[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shandong Provincial Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":487},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,53,79,101,123,146,165,188,209,238,259,285,310,329,353,373,400,432,458],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100641577","phase-4-mazdutide-for-adults-with-prediabetes-a-randomized-double-blind-placebo-controlled-trial-dream-pre-100641577",false,"NCT07654062","Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)","Efficacy and Safety of Mazdutide in Adults With Prediabetes: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial (DREAM-PRE)","DREAM-PRE","Inclusion Criteria:\n\n1. Voluntarily signed written informed consent prior to any study procedures\n2. Age 18 to 75 years (inclusive) at the time of signing informed consent; male or female\n3. Prediabetes confirmed by central laboratory at screening, meeting at least one of the following criteria per Chinese Diabetes Society (CDS) standards, and not meeting diagnostic criteria for diabetes:\n\n   * Impaired Glucose Tolerance (IGT): 75g OGTT 2-hour plasma glucose\n\n     * 7.8 mmol\u002FL and \\\u003C11.1 mmol\u002FL\n   * Impaired Fasting Glucose (IFG): fasting plasma glucose ≥6.1 mmol\u002FL and \\\u003C7.0 mmol\u002FL\n   * Elevated HbA1c: 5.7% ≤ HbA1c \\\u003C 6.5% (39-48 mmol\u002Fmol)\n4. BMI ≥22.0 kg\u002Fm² at screening\n5. Self-reported body weight change \\\u003C10% within 3 months prior to screening; not currently participating in any organized weight-loss program\n6. Able to understand study requirements, complete all planned visits and examinations, self-administer once-weekly subcutaneous injections, and use the study app for daily monitoring\n\nExclusion Criteria:\n\n1. Confirmed diabetes at screening (FPG ≥7.0 mmol\u002FL, OGTT 2h-PG ≥11.1 mmol\u002FL, or HbA1c ≥6.5%); or prior confirmed diagnosis of type 1 diabetes, type 2 diabetes, or other specific types of diabetes. Prior gestational diabetes in whom blood glucose has returned to prediabetes levels after delivery is NOT grounds for exclusion.\n2. Continuous use of any antidiabetic medication for more than 7 days within 3 months prior to screening, including: biguanides (metformin), alpha-glucosidase inhibitors (acarbose, voglibose, miglitol), sulfonylureas (glimepiride, gliclazide, glipizide, glibenclamide), glinides (repaglinide, nateglinide), thiazolidinediones (pioglitazone, rosiglitazone), DPP-4 inhibitors (sitagliptin, saxagliptin, vildagliptin, linagliptin, alogliptin), SGLT2 inhibitors (dapagliflozin, empagliflozin, canagliflozin, ertugliflozin), insulin (any formulation), or traditional Chinese medicine with confirmed glucose-lowering indication.\n3. Use of any of the following within 6 months prior to screening (regardless of duration): GLP-1 receptor agonists (semaglutide, liraglutide, dulaglutide, exenatide, lixisenatide, benaglutide, etc.), GIP\u002FGLP-1 dual agonists (tirzepatide, etc.), any dual or triple agonist containing GLP-1R and\u002For GCGR components (including mazdutide), or any GLP-1 class investigational drug in clinical development.\n4. Use of any prescription weight-loss medication within 3 months prior to screening (regardless of duration), including orlistat, naltrexone\u002Fbupropion combination, phentermine\u002Ftopiramate combination, or any weight-loss drug approved in China or in clinical development. Over-the-counter dietary supplements are not excluded but must be recorded.\n5. Spontaneous body weight change ≥10% within 3 months prior to screening (based on self-report and\u002For available medical records), or currently participating in any organized weight-loss program (including commercial weight-loss plans or weight-loss interventions in other clinical trials).\n6. Prior bariatric or metabolic surgery including Roux-en-Y gastric bypass, sleeve gastrectomy, adjustable gastric banding, biliopancreatic diversion, intragastric balloon placement, or other bariatric surgery.\n7. Prior history of acute pancreatitis (confirmed by imaging or surgery) or chronic pancreatitis; or serum amylase \\>3× ULN or serum lipase \\>3× ULN at screening.\n8. Personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2); first-degree family history of MTC or MEN2; or serum calcitonin ≥50 ng\u002FL at screening.\n9. Any of the following within 6 months prior to screening: acute myocardial infarction (STEMI or NSTEMI), ischemic or hemorrhagic stroke, transient ischemic attack (TIA), coronary revascularization (PCI or CABG), or hospitalization for unstable angina.\n10. NYHA Class III or IV heart failure. (NYHA Class I and II are not grounds for exclusion.)\n11. Clinically significant arrhythmia on 12-lead ECG at screening, including:\n\n    Mobitz Type II or third-degree atrioventricular block, sustained ventricular tachycardia (≥30 seconds or requiring cardioversion), QTcF \\>500 ms, or resting heart rate \\\u003C50 bpm (in subjects not using beta-blockers or calcium channel blockers).\n12. Uncontrolled hypertension: confirmed mean systolic blood pressure ≥180 mmHg and\u002For mean diastolic blood pressure ≥110 mmHg on repeated measurements at screening despite antihypertensive therapy. Subjects with controlled blood pressure on a stable antihypertensive regimen (stable for ≥4 weeks prior to screening) are allowed to enroll.\n13. ALT \\>3× ULN, AST \\>3× ULN, or total bilirubin \\>2× ULN at screening (except confirmed Gilbert's syndrome with normal direct bilirubin).\n14. eGFR (CKD-EPI) \\\u003C45 mL\u002Fmin\u002F1.73 m² at screening. Subjects with eGFR 45-60 mL\u002Fmin\u002F1.73 m² may enroll with enhanced renal function monitoring.\n15. Any of the following gastrointestinal conditions: known gastroparesis (confirmed by gastric emptying study or clinical diagnosis), inflammatory bowel disease (Crohn's disease or ulcerative colitis, active or remission), short bowel syndrome, prior gastrointestinal surgery likely to affect drug absorption (excluding simple appendectomy and laparoscopic cholecystectomy), or other serious gastrointestinal disease likely to significantly affect drug tolerability or absorption.\n16. Diagnosis or active treatment of any malignancy within 5 years prior to screening.\n17. Positive urine pregnancy test at screening, currently breastfeeding, or planning pregnancy during the 48-week study period.\n18. Known allergy to mazdutide or any excipient in its formulation; or prior serious allergic reaction to any GLP-1 class drug (defined as angioedema, anaphylactic shock, or allergic reaction requiring hospitalization).\n19. Participation in any other interventional clinical trial within 3 months prior to screening (excluding purely observational or epidemiological studies not involving investigational drugs or devices), or currently enrolled in any other clinical trial.\n20. Currently on long-term systemic corticosteroids (expected continuous use \\>14 days, oral or intravenous); or currently using drugs known to significantly affect body weight or glucose metabolism that cannot be discontinued or substituted, including antipsychotics (olanzapine, clozapine, quetiapine, etc.), valproate sodium, or lithium.\n21. History of alcohol abuse within 1 year prior to screening, defined as daily consumption \\>3 standard drink units (men) or \\>2 standard drink units (women) sustained for \\>3 months (1 standard drink unit ≈ 10g pure alcohol).","ALL","18 Years","75 Years",{"count":21,"type":22},150,"ESTIMATED","INTERVENTIONAL",[25],"PHASE4","Prediabetes affects millions of adults worldwide and carries a high risk of progression to type 2 diabetes. Mazdutide is a once-weekly injectable drug that activates both GLP-1 and glucagon receptors, lowering blood sugar and body weight simultaneously.\n\nThis study (DREAM-PRE) tests whether mazdutide can help adults with prediabetes return to normal blood sugar levels. Approximately 150 adults aged 18-75 years with prediabetes and BMI ≥22 kg\u002Fm² will be randomly assigned in equal numbers to one of three groups: mazdutide 4 mg once weekly, mazdutide 6 mg once weekly, or placebo once weekly. All participants also receive standardized diet and exercise guidance throughout the study.\n\nTreatment lasts 24 weeks, followed by 24 weeks of off-drug follow-up to see whether any benefits are maintained. The main question is: what proportion of participants achieve completely normal blood sugar (normal HbA1c, fasting glucose, AND glucose tolerance test) after 24 weeks of treatment? The study is conducted at approximately 10 hospitals across China.",[28,29,30],"Prediabetes","Impaired Fasting Glucose","Impaired Glucose Tolerance (Prediabetes)",[32,33,34,28,35,36,37,38,39],"Mazdutide","IBI362","GLP-1R\u002FGCGR dual agonist","Diabetes prevention","Normal glucose regulation","Beta-cell function","Insulin resistance","Weight loss","NOT_YET_RECRUITING","2026-06-13",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":22},"2026-07",{"date":48,"type":22},"2029-07",{"name":50,"class":51},"Shandong Provincial Hospital","OTHER_GOV",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":23,"phases":63,"briefSummary":65,"conditions":66,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":52},"100638001","thyroxine-supplementation-in-small-for-gestational-age-sga-infants-with-birth-weight-1500g-and-tsh-6-20-miuml-100638001","NCT07625722","Thyroxine Supplementation in Small for Gestational Age (SGA) Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Growth and Neurodevelopmental Outcomes at Two Years of Age After Postnatal Thyroid Hormone Supplementation in SGA Infants With Birth Weight \u003C1500g and TSH 6-20 mIU\u002Fml","Inclusion Criteria:\n\n* Preterm infants born Small for Gestational Age (SGA) with a birth weight \\\u003C 1500g；\n* Admitted to a participating Neonatal Intensive Care Unit (NICU) within 7 days of birth；\n* Serum concentrations of TSH, FT4, and FT3 are measured weekly during the first and second weeks of life，any single TSH measurement during this period is between 6 and 20 mIU\u002FmL；\n* Written informed consent obtained from the parents.\n\nExclusion Criteria:\n\n* Diagnosis of Congenital Hypothyroidism (CH) with serum TSH \\> 20 mIU\u002FmL within the first 2 weeks of life and receiving L-T4 treatment;\n* Persistent serum TSH \\\u003C 6 mIU\u002FmL throughout the first 2 weeks;\n* Elevated thyroid hormone levels(T3, T4, FT3, or FT4) above the reference range within the first 2 weeks;\n* Diagnosis of Grade III or IV Intraventricular Hemorrhage (IVH) within the first 2 weeks of life;\n* Presence of major congenital malformations of vital organs or known chromosomal\u002Fgenetic disorders;\n* History of maternal thyroid disease or maternal use of thyroid-related medications.","2 Weeks",{"count":62,"type":22},106,[64],"NA","The primary objective of this clinical trail is to evaluate whether early supplementation of levothyroxine (L-T4) at a dosage of 8 ug\u002Fkg\u002Fd, initiated in the second week of life, improves physical growth and neurodevelopmental outcomes at 2 years of corrected age in Small for Gestational Age (SGA) infants with birth weights \\\u003C 1500g and TSH levels between 6 and 20 mIU\u002Fml. Preterm infants in the intervention group will receive 8 ug\u002Fkg\u002Fd of L-T4, while the control group will receive no supplementation. Physical growth will be assessed through height, weight, and head circumference, while neurodevelopmental status will be evaluated using the Bayley-IV scales and cranial MRI imaging findings.",[67,68,69,70],"Thyroid Function","Preterm","SGA and Growth","Neurodevelopment Outcome","2026-05-29",{"date":73,"type":44},"2026-06-04",{"date":75,"type":22},"2026-06-20",{"date":77,"type":22},"2029-06-20",{"name":50,"class":51},{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":4,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":90,"conditions":91,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":4},"100638624","phase-2-tace-combined-with-thermal-ablation-and-adc-pd-1-and-chemotherapy-as-first-line-treatment-for-her2-highly-expressing-gastric-cancer-with-liver-metastases-a-multicenter-single-arm-prospective-clinical-study-100638624","NCT07602140","TACE Combined With Thermal Ablation and ADC, PD-1, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: A Multicenter, Single-arm Prospective Clinical Study.","TACE Combined With Thermal Ablation and Antibody-drug Conjugates, Immune Checkpoint Inhibitors, and Chemotherapy as First-line Treatment for HER2-highly-expressing Gastric Cancer With Liver Metastases: a Multicenter, Single-arm Prospective Clinical Study.","Inclusion Criteria:\n\n1. Participants voluntarily joined this study, signed informed consent forms, demonstrated good compliance, and cooperated with follow-up.\n2. Male or female, aged 18 or older and 75 or younger;\n3. ECOG score is 0-1;\n4. Expected survival time ≥ 3 months;\n5. Imaging examinations suggest gastric cancer with liver metastasis;\n6. Histopathologically confirmed gastric adenocarcinoma and liver metastatic adenocarcinoma;\n7. Enhanced CT scans were used to observe the staining of liver metastases; tumors with good blood supply were included in this study.\n8. Immunohistochemical results of gastric adenocarcinoma and\u002For liver metastatic adenocarcinoma confirmed high expression of HER2 (defined as: IHC 2+ or 3+);\n9. No prior history of antibody-drug conjugate ( ADC ) therapy ; Note: Patients who have relapsed more than 6 months after receiving neoadjuvant (radiotherapy) chemotherapy + radical surgery, or who have relapsed more than 6 months after completing adjuvant (radiotherapy) chemotherapy or radical concurrent chemoradiotherapy;\n10. Within 28 days prior to the first administration of the study drug, the target lesion had not received local treatment (including transarterial chemoembolization\u002FTACE, hepatic artery infusion chemotherapy\u002FTAC, radiotherapy, radiation embolization or ablation, etc.);\n11. There must be at least one liver metastasis meeting the following criteria:\n\nAt least one patient is eligible for TACE and\u002For thermal ablation treatment; 12. In addition to the ablated lesion, there is at least one measurable lesion in the liver or outside the liver (according to RECIST 1.1 criteria, the long axis of the tumor lesion on CT scan is ≥10 mm, and the short axis of the lymph node lesion on CT scan is ≥10 mm) (for assessing the remote effect).\n\n1.3 . Damage caused by other treatments received by the subject has recovered, including those received other cytotoxic drugs, radiotherapy or surgery for ≥4 weeks, and the wounds have completely healed ; 1.4 . Subjects should not have previously received anti-PD-1, PD-L1, CTLA-4, or CAR-T immunotherapy ; 1.5 . Asymptomatic brain metastases or control of brain metastases after radiotherapy ; 1.6 . Major organ functions are normal, and subjects must meet the following laboratory indicators:\n\n1)In the absence of granulocyte colony-stimulating factor use in the past 14 days, the absolute neutrophil count (ANC) is ≥1.5 x 10⁹ \u002FL .\n\n2)10⁹ \u002FL without blood transfusion in the past 14 days ; 3)Hemoglobin \\>9 g\u002FdL in the absence of blood transfusion or erythropoietin use within the past 14 days ; 4)There is no active bleeding, such as hematemesis, melena, gingival bleeding, epistaxis, or hemorrhoidal bleeding, and the fecal occult blood test is ≤ +.\n\n5)Total bilirubin ≤1.5 × upper limit of normal (ULN); 6)Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5.0×ULN , alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×ULN, and total serum bilirubin (TBIL) ≤1.5×ULN.\n\n7)Serum creatinine ≤1.5×ULN or creatinine clearance ( CrCl ) ≥50 mL\u002Fmin calculated according to the Cockcroft-Gault formula; For women: CrCl = (140 - age × weight (kg) × 0.85 \u002F 72 × serum creatinine (mg\u002FdL)) For males: CrCl = (140 - age × weight (kg) × 1.00 \u002F 72 × serum creatinine (mg\u002FdL)) 8)Good coagulation function is defined as an international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times the ULN; and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN; (For patients receiving anticoagulation therapy, such as those taking anticoagulants like aspirin , warfarin, or clopidogrel , the medication should generally be discontinued for at least 5-7 days, and the investigator should determine that both INR and APTT are within a safe and effective therapeutic range).\n\n9)Normal thyroid function is defined as thyroid-stimulating hormone (TSH) within the normal range. If baseline TSH exceeds the normal range, subjects with normal total T3 (or FT3) and FT4 may also be enrolled.\n\n10)Cardiac enzyme levels within the normal range (simply laboratory abnormalities that are not clinically significant, as determined by the researchers, are also allowed to be enrolled); 11)Doppler ultrasound assessment showed a left ventricular ejection fraction (LVEF) ≥ 50%.\n\n1.7 . Patients with potential fertility need to use a medically approved contraceptive method (such as an intrauterine device, birth control pill, or condom) during the study treatment period and for one month after the end of the study treatment period; and must have a negative serum or urine HCG test within 72 hours before study enrollment, and must not be breastfeeding.\n\nExclusion Criteria:\n\nSubjects meeting the following criteria were not eligible for inclusion in this study:\n\n1. diagnosed with other malignant tumors within 5 years prior to the first dose and who are not cured (excluding radically resected basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has been radically removed);\n2. Currently participating in interventional clinical research treatment, or having received other investigational drugs or used investigational devices within 4 weeks prior to the first dose;\n3. Previous treatment with the following: antibody-drug conjugates, anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or co-inhibit T cell receptors (e.g. CTLA-4, OX-40, CD137);\n4. Within 28 days prior to the first administration of the study drug, the target lesion had received local treatment (including transarterial chemoembolization\u002FTACE, hepatic artery infusion chemotherapy\u002FTAC, radiotherapy, radioembolization or ablation, etc.);\n5. The patient had received systemic treatment with traditional Chinese medicine or immunomodulatory drugs with antitumor indications within 2 weeks prior to the first dose ;\n6. Subjects with any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; subjects with vitiligo or whose childhood asthma was completely remitted and requires no intervention in adulthood are eligible to be included; subjects with asthma requiring medical intervention with bronchodilators are not eligible to be included).\n7. Subjects are currently using immunosuppressants, or systemic or absorbable topical corticosteroids, to achieve immunosuppression (dose \\>10 mg\u002F day prednisone or other equivalent corticosteroids), and have continued to use them within 2 weeks prior to enrollment; Note: Physiological doses of glucocorticoids (≤10 mg\u002Fday prednisone or equivalent drugs) are permitted.\n8. Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n9. known hypersensitivity to the study drugs vedicetumab , sintilimab, and tegafur ;\n10. Active gastrointestinal bleeding or high risk of bleeding within 2 weeks prior to screening; or gastrointestinal perforation\u002Ffistula within 6 months prior to screening; intestinal obstruction, within 30 days after major surgery, uncontrolled hypertension, NYHA class III-IV heart failure, or severe hepatic or renal failure (class 4).\n11. Prior to starting treatment, the individual has not fully recovered from any toxicity and\u002For complications caused by any intervention (i.e., ≤ grade 1 or at baseline, excluding fatigue or hair loss).\n12. Known history of human immunodeficiency virus (HIV) infection (i.e., HIV 1\u002F2 antibody positive );\n13. Untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number greater than the upper limit of normal value in the laboratory of the research center);\n\nNote : Hepatitis B subjects who meet the following criteria may also be enrolled :\n\n1. before the first dose , the subject should receive anti-HBV therapy throughout the study chemotherapy treatment to avoid viral reactivation.\n2. Subjects with positive, negative, anti-HBs, or negative HBV viral loads do not require prophylactic anti-HBV treatment, but close monitoring for viral reactivation is necessary.\n\n14.Subjects with active HCV infection (HCV antibody positive and HCV-RNA level above the detection limit); 15.Those who have received a live vaccine within 4 weeks prior to screening or plan to receive any vaccine during the study period (Note: Injectable inactivated virus vaccines against seasonal influenza are permitted within 30 days prior to the first dose; however, intranasal live attenuated influenza vaccines are not permitted).\n\n16.Pregnant or breastfeeding women; 17.The presence of any serious or uncontrollable systemic disease, such as:\n\n1. Significant and uncontrollable abnormalities in rhythm, conduction, or morphology on resting electrocardiogram, such as complete left bundle branch block, second-degree or higher cardiac conduction block, ventricular arrhythmia, or atrial fibrillation.\n2. According to NYHA standards, heart failure is classified as grade III or IV, or echocardiography shows a left ventricular ejection fraction (LVEF) \\\u003C50%; unstable angina, congestive heart failure, or NYHA grade 3 or higher heart failure.\n3. Subjects who had experienced acute cardiovascular and cerebrovascular diseases such as acute cerebral infarction or acute coronary syndrome within one month, and whose cardiovascular clinical symptoms or diseases were not well controlled;\n4. A history of non-infectious pneumonia requiring glucocorticoid therapy within one year prior to the first dose, or current clinically active interstitial lung disease;\n5. Active pulmonary tuberculosis;\n6. prior to the first use of the study drug , such as severe pneumonia, bacteremia, or infectious complications requiring hospitalization; baseline chest imaging showed active lung inflammation; symptoms and signs of infection existed within 2 weeks prior to the first use of the study drug; or oral and intravenous antibiotics were required, excluding prophylactic antibiotic use.\n7. The patient presents with clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction.\n8. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n9. Patients with a clear tendency to gastrointestinal bleeding include those with the following conditions: active local ulcer lesions and fecal occult blood (++) {those with ++ are not eligible}; those with a history of melena or hematemesis within the past 2 months;\n10. Those with abnormal coagulation function (INR\\>1.5 APTT\\>1.5 ULN) and bleeding tendency;\n11. Long-term unhealed wounds or fractures; major surgery or severe traumatic injury, fracture or ulcer within 4 weeks;\n12. Poorly controlled diabetes (fasting blood glucose (FBG) \\> 10 mmol\u002FL);\n13. Urinalysis results indicate urine protein ≥++, and 24-hour urine protein quantification is confirmed to be \\>1.0 g;\n14. Patients with mental disorders who are unable to cooperate with treatment;\n15. Patients requiring treatment and with a history of lung disease that could potentially affect surgery include, but are not limited to, interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, and acute lung disease.\n16. The patient presents with clinically active diverticulitis, abdominal abscess, and gastrointestinal obstruction.\n17. Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis;\n18. Patients with mental disorders who are unable to cooperate with treatment;\n19. The presence of systemic diseases that researchers have determined are not stably controlled, including diabetes and hypertension; 18.Candidates must have a history of active autoimmune disease requiring systemic treatment (such as immunomodulatory drugs, corticosteroids, or immunosuppressants) within the past two years prior to screening, with permitted replacement therapy (such as thyroxine, insulin, or physiological corticosteroid replacement therapy for renal or pituitary insufficiency), or a history of refractory autoimmune disease. Candidates must have used systemic steroids (dose \\> 10 mg\u002Fday prednisone or equivalent dose of other glucocorticoids) or other systemic immunosuppressive therapies within 14 days prior to screening.\n\n19.Patients must have had other malignant tumors within the 5 years prior to screening, except for those that have been cured by treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer, or ductal carcinoma in situ of the breast treated with radical surgery).\n\n20.Known allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation; 21.Prior to starting treatment, the individual has not fully recovered from any toxicity and\u002For complications caused by any intervention (i.e., ≤ grade 1 or at baseline, excluding fatigue or hair loss).\n\n22.Medical history or disease evidence that may interfere with trial results, prevent participants from participating in the study throughout the process, abnormal treatment or laboratory test values, or other circumstances that the investigator deems unsuitable for enrollment.",{"count":87,"type":22},40,[89],"PHASE2","This study is a multicenter, single-arm prospective clinical trial designed to evaluate the efficacy of TACE combined with thermal ablation, antibody-drug conjugates, immune checkpoint inhibitors, and first-line chemotherapy for the treatment of HER2 - highly expressing gastric cancer with liver metastases.",[92],"Gastric Cancer With Liver Metastases","2026-05-17",{"date":95,"type":44},"2026-05-22",{"date":97,"type":22},"2026-08-01",{"date":99,"type":22},"2029-08-01",{"name":50,"class":51},{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":4},"100639376","safety-and-efficacy-of-early-brain-computer-interface-training-after-reperfusion-therapy-in-acute-ischemic-stroke-100639376","NCT07585058","Safety and Efficacy of Early Brain-Computer Interface Training After Reperfusion Therapy in Acute Ischemic Stroke","RT-BCI","Inclusion Criteria:\n\n* 1\\. Age 18 to 80 years.\n* 2\\. Acute ischemic stroke (AIS) treated with reperfusion therapy, including intravenous thrombolysis (IVT) and\u002For mechanical thrombectomy (MT); for participants undergoing MT, successful recanalization during the procedure defined as eTICI 2b-3.\n* 3\\. Meets the protocol-defined clinical stability criteria for the corresponding treatment pathway (see Section 4.3).\n* 4\\. Unilateral limb motor dysfunction on the same side as the dominant hand.\n* 5\\. Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score of 10 to 50 at T0.\n* 6\\. Pre-stroke modified Rankin Scale (mRS) score \\\u003C= 2.\n* 7\\. Written informed consent provided by the participant and ability to comply with training and follow-up; if necessary, consent may be provided by a legally authorized representative.\n\nExclusion Criteria:\n\n* 1\\. Imaging-confirmed symptomatic intracranial hemorrhage (sICH), or bleeding risk considered unacceptable by the investigator and requiring a change in treatment strategy.\n* 2\\. Overt progressive neurological deterioration or need for urgent intervention, making training inappropriate, such as an increase in National Institutes of Health Stroke Scale (NIHSS) score of \\>=4 from a prior assessment with cause not yet clarified or stabilized.\n* 3\\. Severe disturbance of consciousness, severe aphasia or neglect, or significant cognitive impairment that would prevent completion of BCI training tasks or primary outcome assessment.\n* 4\\. Bilateral significant motor impairment, such as brainstem or bilateral lesions, or pre-existing moderate-to-severe disability of the contralateral upper or lower limb, which would interfere with training or interpretation of assessments under the unilateral impairment framework.\n* 5\\. Severe comorbidity or unstable vital signs, including but not limited to unstable arrhythmia, severe heart failure or respiratory failure, active severe infection or sepsis, or severe hepatic or renal failure, such that the investigator judges the participant unable to safely complete training and follow-up.\n* 6\\. Severe scalp skin damage or infection, or any other condition preventing safe use of the EEG electrode cap.\n* 7\\. Frequent seizures within 7 days before randomization, or seizure risk considered unacceptable by the investigator.\n* 8\\. Pregnancy or breastfeeding.\n* 9\\. Participation in another interventional clinical study that may affect the outcomes of this study, or any other condition that, in the investigator's judgment, makes the participant unsuitable for enrollment.","80 Years",{"count":110,"type":22},60,[64],"This is a multicenter, prospective, randomized controlled trial designed to evaluate the efficacy, safety, and feasibility of early EEG-based non-invasive brain-computer interface (EEG-BCI) training as an add-on to standard early rehabilitation in patients with acute ischemic stroke (AIS) after reperfusion therapy. Eligible participants are adults aged 18 to 80 years with unilateral limb motor dysfunction after intravenous thrombolysis (IVT) and\u002For mechanical thrombectomy (MT). Participants will be randomized to receive either standard early rehabilitation plus closed-loop EEG-BCI dual-module virtual hand and gait training, or standard early rehabilitation alone.\n\nThe EEG-BCI intervention includes upper-limb virtual hand training and lower-limb gait\u002Fankle dorsiflexion training, delivered twice daily for approximately 20 minutes per session over 5 consecutive days. The primary outcome is the change in Fugl-Meyer Assessment for Upper Extremity (FMA-UE) score from baseline (T0) to Day 30. Secondary outcomes include upper- and lower-limb motor function, ambulation, neurological status, disability, and activities of daily living. Safety and feasibility outcomes will also be assessed.",[114],"Acute Ischemic Stroke","2026-05-08",{"date":117,"type":44},"2026-05-13",{"date":119,"type":22},"2026-04",{"date":121,"type":22},"2027-06",{"name":50,"class":51},{"id":124,"slug":125,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":131,"targetDuration":4,"studyType":23,"phases":133,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":52},"100579861","phase-2-a-multicenter-randomized-controlled-phase-ii-trial-of-iparomlimab-and-tuvonralimab-ql1706-combined-with-sox-chemotherapy-versus-chemotherapy-alone-in-the-treatment-of-locally-advanced-gastric-or-gastroesophageal-junction-adenocarcinoma-100579861","NCT06829797","A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma","A Multicenter Randomized Controlled Phase II Trial of Iparomlimab and Tuvonralimab (QL1706) Combined With SOX Chemotherapy Versus Chemotherapy Alone in the Treatment of Locally Advanced Gastric or Gastroesophageal Junction Adenocarcinoma(STAR-03)","STAR-03","Inclusion Criteria:\n\n* Voluntary participation in the study and signing of informed consent;\n* Age ≥18 years and ≤75 years;\n* Pathologically confirmed gastric adenocarcinoma or gastroesophageal junction adenocarcinoma;\n* Clinical staging of T3N+ or T4a any N, M0 (according to AJCC 8th edition staging), with potential radical resection confirmed by CT or MRI;\n* Have not received any anti-tumor therapy (e.g., surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy);\n* Planned to undergo surgery after completion of neoadjuvant therapy;\n* Be able to swallow pills normally;\n* ECOG-PS score 0-1;\n* Expected survival ≥ 12 months;\n* Normal major organ function.\n\nExclusion Criteria:\n\n* Known HER2 positivity;\n* Known peritoneal metastases or positive peritoneal cytology (CY1P0) or T4b (according to AJCC 8th edition);\n* Presence of unresectable factors including unresectable tumors, contraindications to surgery and refusal of surgery;\n* The presence of a pre-existing or concurrent malignancy, with the exception of cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and carcinoma in situ of the breast\n* History of gastrointestinal perforation, history of abdominal abscess or recent (within 3 months) occurrence of intestinal obstruction, or concomitant intestinal obstruction as indicated by imaging or clinical signs;\n* Patients with abnormal coagulation (International Normalized Ratio (INR) \\>2.0 or Prothrombin Time (PT) \\>16s), a bleeding tendency or currently receiving thrombolytic or anticoagulant therapy (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed);\n* Clinically significant bleeding symptoms or significant bleeding tendency such as gastrointestinal bleeding, gastric ulcer bleeding, and vasculitis within 3 months prior to randomization into groups. Patients with positive fecal occult blood at baseline may be retested, and if the retest remains positive, gastroscopy will be required (except for patients who have had a gastroscopy within 3 months prior to enrollment to rule out this condition);\n* Arterial\u002Fvenous thrombotic events such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism within 6 months prior to randomization to group;\n* A known hereditary or acquired predisposition to bleeding and thrombosis (e.g., hemophilia, coagulation disorders, and thrombocytopenia);\n* The presence of active ulcers, unhealed wounds or fractures\n* Urinalysis showing urinary protein ≥++, confirmed by 24-hour urine protein quantification \\>1.0 g;\n* Active infections requiring antimicrobial therapy (e.g., antibacterial, antiviral, and antifungal medications);\n* Active hepatitis (Hepatitis B reference: HBsAg positive and HBV DNA ≥ 500 IU\u002FmL; Hepatitis C reference: HCV antibody positive and HCV viral copy number \\> upper limit of normal (ULN));\n* Congenital or acquired immunodeficiency (e.g., HIV-infected patients);\n* Planned or previous organ or allogeneic bone marrow transplant;\n* Current interstitial pneumonia or interstitial lung disease, or a history of interstitial pneumonia or interstitial lung disease requiring hormonal therapy, or other conditions that may interfere with the assessment and management of immune-related pulmonary toxicity, such as pulmonary fibrosis, opportunistic pneumonia (e.g., occlusive bronchiectasis), pneumoconiosis, drug-associated pneumonia, and idiopathic pneumonitis, or active pneumonitis or severe pulmonary impairment as demonstrated by CT at screening; Active tuberculosis;\n* Any active autoimmune disease or history of autoimmune disease with potential for relapse;\n* Treatment with immunosuppressive drugs or systemic corticosteroids (\\>10 mg\u002Fday of prednisone or equivalent) within 7 days prior to randomization to group;\n* Use of a strong CYP3A4 inducer within 2 weeks prior to randomization subgroup or use of a strong CYP3A4 inhibitor within 1 week prior to randomization subgroup\n* Oral or intravenous administration of therapeutic antibiotics within 4 weeks prior to randomization to subgroups, except for prophylactic antibiotics administered intravenously for no more than 48 hours\n* Known allergy to any study drug or excipient;\n* Participation in a clinical study of another drug within 4 weeks prior to randomization to group;\n* Being a lactating female.",{"count":132,"type":22},96,[89],"To explore the efficacy of Iparomlimab and Tuvonralimab (QL1706) in combination with SOX chemotherapy versus chemotherapy alone for the neoadjuvant treatment of locally-progressed gastric\u002Fgastroesophageal union adenocarcinomas by evaluating the complete pathologic remission rate (pCR).",[136],"Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","RECRUITING","2026-04-24",{"date":140,"type":44},"2026-04-29",{"date":142,"type":44},"2025-03-11",{"date":144,"type":22},"2028-02-29",{"name":50,"class":51},{"id":147,"slug":148,"hasResults":11,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":152,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":154,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":159,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":52},"100574999","phase-2-clinical-study-of-low-dose-interval-radiotherapy-combined-with-tirelizumab-and-sox-chemotherapy-neoadjuvant-therapy-for-locally-advanced-gastricgastroesophageal-junction-adenocarcinoma-100574999","NCT06766578","Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma","Clinical Study of Low-dose Interval Radiotherapy Combined With Tirelizumab and SOX Chemotherapy Neoadjuvant Therapy for Locally Advanced Gastric\u002FGastroesophageal Junction Adenocarcinoma(STAR-02)","STAR-02","Inclusion Criteria:\n\n* Patients voluntarily participated in the study and signed informed consent with good compliance and follow-up;\n* Adenocarcinoma of the gastric\u002Fgastroesophageal junction confirmed by endoscopic pathology (tumor located in the lesser bend of the stomach other than pylorus or the gastroesophageal junction) (Note: Pathology in other hospitals must be consulted by our hospital);\n* Patients with cT4N+M0 AJCC stage 8 combined with endoscopic, CT, MRI, or PETCT findings;\n* Age ≥18 years, ≤75 years, male and female;\n* ECOG PS score 0-1;\n* Presence of measurable and\u002For unmeasurable lesions as defined by the efficacy evaluation criteria for solid tumors (Recist 1.1);\n* Has not received any prior systemic antitumor therapy (including but not limited to systemic chemotherapy, radiotherapy, molecular targeted drug therapy, immunotherapy, biotherapy, topical therapy, or other investigational therapeutic drugs;\n* The functions of vital organs meet the following requirements (no blood components and cell growth factors are allowed to be used 2 weeks before screening) : Neutrophil absolute count (ANC) ≥ 1.5×10 9\u002FL; Platelets ≥100×10 9\u002FL; Hemoglobin ≥9g\u002FdL; Serum albumin ≥2.8g\u002FdL; Total bilirubin ≤ 1.5 ×ULN, ALT, AST and\u002For AKP≤2.5 ×ULN; serum creatinine ≤1.5 ×ULN or creatinine clearance ≥60mL\u002Fmin (calculated according to the Cockcroft-Gault formula); International standardized ratio (INR) and activated partial thrombin time (APTT) ≤1.5×ULN (INR can be screened in the expected treatment range of anticoagulants for stable doses of anticoagulants such as low molecular weight heparin or warfarin);\n* Fertile female subjects shall perform a urine or serum pregnancy test within 72 hours prior to receiving the first study drug, prove negative, and be willing to use an effective method of contraception during the trial period up to 5 months after the last drug administration.Male subjects whose partner is a woman of reproductive age should use an effective method of contraception during the trial period and for 7 months after the last dose.\n\nExclusion criteria\n\n* a history of surgery for gastric\u002Fesophagogastric junction tumors;\n* Previous history of fistula caused by primary tumor invasion;\n* Higher risk of gastrointestinal bleeding and perforation;\n* Poor nutritional status, BMI less than 18.5kg\u002Fm2, or PG-SGA score ≥9;\n* Major surgery or severe trauma within 4 weeks prior to first use of the study drug;\n* Uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage;\n* has received or is currently receiving any of the following previous treatments: anti-PD-1 or anti-PD-L1 antibody therapy, chemotherapy, radiotherapy, targeted therapy;\n* Received any investigational drug within 4 weeks prior to first use of the investigational drug;\n* subjects requiring systemic treatment with corticosteroids (\\> 10mg prednisone equivalent daily dose) or other immunosuppressants within 2 weeks prior to initial use of the study drug, except for corticosteroids for esophageal\u002Fgastric local inflammation and for the prevention of allergy and nausea and vomiting.Other special circumstances, need to communicate with the bid. In the absence of active autoimmune disease, inhaled or topical steroids and adrenocorticosteroid replacement at doses \\> 10mg\u002F d of prednisone efficacy are permitted;\n* those who have received antitumor vaccine or have received live vaccine within 4 weeks prior to the first administration of the study drug;\n* have any active autoimmune disease or a history of autoimmune disease (such as interstitial pulmonary inflammation, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except patients with vitiligo or recovered asthma\u002Fallergy of the same age without any intervention as adults;Patients with autoimmune mediated hypothyroidism treated with stable doses of thyroid hormone replacement and type 1 diabetes treated with stable doses of insulin could be included;\n* have a history of immunodeficiency, including HIV positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation or allogeneic bone marrow transplantation;\n* any condition requiring systemic treatment with corticosteroids (more than 10 mg\u002F day of prednisone or its equivalent) or other immunosuppressant treatment within 14 days prior to treatment (except local, ocular, intraarticular, intranasal and inhaled corticosteroids with minimal systemic uptake); Prophylactic short-term (≤7 days) use of corticosteroids (e.g., to prevent contrast allergy) or for the treatment of non-autoimmune conditions (e.g., delayed hypersensitivity due to allergen exposure);\n* subjects with uncontrolled cardiac clinical symptoms or disease, such as (1) NYHA II or above heart failure (2) unstable angina pecina (3) myocardial infarction within 1 year (4) clinically significant ventricular arrhythmias or ventricular arrhythmias requiring clinical intervention;\n* Severe infection (CTCAE \\> level 2), such as severe pneumonia, bacteremia, and infectious complications requiring hospitalization, occurred within 4 weeks prior to initial use of the study drug; Chest imaging at baseline suggested active lung inflammation and signs and symptoms of infection requiring oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, except for prophylactic antibiotic use;\n* a history of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis or other uncontrolled acute lung disease;\n* Patients with active pulmonary tuberculosis infection found by history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis infection history more than 1 year ago but without formal treatment;\n* Subjects with active hepatitis B (HBV DNA≥2000 IU\u002FmL or 10 4 Copies \u002FmL), hepatitis C (positive hepatitis C antibody, and HCV-RNA higher than the lower limit of detection method);\n* Abnormal values of sodium, potassium and calcium greater than grade 1 in laboratory tests within 2 weeks before enrollment, which could not be improved after treatment;\n* known allergy to macromolecular protein preparations, or to any COMPONENT of PD-1, or allergy, hypersensitivity or contraindication to oxaliplatin or capecitabine or any component used in their preparations;\n* A prior diagnosis of any other malignancy, other than malignancies with a low risk of metastasis and death (5-year survival \\> 90%), such as adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix;\n* pregnant or lactating women; Fertile subjects unwilling or unable to use effective contraception;\n* According to the investigator's judgment, subjects have other factors that may cause them to be forced to terminate the study, such as other serious diseases (including mental diseases) requiring combined treatment, other recent serious diseases (such as myocardial infarction and cerebrovascular accident) with high risk of recurrence, seriously abnormal laboratory test values, family or social factors, which may affect subjects' safety or the collection of test data.",{"count":155,"type":22},32,[89],"To evaluate the initial efficacy and safety of neoadjuvant low-dose interval radiotherapy combined with tirelizumab and SOX chemotherapy in locally advanced gastric\u002Fgastroesophageal junction adenocarcinoma.",[136],{"date":140,"type":44},{"date":161,"type":44},"2024-12-30",{"date":163,"type":22},"2027-12-31",{"name":50,"class":51},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":173,"targetDuration":4,"studyType":23,"phases":175,"briefSummary":177,"conditions":178,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":185,"leadSponsor":187,"locationsCount":52},"100634303","phase-3-intra-arterial-tirofiban-after-complete-recanalization-for-acute-intracranial-large-vessel-occlusion-100634303","NCT07537933","Intra-Arterial Tirofiban After Complete Recanalization for Acute Intracranial Large-Vessel Occlusion","Efficacy and Safety of Immediate Intra-Arterial Tirofiban After Mechanical Thrombectomy Recanalization in Acute Intracranial Large-Vessel Occlusion","IA-Tirofiban","Inclusion Criteria:\n\nAge ≥18 years; Last known well to arterial puncture within 0 to 24 hours; Preoperative imaging confirms anterior circulation large-vessel occlusion, including intracranial internal carotid artery occlusion or middle cerebral artery M1 or dominant M2 occlusion; Baseline National Institutes of Health Stroke Scale (NIHSS) score 6 to 25; Baseline Alberta Stroke Program Early CT Score (ASPECTS) ≥6 on CT or DWI; Pre-stroke modified Rankin Scale (mRS) score ≤1; eTICI 2c to 3 complete recanalization achieved after mechanical thrombectomy, or spontaneous recanalization to eTICI 2c to 3 confirmed intraoperatively without further thrombectomy; Embolic occlusion with no residual fixed stenosis in the target vessel after thrombectomy; Written informed consent provided by the participant or legally authorized representative.\n\nExclusion Criteria:\n\nPregnancy or breastfeeding; Active bleeding within the previous month or known severe bleeding tendency; Major underlying disease with life expectancy \\\u003C6 months, or inability in the investigator's judgment to complete follow-up; Participation in another interventional clinical trial; Use of oral anticoagulants within 48 hours before symptom onset with INR \\>1.7, or recent use of direct oral anticoagulants not meeting institutional cessation or testing requirements; Platelet count \\\u003C50 × 10\\^9\u002FL; Blood glucose \\\u003C2.8 mmol\u002FL or \\>22.2 mmol\u002FL that cannot be corrected promptly Severe renal insufficiency, defined as eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m² or serum creatinine \\>2.5 mg\u002FdL; Uncontrolled blood pressure, defined as systolic blood pressure \\>185 mmHg or diastolic blood pressure \\>110 mmHg despite treatment; Imaging evidence of intracranial hemorrhage, or presence of an intracranial aneurysm, arteriovenous malformation, brain tumor, or other lesion associated with high bleeding risk; Bilateral acute cerebral infarction or multiple intracranial arterial occlusions Intraoperative vessel rupture, dissection, contrast extravasation, or other severe complications requiring a change in the standard anticoagulation strategy; Need for balloon angioplasty, permanent stent placement, or planned initiation of antiplatelet or anticoagulation therapy within 24 hours after the procedure; More than 3 thrombectomy passes or puncture-to-recanalization time \\>90 minutes; Use of an intraoperative intravenous heparin bolus, excluding heparinized saline flush; Suspected embolic stroke due to infection or infectious endocarditis; Severe allergy to contrast agents or tirofiban.",{"count":174,"type":22},344,[176],"PHASE3","The goal of this clinical trial is to learn if immediate intra-arterial tirofiban after complete recanalization can improve recovery in adults with acute ischemic stroke caused by anterior circulation large-vessel occlusion. It will also learn about the safety of this treatment. The main questions it aims to answer are:\n\nDoes immediate intra-arterial tirofiban after complete recanalization increase the number of participants with good functional outcome at 90 days? Does this treatment increase the risk of symptomatic intracranial hemorrhage or other important bleeding events?\n\nResearchers will compare immediate intra-arterial tirofiban with no intra-arterial tirofiban after complete recanalization to see if tirofiban improves recovery and is safe.\n\nParticipants will:\n\nBe enrolled after mechanical thrombectomy achieves complete recanalization Be randomly assigned to receive intra-arterial tirofiban or no intra-arterial tirofiban Receive follow-up assessments during hospitalization and at 90 days",[114,179,180],"Large-vessel Occlusion","Endovascular Treatment","2026-04-17",{"date":183,"type":44},"2026-04-22",{"date":119,"type":22},{"date":186,"type":22},"2028-04",{"name":50,"class":51},{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":195,"targetDuration":4,"studyType":197,"phases":4,"briefSummary":198,"conditions":199,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":201,"lastUpdatePostDateStruct":202,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":52},"100635162","efficacy-and-safety-of-tislelizumab-plus-chemotherapy-as-conversion-therapy-in-unresectable-locally-advanced-escc-100635162","NCT07549100","Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced ESCC","Efficacy and Safety of Tislelizumab Plus Chemotherapy as Conversion Therapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Written informed consent is obtained prior to any study-related procedures.\n2. Age 18 to 75 years, inclusive; both male and female patients are eligible.\n3. Histologically and radiologically confirmed thoracic esophageal squamous cell carcinoma (ESCC) with initially unresectable locally advanced disease, defined as:\n\n   T4b tumors invading adjacent critical structures, including the heart, great vessels, trachea, or other adjacent organs (including liver, pancreas, lung, or spleen); or Multiple-station or bulky lymph node metastases.\n4. No evidence of distant metastasis.\n5. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.\n7. Estimated life expectancy of ≥6 months.\n8. Adequate organ function, as defined below (without transfusion of blood products or use of hematopoietic growth factors within 14 days prior to assessment):\n\n   Hematologic function: absolute neutrophil count (ANC) ≥1,500\u002Fmm³; platelet count ≥100,000\u002Fmm³; hemoglobin ≥9 g\u002FdL (5.6 mmol\u002FL).\n\n   Renal function: serum creatinine ≤1.5 mg\u002FdL and\u002For creatinine clearance ≥60 mL\u002Fmin.\n\n   Hepatic function: total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤1.5 × ULN.\n9. For women of childbearing potential: must have a negative serum or urine pregnancy test within 7 days prior to enrollment, must not be breastfeeding, and must agree to use a medically acceptable method of contraception (e.g., intrauterine device, oral contraceptives, or barrier methods) during the study treatment period and for at least 3 months after the last dose.\n\n   For men with partners of childbearing potential: must agree to use a medically acceptable method of contraception during the study treatment period and for at least 3 months after the last dose.\n10. Willingness to participate in the study, good compliance, and ability to adhere to study procedures, including safety and survival follow-up.\n\nExclusion Criteria:\n\n1. Prior receipt of radiotherapy, chemotherapy, hormonal therapy, surgery, or molecular targeted therapy for esophageal cancer.\n2. Evidence of distant metastasis confirmed by imaging.\n3. History of other malignancies, except for adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix.\n4. Prior treatment with any anti-PD-1 or anti-PD-L1 agents; known hypersensitivity to monoclonal antibodies or any component of tislelizumab.\n5. Active autoimmune disease or a history of autoimmune disease, including but not limited to autoimmune hepatitis, interstitial lung disease, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism.\n6. Patients with vitiligo or a history of childhood asthma that has completely resolved and requires no intervention in adulthood may be eligible.\n7. Patients with asthma requiring bronchodilator therapy are not eligible.\n8. Current use of immunosuppressive medications, including systemic corticosteroids or absorbable local steroids for immunosuppressive purposes (dose \\>10 mg\u002Fday prednisone or equivalent) within 2 weeks prior to enrollment.\n\n   Clinically significant ascites or pleural effusion requiring therapeutic drainage.\n\n   Uncontrolled or clinically significant cardiovascular disease, including but not limited to:\n\n   New York Heart Association (NYHA) class II or higher heart failure; Unstable angina; Myocardial infarction within 1 year prior to enrollment; Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n9. Coagulation abnormalities, defined as: prothrombin time (PT) \\>16 seconds, activated partial thromboplastin time (APTT) \\>43 seconds, thrombin time (TT) \\>21 seconds, or fibrinogen (Fbg) \\>2 g\u002FL; or presence of bleeding tendency, or ongoing thrombolytic or anticoagulant therapy.\n10. Presence of gastrointestinal conditions associated with a high risk of bleeding or perforation within 3 months prior to enrollment, including but not limited to esophageal varices, active gastric or duodenal ulcers, ulcerative colitis, portal hypertension, or unresected tumors with active bleeding; or any other condition judged by the investigator to pose a risk of gastrointestinal bleeding or perforation.",{"count":196,"type":22},30,"OBSERVATIONAL","This is a single-arm, single-center, open-label, observational clinical study. A total of 30 patients with initially unresectable locally advanced esophageal squamous cell carcinoma will be enrolled.Eligible patients will receive albumin-bound paclitaxel (260 mg\u002Fm², day 1, every 3 weeks \\[Q3W\\]) plus cisplatin (75 mg\u002Fm²) or carboplatin (AUC = 5), in combination with tislelizumab (200 mg, day 2, Q3W), for 2-4 cycles. Tumor staging will be reassessed thereafter, and the feasibility of surgical resection will be determined based on multidisciplinary team (MDT) discussion.The primary endpoint is the conversion rate to surgery.\n\nSecondary endpoints include pathological complete response (pCR), objective response rate (ORR), and safety.",[200],"Locally Advanced Esophageal Squamous Cell Carcinoma","2026-04-16",{"date":203,"type":44},"2026-04-23",{"date":205,"type":44},"2023-05-15",{"date":207,"type":22},"2028-12-31",{"name":50,"class":51},{"id":210,"slug":211,"hasResults":11,"nctId":212,"briefTitle":213,"officialTitle":214,"acronym":215,"eligibilityCriteria":216,"healthyVolunteers":217,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":218,"targetDuration":220,"studyType":197,"phases":4,"briefSummary":221,"conditions":222,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":52},"100633517","cardiac-magnetic-resonance-clinical-prediction-model-dilated-cardiomyopathy-100633517","NCT07527715","Cardiac Magnetic Resonance-Clinical Prediction Model-Dilated Cardiomyopathy","Study on Risk Early Warning of Clinical Prediction Model Based on Multi-Parameter Stress Perfusion Cardiac Magnetic Resonance in Adverse Prognosis of Dilated Cardiomyopathy","MPS-CMR-DCM","Inclusion Criteria\n\n1.An elevated left ventricular end-diastolic volume indexed to body surface area and reduced LVEF, compared with published age- and gender-specific reference values Exclusion Criteria\n\n1. significant coronary artery disease (CAD), defined as a stenosis of ˃50% in a major coronary artery\n2. infiltrative disease\n3. valvular cardiomyopathy\n4. arrhythmogenic cardiomyopathy\n5. congenital heart disease",true,{"count":219,"type":22},2000,"6 Months","Dilated cardiomyopathy (DCM) is a common and serious heart disease characterized by left ventricular enlargement and impaired pumping function, with adverse prognosis (including heart failure, arrhythmia, heart-related hospitalization, and death) being a major concern for patients. Currently, a critical gap exists in accurately predicting which DCM patients are at high risk of these severe outcomes, limiting targeted clinical care.\n\nThis observational, non-invasive study aims to develop and validate a clinical prediction model for early risk warning of adverse prognosis in DCM patients. The model integrates multi-parameter stress perfusion cardiac magnetic resonance (MP stress perfusion CMR)-a safe, high-resolution imaging technique that assesses cardiac structure, function, blood perfusion, and tissue damage under mild stress-and standard clinical data (e.g., age, gender, blood pressure, and routine heart test results).\n\nThe model will be trained and tested using follow-up data from hundreds of DCM patients, with the analysis identifying patterns in CMR and clinical data associated with adverse outcomes. Once validated for accuracy, the model will provide doctors with personalized risk scores to prioritize care for high-risk patients (e.g., early intervention, close monitoring) and avoid over-treatment for lower-risk individuals.\n\nBeyond clinical application, the study will enhance understanding of DCM progression, laying the groundwork for improved diagnostic tools, more effective treatments, and better strategies to prevent DCM-related complications, ultimately improving patient quality of life and reducing mortality.",[223,224,225,226,227,228,229],"Cardiomyopathy, Dilated","Prognosis","Magnetic Resonance Imaging, Cardiac","Death, Sudden, Cardiac","Heart Failure","Risk Assessment","Stress Perfusion","2026-04-09",{"date":232,"type":44},"2026-04-14",{"date":234,"type":44},"2021-12-01",{"date":236,"type":22},"2038-12-01",{"name":50,"class":51},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":244,"targetDuration":4,"studyType":23,"phases":246,"briefSummary":247,"conditions":248,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100618566","phase-2-a-multicenter-single-arm-prospective-clinical-study-on-first-line-treatment-of-pancreatic-cancer-liver-metastases-with-arterial-infusion-chemotherapy-and-embolization-combined-with-dual-immune-checkpoint-inhibitors-100618566","NCT07333287","A Multicenter Single-arm Prospective Clinical Study on First-line Treatment of Pancreatic Cancer Liver Metastases With Arterial Infusion Chemotherapy and Embolization Combined With Dual Immune Checkpoint Inhibitors.","Inclusion Criteria:\n\n* 1\\. Voluntarily participate in this study, sign the informed consent form, demonstrate good compliance, and cooperate with follow-up visits.\n\n  2\\. Male or female, aged 18 to 75 years. 3. ECOG performance status score of 0 to 1. 4. Expected survival ≥ 3 months. 5. Histologically or cytologically confirmed, previously untreated unresectable pancreatic ductal adenocarcinoma with liver metastases (TNM stage: IV).\n\n  6\\. Must have measurable lesions according to RECIST 1.1 criteria. 7. No prior systemic therapy for pancreatic cancer or liver metastases, including chemotherapy, targeted therapy, or immunotherapy. (Note: Patients who received only one prior cycle of treatment, or oral targeted\u002Fchemotherapy agents for a cumulative duration ≤ 14 days, or those with recurrence more than six months after completing adjuvant chemotherapy may be considered for inclusion.) 8. Selective arterial catheterization and angiography demonstrate staining of pancreatic tumors and liver metastases. Patients with good tumor blood supply are eligible for this study.\n\n  9\\. No local treatment (including transarterial chemoembolization\u002FTACE, hepatic arterial infusion chemotherapy\u002FHAIC, radiotherapy, radioembolization, or ablation, etc.) on target lesions within 28 days before the first dose of the study drug.\n\n  10\\. Recovery from toxicities caused by prior therapies: ≥4 weeks since prior cytotoxic drugs, radiotherapy, or surgery, with wounds fully healed.\n\n  11\\. No prior treatment with anti-PD-1, anti-PD-L1, anti-CTLA-4 antibodies, or CAR-T cell therapy.\n\n  12\\. Adequate organ function must be confirmed within 28 days before the first dose (without transfusion or use of blood products, G-CSF, or other hematopoietic growth factors for correction within 14 days prior to laboratory tests):\n  1. Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL (without G-CSF support within 14 days).\n  2. Platelets ≥100×10⁹\u002FL (without transfusion within 14 days).\n  3. Hemoglobin \\>9 g\u002FdL (without transfusion or erythropoietin use within 14 days).\n  4. Total bilirubin ≤1.5×ULN.\n  5. AST and ALT ≤2.5×ULN.\n  6. Serum creatinine ≤1.5×ULN and calculated creatinine clearance (Cockcroft-Gault formula) ≥60 mL\u002Fmin.\n  7. Adequate coagulation function, defined as INR or PT ≤1.5×ULN.\n  8. Normal thyroid function, defined as TSH within normal range. If baseline TSH is abnormal, patients may still be enrolled if total T3 (or FT3) and FT4 are within normal limits.\n  9. Cardiac enzymes within normal range (isolated laboratory abnormalities deemed clinically insignificant by the investigator are allowed).\n\n  13\\. Males and females of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until at least 5 months (for females) or 7 months (for males) after the last dose of the study drug. Women of childbearing potential must not be pregnant or breastfeeding.\n\nExclusion Criteria:\n\n* \\*\\*Subjects meeting any of the following criteria will be excluded from this study:\\*\\*\n\n  1. Diagnosis of another malignancy within 5 years prior to the first dose, unless cured (exceptions include radically treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and\u002For carcinoma in situ that has undergone radical resection).\n  2. Currently participating in an interventional clinical study or having received other investigational drugs or devices within 4 weeks prior to the first dose.\n  3. Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2 agents, or drugs targeting another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).\n  4. Poor tumor blood supply as observed during selective arterial catheterization and angiography of pancreatic tumors and liver metastases.\n  5. Systemic treatment with Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs within 2 weeks prior to the first dose.\n  6. Active autoimmune disease requiring systemic treatment (e.g., disease-modifying agents, corticosteroids, or immunosuppressants) within 2 years prior to the first dose. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is not considered systemic treatment.\n  7. Current systemic corticosteroid therapy (excluding nasal sprays, inhalational, or other local corticosteroids) or any other form of immunosuppressive therapy within 7 days prior to the first dose.\n\n     * Note:\\*\\* Physiological doses of corticosteroids (e.g., ≤10 mg\u002Fday prednisone or equivalent) are permitted.\n  8. Known history of allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation.\n  9. Known hypersensitivity to iparomlimab and tuvonralimab or any excipients of the combined chemotherapy drugs used in this study.\n  10. Insufficient recovery from toxicities and\u002For complications of prior interventions (i.e., not recovered to ≤ Grade 1 or baseline, excluding fatigue or alopecia) before starting treatment.\n  11. Known history of human immunodeficiency virus (HIV) infection (i.e., positive for HIV 1\u002F2 antibodies).\n  12. Untreated active hepatitis B (defined as HBsAg positive with HBV-DNA copy number above the upper limit of normal \\[ULN\\] at the local laboratory).\n\n      * Note:\\*\\* Subjects with hepatitis B meeting the following criteria may be enrolled:\n\n        1. HBV viral load \\\u003C 1000 copies\u002FmL (200 IU\u002FmL) prior to the first dose. The subject must receive anti-HBV therapy throughout the study chemotherapy treatment period to prevent viral reactivation.\n        2. Subjects who are anti-HBc (+), HBsAg (-), anti-HBs (-), and have undetectable HBV viral load do not require prophylactic anti-HBV therapy but require close monitoring for viral reactivation.\n  13. Active HCV infection (HCV antibody positive with HCV-RNA levels above the lower limit of detection).\n  14. Administration of a live vaccine within 30 days prior to the first dose (Cycle 1, Day 1).\n\n      * Note:\\*\\* Inactivated seasonal influenza vaccines administered by injection are permitted within 30 days prior to the first dose. However, live attenuated influenza vaccines administered intranasally are not permitted.\n  15. Pregnant or breastfeeding women.\n  16. Any severe or uncontrolled systemic disease, such as:\n\n      1. Resting ECG showing significant and symptomatic abnormalities in rhythm, conduction, or morphology (e.g., complete left bundle branch block, second-degree or higher heart block, ventricular arrhythmia, or atrial fibrillation).\n      2. Unstable angina, congestive heart failure, or chronic heart failure of New York Heart Association (NYHA) Class ≥2.\n      3. Myocardial infarction within 6 months prior to enrollment.\n      4. Poorly controlled hypertension (systolic blood pressure \\>140 mmHg, diastolic blood pressure \\>90 mmHg).\n      5. History of non-infectious pneumonitis requiring corticosteroid treatment within 1 year prior to the first dose, or current clinically active interstitial lung disease.\n      6. Active pulmonary tuberculosis.\n      7. Active or uncontrolled infection requiring systemic therapy.\n      8. Clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction.\n      9. Liver diseases such as cirrhosis, decompensated liver disease, or acute or chronic active hepatitis.\n      10. Poorly controlled diabetes (fasting blood glucose \\>10 mmol\u002FL).\n      11. Urinalysis showing protein ≥++ and confirmed 24-hour urine protein \\>1.0 g.\n      12. Psychiatric disorders that may interfere with treatment compliance.\n  17. Any medical history, condition, treatment, or laboratory abnormality that, in the investigator's judgment, may interfere with the trial results, prevent the subject from completing the study, or pose other potential risks making the subject unsuitable for participation.",{"count":245,"type":22},38,[89],"To evaluate the efficacy of arterial infusion chemotherapy and embolization combined with iparplidutol-volerilis (QL1706) as first-line treatment for pancreatic cancer liver metastases based on progression-free survival (PFS).",[249,250],"Pancreatic Cancer Liver Metastases","Immunotherapy-naive","2025-12-30",{"date":253,"type":44},"2026-01-12",{"date":255,"type":22},"2026-02-01",{"date":257,"type":22},"2028-11-30",{"name":50,"class":51},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":266,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":276,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":284},"100606806","an-empirical-study-on-the-mechanisms-of-biopsychosocial-functional-improvement-in-patients-with-major-depressive-disorder-through-nature-based-tourism-activities-100606806","NCT07180342","An Empirical Study on the Mechanisms of Biopsychosocial Functional Improvement in Patients With Major Depressive Disorder Through Nature-Based Tourism Activities","MDD","Inclusion Criteria:\n\n1. Voluntarily participate in the study and sign the informed consent form;\n2. Age between 18 (inclusive) and 60 (exclusive) at the screening period;\n3. Meet the DSM-5 diagnostic criteria for a Major Depressive Episode (MDE) at enrollment, based on medical records, clinical assessment, and the Mini-International Neuropsychiatric Interview (MINI version 7.0.2);\n4. Hamilton Depression Rating Scale 17-item (HAMD-17) score ≥ 17 at both screening and baseline;\n5. Physically stable based on medical history and vital signs (including blood pressure);\n6. Deemed by the investigator to be capable of independently completing all assessment tools required by the study protocol and willing to comply with the trial procedures throughout the study period.\n\nExclusion Criteria:\n\n1. Current or past diagnosis of: schizophrenia, psychotic disorders (unless substance-induced or due to another medical condition), bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, or other severe psychiatric comorbidities confirmed by medical history and structured clinical assessment using the Mini-International Neuropsychiatric Interview (MINI version 7.0.2);\n2. Current or history of alcohol or substance abuse within the past year;\n3. A score of ≥3 on item 3 (suicide) of the HAMD-17, suicide attempt within the past year, or clinically assessed significant suicide risk;\n4. Depression secondary to other severe medical conditions (e.g., hypothyroidism, Parkinson's disease, etc.);\n5. Cardiovascular diseases: stroke or myocardial infarction within the past year, hypertension (blood pressure \\>140\u002F90 mmHg), or clinically significant arrhythmia;\n6. Other significant comorbid diseases that may interfere with the interpretation of study results or pose risks to participant health (e.g., cardiovascular, respiratory, gastrointestinal, hepatic, renal, or other systemic diseases), as determined by the investigator;\n7. Current participation in an interventional study for Major Depressive Disorder, or participation in such a study within 30 days prior to screening;\n8. Having visited Wulongtan Park, Baotu Spring Park and Daming Lake Park for a prolonged period (single stay ≥1 hour) within the past three years.","59 Years",{"count":268,"type":22},86,[64],"Empirically investigating how natural tourism activities alleviate symptoms in patients with Major Depressive Disorder through multidimensional pathways of physiological, psychological, and social functioning.",[272],"Major Depressive Disorder",[272,274,275],"Tourism","MMD","2025-12-14",{"date":278,"type":44},"2025-12-16",{"date":280,"type":44},"2025-10-09",{"date":282,"type":22},"2027-09-18",{"name":50,"class":51},2,{"id":286,"slug":287,"hasResults":11,"nctId":288,"briefTitle":289,"officialTitle":290,"acronym":4,"eligibilityCriteria":291,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":108,"enrollmentInfo":292,"targetDuration":4,"studyType":23,"phases":294,"briefSummary":295,"conditions":296,"keywords":300,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":303,"lastUpdatePostDateStruct":304,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":52},"100614853","phase-2-scrt-vs-lcrt-followed-by-pd-l1-inhibitor-plus-capeox-as-tnt-in-patients-with-larc-100614853","NCT07284992","SCRT VS LCRT Followed by PD-L1 Inhibitor Plus CAPEOX as TNT in Patients With LARC","Total Neoadjuvant Treatment With Short-course Radiotherapy Versus Long-course Radiotherapy Followed by PD-L1 Inhibitor Plus Capecitabine-Oxaliplatin in Patients With Locally Advanced Rectal Cancer: a Multi-centres, Open-label, Phase 2, Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. sign written informed consent before implementing any test related process;\n* 2\\. Patients diagnosed as rectal adenocarcinoma by primary biopsy and histopathological examination;\n* 3\\. patients with CT stage ≥ T3 or CN stage N1+, M0 or EMVI (+) or MRF (+) or suspected lateral lymph node metastasis (\\>5mm) who are judged by imaging and colonoscopy to be operable and need neoadjuvant therapy.\n* 4\\. according to imaging and colonoscopy, the main body of the tumor was located ≤ 10cm from the anal edge;\n* 5\\. patients with tumor mismatch repair\u002Fmicrosatellite instability (MMR\u002FMSI) status as MSS;\n* 6\\. according to the criteria for evaluating the efficacy of solid tumors (RECIST version 1.1), at least one lesion can be measured by imaging;\n* 7\\. the patient has not received any anti-tumor treatment in the past, including but not limited to surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc;\n* 8\\. ECoG score: 0-1;\n* 9\\. sufficient organ function, the subject shall meet the following laboratory indicators:\n\n  1. The absolute value of neutrophils (ANC) ≥ 1.5x109\u002Fl without granulocyte colony stimulating factor in the past 14 days.\n  2. Platelets ≥ 100 × 109\u002Fl without blood transfusion in recent 14 days.\n  3. Hemoglobin\\>9g\u002Fdl without blood transfusion or use of erythropoietin in recent 14 days;\n  4. Total bilirubin ≤ 1.5 × upper limit of normal value (ULN);\n  5. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in ≤ 2.5 × ULN\n  6. Serum creatinine ≤ 1.5 × ULN and creatinine clearance rate (calculated by Cockcroft Gault formula) ≥ 60 ml\u002Fmin;\n  7. Good coagulation function was defined as international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 times ULN;\n  8. Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH is beyond the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;\n  9. Myocardial enzyme spectrum is within the normal range (for example, simple laboratory abnormalities that are not clinically significant according to the comprehensive judgment of the researcher are also allowed to be included in the group)\n* 10\\. female subjects of childbearing age should receive urine or serum pregnancy test within 3 days before receiving the first study drug administration (the first day of the first cycle) and the result is negative. If the result of urine pregnancy test cannot be confirmed as negative, blood pregnancy test is required. Women of non reproductive age were defined as having been postmenopausal for at least 1 year, or having undergone surgical sterilization or hysterectomy; If there is a risk of pregnancy, all subjects (male or female) need to take contraceptive measures with an annual failure rate of less than 1% during the whole treatment period until 120 days after the last study drug administration (or 180 days after the last chemotherapy drug administration).\n\nExclusion Criteria:\n\n* 1\\. patients diagnosed with other malignant tumors and not cured within 5 years before the first administration (excluding skin basal cell carcinoma, skin squamous cell carcinoma, and\u002For cancer in situ after radical resection);\n* 2\\. Patients with advanced rectal cancer with distant metastasis;\n* 3\\. currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;\n* 4\\. have previously received the following therapies: anti-PD-1, anti-PD-L1 or anti-PD-L2 drugs or drugs that stimulate or synergistically inhibit T cell receptors (e.g., CTLA-4, OX-40, CD137);\n* 5\\. have received systemic treatment with Chinese patent medicine with anti-tumor indications or drugs with immunomodulatory effect within 2 weeks before the first administration;\n* 6\\. active autoimmune diseases requiring systemic treatment (such as the use of disease relieving drugs, glucocorticoids or immunosuppressants) occurred within 2 years before the first administration. Replacement therapy (such as thyroxine, insulin or physiological glucocorticoids for adrenal or pituitary insufficiency, etc.) is not considered as systemic therapy;\n* 7\\. the patients were receiving systemic glucocorticoid therapy (excluding local glucocorticoids via nasal spray, inhalation or other routes) or any other form of immunosuppressive therapy within 14 days before the first administration of the study; Note: it is allowed to use physiological doses of glucocorticoids (≤ 10 mg\u002Fday of prednisone or equivalent drugs); In the absence of active autoimmune diseases, inhaled or topical steroid and prednisone dose\\>10mg\u002Fday or equivalent dose of adrenocortical hormone are allowed to replace;\n* 8\\. known allogeneic organ transplantation (except corneal transplantation) or allogeneic hematopoietic stem cell transplantation;\n* 9\\. those who are known to be allergic to the study drug adebaylimab and the active ingredients or excipients of combined chemotherapy drugs;\n* 10\\. have not fully recovered from the toxicity and\u002For complications caused by any intervention measures before starting treatment (i.e. ≤ grade 1 or reaching the baseline, excluding fatigue or hair loss);\n* 11\\. known history of human immunodeficiency virus (HIV) infection (i.e. HIV 1\u002F2 antibody positive);\n* 12\\. untreated active hepatitis B (defined as HBsAg positive and HBV-DNA copy number detected is greater than the upper limit of normal value in the laboratory of the research center);\n\nNote: hepatitis B subjects who meet the following criteria can also be enrolled:\n\n1. HBV viral load\\\u003C1000 copies\u002Fml (200 iu\u002Fml) before the first administration. Subjects should receive anti HBV treatment during the whole study chemotherapy drug treatment to avoid virus reactivation\n2. For subjects with anti HBC (+), HBsAg (-), anti HBS (-) and HBV viral load (-), preventive anti HBV treatment is not required, but virus reactivation needs to be closely monitored\n\n   * 13\\. active HCV infected subjects (HCV antibody positive and HCV-RNA level higher than the detection limit);\n   * 14\\. inoculate live vaccine within 30 days before the first administration (cycle 1, day 1); Note: it is allowed to receive inactivated virus vaccine for injection against seasonal influenza within 30 days before the first administration; However, live attenuated influenza vaccines administered intranasal are not allowed.\n   * 15\\. pregnant or lactating women;\n   * 16\\. there are any serious or uncontrollable systemic diseases, such as:\n\n1\\) The resting ECG has significant abnormalities in rhythm, conduction or morphology, and the symptoms are serious and difficult to control, such as complete left bundle branch block, heart block above grade II, ventricular arrhythmia or atrial fibrillation; 2) Unstable angina pectoris, congestive heart failure, chronic heart failure with NYHA classification ≥ 2; 3) Myocardial infarction occurred within 6 months before enrollment; 4) Blood pressure control was not ideal (systolic blood pressure\\>140 mmHg, diastolic blood pressure\\>90 mmHg); 5) There was a history of non infectious pneumonia requiring glucocorticoid treatment within 1 year before the first administration, or there was currently clinically active interstitial lung disease; 6) Active pulmonary tuberculosis; 7) Active or uncontrolled infection requiring systemic treatment; 8) There were clinically active diverticulitis, abdominal abscess and gastrointestinal obstruction; 9) Liver diseases such as cirrhosis, decompensated liver disease, acute or chronic active hepatitis; 10) Poor control of diabetes mellitus (FBG\\>10mmol\u002FL); 11) The urine routine showed that the urine protein was ≥++, and it was confirmed that the 24-hour urine protein quantitation was more than 1.0 G; 12) Patients with mental disorders and unable to cooperate with treatment;\n\n* 17\\. for those who have a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity may hinder the signing of informed consent or affect the patient's compliance with oral drugs according to the judgment of the investigator; The medical history or disease evidence, abnormal treatment or laboratory test values that may interfere with the test results, prevent the subjects from participating in the whole process of the study, or the researchers believe that there are other potential risks that are not suitable for the study.",{"count":293,"type":22},208,[89],"This is a multicenter, cohort, prospective study to evaluate the efficacy and safety of Adebrelimab combined with radiotherapy and chemotherapy as preoperative neoadjuvant therapy for patients with locally advanced rectal cancer. In the study, all subjects who meet the inclusion criteria will enter the short-term radiotherapy queue and the long-term radiotherapy queue at the ratio of 1:1. The short-term radiotherapy queue plans to receive Adebrelimab combined with short-term radiotherapy (5\\*5Gy) and Capox chemotherapy as neoadjuvant therapy. The long-term radiotherapy queue plans to receive Adebrelimab combined with long-term radiotherapy (1.8gy × 25-28 times) and capox chemotherapy as neoadjuvant therapy. The TME surgery will be performed 2-3 weeks after the last neoadjuvant therapy is completed. If the surgery cannot be performed within the time window specified in the plan (such as delayed adverse reactions, etc.), the researcher will conduct the surgery according to the patients' requirements.The actual clinical conditions of the subjects were comprehensively considered.",[297,298,299],"Rectal Cancer","Advanced Stage Colorectal Cancer","Radiotherapy",[301,302],"Immune checkpoint inhibitors","Adebrelimab Injection","2025-12-02",{"date":278,"type":44},{"date":306,"type":44},"2025-09-12",{"date":308,"type":22},"2033-06-30",{"name":50,"class":51},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":4,"eligibilityCriteria":316,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":317,"targetDuration":4,"studyType":23,"phases":318,"briefSummary":319,"conditions":320,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":328,"locationsCount":52},"100585900","phase-2-neoadjuvant-ql1706-therapy-for-escc-100585900","NCT06908382","Neoadjuvant QL1706 Therapy for ESCC","A Single-Arm Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Chemotherapy as Neoadjuvant Therapy for Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","Inclusion Criteria:\n\n1. Signed written informed consent form to voluntarily join this study;\n2. Age 18-75 years old, male or female;\n3. ECOG PS 0-1;\n4. Planned surgical treatment after completion of neoadjuvant therapy;\n5. Patients with esophageal squamous cell carcinoma diagnosed pathologically as ct1b-ct2n+or ct3-ct4a any nm0\n\nExclusion Criteria:\n\n1. The subject has any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; the subject suffers from vitiligo; asthma has been completely relieved in childhood and does not need any intervention after adulthood can be included, but asthma that needs bronchodilators for medical intervention cannot be included);\n2. The subjects are using immunosuppressive agents or systemic or absorbable local hormones to achieve the purpose of immunosuppression (dose\\>10mg\u002Fday prednisone or other effective hormones), and continue to use them within 2 weeks before enrollment;\n3. Severe allergic reaction to other monoclonal antibodies;\n4. There are cardiac clinical symptoms or diseases that are not well controlled, such as: (1) heart failure above NYHA grade 2 (2) unstable angina pectoris (3) myocardial infarction within one year (4) clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention (5) qtc\\>450ms (male); Qtc\\>470ms (female);\n5. Patients at risk of massive bleeding\n6. Abnormal coagulation function (inr\\>1.5 or pt\\>16s), bleeding tendency or undergoing thrombolytic or anticoagulant therapy;\n7. Genetic or known to exist Acquired hemorrhage and thrombotic tendency (such as hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism, etc.) or arteriovenous thrombosis events in recent 6 months (until the first use of shr-1210);\n8. Subjects with active infection or fever of unknown origin\\>38.5 degrees during screening and before the first administration;\n9. Patients with previous and current objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, and severe impairment of lung function;\n10. Subjects with congenital or acquired immune deficiency (such as HIV infected), or active hepatitis (hepatitis B reference: HBV DNA detection value exceeds the upper limit of normal value; Hepatitis C reference: HCV virus titer or RNA detection value exceeds the upper limit of normal value);\n11. Those who have used other drugs in clinical trials within 4 weeks before the first medication;\n12. The subjects had previously or simultaneously suffered from other malignant tumors;\n13. Subjects may receive other systemic anti-tumor treatment during the study period;\n14. The subjects had previously received other PD-1 antibody therapy or other immunotherapy for PD-1\u002FPD-L1;\n15. Live vaccines were administered less than 4 weeks before the study or during the study period;\n16. According to the judgment of the investigator, the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which will affect the safety of the subject, or the collection of data and samples.",{"count":155,"type":22},[89],"This study plans to enroll 32 patients with resectable esophageal squamous cell carcinoma. The treatment regimen consists of Iparomlimab and Tuvonralimab(QL1706) combined with chemotherapy: intravenous infusion of QL1706 (5 mg\u002Fkg, q3w) in combination with albumin-bound paclitaxel (260 mg\u002Fm² on day 1, q3w) plus cisplatin (75 mg\u002Fm² on day 1, q3w) or carboplatin (AUC 5 on day 1, q3w) for 3 cycles. Surgical resection will be performed 3-6 weeks after treatment completion. Pre-treatment and surgical tissue specimens will be collected for analysis of tumor immune microenvironment changes using digital gene quantification technology. Peripheral blood samples will be obtained for dynamic ctDNA monitoring at four time points: within 7 days pre-treatment, 7 days pre-surgery, 7-30 days post-surgery, and 6 months post-surgery. The primary endpoint is the pathological complete response (pCR) rate, and secondary endpoints include major pathological response (MPR) and adverse reactions.",[321],"Locally Advanced Resectable Esophageal Squamous Cell Carcinoma","2025-04-15",{"date":324,"type":44},"2025-04-18",{"date":326,"type":22},"2025-04-28",{"date":207,"type":22},{"name":50,"class":51},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":197,"phases":4,"briefSummary":339,"conditions":340,"keywords":342,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100564238","iodine-status-and-characteristics-of-papillary-thyroid-cancer-100564238","NCT06626581","Iodine Status and Characteristics of Papillary Thyroid Cancer","A Cross-sectional Study on Iodine Status and Characteristics of Papillary Thyroid Cancer","Inclusion Criteria:\n\n* Age range: 18\\~65 years old, gender not limited;\n* Living in the residential area for at least 5 years;\n* Patients diagnosed clinically with thyroid cancer and scheduled for thyroid surgery, with pathological diagnosis of papillary thyroid cancer;\n* Complete clinical data: including general information, relevant laboratory tests, pathological reports, surgical reports, ultrasound reports, etc.\n\nExclusion Criteria:\n\n* Pathological diagnosis of other types of thyroid cancer;\n* Diagnosed with other types of cancer;\n* There are serious comorbidities of the heart, liver, and kidneys;","65 Years",{"count":338,"type":22},600,"The effect of iodine on papillary thyroid cancer has been controversial for many years. The investigators designed a cross-sectional study and aimed to explore the relationship between the serum and urine iodine levels and the clinical and molecular characteristics of papillary thyroid cancer.",[341],"Papillary Thyroid Carcinoma",[343,344],"iodine status","papillary thyroid carcinoma","2024-10-03",{"date":347,"type":44},"2024-10-04",{"date":349,"type":22},"2024-11-01",{"date":351,"type":22},"2026-12-31",{"name":50,"class":51},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":360,"targetDuration":362,"studyType":197,"phases":4,"briefSummary":363,"conditions":364,"keywords":4,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":372,"locationsCount":52},"100564002","iodine-nutrition-status-and-clinical-characteristics-of-thyroid-cancer-100564002","NCT06623500","Iodine Nutrition Status and Clinical Characteristics of Thyroid Cancer","Prospective Cohort Study on Clinical Characteristics of Thyroid Cancer in Different Iodine Status Areas","Inclusion Criteria:\n\n1. Age range: 18\\~65 years old, gender not limited;\n2. Living in the selected region for at least 5 years;\n3. Patients who underwent thyroid surgery at various research centers were pathologically diagnosed with thyroid cancer;\n4. The clinical data （general information、surgical scope 、pathological report、utrasonic report, etc ）of the case is complete.\n\nExclusion Criteria:\n\n1. Diagnosed as other types of cancer or thyroid metastatic cancer;\n2. There are serious comorbidities such as heart, liver, and kidney diseases present;\n3. Unable to follow up on prognostic information.",{"count":361,"type":22},1600,"5 Years","The effect of iodine nutritional status on thyroid cancer has been controversial for many years. We designed a prospective cohort study that recruiting patients in different iodine areas who underwent thyroid cancer surgery in branch hospitals from 2012 to 2019，and follow up their clinical outcomes. We aimed to analyse the relationship between regional iodine nutrition level and pathological types, clinical features, and prognosis of thyroid cancer.",[365],"Thyroid Cancer","2024-09-29",{"date":368,"type":44},"2024-10-02",{"date":370,"type":44},"2012-01-01",{"date":351,"type":22},{"name":50,"class":51},{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":380,"enrollmentInfo":381,"targetDuration":4,"studyType":23,"phases":383,"briefSummary":384,"conditions":385,"keywords":388,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":4},"100557619","iodine-supplementation-in-graves-hyperthyroidism-100557619","NCT06540469","Iodine Supplementation in Graves' Hyperthyroidism","Effects of Optimal Iodine Supplementation in Anti-thyroid Drug Therapy for Graves' Hyperthyroidism: a Prospective Randomized Controlled Trial","Inclusion Criteria:\n\n1. patients newly diagnosed with Graves' hyperthyroidism and not treated; or\n2. patients diagnosed with Graves' hyperthyroidism and treated with ATDs regularly less than 3 months, serum TSH is measured below normal reference range, serum FT3 or FT4 or both are measured above normal reference range and serum TRAb is positive; or\n3. patients diagnosed with Graves' hyperthyroidism and not regularly treated with ATDs more than 3 months, serum TSH is measured below normal reference range, serum FT3 or FT4 or both are measured above normal reference range and serum TRAb is positive.\n\nExclusion Criteria:\n\n1. thyroid enlargement of grade 3;\n2. serum TRAb is measured above 40IU\u002FL;\n3. moderate or severe thyroid-associated eye diseases;\n4. hepatic disease history including chronic active hepatitis, severe hepatic dysfunction, liver cirrhosis, etc., and serum transaminase level is 3 times higher than the upper normal limit and\u002For total bilirubin level is higher than 34.2μmol\u002FL with hepatic protective drugs;\n5. history of moderate-to-severe or end-stage renal disease: eGFR\\\u003C60mL\u002Fmin\u002F1.73m2 with simplified MDRD formula;\n6. serum WBC\\\u003C3.0×109／L or neutrophil count\\\u003C1.5×109／L;\n7. history of severe cardiocerebrovascular disease, digestive disease, hematopoietic system disease, other autoimmune diseases in addition to Graves' hyperthyroidism, tumors, psychosis, etc.;\n8. blood pressure\\>180\u002F100mmHg with regular antihypertensive drugs treatment;\n9. severe comorbidities and complications of hyperthyroidism with ATDs treatment;\n10. history of multiple drug allergies;\n11. a family planning plan in 3 years.","70 Years",{"count":382,"type":22},315,[64],"In China, the morbidity of thyroid diseases is high and the harm is serious. Iodine is closely related to thyroid diseases. It should be paid attention to guide patients to supplement iodine scientifically. Thyroid iodine uptake in hyperthyroidism patients is enhanced, and patients are generally advised to limit iodine intake in clinical practice. However, recent studies suggest that there is no definite conclusion on whether patients with hyperthyroidism should strictly limit iodine intake. The purpose of this study is to establish a national multi-center iodine intervention cohort for patients with Graves' hyperthyroidism, identify the effects of different iodine intake on hyperthyroidism, and establish iodine intervention program for hyperthyroidism. This study is a multicenter, prospective, open-level, randomized, controlled, parallel group clinical trial with a total sample size of 315 cases, a total of 3 participating units, each of which completed 105 cases. All subjects meeting the inclusion criteria were completely randomized in each center according to the random procedure with a probability of 1:1:1: ① Iodine Supplementation in Whole Course of Treatment with ATDs; ② Iodine Supplementation During Maintenance Treatment with ATDs; ③ Iodine Restriction in Whole Course of Treatment with ATDs. Information was collected before ATD treatment, at 3 months, 6 months, 12 months, 18 months (withdrawal), 6 months and 12 months after ATDs withdrawal. The primary purpose of this study is to analyze the difference in remission rate of hyperthyroidism between different iodine nutritional interventions. At the same time, the differences of duration from initiation to withdrawal of ATDs, duration from initiation of ATDs to thyroid function (including serum FT3, FT4 and TSH) normalization, duration from initiation of ATDs to serum FT3 and FT4 normalization, quality of life (QOL) in patients with Graves' hyperthyroidism, adverse effects rate of ATDs treatment, duration from initiation of ATDs to serum negative TRAb is first measured were observed.",[386,387],"Graves Disease","Hyperthyroidism",[389,387,390,391],"Graves' Disease","Iodine Supplementation","Anti-Thyroid Drug","2024-08-03",{"date":394,"type":44},"2024-08-06",{"date":396,"type":22},"2024-08-01",{"date":398,"type":22},"2028-07-31",{"name":50,"class":51},{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":409,"briefSummary":410,"conditions":411,"keywords":416,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":423,"lastUpdatePostDateStruct":424,"startDateStruct":426,"completionDateStruct":428,"leadSponsor":430,"locationsCount":431},"100550519","phase-4-henagliflozins-impact-on-prediabetes-remission-100550519","NCT06448130","Henagliflozin's Impact on Prediabetes Remission","Effect of Henagliflozin on the Remission of Prediabetes Population: A National Multicenter, Randomized Controlled Study","Inclusion Criteria:\n\n1. Male or female subjects between the ages of 18 and 65 years;\n2. Individuals without hypoglycemic therapy before, including hypoglycemic drugs or traditional Chinese medicine formulations with hypoglycemic effects;\n3. Prediabetic patients as defined by Expert Consensus on Intervention for Prediabetes in Chinese Adults, 2023 Edition:1)Fasting plasma glucose (FPG) between 6.1 and 7.0 mmol\u002FL and\u002For 2-hour postprandial glucose (2h-PPG) between 7.8 and 11.1 mmol\u002FL; 2)And\u002For HbA1c between 5.7% and 6.5%;\n4. Individuals willing to provide written informed consent and can comply with study procedures and follow-up.\n\nExclusion Criteria:\n\n1. Allergic to Henagliflozin;\n2. Previously diagnosed with diabetes;\n3. HbA1c ≥ 6.5% or FPG ≥ 7.0 mmol\u002FL or PPG ≥ 11.1 mmol\u002FL;\n4. Use of GLP-1 receptor agonists, orlistat, or other weight-reducing drugs in the past 3 months;\n5. Fluctuation in weight by 5% or more in the past month;\n6. Use of drugs affecting glucose synthesis, absorption, or metabolism, such as glucocorticoids (e.g., prednisone, dexamethasone), contraceptives, growth hormone, hormonal replacement therapy (estrogen and progesterone), immunosuppressants (e.g., cyclosporine A, tacrolimus), anti-tuberculosis drugs (e.g., isoniazid, rifampicin);\n7. Untreated hyperthyroidism or hypothyroidism, excluding those with normal thyroid function after treatment;\n8. Persistently uncontrolled hypertension (used antihypertensive drugs but was not effectively controlled in the 3 months prior to enrollment) or currently use 3 or more antihypertensive drugs (including diuretics);\n9. Assessed by the investigator to be at high risk of genitourinary system infections, such as history of recurrent urinary tract infections or reproductive system infections, long-term placement of urinary catheters, or history of urological surgery;\n10. Other obesity caused by endocrine disorders, such as Cushing's syndrome;\n11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \\> 3 times of the upper limit of the normal range (UNL);\n12. eGFR less than 30 mL\u002Fmin\u002F1.73 m2, severe kidney damage, end-stage renal disease or requiring dialysis;\n13. Significant cardiovascular diseases including myocardial infarction, congestive heart failure (≥grade III New York Heart Association), left ventricular ejection fraction≤40%, or cerebrovascular accidents;\n14. Impaired consciousness and various mental health disorders;\n15. Malignant tumors and other serious illnesses;\n16. Pregnant or breast-feeding or planning pregnancy within 24 months;\n17. Enrolled in another clinical trial currently or within the 3 months prior to enrollment;\n18. Identified by the investigator that lacks sufficient motivation to continue the long-term clinical trial (e.g., out-of-town study, work plan, need to care for family members), or considered prefer to withdraw from the trial for non-medical reasons (such as social issues).",{"count":408,"type":22},984,[25],"This clinical trial evaluates the effectiveness of Henagliflozin combined with lifestyle interventions for managing patients with prediabetes. As global prediabetes rates rise, increasing the risk of diabetes and vascular issues, addressing treatment gaps is essential. Henagliflozin, a novel SGLT2 inhibitor developed in China, aims to improve glucose control and metabolic health when paired with lifestyle changes.\n\nThe study's primary objectives include: assessing whether Henagliflozin can achieve normoglycemia in prediabetic patients after 6 months of treatment.\n\nThe trial will compare three groups (Henagliflozin 5mg, 10mg, and a placebo), focusing on efficacy and safety. Participants, assigned randomly, will undergo a 6-month treatment phase and an 18-month follow-up. Regular health assessments will monitor glucose levels, metabolic health, and risks of major complications like cardiovascular events and microvascular diseases, with additional evaluations of C-peptide and insulin changes.\n\nStructured as a multicenter, randomized, double-blind, placebo-controlled study, it involves 984 prediabetic adults across 50 medical institutions in China. This comprehensive approach could redefine prediabetes management by integrating drug therapy with lifestyle modifications.",[412,413,414,415],"PreDiabetes","Prediabetic State","Type 2 Diabetes","Glucose Metabolism Disorders",[417,418,419,420,421,415,422],"Prediabetes management","Henagliflozin","SGLT2 inhibitors","Lifestyle interventions","Type 2 diabetes prevention","Metabolic Diseases","2024-06-03",{"date":425,"type":44},"2024-06-07",{"date":427,"type":22},"2024-06",{"date":429,"type":22},"2027-12",{"name":50,"class":51},50,{"id":433,"slug":434,"hasResults":11,"nctId":435,"briefTitle":436,"officialTitle":437,"acronym":4,"eligibilityCriteria":438,"healthyVolunteers":11,"sex":17,"minAge":439,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":197,"phases":4,"briefSummary":442,"conditions":443,"keywords":445,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":52},"100521221","endocrine-glucose--lipids-metabolism-and-brain-aging-a-longitudinal-study-100521221","NCT06066775","Endocrine Glucose & Lipids Metabolism and Brain Aging: a Longitudinal Study","A Prospective Cohort Study on the Associations of Endocrine Glucose & Lipids With Brain Aging-related Conditions in Chinese Men and Women","Inclusion Criteria:\n\n1. Age \\>= 50 years old;\n2. Gender: males and females;\n3. Provide written informed consent;\n4. Satisfactory compliance.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women\n2. No history of addiction or neurological, psychiatric, or systemic diseases known to affect cognitive function, including head trauma, subdural hematoma, current depression, and epilepsy\n3. Any other condition or major systemic diseases that the investigator feels would interfere with trial participation or evaluation of results.","50 Years",{"count":441,"type":22},10000,"With aging, brain aging leads to a general decline in cognitive ability, and the prevalence of neurodegenerative diseases such as Alzheimer's disease (AD) and Parkinson's disease (PD) increases. The prevalence of abnormal glucose and lipid metabolism also increased with age. The imbalance of glucose and lipid metabolism is closely related to brain aging related conditions and diseases, and the relationship between glucose and lipid metabolism and brain aging has not been fully elucidated.\n\nPhase 1: Baseline investigation (community-based survey) Aims: To investigate whether glucose and lipids are the risk factors for brain aging-related conditions, such as mild cognitive impairment.\n\nSubjects and Methods: A community-based survey will be carried out in 10000 natural population aged \\>=50 years selected from 10-12 communities stratified according to geographic regions (Ciyao, Huafeng, Dongzhuang, Heshan, Geshi, Jiangji, Gangcheng, Fushan, Dongshu, Sidian, Baxianqiao, and Xiangyin, etc) in Ningyang County, Taian City, Shandong Province. A comprehensive examination including questionnaire (including the MMSE and ADL evaluation for the participants), anthropometric measurements, biochemical analysis will be performed in each study participant. In particular, the investigators randomly selected 1000-2000 participants performing MRI of the brain to evaluate the brain aging related conditions.\n\nPhase 2: Cohort follow-up Aims : To examine glucose and lipids metabolism levels and their changes that modify the risk of brain aging-related conditions.\n\nSubjects and Methods: To recruit and follow all 10000 participants for at least 3-5 years. In particular, all 1000-2000 participants with the baseline MRI examination will perform the MRI examination again for the follow-up.",[444],"Brain Aging Related Conditions",[446,447,448,449],"brain aging","cognition","lipid","glucose","2023-10-04",{"date":452,"type":44},"2023-10-06",{"date":454,"type":44},"2023-07-04",{"date":456,"type":22},"2033-12",{"name":50,"class":51},{"id":459,"slug":460,"hasResults":11,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":4,"eligibilityCriteria":464,"healthyVolunteers":217,"sex":17,"minAge":18,"maxAge":465,"enrollmentInfo":466,"targetDuration":4,"studyType":197,"phases":4,"briefSummary":468,"conditions":469,"keywords":473,"overallStatus":137,"whyStopped":4,"lastUpdateSubmitDate":479,"lastUpdatePostDateStruct":480,"startDateStruct":482,"completionDateStruct":484,"leadSponsor":486,"locationsCount":52},"100337158","the-biological-rhythm-of-human-metabolite-100337158","NCT03669809","The Biological Rhythm of Human Metabolite","Association Between Serum Metabolism Markers and Biological Rhythm","Inclusion Criteria:\n\n* Male or female；\n* Aged of 18 to 30 years old;\n\nExclusion Criteria:\n\n* Presence of pituitary\u002Fhypothalamic disorders, polycystic ovarian syndrome， thyroid disorders, hypertension, malignant tumor, cardiac insufficiency，hepatic or renal insufficiency, gastrointestinal disorders and acute infection;\n* Receiving psychotropic or hormonal medications including hormonal contraception and hormone therapies;\n* Taking lipid-lowering agents or hypoglycemic agents and other drugs that known to influence cardiovascular health;\n* Pregnancy or lactation women;\n* Obviously poor compliance.","30 Years",{"count":467,"type":22},200,"The circadian regulation in mammals have been known for a long time. A special group of clock genes, organized in feedback loops, are responsible for the circadian regulation in both the SCN and peripheral organs. The central clock is mainly entrained by the light-dark cycle, while the peripheral ones in organs such as liver and intestine, are more influenced by the feeding-fasting cycles. The coordination of central and peripheral clocks is thought to be essential in the maintenance of physiological homeostasis.This study aim to investigate the association between biological rhythm and metabolism.",[470,471,472],"Rhythm Nodal","Metabolism and Nutrition Disorder","Metabolism Disorder, Lipid",[474,475,476,448,477,478],"biological rhythm","metabolism","hormone","bile acids","obesity","2022-05-10",{"date":481,"type":44},"2022-05-11",{"date":483,"type":4},"2011-05-01",{"date":485,"type":22},"2050-05-01",{"name":50,"class":51},""]