[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Guangdong Provincial People's Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":636},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,81,0,25,[9,49,77,98,124,150,175,203,229,249,272,298,320,353,376,400,427,447,468,495,519,546,570,592,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100650504","universal-star-t-cell-injection-in-autoimmune-kidney-diseases-100650504",false,"NCT07746453","Universal STAR-T Cell Injection in Autoimmune Kidney Diseases","An Exploratory Study to Evaluate the Safety and Efficacy of Universal STAR-T Cell Injection in Subjects With Autoimmune Kidney Diseases","Inclusion Criteria:\n\n* Subjects must meet all the following inclusion criteria to be enrolled in this study:\n\n  1. Age 18-65 years (inclusive), gender (no gender restriction);\n  2. Previous diagnosis of IgA Nephropathy (IgAN) or Primary Membranous Nephropathy (PMN)：\n\n     * IgA Nephropathy (IgAN): Renal biopsy confirmed as IgAN, and meets any one of the following criteria:\n\n       1. Treatment-refractory IgAN: Previously received RAAS inhibitors or SGLT2 inhibitors or endothelin receptor antagonists (ERA) or mineralocorticoid receptor antagonists (MRA) for at least 12 weeks, and combined with\u002For sequentially added at least one immunosuppressant or biologic agent for ≥3 months, with 24-hour urinary protein ≥1.0 g or 24-hour urine protein\u002Fcreatinine ratio (UPCR) ≥0.8 g\u002Fg;\n       2. eGFR decreased by ≥50% within the past 3 months, and acute kidney injury (AKI) is excluded;\n       3. Unable to tolerate conventional treatment, may be considered for enrollment after full evaluation by the investigator.\n     * Primary Membranous Nephropathy (PMN): Renal biopsy confirmed as PMN, and anti-phospholipase A2 receptor antibody (anti-PLA2R) is positive, and meets any one of the following criteria for relapsed or refractory PMN:\n\n       1. Refractory PMN: Received hormone combined with cyclophosphamide or calcineurin inhibitor (CNI) or rituximab for ≥6 months, and meets any one of the following:(a) Anti-PLA2R persistently high titer \\>50 RU\u002FmL;(b) Persistent 24-hour urinary protein \\>3.5 g\u002Fd, and reduction \\\u003C50% during treatment;(c) Unable to tolerate the above immunosuppressive therapy, or discontinued due to severe adverse reactions;\n       2. Relapsed PMN: After achieving complete remission, 24-hour urinary protein re-increased to \\>3.5 g\u002Fd;\n  3. Function of vital organs meets the following requirements:\n\n  \u003C!-- -->\n\n  1. Bone marrow function must satisfy:(a) Neutrophil count ≥1.0×10⁹\u002FL (without colony-stimulating factor treatment within 2 weeks prior to testing, except for disease-induced neutropenia);(b) Hemoglobin ≥60 g\u002FL;(c) Platelet count ≥30×10⁹\u002FL;\n  2. Liver function:(a) ALT ≤3×ULN (elevations due to disease are excluded);(b) AST ≤3×ULN (elevations due to disease are excluded);(c) TBIL ≤1.5×ULN (elevations due to disease are excluded);\n  3. Kidney function: Estimated glomerular filtration rate (eGFR) ≥30 mL\u002Fmin\u002F1.73 m² (calculated by CKD-EPI formula);\n  4. Coagulation function: International Normalized Ratio (INR) ≤1.5×ULN, Prothrombin Time (PT) ≤1.5×ULN;\n  5. Cardiac function: Hemodynamically stable; 4. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use medically accepted contraceptive measures or abstinence during the study and for 24 months after cell infusion; female subjects of childbearing potential must have a negative serum HCG test within 7 days prior to enrollment and must not be lactating: 5. Voluntarily participate in this clinical study and sign the informed consent form.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will be excluded from this study:\n\n  1. Secondary IgAN, secondary membranous nephropathy;\n  2. Use of immunosuppressive agents with therapeutic effect on the disease within five half-lives prior to cell infusion, or biologics within 4 weeks;\n  3. History of severe drug allergy or allergic constitution;\n  4. Uncontrolled or requiring treatment fungal, bacterial, viral, or other infections;\n  5. Active tuberculosis at screening;\n  6. Cardiac insufficiency (NYHA functional class \\>II), unable to tolerate study lymphodepletion and cell reinfusion;\n  7. Subjects with congenital immunoglobulin deficiency;\n  8. History of malignant tumor within the past 5 years that has not yet resolved;\n  9. Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the detection limit; positive for hepatitis C virus (HCV) antibody with peripheral blood HCV RNA positive; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis test;\n  10. Male and female subjects who plan to conceive during the study period or within 24 months after cell infusion;\n  11. Subjects whom the investigator deems otherwise unsuitable for inclusion in this study.","ALL","18 Years","65 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","This is an investigator initiated, single-arm, open-label, dose-escalation study to explore the preliminary efficacy, safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of the universal STAR-T cell injection which is a CD19 and BCMA bispecific CAR-T cells in patients with autoimmune kidney diseases. Approximately 10-24 adult participants diagnosed as IgA nephropathy and primary membranous nephropathy will be enrolled. Three dose levels (1.5 E6 STAR-T cells\u002Fkg, 3.0 E6 STAR-T cells\u002Fkg and 4.5 E6 STAR-T cells\u002Fkg) will be established in this study, and the universal STAR-T cell will be administered as a single intravenous infusion. A recommended dose will be selected for subsequent dose-expansion studies to evaluate the safety and efficacy of universal STAR-T cell injection in participants with autoimmune kidney diseases based on the safety, PK results, and preliminary efficacy data. This study includes the screening period (D-28 to D-6), pre-clearance treatment and observation period (D-5 to D-1), cell infusion and main study endpoint observation period (D0 to W12 after infusion), and extended follow-up period (W12 to W104).",[28,29],"IgA Nephropathy (IgAN)","Primary Membranous Nephropathy",[31,29,32,33,34,35],"IgA Nephropathy","CD 19","BCMA","Safety","Efficacy","NOT_YET_RECRUITING","2026-08-05",{"date":39,"type":40},"2026-08-10","ACTUAL",{"date":42,"type":22},"2026-08-31",{"date":44,"type":22},"2029-10-01",{"name":46,"class":47},"Guangdong Provincial People's Hospital","OTHER",1,{"id":50,"slug":51,"hasResults":12,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":58,"targetDuration":60,"studyType":61,"phases":4,"briefSummary":62,"conditions":63,"keywords":67,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":48},"100650874","microbiota-in-neoadjuvant-chemoimmunotherapy-for-nsclc-100650874","NCT07752589","Microbiota in Neoadjuvant Chemoimmunotherapy for NSCLC","A Prospective Cohort Study Investigating Gut Microbiota as an Immunomodulatory Predictor of Response to Neoadjuvant Chemoimmunotherapy in Resectable Non-small-cell Lung Cancer","Inclusion Criteria:\n\n1. Age between 18 and 80 years;\n2. Newly diagnosed, driver gene-negative non-small cell lung cancer (NSCLC) confirmed by histopathology (Stage IIA-IIIB);\n3. At least one measurable lesion as defined by RECIST version 1.1; Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n4. No prior systemic therapy or radiotherapy;\n5. Eligible for surgical resection and suitable for neoadjuvant immunotherapy or chemotherapy as determined by multidisciplinary evaluation;\n6. Signed written informed consent prior to study participation;\n7. Adequate pulmonary ventilation and diffusion function confirmed by pre-enrollment pulmonary function test to allow for surgical resection.\n\nExclusion Criteria:\n\n1. Requirement for systemic glucocorticoid therapy or other immunosuppressive treatments;\n2. Use of antibiotics or presence of infections requiring antibiotic therapy within the past 3 months;\n3. Probiotic use within 3 months prior to enrollment;\n4. Presence of obstructive pneumonia, cancerous cavitation, or active pulmonary tuberculosis;\n5. Presence of bronchiectasis, concurrent pulmonary infections, pulmonary fibrosis, or uncontrolled diabetes mellitus;\n6. Presence of a primary tumor in another organ;\n7. Receipt of chemotherapy or any other cancer treatment prior to enrollment;\n8. Confirmed brain metastases by contrast-enhanced MRI before enrollment;\n9. Active or pre-existing autoimmune diseases;\n10. Uncontrolled comorbidities including heart failure, uncontrolled hypertension, unstable angina, or interstitial lung disease;\n11. Positive for hepatitis B surface antigen or detectable hepatitis C RNA requiring treatment;\n12. Known history or positive test for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS);\n13. Pregnant or breastfeeding women;\n14. Previous treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibodies.",true,"80 Years",{"count":59,"type":22},100,"5 Years","OBSERVATIONAL","Locally advanced lung cancer (LALC) has poor prognosis despite multimodal therapies. Neoadjuvant chemoimmunotherapy is now standard for resectable stage II-IIIB NSCLC, but patient responses vary. The gut microbiota, a key immune regulator, has been linked to immunotherapy efficacy, with microbial diversity predicting ICI response and fecal microbiota transplantation improving outcomes. While most studies focus on advanced disease, the microbiota's role in LALC during neoadjuvant therapy remains unclear. Exploring its dynamics may uncover novel biomarkers and strategies to optimize treatment",[64,65,66],"Non-Small Cell Carcinoma of Lung","Gut Microbiomes","Neoadjuvant Chemoimmunotherapy",[68,65],"NSCLC","2026-08-03",{"date":71,"type":40},"2026-08-07",{"date":73,"type":22},"2026-07-31",{"date":75,"type":22},"2029-10-31",{"name":46,"class":47},{"id":78,"slug":79,"hasResults":12,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":23,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":92,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":4},"100650469","phase-3-de-escalation-neoadjuvant-therapy-for-intermediate-risk-her2-positive-early-breast-100650469","NCT07748260","De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast","De-escalation Neoadjuvant Therapy for Intermediate Risk HER2-positive Early Breast:a Randomised,Open-label,Multicentre,Phase 3 Trial","neoDIRHP","Inclusion Criteria:\n\nHistopathologically confirmed HER2-positive invasive breast cancer; Clinical staging of disease classified as T2N0M0.\n\nExclusion Criteria:\n\nPatients who have undergone chemotherapy, endocrine therapy, targeted therapy, or radiotherapy for this condition; Due to severe and uncontrolled medical conditions, the investigator deems chemotherapy contraindicated.",{"count":86,"type":22},592,[88],"PHASE3","High pathological complete response (pCR) rates are seen using different neoadjuvant chemotherapy schedules with trastuzumab and pertuzumab in HER2-positive stage II-III breast cancer patients. Total pCR rates in breast and axilla have been described as high as 64%, and with an even higher rate of \\>80% in patients with HER2-positive and hormone receptor (HR) negative tumors.\n\npCR is associated with better long-term outcomes in patients with HER2-positive breast cancer. Neoadjuvant treatment of HER2-positive breast cancer typically consists of six cycles of treatment. Longer duration of treatment is associated with higher pCR-rates but also with increased toxicity. It is therefore important to investigate which patients can safely be treated with less than six cycles of chemotherapy and which patients require six cycles for maximum efficacy.It is hypothesized that patients with a complete pathologic response may not benefit from additional chemotherapy, while those with residual invasive disease require further treatment. This study will evaluate de-escalation of the number of neoadjuvant chemotherapy cycles in intermediate risk HER2-positive breast cancer.",[91],"HER2-positive Breast Cancer",{"date":37,"type":40},{"date":94,"type":22},"2026-09-01",{"date":96,"type":22},"2031-07-01",{"name":46,"class":47},{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":48},"100532632","short-term-effects-of-preoperative-exercise-in-moderate-to-high-perioperative-risk-lung-cancer-patients-100532632","NCT06215326","Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients","Short-term Effects of Preoperative Exercise in Moderate-to-high Perioperative Risk Lung Cancer Patients(PRE-EXELUCA): a Prospective Randomized Controlled Clinical Trial","PRE-EXELUCA","Inclusion Criteria:\n\n1. Age\\>18 years.\n2. Suspected or confirmed primary lung cancer with scheduled surgical treatment.\n3. Moderate-to-high perioperative risk, defined as FEV1\\\u003C60% of predicted value (wedge) or ppo FEV1\\\u003C60% of predicted value (lobectomy\u002Fsegmentectomy) or VO2peak\\\u003C20 ml\u002Fkg\u002F min.\n4. Sign informed consent and accept to comply with the requirements of the study protocol.\n5. Completion of a baseline Complete cardiopulmonary exercise testing (CPET).\n\nExclusion Criteria:\n\n1. Concurrent or previous history of other malignant tumors.\n2. Life expectancy less than 1 year.\n3. Dementia; infirmity; or inability to participate in sports (musculoskeletal limitations, namely, injuries, frailty, and weakness).\n4. Inability to maintain exercise training.\n5. Irregular vital signs (heart rate: \\\u003C 40 or \\> 120 bpm at rest; blood pressure: systolic blood pressure \\> 200 mm Hg or diastolic pressure \\> 110 mm Hg; T: ≥ 38.5 or ≤ 36◦C; SpO2 ≤ 90%).\n6. Currently enrolling in any other clinical trials.\n7. Patient refusal.",{"count":59,"type":22},[25],"The goal of this clinical trail is to compare the effects of preoperative exercise training of different intensities on short-term cardiorespiratory function and postoperative outcomes in patients scheduled for lung resections.",[110],"Lung Cancer",[110,112,113,114,115],"preoperative exercise","moderate-to-high perioperative risk","cardiorespiratory function","postoperative outcomes","RECRUITING","2026-07-30",{"date":69,"type":40},{"date":120,"type":40},"2024-01-23",{"date":122,"type":22},"2027-07-31",{"name":46,"class":47},{"id":125,"slug":126,"hasResults":12,"nctId":127,"briefTitle":128,"officialTitle":129,"acronym":4,"eligibilityCriteria":130,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":146,"completionDateStruct":147,"leadSponsor":149,"locationsCount":48},"100649702","phase-2-terbinafine-for-csa-aki-prevention-100649702","NCT07738328","Terbinafine for CSA-AKI Prevention","Terbinafine for the Prevention of Cardiac Surgery-Associated Acute Kidney Injury: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged ≥18 and ≤75 years, without restriction on gender.\n* Patients with a definite clinical diagnosis scheduled for elective cardiac and macrovascular surgery with cardiopulmonary bypass (CPB) support, including but not limited to coronary artery bypass grafting (CABG), cardiac valve replacement\u002Frepair, structural heart disease surgery, aortic arch plasty, or combined procedures of the above surgeries.\n* Classified as high risk by AKI risk scoring system, with a total score ≥4 points.\n* The subject or their legal representative shall fully understand the purpose, procedures, potential risks and benefits of this study, and voluntarily sign the written informed consent form.\n\nExclusion Criteria:\n\n* Patients with severe chronic renal insufficiency (eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m² or serum creatinine \\> 300 μmol\u002FL), or those receiving any form of renal replacement therapy (e.g., hemodialysis, peritoneal dialysis).\n* Pre-existing acute kidney injury.\n* Presence of chronic or active liver diseases, including decompensated liver cirrhosis, active viral hepatitis, autoimmune liver disease, etc.; or preoperative laboratory tests showing ALT\u002FAST ≥ 2 times the upper limit of normal (ULN).\n* Severe hematological diseases (preoperative white blood cell count \\\u003C 3.0 × 10⁹\u002FL, platelet count \\\u003C 80 × 10⁹\u002FL).\n* Uncontrolled active infections, or known immunodeficiency disorders (e.g., HIV infection, status post organ transplantation).\n* History of severe hypersensitivity to terbinafine or any excipients of its formulation.\n* Pregnant or lactating women, as well as women of childbearing potential who plan to conceive during the study and refuse to use effective contraception.\n* Participation in any other clinical trial of investigational drugs or medical devices within 3 months prior to screening.\n* Patients deemed inappropriate for enrollment in this study at the investigator's clinical discretion.","75 Years",{"count":133,"type":22},208,[135],"PHASE2","Primary Objective: To evaluate the efficacy and safety of perioperative oral terbinafine in reducing the incidence of cardiac surgery-associated acute kidney injury (CSA-AKI).Secondary Objectives:To assess the effects of terbinafine on the severity of post-cardiac surgery AKI, length of hospital stay, and 30-day major adverse kidney events (MAKE30);To evaluate its impacts on biomarkers of renal injury and inflammation.",[138,139],"Acute Kidney Injury","Cardiac Surgical Procedures",[138,141,142,143],"Cardiac Surgery-Associated Acute Kidney Injury","Terbinafine","Randomized","2026-07-27",{"date":73,"type":40},{"date":94,"type":22},{"date":148,"type":22},"2028-05-01",{"name":46,"class":47},{"id":151,"slug":152,"hasResults":12,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":157,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":174},"100648869","multicenter-prospective-validation-of-ai-models-for-malignancy-risk-prediction-in-pulmonary-nodules-100648869","NCT07727122","Multicenter Prospective Validation of AI Models for Malignancy Risk Prediction in Pulmonary Nodules","A Multicenter Prospective Diagnostic Accuracy Study of Three CT-Based Artificial Intelligence Models for Predicting Malignancy Risk in Pulmonary Nodules Using Pathology as the Gold Standard","Inclusion Criteria:\n\n* Age ≥ 18 years, any sex.\n* At least one pulmonary nodule detected on chest CT, with initial nodule diameter ≤ 3 cm.\n* The nodule undergoes surgical resection or biopsy with a definitive benign or malignant pathological diagnosis.\n* Time interval between CT examination and pathological examination ≤ 6 months.\n* Availability of complete CT imaging data in DICOM format with adequate image quality (no severe artifacts), meeting input requirements of all three AI models.\n\nAvailability of complete clinicopathologic information including histologic type and grade, with clear pathological diagnosis suitable as gold standard labels for AI validation.\n\n-The patient (or legally authorized representative) is willing and able to sign written informed consent.\n\nExclusion Criteria:\n\n* Pathological results are unclear, inconclusive, or disputed; nodule nature or grade cannot be reliably determined.\n* The patient receives treatments between CT and pathology that may significantly alter nodule appearance (e.g., chemotherapy, radiotherapy, targeted therapy).\n* CT imaging data are incomplete (missing essential series) or have severe motion, metal, or other artifacts preventing accurate AI analysis.\n* Required metadata for any AI model are missing and cannot be imputed. History of other malignant tumors (malignancies other than the index non-small cell lung cancer).\n* Severe psychiatric illness, cognitive impairment, or other conditions that prevent cooperation with study-related procedures and follow-up.\n\nParticipation in another clinical study that may interfere with the results of this research.\n\n-The patient or legal representative refuses participation.\n\nExclusion (Post-Enrollment \u002F Removal from Analysis)\n\nParticipants already enrolled may be excluded from the analysis set if:\n\n* They are later found not to meet inclusion criteria or to meet exclusion criteria.\n* No usable data are available after enrollment.\n* Required AI model assessments are not completed (e.g., technical failure to generate outputs).\n* Critical data are missing, preventing contribution to primary analysis.\n* The interval between CT and pathology exceeds 6 months.",{"count":158,"type":22},3000,"This multicenter prospective diagnostic accuracy study will compare the performance of three artificial intelligence (AI) models (MVCS, LungDoc, and a United Imaging AI model) for predicting the malignancy risk of pulmonary nodules on chest CT. All enrolled patients will have pulmonary nodules ≤3 cm on CT and a definitive postoperative or biopsy pathological diagnosis. The AI models will generate continuous malignancy probability scores based only on CT images. Pathology will serve as the gold standard.\n\nThe primary objective is to compare the area under the receiver operating characteristic curve (AUC) for malignancy prediction among the three AI models. Secondary objectives include comparison of sensitivity, specificity, positive and negative predictive values, accuracy, F1 score, and calibration. Exploratory analyses will evaluate the MVCS model for predicting pathological invasion degree (pre-invasive, minimally invasive, and invasive adenocarcinoma) and an extended MVCSN model that incorporates clinical and imaging features in a data-complete subset.",[161],"Pulmonary Nodules",[163,164,165,166],"Pulmonary nodule","Artificial intelligence","Deep learning","Diagnostic accuracy","2026-07-22",{"date":144,"type":40},{"date":170,"type":22},"2026-07",{"date":172,"type":22},"2028-12",{"name":46,"class":47},5,{"id":176,"slug":177,"hasResults":12,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":183,"targetDuration":4,"studyType":23,"phases":185,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":4},"100648423","phase-2-bevacizumab-sintilimab-cetuximab-and-irinotecan-in-refractory-ras-wild-type-metastatic-colorectal-cancer-bond-4-trial-100648423","NCT07722754","Bevacizumab, Sintilimab, Cetuximab and Irinotecan in Refractory RAS Wild-type Metastatic Colorectal Cancer: BOND-4 Trial","A Randomized, Multi-center, Open-label Phase II Trial of Irinotecan and Cetuximab With or Without the Combination of Bevacizumab and Sintilimab in RAS Wild-type, Irinotecan-refractory Metastatic Colorectal Cancer","BOND-4","Inclusion Criteria:\n\n* Metastatic and unresectable colorectal adenocarcinom;\n* RAS wild-type and MSS tumor;\n* Measurable lesions;\n* Failed to at least two lines of standard treatment containing fluoropyrimidine, irinotecan and bevacizumab;\n* Eastern Cooperative Oncology Group performance status 2 or less;\n* White blood cell≥ 3\\*10\\^9\u002FL, neutrophil≥ 1.5\\*10\\^9\u002FLplatelet count≥75\\*10\\^9\u002FL, hemoglobin≥60g\u002FL;\n* Total serum bilirubin≤upper limit of normal (ULN), alanine aminotransferase and aspartate aminotransferase ≤ 2.5\\*ULN or ≤5\\*ULN for subjects with liver metastasis;\n* Creatinine ≤ ULN or creatinine clearance ≥ 80 mL\u002Fmin;\n* Urinary protein negative or 24-hour urinary protein ≤ 2g;\n* Activated partial thromboplastin time≤ULN and international normalized ratio≤1.5;\n* Any major surgery ≥ 4 weeks and any minor surgery ≥ 1 week and fully recovered from the procedure;\n* Life expectancy \\> 3 months;\n* Provide fully informed written consent;\n\nExclusion Criteria:\n\n* Other aggressive malignancies within 3 years (Exceptions: non-melanoma skin cancer or carcinoma-in-situ of the cervix that has been treated);\n* Allergy or intolerance to any of the study drugs;\n* Human immunodeficiency virus positive;\n* Concurrent anti-cancer therapy including radiation therapy, chemotherapy, targeted agents or biological agents not otherwise specified within two weeks;\n* Malignant bowel obstruction;\n* Prior treatment with PD-1 antibody;\n* Autoimmune diseases;\n* Significant bleeding events or pre-existing bleeding diathesis within 6 months (unless the source of bleeding has been resected);\n* Gastrointestinal perforation within 12 months;\n* Serious or non-healing wound, ulcer, or bone fracture;\n* Blood pressure \\>= 160\u002F90 mmHg after active anti-hypertensive therapy;\n* Arterial or venous thrombotic or embolic events within 6 months (including but not limited to transient ischemic attack, cerebrovascular accident, unstable angina or myocardial infarction);\n* Uncontrolled illness including active infection, symptomatic congestive heart failure, cardiac arrhythmia, respiratory failure, symptomatic pulmonary fibrosis, interstitial pneumonitis or psychiatric illness that may interfere with the conduct of the study;\n* Known or suspected brain or central nervous system (CNS) metastases, or carcinomatous meningitis;\n* Any of the following: pregnant, nursing, childbearing potential but unwilling to employ contraception.",{"count":184,"type":22},160,[135],"Primary endpoint: objective response rate Secondary endpoints: PFS, OS and adverse events",[188,189],"Colorectal Neoplasms Malignant","Neoplasm, Metastatic",[191,192,193,194],"Bevacizumab","Immune checkpoint inhibitors","Cetuximab","Irinotecan","2026-07-20",{"date":197,"type":40},"2026-07-23",{"date":199,"type":22},"2026-08-01",{"date":201,"type":22},"2029-01-31",{"name":46,"class":47},{"id":204,"slug":205,"hasResults":12,"nctId":206,"briefTitle":207,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":209,"targetDuration":4,"studyType":23,"phases":211,"briefSummary":212,"conditions":213,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":48},"100646636","phase-3-anti-pcsk9-antibody-tafolecimab-and-anti-pd-1-antibody-sintilimab-combined-with-neoadjuvant-chemoradiotherapy-for-pmmr-mss-locally-advanced-rectal-cancer--a-prospective-multicenter-randomized-open-label-parallel-controlled-trial-100646636","NCT07686796","Anti-PCSK9 Antibody Tafolecimab and Anti-PD-1 Antibody Sintilimab Combined With Neoadjuvant Chemoradiotherapy for pMMR\u002F MSS Locally Advanced Rectal Cancer : A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Trial","Inclusion Criteria:\n\n1. Age 18 to 75 years, any sex.\n2. Histologically confirmed rectal adenocarcinoma, determined to be pMMR (proficient mismatch repair) or MSS (microsatellite stable) by immunohistochemistry and\u002For genetic testing; clinical stage cT3\u002FT4 or cN+; distal tumor margin ≤ 12 cm from the anal verge; and eligible for surgical resection.\n3. No evidence of distant metastases.\n4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n5. Adequate hematologic and biochemical function: absolute neutrophil count ≥ 1.5 × 10⁹\u002FL, hemoglobin ≥ 90 g\u002FL, platelets ≥ 100 × 10⁹\u002FL, ALT\u002FAST ≤ 2.5 times the upper limit of normal (ULN), creatinine ≤ 3.0 × ULN.\n6. Anticipated good compliance and provision of written informed consent.\n\nExclusion Criteria:\n\n1. Known allergy or severe adverse reaction to any study drug, including tafolecimab, PD-1 inhibitor (sintilimab), capecitabine, oxaliplatin, or any excipients.\n2. Rectal cancer confirmed as dMMR (deficient mismatch repair) or MSI-H (microsatellite instability-high).\n3. Pregnant or breastfeeding women, or patients of childbearing potential who refuse to use effective contraception during the study.\n4. Other malignancies within the past 5 years, except for cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, papillary thyroid carcinoma, or other malignancies considered cured after adequate treatment.\n5. Prior anti-tumor therapy for rectal cancer, including radiotherapy, chemotherapy, immunotherapy, or local surgical excision.\n6. Previous treatment with a PCSK9 inhibitor for any indication.\n7. Severe or uncontrolled neurological disease, psychiatric disorder, or cognitive impairment that, in the investigator's judgment, would affect informed consent or protocol adherence.\n8. Severe cardiovascular or cerebrovascular disease, including but not limited to: unstable angina, myocardial infarction, coronary revascularization, or stroke within 6 months before enrollment; clinically significant arrhythmia requiring treatment or left ventricular ejection fraction (LVEF) \\\u003C 50%; New York Heart Association (NYHA) class III or IV heart failure.\n9. Active infection requiring long-term systemic therapy (e.g., antibiotics, antivirals, or antifungals).\n10. Active autoimmune disease, or requirement for long-term systemic immunosuppressive therapy or corticosteroids (at a dose equivalent to prednisone \\> 10 mg\u002Fday).\n11. Known history of human immunodeficiency virus (HIV) infection, or active syphilis, or active pulmonary tuberculosis.\n12. Active hepatitis B (HBsAg positive and HBV DNA \\> 200 IU\u002FmL or \\> 1000 copies\u002FmL) or active hepatitis C (HCV RNA positive).\n13. Any other clinical condition that, in the investigator's opinion, could interfere with study assessments, increase treatment risk, or lead to premature study discontinuation (including but not limited to severe alcohol or drug abuse).",{"count":210,"type":22},148,[88],"This is a randomized, controlled clinical trial based on prior exploratory findings, designed to evaluate the efficacy and safety of neoadjuvant chemoradiotherapy combined with tafolecimab(an anti-PCSK9 inhibitor) and sintilimab (an anti-PD-1 inhibitor) versus neoadjuvant chemoradiotherapy combined with sintilimab alone in patients with pMMR\u002FMSS locally advanced rectal cancer. The primary endpoint is the complete response (CR) rate, including the pathological complete response (pCR) rate in patients who undergo surgery after neoadjuvant therapy, and the clinical complete response (cCR) rate in patients managed with a watch-and-wait strategy. Secondary endpoints include major pathological response (MPR) rate, objective response rate (ORR), downstaging rate, R0 resection rate, tumor regression grade, sphincter preservation rate, disease-free survival (DFS), overall survival (OS), and safety.",[214,215,216,217,218,219,220],"Local Advanced Rectal Cancer","PD-1 Inhibitor","PCSK9 Inhibitor","RCT","Radiotherapy","Capecitabine","Oxaliplatin","2026-07-06",{"date":223,"type":40},"2026-07-07",{"date":225,"type":22},"2027-01-01",{"date":227,"type":22},"2035-01-01",{"name":46,"class":47},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":238,"conditions":239,"keywords":241,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":243,"startDateStruct":244,"completionDateStruct":246,"leadSponsor":248,"locationsCount":48},"100627387","multimodal-deep-learning-model-for-multi-task-diagnosis-and-triage-suggestions-of-ophthalmic-diseases-100627387","NCT07447973","Multimodal Deep Learning Model for Multi-task Diagnosis and Triage Suggestions of Ophthalmic Diseases","Development and Validation of Multimodal Deep Learning Model for Autonomous Diagnosis, Generative Reporting, and Specialist Referral in Ophthalmic Diseases: An International Multicenter Cohort Study","Inclusion Criteria:\n\n1. Informed consent obtained;\n2. Participants should be sufficiently able to read, write, and understand Chinese or English;\n3. For normal participants: individuals should have no concerns related to their eyes.\n4. For participants with eye-related chief complaints: individuals should have specific concerns or issues related to their eyes.\n\nExclusion Criteria:\n\n1. Incomplete clinical data to support final diagnosis;\n2. Patients who, in the opinion of the attending physician or clinical study staff, are too medically unstable to participate in the study safely.",{"count":237,"type":22},2000,"Accurate and comprehensive interpretation of anterior segment diseases from slit-lamp and smartphone photographs remains a clinical challenge due to the limited specificity and structure of existing Artificial Intelligence tools. The purpose of this international, multicenter clinical trial is to developed and validated an agent-based framework that integrates vision-language models and large language models to enhance the diagnostic workflow of anterior segment diseases.",[240],"Anterior Segment Diseases",[240,242],"Artificial Intelligence",{"date":223,"type":40},{"date":245,"type":40},"2026-03-10",{"date":247,"type":22},"2027-12-31",{"name":46,"class":47},{"id":250,"slug":251,"hasResults":12,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":258,"conditions":259,"keywords":261,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":48},"100486618","international-big-data-centre-in-emergency-medicine-100486618","NCT05616416","International Big Data Centre in Emergency Medicine","Institute of Sciences in Emergency Medicine - International Big Data Centre in Emergency Medicine","Inclusion Criteria:\n\n* Every patient who ever visited Emergency Department from 2011-2022\n\nExclusion Criteria:\n\n* Patients with missing demographic (age, gender, etc.) and triage data",{"count":257,"type":22},500000,"This observational study aims to use electronic health records to build an International Big Data Centre in Emergency Medicine, within the Institute of Sciences in Emergency Medicine (ISEM) at the Guangdong Provincial People's Hospital. The main questions it seeks to answer are not limited to the following:\n\n* Identify the relationship between Emergency Department Length of Stay (EDLOS), Mortality, and Adverse Events (AE)\n* Identify the risk factors associated with high mortality and AE rate among patients who experience prolonged EDLOS\n* Other research questions related to emergency medicine, such as building prediction and cluster models for acute diseases",[260],"Emergency Medicine",[262,263,242],"Machine Learning","Data Mining","2026-06-27",{"date":266,"type":40},"2026-07-01",{"date":268,"type":40},"2011-01-01",{"date":270,"type":22},"2027-12",{"name":46,"class":47},{"id":273,"slug":274,"hasResults":12,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":12,"sex":279,"minAge":18,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":23,"phases":282,"briefSummary":283,"conditions":284,"keywords":286,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":295,"leadSponsor":297,"locationsCount":48},"100620077","a-novel-intraoperative-fluorescence-guided-system-for-evaluating-margins-during-breast-conserving-surgery-for-breast-cancer-100620077","NCT07352930","A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer","A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer: A Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of primary invasive breast cancer, ductal carcinoma in situ (DCIS), or invasive breast cancer with a DCIS component. Acceptable diagnostic methods include core needle biopsy or fine-needle aspiration biopsy.\n2. Female, age ≥ 18 years.\n3. Scheduled to undergo breast-conserving surgery for the malignant breast lesion.\n4. Willing and able to comply with the study procedures and follow-up.\n5. Has provided written informed consent.\n6. No other uncontrolled serious medical conditions aside from the cancer diagnosis (see Exclusion Criteria for details).\n7. Adequate organ and bone marrow function, defined as:\n\n   * White blood cell count \\> 3,000\u002FμL\n   * Platelet count \\> 75,000\u002FμL\n   * Total bilirubin ≤ institutional upper limit of normal (ULN)\n   * AST (SGOT) \u002F ALT (SGPT) \\\u003C 2.5 × institutional ULN\n   * Serum creatinine ≤ 1.5 mg\u002FdL, OR creatinine clearance \\> 60 mL\u002Fmin\u002F1.73 m² (for participants with serum creatinine levels above institutional ULN)\n8. ECOG performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation.\n2. Suspected pregnancy.\n3. Prior injection of ICG or other fluorescent dyes for sentinel lymph node mapping on the day of surgery, before the planned lumpectomy cavity scan with the study device.\n4. Unresolved adverse events from previous medications or diagnostic agents.\n5. Uncontrolled hypertension, defined as persistent systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg. Patients with known hypertension must be stable on medication within these limits.\n6. History of allergy to any oral or intravenous contrast agent.\n7. Uncontrolled comorbidities, including but not limited to:\n\n   * Active infection\n   * Symptomatic congestive heart failure\n   * Unstable angina pectoris\n   * Cardiac arrhythmia\n   * Hospitalization for COPD or asthma within the past 12 months\n   * Psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n8. Any condition where, in the investigator's judgment, participation would not be in the best interest of the participant.\n9. Planned re-excision lumpectomy due to positive margins from a prior surgery performed before enrollment.\n10. Prior surgical history in the ipsilateral breast, including breast cancer surgery, mastectomy, breast reconstruction, or implant placement.","FEMALE",{"count":281,"type":22},172,[25],"The goal of this clinical trial is to learn if a novel intraoperative fluorescence-guided system (EndoSCell Scanner) can help surgeons more accurately remove all cancerous tissue during breast-conserving surgery in female patients aged 18 years or older, with primary breast cancer. The main questions it aims to answer are:\n\n* Does the use of the EndoSCell Scanner system lower the rate of secondary surgeries needed due to positive cancer margins after the initial operation?\n* How accurate is the EndoSCell Scanner system in detecting residual cancer cells on the walls of the surgical cavity during the operation?\n\nResearchers will compare the surgical outcomes using the EndoSCell Scanner guidance to the expected outcomes from standard surgical practice without this technology to see if the system is effective.\n\nParticipants will:\n\n* Receive their planned breast-conserving surgery (lumpectomy).\n* Have their surgical cavity scanned with the EndoSCell Scanner device after the main tumor is removed.\n* Have additional tissue removed from the cavity wall if the scanner indicates a potential cancer residue.",[285],"Breast-Conserving Surgery",[287,288,289],"Intraoperative Imaging","Fluorescence-Guided Surgery","Positive Margins","2026-06-25",{"date":292,"type":40},"2026-06-29",{"date":294,"type":40},"2026-04-01",{"date":296,"type":22},"2027-03-31",{"name":46,"class":47},{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":305,"targetDuration":4,"studyType":23,"phases":307,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":313,"lastUpdatePostDateStruct":314,"startDateStruct":316,"completionDateStruct":318,"leadSponsor":319,"locationsCount":48},"100568085","phase-1-nk010-or-nk042-in-combination-with-rituximab-for-refractory-systemic-lupus-erythematosuslupus-nephritis-100568085","NCT06676631","NK010 or NK042 in Combination With Rituximab for Refractory Systemic Lupus Erythematosus\u002FLupus Nephritis","NK010 or NK042 Cell Injection in Combination With Rituximab in Patients With Refractory Systemic Lupus Erythematosus or Lupus Nephritis","Inclusion Criteria:\n\n* 18 to 65 years old, male or female.\n* A diagnosis of SLE according to the 2019 EULAR (European League Against Rheumatism)\u002FACR (American College of Rheumatology).\n* Inclusion criteria applicable to the LN subgroup: active type III or IV lupus nephritis (with or without type V) confirmed by renal biopsy according to the 2018 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria. An activity index ≥2 and a chronicity index no more than moderate according to the 2018 RPS Task Force for LN pathologic types and the National Institutes of Health (NIH) Lupus Nephritis Activity and Chronicity Index Score criteria. Urine protein\u002Fcreatinine ratio (UPCR) ≥ 1.0 g\u002Fg or 24-hour urine protein quantification ≥ 1.0 g\u002Fday.\n* One of the following at screening: positive antinuclear antibody (ANA) OR positive anti-dsDNA OR positive anti-Smith antibody.\n* SLEDAI-2000 score ≥ 8.\n* Prior to screening, having received glucocorticoids combined with immunosuppressants and\u002For biologics for at least 3 months with stable doses for \\>2 weeks, but disease still active (i.e., received glucocorticoids + immunosuppressants or glucocorticoids + immunosuppressants + biologics; monotherapy with any of the above drugs is not eligible).\n* Hematologic, hepatic, renal, pulmonary, and cardiac function criteria at screening were as follows: ① leukocytes ≥ 2 ×109\u002FL and lymphocyte count ≥ 0.5 ×109 \u002FL; ② serum ALT and AST ≤ 3 times the upper limit of normal; ③ total bilirubin ≤ 1.5 times the upper limit of normal, with the exception of patients with Gilbert's syndrome, for whom total bilirubin was ≤ 3.0 times the upper limit of normal; ④ eGFR (based on the creatinine based on the CKD-EPI formula) ≥ 30 ml\u002Fmin\u002F1.73m2; ⑤ oxygen saturation ≥ 92% in non-oxygenated state under indoor ventilation; no clinically significant pleural effusion; ⑥ left ventricular ejection fraction ≥ 45%, and no clinically significant abnormal findings on ECG.\n* For participants not receiving therapeutic anticoagulation: International standardized ratio (INR) ≤ 1.5 times the upper limit of normal, or prothrombin time (PT) ≤ 1.5 times the upper limit of normal.\n* Participants receiving hematopoietic growth factor support therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte macrophage-colony-stimulating factor (GM-CSF), and platelet agonists (TPO), must have a 2-week interval between the last growth factor support therapy and the screening period assessment; those receiving blood product transfusion that require at least 1 week between the screening period platelet assessment and the last platelet transfusion, and at least 2 weeks between the screening period hemoglobin assessment and the last red blood cell transfusion.\n* Female participants of childbearing potential must have a negative serum pregnancy test at screening (women who are surgically sterilized or have been menopausal for at least 2 years are not considered to be of childbearing potential). Female subjects of childbearing potential and male subjects must use highly effective methods of contraception throughout the clinical study and for 1 year after the last study treatment; they should also commit not to donate eggs (oocytes, oocytes)\u002Fsperm for assisted reproduction for 1 year after the last study treatment.\n* Participants are willing to participate in this study and sign a paper version of the informed consent form.\n\nExclusion Criteria:\n\n* Requires dialysis treatment (hemodialysis or peritoneal dialysis) at the time of screening or is expected to require dialysis treatment during study treatment.\n* Have received a solid organ or hematopoietic cell transplant or plan to do so during study period.\n* Have a congenital or acquired immunodeficiency that results in a serious infection, or are receiving chronic immunoglobulin replacement therapy.\n* Presence of active mixed connective tissue or systemic sclerosis, an overlapping syndrome, in the 12 months prior to or during screening, and the adverse condition or other treatment may affect study efficacy or safety assessment or outcomes. Overlapping syndromes in which the anticipated condition or treatment does not affect the assessment or outcome are not excluded.\n* Receipt of any B-cell depletion therapy (e.g., anti-CD20, anti-CD19 monoclonal antibody), including but not limited to zolmitriptan in rituximab, obinutuzumab, bortezomib, within 6 months prior to screening; or treatment with any biologic, such as, but not limited to, belimumab, anifrolumab, or tetracycline, within 1 month prior to screening.\n* Participants with known anaphylaxis, hypersensitivity, intolerance, or contraindication to NK010 Cell Injection, NK042 Cell Injection, RTX, or any of the components of the drugs that may be used in the study, or subjects who have had a previous severe allergic reaction.\n* Clinically significant central nervous system disease or pathological changes not due to lupus within 3 months prior to the first dose, including, but not limited to, cerebrovascular accident (ischemia\u002Fhemorrhage), aneurysm, epilepsy, convulsions\u002Fconvulsions, aphasia, severe brain injury, dementia, parkinson's disease, cerebellar disorders, organic brain syndromes, or psychiatric disorders.\n* Unstable cardiovascular function: ① Uncontrollable angina pectoris or life-threatening unstable arrhythmia; ② Myocardial infarction or unstable angina pectoris within 3 months prior to the screening; ③ Previous coronary artery or graft revascularization; ④ Uncontrolled, clinically significant arrhythmia (e.g., sustained ventricular tachycardia, ventricular fibrillation, tip-twisting); ⑤ Mobitz type II Mobitz type II or III atrioventricular block; (6) congestive heart failure or severe cardiac insufficiency with New York Heart Association classification ≥ grade 3; (7) prolongation of the QT interval (QTc) corrected for heart rate (Fridericia) by \\> 480 milliseconds; (8) uncontrolled hypertension (systolic blood pressure \\>160 mm Hg and\u002For diastolic blood pressure \\> 100 mm Hg), or associated with hypertensive crisis or hypertensive encephalopathy.\n* Active bleeding.\n* Any active infection, excluding fungal infections of the nail beds; history of severe recurrent or chronic infections.\n* Presence of active infection treated with intravenous antibiotics within 14 days prior to screening, except for antibiotic prophylaxis (including intravenous administration).\n* Positive serum HIV viral antibodies or history of active HIV infection and positive syphilis antibodies at screening.\n* Positive Hepatitis B Surface Antigen (HBsAg). Participants who are HBsAg negative and Hepatitis B Core Antibody (HBcAb) positive, but Hepatitis B Virus (HBV) DNA negative are eligible for enrollment, but will require monitoring of HBV DNA at each follow-up visit.\n* Positive Hepatitis C Serology. Participants with hepatitis C antibodies positive but do not have detectable hepatitis C virus (HCV) RNA for at least 6 months after completion of antiviral therapy are eligible for enrollment, but require monitoring of HCV RNA at each follow-up visit.\n* Risk of active tuberculosis at screening, with or without completion of adequate treatment, including the presence of signs or symptoms of active tuberculosis (e.g., fever, cough, night sweats, and weight loss) as judged by the investigator at screening; documented active tuberculosis on chest imaging (e.g., chest x-ray, chest CT scan) performed at screening or at any time during the 6 months prior to screening; latent tuberculosis at screening evidence of infection such as a positive gamma-interferon release test.\n* Participants with a malignant tumor, including tumor-associated polymyositis\u002Fdermatomyositis, within 5 years prior to screening. Except for surgically resected and cured non-melanoma skin cancer, cervical carcinoma in situ, localized prostate cancer, low-stage bladder cancer, ductal carcinoma in situ of the breast, or cured participants with no evidence of recurrence within the last 2 years and no need for treatment.\n* Previous received cell therapy such as CAR-T, CAR-NK, ect.\n* Pregnant or lactating women, or (if of childbearing potential) subjects who are not using adequate contraception or planning to donate oocytes and sperm.\n* The presence of any life-threatening disease, medical condition, or organ system dysfunction that, in the opinion of the Investigator, may affect the safety of the subject or compliance with the study.",{"count":306,"type":22},18,[308],"PHASE1","This is an investigator-initiated, open-label, single-arm study to determine safety and preliminary efficacy of NK010 or NK042 in combination with rituximab (RTX) for the treatment of patients with refractory systemic lupus erythematosus (SLE) or lupus nephritis (LN) in China.",[311,312],"Refractory Systemic Lupus Erythematosus","Refractory Lupus Nephritis","2026-06-10",{"date":315,"type":40},"2026-06-12",{"date":317,"type":40},"2025-02-19",{"date":247,"type":22},{"name":46,"class":47},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":131,"maxAge":4,"enrollmentInfo":328,"targetDuration":4,"studyType":23,"phases":330,"briefSummary":331,"conditions":332,"keywords":340,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":48},"100626880","catheter-ablation-plus-laao-versus-anticoagulation-in-frail-elderly-patients-with-atrial-fibrillation-100626880","NCT07441382","Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation","Randomized Controlled Trial - Catheter Ablation Combined With Left Atrial Appendage Occlusion Versus Catheter Ablation Combined With Oral Anticoagulation for Elderly Frailty Patients With Atrial Fibrillation: Comparison of Efficacy and Safety","CLEAR-AF","Inclusion Criteria: (1) Age ≥ 75 years. (2) Confirmed diagnosis of non-valvular atrial fibrillation (paroxysmal or persistent). (3) CHA2DS2-VASc score ≥ 3 (high risk of stroke) . (4) Procedure-related criteria: Sequential Group: Participants who have received catheter ablation for non-valvular AF within 90 to 180 days prior to randomization. One-stop Group: Participants who are scheduled to undergo clinically indicated catheter ablation within 10 days after randomization. (5) Judged by the investigator to be able to tolerate the defined antithrombotic drug regimen. (6) Suitable to undergo Transesophageal Echocardiography (TEE) or Pulmonary Vein Computed Tomography (CT). (7) Able and willing to sign the written informed consent form. (8) Willing to return for all scheduled follow-up visits and examinations. Exclusion Criteria: (1) Presence of thrombus in the left atrium or left atrial appendage identified on preoperative imaging (echocardiogram, pulmonary vein CT, etc). (2) Major bleeding event (per ISTH definition) within 14 days prior to randomization. Participants must be excluded if clinical sequelae persist or if interventions for the bleeding source are planned\u002Fpending, regardless of the time elapsed since the event. (3) Requirement for long-term oral anticoagulation (OAC) for reasons other than stroke risk reduction in AF (e.g., underlying hypercoagulable state) that would prevent OAC discontinuation post-device implantation. (4) Any cardiac or major non-cardiac intervention\u002Fsurgery (excluding AF ablation and cardioversion) performed within 30 days prior to, or scheduled within 60 days after randomization. This includes but is not limited to Percutaneous Coronary Intervention (PCI) or other cardiac ablations. (5) Life expectancy \\\u003C 2 years, malignancy, infectious endocarditis, uncontrolled infection, or physiological evidence of cardiac tamponade. (6) Clinical Frailty Scale (CFS) score of 1-3 (not frail) or 7-9 (severely frail\u002Fterminally ill). (7) Deemed unsuitable for long-term anticoagulation and\u002For antiplatelet therapy by the investigator due to bleeding risk, allergies, or other reasons. (8) Current participation in another clinical trial that interferes with this study, excluding mandatory government or purely observational registries. (9) Stroke or transient ischemic attack (TIA) within 60 days prior to randomization. (10) Documented myocardial infarction (NSTEMI or STEMI) within 90 days prior to randomization, regardless of intervention. (11) History of atrial septal defect (ASD) repair or presence of an ASD\u002FPatent Foramen Ovale (PFO) occluder. (12) Presence of a mechanical prosthetic valve in any position. (13) Participants of childbearing potential who are pregnant or planning pregnancy during the study period. (14) Medical or anatomical contraindications to percutaneous catheter-based interventions. (15) Documented NYHA Class IV heart failure. (16) History of surgical left atrial appendage (LAA) closure.\n\nTransthoracic Echocardiography (TTE) Specific Exclusions: (1) Low LVEF: Left ventricular ejection fraction (LVEF) \\\u003C 30%. (2) Presence of pericardial effusion with a circumferential echo-free space \\> 5mm. (3) Presence of high-risk PFO associated with an atrial septal aneurysm (ASA) with an excursion or length \\> 15mm. (4) Presence of high-risk PFO with a large shunt (defined as appearance of microbubbles within 3 cardiac cycles and\u002For a substantial count of microbubbles). (5) Presence of moderate or severe mitral stenosis (mitral valve area \\\u003C 1.5 cm2).",{"count":329,"type":22},200,[25],"Atrial fibrillation (AF) is the most common arrhythmia, significantly increasing the risk of stroke, heart failure, hospitalization and death in patients. Studies have shown that standardized anticoagulation can effectively reduce the risk of stroke by 64% and the risk of death by 26% in AF patients. Therefore, both European and American guidelines recommend standardized oral anticoagulation (OAC) as an important treatment strategy for stroke prevention in AF patients. However, the use of OAC may also increase the risk of bleeding in patients. Results from large AF anticoagulation randomized trials show that the annual risk of anticoagulation-related bleeding mortality is 2% to 3%. Therefore, according to the guidelines recommendations, assessing the bleeding risk is necessary in patients with anticoagulant indications.\n\nPercutaneous left atrial appendage occlusion (LAAO) is a device-based therapy that aims to prevent ischemic stroke in patients with AF. For patients with contraindications to long-term anticoagulation therapy, LAAO can be considered as an alternative strategy to oral anticoagulation (Class II B recommendation) to prevent ischemic stroke and thromboembolism. Multiple studies have shown that LAAO is non-inferior to warfarin and novel oral anticoagulants in stroke prevention for non-valvular AF patients. Age is not only a risk factor for stroke but also an important risk factor for bleeding. In the elderly population, especially those with frailty, the risk factors for both stroke and bleeding are often increased. Currently, there is insufficient evidence to support the use of OAC in frail elderly patients with relative anticoagulant contraindications. Therefore, elderly AF patients may be one of the potential beneficiary groups for LAAO. However, most previous clinical studies on LAAO were based on small sample sizes to analyze their safety and efficacy, and clinical data on the safety and efficacy of LAAO in this high-risk population of elderly AF patients are still limited. To address this, the study aims to conduct a multicenter randomized controlled trial to compare the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients with high bleeding risk, filling the gap in this research area.\n\nTo address these limitations, this multicenter randomized controlled trial is designed to evaluate the efficacy and safety of catheter ablation combined with LAAO versus catheter ablation combined with OAC in elderly AF patients at high risk for bleeding. The primary objective of the study is to compare the 12-month incidence and time-to-occurrence of the composite clinical endpoint. This endpoint includes stroke\u002FTIA, systemic embolism, ISTH-defined major bleeding. By establishing these metrics within the first year, the study aims to fill the current void in clinical evidence and provide a standardized treatment strategy for high-risk elderly patients. In addition to the primary endpoints, the study will conduct a comprehensive long-term evaluation extending to 24 months post-procedure to assess the durability of both treatment strategies. Secondary objectives include the assessment of perioperative safety, specifically focusing on serious intraoperative complications and major adverse events occurring within the first seven days after the LAAO procedure. The trial will also measure long-term rhythm control by tracking the rate of freedom from AF recurrence at the one-year and two-year marks. Furthermore, the study seeks to verify the hypothesized superiority of the ablation-plus-LAAO strategy in reducing the specific burden of anticoagulation-related major bleeding and stroke.\n\nBeyond clinical safety and efficacy, the trial will analyze the practical aspects of the two interventions, including procedural success rates, operation duration, fluoroscopy time, and the total duration of hospitalization. A critical component of the research involves identifying specific risk factors associated with complications, with a specialized focus on how frailty scores influence procedural tolerance and long-term prognosis. The study will further explore how different types of AF respond to the LAAO strategy and assess the impact of each treatment on non-major bleeding events. Ultimately, the trial aims to determine which strategy offers a superior improvement in the overall quality of life for elderly patients, thereby optimizing future clinical guidelines.",[333,334,335,336,337,338,339],"Atrial Fibrillation (AF)","Stroke","Hemorrhage","Frailty","Atrial Appendage","Catheter Ablation","Anticoagulants",[341,342,334,335,339,336,343,344,338],"Atrial Fibrillation","Left Atrial Appendage Closure","Aged","Randomized Controlled Trial","2026-06-05",{"date":347,"type":40},"2026-06-08",{"date":349,"type":40},"2026-03-24",{"date":351,"type":22},"2028-03-01",{"name":46,"class":47},{"id":354,"slug":355,"hasResults":12,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":360,"targetDuration":4,"studyType":23,"phases":362,"briefSummary":363,"conditions":364,"keywords":366,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":371,"completionDateStruct":373,"leadSponsor":375,"locationsCount":48},"100637897","efficacy-and-safety-of-qishen-yiqi-dropping-pills-in-patients-with-severe-pulmonary-hypertension-100637897","NCT07604805","Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension","Efficacy and Safety of Qishen Yiqi Dropping Pills in Patients With Severe Pulmonary Hypertension: A Prospective, Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Male or female participants aged between 18 and 75 years (inclusive) at the screening visit.\n\n  2\\. Diagnosed with pulmonary arterial hypertension (PAH) classified according to the \\*2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\\*, and belonging to one of the following subgroups:\n* Subgroup Ⅰ: Idiopathic pulmonary arterial hypertension (IPAH) under the category of arterial pulmonary hypertension\n* Subgroup Ⅱ: Pulmonary hypertension secondary to left heart disease (congenital heart disease) 3. World Health Organization (WHO) Functional Class III or IV symptoms at screening.\n\n  4\\. Meet all of the following hemodynamic criteria confirmed by right heart catheterization (RHC) at study screening: mean pulmonary arterial pressure (mPAP) ≥ 25 mmHg and pulmonary capillary wedge pressure (PCWP) ≤ 15 mmHg.\n\n  5\\. Able to walk a minimum of 100 meters and a maximum of 440 meters during the 6-Minute Walk Test (6MWT) at the screening visit; in addition, participants must demonstrate stable baseline 6MWT performance between the screening visit and the randomization visit.\n\n  6\\. Participants with pulmonary hypertension who are either treatment-naïve or currently receiving treatment: for participants who have received prior treatment (defined as having used PAH-targeted therapeutic agents within 4 weeks before screening), mPAP ≥ 25 mmHg and PCWP ≤ 15 mmHg must be confirmed at the randomization visit.\n\n  7\\. Able to understand study procedures, willing to comply with study restrictions, and willing and able to provide written informed consent prior to the initiation of all study-related procedures.\n\nExclusion Criteria:\n\n* 1\\. Meet any of the following criteria: 2. Diagnosed with Group 3 or Group 5 pulmonary hypertension (PH) according to the \\*2021 Chinese Guidelines for the Diagnosis and Treatment of Pulmonary Hypertension\\*.\n\n  3\\. Echocardiogram within 6 months before screening indicates left ventricular ejection fraction (LVEF) ≤ 40%, or clinically significant ischemic mitral or aortic valve disease, or constrictive heart disease as judged by the investigator.\n\n  4\\. Presence of 3 or more of the following risk factors for left ventricular dysfunction:\n* Body mass index (BMI) ≥ 30 kg\u002Fm² at screening visit\n* History of essential hypertension\n* Diabetes mellitus of any type\n* History of significant coronary artery disease (CAD) confirmed by any of the following:\n* History of myocardial infarction\n* History of percutaneous coronary intervention (PCI)\n* Angiographic evidence of ≥ 50% stenosis in at least one major coronary artery\n* Positive cardiac stress imaging test\n* History of coronary artery bypass graft surgery (CABG)\n* History of chronic stable angina or unstable angina 5. Uncontrolled systemic arterial hypertension: systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 110 mmHg at randomization visit (Day 1).\n\n  6\\. History of long QT syndrome or torsades de pointes ventricular tachycardia. 7. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 times the upper limit of normal (ULN) at screening visit.\n\n  8\\. Severe renal impairment: estimated glomerular filtration rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m² at screening calculated by the CKD-EPI formula.\n\n  9\\. Severe hepatic impairment (Child-Pugh Class C) at screening visit, with or without cirrhosis; patients receiving renal dialysis or with a history of renal transplantation.\n\n  10\\. Known coagulation defects, including: hereditary or acquired coagulation disorders (factor XII deficiency, factor XIII deficiency), reduced coagulation factor production due to acute or chronic liver disease, impaired coagulation efficiency caused by lupus anticoagulant, disseminated intravascular coagulation (DIC), or anticoagulant factor autoantibodies.\n\n  11\\. Evidence or history of major hemorrhage or intracranial hemorrhage. 12. History of increased intracranial pressure. 13. Pregnant or lactating women. 14. Any surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of any drug, including but not limited to: history of major gastrointestinal surgery deemed clinically significant by the investigator within 12 months before screening (e.g., gastrectomy, gastrointestinal stoma anastomosis, intestinal resection, gastric bypass surgery, gastroenterostomy, or gastric banding), current active inflammatory bowel disease, or history of active inflammatory bowel disease.\n\n  15\\. Any surgical or medical condition not specified in the protocol that, in the investigator's opinion, would expose the patient to higher risk due to study participation, or may prevent the patient from complying with study requirements or completing the trial period.\n\n  16\\. Patients who are unwilling or unable to safely discontinue current pulmonary arterial hypertension (PAH)-targeted medications during the study as required by the protocol.\n\n  17\\. History of any contraindication or hypersensitivity reaction to any study drug or drugs with similar chemical structures.\n\n  18\\. History of active substance abuse (including alcohol) within the past 1 year, or patients considered potentially unreliable by the investigator.\n\n  19\\. Personnel directly involved in the conduct of this clinical study.",{"count":361,"type":22},120,[25],"This study aims to compare the effectiveness and safety of two treatment approaches for patients with severe pulmonary hypertension: standard targeted drug therapy alone, and a combination of standard targeted drugs plus Qishen Yiqi Dropping Pills over 52 weeks of treatment.\n\nPulmonary hypertension is a chronic condition that raises blood pressure in the lung arteries, causing symptoms like shortness of breath, tiredness, and difficulty with physical activity. While targeted drug treatments are available, many patients still experience persistent symptoms and reduced quality of life. This study will enroll patients with severe pulmonary hypertension to see if adding Qishen Yiqi Dropping Pills to standard treatment can improve patient outcomes.\n\nParticipants will be randomly assigned to one of two groups: the combination treatment group will receive Qishen Yiqi Dropping Pills plus standard targeted drugs, and the control group will receive standard targeted drugs alone. All participants will be followed for 52 weeks, during which we will regularly assess:\n\n* Changes in daily quality of life\n* How far participants can walk in 6 minutes, and their level of breathlessness after the walk\n* Changes in heart function and related blood test indicators\n* Any side effects or discomfort during treatment The primary goal of this study is to see if the combination treatment can improve patients' exercise capacity and quality of life more effectively than standard treatment alone. We will also monitor the safety of adding Qishen Yiqi Dropping Pills to standard therapy. All study procedures follow ethical regulations, and participants can withdraw from the study at any time without affecting their regular medical care.",[365],"Idiopathic Pulmonary Hypertension",[367],"idiopathic pulmonary arterial hypertension","2026-05-18",{"date":370,"type":40},"2026-05-22",{"date":372,"type":40},"2023-10-25",{"date":374,"type":22},"2030-12-31",{"name":46,"class":47},{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":381,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":48},"100632509","weight-loss-via-intelligent-guidance-in-patients-with-coronary-heart-disease-and-obesity-a-randomized-clinical-trial-100632509","NCT07514611","Weight Loss Via Intelligent Guidance in Patients With Coronary Heart Disease and Obesity: a Randomized Clinical Trial","LIGHT-CHD","Inclusion Criteria:\n\n1. Age range: 18-65 years old .\n2. History of coronary heart disease confirmed by coronary angiography or coronary CTA, showing ≥50% stenosis in at least one major coronary artery (left main coronary artery, left anterior descending artery, left circumflex artery, right coronary artery); or a definite history of myocardial infarction, or prior coronary revascularization (PCI or CABG).\n3. BMI: Body Mass Index (BMI) ≥ 28 kg\u002Fm²\n4. Weight loss willingness: Has the intention to lose weight\n5. Smartphone proficiency: Able to use a smartphone.\n6. Daily living ability: Capable of performing basic activities of daily living independently.\n7. Informed consent: Voluntarily participates in the study, signs a written informed consent form, and is willing to cooperate with follow-up\n\nExclusion Criteria:\n\n1. Unstable angina pectoris or acute myocardial infarction occurring within the previous month;\n2. Comorbid endocrine or neurological diseases, cancer, or a history of bariatric surgery that affect body weight; or long-term use of medications that impact body weight;\n3. Comorbid diseases that affect exercise capacity, such as severe cardiopulmonary diseases or osteoarthritic conditions;\n4. Comorbid diseases that affect diet, such as severe mental disorders, bulimia or anorexia nervosa, or cognitive dysfunction;\n5. Significant liver or kidney dysfunction, defined as: glomerular filtration rate \\\u003C 60 ml\u002F(min·1.73m²) or undergoing dialysis; alanine transaminase (ALT) or aspartate transaminase (AST) ≥ 3 times the upper limit of the normal range specified by the research center;\n6. Severe language, psychological, or physical disabilities that prevent participation in the protocol;\n7. Pregnant or lactating women, or individuals of childbearing potential who are unwilling\u002Funable to use effective contraceptive measures;\n8. Participation in other interventional clinical trials;\n9. Body weight change exceeding 5% within the past year;\n10. Patients with a habit of long-term high-intensity exercise(more than 2 sessions per week of high-intensity endurance training, or more than 3 sessions per week of moderate-intensity endurance training);\n11. Patients deemed unsuitable for participation in the study by the researchers.",{"count":384,"type":22},140,[25],"Coronary Heart Disease (CHD) is an ischemic heart disease caused by coronary atherosclerosis, and it is the leading cause of death from cardiovascular diseases worldwide. Weight loss in obese patients can significantly improve metabolic indicators such as dyslipidemia and insulin resistance; therefore, weight loss may become a target for improving the prognosis of obese patients with coronary heart disease. This study is a multicenter, randomized controlled clinical trial aimed at evaluating the effect of software-based healthy weight loss guidance (personalized diet + exercise intervention) in obese patients with coronary heart disease. It is expected that 136 patients will be enrolled in hospitals including Guangdong Provincial People's Hospital, with a total study duration of 1 year.",[388,389],"CHD","Overweight or Obese",[388,391],"overweight or obese","2026-05-08",{"date":394,"type":40},"2026-05-12",{"date":396,"type":22},"2026-04-18",{"date":398,"type":22},"2028-12-31",{"name":46,"class":47},{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":48},"100633047","phase-2-short-course-radiotherapy-nal-iri-capecitabine-and-camrelizumab-for-locally-advanced-mss-rectal-cancer-100633047","NCT07521605","Short-Course Radiotherapy, Nal-IRI, Capecitabine, and Camrelizumab for Locally Advanced MSS Rectal Cancer","Short-Course Radiotherapy Followed by Liposomal Irinotecan, Capecitabine, and Camrelizumab as Neoadjuvant Therapy for Locally Advanced pMMR\u002FMSS Low Rectal Cancer: A Prospective Single-Arm Phase II Trial Protocol","Inclusion Criteria:\n\n1. Aged 18 to 75 years, male or female.\n2. Histologically confirmed diagnosis of rectal adenocarcinoma.\n3. Confirmed mismatch repair proficient (pMMR) or microsatellite stable (MSS) status by immunohistochemistry or PCR methods.\n4. Locally advanced disease assessed by pelvic MRI, classified as cT3-4aN0M0 or any T stage with node-positive (N+) disease, without distant metastasis (M0), according to the AJCC 8th edition staging system.\n5. The lower edge of the tumor is located within 10 cm from the anal verge (defined as low\u002Fmid rectal cancer).\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n7. Adequate bone marrow, hepatic, and renal function, defined as: Absolute Neutrophil Count (ANC) ≥ 1.5 x 10⁹\u002FL，Platelet count ≥ 100 x 10⁹\u002FL，Hemoglobin ≥ 90 g\u002FL，Total Bilirubin ≤ 1.5 times the Upper Limit of Normal (ULN)，Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 2.5 x ULN，Serum creatinine ≤ 1.5 x ULN or Creatinine Clearance ≥ 50 mL\u002Fmin (calculated by Cockcroft-Gault formula)\n8. Voluntarily participates in the study, signs the informed consent form, demonstrates good compliance, and is able to cooperate with follow-up procedures.\n\nExclusion Criteria:\n\n1. Evidence of distant metastasis (M1 disease) on baseline imaging.\n2. Previous radiotherapy to the pelvis, or any prior systemic chemotherapy, targeted therapy, or immunotherapy for colorectal cancer.\n3. History of other active malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, basal cell carcinoma of the skin, or other localized tumors considered cured by local treatment.\n4. Any of the following uncontrolled conditions or comorbidities:\n\n1）Severe active infection requiring systemic therapy. 2）Unstable angina, myocardial infarction, or congestive heart failure (NYHA Class II-IV) within the last 6 months.\n\n3）Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that would compromise the ability to provide informed consent or comply with study procedures.\n\n5\\. Known history of severe immunodeficiency or active autoimmune disease requiring systemic immunosuppressive therapy (e.g., corticosteroids at doses \\> 10mg\u002Fday prednisone equivalent) within the past 2 years.\n\n6\\. Known history of hypersensitivity to any component of the study drugs (Liposomal Irinotecan, Capecitabine, Camrelizumab) or history of severe hypersensitivity reactions to other monoclonal antibodies.\n\n7\\. Pregnant or lactating women, or subjects of childbearing potential who are unwilling to use highly effective contraception during the study period and for at least 6 months after the last dose of study treatment.\n\n8\\. Any other condition or circumstance that, in the opinion of the investigator, would compromise the patient's safety or adherence to the protocol (e.g., inability to swallow oral medications, active gastrointestinal bleeding, intestinal obstruction).",{"count":408,"type":22},44,[135],"This study is for adults with locally advanced rectal cancer that has not spread to distant organs, and is classified as pMMR or MSS (which means it typically does not respond well to immunotherapy alone). The purpose is to see if a new combination of treatments given before surgery (neoadjuvant therapy) can more effectively shrink the tumor and increase the chance of curing the cancer or avoiding surgical removal of the rectum.\n\nThe main things you will do in this study are:\n\n1. Receive a Short Course of Radiation Therapy (5 treatments over 1 week).\n2. After a 1-week break, receive a combination of three drugs:\n\n1）Nal-IRI (a special form of the chemotherapy drug Irinotecan, designed to have fewer side effects) 2）Capecitabine (a chemotherapy pill) 3）Camrelizumab (an immunotherapy drug) 3. This drug combination is given in 8 cycles, with each cycle lasting 3 weeks. 4. After finishing all cycles, the doctors will carefully check how the tumor responded.\n\nThe most important goal of this research is to see how many patients achieve a \"Complete Response,\" which means:\n\n1. No sign of cancer cells in the surgically removed tissue (Pathological Complete Response, pCR), or\n2. No sign of cancer can be found through clinical exams, scans, and scopes, allowing the patient to avoid immediate surgery under a \"Watch and Wait\" strategy (Clinical Complete Response, cCR).\n\nResearchers will also monitor:\n\n1. The safety of the treatment and its side effects.\n2. How well the cancer is controlled over time (e.g., 3-year survival without cancer recurrence).\n3. The rate of successful tumor removal and the rate of preserving the anus.",[412],"Rectal Cancer Patients",[414,415,416,417,418],"Locally advanced rectal cancer","pMMR\u002FMSS","Short-course radiotherapy","Liposomal irinotecan","Neoadjuvant immunochemoradiotherapy","2026-04-08",{"date":421,"type":40},"2026-04-13",{"date":423,"type":22},"2026-05-20",{"date":425,"type":22},"2034-12-31",{"name":46,"class":47},{"id":428,"slug":429,"hasResults":12,"nctId":430,"briefTitle":431,"officialTitle":432,"acronym":4,"eligibilityCriteria":433,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":434,"enrollmentInfo":435,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":437,"conditions":438,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":48},"100631836","scientific-validity-assessment-and-optimization-of-ai-generated-a3a4-type-questions-for-the-chinese-medical-licensing-examination-100631836","NCT07505862","Scientific Validity Assessment and Optimization of AI-Generated A3\u002FA4 Type Questions for the Chinese Medical Licensing Examination","Scientific Validity Assessment and Optimization of AI-Generated A3\u002FA4 Type Questions for the Chinese Medical Licensing Examination: An Empirical Analysis Based on the \"Answering-Generating\" Closed Loop and Transformation of Competency Assessment","Inclusion Criteria:\n\n* 1.Professional Status: Medical students currently enrolled in a Standardized Residency Training (SRT) program.\n\n  2.Educational Background: Holders of a Bachelor of Medicine degree or higher, with foundational clinical knowledge.\n\n  3.Informed Consent: Voluntarily participate in the study and provide written informed consent.\n\n  4.Technical Competency: Proficient in using digital platforms to complete assessments and scoring.\n\nExclusion Criteria:\n\n* 1.Conflict of Interest: Individuals involved in the AI model training, prompt engineering, or the creation of the human-authored question bank for this study.\n\n  2.Inability to Complete: Presence of visual\u002Fauditory impairments or severe illness that precludes completion of the assessment within the specified time.\n\n  3.Investigator's Discretion: Any other condition that, in the opinion of the investigator, renders the participant unsuitable for the study.","60 Years",{"count":436,"type":22},20,"This is a cross-sectional study that primarily employs quantitative analysis, supplemented by qualitative assessment. The research is conducted in two stages: Phase I consists of a model performance comparison experiment, and Phase II involves an item quality evaluation experiment. The entire study adheres to the principles of single-blinding, randomization, and standardization to ensure scientific rigor and reproducibility.\n\nThe single-blind design is implemented during the \"standardized testing\" phase, where the system intersperses AI-generated items with those authored by human experts. Participants remain blinded to the source of each item (AI-generated vs. human-authored) throughout the testing and scoring processes, thereby ensuring the objectivity of the evaluation results.",[439],"AI (Artificial Intelligence)","2026-03-29",{"date":294,"type":40},{"date":443,"type":40},"2025-10-01",{"date":445,"type":22},"2026-03-30",{"name":46,"class":47},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":434,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":456,"briefSummary":457,"conditions":458,"keywords":4,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":463,"completionDateStruct":465,"leadSponsor":467,"locationsCount":174},"100631821","yiyuancong-for-the-treatment-of-sudden-sensorineural-hearing-loss-100631821","NCT07505667","Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss","Yiyuancong for the Treatment of Sudden Sensorineural Hearing Loss: A Multicenter, Randomized, Controlled Trial","Inclusion Criteria:\n\n1. Unilateral sudden sensorineural hearing loss (SSNHL) occurring within 72 hours, with a hearing threshold decrease of 20 dB at at least two consecutive frequencies.\n2. Enrollment must be completed within 14 days of the onset of SSNHL.\n3. Males or females aged 18 to 60 years.\n4. Ability to understand the study protocol and comply with regular follow-up visits.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation (breastfeeding).\n2. History of chronic ear disease, prior ear surgery, autoimmune hearing loss, or a confirmed diagnosis of Meniere's disease.\n3. Receipt of corticosteroid therapy for any reason within the previous 30 days.\n4. Presence of autoimmune diseases or chronic inflammatory diseases.\n5. Severe hepatic or renal impairment.\n6. Any other condition that, in the opinion of the investigator, renders the participant unsuitable for inclusion.",{"count":455,"type":22},128,[25],"This project aims to evaluate the clinical efficacy of Yiyuancong, an independently developed traditional Chinese medicine (TCM) formula based on the homology of medicine and food, in participants with sudden sensorineural hearing loss (SSNHL) and to elucidate its potential underlying mechanisms. This study is designed as a multicenter, randomized controlled trial (RCT), utilizing dynamic randomization for participant allocation. Due to the requirement for the experimental group to continuously administer the TCM preparation for 1-2 months, this study is conducted as an open-label (non-blinded) trial. All participants will undergo audiological evaluations at baseline, day 7 of treatment, and upon completion of the first and second treatment courses.\n\nBased on previous research regarding integrated traditional Chinese and Western medicine for SSNHL, the estimated effect size (ES) for the improvement of pure-tone thresholds compared with Western medicine alone ranges from 0.5 to 0.8. Assuming an effect size of 0.5 for the difference in pure-tone audiometry (PTA) improvement between the experimental and control groups, with a significance level (α) of 0.05 (one-tailed) and a statistical power (1-β) of 0.8, the required sample size calculated via G\\*Power software is 51 per group. Accounting for a 20% dropout rate, the investigators plan to enroll 64 participants per group (total N = 128).",[459,460],"Sudden Hearing Loss","Sensorineural Hearing Loss","2026-03-26",{"date":294,"type":40},{"date":464,"type":40},"2025-11-15",{"date":466,"type":22},"2027-11-15",{"name":46,"class":47},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":18,"enrollmentInfo":476,"targetDuration":478,"studyType":61,"phases":4,"briefSummary":479,"conditions":480,"keywords":482,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":48},"100631061","insights-into-pediatric-pulmonary-hypertension-a-real-world-registry-of-epidemiology-and-outcomes-100631061","NCT07495774","Insights Into Pediatric Pulmonary Hypertension: A Real-World Registry of Epidemiology and Outcomes","Insights Into Epidemiology, Management, and Outcomes of Pediatric Pulmonary Hypertension: The INSPIRE-PH Multicenter Real-World Registry","INSPIRE-PPH","Inclusion Criteria:\n\n* Children and adolescents aged \\\u003C18 years at diagnosis\n* Diagnosed pulmonary hypertension (PH) according to the prevailing diagnostic criteria at the time of enrollment\n* Enrollment in the registry at participating centers\n* Provision of informed consent by patients and\u002For legal guardians\n* Availability for longitudinal follow-up\n\nExclusion Criteria:\n\n* Inability to confirm PH diagnosis due to insufficient clinical or hemodynamic data\n* Refusal or inability to provide informed consent",{"count":477,"type":22},450,"10 Years","Pediatric pulmonary hypertension (PH) shares similarities with PH in adulthood, but specific differences still require unique approaches. Despite major advances, risk scores for pediatric PH still need to be validated, and targeted drug therapies in pediatric populations remain under-studied. Consequently, there is a great need for comprehensive real-world longitudinal data of pediatric PH.\n\nThe INSPIRE-PH registry is a multicenter, observational, real-world registry designed to systematically collect longitudinal clinical data on children and adolescents with PH. Patients enrolled in the registry receive standard clinical care determined by their treating physicians. No study-mandated interventions are imposed. Longitudinal observation of this cohort aims to provide important insights into disease progression, treatment effectiveness, and long-term prognosis in pediatric PH.\n\nThe cohort was initially established prospectively in 2006, with all cases reclassified according to the 7th World Symposium for Pulmonary Hypertension (WSPH) criteria in 2024, and new patients continue to be prospectively enrolled. The registry is supervised by the principal investigator, independently from the financial sponsors.",[481],"Pulmonary Hypertension",[483,484,485,486,487],"pediatric","pulmonary hypertension","real-world","epidemiology","outcome",{"date":489,"type":40},"2026-03-27",{"date":491,"type":40},"2006-01-04",{"date":493,"type":22},"2035-12-31",{"name":46,"class":47},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":501,"targetDuration":4,"studyType":23,"phases":503,"briefSummary":504,"conditions":505,"keywords":507,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":511,"lastUpdatePostDateStruct":512,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":48},"100630333","phase-2-evaluation-of-pressurized-intraperitoneal-aerosol-chemotherapy-with-vrt106-versus-pipac-in-patients-with-advanced-gastric-cancer-and-peritonealmetastasis-a-prospective-multicenter-open-label-randomized-controlled-trial-100630333","NCT07486310","Evaluation of Pressurized Intraperitoneal Aerosol Chemotherapy With VRT106 Versus PIPAC in Patients With Advanced Gastric Cancer and PeritonealMetastasis: A Prospective, Multicenter, Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 75 years, inclusive, regardless of gender.\n2. Histologically or pathologically confirmed gastric adenocarcinoma with peritoneal metastasis (confirmed by imaging findings, previous surgical pathology, or positive cytology from ascites\u002Fperitoneal fluid), and assessed by the investigator as having unresectable peritoneal lesions with a PCI score \\> 6.\n3. Subjects with no contraindications for laparoscopic surgery.\n4. ECOG performance status ≤ 1.\n5. Expected survival time ≥ 6 months.\n6. No blood transfusion or treatment with hematopoietic stimulating factors within 14 days before screening, and meeting the following criteria:\n\n   * Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 100 × 10⁹\u002FL, hemoglobin (Hb) ≥ 90 g\u002FL.\n   * Blood biochemistry: Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) (≤ 3.0 × ULN for subjects with Gilbert syndrome); alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) ≤ 3.0 × ULN; albumin ≥ 2.8 g\u002FdL; creatinine ≤ 1.5 × ULN; or creatinine clearance (Ccr) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula, only required if creatinine \\> 1.5 × ULN).\n   * Coagulation function: Activated partial thromboplastin time (APTT), international normalized ratio (INR), or prothrombin time (PT) ≤ 1.5 × ULN.\n7. Female subjects of childbearing potential or male subjects with partners of childbearing potential must use effective contraception throughout the treatment period and for 3 months after the last dose.\n8. Voluntary participation in the clinical study, with full understanding and signed informed consent form (ICF); willingness and ability to comply with all trial procedures.\n\nExclusion Criteria:\n\n* 1\\. Subjects with gastrointestinal obstruction; 2. Subjects completely dependent on parenteral nutrition; 3. Subjects with decompensated ascites; 4. Subjects with severe abdominal infection (manifesting as peritonitis); 5. Subjects with extensive abdominal adhesions; 6. Subjects undergoing simultaneous cytoreductive surgery and gastrointestinal resection and reconstruction; 7. Subjects with concurrent portal vein thrombosis; 8. Known allergy to any component of the VRT106 formulation (mannitol, human albumin, trehalose, etc.) or to chemotherapy drugs; 9. Use of live attenuated vaccines within 4 weeks prior to the first dose of the study drug, including but not limited to: measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, BCG, and typhoid vaccines. Seasonal influenza vaccines for injection are inactivated virus vaccines and are allowed; intranasal influenza vaccines are live attenuated and are not allowed; 10. Use of systemic glucocorticoids (prednisone \\> 10 mg\u002Fday or equivalent dose of similar drugs) or other immunosuppressive therapy within 1 week prior to the first dose of the study drug, except for the following:\n* Use of topical, ocular, intra-articular, intranasal, and inhaled corticosteroids;\n* Use of corticosteroids for prophylactic treatment (e.g., prevention of contrast agent allergy); 11. Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to the first dose of the study drug; 12. Subjects with active autoimmune disease or a history of autoimmune disease that may recur. However, subjects with the following diseases are not excluded and may be further screened: a. Type 1 diabetes; b. Hypothyroidism (if controlled by hormone replacement therapy alone); c. Controlled celiac disease; d. Skin diseases not requiring systemic treatment (e.g., vitiligo, psoriasis, alopecia); e. Any other disease not expected to recur in the absence of an external trigger; 13. History of splenectomy; 14. Adverse reactions from prior anti-tumor therapy have not recovered to ≤ Grade 1 per NCI-CTCAE v5.0 (excluding alopecia, chemotherapy-induced Grade 2 neurotoxicity, and other toxicities deemed by the investigator to pose no safety risk); 15. History of severe cardiovascular disease, including but not limited to:\n* Severe cardiac rhythm or conduction abnormalities, such as ventricular arrhythmias requiring clinical intervention, second- or third-degree atrioventricular block, QT interval corrected using Fridericia's formula (QTcF) ≥ 480 ms, etc.;\n* Occurrence of acute coronary syndrome, acute myocardial infarction, congestive heart failure, stroke, or other Grade 3 or higher cardiovascular events within 6 months prior to the first dose of the study drug;\n* New York Heart Association (NYHA) functional class ≥ II, or left ventricular ejection fraction (LVEF) \\\u003C 50%;\n* Poorly controlled hypertension per investigator judgment (hypertension not controlled despite standard treatment: systolic blood pressure ≥ 160 mmHg and\u002For diastolic blood pressure ≥ 100 mmHg); 16. Uncontrolled active infection requiring systemic therapy; 17. Presence of other invasive malignancies besides the study disease. Exceptions include: cured basal cell or squamous cell carcinoma of the skin, carcinoma in situ (e.g., breast cancer, cervical carcinoma in situ), superficial bladder cancer, or malignancies with no recurrence and no treatment for the past 2 years; 18. Pregnant or breastfeeding women; 19. Subjects deemed by the investigator to have other serious systemic diseases or other reasons making them unsuitable for participation in this clinical trial; 20. Subjects who have received other unmarketed investigational drugs\u002Fdevice therapies within 4 weeks prior to the first dose of the study drug; 21. Concurrent enrollment in another clinical study, except for observational (non-interventional) clinical studies or the follow-up phase of an interventional study (must be judged by the investigator as not impacting the efficacy and safety evaluation of this study).",{"count":502,"type":22},30,[135],"This study is a prospective, multicenter, open-label, randomized controlled clinical trial, planned to enroll 30 patients with advanced gastric cancer and peritoneal metastasis. It aims to evaluate the safety and efficacy of systemic therapy plus Pressurized Intra-Peritoneal Aerosol Virus (PIPAV) with VRT106 compared to systemic therapy plus Pressurized Intra-Peritoneal Aerosol Chemotherapy (PIPAC).",[506],"Advanced Gastric Cancer",[508,509,510],"Pressurized Intra-Peritoneal Aerosol","VRT106","advanced gastric cancer with peritoneal metastasis","2026-03-17",{"date":513,"type":40},"2026-03-20",{"date":515,"type":22},"2026-03-01",{"date":517,"type":22},"2029-06-01",{"name":46,"class":47},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":57,"enrollmentInfo":527,"targetDuration":4,"studyType":23,"phases":529,"briefSummary":530,"conditions":531,"keywords":534,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":4},"100629269","phase-2-phase-ii-neoadjuvant-study-of-garsorasib-followed-by-ivonescimab-plus-chemotherapy-in-resectable-stage-iia-iiib-kras-g12c-mutant-nsclc-given-study-100629269","NCT07472478","Phase II Neoadjuvant Study of Garsorasib Followed by Ivonescimab Plus Chemotherapy in Resectable Stage IIA-IIIB KRAS G12C-Mutant NSCLC (GIVEN Study)","An Exploratory Phase II Clinical Study Protocol of Perioperative Treatment With Glesorasib Sequentially Combined With Ivonescimab and Chemotherapy for Resectable, Stage IB-IIIB, KRAS G12C-Mutant NSCLC","GIVEN","Inclusion Criteria:\n\n1. Age Range: Males or females aged 18 years or older.\n2. Diagnosis and Stage: Patients with histologically or cytologically confirmed resectable IB-IIIB NSCLC, staged according to the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology, 9th Edition.\n3. Informed Consent: Patients must voluntarily participate in the study, provide written informed consent, and be willing to comply with follow-up procedures.\n4. Prior Therapy: No prior systemic therapy for locally advanced or metastatic NSCLC (including adjuvant chemo\u002Fradiotherapy, neoadjuvant chemo\u002Fradiotherapy, definitive chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, or anti-angiogenic therapy for locally advanced disease).\n5. Mutation Status: KRAS G12C mutation positivity must be confirmed by next-generation sequencing (NGS) or polymerase chain reaction (PCR) testing.\n6. Measurable Disease: At least one measurable target lesion as per RECIST v1.1. Lesions previously treated with radiotherapy or other local-regional therapies cannot be considered target lesions unless clear progression has been documented post-radiotherapy. At baseline, the lesion must be ≥10mm in the longest diameter (≥15mm in short axis for lymph nodes) on CT or MRI and be suitable for accurate repeated measurement per RECIST v1.1.\n7. Performance Status: Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.\n8. Adequate Organ Function: Must meet the following criteria within 14 days prior to relevant tests, without transfusion or use of hematopoietic growth factors:\n\n   1. Platelets (PLT) ≥90 × 10\\^9\u002FL\n   2. Hemoglobin (HGB) ≥90 g\u002FL\n   3. Absolute Neutrophil Count (ANC) ≥1.5 × 10\\^9\u002FL\n   4. Serum creatinine ≤1.5 × ULN or Creatinine Clearance (CrCl) ≥50 mL\u002Fmin (calculated using the Cockcroft-Gault formula)\n   5. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤2.5 × ULN (≤5 × ULN if liver metastases are present)\n   6. Total Bilirubin (TBIL) ≤1.5 × ULN (≤3 × ULN for patients with Gilbert's syndrome)\n   7. International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 × ULN, and Activated Partial Thromboplastin Time (APTT) ≤1.5 × ULN, or patients assessed by the investigator as having controlled bleeding tendency.\n   8. Urinalysis showing urine protein \\\u003C2+ or 24-hour urinary protein quantification \\\u003C1g.\n9. Life Expectancy: Expected survival time ≥3 months.\n10. Contraception: Fertile female subjects must agree to use effective contraception (e.g., IUD, oral contraceptives, condoms) during the study and for 6 months after study completion; have a negative serum pregnancy test within 7 days before enrollment; and must not be breastfeeding. Male subjects must agree to use effective contraception during the study and for 6 months after study completion.\n\nExclusion Criteria:\n\n1. Prior Anti-Tumor Therapy:\n\n   1. Previous receipt of any anti-tumor therapy for lung cancer (including adjuvant chemoradiotherapy, neoadjuvant chemoradiotherapy, chemotherapy, radiotherapy, immune checkpoint inhibitors, targeted therapy, anti-angiogenic therapy, etc.).\n   2. Treatment with any other investigational drug within 28 days prior to the first dose in this study.\n   3. Treatment within 2 weeks prior to the first dose with NMPA-approved Chinese patent medicines explicitly indicated for anti-tumor purposes in their drug说明书 (e.g., Compound Banmao Capsules, Kang'ai Injection, Kanglaite Capsules\u002FInjection, Aidi Injection, Yadanzi Oil Injection\u002FCapsules, Xiaoaiping Tablets\u002FInjection, Huachansu Capsules, etc.).\n2. Recent Surgery: Any surgery within 4 weeks prior to screening examinations.\n3. Concurrent Primary Malignancy: Patients with a concurrent primary malignancy (except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, etc.).\n4. Abnormal Organ Function: Meeting any of the following at screening:\n\n   1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 1.5 times the upper limit of normal (ULN).\n   2. Creatinine clearance rate (CrCl) \\> ULN.\n5. Hematological Abnormalities: Total white blood cell (WBC) count \\> 10.0 × 10\\^9\u002FL or \\\u003C 1.0 × 10\\^9\u002FL at screening.\n6. Significant Comorbidities: History of immunodeficiency diseases (e.g., HIV), other active cancers or malignancy history, autoimmune diseases, severe cardiovascular or cerebrovascular diseases, or any other diseases that may significantly reduce life expectancy.\n7. Conditions Affecting Compliance: Any history of conditions that may affect protocol compliance (e.g., severe psychiatric disorders, cognitive dysfunction, drug abuse or addiction).\n8. Pregnancy, Lactation, and Contraception: Pregnant or lactating women, or subjects of childbearing potential unwilling or unable to use effective contraception.\n9. Allergy: Known allergy to any component of the study drug(s).\n10. Recent Trial Participation: Participation in any drug clinical trial within 6 months prior to screening.\n11. Investigator's Discretion: Any condition considered by the investigator as unsuitable for study participation.\n12. Other Driver Mutations: Non-small cell lung cancer with other standard-therapy-eligible driver gene mutations (e.g., EGFR, ALK, BRAF V600E, HER-2, MET Exon 14, ROS1, RET, or NTRK1\u002F2\u002F3).\n13. Central Nervous System (CNS) Metastases:\n\n    1. Symptomatic or progressive CNS metastases or carcinomatous meningitis.\n    2. Subjects with a history of brain metastases may be considered if they are clinically stable: no neurological symptoms, no corticosteroid treatment required, no indication for radiotherapy, and the largest diameter of the largest metastatic lesion on recent imaging is ≤ 1.5 cm.\n    3. Asymptomatic CNS metastases newly discovered during screening are allowed.\n    4. Subjects with a history of asymptomatic CNS metastases require confirmation of no progression via imaging scans performed at least 2 weeks apart.\n    5. Subjects with symptomatic CNS metastases may be considered if clinically stable after radiotherapy and\u002For surgery.\n    6. Subjects who underwent surgery for CNS metastases must have an interval of at least 4 weeks before the first study dose.\n    7. Asymptomatic subjects after CNS radiotherapy must have discontinued corticosteroids for at least 2 weeks prior to the first dose.\n14. Cardiovascular Disease: Any of the following:\n\n    1. Congestive heart failure of New York Heart Association Class II or above.\n    2. Severe arrhythmia requiring medication.\n    3. Acute myocardial infarction, severe or unstable angina, coronary or peripheral artery bypass graft within 6 months prior to enrollment.\n    4. Left ventricular ejection fraction (LVEF) \\\u003C 50%.\n    5. Prolonged QTcF interval ( \\> 470 ms for females, \\> 450 ms for males) or risk factors for Torsades de Pointes.\n    6. Uncontrolled hypertension (systolic BP ≥ 150 mmHg and\u002For diastolic BP ≥ 100 mmHg after antihypertensive therapy).\n15. Thromboembolic Events: Arterial\u002Fvenous thrombotic events within 6 months, hypertensive crisis, or hypertensive encephalopathy.\n16. History of Epilepsy: Previous history of epilepsy.\n17. Superior Vena Cava Syndrome: Presence of superior vena cava syndrome.\n18. Pulmonary Disease: Active non-infectious interstitial lung disease, radiation pneumonitis, etc., active tuberculosis, pneumoconiosis, ≥ Grade 2 other pneumonias, or severely impaired pulmonary function at screening.\n19. Severe Bone Lesions: Existing or potential severe bone damage from metastases, or uncontrolled bone pain.\n20. Active Infection: Active or uncontrolled severe infection, or unexplained fever \\> 38.5°C.\n21. Third-Space Fluid: Poorly controlled or drainage-requiring pleural effusion, ascites, or pericardial effusion. Subjects stabilized after treatment may be enrolled.\n22. Tumor Invading Major Vessels: Imaging shows tumor invading or with unclear boundaries to major blood vessels.\n23. Bleeding Risk: Evidence or history of bleeding tendency within 2 months before the first dose; history of hemoptysis, or unhealed wounds\u002Fulcers\u002Ffractures within 2 weeks before the first dose.\n24. Gastrointestinal Diseases: Known GI impairment or diseases significantly affecting drug absorption\u002Fmetabolism, or major GI surgery affecting absorption.\n25. Recent Live Vaccination: Administration of a live attenuated vaccine within 4 weeks before the first dose.\n26. Severe Hypersensitivity to mAbs: History of severe hypersensitivity reaction to other monoclonal antibodies.\n27. Autoimmune Disease: Active autoimmune disease requiring systemic treatment within 2 years before the first dose.\n28. Immunosuppressive Therapy: Receiving systemic corticosteroids or other immunosuppressive therapy.\n29. Viral Infections: Positive HIV antibody, or active viral hepatitis.\n\n    1. Active Hepatitis B or active Hepatitis C.\n    2. Carriers require antiviral therapy and monitoring during the study.\n30. Active Syphilis.\n31. Renal Failure: Requiring hemodialysis or peritoneal dialysis.\n32. Poorly Controlled Diabetes: Fasting blood glucose \\> 10 mmol\u002FL.\n33. Organ Transplant: History of or planned organ transplantation.\n34. Recent Major Surgery\u002FTrauma: Major surgery or significant trauma within 4 weeks before the first dose.\n35. Recent Radiotherapy: Palliative radiotherapy within 2 weeks before the first dose.\n36. Residual Toxicity from Prior Therapy: Toxicities from previous anti-cancer therapy not recovered to Grade ≤1.\n37. Other: Any other clinically significant abnormality or disease deemed by the investigator to pose risk or interfere with the study.",{"count":528,"type":22},32,[135],"This study is a multicenter, prospective, open-label clinical trial. It enrolls previously untreated patients with resectable stage IB-IIIB KRAS G12C mutation-positive NSCLC to evaluate the efficacy and safety of glesorasib sequentially combined with ivonescimab and chemotherapy as perioperative treatment for this patient population.",[532,533],"Lung Cancer (NSCLC)","KRAS G12C Lung Cancer",[535,536,537],"lung cancer","KRAS","KRAS G12C","2026-03-13",{"date":540,"type":40},"2026-03-16",{"date":542,"type":22},"2026-03-15",{"date":544,"type":22},"2028-03-31",{"name":46,"class":47},{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":551,"acronym":4,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":279,"minAge":18,"maxAge":131,"enrollmentInfo":553,"targetDuration":4,"studyType":23,"phases":554,"briefSummary":555,"conditions":556,"keywords":560,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":48},"100624479","phase-2-efficacy-and-safety-of-hyperbaric-oxygen-therapy-in-improving-nab-paclitaxel-induced-peripheral-neuropathy-100624479","NCT07410169","Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy","Efficacy and Safety of Hyperbaric Oxygen Therapy in Improving Nab-paclitaxel-Induced Peripheral Neuropathy: A Randomized Clinical Trial","Inclusion Criteria:\n\n1. aged ≥ 18 years and ≤ 75 years, female\n2. early-stage breast cancer or locally advanced breast cancer\n3. Patients who have completed adjuvant or neoadjuvant chemotherapy with nab-paclitaxel\n4. The patient developed nab-paclitaxel induced peripheral neuropathy (Nab-PIPN), as defined by meeting any of the following criteria: Patient Neurotoxicity Questionnaire (PNQ) score ≥ Grade B, NCI-CTCAE (sensory and motor neuropathy) grade ≥ 1, or neuropathic pain score ≥ 4\u002F10.\n5. The patient voluntarily participated in this study, provided written informed consent, and agreed to cooperate with follow-up assessments.\n\nExclusion Criteria:\n\n1. Patients who have previously taken drugs that may affect the evaluation of Nab-PIPN symptoms, such as duloxetine, venlafaxine, gabapentin, pregabalin, and amitriptyline.\n2. Patients with any other pathological conditions or diseases that could affect Nab-PIPN assessment, including alcoholic peripheral neuropathy, uremic peripheral neuropathy, diabetic peripheral neuropathy, thiamine deficiency-related peripheral neuropathy, and chronic axonal peripheral neuropathy of unknown etiology.\n3. Patients who have contraindications for hyperbaric oxygen therapy, including pulmonary disorders (severe chronic obstructive pulmonary disease, bullous lung disease, acute or chronic pulmonary infection, uncontrolled asthma, untreated pneumothorax), history of previous middle ear surgery, middle ear diseases (eustachian tube dysfunction, recurrent vertigo), and ocular conditions (retinal detachment).\n4. Patients with any disease history that may affect compliance, including severe mental disorders, cognitive impairment, substance abuse or addiction.\n5. Karnofsky Performance Status score \\\u003C 80\n6. Patients with any other conditions that the investigator deems unsuitable for participation in the study.",{"count":184,"type":22},[135,88],"The goal of this research is to assess whether hyperbaric oxygen therapy can alleviate the symptoms of Nab-paclitaxel-induced peripheral neuropathy and improve patient-reported quality of life.",[557,558,559],"Breast Cancer","CIPN - Chemotherapy-Induced Peripheral Neuropathy","Paclitaxel-induced Peripheral Neuropathy",[557,561,562],"paclitaxel-Induced Peripheral Neuropathy","Hyperbaric Oxygen Therapy","2026-02-07",{"date":565,"type":40},"2026-02-13",{"date":567,"type":22},"2026-01-31",{"date":247,"type":22},{"name":46,"class":47},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":577,"targetDuration":4,"studyType":23,"phases":579,"briefSummary":580,"conditions":581,"keywords":583,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":586,"startDateStruct":588,"completionDateStruct":590,"leadSponsor":591,"locationsCount":21},"100603459","a-study-of-pegmolesatide-of-in-dialysis-chronic-kidney-disease-ckd-patients-with-anemia-treated-with-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitor-hif-phi-100603459","NCT07136792","A Study of Pegmolesatide of in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI)","Efficacy and Safety of Pegmolesatide in Dialysis Chronic Kidney Disease (CKD) Patients With Anemia Treated With Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitor (HIF-PHI): a Multi-center, Prospective, Open-label, Randomized Parallel Controlled Trial","Inclusion Criteria:\n\n1. Age between 18-75 years, regardless of gender;\n2. Body weight ≥ 45 kg, and body mass index (BMI) ≥ 18.5 kg\u002Fm²;\n3. Diagnosis of chronic renal failure, and having undergone a stable regimen of peritoneal dialysis or hemodialysis for at least 12 weeks prior to enrollment (with stable hemofiltration at a frequency of every 2 or 4 weeks if applicable). Stable dialysis frequency and no plans to change the dialysis modality during the trial;\n4. An up to standard dialysis adequacy testing result before randomization: spKt\u002FV ≥ 1.2 for hemodialysis, Kt\u002FV ≥ 1.7 for peritoneal dialysis;\n5. Roxadustat dose ≤ 360 mg\u002Fweek within 4 weeks before randomization, with stable dose; \\[Stable dose is defined as: (the maximum weekly dose within 4 weeks before randomization - the average weekly dose within 4 weeks before randomization) ÷ the maximum weekly dose within 4 weeks before randomization ≤ 30%\\];\n6. Two pre-dialysis HB test values within 4 weeks before randomization of 8.0 - 12.0 g\u002Fdl, with an absolute difference between the two Hb values ≤ 1.3 g\u002Fdl, and an interval of ≥ 7 days between the two HB tests;\n7. Serum ferritin level ≥ 100 μg\u002FL and transferrin saturation (TAST) ≥ 20% at the time of testing before randomization, serum folate ≥ the lower limit of normal, and vitamin B12 ≥ the lower limit of normal;\n8. Understanding of the study procedures and voluntary signing of the written informed consent form.\n\nExclusion Criteria:\n\n1. Known autoimmune diseases, hematologic disorders (including congenital and acquired conditions such as thalassemia, Fanconi anemia, pure red cell aplasia, myelodysplastic syndrome, hemolytic anemia, and coagulation disorders), or other causes of anemia apart from CKD (such as gastrointestinal bleeding or hookworm disease).\n2. Confirmed diagnosis of acquired immunodeficiency syndrome (AIDS), syphilis, or tuberculosis and currently undergoing treatment.\n3. Known allergy to iron agents or polyethylene glycol molecules.\n4. Treatment history with ESAs in combination with HIF-PHIs drugs within 8 weeks prior to randomization.\n5. Underwent red blood cell or whole blood transfusion within 12 weeks prior to randomization.\n6. Poorly controlled blood pressure (uncontrolled hypertension is defined as: during the screening period, systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg in two or more blood pressure measurements, or although the blood pressure values are below the aforementioned criteria, the investigator deems it necessary to adjust antihypertensive medications).\n7. Active hepatitis or any of the following abnormal test results during the screening period (ALT ≥ 2 times the upper limit of normal, AST ≥ 2 times the upper limit of normal, DBIL ≥ 2 times the upper limit of normal, serum albumin \\\u003C 2.5 g\u002Fdl).\n8. Participants judged by the investigator to have uncontrolled or symptomatic secondary hyperparathyroidism, or those with blood iPTH \\> 800 pg\u002FmL during the screening period.\n9. C-reactive protein ≥ 30 mg\u002FL during the screening period.\n10. Cardiac function assessed as NYHA Class III or IV during the screening period.\n11. Pregnant or breastfeeding women, or those planning to become pregnant during the study period.\n12. Participants who plan to undergo kidney transplantation during the trial period or have already been kidney donors, or those who plan to undergo elective surgery during the trial period.\n13. Participants deemed by the investigator to have any other factors that make them unsuitable for participation in this trial.",{"count":578,"type":22},96,[25],"For patients with renal anemia treated with hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), there is a clinical need of switching to long-acting and safe medications.\n\nPegmolesatide, a polyethylene glycol (PEG)-conjugated erythropoiesis-stimulating peptide, is a long-acting erythropoiesis-stimulating agent (ESA) with sustained activity. It was approved for marketing by the National Medical Products Administration (NMPA) in June 2023. Phase III clinical trials have demonstrated its efficacy and safety in dialysis patients with renal anemia who were previously treated with recombinant human erythropoietin (rHuEPO). However, there are currently no data regarding the efficacy and safety of switching from HIF-PHIs to pegmolesatide, and there is a lack of standard for the dose conversion.\n\nThis study is a multi-center, prospective, open-label, randomized parallel-controlled clinical trial, planning to enroll 96 patients.\n\nAll enrolled patients will receive 12 weeks of treatment and be followed up for 16 weeks.",[582],"Renal Anemia of Chronic Kidney Disease",[584],"Renal Anemia","2026-01-13",{"date":587,"type":40},"2026-01-15",{"date":589,"type":40},"2025-09-08",{"date":270,"type":22},{"name":46,"class":47},{"id":593,"slug":594,"hasResults":12,"nctId":595,"briefTitle":596,"officialTitle":596,"acronym":4,"eligibilityCriteria":597,"healthyVolunteers":56,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":598,"targetDuration":4,"studyType":61,"phases":4,"briefSummary":600,"conditions":601,"keywords":603,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":585,"lastUpdatePostDateStruct":604,"startDateStruct":605,"completionDateStruct":607,"leadSponsor":609,"locationsCount":610},"100453772","a-real-world-multi-centric-observational-registry-study-of-chronic-kidney-diseases-100453772","NCT05188885","A Real World, Multi-centric, Observational Registry Study of Chronic Kidney Diseases","Inclusion Criteria:\n\n* Patients diagnosed with CKD as defined in the KDIGO Clinical Practice Guidelines for the Evaluation and Management of Chronic Kidney Disease 2012 Edition;\n* Non-CKD patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, eGFR (CKD-EPI formula) of 60-89 ml\u002Fmin\u002F1.73m\\^2 and other risk factors for CKD;\n* Healthy population.\n* Signed the informed consent voluntarily.\n\nExclusion Criteria:\n\n。Patients identified to be unsuitable for enrollment by the study physician.",{"count":599,"type":22},90000,"Chronic kidney disease (CKD) refers to a variety of different diseases characterized by impairment of kidney structure and\u002For renal function. The prevalence of CKD in China is as high as 10.8%. With a population of more than 150 million, China has the largest number of CKD patients all over the world. People with CKD would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-CKD population. It has created a heavy burden on people's health and national economy. There is an urgent need to establish an effective system for CKD prevention and control in China. Evidences from large sample cohort and real world based research are still rare. This study will provide good experience for reducing the occurrence and development of CKD.",[602],"Chronic Kidney Disease",[602],{"date":587,"type":40},{"date":606,"type":40},"2021-12-27",{"date":608,"type":22},"2028-12-27",{"name":46,"class":47},8,{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":131,"enrollmentInfo":619,"targetDuration":4,"studyType":23,"phases":621,"briefSummary":622,"conditions":623,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":4},"100612841","the-effectiveness-of-continuous-compression-synchronous-ventilation-bio-cpr-100612841","NCT07258823","the Effectiveness of Continuous Compression-synchronous Ventilation (Bio-CPR)","Study on the Effectiveness of Continuous Compression-synchronous Ventilation (Bio-CPR) in the ACLS Stage of Cardiopulmonary Resuscitation (ACLS) Based on the Bionic Concept to Explore the Best Mechanical Ventilation Strategy","Bio-CPR","Inclusion Criteria:\n\n1. 18-65 years old; 2. Cardiac arrest with witnesses; 3. Onset - compression start time\\\u003C5 minutes; 4. Initial ventricular fibrillation rhythm; 5. Endotracheal intubation and use of a mechanical chest CPR device; Patients with OHCA who meet the above conditions\n\nExclusion Criteria:\n\n* 1\\. OHCA patients who are not suitable for mechanical compression ventilation; 2. The participant or his\u002Fher legally authorized representative (LAR) is unable or unwilling to provide written informed consent.",{"count":620,"type":22},408,[25],"Bio-CPR is an innovative new mechanical resuscitation model proposed by our research group. A multi-center RCT study was established to comprehensively evaluate the efficacy of this model and the current standard CPR protocol, verify its safety and efficacy, and provide high-quality clinical evidence support.",[624,625,626,627],"Out-of-hospital Cardiac Arrest (OHCA)","Cardiac Arrest (CA)","CPR","ACLS","2025-11-21",{"date":630,"type":40},"2025-12-02",{"date":632,"type":22},"2026-02-01",{"date":634,"type":22},"2027-08-31",{"name":46,"class":47},""]