[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Third Affiliated Hospital, Sun Yat-Sen University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":623},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,52,79,103,123,146,167,192,216,243,268,296,323,350,371,392,411,433,451,474,497,524,552,575,598],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100641464","cohort-study-on-neuroimmune-diseases-in-the-reproductive-age-100641464",false,"NCT07653984","Cohort Study on Neuroimmune Diseases in the Reproductive Age","RANID","Inclusion Criteria:\n\n* Patient Group: A total of fifty participants are expected to be enrolled.\n\n  1. Women aged 20-55 years with childbearing potential.\n  2. Voluntary informed consent.\n  3. Availability of complete personal information.\n  4. A confirmed diagnosis of neuromyelitis optica spectrum disorder (NMOSD), multiple sclerosis (MS), autoimmune encephalitis, myasthenia gravis, Guillain-Barré syndrome, or myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).\n\nHealthy Control Group: A total of fifty healthy women are expected to be included.\n\n1. Age- and sex-matched women of childbearing age with plans for pregnancy\n2. Voluntary informed consent.\n3. Availability of complete personal information.\n\nExclusion Criteria:\n\n* Patient Group:\n\n  1. Patients with an undetermined or unconfirmed diagnosis.\n  2. Incomplete personal information that cannot be obtained through follow-up.\n  3. Participants who voluntarily withdrew from the study and revoked informed consent.\n\nHealthy Control Group:\n\n1. Individuals diagnosed with neuroimmune-related disorders.\n2. Incomplete personal information that cannot be obtained through follow-up.\n3. Participants who voluntarily withdrew from the study and revoked informed consent.",true,"FEMALE","20 Years","55 Years",{"count":22,"type":23},100,"ESTIMATED","OBSERVATIONAL","Neuroimmune diseases are more prevalent among women of reproductive age. Studies have shown that neuroimmune diseases may impact fertility. Therefore, effective management of neuroimmune diseases during pregnancy is particularly important. This study included a follow-up period of up to five years in patients with pregnancy-associated neuroimmune disorders. Data collected included relapse frequency, symptomatology, imaging findings, treatment regimens, peripheral blood profiles, EDSS scores, and MRI results. In addition, maternal drug concentrations, postpartum relapse rates, and neonatal development were monitored after delivery. Following the successful completion of the five-year follow-up, the research team plans to continue the prospective epidemiological study with ten-year follow-up phases. The aim of this study is to generate detailed clinical data on pregnancy-associated autoimmune diseases and to equip clinicians with evidence-based strategies for optimizing disease management during the reproductive age.",[27,28,29,30,31,32],"Neuromyelitis Optica Spectrum Disorders (NMOSD)","Multiple Sclerosis","Autoimmune Encephalitis","Myasthenia Gravis","Guillain-Barré Syndrome (GBS)","Myelin Oligodendrocyte Glycoprotein Antibody-Associated Disease (MOGAD)",[34,28,35,36,31,32,37,38],"Neuromyelitis optica spectrum disorders (NMOSD)","Autoimmune encephalitis","myasthenia gravis","reproductive age","cohort study","RECRUITING","2026-06-13",{"date":42,"type":43},"2026-06-17","ACTUAL",{"date":45,"type":43},"2024-04-21",{"date":47,"type":23},"2030-04",{"name":49,"class":50},"Third Affiliated Hospital, Sun Yat-Sen University","OTHER",1,{"id":53,"slug":54,"hasResults":12,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100559336","efficacy-and-safety-of-cytokine-adsorption-and-plasma-exchange-in-patients-with-aclf-and-sepsis-100559336","NCT06562803","Efficacy and Safety of Cytokine Adsorption and Plasma Exchange in Patients With ACLF and Sepsis","Efficacy and Safety of Double Plasma Cytokine Adsorption System With Sequential Low-Dose Plasma Exchange in Treating Acute-on-Chronic Liver Failure and Sepsis: A Multi-center Randomized Controlled Study","Inclusion Criteria:\n\n1. Age between 18 and 70 years with a background of chronic liver disease, regardless of the presence of cirrhosis.\n2. Total bilirubin (TBIL) \\> 12 mg\u002FdL.\n3. International normalized ratio (INR) ≥ 1.5.\n4. Meeting the diagnostic criteria for sepsis: confirmed or suspected infection, with a sequential organ failure assessment (SOFA) score increase of ≥ 2 points. (5) High inflammatory status: IL-6 \\> 80 pg\u002Fml.\n\n(6) Diagnosis of sepsis within the past 72 hours.\n\nExclusion Criteria:\n\n1. Inherited metabolic liver disease (including Wilson's disease, hereditary hemochromatosis, and alpha-1 antitrypsin deficiency).\n2. Patients with hepatocellular carcinoma or other malignancies.\n3. Pregnant or breastfeeding women.\n4. Patients with human immunodeficiency virus (HIV) infection or other immunodeficiency diseases (including active hematological malignancies, congenital immunodeficiency syndromes, or those currently receiving high-dose systemic immunosuppressive therapy).\n5. Unstable phase of cerebrovascular events.\n6. History of organ transplantation.\n7. Patients with irreversible or terminal extrahepatic organ failure that precludes safe extracorporeal circulation or confounds the intervention: ①Terminal chronic obstructive pulmonary disease, terminal cor pulmonale, brain death, or persistent vegetative state, or Grade IV hepatic encephalopathy. ②Requirement for renal replacement therapy (RRT) at the time of screening\u002Fenrollment. ③Despite adequate fluid resuscitation, vasopressors, and steroid treatment, unable to maintain mean arterial pressure above 65 mmHg.\n8. Platelet count \\\u003C 50×10E9\u002FL, severe coagulation disorders (INR\\>3.5), or active bleeding.\n9. Known allergies to extracorporeal circulation, hemoperfusion, or other severe allergic history.\n10. Refusal by the patient or their legally authorized representative (LAR) to participate in the study, or sign the informed consent form.\n11. Inability to return for regular follow-up visits as planned in the study.\n12. Other conditions that, in the judgment of the researchers, make the patient unsuitable for enrollment.","ALL","18 Years","70 Years",{"count":63,"type":23},192,"INTERVENTIONAL",[66],"NA","This study aims to evaluate the efficacy and safety of the double plasma cytokine adsorption system with sequential low-dose plasma exchange (DPCAS+LPE) in patients with acute-on-chronic liver failure (ACLF) complicated by sepsis. The focus is on assessing the impact of the cytokine adsorption column(CA280,Jafron Biomedical Co., Ltd., Zhuhai, China) on survival rates, inflammation markers, and organ function to determine its potential value in clinical practice.\n\nThe primary research questions are: (1) Does DPCAS+LPE artificial liver therapy improve the 4-week mortality rate in ACLF patients with sepsis? (2) Does it improve the 12-week mortality rate in these patients? Additionally, the study examines the effects of this therapy on APACHE II scores, SOFA scores, vasoactive-inotropic score, MELD scores, and COSSH-ACLF II scores, as well as the cytokine adsorption efficiency of the CA280.\n\nPatients were randomly assigned to either the DPCAS+LPE group or the plasma exchange(PE) group. All patients received artificial liver therapy every other day, for a total of two sessions. Follow-up assessments were conducted before and after each therapy session, as well as at 1, 2, 3, 4, and 12 weeks.",[69,70],"Acute-On-Chronic Liver Failure","Sepsis","2026-04-26",{"date":73,"type":43},"2026-04-30",{"date":75,"type":43},"2024-09-27",{"date":77,"type":23},"2027-12-31",{"name":49,"class":50},{"id":80,"slug":81,"hasResults":12,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":85,"targetDuration":4,"studyType":64,"phases":87,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":4},"100634753","phase-2-efficacy-and-safety-of-low-dose-bevacizumab-plus-adebrelimab-combined-with-transarterial-chemoembolization-followed-by-hepatic-arterial-infusion-chemotherapy-tace-haic-as-first-line-treatment-for-unresectable-hepatocellular-carcinoma-a-single-arm-phase-2-trial-100634753","NCT07543783","Efficacy and Safety of Low-dose Bevacizumab Plus Adebrelimab Combined With Transarterial Chemoembolization Followed by Hepatic Arterial Infusion Chemotherapy (TACE-HAIC) as First-line Treatment for Unresectable Hepatocellular Carcinoma: A Single-arm Phase 2 Trial","Inclusion Criteria:\n\nWilling to participate and provide written informed consent. Age ≥ 18 years (on the day of signing informed consent). Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinical diagnosis of HCC according to AASLD criteria in patients with cirrhosis.\n\nEligible for TACE, including BCLC stage B or C, with unresectable HCC (excluding PVTT-Vp4 and extrahepatic metastasis).\n\nNo prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Child-Pugh score A or B7. No history of autoimmune disease. Life expectancy ≥ 3 months. At least one measurable lesion per RECIST v1.1 (spiral CT scan long diameter ≥ 10 mm or short diameter of enlarged lymph node ≥ 15 mm; lesions previously treated with locoregional therapy can be considered target lesions only if progression per RECIST v1.1 is clearly documented).\n\nAdequate hematologic, hepatic, and renal function within 7 days prior to enrollment:\n\nNeutrophils ≥ 1.5 × 10⁹\u002FL Platelets ≥ 50 × 10⁹\u002FL Hemoglobin ≥ 90 g\u002FL ALT\u002FAST ≤ 5 × ULN Serum creatinine ≤ 1.5 × ULN INR \\\u003C 2.3 or prothrombin time ≤ ULN + 6 seconds Albumin ≥ 30 g\u002FL Total bilirubin ≤ 3 × ULN Females of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must not be lactating; they and male participants must agree to use effective contraception during the study and for 6 months after study completion\n\nExclusion Criteria:\n\nKnown cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma. Active malignancy other than HCC within 5 years, excluding cured localized tumors such as basal cell skin cancer, squamous cell skin cancer, superficial bladder cancer, prostate carcinoma in situ, cervical carcinoma in situ, or breast carcinoma in situ.\n\nSevere allergy to iodine contrast precluding TACE-HAIC. Use of immunosuppressants or systemic corticosteroids for immunosuppressive purposes within 1 month prior to enrollment.\n\nActive uncontrolled infection. Severe gastroesophageal varices; untreated or incompletely treated varices (with bleeding or high bleeding risk).\n\nBrain metastases or bone metastases requiring urgent surgical or radiation intervention.\n\nPregnant, suspected pregnancy, or breastfeeding. Current or recent use (within 10 days prior to study treatment) of aspirin (\\> 325 mg\u002Fday) or dipyridamole, ticlopidine, clopidogrel, or cilostazol.\n\nThromboembolic events within 6 months prior to study treatment, including cerebrovascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), pulmonary embolism, etc.\n\nCongenital or acquired immunodeficiency. Myocardial infarction, severe\u002Funstable angina, or congestive heart failure within 12 months prior to study start.\n\nRenal insufficiency requiring dialysis. History of organ transplantation. Any other serious acute or chronic medical or psychiatric condition, or laboratory abnormality that would increase the risk of study participation or interfere with interpretation of results.",{"count":86,"type":23},38,[88],"PHASE2","his is a single-arm, phase II clinical study evaluating the efficacy and safety of low-dose bevacizumab (7.5 mg\u002Fkg, Q3W) plus adebrelimab (1200 mg, Q3W) combined with transarterial chemoembolization (TACE) followed by hepatic arterial infusion chemotherapy (HAIC) with the FOLFOX regimen as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). Eligible participants will receive TACE followed by HAIC (oxaliplatin, leucovorin, and fluorouracil) and subsequent intravenous administration of adebrelimab and low-dose bevacizumab every 3 weeks. The primary endpoint is objective response rate (ORR) assessed by investigators per RECIST v1.1. Secondary endpoints include progression-free survival (PFS), disease control rate (DCR), duration of response (DoR), overall survival (OS), and safety. A total of 38 participants will be enrolled using Simon's two-stage optimal design (alpha=0.05, power=0.8). The study is sponsored by the Third Affiliated Hospital of Sun Yat-sen University. Adebrelimab is provided free of charge for two years by Shanghai Shengdi Pharmaceutical Co., Ltd.",[91,92,93],"Adebrelimab (SHR-1316)","Bevacizumab","Hepatocellular Carcinoma (HCC)","NOT_YET_RECRUITING","2026-04-22",{"date":97,"type":43},"2026-04-28",{"date":99,"type":23},"2026-04-10",{"date":101,"type":23},"2029-08-31",{"name":49,"class":50},{"id":104,"slug":105,"hasResults":12,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":64,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":122,"locationsCount":4},"100634732","low-dose-bevacizumab-and-atezolizumab-combined-with-tace-haic-in-unresectable-hepatocellular-carcinoma-100634732","NCT07543510","Low-Dose Bevacizumab and Atezolizumab Combined With TACE-HAIC in Unresectable Hepatocellular Carcinoma","Efficacy and Safety of Low-Dose Bevacizumab and Atezolizumab Combined With Transarterial Chemoembolization Sequential Hepatic Arterial Infusion Chemotherapy as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Single-Arm, Phase II Trial","Inclusion Criteria:\n\nVoluntarily provides written informed consent. Age ≥18 years. Histologically or cytologically confirmed hepatocellular carcinoma (HCC), or clinically diagnosed HCC in patients with cirrhosis according to AASLD criteria.\n\nUnresectable HCC suitable for TACE treatment, including BCLC stage B or C, without Vp4 portal vein tumor thrombus or extrahepatic metastasis.\n\nNo prior systemic therapy for HCC. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Child-Pugh class A or class B7 liver function. No history of autoimmune disease. Life expectancy of at least 3 months. At least one measurable lesion according to RECIST v1.1.\n\nAdequate hematologic, hepatic, and renal function within 1 week before enrollment:\n\nNeutrophils ≥1.5 × 10\\^9\u002FL Platelets ≥50 × 10\\^9\u002FL Hemoglobin ≥90 g\u002FL ALT and AST ≤5 × upper limit of normal (ULN) Serum creatinine ≤1.5 × ULN INR \\\u003C2.3, or prothrombin time ≤ULN + 6 seconds Albumin ≥30 g\u002FL Total bilirubin ≤3 × ULN Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days before enrollment, must not be breastfeeding, and must agree to use effective contraception during the study and for 6 months after the end of study treatment. Men must also agree to use effective contraception during the study and for 6 months after the end of study treatment.\n\nExclusion Criteria:\n\nKnown intrahepatic cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma, or fibrolamellar carcinoma; or other active malignancy within 5 years, except adequately treated localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, cervix, or breast.\n\nSevere allergy to iodinated contrast agents that precludes TACE-HAIC treatment. Use of immunosuppressive agents or systemic corticosteroids for immunosuppressive purposes within 1 month before enrollment.\n\nActive infection that cannot be effectively controlled. Severe gastroesophageal varices, or untreated\u002Fincompletely treated varices with bleeding or high bleeding risk.\n\nBrain metastases or bone metastases requiring urgent surgical or radiotherapeutic intervention.\n\nPregnancy, suspected pregnancy, or breastfeeding. Current use of, or recent use within 10 days before study treatment of, aspirin \\>325 mg\u002Fday, dipyridamole, ticlopidine, clopidogrel, or cilostazol.\n\nThrombotic or embolic events within 6 months before treatment initiation, including cerebrovascular accident, transient ischemic attack, cerebral hemorrhage, cerebral infarction, or pulmonary embolism.\n\nCongenital or acquired immunodeficiency. Any of the following within 12 months before study start: myocardial infarction, severe or unstable angina, or congestive heart failure.\n\nRenal failure requiring dialysis. Prior organ transplantation. Any other severe acute or chronic medical or psychiatric condition, or laboratory abnormality, that may increase study risk, interfere with interpretation of results, or make the patient unsuitable for enrollment in the investigator's judgment.",{"count":86,"type":23},[66],"This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of low-dose bevacizumab plus atezolizumab combined with transarterial chemoembolization followed by hepatic arterial infusion chemotherapy (TACE-HAIC) as first-line treatment for patients with unresectable hepatocellular carcinoma (HCC). The study plans to enroll approximately 38 patients with unresectable, locally advanced HCC who have not received prior systemic therapy.\n\nAlthough atezolizumab plus bevacizumab has become a standard first-line treatment option for advanced HCC, the objective response rate remains limited. TACE-HAIC may improve tumor control by increasing local chemotherapy exposure, promoting tumor antigen release, and enhancing the anti-tumor activity of immunotherapy and anti-angiogenic therapy. In this study, patients will receive TACE-HAIC in combination with atezolizumab and low-dose bevacizumab, followed by maintenance treatment with atezolizumab plus low-dose bevacizumab until disease progression, unacceptable toxicity, withdrawal of consent, or other protocol-defined discontinuation criteria.\n\nThe primary endpoint is objective response rate (ORR) assessed by investigators according to RECIST version 1.1. Secondary endpoints include ORR by mRECIST, disease control rate, duration of response, progression-free survival, time to progression, overall survival, and safety. This study aims to explore whether this combination strategy can provide improved anti-tumor activity with manageable safety in patients with unresectable HCC.",[114,115,116],"Hepatocellular Carcinoma","Atezolizumab Plus Bevacizumab","Transarterial Chemoembolization","2026-04-15",{"date":95,"type":43},{"date":120,"type":23},"2026-05-01",{"date":101,"type":23},{"name":49,"class":50},{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":4,"eligibilityCriteria":128,"healthyVolunteers":12,"sex":59,"minAge":4,"maxAge":4,"enrollmentInfo":129,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":131,"conditions":132,"keywords":134,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":144,"locationsCount":145},"100590399","hospital-based-management-of-patients-with-chronic-hepatitis-b-virus-infection-100590399","NCT06966908","Hospital-Based Management of Patients With Chronic Hepatitis B Virus Infection","Inclusion Criteria:\n\n* HBsAg-positive patients attending non-infectious disease\u002Fhepatology departments at three study centers.\n\nAdditional inclusion criteria for the PRO sub-study:\n\n* Age ≥ 18 years;\n* Treatment-naïve HBV-infected patients;\n* Meet the treatment criteria according to the \"Chinese Guidelines for the Prevention and Treatment of Chronic Hepatitis B\" (2022 version);\n* Be able to understand the study content, willing to participate, and sign the informed consent;\n* Have the ability to complete questionnaires independently or with assistance.\n\nExclusion Criteria:\n\n* HBsAg-positive patients already under regular follow-up in infectious disease\u002Fhepatology clinics.\n* Chronic HBV patients on regular antiviral treatment.\n\nAdditional exclusion criteria for the PRO sub-study:\n\n* History of chronic liver diseases other than chronic HBV infection, including but not limited to: alcoholic liver disease, autoimmune liver disease, hereditary metabolic liver disease, etc. Co-infection with HCV, HDV, or HIV. Presence of other severe conditions that may affect HRQoL (such as severe cardiovascular and cerebrovascular diseases, uncontrolled mental illnesses, malignant tumors, etc.);\n* Pregnant or lactating women;\n* Use of pegylated interferon during the study;\n* Failure to complete all follow-up visits;\n* Other conditions that the investigator deems inappropriate for participation.",{"count":130,"type":23},16300,"Since 2022, the Third Affiliated Hospital of Sun Yat-sen University has initiated the \"Hot Wave Project\", a comprehensive hepatitis B infection prevention and management system encompassing patient education, screening, referral, treatment, and follow-up. In 2024, this system was expanded to the Sixth Affiliated Hospital and the Fifth Affiliated Hospital of Sun Yat-sen University, transitioning into a multicenter, hospital-based cohort study on hepatitis B management.The primary objective of this study is to increase the referral rate of HBsAg-positive patients in non-hepatology\u002Fnon-infectious disease departments to 50%. The secondary objective is to improve the treatment rate of hepatitis B infected patients in non-hepatology\u002Fnon-infectious disease departments, particularly focusing on the diagnosed but untreated (DBU) population. Furthermore, this study aims to analyze the cost-effectiveness and clinical benefits of in-hospital hepatitis B screening and management strategies.In 2025, a Patient-Reported Outcomes (PRO) sub-study was added to the project to evaluate the impact of antiviral therapy on the Health-Related Quality of Life among a cohort of treatment-naïve patients with chronic hepatitis B.",[133],"Chronic Hepatitis B",[133,135,136,137],"linkage to care","management","patient reported outcome","2026-04-02",{"date":140,"type":43},"2026-04-08",{"date":142,"type":43},"2025-01-03",{"date":77,"type":23},{"name":49,"class":50},3,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":151,"acronym":4,"eligibilityCriteria":152,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":51},"100620099","exploring-the-efficacy-and-safety-of-ofatumumab-in-patients-with-relapsing-multiple-sclerosis-rms-and-its-impact-on-serum-neurofilament-light-chain-snfl-levels-100620099","NCT07353216","Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels","Exploring the Efficacy and Safety of Ofatumumab in Patients With Relapsing Multiple Sclerosis (RMS) and Its Impact on Serum Neurofilament Light Chain (sNfL) Levels：A Multicenter, Open-Label, Observational Real-World Study","Inclusion Criteria:Signed and dated informed consent must be obtained before participation in the study.\n\nAny gender, aged at least 18 years at the time of study enrollment (signing the informed consent form).\n\nPatients with RMS meeting the 2017 Revised McDonald Criteria. EDSS score between 0 and 7. Regular follow-up with MRI monitoring. Willingness to provide blood samples. Willingness to undergo clinical assessments (including scales and physical examinations).\n\n\\-\n\nExclusion Criteria:Decision by the subject\u002Flegal guardian . Pregnancy. Diagnosis of Progressive Multifocal Leukoencephalopathy (PML). Hypersensitivity reaction to the investigational drug. Protocol violation that poses a significant safety risk to the subject. Occurrence of certain adverse events, such as malignancy, hepatic failure, or severe chronic infections (e.g., active hepatitis B, HIV).\n\nAny laboratory abnormality that, considering the subject's overall condition, is deemed to prevent the subject's continued participation in the study.\n\nAny condition that may pose a safety risk due to participation in the study. Non-compliance with the administration of the investigational drug or study procedures\n\n\\-",{"count":154,"type":23},80,"Multiple sclerosis (MS) is an immune-mediated disease characterized primarily by inflammatory demyelinating lesions in the central nervous system (CNS), with the white matter being predominantly affected. Its etiology remains unclear and may be associated with various factors such as genetics, environment, and viral infections . Pathologically, MS presents as multiple demyelinating lesions in the CNS, which may be accompanied by damage to nerve cells and their axons. Lesions on MRI show characteristic distributions, morphologies, and signal intensities . MS typically onset in young adults and is more common in women. Frequent symptoms include visual decline, diplopia, limb sensory disturbances, limb motor impairment, ataxia, and bladder or rectal dysfunction . As MS can lead to varying degrees of neurological deficits, and repeated relapses result in disability progression, it impacts patients' normal lives and work, posing a significant burden on individuals, families, and society. Considerable progress has been made in MS treatment in recent years, with agents such as teriflunomide, fingolimod, siponimod, and dimethyl fumarate having been approved for marketing in China.\n\nIn the two concurrently conducted active-comparator trials, ASCLEPIOS I and II, involving patients with relapsing multiple sclerosis, the annualized relapse rate was significantly lower in the ofatumumab group compared to the teriflunomide group. Ofatumumab was also superior to teriflunomide in suppressing MRI lesion activity . Although the aforementioned studies have confirmed the clinical efficacy of ofatumumab in treating MS, data from Chinese populations are lacking. Its clinical effectiveness, safety, and optimal treatment timing require further support from real-world evidence.\n\nExploring more indicators to predict MS disease activity and progression is crucial for identifying high-risk patients, assessing prognosis, and evaluating treatment response. Neurofilament light chain (NfL) is a specific biomarker for neuroaxonal damage, released into the cerebrospinal fluid (CSF) and serum after axonal injury . Serum and CSF NfL concentrations are highly correlated. Numerous studies in recent years have shown that high sNfL levels are associated with active T2 lesions and relapses, as well as brain volume loss. sNfL can not only monitor disease activity and treatment response at the group level in MS patients but also predict disease course, making it a valuable biomarker for predicting MS relapses and disability progression. It helps identify patients at higher risk of future disease activity and assists in clinical decision-making. Previous data from ASCLEPIOS I and II demonstrated that ofatumumab significantly reduced sNfL concentrations at the first assessment (Month 3) and at all subsequent visits in patients with RMS . However, existing studies have not included data from Chinese populations. This study aims to address this data gap for this specific population.",[28],[158],"NfL, Multiple sclerosis, treatment","2026-01-13",{"date":161,"type":43},"2026-01-20",{"date":163,"type":43},"2023-12-01",{"date":165,"type":23},"2026-12-01",{"name":49,"class":50},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":64,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":4},"100618971","effectiveness-of-a-virtual-health-management-community-vhmc-for-pre-diabetes-in-china-100618971","NCT07338552","Effectiveness of a Virtual Health Management Community (VHMC) for Pre-diabetes in China","A Virtual Community-Based Digital Intervention for Prediabetes Management in China","VHMC","Inclusion Criteria:\n\n* Participants who meet the 1999 World Health Organization (WHO) diagnostic criteria and the 2010 American Diabetes Association (ADA) definition for prediabetes, including: impaired fasting glucose (IFG): fasting plasma glucose (FPG) 6.1-\\\u003C7.0 mmol\u002FL and 2-hour plasma glucose (2-hPG) \\\u003C7.8 mmol\u002FL during a 75-g oral glucose tolerance test (OGTT); or impaired glucose tolerance (IGT): FPG \\\u003C7.0 mmol\u002FL and 2-hPG 7.8-\\\u003C11.1 mmol\u002FL during a 75-g OGTT; or HbA1c 5.7%-6.4%;\n* Age ≥18 years;\n* Clear consciousness and adequate comprehension ability;\n* Able to use a smartphone and have access to the Internet at home;\n* Willing to participate in the study and provide written informed consent;\n* Able to understand the purpose, procedure, and nature of the study.\n\nExclusion Criteria:\n\n* Participants with significant cognitive impairment or mental disorders;\n* Participants with severe malignant tumours;\n* Participants with severe acute or chronic complications, such as blindness, heart failure, or end-stage renal disease.","80 Years",{"count":177,"type":23},146,[66],"Individuals with prediabetes are at high risk for developing type 2 diabetes mellitus (T2DM) and are therefore prone to serious complications such as stroke, kidney failure, blindness, and lower-limb amputation. Prediabetes can be reversed, and lifestyle modification is considered the most effective intervention for diabetes prevention. However, it is difficult for individuals with prediabetes to maintain long-term healthy lifestyle changes owing to psychological burnout and poor adherence during daily self-management. We developed a novel virtual health management community (VHMC) model based on group interaction management. The purpose of this study is to evaluate whether a virtual health management community-based intervention can improve glycemic control and related health outcomes in adults with prediabetes.\n\nParticipants in the intervention group will receive lifestyle management support through a virtual health management community, including health education, lifestyle guidance, and group-based interaction delivered via a digital platform.\n\nParticipants will be randomly assigned to either the virtual health management community intervention group or a usual care control group.\n\nThe study will follow participants for approximately 6 months.\n\nParticipants in the intervention group will receive lifestyle management support through a virtual health management community, including health education, lifestyle guidance, and group-based interaction delivered via a digital platform.\n\nParticipants will be randomly assigned to either the virtual health management community intervention group or a usual care control group.\n\nThe study will follow participants for approximately 6 months.",[181],"Prediabetes",[181,183],"Health management","2026-01-05",{"date":186,"type":43},"2026-01-14",{"date":188,"type":23},"2025-12-30",{"date":190,"type":23},"2026-12-30",{"name":49,"class":50},{"id":193,"slug":194,"hasResults":12,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":199,"enrollmentInfo":200,"targetDuration":4,"studyType":64,"phases":202,"briefSummary":203,"conditions":204,"keywords":205,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":4},"100614597","transarterial-chemoembolization-with-low-dose-bevacizumab-plus-atezolizumab-as-first-line-treatment-for-unresectable-hepatocellular-carcinoma-100614597","NCT07281664","Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma","Transarterial Chemoembolization Combined With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hepatocellular Carcinoma: A Phase II, Single-Arm Clinical Trial","Inclusion Criteria:\n\n* Age between18 and 75 years;\n* Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n* Child-Pugh class A;\n* Eastern Cooperative Group performance status (ECOG) score of 0-1;\n* No prior systemic therapy for HCC.\n* Adequate hematologic and end-organ function;\n* At least one measurable intrahepatic target lesion.\n\nExclusion Criteria:\n\n* Diffuse HCC;\n* Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular\u002Fcholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;\n* Evidence of extrahepatic spread (EHS);\n* Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;\n* Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \\>CTCAE grade 3 within 4 weeks prior to randomization;\n* Active or history of autoimmune disease or immune deficiency;\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high risk for bleeding;\n* A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment;\n* Evidence of bleeding diathesis or significant coagulopathy;\n* Pregnant or breastfeeding females;\n* Significant cardiovascular disease;\n* Severe infection, such as active tuberculosis;\n* Serious medical comorbidities;\n* History of organ or cells transplantation;\n* History of other uncurable malignancies.","75 Years",{"count":201,"type":23},30,[66],"This study aims to evaluate the safety and effectiveness of a combined treatment for patients with unresectable hepatocellular carcinoma (HCC), a type of liver cancer that cannot be removed by surgery. The treatment includes transarterial chemoembolization (TACE), which delivers chemotherapy directly into the liver tumor, together with low-dose bevacizumab and atezolizumab, two medicines that help the immune system fight cancer and inhibit tumor blood vessel growth.\n\nAll participants in this study will receive the same combination treatment as their first-line therapy. The study will observe how well the tumor responds, how long the treatment can control the cancer, and what side effects may occur. The goal is to learn whether this combined approach can provide clinical benefit and improve outcomes for patients with advanced, unresectable liver cancer.",[114,116],[114,206,92,207],"Transarterial chemoembolization","Atezolizumab","2025-12-12",{"date":210,"type":43},"2025-12-15",{"date":212,"type":23},"2026-01-01",{"date":214,"type":23},"2029-12-31",{"name":49,"class":50},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":223,"enrollmentInfo":224,"targetDuration":4,"studyType":64,"phases":226,"briefSummary":228,"conditions":229,"keywords":231,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":4},"100612411","early-phase-1-treatment-of-spinal-cord-injury-using-autologous-concentrated-growth-factors-100612411","NCT07253233","Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors","A Prospective, Single-center, Single-arm Clinical Study Protocol on the Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors","Inclusion Criteria:\n\n* Chinese citizens, aged 18-60;\n\n  * Spinal cord injury caused by trauma;\n\n    * ASIA spinal cord injury grade C-D; ④ Duration of the disease: Acute, subacute and chronic spinal cord injuries are all acceptable; ⑤ Cooperate to complete the follow-up.\n\nExclusion Criteria:\n\n* Severe systemic diseases;\n\n  * Joint contractures;\n\n    * Having hematological diseases, autoimmune diseases and infectious diseases;\n\n      * Prohibited conditions for magnetic resonance imaging and electrophysiological examinations（For example：intracranial metal implants， cardiac stents, spinal stimulators, spinal internal fixators)；\n\n        * Severe anxiety\u002Fdepression\u002Fmanic states， or diagnosed with mental illness or epilepsy； ⑥ Spinal cord injury caused by myelitis， multiple sclerosis， or spinal tumors；\n\n          * Complicated with bleeding disorders or coagulation dysfunction；\n\n            * Individuals with osteoporosis and a high risk of pathological fractures； ⑨ Poor compliance， or unable to correctly understand and cooperate to complete follow-up； ⑩ Pregnant or lactating women； ⑪ Those who have received other spinal cord injury intervention treatments such as stem cells or growth factors within the past 3 months.","60 Years",{"count":225,"type":23},10,[227],"EARLY_PHASE1","Spinal cord injury (SCI) is a severe disorder of the central nervous system, and effective clinical management remains a significant global challenge. Current therapeutic approaches can only partially restore neurological function, leaving the majority of individuals with SCI facing profound and lifelong disabilities. The Department of Spine Surgery at the Third Affiliated Hospital of Sun Yat-sen University is conducting a clinical study on the use of autologous concentrated growth factors for the treatment of spinal cord injury, with the aim of developing a novel and effective clinical intervention strategy.",[230],"Spinal Cord Injury",[232,233,234],"spinal cord injury","growth factors","autologous","2025-11-19",{"date":237,"type":43},"2025-11-28",{"date":239,"type":23},"2025-12-01",{"date":241,"type":23},"2027-07-31",{"name":49,"class":50},{"id":244,"slug":245,"hasResults":12,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":223,"enrollmentInfo":250,"targetDuration":4,"studyType":64,"phases":252,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":260,"lastUpdatePostDateStruct":261,"startDateStruct":263,"completionDateStruct":265,"leadSponsor":267,"locationsCount":51},"100453278","phase-4-peginterferon-treatment-study-for-inactive-chronic-hepatitis-b-patients-100453278","NCT05182463","Peginterferon Treatment Study for Inactive Chronic Hepatitis B Patients","Real World Study of Peginterferon Alpha-2b Treatment for Inactive Chronic Hepatitis B Patients: E-Cure Study","Inclusion Criteria:\n\n* Age 18-60, no gender limitation\n* HBsAg is positive for more than 6 months\n* Hepatitis B e antigen(HBeAg) is negative and anti-HBe is positive\n* Serum HBV DNA is less than 2000 IU\u002FmL\n* Alanine aminotransferase(ALT) and\u002For Aspartate aminotransferase(AST) is normal\n* No antiviral durg (including nucleos(t)ide analogue and interferon) was used before enrollment\n* Good compliance and voluntarily signed informed consent\n\nExclusion Criteria:\n\n* Allergic to pegylated interferon α-2b\n* Any indication of liver cirrhosis\n* Coinfection with hepatitis A virus(HAV), hepatitis C virus(HCV), hepatitis D virus(HDV), hepatitis E virus(HEV) or human immunodeficiency virus(HIV)\n* Combined with other liver diseases (including drug-related, alcoholic, autoimmune, genetic metabolic liver diseases, etc.)\n* There are serious lesions in the important organs, such as heart, lung, kidney, brain and fundus\n* Patients with autoimmune diseases, unstable diabetes or thyroid diseases(hyperthyroidism or hypothyroidism)\n* Confirmed or suspected liver cancer or other malignant tumors\n* Patients after or preparing for organ transplantation\n* Peripheral blood white blood cell count \\\u003C 3.5×109\u002FL and\u002For platelet count \\\u003C 80×109\u002FL\n* Under immunosuppressant treatment\n* Pregnant or planned pregnancy in a short term or lactation patients\n* Alcohol abuse (average alcohol intake is more than 40 g\u002Fd in males or 20g\u002Fd in women) or drug addicts\n* Present or past history of mental or psychological diseases\n* Other conditions that the investigators deem inappropriate for the study.",{"count":251,"type":23},5000,[253],"PHASE4","There are about 400 million chronic hepatitis B virus (HBV) infection patients worldwide, posing a serious threat to global public health security. In China, HBV infection occured mainly in the perinatal period or infants, and about 10% of patients in the immune tolerance stage spontaneously transit to the immune clearance stage every year and become HBeAg-negative chronic HBV infection, resulting in a significant increase in the number of inactive chronic hepatitis B (CHB) patients.\n\nIn recent years, different guidelines have not reached consensus on the need to initiate antiviral therapy for inactive CHB patients: In the guidelines of Asian Pacific Association for The Study of Liver(APASL)-2015 and American Association for the Study of Liver Diseases(AASLD)-2018, antiviral therapy is generally not recommended for this group of patients, and regular outpatient follow-up is recommended. Guideline of European Association for the Study of the Liver(EASL)-2017 suggests that people with a family history of cirrhosis and liver cancer at this stage could be treated with antiviral therapy even if they did not meet the indications of antiviral therapy. According to Guidelines for the Prevention and Treatment of Chronic Hepatitis B (version 2019) of China, antiviral therapy is still recommended for some patients with inactive HBsAg carrier status who are HBV DNA positive and meet the treatment indications. Studies have shown that some patients in immune tolerance stage may enter the immune clearance stage and have hepatitis flare. Patients of inactive CHB have the potential to develop HBeAg-negative CHB, and studies of long-term follow-up in this population have indicated the risk of hepatocellular carcinoma. With the popularization of the concept of functional cure for chronic hepatitis B, more and more people with inactive CHB have a strong desire for treatment. In recent years, several studies have demonstrated that Pegylated-interferon therapy can achieve high functional cure rate in patients with inactive CHB.\n\nThe purpose of this study is to establish a national multi-center, prospective real world study to compare the efficacy of different antiviral treatment regimens for patients with inactive CHB and seek for the factors of functional cure.",[256],"Hepatitis B, Chronic",[258,259],"inactive chronic hepatitis B","functional cure","2025-04-28",{"date":262,"type":43},"2025-05-01",{"date":264,"type":43},"2022-01-08",{"date":266,"type":23},"2029-11-30",{"name":49,"class":50},{"id":269,"slug":270,"hasResults":12,"nctId":271,"briefTitle":272,"officialTitle":273,"acronym":274,"eligibilityCriteria":275,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":277,"targetDuration":4,"studyType":64,"phases":279,"briefSummary":280,"conditions":281,"keywords":283,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":291,"completionDateStruct":293,"leadSponsor":295,"locationsCount":51},"100574789","protein-a-immunoadsorption-for-the-treatment-of-acute-episodes-of-neuromyelitis-optica-spectrum-disorder-100574789","NCT06763848","Protein A immuNoaDsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder","Protein A Immunoadsorption for the Treatment of Acute Episodes of Neuromyelitis Optica Spectrum Disorder：A Multicenter, Open-label, Superiority, Randomised Trial","PANDA","Inclusion Criteria:\n\n* The inclusion criteria for the study are as follows:\n\n  1. clinical diagnosis of acute Neuromyelitis Optica Spectrum Disorders (NMOSD)\n  2. Age and Gender: Participants must be between 18 and 65 years old, inclusive, with no gender restrictions.\n  3. Serological Marker: Participants must test positive for AQP4-IgG using the cell-based assay (CBA) method.\n  4. Understanding and Consent: Participants or their legal representatives must be able to understand the study's purpose, demonstrate sufficient compliance with the study protocol, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Women who are pregnant or breastfeeding.\n2. Participants who cannot establish peripheral or central venous access, or have a history of allergic reactions to plasmapheresis.\n3. Participants with contraindications to intravenous methylprednisolone treatment.\n4. Participants who have used monoclonal antibodies in the last 6 months, or FcRn antagonists in the last 3 months.\n5. Participants who must use ACE inhibitors (ACEI) within 1 week before the start of treatment or during the study, and cannot discontinue their use.\n6. Severe Bleeding or Bleeding Disorders\n7. Severe Heart Failure\n8. Severe Infections","65 Years",{"count":278,"type":23},144,[66],"To clarify the efficacy and safety of protein A immunoadsorption therapy for acute exacerbations of neuromyelitis optica spectrum disorders(NMOSD), we designed a multicenter, open-label, superiority randomized controlled clinical trial, planning to enroll 144 patients with NMOSD. We plan to treat patients with acute NMOSD using protein A immunoadsorption combined with high-dose intravenous methylprednisolone, and compare this with treatment using high-dose intravenous methylprednisolone alone. The aim is to observe the impact and safety of protein A immunoadsorption on the treatment efficacy for these patients experiencing acute exacerbations of NMOSD, ultimately providing more comprehensive clinical evidence to support treatment protocols for the acute phase of NMOSD.",[282],"Neuromyelitis Optica Spectrum Disorders",[284,285,286,287],"neuromyelitis optica spectrum disorders","immunoadsorption","acute episodes","treatment","2025-04-27",{"date":290,"type":43},"2025-04-30",{"date":292,"type":43},"2025-04-25",{"date":294,"type":23},"2026-12-31",{"name":49,"class":50},{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":4,"eligibilityCriteria":302,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":303,"targetDuration":4,"studyType":64,"phases":304,"briefSummary":306,"conditions":307,"keywords":311,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":51},"100579536","phase-1-msc-evs-in-acute-acute-on-chronic-liver-failure-after-liver-transplantation-100579536","NCT06825572","MSC-EVs in Acute\u002F Acute-on-Chronic Liver Failure After Liver Transplantation","Mesenchymal Stem Cells-Derived Extracellular Vesicles (MSC-EV) in Acute\u002FAcute-on-Chronic Liver Failure After Liver Transplantationa：a Prospective, Randomized, Controlled Clinical Study","Inclusion Criteria:\n\n* aged 18-70 years;\n* Acute on chronic liver failure-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin \\[TBil\\] ≥ 10×ULN umol\u002FL) and coagulopathy (international normalized ratio \\[INR\\] ≥ 1.5 or prothrombin activity \\\u003C 40%), complicated within 4 weeks by ascites and\u002For encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease; Requiring liver transplantation due to acute on chronic liver failure;\n* Obtain the patients' consent after informing patients of the purpose and method of the clinical trial;\n\nExclusion Criteria:\n\n* Past history of malignant disease\n* Active uncontrolled infection;\n* Combined transplantation\n* EBV-negative;\n* HIV or HCV positive;\n* Retransplantation;",{"count":201,"type":23},[305],"PHASE1","Acute liver failure (ALF) refers to a potentially reversible disorder that was the result of severe liver injury, with an onset of encephalopathy within 8 weeks of symptom appearance and in the absence of pre-existing liver disease. Acute-on-chronic liver failure refers to a liver failure syndrome in which some patients with chronic liver disease with relatively stable liver function suffer from acute liver decompensation and liver failure due to the effects of various acute injury factors. Liver transplantation is the only curative treatment for this type of end-stage liver disease. The potential of MSCs to repair or regenerate damaged tissue and suppress immune responses makes them promising in the treatment of liver diseases, especially in the field of liver transplantation. Many studies have shown that MSC-based therapies can reduce the symptoms of liver disease due to their paracrine effects. Therefore, compared to the cells they derive from, mesenchymal stem cells-derived extracellular vesicles (MSC-EV) are gradually gaining attention for their enhanced safety, as they do not replicate or cause microvascular embolism, and can be easily stored without losing their properties. It represents a novel and effective cell-free therapeutic agent as alternative to cell-based therapies for liver diseases, and liver failure was also concerned. This study was designed to evaluate the safety and tolerability of MSC-EV in acute-on-chronic liver failure after liver transplantation.",[308,309,310],"Liver Failure","Mesenchymal Stem Cell","Extracellular Vesicles",[312,313,314],"MSC-EV","Liver transplantation","Liver failure","2025-02-09",{"date":317,"type":43},"2025-02-13",{"date":319,"type":23},"2025-04-01",{"date":321,"type":23},"2026-09-30",{"name":49,"class":50},{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":328,"acronym":4,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":199,"enrollmentInfo":330,"targetDuration":4,"studyType":64,"phases":332,"briefSummary":333,"conditions":334,"keywords":337,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":342,"lastUpdatePostDateStruct":343,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":349,"locationsCount":51},"100514900","tace-plus-atezolizumabbevacizumab-and-i-125-seeds-brachytherapy-for-hcc-with-branch-pvtt-100514900","NCT05984511","TACE Plus Atezolizumab\u002FBevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT","TACE Plus Atezolizumab\u002FBevacizumab and I-125 Seeds Brachytherapy for HCC With Branch PVTT: A Phase III, Randomized Clinical Trial","Inclusion Criteria:\n\n* Age between18 and 75 years;\n* Has a diagnosis of HCC confirmed by radiology, histology, or cytology;\n* Type I PVTT or type II PVTT;\n* Child-Pugh class A;\n* Eastern Cooperative Group performance status (ECOG) score of 0-1;\n* No prior systemic therapy for HCC.\n* Adequate hematologic and end-organ function;\n* At least one measurable intrahepatic target lesion.\n\nExclusion Criteria:\n\n* Diffuse HCC;\n* Cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular\u002Fcholangiocarcinoma subtypes (confirmed by histology, or pathology) are not eligible;\n* Evidence of extrahepatic spread (EHS);\n* Any condition representing a contraindication to TACE or I-125 seeds brachytherapy as determined by the investigators;\n* Evidence or history of bleeding diathesis or any hemorrhage or bleeding event \\>CTCAE grade 3 within 4 weeks prior to randomization;\n* Active or history of autoimmune disease or immune deficiency;\n* Untreated or incompletely treated esophageal and\u002For gastric varices with bleeding or high risk for bleeding;\n* A prior bleeding event due to esophageal and\u002For gastric varices within 6 months prior to initiation of study treatment;\n* Evidence of bleeding diathesis or significant coagulopathy;\n* Pregnant or breastfeeding females;\n* Significant cardiovascular disease;\n* Severe infection, such as active tuberculosis;\n* Serious medical comorbidities;\n* History of organ or cells transplantation;\n* History of other uncurable malignancies.",{"count":331,"type":23},234,[66],"The present study aimed to assess the effectiveness of the combination treatment of Atezolizumab\u002FBevacizumab, transcatheter arterial chemoembolization (TACE) and I-125 Seeds Brachytherapy (TACE-AB-I) in patients with advanced hepatocellular carcinoma (HCC) and portal vein tumor thrombosis (PVTT). The investigators confirmed that the combination therapy yielded better survival data than the combined administration of Atezolizumab\u002FBevacizumab and TACE (TACE-AB) in patients with advanced HCC and Type I\u002FII PVTT (Based on Cheng's PVTT classification).",[114,335,336],"Hepatic Portal Vein Tumor Invasion","Tumor Thrombus",[93,338,339,340,341],"Portal vein tumor thrombosis (PVTT)","Transcatheter arterial chemoembolization (TACE)","I-125 Seeds Brachytherapy","Atezolizumab plus Bevacizumab","2025-02-07",{"date":344,"type":43},"2025-02-11",{"date":346,"type":43},"2023-08-30",{"date":348,"type":23},"2029-08-01",{"name":49,"class":50},{"id":351,"slug":352,"hasResults":12,"nctId":353,"briefTitle":354,"officialTitle":355,"acronym":4,"eligibilityCriteria":356,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":357,"targetDuration":4,"studyType":64,"phases":359,"briefSummary":360,"conditions":361,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":364,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":51},"100476513","efficacy-and-safety-of-alss-treatment-for-icis-lf-in-patients-with-hcc-100476513","NCT05484908","Efficacy and Safety of ALSS Treatment for ICIs-LF in Patients With HCC","Efficacy and Safety of Artificial Liver Support System Treatment for Immune Checkpoint Inhibitors Related Liver Failure in Patients With Hepatocellular Carcinoma","Inclusion Criteria:\n\n1. Age from 18 to 65 years old;\n2. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \\> 0.5 year);\n3. Clinical diagnosis of hepatocellular carcinoma and receive immune checkpoint inhibitors treatment. The last treatment of immune checkpoint inhibitors is less than three months from inclusion;\n4. The level of hepatitis b virus DNA \\\u003C 2000 IU\u002FmL；\n5. Serum aspartate aminotransferase\u002Falanine aminotransferase \\> 20 times upper limit of normal；serum total bilirubin\\>10 times upper limit of normal；\n6. Prothrombin time international ratio \\> 1.5;\n7. Platelets \\> 50\\*10 E9\u002FL;\n8. Without intrahepatic bile duct dilation due to tumor progression.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events; other important organ dysfunctions or transplantation;\n6. Active bleeding, disseminated intravascular coagulation, thrombosis, or thrombotic disease;\n7. Patients received artificial liver support system treatment in one week before inclusion;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate",{"count":358,"type":23},60,[66],"This study aims to investigate the efficacy and safety of artificial liver support system treatment for immune checkpoint inhibitors related liver failure in patients with hepatocellular carcinoma.",[362,308,114],"Immune-Mediated Hepatitis","2024-11-26",{"date":365,"type":43},"2024-11-29",{"date":367,"type":43},"2022-08-12",{"date":369,"type":23},"2024-12-31",{"name":49,"class":50},{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":378,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":380,"conditions":381,"keywords":382,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":387,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":51},"100408337","combination-of-dpmas-and-low-volume-pe-for-patients-with-hbv-related-aclf-100408337","NCT04597164","Combination of DPMAS and Low Volume PE for Patients With HBV Related ACLF","Double Plasma Molecular Adsorption System With Sequential Low-Dose Plasma Exchange in Patients With Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Prospective Cohort Study","Inclusion Criteria:\n\n1. Clinical diagnosis of chronic hepatitis b virus infection (positive hepatitis b surface antigen or positive hepatitis b virus DNA \\> 0.5 year);\n2. Age from 18 to 65 years old;\n3. Clinical diagnosis of liver failure (serum total bilirubin level \\> 10 times upper limit of normal; prothrombin time activity \\\u003C 40% and ≥20%, or prothrombin time international ratio ≤ 2.6 and \\> 1.5);\n4. Platelets \\> 50\\*10 E9\u002FL.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Hepatocellular carcinoma or other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases; unstable infarction due to cardio-cerebrovascular events;\n6. Other important organ dysfunctions or transplantation;\n7. Severe complications including severe infection, gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate.",{"count":379,"type":23},200,"This study is to investigate investigate the safety and efficacy of Double plasma molecular adsorption system with sequential low-dose plasma exchange in treating hepatitis B virus-related acute-on-chronic liver failure.",[256,69],[383,384,385,386],"hepatitis b virus","acute-on-chronic liver failure","double plasma molecular adsorption system","plasma exchange",{"date":365,"type":43},{"date":389,"type":43},"2020-12-22",{"date":369,"type":23},{"name":49,"class":50},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":399,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":401,"conditions":402,"keywords":404,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":406,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":410,"locationsCount":51},"100386365","long-term-prognosis-of-patients-with-hepatitis-b-related-acute-on-chronic-liver-failure-100386365","NCT04310787","Long-term Prognosis of Patients With Hepatitis B Related Acute-on-chronic Liver Failure","The Investigation on Long-term Outcomes and Prognostic Factors of Patients With Hepatitis B Related Acute-on-chronic Liver Failure","Inclusion Criteria:\n\n* Age from 18 to 65 years old;\n* The diagnosis consistent with hepatitis b associated chronic acute liver failure；\n* After hospitalization, the survival time \\> 90 days；\n* The inpatient clinical data are complete.\n\nExclusion Criteria:\n\n* Human immunodeficiency virus infection or congenital immune deficiency diseases;\n* Liver cancer and other tumors, autoimmune liver disease, genetic and metabolic liver disease, or other serious diseases that significantly affect patient survival;\n* Other conditions that the researchers judged not appropriate for inclusion.",{"count":400,"type":23},300,"This study is to investigate the long-term outcomes and prognostic risk factors in patients recovered from hepatitis B virus related acute on-chronic liver failure.",[403,69],"Hepatitis B",[403,69,405],"Prognosis",{"date":365,"type":43},{"date":408,"type":43},"2020-05-15",{"date":369,"type":23},{"name":49,"class":50},{"id":412,"slug":413,"hasResults":12,"nctId":414,"briefTitle":415,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":12,"sex":59,"minAge":419,"maxAge":276,"enrollmentInfo":420,"targetDuration":4,"studyType":64,"phases":422,"briefSummary":423,"conditions":424,"keywords":425,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":51},"100356408","three-types-of-nucleotidenucleoside-analogues-treatment-in-hbv-related-aclf-100356408","NCT03920618","Three Types of Nucleotide\u002FNucleoside Analogues Treatment in HBV Related ACLF","Study on Three Types of Nucleotide\u002FNucleoside Analogues Treatment in Patients With Hepatitis b Virus Related Acute-on-chronic Liver Failure","HBV","Inclusion Criteria:\n\n1. Positive hepatitis b surface antigen or hepatitis b virus DNA \\> 0.5 year;\n2. Age from 12 to 65 years old;\n3. Serum total bilirubin level \\> 10 times upper limit of normal;\n4. Prothrombin time activity \\\u003C 40% or prothrombin time international ratio \\> 1.5；\n5. Do not receive nucleotide\u002Fnucleoside analogues treatment in the past half year.\n\nExclusion Criteria:\n\n1. Other active liver diseases;\n2. Hepatocellular carcinoma or other malignancy;\n3. Pregnancy or lactation;\n4. Human immunodeficiency virus infection or congenital immune deficiency diseases;\n5. Severe diabetes, autoimmune diseases;\n6. Other important organ dysfunctions;\n7. Using glucocorticoid;\n8. Patients can not follow-up;\n9. Investigator considering inappropriate.","12 Years",{"count":421,"type":23},150,[66],"This study is to investigate the clinical efficacy of three types of nucleotide\u002Fnucleoside analogues in treatment of HBV-related acute-on-chronic liver failure.",[403,69],[383,384,426,427],"nucleotide","nucleoside",{"date":365,"type":43},{"date":430,"type":43},"2019-02-21",{"date":369,"type":23},{"name":49,"class":50},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":440,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":441,"conditions":442,"keywords":444,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":363,"lastUpdatePostDateStruct":446,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":450,"locationsCount":51},"100276849","therapeutic-effects-and-long-term-follow-up-after-ending-nucleostide-analogs-therapy-in-chronic-hepatitis-b-100276849","NCT02883647","Therapeutic Effects and Long-term Follow-up After Ending Nucleos(t)Ide Analogs Therapy in Chronic Hepatitis b","Clinical Investigation About Therapeutic Effects and Long-term Follow-up After Ending Anti-hepatitis B Virus Therapy With Nucleos(t)Ide Analogs in Patients With Chronic Hepatitis b","Inclusion Criteria:\n\n1. Patients received anti-HBV therapy with nucleos(t)ide analogs.\n2. Last anti-HBV therapy should continue for at least 2 years.\n3. For HBeAg positive patients, HBV DNA should keep negative for at least 1 year after HBeAg seroconversion before the therapy ending; for HBeAg negative patients, HBV DNA should keep negative for at least 2 years before the therapy ending.\n\nExclusion Criteria:\n\n1. Liver cirrhosis, HCC;\n2. Patients with other factors causing active liver diseases;\n3. Pregnancy or lactation;\n4. Patients with HIV infection or congenital immune deficiency diseases;\n5. Patients with severe diabetes, autoimmune diseases, other important organ dysfunctions and other serious complications.",{"count":22,"type":23},"The study is to observe the therapeutic effects and long-term follow-up after ending anti-HBV therapy with nucleos(t)ide analogs in patients with chronic hepatitis b.",[443],"Chronic Hepatitis b",[445],"chronic hepatitis b, nucleos(t)ide analog",{"date":365,"type":43},{"date":448,"type":4},"2014-01-01",{"date":369,"type":23},{"name":49,"class":50},{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":64,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":466,"lastUpdatePostDateStruct":467,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":51},"100559704","phase-2-low-dose-gemcitabine-and-cisplatin-and-pd-1pd-l1-antibody-therapy-in-intrahepatic-cholangiocarcinoma-100559704","NCT06567600","Low-dose Gemcitabine and Cisplatin and PD-1\u002FPD-L1 Antibody Therapy in Intrahepatic Cholangiocarcinoma","Combined Therapy Using Low-dose Gemcitabine and Cisplatin Chemotherapy and PD-1\u002FPD-L1Antibody for Patients With Advanced and Unresectable Intrahepatic Cholangiocarcinoma: an Open-label, Multicenter, Single-arm Clinical Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years old, male or female;\n2. Histopathologically confirmed intrahepatic cholangiocarcinoma;\n3. TNM Staging≥Stage II (American Joint Committee on Cancer Prognostic Groups)\n4. Presence of at least one measurable lesion assessed using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST version 1.1);\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Child-Pugh score ≤ 7;\n7. Adequate organ function (neutrophil count of ≥1.5×10\\^9 cells\u002FL, hemoglobin concentrations of ≥90 g\u002FL, platelet cell count of ≥100×10\\^9 cells\u002FL, bilirubin ≤1.5×ULN, Alanine aminotransferase (ALT) and Aspartate aminotransferase (AST) ≤ 5×ULN, serum creatinine ≤ 1.5 x ULN, Thyroid stimulating hormone (TSH) ≤ 1 x ULN;\n8. The patient must be required to sign an informed consent form;\n\nExclusion Criteria:\n\n1. Patients who have received previous treatment with interventional therapy, radiotherapy, ablation, chemotherapy, targeted therapy, immunotherapy (PD-1, PD-L1, CLTA-4 antibody, etc), or surgery within the last 2 months;\n2. Patients with other malignant tumors within the last 5 years, except for cured non-melanoma skin cancer, cervical carcinoma in situ, and papillary thyroid carcinoma;\n3. Active tuberculosis infection. Patients with active tuberculosis infection within 1 year prior to enrollment; had a history of active tuberculosis infection more than 1 year before enrollment, did not receive formal anti-tuberculosis treatment or tuberculosis is still active;\n4. Active infection requiring systemic therapy;\n5. Human immunodeficiency virus (HIV) positive;\n6. Have an active, known, or suspected autoimmune disease. Subjects who require only hormone replacement therapy for hypothyroidism and skin diseases that do not require systemic therapy may be enrolled;\n7. Suffering from high blood pressure, and can not be well controlled by antihypertensive drugs (systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg);\n8. Abnormal blood coagulation (INR \\>1.5, or PT\\>ULN+4s, or APTT \\>1.5 x ULN), with a bleeding tendency or receiving thrombolytic or anticoagulant therapy;\n9. Pregnant or lactating women;\n10. Participated in other trials within the last 4 weeks;\n11. Has a history of allergy to platinum;\n12. Other factors that may influence the safety of the subject or the compliance of the test by the investigator. Serious illnesses (including mental illness), severe laboratory tests, or other family or social factors that require combined treatment.",{"count":459,"type":23},43,[88],"In this phase 2 study, researchers aimed to evaluate the efficacy and safety of low-dose gemcitabine and cisplatin chemotherapy and the immune checkpoint inhibitor PD-1\u002FPD-L1 antibody in patients with advanced and unresectable intrahepatic cholangiocarcinoma.",[463,464,465],"Intrahepatic Cholangiocarcinoma","Chemotherapy Effect","Immunotherapy","2024-08-20",{"date":468,"type":43},"2024-08-22",{"date":470,"type":23},"2024-09-01",{"date":472,"type":23},"2028-12-31",{"name":49,"class":50},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":4,"eligibilityCriteria":480,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":481,"targetDuration":4,"studyType":64,"phases":482,"briefSummary":483,"conditions":484,"keywords":486,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":4},"100555286","phase-4-a-randomized-clinical-trial-of-intravenous-methylprednisolone-with-2-protocols-in-patients-with-graves-orbitopathy-100555286","NCT06510114","A Randomized Clinical Trial of Intravenous Methylprednisolone With 2 Protocols in Patients With Graves Orbitopathy","Comparison of Two Intravenous Methylprednisolone Protocols in Patients With Graves Orbitopathy: a Randomized Clinical Trial","Inclusion Criteria:\n\n1. Age 18-65 years old;\n2. diagnosed as thyroid associated ophthalmopathy by using Bartley criteria，Moderate to severe (EUGOGO grade), with CAS≥3 points;\n3. Thyroid function normally lasts for more than 2 months, with oral antithyroid drugs or thyroid surgery, or six months after iodine-131 treatment;\n4. without receiving immunosuppressive therapy for thyroid eye disease before.\n\nExclusion Criteria:\n\n(1) severe cardiac, liver and renal insufficiency (2) acute or chronic viral hepatitis or tuberculosis (3) optic neuropathy (4) received immunosuppressive and glucocorticoid therapy for any reason within the past 3 months",{"count":421,"type":23},[253],"Intravenous glucocorticoid (IVGC) is an accessible and effective therapy for Graves orbitopathy (GO); the 4.5-g weekly protocol is well studied, but many details of treatment protocols need to be clarified. The goal of this trial is to compare the efficacy and safety of weekly and daily protocol of IVGC in GO. Researchers will compare daily protocol to weekly protocol to see if daily protocol works to treat GO.",[485],"Graves Ophthalmopathy",[487,485,488],"Hyperthyroidism","glucocorticoid","2024-07-15",{"date":491,"type":43},"2024-07-19",{"date":493,"type":23},"2024-07",{"date":495,"type":23},"2026-12",{"name":49,"class":50},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":59,"minAge":504,"maxAge":199,"enrollmentInfo":505,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":51},"100522331","open-source-artificial-pancreas-system-use-among-people-with-type-1-diabetes-mellitus-in-china-100522331","NCT06081231","Open-Source Artificial Pancreas System Use Among People With Type 1 Diabetes Mellitus in China","The Safety and Efficacy of Open-Source Artificial Pancreas System Among People With Type 1 Diabetes Mellitus in China","Inclusion Criteria:\n\n1. diagnosed T1DM.\n2. Currently use open-source APS for at least 3 months.\n3. Willing and able to provide informed consent (or be a parent or other legally authorized representative) and to provide the data.\n4. reside in China.\n\nExclusion Criteria:\n\nNone","3 Years",{"count":506,"type":23},500,"This real-world observational study aims to reveal the current status of the open-source artificial pancreas system (APS) use among people with T1DM in China and assess the glycemic efficacy and potential related factors of the open-source APS.",[509],"Type 1 Diabetes Mellitus",[511,512,513,514,515],"artificial pancreas system","automated insulin delivery","do-it-yourself","closed loop","open source","2024-06-20",{"date":518,"type":43},"2024-06-24",{"date":520,"type":43},"2019-01-01",{"date":522,"type":23},"2026-06-01",{"name":49,"class":50},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":59,"minAge":532,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":64,"phases":535,"briefSummary":536,"conditions":537,"keywords":539,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100526451","prevention-of-osteoporotic-fracture-2-pilot-study-100526451","NCT06134908","PRevention of OsTEoporotiC FracTure 2 Pilot Study","The Application of \"Precise Education + Shared Decision-Making\" Program for the Secondary Prevention of Fragility Fractures Based on Behavioral Theories: A Pilot Cluster Randomized Controlled Trial","PROTECT-2","Inclusion Criteria:\n\n1. Local residents (live in the city where the hospital is located for half a year or more);\n2. Hospitalized patients with fractures aged 50 years and above;\n3. First fracture, without history of fracture;\n4. Never diagnosed as \"osteoporosis\" before admission;\n5. No fracture history, and never receive any bone mineral density test, and never take anti-osteoporosis medication in the 4 years before admission;\n6. Hospitalized patients with the following fractures: hip fracture, thoracic spine fracture, and lumbar spine fracture;\n7. New fragility fracture: fracture that occurs after minor trauma or daily activities, such as a fracture caused by a fall from standing height or less; fracture happened within 6 weeks;\n8. Not living in a nursing or rehabilitation institution before fracture;\n9. Possess reading ability, and can read and understand informed consent forms or medical materials independently.\n\nExclusion Criteria:\n\n1. Patients with pathological fractures caused by tumor or infection;\n2. Patients with cognitive dysfunction or mental disorder;\n3. AIDS patients;\n4. Patients who refuse to follow-up, or have poor compliance for follow-up, or fail to understand and cooperate for follow-up;\n5. Hearing or visual impairment, and unable to communicate or read materials;\n6. Patients who have participate in other studies;\n7. Other conditions that the investigator considered inappropriate to enroll.","50 Years",{"count":534,"type":23},50,[66],"With the aging of the world population, osteoporosis and fragility fractures have become global public health concerns. It has been estimated the population of people ≥60 years of age will increase from 229 million (16.2%) in 2017 to 479 million (35.1%) by 2050 in China. Because age is an important predictor of osteoporosis and fragility fracture, the incidence of fragility fracture has increased dramatically in China over the past decades. Timely treatment of osteoporosis is an effective way to decrease additional fracture risk among patients with fragility fractures, but anti-osteoporosis treatment rate is relatively low in China. Effective fracture prevention intervention is urgently needed in China.\n\nAs a potential way to achieve effective risk communication, shared decision-making allows patients to be active participants in the management of osteoporosis. The investigators designed a multifaceted intervention, which was named as \"Precise Education + Shared Decision-Making\" program for the secondary prevention of fragility fractures based on behavioral theories, and assessed the effectiveness for fracture prevention using a pilot cluster randomized controlled trial among several hospitals in China.\n\nThe aim of this pilot study is to test the acceptability and feasibility as well as preliminary efficacy of this program in patients with fragility fractures.",[538],"Fragility Fracture",[540,538,541,542],"Osteoporosis","Shared Decision-Making","Education","2024-05-23",{"date":545,"type":43},"2024-05-28",{"date":547,"type":43},"2024-01-13",{"date":549,"type":23},"2027-06",{"name":49,"class":50},7,{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":276,"enrollmentInfo":560,"targetDuration":4,"studyType":64,"phases":561,"briefSummary":562,"conditions":563,"keywords":565,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":567,"lastUpdatePostDateStruct":568,"startDateStruct":570,"completionDateStruct":572,"leadSponsor":574,"locationsCount":51},"100380282","nucleoside-acid-analogues-treatment-in-patients-with-normal-alt-and-positive-hbvdna-100380282","NCT04231565","Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.","Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial","ALTHBV","Inclusion Criteria:\n\n* Positive hepatitis b surface antigen and hepatitis b antibody \\> 0.5 year;\n* Age from 18 to 65 years old;\n* Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;\n* Positive Hepatitis b virus(HBV);\n* Do not receive nucleotide\u002Fnucleoside analogues or interferon treatment in the past half year.\n\nExclusion Criteria:\n\n* Other active liver diseases;\n* Hepatocellular carcinoma or other malignancy;\n* Pregnancy or lactation;\n* Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.",{"count":379,"type":23},[66],"This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.",[564],"Hepatitis B Virus",[566,427,426],"hepatitis B virus","2024-02-28",{"date":569,"type":43},"2024-03-01",{"date":571,"type":43},"2020-06-04",{"date":573,"type":23},"2027-07-01",{"name":49,"class":50},{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":4,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":59,"minAge":582,"maxAge":583,"enrollmentInfo":584,"targetDuration":4,"studyType":64,"phases":586,"briefSummary":587,"conditions":588,"keywords":4,"overallStatus":94,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":4},"100531881","the-therapeutic-effect-of-different-exercise-intensities-on-weight-loss-in-obese-children-100531881","NCT06205563","The Therapeutic Effect of Different Exercise Intensities on Weight Loss in Obese Children","The Effects of Short-term Supervised High-intensity Interval Training and Moderate Intensity Continuous Training on Weight Loss and Metabolic Indicators in Obese Children Under Energy Limited Balanced Diet","Inclusion Criteria:\n\n1. The guardian understands and signs the informed consent. If the subject is at least 8 years old, the informed consent must be signed.\n2. Age 6\\~16 years old, male and female;\n3. BMI≥ \\"sex-age BMI reference point for obesity screening of school-age children aged 6-18 years\\";\n4. no disability;\n5. Joint cardiopulmonary function assessment showed that participation was safe;\n6. At least one year of follow-up is expected.\n\nExclusion Criteria:\n\n1. Have high blood pressure (defined as systolic or diastolic blood pressure values above the 95th percentile), any history or evidence of heart disease and\u002For abnormal resting or stress echocardiography or a combined cardiopulmonary function assessment indicating that participation is not safe;\n2. have any chronic disease, such as chronic asthma, kidney disease, type 1 diabetes, epilepsy, etc.;\n3. suffering from organic diseases, such as ovarian tumors, hamartoma, etc.;\n4. A smoking habit or orthopedic\u002Fneurological condition that may limit exercise ability;\n5. Confirmed attention deficit hyperactivity disorder and steroid use.","6 Years","16 Years",{"count":585,"type":23},388,[66],"The incidence of childhood obesity is increasing, followed by metabolic diseases related to overweight and obesity in children. High intensity interval training (HIIT) has recently been shown to improve the body composition and cardiovascular health of obese children. Currently, there is little evidence on the impact of exercise intensity on endocrine and metabolic indicators and quality of life in obese children.\n\nThe main purpose of this study is to compare the effects of short-term supervised high-intensity interval training and moderate intensity continuous training (MICT) on metabolic indicators in obese children under an energy limited balanced diet. A multicenter prospective randomized controlled trial was conducted on 388 obese children in South China. The experimental group will be randomly assigned to (1) HIIT and energy limited balanced diet, and (2) MICT and energy limited balanced diet. The experimental group will participate in a 3-month (supervised) exercise training. The measurement of the study endpoint will be followed up at baseline, 3 months (after supervised intervention), 9 months, and 1 year. The primary endpoint is the percentage of weight loss (△ Wt%). Secondary endpoints include waist to height ratio, body mass index (BMI), body fat percentage, insulin resistance index (HOMA-IR), insulin secretion index (ISI), and Δ HtSDSBA. The results of this study will generate a wealth of information on the impact of exercise intensity on weight loss and endocrine metabolism in obese children, and develop more effective evidence-based exercise prescription guidelines in this population.",[589,590],"Weight Loss","Obese Children and Adolescents","2024-01-03",{"date":593,"type":43},"2024-01-16",{"date":595,"type":23},"2024-05-01",{"date":190,"type":23},{"name":49,"class":50},{"id":599,"slug":600,"hasResults":12,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":4,"eligibilityCriteria":604,"healthyVolunteers":12,"sex":59,"minAge":60,"maxAge":4,"enrollmentInfo":605,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":607,"conditions":608,"keywords":611,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":615,"lastUpdatePostDateStruct":616,"startDateStruct":618,"completionDateStruct":620,"leadSponsor":622,"locationsCount":51},"100515465","multifaceted-comparison-of-ultrasound-guided-ablation-and-laparoscopic-adrenalectomy-for-aldosterone-producing-adenoma-100515465","NCT05991856","Multifaceted Comparison of Ultrasound-guided Ablation and Laparoscopic Adrenalectomy for Aldosterone-producing Adenoma","Resident Doctor, Master Degree Candidate","Inclusion Criteria:\n\n1. APA was confirmed with unilateral lesions;\n2. Benign tumor without adrenal metastasis and endovascular tumor embolus;\n3. Receive ultrasound-guided adrenal RFA treatment or laparoscopic resection, and sign the informed consent for surgery;\n4. Age ≥ 18;\n5. Age ≥ 40 years old should meet the following criteria: blood potassium ≤3.5mmol\u002FL; PAC≥20ng\u002FdL; PRC≤5μIU\u002FmL; A unilateral adrenal nodule of 10mm or more was completely normal on the opposite side.\n\nExclusion Criteria:\n\n1. Bilateral adrenal diseases;\n2. Multiple adrenal tumors;\n3. Other adrenal diseases, such as adrenal hyperplasia, Cushing's syndrome, pheochromocytoma, etc.;\n4. Imaging suggests that the tumor may be difficult to reach;\n5. Imaging showed potential malignant adrenal tumor;\n6. Pregnant and\u002For planning a pregnancy;\n7. Refusing to participate in follow-up visits.",{"count":606,"type":23},45,"The purpose of this study is to retrospectively and prospectively analyze the efficacy and safety of ultrasound-guided radiofrequency ablation and laparoscopic adrenalectomy in the treatment of aldosterone-producing adenoma (APA). It is planned to retrospectively collect 30 patients with adrenal radiofrequency ablation for APA and 15 patients with age - and sex-matched laparoscopic adrenalectomy for APA in our hospital from January 2020 to June 2024, and continue to follow up for 3 years.",[609,610],"Aldosterone-producing Adenoma","Radiofrequency Ablation",[612,613,614],"aldosterone-producing adenoma","radiofrequency ablation","laparoscopic adrenalectomy","2023-08-13",{"date":617,"type":43},"2023-08-15",{"date":619,"type":43},"2020-01-01",{"date":621,"type":23},"2030-12-01",{"name":49,"class":50},""]