[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Tianjin Medical University General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":501},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,21,0,[8,44,76,100,125,152,170,194,214,240,266,292,312,329,348,374,393,413,440,461,483],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100640420","the-effect-of-intraoperative-esketamine-infusion-on-pruritus-in-elderly-surgical-patients-100640420",false,"NCT07597486","The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients","The Effect of Intraoperative Esketamine Infusion on Pruritus in Elderly Surgical Patients: A Single-Center Randomized Controlled Trial","Inclusion Criteria:\n\n1. Meet the diagnostic criteria for senile pruritus:\n\n   1. Aged ≥ 65 years old;\n   2. Presenting with only skin pruritus without obvious primary skin lesions, with or without scratch-induced skin lesions;\n   3. Daily or nearly daily pruritus lasting for more than 6 weeks.\n2. Patients undergoing elective general anesthesia for orthopedic knee arthroplasty.\n3. Patients aged ≥ 65 years old, with ASA physical status classification Ⅰ-Ⅲ; BMI ranging from 18 to 30 kg\u002Fm², with no restriction on gender.\n4. Patients have fully understood the nature of this study, are capable of understanding and completing evaluation scales preoperatively, voluntarily participate in this trial, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Those who are allergic to the pharmaceutical ingredients of this study or have an allergic constitution;\n2. Those with a history of allergy to general anesthetics, opioids, or non-steroidal anti-inflammatory drugs;\n3. Those with severe cognitive impairment, a history of neurological diseases, chronic pain, drug addiction, alcoholism, long-term opioid use, or administration of opioids within 48 hours before surgery;\n4. Patients with ASA physical status classification Grade IV-V;\n5. Those with severe coronary heart disease\u002Farrhythmia\u002Fcardiac insufficiency, bronchial asthma, severe hypertension, severe hematopoietic system dysfunction, severe abnormal liver and kidney function, or significant electrolyte disorders;\n6. Those with a history of gastrointestinal diseases (peptic ulcer, Crohn's disease, ulcerative colitis);\n7. Those with respiratory insufficiency or respiratory failure;\n8. Those with BMI \\\u003C 18 kg\u002Fm² or BMI \\> 30 kg\u002Fm²;\n9. Those with poor compliance who cannot complete the trial in accordance with the research protocol;\n10. Those who have participated in other clinical drug trials within the past 4 weeks;\n11. Those deemed unsuitable for enrollment by the researchers for any reason. -","ALL","65 Years","80 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","To explore the effect of intraoperative esketamine on pruritus in elderly patients undergoing elective general anesthesia for knee replacement surgery",[27],"Senile Pruritus",[29,30],"esketamine","pruritus","NOT_YET_RECRUITING","2026-05-18",{"date":34,"type":35},"2026-05-19","ACTUAL",{"date":37,"type":21},"2026-05-15",{"date":39,"type":21},"2027-09-30",{"name":41,"class":42},"Tianjin Medical University General Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":43},"100625258","phase-3-modified-zipper-therapy-for-aqp4-igg-positive-neuromyelitis-optica-spectrum-disorder-100625258","NCT07420296","Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder","Modified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder: A Multicenter Randomized Controlled Trial Study","ELITE","Inclusion Criteria:\n\n1. Participants ≥ 18 years of age\n2. Definite diagnosis according to the 2015 IPND diagnostic criteria for AQP4-IgG-positive NMOSD\n3. Seropositivity for anti-AQP4 antibody.\n4. Time from onset to enrollment ≤ 30 days.\n5. For patients with optic neuritis: visual acuity ≤ 20\u002F200 at screening; for relapse cases, baseline visual acuity prior to this acute episode must have been ≥ 20\u002F60.\n6. For patients with longitudinal extensive transverse myelitis (LETM): EDSS score ≥ 5.5 at screening; for relapse cases, baseline EDSS score prior to this acute episode must have been ≤ 3.5.\n7. Ability to understand and voluntarily provide written informed consent-\n\nExclusion Criteria:\n\n1. Patients with concurrent neuromuscular disorders.\n2. Patients with severe coagulation dysfunction.\n3. Patients with known allergy to plasma or intravenous immunoglobulin (IVIG).\n4. Patients with active hepatitis B or C virus infection, human immunodeficiency virus (HIV) infection, or those deemed at high risk for the onset or reactivation of syphilis or tuberculosis at screening.\n5. Patients with active systemic infection at screening, or a history of severe chronic or recurrent infections.\n6. Pregnant or lactating patients.\n7. Patients with chronic, severe medical conditions that may affect study compliance.\n8. Patients with any clinically significant abnormal laboratory findings as determined by the investigator (e.g., severe anemia, leukopenia, thrombocytopenia, etc.).\n9. Patients whom the investigator considers unlikely to complete the study or unlikely to comply with the study requirements (for administrative reasons or otherwise).","18 Years",{"count":54,"type":21},198,[56],"PHASE3","Study Title: A National, Multicenter, Randomized Controlled Trial of the Modified Zipper Therapy in AQP4 Antibody-Positive Neuromyelitis Optica Spectrum Disorder (ELITE Study)\n\nBrief Summary:\n\nThe goal of this clinical trial is to evaluate the efficacy and safety of a novel sequential immunomodulation strategy, termed \"Modified Zipper Therapy,\" in patients with acute attacks of Aquaporin-4 antibody-positive Neuromyelitis Optica Spectrum Disorder (AQP4-IgG+ NMOSD). The therapy aims to enhance neurological recovery by combining plasma exchange (PE) with immediate complement inhibition using eculizumab, following high-dose corticosteroid pulse therapy.\n\nThe main questions this trial aims to answer are:\n\nEfficacy: Does the Modified Zipper Therapy (high-dose corticosteroids + plasma exchange + eculizumab) lead to a higher rate of neurological improvement at Week 12 compared to standard therapy (high-dose corticosteroids + plasma exchange alone)?\n\nFor patients with NMOSD-related optic neuritis (NMOSD-ON), improvement is defined as a gain of ≥10 letters on the ETDRS chart or a decrease of ≥0.2 LogMAR in best-corrected visual acuity (BCVA).\n\nFor patients with NMOSD-related longitudinally extensive transverse myelitis (NMOSD-LETM), improvement is defined as a reduction of ≥2 points on the Expanded Disability Status Scale (EDSS).\n\nSafety: What is the nature and frequency of adverse events experienced by participants receiving the Modified Zipper Therapy compared to those receiving standard therapy?\n\nResearchers will compare the Modified Zipper Therapy group to the Standard Therapy group to see if the novel combination is more effective in improving visual and functional outcomes in acute AQP4-IgG+ NMOSD.\n\nParticipants will:\n\nBe randomly assigned (like a coin toss) to receive either the Modified Zipper Therapy or the Standard Therapy.\n\nUndergo a treatment period involving intravenous corticosteroids and a series of plasma exchange sessions. The Modified Zipper Therapy group will also receive intravenous eculizumab infusions timed around the plasma exchange procedures.\n\nBe followed for 24 weeks after treatment completion.\n\nAttend scheduled clinic visits for comprehensive assessments including:\n\nVisual acuity testing (using ETDRS, Snellen, and low-contrast charts).\n\nNeurological function evaluations (EDSS and OSIS scores).\n\nOptical coherence tomography (OCT) and visual evoked potential (VEP) tests.\n\nMagnetic resonance imaging (MRI) scans of the optic nerves.\n\nSafety monitoring (physical exams, lab tests, ECGs).",[59],"Neuromyelitis Optica Spectrum Disorders (NMOSD)",[61,62,63,64,65,66],"NMOSD","Eculizumab","Plasma exchange","Corticosteroid pulse therapy","Optic neuritis","Longitudinally extensive transverse myelitis","RECRUITING","2026-05-11",{"date":70,"type":35},"2026-05-14",{"date":72,"type":35},"2026-01-01",{"date":74,"type":21},"2027-06-30",{"name":41,"class":42},{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":4,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":83,"minAge":52,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":43},"100636056","the-effect-of-a-single-intravenous-injection-of-esketamine-during-cesarean-section-on-postoperative-pruritus-in-patients-with-intrahepatic-cholestasis-of-pregnancy-100636056","NCT07560722","The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy","The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.\n2. Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.\n3. Meet the diagnostic criteria of the \"Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)\" : fasting serum TBA≥10 μmol\u002FL or postprandial serum TBA≥19 μmol\u002FL.\n4. Reporting pruritus NRS ≥ 4 points twice within one week.\n5. Planned to undergo cesarean section under intraspinal anesthesia.\n6. ASA classification: I - III grade.\n\nExclusion Criteria:\n\n1. Those who are known to be allergic to the drug components or have an allergic constitution.\n2. Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.\n3. Those with severe organic diseases and liver diseases.\n4. Those with malignant tumors.\n5. Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.\n6. Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.\n7. ASA classification as grade IV.\n8. Those with poor compliance and unable to complete the trial according to the research protocol.\n9. Those who have participated in other drug clinical trials within the past 4 weeks.\n10. Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.\n\n    \\-","FEMALE","40 Years",{"count":86,"type":21},160,[24],"To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.",[90],"Intrahepatic Cholestasis of Pregnancy",[29,30],"2026-04-23",{"date":94,"type":35},"2026-05-01",{"date":96,"type":21},"2026-05-05",{"date":98,"type":21},"2027-08-11",{"name":41,"class":42},{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":43},"100631197","phase-3-normal-saline-infusion-after-intravenous-thrombolysis-in-stroke-100631197","NCT07497542","Normal Saline Infusion After Intravenous Thrombolysis in Stroke","Safety and Efficacy of Immediate Abundant Intravenous Normal Saline Infusion for Stroke After Intravenous Thrombolysis: a Multi-centre Randomized Controlled Phase III Trial","Inclusion Criteria:\n\n1. Age 18 to 80 years.\n2. Acute ischemic stroke treated with intravenous thrombolysis.\n3. Prestroke mordified Rankin Scale score ≤1;\n4. Admission NIHSS score 4-25, with NIHSS 4-5 requiring the presence of a disabling deficit as defined in the 2026 AHA\u002FASA Guideline for the Early Management of Patients With Acute Ischemic Stroke.\n5. Onset-to-needle time≤4.5 hours or DWI-FLAIR mismatch (guided by MRI evaluation) for patients with uncertain stroke onset time according to the inclusion criteria of the WAKE-UP study.\n6. Signed informed consent.\n\nExclusion Criteria:\n\n1. Contraindications to intravenous thrombolysis.\n2. Planned endovascular treatment prior to enrollment.\n3. History of heart failure, or pre-enrollment brain natriuretic peptide (BNP) ≥100 pg\u002FmL, or clinical presentations or signs suggestive of heart failure.\n4. History of atrial fibrillation, or pre-enrollment electrocardiogram indicating atrial fibrillation.\n5. History of valvular heart disease or valve replacement surgery, suggesting cardioembolic stroke.\n6. History of renal dysfunction, or pre-enrollment serum creatinine \\>133 μmol\u002FL, or estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m².\n7. Severe hemorrhage prior to enrollment, including symptomatic intracranial hemorrhage, gastrointestinal bleeding, respiratory tract bleeding, or massive skin and mucous membrane bleeding.\n8. Premature termination of intravenous thrombolysis due to any reason, such as hemorrhage, allergic reaction, or seizure.\n9. Participation in another clinical trial within the previous 3 months.\n10. Poor compliance, or inability to adhere to the trial protocol or complete follow-up.",{"count":108,"type":21},752,[56],"The intravenous administration of abundant normal saline is an easy-to-use strategy commonly employed to expand the blood volume. This study aimed to evaluate the efficacy and safety of the early administration of an abundant normal saline infusion after intravenous thrombolysis for promoting functional independence in patients with acute ischemic stroke. This multicenter, randomized, phase III clinical trial intends to enroll stroke participants who have undergone intravenous thrombolysis. Eligible patients are randomized to receive either abundant intravenous normal saline infusion (2,000-2,500 mL; normal saline group) or a small volume of intravenous normal saline infusion (≤600 mL; control group) immediately after thrombolysis. The primary outcome is the comparison of the ordinal modified Rankin Scale score at 90 days (±3) after randomization between the treatment groups.",[112],"Brain Infarction",[114,115,116,117],"brain infarction","thrombolysis","haemodilution","normal saline","2026-04-19",{"date":92,"type":35},{"date":121,"type":21},"2026-04",{"date":123,"type":21},"2029-09",{"name":41,"class":42},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":137,"conditions":138,"keywords":140,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":4},"100631278","early-phase-1-tils-plus-third-generation-egfr-tki-therapy-for-tki-resistant-nsclc-100631278","NCT07498595","TILs Plus Third-Generation EGFR-TKI Therapy for TKI-Resistant NSCLC","Safety Study of Tumor-Infiltrating Lymphocytes (TILs) Combined With Third-Generation Epidermal Growth Factor Receptor-Tyrosine Kinase Inhibitor (EGFR-TKI) Therapy for TKI-Resistant Advanced Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n* (1) Age 18-75 years, male or female; (2) Patients with a history of surgical resection, pathologically diagnosed with NSCLC, genetically tested for EGFR mutation, who experienced disease progression (local recurrence or distant metastasis) after EGFR-TKI treatment and refused chemotherapy or other therapies; (3) Ability to obtain approximately 5 tumor samples via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes; (4) ECOG performance status score of 0-2; (5) HGB ≥70 g\u002FL, transfusion-eligible; (6) No severe hepatic, renal, cardiac, or pulmonary dysfunction, with the following requirements met: Creatinine ≤ 1.5 × ULN; Oxygen saturation \\> 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; (7) Expected survival \\> 3 months; complete clinical documentation.\n\nExclusion Criteria:\n\n* (1) Patients with pathological diagnosis of small cell lung cancer components; (2) Patients who have previously undergone organ transplantation or cytoreductive therapy including lymph node clearance; (3) Patients currently receiving immunotherapy or steroid therapy; (4) Patients with concurrent severe or persistent infections that cannot be effectively controlled; (5) Patients with concurrent severe autoimmune diseases or congenital immunodeficiency; (6) History of severe allergic reactions to biological products (including antibiotics); (7) Active hepatitis (quantitative hepatitis B virus DNA \\[HBV-DNA\\] above the lower limit of detection for the assay method, or positive hepatitis C antibodies \\[HCV-Ab\\] with HCV-RNA above the lower limit of detection for the assay method); (8) HIV infection or syphilis infection; (9) Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months; (10) Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.","75 Years",{"count":134,"type":21},50,[136],"EARLY_PHASE1","This is a single-arm study designed to evaluate the safety and efficacy of TILs combined with third-generation EGFR-TKIs therapy for patients with EGFR-mutant NSCLC resistant to TKI.",[139],"EGFR-TKI-resistant Non-Small Cell Lung Cancer",[141,142,143],"EGFR-TKI-resistant","TILs","Non-Small Cell Lung Cancer","2026-03-25",{"date":146,"type":35},"2026-03-27",{"date":148,"type":21},"2026-03-31",{"date":150,"type":21},"2030-03-31",{"name":41,"class":42},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":132,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":168,"leadSponsor":169,"locationsCount":4},"100631266","early-phase-1-tils-therapy-for-multiple-primary-early-stage-nsclc-100631266","NCT07498439","TILs Therapy for Multiple Primary Early-Stage NSCLC","Safety Study of Tumor-Infiltrating Lymphocytes (TILs) Therapy for Multifocal Early-Stage Non-Small Cell Lung Cancer (NSCLC)","Inclusion Criteria:\n\n1. Age 18-75 years, male or female;\n2. Imaging findings showing multiple pulmonary nodules persisting after one year of follow-up, clinically diagnosed as multiple lung cancers by two associate senior or higher-level radiologists, two associate senior or higher-level thoracic surgeons, and one associate senior or higher-level oncologist, with patients refusing continued observation;\n3. Patients with a history of surgical resection and pathological diagnosis of NSCLC, who subsequently show disease progression on imaging (progression of primary lesion or new nodules) during follow-up or after targeted therapy, diagnosed as lung cancer by a multidisciplinary expert team, and who refuse surgery or other treatments;\n4. Ability to obtain a tumor sample of approximately 1-1.5 cm³ via surgery, biopsy, or bronchoscopy for preparation of autologous tumor-infiltrating lymphocytes;\n5. ECOG performance status score of 0-2;\n6. HGB ≥70 g\u002FL, transfusion-eligible;\n7. No severe hepatic, renal, cardiac, or pulmonary dysfunction, meeting the following criteria:\n\n   Creatinine ≤ 1.5 × ULN; Oxygen saturation \\> 90%; Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN;\n8. Estimated survival \\> 5 years with complete clinical documentation.\n\nExclusion Criteria:\n\n1. Patients with pathological diagnosis of small cell lung cancer components;\n2. Suspicious lesions appearing and follow-up duration less than six months, or remission after anti-inflammatory treatment;\n3. Previous history of allogeneic organ transplantation or cytoreductive therapy including lymph node clearance;\n4. Patients currently undergoing steroid therapy;\n5. Concurrent severe or persistent infections unresponsive to effective control;\n6. Concurrent severe autoimmune disease or congenital immunodeficiency;\n7. History of severe allergic reactions to biological products (including antibiotics);\n8. Active hepatitis (quantitative hepatitis B virus DNA \\[HBV-DNA\\] above the lower limit of detection for the assay method, or positive hepatitis C antibodies \\[HCV-Ab\\] with HCV-RNA above the assay method's lower limit of detection);\n9. HIV infection or syphilis infection;\n10. Female patients who are pregnant, breastfeeding, or planning pregnancy within 12 months;\n11. Conditions deemed by the investigator to potentially increase subject risk or interfere with trial results.",{"count":134,"type":21},[136],"This is a single-arm study aimed at evaluating the safety of TILs therapy for multiple primary early-stage NSCLC",[163],"Primary Early-stage Non-small Cell Lung Cancer",[142,165],"NSCLC",{"date":146,"type":35},{"date":148,"type":21},{"date":150,"type":21},{"name":41,"class":42},{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":177,"targetDuration":179,"studyType":180,"phases":4,"briefSummary":181,"conditions":182,"keywords":186,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":187,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":43},"100630771","china-monogenic-diabetes-registry-100630771","NCT07492004","China Monogenic Diabetes Registry","CMDR","Inclusion Criteria:\n\n1. Diabetes diagnosed before 25 years of age; OR diabetes diagnosed before 35 years of age with ≥1 first-degree relative (parent, sibling, or offspring) diagnosed with diabetes before 40 years of age\n2. Body mass index (BMI) at diagnosis 28 kg\u002Fm²\n3. Negative glutamic acid decarboxylase antibody (GAD-Ab)\n\nExclusion Criteria:\n\n1. Secondary diabetes\n2. Active malignancy or history of malignant tumor within the past 5 years",{"count":178,"type":21},5000,"5 Years","OBSERVATIONAL","This observational study aims to establish a digital registry, screening platform for patients with monogenic diabetes using internet-based and mobile application technologies. The primary objectives are to:\n\nCharacterize the genetic landscape of monogenic diabetes in the Chinese population, including pathogenic variants and their distribution\n\nParticipants will:\n\n* Enroll in the monogenic diabetes registry via mobile application or web-based platform\n* Undergo molecular genetic testing to establish a definitive diagnosis",[183,184,185],"Neonatal Diabetes","Monogenic Diabetes","Maturity Onset Diabetes of the Young",[184,183,185],"2026-03-19",{"date":144,"type":35},{"date":190,"type":35},"2021-02-28",{"date":192,"type":21},"2030-07-31",{"name":41,"class":42},{"id":195,"slug":196,"hasResults":11,"nctId":197,"briefTitle":198,"officialTitle":198,"acronym":4,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":132,"enrollmentInfo":200,"targetDuration":4,"studyType":22,"phases":202,"briefSummary":204,"conditions":205,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":207,"lastUpdatePostDateStruct":208,"startDateStruct":210,"completionDateStruct":211,"leadSponsor":213,"locationsCount":4},"100594356","phase-4-the-effect-of-oliceridine-patient-controlled-intravenous-analgesia-on-postoperative-chronic-pain-after-video-assisted-thoracoscopic-lobectomy-100594356","NCT07018375","The Effect of Oliceridine Patient-Controlled Intravenous Analgesia on Postoperative Chronic Pain After Video-Assisted Thoracoscopic Lobectomy","Inclusion Criteria:\n\n* ① Age 18-75 years, ASA physical status I-III, BMI 18-30 kg\u002Fm²;\n\n  * Scheduled for unilateral video-assisted thoracoscopic surgery (VATS) lung resection, including wedge resection, segmentectomy, lobectomy, or radical resection for lung cancer;\n\n    * Preoperative pain score \\\u003C1 on the Numeric Rating Scale (NRS);\n\n      * Ability to understand the study objectives and procedures, with voluntary informed consent obtained;\n\n        * Expected postoperative recovery in the general ward setting.\n\nExclusion Criteria:\n\n* ① History of chronic pain or long-term analgesic use prior to surgery;\n\n  * Previous ipsilateral thoracic surgery;\n\n    * Prior neoadjuvant radiotherapy or chemotherapy;\n\n      * Severe cardiovascular or cerebrovascular disease, or hepatic\u002Frenal dysfunction (ALT\u002FAST \\>3× upper limit of normal; eGFR \\\u003C60 mL\u002Fmin\u002F1.73m²);\n\n        * Concurrent malignancy or active infection;\n\n          * Pre-existing psychiatric disorders or communication barriers precluding study participation;\n\n            * Known hypersensitivity to study medications (opioids, adjuvant analgesics, anesthetics, or antiemetics);\n\n              * Any condition deemed unsuitable for study participation by the investigator",{"count":201,"type":21},320,[203],"PHASE4","The primary objective is to evaluate the impact of oliceridine versus sufentanil for perioperative analgesia on the incidence of chronic postsurgical pain (CPSP) in patients undergoing video-assisted thoracoscopic surgery.",[206],"Chronic Postsurgical Pain","2026-01-05",{"date":209,"type":35},"2026-01-06",{"date":209,"type":21},{"date":212,"type":21},"2027-04-30",{"name":41,"class":42},{"id":215,"slug":216,"hasResults":11,"nctId":217,"briefTitle":218,"officialTitle":219,"acronym":220,"eligibilityCriteria":221,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":18,"enrollmentInfo":222,"targetDuration":4,"studyType":22,"phases":224,"briefSummary":225,"conditions":226,"keywords":230,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":239,"locationsCount":4},"100605405","phase-4-hypoxia-inducible-factor-prolyl-hydroxylase-inhibitors-on-sarcopenia-in-hemodialysis-patients-100605405","NCT07162090","Hypoxia-inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients","Observation of the Impact of Hypoxia - Inducible Factor Prolyl Hydroxylase Inhibitors on Sarcopenia in Hemodialysis Patients","HIF-PHI","Inclusion Criteria:\n\n* Age: 18 to 80 years old (inclusive), gender unrestricted.\n* End-stage renal disease and maintenance hemodialysis for at least 16 weeks.\n* The average Hb level is 7.0\\~10.0 g\u002FdL (the last two evaluations).\n* And have not received or have discontinued ESA\u002Froxadustat treatment.\n* Vascular access: internal fistula or long-term hemodialysis catheter.\n* Weight between 45-100 kg.\n* Sarcopenia Diagnosis (Reference: AWGS 2019 Consensus):\n* Decreased muscle strength: Male grip strength \\\u003C 28 kg, female grip strength \\\u003C 18 kg.\n* Muscle mass decline: Assessed by bioelectrical impedance analysis (BIA) or dual-energy X-ray absorptiometry (DXA), it is characterized by appendicular skeletal muscle mass index (ASMI): \\\u003C 7.0 kg\u002Fm² for men and \\\u003C 5.7 kg\u002Fm² for women (BIA standard, the device and formula used should be specified).\n* Sarcopenia can be diagnosed when both \"decreased muscle strength\" and \"reduced muscle mass\" are present. If resources permit, \"decreased physical function\" (such as a 6-meter walking speed \\\u003C 1.0 m\u002Fs) can be added as an indicator for severity grading.\n* Voluntary participation in this study.\n* Must be able to swallow tablets。\n\nExclusion Criteria:\n\n* Non-renal anemia: Anemia caused by other main reasons (such as thalassemia, megaloblastic anemia due to vitamin B12 or folic acid deficiency, active bleeding, hemolytic anemia, hematological malignancies, etc.).\n* Contraindications and related risks of Roxadustat:\n* People who are allergic to roxadustat or any of its excipients.\n* Uncontrolled hypertension (sitting systolic blood pressure remains \\> 160 mmHg or diastolic blood pressure \\> 100 mmHg after active antihypertensive treatment).\n* There have been thrombotic events such as acute myocardial infarction, unstable angina pectoris, stroke, deep vein thrombosis or pulmonary embolism within the past six months.\n* Those with known active malignant tumors or undergoing anti-tumor treatment (except for basal cell carcinoma, etc.) are excluded.\n* Diseases affecting muscle metabolism and assessment:\n* Severe thyroid dysfunction (uncontrolled).\n* Diagnosed with chronic liver cirrhosis, acute exacerbation of chronic obstructive pulmonary disease (COPD), congestive heart failure (NYHA class IV), and other chronic diseases that seriously affect muscle metabolism.\n* Due to severe limitations in limb movement caused by rheumatoid arthritis, Parkinson's disease, spinal cord injury, etc., it is impossible to complete muscle strength and functional tests.\n* Long-term and excessive use of glucocorticoids (equivalent to prednisone \\> 7.5 mg\u002Fday) or other drugs that may affect muscle metabolism (such as androgens).\n* Other serious systemic diseases:\n* Severe liver dysfunction (Child-Pugh grade C or ALT\u002FAST \\> 3 times the upper limit of normal).\n* Active, uncontrolled severe infection.\n* Life expectancy is less than one year.\n* Special circumstances related to the research:\n* A kidney transplant is planned within the next six months.\n* Has participated in any other interventional clinical trials within the past 3 months.\n* Poor compliance and special populations:\n* There are mental or cognitive impairments, making it impossible to understand or cooperate with the research.\n* Pregnant or lactating women, or women of childbearing age who are unwilling to take effective contraceptive measures during the study period.",{"count":223,"type":21},60,[203],"Sarcopenia, abbreviated as muscle loss, is a prevalent complication among patients with chronic kidney disease (CKD), particularly those with end - stage renal disease (ESRD). It significantly impacts patients' quality of life. The prevalence of sarcopenia in patients receiving maintenance hemodialysis (MHD) ranges from 32.7% to 73.5%, which is substantially higher than that in the general population (5% - 13%). Sarcopenia significantly elevates the mortality risk in MHD patients. Specifically, sarcopenia patients experience an increased all - cause mortality rate, a heightened risk of cardiovascular events, a decline in quality of life, and an augmented risk of falls and fractures. A close pathophysiological relationship exists between the hypoxia - inducible factor - 1 (HIF - 1) pathway and sarcopenia. HIF - 1α serves as a key transcription factor for cells to respond to hypoxic conditions. Under normoxic conditions, HIF - 1α is hydroxylated by prolyl hydroxylase (PHD) and subsequently undergoes ubiquitination - mediated degradation. Conversely, under hypoxic circumstances, HIF - 1α is stably expressed, translocates into the nucleus, and activates downstream target genes. HIF - 1α promotes the expression of genes associated with glycolysis, such as GLUT1 and LDHA, while inhibiting mitochondrial oxidative phosphorylation. This results in a shift of skeletal muscle energy metabolism from aerobic to anaerobic pathways. Research has revealed that the protein level of HIF - 1α is significantly decreased in sarcopenia patients. Roxadustat capsules, an oral medication, represent the world's first small - molecule hypoxia - inducible factor prolyl hydroxylase inhibitor (HIF - PHI) developed for the treatment of renal anemia. The physiological function of HIF - 1α not only enhances the expression of erythropoietin but also upregulates the expression of erythropoietin receptors and proteins involved in promoting iron absorption and circulation. Theoretically, roxadustat has the potential to improve sarcopenia. However, due to its prominent effect on anemia correction, it is currently only clinically applicable to anemic patients. This study aims to use ESA as a control to investigate the effect of roxadustat on sarcopenia in hemodialysis patients during the treatment of renal anemia.",[227,228,229],"Sarcopenia","Anemia Associated With Chronic Kidney Disease (CKD)","Dialysis Patients",[227,231],"Anemia","2025-09-07",{"date":234,"type":35},"2025-09-09",{"date":236,"type":21},"2025-09-10",{"date":238,"type":21},"2026-12-31",{"name":41,"class":42},{"id":241,"slug":242,"hasResults":11,"nctId":243,"briefTitle":244,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":22,"phases":250,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":4},"100603121","phase-3-slow-vs-rapid-glucocorticoids-tapering-with-inebilizumab-in-nmosd-100603121","NCT07132398","Slow vs. Rapid Glucocorticoids Tapering With Inebilizumab in NMOSD","The Efficacy of Slow - Tapering Versus Rapid - Tapering Glucocorticoid Strategies in Preventing Relapses of Neuromyelitis Optica Spectrum Disorder (NMOSD) When Combined With Inebilizumab: A Multicenter, Open - Label, Randomized Parallel - Controlled Clinical Trial","STARGlu-NMO","Inclusion Criteria:\n\n1. Ability and willingness to provide written informed consent and comply with the requirements of the study protocol.\n2. Age ≥18 years, regardless of sex.\n3. Diagnosis of NMOSD according to the 2015 International Panel for NMO Diagnosis (IPND) criteria.\n4. Serum AQP4-IgG antibody positivity at screening.\n5. An acute clinical attack (including the first attack) within 1 month before screening. After the acute attack was treated with high-dose corticosteroids, the current oral prednisone dose was reduced to 60 mg per day.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women planning to become pregnant during the study period.\n2. Subjects with any serious acute, chronic, or recurrent infections (e.g., pneumonia, pyelonephritis, recurrent pneumonia, chronic bronchiectasis, tuberculosis, etc.).\n3. Carriers of hepatitis B virus, or patients with chronic active hepatitis B or C, other chronic liver diseases, or HIV infection.\n4. Abnormal liver function (ALT\u002FAST \\>2 times the upper limit of normal); moderate to severe renal impairment (glomerular filtration rate \\\u003C60 mL\u002Fmin\u002F1.73 m²).\n5. Active malignancy.\n6. Severe immunodeficiency.\n7. Receipt of any B-cell depleting therapy within 6 months prior to initiation of baseline treatment, with B-cell counts below the lower limit of normal.\n8. Receipt of other investigational treatments within 30 days prior to initiation of baseline treatment.",{"count":249,"type":21},170,[56],"Neuromyelitis optica spectrum disorder (NMOSD) is a central nervous system autoimmune condition mainly involving the spinal cord, optic nerves, and area postrema. The anti-aquaporin-4 (AQP4)-Immunoglobulin G (IgG) is a specific biomarker for NMOSD. Glucocorticoids(GCs) are used as first-line treatment for NMOSD. Oral glucocorticoids tapering is always suggested following the pused therapy in the maintenance phase. Inebilizumab, a humanized monoclonal antibody targeting CD19, has been proven effective in preventing NMOSD relapses. This study aims to evaluate and compare the efficacy and differences between glucocorticoids slow-tapering and rapid-tapering strategies combined with inebilizumab in preventing relapses in AQP4-IgG-seropositive NMOSD patients following an acute attack, with the goal of determining the optimal approach to steroid tapering and discontinuation after initiation of inebilizumab.",[253,59],"Neuromyelitis Optica (NMO)",[255,61,256,257],"NMO","Inebilizumab","Glucocorticoids","2025-08-12",{"date":260,"type":35},"2025-08-20",{"date":262,"type":21},"2025-09-01",{"date":264,"type":21},"2028-08-31",{"name":41,"class":42},{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":284,"lastUpdatePostDateStruct":285,"startDateStruct":287,"completionDateStruct":289,"leadSponsor":291,"locationsCount":43},"100594649","phase-1-safety-and-efficacy-of-baff-r-cart-for-refractory-neuroimmune-diseases-100594649","NCT07022197","Safety and Efficacy of BAFF-R CART for Refractory Neuroimmune Diseases","Inclusion Criteria:\n\n1\\. Assessed by the investigator as having a refractory neuroimmune disease;\n\nRefractory neuroimmune diseases were defined as:\n\n1. Poor symptom control on at least three immunosuppressive agents for more than one year;\n2. Clinical evidence of at least two relapses within 12 months or three relapses within 24 months and one relapse within 12 months prior to screening.\n\n2\\. Male study participants must agree to use contraception during the treatment period for 1 year after receiving study treatment, and sperm donation is prohibited throughout the study period;\n\n3\\. In the case of females with childbearing potential, need to agree to use contraception during the treatment period and for at least 1 year after receiving study treatment. Participants must have a negative serum pregnancy test result at screening and a confirmed negative urine pregnancy test result prior to first CART treatment.\n\nExclusion Criteria:\n\n1. Any medical or psychiatric condition that, in the opinion of the investigator, may jeopardize the study participant or affect the study participant's ability to participate in this study;\n2. A history of drug or alcohol abuse within the 12 months prior to baseline, or any condition that in the opinion of the investigator is associated with poor adherence;\n3. Women who are breastfeeding or pregnant, or who plan to become pregnant at any time during the 12-month time period following treatment with CART, or a history of spontaneous or induced abortion within 4 weeks prior to screening;\n4. Study participants with a clinically relevant active infection (e.g., sepsis, pneumonia, or abscess) or serious infection (resulting in hospitalization or requiring antibiotic therapy) within 4 weeks prior to baseline;\n5. The study participant has received a live attenuated vaccination within 8 weeks prior to baseline; or is scheduled to receive a live vaccination (including COVID-19 vaccine) within 8 weeks after treatment;\n6. Study participants who have received prior treatment with rituximab within 6 months prior to baseline;\n7. Study participants had received tolizumab, eculizumab within 3 months prior to baseline;\n8. Study participants who have received intravenous human immunoglobulin, plasma exchange, undergone immunotherapy within 4 weeks prior to baseline;\n9. Known concomitant serious underlying diseases, such as hepatic and renal impairment, hematologic disorders, previous severe cardiovascular disease, severe hypertension, diabetes mellitus, poor control of blood pressure and blood glucose;\n10. Comorbid mental illness, suicidal ideation (affirmative answer (yes) to question 4 or question 5 of the Colombian Suicide Severity Rating Scale (C-SSRS) indicating a suicide attempt within the last 6 months);\n11. Any of the following laboratory abnormalities during the screening period (a repeat measurement may be taken during the screening period prior to randomization to confirm results); (1) Elevated liver enzymes: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 times the upper limit of normal (ULN); (2) Total bilirubin \\> 1.5 times the ULN; (3) Estimated glomerular filtration rate (eGFR) \\\u003C45 mL\u002Fmin\u002F1.73 m2; (4) CD19 + B cell count \\\u003C40 cells\u002FµL;\n12. Presence of a history of tuberculosis infection, high risk of acquired tuberculosis infection;\n13. known immunodeficiency diseases, including human immunodeficiency virus (HIV) infection;\n14. Viral hepatitis B surface antigen (HBsAg) positivity during the screening period;\n15. Receiving blood transfusion therapy 4 weeks prior to baseline or during the screening period;\n16. Any other condition that the investigator deems inappropriate for participation in the study.","60 Years",{"count":274,"type":21},27,[276,277],"PHASE1","PHASE2","This study is a phase Ib\u002FIIa dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of autologous T cells expressing chimeric antigen receptor (CAR)-targeted B-cell activating factor receptor (BAFFR) in refractory neuroimmune diseases. The study design is divided into two parts, the first of which will be given to each patient at 3 incremental dose levels to establish the maximum tolerated dose (MTD). Each disease is expected to enroll 12 patients who meet the inclusion criteria. In the second part, 15 patients per disease will be recruited to further characterize the efficacy of the MTD.",[280,281,282,283],"Chronic Inflammatory Demyelinating Polyradiculoneuropathy","NMO Spectrum Disorder","Myasthenia Gravis","Idiopathic Inflammatory Myopathies","2025-06-06",{"date":286,"type":35},"2025-06-15",{"date":288,"type":35},"2025-04-10",{"date":290,"type":21},"2027-12-30",{"name":41,"class":42},{"id":293,"slug":294,"hasResults":11,"nctId":295,"briefTitle":296,"officialTitle":296,"acronym":4,"eligibilityCriteria":297,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":272,"enrollmentInfo":298,"targetDuration":4,"studyType":22,"phases":300,"briefSummary":301,"conditions":302,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":4},"100559198","phase-1-safety-and-efficacy-of-baffr-cart-for-relapsed-refractory-neuromyelitis-optica-spectrum-disorder-100559198","NCT06561009","Safety and Efficacy of BAFFR CART for Relapsed\u002F Refractory Neuromyelitis Optica Spectrum Disorder","Inclusion Criteria:\n\n1. Male or female subjects aged 18-60 years;\n2. Patients must be diagnosed as AQP4-IgG-positive NMOSD;\n3. At least one immunosuppressant has been used for over a year with poorly controlled symptoms;\n4. Clinical evidence of at least two relapses in the last 12 months or three relapses in the last 24 months and one relapse in the preceding 12 months before screening.\n5. Subjects and their partners must be willing to use effective and reliable methods of contraception, devices or medicines, within one year before BAFFR CART cells infusion.\n6. Subjects must provide written informed consent before the study begins and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Subjects have received B cell deletion treatment within 6 months before screening;\n2. Chronic and active hepatitis B (HBV), hepatitis C (HCV), Human Immunodeficiency Virus (HIV) infection, CMV or syphilis infections concurrently.\n3. Subjects with Papovaviruses infection.\n4. Subjects have received live attenuated vaccine vaccination within 8 weeks before screening; or plan to receive live vaccine vaccination within 8 weeks after treatment;\n5. History of psychoactive drug abuse and failed to withdraw, or have a history of psychiatric disorders.\n6. Pregnant or lactating women.\n7. Subjects with severe heart, liver, kidney or bone marrow function disorder.\n8. Allergic constitution or a history of severe allergies.\n9. Subjects with conditions adjudicated by the investigator as unsuitable for lymphodepletion or cell infusion.",{"count":299,"type":21},20,[276,277],"This is an open-label, single-arm, dose-escalation study in up to 20 participants with relapsed\u002Frefractory Neuromyelitis Optica Spectrum Disorders (NMOSD). The aim is to evaluate the safety and efficacy of the treatment with BAFFR CART.",[303],"Neuromyelitis Optica Spectrum Disorder","2025-05-25",{"date":306,"type":35},"2025-05-30",{"date":308,"type":21},"2025-12-01",{"date":310,"type":21},"2028-10-01",{"name":41,"class":42},{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":316,"acronym":4,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":272,"enrollmentInfo":318,"targetDuration":4,"studyType":22,"phases":319,"briefSummary":320,"conditions":321,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":323,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":4},"100533666","autologous-hematopoietic-stem-cell-transplantation-for-refractory-multiple-sclerosis-100533666","NCT06228781","Autologous Hematopoietic Stem Cell Transplantation for Refractory Multiple Sclerosis","Inclusion Criteria:\n\n1. Age 18-60 years;\n2. Diagnosed multiple sclerosis with relapses or progression and sustained accumulated impairment by a neurologist expert in the field;\n3. EDSS score of 3-6 (including 3 and 6);\n4. EDSS cerebellar functional score ≥ 3 or EDSS pyramidal functional score ≥3；\n5. Evidence of current disease activity;\n6. If a patient has previously received a cytotoxic agent (mitoxantrone, cyclophosphamide etc.) they must have normal bone marrow morphology and cytogenetics before being considered eligible for this study ;\n7. No evidence of hepatic inflammation or fibrosis;\n\nExclusion Criteria:\n\n1. Patients with evidence of myelodysplasia or other non-autoimmune cytopenia;\n2. Patients having received a cytotoxic agent within one month of enrolling in this study;\n3. Patient with any active or chronic infection (herpes simplex virus, varicella-zoster virus, cytomegalovirus, EB virus, human immunodeficiency virus, hepatitis virus, syphilis, etc.);\n4. Patients having received a cytotoxic agent within one month of enrolling in this study;\n5. Patients with a malignant tumor currently or within the last 5 years;\n6. Patients with cardiac, renal, pulmonary, hepatic or other organ impairment;\n7. Patients whose life expectancy is severely limited by another conditions;\n8. Pregnancy or risk of pregnancy;\n9. Patients unable to give written informed consent in accordance with research ethics board guidelines.",{"count":299,"type":21},[24],"Autologous hematopoietic stem cell transplantation (aHSCT) is the only treatment for refractory autoimmune diseases capable of inducing long-term, drug-free and asymptomatic remission. Over the past two decades, aHSCT has been used to treat inflammatory autoimmune disease of the CNS. Patients with relapsing-remitting multiple sclerosis benefit from aHSCT treatment. However, a certain percentage of patients still experience recurrence 3 or 5 years after transplantation. Therefore, exploration of conditioning regimens will drive therapeutic advances in aHSCT in autoimmune diseases of the CNS.",[322],"Multiple Sclerosis",{"date":306,"type":35},{"date":325,"type":21},"2026-12-01",{"date":327,"type":21},"2029-01-01",{"name":41,"class":42},{"id":330,"slug":331,"hasResults":11,"nctId":332,"briefTitle":333,"officialTitle":333,"acronym":4,"eligibilityCriteria":334,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":335,"targetDuration":4,"studyType":22,"phases":337,"briefSummary":338,"conditions":339,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":341,"startDateStruct":343,"completionDateStruct":345,"leadSponsor":347,"locationsCount":43},"100467636","phase-2-efficacy-and-safety-of-mirabegron-in-intracerebral-hemorrhage-100467636","NCT05369351","Efficacy and Safety of Mirabegron in Intracerebral Hemorrhage","Inclusion Criteria:\n\n1. Male or female patients aged above 18 years old.\n2. The volume of the hematoma is 5-30 ml (including the cerebral cortex; Putamen, thalamus, caudate nucleus and related deep tracts; Cerebellar hemorrhage), which determined by CT scan.\n3. The onset of cerebral hemorrhage symptoms or the time from last normal to detection is not more than 72 hours.\n4. Patients with Glasgow Coma Scale (GCS) score ≥6 and \\\u003C 12.\n5. Before the onset of the disease, function was independent and mRS score\\\u003C1.\n6. Able and willing to sign written informed consent and comply with the requirements of the research protocol.\n\nExclusion criteria:\n\n1. Multifocal cerebral hemorrhage, brain stem hemorrhage, or ventricular hemorrhage.\n2. Secondary cerebral hemorrhage caused by aneurysm, brain tumor, arteriovenous malformation, thrombocytopenia, coagulation disorder, traumatic brain injury, etc.\n3. Patients who require hematoma removal surgery or other emergency surgical interventions (such as decompressive craniectomy), or who are critically ill and close to death.\n4. Patients who interfere with drug use due to nausea or vomiting.\n5. Combined with the following conditions that preclude participation in the study due to other systemic diseases: Severe hepatic or renal impairment, atrial fibrillation or tachycardia, pulmonary infection, severe urinary tract infection, severe urinary tract obstruction, medically uncontrolled hypertension (systolic blood pressure ≥180mmHg or diastolic blood pressure ≥110mmHg), pregnant and lactating women, and a history of malignant tumors within 5 years.",{"count":336,"type":21},25,[277],"Intracerebral hemorrhage (ICH) accounts for 10-15% of all strokes without effective pharmacological treatment. Inflammation following ICH contributes to barrier disruption and peri-hematoma edema, leading to deterioration of neurological function. Preclinical evidence suggests that bone marrow hematopoietic stem and progenitor cells (HSPCs) are swiftly activated after ICH. Thereafter, these HSPCs produce an increased output of anti-inflammatory monocytes as an endogenous protective mechanism. Stimulation of β3 adrenergic receptor using selective agonists promotes the production of anti-inflammatory monocytes in bone marrow, and thereby reduces neuroinflammation, brain edema and neurological deficits. This study is to assess the safety and efficacy of a β3 adrenergic receptor agonist Mirabegron as a potential treatment option in ICH patients.",[340],"Intracerebral Haemorrhage",{"date":342,"type":35},"2025-05-28",{"date":344,"type":35},"2024-01-17",{"date":346,"type":21},"2026-11-10",{"name":41,"class":42},{"id":349,"slug":350,"hasResults":11,"nctId":351,"briefTitle":352,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":355,"targetDuration":4,"studyType":22,"phases":357,"briefSummary":358,"conditions":359,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":366,"lastUpdatePostDateStruct":367,"startDateStruct":369,"completionDateStruct":371,"leadSponsor":373,"locationsCount":43},"100586156","phase-1-the-application-of-car-t-cell-therapy-in-relapsed-and-refractory-malignant-hematologic-tumors-100586156","NCT06911710","The Application of CAR-T Cell Therapy in Relapsed and Refractory Malignant Hematologic Tumors","CAR-T","Inclusion Criteria:\n\nWith their own consent and have signed an informed consent form, willing and able to comply with the planned visits, study treatment, laboratory tests and other experimental procedures; Patients with recurrent\u002Frefractory malignant hematologic tumors as determined by clinical diagnosis; Age 18 years and above, both male and female; Subjects with a physical status of 0\\~2 on the Eastern Cooperative Oncology Group (ECOG) score; Expected survival \\>3 months from the date of informed consent; HGB ≥ 60g\u002FL (transfusion is allowed); Liver and kidney function, cardiopulmonary function meet the following requirements: a) creatinine ≤1.5×ULN;b) Left ventricular ejection fraction ≥50%; c) Blood oxygen saturation \\>90%;d) Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; Subjects with pregnancy plans must agree to use contraception prior to enrollment in the study and after the study has lasted for six months; subjects should notify the investigator immediately if they become pregnant or suspect pregnancy.\n\nSubjects in the different cohorts will still be required to fulfill the following conditions:\n\nLymphoma Cohort:\n\nB-cell lymphoma Diagnosis of CD19+ and\u002For CD20+ and\u002For CD22+ and\u002For BAFF+ B-cell lymphoma confirmed by pathology and histology; Inert B-cell lymphoma (CLL, FL, MZL, LPL, HCL); Aggressive B-cell lymphoma (DLBCL, BL, MCL).\n\nMeet the following criteria for relapsed or refractory B-cell lymphoma (meet 1 of the first 2 plus 3 below):\n\nLess than 50% tumor shrinkage or disease progression after 4 courses of standard regimen regulated chemotherapy; relapse after achieving CR after standard regimen chemotherapy; subjects must have received adequate prior therapy, including at least: Anti-CD20 monoclonal antibody; Anthracycline-containing combination chemotherapy. T-cell lymphoma\n\nDiagnosis of CD7+ refractory\u002Frelapsed T-lymphocyte lymphoma confirmed by pathology and histology, meeting any of the following criteria:\n\nRelapsed: Disease relapse determined after having previously received at least two standardized treatment regimens to achieve complete remission, or disease relapse after having undergone stem cell transplantation to achieve complete remission; Refractory: previous treatment with at least two regimens and failure to achieve complete remission after the last treatment, or failure to achieve remission or disease progression after stem cell transplantation.\n\nII Acute lymphoblastic leukemia cohort:\n\nAcute B-lymphoblastic leukemia Refractory\u002Frelapsed B-lymphoblastic leukemia diagnosed as CD19+ and\u002For CD20+ and\u002For CD22+ and\u002For BAFF+ confirmed by immunohistochemistry or flow cytometry.\n\nRefractory\u002Frelapsed B-lymphoblastic leukemia (meeting 1 of the following 4 criteria is sufficient):\n\nRelapse within 6 months of first remission; first refractory without achieving complete remission with 2 cycles of standard chemotherapy regimen; failure to achieve complete remission or relapse after first or multiple lines of salvage chemotherapy; those who are not suitable for HSCT, or who have abandoned HSCT due to medical constraints, or those who have relapsed after HSCT.\n\nAcute T-lymphoblastic leukemia\n\nDiagnosis of CD7+ refractory\u002Frelapsed T-ALL\u002FLBL confirmed by immunohistochemistry or flow cytometry, meeting any of the following criteria:\n\nNo CR after standard chemotherapy; CR after first treatment, but CR lasted less than 12 months; No CR after first or more remedial therapy; Relapse two or more times.\n\nIII. multiple myeloma cohort:\n\nPositive expression of BCMA and\u002For CD19 and\u002For GPRC5D in myeloma cells by flow or immunohistochemistry; Patients with relapsed\u002Frefractory multiple myeloma who have received at least 1 prior therapy (including proteasome inhibitors (PIs) and immunomodulatory drugs (IMiDs)) or are resistant to proteasome inhibitors and\u002For immunomodulatory agents.\n\nIV. myeloid tumor cohort:\n\nPositive tumor cell antigen test results (CD7 and\u002For CD19 and\u002For CD47) confirmed by immunohistochemistry or flow cytometry; Diagnosis of myeloid tumors, including but not limited to AML and MDS, confirmed by pathology and the patient meets the following\n\nRelapse or refractory requirements:\n\nRelapse: reappearance of leukemic cells in the peripheral blood, or \\>5% of primitive cells found in the bone marrow, or extramedullary relapse after second-line or higher salvage therapy to achieve CR\u002FCRi; Refractory: failure to achieve CR\u002FCRi after at least 2 cycles of standard chemotherapy.\n\nExclusion Criteria:\n\na history of severe cardiac insufficiency with a left ventricular ejection fraction \\\u003C50%; A history of severe lung function-impairing disease; Combination of other malignant tumors in progressive stages; Combination of severe infections that cannot be effectively controlled; Combination of severe autoimmune disease or congenital immunodeficiency; Active hepatitis (Hepatitis B virus deoxyribonucleic acid \\[HBV-DNA\\] or Hepatitis C virus ribonucleic acid \\[HCV-RNA\\] test results above the lower limit of detection); Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; History of severe allergy to biological products (including antibiotics); Allogeneic hematopoietic stem cell transplantation patients who still have acute graft-versus-host reaction (GvHD) one month after stopping immunosuppressive drugs; Presence of other serious physical or mental illnesses or abnormal laboratory tests that may increase the risk of participation in the study or interfere with the results of the study, as well as patients who, in the opinion of the investigator, are not suitable for participation in this study.",{"count":356,"type":21},90,[276,277],"This study is an open, single-arm, prospective, Phase I\u002FII clinical study using \"3+3\" dose escalation and dose expansion to investigate the safety, maximum tolerated dose, in vivo pharmacokinetic profile, and preliminary efficacy of CAR-T cell injections for the treatment of relapsed\u002Frefractory malignant hematological neoplasms in subjects.",[360,361,362,363,364,365],"Lymphoma, B-cell, Aggressive Non-Hodgkin (B-NHL)","AML (Acute Myelogenous Leukemia)","Myeloma Multiple","B-ALL","T-ALL\u002FLymphoma","T-lymphocyte Lymphoma","2025-04-03",{"date":368,"type":35},"2025-04-04",{"date":370,"type":35},"2024-11-09",{"date":372,"type":21},"2027-02-28",{"name":41,"class":42},{"id":375,"slug":376,"hasResults":11,"nctId":377,"briefTitle":378,"officialTitle":378,"acronym":4,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":22,"phases":382,"briefSummary":383,"conditions":384,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":385,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":392,"locationsCount":43},"100573463","screening-and-molecular-diagnosis-based-individualized-precision-management-of-monogenic-diabetes-100573463","NCT06746610","Screening and Molecular Diagnosis-based Individualized Precision Management of Monogenic Diabetes","Inclusion Criteria:\n\n1. Diabetes patients who developed before 25 years old; Or they were diagnosed with diabetes before the age of 35, and two or more immediate relatives were diagnosed with diabetes before the age of 45;\n2. Body mass index (BMI) at diagnosis \\\u003C 28 kg\u002Fm2;\n3. Anti glutamic acid decarboxylase antibody (GAD Ab), anti islet cell antibody (ICA Ab), and anti insulin autoantibody (IAA Ab) were all negative;\n\nExclusion Criteria:\n\n1. Secondary diabetes patients with other endocrine diseases, such as hyperthyroidism or hypothyroidism, hyperparathyroidism or hypothyroidism, acromegaly, Cushing's syndrome, autoimmune multiple endocrine diseases, etc.;\n2. Systemic use of corticosteroids, immunosuppressants, and other drugs within the past 6 months;\n3. Patients with malignant tumors.",{"count":381,"type":21},2000,[24],"The goal of this observational study is to establish a registry, screening, and individualized management platform for patients with monogenic diabetes mellitus(MDM) using internet-based and mobile application software. The main questions it aims to answer are:\n\n* What are the genetic mutations causing MDM in China (genetic landscape)?\n* How effective and safe is the individualized, molecular-diagnosis-based management platform for MDM in improving patient outcomes?\n\nParticipants will:\n\n* Register in the MDM platform via mobile app or internet-based software\n* Undergo genetic screening for MDM diagnosis\n* Participate in follow-up visits for individualized management and monitoring of blood glucose control and outcomes",[184],"2024-12-18",{"date":387,"type":35},"2024-12-24",{"date":389,"type":35},"2022-08-01",{"date":391,"type":21},"2027-07-31",{"name":41,"class":42},{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":397,"acronym":4,"eligibilityCriteria":398,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":22,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":43},"100500146","phase-1-efficacy-and-safety-of-baricitinib-in-neuromyelitis-optica-spectrum-disorders-100500146","NCT05792462","Efficacy and Safety of Baricitinib in Neuromyelitis Optica Spectrum Disorders","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years old;\n2. Diagnosis of NMO or NMO spectrum disorder according to the 2015 International Panel for Neuromyelitis Optica Diagnosis criteria;\n3. Clinical evidence of either at least one attack requiring rescue therapy (intravenous corticosteroids, intravenous immunoglobulin, plasma exchange, or a combination of these therapies) in the year before screening or at least two attacks requiring rescue therapy in the 2 years before screening;\n4. EDSS \\\u003C=6.0;\n5. Patients were seropositive for AQP4-IgG;\n6. Able and willing to give written informed consent and comply with the requirements of the study protocol.\n\nExclusion Criteria:\n\n1. Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus, human immunodeficiency virus, Hepatitis viruses, Syphilis, etc);\n2. Participation in another interventional trial within the last 3 months Tumor disease currently or within last 5 years;\n3. Pregnant, breastfeeding, or child-bearing potential during the course of the study Clinically relevant heart, liver, kidney or bone marrow function disorder.\n4. Have a history of venous thromboembolism (VTE), or are considered at high risk for VTE by the investigator.","85 Years",{"count":401,"type":21},12,[276,277],"Neuromyelitis Optica Spectrum Disorders (NMOSD) is associated with a pathological humoral immune response against the aquaporin-4(AQP-4) water channel. Baricitinib is an oral Janus kinase (JAK)1\u002FJAK2 inhibitor that blocks the upregulated JAK-STAT pathway in patients with neuroimmune disorders, which is important in bone marrow regulation of B cell proliferation and differentiation. Baricitinib may benefit some patients with NMOSD due to the important role of B cells in the pathogenesis of NMOSD. Clinical trials may be needed to observe its efficacy and safety.",[281],"2024-10-13",{"date":407,"type":35},"2024-10-16",{"date":409,"type":35},"2023-04-15",{"date":411,"type":21},"2025-12-30",{"name":41,"class":42},{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":16,"minAge":420,"maxAge":17,"enrollmentInfo":421,"targetDuration":4,"studyType":22,"phases":423,"briefSummary":424,"conditions":425,"keywords":427,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":432,"lastUpdatePostDateStruct":433,"startDateStruct":435,"completionDateStruct":437,"leadSponsor":439,"locationsCount":43},"100524446","esketamine-combined-with-remimazolam-on-postoperative-sleep-disturbance-and-anxiety-in-patients-100524446","NCT06108830","Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients","Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies","Inclusion Criteria:\n\n1. Age 20-65 years old;\n2. ASA classification is grade I-III;\n3. Elective surgery is proposed\n4. BMI of 19-30 kg\u002Fm2;\n5. Patients who agreed to enroll in this study voluntarily\n\nExclusion Criteria:\n\n1. Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;\n2. Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;\n3. History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery;\n4. ASA rating of IV or V;\n5. Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;\n6. History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);\n7. Respiratory insufficiency, respiratory failure;\n8. Patients who refused to use intravenous PCA for analgesia;\n9. Pregnant or lactating women;\n10. BMI\\\u003C18 kg\u002Fm2 or BMI\\>30kg\u002Fm2;\n11. Poor compliance, unable to complete the experiment according to the study plan;\n12. Participants who have participated in clinical trials of other drugs within the last 4 weeks;\n13. Any circumstances deemed unsuitable for inclusion by the researcher for any reason.","20 Years",{"count":422,"type":21},400,[24],"To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies",[426],"Sleep Disturbance",[428,429,430,431],"Esketamine","remimazolam","anxiety","gastroenteroscopy","2024-09-01",{"date":434,"type":35},"2024-09-04",{"date":436,"type":35},"2023-12-01",{"date":438,"type":21},"2024-12-10",{"name":41,"class":42},{"id":441,"slug":442,"hasResults":11,"nctId":443,"briefTitle":444,"officialTitle":444,"acronym":445,"eligibilityCriteria":446,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":4,"enrollmentInfo":447,"targetDuration":4,"studyType":22,"phases":449,"briefSummary":450,"conditions":451,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":43},"100558260","phase-1-efficacy-and-safety-of-baricitinib-in-the-post-intracerebral-hemorrhage-pulmonary-injury-100558260","NCT06548802","Efficacy and Safety of Baricitinib in the Post-intracerebral Hemorrhage Pulmonary Injury","BRIGHT","Inclusion Criteria:\n\n1. Male or female patients ≥ 18 years old;\n2. The diagnosis was non-traumatic intracerebral hemorrhage, subarachnoid hemorrhage (including supratentorial deep hemorrhage, lobal hemorrhage, cerebellar hemorrhage, brainstem hemorrhage, intracerebral hemorrhage, intracerebral parenchymal hemorrhage into ventricle, subarachnoid hemorrhage), which was confirmed by CT scan.\n3. Onset of ARDS within 48 hours to 7 days after admission (as defined by Berlin) : ① Patients with moderate to severe ARDS symptoms or progressive dyspnea within 7 days (100mmHg \\\u003C PaO2\u002FFiO2≤200, PEEP≥5cmH2O); ② Hypoxemia: SpO2\u002FFiO2≤315mmHg and SpO2≤97%, and could not be explained by acute heart failure and fluid overload; ③ Need intubation or mechanical ventilation; ④ Imaging findings (chest X-ray\u002Fchest CT) : infiltration of both lungs, cannot be completely explained by pleural effusion, lobar\u002Fwhole lung atelectasis and nodule;\n4. There was no uncured pneumonia, interstitial lung disease, or chronic respiratory failure before the onset of the disease.\n5. Able and willing to sign written informed consent and comply with the requirements of the research protocol.\n\nExclusion Criteria:\n\n1. Patients diagnosed with severe intracerebral hemorrhage requiring surgical intervention with decompressive craniotomy or critically ill, near death;\n2. Diagnosis of aneurysm, brain tumor, arteriovenous malformation requires surgery;\n3. Recently received live or attenuated vaccine; other JAK inhibitors or other organisms are being used, or enrolled in other clinical trials;\n4. Combine the following cases that are not eligible to participate in this study: ① Severe hepatic insufficiency (ALT\u002FAST \\> 5xULN); ② Moderate to severe renal insufficiency (eGFR \\\u003C 60ml\u002Fmin\u002F1.73m2); ③ Undergoing hemodialysis or hemofiltration; ④ Neutrophils or lymphocytes decreased (Absolute neutrophil count \\\u003C 1000\u002Ful, absolute lymphocyte count \\\u003C 200\u002Ful); ⑤ During pregnancy or childbirth;\n5. Venous thromboembolism or risk of thrombosis;\n6. Life expectancy after enrollment ≤24h.",{"count":448,"type":21},100,[276,277],"Some patients with intracerebral hemorrhage will develop severe lung injury such as respiratory distress syndrome. Baricitinib has been approved by the FDA for severe pneumonia caused by the coronavirus, and has been used in the treatment of hospitalized patients with COVID-19. Baricitinib significantly reduced the risk of death and shortened the length of stay in COVID-19 patients. According to clinical observations, there was no significant increase in deaths or infections due to non-COVID-19 causes during recovery, nor was there a significant increase in thrombosis. Excessive inflammatory factors release can cause inflammatory storms that damage lung cells, lead to lung injury, and eventually lead to respiratory failure, respiratory distress syndrome and other conditions, endangering life safety. Studies have shown that Baricitinib can inhibit the production of excessive pro-inflammatory cytokines by lung macrophages through the JAK pathway and reduce lung injury caused by inflammatory storms. Therefore, in patients with acute stroke with lung infection or severe lung injury, short-term use of baricitinib will help to reduce lung injury and promote the recovery of neurological function, and shorten the length of hospital stay. However, there is currently a lack of effective clinical evidence of baricitinib in the treatment of lung injury after intracerebral hemorrhage, and further research is needed.",[452],"Pulmonary Injury After Intracerebral Hemorrhage","2024-08-07",{"date":455,"type":35},"2024-08-12",{"date":457,"type":35},"2024-02-29",{"date":459,"type":21},"2026-06",{"name":41,"class":42},{"id":462,"slug":463,"hasResults":11,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":132,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":475,"lastUpdatePostDateStruct":476,"startDateStruct":478,"completionDateStruct":480,"leadSponsor":482,"locationsCount":4},"100554306","phase-2-fcrn-antagonists-efgartigimod-for-acute-nmosd-attack-100554306","NCT06497374","FcRn Antagonists (Efgartigimod) for Acute NMOSD Attack","FcRn Antagonists (Efgartigimod) for Acute Neuromyelitis Optica Spectrum Disorders (NMOSD) Attack: a Phase 2, Randomized Controlled Trial.","FACT","Inclusion Criteria:\n\n1. Male or female, ages 18 to 75.\n2. Meet the 2015 International Panel of Experts (IPND) diagnostic criteria for neuromyelitis optica spectrum disorders.\n3. Acute EDSS nadir of 2.5-7.5, and a change of at least 0.5 points from baseline due to an acute relapse event.\n4. Confirmation of serum AQP4-IgG antibody positivity using the CBA assay.\n5. Confirmation of an acute attack of neuromyelitis optica spectrum disorders either with an acute optic neuritis and\u002For acute myelitis, defined as a worsening in the patient's signs and symptoms of neurological\u002Fvisual impairment, an increase in the EDSS score, and symptoms lasting more than 24 hours and occurring more than 1 month since the last attack. Combination of imaging and clinical evaluation will be used to assess relapse and rule out a pseudorelapse.\n6. New lesions or enhanced lesions need to be found in MRI.\n7. Subjects who were receiving immunosuppressive therapy prior to the screening period will be required to agree to discontinue immunosuppression.\n8. Treatment is stable at least 3 months.\n\nExclusion Criteria:\n\n1. Other core clinical symptoms besides optic neuritis and myelitis.\n2. Severe neuromyelitis optica spectrum disorder attack, which in the judgment of the investigator is not appropriate for this study. Severe is defined as requiring assisted ventilation or likely to require assisted ventilation during the study based on the judgment of the investigator.\n3. Subjects with total IgG levels ≤ 6 g\u002FL at screening.\n4. Subjects with a B-cell count ≤ 5% of the lower limit of normal at screening.\n5. Received high-dose intravenous methylprednisolone within 4 weeks prior to the screening period.\n6. Received intravenous immunoglobulin, plasma exchange, or immunoadsorption treatment within 4 weeks prior to the screening period.\n7. Received a vaccination within the first 4 weeks of the screening period or planned during the study.\n8. Using of a monoclonal antibody or investigational drug not mentioned above that has immunomodulatory effects within 3 months or 5 half-lives (whichever is longer) prior to the screening period.\n9. Subject is known to be allergic to any component of the study drug or any other FcRn drug or contrast medium for enhanced MRI.\n10. Subject is known to have contraindications to taking methylprednisolone (for subjects in A and B group).\n11. Subjects with clinically significant active infections (including unresolved or inadequately treated infections, including active tuberculosis) as assessed by the investigator.\n12. Subjects with positive screening tests for hepatitis B and C who have received live or live attenuated vaccine within 6 weeks prior to baseline.\n13. Subjects is known unable to taken MRI.\n14. Subjects is known to have other ophthalmic disease that affect vision as assessed by the investigator.",{"count":470,"type":21},63,[277],"NMOSD is an autoimmune disease of the central nervous system that predominantly affects the spinal cord and optic nerves. The objectives of this study are to assess the efficacy and safety of FcRn antagonists (efgartigmod) for treatment of patients with neuromyelitis optica spectrum disorders during acute phase who are anti-aquaporin-4 (AQP4) antibody-positive. The potential of efgartigimod, an IgG1 Fc fragment that competes with IgG for FcRn binding, thereby lowering IgG levels, warrants further investigation as a treatment for acute neuromyelitis optica spectrum disorders attacks. This study aims to evaluate the therapeutic potential of efgartigmod in acute NMOSD attack.",[474,303,281],"Neuromyelitis Optica","2024-07-04",{"date":477,"type":35},"2024-07-11",{"date":479,"type":21},"2024-07-05",{"date":481,"type":21},"2026-06-30",{"name":41,"class":42},{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":487,"acronym":4,"eligibilityCriteria":488,"healthyVolunteers":11,"sex":16,"minAge":52,"maxAge":272,"enrollmentInfo":489,"targetDuration":4,"studyType":22,"phases":490,"briefSummary":491,"conditions":492,"keywords":4,"overallStatus":67,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":499,"leadSponsor":500,"locationsCount":43},"100541253","phase-2-evaluate-the-efficacy-and-safety-of-atorvastatin-combined-with-temozolomide-in-the-treatment-of-glioblastoma-100541253","NCT06327451","Evaluate the Efficacy and Safety of Atorvastatin Combined With Temozolomide in the Treatment of Glioblastoma","Inclusion Criteria:\n\n1. age ≥18 years old and \\\u003C 60 years old, both sexes;\n2. sufficient evidence of glioma by MRI scan;\n3. According to the 2021 WHO latest classification, the molecular pathology of postoperative glioma samples was diagnosed as WHO 4 glioblastoma;\n4. The immunohistochemical results of postoperative glioma samples showed that EGFR score was 3 (standard: 0 was negative, 1-3 was positive);\n5. normal blood routine and liver function;\n6. fully understand the nature of the trial and sign the informed consent;\n7. be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures;\n8. no serious diseases or accidents requiring surgery;\n9. normal immune function.\n\nExclusion Criteria:\n\n1. allergy to atorvastatin or its components;\n2. concomitant use of clarithromycin, itraconazole, ritonavir, saquinavir, lopinavir, cyclosporine, rifampicin, efavirenz, digoxin, warfarin, oral contraceptives;\n3. other tumors (except glioma), hematological diseases or other known multiple organ failure, history of myasthenia gravis, heart failure, cerebral hernia and other serious complications;\n4. History of cardiac insufficiency, arrhythmia, retinopathy, acute hepatic porphyrin, hepatic and renal insufficiency, obesity, uncontrolled diabetes and other metabolic diseases;\n5. abnormal liver function or liver disease, including uncontrolled hepatitis;\n6. other diseases that might interfere with the study, as determined by 2 attending neurosurgeons;\n7. patients enrolled in a clinical trial within the past 4 weeks;\n8. pregnant or lactating patients;\n9. patients with poor compliance who could not complete the treatment;\n10. other conditions that made the patient ineligible for enrollment as determined by the study investigator;\n11. patients with a history of HIV and\u002For HBV\u002FHCV or presence of HIV\u002FHCV;\n12. patients with a history of tuberculosis or known existence of tuberculosis;\n13. patients with severe infection or signs\u002Fsymptoms of infection within 2 weeks before the first dose of study drug;\n14. patients who received live attenuated vaccine within 4 weeks before the first dose of study drug;\n15. patients with previous solid organ transplantation or hematopoietic stem cell transplantation.\n\nThose who meet any of the above criteria will not be selected.",{"count":134,"type":21},[277],"Glioblastoma (GBM) is the primary intracranial malignant tumor with the highest morbidity and mortality, and the 5-year survival rate is less than 10%. The number of primary diagnostic patients and deaths of GBM in China ranks first in the world every year, which seriously threatens people's life and health. At present, the clinical treatment strategy of maximum surgical resection combined with concurrent chemo- and radio-therapy and TTF treatment is still not satisfactory, and the median survival time of GBM patients is only 14.4 months. Statins inhibit cholesterol production with few side effects and are widely used for cholesterol control in patients with hyperlipidemia. In recent years, statins have shown good anti-tumor effect. Our previous study found that statins can block the malignant progression of glioma mediated by EGFR pathway. Therefore, the investigators report a clinical study protocol designed to evaluate the clinical efficacy of a comprehensive treatment strategy of atorvastatin (ATO) combined with temozolomide (TMZ) in primary and recurrent glioblastomas with high EGFR expression.\n\nThe investigators designed a multicenter, single-arm, double-blind, phase II clinical trial to evaluate the efficacy and safety of oral ATO combined with TMZ in EGFR-high expressing GBM. After informed consent was signed by the patient or authorized family members, the patients were treated with the current STUPP regimen and ATO (20mg, qn) orally. The patients were regularly followed up for 52 weeks after treatment. The primary endpoint was progression-free survival (PFS), which was defined as the time from the start of GBM surgery to tumor progression (recurrence) or death. The secondary end point was the rate of tumor control, which was defined as the proportion of patients with a complete response, a partial response, or a stable disease that had shrunk or remained stable for a given period of time. Safety will be assessed during the study by monitoring of regular MRI scans, laboratory tests (liver function, lipid profile, blood routine), electrocardiography, vital signs (blood pressure, pulse, temperature), and weight.\n\nThe results of this clinical trial will provide key information on whether the oral combination of atorvastatin and temozolomide prolongs PFS in EGFR-high GBM patients with efficacy and safety.",[493],"Glioblastoma, IDH-wildtype","2024-03-21",{"date":496,"type":35},"2024-03-25",{"date":498,"type":21},"2024-04-01",{"date":372,"type":21},{"name":41,"class":42},""]