[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fujian Provincial Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":493},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,47,70,102,129,156,182,203,231,256,282,307,324,353,378,398,420,446,471],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641365","moderate-intensity-aerobic-calisthenics-for-rural-elderly-with-motoric-cognitive-risk-syndrome-100641365",false,"NCT07658469","Moderate-Intensity Aerobic Calisthenics for Rural Elderly With Motoric Cognitive Risk Syndrome","A Study on the Application of Moderate-Intensity Aerobic Calisthenics in Rural Elderly With Motoric Cognitive Risk Syndrome","Inclusion Criteria:\n\n* Age ≥60 years;\n\n  * Meeting the diagnostic criteria for Motor Cognitive Risk Syndrome (MCR);\n\n    * Clear consciousness and ability to communicate clearly;\n\n      * Permanent residents of rural areas in nine prefecture-level cities of Fujian Province (with an annual residence of ≥9 months) and no plan to relocate within the next year; -⑤ Willing to voluntarily participate and sign the informed consent form.\n\nExclusion Criteria:\n\n* Presence of severe mental disorders, history of stroke, Parkinson's disease, or severe visual\u002Fauditory impairments;\n\n  * Physical disability that prevents independent walking;\n\n    * Comorbid severe systemic diseases, such as cardiopulmonary conditions; -④ Regular exercise habits within the past 6 months (≥30 minutes\u002Fday, ≥3 days\u002Fweek) or a long-term history of exercise; -⑤ Current participation in other interventional studies.",true,"ALL","60 Years",{"count":20,"type":21},106,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aging of China's rural population is severe, with both the prevalence and mortality rates of dementia higher in rural areas than in urban areas. Motor Cognitive Risk Syndrome (MCR), as a novel pre-dementia syndrome characterized by both subjective cognitive decline and slow gait, represents a \"golden window of opportunity\" for the early prevention and treatment of dementia. Currently, there is no specific pharmacological treatment for MCR; non-pharmacological interventions, particularly exercise interventions, are key strategies. Moderate-intensity aerobic calisthenics, which integrates music, dance, and gymnastic elements, is economical, simple, highly engaging, safe, and has demonstrated potential for improving both cognitive and gait function, making it especially suitable for promotion in resource-limited rural settings. However, there is a lack of systematic, theory-guided exercise intervention protocols and effectiveness validation for rural older adults with MCR. Therefore, this study aims to develop and validate a moderate-intensity aerobic calisthenics intervention protocol tailored to this population.",[27,28],"Cognition Disorders","Aged",[30,31,32,33,28],"MCR","Motoric Cognitive Risk Syndrome","moderate-intensity aerobic exercise","rural areas","NOT_YET_RECRUITING","2026-06-14",{"date":37,"type":38},"2026-06-22","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2027-01-31",{"name":44,"class":45},"Fujian Provincial Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100639592","phase-4-dose-response-interaction-of-metoprolol-and-sufentanil-for-attenuating-hemodynamic-responses-in-tracheal-intubation-100639592","NCT07597564","Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation","Dose-Response Interaction of Metoprolol and Sufentanil for Attenuating Hemodynamic Responses in Tracheal Intubation: Prospective Randomized Double-blind Study","Inclusion Criteria:\n\n* Age 18 to 65 years.\n* American Society of Anesthesiologists physical status I or II.\n* Scheduled for elective non-cardiac surgery.\n* Planned general anaesthesia with endotracheal intubation.\n\nExclusion Criteria:\n\n* Cardiovascular or respiratory diseases, such as uncontrolled hypertension or bronchial asthma.\n* Current use of β-blockers.\n* History of chronic drug use or alcohol abuse.\n* Hepatic or renal impairment.\n* Known allergy to any study drug.\n* Anticipated difficult airway.\n* Any other condition that may affect the conduct of the study.","18 Years","65 Years",{"count":57,"type":21},900,[59],"PHASE4","This randomized, double-blind, controlled clinical study will evaluate the effects of different dose combinations of intravenous metoprolol and sufentanil on cardiovascular responses during oral endotracheal intubation under general anesthesia.\n\nEndotracheal intubation may cause transient increases in heart rate and blood pressure due to sympathetic stimulation. This study aims to determine whether metoprolol, in combination with different doses of sufentanil, can improve hemodynamic stability during and after intubation.\n\nA total of 900 adult patients aged 18 to 65 years with American Society of Anesthesiologists physical status I or II who are scheduled for elective non-cardiac surgery under general anesthesia with endotracheal intubation will be enrolled. Participants will be randomly assigned to one of 30 groups according to the combination of metoprolol dose and sufentanil dose. Metoprolol doses include 0, 0.1, 0.2, 0.3, 0.4, and 0.5 mg\u002Fkg, and sufentanil doses include 0.1, 0.2, 0.3, 0.4, and 0.5 mcg\u002Fkg.\n\nAll participants will receive standardized anesthetic induction and maintenance. Hemodynamic changes will be observed for 10 minutes after intubation. The main outcome is the success rate of hemodynamic stability within 0 to 10 minutes after intubation. Secondary outcomes include the incidence of hypotension, hypertension, bradycardia, and tachycardia.",[62],"General Anesthesia; Tracheal Intubation","2026-05-18",{"date":65,"type":38},"2026-05-20",{"date":37,"type":21},{"date":68,"type":21},"2027-05-22",{"name":44,"class":45},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":46},"100629214","prospective-lifespan-cohort-of-myocardial-infarction-100629214","NCT07471763","Prospective Lifespan Cohort of Myocardial Infarction","A Prospective Lifespan Cohort Study of Myocardial Infarction for Building an Integrated Multidimensional Database and Developing an Artificial Intelligence- and Multi-omics-Driven Precision Prevention and Control System","Inclusion Criteria:\n\nAge 18 to 74 years\n\nDiagnosed with stable angina, unstable angina, or acute myocardial infarction\n\nFor acute myocardial infarction: symptom onset to hospital admission less than 24 hours, with patients undergoing emergency percutaneous coronary intervention prioritized\n\nDiagnosis of acute myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction\n\nWilling to participate and able to provide written informed consent\n\nAble to complete baseline assessment, biospecimen collection, and long-term follow-up\n\nExclusion Criteria:\n\nEnd-stage malignant tumor with expected survival of less than 1 year\n\nSevere hepatic or renal dysfunction (estimated glomerular filtration rate \\\u003C30 mL\u002Fmin\u002F1.73 m² or Child-Pugh class C)\n\nActive autoimmune disease or long-term use of immunosuppressive agents\n\nPregnant or breastfeeding women\n\nInability to provide informed consent or severe cognitive impairment\n\nPrevious participation in another clinical study that may conflict with this project\n\nAny other condition considered by the investigators to make participation inappropriate","74 Years",{"count":79,"type":21},6000,"OBSERVATIONAL","This prospective cohort study aims to establish a lifespan cohort of myocardial infarction and build a standardized, multidimensional, and shareable disease-specific database by systematically integrating clinical phenotypes, multi-omics data, and longitudinal follow-up information. Based on artificial intelligence and multi-omics integration, the study further seeks to develop a precision prevention and control framework for acute myocardial infarction covering the full continuum from early risk warning and accurate diagnosis to individualized treatment and long-term risk management.\n\nThe study will enroll adults aged 18 to 74 years, including two major populations: individuals at high risk of acute myocardial infarction, such as those with stable or unstable angina, and patients with confirmed acute myocardial infarction diagnosed according to the Fourth Universal Definition of Myocardial Infarction. Biospecimens, including venous blood, urine, and feces, will be collected, and participants will undergo standardized baseline assessment and follow-up.\n\nThe primary outcome is all-cause mortality during follow-up. Secondary outcomes include cardiovascular death, recurrent myocardial infarction, readmission due to heart failure, revascularization, stroke, stent thrombosis, and severe bleeding. This study is expected to provide scientific evidence and technical support for precision prevention, diagnosis, treatment, and long-term management of myocardial infarction.",[83,84,85],"Acute Myocardial Infarction (AMI)","Stable Angina","Unstable Angina",[87,88,89,90,91,92,93],"prospective cohort","multi-omics","artificial intelligence","risk prediction","precision medicine","acute myocardial infarction","lifespan cohort","2026-03-22",{"date":96,"type":38},"2026-03-25",{"date":98,"type":21},"2026-04-10",{"date":100,"type":21},"2031-04-10",{"name":44,"class":45},{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":22,"phases":110,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},"100612248","ai-assisted-endoscopic-ultrasound-grading-of-early-esophageal-cancer-invasion-depth-a-multicenter-prospective-randomized-cohort-study-100612248","NCT07251114","AI-assisted Endoscopic Ultrasound Grading of Early Esophageal Cancer Invasion Depth: A Multicenter, Prospective, Randomized Cohort Study","Inclusion Criteria:\n\n* Satisfy ①⑧⑨ and one of the following conditions simultaneously: ②③④⑤⑥⑦ ① Age over 18 years old, ② Esophageal ulcer, ③ low-grade intraepithelial neoplasia, ④ high-grade intraepithelial neoplasia, ⑤ patients with esophageal squamous cell carcinoma, ⑥ white patches of esophageal mucosa, ⑦ esophageal polyps, ⑧ with endoscopic examination records and detailed pathological records, ⑨ agree to participate in the study;\n\nExclusion Criteria:\n\n* ① Patients who have undergone esophageal cancer surgery, ② those with a history of radiotherapy and chemotherapy for esophageal cancer, ③ patients with missing data.",{"count":109,"type":21},200,[24],"This study mainly uses an artificial intelligence system to assist in the classification of the depth of invasion of early esophageal squamous cell carcinoma under ultrasound endoscopy, providing a basis for preoperative T staging and diagnosis and treatment decisions.",[113,114],"Esophageal Cancer Stage","Early Esophageal Cancer",[116,117,118],"early esophageal cancer","Artificial Intelligence","EUS","RECRUITING","2025-11-18",{"date":122,"type":38},"2025-11-26",{"date":124,"type":21},"2025-11-20",{"date":126,"type":21},"2028-12-31",{"name":44,"class":45},5,{"id":130,"slug":131,"hasResults":11,"nctId":132,"briefTitle":133,"officialTitle":134,"acronym":4,"eligibilityCriteria":135,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":143,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":46},"100559467","electroacupuncture-for-preventing-postoperative-delirium-in-older-adults-undergoing-total-knee-arthroplasty-100559467","NCT06564506","Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty","Electroacupuncture for Preventing Postoperative Delirium in Older Adults Undergoing Total Knee Arthroplasty: a Multicentre Randomised Controlled Trial","Inclusion Criteria:\n\n* Aged 65-90 years\n* American Society of Anaesthesiologists (ASA) physical status class II or III\n* Scheduled for elective unilateral total knee arthroplasty under general anesthesia\n\nExclusion Criteria:\n\n* Baseline dementia or Mini-Mental State Examination (MMSE) score below 24\n* Implanted electrical devices (eg, pacemakers, brain or spinal cord neurostimulator)\n* Infection or abscess at any selected acupuncture point\n* Severe hematopoietic or hemorrhagic disease\n* Severe audio-visual impairments or inability to communicate in Mandarin\n* Alcohol or illicit drug misuse disorder\n* Current use of sedatives, antidepressants or glucocorticoids\n* Received acupuncture or electroacupuncture within one month before surgery\n* Any condition deemed unsafe or unsuitable by the research team","90 Years",{"count":138,"type":21},1460,[24],"Electroacupuncture may improve cognitive function and altered consciousness, but its effect on postoperative delirium in older arthroplasty patients remains unexplored. This study aims to assess the efficacy of electroacupuncture in preventing postoperative delirium in older adults undergoing total knee arthroplasty.",[142],"Postoperative Delirium",[144,145,146,147],"Older adults","Electroacupuncture","Postoperative delirium","Total knee arthroplasty","2025-09-25",{"date":150,"type":38},"2025-09-26",{"date":152,"type":21},"2025-11-10",{"date":154,"type":21},"2026-08-30",{"name":44,"class":45},{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":162,"enrollmentInfo":163,"targetDuration":165,"studyType":80,"phases":4,"briefSummary":166,"conditions":167,"keywords":171,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":46},"100517710","effects-of-different-continuous-renal-replacement-therapy-patterns-on-ionized-calcium-in-patients-with-citrate-anticoagulants-using-calcium-containing-replacement-solutions-100517710","NCT06021080","Effects of Different Continuous Renal Replacement Therapy Patterns on Ionized Calcium in Patients With Citrate Anticoagulants Using Calcium-containing Replacement Solutions","Inclusion Criteria:\n\n1. Age ≥ 18 years old;\n2. Receiving citrate anticoagulation;\n3. Obtain Informed consent from patients or next of kin.\n\nExclusion Criteria:\n\n1. Pregnant or lactating women;\n2. Allergic to citrate anticoagulants;\n3. Severe liver dysfunction (total bilirubin levels exceeding two times the normal range);\n4. Hypoxemia (PaO2 \\\u003C 60 mmHg);\n5. Inadequate tissue perfusion (blood pressure \\\u003C 90\u002F60 mmHg despite high doses of vasoactive agents);\n6. Hyperlactatemia (lactate\\> 4 mmol\u002FL);\n7. Hypernatremia;\n8. Estimated length of hospital stay \\\u003C 48h;\n9. Participated in other studies.","100 Years",{"count":164,"type":21},30,"1 Month","It is unclear whether different modes of continuous renal replacement therapy (CRRT) impact post-filter ionized calcium concentrations during regional citrate anticoagulation (RCA) when using calcium-containing replacement fluid.\n\nThis prospective, single-center, observational cohort study will screen all patients receiving CRRT for eligibility. General clinical information will be collected before commencing CRRT treatment. Patients will be randomly assigned to either the veno-venous hemofiltration (CVVH) or continuous veno-venous hemodialysis (CVVHD) group and switch to the alternative mode in the subsequent treatment session. Pre-filter and post-filter ionized calcium, systemic total and ionized calcium, and effluent total and ionized calcium will be measured 2 hours after the initiation of CRRT. Electrolyte levels, arterial blood gases, hourly citrate dose, and total citrate dose will be recorded every 6 hours until the end of CRRT. The primary outcome is the difference in ionized calcium concentrations at each site over time between the two modes.",[168,169,170],"Renal Injury","Regional Citrate Anticoagulation","Continuous Renal Replacement Therapy",[168,172,173],"Regional citrate anticoagulation","Continuous renal replacement therapy","2025-08-05",{"date":176,"type":38},"2025-08-06",{"date":178,"type":38},"2023-10-09",{"date":180,"type":21},"2026-12-09",{"name":44,"class":45},{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":4,"eligibilityCriteria":188,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":189,"enrollmentInfo":190,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":46},"100565517","d-tace-haic-combined-with-envafolimab-and-lenvatinib-for-unresectable-icc-100565517","NCT06643208","D-TACE-HAIC Combined With Envafolimab and Lenvatinib for Unresectable ICC","Department of Hepatobiliary Pancreatic Surgery, Fujian Provincial Hospital","Inclusion Criteria:\n\n* 1\\. Ages of 18 and 75;\n* 2\\. Child-Pugh liver function grade: A\u002FB;\n* 3\\. ECOG score (see annex for scoring standards) : ≤1 score;\n* 4\\. ICC was confirmed by pathology and evaluated by two senior hepatobiliary surgeons as unresectable for surgery (including multiple intrahepatic lesions, local vascular invasion, local lymph node metastasis, and distant metastasis);\n* 5\\. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (the CT\u002FMRI scan diameter of the lesion can be measured ≥10mm, and the lesion has not received local treatment such as radiotherapy or freezing);\n* 6\\. The expected survival time is greater than 3 months;\n* 7\\. Patients who had not received any tumor-related targeting, immunization, radiotherapy or chemotherapy before enrollment;\n* 8\\. Functional indexes of vital organs met the following requirements: · Routine blood: absolute neutrophil count ≥1.5×109\u002FL, Hb≥9.0g\u002FL, PLT≥75×109\u002FL; · Liver function: total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage in patients with obstructive jaundice); Alanine aminotransferase (ALT), aspartate aminotransferase (AST)≤ 5x ULN, albumin ≥30g \u002FL; · Renal function: serum creatinine ≤1.5mg\u002FdL, creatinine clearance ≥60ml \u002Fmin; · Coagulation function: International standardized ratio (INR) and activated partial thromboplastin time (APTT)≤1.5 times ULN;\n* 9\\. No history of severe arrhythmia or heart failure; No history of severe ventilation dysfunction or severe pulmonary infection;\n* 10\\. Women of childbearing age should agree to use contraception during the use of medication and for 6 months after the end of medication; Patients who had a negative serum or urine pregnancy test in the 7 days prior to study enrollment and must be non-lactating patients, men should consent to use contraception during the study period and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n* 1\\. Patients who have previously received other local anti-tumor treatments (such as radiotherapy, radiofrequency ablation, etc.), who are allowed to relapse 6 months after previous surgery, and who are allowed to undergo biliary drainage (including PTCD and biliary stent implantation);\n* 2\\. History of allergy to gemcitabine, oxaliplatin, Envolizumab, Renvastinib and its components;\n* 3\\. A history of other malignant tumors within the past 5 years or at the same time, except cured basal cell carcinoma of the skin, cervical carcinoma in situ and thyroid papillary carcinoma;\n* 4\\. Patients who have previously received an organ transplant or are planning to receive an organ transplant;\n* 5\\. The presence of any active autoimmune disease or patients with autoimmune disease and expected recurrence (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);\n* 6\\. History of immune deficiency; The patient is taking immunosuppressants or systemic hormone therapy for immunosuppressive purposes and continues to use it within 2 weeks prior to signing the informed consent;\n* 7\\. Known hereditary or acquired bleeding (e.g. coagulation disorders) or thrombotic tendencies, e.g. in hemophiliacs; Is currently or recently (within 10 days prior to the start of study therapy) used full dose oral or injectable anticoagulants or thrombolytic agents for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular weight heparin permitted);\n* 8\\. Serious infections, such as severe pneumonia, bacteremia, and comorbiditis requiring hospitalization, occurred within 4 weeks prior to the first use of the study drug; Baseline chest imaging findings indicate active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first use of the study drug, or the need for oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use);\n* 9\\. Patients with mental illness; Have a history of psychotropic substance abuse, alcoholism and drug use;\n* 10\\. Pregnant or lactating women;\n* 11\\. Those who, according to the judgment of the researcher, should not participate in this experiment for other reasons;","75 Years",{"count":191,"type":21},37,"This is a prospective, single-arm, multicenter, phase II trial to evaluate the efficacy and safety of D-TACE-HAIC (GEMOX protocol) in combination with Envafolimab and Lenvatinib for unresectable intrahepatic cholangiocarcinoma.",[194],"Intrahepatic Cholangiocarcinoma","2025-06-21",{"date":197,"type":38},"2025-06-26",{"date":199,"type":38},"2024-07-01",{"date":201,"type":21},"2027-03-01",{"name":44,"class":45},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":189,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":215,"conditions":216,"keywords":219,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},"100574572","phase-1-mfolfirinox-plus-anlotinib-and-sintilimab-for-advanced-pancreatic-cancer-100574572","NCT06761027","mFOLFIRINOX Plus Anlotinib and Sintilimab for Advanced Pancreatic Cancer","mFOLFIRINOX Combined With Anlotinib and Sintilimab as First-Line Therapy for Locally Advanced or Metastatic Pancreatic Cancer: A Prospective, Single-arm, Multicenter, Phase Ib\u002FII Clinical Study","Inclusion Criteria:\n\n1. Fully understand this study and voluntarily sign the informed consent form;\n2. Age between 18 and 75 years inclusive, with no gender restrictions;\n3. Patients with locally advanced or metastatic pancreatic cancer diagnosed by histology or cytology;\n4. No prior anti-cancer treatment;\n5. Patients must have at least one measurable lesion (according to RECIST 1.1 criteria);\n6. ECOG PS score of 0-1;\n7. Expected survival of at least 3 months;\n8. No severe organic diseases of the heart, lungs, brain, liver, kidneys, or other organs;\n9. Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment; negative serum or urine pregnancy test within 7 days before study enrollment, and must be non-lactating, men must agree to use contraceptive measures during the study period and for 6 months after the study ends.\n\nExclusion Criteria:\n\n1. Have already received or are currently receiving additional anti-tumor treatment measures such as chemotherapy, radiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine treatment;\n2. Known allergies to any of the drugs in the study;\n3. Symptomatic brain metastases or metastases with symptom control time less than 2 months;\n4. A large liver metastasis burden, occupying more than 70% of the liver volume;\n5. Patients with obstructive jaundice whose bilirubin cannot be reduced to the expected level after adequate decompression;\n6. Presence of any active autoimmune diseases or patients with autoimmune diseases expected to relapse (such as interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes);\n7. History of immunodeficiency; patients currently using immunosuppressants, systemic corticosteroid therapy, or any other form of immunosuppressive treatment;\n8. Known genetic or acquired bleeding tendencies (such as coagulation disorders) or thrombosis, such as hemophiliacs; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed);\n9. Serious infections (CTC AE greater than grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging suggests active pulmonary inflammation, presence of symptoms and signs of infection within 2 weeks before the first use of the study drug, or requiring oral or intravenous antibiotic treatment (excluding the use of antibiotics for prevention);\n10. History of other malignant tumors within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma;\n11. Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction;\n12. Pregnant or lactating women;\n13. Deemed by the investigator as unsuitable to participate in this trial for other reasons.",{"count":211,"type":21},29,[213,214],"PHASE1","PHASE2","This study is a prospective, single-arm, multicenter, phase Ib\u002FII clinical trial that treats previously untreated patients with locally advanced or metastatic pancreatic cancer using mFOLFIRINOX in combination with anlotinib and sintilimab. The purpose of this trial is to evaluate the efficacy and safety of this treatment regimen and to preliminarily explore the correlation between biomarkers and treatment outcomes.",[217,218],"Locally Advanced Pancreatic Cancer","Metastatic Pancreatic Cancer",[220,221],"anlotinib","sintilimab","2025-01-04",{"date":224,"type":38},"2025-01-07",{"date":226,"type":38},"2024-12-23",{"date":228,"type":21},"2027-05",{"name":44,"class":45},4,{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":235,"acronym":4,"eligibilityCriteria":236,"healthyVolunteers":11,"sex":17,"minAge":237,"maxAge":189,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":244,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":46},"100571252","the-effects-of-tai-chi-on-metabolic-dysfunction-associated-fatty-liver-disease-in-middle-aged-and-older-adults-100571252","NCT06717828","The Effects of Tai Chi on Metabolic Dysfunction-associated Fatty Liver Disease in Middle-Aged and Older Adults","Inclusion Criteria:\n\n1. Age between 40 and 75 years;\n2. Liver fat content measured by mDixon QUANT is ≥5%;\n3. Diagnosis of metabolic associated fatty liver disease;\n4. Overweight\u002Fobesity (BMI ≥ 24 kg\u002Fm²);\n5. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Excessive alcohol consumption (definition: in the past 6 months, males have consumed more than 140g of alcohol per week, and females have consumed more than 70g);\n2. Fatty liver due to other causes: such as alcoholic fatty liver, acute and chronic viral hepatitis, drug-induced hepatitis, autoimmune hepatitis, etc.;\n3. Severe cardiovascular diseases, including myocardial infarction within the past 6 months;\n4. Heart failure (NYHA classification: III - IV);\n5. Biliary diseases: such as obstructive biliary diseases;\n6. Other diseases affecting glucose and lipid metabolism: diabetes, hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.;\n7. Poorly controlled blood pressure: SBP ≥ 180 mmHg, DBP ≥ 100 mmHg;\n8. Chronic kidney disease or severe renal impairment, defined as serum creatinine of 135 µmol\u002FL (1.5 mg\u002FdL) for males and 110 µmol\u002FL (1.3 mg\u002FdL) for females;\n9. Patients unable to communicate normally, such as those with dementia or cognitive impairment;\n10. Currently pregnant or planning to become pregnant in the near future;\n11. Other conditions preventing participation in follow-up interventions;\n12. Other clinical diseases that make participation in exercise unsuitable, such as inability to cooperate with exercise therapy due to severe pain or joint deformities, or the use of medications that may interfere with the assessment of exercise effects (such as corticosteroids, liver protection drugs, etc.), or medications that affect heart rate (such as beta-blockers).","40 Years",{"count":239,"type":21},250,[24],"Background: Metabolic dysfunction-associated fatty liver disease (MAFLD) is a liver condition primarily driven by metabolic dysfunctions that may progress to hepatitis, cirrhosis, and hepatocellular carcinoma. It is also implicated in the development of other metabolic dysfunction-related diseases. MAFLD has emerged as a growing public health concern in China. Despite its potential benefits, Tai Chi exercise has not been widely adopted for individuals with MAFLD, and there is limited research investigating its therapeutic efficacy. This study aims to evaluate the effects of a structured Tai Chi intervention on middle-aged and elderly individuals with MAFLD.\n\nMethods: The study employs a comprehensive open, randomized, parallel, and controlled design. Eligible participants will be randomly allocated into three groups: Tai Chi, conventional exercise, and control. A total of 250 participants will be enrolled, comprising 100 participants each for the Tai Chi and conventional exercise groups and 50 for the control group. Both the Tai Chi and conventional exercise groups will participate in a structured 6-month exercise program. During the intervention, both groups will also receive regular health education on fatty liver disease. Participants will be encouraged to maintain their usual activities but will be advised against starting new exercise regimens. The control group will receive only health education on fatty liver disease. The primary efficacy endpoint is the change in hepatic triglyceride content measured via validated imaging techniques after 6 months. Secondary endpoints include changes in total body fat, waist circumference, body weight, blood pressure, blood lipids, blood glucose, insulin sensitivity, pancreatic beta-cell function, kidney function, and pulse wave velocity. Outcomes will be assessed at baseline and post-intervention.\n\nDiscussion: Tai Chi exercises demonstrate therapeutic potential in reducing intrahepatic fat content, promoting weight loss, and mitigating cardiovascular risk factors. Furthermore, their efficacy appears superior to that of conventional exercise modalities.",[243],"Non-Alcoholic Fatty Liver Disease",[245,246,247],"MAFLD","Tai Chi","Intrahepatic Fat Content","2024-12-01",{"date":250,"type":38},"2024-12-05",{"date":252,"type":38},"2024-11-01",{"date":254,"type":21},"2026-12-31",{"name":44,"class":45},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":189,"enrollmentInfo":263,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":265,"conditions":266,"keywords":268,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":274,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":4},"100565542","fecal-microbiota-transplantation-in-reversing-drug-resistance-in-unresectable-hcc-talenp004-100565542","NCT06643533","Fecal Microbiota Transplantation in Reversing Drug Resistance in Unresectable HCC (TALENP004)","Safety and Efficacy of Fecal Microbiota Transplantation in Reversing Drug Resistance in Patients With Intermediate-advanced Unresectable Hepatocellular Carcinoma Undergoing Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Sintilimab.","Inclusion Criteria:\n\n1. Patients with intermediate to advanced Hepatocellular Carcinoma (HCC) who have experienced disease progression (PD) after treatment with the triple therapy of Transarterial Chemoembolization (TACE), lenvatinib, and sintilimab.\n2. Patients must have at least one measurable lesion according to the mRECIST 1.1 criteria (the longest diameter of measurable lesions on CT\u002FMRI scan ≥10mm).\n3. Expected survival time greater than 3 months.\n4. No prior treatment with Fecal Microbiota Transplantation (FMT).\n5. No history of taking probiotics after the diagnosis of HCC.\n6. Child-Pugh class A\u002FB.\n7. ECOG performance status: ≤1.\n8. Age between 18 and 75 years old.\n9. No other antitumor treatments except the triple therapy before enrollment.\n10. Key organ function indicators meet the following requirements:\n\n    Hematology: Absolute neutrophil count ≥1.5×10\\^9\u002FL, Hb ≥9.0g\u002FL, Platelets ≥75×10\\^9\u002FL Liver function: Total bilirubin ≤1.5 times the upper limit of normal (ULN) (≤2.5 times ULN after biliary drainage for obstructive jaundice); Alanine aminotransferase (ALT), Aspartate aminotransferase (AST) ≤5 times ULN, Albumin ≥30g\u002FL Renal function: Serum creatinine ≤1.5mg\u002FdL, Creatinine clearance rate ≥60ml\u002Fmin Coagulation function: International normalized ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤1.5 times ULN\n11. No history of severe arrhythmias, heart failure, severe ventilatory dysfunction, or severe pulmonary infections.\n12. Women of childbearing age must agree to use contraceptive measures during the treatment period and for 6 months after the end of treatment, with a negative serum or urine pregnancy test within 7 days before study enrollment, and must not be breastfeeding. Men must agree to use contraceptive measures during the study period and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. Mixed hepatocellular-cholangiocarcinoma.\n2. Severe tumor progression (tumor volume occupies two-thirds or more of the liver volume or diffuse intrahepatic lesions).\n3. History of allergy to PD-1, lenvatinib, or their components.\n4. History of other malignant tumors within the past 5 years, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid cancer.\n5. Patients who have undergone organ transplantation or are planning to undergo organ transplantation.\n6. Any active autoimmune disease or autoimmune disease with expected recurrence (such as interstitial pneumonia, colitis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes).\n7. History of immunodeficiency; patients who are using immunosuppressants or systemic corticosteroid therapy for immunosuppression and have continued use within 2 weeks before signing the informed consent.\n8. Known hereditary or acquired bleeding (such as coagulation disorders) or thrombotic tendencies, such as hemophilia patients; currently using or have recently (within 10 days before the start of the study treatment) used full-dose oral or injectable anticoagulants or thrombolytic drugs for therapeutic purposes (preventive use of low-dose aspirin, low molecular weight heparin is allowed).\n9. Serious infections within 4 weeks before enrollment, such as severe pneumonia requiring hospitalization, bacteremia, infectious complications, etc.; baseline chest imaging indicates active pulmonary inflammation, presence of infection symptoms and signs or need for oral or intravenous antibiotic treatment within 2 weeks before the first use of the study drug (excluding the use of antibiotics for prevention).\n10. Patients with mental illness; history of abuse of psychotropic drugs, alcoholism, and drug addiction.\n11. Chronic intestinal diseases (such as celiac disease, malabsorption, etc.).\n12. Pregnant or breastfeeding women.\n13. Deemed by the investigator to be unsuitable for participation in this trial for other reasons.",{"count":264,"type":21},15,"This study aims to evaluate the safety and efficacy of fecal microbiota transplantation (FMT) in reversing drug resistance to the triple therapy regimen in patients with unresectable hepatocellular carcinoma (HCC). The triple therapy consists of transarterial chemoembolization (TACE), lenvatinib, and Sintilimab. The study is a prospective, single-arm, multicenter clinical trial involving 15 participants with mid-to-late stage HCC that has progressed despite the triple therapy. FMT capsules will be prepared by matching the gut microbiome profiles of healthy donors to those of patients who achieved complete response (CR) with the triple therapy. The primary endpoints include objective response rate (ORR), treatment-related adverse events (AEs). Secondary endpoints will assess overall survival (OS), progression-free survival (PFS), and disease control rate (DCR), changes in gut microbiome, metabolomics, and immune subsets before and after FMT.",[267],"Hepatocellular Carcinoma Non-resectable",[269,270,271,272,273],"Fecal Microbiota Transplantation","Hepatocellular Carcinoma","TACE","Lenvatinib","PD-1 inhibitor","2024-10-13",{"date":276,"type":38},"2024-10-16",{"date":278,"type":21},"2025-01-01",{"date":280,"type":21},"2027-12-31",{"name":44,"class":45},{"id":283,"slug":284,"hasResults":11,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":4,"eligibilityCriteria":288,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":189,"enrollmentInfo":289,"targetDuration":291,"studyType":80,"phases":4,"briefSummary":292,"conditions":293,"keywords":294,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":306},"100562349","triple-therapy-for-intermediate-advanced-hcc-with-bdtt-talenp002-100562349","NCT06602011","Triple Therapy for Intermediate-advanced HCC With BDTT (TALENP002)","Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Tislelizumab for Intermediate-advanced Hepatocellular Carcinoma With Bile Duct Tumor Thrombus: A Multicenter, Single-arm, Real-world Study","Inclusion Criteria:\n\n1. Age between 18 and 75 years old;\n2. Patients with clinical diagnosis of Hepatocellular Carcinoma (HCC) combined with bile duct tumor thrombus (BDTT) (refer to the diagnostic criteria of the Chinese Expert Consensus on Multidisciplinary Diagnosis and Treatment of HCC with BDTT (2020 Edition)), BCLC Stage B or Stage C, and unresectable HCC (decided after multidisciplinary discussion);\n3. Patients who had not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;\n4. Patients with at least one measurable lesion according to the mRECIST criteria (measurable lesion with a CT\u002FMRI scan length diameter ≥ 10 mm and measurable lesion has not received localized treatment such as TACE, radiofrequency, cryotherapy, etc.);\n5. ECOG score: 0-1;\n6. liver function Child-Pugh class A or B; if combined with obstructive jaundice, total bilirubin ≤50umol\u002FL is required. If higher than 50umol\u002FL, biliary drainage is recommended;\n7. Blood routine: absolute neutrophil count ≥1.5×10\\^9\u002FL, Hb≥8.5g\u002FL, PLT≥75×10\\^9\u002FL;\n8. No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance \\>40mL\u002Fmin;\n9. Expected survival time greater than 3 months.\n\nExclusion Criteria:\n\n1. The tumor with extrahepatic metastasis or invaded adjacent organs;\n2. Patients received other anti-tumor treatments;\n3. Existence of contraindications to TACE;\n4. History of allergy to the components or excipients of Lenvatinib or Tislelizumab;\n5. The patient has any active autoimmune disease or has an autoimmune disease with expected relapse. Patients are on immunosuppressive or systemic hormone therapy for immunosuppression;\n6. Patients with proteinuria suggestive of ≥ 1 + in routine urine will undergo a 24-hour urine protein test for patients with ≥ 1 g of 24-hour urine protein;\n7. Patients with co-morbidities of other malignant tumors;\n8. Patients with co-morbid psychiatric disorders;\n9. Patients with pregnant or lactating women;\n10. Patients with organ transplant patients;\n11. Patients with hypothyroidism or hyperthyroidism.",{"count":290,"type":21},20,"3 Years","This is a multicenter, Single-arm, Real-world Study to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combined with Tislelizumab (Triple Therapy) for patients with Hepatocellular Carcinoma (HCC) with bile duct tumor thrombus (BDTT).",[270],[295,296,271,272,297],"Hepatocellular carcinoma","bile duct tumor thrombus","Tislelizumab","2024-10-11",{"date":300,"type":38},"2024-10-15",{"date":302,"type":38},"2024-09-30",{"date":304,"type":21},"2028-10-01",{"name":44,"class":45},6,{"id":308,"slug":309,"hasResults":11,"nctId":310,"briefTitle":311,"officialTitle":312,"acronym":313,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":189,"enrollmentInfo":315,"targetDuration":291,"studyType":80,"phases":4,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":319,"startDateStruct":320,"completionDateStruct":321,"leadSponsor":323,"locationsCount":306},"100559850","neoadjuvant-triple-therapy-for-resectable-hcc-100559850","NCT06569498","Neoadjuvant Triple Therapy for Resectable HCC","Neoadjuvant Transcatheter Arterial Chemoembolization Combined With Lenvatinib Plus Cadonilimab for Resectable Hepatocellular Carcinoma: A Single-Arm Phase II Clinical Trial","TALENP001","Inclusion Criteria:\n\n1. Voluntarily join the study and sign the informed consent form.\n2. Male or female patients aged between 18 and 75 years.\n3. Child-Pugh class A.\n4. Indocyanine green 15-minute retention rate (ICGR-15) \\\u003C 15%.\n5. ECOG performance status 0-1.\n6. Diagnosed with hepatocellular carcinoma (HCC) according to the \"Guidelines for Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).\"\n7. BCLC stage A or B, with a single tumor larger than 5 cm or multiple tumors, and considered surgically resectable after multidisciplinary discussion.\n8. According to RECIST 1.1 criteria, the patient has at least one measurable lesion (a measurable lesion with a long diameter ≥ 10 mm on CT\u002FMRI scan, and the measurable lesion has not received local treatments such as radiotherapy or cryotherapy).\n9. Blood routine: absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL, Hb ≥ 8.5 g\u002FL, PLT ≥ 75 × 10\\^9\u002FL.\n10. No history of severe arrhythmia, heart failure, severe pulmonary ventilation disorders, or severe lung infections; no acute or chronic renal failure, and creatinine clearance rate \\> 40 mL\u002Fmin.\n11. Women of childbearing potential must agree to use contraception during the medication period and for 6 months after the end of medication; have a negative serum or urine pregnancy test within 7 days prior to enrollment, and must not be breastfeeding. Men must agree to use contraception during the study period and for 6 months after the end of the study.\n\nExclusion Criteria:\n\n1. Tumor rupture with bleeding or suspected abdominal cavity metastasis.\n2. Previous treatment with any antitumor therapies before enrollment, such as targeted drugs, PD-1\u002FPD-L1\u002FCTLA-4 monoclonal antibodies, surgery, TACE, FOLFOX systemic chemotherapy, radiotherapy, and Huaier granules.\n3. History of allergy to lenvatinib, cadonilimab, or their components.\n4. Presence of any active autoimmune disease or a history of autoimmune disease with expected recurrence (e.g., interstitial pneumonia, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including but not limited to these diseases and syndromes); hypothyroidism treated with stable doses of thyroid replacement hormone; type 1 diabetes mellitus treated with stable doses of insulin; excluding patients with vitiligo or childhood asthma\u002Fallergies that have resolved and require no intervention in adulthood.\n5. History of immunodeficiency; patients using immunosuppressive drugs or systemic corticosteroids for immunosuppressive purposes and who have continued using them within 2 weeks before signing the informed consent form.\n6. Known hereditary or acquired bleeding (e.g., coagulopathy) or thrombotic tendency, such as hemophilia; currently receiving or recently (within 10 days before the start of study treatment) receiving full-dose oral or injectable anticoagulants or thrombolytics for therapeutic purposes (prophylactic use of low-dose aspirin and low-molecular-weight heparin is allowed).\n7. Severe infection within 4 weeks before the first use of the study drug (CTC AE grade \\> 2), such as severe pneumonia requiring hospitalization, bacteremia, or infection complications; baseline chest imaging indicating active lung inflammation; symptoms and signs of infection within 2 weeks before the first use of the study drug or requiring oral or intravenous antibiotic treatment (excluding prophylactic antibiotic use).\n8. Urinalysis indicating proteinuria ≥ 1+; if so, a 24-hour urine protein test is required; patients with 24-hour urine protein ≥ 1 g.\n9. History of other malignancies within the past 5 years or concurrently, except for cured basal cell carcinoma of the skin, cervical carcinoma in situ, and papillary thyroid carcinoma.\n10. Patients with concomitant psychiatric disorders; history of substance abuse, alcohol, or drug addiction.\n11. Pregnant or breastfeeding women.\n12. Patients with significant surgical contraindications, such as renal and cardiopulmonary insufficiency, as judged by the investigator, or any other reasons deemed unsuitable for participation in this trial by the investigator.",{"count":290,"type":21},"This study is a single-arm, multi-center, prospective phase II trial aimed at evaluating the efficacy and safety of neoadjuvant therapy with transarterial chemoembolization (TACE) combined with lenvatinib and camrelizumab (triple therapy) in patients with resectable hepatocellular carcinoma (HCC). The study plans to enroll 20 patients. The primary endpoints are major pathological response (MPR) rate and safety, while the secondary endpoints are recurrence-free survival (RFS), objective response rate (ORR), R0 resection rate, and overall survival (OS).",[318],"Resectable Hepatocellular Carcinoma",{"date":300,"type":38},{"date":302,"type":38},{"date":322,"type":21},"2026-12-01",{"name":44,"class":45},{"id":325,"slug":326,"hasResults":11,"nctId":327,"briefTitle":328,"officialTitle":329,"acronym":4,"eligibilityCriteria":330,"healthyVolunteers":11,"sex":17,"minAge":291,"maxAge":331,"enrollmentInfo":332,"targetDuration":4,"studyType":22,"phases":334,"briefSummary":335,"conditions":336,"keywords":338,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":46},"100560652","phase-4-effects-of-esketamine-on-postoperative-behavioral-changes-in-children-undergoing-tonsillectomy-andor-adenoidectomy-100560652","NCT06579937","Effects of Esketamine on Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and\u002For Adenoidectomy","Esketamine for the Prevention of Postoperative Behavioral Changes in Children Undergoing Tonsillectomy and\u002For Adenoidectomy: a Randomized Controlled Trial","Inclusion Criteria:\n\n* American society of Aneshesiologists physical status I or II;\n* Aged 3-7 years;\n* Scheduled for elective tonsillectomy and (or) adenoidectomy.\n\nExclusion Criteria:\n\n* Parents refusing to allow their children to participate;\n* Intake of sedative or analgesic medication within 48 hours before surgery;\n* Developmental delay;\n* Psychosis;\n* Body mass index \\> 30 kg\u002Fm2;\n* Allergy to study drugs;\n* Major life changes 1 month before the operation, such as the divorce of parents, death of parents, moving to a new home, changing to a new kindergarten, etc.;\n* Any other conditions that precluded study inclusion.","7 Years",{"count":333,"type":21},172,[59],"The goal of this clinical trial is to learn the effect of intravenous esketamine in postoperative negative behavior changes in children compared to placebo (a look-alike substance that contains no drug). It will also learn about the effect of esketamine in emergence delirium. The main questions are:\n\nDose esketamine lower the incidence of postoperative negative behavior changes compared to placebo? Dose esketamine lower the incidence of emergence delirium compared to placebo? Researchers will compare esketamine to placebo to see if esketamine works to treat postoperative negative behavior change and emergence delirium.\n\nParticipants will:\n\nReceive intravenous esketamine or placebo (a look-alike substance that contains no drug) during anesthesia induction; Fill in the Post hospitalization behavior questionnaire for ambulatory surgery postoperative 1, 7, and 30",[337],"Behavior Problem",[339,340,341,342,343,344],"esketamine","postoperative negative behavioral change","pediatrics","emergence delirium","tonsillectomy","adenoidectomy","2024-09-27",{"date":347,"type":38},"2024-10-01",{"date":349,"type":38},"2024-09-02",{"date":351,"type":21},"2025-10-30",{"name":44,"class":45},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":367,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":373,"startDateStruct":374,"completionDateStruct":375,"leadSponsor":377,"locationsCount":46},"100560287","phase-4-dexmedetomidine-reduces-sevoflurane-mac-bar-during-pneumoperitoneum-100560287","NCT06575179","Dexmedetomidine Reduces Sevoflurane MAC-BAR During Pneumoperitoneum","Effect of Dexmedetomidine on Sevoflurane Minimum Alveolar Concentration for Attenuating Adrenergic Response to CO2 Pneumoperitoneum: A Randomized Controlled Trial","Inclusion Criteria:\n\n* 1\\. Aged 18-45 years.\n* 2\\. American Society of Anesthesiologists (ASA) grade I - II.\n* 3\\. Patients undergoing elective laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\n* 1\\. Inability to provide informed consent;\n* 2\\. History of chronic pain or substance abuse;\n* 3\\. Pregnancy;\n* 4\\. Body mass index (BMI) ≥ 30 kg\u002Fm2;\n* 5\\. Known allergies to the study medications;\n* 6\\. Intake of medications within the last 72 hours that potential interfere with the determination of the MAC-BAR;\n* 7\\. Any other condition deemed exclusionary by the investigators.","45 Years",{"count":362,"type":21},90,[59],"This clinical trial aims to learn the impact of dexmedetomidine on the minimum alveolar concentration blunting the adrenergic response (MAC-BAR) of sevoflurane to carbon dioxide pneumoperitoneum in patients undergoing laparoscopic cholecystectomy. It will also learn about the effect of dexmedetomidine on hemodynamic parameters. The main questions are:\n\n* Does dexmedetomidine reduce the MAC-BAR of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum?\n* Would dexmedetomidine administration dose-dependently reduce the minimum alveolar concentration blunting the adrenergic response of sevoflurane required to suppress the sympathetic response to carbon dioxide pneumoperitoneum? Researchers will compare low-dose dexmedetomidine to high-dose dexmedetomidine to see if dexmedetomidine works to treat postoperative negative behavior change and emergence delirium.\n\nParticipants will:\n\n* Take intravenous dexmedetomidine or 0.9% saline (a look-alike substance that contains no drug)\n* Study drug infusions were initiated 15 minutes prior to anesthesia induction, allowing a minimum of 30 minutes to elapse before surgical incision to achieve steady-state plasma and brain concentrations.",[366],"Laparoscopic Cholecystectomy",[368,369,370,371,372],"dexmedetomidine","MAC-BAR","sevoflurane","laparoscopic surgery","α2-adrenergic receptor agonist",{"date":347,"type":38},{"date":349,"type":38},{"date":376,"type":21},"2024-12-30",{"name":44,"class":45},{"id":379,"slug":380,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":382,"acronym":4,"eligibilityCriteria":383,"healthyVolunteers":11,"sex":17,"minAge":384,"maxAge":4,"enrollmentInfo":385,"targetDuration":4,"studyType":22,"phases":387,"briefSummary":388,"conditions":389,"keywords":4,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":397,"locationsCount":46},"100550120","impact-of-the-digital-multi-domain-cognitive-intervention-in-high-risk-populations-for-dementia-100550120","NCT06442943","Impact of the Digital Multi-domain Cognitive Intervention in High-risk Populations for Dementia","Inclusion Criteria:\n\n* MCI (refer to Peterson's diagnostic criteria) or SCD (refer to the diagnostic framework proposed by Jak bondi and Jessen et al.);\n* Able to communicate normally in Mandarin;\n* Certain level of comprehension and judgment abilities, aware of the purpose of the survey and consents to participate.\n\nExclusion Criteria:\n\n* Patients with dementia exhibiting abnormal mental behavior;\n* Individuals with severe hearing or speech impairments;\n* Those with serious physical illnesses who are unable to cooperate and complete the survey.","55 Years",{"count":386,"type":21},128,[24],"Dementia is a chronic, progressive neurodegenerative disease characterized by acquired cognitive impairment as its core manifestation. The most common type of dementia is Alzheimer's Disease (AD), also known as \"Senile Dementia,\" accounting for 60-80% of all dementia cases. Currently, there are approximately 10 million AD patients in China, with the number showing an increasing trend year by year, imposing a heavy economic and caregiving burden on families and society. Studies have shown that AD has a clinically silent period of 15 to 20 years (SCD\\\\MCI), where the risk of developing dementia is ten times higher than that of healthy elderly individuals. Nearly 50% of MCI patients progress to dementia within 5 years, and about 14.1% of SCD patients develop dementia within the same timeframe. Early detection, diagnosis, and intervention are currently the most effective strategies for preventing and treating AD. Therefore, this study aims to verify the intervention effect of integrated cognitive intervention in high-risk populations for senile dementia (SCD, MCI) based on the cognitive rehabilitation model through randomized controlled trials, and to analyze attrition rates, participation rates, etc., which have good research and application value.",[390],"Cognitive Dysfunction","2024-09-05",{"date":393,"type":38},"2024-09-19",{"date":395,"type":38},"2024-06-04",{"date":254,"type":21},{"name":44,"class":45},{"id":399,"slug":400,"hasResults":11,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":189,"enrollmentInfo":405,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":230},"100559228","triple-therapy-sequential-radiotherapy-in-unresectable-hcc-talenp003-100559228","NCT06561399","Triple Therapy Sequential Radiotherapy in Unresectable HCC (TALENP003)","A Single-arm, Phase II, Prospective Study of Transcatheter Arterial Chemoembolization, Lenvatinib Combination With Sintilimab Sequential Radiotherapy in Patients With Initial Unresectable Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Be willing and able to enrollment in this study, signing the informed consent form;\n2. Age between 18 and 75 years old, male or female patients;\n3. Child-Pugh class A;\n4. Indocyanine green 15 min retention rate (ICGR-15) \\\u003C15%;\n5. ECOG score 0-1;\n6. Diagnosis of hepatocellular carcinoma according to the Chinese HCC Diagnosis and Treatment Guidelines 2022 Edition and expected survival time greater than 4 months.\n7. Patients with a diagnosis of initial unresectable HCC (BCLC stage B or C), evaluated as partial response (PR) or stable disease (SD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combination with Sintilimab. The number of residual active lesions in the liver was 1 to 3 and suitable for radiation therapy. Fusion lesions in the liver were considered as 1 lesion, and portal vein cancer thrombus was considered as 1 lesion for treatment.\n8. Normal tissue limits were performed according to the UK Consensus on Normal Tissue Dose Constraints for Stereotactic Radiotherapy.\n9. Patients who have not received any tumor-related targeted, immunotherapy, radiotherapy and chemotherapy before enrollment;\n10. Patients with at least one measurable lesion according to RECIST 1.1 criteria (measurable lesion CT\u002FMRI scan length diameter ≥10mm, and measurable lesion has not received localized treatments such as radiotherapy, cryotherapy, etc.);\n11. Blood routine: absolute neutrophil count ≥1.5×10\\^9\u002FL, Hb ≥8.5g\u002FL, PLT ≥75×10\\^9\u002FL;\n12. No history of severe cardiac arrhythmia or heart failure; no history of severe ventilatory dysfunction or severe pulmonary infection; no acute or chronic renal failure with creatinine clearance \\>40 mL\u002Fmin;\n13. Women of childbearing age should agree that they must use contraception during and for 6 months after the end of the dosing period; patients who have had a negative serum or urine pregnancy test within 7 days prior to study enrollment and must be non-lactating, and men should agree that they must use contraception during and for 6 months after the end of the study period.\n\nExclusion Criteria:\n\n1. Patients with a diagnosis of initial unresectable HCC, assessed as complete response (CR) or Progressive disease (PD) by RECIST 1.1 after 2 months of treatment with TACE, Lenvatinib combined with Sintilimab;\n2. Tumor combined with cancerous thrombus in the inferior vena cava and the tumor has developed extrahepatic metastasis;\n3. Treatment with other antitumor therapy such as targeted drugs, PD-1\u002FPD-L1 inhibitors, surgery, TACE, radiotherapy, FOLFOX systemic chemotherapy, and locus coeruleus granule drugs prior to study entry;\n4. History of allergy to Lenvatinib, Sintilimab and their components;\n5. Tumor volume accounting for two-thirds or more of the liver volume or diffuse distribution of intrahepatic lesions;\n6. Presence of any active autoimmune disease or patients with autoimmune disease with expected relapse (e.g., interstitial pneumonitis, colitis, hepatitis, pituitary gland inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism, including, but not limited to, these disorders and syndromes); hypothyroidism treated with stabilized doses of thyroid-replacing hormone; 1-year old diabetes mellitus using stabilized doses of insulin; or Type 1 diabetes mellitus; but not vitiligo or resolved childhood asthma\u002Fallergies that do not require any intervention in adulthood;\n7. Patients have history of immunodeficiency; patients who are on immunosuppressive or systemic hormone therapy for immunosuppression and have continued to do so within 2 weeks prior to signing the informed consent form\n8. Have known hereditary or acquired bleeding (e.g., coagulation disorders) or thrombotic tendencies, such as in patients with hemophilia; current or recent (within 10 days prior to initiation of study treatment) use of full-dose oral or injectable anticoagulant or thrombolytic medications for therapeutic purposes (prophylactic use of low-dose aspirin, low-molecular heparin is permitted)\n9. Severe infections (CTCAE \\> Grade 2) such as severe pneumonia requiring hospitalization, bacteremia, or infectious co-morbidities within 4 weeks prior to the first dose of study drug; baseline chest imaging suggestive of active lung inflammation, signs and symptoms of infection within 2 weeks prior to the first dose of study drug, or requiring treatment with oral or intravenous antibiotics (excluding prophylactic antibiotics). (excluding prophylactic use of antibiotics);\n10. Patients with proteinuria with routine urinalysis suggestive of ≥ 1 + will undergo a 24-hour urine protein test for 24-hour urine protein ≥ 1g;\n11. Have history of other malignant tumors within the previous 5 years or concurrently, except for cured basal cell carcinoma of the skin and carcinoma in situ of the cervix and papillary thyroid carcinoma;\n12. Patients with co-morbid mental diseases; history of psychotropic substance abuse, alcoholism and drug addiction;\n13. Women who are pregnant or breastfeeding\n14. Patients with obvious contraindications to surgery, such as renal and cardiopulmonary insufficiency, as judged by the investigator, and those who, in the opinion of the investigator, should not participate in this trial for other reasons.",{"count":406,"type":21},28,"This is an Open-label, Multicenter, Phase II clinical trial to evaluate the efficacy and safety of Transcatheter arterial chemoembolization (TACE), Lenvatinib combination with Sintilimab (Triple Therapy) sequential radiotherapy in patients with Unresectable Hepatocellular Carcinoma (uHCC).",[267],[295,271,272,410,411],"Sintilimab","radiotherapy","2024-08-18",{"date":414,"type":38},"2024-08-20",{"date":416,"type":21},"2024-08-15",{"date":418,"type":21},"2028-07-01",{"name":44,"class":45},{"id":421,"slug":422,"hasResults":11,"nctId":423,"briefTitle":424,"officialTitle":425,"acronym":4,"eligibilityCriteria":426,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":433,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":438,"lastUpdatePostDateStruct":439,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":46},"100548093","personalized-interventions-via-health-portraits-in-mild-behavioral-impairment-100548093","NCT06416514","Personalized Interventions Via Health Portraits in Mild Behavioral Impairment","Construction and Empirical Study of Personalized Intervention Based on Health Portrait in Mild Behavioral Impairment","Inclusion Criteria:\n\n* Meet the ISTAART diagnostic criteria for MBI;\n* Age ≥60 years old;\n* No obvious visual or hearing impairment;\n* Have the ability of language communication, can complete the scale assessment.\n\nExclusion Criteria:\n\n* Patients with severe physical diseases and unable to complete cognitive function screening;\n* Patients with other neurological diseases and serious medical diseases that can cause brain dysfunction.",{"count":428,"type":21},60,[24],"The incidence of MBI and the probability of progression to dementia are high. Early detection and intervention have important clinical significance to reduce the occurrence of dementia, delay the progression of dementia and promote healthy aging to active aging. The occurrence and development of NPS in MBI patients may be related to genetic and degenerative changes in the central nervous system. The evaluation of MBI patients is mainly based on neuropsychological tests, including NPS and cognitive function assessment. Landmark model is an effective tool for dynamic risk prediction of the progress of MBI. It can make dynamic prediction at different time points according to various existing measurement indicators of an individual and calculate the individual prediction probability, which is one of the best models for studying the outcome of disease at present. The Landmark model is applied to the elderly MBI population to study the influencing factors of normal aging, MBI and dementia and the probability of metastasis, which is a beneficial attempt to further advance the defense line of dementia. Personalized non-drug intervention is the preferred treatment for MBI, which mainly includes cognitive\u002Femotional intervention, sensory stimulation, exercise therapy, etc. Currently, it is recommended to adopt diversified strategies to implement individualized precision treatment programs for patients. The hierarchical and classified health management of elderly MBI patients combined with health portrait technology is helpful to improve management efficiency and better meet the needs of personalized health management for the elderly.",[432],"Neurocognitive Disorders",[434,144,435,436,437],"Mild behavioral impairment","Personalized intervention","Health portrait","Neuropsychiatric symptoms","2024-07-17",{"date":440,"type":38},"2024-07-18",{"date":442,"type":38},"2024-06-25",{"date":444,"type":21},"2027-12-30",{"name":44,"class":45},{"id":447,"slug":448,"hasResults":11,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":4,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":453,"enrollmentInfo":454,"targetDuration":4,"studyType":22,"phases":456,"briefSummary":457,"conditions":458,"keywords":460,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":46},"100548381","phase-4-deeper-intubation-make-effects-on-cervical-esophageal-esd-100548381","NCT06420258","Deeper Intubation Make Effects on Cervical Esophageal ESD","A Study on the Effectiveness and Safety of Intratracheal Deep Intubation Compared to Traditional Tracheal Intubation in Endoscopic Submucosal Dissection for Early Esophageal Cancer in the Cervical Esophagus: A Randomized Controlled Trial.","Inclusion Criteria:\n\n1. The lesions mainly involve superficial esophageal squamous cell carcinoma or high-grade intraepithelial neoplasia (HGIN) in the cervical esophagus;\n2. There is no evidence of regional lymph node or distant metastasis on endoscopic ultrasound (EUS) or CT\u002FMRI imaging;\n3. Participants have a thorough understanding of this study and voluntarily sign the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Patients who have received radiotherapy or chemotherapy before endoscopic submucosal dissection surgery; 2. Patients with severe comorbidities who are not suitable for endoscopic submucosal dissection surgery.","80 Years",{"count":455,"type":21},40,[59],"To compare the efficacy and safety of intratracheal deep intubation with traditional intubation in endoscopic submucosal dissection for early esophageal cancer in the cervical esophagus, and to follow up and assess their short-term clinical outcomes.",[459],"Carcinoma in Situ of Cervical Part of Esophagus",[461,462,463],"Deep tracheal intubation","Cervical esophageal cancer","ESD","2024-05-14",{"date":466,"type":38},"2024-05-17",{"date":468,"type":38},"2022-10-01",{"date":254,"type":21},{"name":44,"class":45},{"id":472,"slug":473,"hasResults":11,"nctId":474,"briefTitle":475,"officialTitle":476,"acronym":4,"eligibilityCriteria":477,"healthyVolunteers":16,"sex":17,"minAge":478,"maxAge":189,"enrollmentInfo":479,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":481,"conditions":482,"keywords":484,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":486,"lastUpdatePostDateStruct":487,"startDateStruct":489,"completionDateStruct":491,"leadSponsor":492,"locationsCount":46},"100523936","cohort-study-in-fujian-province-100523936","NCT06102187","Cohort Study in Fujian Province","Fujian Cohort Study of cARdiomEtabolic Disease and Comorbidity(Fu-CARE)","Inclusion Criteria:\n\n* Aged 35-75, having lived in Fuzhou, Putian, Quanzhou, Nanping, Xiamen, Zhangzhou, Longyan, Sanming, or Ningde in Fujian Province for more than 6 months.\n\nExclusion Criteria:\n\n* Anyone diagnosed with coronary heart disease, stroke, or cancer.\n* Anyone with a severe disability who is unable to participate in the study.","35 Years",{"count":480,"type":21},150000,"In this study, Chinese residents aged 35 to 75 years old were recruited from Fujian Province. Physical examination, questionnaire survey and biological sample collection were performed at baseline, and at least 4 years of follow-up were conducted. Information on newly discovered cardiovascular metabolic illnesses and comorbidities was collected during follow-up, and repeated surveys similar to baseline were conducted. To explore the relationship between environment, diet and lifestyle and the risk of cardiovascular metabolic diseases and concomitant disorders.",[483],"Chronic Disease",[485],"Cardiovascular and metabolic disease comorbidity","2023-11-01",{"date":488,"type":38},"2023-11-03",{"date":490,"type":38},"2017-01-01",{"date":254,"type":21},{"name":44,"class":45},""]