[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanghai Changzheng Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":606},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,52,0,25,[9,48,73,99,129,148,172,195,216,238,260,280,303,330,356,377,401,420,439,474,495,517,542,563,587],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100633412","early-phase-1-mts109-in-patients-with-refractory-autoimmune-diseases-100633412",false,"NCT07526350","MTS109 in Patients With Refractory Autoimmune Diseases","A Study on the Safety, Tolerability and Efficacy of MTS109 Injection in the Treatment of Moderate to Severe Refractory Autoimmune Diseases, an Investigator-Initiated Trial","Inclusion Criteria:\n\n1\\) The subject or his\u002Fher legal representative has voluntarily signed a written informed consent form and is willing and able to comply with study procedures. 2) Aged 18 to 65 years (inclusive) at the time of signing the informed consent form, with no gender restriction.\n\n3\\) Subjects with SLE must meet the following criteria: a) Meet the 2019 EULAR\u002FACR classification criteria for systemic lupus erythematosus (SLE); b) SLEDAI-2K score ≥6, with at least 1 BILAG-2004 organ domain score of Grade A (severe manifestation) or 2 Grade B (moderate manifestation), or both; or SLEDAI-2000 score ≥8; c) Meet the definition of refractory and relapsing disease: inadequate response to conventional therapy for more than 6 months, or disease flare after remission. Conventional therapy is defined as: glucocorticoids plus at least 2 of the following immunomodulatory agents: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab, and telitacicept.\n\n4\\) Subjects with idiopathic inflammatory myopathy (IIM) must meet the following criteria: a) Meet the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies (including dermatomyositis \\[DM\\], polymyositis \\[PM\\], anti-synthetase syndrome \\[ASS\\], and necrotizing myopathy \\[NM\\]); b) Positive for myositis-specific antibodies; c) Moderate-to-severe IIM during screening, defined as: MMT-8 ≥142 with active interstitial lung disease (ILD) (ground-glass opacity on HRCT); OR MMT-8 \\\u003C142 and at least 2 of the following: Physician's Global Assessment (PGA, VAS) ≥2 cm (10-cm VAS scale); Patient's Global Assessment (PtGA, VAS) ≥2 cm (10-cm VAS scale); Health Assessment Questionnaire Disability Index (HAQ-DI) \\>0.25; One or more muscle enzymes (CK, LDH, AST, ALT) ≥1.5 × upper limit of normal (ULN); d) Meet the definition of refractory, relapsing, or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: worsening myositis or rapidly progressive interstitial lung disease.\n\n5\\) Subjects with systemic sclerosis (SSc) must meet the following criteria: a) Meet the 2013 ACR classification criteria for systemic sclerosis; b) Positive for SSc-related specific antibodies; c) Meet the definition of refractory or progressive disease: Refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE; Progressive: rapid skin progression (increase in mRSS \\>25%); or progressive lung disease (decrease in FVC ≥10%, or decrease in FVC \\>5% with decrease in DLCO ≥15%).\n\n6\\) Subjects with ANCA-associated vasculitis (AAV) must meet the following criteria: a) Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis; b) Positive for ANCA-associated antibodies (MPO-ANCA or PR3-ANCA); c) Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63), indicating active vasculitis; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n7\\) Subjects with Sjögren's syndrome (SS) must meet the following criteria: a) Meet the 2002 AECG criteria for primary Sjögren's syndrome or the 2016 ACR\u002FEULAR classification criteria; b) Disease activity ESSDAI ≥6; c) Positive for anti-SSA\u002FRo antibody; d) Meet the definition of refractory: inadequate response to conventional therapy for more than 6 months, or disease flare after remission; conventional therapy as defined for SLE.\n\n8\\) Screening laboratory results meet the following criteria (excluding abnormalities related to the study disease): a) Neutrophil count ≥1.5 ×10⁹\u002FL; b) Hemoglobin ≥80 g\u002FL; platelet count ≥50 ×10⁹\u002FL; c) Alanine aminotransferase (ALT) ≤3 × ULN; aspartate aminotransferase (AST) ≤3 × ULN (unless elevation is judged by the investigator to be related to PM or DM); total bilirubin (TBIL) \\\u003C2 × ULN (for subjects with Gilbert syndrome, direct bilirubin \\[DBIL\\] ≤1.5 × ULN); d) Creatinine clearance ≥30 mL\u002Fmin; e) Activated partial thromboplastin time (APTT) ≤1.5 × ULN; prothrombin time (PT) ≤1.5 × ULN; f) Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%, with no clinically significant electrocardiogram (ECG) abnormalities; g) Baseline oxygen saturation \\>92% while breathing room air.\n\n9\\) Female subjects of childbearing potential: negative serum β-human chorionic gonadotropin (β-hCG) pregnancy test at screening.\n\n10\\) Male subjects with female partners and female subjects of childbearing potential agree to use effective contraceptive methods (e.g., oral contraceptives, intrauterine device, condom) from screening until at least 1 year after the last dose of MTS109.\n\nExclusion Criteria:\n\n1. SLE subjects: a) Drug-induced SLE; b) Subjects with lupus crisis, or who require medications prohibited by the protocol due to comorbidities, or who are considered ineligible by the investigator.\n2. IIM subjects: a) Subjects with documented inclusion body myositis (IBM), drug-induced PM or DM, malignancy-associated PM or DM, or non-inflammatory myopathy (e.g., muscular dystrophy); b) Uncontrolled extramuscular involvement related to PM or DM: ILD: FVC \\\u003C55% or requiring oxygen therapy (FVC ≥55% to be evaluated for eligibility by the lead investigator); Severe dysphagia that, in the investigator's judgment, would increase subject risk by participating in the clinical trial; Severe cardiac manifestations (e.g., congestive heart failure, arrhythmia, treatable conduction abnormality, or myocardial infarction) that, in the investigator's judgment, would increase subject risk by participating in the clinical trial.\n3. SSc subjects: a) Uncontrolled severe pulmonary arterial hypertension (PAH) related to SSc; b) Rapidly progressive lower gastrointestinal tract (small and large intestine) involvement related to SSc requiring parenteral nutrition; active gastric antral vascular ectasia; c) Uncontrolled or rapidly progressive ILD with oxygen saturation (SaO2) \\\u003C92% on room air; or requiring mechanical ventilatory support within 1 year prior to signing informed consent.\n4. AAV subjects: a) Crescentic glomerulonephritis, acute polyneuritis, or central nervous system (CNS) involvement other than AAV at screening; b) Life-threatening severe vasculitis (including diffuse alveolar hemorrhage, respiratory failure, intestinal perforation or massive bleeding, cerebral vasculitis, cardiac vasculitis, etc.); c) Secondary vasculitis (e.g., SLE, Henoch-Schönlein purpura, drug-induced, malignancy-associated, infection-induced, primary immunodeficiency, etc.).\n5. SS subjects: a) Poorly controlled severe systemic primary Sjögren's syndrome (pSS) manifestations at baseline that, in the investigator's assessment, may place the subject at excessive risk; b) Secondary Sjögren's syndrome with other confirmed autoimmune diseases (e.g., rheumatoid arthritis, SLE, scleroderma, inflammatory bowel disease); c) Subjects requiring regular use of medications known to cause dry mouth\u002Fdry eye as common major side effects; d) Subjects with other diseases that may interfere with efficacy assessment of primary Sjögren's syndrome, such as inflammatory bowel disease, gout, sarcoidosis, amyloidosis, IgG4-related disease, etc. All subjects:\n6. Subjects with a history of severe hypersensitivity or anaphylaxis;\n7. Subjects with contraindications or hypersensitivity to any component of the investigational product;\n8. Subjects with any of the following cardiac diseases: a) New York Heart Association (NYHA) Class III or IV congestive heart failure; b) Myocardial infarction or coronary artery bypass grafting within 6 months prior to screening; c) Clinically significant ventricular arrhythmia at screening, history of unexplained syncope not due to vasovagal reaction or dehydration, corrected QT interval (QTc) \\>480 ms, or history of severe non-ischemic cardiomyopathy;\n9. Subjects with any active malignancy or history of malignancy within 5 years prior to screening, excluding: early-stage tumors treated with curative intent (carcinoma in situ or Stage I tumor, non-ulcerated primary melanoma \\\u003C1 mm depth without lymph node involvement), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, or breast carcinoma in situ treated with potentially curative therapy;\n10. Subjects with any other known autoimmune disease other than the study disease;\n11. Subjects requiring long-term use of anticoagulants affecting coagulation function;\n12. Subjects with clinically significant bleeding symptoms or obvious bleeding tendency within 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.; hereditary or acquired bleeding and thrombotic tendency (e.g., hemophilia, coagulopathy, hypersplenism, etc.); subjects with arterial or venous thrombotic events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis and\u002For pulmonary embolism;\n13. Subjects with any severe underlying disease at screening, e.g.: a) Evidence of uncontrolled infection or viral, bacterial, fungal, or other infection treated with systemic intravenous antibiotics; b) Evidence of clinically significant dementia or altered mental status; c) History of any other central nervous system disease or neurodegenerative disease, such as epilepsy, seizure, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, psychosis;\n14. Subjects with positive screening results for any of the following: a) Positive human immunodeficiency virus (HIV) antibody; b) Positive hepatitis B surface antigen (HBsAg); or positive hepatitis B core antibody (HBcAb) with HBV-DNA above the lower limit of detection of the assay; c) Positive hepatitis C virus (HCV) antibody with HCV RNA above the lower limit of detection of the assay; d) Active syphilis (excluding false-positive due to disease);\n15. Subjects with positive plasma cytomegalovirus (CMV) DNA or plasma Epstein-Barr virus (EBV) DNA (viral active);\n16. Subjects with active tuberculosis or untreated latent tuberculosis prior to screening;\n17. Subjects who received other investigational drugs within 4 weeks prior to signing informed consent form (ICF), or for whom the time from the last dose of a previous investigational drug to the date of signing ICF is less than 5 elimination half-lives of that drug (whichever is longer);\n18. Subjects who received plasmapheresis or immunoadsorption therapy within 4 weeks prior to dosing;\n19. Subjects who received B-cell targeted therapy within 6 months prior to dosing, including but not limited to belimumab, telitacicept, etc.;\n20. Subjects who received biologic therapy such as anti-TNF-α antibody within 12 weeks prior to dosing;\n21. Subjects who received tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolic acid, methotrexate, etc., within 2 weeks prior to dosing;\n22. Subjects who received neonatal Fc receptor (FcRn) antagonist therapy (e.g., efgartigimod) within 3 weeks prior to dosing;\n23. Subjects who received complement inhibition therapy (e.g., eculizumab) within 3 weeks prior to dosing;\n24. Subjects who received live attenuated vaccine or mRNA vaccine within 8 weeks prior to enrollment, or inactivated vaccine within 2 weeks prior to enrollment;\n25. Subjects who underwent major surgery within 8 weeks prior to screening or plan to undergo surgery during the study;\n26. Subjects with a history of organ\u002Fbone marrow\u002Fperipheral blood\u002Fumbilical cord blood transplantation;\n27. Subjects who previously received CAR-T product therapy targeting any target;\n28. Subjects with any condition that, in the investigator's judgment, may prevent completion of the entire study, interfere with study results, or make participation in the study not in the subject's best interest.","ALL","18 Years","65 Years",{"count":21,"type":22},15,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","This is the first-in-human trial of MTS109 (mRNA-LNP). The goal of this clinical trial is to evaluate the safety, tolerability of intravenous injection of MTS109 in moderate to severe autoimmune diseases.",[28,29,30,31,32],"Systemic Lupus Erythematosus","Idiopathic Inflammatory Myopathies","Systemic Sclerosis (SSc)","ANCA-Associated Vasculitis (AAV)","Sjogren's Syndrome (SS)",[34],"MTS109","RECRUITING","2026-06-26",{"date":38,"type":39},"2026-06-30","ACTUAL",{"date":41,"type":39},"2026-03-24",{"date":43,"type":22},"2029-04-01",{"name":45,"class":46},"Shanghai Changzheng Hospital","OTHER",1,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":47},"100641381","phase-2-kcd-carfilzomibcyclophosphamidedexamethasone-regimen-for-the-treatment-of-newly-diagnosed-poems-syndrome-100641381","NCT07652879","KCD (Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome","A Single-center, Prospective, Open-label Investigation of the KCD (Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) Regimen for the Treatment of Newly Diagnosed POEMS Syndrome","Inclusion Criteria:\n\n1. Newly diagnosed POEMS syndrome meeting the Dispenzieri diagnostic criteria (2023 version);\n2. Age 18-75 years;\n3. ECOG performance status 0-3, with an estimated life expectancy \\>3 months;\n4. No active infective diseases;\n5. No prior anti-POEMS therapy except for corticosteroids;\n6. No severe organic impairment of major organs, meeting the following laboratory requirements: creatinine clearance ≥40 mL\u002Fmin, total bilirubin ≤1.5 × upper limit of normal (ULN); AST and ALT ≤2.5 × ULN; cardiac enzymes \\\u003C2 × ULN; left ventricular ejection fraction within normal range on echocardiography, and no clinically significant electrocardiogram abnormalities;\n7. Absolute neutrophil count ≥1.5 × 10\\^9\u002FL without prior growth factor support; platelet count ≥50 × 10\\^9\u002FL without platelet transfusion within 7 days prior to screening; hemoglobin ≥60 g\u002FL;\n8. Ability to swallow and take medication orally;\n9. Completion of all screening and assessments as outlined in the study protocol;\n10. Signed informed consent for chemotherapy.\n\nExclusion Criteria:\n\n1. POEMS syndrome complicated by multiple myeloma, light chain amyloidosis, or Waldenström macroglobulinemia;\n2. HIV positivity, or active hepatitis A, hepatitis B, or hepatitis C infection; or hepatitis B virus DNA \\>10\\^2 copies\u002FmL;\n3. Concurrent severe unstable medical conditions, including heart failure, renal failure, liver failure, bleeding disorders, arterial\u002Fvenous thrombotic events within 6 months, uncontrolled diabetes mellitus, or a history of active hemorrhagic cystitis;\n4. History of autoimmune diseases (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) within the past 2 years that caused end-organ damage or required systemic immunosuppressive or disease-modifying therapy;\n5. Severe active infections (e.g., untreated tuberculosis, pulmonary aspergillosis);\n6. Presence of other malignancies (except non-melanoma skin cancer, in situ cervical, bladder, or breast cancer with disease-free survival \\>5 years);\n7. Epilepsy requiring medication, dementia, or other mental status abnormalities that interfere with understanding or complying with the study protocol;\n8. Drug use, medical, psychological, or social conditions that may interfere with study participation or outcome assessment;\n9. Pregnancy or breastfeeding;\n10. Any condition deemed by the investigator to make the patient unsuitable for enrollment.","75 Years",{"count":57,"type":22},20,[59],"PHASE2","This study is a single-center, prospective, open-label clinical study to evaluate the efficacy and safety of KCD(Carfilzomib\u002FCyclophosphamide\u002FDexamethasone) regimen in subjects with newly diagnosed POEMS Syndrome.",[62],"POEMS Syndrome",[64],"POEMS syndrome, Carfilzomib","2026-06-16",{"date":67,"type":39},"2026-06-17",{"date":69,"type":22},"2026-06-15",{"date":71,"type":22},"2028-01",{"name":45,"class":46},{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":82,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":4},"100641601","phase-2-hipec-priming-followed-by-serplulimab-plus-soxxelox-in-locally-advanced-gastric-cancer-100641601","NCT07621484","HIPEC Priming Followed by Serplulimab Plus SOX\u002FXELOX in Locally Advanced Gastric Cancer","A Prospective Exploratory Study of a HIPEC Priming Strategy Followed by Serplulimab Combined With SOX\u002FXELOX as Neoadjuvant Therapy for Locally Advanced Gastric Cancer","Inclusion Criteria:\n\n* Aged 18 to 75 years (inclusive); gender unrestricted.\n* Histologically confirmed gastric or gastroesophageal junction adenocarcinoma via endoscopic biopsy.\n* Clinical stage cT3-4a (imaging evidence of tumor invasion into or penetration through the serosa), any N (lymph node positive), M0 (no distant organ metastasis), based on the 8th Edition of the AJCC Staging Manual.\n* HER2-negative disease, defined as HER2 IHC 0 or 1+, or IHC 2+ with negative ISH.\n* Diagnostic laparoscopy confirms the absence of macroscopic peritoneal metastasis (P0) and negative peritoneal lavage cytology (CY0).\n* Adequate cardiac function, rendering the patient eligible for curative-intent resection. If clinically indicated, patients with underlying ischemic heart disease, valvular heart disease, or other severe cardiac conditions must undergo a preoperative cardiac evaluation by a cardiologist.\n* ECOG Performance Status (PS) score of 0 or 1 within 7 days prior to enrollment.\n* Anticipated survival time of ≥ 6 months.\n* Hepatitis B surface antigen (HBsAg) negative (-) and Hepatitis B core antibody (HBcAb) negative (-). If HBsAg is positive (+) or HBcAb is positive (+), the Hepatitis B virus DNA (HBV-DNA) level must be \\\u003C 1000 copies\u002FmL, \\\u003C 200 IU\u002FmL, or below the upper limit of normal (ULN) at the study center to be eligible for enrollment.\n* HCV antibody negative (-).\n* Major organ function is normal, defined as meeting the following criteria (having not received transfusions of blood products, albumin, recombinant human thrombopoietin, or colony-stimulating factors \\[CSF\\] within 14 days prior to randomization):\n\nHematologic System Absolute Neutrophil Count (ANC) ≥ 1.5×10⁹\u002FL Platelets (PLT) ≥ 100×10⁹\u002FL Hemoglobin (Hb) ≥ 90 g\u002FL Liver Function Total Bilirubin (TBIL) ≤ 1.5×Upper Limit of Normal (ULN) Alanine Aminotransferase (ALT) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Aspartate Aminotransferase (AST) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver metastases Alkaline Phosphatase (ALP) ≤ 2.5×ULN; ≤ 5.0×ULN for patients with liver and\u002For bone metastases Albumin ≥ 25 g\u002FL Renal Function Creatinine Clearance (CrCl) ≥ 50 mL\u002Fmin (calculated using the Cockcroft-Gault formula) Coagulation Function Activated Partial Thromboplastin Time (APTT) ≤ 1.5×ULN Prothrombin Time (PT) ≤ 1.5×ULN International Normalized Ratio (INR) ≤ 1.5×ULN -Female patients must meet the following criteria:\n\nBe in a postmenopausal state (defined as having had no menstruation for at least 1 year, with no other confirmed cause for amenorrhea other than menopause), or have undergone surgical sterilization (removal of ovaries and\u002For uterus); alternatively, patients with reproductive potential must simultaneously meet the following requirements:\n\n* A serum pregnancy test result must be negative within 7 days prior to randomization;\n* Agree to use a contraceptive method with an annual failure rate of \\\u003C 1% or practice abstinence (avoidance of heterosexual intercourse) (from the time of signing the informed consent form until at least 120 days after the last dose of the investigational drug, and at least 6 \\[months\\] after the last dose of the chemotherapy drug ...months (contraceptive methods with an annual failure rate of \\\u003C 1% include bilateral tubal ligation, vasectomy, correct use of ovulation-suppressing hormonal contraceptives, hormone-releasing intrauterine devices \\[IUDs\\], and copper-containing IUDs);\n* Must not be breastfeeding. -Male patients must meet the following criteria: Agree to practice abstinence (avoid heterosexual intercourse) or use contraception, as specified below: If the partner is a female of childbearing potential or is pregnant, the male patient must practice abstinence or correctly use condoms for contraception-to prevent drug exposure to the embryo-during the chemotherapy treatment period and for at least 6 months after the last dose of chemotherapy medication, and for at least 120 days after the last dose of the investigational drug. The reliability of sexual abstinence should be evaluated with reference to the duration of the clinical study, patient preference, and lifestyle. Periodic abstinence (e.g., calendar-based, ovulation-based, basal body temperature, or post-ovulation methods) and withdrawal (coitus interruptus) are not considered acceptable methods of contraception.\n\nExclusion Criteria:\n\n* History of other active malignancies within the past 5 years, or the presence of other active malignancies at the time of enrollment. Patients with cured 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, carcinoma in situ of the cervix, or carcinoma in situ of the breast-are eligible for enrollment.\n* Presence of documented distant metastases (e.g., liver, lung, or bone metastases) or laparoscopically confirmed peritoneal seeding (P1).\n* Patients scheduled to undergo, or with a history of having undergone, organ or bone marrow transplantation.\n* Occurrence of myocardial infarction or poorly controlled arrhythmias (including a QTc interval ≥ 450 ms for males or ≥ 470 ms for females; QTc interval calculated using the Fridericia formula) within 6 months prior to enrollment.\n* Presence of NYHA Class III or IV heart failure, or a cardiac ultrasound result showing a Left Ventricular Ejection Fraction (LVEF) \\\u003C 50%.\n* Human Immunodeficiency Virus (HIV) infection.\n* Presence of active pulmonary tuberculosis.\n* History of, or current presence of, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe impairment of pulmonary function that could interfere with the detection or management of suspected drug-related pulmonary toxicity.\n* Presence of a known active or suspected autoimmune disease. Exceptions are made for patients whose disease is in a stable state at the time of enrollment (defined as requiring no systemic immunosuppressive therapy).\n* Receipt of a live vaccine within 28 days prior to enrollment; inactivated viral vaccines for seasonal influenza are permitted.\n* Patients requiring systemic corticosteroid therapy (at a prednisone-equivalent dose \\> 10 mg\u002Fday) or other immunosuppressive medications within 14 days prior to enrollment or during the study period. However, the following exceptions are permitted: in the absence of active autoimmune disease, patients may use topical or inhaled corticosteroids, or receive adrenal replacement therapy at a prednisone-equivalent dose ≤ 10 mg\u002Fday.\n* Presence of any active infection requiring systemic anti-infective treatment within 14 days prior to enrollment; prophylactic antibiotic treatment (e.g., for the prevention of urinary tract infections or chronic obstructive pulmonary disease) is an exception.\n* Prior receipt of any anti-tumor therapy for the current gastric cancer, including chemotherapy, radiotherapy, targeted therapy, or immunotherapy.\n* Currently receiving treatment in another clinical study, or the planned start date of the treatment in this study is less than 14 days after the completion of treatment in a previous clinical study.\n* Known history of severe allergy to any monoclonal antibody or excipients of the investigational drug.\n* Known history of substance abuse (including drug abuse); patients who have ceased alcohol consumption are eligible for enrollment.\n* Presence of any condition that may increase the risks associated with study participation or the investigational drug, or presence of other severe, acute, or chronic diseases that, in the investigator's judgment, render the patient unsuitable for participation in the clinical study.",{"count":81,"type":22},48,[59],"Patients with locally advanced gastric cancer (LAGC), particularly those with serosal invasion, remain at high risk of peritoneal recurrence despite standard perioperative treatment. Hyperthermic intraperitoneal chemotherapy (HIPEC) may eradicate free intraperitoneal tumor cells and microscopic peritoneal disease while potentially enhancing systemic anti-tumor immune activation.\n\nThis is a prospective, single-center, single-arm exploratory study evaluating a HIPEC priming strategy followed by serplulimab-based neoadjuvant therapy in patients with locally advanced gastric cancer (cT3-4aN+M0). Eligible patients will undergo diagnostic laparoscopy confirming no visible peritoneal metastasis (P0) and negative peritoneal cytology (CY0), followed by docetaxel-based HIPEC.\n\nAfter recovery from HIPEC, patients will initially receive one cycle of serplulimab combined with fluoropyrimidine monotherapy (S-1 or capecitabine), followed by subsequent cycles of serplulimab combined with SOX\u002FXELOX chemotherapy prior to radical gastrectomy.\n\nThe primary endpoints are pathological complete response (pCR) rate and major pathological response (MPR) rate. Secondary endpoints include R0 resection rate, objective response rate (ORR), peritoneal recurrence-free survival (PRFS), overall survival (OS), and safety.",[85,86,87],"Locally Advanced Gastric Cancer","Gastric Adenocarcinoma","Gastroesophageal Junction Adenocarcinoma",[85,89,90,91],"HIPEC","Hyperthermic Intraperitoneal Chemotherapy","Peritoneal Recurrence","NOT_YET_RECRUITING",{"date":67,"type":39},{"date":95,"type":22},"2026-07-01",{"date":97,"type":22},"2028-05-09",{"name":45,"class":46},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":4,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":108,"briefSummary":110,"conditions":111,"keywords":116,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":4},"100633530","the-effect-of-radiotherapy-after-separation-surgery-for-spinal-metastases-100633530","NCT07527884","The Effect of Radiotherapy After Separation Surgery for Spinal Metastases","Postoperative Radiotherapy Versus No Radiotherapy Following Separation Surgery for Spinal Metastases: A Mixed Cohort Study","Inclusion Criteria:\n\n1. Age over 18 years old, gender not limited;\n2. The patient has undergone separation surgery within 3 weeks;\n3. The pathological result of the separation surgery site of the patient indicates that the lesion is a metastatic tumor, and the primary lesion is located outside the spine;\n4. The expected survival period is ≥ 6 months;\n5. The patient has signed the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with poor general condition and those who are intolerant to radiotherapy, chemotherapy, and targeted therapy;\n2. Patients whose treatment segments have not received any other surgical treatment or radiotherapy;\n3. Patients who participated in other clinical trials of drugs or medical devices within 3 months before enrollment;\n4. Other situations judged by the investigator as making the subject unsuitable for enrollment.",{"count":107,"type":22},130,[109],"NA","The aim of this clinical study is to explore the impact of whether radiotherapy is administered after spinal metastasis surgery on the prognosis and survival of patients, to describe the clinical outcomes, and to optimize future clinical decisions.",[112,113,114,115],"Spinal Metastases","Spinal Tumor","Radiotherapy","Separation Surgery",[117,118,119,120],"spinal metastases","spinal tumor","radiotherapy","separation surgery","2026-04-09",{"date":123,"type":39},"2026-04-14",{"date":125,"type":22},"2026-05-01",{"date":127,"type":22},"2028-06-30",{"name":45,"class":46},{"id":130,"slug":131,"hasResults":12,"nctId":132,"briefTitle":133,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":138,"conditions":139,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":146,"leadSponsor":147,"locationsCount":4},"100633518","postoperative-neurological-recovery-and-risk-factor-analysis-in-patients-with-paralysis-due-to-spinal-metastases-100633518","NCT07527728","Postoperative Neurological Recovery and Risk Factor Analysis in Patients With Paralysis Due to Spinal Metastases","Inclusion Criteria:\n\n1. Age between 18 and 80 years at the time of enrollment.\n2. Clinical diagnosis of spinal metastases with resulting motor paralysis.\n3. Scheduled for surgical decompression and\u002For spinal stabilization.\n4. Medically fit to undergo surgery as determined by preoperative evaluation.\n5. Ability to understand the study and provide written informed consent.\n6. Willingness and ability to complete neurological and functional follow-up assessments.\n\nExclusion Criteria:\n\n1. Medically unfit for surgery due to unstable comorbidities or poor general condition.\n2. Pregnant or breastfeeding at the time of enrollment.\n3. Significant cognitive impairment or psychiatric illness that interferes with informed consent or study participation.\n4. Expected difficulty in completing follow-up assessments or anticipated loss to follow-up.\n5. Missing critical baseline or follow-up data relevant to study endpoints.",{"count":136,"type":22},150,"OBSERVATIONAL","Metastatic spinal tumors represent a common and devastating complication in patients with advanced solid malignancies. Up to 40% of cancer patients may develop spinal metastases during the course of their disease, often resulting in intractable pain, neurological deficits, and spinal instability. One of the most serious consequences is motor paralysis caused by metastatic epidural spinal cord compression (MESCC), which can severely impair patients' quality of life and limit their ability to receive subsequent anti-tumor therapy. Although surgical decompression and stabilization are recognized as effective strategies for relieving spinal cord compression and restoring spinal integrity, the neurological prognosis for patients who present with paralysis remains uncertain and heterogeneous.\n\nThis prospective, single-center, observational cohort study aims to evaluate the early and mid-term neurological recovery trajectories in patients with paralysis caused by spinal metastases, and to identify perioperative clinical factors associated with favorable or poor functional outcomes. The study will be conducted at Shanghai Changzheng Hospital, a tertiary care academic center with extensive experience in spinal oncology and multidisciplinary cancer care.\n\nThe investigators plan to consecutively enroll adult patients (aged 18-80) diagnosed with spinal metastatic tumors who present with motor paralysis and are deemed appropriate surgical candidates by a multidisciplinary tumor board. Participants will undergo surgical decompression and stabilization based on individualized tumor location and spinal instability. The study does not involve any investigational drug or device. All surgical procedures and adjuvant treatments (such as radiotherapy or systemic therapy) will be delivered according to standard of care.\n\nPreoperative evaluations will include spinal imaging (MRI, CT), neurological scoring using the ASIA Impairment Scale, and assessments of systemic condition, spinal instability (SINS), and epidural compression severity (ESCC scale). Participants will be followed at 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery to monitor neurological recovery, pain control, bowel\u002Fbladder function, treatment complications, and survival.\n\nThe primary outcome is the improvement in motor function at 1 month postoperatively, quantified by changes in ASIA motor scores. Secondary outcomes include longer-term neurological recovery, progression of bowel and bladder function, quality of life, complication rates, disease progression, and survival outcomes. Additional analyses will explore the impact of variables such as timing of surgery, tumor histology, location of compression, and performance status on recovery.\n\nThis study will employ both univariate and multivariate statistical methods to identify independent predictors of postoperative neurological improvement, using logistic regression and time-to-event analyses. A total of 150 participants will be recruited, based on power analysis accounting for key covariates and anticipated dropout rates.\n\nThrough this prospective clinical registry and analysis, the study aims to provide evidence-based data to guide clinical decision-making in the management of MESCC with paralysis. The findings will help inform surgical indications, optimize timing of intervention, and support the development of prognostic tools for patient counseling. Given the limited life expectancy of many patients with advanced cancer, maximizing early neurological recovery may directly impact patient autonomy, eligibility for systemic therapy, and overall quality of life.",[140,141,142,143],"Metastatic Spinal Tumors","Spinal Cord Compression","Paralysis","Neurological Deficits",{"date":123,"type":39},{"date":125,"type":22},{"date":127,"type":22},{"name":45,"class":46},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":155,"targetDuration":4,"studyType":23,"phases":156,"briefSummary":157,"conditions":158,"keywords":160,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":47},"100588925","hiscs-in-the-treatment-of-rheumatoid-arthritis-100588925","NCT06947746","HiSCs in the Treatment of Rheumatoid Arthritis","A Single-arm Clinical Study Assessing the Safety, Tolerability, and Preliminary Efficacy of a Single Intra-Articular Injection of hiSCs for Rheumatoid Arthritis Treatment","Inclusion Criteria:\n\nSubjects must meet all of the following inclusion criteria\n\n1. Voluntarily sign the informed consent;\n2. Male or female aged 18-65 years (inclusive) at the time of signing the informed consent;\n3. Diagnosis of RA for ≥3 months according to the ACR\u002FEULAR 2010 Rheumatoid Arthritis Classification Criteria at the screening visit;\n4. At the screening visit, presence of recurrent swelling and pain in at least one knee, with a WOMAC pain score ≥4, synovial inflammation confirmed by joint ultrasound, and no significant improvement following 3 months of anti-RA treatment (including prior use of MTX standard therapy, biologics, or small molecule targeted drugs);\n5. Subjects must have received csDMARD therapy for ≥3 months, with a stable dose for ≥4 weeks prior to screening;\n6. Background treatment with stable-dose MTX standard therapy, biologics, or small molecule targeted drugs, either alone or in combination, is permitted;\n7. The following csDMARDs, either alone or in combination, are permitted as background treatment, provided the dose has been stable for ≥4 weeks prior to screening: oral or IV MTX (10-25 mg\u002Fweek; for subjects intolerant to doses ≥10 mg\u002Fweek, the dose should be ≥7.5 mg\u002Fweek), SAS (≤3 g\u002Fday), hydroxychloroquine (≤400 mg\u002Fday), and LEF (≤20 mg\u002Fday);\n8. Stable-dose NSAIDs are permitted, provided the dose has remained stable for ≥2 weeks prior to screening;\n9. All females of childbearing potential must have a negative blood pregnancy test within 7 days prior to treatment initiation and must not be breastfeeding. Females not of childbearing potential may be exempt from the pregnancy test and contraception. All enrolled patients (regardless of gender) must use at least one highly effective method of contraception, including adequate barrier methods, throughout the study duration;\n10. Subjects must be in good overall health, able to ambulate independently (excluding those requiring a wheelchair, walker, or crutches);\n11. Willingness and ability to adhere to scheduled visits, treatment regimens, laboratory tests, and other study-related procedures.\n\nExclusion Criteria:\n\nSubjects who meet any of the following exclusion criteria will be excluded from this study：\n\n1. Presence of other immune-mediated disorders at the baseline visit that may interfere with the administration or efficacy evaluation of the study intervention;\n2. History or current evidence of clinically significant cardiovascular, neuropsychiatric, renal, hepatic, immune, or endocrine disorders (including uncontrolled diabetes or thyroid disease), abnormal laboratory findings, or conditions requiring medications prohibited by the study protocol. \"Clinically significant\" refers to conditions that, in the investigator's judgment, may jeopardize subject safety or impact efficacy or safety analyses if the disease\u002Fcondition exacerbates during the study;\n3. Subjects with positive test results for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or syphilis (refer to laboratory tests for details);\n4. Evidence of active tuberculosis (TB) or a history of active TB without adequate documented treatment;\n5. Any other acute or chronic disorder leading to coagulation dysfunction that, in the investigator's judgment, may compromise patient safety and\u002For interfere with the evaluation of target knee outcomes;\n6. Clinically significant infection within 1 month prior to the screening visit (requiring hospitalization and parenteral administration of antibiotics, antivirals, antifungals, etc., for ≥3 days) or active infection being treated during the screening period;\n7. Infection in the target knee within 3 months before baseline;\n8. Intra-articular corticosteroid or other drug injections in the target knee within 3 months before baseline;\n9. History of knee injury or prior knee surgery in the target knee within 1 year prior to the baseline visit;\n10. Serum transaminase (ALT or AST) levels ≥2 times the upper limit of normal (ULN) during screening;\n11. Creatinine clearance (Ccr) \\\u003C45 mL\u002Fmin (based on the Cockcroft-Gault formula) during screening;\n12. Evidence of hematopoietic dysfunction during screening:\n\n    1. Hemoglobin level \\\u003C9.0 g\u002FdL or hematocrit \\\u003C30%;\n    2. White blood cell count \\\u003C3.0×10⁹\u002FL or absolute neutrophil count (ANC) \\\u003C1.2×10⁹\u002FL;\n    3. Platelet count \\\u003C100×10⁹\u002FL;\n13. Abnormal 12-lead ECG findings at screening or baseline that, in the investigator's judgment, may increase the safety risk of the study intervention or affect the interpretation of study results;\n14. Uncontrolled hypertension with systolic blood pressure ≥160 mmHg and\u002For diastolic blood pressure ≥90 mmHg at screening\u002Fbaseline;\n15. Body mass index (BMI) \\>30 kg\u002Fm² during screening;\n16. Contraindications to MRI, including but not limited to the presence of cardiac pacemakers, stents, artificial heart valves, etc.;\n17. Subjects with a current psychiatric disorder such as anxiety or depression, or a history of such disorders, and who are deemed by the investigator to be unsuitable for participation in the study;\n18. Subjects with a history of malignancy (except for adequately treated or excised non-metastatic basal cell or squamous cell carcinoma of the skin);\n19. Pregnant or breastfeeding women, women planning to become pregnant during the study, and men planning to donate sperm during the study;\n20. Use of high-dose corticosteroids (i.e., intravenous or intramuscular corticosteroids or oral prednisone equivalent \\>10 mg\u002Fday) or unstable doses (regardless of treatment for rheumatoid arthritis or other conditions) within 28 days prior to the baseline visit;\n21. Subjects with a history of hypersensitivity to any component of the study intervention or similar compounds;\n22. Participation in another interventional clinical study within 4 weeks prior to the baseline visit or within 5 half-lives of the last dose of the investigational drug at baseline;\n23. History of alcohol or drug abuse within 6 months prior to the start of study intervention treatment, deemed by the investigator to hinder study participation;\n24. Receipt of any live virus vaccination within 8 weeks prior to the baseline visit;\n25. Subjects classified as legally disabled according to the April 2008 version of the \"Law of the People's Republic of China on the Protection of Persons with Disabilities\";\n26. Subjects with potential health, mental, or social conditions that, in the investigator's judgment, may prevent or hinder compliance with the study protocol;\n27. Peripheral or central nervous system disorders that, in the investigator's judgment, may interfere with the assessment of knee pain and function, such as fibromyalgia, significant low back pain, hip pain, sciatica, lumbar disc herniation, etc.;\n28. Any other condition that is deemed by the investigator to be unsuitable for participation in the study.",{"count":21,"type":22},[109],"This trial is a single-center, single-arm exploratory clinical study aimed at assessing the safety, tolerability, and preliminary efficacy of a single intra-articular injection of hiSCs for the treatment of rheumatoid arthritis.",[159],"Rheumatoid Arthritis (RA)",[161,159,162,163],"Sertoli cells","intra-articular injection","hiSCs","2026-02-25",{"date":166,"type":39},"2026-02-27",{"date":168,"type":39},"2025-05-01",{"date":170,"type":22},"2027-04-01",{"name":45,"class":46},{"id":173,"slug":174,"hasResults":12,"nctId":175,"briefTitle":176,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":178,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":181,"conditions":182,"keywords":185,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":192,"leadSponsor":194,"locationsCount":47},"100620915","a-study-on-the-correlation-between-tear-iron-levels-and-the-severity-of-dry-eye-disease-100620915","NCT07363824","A Study on the Correlation Between Tear Iron Levels and the Severity of Dry Eye Disease.","Inclusion Criteria:\n\n* Aged between 18 and 70 years, inclusive.\n* Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n* History or clinical suspicion of significant systemic conditions: hematologic diseases, severe systemic infections, malignancies (treated or untreated), or chronic hepatic\u002Frenal insufficiency.\n* Use of artificial tears or any topical eye drops within 2 hours prior to examination.\n* Active ocular allergy, infection, or severe blepharitis within the past 1 month.\n* Systemic or topical use of antibiotics, corticosteroids, NSAIDs, or immunosuppressants within the past 1 month.\n* History of contact lens wear within the past 1 month.\n* History of blood transfusion, ocular surgery, or significant ocular trauma within the past 6 months.\n* Women who are pregnant, breastfeeding, or postmenopausal women undergoing hormone replacement therapy.\n* Known hypersensitivity to fluorescein sodium.",true,"70 Years",{"count":5,"type":22},"This study aims to see if the amount of iron in tears is linked to how severe dry eye disease is. We hope this can lead to a new way to help diagnose and understand dry eye. This is an observational study. We will compare tear samples from people with dry eye to samples from people with healthy eyes. We will measure the iron content in the tears and see if it correlates with standard dry eye test results and symptom scores.",[183,184],"Dry Eye Disease","Iron",[186,187],"DED","iron","2026-02-06",{"date":190,"type":39},"2026-02-10",{"date":188,"type":39},{"date":193,"type":22},"2029-05",{"name":45,"class":46},{"id":196,"slug":197,"hasResults":12,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":4,"eligibilityCriteria":201,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":202,"targetDuration":4,"studyType":23,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":47},"100623568","phase-2-anlotinib-combined-with-sintilimab-as-first-line-treatment-for-advanced-non-liver-metastatic-colorectal-cancer-100623568","NCT07398326","Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer","Phase II Study of Anlotinib Combined With Sintilimab as First-line Treatment for Advanced Non-liver Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Patients with histologically or cytologically confirmed advanced colorectal adenocarcinoma.\n* Patients with non-hepatic metastases who explicitly refuse chemotherapy.\n* Patients who have not received prior systemic therapy, or those with metastasis or recurrence occurring ≥12 months after completion of adjuvant therapy.\n* At least one measurable lesion according to RECIST 1.1 criteria.\n* Prior local radiotherapy is permitted if completed at least 3 weeks before the first study drug administration; however, lesions used for RECIST evaluation must be outside the radiation field.\n* Age ≥18 years.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Life expectancy ≥12 weeks.\n* Ability to understand and voluntarily provide written informed consent.\n* For women of childbearing potential, a negative pregnancy test within 7 days prior to treatment initiation. Both patients and their partners must agree to use effective contraception during the study period.\n\nExclusion Criteria:\n\n* Patients who have undergone major surgery or sustained severe trauma within 4 weeks prior to the first dose of the study drug.\n* Patients with a history of hypersensitivity to any component of the study regimen.\n* Patients who are planning to conceive, are pregnant.\n* Patients with brain metastases who are unable to accurately describe their symptoms or condition.\n* Patients with a history of autoimmune diseases or organ transplantation.\n* Use of immunosuppressive medications within 2 weeks prior to the initiation of study treatment (excluding inhaled corticosteroids, or physiological replacement doses of steroids equivalent to ≤10 mg\u002Fday of prednisone).\n* Administration of a live attenuated vaccine within 4 weeks prior to the start of study treatment or planned vaccination during the study period.\n* Prior treatment with anlotinib, anti-PD-1\u002FPD-L1 monoclonal antibodies, or any other therapy targeting T-cell co-stimulation or immune checkpoint pathways.\n* History of any of the following within 6 months before starting study treatment: myocardial infarction, severe\u002Funstable angina, congestive heart failure of New York Heart Association (NYHA) Class 2 or higher, or poorly controlled cardiac arrhythmias.\n* Laboratory test abnormalities meeting any of the following criteria:\n\n  1. Absolute neutrophil count (ANC) \\\u003C1,500\u002Fmm³.\n  2. Platelet count \\\u003C75,000\u002Fmm³.\n  3. Total bilirubin \\>1.5 times the upper limit of normal (ULN).\n  4. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\>2.5 times ULN.\n  5. Serum creatinine \\>1.5 times ULN.\n* Diagnosis of any malignancy other than advanced colorectal cancer within the 5 years preceding the start of study treatment, except for carcinoma in situ of the cervix, cured basal cell carcinoma, or bladder epithelial tumors.\n* Patients with colorectal cancer amenable to curative surgical resection (however, those who explicitly refuse surgery or are deemed unsuitable for surgery may be eligible).\n* History of substance abuse, drug use, or alcohol dependence.\n* Lack of legal capacity or limited civil capacity.\n* Any other condition that, in the opinion of the Investigator, makes the patient unsuitable for study participation.",{"count":203,"type":22},37,[59],"Colorectal cancer (CRC) is the third most common malignant tumor worldwide and the second leading cause of cancer-related deaths. Despite recent progress in CRC research, approximately 15% to 30% of patients have metastatic lesions at the time of initial diagnosis, and another 20% to 50% of patients with primary localized CRC eventually develop metastatic disease. The conventional treatment for first-line metastatic colorectal cancer (mCRC) is chemotherapy based on fluorouracil combined with anti-EGFR\u002FVEGF targeted drugs. However, some mCRC patients may not be able to receive standard dual or triple chemotherapy combined with targeted therapy due to factors such as advanced age, poor physical condition, comorbidities, or personal preferences. Therefore, exploring new, highly effective, and low-toxicity treatment regimens is of significant clinical importance. The combination of immune checkpoint inhibitors and antiangiogenic TKIs is expected to form a strong synergistic antitumor effect, which opens up a new approach for \"chemotherapy-free\" treatment of mCRC when the immune system is functioning normally. Previously, we conducted the APICAL-CRC study, enrolling a total of 30 patients. The clinical objective response rate (ORR) was 48.3%, the disease control rate was 89.7%, and the median progression-free survival (mPFS) and median overall survival (mOS) were 8.6 months and 22.9 months, respectively. Subgroup analysis later revealed that the ORR for non-liver metastasis patients was 70%, with an mPFS of 14.9 months, significantly higher than that of liver metastasis patients (ORR 36.8%). At the same time, patients with better physical performance scores (ECOG PS 0-1) had an ORR of 66.7%, which was superior to that of patients with ECOG PS 2 (21.4%). In terms of safety, the incidence of grade ≥ 3 treatment-related adverse events (TRAEs) for the combination of anlotinib and sintilimab was only 13.3%. Based on the preliminary results of the APICAL-CRC study, we consider further precise screening of the advantageous population among advanced CRC patients for subsequent research. We plan to limit the enrolled patients to those without liver metastasis and with ECOG PS 0-1, providing new strategies and methods for precise treatment of advanced CRC.The purpose of this study is to evaluate the efficacy and safety of anlotinib combined with sintilimab as first-line treatment for non-liver metastatic advanced colorectal cancer. The study will be conducted at Shanghai Changzheng Hospital. The study drugs, anlotinib and sintilimab, are both marketed drugs in China.",[207],"Colorectal Cancer","2026-02-04",{"date":210,"type":39},"2026-02-09",{"date":212,"type":22},"2026-02-24",{"date":214,"type":22},"2028-12-31",{"name":45,"class":46},{"id":217,"slug":218,"hasResults":12,"nctId":219,"briefTitle":220,"officialTitle":220,"acronym":221,"eligibilityCriteria":222,"healthyVolunteers":178,"sex":17,"minAge":18,"maxAge":179,"enrollmentInfo":223,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":225,"conditions":226,"keywords":229,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":234,"completionDateStruct":236,"leadSponsor":237,"locationsCount":47},"100622268","eye-tracking-study-on-eye-movement-function-and-visual-attention-patterns-in-patients-with-thyroid-associated-ophthalmopathy-100622268","NCT07381413","Eye Tracking Study on Eye Movement Function and Visual Attention Patterns in Patients With Thyroid-Associated Ophthalmopathy","TAO-A","Inclusion Criteria:\n\n* Aged between 18 and 70 years, inclusive.\n* Willing and able to provide written informed consent.\n* Best-corrected visual acuity (BCVA) ≥ 1.0 in both eyes, with no history of ocular diseases or thyroid disorders.\n\nExclusion Criteria:\n\n* Non-TAO Ocular Motility Disorders: History of conditions like myasthenia gravis, cranial nerve palsy, or congenital strabismus.\n* Neurological Diseases: Disorders affecting oculomotor control (e.g., Parkinson's, MS, stroke, or brain tumors).\n* Significant Visual Impairment: BCVA \\\u003C 0.5 due to media opacities or retinopathy, preventing clear visualization of stimuli.\n* Prior Ocular Surgery: History of surgeries affecting extraocular muscle mechanics (e.g., strabismus surgery, scleral buckling).\n* Psychiatric or Cognitive Disorders: Inability to follow instructions or conditions affecting eye movements (e.g., schizophrenia).\n* Medication Interference: Use of drugs affecting reaction time (e.g., sedatives) within 48 hours of testing.",{"count":224,"type":22},100,"This study focuses on eye health and visual function in patients with Thyroid-Associated Ophthalmopathy (TAO), a condition that often causes bulging eyes and restricted eye movement. The purpose of this study is to use non-invasive eye-tracking technology to evaluate how the disease affects eye movement function. The investigators hypothesize that compared to healthy individuals, patients with TAO will show measurable differences in eye stability and the ability to track moving objects. Additionally, the investigators believe the disease may alter how patients visually scan faces (e.g., avoiding eye contact). The study will enroll 100 participants, including both patients and healthy volunteers. By recording gaze patterns while participants look at a screen, the investigators aim to objectively quantify the physical and social impact of the disease, providing better data for future treatment plans.",[227,228],"Thyroid Associated Ophthalmopathies","Eye Tracking",[230,231],"TAO","eye tracking","2026-02-03",{"date":188,"type":39},{"date":235,"type":39},"2026-01-31",{"date":193,"type":22},{"name":45,"class":46},{"id":239,"slug":240,"hasResults":12,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":245,"minAge":18,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":23,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":47},"100622866","early-phase-1-safety-and-preliminary-efficacy-evaluation-of-lc-k76-plus-anti-pd-1-therapy-in-patients-with-metastatic-castration-resistant-prostate-cancer-mcrpc-100622866","NCT07389187","Safety and Preliminary Efficacy Evaluation of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","An Open-Label, Single-Arm, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 Plus Anti-PD-1 Therapy in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)","Inclusion Criteria:\n\n1. Male, aged 18 to 85 years.\n2. Histologically confirmed prostate adenocarcinoma, without small cell carcinoma components.\n3. Metastatic Castration-Resistant Prostate Cancer (mCRPC) with disease progression after at least one novel endocrine therapy (e.g., abiraterone or enzalutamide) and\u002For docetaxel chemotherapy.\n4. Evidence of bone metastasis on PSMA-PET-CT or bone scan (ECT).\n5. Serum testosterone at castration levels (\\\u003C 50 ng\u002FdL or 1.75 nmol\u002FL).\n6. ECOG performance status ≤ 2.\n7. Life expectancy \\> 6 months.\n8. Adequate bone marrow, hepatic, and renal function.\n9. Willing to undergo biopsies before and during treatment\n\nExclusion Criteria:\n\n1. Lack of pathological evidence for prostate cancer.\n2. Other primary malignant tumors active or requiring treatment within the past 3 years.\n3. Has visceral metastases.\n4. Poorly controlled diabetes after continuous insulin therapy.\n5. Significant abnormalities in laboratory values at randomization (Hb \\\u003C 90 g\u002FL; Neutrophils \\\u003C 1.5x10\\^9\u002FL; Platelets \\\u003C 75x10\\^9\u002FL; ALT\u002FAST \\> 2.5xULN; Bilirubin \\> 1.5xULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m\\^2) .\n6. Severe cardiopulmonary disease or high-risk conditions.\n7. Prior therapy with any immune checkpoint inhibitors (e.g., anti-PD-1\u002FPD-L1).\n8. Intolerance to anti-PD-1 monoclonal antibody or dandelion extracts.\n9. History of severe drug allergies.\n10. Factors affecting drug intake\u002Fabsorption (e.g., swallowing difficulty, chronic diarrhea).\n11. Concurrent psychiatric or neurological conditions","MALE","85 Years",{"count":248,"type":22},10,[25],"This open-label, single-arm study evaluates the safety and preliminary efficacy of LC-K76 combined with Tislelizumab and ADT in 10 patients with Metastatic Castration-Resistant Prostate Cancer (mCRPC) who progressed on prior therapies. Participants will receive oral LC-K76 and intravenous Tislelizumab for a 24-week treatment period.",[252],"mCRPC",{"date":254,"type":39},"2026-02-05",{"date":256,"type":22},"2026-02",{"date":258,"type":22},"2028-06",{"name":45,"class":46},{"id":261,"slug":262,"hasResults":12,"nctId":263,"briefTitle":264,"officialTitle":265,"acronym":4,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":245,"minAge":18,"maxAge":246,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":270,"conditions":271,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":275,"startDateStruct":276,"completionDateStruct":277,"leadSponsor":279,"locationsCount":47},"100622865","early-phase-1-safety-and-efficacy-evaluation-of-lc-k76-in-patients-with-metastatic-hormone-sensitive-prostate-cancer-100622865","NCT07389174","Safety and Efficacy Evaluation of LC-K76 in Patients With Metastatic Hormone-Sensitive Prostate Cancer","An Open-Label, Exploratory Study to Evaluate the Safety and Preliminary Efficacy of LC-K76 in Combination With Endocrine Therapy in Patients With Metastatic Hormone-Sensitive Prostate Cancer","Inclusion Criteria:\n\n1. Male, aged ≥ 18 years.\n2. Histologically or cytologically confirmed newly diagnosed metastatic hormone-sensitive prostate adenocarcinoma, without small cell carcinoma or small cell components.\n3. Presence of at least one bone metastasis or visceral metastasis (excluding lymph nodes) detected by systemic imaging (CT\u002FMRI).\n4. No prior treatment for prostate cancer before enrollment (including but not limited to radical surgery, radiotherapy, endocrine therapy, or chemotherapy).\n5. No history of allergy to dandelion or dandelion products.\n6. ECOG performance status ≤ 2.\n7. Plan to receive and maintain Androgen Deprivation Therapy (ADT) combined with an androgen receptor antagonist (e.g., enzalutamide, apalutamide, darolutamide), abiraterone acetate, or other drugs inhibiting testosterone synthesis during the study period.\n8. Subjects are able to comply with oral LC-K76 capsule administration and adhere to study requirements throughout the study\n\nExclusion Criteria:\n\n1. Lack of pathological evidence for prostate cancer diagnosis.\n2. Prior receipt of any treatment modality for prostate cancer.\n3. Patients with other primary malignant tumors that were progressive or required active treatment within the past 3 years.\n4. Patients with diabetes requiring continuous insulin therapy or poorly controlled diabetes.\n5. Known or suspected central nervous system metastases or active leptomeningeal disease.\n6. Significant abnormalities in bone marrow, coagulation, renal, and hepatic function, defined as laboratory values at randomization: Hemoglobin \\\u003C 90 g\u002FL, Neutrophils \\\u003C 1.5 × 10$\\^9$\u002FL, Platelets \\\u003C 75 × 10$\\^9$\u002FL, ALT \\> 2.5 × ULN, AST \\> 2.5 × ULN, or Serum Total Bilirubin \\> 1.5 × ULN; eGFR \\\u003C 60 mL\u002Fmin\u002F1.73m$\\^2$.\n7. Any severe disease affecting cardiopulmonary function or high-risk conditions.\n8. History of severe drug allergies.\n9. Presence of factors interfering with swallowing, chronic diarrhea, intestinal obstruction, or other factors affecting drug intake and absorption.\n10. Concurrent psychiatric illness or neurological symptoms judged to make participation difficult.\n11. Any condition that, in the judgment of the investigator, poses a severe safety risk to the patient, may confound study results, or may affect the patient's ability to complete the study (e.g., poorly controlled hypertension, severe diabetes, neurological or psychiatric disorders), or any other relevant conditions.\n12. Concurrent participation in other clinical trials or use of other investigational drugs.\n13. Refusal or inability to sign the informed consent form.",{"count":268,"type":22},40,[25],"This study is a single-centre, randomised, paired 24-week intervention dosing trial. Its purpose is to evaluate the safety profile and efficacy of the investigational drug in subjects with metastatic hormone-sensitive prostate cancer receiving oral LC-K76 treatment.\n\nFollowing a screening period not exceeding three weeks, subjects will enter a one- to two-week matching and randomization phase. Subsequently, subjects will be assigned to receive the study drug for a 24-week treatment period, followed by a 24-week follow-up period.",[272,273,274],"mHSPC","mHNPC","Prostate Cancer Adenocarcinoma",{"date":254,"type":39},{"date":256,"type":22},{"date":278,"type":22},"2027-06",{"name":45,"class":46},{"id":281,"slug":282,"hasResults":12,"nctId":283,"briefTitle":284,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":287,"targetDuration":4,"studyType":23,"phases":289,"briefSummary":290,"conditions":291,"keywords":293,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":47},"100622256","early-phase-1-efficacy-and-safety-of-rifaximin--in-treating-masld-100622256","NCT07381257","Efficacy and Safety of Rifaximin-α in Treating MASLD","Efficacy and Safety of Rifaximin-α in the Treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease: A Randomized, Open-Label, Controlled Pilot Clinical Trial","Inclusion Criteria\n\n1. Willingness to provide written informed consent.\n2. Aged 18 to 75 years, inclusive, regardless of gender.\n3. Diagnosis of hepatic steatosis (fatty liver) within the past 6 months.\n4. Presence of at least one metabolic\u002Fcardiovascular risk factor:\n\n   A. BMI ≥ 23.0 kg\u002Fm², or waist circumference ≥ 90 cm (male) \u002F 80 cm (female). B. Fasting plasma glucose (FPG) ≥ 5.6 mmol\u002FL, or 2-hour postprandial glucose ≥ 7.8 mmol\u002FL, or HbA1c ≥ 5.7%, or documented history of type 2 diabetes mellitus (T2DM) or current use of anti-diabetic medication.\n\n   C. Fasting serum triglycerides (TG) ≥ 1.70 mmol\u002FL, or current use of medication for hypertriglyceridemia.\n\n   D. Serum high-density lipoprotein (HDL) cholesterol ≤ 1.0 mmol\u002FL (male) and ≤ 1.3 mmol\u002FL (female), or current use of lipid-lowering medication.\n\n   E. Blood pressure ≥ 130\u002F85 mmHg, or current use of antihypertensive medication.\n5. Liver fat content ≥ 8% as measured by Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF).\n\nExclusion Criteria\n\n1. Confirmed diagnosis of liver cirrhosis based on clinical, laboratory, imaging, and\u002For liver biopsy findings.\n2. Evidence of other specific etiologies of chronic liver disease confirmed by history or laboratory tests, including but not limited to: viral hepatitis (B or C, etc.), autoimmune liver disease, alcohol-related liver disease (defined as \\>20 g\u002Fday for females or \\>30 g\u002Fday for males), drug-induced liver injury, Wilson's disease, alpha-1 antitrypsin deficiency, or hereditary hemochromatosis.\n3. Other identifiable causes of hepatic steatosis confirmed by history or laboratory tests, such as: specific medications (e.g., tamoxifen, amiodarone, valproate, methotrexate, glucocorticoids, olanzapine), total parenteral nutrition, hypothyroidism, inflammatory bowel disease, Cushing's syndrome, celiac disease, abetalipoproteinemia, lipodystrophic diabetes, Mauriac syndrome, hypopituitarism, hypogonadism, polycystic ovary syndrome, etc.\n4. Use of medications known to alter gut microbiota (e.g., lactulose, systemic antibiotics, any intestinal microecological preparations) within 4 weeks prior to screening.\n5. Dose of hepatoprotective or lipid-lowering medications not stabilized for at least 4 weeks prior to screening.\n6. Received any Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or remeglutide treatment within 12 weeks prior to screening, or plans to receive such treatment during the study.\n7. Dose of medications that may affect MASLD, anti-diabetic agents (excluding GLP-1 RAs and remeglutide), or weight-loss drugs not stabilized for at least 12 weeks prior to screening.\n8. Self-reported weight change \\>5% within 4 weeks prior to screening.\n9. BMI \\> 35 kg\u002Fm².\n10. Poorly controlled glycemia: HbA1c \\> 9%.\n11. Total bilirubin \\> 1.5 mg\u002FdL (except with normal direct bilirubin), or Alanine Aminotransferase (ALT) \\> 5 times the Upper Limit of Normal (ULN), or Aspartate Aminotransferase (AST) \\> 5 times ULN, or Alkaline Phosphatase (ALP) \\> 2 times ULN.\n12. Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m².\n13. History of or planned bariatric\u002Fmetabolic therapy, including but not limited to endoscopic interventions, surgical procedures, or Traditional Chinese Medicine therapies. Exceptions may be made if previous interventions have been reversed or removed (e.g., intragastric balloon, subcutaneous threads) for more than 12 weeks.\n14. History of or current hepatocellular carcinoma (HCC).\n15. Diagnosis of any malignancy within the past 5 years, except for malignancies with low risk of metastasis or death (estimated 5-year overall survival \\>90%), such as effectively treated early-stage gastrointestinal cancer, carcinoma in situ of the cervix, non-melanoma skin cancer, or localized prostate cancer.\n16. Significant comorbid conditions affecting the cardiovascular, respiratory, rheumatological\u002Fimmunological, hematological, biliary, or pancreatic systems; or history of myocardial infarction, stroke, heart failure, unstable angina, or transient ischemic attack within 6 months prior to screening; or presence of psychiatric disorders.\n17. HIV infection.\n18. Known allergy or hypersensitivity to rifaximin.\n19. Contraindications to MRI, such as incompatible metallic implants, claustrophobia, or body size exceeding scanner capacity.\n20. Pregnant or lactating women, women of childbearing potential not using effective contraception, or individuals planning pregnancy.\n21. Participation in another investigational drug trial within 3 months prior to screening.\n22. Any other condition deemed by the investigator to be unsuitable for participation in the study.",{"count":288,"type":22},60,[25],"Study Objective: To evaluate the efficacy and safety of Rifaximin-α in the treatment of Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), and investigate the underlying mechanisms by which Rifaximin-α influences MASLD progression.\n\nTarget Population: Patients diagnosed with MASLD. Intervention: This trial is a multicenter, prospective, randomized, controlled study. Enrolled MASLD patients who meet the inclusion criteria, do not meet any exclusion criteria, and provide written informed consent will be randomized in a 2:1 ratio to the Rifaximin-α treatment group (40 cases) or the control group (20 cases). All patients are advised to maintain daily physical activity and follow a recommended dietary plan (e.g., Mediterranean diet). The Rifaximin-α treatment group will receive oral Rifaximin-α at a dose of 1200 mg per day for 24 weeks. Both groups of patients will enter a 24-week follow-up period after completing the 24-week treatment. During the study, patients' existing foundational treatments (such as liver-protecting, lipid-lowering, glucose-lowering, and antihypertensive therapies) will be maintained. Relevant indicators will be closely monitored. And avoid the use of medications known to alter the gut microbiota, such as lactulose, antibiotics, and various types of intestinal microecological preparations.\n\nInvestigational Drug: Rifaximin-α (Alfa Wassermann S.p.A., Italy).",[292],"Metabolic Dysfunction-Associated Steatotic Liver Disease",[292,294],"Rifaximin","2026-01-23",{"date":297,"type":39},"2026-02-02",{"date":299,"type":22},"2026-01-15",{"date":301,"type":22},"2027-12-31",{"name":45,"class":46},{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":178,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":310,"targetDuration":4,"studyType":23,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":329},"100617120","early-phase-1-a-study-on-the-changes-of-glucose-metabolism-and-exocrine-function-in-patients-with-chronic-pancreatitis-100617120","NCT07314489","A Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis","A Prospective Cohort Study on the Changes of Glucose Metabolism and Exocrine Function in Patients With Chronic Pancreatitis Complicated With Exocrine Dysfunction After Pancreatic Enzyme Intervention","Inclusion Criteria:\n\n* 1\\. Male or female Chinese subjects aged 18 years or older; 2. Patients with a clear diagnosis of chronic pancreatitis; 3. Glycated hemoglobin (HbA1c) levels between 4% and 6%; 4. FE-1 \\\u003C 100 µg\u002Fg.\n\nExclusion Criteria:\n\n* 1\\. A history of diabetes or prediabetes, or preoperative glycated hemoglobin (HbA1c) ≥ 6.0% or fasting venous glucose ≥ 6.1 mmol\u002FL; 2. Positive for islet-related antibodies; 3. Patients who are currently receiving or have previously received pancreatic enzyme replacement therapy (PERT); 4. Allergy to the components of PERT drugs; 5. Exocrine pancreatic insufficiency (EPI) caused by other reasons, such as post-gastrectomy or post-intestinal resection; 6. Undergoing pancreatic surgery other than endoscopic retrograde cholangiopancreatography (ERCP); 7. Renal disease of stage G3, G4, or G5; 8. Decompensated chronic liver disease; 9. Receiving glucocorticoid therapy; 10. Pregnant or breastfeeding women; 11. Patients with malignant tumors.",{"count":311,"type":22},80,[25],"This study aims to investigate the impact of pancreatic exocrine insufficiency on the glucose profile and pancreatic and gastrointestinal endocrine hormones in patients with chronic pancreatitis through pancreatic enzyme intervention in a reverse manner.\n\nThe primary objective is to observe the changes in glucose profile following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.\n\nThe secondary objective is to observe the changes in pancreatic endocrine and exocrine functions and gastrointestinal endocrine hormone levels following pancreatic enzyme intervention in patients with chronic pancreatitis complicated by exocrine insufficiency and normal glucose metabolism.",[315],"Chronic Pancreatitis Pancreatic Exocrine Insufficiency Blood Glucose",[317,318,319,320],"chronic pancreatitis","pancreatitis","exocrine insufficiency","blood glucose","2025-12-17",{"date":323,"type":39},"2026-01-02",{"date":325,"type":39},"2025-04-01",{"date":327,"type":22},"2035-12-31",{"name":45,"class":46},2,{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":178,"sex":245,"minAge":18,"maxAge":336,"enrollmentInfo":337,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":339,"conditions":340,"keywords":344,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":355},"100611313","application-of-quantum-detection-driven-artificial-intelligence-algorithms-for-single-molecule-cfdna-characterization-in-the-early-diagnosis-of-prostate-cancer-100611313","NCT07238959","Application of Quantum Detection-Driven Artificial Intelligence Algorithms for Single-Molecule cfDNA Characterization in the Early Diagnosis of Prostate Cancer","Inclusion Criteria:\n\n1. Male, aged 18-80 years;\n2. PSA \\> 4 ng\u002Fml;\n3. Patients meeting criteria for prostate biopsy:\n\n   * fPSA\u002FPSA \\\u003C 0.16 or PSA D \\> 0.15 or PSA V \\> 0.75; ② Positive digital rectal examination (DRE); ③ Imaging studies (ultrasound\u002FMRI) showing suspicious lesions.\n\nExclusion Criteria:\n\n1. Patients diagnosed with any malignant tumour within the past five years;\n2. Patients who have undergone transurethral resection or enucleation of the prostate;\n3. Patients who have previously received treatment for prostate cancer, including but not limited to endocrine therapy, targeted therapy, or immunotherapy;\n4. Patients on long-term anticoagulant or antiplatelet therapy (anticoagulants discontinued for less than one week);\n5. Patients who have received any form of tumour treatment prior to enrolment blood sampling, including surgery, radiotherapy\u002Fchemotherapy, endocrine therapy, targeted therapy, or immunotherapy;\n6. Concurrent severe systemic diseases deemed by the investigator likely to interfere with trial treatment, evaluation, or compliance, including serious respiratory, circulatory, neurological, psychiatric, gastrointestinal, endocrine, immunological, or urological disorders;\n7. Organ transplant recipients or individuals with prior non-autologous (allogeneic) bone marrow or stem cell transplantation;\n8. Subjects who have undergone blood transfusion within one month prior to blood sampling;\n9. Patients currently participating in other clinical trials, or who have participated in other clinical trials within the past year;\n10. Patients deemed unsuitable for this clinical trial by the investigator;\n11. Patients meeting any of the above criteria shall not be eligible for inclusion as subjects.","80 Years",{"count":338,"type":22},1100,"This research project aims to develop a novel blood testing method integrating cutting-edge quantum sensing and artificial intelligence technologies to achieve precise, non-invasive early diagnosis of prostate cancer. The research will employ quantum sensors to perform ultra-high-sensitivity measurements of circulating free DNA (cfDNA) in blood, thereby training a dedicated AI diagnostic model. The ultimate objective is to establish the diagnostic efficacy of this approach through clinical validation, providing clinicians with a novel diagnostic tool capable of significantly reducing unnecessary prostate biopsy procedures.",[341,342,343],"Benign Prostate Hypertrophy(BPH)","Prostate Cancer (Diagnosis)","Prostate Neoplasm",[345,346],"Early diagnosis","cfDNA","2025-11-15",{"date":349,"type":39},"2025-11-20",{"date":351,"type":22},"2025-12",{"date":353,"type":22},"2027-12",{"name":45,"class":46},7,{"id":357,"slug":358,"hasResults":12,"nctId":359,"briefTitle":360,"officialTitle":361,"acronym":4,"eligibilityCriteria":362,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":363,"targetDuration":4,"studyType":23,"phases":364,"briefSummary":365,"conditions":366,"keywords":368,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":370,"lastUpdatePostDateStruct":371,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":376,"locationsCount":47},"100607236","early-phase-1-efficacy-and-safety-of-rifaximin-in-treating-mafld-100607236","NCT07185932","Efficacy and Safety of Rifaximin in Treating MAFLD","Efficacy and Safety of Rifaximin in Treating Metabolic Associated Fatty Liver Disease: A Pilot Trial","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent;\n2. Aged 18 to 75 years, regardless of gender;\n3. Diagnosed with fatty liver disease within the past 6 months;\n4. Presence of at least one of the following metabolic abnormalities:\n\n(1) Overweight or obesity (BMI ≥23 kg\u002Fm²) (2) Type 2 diabetes (T2DM) (3) Clinical evidence of metabolic dysfunction (defined as meeting at least two of the following criteria): A. Waist circumference ≥90 cm for males or ≥80 cm for females B. Blood pressure ≥130\u002F85 mmHg and\u002For diagnosed hypertension under treatment C. Fasting plasma triglycerides ≥1.7 mmol\u002FL (150 mg\u002FdL) or diagnosed hypertriglyceridemia under treatment D. Fasting HDL-C \\\u003C1.0 mmol\u002FL (40 mg\u002FdL) for males or \\\u003C1.3 mmol\u002FL (50 mg\u002FdL) for females, or diagnosed dyslipidemia under treatment E. Prediabetes: fasting glucose 5.6-6.9 mmol\u002FL (100-125 mg\u002FdL) or 2-hour postprandial glucose 7.8-11.0 mmol\u002FL (140-199 mg\u002FdL) or HbA1c 5.7%-6.4% (39-47 mmol\u002Fmol) F. Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score ≥2.5 G. Plasma high-sensitivity C-reactive protein (hs-CRP) \\>2 mg\u002FL 5. Liver fat content ≥8% as measured by MRI proton density fat fraction (MRI-PDFF).\n\nExclusion Criteria\n\n1. Cirrhosis - Confirmed by clinical, laboratory, imaging, and\u002For liver biopsy.\n2. Chronic liver disease of other etiologies (e.g., viral\u002Fautoimmune hepatitis, alcoholic liver disease, drug-induced liver injury)\n3. Secondary hepatic steatosis (e.g., drug-induced, total parenteral nutrition-related, or hypothyroidism-associated);\n4. Recent use of intestinal flora-modifying agents, or unstable regimens of medications (including hepatoprotectants, metformin, thiazolidinediones, fibrates, statins, et al) within 4 weeks prior to enrollment;\n5. Agents with potential effects on MAFLD progression administered within 12 weeks prior to enrollment, excluding those maintained at stable doses for ≥24 weeks (e.g., Glucagon-like peptide-1 receptor agonists, Dipeptidyl peptidase IV inhibitors, Obeticholic acid, Sodium-glucose cotransporter 2 inhibitors, Resmetirom or anti-obesity medications)\n6. Poorly controlled diabetes (HbA1c \\>9%)\n7. Jaundice (total bilirubin ≥85 μmol\u002FL), or Renal dysfunction (serum creatinine ≥1.2 × ULN)\n8. History of bariatric surgery\n9. Active or suspected malignancy\n10. Severe systemic conditions - Including: Inflammatory diseases (e.g., connective tissue disorders), Biliary\u002Fpancreatic disorders, Chronic\u002Facute infections, Severe cardiovascular, pulmonary, or hematologic diseases, Myocardial infarction or stroke within 6 months, Psychiatric disorders\n11. HIV infection\n12. Known hypersensitivity to rifaximin\n13. MRI contraindications - Including: Metal implants, Claustrophobia, Body size exceeding scanner capacity\n14. Pregnancy, lactation, or planned pregnancy\n15. Participation in another drug trial within 3 months\n16. Other conditions deemed unsuitable by investigators",{"count":268,"type":22},[25],"Study Objective: to evaluate the efficacy and safety of rifaximin in the treatment of metabolic-associated fatty liver disease (MAFLD), and investigate the underlying mechanisms by which rifaximin influence MAFLD progression.\n\nTarget Population: patients diagnosed with MAFLD. Intervention: this single-center, single-arm exploratory study will enroll up to 40 eligible MAFLD patients who meet the inclusion criteria, do not meet any exclusion criteria, and provide written informed consent. Participants will receive oral rifaximin at a dosage of 1200 mg\u002Fday (400 mg, three times daily) for 24 weeks. Patients will be advised to maintain their usual physical activity and adhere to a recommended dietary plan (e.g., Mediterranean diet). Concurrent therapies such as hepatoprotective agents, lipid-lowering medications, and antihypertensive treatments will remain unchanged, with close monitoring of relevant parameters. No additional prescription or over-the-counter drugs that may affect fatty liver progression or alter gut microbiota composition will be permitted during the study.\n\nThe primary endpoint will be assessed at 24 weeks. If liver proton density fat fraction (PDFF) remains ≥ 8% after 24 weeks of rifaximin therapy, treatment will be extended for an additional 12 weeks, followed by reevaluation of PDFF changes. The maximum total treatment duration will not exceed 48 weeks. All patients will undergo a 24-week post-treatment follow-up period after discontinuation of rifaximin.\n\nInvestigational Drug: Rifaximin (Alfa Wassermann S.p.A., Italy).",[367],"Metabolic-associated Fatty Liver Disease",[369,294],"metabolic-associated fatty liver disease","2025-09-12",{"date":372,"type":39},"2025-09-22",{"date":374,"type":39},"2024-08-10",{"date":301,"type":22},{"name":45,"class":46},{"id":378,"slug":379,"hasResults":12,"nctId":380,"briefTitle":381,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":387,"conditions":388,"keywords":389,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":396,"completionDateStruct":398,"leadSponsor":400,"locationsCount":47},"100604659","phase-4-evaluation-of-the-efficacy-and-safety-observation-of-ibi311-treatment-in-patients-with-inactive-tao-100604659","NCT07152392","Evaluation of the Efficacy and Safety Observation of IBI311 Treatment in Patients With Inactive TAO","Inclusion Criteria:\n\n* Diagnosed with TAO by Bartley criteria.\n* Moderate to severe patients defined by EUGOGO.\n* CAS \\\u003C3 (on the 7-item scale) for the study eye.\n* Participant with intractable diplopia, or incomplete closure of both eyes, or requiring further surgical intervention.\n* Participant with a strong willingness for further intervention.\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.\n* Combined with other lesions in the orbit.\n* Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.\n* During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency).\n* At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU\u002F mL), or being receiving anti-hepatitis B virus treatment.\n* During screening, the Glomerular Filtration Rate (GFR) was \\\u003C 30 ml\u002F min\u002F1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg\u002F dl) -1.154× (age) -0.203× (0.742 \\[if female\\]), unit conversion of serum creatinine: 1 μmol\u002FL=0.0113 mg\u002FdL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \\[oral or injection\\] or a dose change of the current prescribed diabetes drug \\> 10% within 60 days before screening).\n* Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days before screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.).\n* At the time of screening, the 12-lead ECG showed a heart rate of \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \\> 450 ms (for men) and QTcF \\> 470 ms (for women) should be excluded.\n* HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department).\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study.\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study.\n* Pregnant or lactating.",{"count":384,"type":22},50,[386],"PHASE4","Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.\n\nIBI311 is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.\n\nHowever, there are still significant gaps in the existing research evidence: There is a lack of reports on the efficacy and safety of IBI311 in inactive moderate to severe TAO patients.\n\nThe aim of this clinical study is to:\n\n1. To evaluate the efficacy of IBI311 treatment in patients with inactive moderate to severe TAO.\n2. To observe the safety of IBI311 treatment in patients with inactive moderate to severe TAO.",[227],[390,391,392],"IGF-1R","TED","MR Imaging","2025-08-31",{"date":395,"type":39},"2025-09-03",{"date":397,"type":39},"2025-04-15",{"date":399,"type":22},"2035-04-15",{"name":45,"class":46},{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":4,"eligibilityCriteria":407,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":408,"targetDuration":4,"studyType":23,"phases":410,"briefSummary":411,"conditions":412,"keywords":413,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":418,"leadSponsor":419,"locationsCount":47},"100604657","phase-4-efficacy-and-safety-of-sequential-hormone-therapy-and-tetuzumab-therapy-in-patients-with-moderate-to-severe-tao-in-the-active-stage-after-glucocorticoid-treatment-100604657","NCT07152366","Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment.","Efficacy and Safety of Sequential Hormone Therapy and Tetuzumab Therapy in Patients With Moderate to Severe TAO in the Active Stage After Glucocorticoid Treatment","Inclusion Criteria:\n\n* Inclusion Criteria:\n* Diagnosed with TAO by Bartley criteria.\n* Moderate to severe patients defined by EUGOGO.\n* CAS ≥4 (on the 7-item scale) for the study eye.\n* participants have received glucocorticoid treatment for TAO in the past，but did not responsive or has an unsatisfactory effect.\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.\n* Combined with other lesions in the orbit.\n* Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.\n* During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency).\n* At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU\u002FmL), or being receiving anti-hepatitis B virus treatment.\n* During screening, the Glomerular Filtration Rate (GFR) was \\\u003C 30 ml\u002Fmin\u002F1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg\u002Fdl) -1.154× (age) -0.203× (0.742 \\[if female\\]), unit conversion of serum creatinine: 1 μmol\u002FL=0.0113 mg\u002FdL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \\[oral or injection\\] or a dose change of the current prescribed diabetes drug \\> 10% within 60 days before screening).\n* Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days befor screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.).\n* At the time of screening, the 12-lead ECG showed a heart rate of \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \\> 450 ms (for men) and QTcF \\> 470 ms (for women) should be excluded.\n* HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department).\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study.\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study.\n* Pregnant or lactating.",{"count":409,"type":22},96,[386],"Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO. Tetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.\n\nHowever, there are still significant gaps in the existing research evidence: There is a lack of reports on the efficacy and safety of Tetuzumab (IBI311) in the population after glucocorticoid treatment.\n\nThe aim of this clinical study is to:\n\n1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO after glucocorticoid treatment.\n2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO after glucocorticoid treatment.",[227],[390,391,414,415],"glucocorticoids","MRI",{"date":395,"type":39},{"date":397,"type":39},{"date":399,"type":22},{"name":45,"class":46},{"id":421,"slug":422,"hasResults":12,"nctId":423,"briefTitle":424,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":428,"briefSummary":429,"conditions":430,"keywords":431,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":433,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":329},"100604655","phase-4-the-safety-and-efficacy-of-sequential-hormone-therapy-and-ibi311-therapy-in-patients-with-active-moderate-to-severe-tao-in-the-initial-treatment-100604655","NCT07152340","The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.","Inclusion Criteria:\n\n* Diagnosed with TAO by Bartley criteria.\n* Moderate to severe patients defined by EUGOGO.\n* CAS ≥4 (on the 7-item scale) for the study eye.\n* Have not received glucocorticoid treatment for TAO in the past.\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision.\n* Combined with other lesions in the orbit.\n* Receive orbital radiotherapy or surgical treatment for TED, including orbital decompression, strabismus surgery and eyelid retraction correction.\n* During the screening period, if either ear has a history of tinnitus or other hearing impairment; Or abnormal pure tone audiometry results (defined as an average bone conduction hearing threshold of ≥25 dB at 0.5, 1, 2, 4 kHz or a bone conduction hearing threshold of ≥40 dB at any frequency).\n* At the time of screening, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times ULN, or accompanied by active hepatitis B (defined as HBsAg positive with HBV-DNA load greater than 1000 IU\u002FmL), or being receiving anti-hepatitis B virus treatment.\n* During screening, the Glomerular Filtration Rate (GFR) was \\\u003C 30 ml\u002Fmin\u002F1.73m2 (using the MDRD formula: GFR =186× serum creatinine (mg\u002Fdl) -1.154× (age) -0.203× (0.742 \\[if female\\]), unit conversion of serum creatinine: 1 μmol\u002FL=0.0113 mg\u002FdL); 10) At the time of screening, there was poorly controlled diabetes (defined as glycated hemoglobin ≥7.0% at the time of screening, or a new diabetes drug \\[oral or injection\\] or a dose change of the current prescribed diabetes drug \\> 10% within 60 days before screening).\n* Screening for poorly controlled hypertension, with systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg; Or adjust the antihypertensive drug (dosage or type of drug) within 30 days before screening; Evidence of renal artery stenosis or unstable blood pressure (including orthostatic hypotension, etc.).\n* At the time of screening, the 12-lead ECG showed a heart rate of \\\u003C 50 beats\u002Fmin or \\> 100 beats\u002Fmin. The ECG indicated active heart disease, or the researchers believed that the abnormal ECG at the time of screening would interfere with the interpretation of the ECG results in the subsequent follow-up process. Especially, QTcF \\> 450 ms (for men) and QTcF \\> 470 ms (for women) should be excluded.\n* HIV antibody or HCV antibody positive individuals or those with active syphilis (defined as those with positive non-specific syphilis antibodies or those who need anti-syphilis treatment after consultation by the infectious disease department).\n* History of systemic (eg, oral or IV) steroid use of methylprednisolone for the treatment of TAO.\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigators judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study.\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participants participation in the study.\n* Pregnant or lactating.",{"count":427,"type":22},64,[386],"Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.\n\nTetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO.\n\nHowever, there are still significant gaps in the existing research evidence: the lack of head-to-head studies of temumab and glucocorticoids.\n\nThe aim of this clinical study is to:\n\n1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment.\n2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment.\n3. Head-to-head comparison of sequential hormone therapy and IBI311 therapy in patients with active moderate to severe TAO in the initial treatment.",[227],[390,391,414,432],"MRI imaging",{"date":395,"type":39},{"date":435,"type":39},"2025-04-10",{"date":437,"type":22},"2030-05-01",{"name":45,"class":46},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":178,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":448,"studyType":137,"phases":4,"briefSummary":449,"conditions":450,"keywords":461,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":473,"locationsCount":47},"100596262","cardiovascular-kidney-metabolic-syndrome-in-shanghai-zicitizens-100596262","NCT07043166","Cardiovascular-Kidney-Metabolic Syndrome in Shanghai Zicitizens","Epidemiological Survey and Follow-up of Cardiovascular-Kidney-Metabolic Diseases Among Adults in Shanghai","Inclusion Criteria:\n\n1. The 4,094 residents of Shanghai communities who have been enrolled in the STONE cohort.\n2. Individuals who completed the baseline questionnaire survey, physical examination, and related clinical tests between 2016 and 2017, with complete data records.\n3. Willingness to participate in this follow-up study and provision of informed consent.\n\nExclusion Criteria:\n\n1. Participants who have moved away from their original community and have been living elsewhere for more than two years.\n2. Participants whose contact information has changed or become invalid, resulting in loss of contact (those who remain uncontactable after three attempts to reach out).",{"count":447,"type":22},4094,"10 Years","The main purpose of this study is to conduct follow-up assessments and update the cardiorenal outcomes among the STONE cohort that was established during 2016-2017. The secondary aim is to compare metabolic risk factors, metabolic disturbances, and clinically relevant metabolic outcomes between the follow-up period and the baseline assessment. The exploratory goal is to examine the relationships between changes in risk factors and clinical outcomes in the participants.\n\nThe study is planned to begin in May 2025 and will finalize the data collection for the entire population by June 2026. During this time, participants will be categorized based on CKM staging. The follow-up phase will continue until 2035.",[451,452,453,454,455,456,457,458,459,460],"Metabolic Syndrome","Diabetes","Obesity and Overweight","Hypertension","Dyslipidemia","Thyroid Diseases","Bone Metabolism Disorder","Chronic Kidney Disease(CKD)","Cardiovascular Diseases (CVD)","Cardiovascular-kidney-metabolic Syndrome",[462,463,464,465,466,467],"Cardiovascular-Kidney-Metabolic Syndrome","metabolic disorders","screening","risk factor","evaluation","prediction",{"date":469,"type":39},"2025-09-08",{"date":471,"type":39},"2025-07-01",{"date":327,"type":22},{"name":45,"class":46},{"id":475,"slug":476,"hasResults":12,"nctId":477,"briefTitle":478,"officialTitle":478,"acronym":4,"eligibilityCriteria":479,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":480,"enrollmentInfo":481,"targetDuration":4,"studyType":23,"phases":482,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":47},"100600937","phase-1-inhaled-mesenchymal-stem-cell-derived-exosomes-in-the-treatment-of-post-infectious-cough-a-single-center-randomized-controlled-clinical-trial-100600937","NCT07103980","Inhaled Mesenchymal Stem Cell-Derived Exosomes in the Treatment of Post-Infectious Cough: A Single-Center Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Patients aged 18-60 years.\n2. Diagnosis of post-infectious cough, which is defined as: after the symptoms of acute respiratory infection have disappeared, chest radiographs are normal, irritating dry cough or cough with small amounts of mucoid phlegm occurs, cough persists for 3 to 8 weeks, and other causes of cough are ruled out.\n3. Baseline cough visual analog scale\\>=60mm.\n\nExclusion Criteria:\n\n1. patients with any other disease that causes coughing (eg, Upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough, bronchial asthma, chronic obstructive pulmonary disease and bronchiectasis).\n2. Patients with serious lung diseases (eg, lung cancer, tuberculosis or pulmonary fibrosis).\n3. Patients with serious comorbidities, (eg, cardiovascular, cerebrovascular, liver, kidney or hematopoietic system diseases or other serious primary diseases)\n4. Current or ex-smokers quitting smoking for less than 6 months.\n5. Patients with a body temperature ≥37.3℃.\n6. Patients with white blood cell count or neutrophil count is higher than the upper limit of normal.\n7. Patients with abnormal chest X-rays.\n8. Patients Suspected or confirmed history of alcohol or drug abuse or mental illness.\n9. Patients with pregnancy, lactation or planning pregnancy.","60 Years",{"count":268,"type":22},[483,59],"PHASE1","This study is an exploratory clinical trial. It is intended to investigate the efficacy of mesenchymal stem cell-derived exosome nebulization in the treatment of postinfectious cough through a randomized controlled clinical study, with a view to providing better treatment options for patients with postinfectious cough, improving their quality of life, and providing reference data for the subsequent multi-center clinical trials.",[486],"Post-Infectious Cough","2025-07-29",{"date":489,"type":39},"2025-08-05",{"date":491,"type":39},"2024-07-16",{"date":493,"type":22},"2025-12-30",{"name":45,"class":46},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":499,"acronym":4,"eligibilityCriteria":500,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":501,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":503,"conditions":504,"keywords":506,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":510,"startDateStruct":512,"completionDateStruct":514,"leadSponsor":516,"locationsCount":47},"100601065","observational-study-of-sacral-nerve-function-after-sacral-tumor-resection-100601065","NCT07105644","Observational Study of Sacral Nerve Function After Sacral Tumor Resection","Inclusion Criteria:\n\nAge between 12 and 80 years Confirmed diagnosis of sacral tumor (either a primary bone tumor or a metastatic tumor from another solid malignancy) Able to understand the study requirements and provide written informed consent\n\nExclusion Criteria:\n\nPoor general condition rendering the patient unable to tolerate surgery History of diseases or surgeries affecting bowel or bladder function Missing intraoperative data regarding sacral resection level or nerve root sacrifice Pregnant or currently breastfeeding Missing critical follow-up data or lost to follow-up",{"count":502,"type":22},400,"The goal of this observational study is to evaluate the long-term effects of sacral tumor resection on sacral nerve function in patients with primary sacral tumors, including chordomas and chondrosarcomas. The study will primarily focus on understanding how the level of sacral resection impacts postoperative motor, bowel, bladder, and sexual functions. The main questions it aims to answer are:\n\nHow does the level of sacral resection influence bowel and bladder function at 12 months post-surgery? What is the role of preserving the sacral nerve root in maintaining motor function and sexual function? Participants will include patients who have undergone sacral tumor resection and will be followed for 12 months post-surgery. They will provide data on their bowel, bladder, and motor functions, as well as sexual function, through clinical evaluations and standardized questionnaires.\n\nParticipants will:\n\nComplete surveys on bowel, bladder, and motor function at baseline and at 3, 6, and 12 months after surgery Undergo clinical assessments, including anorectal manometry, post-void residual urine volume measurements, and sensory evaluations Be evaluated for changes in sexual function using standardized surveys like IIEF (for males) and FSFI (for females)",[505],"Sacral Tumors",[507,508,509],"sacral nerve function","motor functions","bowel functions",{"date":511,"type":39},"2025-08-06",{"date":513,"type":22},"2025-08-01",{"date":515,"type":22},"2027-08-31",{"name":45,"class":46},{"id":518,"slug":519,"hasResults":12,"nctId":520,"briefTitle":521,"officialTitle":522,"acronym":4,"eligibilityCriteria":523,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":55,"enrollmentInfo":524,"targetDuration":4,"studyType":23,"phases":526,"briefSummary":527,"conditions":528,"keywords":531,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":537,"startDateStruct":539,"completionDateStruct":540,"leadSponsor":541,"locationsCount":47},"100596041","evaluation-of-the-efficacy-and-safety-of-absorbable-vs-traditional-bone-wax-for-facet-fusion-after-lumbar-fusion-surgery-100596041","NCT07040293","Evaluation of the Efficacy and Safety of Absorbable vs Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery","Evaluation of the Efficacy and Safety of Absorbable Bone Wax and Traditional Bone Wax for Facet Fusion After Lumbar Fusion Surgery: A Multicenter, Randomized, Open-label, Superiority Clinical Trial","Inclusion Criteria:\n\n* Participants must be aged between 18 and 75 years, with no restrictions on gender.\n* Participants with conditions such as single-segment lumbar intervertebral disc protrusion, lumbar spondylolisthesis, and lumbar spinal stenosis who are scheduled to undergo posterior decompression, intervertebral fusion, and internal fixation surgery.\n* Participants must be able to comprehend the objectives of the study, willingly participate, and provide informed consent by signing the consent form.\n\nExclusion Criteria:\n\n* Individuals with a hemorrhagic predisposition or coagulation disorders, indicated by a prothrombin time (PT) of 18 seconds or greater, and those with a history of prolonged anticoagulant use.\n* Individuals presenting with lumbar spine infections or fractures.\n* Individuals with known allergies to materials such as polyethylene glycol, sodium carboxymethyl cellulose, and bone wax (including beeswax, paraffin, and isopropyl palmitate).\n* Individuals whose conditions are critical, making it challenging to accurately assess the efficacy and safety of the equipment.\n* Individuals deemed by researchers to have poor compliance, rendering them unable to fulfill the study requirements.\n* Women who are currently pregnant, intend to become pregnant within the past year, or are breastfeeding.\n* Individuals who have participated in other clinical trials within the preceding 30 days to prevent cross-interference.\n* Individuals with significant complications or comorbidities, such as severe cardiovascular, hepatic, renal, or other chronic conditions that could influence surgical risks and research outcomes.\n* Individuals identified by researchers as having a life expectancy of less than six months.\n* Individuals with severe osteoporosis, defined as a bone mineral density T-score of ≤-2.5 accompanied by fragility fractures.\n* Any other individuals deemed unsuitable for participation in this clinical trial by the researchers.",{"count":525,"type":22},330,[109],"Hemorrhage on the surface of cancellous bone presents a significant challenge in orthopedic surgery. Traditional bone wax, commonly utilized for hemostasis in bone wounds, is non-absorbable and associated with various complications, including pseudarthrosis, paralysis, venous sinus thrombosis, chronic inflammation, allergic reactions, and infections, thereby limiting its clinical utility. In contrast, absorbable bone wax, primarily composed of medical-grade water-soluble polymer materials, exhibits excellent biocompatibility. It is fully absorbed, excreted, or eliminated by the body without leaving toxic residues. This study employs a rigorous efficacy design to select an appropriate patient cohort for lumbar fusion surgery, based on specific inclusion and exclusion criteria. Participants are randomly assigned to either an experimental group receiving absorbable bone wax or a control group receiving traditional bone wax, facilitating a randomized, open-label, parallel-controlled clinical trial. This study aims to evaluate the comparative effects of absorbable bone wax versus traditional bone wax on the rate of bone fusion following hemostasis of bone wounds. The objective is to furnish robust evidence-based insights into the application of absorbable bone wax for bone wounds necessitating fusion, thereby establishing a safe, effective, and broadly applicable technique for bone wound hemostasis in clinical practice.",[529,530],"Lumbar Fusion Surgery","Fusion of Joint",[532,533,534,535],"absorbable bone wax","traditional bone wax","facet fusion after lumbar fusion surgery","hemostasis","2025-06-26",{"date":538,"type":39},"2025-06-27",{"date":471,"type":22},{"date":127,"type":22},{"name":45,"class":46},{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":4,"eligibilityCriteria":548,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":549,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":550,"conditions":551,"keywords":555,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":536,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":562,"locationsCount":47},"100561047","pancreatic-cancer-and-diabetes-mellitus-100561047","NCT06585072","Pancreatic Cancer and Diabetes Mellitus","Prospective Cohort Study on Endo-Exdo Secretory Function Alterations and All-round Outcomes After Pancreatic Cancer","Inclusion Criteria:\n\n1\\. male or female Chinese subjects; 2. Age ≥ 18 years; 3. patients with pancreatic cancer who are proposed to undergo pancreatectomy by pancreaticobiliary surgery at our hospital; 4. those who voluntarily completed the Pancreatobiliary Surgery Cohort Study and signed the informed consent; 5. those who have completed and banked serum and pathological specimens at our hospital.\n\n\\-\n\nExclusion Criteria:\n\n1\\. those with a previous history of comorbid diabetes mellitus or pre-diabetes mellitus, or preoperative HbA1C ≥ 6.0% or fasting blood glucose ≥ 6.1 mmol\u002Fl; 2. those with positive islet-associated antibodies 3. those with the presence of medications, endocrine disease exposures that can lead to a risk of secondary diabetes; 4. pregnant or nursing women; 5. Cognitive impairment or other reasons for failing to sign the informed consent form.\n\n\\-",{"count":136,"type":22},"The goal of this observational study is to learn about post-surgery of pancreatic cancer diabetes mellitus.The main questions it aims to answer are:\n\n1. Are the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) after pancreatic cancer of different etiologies the same?\n2. Are alterations in endocrine and exdocrine secretory function in patients with pancreatic surgery associated with all-round outcomes? All patients with pancreatic surgery have been given the standardized treatment for the condition.\n\nThe reasearchers will summarize the incident rates of glucose metabolic disorders (pre-diabetes and diabetes mellitus) during different surgical procedures to explore the association between alternations in endocrine and exdocrine secrectory function and all-round outcomes.",[552,553,554],"Pancreatic Cancer","Surgery","Diabetes Mellitus",[552,553,554,556],"Risk factor",{"date":471,"type":39},{"date":559,"type":39},"2025-01-03",{"date":561,"type":22},"2026-09-01",{"name":45,"class":46},{"id":564,"slug":565,"hasResults":12,"nctId":566,"briefTitle":567,"officialTitle":568,"acronym":4,"eligibilityCriteria":569,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":570,"targetDuration":4,"studyType":23,"phases":571,"briefSummary":572,"conditions":573,"keywords":577,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":586,"locationsCount":47},"100596816","early-phase-1-a-dose-expansion-trial-of-intravenous-hnf4-srrna-for-unresectable-or-metastatic-colorectal-cancer-100596816","NCT07050394","A Dose-Expansion Trial of Intravenous HNF4α srRNA for Unresectable or Metastatic Colorectal Cancer","A Dose-expansion Trial Exploring the Safety and Efficacy of Intravenous HNF4α srRNA in Patients With Unresectable Locally Advanced or Metastatic Colorectal Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years, regardless of gender.\n2. Patients with colorectal cancer confirmed by histology or cytology.\n3. Patients with unresectable locally advanced or metastatic colorectal cancer.\n4. Patients who are not suitable for or intolerant of standard systemic therapy; or patients who have progressed after receiving standard systemic therapy (including but not limited to the following regimens) as confirmed by RECIST v1.1: chemotherapy based on fluorouracil, oxaliplatin, or irinotecan, and targeted drugs such as anti-VEGF\u002FEGFR monoclonal antibodies.\n5. According to RECIST v1.1, patients must have at least one measurable lesion. Lesions that have received local treatment (including surgery, radiotherapy, TACE, and ablation) cannot be selected as target lesions, unless the lesion is the only measurable lesion and has clearly progressed according to imaging, in which case it may be considered as a target lesion.\n6. Life expectancy ≥ 12 weeks.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.\n8. Fertile male participants and women of childbearing age must agree to use effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug. Women of childbearing age include premenopausal women and women within 2 years of menopause. Women of childbearing age must have a negative serum pregnancy test within ≤7 days before the first dose of the investigational drug.\n9. Willing to sign the written informed consent form and voluntarily comply with the protocol.\n\nExclusion Criteria:\n\n1. Patients who have completed standard adjuvant chemotherapy after tumor resection and relapsed or developed metastasis after a drug-free interval of 6 months, and have not received standard systemic therapy.\n2. Patients with tumor tissue testing confirming mismatch repair deficiency or high microsatellite instability (dMMR\u002FMSI-H) who have not received immune checkpoint inhibitor treatment (PD-1 monoclonal antibody or PD-L1 monoclonal antibody).\n3. Patients with clinical or radiological evidence of current intestinal obstruction, perforation, or bleeding; or patients assessed by the investigator to be at high risk of perforation or bleeding.\n4. Serum albumin \\\u003C 28 g\u002FL, or bilirubin \\> 3×ULN, or aspartate aminotransferase (AST), alkaline phosphatase (ALP), or alanine aminotransferase (ALT) \\> 5×ULN.\n5. Patients with significant renal impairment, serum creatinine \\> 1.5×ULN, or creatinine clearance \\\u003C 40 mL\u002Fmin; urine protein \\\u003C2+ (if urine protein ≥2+, a 24-hour urine protein quantification is required, and patients with 24-hour urine protein quantification \\\u003C1 g may be eligible).\n6. Absolute neutrophil count \\\u003C 1.5×10\\^9\u002FL, or platelets \\\u003C 50×10\\^9\u002FL, or hemoglobin \\\u003C 9 g\u002FdL.\n7. International Normalized Ratio (INR) \\> 2.\n8. Patients with known brain metastases from tumors.\n9. Patients with uncontrolled hypertension, diabetes, or other severe cardiac or pulmonary diseases, or severe organ dysfunction.\n10. Patients who have received local or systemic anti-tumor treatments (including immunotherapy, targeted therapy, or chemotherapy) within 4 weeks, or radiotherapy within 3 weeks, except for treatment regimens assessed as disease progression according to RECIST (version 1.1) criteria.\n11. Patients with adverse events related to previous local or systemic anti-tumor treatments still ≥ Grade 2 (excluding alopecia and other events deemed tolerable by the investigator).\n12. Patients with uncontrollable active infections (e.g., pulmonary or abdominal infections).\n13. Patients with malignancies other than colorectal cancer within the past 5 years, with the exception of low-risk malignancies with a low risk of metastasis or death (estimated 5-year overall survival \\> 90%), such as early gastrointestinal cancer treated effectively, cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, etc.\n14. Patients with active autoimmune diseases requiring systemic therapy within the past 2 years, or autoimmune diseases judged by the investigator to have a potential for recurrence or planned treatment, including but not limited to inflammatory bowel disease, celiac disease, Wegener's granulomatosis, Hashimoto's thyroiditis, systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis.\n15. Patients who require systemic treatment with corticosteroids (prednisone or equivalent \\> 10 mg\u002Fday) or other immunosuppressive drugs within 14 days before the first dose of the investigational drug.\n16. Patients who are preparing for or have previously undergone allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n17. Patients who are positive for HBV-DNA or HCV RNA.\n18. Patients with known active tuberculosis. Patients suspected of having active tuberculosis must be excluded based on chest imaging, sputum tests, and clinical symptoms and signs.\n19. Patients who are positive for human immunodeficiency virus (HIV).\n20. Pregnant or breastfeeding women, or women who cannot rule out the possibility of pregnancy.\n21. Patients who have participated in other drug trials within the past 4 weeks.\n22. Other situations deemed by the investigator as unsuitable for participation in this clinical trial.",{"count":57,"type":22},[25],"This study is a single-arm, open-label, exploratory clinical trial. Building on the previous dose-escalation trial, this dose-expansion trial aims to evaluate the safety and tolerability of intravenous monotherapy with CD-GA-102 or its combination with immunotherapy and other systemic treatments in patients with unresectable locally advanced or metastatic colorectal cancer, and to preliminarily explore its efficacy in treating colorectal cancer.",[574,575,576],"Colorectal Cancer Metastatic","Colorectal Cancer Recurrent","Colorectal Cancer Stage IV",[207,578,579],"Hepatocyte nuclear factor 4α","Differentiation therapy","2025-06-25",{"date":582,"type":39},"2025-07-03",{"date":584,"type":39},"2025-06-10",{"date":258,"type":22},{"name":45,"class":46},{"id":588,"slug":589,"hasResults":12,"nctId":590,"briefTitle":591,"officialTitle":592,"acronym":4,"eligibilityCriteria":593,"healthyVolunteers":178,"sex":17,"minAge":18,"maxAge":336,"enrollmentInfo":594,"targetDuration":4,"studyType":137,"phases":4,"briefSummary":595,"conditions":596,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":47},"100561442","establishment-of-multiparametric-prediction-models-for-moderate-to-severethyroid-associated-ophthalmopathy-100561442","NCT06590220","Establishment of Multiparametric Prediction Models for Moderate to SevereThyroid Associated Ophthalmopathy","Establishment of Multiparametric Prediction Models for Moderate to Severe Thyroid Associated Ophthalmopathy","Inclusion Criteria:\n\n* According to the Bartley criteria，diagnosed TAO at our hospital after 2024\u002F8\u002F31\n* Moderate to severe patients defined by EUGOGO\n* CAS ≥3 (on the 7-item scale) for the study eye\n\nExclusion Criteria:\n\n* Anticipated need for intervention due to sight-threatening complications or other significant and acute deterioration in vision\n* History of systemic (eg, oral or IV) steroid use with a cumulative dose equivalent to \\>1 g of methylprednisolone for the treatment of TAO.\n* Any major illness\u002Fcondition or evidence of an unstable clinical condition that, in the investigator\\'s judgment, will substantially increase the risk to the participant, or confound the interpretation of safety assessments, if they were to participate in the study\n* Any other condition that, in the opinion of the investigator, would impair the ability of the participant to comply with the study procedures or impair the ability to interpret data from the participant\\'s participation in the study\n* Pregnant or lactating\n* Any other condition that,would impair the ability of the participant to undergo orbital MRI\n* Incomplete information",{"count":136,"type":22},"Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO.\n\nThe aim of this clinical study is to:\n\n1. Found the new diagnostic markers or imaging sequences.\n2. Establish and validate a multimodal and multiparameter prediction model for moderate to severe TAO.",[597],"Thyroid Associated Ophthalmopathy","2025-06-21",{"date":600,"type":39},"2025-06-24",{"date":602,"type":39},"2024-10-09",{"date":604,"type":22},"2028-09-06",{"name":45,"class":46},""]