[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Xi'an International Medical Center Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":104},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,83],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100650453","phase-4-insulin-icodec-initiation-strategies-and-day-4-supplemental-dosing-in-type-2-diabetes-100650453",false,"NCT07747402","Insulin Icodec Initiation Strategies and Day-4 Supplemental Dosing in Type 2 Diabetes","Effects of Different Insulin Icodec Initiation Strategies and a Day-4 Supplemental Dosing Decision on Early Fasting Blood Glucose Target Attainment in Type 2 Diabetes: A Multicenter, Randomized, Open-Label, 3x2 Factorial Trial","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of type 2 diabetes mellitus for at least 180 days\n* No insulin treatment of any kind within the past 3 months\n* Currently treated with at least one non-insulin glucose-lowering agent (oral agent or GLP-1 receptor agonist) with inadequate glycemic control, and a clinical indication to start basal insulin\n* HbA1c of 7.0% to 11.0% at screening\n* Body mass index of 35.0 kg\u002Fm2 or lower\n* Able and willing to wear a continuous glucose monitor per protocol, to undergo day-4 fasting blood glucose assessment, and to attend all scheduled visits\n* Provides written informed consent\n\nExclusion Criteria:\n\n* Type 1 diabetes, specific types of diabetes, or recent acute complications such as diabetic ketoacidosis or hyperosmolar hyperglycemic state\n* Level 2 or level 3 hypoglycemia within the past 3 months, or hypoglycemia unawareness\n* Current use, or use within the past 3 months, of systemic glucocorticoids (excluding inhaled or topical preparations) or other agents that markedly affect blood glucose\n* Moderate to severe renal impairment (eGFR below 45 mL\u002Fmin\u002F1.73 m2 by the CKD-EPI 2021 creatinine equation) or need for dialysis\n* Active liver disease, abnormal liver function (ALT or AST above 3 times the upper limit of normal), or decompensated cirrhosis\n* Marked edema, large-volume ascites, amputation, or other conditions that may impair accurate body weight measurement or distort weight-based dosing\n* Known allergy to insulin icodec or its excipients\n* Extensive skin lesions, allergy to continuous glucose monitor adhesive, or anticipated frequent magnetic resonance imaging that may interfere with monitor wear or interpretation\n* Active malignancy\n* Acute cardiovascular or cerebrovascular event (such as myocardial infarction, stroke, or unstable angina) within the past 6 months, or other major illness with short expected survival or poor compliance\n* Pregnancy or lactation, or women of childbearing potential with pregnancy plans\n* Participation in another drug or device clinical trial within the past 3 months\n* Other conditions judged by the investigator to be unsuitable for enrollment or likely to affect participant safety or data reliability","ALL","18 Years",{"count":19,"type":20},462,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The goal of this clinical trial is to find the best way to start once-weekly insulin icodec in adults with type 2 diabetes who have not used insulin in the past 3 months, so that their fasting blood glucose reaches the target range within the first week. The main questions it aims to answer are:\n\n* Which of three starting-dose methods brings the most people to their fasting blood glucose target by the end of the first week?\n* On day 4 after starting, if fasting blood glucose is still high, does giving one extra half-dose of insulin help more people reach target safely?\n\nParticipants will be randomly placed into one of three starting-dose groups: a fixed weekly dose, a dose based on their fasting blood glucose, or a dose based on their body weight. Within each group, participants will also be randomly assigned either to receive an extra insulin dose on day 4 if their fasting blood glucose is at or above a set level, or to receive no extra dose.\n\nParticipants will:\n\n* Start once-weekly insulin icodec and continue their current non-insulin diabetes medicines\n* Check their fasting blood glucose, including on day 4 after starting\n* Wear a blinded continuous glucose monitor during the first 2 weeks and the last 2 weeks\n* Attend weekly visits for dose adjustment and safety checks over 12 weeks, followed by a 5-week safety follow-up",[26],"Type 2 Diabetes",[28,29,30,31,32,33,34,35,36,37],"Insulin icodec","Once-weekly insulin","Basal insulin","Insulin initiation","Fasting blood glucose","Glycemic target attainment","Supplemental dosing","Factorial trial","Continuous glucose monitoring","Diabetes management","NOT_YET_RECRUITING","2026-07-30",{"date":41,"type":42},"2026-08-05","ACTUAL",{"date":44,"type":20},"2027-01",{"date":46,"type":20},"2028-03",{"name":48,"class":49},"Xi'an International Medical Center Hospital","OTHER",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":21,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":50},"100582017","myocardialbridge-bypass-graft-surgery-efficacy-verification-100582017","NCT06857838","Myocardialbridge Bypass Graft Surgery Efficacy Verification","Inclusion Criteria:\n\n* Patients with myocardialbridge requiring drug therapy or surgical intervention.\n\nExclusion Criteria:\n\n* patients with myocardialbridge not requiring drug therapy or surgical intervention, or unwilling to be enrolled for any reason","80 Years",{"count":59,"type":20},500,[61],"NA","Myocardial Bridge Bypass Graft surgery is introduced to relieve the unmedical symptoms of patients with long-segment or deep myocardial bridge, clinical outcomes will be collected to verify the effectiveness of the surgery.",[64,65,66,67,68,69,70,71,72,73],"Myocardial Bridge of Coronary Artery","Myocardial Bridge","Myocardial Bridging","Myocardial Infarction","Myocardial Ischemia","Pectoris, Stable Angina","Sudden Cardiac Death","Bypass Graft Stenosis","Bypass Graft Occlusion","Bypass Graft Thrombosis","RECRUITING","2025-02-26",{"date":77,"type":42},"2025-03-04",{"date":79,"type":42},"2020-01-01",{"date":81,"type":20},"2040-12-31",{"name":48,"class":49},{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":89,"minAge":17,"maxAge":4,"enrollmentInfo":90,"targetDuration":4,"studyType":21,"phases":92,"briefSummary":93,"conditions":94,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":50},"100517251","efficacy-and-safety-of-disitamab-vedotin-plus-pyrotinib-or-naratinib-in-her2-positive-breast-cancer-patients-with-brain-metastasis-100517251","NCT06015113","Efficacy and Safety of Disitamab Vedotin Plus Pyrotinib or Naratinib in HER2-positive Breast Cancer Patients With Brain Metastasis","Inclusion Criteria:\n\n* Patients who can voluntarily sign an informed consent form;\n* Females aged ≥18 years old when signing the informed consent form;\n* ECOG PS physical status score of 0 to 2 points;\n* Histologically confirmed HER2-positive metastatic breast cancer patients; Note: HER2 positivity refers to at least one occurrence of tumor cell immunohistochemical staining intensity of 3+ or confirmed as positive by fluorescence in situ hybridization \\[FISH\\] in the pathological testing\u002Fre-review of the primary or metastatic lesions conducted by the participating center's pathology department;\n* Brain metastases confirmed by MRI\u002Fenhanced CT, with at least one measurable lesion in the brain based on RECIST 1.1 criteria;\n* Expected survival period ≥3 months;\n* Patient types: Cohort A - newly diagnosed brain metastases patients; Cohort B - patients with progression after whole-brain radiotherapy or stereotactic radiosurgery;\n* Left ventricular ejection fraction (LVEF) ≥50%;\n* QT interval corrected by Fridericia formula (QTcF) of 12-lead electrocardiogram: \\\u003C450ms for males, \\\u003C470ms for females;\n* The following conditions should be met in the blood routine examination:① Absolute neutrophil count (ANC) ≥1.5×10\\^9\u002FL, ② Platelet count ≥100×10\\^9\u002FL, ③ Hemoglobin ≥90g\u002FL, ④ White blood cell count ≥3.0×10\\^9\u002FL;\n* Liver function meets the following conditions: ① Serum total bilirubin ≤1.5×upper limit of normal (ULN), or ≤3×ULN if there are liver metastases, ② Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤3×ULN, or ≤5×ULN if there are liver metastases;\n* Renal function meets the following conditions: Serum creatinine ≤1.5×ULN or creatinine clearance ≥50mL\u002Fmin (calculated according to the Cockroft-Gault formula);\n* Female patients who meet the following conditions can participate in this study: ① Infertility; ② Capable of fertility, with a negative blood pregnancy test result within 7 days before the first administration of the investigational drug, not breastfeeding, and adopting effective contraceptive measures during the screening period, throughout the study, and within 6 months after the last administration of the study drug.\n\nExclusion Criteria:\n\n* Patients who have received treatment with anti-HER2 ADC drugs;\n* Patients who have received sequential treatment with pyrotinib and neratinib;\n* Patients with extensive leptomeningeal metastases and poor response to steroid dehydration therapy for brain metastases;\n* Presence of third space fluid accumulation (such as significant pleural effusion or ascites) that cannot be controlled by drainage or other methods;\n* Patients who have received chemotherapy, major surgery, or molecular targeted therapy within 2 weeks prior to enrollment; patients who have received endocrine therapy within 1 week prior to enrollment; patients who have received nitrosoureas or mitomycin chemotherapy within 6 weeks prior to enrollment;\n* Concurrent use of any other anticancer treatment;\n* History of or current concurrent malignancies within the past 5 years, excluding cured cervical carcinoma in situ, non-melanoma skin cancer, and superficial bladder carcinoma \\[Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor invading the lamina propria)\\];\n* Underwent major surgery (including thoracotomy biopsy), experienced significant trauma (such as fractures), had unhealed wounds or fractures at the time of screening, or anticipated the need for major surgery during the study treatment period, within the 4 weeks prior to randomization;\n* History of myocardial infarction within the past 6 months; history of New York Heart Association (NYHA) class ≥II congestive heart failure that is not controlled by medication, severe arrhythmias that cannot be controlled (excluding atrial fibrillation and paroxysmal supraventricular tachycardia); known decrease in LVEF to below 50% during or after previous treatment with trastuzumab;\n* Known allergy to the drugs and excipients involved in this trial;\n* Known history of hypersensitivity reactions to any investigational drugs;\n* Subjects deemed unsuitable for participation by other investigators.","FEMALE",{"count":91,"type":20},20,[61],"Basis: Brain metastasis is very common in breast cancer, and HER2 positivity is a risk factor for high incidence of brain metastasis, with approximately 50% of HER2+ MBC cases experiencing brain metastasis. The reason for this is that as the efficacy of HER2-targeted therapy improves, the survival of these patients significantly extends, leading to an increase in the occurrence rate of brain metastasis events in the late stage of MBC. In the systemic treatment of HER2+ breast cancer brain metastasis, various HER2-targeted drugs have been explored, but none have achieved satisfactory therapeutic effects. Therefore, it is imperative to explore new treatment options. ADC drugs have shown some efficacy in brain metastasis patients, and as a domestically developed ADC drug, trastuzumab vedotin has demonstrated good anti-tumor effects. The treatment model combining trastuzumab vedotin with small molecule TKIs has been rarely reported, so we are attempting to use the treatment model of trastuzumab vedotin combined with pyrotinib or neratinib to explore its efficacy and safety in patients with HER2-positive brain metastasis.\n\nMethod: The plan is to recruit HER2-positive breast cancer patients with brain metastasis and use the treatment of trastuzumab vedotin combined with pyrotinib or neratinib (specific treatment drugs to be selected during the study).\n\nProcedure: All subjects will undergo screening, treatment, and follow-up periods, strictly adhering to relevant GCP regulations during the treatment process.\n\nExpectations: Through this study, preliminary efficacy and safety data of trastuzumab vedotin combined with pyrotinib or neratinib treatment will be provided for patients with HER2+ brain metastatic BC.",[95],"Breast Cancer","2023-08-27",{"date":98,"type":42},"2023-08-29",{"date":100,"type":20},"2023-09",{"date":102,"type":20},"2027-04",{"name":48,"class":49},""]