[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zunyi Medical College\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":125},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,76,104],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100619361","robotlaparoscopic-assisted-transanal-transection-duhamel-versus-modified-soave-pull-through-for-tca-100619361",false,"NCT07343622","Robot\u002FLaparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for TCA","Robot\u002FLaparoscopic-Assisted Transanal Transection Duhamel Versus Modified Soave Pull-Through for Total Colonic Hirschsprung Disease: A Multicenter Controlled Trial","Inclusion Criteria:\n\n1. Definitive diagnosis of total colonic Hirschsprung disease confirmed by pathology from biopsy at neonatal enterostomy, consistent with total colonic aganglionosis.\n2. Two-stage surgical strategy: neonatal enterostomy performed first, followed by definitive pull-through as a second-stage procedure.\n3. Planned definitive reconstruction by one of the following techniques:\n4. Robot-assisted transanal transection Duhamel, orModified Soave pull-through (minimally invasive abdominal phase allowed).\n5. Availability for follow-up assessments and outcomes collection per protocol.\n\nExclusion Criteria:\n\n1. Trisomy 21 (Down syndrome).\n2. Definitive surgery performed by open laparotomy approach or Swenson procedure.\n3. One-stage primary pull-through without neonatal enterostomy (single-stage definitive management).","ALL","1 Month","14 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","Total colonic Hirschsprung disease (TCA) is the most severe form of Hirschsprung disease and is commonly managed with neonatal enterostomy followed by delayed definitive pull-through. Despite widespread use, the optimal reconstructive procedure for TCA remains uncertain. The Duhamel and modified Soave pull-through procedures are the two most frequently adopted techniques, each with distinct theoretical advantages and limitations regarding bowel function, enterocolitis risk, and anorectal physiology. With the increasing application of minimally invasive and robot-assisted surgery, both procedures have been further refined; however, robust comparative evidence, particularly for total colonic disease, is lacking. To date, no multicenter study has provided a detailed comparison of postoperative functional outcomes and Hirschsprung-associated enterocolitis between transanal transection Duhamel and modified Soave procedures. This multicenter study compares robot-assisted transanal transection Duhamel and modified Soave pull-through in patients with pathologically confirmed TCA after neonatal enterostomy, focusing on postoperative bowel function and enterocolitis incidence.",[27,28,29,30],"Total Colonic Aganglionosis","Hirschsprung Disease","Duhamel","Soave",[32,33,34,35,36],"Robotic surgery","total colonic aganglionosis","modified Duhamel procedure","modified Soave procedure","Hirschsprung disease","NOT_YET_RECRUITING","2026-01-14",{"date":40,"type":41},"2026-01-15","ACTUAL",{"date":43,"type":21},"2026-01-30",{"date":45,"type":21},"2027-12-31",{"name":47,"class":48},"Zunyi Medical College","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":49},"100552227","phase-1-a-real-world-study-of-pyrrolitinib-maleate-tablets-for-her-2-positive-early-or-locally-advanced-breast-cancer-after-adjuvant-trastuzumab-therapy-100552227","NCT06470347","A Real-World Study of Pyrrolitinib Maleate Tablets for HER-2-Positive Early or Locally Advanced Breast Cancer After Adjuvant Trastuzumab Therapy","Inclusion Criteria:\n\n* Age: 18-75 years;\n* Invasive breast cancer with clinical stage 0-III and treated surgically;\n* Histopathologically confirmed HER-2 positivity: immunohistochemistry (IHC) result of 3+ or in situ hybridization (ISH) result of HER-2 gene amplification (HER-2\u002FCEP17 ≥ 2.0 or average HER-2 copy number\u002Fcell ≥ 6);\n* Have undergone radical mastectomy or breast-conserving surgery for breast cancer, with no cancer left in the body and no recurrence of metastatic disease after surgery:\n\n  1. Pathologic test confirms that there is no residual invasive cancer at the margins and no residual ductal carcinoma in situ;\n  2. Patients who have not received neoadjuvant therapy should have negative surgical margins, and there is no requirement for the presence of lymph node metastasis (including the presence of lymph node micrometastasis) suggested by postoperative pathological tests;\n  3. Patients receiving neoadjuvant therapy are not allowed to have postoperative pathologic evidence of invasive carcinoma in the breast or axillary lymph nodes;\n* Previous trastuzumab anti-HER-2 therapy: completion of ≥24 weeks (8 dosing cycles) of trastuzumab in the neoadjuvant and\u002For adjuvant phases; the interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year.\n* Known hormone receptor status (ER\u002FPR);\n* ECOG score of 0-1;\n\nNormal function of major organs:\n\n1. Blood count:\n\n   Neutrophils (ANC) ≥ 1.5 x 109\u002FL; Platelet count (PLT) ≥90×109\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n2. Blood biochemistry:\n\n   Total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5 × ULN; Alkaline phosphatase ≤ 2.5 x ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN;\n3. Cardiac ultrasound:\n\n   Left ventricular ejection fraction (LVEF) ≥55%;\n4. 12-lead electrocardiogram: Fridericia-corrected QT interval (QTcF) \\\u003C 470 msec.\n\n   * For female patients who are not menopausal or surgically sterilized: consent to abstinence or use of an effective non-hormonal pharmacologic method of contraception for the duration of treatment and for 8 weeks after the last dose of study treatment;\n   * Benefit in the opinion of the investigator;\n   * Voluntarily participate in the study by signing an informed consent form.\n\nExclusion Criteria:\n\n* Confirmed local\u002Fregional recurrence\u002Fmetastasis at enrollment;\n* Prior anti-HER-2 therapy with pyrrolitinib, lenatinib, lapatinib and other tyrosine kinase inhibitors;\n* History of gastrointestinal disease with diarrhea as the primary symptom;\n* Psychiatric illness or psychotropic substance abuse that prevents cooperation;\n* Female patients who are pregnant or breastfeeding;\n* Those who, in the opinion of the investigator, are not suitable for enrollment.","FEMALE","18 Years","75 Years",{"count":60,"type":21},67,[62,63],"PHASE1","PHASE2","Purpose of the Study:\n\nPrimary Study Objective:\n\nTo evaluate the efficacy of pyrrolitinib maleate tablets in the treatment of HER-2-positive early or locally advanced breast cancer after adjuvant therapy with trastuzumab\n\nSecondary Research Objectives:\n\nTo evaluate the safety of pyrrolitinib maleate tablets in the treatment of HER-2 positive early or locally advanced breast cancer after trastuzumab adjuvant therapy\n\nStudy Endpoints Primary Study Endpoint:\n\nInvasive disease free survival (iDFS)\n\nSecondary Study Endpoints:\n\n1. overall survival (OS);\n2. disease-free survival (DFS);\n3. distant metastasis free survival (DDFS);\n4. safety Study Population: Patients with early or locally advanced HER-2 positive breast cancer with clinical stage 0-III who have received prior neoadjuvant or adjuvant therapy. where the neoadjuvant and\u002For adjuvant treatment phase has been completed at least ≥24 weeks (8 dosing cycles) of trastuzumab therapy and the time interval between the end of the last course of trastuzumab therapy and entry into the study must be ≤1 year Study Design: Single-arm, multicenter, interventional study Administration Pyrrolitinib: The recommended dose of this product is 400 mg orally once daily within 30 minutes after breakfast for 52 weeks (approximately one year).\n\nDose adjustments may be made in accordance with this protocol, taking into account adverse reactions in subjects. Each consecutive suspension of piretinib during the course of the study should not exceed 14 days, prophylactic use of medications for the treatment of diarrhea is permitted during the course of treatment, multiple suspensions of study medication due to adverse events are permitted, and doses of piretinib that are missed for any reason will not be made up.",[66],"HER-2 Positive Advanced Breast Cancer","RECRUITING","2024-06-21",{"date":70,"type":41},"2024-06-24",{"date":72,"type":41},"2022-11-01",{"date":74,"type":21},"2025-11-01",{"name":47,"class":48},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":83,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":49},"100537904","phase-4-cyp2c19-genotype-guided-p2y12-receptor-inhibitor-selection-after-complex-percutaneous-coronary-intervention-100537904","NCT06283888","CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection After Complex Percutaneous Coronary Intervention","Safety and Efficacy of CYP2C19 Genotype-Guided P2Y12 Receptor Inhibitor Selection Versus Conventional Antiplatelet Therapy After Complex Percutaneous Coronary Intervention: The PRECISE-PCI Randomized Clinical Trial","Inclusion Criteria:\n\n1. Clinical Criteria:\n\n   * Patients aged between 18-80 years old.\n   * Patients with ACS (UA\u002FNSTEMI\u002FSTEMI) undergoing PCI.\n   * Patients will be treated with DAPT (P2Y12 inhibitors+aspirin) for at least 3 months.\n   * Patients are willing to provide a DNA sample (via blood draw) for CYP2C19 genotyping.\n   * Patients provide written informed consent before enrollment.\n2. Angiographic Criteria (meet at least 1 of the following characteristics):\n\n   * Thrombotic target lesion.\n   * Calcified target lesion requiring rotational atherectomy or intravascular lithotripsy\n   * Multivessel (≥2 vessels) disease will be treated.\n   * Multi-target lesions (≥3 lesions) will be treated.\n   * Multi-stent (≥3 stents) will be implanted.\n   * Total stent length≥60 mm.\n   * Bifurcation lesion requiring at least 2 stents.\n   * PCI for left main.\n   * PCI for chronic total occlusion.\n   * PCI for bypass graft.\n\nExclusion Criteria:\n\n* Patient with known CYP2C19 genotype before randomization.\n* Anticipated discontinuation of clopidogrel or ticagrelor within the 12-month follow-up period.\n* Planned surgery within 90 days.\n* Requiring oral anticoagulation therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism)\n* Intracranial\u002Fgastrointestinal\u002Furogenital bleeding within 6 months.\n* Active bleeding or bleeding diathesis, thrombocytopenia (platelet \\\u003C100,000\u002FmL) or hemoglobin \\\u003C10 g\u002FdL\n* Hepatic dysfunction (serum liver enzyme\\>3 times the normal limit)\n* Renal failure (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2 or requiring dialysis)\n* Concomitant therapy with a strong CYP3A4 inhibitor or inducer\n* Life expectancy \\\u003C 1 year","80 Years",{"count":85,"type":21},1200,[87],"PHASE4","In Ease Asia clinical trials, P2Y12 inhibitor (ticagrelor or clopidogrel) monotherapy after 3-month dual antiplatelet therapy (DAPT) resulted in a lower incidence of clinically significant bleeding, without increasing risk of major adverse cardiac and cerebrovascular events, even if acute coronary syndrome (ACS) following complex percutaneous coronary intervention (PCI) when compared with standard DAPT. Although better understood \"East Asian Paradox\", finding the right CYP2C19 genotype-guided P2Y12 inhibitor selection to balance maintaining ischaemic prevention and less bleeding remains a topic in real-world clinical practice.",[90,91],"ACS - Acute Coronary Syndrome","CYP2C19 Polymorphism",[93,94,95],"CYP2C19 Genotype","P2Y12 Receptor Inhibitor","Complex PCI","2024-03-18",{"date":98,"type":41},"2024-03-20",{"date":100,"type":21},"2024-04-01",{"date":102,"type":21},"2028-12-01",{"name":47,"class":48},{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":4,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":58,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":123,"leadSponsor":124,"locationsCount":49},"100517090","phase-4-century-clot-guided-prophylactic-rivaroxaban-for-post-stemi-complicating-left-ventricular-thrombus-100517090","NCT06013020","Century Clot-Guided Prophylactic Rivaroxaban for Post STEMI Complicating Left Ventricular Thrombus","Safety and Efficacy of Century Clot-Guided Prophylactic Rivaroxaban Therapy for Post ST-Segment Elevation Myocardial Infarction Complicating Left Ventricular Thrombus Compared With Conventional Antiplatelet Therapy","Inclusion Criteria:\n\n* Ischemic chest discomfort for at least 30 minutes, with at least 1-mm (0.1-mv) ST-segment elevation in anterior leads on a standard 12-lead electrocardiogram.\n* Patients provide written informed consent prior to enrollment.\n\nExclusion Criteria:\n\n* Intracranial, gastrointestinal, or urogenital bleeding within 6 months\n* Requiring OAC therapy (eg, atrial fibrillation, deep vein thrombosis, pulmonary thromboembolism);\n* Bleeding diathesis, thrombocytopenia (platelet \\\u003C100,000\u002FmL) or hemoglobin \\\u003C10 g\u002FdL, and CRUSADE score-based high bleeding risk\n* Hepatic dysfunction (serum liver enzyme\\>3 times the normal limit)\n* Renal failure (eGFR \\\u003C15 ml\u002Fmin\u002F1.73m2 or requiring dialysis)\n* Severe chronic obstructive pulmonary disease\n* Severe bradycardia (sick sinus syndrome or high degree atrioventricular block without pacemaker protection)\n* Drugs interfering with CYP3A4 metabolism (to avoid interaction with ticagrelor): ketoconazole, itraconazole, voriconazole, clarithromycin, nefazodone, ritonavir, saquinavir, nelfinavir, indinavir, atazanavir, and telithromycin\n* Life expectancy \\\u003C 1 year",{"count":112,"type":21},374,[87],"To manage the ST-segment elevation myocardial infarction (STEMI) caused by plaque rupture, triggers platelet activation\u002Faggregation and thrombin generation, requires dual (platelet and coagulation) pathway inhibition. However, triple antithrombotic therapy with standard dual antiplatelet therapy (DAPT) and oral anticoagulant (OAC) in the STEMI setting is a challenge, since that increase in potential risk of bleeding.\n\nAlthough the incidence of left ventricular thrombus (LVT) formation after STEMI decreased in modern reperfusion therapy, including primary percutaneous coronary intervention (PCI), remains at 4% to 26%, especially that complicated by anterior STEMI. The recommendation of an OAC prophylactic therapy for preventing LVT formation in current STEMI guidelines is limited. How to optimize antithrombotic therapy to balance the bleeding-thrombotic profile, and prevent LVT formation is challenging, since insufficient evidence is available from randomized trials.\n\nCentury Clot analyzer is point-of-care testing that could assess the coagulate state: normal, hypo-coagulable, or hyper-coagulable states according to clot rate (CR) value. Whether Century Clot-guided rivaroxaban prophylactic therapy (2.5 mg twice daily, if the hypercoagulable state, defined as CR ≥24) in combination with standard DAPT could reduce LVT formation without increasing major bleeding is uncertain.",[116],"STEMI - ST Elevation Myocardial Infarction",[118],"Century Clot analyzer; Prophylactic; Rivaroxaban; LVT; STEMI","2024-03-16",{"date":121,"type":41},"2024-03-19",{"date":100,"type":21},{"date":45,"type":21},{"name":47,"class":48},""]