[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xiao Hui Zhang\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":96},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,66],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":27,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100642410","hbv-reactivation-prediction-model-in-allo-hsct-100642410",false,"NCT07644026","HBV Reactivation Prediction Model in Allo-HSCT","Development and External Validation of a Nomogram for Predicting Hepatitis B Virus Reactivation in HBsAg-Negative\u002FAnti-HBc-Positive Patients Undergoing Allogeneic Haematopoietic Stem Cell Transplantation: A Multicentre Prospective Study","HBV-post HSCT","Inclusion Criteria:\n\n* Patients must meet all of the following criteria to be enrolled in the study:\n\nPlanned allogeneic HSCT: Scheduled to undergo first allogeneic hematopoietic stem cell transplantation (allo-HSCT) for any hematologic malignancy or non-malignant hematologic disorder. Any donor type is permitted.\n\nResolved HBV infection: Documentation of both of the following serological markers on a blood sample collected within 30 days prior to the start of conditioning:\n\nHepatitis B surface antigen (HBsAg): negative Antibody to hepatitis B core antigen (anti-HBc): positive Note: Patients may be either positive or negative for anti-HBs at baseline. Willingness to follow protocol-defined monitoring: Patients (or legally authorized representatives) must agree to adhere to the study-specific HBV monitoring schedule as outlined in the protocol.\n\nInformed consent: Written informed consent obtained from the patient or a legally authorized representative prior to any study-related procedures.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the study:\n\nCo-infection with other hepatotropic viruses:\n\nPositive serology for hepatitis C virus (HCV) (anti-HCV antibody positive with detectable HCV RNA) Positive serology for hepatitis D virus (HDV) (anti-HDV antibody positive) Positive serology for human immunodeficiency virus (HIV)\n\nPre-existing advanced liver disease:\n\nClinical or histological evidence of liver cirrhosis (METAVIR stage F4, or imaging showing nodular liver surface\u002Fsplenomegaly\u002Fvarices) History of hepatic encephalopathy or variceal bleeding History of hepatocellular carcinoma (HCC) Prior solid organ transplantation (including kidney, liver, heart, or lung transplantation).\n\nPrevious allogeneic HSCT (patients receiving a second or subsequent allo-HSCT are excluded; prior autologous HSCT is allowed).\n\nActive uncontrolled infection at the time of enrollment that, in the opinion of the treating physician, would preclude safe participation.\n\nPregnancy or lactation at the time of enrollment. Female patients of childbearing potential must have a negative pregnancy test within 7 days before starting conditioning.\n\nLife expectancy \\\u003C6 months due to underlying disease or comorbid conditions, as judged by the treating physician.\n\nInability to comply with follow-up due to geographic, psychiatric, or social reasons.\n\nEnrollment in another interventional trial that prohibits co-enrollment in observational studies (at the discretion of the principal investigator).","ALL",{"count":19,"type":20},300,"ESTIMATED","3 Years","OBSERVATIONAL","Hepatitis B virus (HBV) reactivation is a serious complication after allogeneic haematopoietic stem cell transplantation (allo-HSCT), particularly in patients with resolved HBV infection (HBsAg-negative, anti-HBc-positive). The incidence ranges from 10% to 40%, and severe reactivation can lead to hepatitis flare, hepatic failure, and death.\n\nSeveral risk factors have been identified: low recipient anti-HBs titre, donor anti-HBs negativity, recipient age ≥50 years, chronic GVHD, and use of rituximab. However, no validated clinical prediction model exists for this specific population. The only available study (Zhang et al., BBMT 2020) performed risk factor analysis but did not develop a predictive nomogram, and the sample size was limited (only 16 reactivation events). Therefore, we aim to develop and externally validate a robust nomogram using a large multicentre retrospective cohort and then validate its performance in a prospective cohort",[25,26],"HBV Reactivation","HSCT",[25,26,28],"A Multicentre Prospective Observational Study","NOT_YET_RECRUITING","2026-06-08",{"date":32,"type":33},"2026-06-12","ACTUAL",{"date":35,"type":20},"2026-06-20",{"date":37,"type":20},"2029-06-30",{"name":39,"class":40},"Xiao Hui Zhang","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100639983","prospective-validation-of-engraftment-syndrome-phenotypes-and-outcomes-after-hematopoietic-stem-cell-transplantation-100639983","NCT07577375","Prospective Validation of Engraftment Syndrome Phenotypes and Outcomes After Hematopoietic Stem Cell Transplantation","A Prospective Observational Cohort Study to Validate Engraftment Syndrome Phenotypes and Their Associations With Acute Graft-Versus-Host Disease and Clinical Outcomes After Hematopoietic Stem Cell Transplantation","ES after HSCT","Inclusion Criteria:\n\n1. Patients undergoing allogeneic hematopoietic stem cell transplantation at the participating center.\n2. Development of engraftment syndrome after hematopoietic stem cell transplantation, diagnosed according to predefined institutional or published clinical criteria.\n3. Availability of key clinical and laboratory data required for engraftment syndrome phenotyping, including engraftment kinetics, clinical manifestations, inflammatory markers, and organ-injury parameters.\n4. Ability to undergo prospective follow-up for post-transplant outcomes, including acute graft-versus-host disease and survival outcomes.\n5. Written informed consent provided by the patient or legally authorized representative, when required by the institutional review board or ethics committee.\n\nExclusion Criteria:\n\n1. Patients who do not develop engraftment syndrome after hematopoietic stem cell transplantation.\n2. Patients with insufficient clinical or laboratory data to confirm the diagnosis of engraftment syndrome.\n3. Patients with missing essential follow-up information for assessment of primary outcome measures.\n4. Patients who withdraw consent or decline participation in prospective follow-up.\n5. Patients enrolled in another study that, in the opinion of the investigators, may interfere with the observational assessment of engraftment syndrome phenotypes or post-transplant outcomes.",{"count":50,"type":20},250,"Engraftment syndrome (ES) is an early inflammatory complication after hematopoietic stem cell transplantation (HSCT) and has been associated with subsequent transplant-related complications and adverse clinical outcomes. However, ES is clinically heterogeneous, and its relationship with acute graft-versus-host disease (aGVHD), survival, and other post-transplant outcomes remains incompletely defined.\n\nThis prospective observational cohort study aims to validate previously identified ES-associated risk factors, severity-oriented ES phenotypes, and their associations with grade II-IV aGVHD and clinical outcomes after HSCT. Patients undergoing HSCT will be prospectively followed for the development of ES, grade II-IV aGVHD, and clinical outcomes including overall survival, disease-free survival, relapse, and non-relapse mortality. The study will evaluate whether ES phenotypes and ES-related clinical characteristics can stratify patients according to subsequent aGVHD risk and post-transplant prognosis.",[53,54],"Engraftment Syndrome","Allo-HSCT",[53,56,57],"allo-HSCT","acute GVHD","2026-05-03",{"date":60,"type":33},"2026-05-11",{"date":62,"type":20},"2026-06-01",{"date":64,"type":20},"2029-06-01",{"name":39,"class":40},{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":17,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100625705","development-and-prospective-validation-of-an-ai-model-for-prognosis-in-itp-patients-undergoing-coronary-revascularization-100625705","NCT07426107","Development and Prospective Validation of an AI Model for Prognosis in ITP Patients Undergoing Coronary Revascularization","An Artificial Intelligence-Enhanced Longitudinal Cohort Study to Optimize Revascularization Decisions in Patients With Coronary Artery Disease and Immune Thrombocytopenia (The ITP-CAD AI-REVASC Study)","ITP with CAD","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Diagnosis of primary Immune Thrombocytopenia (ITP) according to international working group criteria.\n3. Diagnosis of Coronary Artery Disease (stable angina or Acute Coronary Syndrome) confirmed by coronary angiography.\n4. The diagnosis of ITP must be established and documented prior to the diagnosis of CAD.\n5. Capable of providing informed consent (for prospective enrollment and data collection).\n\nExclusion Criteria:\n\n1. Secondary causes of thrombocytopenia (e.g., drug-induced, hematologic malignancy, hypersplenism, liver disease).\n2. Conditions requiring long-term therapeutic anticoagulation (e.g., atrial fibrillation, mechanical heart valve).\n3. Life expectancy less than 1 year due to non-cardiovascular disease.\n4. Inability to comply with follow-up.\n5. Inability to give informed consent.\n6. Pregnancy or breastfeeding.\n7. A history of Type 2 Myocardial Infarction prior to the index treatment decision.","18 Years","90 Years",{"count":77,"type":20},600,"This study employs a dual-cohort design to develop and validate a prognostic model for Major Adverse Cardiovascular Events (MACE) following revascularization in immune thrombocytopenia (ITP) patients with Coronary Artery Disease (CAD). The model will be developed and trained using a retrospective multi-center cohort (development\u002Ftraining cohort). Its performance will then be prospectively validated in a separate, consecutively enrolled prospective cohort (validation cohort). The goal is to create an AI-based tool to assist in personalized risk assessment and decision-making for this high-risk population.",[80,81],"Immune Thrombocytopenic Purpura","Coronary Artery Disease",[83,84,85,86,87],"immune thrombocytopenia","coronary artery disease","coronary revascularization","prognostic model","MACE","2026-02-15",{"date":90,"type":33},"2026-02-23",{"date":92,"type":20},"2026-02-25",{"date":94,"type":20},"2029-02-25",{"name":39,"class":40},""]