[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Second Xiangya Hospital of Central South University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":641},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,43,64,89,111,142,168,193,216,242,265,298,320,345,369,395,423,447,469,491,512,542,570,594,617],{"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":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100605359","brain-functional-connectivity-mechanism-of-cognitive-flexibility-impairment-and-rtms-intervention-in-major-depressive-disorder-100605359",false,"NCT07161492","Brain Functional Connectivity Mechanism of Cognitive Flexibility Impairment and rTMS Intervention in Major Depressive Disorder","Individualized Dual-Target Repetitive Transcranial Magnetic Stimulation (rTMS) Targeting Left Inferior Parietal Lobule and Right Dorsolateral Prefrontal Cortex Functional Connectivity for Cognitive Flexibility Impairment in Major Depressive Disorder: A Randomized, Double-Blind-Controlled Trial","Inclusion Criteria:\n\nMeet DSM-5 criteria for major depressive episode confirmed by the Structured Clinical Interview for DSM-5 Disorders (SCID-5), with no prior manic or hypomanic episodes; diagnosed as major depressive disorder without psychotic features by two attending psychiatrists.\n\nFirst episode or recurrent, currently in a depressive episode (HAMD\\_17≥17).\n\nAge 18 to 45 years, all sexes and genders. Han Chinese, right-handed. Junior high school education or above, no color blindness, able to understand and provide informed consent, and complete assessments and tests.\n\nWilling to participate voluntarily and sign written informed consent.\n\nExclusion Criteria:\n\nMeet DSM-5 diagnostic criteria for any psychiatric disorder other than major depressive disorder.\n\nReceived non-pharmacological treatments within the past 6 months, such as electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS), or systematic psychotherapy (≥ 10 sessions).\n\nPrior treatment with CCRT. Received antipsychotics or other medications affecting cognitive function within the past month, or cholinergic agents (e.g., donepezil, galantamine) within 14 days, memantine within 20 days, or other racetam drugs (e.g., piracetam) within 2 days prior to randomization.\n\nOrganic brain disorders or severe physical illnesses (e.g., thyroid disease, lupus erythematosus, diabetes, liver\u002Fkidney\u002Flung impairment, infection, major trauma).\n\nHistory of traumatic brain injury with loss of consciousness or other conditions that may interfere with this study.\n\nHistory of alcohol or substance abuse or dependence. Severe suicidal ideation or suicide attempt . Currently receiving hormonal therapy. Pregnancy, lactation, possibility of pregnancy, or planned pregnancy. History of epilepsy or family history of epilepsy. Implanted metal materials in the body (e.g., pacemaker, dental implants, metal intrauterine device).\n\nAny other factors that, in the investigator's opinion, place the participant at potential risk or interfere with the study participation.","ALL","18 Years","45 Years",{"count":21,"type":22},105,"ESTIMATED","INTERVENTIONAL",[25],"NA","Major depressive disorder (MDD) often involves cognitive deficits, particularly in cognitive flexibility, which is inadequately addressed by standard antidepressants. This study tests an innovative brain stimulation regimen: individualized dual-target repetitive transcranial magnetic stimulation (rTMS) to improve cognitive flexibility in MDD patients.\n\nThis is a randomized, double-blind, sham-controlled trial that plans to enroll 105 MDD patients with cognitive flexibility impairment. Participants will be randomly assigned to one of three groups: (1) Active dual-target group - receiving active rTMS over both the left inferior parietal lobule (IPL) and the right dorsolateral prefrontal cortex (DLPFC); (2) Active single-target group - receiving active rTMS over the left IPL and sham stimulation over the right DLPFC; (3) Sham control group - receiving sham stimulation over both targets. All participants will continue their stable antidepressant medication (SSRI or SNRI). The rTMS intervention lasts 10 days, with 5 stimulation sessions per day.\n\nCognitive flexibility, depressive symptoms, and brain functional connectivity will be assessed at baseline, immediately after the 10-day treatment, and at 2-week and 4-week follow-ups using neurocognitive tests, clinical rating scales (e.g., HAMD), and functional MRI. The results will help confirm the role of the IPL-DLPFC connectivity in cognitive flexibility and may establish a new treatment target for cognitive dysfunction in MDD.",[28,29],"Depressive Disorder, Major","Cognitive Impairment","NOT_YET_RECRUITING","2026-06-22",{"date":33,"type":34},"2026-06-25","ACTUAL",{"date":36,"type":22},"2026-07",{"date":38,"type":22},"2028-10",{"name":40,"class":41},"Second Xiangya Hospital of Central South University","OTHER",1,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":49,"maxAge":19,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":42},"100641371","mechanisms-of-sulforaphane-supplementation-in-alleviating-negative-symptoms-and-cognitive-impairment-in-schizophrenia-100641371","NCT07652866","Mechanisms of Sulforaphane Supplementation in Alleviating Negative Symptoms and Cognitive Impairment in Schizophrenia","Inclusion Criteria:\n\n1. Diagnosis of schizophrenia according to DSM-5 criteria.\n2. First-episode or illness duration ≤ 10 years, but currently in a non-acute phase of schizophrenia.\n3. Negative symptoms present for ≥ 6 months prior to study entry. Patients must be outpatients or hospitalized for social reasons rather than symptom exacerbation.\n4. PANSS negative subscale (7 items) total score ≥ 20; at least one negative item score \\> 3; no change \\> 3 points between screening and baseline. PANSS positive subscale items related to agitation (P4 excitement, P6 suspiciousness\u002Fpersecution, P7 hostility, G8 uncooperativeness, G14 poor impulse control) each ≤ 4.\n5. Currently taking ≤ 2 antipsychotic medications.\n6. Antipsychotic regimen remains unchanged during the study period.\n7. No anticipated relocation, transportation difficulties, or access problems that would interfere with study participation.\n8. Able to understand and comply with study procedures, complete all required tests and examinations, communicate well with the investigator, and voluntarily provide written informed consent\n\nExclusion Criteria:\n\n1. Psychiatric symptoms attributable to any other DSM-5 diagnosis besides schizophrenia.\n2. History of substance dependence, or psychotic symptoms caused by other medical conditions.\n3. Calgary Depression Scale for Schizophrenia (CDSS) total score \\> 6.\n4. Barnes Akathisia Rating Scale (BARS) score indicating at least moderate akathisia.\n5. Current or past major physical illness, neurological disorder, or traumatic brain injury affecting brain structure\u002Ffunction.\n6. Suicidal attempt or current suicidal ideation.\n7. Currently receiving antidepressants, mood stabilizers; or use of rTMS, MECT, or systematic psychotherapy within 3 months or for the current episode.\n8. Current use of medications that may affect cognitive function, such as Ginkgo biloba extract, minocycline, selegiline.\n9. Presence of hepatic or renal insufficiency, severe gastrointestinal, respiratory, endocrine, or hematologic disorders, or disorders of absorption or metabolism.\n10. Pregnant or breastfeeding women.","12 Years",{"count":51,"type":22},60,[25],"The goal of this randomized, double-blind, placebo-controlled clinical trial with an open-label extension is to evaluate whether sulforaphane can improve negative symptoms and cognitive impairment, and to explore its underlying mechanisms in patients with schizophrenia (aged 12-45 years, both sexes, stable on antipsychotic medication). The study duration includes 12 weeks of double-blind treatment followed by a 12-week open-label extension. In the randomized controlled double-blind phase, a total of 60 participants will be randomized 1:1 to receive either six oral tablets (411 μmol GR) of sulforaphane (SFN group, n = 30) or placebo (placebo group, n = 30) for 12 weeks. In the open-label phase, participants will choose whether to continue taking the drugs originally assigned. The primary outcome is the change in PANSS and BNSS scores during the randomized double-blind phase. Secondary outcomes include changes in brain MRI measures, as well as changes in MCCB, CGI-SI, CGI-GI, PSP, SNS, and SAFTEE scores during the randomized double-blind phase; and changes in PANSS, BNSS, and MCCB scores during the open-label phase.SAFTEE scale, serious adverse event record and blood test will be used for safety monitoring.",[55],"Schizophrenia Disorder","2026-06-17",{"date":58,"type":34},"2026-06-18",{"date":60,"type":22},"2026-06-02",{"date":62,"type":22},"2028-12-31",{"name":40,"class":41},{"id":65,"slug":66,"hasResults":12,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":12,"sex":17,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":42},"100638903","genetic-risk-score-of-type-1-diabetes-mellitus-for-progression-to-insulin-in-diabetic-patients-lack-of-predictive-value-a-multicenter-nested-case-control-study-100638903","NCT07621445","Genetic Risk Score of Type 1 Diabetes Mellitus for Progression to Insulin in Diabetic Patients Lack of Predictive Value: a Multicenter Nested Case-control Study","Inclusion Criteria:\n\n* Gender is not restricted.\n* Age ranges from 14 to 50 years old.\n* Diagnosis of diabetes within \\\u003C 1 year:\n\n  1. If there are diabetes symptoms and meet any of the following criteria:① Plasma glucose at any time ≥ 11.1 mmol\u002FL (200 mg\u002FdL), or② Fasting plasma glucose ≥ 7.0 mmol\u002FL (126 mg\u002FdL), or③ Plasma glucose 2 hours after OGTT\u002Fpost - meal ≥ 11.1 mmol\u002FL (200 mg\u002FdL), or④ HbA1c ≥ 6.5%.\n  2. If there are no diabetes symptoms, another test on a different day is required for diagnosis.\n* Newly - diagnosed diabetes patients whose type diagnosis is considered unclear clinically.\n\nExclusion Criteria:\n\n* Peak C-peptide \\\u003C 200 pmol\u002FL;\n* Gestational diabetes, monogenic diabetes (neonatal diabetes, MODY), exocrine pancreatic diseases (cystic fibrosis), diabetes caused by drugs or chemicals;\n* Those who have been under long-term treatment with hormones or immunosuppressants;\n* Pregnant or lactating women;\n* Those with concurrent malignant tumors or severe heart, liver, and kidney diseases;\n* Those with an expected survival time of less than 3 years;\n* Those with mental disorders or unable to cooperate with the investigation for other reasons;\n* Acute phase of diabetic ketoacidosis;\n* Stress conditions such as severe infection, fever, trauma, and major surgery;\n* Patients lacking major clinical information;\n* Those considered by the researcher as unfit to participate in this study.","14 Years","50 Years",{"count":73,"type":22},2950,"OBSERVATIONAL","The goal of this observational study is to evaluate the predictive value of the genetic risk score for type 1 diabetes in the progression to insulin deficiency in diabetic patients. The main question it aims to answer is:\n\n1. To investigate the predictive efficacy of the genetic risk score for T1DM in determining whether diabetic patients will progress to insulin deficiency;\n2. To compare the differences in genetic characteristics between the insulin-deficient cohort and the non-insulin-deficient cohort.\n\nThis study is a nested case-control study, in which a case group and a control group are set up for the collection of observational indicators. Case group: Diabetic patients who \"progressed to insulin deficiency\" and those who \"progressed to severe insulin deficiency\". Control group: Patients who did not progress to insulin deficiency. The study period is 3 years.",[77,78],"Diabetes Mellitus","Diabetes Mellitus, Type 1",[80],"Genetic risk score","RECRUITING","2026-05-31",{"date":60,"type":34},{"date":85,"type":34},"2025-10-27",{"date":87,"type":22},"2029-12-31",{"name":40,"class":41},{"id":90,"slug":91,"hasResults":12,"nctId":92,"briefTitle":93,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":23,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":42},"100602871","mobile-health-and-wearable-devices-for-diabetes-complication-management-100602871","NCT07129148","Mobile Health and Wearable Devices for Diabetes Complication Management","Study on the Applicability of New Technologies for Diabetes Complication Management Based on Mobile Health and Wearable Devices","Inclusion Criteria:\n\n1. Confirmed diagnosis of Type 2 Diabetes;\n2. Aged ≥ 18 years;\n3. Able to accept the diabetes management model with AI-assisted management and wearable device monitoring;\n4. Able to provide complete lifestyle records, including medical history, medication status, diet, exercise, etc.;\n5. Fully understand the purpose, nature, and methods of the study, voluntarily participate in this study, accept a 3-month follow-up, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Having severe mental illness or language barriers;\n2. Suffering from malignant tumors;\n3. Pregnant or lactating women;\n4. Suspected active infections (such as active pulmonary tuberculosis, pneumonia, etc.);\n5. Severe hepatic and renal insufficiency (alanine transaminase and\u002For aspartate transaminase \\> 3 times the upper limit of normal; estimated glomerular filtration rate \\\u003C 15 mL\u002Fmin\u002F1.73 m²);\n6. A history of definite major adverse cardiovascular events and\u002For revascularization and\u002For intravenous thrombolysis and\u002For endovascular thrombectomy;\n7. Uncontrolled hyperthyroidism or hypothyroidism, pituitary-adrenal dysfunction, or other endocrine diseases;\n8. Alcoholism or drug addiction;\n9. Receiving insulin therapy;\n10. Unable to accept new comprehensive intervention technologies for various reasons (such as personal beliefs, economic factors, etc.).",{"count":97,"type":22},6000,[25],"The value of intelligent lifestyle intervention for T2D and its complications has been initially explored, but evidence-based support for the effectiveness of related AI risk prediction models and intervention models remains to be confirmed. The primary objective of this study is to verify the effectiveness of an AI model for predicting the risk of T2D complications based on phenotype, laboratory indicators and wearable device indicators, and to explore the effect and applicability of an intelligent lifestyle intervention model combining wearable devices and smartphones in preventing T2D complications.",[101,102],"Diabetes Mellitus Type 2","Diabetes Mellitus Complications","2026-05-27",{"date":105,"type":34},"2026-06-01",{"date":107,"type":34},"2025-10-01",{"date":109,"type":22},"2027-10-01",{"name":40,"class":41},{"id":112,"slug":113,"hasResults":12,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":4,"eligibilityCriteria":117,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":23,"phases":121,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":42},"100628338","effects-of-cofrogliptin-on-beta-cell-function-in-lada-patients-100628338","NCT07460336","Effects of Cofrogliptin on Beta-Cell Function in LADA Patients","Key Effects of Cofrogliptin on Beta-cell Function in Adults With Latent Autoimmune Diabetes (LADA): A Single-Center, Randomized, Controlled Trial - KOLA Study","Inclusion Criteria:\n\n* 1\\. Voluntarily signed informed consent.\n* 2\\. Age 18 to 70 years, inclusive.\n* 3\\. Diagnosed with LADA, defined as meeting all of the following:\n* (1) Meets 1999 WHO criteria for diabetes mellitus.\n* (2) Age at diagnosis of diabetes ≥ 18 years.\n* (3) Positive for at least one islet autoantibody (GADA, IA-2A, or ZnT8A).\n* (4) Did not require continuous insulin therapy for at least 6 months after diagnosis.\n* 4\\. Stimulated C-peptide ≥ 200 pmol\u002FL.\n* 5\\. Glycated Hemoglobin (HbA1c) ≤ 9.0%.\n* 6\\. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.\n\nExclusion Criteria:\n\n* 1\\. Pregnant, breastfeeding, or planning to become pregnant during the study.\n* 2\\. Gestational diabetes or other specific types of diabetes.\n* 3\\. Known hypersensitivity to Cogliptin, Vitamin D3, or their excipients.\n* 4\\. Use of DPP-4 inhibitors, GLP-1 receptor agonists, or thiazolidinediones (TZDs) within 8 weeks prior to randomization.\n* 5\\. Hypercalcemia (serum calcium above the upper limit of the normal range).\n* 6\\. Systemic corticosteroid therapy (oral or IV) for more than 7 consecutive days within 6 months prior to screening.\n* 7\\. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times the upper limit of normal (ULN), or total bilirubin \\> 2 times ULN.\n* 8\\. Estimated glomerular filtration rate (eGFR) \\\u003C 45 mL\u002Fmin\u002F1.73 m².\n* 9\\. History of acute diabetic complications such as diabetic ketoacidosis (DKA) or hyperosmolar hyperglycemic state.\n* 10\\. History of pancreatitis or pancreatic surgery.\n* 11\\. New York Heart Association (NYHA) class III or IV congestive heart failure, or known left ventricular ejection fraction (LVEF) \\\u003C 40%.\n* 12\\. History of malignancy.\n* 13\\. Severe psychiatric illness.\n* 14\\. History of alcohol or illicit drug dependence.\n* 15\\. Any other severe systemic disease that the investigator deems unsuitable for enrollment.","70 Years",{"count":120,"type":22},84,[25],"This single-center, randomized, open-label, controlled study aims to evaluate the effect of cofrogliptin on pancreatic β-cell function in adults with latent autoimmune diabetes in adults (LADA). Following a screening period of up to 6 weeks, 84 eligible participants will be randomized in a 1:1 ratio via a sealed-envelope method, stratified by baseline GADA titer (≥0.3 vs \\\u003C0.3). Participants will be assigned to one of two treatment arms: (1) metformin (with or without insulin) plus vitamin D3, or (2) metformin (with or without insulin) plus vitamin D3 and cofrogliptin. Cofrogliptin will be administered orally at a dose of 10 mg once every 2 weeks, and vitamin D3 at 2000 IU once daily, for a total treatment duration of 52 weeks. Study visits are planned at baseline and at Weeks 12, 26, 38, and 52, during which mixed-meal tolerance tests (MMTT) and other protocol-specified assessments will be conducted.",[124],"Latent Autoimmune Diabetes in Adults (LADA)",[126,127,128,129,130,131,132,133],"LADA","Adult-Onset Autoimmune Diabetes","DPP-4 inhibitor","Beta-cell Function","Randomized Controlled Trial","C-peptide","Vitamin D3","Cofrogliptin","2026-05-05",{"date":136,"type":34},"2026-05-08",{"date":138,"type":22},"2026-05-15",{"date":140,"type":22},"2027-12-31",{"name":40,"class":41},{"id":143,"slug":144,"hasResults":12,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":4,"eligibilityCriteria":148,"healthyVolunteers":12,"sex":149,"minAge":18,"maxAge":4,"enrollmentInfo":150,"targetDuration":4,"studyType":23,"phases":152,"briefSummary":153,"conditions":154,"keywords":158,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":165,"leadSponsor":167,"locationsCount":42},"100634309","effects-of-a-acceptance-and-commitment-therapy-based-psychosocial-intervention-on-mental-health-of-women-with-perinatal-loss-a-pilot-randomised-controlled-trial-100634309","NCT07538011","Effects of a Acceptance and Commitment Therapy-Based Psychosocial Intervention on Mental Health of Women With Perinatal Loss: A Pilot Randomised Controlled Trial","Effects of an Acceptance and Commitment Therapy-Based Psychosocial Intervention on Mental Health of Women With Perinatal Loss: A Pilot Study","Inclusion Criteria:\n\n* Women aged ≥18 years\n* Experienced perinatal loss (including miscarriage, stillbirth, or early neonatal death) within the past 12 months\n* Spouse\u002Fpartner willing to participate throughout the entire study\n* Able to read and communicate in Chinese\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Current diagnosis of severe mental illness (e.g., schizophrenia, bipolar disorder acute episode, psychotic disorder)\n* Active suicidal ideation with plan or intent, as assessed by clinical judgment or PHQ-9 item 9 score ≥1\n* Concurrent participation in other systematic psychotherapy or psychosocial intervention\n* Cognitive impairment that precludes understanding of the intervention content","FEMALE",{"count":151,"type":22},88,[25],"The purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary effects of an Acceptance and Commitment Therapy (ACT)-based psychosocial intervention for women who have experienced perinatal loss (miscarriage, stillbirth, or neonatal death). The intervention is a 4-week programme delivered in a mixed format: four in-person sessions (hospital setting, one-on-two with spouse\u002Fsignificant other) and two videoconferencing sessions (post-discharge, one-on-one), plus a 30-minute booster session one month after completion. Outcome assessments will occur at baseline (pre-intervention), immediately post-intervention, and three months post-intervention. Primary feasibility and acceptability metrics include recruitment, retention, session attendance, and participant-rated satisfaction. Preliminary effectiveness outcomes include perinatal grief, post-traumatic stress, depression, anxiety, psychological flexibility, and perceived social support. A qualitative component (semi-structured interviews) will explore participants' experiences and suggestions for refinement.",[155,156,157],"ACT","Perinatal Loss","Mental Health",[155,157,159,160],"perinatal loss","Pilot RCT","2026-04-26",{"date":163,"type":34},"2026-04-30",{"date":105,"type":22},{"date":166,"type":22},"2027-06-30",{"name":40,"class":41},{"id":169,"slug":170,"hasResults":12,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":149,"minAge":18,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":23,"phases":176,"briefSummary":178,"conditions":179,"keywords":182,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":189,"completionDateStruct":190,"leadSponsor":192,"locationsCount":42},"100618966","phase-1-a-clinical-study-of-nanocrystalline-megestrol-acetate-in-concurrent-chemoradiotherapy-for-locally-advanced-cervical-cancer-100618966","NCT07338487","A Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","A Prospective, Randomized, Parallel-Controlled Clinical Study of Nanocrystalline Megestrol Acetate in Concurrent Chemoradiotherapy for Locally Advanced Cervical Cancer","Eligibility Criteria:\n\n1. Voluntarily sign the written ICF.\n2. Age ≥ 18 years at the time of enrollment.\n3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.\n4. Expected survival period ≥ 6 months.\n5. Histologically or cytologically confirmed locally advanced cervical cancer (Stage IB3\u002FIIA2\u002FIIB-IVA) that is not amenable to complete surgical resection, classified according to the International Federation of Gynecology and Obstetrics (FIGO) staging system.\n6. Scheduled to undergo radical concurrent chemoradiotherapy.\n7. At least one measurable tumor lesion according to RECIST v1.1.\n8. Adequate organ function defined as follows:\n\n   a) Hematology (without any blood component or growth factor support within 7 days prior to initiation of study treatment): i. Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL (1,500\u002Fmm³); ii. Platelet count ≥ 100 × 10⁹\u002FL (100,000\u002Fmm³); iii. Hemoglobin ≥ 90 g\u002FL. b) Renal: i. Calculated creatinine clearance\\* (CrCl) ≥ 50 mL\u002Fmin\n   * CrCl will be calculated using the Cockcroft-Gault formula:\n\n   CrCl (mL\u002Fmin) = (140 - age) × weight (kg) × F \u002F (serum creatinine \\[mg\u002FdL\\] × 72) F = 1 for males; F = 0.85 for females ii. Urine protein ≤ 1+ or 24-hour urinary protein quantification \\\u003C 1.0 g. c) Hepatic: i. Total bilirubin (TBil) ≤ 1.5 × ULN; for patients with liver metastases or confirmed\u002Fsuspected Gilbert's disease, TBil ≤ 3 × ULN; ii. AST and ALT ≤ 2.5 × ULN; for patients with liver metastases, AST and ALT ≤ 5 × ULN; iii. Serum albumin (ALB) ≥ 28 g\u002FL. d) Coagulation: i. International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (unless the patient is receiving anticoagulant therapy and coagulation parameters \\[PT\u002FINR and APTT\\] are within the therapeutic range at screening).\n\n   e) Cardiac: i. Left ventricular ejection fraction (LVEF) ≥ 50%.\n9. Female patients of childbearing potential must have a negative urine or serum pregnancy test within 3 days prior to the first dose (if urine pregnancy test result is not confirmed negative, a serum pregnancy test will be required, and the serum result shall prevail). If a female patient of childbearing potential engages in sexual activity with a non-sterilized male partner, she must use acceptable contraceptive methods starting from screening and continue for 120 days after the last dose of study drug; whether to discontinue contraception after this time point should be discussed with the investigator. If a non-sterilized male patient engages in sexual activity with a female partner of childbearing potential, he must use effective contraceptive methods from screening until 120 days after the last dose; whether to discontinue contraception after this time point should be discussed with the investigator.\n10. The patient is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study requirements.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be ineligible for this study:\n\n1. Conditions affecting gastrointestinal absorption such as dysphagia, malabsorption, or uncontrolled vomiting; ongoing tube feeding or parenteral nutrition; presence of anorexia nervosa, psychogenic anorexia, or pain-induced feeding difficulties.\n2. Current or planned use of medications that increase appetite or weight, including but not limited to: adrenal corticosteroids (except short-term dexamethasone during chemotherapy), androgens, progestins, thalidomide, olanzapine, anamorelin, or other appetite stimulants.\n3. Diagnosis of Cushing's syndrome, adrenal or pituitary insufficiency; poorly controlled diabetes mellitus.\n4. Current radiographic or clinical evidence of gastrointestinal obstruction.\n5. Active autoimmune disease requiring systemic treatment within the past two years (e.g., disease-modifying agents, corticosteroids, immunosuppressants). History of non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic glucocorticoid therapy, or current non-infectious pneumonitis.\n6. Uncontrolled concurrent illnesses including but not limited to decompensated cirrhosis, renal failure, uncontrolled metabolic disorders, severe active peptic ulcer disease\u002Fgastritis, or psychiatric\u002Fsocial conditions that would limit compliance with study requirements or the ability to provide written informed consent.\n7. Within 12 months prior to the first dose: unstable angina requiring hospitalization, myocardial infarction, congestive heart failure (NYHA Class II or higher), vascular disease (e.g., aortic aneurysm at risk of rupture), or other cardiac impairments that may affect safety evaluation of the study drug (e.g., poorly controlled arrhythmia, myocardial ischemia). Within 6 months prior to the first dose: history of esophagogastric varices, severe ulcers, gastrointestinal perforation and\u002For fistula, gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), intra-abdominal abscess, or acute gastrointestinal bleeding.\n8. Within 6 months prior to the first dose: any arterial thromboembolic events, Grade 3 or higher venous thromboembolism per NCI CTCAE v5.0 requiring urgent intervention (e.g., pulmonary embolism or intracardiac thrombosis), transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy. Within 1 month prior to the first dose: acute exacerbation of chronic obstructive pulmonary disease. Current hypertension with systolic BP ≥160 mmHg or diastolic BP ≥100 mmHg despite oral antihypertensive therapy.\n9. History of severe bleeding tendency or coagulopathy; clinically significant bleeding symptoms within 1 month prior to the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing\u002Fexpectorating ≥1 teaspoon of fresh blood or small clots, or blood without sputum; patients with blood-tinged sputum are eligible), epistaxis (excluding minor nasal bleeding and blood-tinged postnasal drip).\n10. Within 4 weeks prior to the first dose: severe infections including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; within 2 weeks prior to the first dose: active infection requiring systemic antimicrobial therapy (excluding antiviral therapy for hepatitis B\u002FC).\n11. Any condition, treatment, or laboratory abnormality that may confound study results, impede complete study participation, or make participation not in the patient's best interest.",{"count":151,"type":22},[177],"PHASE1","Cervical cancer, ranking as the fourth most prevalent malignancy in women globally, presents significant challenges in nutritional management. Approximately 31% of patients develop cancer-related malnutrition\u002Fcachexia, with 10-20% of deaths directly attributable to nutritional depletion. The disease process and its treatment - particularly concurrent chemoradiotherapy (CCRT) - create a destructive cycle through multiple mechanisms. Tumor-derived factors (including activins and myostatin) and inflammatory cytokines (such as TNF-α and IL-6) actively promote muscle and fat catabolism. CCRT toxicity, especially from platinum-based drugs, worsens this condition by inducing mitochondrial dysfunction and accelerating protein degradation, leading to clinically significant sarcopenia. This metabolic disruption has dire consequences, with studies showing severe weight loss during CCRT correlating with a 2.37-fold increase in mortality risk (HR 2.37, p=0.036).\n\nNanocrystalline megestrol acetate (MA) emerges as a promising therapeutic intervention with dual mechanisms of action. Centrally, it modulates D2 receptors to upregulate neuropeptide Y (NPY), effectively stimulating appetite. Peripherally, it suppresses key inflammatory cytokines (IL-6 and TNF-α), thereby reducing systemic inflammation and muscle wasting. Its efficacy is well-established, with endorsement from major oncology guidelines (ASCO, NCCN, ESMO) for cancer cachexia management. A comprehensive meta-analysis of 35 clinical trials involving 4,234 patients demonstrated MA's superiority over placebo, showing significant improvements in appetite (RR 2.2), weight gain (RR 1.6), and quality of life (RR 1.8).\n\nThe nanocrystalline formulation represents a substantial pharmacological advancement over conventional MA. While traditional preparations have limited solubility (2 µg\u002FmL) and require high-fat meals for adequate absorption, the nanocrystalline version (with particles reduced to 26.6 nm) demonstrates 22% greater bioavailability. This translates to clinically meaningful differences: fasting-state peak concentrations increase from 187 ng\u002FmL to 1,133 ng\u002FmL, the time to observable effect shortens from 14 days to just 3 days, and 12-week weight gain improves from 3.5 kg to 5.4 kg (with 40% being lean mass). Dose optimization studies confirm 800 mg\u002Fday as the optimal conventional MA dose, with the nanocrystalline equivalent being 625 mg\u002Fday due to its enhanced bioavailability.\n\nThe proposed clinical investigation will evaluate this intervention in FIGO IB3-IVA cervical cancer patients (n=5) undergoing CCRT. The study employs a two-arm design comparing nanocrystalline MA (625 mg\u002Fday) plus CCRT against CCRT alone. Primary endpoints focus on BMI changes at 8 weeks, with secondary assessments of nutritional status, inflammatory markers, and quality of life measures. This research aims to establish nanocrystalline MA as a means to break the cachexia cycle in cervical cancer treatment, potentially improving both treatment tolerance and survival outcomes.",[180,181],"Locally Advanced Cervical Cancer","Cachexia",[180,183,181,184,185],"Nanocrystalline Megestrol Acetate","Clinical Research","Control Group","2026-04-23",{"date":188,"type":34},"2026-04-24",{"date":163,"type":22},{"date":191,"type":22},"2026-12-05",{"name":40,"class":41},{"id":194,"slug":195,"hasResults":12,"nctId":196,"briefTitle":197,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":199,"targetDuration":201,"studyType":74,"phases":4,"briefSummary":202,"conditions":203,"keywords":206,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},"100477592","china-diabetes-type-1-study-cd1s-by-china-alliance-for-type-1-diabetes-100477592","NCT05498974","China Diabetes Type 1 Study (CD1S) by China Alliance for Type 1 Diabetes","Inclusion Criteria:\n\n* 1\\. Patients with type 1 diabetes mellitus of any duration; meeting criteria (1) or any of (2) or any of (3)\n\n  1. Clinical diagnosis of type 1 diabetes by a specialist\n  2. Age at onset \\\u003C 15 years; no overweight or obesity at onset; previous diabetic ketoacidosis; highest random C-peptide \\\u003C 200 pmol\u002FL\n  3. Initiation and continuation of insulin therapy (except pancreatic or islet transplantation) after diagnosis; positive islet autoantibodies Or 2. Children and adolescents with diabetes mellitus at age of onset \\\u003C= 20 years, regardless of type and duration of disease.\n\nExclusion Criteria:\n\n* For enrolment of patients with T1D, exclusion was made if any of the following criteria were met (not applicable to those with onset under 20 years of age)\n\n  * No insulin dependence for at least 6 months after diagnosis of diabetes mellitus.\n\n    * No DKA for 1 month off insulin for those with a history of diabetes \\> 1 year. ③ C-peptide \\> 800 pmol\u002FL at any time point.",{"count":200,"type":22},20000,"10 Years","The aim of the China Diabetes Type 1 Study (CD1S) is to conduct a nationwide type 1 diabetes (T1D) registry study in patients with T1D and in pediatric adolescent patients with diabetes who had an age of onset \\\u003C= 20 years.\n\nCD1S compromises a retrospective study enrolling inpatients hospitalized from Jan 1st, 2016 to Dec 31, 2021, and a prospective study beginning from the year 2022.",[204,205],"Type1diabetes","Diabetes",[207],"Type 1 diabetes; Diabetes in Young",{"date":209,"type":34},"2026-04-28",{"date":211,"type":34},"2022-01-01",{"date":213,"type":22},"2035-12-31",{"name":40,"class":41},11,{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":118,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":225,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":240,"locationsCount":241},"100635887","evaluation-of-chiglitazar-sodium-with-lifestyle-intervention-for-reversing-prediabetes-100635887","NCT07558525","Evaluation of Chiglitazar Sodium With Lifestyle Intervention for Reversing Prediabetes","Prediabetes Reversion Through Combined Intervention and Strict Evaluation Trial: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study on the Efficacy of Chiglitazar Sodium Combined With Lifestyle Intervention in Restoring Normal Glucose Tolerance in Prediabetic Patients","Inclusion Criteria:\n\n1.Voluntarily signed informed consent. 2. Age 18 to 70 years, inclusive. 3. Diagnosed with prediabetes according to the Chinese expert consensus on intervention for adults with pre-diabetes (2023 edition), meeting any of the following criteria:\n\n1. Impaired fasting glucose (IFG): fasting plasma glucose (FPG) ≥ 6.1 mmol\u002FL and \\\u003C 7.0 mmol\u002FL, with 2-hour postprandial glucose (2hPG) \\\u003C 7.8 mmol\u002FL and HbA1c \\\u003C 6.5%\n2. Impaired glucose tolerance (IGT): FPG \\\u003C 6.1 mmol\u002FL, with 2hPG ≥ 7.8 mmol\u002FL and \\\u003C 11.1 mmol\u002FL, and HbA1c \\\u003C 6.5%\n3. IFG + IGT, with HbA1c \\\u003C 6.5%\n4. HbA1c 5.7% to 6.4% (inclusive), with FPG and OGTT 2hPG not meeting diabetes diagnostic criteria 4. Body Mass Index (BMI) 20-32 kg\u002Fm². 5. For women of childbearing potential, must agree to use a highly effective method of contraception throughout the study.\n\nExclusion Criteria:\n\n1. Use of glucose-lowering medications within 3 months prior to screening.\n2. Major cardiovascular or cerebrovascular events within 6 months prior to screening, defined as:\n\n1)Acute myocardial infarction, coronary angioplasty or bypass surgery, valvular heart disease or valve repair, severe arrhythmias (e.g., ventricular fibrillation, atrial flutter, atrial fibrillation, etc.), unstable angina, transient ischemic attack, ischemic stroke, or hemorrhagic stroke 2)New York Heart Association (NYHA) class III or IV congestive heart failure 3)Current use of loop diuretics or digitalis 3.Uncontrolled hypertension: systolic blood pressure (SBP) ≥ 160 mmHg and\u002For diastolic blood pressure (DBP) ≥ 100 mmHg despite treatment, or use of three or more antihypertensive agents with inadequate control (SBP ≥ 160 mmHg or DBP ≥ 100 mmHg).\n\n4.eGFR ≤ 15 mL\u002Fmin\u002F1.73 m² (CKD-EPI Creatinine Equation 2021). 5.Urinary albumin-to-creatinine ratio (UACR) \\> 300 mg\u002Fg. 6.Hemoglobin \\\u003C 110 g\u002FL. 7.Fasting triglycerides \\> 5.6 mmol\u002FL (500 mg\u002FdL). 8.Active liver disease or significant hepatic dysfunction, defined as AST \\> 2.5×ULN and\u002For ALT \\> 2.5×ULN and\u002For total bilirubin \\> 1.5×ULN.\n\n9.Severe pulmonary disease with treatments that may potentially affect glucose metabolism (e.g., inhaled corticosteroids, beta-agonists).\n\n10.History of acute or chronic pancreatitis, or history of gallbladder or bile duct disease (except post-cholecystectomy for gallstones or cholecystitis).\n\n11.Gastrointestinal disorders affecting gastric emptying, such as gastroparesis, postoperative gastric stasis, idiopathic gastroparesis, gastroesophageal reflux disease, pyloric stenosis or obstruction, intestinal obstruction; severe chronic gastrointestinal disease (e.g., active ulcer, intestinal tuberculosis within 6 months prior to screening); history of frequent nausea, vomiting, or irregular gastrointestinal motility from any cause (e.g., habitual diarrhea, habitual constipation, inflammatory bowel disease, irritable bowel syndrome); or long-term use of medications directly affecting gastrointestinal motility.\n\n12.Recent abdominal surgery or history of major abdominal surgery. 13.Thyroid dysfunction or other endocrine diseases affecting glucose metabolism (Cushing's syndrome, acromegaly, pheochromocytoma, prolactinoma, etc.), except stable treated hypothyroidism (for 3 months) or subclinical hypothyroidism not requiring treatment.\n\n14.History of malignancy within 5 years prior to screening, or current malignancy.\n\n15.History of tuberculosis or current use of anti-tuberculosis medications. 16.Current use of antipsychotic agents, alcohol abuse, or drug dependence. 17.Current use of thiazide diuretics, beta-blockers, nicotinic acid for lipid-lowering, systemic glucocorticoids, or weight-loss medications.\n\n18.Known hypersensitivity to Chiglitazar Sodium or its components. 19.Pregnancy or breastfeeding. 20.Unexplained weight loss \\> 10% of baseline body weight within 6 months prior to screening.\n\n21.Participation in another clinical trial within 3 months prior to screening. 22.Any other condition that, in the investigator's judgment, would preclude the participant from completing the study or pose significant risk to the participant.",{"count":224,"type":22},472,[25],"This multicenter, randomized, double-blind, placebo-controlled trial aims to evaluate the efficacy and safety of Chiglitazar Sodium combined with lifestyle intervention for reversing prediabetes to normal glucose metabolism. Eligible participants with prediabetes will be randomized 1:1 to receive either Chiglitazar Sodium 48 mg once daily or matching placebo, both combined with standardized lifestyle intervention, for 52 weeks, followed by a 12-week observation period and optional long-term extension. The primary endpoint is the reversion rate to normal glucose metabolism at week 64. Secondary endpoints include progression to type 2 diabetes, glycemic control, lipid profile, blood pressure, UACR, HOMA-IR, HOMA-β, body weight, BMI, and waist-to-height ratio. Exploratory endpoints include inflammatory markers and long-term cardiovascular outcomes. Safety endpoints include adverse events, vital signs, ECG, and laboratory parameters.",[228],"Prediabetes",[230,231,228,232,233,234],"Chiglitazar Sodium","PPAR agonist","Impaired Glucose Tolerance","Impaired Fasting Glucose","Lifestyle Intervention","2026-04-22",{"date":163,"type":34},{"date":238,"type":22},"2026-04-18",{"date":87,"type":22},{"name":40,"class":41},30,{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":4,"eligibilityCriteria":248,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":249,"targetDuration":4,"studyType":23,"phases":251,"briefSummary":252,"conditions":253,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100614388","act-based-parenting-program-for-caregivers-of-children-with-hearing-loss-post-cochlear-a-pilot-randomised-controlled-trial-100614388","NCT07278947","ACT-based Parenting Program for Caregivers of Children With Hearing Loss Post-cochlear: A Pilot Randomised Controlled Trial","Effects of an Online Psychoeducational and Psychotherapeutic Programme for Caregivers of Children With Hearing Loss Post-Cochlear Implantation: A Pilot Randomised Controlled Trial","Inclusion Criteria:\n\n1. Mandarin-speaking Chinese residents aged ≥18 years.\n2. Their child is scheduled to undergo cochlear implant surgery within the next month or has undergone cochlear implant surgery within the past month.\n3. Living with their child with hearing loss who uses (or will use) a cochlear implant.\n4. Primary caregiver responsible for the child's daily care.\n5. Has reliable internet access via a computer and\u002For smartphone for video-conferencing (e.g., TenCent Meeting, Zoom) and is willing to maintain access for the duration of the intervention.\n\nExclusion Criteria:\n\n1. Parents with cognitive deficiency, severe mental illness and\u002For disability conditions that interfere with their ability to comprehend the programme's content.\n2. Current substance or alcohol dependence.\n3. Pregnancy or postpartum period (\\\u003C6 months).\n4. Participation in any ACT-based intervention within the past six months.",{"count":250,"type":22},64,[25],"The purpose of the proposed pilot randomized controlled design study is to evaluate the feasibility, acceptability, and potential effectiveness of using a videoconferencing-based individual Acceptance and Commitment Therapy (ACT) approach to enhance the mental well-being and parenting competence of parents of children with hearing loss post-cochlear implantation over a three-month period after the intervention has taken place.",[254,255,256],"Hearing Loss","Stress","Depression, Anxiety","2026-03-16",{"date":259,"type":34},"2026-03-17",{"date":261,"type":22},"2026-03-28",{"date":263,"type":22},"2026-12-31",{"name":40,"class":41},{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":23,"phases":275,"briefSummary":277,"conditions":278,"keywords":281,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100589225","phase-2-ctdna-mrd-guided-escalation-of-ivonescimab-and-docetaxel-in-advanced-nsclc-with-long-term-responses-to-first-line-immunotherapy-cr1stal-adaptive-100589225","NCT06951646","ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy (CR1STAL-Adaptive)","ctDNA-MRD Guided Escalation of Ivonescimab and Docetaxel in Advanced NSCLC With Long-Term Responses to First-line Immunotherapy: a Randomized, Open-label, Phase II Trial (CR1STAL-Adaptive)","Inclusion Criteria:\n\n1. Sign written informed consent prior to any study-related procedures, be willing and able to complete the visits, treatment regimen, and laboratory tests specified in the schedule, and comply with other requirements of the study;\n2. Aged ≥18 and ≤75 years old;\n3. ECOG PS score 0-1;\n4. Expected survival time ≥ 12 weeks;\n5. Patients with stage IIIB-IIIC and IV non-small cell lung cancer confirmed by histology or cytology that cannot be treated locally (TNM lung cancer staging of the 9th edition of the International Association for the Study of Lung Cancer and the American Joint Committee on Cancer Classification);\n6. There must be no EGFR gene-sensitive mutation, ALK gene fusion or ROS1 gene fusion in non-squamous carcinoma\n7. Immunotherapy combined with platinum-containing doublet chemotherapy as a first-line standard treatment regimen;\n8. Non-PD with PFS at screening enrollment is 11 to 15 months;\n9. According to the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1), it is recommended to have at least one measurable lesion, but patients without measurable lesions can still be included in the group (primary tumor recurrence or new metastatic lesions are considered PD).\n\nParticipants with brain metastases who are asymptomatic or whose symptoms are stable after local treatment are allowed to enroll, as long as the participants meet the following conditions:\n\n1. There are measurable lesions outside the central nervous system\n2. No central nervous system symptoms or no worsening of symptoms for at least 2 weeks\n3. No need for glucocorticoid treatment, or glucocorticoid treatment was discontinued within 7 days before the first dose, or the glucocorticoid dosage was stable and reduced to less than 10mg\u002Fday prednisone (or equivalent dose) within 7 days before the first dose.\n\n10\\. Meet the following laboratory indicators (within 14 days before the first treatment):\n\n1. Routine blood test: absolute neutrophil count ≥1.5×109\u002FL; platelet count ≥100×109\u002FL; hemoglobin content ≥9.0 g\u002FdL (no blood transfusion or erythropoietin-dependent administration within 7 days).\n2. Liver function: total bilirubin (TBIL) ≤1.5×upper limit of normal (ULN); for patients with liver metastasis or confirmed\u002Fsuspected Gilbert's syndrome, TBIL ≤3×ULN; in the absence of liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN. For patients with liver metastasis, ALT or AST ≤5×ULN.\n3. Renal function: serum creatinine (Cr) ≤ 1.5 times ULN or Cr clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula), and urine routine test results show urine protein (UPRO) \\\u003C2+ or 24-hour urine protein quantification \\\u003C1g.\n4. Coagulation function: international normalized ratio (INR) ≤ 1.5 times ULN or partial thromboplastin time (PTT) or activated partial thromboplastin time (APTT) ≤ 1.5 times ULN; if the study participants are receiving anticoagulant therapy, as long as PT is within the range of the anticoagulant drug;\n5. Cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% 11. For female study participants of childbearing age, a urine or serum pregnancy test with a negative result should be performed within 3 days before the first dose of study drug (Day 1 of Cycle 1). If the urine pregnancy test result cannot be confirmed as negative, a blood pregnancy test is required. Women of non-childbearing age are defined as women who have been postmenopausal for at least 1 year, or have undergone surgical sterilization or hysterectomy; if there is a risk of pregnancy, all study participants (whether male or female) must use contraceptive measures with an annual failure rate of less than 1% throughout the treatment period until 120 days after the last dose of study drug (or 180 days after the last dose of study drug).\n\n12\\. If an intact male study participant has sexual intercourse with a female partner of reproductive potential, the study participant must use effective contraception from screening until day 120 after the last dose. Whether to discontinue contraception after this time point should be discussed with the investigator.\n\nExclusion Criteria:\n\n1. Concurrent participation in another interventional clinical study or receipt of another investigational drug, unless participating in an observational clinical study；\n2. Systemic therapy with proprietary Chinese medicines with anti-tumor indications or immunomodulatory drugs (including thiopeptides, interferons, interleukins, except those used locally for the control of hydrothorax or ascites) within 2 weeks prior to the first dose；\n3. No measurable lesions as defined by RECIST 1.1 due to prior radical treatment (e.g., surgery or radiotherapy)\n4. Subjects who have received systemic antiangiogenic therapy;\n5. Subjects who are enrolled in another clinical study at the same time, unless it is a non-interventional clinical study or the follow-up period of an interventional study (defined as the time between the first dose of this study and the last dose of the previous clinical study being more than 4 weeks or more than 5 half-lives of other study drugs, whichever is shorter);\n6. During the screening period, imaging shows that the tumor surrounds important blood vessels or there is significant necrosis or cavity, and the investigator determines that entering the study will cause a risk of bleeding;\n7. Imaging findings during the screening period show that the tumor invades important peripheral organs and blood vessels (such as the heart and pericardium, trachea, esophagus, aorta, superior vena cava, etc.) or there is a risk of developing esophagotracheal fistula or esophagopleural fistula;\n8. Active autoimmune diseases requiring systemic treatment (such as treatment with disease-modifying drugs, corticosteroids, and immunosuppressants) within 2 years before the first dose (excluding irAEs caused by the use of PD-1\u002FL1 inhibitors). Replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a systemic treatment;\n9. A history of major diseases within 1 year before the first dose, specifically:\n\n   * Unstable angina, myocardial infarction, congestive heart failure (NYHA classification ≥ Class 2) or vascular diseases (such as aortic aneurysm with a risk of rupture) that require hospitalization within 12 months before the first dose, or other cardiac damage that may affect the safety evaluation of the study drug (such as poorly controlled arrhythmia, myocardial ischemia, etc.);\n   * Hepatic encephalopathy, hepatorenal syndrome or Child-Pugh class B or more severe cirrhosis\n   * Current hypertension with systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg after oral antihypertensive therapy;\n   * Hyperglycemia that cannot be controlled after treatment (fasting blood glucose \\> 10 mmol\u002FL);\n   * A history of esophageal and gastric varices, with severe ulcers and unresolved wounds, abdominal fistulas, intraabdominal abscesses, or acute gastrointestinal bleeding within 6 months before the first dose;\n   * Any arterial thromboembolic events, venous thromboembolic events of grade 3 orabove as specified in NCI CTCAE 5.0, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy that occurred within 6 months before the first dose;\n   * Acute exacerbation of chronic obstructive pulmonary disease that occurred within 4 weeks before the first dose;\n   * Active or prior history of inflammatory bowel disease (such as Crohn's disease, ulcerative colitis, or chronic diarrhea);\n10. A history of gastrointestinal perforation and\u002For fistula, a history of gastrointestinal obstruction (including incomplete intestinal obstruction requiring parenteral nutrition), or extensive bowel resection (partial colon resection or extensive small bowel resection, with chronic diarrhea) within 6 months before the first dose;\n11. Those who have received chest radiotherapy \\>30 Gy within 6 months before the first dose, non-chest radiotherapy \\>30 Gy within 4 weeks before the first dose, and palliative radiotherapy ≤ 30 Gy within 2 weeks before the first dose, and who have not recoveredfrom the toxicity and\u002For complications of these interventions to NCI-CTC AE ≤ grade 1 (excluding alopecia and fatigue). Palliative radiotherapy to control symptoms is allowed, but it must be completed at least 2 weeks before the first dose, and no additional radiotherapy is scheduled for the same lesion;\n12. Those who have received live or live attenuated vaccines within 4 weeks before the first dose, or plan to receive live or live attenuated vaccines during the study period. The use of inactivated vaccines is allowed;\n13. Severe infections within 4 weeks before the first dose, including but not limited to complications requiring hospitalization such as sepsis, or severe pneumonia; active infections that have received systemic anti-infective treatment within 2 weeks before the first dose (excluding antiviral treatment for hepatitis B or C);\n14. Those with a history of severe bleeding tendencies or coagulation disorders; those with clinically significant bleeding symptoms within 4 weeks before the first dose, including but not limited to gastrointestinal bleeding, hemoptysis (defined as coughing up or vomiting up ≥ 1 teaspoon of blood or small blood clots, or only coughing up blood without sputum; those with blood in the sputum are allowed to be enrolled), nasal bleeding (excluding epistaxis and bloody nasal discharge); those who have received continuous antiplatelet or anticoagulant therapy (except for preventive use of anticoagulants, such as the use of anticoagulants to maintain venous patency) within 14 days before the first dose;\n15. Those who have undergone major surgery or experienced severe trauma within 4 weeks before the first dose, or have a major surgery planned within 4 weeks after the first dose (as determined by the investigator);\n16. Presence of clinically uncontrolled pleural effusion or ascites (subjects may be recruited who do not require drainage of the effusion or who do not have a significant increase in the effusion after 3 days of cessation of drainage)\n17. Previous history of non-infectious pneumonia requiring systemic glucocorticoid treatment or current interstitial lung disease;\n18. Those with a history of immunodeficiency; those with positive HIV antibody tests;\n19. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;\n20. Subjects with untreated active hepatitis B (HBsAg positive and HBV-DNA \\> 1000 copies\u002FmL (200 IU\u002FmL) or above the lower limit of detection, whichever is higher), for subjects with hepatitis B who are required to receive anti-hepatitis B virus treatment during the study treatment period; subjects with active hepatitis C subjects (HCV antibody positive and HCV-RNA levels above the lower limit of detection);\n21. Known presence of active pulmonary tuberculosis (TB);\n22. Known active syphilis infection;\n23. Known allergy to any component of any study drug; a known history of severe hypersensitivity to other monoclonal antibodies\n24. Those with a history of immunodeficienc; those who are currently receiving long-term systemic corticosteroids or other immunosuppressants;\n25. A known history of mental illness, drug abuse, alcohol or drug addiction;\n26. The toxicity of previous anti-tumor therapy has not been relieved, which is defined as the toxicity has not returned to grade 1 or below specified in NCI CTCAE 5.0, or the level specified in the inclusion\u002Fexclusion criteria, except for alopecia and fatigue;\n27. Known symptomatic CNS metastases and\u002For carcinomatous meningitis. Subjects with previously treated brain metastases may be enrolled in the trial if they are clinically stable (no evidence of imaging progression for at least 4 weeks prior to the first dose of the experimental treatment, no evidence of new brain metastases or increase in size of pre-existing brain metastases as confirmed by repeat imaging) and do not require steroid therapy for at least 14 days prior to the first dose of the experimental treatment. This exception does not include carcinomatous meningitis, which should be excluded regardless of whether it is clinically stable.\n28. History of other primary malignancies within 5 years, except：\n\n    * malignancies that have been in complete remission for at least 2 years prior to enrolment and for which no other treatment was required during the study period.\n    * adequately treated non-melanoma skin cancer or malignant nevus with no evidence of disease recurrence.\n    * adequately treated carcinoma in situ without evidence of disease recurrence\n29. Subjects who are pregnant or breastfeeding or plan to breastfeed during the study;\n30. Other acute or chronic illnesses, psychiatric disorders, or abnormal laboratory test values that could increase the risks associated with study participation or study drug administration or interfere with the interpretation of study results and, in the investigator's judgment, render the patient ineligible for participation in the study.\n31. Uncontrolled metabolic disorders, or local or systemic diseases due to non-malignant tumors, or diseases or symptoms secondary to the tumor, which may lead to higher medical risk and\u002For uncertainty in survival assessment, or diseases that the investigator considers unsuitable for enrollment;","75 Years",{"count":274,"type":22},70,[276],"PHASE2","The CR1STAL-Adaptive study is a randomized, open-label, phase II multicenter interventional trial designed to evaluate the safety and efficacy of Ivonescimab (PD-1\u002FVEGF bispecific antibody) combined with docetaxel versus standard treatment in patients with advanced NSCLC who have achieved long-term benefit from first-line immune checkpoint inhibitors (ICIs), but are ctDNA-MRD positive. Building upon insights from previous CR1STAL study (NCT05198154), the CR1STAL-Adaptive study supports the development of precision-guided, adaptive treatment strategies to delay progression and improve outcomes in NSCLC patients with a long-term response to immunotherapy. It represents a step forward in integrating dynamic molecular monitoring with individualized intervention strategies in the era of immunotherapy.",[279,280],"Non Small Cell Lung Cancer","Immune Checkpoint Inhibitors (ICIs)",[282,280,283,284,285,286,287,288],"Non Small Cell Lung Cancer (NSCLC)","Circulating-tumor DNA (ctDNA)","Minimal Residual Disease (MRD)","Ivonescimab (AK112)","Adaptive Therapy","Bispecific Antibody","Escalation","2026-03-06",{"date":291,"type":34},"2026-03-09",{"date":293,"type":22},"2026-03-10",{"date":295,"type":22},"2030-06-01",{"name":40,"class":41},20,{"id":299,"slug":300,"hasResults":12,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":4,"eligibilityCriteria":304,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":305,"enrollmentInfo":306,"targetDuration":4,"studyType":23,"phases":308,"briefSummary":309,"conditions":310,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":4},"100533546","phase-2-efficacy-and-safety-of-sorafenib-in-new-onset-type-1-diabetes-mellitus-100533546","NCT06227221","Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus","A Phase 2, Randomized, Placebo Controlled Study Investigating the Efficacy and Safety of Sorafenib in New-Onset Type 1 Diabetes Mellitus","Inclusion Criteria:\n\n1. Subjects with written informed consent;\n2. Age: 18-60 years;\n3. Diagnosis of T1DM according to ADA criteria within 1 year prior to starting study drug;\n4. Islet autoantibody positivity (one or more of GADA, IA-2A, ZnT8A);\n5. Stimulated C-peptide \\> 200 pmol\u002FL;\n6. Participants of childbearing age who are sexually active must agree to use of effective birth control until the end of the study\n\nExclusion Criteria:\n\n1. Non-Type 1 Diabetes Mellitus.\n2. Signs of chronic active infection (e.g., hepatitis, tuberculosis, cytomegalovirus, Epstein-Barr virus, herpes zoster, or toxoplasmosis), or screening laboratory evidence consistent with chronic active infection:\n\n   * Positivity for human immunodeficiency virus\n   * Positive purified protein derivative or interferon-γ release assay suggestive of tuberculosis\n   * Positivity for hepatitis B surface antigen And acute infections (e.g., respiratory, urinary tract, or gastrointestinal infections) must be resolved before reevaluation;\n3. Severe hypertension (systolic blood pressure \\> 200 mmHg and\u002For diastolic blood pressure \\> 110 mmHg, or those requiring the concurrent use of 3 or more antihypertensive medications);\n4. Previous or current cerebro-cardiovascular diseases:\n\n   * Congestive heart failure (NYHA Class III-IV)\n   * Myocardial infarction\n   * unstable ischemic heart disease,\n   * Arrhythmia\n   * Syncope of cardiac or unknown origin\n   * Structural defects\n   * Signs of QT prolongation on electrocardiogram (450 ms in men, 470 ms in women)\n   * Stroke\n   * Transient Ischemic Attack\n5. Hematological conditions:\n\n   * Anemia (hemoglobin below 120 g\u002FL in men and 110 g\u002FL in women)\n   * Leukopenia (\\\u003C4000 leukocytes per μL)\n   * Thrombocytopenia (\\\u003C100,000 platelets per μL)\n   * Neutropenia (\\\u003C1500 neutrophils per μL)\n6. Abnormal coagulation function during the screening period: Prothrombin time (PT) is prolonged beyond the upper limit of normal for 3 seconds and\u002For activated partial thromboplastin time (APTT) is prolonged beyond the upper limit of normal for 10 seconds;\n7. Liver and renal dysfunction:\n\n   * acute or chronic active hepatitis\n   * alanine aminotransferase or aspartate aminotransferase \\>2·0 times the upper limit of normal persisting for persisting for more than one week\n   * impaired renal function defined by estimated glomerular filtration rate (according to the CKD-EPI) of \\\u003C 60 mL\u002Fmin\u002F1.73 m2\n8. History of severe gastrointestinal diseases such as gastrointestinal ulcers, gastrointestinal hemorrhage, pyloric stenosis, gastric bypass surgery, acute or chronic pancreatitis, etc;\n9. Have had any major surgery within 8 weeks prior to screening or will require major surgery during the study;\n10. Anticipated ongoing use of diabetes medications other than insulin;\n11. Known hypersensitivity to sorafenib, or history of severe allergic reactions to other medications (e.g., anaphylaxis, angio-edema, or serious cutaneous drug reactions);\n12. Use of medications in the last month known to cause an ongoing change in the course of type 1 diabetes or immunological status (e.g., high-dose inhaled, extensive topical, or systemic glucocorticoids);\n13. Previous treatment with sorefenib or related multikinase inhibitor;\n14. Concurrent use of medications that affect cytochrome P450 3A4 or use of drugs that interact with sorefenib, leading to altered plasma concentrations of the drugs;\n15. For men: unwilling to adopt contraception during the whole study period;\n16. For women:\n\n    * Pregnancy or breastfeeding\n    * Less than 100 days postpartum before enrollment\n    * Unwilling to defer pregnancy during the 1-year study period\n17. Known coagulation disorders or use of anticoagulants (e.g., warfarin, rivaroxaban, or low molecular weight heparin);\n18. Other situations in which the investigator considers it inappropriate to participate in this trial.","60 Years",{"count":307,"type":22},10,[276],"The purpose of this study is to investigate the therapeutic effect and safety of Sorafenib in T1DM patients.",[311],"Type 1 Diabetes","2026-02-09",{"date":314,"type":34},"2026-02-12",{"date":316,"type":22},"2026-02",{"date":318,"type":22},"2029-06",{"name":40,"class":41},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":305,"enrollmentInfo":328,"targetDuration":330,"studyType":74,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":337,"lastUpdatePostDateStruct":338,"startDateStruct":340,"completionDateStruct":342,"leadSponsor":344,"locationsCount":4},"100619325","multimodal-brain-function-in-migraine-patients-with-patent-foramen-ovale-100619325","NCT07343154","Multimodal Brain Function in Migraine Patients With Patent Foramen Ovale","A Prospective Study on the Effects of Percutaneous Patent Foramen Ovale Closure on Multimodal Brain Function, Cognition, and Emotion in Patients With Migraine and Patent Foramen Ovale","NEURO-PFO","Inclusion Criteria:\n\n* Age ≥18 years and \\\u003C60 years at Screening\u002FBaseline.\n* Diagnosis of migraine with aura established by a neurologist according to the International Classification of Headache Disorders, 3rd edition (ICHD-3) criteria.\n* Migraine history ≥1 year AND, during the 3-month screening\u002Frun-in period, an average of ≥4 migraine days per month; participant is willing and able to complete a headache diary, which will be reviewed by the investigator prior to enrollment.\n* Patent foramen ovale (PFO) identified by transthoracic echocardiography (TTE) and confirmed by contrast transesophageal echocardiography (cTEE), with at least moderate atrial-level right-to-left shunt (RLS) during Valsalva maneuver.\n* RLS grading by microbubbles in the left-sided cardiac chambers per frame on single-frame images:\n* No RLS: 0 microbubbles\n* Grade I (small): 1-10 microbubbles\u002Fframe\n* Grade II (moderate): 11-30 microbubbles\u002Fframe\n* Grade III (large): \\>30 microbubbles\u002Fframe or near-complete opacification of the left chambers (\"hazy\" appearance)\n* Prior use of at least three different classes of migraine preventive therapies with either \\\u003C50% improvement in migraine frequency during treatment OR intolerable adverse effects.\n* At least two therapies must be from different categories among (a-f); the third may be one of (g-j):\n\n  1. Beta-blockers\n  2. Tricyclic antidepressants\n  3. Verapamil or flunarizine\n  4. Sodium valproate (or divalproex sodium)\n  5. Topiramate\n  6. Other anticonvulsants\n  7. Any therapy supported as effective by at least one positive randomized controlled trial\n  8. Nonsteroidal anti-inflammatory drugs (NSAIDs)\n  9. Metabolic agents (e.g., vitamin B2 or coenzyme Q10)\n  10. Traditional Chinese medicine\n* Participant has been on a stable daily dose regimen of preventive headache medication for ≥3 consecutive months prior to enrollment (to be verified during screening).\n* Written informed consent provided and willingness to comply with study procedures and follow-up schedule.\n\nExclusion Criteria:\n\n* Expected life expectancy ≤1 year at Screening\u002FBaseline.\n* Secondary migraine attributable to other causes.\n* History of transient ischemic attack (TIA), stroke, or intracranial hemorrhage.\n* Investigator-determined anatomical findings on TEE that are unfavorable for successful PFO occluder deployment or any contraindication to device implantation, including (but not limited to):\n* Inability to undergo\u002Fcomplete TEE\n* Vascular access unable to accommodate the delivery system\n* Requirement for transseptal puncture\n* Requirement for implantation of more than one occluder\n* Defect size estimated too large for successful closure\n* Potential interference between the occluder and other intracardiac structures\n* Anatomy preventing adequate apposition of the occluder discs to the atrial septum\n* Allergy to any component\u002Fmaterial of the AMPLATZER™ PFO Occluder (e.g., nickel allergy).\n* Current or past diagnosis of severe psychiatric disorder (e.g., schizophrenia, bipolar disorder, major depressive disorder), or unstable psychiatric illness defined as psychiatric hospitalization, medication dose adjustment, or marked symptom fluctuation within the past 6 months.\n* Neurological and\u002For neurodegenerative disease (e.g., Alzheimer's disease, Parkinson's disease, multiple sclerosis), uncontrolled epilepsy\u002Fseizures within the past 1 year, central nervous system tumor, or history of traumatic brain injury.\n* History of myocardial infarction.\n* History of pacemaker implantation, atrial septal defect (ASD) closure, or left atrial appendage (LAA) closure.\n* Intracardiac right-to-left shunt due to causes other than PFO.\n* Contraindications to aspirin and\u002For clopidogrel, including significant thrombocytopenia, major trauma, acute clinically significant bleeding, or allergy to study medications.\n* Hepatic impairment defined as PT and\u002For APTT \\>2× the upper limit of normal (ULN) OR total bilirubin ≥3 mg\u002FdL.\n* Poorly controlled diabetes mellitus at Screening\u002FBaseline (as judged by the investigator).\n* Poorly controlled atrial fibrillation at Screening\u002FBaseline (as judged by the investigator).\n* Poorly controlled hypertension at Screening\u002FBaseline, defined as blood pressure \\>160\u002F90 mmHg despite appropriate pharmacologic treatment.\n* Active autoimmune disease at Screening\u002FBaseline (e.g., systemic lupus erythematosus, rheumatoid arthritis, polyarteritis nodosa, central nervous system granulomatous vasculitis).\n* Active infection at Screening\u002FBaseline that cannot be fully resolved prior to enrollment.\n* Alcohol abuse or drug dependence at Screening\u002FBaseline.\n* Ongoing anticoagulation therapy that cannot be discontinued.\n* Unable to accurately describe headache status and\u002For unable to complete\u002Fmaintain a headache diary.\n* Currently participating in another device or drug clinical trial in which the primary endpoint has not been reached, or that may clinically confound this study's endpoints, or that prohibits co-enrollment.\n* Pregnant or planning pregnancy during the study period.\n* Planned elective surgery during the study period.\n* Any medical condition or circumstance that, in the investigator's opinion, poses a significant risk to participant safety, confounds study results, or interferes with study participation.\n* Any other medical or non-medical reason that, in the investigator's opinion, makes the participant unsuitable (e.g., inability to comply with study procedures\u002Fvisits, plans to relocate during the study period).",{"count":329,"type":22},45,"3 Years","This investigator-initiated, single-center prospective study is designed to clarify how patent foramen ovale (PFO) relates to brain function abnormalities in patients with drug-refractory migraine with aura (MA), and whether percutaneous PFO closure is associated with measurable, longitudinal improvements in neurophysiological and neuroimaging markers as well as clinical symptoms.\n\nThe study addresses two core questions: (1) Do MA patients with clinically significant right-to-left shunt due to PFO demonstrate distinct resting-state brain function patterns-captured by high-density EEG (hdEEG), resting-state functional MRI (rs-fMRI), and standardized cognitive testing-compared with MA patients without PFO? (2) In MA patients with PFO who undergo clinically indicated percutaneous PFO closure, do these multimodal brain function measures change over time after closure (pre-procedure vs 1, 6, and 12 months), and are such changes accompanied by improvement in migraine burden, quality of life, and mood\u002Fanxiety symptoms? The protocol includes two phases. In Phase 1 (cross-sectional comparison), two groups are evaluated at baseline: MA with PFO (PFO+\u002FMA+) and MA without PFO (PFO-\u002FMA+). Participants complete hdEEG and rs-fMRI to characterize whole-brain power spectral density and connectivity, and undergo MATRICS Consensus Cognitive Battery (MCCB) testing and validated symptom\u002Fpsychological assessments (e.g., MIDAS, MSQ v2.1, PHQ-9, GAD-7, RoPE). In Phase 2 (prospective self-controlled cohort), eligible PFO+\u002FMA+ participants who proceed to percutaneous PFO closure as part of routine clinical care are followed longitudinally with repeated multimodal assessments at pre-closure baseline and post-closure 1, 6, and 12 months. This phase evaluates within-person trajectories of resting-state brain function (hdEEG, rs-fMRI) and cognition\u002Femotion measures, together with migraine diary-based outcomes and patient-reported quality of life\u002Fdisability and mood\u002Fanxiety scales. Key eligibility focuses on adults aged 18-65 years with ICHD-3-defined migraine with aura and a history of frequent migraine (≥4 migraine days\u002Fmonth during screening) despite prior preventive therapy trials; the PFO group requires echocardiographic confirmation of PFO with at least moderate right-to-left shunt (e.g., during Valsalva on contrast TEE), consistent with the study's focus on clinically meaningful shunt physiology.\n\nThe primary endpoints are multimodal brain function and cognition measures. In Phase 1, the main outcomes include between-group differences in MCCB composite score, rs-fMRI whole-brain functional connectivity strength, and hdEEG spectral power across frequency bands (delta\u002Ftheta\u002Falpha\u002Fbeta\u002Fgamma) and theta-band connectivity quantified by whole-brain phase-lag index (PLI). In Phase 2, the primary outcome is the 12-month post-closure change in these multimodal resting-state brain function measures, reflecting dynamic neural recovery or reorganization after PFO closure.\n\nSecondary outcomes include changes in migraine clinical metrics (monthly migraine days, attack frequency and duration, and complete remission rate), migraine-specific quality of life (MSQ v2.1), disability (MIDAS), and depression\u002Fanxiety symptom scores (PHQ-9 and GAD-7) over follow-up. Safety outcomes include adverse events potentially related to the closure procedure and routine post-procedural anti-thrombotic therapy, captured throughout follow-up.",[333,334,335,336],"PFO","Cognitive","Cognitive Functions","Migraine","2026-01-06",{"date":339,"type":34},"2026-01-15",{"date":341,"type":22},"2026-02-01",{"date":343,"type":22},"2029-06-30",{"name":40,"class":41},{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":4,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":361,"lastUpdatePostDateStruct":362,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":4},"100611258","risk-factors-for-recurrence-of-trigeminal-neuralgia-after-percutaneous-balloon-compression-100611258","NCT07238244","Risk Factors for Recurrence of Trigeminal Neuralgia After Percutaneous Balloon Compression","Development and Validation of a Machine Learning-Based Risk Prediction Model for Recurrence After Percutaneous Balloon Compression in Trigeminal Neuralgia Patients: A Retrospective Cohort Study","Inclusion Criteria:\n\n1. Aged ≥ 18 years.\n2. Meet the diagnostic criteria for primary trigeminal neuralgia according to the International Classification of Headache Disorders, 3rd edition (ICHD-3).\n3. Undergo the first PBC treatment.\n4. Have complete preoperative clinical data, imaging data, and intraoperative records.\n5. Have at least one postoperative follow-up record available for determining the recurrence status.\n\nExclusion Criteria:\n\n1. Secondary trigeminal neuralgia (e.g., caused by cerebellopontine angle tumors, multiple sclerosis, etc.).\n2. Missing rate of key predictor variables (e.g., balloon shape) or outcome variables \\> 15%.\n3. Postoperative loss to follow-up (defined as no follow-up records available).",{"count":353,"type":22},700,"The goal of this observational study is to develop and validate a machine learning-based model for predicting pain recurrence risk after percutaneous balloon compression (PBC) in adult patients with primary trigeminal neuralgia (TN) who had their first PBC treatment. The main questions it aims to answer are:\n\nCan the machine learning-based model accurately predict pain recurrence after PBC in these primary TN patients? What key factors (like patient baseline traits, imaging parameters, surgical operation data) affect PBC post-operative pain recurrence? Do machine learning algorithms perform better than traditional Cox proportional hazards regression in predicting such recurrence? Participants (with existing PBC treatment records) will have their past data-including clinical info from the hospital's electronic medical record system, imaging data from the image archiving system, surgical data from the surgical anesthesia system, and follow-up data from the outpatient system-collected and analyzed to build and validate the prediction model.",[356],"Trigeminal Neuralgia",[356,358,359,360],"Percutaneous Balloon Compression","predication","Machine Learning Model","2025-11-17",{"date":363,"type":34},"2025-11-20",{"date":365,"type":22},"2025-12-15",{"date":367,"type":22},"2026-03-15",{"name":40,"class":41},{"id":370,"slug":371,"hasResults":12,"nctId":372,"briefTitle":373,"officialTitle":374,"acronym":375,"eligibilityCriteria":376,"healthyVolunteers":377,"sex":17,"minAge":378,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":381,"conditions":382,"keywords":384,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":387,"lastUpdatePostDateStruct":388,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":394,"locationsCount":4},"100605749","ppv-for-predicting-pih-in-the-elderly-100605749","NCT07166562","PPV for Predicting PIH in the Elderly","Pulse Pressure Variation During Forced Inspiratory Breathing Could Predict Post-Induction Hypotension in Elderly Patients: A Prospective, Observational Study","PPVfi-PIH","Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) classification ≤ Grade III;Age ≥ 65 years old; Elective surgery; Patients who require invasive arterial blood pressure monitoring during surgery.\n\nExclusion Criteria:\n\n* Presence of moderate or severe systemic diseases, such as heart failure, arrhythmias, valvular heart disease, pulmonary hypertension, severe pulmonary diseases (e.g., chronic obstructive pulmonary disease (COPD), asthma, bronchiectasis), endocrine disorders, etc.;Preoperative systolic blood pressure (SBP) ≥160 mmHg, mean arterial pressure (MAP) ≥110 mmHg, or heart rate (HR) ≥120 beats per minute;Patients with comorbid psychiatric or neurological disorders, or communication impairments.",true,"65 Years",{"count":380,"type":22},86,"The purpose of this observational study is to investigate the predictive power of pulse pressure variability during forced inhalation（PPVfi） on the occurrence of hypotension in elderly patients after induction of general anesthesia. The main question it aims to answer is:\n\nCan the PPVfi predict the occurrence of hypotension in elderly patients after induction of general anesthesia? By recording the PPV of patients during forced inhalation before anesthesia induction, with the incidence of hypotension as the state variable and PPV as the test variable, the area under the ROC curve was calculated to determine the optimal threshold, sensitivity, and specificity of PPV.",[383],"Hypotension on Induction",[385,386],"Post-induction Hypotension","Pulse Pressure Variation","2025-09-03",{"date":389,"type":34},"2025-09-10",{"date":391,"type":22},"2025-09-05",{"date":393,"type":22},"2025-11-15",{"name":40,"class":41},{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":4,"eligibilityCriteria":401,"healthyVolunteers":12,"sex":17,"minAge":402,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":23,"phases":405,"briefSummary":406,"conditions":407,"keywords":408,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":307},"100600463","efficacy-of-glycemic-improvement-project-glitter-study-in-type-1-diabetes-glitter-study-2-100600463","NCT07097818","Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2","Efficacy of Glycemic Improvement Project (GLITTER Study) in Type 1 Diabetes-GLITTER Study 2: a Multicentre, Cluster-randomized, Controlled Trial","Eligibility criteria for study hospitals:\n\n1. Members of the China Diabetes Type 1 Study (CD1S).\n2. Experience in type 1 diabetes management: treat more than 50 T1D patients per year and have held camp activities at least once.\n3. Have type 1 diabetes educators.\n\nEligibility criteria of study participants:\n\n1. Diagnosis of Type 1 Diabetes.\n2. Age ≥6 years, regardless of gender.\n3. Duration of disease \\>3 months.\n4. Planned to attend follow-up visits at this hospital within the next year.\n5. Possess sufficient cognitive ability to operate all study-related devices.\n6. Willing to use continuous glucose monitoring and insulin pumps, upload data, and participate in remote monitoring.\n7. Willing to attend structured education sessions and camp activities on time (for the intervention group only).\n8. Willing and able to adhere to the study protocol.\n9. Willing to sign the informed consent form.\n\nExclusion Criteria of study participants:\n\n1. Patients who plan to receive diabetes treatment at other hospitals.\n2. Patients who have used an automated insulin delivery system or sensor-augmented pump within 3 months prior to screening.\n3. Patients who refuse to use continuous glucose monitoring or insulin pumps, or refuse data upload and remote monitoring.\n4. Patients with severe cardiovascular, cerebrovascular, hepatic, or renal diseases; uncontrolled systemic diseases, thyroid diseases; autoimmune diseases; or malignancies.\n5. Patients diagnosed with hematologic or bleeding disorders.\n6. Patients who have received red blood cell transfusions or erythropoiesis-stimulating agents within 3 months prior to screening.\n7. Patients who have used any oral, injectable, or intravenous corticosteroids within 8 weeks prior to screening, or who plan to use corticosteroids during the trial.\n8. Patients with severe skin diseases that may affect the application sites of continuous glucose monitoring or insulin pump patches.\n9. Patients with auditory or visual impairments.\n10. Patients with alcohol or drug abuse.\n11. Patients who plan to receive blood transfusions during the study period.\n12. Patients who plan to undergo elective surgery requiring general anesthesia or dialysis during the study period.\n13. Pregnant women, women planning to become pregnant within 1 year of the study, or women who are breastfeeding.\n14. Patients who are currently participating in or have participated in other drug or device trials within the last 2 weeks.\n15. Patients who, in the investigator's opinion, are not suitable for participation in this clinical trial, such as those with a history of vision impairment, eating disorders, celiac disease, etc.","6 Years",{"count":404,"type":22},400,[25],"The GLITTER Study 2 is a cluster randomized trial that will evaluate the impact of comprehensive and intensive management, comprising a team, technology, education, and peer resources, on metabolic control and psychological outcomes in patients with type 1 diabetes.",[311],[409,410,411,412,413,414,415],"Type 1 diabetes","Comprehensive management","T1D teams","Structured education","Peer resources","Diabetes technologies","Glycemic control","2025-09-01",{"date":387,"type":34},{"date":419,"type":34},"2025-08-18",{"date":421,"type":22},"2027-04-01",{"name":40,"class":41},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":427,"acronym":4,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":305,"enrollmentInfo":429,"targetDuration":4,"studyType":23,"phases":431,"briefSummary":432,"conditions":433,"keywords":435,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":440,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":42},"100600891","efficacy-and-safety-of-attapulgite-in-patients-with-obesity-an-exploratory-clinical-trial-100600891","NCT07103382","Efficacy and Safety of Attapulgite in Patients With Obesity: An Exploratory Clinical Trial","Inclusion Criteria:\n\nObese individuals:\n\n* Aged 18-60 years, regardless of sex\u002Fgender\n* BMI≥28.0kg\u002Fm2\n\nOverweight or obese individuals with type 2 diabetes:\n\n* Aged 18-60 years, regardless of sex\u002Fgender\n* BMI≥24.0kg\u002Fm2\n* HbA1c ≥7.0% and ≤10.0% or the fasting blood glucose ≥7.0 mmol\u002Fl and ≤ 13.3 mmol\u002Fl at screening\n* Stable diabetes treatment for at least 6 months or more\n\nExclusion Criteria:\n\n* Type 1 diabetes, monogenic diabetes, or diabetes due to pancreatic injury or other secondary diabetes\n* Severe diabetic complications within three months before the study initiation, including severe hypoglycemia, diabetic ketoacidosis, or infections\n* Use of weight-affecting products within the past three months or planned use during the study\n* Weight fluctuation \\>5 kg or \\>10% within the past three months\n* Obesity or overweight due to endocrine disorders (such as thyroid dysfunction or Cushing's syndrome)\n* Uncontrolled hypertension, severe cardiac\u002Fhepatic\u002Frenal dysfunction\n* History of gastrointestinal surgery (such as cholecystectomy) within the past year or non-gastrointestinal surgery within six months, or prior bariatric surgery\n* Chronic gastrointestinal disorders (such as recurrent constipation, celiac disease, or food intolerances) or any condition impairing digestion\u002Fabsorption function\n* History of malignant tumors within five years, regardless of whether there is recurrence or metastasis and severe immune dysfunction (such as malignant tumors, HIV\u002FAIDS, immunodeficiency diseases)\n* Use of probiotics, prebiotics, or antibiotics within three months prior to enrollment, or alcohol abuse; Consumption of yogurt within two weeks before the study or during the trial period; History of psychiatric or infectious diseases\n* Pregnancy, lactation, or plans for pregnancy during the study\n* Participation in other clinical trials within the past three months\n* Any condition that in the judgement of the investigator precludes participation",{"count":430,"type":22},40,[25],"To explore the safety and efficacy of attapulgite in the treatment of obese individuals or overweight\u002Fobese individuals with type 2 diabetes.",[434],"Obesity",[436,437,438,439],"attapulgite","obesity","placebo-controlled study","randomized controlled trial","2025-08-30",{"date":391,"type":34},{"date":443,"type":34},"2025-06-26",{"date":445,"type":22},"2025-12",{"name":40,"class":41},{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":454,"targetDuration":4,"studyType":23,"phases":455,"briefSummary":456,"conditions":457,"keywords":459,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":463,"lastUpdatePostDateStruct":464,"startDateStruct":466,"completionDateStruct":467,"leadSponsor":468,"locationsCount":42},"100602284","hybrid-closed-loop-for-perioperative-glycemic-control-in-t2dm-with-parenteral-nutrition-100602284","NCT07121504","Hybrid Closed-Loop for Perioperative Glycemic Control in T2DM With Parenteral Nutrition","Effect of Hybrid Closed-Loop Insulin Delivery System on Glycemic Management in Perioperative Patients With Type 2 Diabetes Receiving Parenteral Nutrition: An Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Diagnosis of T2DM requiring surgical procedures (duration ≥2 hours) with anticipated short-term total parenteral nutrition (TPN) during the perioperative period (expected hospitalization \\>72 hours).\n3. Glycemic control criteria (meeting any of the following):\n\n   ①HbA1c ≥7.5% or random plasma glucose ≥13.9 mmol\u002FL\n   * Established T2DM with poor glycemic control (HbA1c ≥7.5%) despite combination therapy (≥2 oral antidiabetic drugs) ③Insulin-treated patients with suboptimal control (HbA1c ≥7.0%) after adequate dose adjustment.\n4. Willing to sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with acute diabetic complications, including: diabetic ketoacidosis (DKA), hyperglycemic hyperosmolar state (HHS), etc.\n2. Patients with type 1 diabetes or other specific types of diabetes.\n3. Patients with severe organ dysfunction, defined as:\n\n   * Cardiac function ≥Class III (NYHA classification)\n\n     * ALT\u002FAST \\>3× upper limit of normal (ULN) ③ eGFR ≤30 mL\u002Fmin\u002F1.73 m²\n\n       * Hemoglobin \\\u003C90 g\u002FL ⑤ WBC count \\\u003C4.0×10⁹\u002FL or platelets \\\u003C90×10⁹\u002FL ⑥ Hemodynamic instability\n4. Patients with endocrine disorders affecting glucose metabolism, such as: hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.\n5. Patients with known hypersensitivity to any drugs or materials used in the study protocol.\n6. Patients who have contraindications to conventional insulin pump therapy.\n7. Patients with dermatological conditions (e.g., skin rash, prurigo) or coagulation disorders.\n8. Patients with impaired consciousness or psychiatric disorders affecting decision-making capacity or communication ability.\n9. Patients who have other conditions deemed unsuitable for trial participation by investigators.\n10. Patients who suffer severe surgical complications.",{"count":430,"type":22},[25],"Glycemic control in surgical patients with type 2 diabetes mellitus (T2DM) receiving parenteral nutrition represents a major clinical challenge. This randomized controlled trial evaluates the comparative effectiveness and safety of hybrid closed-loop (HCL) insulin delivery versus conventional insulin pumps combined with continuous glucose monitoring (CGM) in perioperative T2DM patients requiring short-term parenteral nutrition.",[458],"Type 2 Diabetes",[460,461,462],"hybrid closed-loop","perioperative","parenteral nutrition","2025-08-06",{"date":465,"type":34},"2025-08-13",{"date":443,"type":34},{"date":105,"type":22},{"name":40,"class":41},{"id":470,"slug":471,"hasResults":12,"nctId":472,"briefTitle":473,"officialTitle":474,"acronym":4,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":23,"phases":479,"briefSummary":480,"conditions":481,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":483,"lastUpdatePostDateStruct":484,"startDateStruct":486,"completionDateStruct":488,"leadSponsor":490,"locationsCount":42},"100600965","study-of-cm355-in-patients-with-systemic-lupus-erythematosus-100600965","NCT07104344","Study of CM355 in Patients With Systemic Lupus Erythematosus","A Single-center, Open-label, Single-arm Clinical Study to Observe the Safety and Efficacy of CM355 in the Treatment of Refractory Systemic Lupus Erythematosus","Inclusion Criteria:\n\n* Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF);\n* Age ≥ 18 to ≤ 65 years old, male or female;\n* At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)\u002F American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months；\n* systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and\u002For anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and\u002For anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening；\n* Definition of refractory SLE;\n* The treatment regimen for SLE was stable for more than 4 weeks before the first dose.\n\nExclusion Criteria:\n\n* Renal disease: patients with severe lupus nephritis;\n* Patients with central nervous system diseases;\n* Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ;\n* Any other condition assessed by investigator as unsuitable for participation in the study.","64 Years",{"count":478,"type":22},5,[25],"This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.",[482],"Systemic Lupus Erythematosus","2025-07-29",{"date":485,"type":34},"2025-08-05",{"date":487,"type":22},"2025-09-25",{"date":489,"type":22},"2026-10",{"name":40,"class":41},{"id":492,"slug":493,"hasResults":12,"nctId":494,"briefTitle":495,"officialTitle":495,"acronym":4,"eligibilityCriteria":496,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":497,"targetDuration":4,"studyType":23,"phases":499,"briefSummary":500,"conditions":501,"keywords":503,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":307},"100600462","glycemic-improvement-with-team-technology-education-and-peer-resources-in-type-1-diabetes-glitter-study-100600462","NCT07097805","Glycemic Improvement With Team, Technology, Education and Peer Resources in Type 1 Diabetes-GLITTER Study","Inclusion Criteria:\n\n1\\. Patients with type 1 diabetes of all age groups, regardless of disease duration.\n\nThe diagnosis criteria for type 1 diabetes are met by fulfilling any one point from the first two criteria plus any one point from the third criterion.\n\n1. Clinically diagnosed as Type 1 Diabetes by a specialist physician.\n2. Meet any one of the following criteria:\n\n   A. Age of onset \\\u003C15 years B. No obesity at the time of onset C. diabetic ketoacidosis onset D. Maximum random C-peptide \\\u003C200 pmol\u002FL\n3. Meet any one of the following criteria:\n\nA. Initiation and continuation of insulin therapy after diagnosis (excluding pancreas or islet transplantation) B. Positive for islet cell antibodies",{"count":498,"type":22},3000,[25],"The GLITTER study is comprised of four key components: Team, Technology, Education, and Peer Resources. The aim of the GLITTER Study is to improve the metabolic control rate in patients with type 1 diabetes through a comprehensive management approach.",[502],"Type 1 Diabetes (T1D)",[409,410],"2025-07-24",{"date":506,"type":34},"2025-07-31",{"date":508,"type":34},"2025-01-01",{"date":510,"type":22},"2028-03-01",{"name":40,"class":41},{"id":513,"slug":514,"hasResults":12,"nctId":515,"briefTitle":516,"officialTitle":517,"acronym":518,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":522,"studyType":74,"phases":4,"briefSummary":523,"conditions":524,"keywords":529,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":534,"lastUpdatePostDateStruct":535,"startDateStruct":537,"completionDateStruct":539,"leadSponsor":541,"locationsCount":42},"100591050","the-associations-of-sleep-disturbance-with-therapy-efficacy-and-prognosis-of-lung-cancer-100591050","NCT06975384","The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer","The Associations of Sleep Disturbance With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging","Nezha","Cohort 1:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1;\n5. Treatment naïve;\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1);\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed consent to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) fusion and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Presence of other malignant tumors or malignant diseases within 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Patients receiving sleep medication;\n5. Prior participation in other clinical drug trials;\n6. Symptomatic brain metastasis;\n7. Inability to complete scale assessments.\n\nCohort 2:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Histologically confirmed diagnosis of SCLC；\n3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;\n4. ECOG PS of 0-1;\n5. Treatment naïve;\n6. Presence of at least one measurable lesion according to the RECIST v1.1 ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed consent to participate in the study;\n\nExclusion Criteria:\n\n1. Presence of other malignant tumors or malignant diseases within 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Patients receiving sleep medication;\n4. Prior participation in other clinical drug trials;\n5. Symptomatic brain metastasis;\n6. Inability to complete scale assessments.\n\nCohort 3:\n\nInclusion Criteria:\n\n1. Age ≥18 years old;\n2. Pathologically diagnosed as NSCLC;\n3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;\n4. At least one measurable lesion can be evaluated according to the RECIST v1.1;\n5. Treatment naïve;\n6. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy as neoadjuvant therapy;\n7. Cardiopulmonary function can withstand surgery;\n8. Informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. EGFR-sensitizing mutation and\u002For ALK fusion and\u002For ROS1 fusion-positive;\n2. Presence of other malignant tumors or malignant diseases within 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Patients receiving sleep medication;\n5. Prior participation in other clinical drug trials;\n6. Symptomatic brain metastasis;\n7. Inability to complete scale assessments.\n\nCohort 4:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Pathologically diagnosed as NSCLC;\n3. Pathologically stage confirmed as early stage of IA-IIIA;\n4. Available for tumor tissue samples;\n5. Treatment naïve;\n6. Receiving radical surgery;\n7. Informed consent to participate in the study;\n\nExclusion Criteria:\n\n1. Presence of other malignant tumors or malignant diseases within 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Patients receiving sleep medication;\n4. Prior participation in other clinical drug trials;\n5. Inability to complete scale assessments.\n\nCohort 5:\n\nInclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. ECOG PS of 0-1;\n5. Treatment naive;\n6. Presence of at least one measurable lesion according to the RECIST v1.1;\n7. Receiving targeted therapy or combination with chemotherapy;\n8. Informed consent to participate in the study;\n9. Driver gene-positive.\n\nExclusion Criteria:\n\n1. Presence of other malignant tumors or malignant diseases within 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Patients receiving sleep medication;\n4. Prior participation in other clinical drug trials;\n5. Symptomatic brain metastasis;\n6. Inability to complete scale assessments.",{"count":521,"type":22},1270,"5 Years","This is the prospective, observational cohort study (Nezha) to explore the associations of sleep disturbance with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received either first-line therapy (ICIs or targeted agents) or neoadjuvant therapy with ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early non-small-cell lung cancer (NSCLC) receiving surgery.",[525,526,527,528],"Lung Cancer","Sleep Disturbance","Immune Checkpoint Inhibitors","Cancer, Treatment-Related",[525,527,526,530,531,532,533],"Circadian Rhythm","Cancer Progression","Prognosis","Biomarker","2025-05-09",{"date":536,"type":34},"2025-05-16",{"date":538,"type":34},"2024-11-01",{"date":540,"type":22},"2030-12-31",{"name":40,"class":41},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":555,"conditions":556,"keywords":558,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":563,"lastUpdatePostDateStruct":564,"startDateStruct":566,"completionDateStruct":568,"leadSponsor":569,"locationsCount":42},"100587159","phase-2-interleukin-2-for-refractory-chronic-spontaneous-urticaria-100587159","NCT06924762","Interleukin-2 for Refractory Chronic Spontaneous Urticaria","Efficacy and Safety of Interleukin-2 Treatment in Moderate to Severe Chronic Spontaneous Urticaria With Poor Control by Antihistamines: a Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial","ESIT-CSU","Inclusion Criteria:\n\n1. Gender: Not limited; Age: at least 18 years old and less than 75 years old;\n2. Diagnosed with chronic spontaneous urticaria (CSU) (including patients overlapped with chronic inducible urticaria) according to the 2021 EAACI\u002FGA²LEN\u002FEDF\u002FAAAAI guidelines;\n3. Disease course of CSU for at least 12 weeks;\n4. The patient has been treated with second-generation antihistamines (one or more types, up to 4 tablets per day) every day for 2 weeks or more but still experiences significant symptoms of wheals and\u002For itching, with a UAS7 score ≥16 or a UCT score \\\u003C12;\n5. UAS7 ≥16 on the date prior to randomization (according to complete daily symptom log data recorded in the past 7 days before randomization);\n6. Willing and able to complete daily symptom logs throughout the entire study period;\n7. The patient voluntarily consents to participate in this research project and has signed the informed consent.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women, or women planning to conceive within 6 months;\n* Has used corticosteroids, immunosuppressants, leukotriene receptor antagonists, H2 receptor antagonists, intravenous immunoglobulin (IVIG) therapy, and\u002For undergone plasma exchange in the past 4 weeks;\n* Has received omalizumab or other biologic treatments in the past 12 weeks;\n* Has previously undergone interleukin-2 treatment;\n* Has a history of anaphylactic shock;\n* Plans or anticipates the use of any prohibited drugs or treatments during the screening and\u002For treatment periods;\n* Currently has active or recurrent severe infections, such as active tuberculosis;\n* Has a congenital or acquired immunodeficiency disorder;\n* Has a history of drug or alcohol abuse, mental disorders, or poor compliance, making them unable to adhere to treatment;\n* Currently enrolled in another clinical trial;\n* Is an employee of the clinical research facility or directly involved in the study, or is an immediate family member of such an individual;\n* Any other reason that makes participation in this trial inappropriate.","74 Years",{"count":552,"type":22},124,[276,554],"PHASE3","The goal of this clinical trial is to learn if human interleukin-2 (IL-2) works to treat moderate to severe chronic spontaneous urticaria in adults who remain symptomatic despite oral antihistamine treatment (refractory CSU). It will also learn about the safety of IL-2. The main questions it aims to answer are:\n\nDoes IL-2 alleviate the symptoms of urticaria in patients? What medical problems do participants have when given IL-2? Researchers will compare IL-2 to a placebo (a look-alike and smell-like substance that contains no IL-2) to see if IL-2 works to treat refractory, moderate to severe CSU.\n\nParticipants will:\n\nReceive IL-2 or a placebo intramuscular injections for 3 rounds at Week 0, 4 and 8, in which each round includes one injection daily for seven consecutive days.\n\nVisit the clinic for checkups and tests at Week 2, 4, 8, 12 and 24. Keep a diary of their symptoms and the number of tablets of oral antihistamines.",[557],"Chronic Spontaneous Uriticaria",[559,560,561,562],"Interleukin-2","Chronic spontaneous uriticaria","urticaria control test","poor response to second-generation antihistamines","2025-04-06",{"date":565,"type":34},"2025-04-11",{"date":567,"type":34},"2025-03-19",{"date":82,"type":22},{"name":40,"class":41},{"id":571,"slug":572,"hasResults":12,"nctId":573,"briefTitle":574,"officialTitle":575,"acronym":4,"eligibilityCriteria":576,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":577,"targetDuration":522,"studyType":74,"phases":4,"briefSummary":579,"conditions":580,"keywords":582,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":587,"lastUpdatePostDateStruct":588,"startDateStruct":590,"completionDateStruct":592,"leadSponsor":593,"locationsCount":42},"100475980","the-associations-of-psychological-stress-with-therapy-efficacy-and-prognosis-of-lung-cancer-stress-lung-100475980","NCT05477979","The Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer (STRESS-LUNG)","Cohort Studies of Associations of Psychological Stress With Therapy Efficacy and Prognosis of Lung Cancer, Including Non-small-cell Lung Cancer and Small-cell Lung Cancer With Early and Advanced Staging (STRESS-LUNG)","Cohort 1 (STRESS-LUNG-1):\n\nInclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Histologically confirmed diagnosis of NSCLC;\n3. Unresectable locally advanced, metastatic, or recurrent stage ⅢB-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) gene and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Combined with other malignant tumors in the past 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Current receiving anti-depressive or anti-anxiety therapy;\n5. Previous treatment with other clinical drug trials;\n6. Patients with symptomatic brain metastasis;\n7. Can't cooperate with psychological scale assessment;\n\nCohort 2 (STRESS-LUNG-2):\n\n1. Age ≥ 18 years；\n2. Pathologically diagnosed as small cell lung cancer；\n3. Unresectable locally advanced, metastatic, or recurrent stage Ⅲ-Ⅳ based on AJCC TNM staging 8th edition;\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Presence of at least one measurable lesion according to the Response Evaluation Criteria in Advanced Solid Tumors version 1.1 (RECIST v1.1) ;\n7. Receiving PD-1\u002FPD-L1 inhibitors monotherapy or combination with chemotherapy;\n8. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Combined with other malignant tumors in the past 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Current receiving anti-depressive or anti-anxiety therapy;\n4. Previous treatment with other clinical drug trials;\n5. Patients with symptomatic brain metastasis;\n6. Can't cooperate with psychological scale assessment;\n\nCohort 3 (STRESS-LUNG-3):\n\n1. Age ≥18 years ；\n2. Pathologically diagnosed as non-small cell lung cancer;\n3. Resectable clinical stage IB-IIIB based on AJCC TNM staging 8th edition;\n4. At least one measurable lesion can be evaluated according to the RECIST 1.1 standard；\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Receiving PD-1\u002FPD-L1 inhibitors combined with chemotherapy as neoadjuvant therapy.\n\n6\\. Cardiopulmonary function can withstand surgery; 7. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Epidermal growth factor receptor (EGFR)-sensitizing mutation and\u002For anaplastic lymphoma kinase (ALK) gene and\u002For ROS proto-oncogene 1 (ROS1) fusion-positive;\n2. Combined with other malignant tumors in the past 3 years;\n3. Concurrent acute or chronic psychiatric disorders;\n4. Current receiving anti-depressive or anti-anxiety therapy;\n5. Previous treatment with other clinical drug trials;\n6. Can't cooperate with psychological scale assessment;\n\nCohort 4 (STRESS-LUNG-4):\n\n1. Age ≥18 years;\n2. Pathologically diagnosed as non-small-cell lung cancer；\n3. Pathologically stage conformed as early stage of IA-IIIA\n4. Available for tumor tissue samples；\n5. Systematic treatments naive ( e. g., chemotherapy, anti-angiogenic drugs, targeted drugs, and immunotherapy );\n6. Receiving radical surgery;\n7. Informed and agreed to participate in the study;\n\nExclusion Criteria:\n\n1. Combined with other malignant tumors in the past 3 years;\n2. Concurrent acute or chronic psychiatric disorders;\n3. Current receiving anti-depressive or anti-anxiety therapy;\n4. Previous treatment with other clinical drug trials;\n5. Can't cooperate with psychological scale assessment;",{"count":578,"type":22},750,"This is the prospective, observational cohort study (STRESS-LUNG) to explore the associations of psychological stress with progression, efficacy of immune checkpoint inhibitors (ICIs) and prognosis of Lung Cancer. The participants including the patients diagnosed with advanced non-small-cell lung cancer (NSCLC) who received the first-line therapy or neoadjuvant therapy of ICIs; patients diagnosed with advanced small-cell lung cancer (SCLC) receiving the first-line therapy ICIs; patients diagnosed with early small-cell lung cancer (SCLC) receiving surgery.",[525,581,527,528],"Psychological Stress",[583,584,585,586,532,533],"Lung cancer","Immune checkpoint inhibitors","Psychological stress","Cancer progression","2025-02-21",{"date":589,"type":34},"2025-02-25",{"date":591,"type":34},"2020-06-01",{"date":62,"type":22},{"name":40,"class":41},{"id":595,"slug":596,"hasResults":12,"nctId":597,"briefTitle":598,"officialTitle":599,"acronym":600,"eligibilityCriteria":601,"healthyVolunteers":377,"sex":17,"minAge":602,"maxAge":118,"enrollmentInfo":603,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":605,"conditions":606,"keywords":607,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":616,"locationsCount":4},"100579433","diabetic-cardiovascular-complications-multi-omics-analysis-100579433","NCT06824233","Diabetic Cardiovascular Complications: Multi-Omics Analysis","Deciphering the Molecular Landscape of Diabetic Cardiovascular Complications Based on Multi-Omics Analysis","D-CCMOA","Inclusion Criteria:\n\n1. Age: Patients aged between 20 and 70 years.\n2. Coronary Angiography: Patients who have undergone coronary angiography at the Second Xiangya Hospital of Central South University for various reasons.\n3. Informed Consent: Patients who have signed the informed consent form and are willing to participate in the collection and analysis of multi-omics data.\n4. Medical History and Samples: Patients who can provide complete medical history and biological samples.\n\nExclusion Criteria:\n\n1. Severe Diseases or Malignancy: Patients with other severe diseases or malignancies that may affect the study.\n2. Cognitive or Psychiatric Disorders: Patients with cognitive or psychiatric disorders that would prevent participation or cooperation in the study.\n3. Pregnancy or Lactation: Women who are pregnant or breastfeeding.\n4. Short Life Expectancy: Patients with a life expectancy of less than 6 months.\n5. Inability to Provide Consent: Patients unable or unwilling to provide informed consent.","20 Years",{"count":604,"type":22},300,"The goal of this observational study is to learn about the molecular mechanisms underlying cardiovascular complications in individuals with type 2 diabetes (T2DM) and how they differ from healthy individuals. The study will also identify biomarkers and potential therapeutic targets for better managing diabetes-related heart disease.\n\nThe main questions it aims to answer are:\n\n1. What molecular changes are associated with cardiovascular complications in T2DM patients compared to healthy individuals?\n2. How do genetic, gene expression, and protein profiles differ between T2DM patients with and without cardiovascular complications? Researchers will compare the molecular profiles of three groups: healthy controls, individuals with T2DM but no cardiovascular complications, and those with T2DM and cardiovascular complications.\n\nParticipants will:\n\n1. Provide blood samples for genomics, transcriptomics, and proteomics analysis\n2. Undergo standard clinical tests such as blood pressure, echocardiogram, and ankle-brachial index measurements\n3. Be followed for 12 to 24 months to track the development of cardiovascular events Participate in follow-up phone interviews to record major cardiovascular events like heart attacks or strokes",[205],[608,205,609],"Multi-Omics Analysis","Cardiovascular Complications","2025-02-07",{"date":612,"type":34},"2025-02-13",{"date":614,"type":22},"2025-03-01",{"date":510,"type":22},{"name":40,"class":41},{"id":618,"slug":619,"hasResults":12,"nctId":620,"briefTitle":621,"officialTitle":622,"acronym":623,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":522,"studyType":74,"phases":4,"briefSummary":627,"conditions":628,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":634,"lastUpdatePostDateStruct":635,"startDateStruct":637,"completionDateStruct":639,"leadSponsor":640,"locationsCount":42},"100485242","exploring-the-mechanism-of-primary-resistance-to-third-generation-egfr-tkis-as-first-line-treatment-in-egfr-positive-advanced-nsclc-precise-study-100485242","NCT05598528","Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","A Multicenter Clinical Study to Explore the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)","PRECISE","Inclusion Criteria:\n\n1. Age \\>18 years;\n2. Histological or cytopathological diagnosed NSCLC;\n3. According to the American Joint Committee on Cancer (AJCC) eighth edition of the Lung Cancer Staging Manual, the clinical stage is unresectable IIIB-IV or recurrence and metastasis after surgery;\n4. At least one measurable lesion can be evaluated according to the Response Evaluation Criteria In Solid Tumours v1.1 (RECIST1.1) criteria;\n5. Positive EGFR mutation confirmed by tissue or cytology (pleural fluid, cerebrospinal fluid, etc.);\n6. Use of third-generation EGFR-TKIs approved by the NMPA for NSCLC as first-line therapy;\n7. Cooperate with the provision of clinicopathological data, imaging data, sample collection, and follow-up required for the research process, and agree to use the test data for subsequent research and product development;\n8. Agree to participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Patients who cannot understand the content of the experiment and cannot cooperate, and those who refuse to sign the informed consent form;\n2. Pregnant and lactating women;\n3. Other malignant neoplastic diseases within 3 years;\n4. Patients who have undergone other clinical drug trials;\n5. Received systemic anti-tumor therapy within 2 years;",{"count":626,"type":22},210,"Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients.\n\nHowever, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term.\n\nThis study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.",[629,630,631,632,633],"Lung Cancer, Non-small Cell","EGFR Gene Mutation","EGFR-TKI Resistant Mutation","Primary Resistance","Circulating Tumor DNA","2024-11-27",{"date":636,"type":34},"2024-12-02",{"date":638,"type":34},"2021-09-28",{"date":263,"type":22},{"name":40,"class":41},""]