment;\n* 3\\. Subjects with clinically significant cardiovascular diseases.\n* 4\\. Subjects with severe and\u002For uncontrolled concomitant diseases, such as uncontrolled hypertension, symptomatic or recurrent pleural effusion, pericardial effusion, or ascites requiring drainage.\n* 5\\. Subjects diagnosed with active hepatitis B or active hepatitis C.\n* 6\\. Subjects with known uncontrolled HIV infection.\n* 7\\. Subjects with known active tuberculosis.\n* 8\\. Subjects with documented severe dry eye syndrome, severe meibomian gland dysfunction and\u002For blepharitis, or a history of corneal disorders that impair or delay corneal healing.\n* 9\\. Subjects who have undergone major surgery (as defined by the investigator) within 30 days prior to the first dose of study treatment or who have not recovered from prior surgery.\n* 10\\. Subjects with known hypersensitivity or anaphylaxis to the study drug or its excipients; or a history of severe hypersensitivity reactions to monoclonal antibodies.\n* 11\\. Subjects with a history of interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, currently suffering from ILD\u002Fpneumonia, or unable to rule out suspected ILD\u002Fpneumonia through imaging at screening.\n* 12\\. Subjects with a history of allogeneic tissue\u002Forgan transplantation.\n* 13\\. Subjects with autoimmune diseases requiring systemic treatment within the past 2 years or requiring immunosuppressive treatment during the study period. Subjects with controllable type 1 diabetes, thyroiditis with normal thyroid function, or hypothyroidism well controlled by hormone replacement therapy (HRT), or skin diseases (such as vitiligo, psoriasis) that do not require systemic treatment can be included.\n* 14\\. Subjects who have previously received TROP2-targeted drugs or any therapy containing a topoisomerase I inhibitor, including antibody-drug conjugates (ADCs).\n* 15\\. Subjects who have previously used any experimental anti-tumor vaccines.\n* 16\\. Subjects who received live vaccines within 30 days prior to the first dose of study treatment or plan to receive live vaccines during the study.\n* 17\\. Subjects who need to use strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first study treatment and during the study period.\n* 18\\. Subjects who received any chemotherapy, radiotherapy, immunotherapy, or biologic therapy within 4 weeks prior to the first dose of study treatment; subjects who received small molecule tyrosine kinase inhibitors (TKIs), anti-tumor hormone therapy, systemic immunostimulants (including but not limited to interferon, IL-2), or approved anti-tumor Chinese herbal preparations within 2 weeks before the first study treatment.\n* 19\\. Subjects who received systemic anti-infective treatment within 2 weeks prior to the first dose of study treatment.\n* 20\\. Pregnant or lactating women.\n* 21\\. Any other conditions deemed by the investigator to make the patient unsuitable for participation in this study.","FEMALE",{"count":150,"type":22},80,[26],"This is a prospective, open-label, multicenter, single-arm Phase II study designed to evaluate the efficacy and safety of sacituzumab tirumotecan (sac-TMT\u002FSKB264) in combination with tagitanlimab (KL-A167) as second-line or later therapy in patients with recurrent or metastatic MSI-H\u002FdMMR gynecological malignancies, including endometrial cancer, ovarian cancer, and cervical cancer. The primary objective is to evaluate the objective response rate (ORR) per RECIST v1.1 as assessed by the investigator. Secondary objectives include evaluating overall survival (OS), progression-free survival (PFS) per RECIST v1.1, disease control rate (DCR), duration of response (DoR), and the safety and tolerability of the combination regimen.",[154],"Recurrent or Metastatic MSI-H\u002FdMMR Gynecological Malignancies","2026-07-28",{"date":134,"type":36},{"date":65,"type":22},{"date":159,"type":22},"2029-12-30",{"name":42,"class":43},2,{"id":163,"slug":164,"hasResults":12,"nctId":165,"briefTitle":166,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":168,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":170,"conditions":171,"keywords":176,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":184,"leadSponsor":186,"locationsCount":44},"100649751","development-and-validation-of-a-risk-prediction-model-for-cardiac-surgery-associated-acute-kidney-injury-based-on-the-gut-kidney-axis-incorporating-gut-microbiota-and-their-metabolites-100649751","NCT07738796","Development and Validation of a Risk Prediction Model for Cardiac Surgery-associated Acute Kidney Injury Based on the Gut-Kidney Axis, Incorporating Gut Microbiota and Their Metabolites","Inclusion Criteria:\n\n1. Aged 18 years or older;\n2. Scheduled for elective cardiac surgery;\n3. Surgery performed under cardiopulmonary bypass (CPB);\n4. Able to complete preoperative stool and blood sample collection independently;\n5. The patient and their family members voluntarily participate in this study, agree to the collection of preoperative stool samples, blood samples and clinical data, cooperate with follow-up visits, and sign the informed consent form.-\n\nExclusion Criteria:\n\n（1) Patients with end-stage renal disease or dependence on renal replacement therapy before surgery; (2) Patients with a preoperative estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin\u002F1.73m² or severe chronic kidney disease (CKD stage 4-5); (3) Patients with a history of renal transplantation or unilateral nephrectomy; (4) Patients who received antibiotic treatment within 4 weeks before surgery; (5) Patients who took probiotic or prebiotic preparations within 4 weeks before surgery; (6) Patients with a previous history of intestinal surgery, such as colectomy and small bowel resection; (7) Patients with active inflammatory bowel disease, chronic diarrhea or constipation requiring pharmacological intervention; (8) Patients with preoperative intestinal obstruction, gastrointestinal bleeding, or those requiring fasting for more than 24 hours; (9) Patients undergoing emergency surgery (time from admission to surgery \\\u003C 24 hours), or those unable to complete preoperative informed consent, dietary investigation and baseline sample collection; (10) Patients who received mechanical bowel preparation (e.g., enema) within 24 hours before surgery; (11) Patients with preoperative active infection or sepsis; (12) Patients treated with preoperative glucocorticoids or immunosuppressants (excluding routine doses); (13) Patients who died intraoperatively or within 24 hours postoperatively, or those who could not complete the evaluation of the primary outcome (postoperative 7-day acute kidney injury \\[AKI\\]); (14) Female patients who are pregnant, lactating or in menstruation; (15) Patients complicated with gastrointestinal malignant tumors or receiving systemic chemotherapy, targeted therapy or abdominal radiotherapy; (16) Patients with severe liver disease (Child-Pugh grade B or above).",{"count":169,"type":22},182,"This is a single-center prospective observational cohort study enrolling adult patients scheduled for cardiac surgery. Multi-timepoint clinical indicators, stool samples for gut microbiota and metabolomics profiling and artery blood will be collected before and after surgery. We aim to construct and validate a multi-dimensional preoperative predictive model for CSA-AKI based on clinical, microbial and metabolic signatures. Meanwhile, this research will explore the potential mediating role of the gut-kidney axis in the pathogenesis of cardiac surgery-associated acute kidney injury, and provide novel mechanistic evidence for early risk stratification and intervention of CSA-AKI.",[172,173,174,175],"Acute Kidney Injury After Adult Cardiac Surgery","Gastrointestinal Microbiome","Metabolome","Risk Assessment",[177,178,179,180,181],"cardiac surgery-associated acute kidney injury","gut microbiota","metabolites","gut-kidney axis","preoperative predictive model",{"date":134,"type":36},{"date":136,"type":22},{"date":185,"type":22},"2027-08-01",{"name":42,"class":43},{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":4,"eligibilityCriteria":193,"healthyVolunteers":12,"sex":148,"minAge":194,"maxAge":195,"enrollmentInfo":196,"targetDuration":4,"studyType":23,"phases":198,"briefSummary":199,"conditions":200,"keywords":202,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":206,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":44},"100649579","clinical-study-on-shoutai-pills-for-improving-reduced-ovarian-reserve-100649579","NCT07737847","Clinical Study on ShouTai Pills for Improving Reduced Ovarian Reserve","A Study on Biological Subtyping of Reduced Ovarian Reserve With Kidney Essence Deficiency Syndrome Based on Follicular Fluid Metabolomics and Efficacy Prediction of ShouTai Pills","Inclusion Criteria:\n\n1. The inclusion criteria are as follows: ① meeting the above-mentioned integrated Chinese and Western medicine diagnostic criteria for DOR\n2. ② no use of estrogen-containing medications within the past 1 month\n3. ③ patients scheduled to undergo IVF-ET\n4. ④ provision of signed informed consent, voluntary participation, and good compliance.\n\nExclusion Criteria:\n\n1. The exclusion criteria are as follows: ① patients with polycystic ovary syndrome (PCOS) or stage III\u002FIV endometriosis\n2. ② uterine conditions including untreated submucous myomas, intramural myomas \\>4 cm in diameter, intrauterine adhesions, uterine septum, or other uterine anomalies\n3. ③ couples undergoing preimplantation genetic diagnosis (PGD) for genetic reasons\n4. ④ body mass index (BMI) ≥28 kg\u002Fm²\n5. ⑤ history of prior pelvic radiotherapy or cytotoxic chemotherapy\n6. ⑥ significant systemic diseases, such as uncontrolled hypertension, diabetes mellitus, thyroid dysfunction, hepatic or renal insufficiency, cardiac disorders, or autoimmune diseases\n7. ⑦ use of medications that may interfere with this study within the past 1 month, including but not limited to estrogens, hepatic enzyme modulators, and agents that may affect the endocrine system (hormonal drugs)\n8. ⑧ known allergy to any components of the study medication\n9. and ⑨ participation in another drug trial within the past 3 months. -","20 Years","50 Years",{"count":197,"type":22},136,[78],"Grounded in the 'disease-syndrome combination' paradigm, this study endeavors to address the pivotal scientific issues pertaining to the clinical precision of Traditional Chinese Medicine (TCM) in managing Diminished Ovarian Reserve (DOR) classified as the Kidney Essence Deficiency type, through the application of systems biology technologies, including metabolomics.",[201],"Diminished Ovarian Reserve (DOR)",[203,204,205],"shoutai pill","oocyte","Diminished Ovarian Reserve",{"date":132,"type":36},{"date":208,"type":22},"2026-10-01",{"date":210,"type":22},"2028-12-31",{"name":42,"class":43},{"id":213,"slug":214,"hasResults":12,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":218,"targetDuration":4,"studyType":23,"phases":219,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":44},"100617908","exploring-the-novel-value-of-psma-pet-in-sjgrens-syndrome-integrated-analysis-with-established-fapi-pet-imaging-100617908","NCT07324733","Exploring the Novel Value of PSMA PET in Sjögren's Syndrome: Integrated Analysis With Established FAPI PET Imaging","Inclusion Criteria:\n\n* Age 18-80 years;\n* Fulfillment of the 2016 ACR-EULAR Classification Criteria for pSS at enrollment. OR diagnosis of a solid tumor scheduled for FAPI PET imaging\n\nExclusion Criteria:\n\n* Combined with tumors or other connective tissue diseases (for SS group);\n* Patients who are currently using hormones\u002Fbiological agents (for both groups)；\n* Pregnancy or lactation",{"count":54,"type":22},[78],"Primary Sjögren's syndrome (pSS) is a chronic autoimmune exocrinopathy characterized by lymphocytic infiltration, progressive destruction of salivary gland acini, and varying degrees of functional impairment and fibrosis. Conventional imaging provides limited ability to simultaneously evaluate glandular function and inflammatory activity, leading to challenges in disease staging and treatment decision-making. This study explores a conceptual dual-tracer imaging framework using PSMA PET and FAPI PET to delineate complementary biological processes in pSS.",[222,223],"Primary Sjögren Syndrome","PET",{"date":225,"type":36},"2026-07-29",{"date":227,"type":36},"2023-10-01",{"date":229,"type":22},"2026-09-30",{"name":42,"class":43},{"id":232,"slug":233,"hasResults":12,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":23,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":247,"leadSponsor":249,"locationsCount":44},"100649517","phase-2-efficacy-and-safety-of-golidocitinib-for-rapidly-progressive-interstitial-lung-disease-100649517","NCT07737249","Efficacy and Safety of Golidocitinib for Rapidly Progressive Interstitial Lung Disease","A Prospective, Multi-center, Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Golidocitinib in Rapidly Progressive Interstitial Lung Disease","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Meet the diagnostic criteria for rapidly progressive interstitial lung disease (RP-ILD) and require treatment with corticosteroids and immunosuppressants, defined as: Acute worsening of cough and dyspnea occurring within 1 month; Chest CT showing ILD manifestations with new or worsening exudative lesions (ground-glass opacities and\u002For consolidation); Presence of respiratory failure (PaO₂ \\\u003C 60 mmHg at rest without oxygen supplementation, or SpO₂ \\\u003C 90% on room air), or significant worsening of hypoxemia (a decrease in PaO₂ of ≥ 10 mmHg), or a clear decline in two recent pulmonary function tests: a decrease in FVC % predicted of ≥ 10% and\u002For a decrease in DLCO % predicted of ≥ 15% accompanied by a decline in FVC; Exclusion of heart failure or fluid overload, pulmonary infectious diseases, and pulmonary embolism\n* No prior treatment with JAK inhibitors\n* Able to comply with scheduled follow-up visits\n* Patient and family members understand the study protocol, are willing to participate, and are able to provide written informed consent.\n\nExclusion Criteria:\n\n* The patient or family members are unable to understand the conditions and objectives of this study, or are unable to provide informed consent\n* Subjects who are unable to comply with the follow-up schedule as required by the protocol, including those who cannot cooperate with pulmonary function testing\n* Presence of other severe diseases that, in the investigator's opinion, may affect patient safety or compliance\n* Any significant clinical or laboratory abnormalities that, in the investigator's opinion, may affect the safety evaluation\n* Oxygenation index ≤ 100, and\u002For requirement for invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO) support\n* Pregnant or lactating women, as well as patients who are unable to use effective contraception during the study period and within 3 months after the end of the study\n* Presence of contraindications to golidocitinib administration, including a history of allergy to relevant drugs, or presence of active and uncontrolled infections, such as evidence of HIV, HBV (HBsAg-positive, HBV-DNA-positive or ≥ 1000 copies\u002FmL), HCV (anti-HCV antibody-positive or HCV-RNA-positive), or any symptomatic bacterial, viral, parasitic, or fungal infection requiring treatment\n* Need for concomitant use of acetaminophen or propacetamol, or preparations containing these ingredients","100 Years",{"count":54,"type":22},[26],"The goal of this clinical trial is to learn whether adding the JAK inhibitor golidocitinib to standard corticosteroid therapy works to treat rapidly progressive interstitial lung disease (RP-ILD) in patients with acute worsening. It will also learn about its safety compared to standard treatment without JAK inhibitors (i.e., corticosteroids plus other immunosuppressants such as mycophenolate mofetil, tacrolimus, cyclophosphamide, or biologics).\n\nThe main questions it aims to answer are:\n\n* How much does the addition of golidocitinib improve lung function, measured by the absolute change in FVC (mL), after 12 weeks of treatment?\n* How does it compare to standard therapy in terms of changes in FVC% predicted, oxygenation index, chest CT score, need for invasive respiratory support, all-cause mortality, relapse rate, and incidence of opportunistic infections?\n\nResearchers will compare the golidocitinib group (golidocitinib 150 mg once daily plus corticosteroids) to the control group (corticosteroids plus non-JAK inhibitor immunosuppressants). All patients receive high-dose corticosteroids (prednisone equivalent ≥1 mg\u002Fkg\u002Fday) with a tapering regimen.\n\nParticipants will:\n\n* Receive either golidocitinib plus corticosteroids or control treatment for 12 weeks\n* Visit the clinic for check-ups, blood tests, and lung function tests at weeks 1, 2, 4, 6-8, and 12\n* Have chest high-resolution CT scans at weeks 2, 4-6, and 12 to monitor disease progression\n* Be monitored for adverse events and efficacy outcomes throughout the 12-week period",[243],"Interstitial Lung Diseases","2026-07-27",{"date":132,"type":36},{"date":65,"type":22},{"date":248,"type":22},"2027-08-31",{"name":42,"class":43},{"id":251,"slug":252,"hasResults":12,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":12,"sex":17,"minAge":258,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":23,"phases":261,"briefSummary":263,"conditions":264,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":269,"completionDateStruct":270,"leadSponsor":272,"locationsCount":161},"100649034","phase-4-perioperative-statins-to-prevent-afib-after-lung-surgery-100649034","NCT07727681","Perioperative Statins to Prevent AFib After Lung Surgery","Perioperative Statin Therapy for the Prevention of Atrial Fibrillation After Anatomical Lung Resection: A Randomized Controlled Trial","STAT-LUNG","Inclusion Criteria:\n\n* Age 60 years or older.\n* Scheduled to undergo isolated anatomical lung resection, including pulmonary segmentectomy or lobectomy.\n* Sinus rhythm documented by a preoperative electrocardiogram.\n* Not receiving antiarrhythmic medication, with the exception of beta-blockers.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* Untreated hyperthyroidism or hypothyroidism.\n* History of obstructive hepatobiliary disease, active liver disease, or other serious liver disease.\n* Preoperative serum creatinine greater than 150 μmol\u002FL.\n* Known allergy to atorvastatin or another statin, or a history of a serious statin-related adverse reaction, including statin-associated myopathy.\n* Personal or family history of an inherited muscle disorder.\n* Continuous use within 1 month before randomization of fibrates, niacin, or medications that strongly inhibit cytochrome P450 or P-glycoprotein, including cyclosporine, oral azole antifungal agents, certain interacting antibiotics, protease inhibitors, nefazodone, or amiodarone.\n* Consumption of 1 liter or more of grapefruit juice per day within 1 month before randomization.\n* Current treatment with a high-intensity statin regimen, including atorvastatin 40 mg\u002Fday or higher or rosuvastatin 20 mg\u002Fday or higher.\n* Any other condition that, in the investigator's judgment, would make participation unsafe or interfere with the conduct or evaluation of the study.","60 Years",{"count":260,"type":22},540,[262],"PHASE4","The goal of this clinical trial is to learn whether short-term treatment with atorvastatin can prevent new abnormal rapid heart rhythms after lung surgery in adults aged 60 years or older who are scheduled to have a lung segment or lung lobe removed. The study will also evaluate the safety of short-term atorvastatin treatment around the time of surgery.\n\nThe main questions this study aims to answer are:\n\n* Does perioperative atorvastatin lower the number of participants who develop atrial fibrillation or a related rapid rhythm from the upper chambers of the heart during the first 72 hours after surgery?\n* What medical problems or changes in liver, kidney, or muscle-related laboratory tests occur during treatment?\n\nParticipants will be assigned by chance to receive either short-term atorvastatin treatment or a matching placebo-based comparison treatment. A placebo is a look-alike tablet that does not contain atorvastatin. Participants who were already taking a statin (moderate-intensity) before the study will receive a standardized background statin regimen so that their usual treatment is not stopped unnecessarily. Neither the participants nor most members of the research team will know which treatment has been assigned.\n\nStudy treatment will usually begin 2 to 7 days before surgery and continue until 72 hours after surgery. After surgery, participants will wear a portable heart monitor continuously for 72 hours to identify abnormal heart rhythms. Researchers will also collect routine clinical information, blood test results, and safety information during the hospital stay and will follow participants for 30 days after surgery.",[265,266],"Postoperative Atrial Fibrillation","Lung Surgery","2026-07-25",{"date":155,"type":36},{"date":136,"type":22},{"date":271,"type":22},"2028-01-02",{"name":42,"class":43},{"id":274,"slug":275,"hasResults":12,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":4},"100648186","a-randomized-controlled-trial-of-3d-airway-reconstruction-for-precise-double-lumen-bronchial-intubation-100648186","NCT07719959","A Randomized Controlled Trial of 3D Airway Reconstruction for Precise Double-Lumen Bronchial Intubation","A Randomized Controlled Clinical Study on the Precise Positioning of Double-lumen Bronchial Intubation Guided by Medical Imaging-based Airway Three-dimensional Reconstruction Technology","Inclusion Criteria:\n\n* ①Aged 18-75 years, undergoing elective VATS thoracic surgery, with DLT during the procedure; ②ASA physical status I-III; ③ Preoperative chest CT data available for 3D reconstruction; ④ Agree to participate in this study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* ① Preoperative presence of severe respiratory diseases, such as severe chronic obstructive pulmonary disease (COPD), pulmonary infection, and asthma exacerbation; ② Clinically assessed as a difficult airway, such as limited head tilt, spinal deformity, airway or head and neck masses, significant abnormalities in airway anatomy, etc.",{"count":281,"type":22},174,[78],"This is a very safe and beneficial clinical study. We hope to obtain near-real airway anatomical parameters of patients before surgery through airway three-dimensional reconstruction technology, to assist anesthesiologists in matching the most suitable double-lumen bronchial tube size for each patient, thereby reducing the rate of intubation failure and the occurrence of perioperative adverse events to a certain extent.",[285],"Pulmonary Nodules",[287,288,289,290,291],"Thoracic Surgery","Anesthetic Management","Double-Lumen Tube Intubation","Chest CT","3D Airway Reconstruction","2026-07-23",{"date":294,"type":36},"2026-07-24",{"date":296,"type":22},"2026-07",{"date":298,"type":22},"2027-04",{"name":42,"class":43},{"id":301,"slug":302,"hasResults":12,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":12,"sex":17,"minAge":308,"maxAge":18,"enrollmentInfo":309,"targetDuration":4,"studyType":23,"phases":311,"briefSummary":312,"conditions":313,"keywords":316,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100648292","phase-4-childhood-onset-lupus-nephritis-initial-glucocorticoid-dose-harmonization-trial-light-trial-100648292","NCT07719140","Childhood-onset Lupus Nephritis Initial Glucocorticoid-dose Harmonization Trial (LIGHT Trial)","Low- Versus High-Dose Initial Glucocorticoid Therapy for Childhood-Onset Proliferative Lupus Nephritis: a Multicenter Open-Label Noninferiority Randomized Controlled Trial","LIGHT","Inclusion Criteria:\n\n* Age ≥6 years and \\\u003C18 years, with body weight ≥20 kg\n* Meets the 2019 European League Against Rheumatism (EULAR) and American College of Rheumatology (ACR) classification criteria for Systemic Lupus Erythematosus (SLE)\n* Renal biopsy confirming Lupus Nephritis class III, IV, III+V, or IV+V according to the International Society of Nephrology \u002F Renal Pathology Society (ISN\u002FRPS) classification\n* At screening: 24-hour urinary protein ≥1.0 g (or ≥25 mg\u002Fkg), or urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg\n* White blood cell count ≥3.0 × 10⁹\u002FL and lymphocyte count ≥1.0 × 10⁹\u002FL\n* No prior intravenous methylprednisolone pulse therapy before enrollment, and glucocorticoid exposure ≤2 weeks before enrollment, with a maximum prednisone-equivalent dose ≤30 mg\u002Fday (or ≤1 mg\u002Fkg\u002Fday)\n* Written informed consent obtained and good treatment compliance expected\n\nExclusion Criteria:\n\n* Uncertain diagnosis of SLE, genetically confirmed monogenic lupus, or a history of immunodeficiency\n* Severe infection, including hepatitis C, active hepatitis B, HIV infection, tuberculosis infection, severe fungal infection, etc.\n* Severe neuropsychiatric lupus\n* Peripheral blood hemoglobin \\\u003C60 g\u002FL, platelet count \\\u003C10 × 10⁹\u002FL, or concomitant aplastic anemia\n* Severe cardiac insufficiency (NYHA functional class ≥ II)\n* Severe pulmonary involvement, including pulmonary hemorrhage, respiratory failure, pulmonary embolism, or other conditions requiring respiratory support\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m²\n* Severe gastrointestinal bleeding, pancreatitis, or hepatic lesions\n* Patients deemed by the investigator to be unsuitable for participation in this trial","6 Years",{"count":310,"type":22},198,[262],"Childhood-onset systemic lupus erythematosus (cSLE) is a severe chronic autoimmune disease with a high burden of major-organ involvement. Lupus nephritis (LN) affects more than half of children with SLE, and proliferative LN-including class III, IV, III+V, and IV+V disease-is associated with acute kidney injury, progression to end-stage kidney disease, and poor long-term outcomes.\n\nGlucocorticoids remain a cornerstone of induction therapy for proliferative LN. However, the optimal initial dose in children is uncertain. Although recent adult SLE and LN guidelines increasingly recommend lower-dose glucocorticoid regimens with rapid tapering, pediatric guidelines still commonly recommend high initial prednisone doses of 1.5-2.0 mg\u002Fkg\u002Fday. Adult trials and comparative observational studies suggest that lower-dose glucocorticoid regimens may preserve efficacy while reducing treatment-related toxicity.\n\nBecause cumulative glucocorticoid exposure in children may impair growth, development, psychosocial well-being, and medication adherence, this trial will compare low-dose versus high-dose initial glucocorticoid regimens for induction treatment of pediatric proliferative LN. The objective is to determine whether a lower-dose regimen is non-inferior in efficacy while reducing glucocorticoid-related adverse effects and improving quality of life.",[314,315],"Childhood-onset Systemic Lupus Erythematosus","Lupus Nephritis (LN)",[317,318,319,320,321],"Children","Systemic lupus erythematosus","Lupus nephritis","Glucocorticoid","Therapy","2026-07-17",{"date":324,"type":36},"2026-07-22",{"date":296,"type":22},{"date":327,"type":22},"2029-03",{"name":42,"class":43},8,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":337,"targetDuration":4,"studyType":23,"phases":339,"briefSummary":340,"conditions":341,"keywords":343,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":44},"100647090","phase-2-phase-ii-study-of-trastuzumab-rezetecan-combined-with-adebrelimab-and-lenvatinib-in-advanced-her2-positivelow-expression-biliary-tract-cancer-100647090","NCT07704177","Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive\u002FLow-Expression Biliary Tract Cancer","A Prospective, Open-Label, Multicenter Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib for HER2-Positive or Low-Expression Locally Advanced or Metastatic Biliary Tract Cancer in the Second-Line or Later Setting","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.\n2. Age: 18 years or above, Gender: Open to al\n3. Locally advanced or metastatic cholangiocarcinoma confirmed by pathological histology or cytology, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer\n4. Having progressed or experienced intolerance after at least one systemic treatment regimen in the past\n5. HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2\u002FCEP17 ≥ 2.0), HER2 low expression (IHC 2+\u002FFISH- or IHC 1+)\n6. There is at least one measurable lesion that meets the requirements of RECIST v1.1.\n7. The ECOG score is between 0 and 1.\n8. Expected survival period ≥ 12 weeks\n9. The organs and bone marrow have sufficient functions and meet the following requirements: (within 14 days before starting the treatment): 1) Blood routine examination: (within 14 days before the screening, no blood transfusion, no use of granulocyte colony-stimulating factor \\[G-CSF\\], no use of drugs to correct): A. Hemoglobin (Hb) ≥ 90 g\u002FL; B. Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; C. Platelet count (PLT) ≥ 75 × 109\u002FL; 2) Blood biochemical examination should meet the following standards (within 14 days before the screening, no albumin transfusion): A. Serum total bilirubin \\[BIL\\] ≤ 2xULN (for Gibert syndrome patients, ≤ 3xULN); B. Alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] ≤ 3.0xULN; C. For patients with liver metastasis, ALT and AST should be ≤ 5xULN; Serum creatinine (Cr) ≤ 1.5xULN or endogenous creatinine clearance rate ≥ 50 ml\u002Fmin (Cockcroft-Gault formula): Male: Cr clearance rate = ((140 - age) x weight) \u002F (72 x blood Cr); Female: Cr clearance rate = ((140 - age) x weight) \u002F (72 x blood Cr) x 0.85 (weight unit: kg; blood Cr unit: mg\u002FmL)\n10. For both male participants with fertile female partners and female participants with fertile partners, they must take effective contraceptive measures from the moment they sign the informed consent form until 7 months after the last administration of the test drug. During the same period, male participants must agree not to donate sperm, and female participants must agree not to donate eggs. For female participants with fertility, the serum HCG test must be negative within 7 days before the first administration of the drug, and they must be in the non-lactation period.\n\nExclusion Criteria:\n\n1. Histopathological examination confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc\n2. Having another active malignant tumor within 5 years or simultaneously, excluding cervical carcinoma in situ that has been fully treated, as well as skin basal cell or squamous cell carcinoma\n3. The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other situations judged by the investigator not to affect the treatment with the study drug)\n4. Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to large amounts of pleural effusion, pericardial effusion, accompanied by acute or chronic uncontrolled pancreatitis, active bleeding disorders, active infections, active ILD\u002Finterstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, mental disorders\u002Fsocioeconomic conditions) or the history of allogeneic organ or syngeneic bone marrow transplantation that the researchers consider makes the subject unsuitable for participation in the study or affects the compliance with the study protocol\n5. History of severe cardiovascular and cerebrovascular diseases: Within 12 months prior to randomization, there were manifestations of NYHA \"grade 3 or above\" congestive heart failure, unstable angina pectoris, myocardial infarction, poorly controlled arrhythmia or cerebral hemorrhage; cardiac echocardiography showed left ventricular ejection fraction (LVEF) \\\u003C 50%; corrected QT interval (QTe) \\> 480ms (calculated using the Fredericia method; if QTc is abnormal, it can be continuously detected for 3 times at intervals of 2 minutes, and the average value is taken); poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, based on the average value obtained from ≥ 2 measurements); previous occurrence of hypertensive crisis or hypertensive encephalopathy\n6. The subjects have congenital or acquired immune system deficiencies (such as HIV-infected individuals); or have a history of organ transplantation.\n7. Those who had active tuberculosis within 1 year prior to enrollment, or those who had a history of active tuberculosis infection more than 1 year ago but did not receive proper treatment.\n8. The study excluded patients who had a history of gastrointestinal bleeding within 6 months prior to treatment or who had a clear tendency towards gastrointestinal bleeding; patients with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies were also excluded.\n9. Within 4 weeks prior to the start of the treatment, had undergone major surgical procedures (except for biopsy procedures); the surgical incision had not yet fully healed; was expected to undergo major surgical treatment during the study period; minor traumatic surgeries (such as biopsy procedures) that were performed within 7 days prior to the start of the treatment\n10. Severe, non-healed or open wounds, active ulcers or untreated fractures\n11. Previous or current presence of central nervous system metastasis\n12. The first study: Using attenuated live vaccines within 28 days before the start of the treatment, or it is expected that attenuated live vaccines will be needed during the study treatment period or within 60 days after the last administration of the study drug.\n13. Patients with active autoimmune diseases, or those who have a history of autoimmune diseases and require long-term use of systemic glucocorticoids (equivalent dose of prednisone ≥ 10 mg\u002Fday, for more than 2 weeks) or immunosuppressants for treatment\n14. Based on the researchers' assessment, there are other factors that might have affected the research results or led to the premature termination of this study, such as alcohol abuse, drug addiction, having other serious diseases (including mental illnesses) that require combined treatment, severely abnormal laboratory test values, family or social factors, and other circumstances that might have affected the safety of the subjects or the collection of trial data.",{"count":338,"type":22},70,[26],"An investigation into the survival outcomes, progression-free survival, and safety of triple therapy with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib in patients with advanced HER2-positive\u002Flow-expressing biliary tract cancer after the failure of at least two prior systemic therapies.",[342],"Biliary Tract Neoplasms Immunotherapy",[344,345,346,347,348,349],"Biliary Tract Cancer","Immune Checkpoint Inhibitors","Trastuzumab Rezetecan","Adebrelimab","Lenvatinib","HER2-Positive\u002FLow-Expression","2026-07-14",{"date":352,"type":36},"2026-07-15",{"date":354,"type":36},"2026-04-15",{"date":356,"type":22},"2028-04-15",{"name":42,"class":43},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":17,"minAge":366,"maxAge":52,"enrollmentInfo":367,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":370,"conditions":371,"keywords":375,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":383,"leadSponsor":385,"locationsCount":386},"100628792","phase-4-pcsk9-inhibitor-for-intracranial-atherosclerosis-related-acute-ischemic-stroke-100628792","NCT07466251","PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke","PCSK9 Inhibitor for Intracranial Atherosclerosis Related Acute Ischemic Stroke (PISTIAS-3): a Randomized, Double-blind, Placebo-controlled Trial","PISTIAS-3","Inclusion Criteria\n\n1. Age 30 to 80 years, inclusive.\n2. Acute ischemic stroke with symptom onset within 72 hours before screening, diagnosed on the basis of neurological deficits and CT or MRI findings.\n3. National Institutes of Health Stroke Scale (NIHSS) score of 4 to 25 at hospital admission.\n4. CTA, DSA, or MRA evidence that the culprit intracranial artery has atherosclerotic stenosis of 50% to 99%.\n\nExclusion Criteria\n\n1. Intracranial arterial stenosis attributable to a nonatherosclerotic cause, such as arterial dissection, moyamoya disease, or systemic vasculitis.\n2. Any definite source of cardioembolism, such as atrial fibrillation, a mechanical prosthetic heart valve, left ventricular thrombus, or patent foramen ovale.\n3. Clinical and imaging findings suggesting that the index ischemic event is primarily attributable to cerebral small vessel disease.\n4. Pre-stroke disability, defined as a modified Rankin Scale score of 2 or higher before the index ischemic event.\n5. Extensive cerebral infarction on CT or MRI, such as an Alberta Stroke Program Early CT Score (ASPECTS) below 6 or an infarct volume of 70 mL or greater.\n6. Previous stent implantation in the culprit vessel or planned stent implantation in the culprit vessel within 3 months after enrollment.\n7. Any intracranial hemorrhage within 3 months before enrollment.\n8. An intracranial tumor; or a cerebral aneurysm or arteriovenous malformation judged to require interventional treatment.\n9. Severe active bleeding tendency or coagulation disorder.\n10. Severe cardiac, hepatic, renal, or other major organ dysfunction.\n11. Treatment with a PCSK9 monoclonal antibody inhibitor within 1 month before enrollment or with a PCSK9-targeting small interfering RNA therapy within 6 months before enrollment.\n12. A definite contraindication to statin therapy or a history of statin intolerance.\n13. Pregnant or breastfeeding, or planning to become pregnant during the study.\n14. Current participation in another clinical trial.","30 Years",{"count":368,"type":22},1212,[262],"This study is a prospective, multicenter, double-blind, randomized, placebo-controlled clinical trial designed to evaluate whether early administration of PCSK9 inhibitors can effectively improve functional outcomes at 90 days in patients with ischemic stroke (AIS) associated with intracranial atherosclerotic stenosis (ICAS), primarily assessed using the modified Rankin Scale at 90 days.",[372,373,374],"Acute Ischemic Stroke AIS","Intracranial Atherosclerosis ICAS","Atherosclerotic Plaque",[376,377,378,379,380],"Intracranial Atherosclerosis","intracranial artery stenosis","atherosclerotic plaque","PCSK9 inhibitor","Recaticimab",{"date":352,"type":36},{"date":65,"type":22},{"date":384,"type":22},"2029-12-31",{"name":42,"class":43},19,{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":148,"minAge":18,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":406,"lastUpdatePostDateStruct":407,"startDateStruct":409,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100647298","bionic-balloon-assisted-delivery-technology-on-the-labor-process-100647298","NCT07707804","Bionic Balloon-assisted Delivery Technology on the Labor Process","Study on The Impact of Bionic Balloon-assisted Delivery Technology on the Labor Process and Maternal and Neonatal Outcomes","Inclusion Criteria:\n\n* Age: 18-45 years;\n* Nulliparous women with singleton, term pregnancy, cephalic presentation, and no contraindications to vaginal delivery;\n* Latent phase longer than 3 hours, cervical dilation greater than 4-5 cm (entry into the active phase), fetal head engagement, and no obvious cephalopelvic disproportion;\n* Voluntary participation in this study and signing of written informed consent.\n\nExclusion Criteria:\n\n* Multiparous women;\n* Non-cephalic presentation;\n* Genital tract infection;\n* High-risk pregnancy score classified as \"red ball,\" \"purple ball,\" or some \"orange ball\" categories, including severe medical or surgical comorbidities, placenta previa, scarred uterus, etc.;\n* Presence of cephalopelvic disproportion, abnormal fetal heart rate, or other conditions unsuitable for vaginal delivery and requiring cesarean section;\n* Other conditions considered unsuitable for enrollment by the clinician.","45 Years",{"count":396,"type":22},300,[78],"This multicenter, prospective, randomized controlled trial will evaluate the efficacy and safety of bionic balloon-assisted delivery technology in nulliparous women planning vaginal delivery. Eligible participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Participants in the control group will receive routine labor management, while participants in the intervention group will receive bionic balloon-assisted delivery in addition to routine labor management after entering the active phase of labor.\n\nThe primary outcome is the duration of labor, including the first, second, and third stages of labor. Secondary outcomes include intrapartum cesarean conversion rate, intrapartum and postpartum complications, neonatal outcomes, postpartum pelvic floor dysfunction, postpartum depression, and maternal satisfaction. This study aims to determine whether bionic balloon-assisted delivery can shorten labor duration, reduce intrapartum cesarean conversion, and improve maternal and neonatal outcomes without increasing adverse events.",[400],"Vaginal Delivery",[402,403,404,405],"Bionic balloon-assisted delivery","Labor duration","Maternal outcomes","Neonatal outcomes","2026-07-12",{"date":408,"type":36},"2026-07-16",{"date":352,"type":22},{"date":411,"type":22},"2027-07-15",{"name":42,"class":43},4,{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":4,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":4,"studyType":23,"phases":423,"briefSummary":424,"conditions":425,"keywords":427,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":440,"locationsCount":44},"100616759","lung-eit-image-guide-ventilation-in-ards-100616759","NCT07309783","Lung EIT Image Guide Ventilation in ARDS","Personalised EIT-guided Ventilation Strategy Versus Conventional Protective Ventilation Strategy in ARDS Patients: a Multicenter, Randomized, Controlled triaL","Inclusion Criteria:\n\n* Patients with ARDS receiving mechanical ventilation who meet the following diagnostic criteria:\n\n  1. Triggered by acute risk factors such as pneumonia, non-pulmonary infection, trauma, transfusion, aspiration, or shock. Pulmonary edema is not entirely or predominantly attributable to cardiogenic causes or fluid overload, and hypoxemia\u002Fgas exchange impairment is not mainly due to atelectasis. However, ARDS can be diagnosed in the presence of these conditions if predisposing risk factors exist.\n  2. Acute onset or worsening of hypoxemic respiratory failure within 1 week of the identified risk factor or onset of new or worsening respiratory symptoms.\n  3. Bilateral opacities on chest radiograph or CT, or bilateral B-lines and\u002For consolidation on ultrasound, not fully explained by effusion, atelectasis, or nodules\u002Fmasses.\n  4. PaO₂\u002FFiO₂ ≤ 300 mm Hg or SpO₂\u002FFiO₂ ≤ 315 (if SpO₂ ≤ 97%).\n* ARDS onset within 1 week.\n* Mechanical ventilation ≤ 72 hours.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years.\n* Pregnancy.\n* Contraindications to EIT application (e.g., local skin lesions, cardiac pacemaker).\n* Contraindications to prone positioning (e.g., increased intracranial pressure, intra-abdominal hypertension, spinal fractures).\n* Evidence of barotrauma such as pneumothorax, mediastinal emphysema, or subcutaneous emphysema.\n* End-stage disease.\n* Informed consent not signed by legal guardians or family.",{"count":422,"type":22},574,[78],"The goal of this multi-center randomized controlled clinical trial is to learn if an individualized, bedside electrical impedance tomography (EIT)-guided ventilation strategy (including EIT-guided prone positioning and PEEP titration) can improve outcomes compared with a conventional lung-protective ventilation strategy in adult patients with acute respiratory distress syndrome (ARDS).\n\nThe main questions it aims to answer are:\n\nDoes the individualized EIT-guided ventilation strategy reduce 28-day mortality in ARDS patients? Researchers will compare the EIT-guided intervention arm to a control arm receiving routine lung-protective ventilation (without bedside EIT guidance) to see if the EIT-guided approach lowers 28-day mortality and improves other clinical outcomes.\n\nAdult ARDS patients who meet inclusion criteria will be assigned to EIT-guided group and control group through stratified randomization:\n\nEIT-guided group: Undergo bedside EIT assessments using a China-manufactured EIT device to guide decisions about prone positioning and individualized PEEP titration (including a recruitment maneuver).\n\nControl group: Receive PEEP setting per conventional PEEP-FiO₂ tables and prone positioning per standard clinical indications without EIT guidance.\n\nBoth groups: Receive standard supportive ICU care and routine outcome assessments at multiple time points.\n\nPrimary outcome: 28-day mortality. Other outcomes include ventilator-free days to day 28 and so on.",[426],"ARDS (Acute Respiratory Distress Syndrome)",[428,429,430,431,432],"ARDS","EIT-guided ventilation strategy","EIT-guided prone positioning","EIT-guided PEEP setting","RCT","2026-07-08",{"date":435,"type":36},"2026-07-09",{"date":437,"type":36},"2026-03-24",{"date":439,"type":22},"2029-06-20",{"name":42,"class":43},{"id":442,"slug":443,"hasResults":12,"nctId":444,"briefTitle":445,"officialTitle":445,"acronym":4,"eligibilityCriteria":446,"healthyVolunteers":447,"sex":17,"minAge":18,"maxAge":448,"enrollmentInfo":449,"targetDuration":451,"studyType":55,"phases":4,"briefSummary":452,"conditions":453,"keywords":455,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":458,"lastUpdatePostDateStruct":459,"startDateStruct":460,"completionDateStruct":462,"leadSponsor":463,"locationsCount":44},"100646415","study-on-the-application-of-liquid-chromatography-tandem-mass-spectrometry-for-the-determination-of-aldosterone-and-renin-activity-in-the-diagnosis-of-primary-aldosteronism-by-captopril-test-100646415","NCT07691801","Study on the Application of Liquid Chromatography-Tandem Mass Spectrometry for the Determination of Aldosterone and Renin Activity in the Diagnosis of Primary Aldosteronism by Captopril Test","Normal Control Group\n\nInclusion Criteria\n\n* Age 18-70 years old\n* BMI: 18.5-23.9kg\u002Fm²\n* Gender not restricted\n* Blood pressure: 100-120\u002F60-80mmHg\n* No history of hypertension\n* No abnormal nodules found in adrenal CT\n* Previous blood potassium and electrocardiogram were all within normal ranges\n* No history of liver or kidney dysfunction, malignant tumors, metabolic diseases or cardiovascular diseases\n* No medication used\n\nExclusion Criteria\n\n* Those with a family history of hypertension or with clinical manifestations of secondary hypertension\n* Those who have been taking drugs that may affect the RAAS system for a long time (such as contraceptives, steroids, etc.)\n* Those with cardiac dysfunction or severe arrhythmia and unable to tolerate the test\n\nPatients with suspected primary aldosteronism\n\nInclusion Criteria:\n\n* Patients with suspected primary aldosteronism in the outpatient setting\n* Willing to undergo 4-week spironolactone treatment and cooperate with follow-up\n\nExclusion Criteria:\n\n* Patients who did not complete the captopril suppression test\n* Patients with Cushing's syndrome or other endocrine tumors\n* Patients allergic to spironolactone or with contraindications for its use (such as severe hyperkalemia, eGFR \\\u003C 30)\n* History of liver or kidney dysfunction\n* Coexisting severe cardiovascular or cerebrovascular diseases\n* History of malignant tumors\n* Other types of endocrine hypertension (hyperthyroidism, pheochromocytoma, Cushing's syndrome, etc.)\n* Renal artery stenosis\n* Hypokalemia caused by other factors (renal tubular acidosis, Bartter syndrome, Gitelman syndrome, etc.)\n* Diabetes with HbA1c \\> 7.0% or currently using or having used insulin or SGLT2 inhibitor drugs\n* Taking special medications such as glucocorticoids, immunosuppressants, oral contraceptives, etc",true,"70 Years",{"count":450,"type":22},800,"6 Months","Primary aldosteronism (PA) is the most common cause of secondary hypertension. Liquid chromatography-tandem mass spectrometry (LC-MS\u002FMS) is more accurate than the traditional radioimmunoassay method in measuring aldosterone. This study aims to establish a more precise diagnostic cutoff value for the captopril stimulation test (CCT) by measuring aldosterone levels using LC-MS\u002FMS. The investigators will combine the detection results of CCT from healthy volunteers and suspected PA patients, etc., to determine the new CCT cutoff value. The investigators expect to improve the diagnostic accuracy of PA, helping clinicians identify this curable cause of hypertension earlier and more accurately, and achieving precise treatment.",[454],"Primary Aldosteronism",[456,457],"diagnose","Captopril Inhibition Test (CCT)","2026-07-07",{"date":435,"type":36},{"date":461,"type":36},"2025-04-28",{"date":136,"type":22},{"name":42,"class":43},{"id":465,"slug":466,"hasResults":12,"nctId":467,"briefTitle":468,"officialTitle":469,"acronym":470,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":52,"enrollmentInfo":472,"targetDuration":474,"studyType":55,"phases":4,"briefSummary":475,"conditions":476,"keywords":479,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":492,"completionDateStruct":493,"leadSponsor":494,"locationsCount":495},"100646260","early-identification-and-diagnosis-of-bad-related-stroke-100646260","NCT07693816","Early Identification and Diagnosis of BAD-related Stroke","Establishment and Validation of a Novel Intelligent Diagnostic Model for BAD-related Stroke Based on the Fusion of Multi-source Clinical Image Information and Its Promotion","SMART-BAD","Inclusion Criteria:\n\n* Age 18 to 80 years.\n* Diagnosis of acute ischemic stroke.\n* Time from symptom onset to enrollment ≤ 1 week; if the onset time is unknown, time from last known well to enrollment ≤ 1 week.\n* Availability of required baseline clinical and neuroimaging assessments according to the study protocol.\n* Written informed consent provided by the participant or legally authorized representative.\n\nParticipants will be classified into the BAD-related stroke cohort if they meet all predefined BAD-related stroke diagnostic criteria, including:\n\n* A single isolated deep subcortical infarct on diffusion-weighted imaging.\n* The presumed culprit perforating artery is the lenticulostriate artery or the paramedian pontine artery.\n* For lenticulostriate artery territory infarction: a comma-shaped lesion extending from inferior to superior direction on coronal DWI or involvement of ≥3 axial DWI slices with 5-7 mm slice thickness.\n* For paramedian pontine artery territory infarction: a lesion extending from the deep pons to the ventral surface of the pons on axial DWI.\n* No ≥50% stenosis of the corresponding parent artery, confirmed by MRA, CTA, or DSA.\n\nParticipants with acute ischemic stroke who do not meet BAD-related stroke criteria will be classified into the non-BAD acute ischemic stroke cohort.\n\nExclusion Criteria:\n\nGeneral exclusion criteria for all participants:\n\n* Intracranial hemorrhage, vascular malformation, aneurysm, brain abscess, malignant intracranial mass, or other non-ischemic intracranial lesion on baseline CT, MRI, MRA, CTA, or DSA.\n* Pre-stroke modified Rankin Scale score ≥2.\n* Life expectancy ≤6 months.\n* Unable to tolerate MRI examination.\n* Pregnancy or breastfeeding.\n* Participation in another clinical study within 3 months before informed consent or current participation in another clinical study that may interfere with this study.\n\nAdditional criteria that preclude classification as BAD-related stroke:\n\n* Ipsilateral extracranial tandem artery stenosis ≥50%.\n* Definite cardioembolic source, including atrial fibrillation, myocardial infarction, clinically significant valvular heart disease, dilated cardiomyopathy, infective endocarditis, atrioventricular conduction disease, or heart rate \\\u003C50 beats\u002Fmin as defined in the protocol.\n* Receipt of or planned acute-phase endovascular treatment after stroke onset.\n* Stroke due to other determined causes, such as moyamoya disease, arterial dissection, or vasculitis.",{"count":473,"type":22},1602,"90 Days","Branch atheromatous disease (BAD)-related stroke is an important subtype of acute ischemic stroke involving penetrating arteries and is associated with early neurological deterioration. Early recognition and standardized diagnosis remain challenging in routine clinical practice because clinical symptoms are often non-specific and the diagnosis requires integrated clinical and imaging assessment.\n\nThis multicenter prospective observational study will collect demographic, clinical, laboratory, electrocardiographic, ultrasound, and multimodal neuroimaging data from adults with acute ischemic stroke within 1 week of symptom onset. Participants will receive routine clinical care determined by their treating physicians; no treatment or management strategy will be assigned by the study protocol. An independent central clinical-imaging adjudication committee will classify participants as BAD-related stroke or non-BAD acute ischemic stroke according to predefined diagnostic criteria. The study aims to develop and externally validate artificial intelligence-assisted screening and diagnostic models for BAD-related stroke and to evaluate their discrimination, calibration, and potential clinical utility.",[58,477,478],"Acute Ischemic Stroke","Cerebral Infarction",[480,481,482,483,484,485,486,487,488,489],"Branch atheromatous disease","Acute ischemic stroke","Artificial intelligence","Machine learning","Deep learning","Diagnostic model","Multimodal imaging","Magnetic resonance imaging","Lenticulostriate artery","Paramedian pontine artery","2026-07-05",{"date":435,"type":36},{"date":352,"type":22},{"date":210,"type":22},{"name":42,"class":43},11,{"id":497,"slug":498,"hasResults":12,"nctId":499,"briefTitle":500,"officialTitle":501,"acronym":4,"eligibilityCriteria":502,"healthyVolunteers":447,"sex":17,"minAge":18,"maxAge":503,"enrollmentInfo":504,"targetDuration":4,"studyType":23,"phases":506,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":515,"lastUpdatePostDateStruct":516,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":520,"locationsCount":44},"100646338","effect-of-a-localized-icu-ai-teaching-agent-on-rotating-icu-residents-100646338","NCT07692035","Effect of a Localized ICU AI Teaching Agent on Rotating ICU Residents","Effect of a Localized ICU-Specific AI Teaching Agent on Institutional Workflow Mastery and Clinical Competency in Rotating ICU Residents: A Single-Center, Parallel-Group, Randomized Controlled Superiority Trial","Inclusion Criteria:\n\n1. First-time rotating residents with no prior formal ICU clinical rotation experience\n2. Scheduled to complete a minimum of 4 consecutive weeks of ICU training\n3. Able to complete all scheduled assessments at Day 3, Day 7, and Day 14 post-randomization\n4. Possess basic digital literacy to operate assigned AI tools on standard clinical devices\n5. Voluntarily provide written informed consent to participate in the trial\n\nExclusion Criteria:\n\n1. Cumulative prior formal ICU clinical experience exceeding 7 calendar days\n2. Regular daily clinical use of AI tools for medical decision-making in the 3 months preceding enrollment\n3. Physical or cognitive impairment that prevents completion of trial assessments\n4. Inability to provide written informed consent","40 Years",{"count":505,"type":22},44,[78],"This trial is an ongoing single-center, pragmatic, parallel-group randomized controlled superiority trial currently in participant recruiting phase, conducted within intensive care unit teaching wards at Peking Union Medical College Hospital, Beijing, China. The scheduled trial implementation period spans March 2026 to June 2026, aiming to evaluate whether an institution-specific, protocol-bound retrieval-augmented AI educational agent (named ICU-Tutor) can reduce residents' extraneous cognitive load and improve standardized ICU protocol task performance compared with free access to unrestricted commercial general-purpose large language model AI tools during early ICU clinical rotation.\n\nThe trial plans to screen a total of 44 first-time ICU rotating resident candidates, with pre-defined exclusion standards to eliminate unqualified individuals; approximately 44 eligible residents will undergo 1:1 stratified randomization and be split into two research arms: 22 participants assigned to the ICU-Tutor intervention group and 22 assigned to the unrestricted general AI control group.\n\nAll enrolled subjects will complete standardized 14-day follow-up assessments as pre-specified in the trial protocol. Both study cohorts receive unified 15-minute standardized training covering standardized safe AI clinical application rules prior to formal intervention initiation. ICU-Tutor is strictly built on a curated knowledge base including 247 ICU institutional protocols validated by senior attending intensivists, with all AI outputs traceable back to original local protocol documents and constrained within verified institutional guidance content only. The control arm allows participants to select and utilize any mainstream general large-model AI tools per personal preference without content or access limitations, consistent with real-world daily resident clinical practice.\n\nTwo co-primary endpoints are uniformly scheduled to be measured on the 7th day after randomization, including total completion duration of standardized ICU protocol task battery and Paas 9-point validated cognitive load scale score reflecting participants' subjective mental workload during task execution. Three confirmatory secondary endpoints are pre-defined for centralized assessment: composite task performance score on Day7, written institutional protocol knowledge retention score tested on Day14, and 0-100-point visual analog scale (VAS) evaluating resident satisfaction toward allocated AI support on Day7. Individual sub-station scores of three split practical ICU skill modules are set as exploratory secondary endpoints for post-hoc descriptive analysis only.\n\nThe statistical analysis framework is pre-specified to follow intention-to-treat principle entirely. Analysis of covariance (ANCOVA) is selected as core analytical method for all continuous outcomes, with Day3 baseline assessment result and participants' academic training background set as pre-planned covariates. Bonferroni multiple-testing correction is applied for dual co-primary endpoints, while Benjamini-Hochberg false discovery rate (FDR) correction is pre-specified to control type I error across three confirmatory secondary outcomes. Effect sizes will be quantified via Cohen's d after raw data collection and database lock.\n\nThe trial has obtained formal ethical approval from the Institutional Review Board of Peking Union Medical College Hospital (Approval ID: I-26ZM0024). Every enrolled resident provides written informed consent before random assignment.",[509],"Cognitive Load and Task Performance in Rotating Residents",[511,512,513,514],"AI Agent","Cognitive Load","Rotating Residents","Medical Education","2026-07-02",{"date":435,"type":36},{"date":518,"type":36},"2026-03-20",{"date":490,"type":22},{"name":42,"class":43},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":4,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":528,"targetDuration":4,"studyType":23,"phases":530,"briefSummary":531,"conditions":532,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":535,"lastUpdatePostDateStruct":536,"startDateStruct":538,"completionDateStruct":540,"leadSponsor":542,"locationsCount":4},"100646975","phase-1-mrg003-with-gemcitabine-for-second-line-advanced-pdac-100646975","NCT07685470","MRG003 With Gemcitabine for Second-line Advanced PDAC","A Prospective, Single-arm, Ib\u002FII Exploratory Study of Becotatugvedotin(MRG003) in Combination With Gemcitabine for Second-line Advanced Pancreatic Ductal Adenocarcinoma","Inclusion Criteria:\n\nECOG performance status score of 0-2;\n\nHistopathologically confirmed locally advanced unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC);\n\nFailure of prior first-line systemic therapy:\n\n1. Radiographic progression or worsening of clinical symptoms; disease progression occurring within 6 months after completion of neoadjuvant\u002Fadjuvant therapy is also considered first-line treatment failure.\n2. Intolerance to first-line therapy, as fully assessed by the investigator, may also allow enrollment into the study. Intolerance to prior study treatment is defined as follows:\n\ni. Any grade ≥3 hematologic toxicity (per NCI-CTCAE v5.0) that does not recover to grade 1 or pre-treatment level after 14 days of best supportive care; ii. Any grade ≥3 non-hematologic toxicity (excluding alopecia and asymptomatic laboratory abnormalities) per NCI-CTCAE v5.0 that does not recover to normal after 14 days of best supportive care.\n\nAdequate organ and bone marrow function;\n\nEstimated life expectancy \\> 3 months;\n\nSubjects must agree to provide sufficient tumor tissue samples for EGFR and PD-L1 immunohistochemistry (IHC) expression testing, next-generation sequencing (NGS), and multi-omics analysis. This includes archived tumor samples (paraffin blocks or unstained sections meeting the testing requirements specified in the study); if no archived tumor tissue sample is available, the subject agrees to undergo re-biopsy of the tumor lesion.\n\nExclusion Criteria:\n\n* Failure of first-line gemcitabine-based therapy.\n\nOther histologic types of pancreatic tumors, such as neuroendocrine tumors, acinar cell carcinoma, cystic carcinoma, etc.\n\nPrior treatment with an MMAE-loaded ADC (antibody-drug conjugate).\n\nCongenital or acquired immunodeficiency (e.g., HIV infection), active hepatitis B (HBV-DNA ≥ 10⁴ copies\u002FmL), or hepatitis C (positive HCV antibody with HCV-RNA above the lower limit of detection of the assay).\n\nKnown hypersensitivity to the study drug or any of its excipients, or a history of severe allergic reactions to other monoclonal antibodies.\n\nOccurrence of the following within 6 months before randomization: myocardial infarction, severe\u002Funstable angina pectoris, New York Heart Association (NYHA) Class ≥2 cardiac insufficiency, or symptomatic congestive heart failure.\n\nVaccination with a live vaccine within 4 weeks before the first dose of study drug. Inactivated virus vaccines for seasonal influenza (administered by injection) are permitted, but live attenuated influenza vaccine administered via the intranasal route is not allowed.\n\nKnown history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n\nKnown history of substance abuse (psychoactive drugs) or drug addiction.\n\nPregnant or breastfeeding women.\n\nDiagnosis of any other malignancy within 5 years before study entry, except for curatively treated basal cell carcinoma or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, ductal carcinoma in situ of the breast, and papillary thyroid carcinoma that have been treated with local therapy and cured.\n\nPresence of any other serious physical or psychiatric illness, or laboratory abnormalities that may increase the risk of study participation, interfere with the study results, or render the patient unsuitable for participation in the opinion of the investigator.\n\nNote: Subjects with hepatitis B meeting the following criteria may also be enrolled:\n\nHBV viral load \\\u003C 1000 copies\u002FmL (\\\u003C200 IU\u002FmL) before the first dose, and the subject must receive anti-HBV therapy during the entire study treatment period to prevent viral reactivation.\n\nFor subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and HBV viral load (-), prophylactic anti-HBV therapy is not required, but close monitoring for viral reactivation is necessary.\n\nSubjects with active HCV infection (positive HCV antibody and HCV-RNA levels above the lower limit of detection).\n\nVaccination with a live vaccine within 30 days before the first dose (Cycle 1, Day 1).\n\nNote: Inactivated injectable vaccines for seasonal influenza are permitted within 30 days before the first dose; live attenuated influenza vaccine administered intranasally is not allowed.\n\nPresence of any serious or uncontrolled systemic disease, for example:\n\nClinically significant and severe, difficult-to-control abnormalities in cardiac rhythm, conduction, or morphology on resting ECG, such as complete left bundle branch block, second-degree or higher atrioventricular block, ventricular arrhythmia, or atrial fibrillation.\n\nUnstable angina pectoris, congestive heart failure, or chronic heart failure of NYHA Class ≥2.\n\nAny arterial thrombotic, embolic, or ischemic event (e.g., myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack) within 6 months before study treatment.\n\nPoorly controlled blood pressure (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg).\n\nActive tuberculosis.\n\nActive or uncontrolled infection requiring systemic therapy.\n\nClinically active diverticulitis, intra-abdominal abscess, or gastrointestinal obstruction.\n\nLiver disease such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.\n\nPoorly controlled diabetes mellitus (fasting blood glucose \\> 10 mmol\u002FL).\n\nUrinalysis showing proteinuria ≥ 2+, with confirmed 24-hour urine protein \\> 1.0 g.\n\nPsychiatric disorders that prevent the patient from cooperating with treatment.\n\nHistory or evidence of disease, treatment, or laboratory abnormalities that could interfere with the study results or prevent the subject from completing full participation in the study, or any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment, including potential risks that are not explicitly listed above.",{"count":529,"type":22},30,[25,26],"This is a Phase Ib\u002FII clinical study aimed to evaluate the tolerability of becotatugvedotin in combination with gemcitabine, determine the clinically recommended dose for the combination regimen, and assess the efficacy and safety of becotatugvedotin combined with gemcitabine in patients with advanced second-line pancreatic ductal adenocarcinoma (PDAC). The study plans to enroll 27-30 patients, including 3-6 patients in the first stage (Phase I) and 24 patients in the second stage (Phase II).\n\nThe study consists of three periods: screening period (including baseline), treatment period, and follow-up period (safety follow-up and survival follow-up). Eligible patients must have locally advanced unresectable or metastatic pancreatic cancer confirmed by histopathology.\n\nPhase I: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. Becotatugvedotin will be administered at doses of 1.5 mg\u002Fkg or 2.0 mg\u002Fkg once every 3 weeks (Q3W) using a 3+3 dose escalation design. Gemcitabine will be given at 1000 mg\u002Fm² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, dose-limiting toxicities (DLTs), withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Upon completion of Phase I, the study will proceed to Phase II.\n\nPhase II: After the screening period, patients will receive treatment with becotatugvedotin and gemcitabine. The dose of becotatugvedotin will be the recommended Phase II dose (RP2D) selected based on the results from Phase I, while gemcitabine will be administered at 1000 mg\u002Fm² on days 1 and 8 of each 3-week cycle (Q3W). Treatment will continue until disease progression, intolerable toxicity, withdrawal of informed consent, death, pregnancy, investigator decision to discontinue treatment, or study termination, whichever occurs first. Tumor imaging assessments will be performed using RECIST v1.1 every 6 weeks (i.e., every 2 treatment cycles). Safety assessments will be conducted using the NCI-CTCAE version 5.0 criteria from the first dose through 30 days after the last dose.",[533,534],"Pancreatic Ductal Adenocarcinoma (PDAC)","Second Line Treatment","2026-07-01",{"date":537,"type":36},"2026-07-06",{"date":539,"type":22},"2026-06-08",{"date":541,"type":22},"2029-06-07",{"name":42,"class":43},{"id":544,"slug":545,"hasResults":12,"nctId":546,"briefTitle":547,"officialTitle":548,"acronym":4,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":550,"targetDuration":4,"studyType":23,"phases":552,"briefSummary":553,"conditions":554,"keywords":555,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":562,"completionDateStruct":564,"leadSponsor":566,"locationsCount":44},"100645135","phase-2-a-phase-ii-study-of-adjuvant-durvalumab-combined-with-gemoxgc-chemotherapy-followed-by-lenvatinib-versus-capecitabine-in-biliary-tract-cancer-100645135","NCT07679399","A Phase II Study of Adjuvant Durvalumab Combined With GEMOX\u002FGC Chemotherapy Followed by Lenvatinib Versus Capecitabine in Biliary Tract Cancer.","A Randomized, Open-label, Phase II Clinical Study of Durvalumab Combined With GEMOX\u002FGC Chemotherapy Followed by Lenvatinib Versus Capecitabine as Adjuvant Therapy for Biliary Tract Cancer.","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and agreed to sign the written informed consent. They had good compliance and cooperated with the follow-up.\n2. When signing the informed consent form, one must be at least 18 years old and no older than 75 years old, and there is no restriction on gender.\n3. Histologically confirmed cholangiocarcinoma or gallbladder cancer (excluding pancreatic cancer or ampullary cancer)\n4. Having undergone radical surgical treatment (R0 or R1 resection)\n5. The ECOG score is between 0 and 1\n6. The hematology and organ functions are adequate. Based on the following laboratory test results obtained within 14 days prior to the start of the treatment (unless otherwise specified)\n7. Blood routine test: (Within 14 days before screening, no blood transfusion, no use of G-CSF, and no use of drugs for correction) Hb ≥ 90 g\u002FL; Neutrophils ≥ 1.5 × 10\\^9\u002FL; PLT ≥100×10\\^9\u002FL\n8. Biochemical test: (No albumin transfusion within 14 days)\n9. Appropriate liver function: ALT and AST ≤ 2.5 × ULN; serum bilirubin ≤ 2.0 × normal upper limit (ULN); these conditions do not apply to patients with confirmed Gilbert syndrome. Any clinically significant biliary obstruction should be relieved before enrollment. Albumin ≥ 2.8 g\u002FdL. Appropriate renal function: creatinine ≤ 1.5 × ULN, or creatinine clearance rate (CCr) \\> 50 mL\u002Fmin (calculated using the standard Cockcroft-Gault formula)\n10. Coagulation function: International Normalized Ratio (INR) ≤ 1.5\n11. Fertile women: Agree to abstain from sexual intercourse (avoiding heterosexual intercourse) or use a contraceptive method with a failure rate of less than 1% during the treatment period and for at least 6 months after the last administration. If the female patient has menstruated, has not reached post-menopausal status (continuous absence of menstruation for ≥ 12 months, no other causes found apart from menopause), and has not undergone sterilization surgery (removal of ovaries and\u002For uterus), then it is considered that the patient is fertile. Examples of contraceptive methods with a failure rate of less than 1% include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormonal release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature, or post-ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.\n12. Male: Agree to abstinence (not engaging in heterosexual sexual intercourse) or use of contraceptive measures, agree not to donate sperm, defined as follows: When the female partner has reproductive capacity, the male patient must abstain from sexual activity during the treatment period and for 6 months after the last administration, or use condoms and other contraceptive methods to ensure a contraceptive failure rate of less than 1% per year. During the same period, the male patient must also agree not to donate sperm. When the female partner is pregnant, the male patient must abstain from sexual activity or use condoms for contraception during the treatment period and for 6 months after the last administration, to avoid any impact on the fetus. The reliability of sexual abstinence should be evaluated relative to the duration of the clinical trial and the patient's preferred lifestyle and daily routine. Periodic abstinence (such as calendar days, ovulation period, symptom-based body temperature or after ovulation methods) and withdrawal from sexual intercourse are unacceptable contraceptive methods.\n\nExclusion Criteria:\n\n1. Pancreatic cancer or ampullary cancer\n2. Not yet fully recovered from the surgery or with unremoved bile duct obstruction\n3. Pregnant women (with a positive pregnancy test before taking the medicine) or lactating women\n4. Having had other untreated malignant tumors in the past (within the last 5 years) or simultaneously, excluding cured skin basal cell carcinoma, skin squamous cell carcinoma, in situ breast cancer and in situ cervical cancer, treated superficial bladder cancer, and prostate adenocarcinoma that underwent surgical treatment and whose PSA tumor marker was within the normal range.\n5. Who has previously received immunotherapy or chemotherapy\n6. Serious coexisting diseases that may interfere with the treatment of the proposed plan, including potential severe infections\n7. There is drug abuse; or any medical, psychological or social condition that may affect the research, the patient's compliance, be unstable, or even potentially endanger the patient's safety.\n8. Significant clinical cardiovascular and cerebrovascular diseases, including but not limited to acute myocardial infarction occurring within 6 months prior to enrollment, severe\u002Funstable angina pectoris, cerebrovascular accident or transient cerebral ischemic attack, congestive heart failure (NYHA classification ≥ 2 grade); arrhythmias requiring anti-arrhythmic drugs (except beta-blockers or digoxin); repeated electrocardiogram QTc interval \\> 480 milliseconds (ms)\n9. Presence of persistent infection of grade 2 or above (CTCAE 5.0)\n10. Having a history of thromboembolic events within the past 6 months (including stroke and\u002For transient ischemic attack)\n11. Hypertension that has not been well controlled by antihypertensive drugs (systolic blood pressure \\> 160 mmHg, diastolic blood pressure \\> 100 mmHg)\n12. Participants who had active autoimmune diseases or autoimmune disease history in the past two years; those with active, known, or suspected autoimmune diseases that may affect important organ functions or that may require systemic immunosuppressive therapy, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, antiphospholipid syndrome related to vascular thrombosis, Wegener's granulomatosis, Sjogren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis or glomerulonephritis. However, type 1 diabetes, hypothyroidism requiring only hormone replacement, skin diseases that do not require systemic treatment (such as vitiligo, psoriasis or alopecia) or participants who will not have a recurrence without external triggering factors are allowed. Alternative therapies (such as thyroid hormone, insulin or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) are not considered as a form of systemic treatment.\n13. A known history of active tuberculosis (with the tuberculosis bacteria)\n14. Those who have a history of gastrointestinal bleeding within the past 6 months or have a clear tendency towards gastrointestinal bleeding, such as esophageal varices with bleeding risk, active gastrointestinal ulcer lesions, or fecal occult blood ≥ (++), are not eligible for enrollment; those with evidence or history of ≥ 3 grade (CTCAE 5.0) bleeding events due to bleeding mechanism disorders are also excluded.\n15. Severe non-healing wounds, ulcers or fractures\n16. There are unresolved toxicities of grade \\> 1 that were caused by any previous treatment\u002Foperation (CTCAE 5.0, except for hair loss, anemia, and hypothyroidism)\n17. Patients who have objective evidence of severe lung function impairment in the past and at present, such as a history of severe pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, or drug-related pneumonia\n18. After the researchers' comprehensive assessment of the patient's condition, it was determined that the patient was not suitable for participating in this study.\n19. At the same time, he\u002Fshe was also involved in another clinical study.",{"count":551,"type":22},222,[26],"This study is designed as a prospective, randomized, open-label, phase II clinical trial to systematically evaluate the efficacy and safety of durvalumab combined with GEMOX\u002FGC chemotherapy followed by lenvatinib, compared with capecitabine monotherapy, as adjuvant therapy for biliary tract cancer (BTC) after curative-intent resection.The primary objective is to determine whether the combination regimen can significantly improve the 1-year recurrence-free survival (RFS) rate. Secondary objectives include assessment of overall survival (OS) and the incidence of treatment-related adverse events. The overall aim is to identify a more effective and safer treatment strategy for postoperative adjuvant therapy in BTC.",[342],[344,556,557,558,559],"durvalumab","lenvatinib","capecitabine","adjuvant therapy","2026-06-30",{"date":535,"type":36},{"date":563,"type":36},"2025-06-01",{"date":565,"type":22},"2027-06-01",{"name":42,"class":43},{"id":568,"slug":569,"hasResults":12,"nctId":570,"briefTitle":571,"officialTitle":571,"acronym":572,"eligibilityCriteria":573,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":574,"targetDuration":4,"studyType":23,"phases":576,"briefSummary":577,"conditions":578,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":44},"100616550","real-time-algorithm-driven-ventilation-feedback-to-improve-lung-protective-ventilation-in-patients-with-ards-realvent-study-100616550","NCT07307066","Real-Time Algorithm-Driven Ventilation Feedback to Improve Lung-Protective Ventilation in Patients With ARDS (REALVENT-study)","REALVENT","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* Receiving invasive mechanical ventilation via endotracheal intubation at the time of screening\n* Initiation of invasive mechanical ventilation within the past 24 hours\n* PaO₂\u002FFiO₂ ≤ 200 mmHg on PEEP ≥ 8 cmH₂O or, if arterial blood gas is unavailable: SpO₂\u002FFiO₂ ≤ 235 with SpO₂ ≤ 97%\n* Chest imaging (chest X-ray or CT) showing bilateral pulmonary infiltrates not fully explained by pleural effusions, lobar collapse, or pulmonary nodules\n* Respiratory failure not fully explained by cardiac failure or fluid overload\n* Expected to require invasive mechanical ventilation for ≥ 72 hours after enrollment\n\nExclusion Criteria:\n\n* Receipt of extracorporeal membrane oxygenation (ECMO) or high-frequency oscillatory ventilation at screening\n* Brain death or anticipated withdrawal of life-sustaining treatment within 72 hours\n* Pregnancy\n* Known neuromuscular disease affecting spontaneous respiratory effort\n* Prisoners or individuals unable to provide informed consent or surrogate consent\n* Simultaneous enrollment in another interventional ICU study\n* Lack of digital infrastructure for real-time ventilator waveform acquisition",{"count":575,"type":22},208,[78],"The REALVENT trial is designed to evaluate whether a real-time, algorithm-driven ventilation feedback strategy can improve lung-protective ventilation (LPV) achievement rates in critically ill patients receiving invasive mechanical ventilation. This multicentre randomised controlled trial will compare real-time respiratory waveform monitoring with automated feedback against standard ICU care. The primary endpoint is the LPV achievement rate over the first 72 hours.",[426,579,580,581],"VILI (Ventilator-induced Lung Injury)","Respiratory Failure","Critical Illness","2026-06-29",{"date":535,"type":36},{"date":585,"type":36},"2025-12-30",{"date":587,"type":22},"2027-02-28",{"name":42,"class":43},{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":596,"targetDuration":4,"studyType":23,"phases":597,"briefSummary":598,"conditions":599,"keywords":600,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":602,"startDateStruct":604,"completionDateStruct":606,"leadSponsor":608,"locationsCount":44},"100644567","phase-2-phase-ii-study-of-trastuzumab-rezetecan-combined-with-adebrelimab-and-lenvatinib-as-first-line-therapy-for-advanced-her2-positiveher2-low-biliary-tract-cancer-100644567","NCT07670273","Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib as First-Line Therapy for Advanced HER2-Positive\u002FHER2-Low Biliary Tract Cancer","A Prospective, Open-label, Multicenter Phase II Clinical Study of Rikang Trastuzumab in Combination With Adebrelimab and Lenvatinib for First-line Treatment of HER2-positive or Low-expressing Locally Advanced or Metastatic Biliary Tract Cancer","Inclusion Criteria:\n\n1. The HER2-positive subjects voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.\n2. Age ≥ 18 years old, gender not limited;\n3. Locally advanced or metastatic cholangiocarcinoma, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer, which has been confirmed by pathological histology or cytology;\n4. Not suitable for radical surgical resection or local treatment. Subjects who have not received any systemic anti-tumor therapy in the past; allowed to have received radical treatment previously (including surgical treatment and postoperative adjuvant chemotherapy and\u002For radiotherapy), and the interval from the last administration of radical treatment to disease recurrence is at least 6 months, and no systemic anti-tumor treatment was received during the recurrence or metastasis stage.\n5. HER2 positive (IHC 3+ or IHC 2+ and FISH detects HER2\u002FCEP17 ≥ 2.0), HER2 low expression (IHC 2+\u002FFISH- or IHC 1+);\n6. There is at least one measurable lesion that meets the requirements of RECIST v1.1.\n7. The ECOG score is between 0 and 1.\n8. Expected survival period ≥ 12 weeks;\n9. The organs and bone marrow have sufficient functions and meet the following requirements: (within 14 days before starting the treatment) 1) Blood routine examination: (within 14 days before the screening, no blood transfusion, no use of granulocyte colony-stimulating factor \\[G-CSF\\], no use of drugs to correct): A. Hemoglobin (Hb) ≥ 90 g\u002FL; B. Neutrophil count (ANC) ≥ 1.5 × 109\u002FL; C. Platelet count (PLT) ≥ 75 × 109\u002FL; 2) Blood biochemical examination should meet the following standards (no albumin transfusion within 14 days before the screening): A. Serum total bilirubin \\[BIL\\] ≤ 2xULN (for Gibert syndrome patients, ≤ 3xULN); B. Alanine aminotransferase \\[ALT\\] and aspartate aminotransferase \\[AST\\] ≤ 3.0xULN; C. For patients with liver metastasis, ALT and AST should be ≤ 5xULN; Serum creatinine (Cr) ≤ 1.5xULN or endogenous creatinine clearance rate ≥ 50 ml\u002Fmin (Cockcroft-Gault formula): Male: Cr clearance rate = ((140 - age) × weight) \u002F (72 × blood Cr); Female: Cr clearance rate = ((140 - age) × weight) \u002F (72 × blood Cr) × 0.85 (weight unit: kg; blood Cr unit: mg\u002FmL)\n10. For both male subjects with fertile partners and female subjects with fertile partners, they must take effective contraceptive measures from the moment they sign the informed consent form until 7 months after the last administration of the test drug. During the same period, male subjects must agree not to donate sperm, and female subjects must agree not to donate eggs. For female subjects with fertility, the serum HCG test must be negative within 7 days before the first administration of the drug, and they must be in the non-breastfeeding period.\n\nExclusion Criteria:\n\n1. Histological or cytological pathology confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc.\n2. Having another active malignant tumor within 5 years or simultaneously; excluding cervical carcinoma in situ that has been fully treated, as well as basal cell or squamous cell carcinomas of the skin.\n3. Participants who have previously received immunotherapy, HER2-targeted, or ADC drug treatment, including immune checkpoint inhibitors (such as anti-PD-1\u002FL1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such as CD40, CD137, OX40 antibodies, etc.), and any other treatments targeting the immune mechanism of tumor treatment;\n4. The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other situations determined by the investigator not to affect the treatment with the study drug).\n5. Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to large amounts of pleural effusion, pericardial effusion, accompanied by acute or chronic uncontrolled pancreatitis, active bleeding disorders, active infections, active ILD\u002Finterstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, mental disorders\u002Fsocioeconomic conditions) or the history of allogeneic organ or syngeneic bone marrow transplantation that the researchers consider makes the subject unsuitable for participation in the study or affects the compliance with the study protocol;\n6. History of severe cardiovascular and cerebrovascular diseases: Within 12 months prior to randomization, there were manifestations of NYHA \"grade 3 or above\" congestive heart failure, unstable angina pectoris, myocardial infarction, poorly controlled arrhythmia or cerebral hemorrhage; cardiac echocardiography showed left ventricular ejection fraction (LVEF) \\\u003C 50%; corrected QT interval (QTe) \\> 480ms (calculated using the Fredericia method; if QTc is abnormal, it can be continuously detected for 3 times at intervals of 2 minutes, and the average value is taken); poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg, based on the average value obtained from ≥ 2 measurements); previous occurrence of hypertensive crisis or hypertensive encephalopathy.\n7. The subjects have congenital or acquired immune system deficiencies (such as HIV-infected individuals); or have a history of organ transplantation;\n8. Those who had active tuberculosis within one year prior to enrollment, or those who had a history of active tuberculosis infection more than one year ago but did not receive proper treatment.\n9. The study excluded those who had a history of gastrointestinal bleeding within 6 months prior to treatment or who had a clear tendency towards gastrointestinal bleeding; those with known hereditary or acquired bleeding disorders (such as coagulation dysfunction) or thrombosis tendencies;\n10. Within 4 weeks prior to the start of the treatment, if one has undergone major surgical procedures (except for biopsy procedures); if the surgical incision has not fully healed; if major surgical treatment is expected to be required during the study period; if a minor traumatic surgical procedure (such as biopsy procedures) was performed within 7 days prior to the start of the treatment.\n11. Severe, non-healed or open wounds, active ulcers or untreated fractures;\n12. Previous or current presence of central nervous system metastasis;\n13. The first study requires that the subjects use attenuated live vaccines within 28 days before the start of the treatment, or that they are expected to use attenuated live vaccines during the study treatment period or within 60 days after the last administration of the study drug.\n14. Patients with active autoimmune diseases, or those with a history of autoimmune diseases and who require long-term use of systemic glucocorticoids (equivalent dose of prednisone ≥ 10 mg\u002Fday, for more than 2 weeks) or immunosuppressants.\n15. Based on the researchers' assessment, there are other factors that might have affected the research results or led to the premature termination of this study, such as alcohol abuse, drug abuse, having other serious diseases (including mental illnesses) that require combined treatment, severely abnormal laboratory test values, family or social factors, and other situations that might have affected the safety of the subjects or the collection of trial data.",{"count":338,"type":22},[26],"This phase II study evaluates the efficacy and safety of Trastuzumab Rezetecan in combination with Adebrelimab and Lenvatinib as first-line therapy for patients with locally advanced or metastatic HER2-positive or HER2-low biliary tract cancer. The primary objective is the objective response rate (ORR). Key secondary objectives include efficacy endpoints-progression-free survival (PFS), overall survival (OS), disease control rate (DCR), and duration of response (DoR)-and safety assessments comprising adverse events (AEs), serious adverse events (SAEs), vital signs, and laboratory findings.",[342],[344,345,346,347,348,349],"2026-06-25",{"date":603,"type":36},"2026-06-26",{"date":605,"type":36},"2026-04-29",{"date":607,"type":22},"2028-04-29",{"name":42,"class":43},{"id":610,"slug":611,"hasResults":12,"nctId":612,"briefTitle":613,"officialTitle":614,"acronym":4,"eligibilityCriteria":615,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":616,"targetDuration":618,"studyType":55,"phases":4,"briefSummary":619,"conditions":620,"keywords":623,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":601,"lastUpdatePostDateStruct":627,"startDateStruct":628,"completionDateStruct":630,"leadSponsor":632,"locationsCount":44},"100644523","spatial-multi-omics-and-intelligent-early-warning-of-pancreatic-cancer-cachexia-100644523","NCT07670286","Spatial Multi-omics and Intelligent Early Warning of Pancreatic Cancer Cachexia","Spatial Multi-omics Mechanism Analysis and Multimodal Intelligent Early Warning of Cachexia in Pancreatic Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed pancreatic ductal adenocarcinoma.\n* Aged ≥18 years with an expected survival time of ≥1 month (to be assessed for the advanced cohort). Assessment criteria: Comprehensive evaluation based on the patient's radiological tumor burden, vital organ function and physical status. Specific quantitative indicators: Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2, or Karnofsky Performance Status (KPS) score of ≥60. For patients in the advanced cohort, the assessment shall be jointly confirmed by two attending physicians with the professional title of associate chief physician or above in combination with radiological examination results.\n* Voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* Complicated with other untreated malignant tumors or severe mental disorders.\n* Pregnant women or patients unable to cooperate with follow-up.",{"count":617,"type":22},500,"1 Year","The goal of this observational study is to explore the spatial multi-omics mechanism of cachexia in pancreatic cancer and construct a high-precision multimodal intelligent early warning model for its early diagnosis in pathologically confirmed pancreatic ductal adenocarcinoma patients aged ≥18 years with an expected survival of ≥1 month.\n\nThe main questions it aims to answer are: 1) Can spatial transcriptomics\u002Fmetabolomics reveal the interaction mechanism between tumor microenvironment and metabolism in pancreatic cancer cachexia? 2)Can a multimodal AI early warning model be built to achieve accurate early identification of pancreatic cancer cachexia? Researchers will compare the surgical cohort and advanced cohort to see the differences in cachexia incidence and progression rules among different subgroups. Participants will complete baseline questionnaires on physical and mental state, nutrition and muscle strength, undergo imaging examinations and provide biological samples (blood, feces, tissue etc.), and receive regular follow-ups for updated questionnaires, imaging rechecks and supplementary biological sample collection until death, loss to follow-up or voluntary withdrawal.",[621,622],"Pancreatic Cancer","Cachexia; Cancer; Sarcopenia",[624,625,621,626],"Spatial Multi-omics","Multimodal intelligent","Cachexia",{"date":603,"type":36},{"date":629,"type":36},"2026-04-24",{"date":631,"type":22},"2028-08-31",{"name":42,"class":43},""]