[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Second Affiliated Hospital, Zhejiang University, School of Medicine\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":475},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,40,64,91,122,148,170,188,216,238,266,290,324,344,363,384,402,425,454],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100627476","ai-assisted-screening-for-vhd-using-routine-chest-ct-scans-100627476",false,"NCT07449130","AI Assisted Screening for VHD Using Routine Chest CT Scans","Artificial-Intelligence Assisted Opportunistic Screening for Valvular Heart Disease Using Non-contrast Chest CT Scans: A Prospective, Multicenter Study","ARTEMIS","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Complete electronic health record.\n3. Non-contrast chest CT performed between Nov 1, 2025 - Nov 1, 2026 in any medical context (including physical exam, outpatient, inpatient, or emergency).\n4. AI-predicted moderate or severe valvular heart disease, or deemed to require clinical intervention, or selected negative cases from sampling verification.\n\nExclusion Criteria:\n\n1. Poor-quality non-contrast chest CT images.\n2. Incomplete clinical records, involving severe deficiencies in critical diagnostic results, treatment records, imaging data, surgical records, medical history summaries, laboratory test results, or other essential medical information.\n3. Presence of prosthetic valve implants, including aortic valves (mechanical valves, bioprosthetic valves), mitral valves (transcatheter edge-to-edge repair, bioprosthetic valves, mechanical valves, annuloplasty rings), tricuspid valves (TEER clipping, bioprosthetic valves, mechanical valves, annuloplasty rings), pulmonary valves (bioprosthetic valves), etc.\n4. Abnormalities or conditions deemed by the investigator to warrant exclusion from the study enrollment.",true,"ALL","18 Years",{"count":21,"type":22},3000,"ESTIMATED","OBSERVATIONAL","This is a prospective, multicenter study designed to validate a deep learning model for screening valvular heart diseases using routine, non-contrast chest computed tomography (CT) scans.\n\nThe primary objective is to evaluate the model's diagnostic performance, with the sensitivity serving as the primary efficacy endpoint. Secondary endpoints will include other performance metrics such as area under the receiver operating characteristic curve (AUC), specificity, and accuracy, etc.",[26],"Heart Valve Diseases","RECRUITING","2026-08-19",{"date":30,"type":31},"2026-08-21","ACTUAL",{"date":33,"type":31},"2026-03-02",{"date":35,"type":22},"2026-11-01",{"name":37,"class":38},"Second Affiliated Hospital, Zhejiang University, School of Medicine","OTHER",3,{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":55,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100510211","routine-angiography-follow-up-after-percutaneous-coronary-intervention-in-high-risk-patients-100510211","NCT05923489","Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients","Routine Angiography Follow-Up After Percutaneous Coronary Intervention in High-Risk Patients (The REVISE Trial)","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Successful PCI with at least two of the following high-risk factors:\n\nA. Left main lesion; B. Bifurcation lesion (true bifurcation); C. Ostial lesion of main vessels (left anterior descending, left circumflex artery, right coronary artery); D. Chronic total occlusion; E. Multivessel revascularization (≥ 2 vessels); F. In-stent restenosis; G. Diffuse long lesion (lesion length ≥ 30 mm or stent length ≥ 38 mm); H. Severe calcified lesion (Significant severe calcification on angiography); I. Bypass graft lesion; J. Diabetes mellitus; K. Chronic kidney disease (defined as an estimated glomerular filtration rate of \\\u003C30 ml per minute per 1.73 m2 of body-surface area or the receipt of dialysis); L. Myocardial infarction;\n\n\\- He\u002Fshe or his\u002Fher legally authorized representative provides written informed\n\nExclusion Criteria:\n\n* Revascularization with bare metal stents and\u002For balloon angioplasty with non-drug-coated balloons.\n* Pregnant and\u002For lactating women.\n* Life expectancy of less than 2 years.\n* Repeat interventional therapy is planned.\n* Subject was unable to provide written informed consent.",{"count":48,"type":22},2618,"INTERVENTIONAL",[51],"NA","Comparison of clinical outcomes between routine angiography follow-up and routine clinical follow-up after percutaneous coronary intervention in high-risk patients.",[54],"Coronary Artery Disease",[56],"percutaneous coronary intervention",{"date":30,"type":31},{"date":59,"type":31},"2023-10-26",{"date":61,"type":22},"2029-10-15",{"name":37,"class":38},1,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":49,"phases":75,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100652343","transcutaneous-auricular-vagus-nerve-stimulation-tavnstherapy-for-social-anxiety-disorder-100652343","NCT07772401","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)Therapy for Social Anxiety Disorder","Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)for Social Anxiety Disorder: A Randomized Controlled Clinical Trial.","taVNS","Inclusion Criteria:\n\nFulfillment of the DSM-5 diagnostic criteria for Social Anxiety Disorder (SAD). A Liebowitz Social Anxiety Scale (LSAS) score of ≥30 and a Clinical Global Impression-Severity (CGI-S) score of ≥4.\n\nAge between 18 and 70 years. Voluntary provision of written informed consent. If on psychotropic medications, maintenance of a stable dose for at least six weeks prior to enrollment.\n\nExclusion Criteria:\n\nA lifetime history of bipolar disorder, schizophrenia, or obsessive-compulsive disorder.\n\nAny cognitive impairments that could interfere with the study. Significant suicidal ideation or behavior within the past six months. Patients with rapidly deteriorating conditions. Previous taVNS treatment within the past month. Contraindications to auricular vagus nerve stimulation, such as ear infections, inflammation, skin lesions, or hypersensitivity of the ear.\n\nPresence of a pacemaker or other implanted medical devices, or severe neurological, renal, cardiovascular, or hepatic diseases.\n\nConcurrent engagement in any form of psychotherapy. History of substance or alcohol abuse. Inability to comply with psychological assessments. Incapable of providing informed consent. Pregnant or lactating. Other reasons as deemed unsuitable for inclusion by the research team.","70 Years",{"count":74,"type":22},100,[51],"This clinical trial aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with social anxiety disorder (SAD). The study addresses the following key research questions:\n\n* Does taVNS demonstrate preliminary clinical efficacy in the treatment of SAD?\n* What adverse events may occur during taVNS treatment, and what is the treatment compliance of the subjects?",[78,79],"Social Anxiety Disorder","Social Fear",[81,82],"vagus nerve stimulation","social anxiety disorder","2026-08-15",{"date":28,"type":31},{"date":86,"type":31},"2026-05-05",{"date":88,"type":22},"2026-12-01",{"name":37,"class":38},2,{"id":92,"slug":93,"hasResults":11,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":49,"phases":100,"briefSummary":101,"conditions":102,"keywords":106,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":63},"100651523","effect-of-agent-assisted-llm-assisted-and-traditional-workflows-on-physician-admission-diagnosis-100651523","NCT07760051","Effects of Agent-assisted, LLM-assisted and Traditional Workflows on Diagnosis and Management Planning at Admission","Effects of Agent-assisted, LLM-assisted and Traditional Workflows on Diagnosis and Management Planning at Admission: A Randomized Controlled Study","Inclusion Criteria\n\n* Hold a Medical Practitioner Qualification Certificate and\u002For Medical License, or be a recognized standardized resident physician; able to independently read electronic medical records, laboratory and imaging reports on an HIS.\n* Currently engaged in clinical work in internal medicine or surgery at one of the 15 participating hospitals.\n* Able to complete the case assessment in one continuous hour without breaks.\n* Able to participate remotely under video proctoring, with a stable internet connection and a working camera.\n* Voluntarily agree to participate and sign the informed consent form, including the declaration not to use unauthorized AI tools during the assessment.\n* Have not participated in case drafting, review, rubric development, or any activity that may leak the reference standard.\n\nExclusion Criteria\n\n* Have previously accessed the official test cases or reference standard of this study.\n* Unable to complete the training module, qualification test, or all experimental tasks.\n* Have conflicts of interest, e.g. participation in developing core algorithms of the tested system.\n* Unwilling to comply with remote proctoring, including keeping the camera on throughout.\n* Judged unsuitable by the investigators.",{"count":99,"type":22},180,[51],"The goal of this clinical trial is to evaluate whether AI-assisted workflows improve physicians' admission diagnosis and management planning performance on standardized simulated inpatient cases, among practicing internal medicine and surgery physicians across all seniority levels and across three tiers of the Chinese healthcare system.\n\nThe main questions it aims to answer are:\n\n* Does the Agent-assisted workflow yield better structured admission diagnosis and management planning scores than standalone LLM assistance?\n* Does the Agent-assisted workflow outperform the traditional workflow without AI tools? Researchers will compare three parallel groups (traditional workflow group, LLM-assisted group, Agent-assisted group) to determine whether the Agent tool can improve diagnostic accuracy and efficiency.\n\nParticipants will:\n\n* Be recruited from 15 hospitals in China and participate remotely under video proctoring\n* Be randomly assigned to one of the three fixed workflows, with randomization stratified by hospital tier, specialty and seniority\n* Complete 6 anonymized simulated HIS admission cases within one hour\n* Submit structured answers for each case covering principal diagnosis, secondary diagnoses, differential diagnoses, diagnostic justification, next diagnostic or therapeutic steps, consultation and referral decisions, and diagnostic confidence\n* Have their operation logs and time consumption recorded automatically by the study platform",[103,104,105],"Clinical Decision Support Systems","Diagnostic Reasoning","Artificial Intelligence (AI)",[107,108,109,110,111,104,112,113],"AI agent","Large Language Model","Clinical Decision Support","Admission Diagnosis","Diagnostic Accuracy","Randomized Controlled Trial","Management Planning","NOT_YET_RECRUITING",{"date":116,"type":31},"2026-08-18",{"date":118,"type":22},"2026-08",{"date":120,"type":22},"2026-12",{"name":37,"class":38},{"id":123,"slug":124,"hasResults":11,"nctId":125,"briefTitle":126,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":131,"conditions":132,"keywords":136,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":4},"100651668","ai-based-precision-transfusion-prediction-model-in-critically-ill-patients-100651668","NCT07762131","AI-Based Precision Transfusion Prediction Model in Critically Ill Patients","Artificial Intelligence-Based Precision Transfusion Prediction Model for Prevention of Multiple Organ Dysfunction Syndrome in Critically Ill Patients: A Multicenter Observational Study","Inclusion Criteria:\n\n* Adult patients (aged ≥18 years) admitted to the intensive care unit.\n* Patients with available clinical data, including demographic characteristics, laboratory parameters, transfusion-related information, and clinical outcomes.\n* Patients meeting the requirements for model development and analysis.\n\nExclusion Criteria:\n\n* Patients younger than 18 years.\n* Patients with missing key clinical information required for analysis.\n* Patients with repeated ICU admissions during the study period (only the first ICU admission will be included).\n* Patients whose data cannot be used for research purposes according to ethical requirements.",{"count":130,"type":22},2598,"This multicenter observational study aims to develop and validate an artificial intelligence-based precision transfusion prediction model for critically ill patients. The study will collect clinical characteristics, laboratory parameters, transfusion-related information, physiological data, and clinical outcomes from critically ill patients admitted to intensive care units. An AI model will be developed using retrospective data and further evaluated using prospective observational data. The primary objective is to investigate factors associated with multiple organ dysfunction syndrome (MODS) and establish a predictive model to support individualized transfusion management in critically ill patients.",[133,134,135],"Critical Illness","Multiple Organ Dysfunction Syndrome","Blood Transfusion",[137,138,139,134],"Artificial Intelligence","Precision Transfusion","Critically Ill Patients","2026-08-11",{"date":142,"type":31},"2026-08-13",{"date":144,"type":22},"2026-09-01",{"date":146,"type":22},"2029-09-01",{"name":37,"class":38},{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":154,"enrollmentInfo":155,"targetDuration":4,"studyType":49,"phases":157,"briefSummary":158,"conditions":159,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":63},"100651467","protective-mechanisms-of-phycocyanin-in-partial-hepatectomy-associated-liver-injury-100651467","NCT07760038","Protective Mechanisms of Phycocyanin in Partial Hepatectomy-Associated Liver Injury","Inclusion Criteria:\n\n* Diagnosis of intrahepatic cholangiocarcinoma\n* Child-Pugh class A liver function\n* Planned neoadjuvant treatment with gemcitabine plus oxaliplatin, lenvatinib, and a PD-1 inhibitor\n* Planned anatomical hemihepatectomy with an expected future liver remnant greater than 40%\n* Age 18 to 75 years\n* Willing and able to participate and provide written informed consent\n* No acute illness or significant worsening of symptoms within 4 weeks before enrollment\n\nExclusion Criteria:\n\n* Serious coexisting medical conditions\n* Known allergy to phycocyanin\n* Other malignant tumors\n* Previous liver resection\n* History of severe psychiatric illness that may affect treatment adherence","75 Years",{"count":156,"type":22},30,[51],"The goal of this study is to find out whether phycocyanin, a natural protein from spirulina, can help protect the liver and support recovery in adults having part of their liver removed. The study will also look at whether phycocyanin is safe to take.The main questions are:\n\nDoes phycocyanin reduce liver injury after surgery? Does it help the liver grow back and recover? What side effects or medical problems happen while taking it?\n\nResearchers will compare phycocyanin with a placebo, which looks similar but does not contain phycocyanin. About 30 people will take part. Each person will be randomly placed into one of the two groups, and neither the participants nor the researchers will know which treatment each person receives during the study.\n\nParticipants will:\n\nTake 1.5 grams of phycocyanin or placebo every day for 3 weeks before surgery and 3 weeks after surgery Receive the usual care for liver surgery Give blood and stool samples before and after treatment Allow researchers to study a small piece of liver tissue removed during surgery Return for follow-up for up to 90 days after surgery\n\nThe samples will be used to check liver function, inflammation, gut bacteria, and changes linked to liver healing. Possible side effects include an allergic reaction or stomach discomfort. The study has been approved by an ethics committee.",[160,161],"Intrahepatic Cholangiocarcinoma (Icc)","Liver Injury","2026-08-09",{"date":164,"type":31},"2026-08-12",{"date":166,"type":31},"2026-06-01",{"date":168,"type":22},"2029-05-30",{"name":37,"class":38},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":178,"targetDuration":179,"studyType":23,"phases":4,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":182,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":63},"100641396","assessment-of-ct-ffr-in-patients-with-ccs-a-prospective-multicenter-cohort-study-100641396","NCT07659119","Assessment of CT-FFR in Patients With CCS: A Prospective Multicenter Cohort Study","Assessment of Coronary Computed Tomography-Derived Fractional Flow Reserve in Patients With Chronic Coronary Syndrome: A Prospective Multicenter Cohort Study","ACCURATE-PRO","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Clinical diagnosis of chronic coronary syndrome (CCS).\n* Completed coronary computed tomography angiography (CCTA) examination and successfully obtained CT-derived fractional flow reserve (CT-FFR) results.\n* The subject or their legal representative voluntarily participates in this study and has signed the written informed consent form.\n\nExclusion Criteria:\n\n* Acute coronary syndrome (ACS), including ST-segment elevation myocardial infarction (STEMI), non-ST-segment elevation myocardial infarction (NSTEMI), or acute episodes of unstable angina.\n* Unable to obtain valid CT-FFR results, or the image quality is insufficient to support analysis.\n* Pregnant patients or those who intend to become pregnant during the study period.\n* Non-cardiac comorbidities indicating a life expectancy of less than one year.\n* Failure to sign the informed consent form.\n* Inability to complete the follow-up or explicit refusal to participate in the follow-up.\n* Patients with cognitive impairment or psychiatric disorders confirmed by clinical diagnosis or investigator assessment.\n* Patients who are illiterate or semi-literate, or who, due to any visual impairment or reading\u002Fwriting disability, are unable to independently read the subject information sheet without assistance and are unable to personally provide written informed consent.\n* Any other conditions deemed unsuitable for participation in this study by the investigators",{"count":21,"type":22},"5 Years","The ACCURATE-PRO study is an investigator-initiated, prospective, multicenter, observational, real-world cohort study. The core objective in managing chronic coronary syndrome (CCS) is to identify clinically significant myocardial ischemia to guide treatment decisions and improve long-term prognosis. While coronary computed tomography angiography (CCTA) is a crucial non-invasive anatomical imaging tool, it has limitations in determining the functional significance of coronary stenosis. Computed tomography-derived fractional flow reserve (CT-FFR) provides this functional assessment non-invasively based on CCTA images. However, there is a lack of systematic, prospective, multicenter evidence regarding its clinical value in risk stratification, treatment decision support, and prognostic evaluation for a continuous, real-world spectrum of CCS patients in China.\n\nThis study aims to evaluate the relationship between abnormal CT-FFR results and the risk of 1-year major adverse clinical events in CCS patients undergoing CCTA and CT-FFR. The study hypothesizes that abnormal CT-FFR is associated with a higher risk of 12-month major adverse clinical events, and that CT-FFR results are significantly correlated with subsequent treatment strategies, providing important value in risk stratification and mid-to-long-term prognosis.\n\nThe trial plans to consecutively enroll approximately 3,000 patients across multiple clinical centers in China. Eligible participants must be 18 years or older, have a clinical diagnosis of CCS, and have successfully obtained CT-FFR results following a CCTA examination. Patients will be excluded if they have acute coronary syndrome (such as STEMI, NSTEMI, or acute unstable angina), unanalyzable CT-FFR results\u002Fimage quality, or non-cardiac conditions limiting their life expectancy to less than one year.\n\nSince this is an observational study, it will not alter routine clinical care pathways or assign interventions. The primary exposure factor analyzed will be the lowest CT-FFR result per patient, comparing an abnormal CT-FFR group (≤ 0.80) to a normal CT-FFR group (\\> 0.80).\n\nParticipants will be followed up via telephone, outpatient visits, or hospitalization at 6, 12, 24, and 60 months after enrollment. The primary endpoint is a composite of all-cause death, myocardial infarction (MI), or ischemia-driven revascularization within 1 year after enrollment. Key secondary endpoints include the occurrence of the primary endpoint at 24 and 60 months, target vessel failure (a composite of cardiac death, target vessel MI, or target vessel revascularization), stroke, health economics analysis, and the association between CT plaque characteristics and clinical outcomes.",[54],{"date":164,"type":31},{"date":184,"type":31},"2024-09-23",{"date":186,"type":22},"2034-05-31",{"name":37,"class":38},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":194,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":18,"minAge":196,"maxAge":4,"enrollmentInfo":197,"targetDuration":4,"studyType":49,"phases":199,"briefSummary":200,"conditions":201,"keywords":205,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":209,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100627805","art-trial-transcatheter-j-valve-versus-surgery-for-aortic-regurgitation-therapy-100627805","NCT07453407","ART Trial: Transcatheter J-VALVE Versus Surgery for Aortic Regurgitation Therapy","J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement for Patients With Aortic Regurgitation Therapy","ART","Inclusion Criteria:\n\n* 1\\) Age ≥65 years；\n* 2\\) a. Symptomatic patients with severe AR b. Asymptomatic patients with severe AR and evidence of LV function impairment (per current ESC \u002F ACC guidelines) Any of the following perimeters\n\n  1. LVEF ≤55%\n  2. LVESD \\>50 mm\n  3. LVESDi \\>22 mm\u002Fm2\n  4. LVESVi \\>45 mL\u002Fm2\n  5. normal LV systolic function at rest (LVEF \\>55%), and a progressive decline in LVEF on at least 3 serial studies to the low-normal range (LVEF 55% to 60%) or a progressive increase in LV dilation into the severe range (LV end-diastolic dimension \\[LVEDD\\] \\>65 mm),\n* 3\\) Evaluated by a multi-disciplinary heart team to be suitable for both surgery and transcatheter valve replacement\n* 4\\) Informed of the nature of the study, agrees to its provisions, has provided written informed consent, and agrees to comply with all required post-procedure follow-up visits\n\nExclusion Criteria:\n\n* 1\\. Confirmed moderate or less AR severity (Grade≤2+) by core laboratory evaluation\n* 2\\. Moderate or severe aortic valve stenosis\n* 3\\. Mixed with clinical relevant severe mitral or tricuspid disease that require valve intervention\n* 4\\. Pre-existing mechanical or bioprosthetic valve in any position. (of note, mitral ring is not an exclusion)\n* 5\\. Subject is high-risk for SAVR as determined by the local heart team\n* 6\\. Subject refuses SAVR as a treatment option\n* 7\\. Subject is selected for aortic valve repair or aortic surgery\n* 8\\. Need for emergency surgery or TAVR for any reason\n* 9\\. Anatomical exclusion criteria (ANY of the following):\n\n  1. Aortic Annulus Perimeter \\\u003C53 mm or \\>94 mm measured by CT\n  2. Maximal ascending aortic diameter ≥50 mm\n  3. Congenital aortic valve disease including unicuspid, bicuspid, or quadricuspid aortic valve anatomy\n  4. Iliofemoral vessel characteristics that would preclude safe placement of the introducer sheath (e.g., calcification, tortuosity).\n  5. Significant abdominal or thoracic aortic disease (such as porcelain aorta, severe calcification, aortic coarctation, etc.) that preclude safe passage of the delivery system or cannulation and aortotomy for surgical AVR.\n* 10\\. Hemodynamic or respiratory instability requiring inotropic support, mechanical ventilation or mechanical heart assistance within 30 days of the screening visit\n* 11\\. Cardiac resynchronization therapy (CRT) device implantation within 30 days of the screening visit\n* 12\\. Any condition considered a contraindication to mechanical circulatory support\n* 13\\. Hostile chest or conditions or complications from prior surgery that preclude safe reoperation (e.g., mediastinitis, radiation damage, abnormal chest wall, adhesion of aorta or IMA to sternum, etc.)\n* 14\\. Subject refuses blood transfusion\n* 15\\. Marfan syndrome or other known connective tissue disease that would necessitate aortic root replacement\u002Fintervention\n* 16\\. Evidence of acute myocardial infarction within 30 days of the screening visit\n* 17\\. Any percutaneous coronary or peripheral interventional procedure performed within 30 days of the screening visit (Subjects with placement of coronary or peripheral stent(s) should be assessed for the ability to safely proceed with SAVR within the protocol timeframe)\n* 18\\. Complex coronary artery disease (one of the following):\n\n  1. Unprotected left main coronary artery disease ≥50%\n  2. True bifurcation lesion (Medina: 1.1.1) and the diameter of the branch vessels is \\>2.5 mm\n  3. Chronic total occlusion (CTO)\n  4. Long lesion, expected stent length \\>38 mm\n  5. Multivessel lesion (at least 2 coronary arteries require interventional treatment)\n  6. Need to use multiple stents (planned \\> 3 stents)\n  7. Lesion with in-stent restenosis\n  8. Severe calcification lesion\n  9. Coronary ostial lesion\n  10. Heart Team assessment that optimal revascularization cannot be performed with either CABG at the time of SAVR or PCI at the time of TAVR.\n* 19\\. Symptomatic carotid or vertebral artery disease or carotid intervention within 30 days of the screening visit\n* 20\\. Stroke or transient ischemic attack (TIA) within 90 days of the screening visit\n* 21\\. Severe left ventricular dysfunction, defined as a resting left ventricular ejection fraction \\\u003C25%; or left ventricular end-systolic diameter (LVESD) \\>70 mm; or the presence of an artificial heart or left ventricular assist device; or being listed for heart transplantation or status post heart transplantation.\n* 22\\. Moderate to severe or worse right ventricular dysfunction on resting echocardiogram according to core laboratory\n* 23\\. Cardiac imaging (echocardiography, CT, and\u002For MRI) evidence of intracardiac mass, thrombus or vegetation\n* 24\\. Left atrial thrombus without continuous appropriate anticoagulation within 90 days of the study procedure\n* 25\\. Uncontrolled atrial fibrillation (i.e., resting heart rate \\>120 bpm)\n* 26\\. Hemodynamically significant hypertrophic Obstructive cardiomyopathy (HOCM), Peak LVOT gradient ≥50mmHg (resting or provoked) ESC 2022\u002F ACC 2020\n* 27\\. Untread Leukopenia (WBC\\\u003C3.0\\*109\u002FL), Untread Thrombocytopenia (Platelet count \\\u003C50\\*109), history of bleeding diathesis or coagulopathy, or hypercoagulable states, Acute posthemorrhagic anemia (hemoglobin \\\u003C9.0 g\u002FdL)\n* 28\\. Severe chronic obstructive pulmonary disease (COPD) (FEV1 \\\u003C50% predicted) or currently on home oxygen\n* 29\\. Severe pulmonary hypertension (e.g., PA systolic pressure ≥2\u002F3 systemic pressure)\n* 30\\. Severe chronic liver disease (Child-Pugh C) or any active liver disease\n* 31\\. Renal insufficiency (eGFR\\\u003C30mL\u002Fmin\u002F1.73m²) and\u002For requiring chronic peritoneal dialysis at the time of screening and\u002For requiring chronic hemodialysis at the time of screening\n* 32\\. Ongoing sepsis or active infective endocarditis with ongoing antibiotic (including suppressive) therapy or positive blood cultures within 6 weeks\n* 33\\. Subject has a known hypersensitivity or contraindication to all anticoagulation\u002Fantiplatelet medications (or inability to be anticoagulated for the index procedure), implant-related materials, or sensitivity to contrast media which cannot be adequately pre-medicated\n* 34\\. Inability to tolerate anti-thrombotic\u002Fanticoagulation therapy during or after the valve implant procedure\n* 35\\. Active gastrointestinal bleeding precluding anticoagulation or antiplatelet therapy\n* 36\\. BMI \\>50 kg\u002Fm2 or \\\u003C18.5 kg\u002Fm2\n* 37\\. Estimated life expectancy \\\u003C24 months due to associated non- cardiac comorbid conditions\n* 38\\. Immobility that would prevent completion of study procedures\n* 39\\. Currently participating in a cardiovascular investigational drug or another device study and not yet completed follow-up for the primary endpoint. Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials. Observational studies are not considered exclusionary\n* 40\\. Severe cognitive decline (resulting in either inability to provide informed consent for the trial\u002Fprocedure, prevents independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up visits)\n* 41\\. Pregnancy or intent to become pregnant (women suspected of becoming pregnant must have a negative serum or urine test for human chorionic gonadotropin before being included in the study)\n* 42\\. Other patients considered unsuitable for this clinical study by the investigator","65 Years",{"count":198,"type":22},1250,[51],"The overall purpose of ART trial is to establish the Safety and Efficacy of the J-VALVE Transcatheter Aortic Valve Replacement Versus Surgical Aortic Valve Replacement in Patients with Grade≥3+ Native Aortic Regurgitation.",[202,203,204],"Aortic Regurgitation","Aortic Valve Insufficiency","Aortic Insufficiency",[202,206,207,208],"TAVR","SAVR","RCT",{"date":164,"type":31},{"date":211,"type":31},"2026-03-05",{"date":213,"type":22},"2038-03",{"name":37,"class":38},28,{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":49,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":63},"100558339","the-effect-of-nutrition-optimized-prehabilitation-on-perioperative-intervention-in-primary-hepatocellular-carcinoma-100558339","NCT06549829","the Effect of Nutrition-optimized Prehabilitation on Perioperative Intervention in Primary Liver Carcinoma","Nutrition-Optimized Prehabilitation's Impact on Perioperative Outcomes in Primary Liver Carcinoma: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients diagnosed with primary liver cancer.\n\n  * Patients between the ages of 18 and 80.\n\n    * Patients who are feasible for surgical treatment after clinical evaluation.\n\nExclusion Criteria:\n\n* Patients with liver metastases or combined with other tumors.\n\n  * Patients with allergy to the ingredients of nutritional preparations. ③Patients with severe malnutrition who cannot eat by mouth. ④Patients with hyperthyroidism, fistula, and combined digestive system diseases.","80 Years",{"count":225,"type":22},120,[51],"The aim of this project is to investigate the effect of triple prehabilitation led by nutritional optimization in liver cancer patients' surgery. It improves the preoperative nutritional status of cancer patients, reduces the incidence of early postoperative complications, promotes postoperative recovery, and improves the quality of patients' survival. Patients were randomized into experimental and control groups based on exclusion and inclusion criteria. Nutritional interventions and exercise and psychological interventions for patients. Routine clinical blood tests will be performed at the time of enrollment, on the first day before surgery and on the first, third and fifth days after surgery. Enrolled patients were followed up by telephone or outpatient clinic at 1 month postoperatively.",[229,230,231],"Hepatocellular Carcinoma","Liver Carcinoma","Hepatobiliary Cancers",{"date":164,"type":31},{"date":234,"type":31},"2024-09-01",{"date":236,"type":22},"2026-10-31",{"name":37,"class":38},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":246,"targetDuration":4,"studyType":49,"phases":247,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":260,"startDateStruct":262,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100650698","phase-4-ezetimibe-for-arrhythmia-recurrence-after-af-ablation-100650698","NCT07752758","Ezetimibe for Arrhythmia Recurrence After AF Ablation","Ezetimibe for Reducing Atrial Arrhythmia Recurrence After Atrial Fibrillation Ablation: a Prospective Randomized Controlled Pilot Study","EAFA","Inclusion Criteria:\n\n1. Age 18 to 80 years, male or female.\n2. Diagnosis of persistent atrial fibrillation (AF) scheduled for first catheter ablation.\n3. Able to provide written informed consent.\n4. Able to comply with study follow-up and ECG monitoring requirements.\n\nExclusion Criteria:\n\n1. Previous catheter ablation for atrial fibrillation.\n2. Life expectancy \\\u003C12 months due to non-cardiac comorbidities.\n3. Severe valvular heart disease requiring surgery or intervention.\n4. Acute myocardial infarction or stroke within the past 3 months.\n5. Current participation in another investigational drug\u002Fdevice study.\n6. Inability to adhere to study procedures or follow-up.\n7. Pregnancy or breastfeeding (female participants).",{"count":225,"type":22},[248],"PHASE4","This single-center, prospective, single-blind randomized controlled pilot trial aims to explore whether oral ezetimibe can reduce the 6-month recurrence rate of atrial tachyarrhythmia after catheter ablation in patients with persistent atrial fibrillation. A total of 120 eligible patients will be randomized at a 1:1 ratio into the ezetimibe group and the control group within 24 hours after ablation. Stratified randomization based on body mass index (BMI) and left atrial diameter will be performed via an interactive web response system (IWRS). This study adopts a single-blind design: patients and investigators are unblinded to group allocation, whereas an independent Endpoint Adjudication Committee consisting of three electrophysiologists will blindly review all ECG data to determine arrhythmia recurrence. The intervention group will receive 10 mg oral ezetimibe once daily for six months following ablation, and the use of hobimibe is prohibited in this group. The control group will refrain from the use of both ezetimibe and hobimibe, with standardized postoperative management maintained consistently across the two groups. The primary endpoint is the recurrence of atrial tachyarrhythmia lasting ≥30 seconds after the blanking period within six months post-ablation. Secondary endpoints include early atrial tachyarrhythmia recurrence, atrial fibrillation burden, changes in left atrial diameter, quality of life scores, and composite cardiovascular events. Safety outcomes encompass hepatic and muscular adverse reactions as well as serious adverse events. This prospective pilot study will provide preliminary clinical evidence for optimizing rhythm control strategies after atrial fibrillation catheter ablation.",[251,252],"Atrial Fibrillation","Post-Catheter Ablation Atrial Arrhythmia Recurrence",[251,254,255,256,257,258],"Catheter Ablation","Ezetimibe","Atrial Arrhythmia Recurrence","Single-Blind RCT","Atrial Remodeling","2026-08-05",{"date":261,"type":31},"2026-08-07",{"date":83,"type":22},{"date":264,"type":22},"2028-06-30",{"name":37,"class":38},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":49,"phases":275,"briefSummary":277,"conditions":278,"keywords":280,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":284,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":63},"100622298","phase-3-the-impact-of-fexofenadine-hydrochloride-on-the-prognosis-of-patients-post-acute-myocardial-infarction-100622298","NCT07381803","The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction","The Impact of Fexofenadine Hydrochloride on the Prognosis of Patients Post-Acute Myocardial Infarction: A Randomized Clinical Trial (FEND Ⅱ)","Inclusion Criteria:\n\n* Age ≥ 18 years old.\n* Able to verbally confirm understanding of the trial risks, benefits, and treatment options of fexofenadine hydrochloride therapy. He\u002Fshe or his\u002Fher legal representative must provide written informed consent prior to participating in the clinical trial.\n* Acute ST-segment elevation myocardial infarction (STEMI) occurring within 7 days, with diagnostic criteria including:\n\n  i) Typical clinical symptoms: such as severe crushing pain in the retrosternal or precordial area, usually lasting more than 10-20 minutes, which may radiate to the left upper arm, jaw, neck, back, or shoulders, etc.; ii) Elevated serum cardiac troponin (cTn): at least one measurement above the upper limit of normal (99th percentile of the reference upper limit); iii) ST-segment elevation: new ST-segment elevation at the J point in 2 adjacent leads.\n* Echocardiography indicating segmental wall motion abnormalities.\n\nExclusion Criteria:\n\n* Need for long-term use of fexofenadine hydrochloride or other H1 receptor inhibitors.\n* Previous coronary artery bypass grafting (CABG) surgery.\n* History of severe renal failure with estimated glomerular filtration rate (eGFR) \\\u003C 30 ml\u002Fmin.\n* History of severe liver dysfunction.\n* History of concurrent severe infection, hepatobiliary obstruction, or malignant tumor.\n* Expected life expectancy of less than 2 years due to non-cardiac diseases.\n* Currently receiving immunosuppressive therapy.\n* Pregnant, potentially pregnant, or lactating women.\n* Contraindication to the study drug or examinations.\n* Failure to provide written informed consent.\n* Presence of mechanical complications (ventricular septal defect, papillary muscle dysfunction, acute mitral regurgitation), refractory cardiogenic shock unresponsive to vasopressors, acute left heart failure or pulmonary edema, or malignant arrhythmias uncontrolled by antiarrhythmic drugs at enrollment.",{"count":274,"type":22},2804,[276],"PHASE3","The goal of this study is o evaluate the prognostic effect of fexofenadine hydrochloride in patients with myocardial infarction",[279],"Zhejiang University",[281,282,283],"myocardial infarction","cardiac fibrosis","cardiac MRI",{"date":261,"type":31},{"date":286,"type":31},"2025-01-27",{"date":288,"type":22},"2027-06",{"name":37,"class":38},{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":296,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":298,"minAge":19,"maxAge":4,"enrollmentInfo":299,"targetDuration":301,"studyType":23,"phases":4,"briefSummary":302,"conditions":303,"keywords":306,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":317,"startDateStruct":319,"completionDateStruct":321,"leadSponsor":323,"locationsCount":63},"100616386","a-prospective-multicenter-study-of-the-tufest-ln-model-for-axillary-lymph-node-status-assessment-in-breast-cancer-100616386","NCT07304934","A Prospective Multicenter Study of the TuFEst-LN Model for Axillary Lymph Node Status Assessment in Breast Cancer","A Prospective Multi-center Cohort Study Based on Deep Learning-based cfDNA Fragment Omics to Verify the TuFEst Model for Axillary Lymph Node Status Assessment in Breast Cancer Patients Undergoing Primary Surgery or Neoadjuvant Therapy","PRO-TuFEst-LN","Cohort 1-Specific Inclusion Criteria\n\nParticipants in Cohort 1 must meet all of the following criteria:\n\n1. Histologically confirmed invasive breast cancer.\n2. Clinical stage cT1-3, cN0, M0 disease at enrollment.\n3. No clinically palpable suspicious metastatic axillary lymph nodes identified by physical examination.\n4. No radiologically suspicious metastatic axillary lymph nodes identified by preoperative axillary imaging (at least ultrasound examination). Patients with suspicious lymph nodes must have negative cytological or histological findings confirmed by fine-needle aspiration or core needle biopsy.\n5. No prior neoadjuvant therapy, including chemotherapy, targeted therapy, immunotherapy, endocrine therapy, or breast\u002Faxillary radiotherapy before enrollment.\n6. Planned to undergo definitive breast surgery with sentinel lymph node biopsy (SLNB) and\u002For axillary lymph node dissection (ALND).\n7. Ability to provide qualified preoperative plasma samples for cfDNA analysis.\n\nCohort 2-Specific Inclusion Criteria\n\nParticipants in Cohort 2 must meet all of the following criteria:\n\n1. Histologically confirmed invasive breast cancer.\n2. Ipsilateral axillary lymph node metastasis confirmed by fine-needle aspiration or core needle biopsy at initial diagnosis.\n3. No evidence of distant metastasis (M0), and planned to receive standard neoadjuvant systemic therapy followed by definitive breast and axillary surgery.\n4. Completion of the planned neoadjuvant therapy, or premature discontinuation due to clinical reasons while remaining eligible for subsequent surgery.\n5. Ability to provide a baseline plasma sample (T0) within 24-72 hours before initiation of the first systemic treatment (including chemotherapy, immunotherapy, or targeted therapy).\n6. Availability of preoperative breast and axillary magnetic resonance imaging (MRI) after completion of neoadjuvant therapy. Patients unable to undergo MRI due to contraindications or other reasons may be included in the cfDNA-only analysis set but will not be included in the complete-case analysis of the combined cfDNA-MRI model.\n7. Ability to provide a second plasma sample (T1) within 24-72 hours before surgery after completion of neoadjuvant therapy. Patients without T0 samples may still be included in the exploratory analysis of T1 cfDNA combined with MRI for ypN prediction.\n8. Availability of complete postoperative breast and axillary pathological evaluation results.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Pregnancy or breastfeeding.\n2. Prior surgical removal of the primary breast lesion before enrollment, resulting in inability to obtain the required preoperative blood samples.\n3. Presence of confirmed distant metastasis.\n4. Presence of supraclavicular, internal mammary, or other lymph node lesions that cannot be adequately assessed by planned surgery and pathological evaluation.\n5. History of another active malignancy within the previous 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, or other malignancies considered by investigators unlikely to affect study outcomes.\n6. Receipt of whole blood, plasma, or other blood product transfusion within 30 days prior to enrollment.\n7. Insufficient plasma sample volume, severe hemolysis, or failure to meet cfDNA sequencing quality control requirements determined by the central laboratory.\n8. Absence of evaluable axillary surgical pathological results.\n9. Any other condition considered by the investigator to make the patient unsuitable for participation in this study.","FEMALE",{"count":300,"type":22},400,"1 Year","Through the research of this project, we expect to validate the clinical utility of the TuFEst-LN model in assessing axillary lymph node status in breast cancer patients. Specifically, we aim to prospectively validate its ability to identify pathologically node-negative patients among clinically and radiologically assessed cN0 patients undergoing upfront surgery ，and explore the predictive value of the TuFEst-LN model combined with preoperative MRI for ypN status assessment in initially node-positive patients following neoadjuvant therapy.",[304,305],"Breast Cancer","Axillary Lymph Node Metastasis",[307,308,309,310,311,312,313,314,315,316],"breast cancer","cfDNA","TuFEst model","Fragmentomics","Axillary lymph node","Sentinel lymph node biopsy","Neoadjuvant therapy","Magnetic resonance imaging","Diagnostic accuracy","Machine learning",{"date":318,"type":31},"2026-08-10",{"date":320,"type":31},"2025-08-01",{"date":322,"type":22},"2027-12-31",{"name":37,"class":38},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":328,"acronym":329,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":331,"targetDuration":4,"studyType":49,"phases":333,"briefSummary":335,"conditions":336,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":259,"lastUpdatePostDateStruct":338,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":63},"100558214","effect-and-safety-of-fexofenadine-hydrochloride-vs-placebo-in-patients-with-acute-myocardial-infaction-a-randomized-clinical-trial-100558214","NCT06548204","Effect and Safety of Fexofenadine Hydrochloride vs Placebo in Patients With Acute Myocardial Infaction: A Randomized Clinical Trial","FEND-AMI","Inclusion Criteria:\n\n* Ages above 18;\n* Being able to verbally confirm understanding of the trial risks, benefits, and treatment options of receiving treatment with fexofenadine hydrochloride. He\u002Fshe or his\u002Fher legal representative shall provide written informed consent before participating in the clinical trial.\n* Meet the diagnostic criteria for STEMI, the diagnostic criteria includes:\n\n  1. Clinical symptoms: ischemic chest pain lasting for over 30 minites;\n  2. Elevated serum cTn: at least once higher than the upper limit of normal values (99th percentile of the reference upper limit);\n  3. ST segment elevation: new ST segment elevation in two or more adjacent leads on the ECG;\n* Emergency coronary angiography and revascularization should be performed;\n* Ultrasonic cardiogram indicates regional wall motion abnormality, and transthoracic echocardiography shows LVEF ≤ 50% within 72 hours after revascularization.\n\nExclusion Criteria:\n\n* Long term use of fexofenadine hydrochloride or other H1 receptor inhibitors;\n* Previously suffered from myocardial infarction or received coronary artery bypass grafting;\n* Patients with concomitant cardiomyopathy or valve disease;\n* History of severe renal failure, estimated glomerular filtration rate (eGFR) \\\u003C 30ml\u002Fmin;\n* History of severe liver dysfunction;\n* Concurrent severe infections, or liver\u002Fgallbladder obstruction, or history of malignant tumors;\n* Currently receiving immunosuppressive therapy;\n* Pregnant or potentially pregnant and breastfeeding women;\n* Contraindications for fexofenadine hydrochloride or cardiac magnetic resonance examinations;\n* Without obtaining written informed consent.\n* Patients with hemodynamic instability.",{"count":332,"type":22},152,[334],"PHASE2","The purpose of this study was to evaluate the efficacy and safety of fexofenadine hydrochloride on the basis of standard treatment after PCI in STEMI patients.",[337],"ST-segment Elevation Myocardial Infarction (STEMI)",{"date":318,"type":31},{"date":340,"type":31},"2025-01-20",{"date":342,"type":22},"2027-12-30",{"name":37,"class":38},{"id":345,"slug":346,"hasResults":11,"nctId":347,"briefTitle":348,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":49,"phases":352,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":358,"startDateStruct":359,"completionDateStruct":360,"leadSponsor":362,"locationsCount":4},"100650405","phase-3-study-on-anti-thrombotic-regimens-for-secondary-prevention-in-ischemic-stroke-patients-with-possible-benefit-from-anticoagulation-therapy-100650405","NCT07746882","Study on Anti-Thrombotic Regimens for Secondary Prevention in Ischemic Stroke Patients With Possible Benefit From Anticoagulation Therapy","Inclusion Criteria:\n\n* Age ≥18 years\n* Ischemic stroke patients with undetermined etiology, within 14 days of onset, with completed etiological assessment\n* At least one of the following:\n\n  1. Cortical or multi-territorial infarct\n  2. Recurrent stroke or stroke on antiplatelet therapy\n  3. Left atrial diameter \\>40 mm\n  4. Left ventricular dysfunction (EF 30-40% or regional wall motion abnormality)\n  5. Atrial premature beats \\>1500\u002F24h\n\nExclusion Criteria:\n\n* Stenosis ≥50% in the responsible vessel or high-risk plaque\n* Identified cardioembolic source\n* PFO with planned closure\n* Malignancy\n* Indication for mandatory anticoagulation\u002Fantiplatelet therapy\n* Active bleeding (intracranial, subarachnoid, gastrointestinal, etc.)\n* History of intracranial hemorrhage\n* Current or recent gastrointestinal ulcer\n* Recent brain or spinal injury\u002Fsurgery\n* Known or suspected vascular malformations or aneurysms\n* Severe renal impairment (CrCl \\\u003C30 ml\u002Fmin)\n* Liver disease with bleeding risk (Child-Pugh B or C)\n* Pregnancy or lactation\n* Other contraindications to anticoagulation",{"count":351,"type":22},680,[276],"To screen ischemic stroke patients likely to benefit from anticoagulation and compare the effectiveness and safety of anticoagulation versus antiplatelet therapy in preventing recurrent ischemic stroke within 3 months.",[355,356],"Stroke","Acute Ischemic Stroke","2026-08-04",{"date":259,"type":31},{"date":83,"type":22},{"date":361,"type":22},"2028-11-30",{"name":37,"class":38},{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":4,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":223,"enrollmentInfo":370,"targetDuration":4,"studyType":49,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":357,"lastUpdatePostDateStruct":379,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":63},"100622641","a-trial-of-adacolumn-on-cerebral-edema-after-anterior-circulation-ischemic-stroke-100622641","NCT07386262","A Trial of Adacolumn on Cerebral Edema After Anterior Circulation Ischemic Stroke","Efficacy and Safety of the Adacolumn® Granulocyte and Monocyte\u002FMacrophage Apheresis Device for Cerebral Edema After Acute Anterior Circulation Occlusive Cerebral Infarction: A Prospective, Randomized, Controlled Clinical Trial","Inclusion Criteria:\n\n1. Age 18-80 years, regardless of gender;\n2. A clinical diagnosis of acute ischemic stroke;\n3. Proven large vessel occlusion in ICA or MCA-M1 occlusion (carotid occlusions can be cervical or intracranial, with or without tandem MCA lesions) determined by MRA or CTA or DSA;\n4. NIHSS score ≥10 at screening;\n5. Pre-stroke mRS score \\\u003C2 (independent in all activities of daily living);\n6. Time from stroke onset to initiation of the first Adacolumn treatment is ≤24 hours, stroke onset is defined as the last time the patient was known to be at their neurological baseline (wake-up strokes qualify if within this time window);\n7. All endovascular thrombectomy and\u002For intravenous thrombolysis must strictly adhere to the \"2024 Chinese Stroke Association Guidelines for Reperfusion Therapy in Acute Ischemic Stroke\" and the latest prescribing information regarding indications, contraindications, and procedural standards;\n8. Written informed consent obtained from the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Decompressive craniectomy performed before enrollment or between enrollment and initiation of study treatment;\n2. After endovascular thrombectomy: extensive contrast extravasation (diffuse subarachnoid high density or parenchymal high density not consistent with hematoma), new subarachnoid hemorrhage（SAH）, or symptomatic intracranial hemorrhage (sICH);\n3. Large-vessel occlusion is attributed to other determined etiologies per TOAST classification, such as tumor-related, dissection-related, or other clearly identifiable non-LAA\u002Fnon-CE causes.\n4. Clinical signs of brain herniation, such as unilateral or bilateral fixed dilated pupils and\u002For other loss of brainstem reflexes attributable to cerebral edema or herniation in the investigator's opinion;\n5. Intracranial lesions conferring markedly increased bleeding risk (known brain tumor, arteriovenous malformation, aneurysm);\n6. Inability to undergo MRI;\n7. Absolute neutrophil count \\\u003C1.5×10⁹\u002FL or \\>15×10⁹\u002FL\n8. Absolute monocyte count \\> 1.0 ×10⁹\u002FL;\n9. Red blood cells \\\u003C3.0×10¹²\u002FL ;\n10. Active internal bleeding or bleeding tendency (such as platelet count \\\u003C100×10⁹\u002FL, INR \\>1.7, PT \\>15 seconds);\n11. Marked hypercoagulability (fibrinogen \\>700 mg\u002FdL);\n12. Intracranial or spinal surgery or severe head trauma within the past 3 months;\n13. Refractory hypertension (persistent systolic blood pressure \\>185 mmHg or diastolic \\>110 mmHg);\n14. Known allergy to components of the blood purification system (including adsorption membrane, anticoagulants);\n15. Acute ST-segment elevation myocardial infarction and\u002For acute decompensated heart failure and\u002For corrected QT interval \\>520 ms and\u002For history of cardiac arrest within the past 6 months(pulseless electrical activity, ventricular tachycardia, ventricular fibrillation, or asystole);\n16. Body temperature \\>38°C or active infection;\n17. Active autoimmune disease or immunodeficiency;\n18. Participation in another interventional clinical trial within the past 30 days;\n19. Any other condition deemed unsuitable for participation by the investigator.",{"count":371,"type":22},10,[51],"The primary objective is to investigate whether treatment with Adacolumn can ameliorate the progression of cerebral edema within 72 hours in patients with anterior circulation ischemic stroke. The secondary objective is to explore if Adacolumn could improve acute neurologic status, functional outcomes, treatment requirements and safety in patients with anterior circulation ischemic stroke.",[375,376,377,378],"Cerebral Edema","Ischemic Stroke, Acute","Malignant Cerebral Edema","Anterior Circulation Brain Infarction",{"date":261,"type":31},{"date":318,"type":22},{"date":382,"type":22},"2028-12-31",{"name":37,"class":38},{"id":385,"slug":386,"hasResults":11,"nctId":387,"briefTitle":388,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":154,"enrollmentInfo":391,"targetDuration":4,"studyType":49,"phases":392,"briefSummary":393,"conditions":394,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":399,"leadSponsor":401,"locationsCount":63},"100650705","phase-2-a-randomized-open-label-multi-center-study-of-vestibular-migraine-prevention-rimegepant-versus-flunarizine-non-inferiority-study-100650705","NCT07751497","A Randomized, Open-Label, Multi-Center Study of Vestibular Migraine Prevention: Rimegepant Versus Flunarizine Non-inferiority Study","VERIFY","Inclusion Criteria:\n\n* Male or female subjects aged 18 to 75 years；\n* Diagnosis of definite vestibular migraine per Bárány society criteria： A. At least 5 episodes with vestibular symptoms of moderate or severe intensity, lasting 5 min to 72 hours； B. Current or previous history of migraine with or without aura according to the International Classification of Headache Disorders (ICHD)；\n\nC. One or more migraine features with at least 50% of the vestibular episodes:\n\n1. headache with at least two of the following characteristics:\n\n   * one sided location\n   * pulsating quality\n   * moderate or severe pain intensity\n   * aggravation by routine physical activity\n2. photophobia and phonophobia；\n3. visual aura; D. Not better accounted for by another vestibular or ICHD diagnosis.\n\n   * Baseline (day 0 to 28) moderate or severe vestibular symptom days ≥ 4;\n   * 80% adherence or better to electronic diary(eDiary) during observational phase\n   * VM-PATHI2(Vestibular Migraine Patient Assessment Tool and Handicap Inventory) score \\> 25 at screening and baseline visit;\n   * Written informed consent must be obtained before patient enrolled;\n   * Fluency in local main language;\n   * Access to email, and cell phone.\n\nExclusion Criteria:\n\n* Vestibular hypofunction (unilateral or bilateral);\n* History of ear surgery (other than ear tubes);\n* Other vestibular diagnoses (excluding treated benign paroxysmal positional vertigo (BPPV)), including Meniere's disease, superior semicircular canal dehiscence syndrome, vestibular neuritis, persistent postural-perceptual dizziness, unilateral or bilateral vestibular hypofunction, cerebellar or brainstem disorders, multiple sclerosis, or motion sickness;\n* Prior or current use of any prophylactic medication targeting the calcitonin gene-related peptide (CGRP);\n* Prior or current treatment with flunarizine;\n* Individuals are allergic to rimegepant sulfate oral disintegrating tablets or any excipients of rimegepant sulfate oral disintegrating tablets;\n* Pregnant women, breastfeeding women, or those unwilling to use approved contraceptive methods during the study participation;\n* History of serious medical or psychiatric disease, at the discretion of the treating physician (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, kidney disease, liver disease, and uncontrolled psychiatric disease or past psychiatric hospitalization);\n* A history of severe medical or psychiatric conditions (including significant coronary artery disease, peripheral vascular disease, cerebrovascular disease, renal disease, liver disease, Raynaud's disease, uncontrolled psychiatric disorders, or previous psychiatric hospitalizations) as determined by the treating physician;\n* A history of mania, psychosis, or suicidal ideation;\n* A history of drug or alcohol abuse within the 12 months prior to screening, based on the subject's medical records or self-report;\n* Individuals who have received head, face, or neck botulinum toxin injections (such as Dysport®, Botox®, Xeomin®, Myobloc®, and JeuveauTM) within 4 months before screening or are scheduled for such injections during the study period;\n* Unwilling to use approved form of birth control during the study;\n* Other conditions judged by the investigator as unsuitable for inclusion.",{"count":300,"type":22},[334],"Vestibular migraine is a common condition that causes repeated episodes of dizziness or vertigo, often with migraine headaches, sensitivity to light and sound, and nausea. It affects 1% to 2.7% of the general population and is one of the most frequent diagnoses in dizziness clinics. Despite its prevalence, there is very little high-quality evidence to guide preventive treatment.\n\nThis study compares two preventive treatments for vestibular migraine: rimegepant (a newer medication that blocks a protein called CGRP involved in migraine attacks) and flunarizine (a medication commonly used for vestibular migraine prevention in some countries). The study hypothesis is that rimegepant is not inferior to flunarizine in reducing the number of days with moderate-to-severe vestibular symptoms.\n\nApproximately 400 adults aged 18 to 75 with definite vestibular migraine will be enrolled across multiple countries (China, Italy, Spain, and the United Kingdom). Participants will be randomly assigned in a 1:1 ratio to receive either rimegepant 75 mg once daily or flunarizine 10 mg once nightly for 12 weeks. The total study participation is 20 weeks, including a 4-week observation period, a 12-week treatment period, and a 4-week safety follow-up period. Participants will complete daily electronic diaries to record their symptoms throughout the study.\n\nThe primary outcome is the change in the number of moderate-to-severe vestibular symptom days from the observation period to weeks 13-16, comparing the two treatment groups. Secondary outcomes include treatment completion rates, changes in monthly migraine days, adverse events, and patient-reported outcomes including dizziness-related disability, anxiety, depression, and global impression of change.",[395],"Vestibular Migraine","2026-08-03",{"date":261,"type":31},{"date":88,"type":22},{"date":400,"type":22},"2029-04-01",{"name":37,"class":38},{"id":403,"slug":404,"hasResults":11,"nctId":405,"briefTitle":406,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":409,"targetDuration":4,"studyType":49,"phases":411,"briefSummary":412,"conditions":413,"keywords":4,"overallStatus":114,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":418,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":4},"100650509","intravascular-lithotripsy-versus-rotational-atherectomy-for-severe-coronary-artery-calcification-a-prospective-multicenter-non-inferiority-randomized-controlled-trial-100650509","NCT07750964","Intravascular Lithotripsy Versus Rotational Atherectomy for Severe Coronary Artery Calcification: A Prospective, Multicenter, Non-inferiority Randomized Controlled Trial","LIRAC","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Target lesion with diameter stenosis ≥ 50% (visual estimation) associated with evidence of myocardial ischemia;\n3. Target lesion must be a de novo, in-situ severely calcified coronary lesion, where severe calcification is defined as: radiopacity visible prior to contrast injection and in the absence of cardiac pulsation, typically involving both sides of the vessel wall; and ≥270° circumferential calcification as evidenced by intravascular ultrasound (IVUS);\n4. Target vessel reference diameter between 2.5 and 4.0 mm, with successful guidewire traversal;\n5. A maximum of two non-target lesions requiring interventional treatment, which must be successfully treated prior to the target lesion;\n6. Patients presenting with evidence of symptomatic or asymptomatic myocardial ischemia, stable or unstable angina pectoris, or prior myocardial infarction;\n7. Signed written informed consent obtained.\n\nExclusion Criteria:\n\n1. Cardiogenic shock or hemodynamic instability;\n2. Chronic total occlusion (CTO);\n3. Requirement for intraprocedural mechanical circulatory support, such as intra-aortic balloon pump (IABP) or Impella device;\n4. Acute ST-segment elevation myocardial infarction (STEMI) occurring within 1 month prior to enrollment;\n5. Angiographically visible thrombus at the target lesion site;\n6. Left main ostial lesion with stenosis ≥ 50%;\n7. Left ventricular ejection fraction (LVEF) \\\u003C 40%;\n8. New-onset stroke or transient ischemic attack (TIA) within 90 days;\n9. Bypass graft lesion;\n10. Coronary artery dissection of type B or greater (NHLBI classification);\n11. Pregnant or lactating patients;\n12. Life expectancy \\\u003C 1 year;\n13. Active bleeding;\n14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m²;\n15. Presence of cognitive or psychiatric disorders, as confirmed by clinical diagnosis or investigator assessment;\n16. Illiteracy, semi-literacy, or any visual impairment, reading\u002Fwriting disability that prevents the patient from independently reading the patient information sheet and personally providing written informed consent without assistance.",{"count":410,"type":22},190,[51],"Severely calcified coronary lesions represent one of the major challenges in interventional cardiology. Severe coronary calcification increases the difficulty and complexity of percutaneous coronary intervention (PCI), impedes device delivery, and may even lead to device failure. Moreover, stent underexpansion further elevates the risks of cardiac death, myocardial infarction, target vessel revascularization, and in-stent thrombosis. Rotational atherectomy (RA) is an effective modality for treating severely calcified coronary lesions, as it adequately modifies calcific plaques, facilitates luminal enlargement, and improves device deliverability. However, RA fragments calcific plaques into microparticles that are subsequently cleared by the reticuloendothelial system in the distal microvasculature, potentially inducing microvascular dysfunction.\n\nIn recent years, intravascular lithotripsy (IVL) has emerged as an innovative calcium-modification technique in clinical practice. This technology employs acoustic pressure waves to selectively disrupt deep-seated calcific plaques, inducing fractures within the calcium while sparing the soft tissue of the vessel wall from substantial injury. IVL is performed with low-pressure balloon inflation (4-6 atm), which helps to minimize the risk of vascular injury; its mechanism of action does not produce macroscopic debris, theoretically obviating distal embolization and associated microcirculatory disturbances. Recently published prospective observational studies-the REPLICA-EPIC18 and BENELUX-IVL registries-have demonstrated that IVL is feasible and safe in \"real-world\" severely calcified lesions, effectively facilitating stent implantation.\n\nAlthough both RA and IVL are important tools for managing severe calcific lesions, there remains a paucity of high-level, head-to-head evidence directly comparing post-procedural minimal stent area between the two modalities. Clarifying this issue is of significant clinical importance for guiding clinicians in selecting optimal revascularization strategies tailored to distinct pathological characteristics and patient profiles, thereby improving procedural safety and patient outcomes. To this end, we plan to conduct a prospective, multicenter, randomized clinical trial (RCT) aimed at comparing the minimal stent area between intravascular lithotripsy and rotational atherectomy in patients with severely calcified lesions.",[414,415,416,417],"Coronary Artery Calcifications","Intravascular Lithotripsy","Rotational Atherectomy","Intravascular Ultrasound",{"date":419,"type":31},"2026-08-06",{"date":421,"type":22},"2026-10-01",{"date":423,"type":22},"2030-06-30",{"name":37,"class":38},{"id":426,"slug":427,"hasResults":11,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":11,"sex":18,"minAge":196,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":434,"conditions":435,"keywords":440,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":448,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":63},"100650457","remimazolam-versus-midazolam-for-general-anesthesia-induction-in-elderly-patients-undergoing-non-cardiac-surgery-100650457","NCT07746505","Remimazolam Versus Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery","Effectiveness and Safety of Remimazolam Compared With Midazolam for General Anesthesia Induction in Elderly Patients Undergoing Non-Cardiac Surgery: A Prospective Observational Cohort Study","Inclusion Criteria:\n\n1. Age 65 years or older.\n2. Scheduled for elective non-cardiac surgery under general anesthesia.\n3. American Society of Anesthesiologists physical status I to IV.\n4. Planned airway management with tracheal intubation or a laryngeal mask airway.\n5. Written informed consent provided by the participant or the participant's legally authorized representative.\n\n   \\-\n\nExclusion Criteria:\n\n1. Long-term preoperative benzodiazepine use.\n2. Known allergy or contraindication to benzodiazepines, flumazenil, opioids, naloxone, or related drugs.\n3. History of drug abuse or alcoholism within the past 2 years.\n4. No preoperative cognitive assessment available.\n5. Preoperative cognitive impairment, defined as a Mini-Mental State 6.Examination score less than 18.\n\n7.Refusal to provide informed consent.\n\n\\-",{"count":433,"type":22},1000,"This prospective observational cohort study evaluates the effectiveness and safety of two benzodiazepine sedatives-remimazolam and midazolam-used for general anesthesia induction in elderly patients (≥65 years) undergoing elective non-cardiac surgery. Elderly patients have reduced organ reserve and altered pharmacokinetics\u002Fpharmacodynamics, increasing their susceptibility to anesthesia-related complications such as intraoperative hypotension, delayed emergence, and postoperative delirium. Remimazolam, an ultra-short-acting benzodiazepine metabolized by organ-independent tissue esterases, is hypothesized to offer greater hemodynamic stability, faster recovery, and a more favorable safety profile than midazolam in this vulnerable population. Investigators prospectively observe and collect data without altering routine clinical care; the choice of sedative is made by the attending anesthesiologist according to standard practice. Propensity score methods will be used to reduce confounding by indication.",[436,437,438,439],"General Anesthesia","Aged","Intraoperative Hypotension","Anxiety",[441,442,443,444,445,446,447],"Remimazolam","Midazolam","Elderly","Non-cardiac surgery","Anesthesia induction","Hemodynamic stability","Quality of recovery",{"date":259,"type":31},{"date":450,"type":31},"2026-06-15",{"date":452,"type":22},"2027-07-15",{"name":37,"class":38},{"id":455,"slug":456,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":461,"targetDuration":4,"studyType":49,"phases":463,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":63},"100650310","phase-1-amivantamab-combined-with-intrathecal-pemetrexed-for-lm-from-egfr-mutated-lung-adenocarcinoma-100650310","NCT07744529","Amivantamab Combined With Intrathecal Pemetrexed for LM From EGFR-Mutated Lung Adenocarcinoma","A Single-Arm Phase II Exploratory Clinical Study of Amivantamab Combined With Intrathecal Pemetrexed for Leptomeningeal Metastasis From EGFR-Mutated Lung Adenocarcinoma","Inclusion Criteria:\n\n* Voluntary participation in the clinical study: fully understands and is informed of this study and signs the written informed consent form; is willing and able to complete all trial procedures.\n* Age: \\>=18 years; male or female.\n* Patients with EGFR-mutated lung adenocarcinoma with leptomeningeal metastasis diagnosed according to the EANO-ESMO guidelines.\n* Expected survival of at least 3 months.\n* Adequate organ and bone marrow function, with no severe hematopoietic abnormality and no severe cardiac, pulmonary, hepatic or renal dysfunction or immunodeficiency (within 14 days before use of study drug, no blood transfusion, granulocyte colony-stimulating factor or other relevant medical support):\n\n  1. Complete blood count: absolute neutrophil count (ANC) \\>=1.5 x 10\\^9\u002FL (1500\u002Fmm\\^3), platelets \\>=75 x 10\\^9\u002FL, hemoglobin \\>=9 g\u002FdL (if bone marrow is involved, platelets \\>=50 x 10\\^9\u002FL, ANC \\>=1.0 x 10\\^9\u002FL and hemoglobin \\>=8 g\u002FdL).\n  2. Liver function: serum bilirubin \\\u003C=1.5 x upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \\\u003C=1.5 x ULN (if there is liver involvement, AST and ALT \\\u003C=5 x ULN are allowed).\n  3. Renal function: serum creatinine \\\u003C=1.5 x ULN.\n  4. Coagulation function: INR \\\u003C=1.5 x ULN; PT and APTT \\\u003C=1.5 x ULN (unless the subject is receiving anticoagulant therapy and PT and APTT are within the expected range of anticoagulant treatment at screening).\n* Left ventricular ejection fraction (LVEF) in cardiac function examination \\>=50%.\n* Negative serum pregnancy test, and effective contraception from signing the informed consent form until 6 months after the last chemotherapy dose.\n* Thyroid-stimulating hormone (TSH), free thyroxine (FT4) or free triiodothyronine (FT3) within +\u002F-10% of the normal range.\n* Ophthalmic examination, including dilated fundus examination, slit-lamp examination and color fundus photography.\n\nExclusion Criteria:\n\n* Currently participating in another clinical study, or less than 4 weeks between the first dose of the study drug and the end of treatment in a previous clinical study.\n* History of other malignancies within the past 5 years.\n* Patients who have received CNS-directed prophylactic treatment.\n* Patients with known history of human immunodeficiency virus (HIV) infection and\u002For acquired immunodeficiency syndrome.\n* Patients with active autoimmune disease or a history of autoimmune disease with a high risk of recurrence, including but not limited to immune-related neuropathy, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis, systemic lupus erythematosus, connective tissue disease, scleroderma, inflammatory bowel cancer (including Crohn disease and ulcerative colitis), autoimmune hepatitis, toxic epidermal necrolysis or Stevens-Johnson syndrome.\n* Patients with active chronic hepatitis B or active hepatitis C. Patients who are positive for hepatitis B surface antigen or hepatitis C virus antibody during screening may be enrolled only after further HBV DNA titer testing (not higher than 1000 IU\u002FmL) and HCV RNA testing (not exceeding the lower limit of detection of the assay), and after active hepatitis B or hepatitis C infection requiring treatment has been excluded. Hepatitis B virus carriers, patients with stable hepatitis B after drug treatment and patients with cured hepatitis C may be enrolled.\n* Active pulmonary tuberculosis.\n* Current interstitial lung disease or infectious pneumonia.\n* Active infection requiring systemic anti-infective therapy, including but not limited to bacterial, fungal or viral infection.\n* Within 6 months before screening, New York Heart Association (NYHA) class III or IV heart failure, unstable angina, severe poorly controlled ventricular arrhythmia, or electrocardiographic evidence of acute ischemia or myocardial infarction.\n* QTcF interval \\>480 msec, unless secondary to bundle branch block.\n* Uncontrolled comorbid disease, including but not limited to uncontrolled hypertension, active peptic ulcer or bleeding disorder.\n* History of psychiatric illness; incapacity or limited capacity for civil conduct.\n* In the judgment of the investigator, the patient's underlying condition may increase the risk of receiving study drug treatment or confound the occurrence and assessment of toxic reactions.\n* Other patients whom the investigator considers unsuitable for participation in this study.",{"count":462,"type":22},15,[464,334],"PHASE1","The goal of this clinical trial is to learn whether amivantamab combined with intrathecal pemetrexed is safe and may help treat leptomeningeal metastasis in adults with EGFR-mutant lung adenocarcinoma. Leptomeningeal metastasis occurs when cancer cells spread to the membranes surrounding the brain and spinal cord or to the cerebrospinal fluid. It is a serious complication of advanced lung cancer and is difficult to treat because many systemic drugs do not reach high enough levels in the cerebrospinal fluid.\n\nThe main questions this study aims to answer are:\n\nWhat medical problems do participants have when receiving amivantamab combined with intrathecal pemetrexed? How long do participants live without their disease getting worse after receiving this treatment? How long do participants survive after starting this treatment?\n\nParticipants will:\n\nReceive amivantamab by intravenous infusion according to the study schedule. Receive intrathecal pemetrexed, together with dexamethasone and normal saline, once every week.\n\nContinue their original EGFR tyrosine kinase inhibitor treatment as determined by the study doctor.\n\nHave cerebrospinal fluid pressure measured and cerebrospinal fluid samples collected before each intrathecal treatment.\n\nHave tests of cerebrospinal fluid, including routine tests, biochemical tests, tumor markers, albumin, IgG, and cytology.\n\nHave imaging tests, including enhanced MRI, about every 3 months to check the disease.\n\nBe followed by clinic visits and\u002For telephone calls to collect information about survival, disease status, side effects, and any later cancer treatments.",[467],"Leptomeningeal Metastasis From Lung Cancer","2026-08-01",{"date":357,"type":31},{"date":471,"type":31},"2026-05-28",{"date":473,"type":22},"2028-05-28",{"name":37,"class":38},""]