[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shanxi Bethune Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":451},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,44,70,95,119,140,160,185,207,228,249,271,289,308,332,357,380,408,428],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":21,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100632466","predicting-response-to-selinexor-based-therapy-in-relapsedrefractory-multiple-myeloma-a-multicenter-prospective-study-100632466",false,"NCT07514052","Predicting Response to Selinexor-Based Therapy in Relapsed\u002FRefractory Multiple Myeloma: A Multicenter Prospective Study","Efficacy Prediction of Selinexor-Based Regimens in Relapsed\u002FRefractory Multiple Myeloma Based on Differential Multigene Expression: A Multicenter Prospective Clinical Study","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of multiple myeloma (MM) based on bone marrow aspiration or biopsy, in accordance with the International Myeloma Working Group (IMWG) criteria.\n2. Patients with relapsed\u002Frefractory MM after 2-4 prior lines of therapy.\n3. Age ≥18 years.\n4. Provision of written informed consent, with willingness to participate in the study and to provide relevant clinical samples and follow-up information.\n\nExclusion Criteria:\n\n1. Patients with relapsed MM whose toxicities from prior chemotherapy have not recovered to baseline or ≤ Grade 1.\n2. Presence of other active malignancies or severe systemic diseases (e.g., significant cardiovascular or cerebrovascular disease, hepatic or renal insufficiency) that may affect study outcomes or limit tolerance to treatment or follow-up.\n3. Prior history of bone marrow transplantation or other treatments that may affect the bone marrow microenvironment or immune function within 6 months before study initiation.\n4. Known hypersensitivity to selinexor, ixazomib, or any components of the study drugs, or a history of severe allergic reactions.\n5. Known human immunodeficiency virus (HIV) infection (HIV antibody positive).\n6. Participation in another clinical trial within 30 days prior to study initiation or during the study period.\n7. Pregnant or breastfeeding women.\n8. Patients with psychiatric disorders or those unable to comply with study procedures.","ALL","18 Years",{"count":19,"type":20},127,"ESTIMATED","1 Year","OBSERVATIONAL","Background:\n\nRelapsed\u002Frefractory multiple myeloma (RRMM) remains a major clinical challenge due to treatment resistance and disease heterogeneity. Selinexor-based regimens have demonstrated promising efficacy; however, predictive biomarkers for treatment response are still lacking. This study aims to evaluate the predictive value of differential multigene expression in RRMM patients treated with selinexor-based therapy.\n\nMethods:\n\nThis is a multicenter, prospective clinical study enrolling 127 patients with RRMM. Eligible patients are aged ≥18 years, have a confirmed diagnosis of multiple myeloma based on International Myeloma Working Group (IMWG) criteria, and have received 2-4 prior lines of therapy. Key exclusion criteria include unresolved toxicities from prior treatments, severe comorbidities, prior bone marrow transplantation within 6 months, hypersensitivity to study drugs, HIV infection, pregnancy or lactation, and participation in other clinical trials within 30 days.\n\nAll patients receive a selinexor-based regimen consisting of selinexor 60 mg orally once weekly (Day 1 of each week) in combination with standard agents. Each treatment cycle lasts 28 days. Treatment response is assessed every two cycles using bone marrow examination, M-protein quantification, and imaging studies. After treatment completion, patients are followed every 3 months for up to 2 years.\n\nEndpoints:\n\nThe primary endpoint is overall response rate (ORR) after two treatment cycles. Secondary endpoints include progression-free survival (PFS), overall survival (OS), and safety. Exploratory endpoints focus on the association between the expression levels of candidate genes (hnRNPU, IRF3, ALB2RP, ZBTB17, ATRX, ABCC4, ASB8, and E2F1) and ORR following two cycles of selinexor-based therapy.\n\nStatistical Analysis:\n\nStatistical analyses are performed using Excel 2019 and SPSS 26.0. Continuous variables are tested for normality using the Shapiro-Wilk test and Q-Q plots. Normally distributed data are presented as mean ± standard deviation, while non-normally distributed data are described using median and interquartile range (IQR). Categorical variables are expressed as counts and percentages. Logistic regression analysis is used to evaluate factors associated with ORR. Survival outcomes (PFS and OS) are estimated using the Kaplan-Meier method. All statistical tests are two-sided, and a P-value \\\u003C0.05 is considered statistically significant.\n\nEthics and Timeline:\n\nThe study is conducted in accordance with ethical principles, and all patients provide written informed consent. Patient enrollment is planned from January 2026 to January 2027, with final data analysis expected in 2027. The total study duration is 2 years.\n\nConclusion:\n\nThis study aims to identify potential gene expression biomarkers predictive of response to selinexor-based therapy in RRMM, which may contribute to individualized treatment strategies and improved clinical outcomes.",[25],"Multiple Myeloma of Bone",[27,28,29,30],"Selinexor","Relapsed\u002FRefractory Multiple Myeloma","Multigene Expression","Biomarkers","RECRUITING","2026-03-31",{"date":34,"type":35},"2026-04-07","ACTUAL",{"date":37,"type":35},"2026-01-01",{"date":39,"type":20},"2027-04-30",{"name":41,"class":42},"Shanxi Bethune Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":52,"targetDuration":54,"studyType":22,"phases":4,"briefSummary":55,"conditions":56,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":43},"100631168","epunamin-combined-with-decp-for-relapsedrefractory-multiple-myeloma-100631168","NCT07497165","Epunamin Combined With DECP for Relapsed\u002FRefractory Multiple Myeloma","A Multicenter Real-World Study Evaluating Epunamin in Combination With a DECP-Based Regimen for Relapsed\u002FRefractory Multiple Myeloma","Inclusion Criteria:\n\nAdults aged 18 to 75 years with relapsed\u002Frefractory Multiple Myeloma diagnosed according to revised IMWG criteria.\n\nReceived at least one prior systemic treatment regimen. Eastern Cooperative Oncology Group Performance Status score of 0-3. Able to understand treatment-related changes and management options during therapy and follow-up, with good treatment adherence and follow-up compliance.\n\nProvided written informed consent. -\n\nExclusion Criteria:\n\nSevere dysfunction of major organs, including cardiac, pulmonary, hepatic, or renal impairment, defined as left ventricular ejection fraction \\\u003C50%, diffusion capacity for carbon monoxide \\\u003C50% of predicted value due to chronic respiratory disease, serum bilirubin \\>2 mg\u002FdL, alanine aminotransferase or aspartate aminotransferase \\>2.5 × upper limit of normal, or estimated glomerular filtration rate \\\u003C30 mL\u002Fmin.\n\nToxicities from prior chemotherapy not recovered to baseline or grade ≤1. Peripheral neuropathy grade ≥2, or grade 1 with pain. Major surgery, radiotherapy, infection requiring systemic antibiotic treatment, or other severe infection within 14 days before enrollment.\n\nHigh-risk plasma cell leukemia with peripheral blood plasma cells ≥20%. Psychiatric disorders, cognitive impairment, or other conditions affecting self-control or study compliance.\n\nPregnant or breastfeeding women, or fertile patients unwilling to use adequate contraception during the study. Male patients unwilling to use effective contraception or refrain from sperm donation during treatment and for 3 months after the last dose.\n\nDiagnosis or treatment of another malignancy within 2 years before enrollment. Known hypersensitivity to Epunamin, Dexamethasone, Cisplatin, Etoposide, or Cyclophosphamide.\n\nHuman Immunodeficiency Virus Infection positive. Participation in another clinical trial within 30 days before enrollment or during the study period.\n\nAny condition considered unsuitable for participation by the investigator.","75 Years",{"count":53,"type":20},48,"17 Months","Background:\n\nMultiple Myeloma remains an incurable hematologic malignancy, and outcomes for relapsed\u002Frefractory multiple myeloma (RRMM) remain unsatisfactory despite advances in therapy. This study aims to evaluate the efficacy and safety of Epunamin combined with a DECP-based regimen in a real-world clinical setting.\n\nMethods:\n\nThis multicenter, single-arm, real-world observational study will enroll 48 patients aged 18-75 years with RRMM diagnosed according to revised IMWG criteria who have received at least one prior systemic treatment. Eligible patients must have an ECOG performance status of 0-3, adequate treatment compliance, and written informed consent.\n\nKey exclusion criteria include severe cardiac, pulmonary, hepatic, or renal dysfunction; unresolved prior treatment toxicity above grade 1; grade ≥2 peripheral neuropathy or grade 1 with pain; severe infection within 14 days; plasma cell leukemia; psychiatric disorders affecting compliance; pregnancy or lactation; recent other malignancies; hypersensitivity to study drugs; HIV infection; participation in another clinical trial within 30 days; or any condition deemed unsuitable by investigators.\n\nEndpoints:\n\nThe primary endpoint is overall response rate (ORR) after four treatment cycles. Secondary endpoints include very good partial response (VGPR), complete response (CR), stringent complete response (sCR), minimal residual disease (MRD), duration of response (DOR), and time to next treatment (TTNT), assessed according to revised IMWG criteria.\n\nStatistical Analysis:\n\nContinuous variables will be summarized using mean, median, standard deviation, minimum, and maximum values. Normally distributed data will be analyzed using Student's t-test or ANOVA, while non-normally distributed data will use rank-sum tests. Categorical variables will be analyzed using chi-square or Fisher's exact tests, and ordinal variables by Ridit analysis or nonparametric tests. Survival outcomes including progression-free survival (PFS) and overall survival (OS) will be estimated using Kaplan-Meier analysis and compared by log-rank test. A two-sided P value \\\u003C0.05 will be considered statistically significant.\n\nStudy Period:\n\nOctober 2025 to September 2027.",[57,58],"Relapsed\u002FRefractory Multiple Myeloma (RRMM)","Multiple Myeloma",[60,61,58],"Epunamin","DECP-Based Regimen","2026-03-23",{"date":64,"type":35},"2026-03-27",{"date":66,"type":35},"2025-11-01",{"date":68,"type":20},"2027-06-30",{"name":41,"class":42},{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":4},"100621508","clinical-study-of-recombinant-anti-cd19m-cd3-antibody-injection-a-319-100621508","NCT07371533","Clinical Study of Recombinant Anti-CD19m-CD3 Antibody Injection (A-319)","Recombinant Anti-CD19m-CD3 Antibody Injection (A-319) for Refractory\u002FRelapsed or MRD-Positive After Induction Chemotherapy Acute B-Cell Lymphoblastic Leukemia (B-ALL) Clinical Study","A-319","Inclusion Criteria:\n\nAll of the following criteria must be met for refractory\u002Frelapsed acute B-cell lymphoblastic leukemia:\n\n* 1.Aged 18 to 75 years (inclusive), regardless of gender;\n* 2.Confirmed diagnosis of refractory or relapsed acute B-cell lymphoblastic leukemia (B-ALL) with positive CD19 expression. Definition of refractory or relapsed: failure to respond to conventional induction chemotherapy; early relapse (relapse within 12 months of first remission); relapse after 12 months of first remission with failure to achieve remission following re-induction with the original regimen; second or subsequent relapse, relapse after autologous hematopoietic stem cell transplantation (Auto-HSCT), or relapse after allogeneic hematopoietic stem cell transplantation (Allo-HSCT). (For patients with Philadelphia chromosome-positive \\[Ph+\\] disease, they must have received treatment with at least one tyrosine kinase inhibitor \\[TKI\\].);\n* 3.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* 4.Bone marrow blast percentage of at least 5% (determined by morphology);\n* 5.Expected life expectancy of at least 3 months;\n* 6.Ability to sign the informed consent form and comply with protocol requirements; if the patient is unable to sign, their legal guardian or representative must sign on their behalf.\n\nAll of the following criteria must be met for acute B-cell lymphoblastic leukemia (B-ALL) with positive minimal residual disease (MRD) despite achieving complete remission (CR) via induction chemotherapy:\n\n* 1.Aged 18 to 75 years (inclusive), regardless of gender;\n* 2.Confirmed diagnosis of acute B-cell lymphoblastic leukemia (B-ALL) with positive CD19 expression;\n* 3.B-ALL that has achieved complete morphological remission (CR) via at least 2 cycles of induction chemotherapy# but remains minimal residual disease (MRD)-positive. MRD positivity is defined as detectable nucleated blast cells ≥ 10-⁴. (For patients with Philadelphia chromosome-positive \\[Ph+\\] disease, they must have received treatment with tyrosine kinase inhibitors \\[TKIs\\] combined with chemotherapy);\n* 4.Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 2;\n* 5.Ability to sign the informed consent form and comply with protocol requirements; if the patient is unable to sign, their legal guardian or representative must sign on their behalf.\n\nExclusion Criteria:\n\n* 1.Central nervous system (CNS) leukemia (confirmed by cerebrospinal fluid \\[CSF\\] analysis) or acute lymphoblastic leukemia (ALL) with clinically relevant CNS involvement;\n* 2.Burkitt's leukemia, testicular infiltration in acute lymphoblastic leukemia (ALL);\n* 3.A history of malignancy other than ALL within 5 years prior to the initiation of protocol-specific treatment. Exceptions include: malignancies treated with curative intent, with no known active disease for 5 years before enrollment, and deemed by the treating physician to have a low recurrence risk; non-melanoma skin cancer or lentigo maligna that has been adequately treated with no evidence of recurrence; carcinoma in situ of the cervix that has been adequately treated with no evidence of recurrence; ductal carcinoma in situ of the breast that has been adequately treated with no evidence of recurrence;and prostatic intraepithelial neoplasia with no evidence of prostate cancer;\n* 4.Patients with grade 2-4 acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (Allo-HSCT), or those with chronic GVHD requiring immunosuppressive therapy;\n* 5.Receipt of autologous hematopoietic stem cell transplantation (Auto-HSCT) within 6 weeks, or allogeneic hematopoietic stem cell transplantation (Allo-HSCT) within 3 months, prior to the start of study drug treatment;\n* 6.Concurrent chemotherapy, radiotherapy, or systemic treatment for GVHD within 2 weeks prior to the start of study drug treatment;\n* 7.Patients with diseases, medical conditions, or social factors that, in the investigator's judgment, may affect study results or compliance. The protocol specifies the following conditions that disqualify patients from participating in the study: uncontrolled acute infection or confirmed bacteremia; known human immunodeficiency virus (HIV) infection, or acute hepatitis B or hepatitis C; patients with severe dyspnea, impaired pulmonary function, or requiring continuous oxygen supplementation; New York Heart Association (NYHA) heart failure classification of grade 3 or 4; myocardial infarction, unstable angina, stroke, transient ischemic attack, severe arrhythmia, or uncontrolled hypertension (systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg) within 6 months prior to drug administration;\n* 8.Laboratory test requirements are as follows: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN), or \\> 5 × ULN if liver metastasis is present; total bilirubin \\> 1.5 × ULN;creatinine clearance \\\u003C 50 mL\u002Fmin (calculated using the Cockroft-Gault formula); coagulation function: International Normalized Ratio (INR) \\> 1.6 (unless on anticoagulant therapy);for patients on oral anticoagulant therapy with a stable dose (for at least 14 days) (e.g., warfarin), INR must be ≤ 3.0 with no bleeding tendency (i.e., no bleeding within 14 days prior to the first dose of the study drug); use of low-molecular-weight heparin is permitted for subjects;\n* 9.Previous receipt of anti-CD19 therapy (including CAR-T cell therapy), or immunotherapy (e.g., rituximab) within 4 weeks prior to A-319 treatment;\n* 10:Presence of adverse events (except alopecia) caused by anti-tumor treatment that have not resolved to grade 1;\n* 11.Pregnant women (positive pregnancy test), lactating women, or women of childbearing potential who refuse to use contraception from the time of signing the informed consent form until at least 3 months after the end of the study; women of childbearing potential must have a positive pregnancy test (human chorionic gonadotropin \\[HCG\\] test) within 7 days prior to Day 1 of treatment;\n* 12.Male patients (except those who have undergone surgical sterilization) who refuse to use contraception from the time of signing the informed consent form until at least 3 months after the end of the study;\n* 13.Known hypersensitivity to the study drug or its excipients;\n* 14.Patients deemed unsuitable for participation in this study by the investigator.",{"count":79,"type":20},18,"INTERVENTIONAL",[82],"NA","This is an exploratory study with an open-label, single-arm, single-center design. It plans to enroll subjects with refractory\u002Frelapsed acute B-cell lymphoblastic leukemia (B-ALL), or treatment-naive or previously treated B-ALL subjects who achieved complete remission (CR) after induction chemotherapy but still have positive minimal residual disease (MRD). The primary objectives are to preliminarily evaluate the safety, tolerability, pharmacokinetics, biology, preliminary efficacy, and immunogenicity of A-319 subcutaneous injection.",[85],"Acute Lymphocytic Leukemia","NOT_YET_RECRUITING","2026-01-19",{"date":89,"type":35},"2026-01-28",{"date":91,"type":20},"2026-02-02",{"date":93,"type":20},"2028-01-31",{"name":41,"class":42},{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":4,"eligibilityCriteria":101,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":102,"targetDuration":4,"studyType":80,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":116,"leadSponsor":118,"locationsCount":43},"100613319","integrated-tcm---western-medicine-strategy-for-long---distance-diabetes-management-100613319","NCT07265037","Integrated TCM - Western Medicine Strategy for Long - Distance Diabetes Management","Development of a New Integrated Strategy for Long-Distance and Full-Course Management of Diabetes Using Both Traditional Chinese and Western Medicine: A Combined Online and Offline Approach","Inclusion Criteria:\n\n* Presence of typical diabetes symptoms (polyuria, polydipsia, polyphagia, and unexplained weight loss) AND meeting any one of the following laboratory criteria: Fasting venous plasma glucose ≥ 7.0 mmol\u002FL, or Random plasma glucose ≥ 11.1 mmol\u002FL, or Glycated hemoglobin (HbA1c) ≥ 6.5%.\n* OR, meeting the following oral glucose tolerance test criteria:Fasting plasma glucose ≥ 7.0 mmol\u002FL AND 2-hour plasma glucose ≥ 11.1 mmol\u002FL after a 75g glucose load.\n\nExclusion Criteria:\n\n* Comorbidities that may prevent compliance with the study protocol, including but not limited to: active malignancy, rheumatic autoimmune diseases, severe infections, multiple organ failure, or psychiatric disorders.",{"count":103,"type":20},10000,[82],"The management of diabetes is of great value in reducing the risk of complications and alleviating the socioeconomic burden. Currently, the diabetes management models in China have not effectively integrated the advantages of traditional Chinese medicine (TCM) and Western medicine. They also fail to achieve intelligent and automated management, resulting in high management costs and low efficiency. Therefore, it is extremely urgent to explore a new, efficient, convenient, low - cost, and personalized long - distance, full - course, intelligent management model for diabetes that integrates TCM and Western medicine both online and offline.\n\nBased on this, our research group plans to rely on the pre - designed and developed Idata database. We will deeply integrate the diagnostic and treatment advantages of TCM constitution differentiation and Western medical examinations and laboratory tests, construct an automated follow - up path, and build an integrated online diabetes management platform for Internet hospitals, which consists of \"intelligent hardware + APP + cloud services + a back - end think - tank of TCM and Western medicine experts + a back - end professional management and care team\".\n\nThis initiative aims to blaze a new trail in the field of long - distance, full - course, and personalized management of diabetes through the synergy of TCM and Western medicine for Chinese diabetes patients. We expect to significantly reduce the incidence of diabetes complications, remarkably improve the overall health status and quality of life of patients, and bring unprecedented positive impacts on the well - being of diabetes patients.",[107,108,109,110,111],"Diabetes Mellitus, Type 2","Integrated Traditional Chinese Medicine and Western Medicine","Telemedicine","Chronic Disease Management","Digital Health","2025-11-23",{"date":114,"type":35},"2025-12-04",{"date":66,"type":35},{"date":117,"type":20},"2026-05-31",{"name":41,"class":42},{"id":120,"slug":121,"hasResults":11,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":4,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":127,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":129,"conditions":130,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":135,"completionDateStruct":137,"leadSponsor":139,"locationsCount":43},"100611345","intraosseous-infusion-in-hematologic-critical-patients-100611345","NCT07239375","Intraosseous Infusion in Hematologic Critical Patients","Application of Intraosseous Infusion in Hematologic Critical Patients","Inclusion Criteria:\n\n* 1\\. Age: 18 to 65 years old. 2. Critically patients with hematologic diseases, including:① Highly suspected or diagnosed patients with rapidly progressing highly lethal hematological diseases;② Patients with hematological disorders complicated by severe complications, including agranulocytosis, thrombocytopenia, severe anemia, advanced tumors,septic shock, sepsis, DIC、 severe gastrointestinal bleeding, involvement of the central nervous system or intracranial hemorrhage, etc;③ Patients with hematological diseases combined with important organ dysfunction, including respiratory failure, heart failure, renal failure, liver failure, etc;④ Patients undergoing hematopoietic stem cell transplantation or those experiencing serious complications in new immunotherapy, such as hyperacute graft-versus-host disease (GVHD), grade 3-4 cytokine release syndrome (CRS) or immune effector cell associated neurotoxicity syndrome (ICANS), grade 3-4 immune checkpoint inhibitor associated interstitial lung disease, etc;⑤ Other critically patients who require life support and 24-hour monitoring.\n\nExclusion Criteria:\n\n* 1\\. Fracture at the intended puncture site (due to the risk of fluid extravasation into subcutaneous tissues).\n\n  2\\. Extensive soft tissue injury at the intended puncture site, resulting in insufficient anatomical landmarks for safe puncture.\n\n  3\\. Local infection in the intended puncture area. 4. History of major orthopedic surgery in the intended puncture region. 5. Presence of a local prosthetic implant. 6. A site previously used for intraosseous (IO) access within the last 24 hours (to avoid re-puncture).","65 Years",{"count":128,"type":20},52,"This single-center, prospective observational study will enroll 52 critically hematology patients aged 18-65 years including agranulocytosis, thrombocytopenia, severe anemia, advanced tumors, septic shock, sepsis DIC、 severe gastrointestinal bleeding, involvement of the central nervous system or intracranial hemorrhage, patients undergoing hematopoietic stem cell transplantation，etc. Vascular access will be established via intraosseous (IO) needle placement, primarily to evaluate first-attempt puncture success rate, therapeutic efficacy, and overall survival rate. Secondary endpoints include infusion speed, hemodynamic improvement, and procedural complications such as local infection and fat embolism. The study aims to definitively assess the efficacy and safety of IO infusion as a rapidly established, \"non-collapsible\" alternative vascular access route in the hematologic intensive care setting.",[131],"Intraosseous Infusions","2025-11-16",{"date":134,"type":35},"2025-11-20",{"date":136,"type":20},"2025-11-22",{"date":138,"type":20},"2027-10-23",{"name":41,"class":42},{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":147,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":149,"conditions":150,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":43},"100608666","efficacy-of-empirical-anti-infective-therapy-in-neutropenic-febrile-patients-100608666","NCT07204522","Efficacy of Empirical Anti-Infective Therapy in Neutropenic Febrile Patients.","Observational Study on the Efficacy of Empirical Antimicrobial Therapy in Febrile Neutropenia.","Inclusion Criteria:\n\n* Age 18-75 years.\n* Documented haematological malignancy: acute leukaemia, severe aplastic anaemia, lymphoma, or multiple myeloma.\n* Neutropenia: absolute neutrophil count (ANC) \\\u003C 0.5 × 10⁹\u002FL, or ANC anticipated to fall below this threshold within 48 h; severe neutropenia defined as ANC \\\u003C 0.1 × 10⁹\u002FL.\n* Fever: single oral temperature ≥ 38.3 °C (axillary ≥ 38.0 °C), or oral temperature ≥ 38.0 °C (axillary ≥ 37.7 °C) sustained for \\> 1 h.\n* Eastern Cooperative Oncology Group performance status (ECOG-PS) 0-2.\n* Planned or current empirical use of ceftazidime-avibactam (CAZ-AVI) for febrile neutropenia.\n\nExclusion Criteria:\n\n* Drug-related fever or fever attributable to rheumatic\u002Fautoimmune disease.\n* Concomitant intracranial haemorrhage.\n* Pregnancy, lactation, or intention to become pregnant.\n* Psychiatric disorder or any condition precluding protocol compliance.\n* Life-threatening arrhythmia or QTc \\> 500 ms on electrocardiography.",{"count":148,"type":20},20,"This single-arm, open-label clinical study evaluates the efficacy and safety of a standardized empirical anti-infective escalation protocol for patients with hematological malignancies complicated by febrile neutropenia. The treatment algorithm follows a sequential strategy: initial carbapenem monotherapy (2 days) → if ineffective, combination with vancomycin\u002Flinezolid (3 days) → if no response, escalation to antifungal therapy (7 days). For patients demonstrating persistent or recurrent fever with uncontrolled infection parameters after 12-14 days of prior empirical anti-infective therapy, switching to ceftazidime-avibactam combined with aztreonam is implemented. Therapeutic efficacy is assessed through comprehensive evaluation of clinical manifestations, inflammatory biomarkers, radiographic imaging, and microbiological findings. Comprehensive safety surveillance includes continuous monitoring of adverse events and all-cause mortality throughout the treatment course.",[151],"Febrile Neutropenia","2025-09-24",{"date":154,"type":35},"2025-10-02",{"date":156,"type":20},"2025-09-22",{"date":158,"type":20},"2027-09-22",{"name":41,"class":42},{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":11,"sex":16,"minAge":167,"maxAge":51,"enrollmentInfo":168,"targetDuration":4,"studyType":80,"phases":170,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":43},"100566082","umbilical-cord-blood-supported-haplo-hsct-for-aplastic-anemia-treatment-study-100566082","NCT06650553","Umbilical Cord Blood-Supported Haplo-HSCT for Aplastic Anemia Treatment Study","Clinical Study on Umbilical Cord Blood-Supported Haploidentical Hematopoietic Stem Cell Transplantation for the Treatment of Aplastic Anemia","Inclusion Criteria:\n\n* A patient age of 6-75 years\n* Patients diagnosed with Severe Aplastic Anemia (SAA) , Transfusion-Dependent Non-Severe Aplastic Anemia (TD-NSAA) or Paroxysmal nocturnal hemoglobinuria (PNH) acquired clonal-aplastic anemia(AA) according to the Chinese Guidelines for the Diagnosis and Treatment of Aplastic Anemia (2022 Edition) and suitable for allo-HSCT\n* Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study\n\nExclusion Criteria:\n\n* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure)\n* Patients with any conditions not suitable for the trial (investigators' decision)","6 Years",{"count":169,"type":20},110,[82],"Aplastic anemia (AA) is a rare bone marrow failure syndrome with an annual incidence of about 0.74\u002F100,000, affecting all ages but more common in the elderly. It's divided into congenital and acquired forms, with the latter being more prevalent. The primary acquired form is linked to T lymphocyte activation and genetic factors. The best treatment is allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a near 90% cure rate. Sibling allo-HSCT is ideal but finding a match is challenging. For those who relapse after immunosuppressive therapy, haploidentical HSCT is a viable option despite risks like graft failure and GVHD. Advances in transplantation have made haplo-HSCT's efficacy comparable to other methods. Recent studies suggest co-transplantation with umbilical cord blood cells can improve outcomes by hastening hematopoietic recovery and prognosis. Our study will evaluate the feasibility and safety of this approach in AA treatment, comparing it to sibling fully matched transplantation, with a focus on infection rates, GVHD incidence, TRM, and EFS, aiming to enhance treatment practices and benefit patients and the medical industry.",[173],"Aplastic Anemias",[173,175,176],"Stem Cell Transplantation","Umbilical Cord Blood","2025-08-10",{"date":179,"type":35},"2025-08-14",{"date":181,"type":35},"2024-06-01",{"date":183,"type":20},"2027-07",{"name":41,"class":42},{"id":186,"slug":187,"hasResults":11,"nctId":188,"briefTitle":189,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":16,"minAge":192,"maxAge":126,"enrollmentInfo":193,"targetDuration":4,"studyType":80,"phases":195,"briefSummary":197,"conditions":198,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":203,"completionDateStruct":204,"leadSponsor":206,"locationsCount":43},"100601287","phase-2-efficacy-of-integrated-induction-consolidation-chemotherapy-and-transplantation-for-adult-acute-myeloid-leukemia-multicenter-study-100601287","NCT07108530","Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study","Integrated Treatment Protocol for Induction\u002FConsolidation Chemotherapy and Transplantation in Adult Acute Myeloid Leukemia Multicenter Study on the Efficacy of an Integrated Treatment Approach","Inclusion Criteria:\n\n* Age: 14 years - 65 years;\n* Excluding AML-M3 (Acute Promyelocytic Leukemia) patients;\n* Diagnosis conforming to the Chinese Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non-APL) (2023 Edition), including low-risk, intermediate-risk, and high-risk patients;\n* Bone marrow morphology indicating hypercellularity or hypocellularity;\n* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2.\n\nExclusion Criteria:\n\n* Presence of intracranial hemorrhage;\n* Pregnancy;\n* Psychiatric illness or other conditions precluding protocol adherence;\n* Severe cardiac arrhythmia, abnormal ECG (QTc \\>500 ms).","14 Years",{"count":194,"type":20},50,[196],"PHASE2","This is a multicenter, single-arm, open-label clinical study designed to evaluate the efficacy and safety of an integrated \"induction-consolidation-transplantation\" treatment protocol in adult patients with acute myeloid leukemia (AML, excluding M3 subtype). Based on patients' economic conditions, two induction regimens are offered: the IAV regimen (idarubicin + cytarabine + venetoclax) for those with better financial resources, and the DAV regimen (daunorubicin + cytarabine + venetoclax) for those with limited resources. During the consolidation phase, patients receive either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine monotherapy. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a FA-BuCy\u002FATG conditioning regimen and an innovative graft-versus-host disease (GVHD) prophylaxis strategy using anti-CD25 monoclonal antibody combined with delayed oral cyclosporine. The entire treatment plan is designed to be completed within four months of diagnosis. The study plans to enroll 50 newly diagnosed patients aged 14-65 years. Primary endpoints include disease-free survival (DFS), complete remission rate (CR\u002FCRi), and the efficacy of the transplantation protocol. Secondary endpoints include relapse rate, treatment-related mortality, 2-year overall survival, and treatment safety. This study aims to explore a new strategy to improve the cure rate of AML by optimizing drug combinations and shortening the treatment duration.",[199],"Acute Myeloid Leukemia","2025-08-06",{"date":202,"type":35},"2025-08-07",{"date":200,"type":35},{"date":205,"type":20},"2027-08-06",{"name":41,"class":42},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":213,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":223,"completionDateStruct":225,"leadSponsor":227,"locationsCount":4},"100599103","research-on-the-psychological-status-of-patients-with-hiv-1-infection-100599103","NCT07080138","Research on the Psychological Status of Patients With HIV-1 Infection","Inclusion Criteria:\n\n1. Diagnosis: PLWH can be diagnosed if one of the following three items is met according to the Chinese AIDS Diagnosis and Treatment Guidelines (2021):\n\n   ① HIV antibody screening test positive and HIV supplementation test positive (antibody supplementation test positive or nucleic acid qualitative test positive or nucleic acid quantification\\>5000 copies\u002FmL);\n\n   ② Has a history of epidemiology or clinical manifestations related to AIDS, tested positive for HIV nucleic acid twice;\n\n   ③ HIV isolation test positive;\n2. Receive treatment at the hospital participating in the study; Age range: 18-80 years old, male or female not limited;\n3. Patients who are willing to participate in this clinical study and sign the informed consent form for this study.\n\nExclusion Criteria:\n\nIndividuals who meet any of the following criteria are not eligible to participate in this study:\n\n1. Pregnant or lactating women; Men and women who are preparing for natural conception or artificial assisted reproduction;\n2. Severe aphasia, physical disability, or any other non neuropsychological factors that may hinder the completion of the assessment;\n3. is currently involved in other research;\n4. Having a tendency towards violence may endanger the safety of others.","80 Years",{"count":215,"type":20},500,"The goal of this observational study is to investigate the neuropsychological states of People Living With HIV(PLWH), the prevalence of social and psychological stress adaptation overload and poor episodic memory in PLWH. The main questions it aims to observe are: to observe the prevalence of psychopathic states in PLWH with different viral loads and to compare the effects of different treatments on the prevalence of psychopathic states in PLWH. It is helpful to understand the mental health burden faced by PLWH in China, to improve clinicians' awareness of PLWH's mental and psychological state, and formulate targeted psychological support, treatment and nursing programs.",[218,219],"HIV-1-infection","Anxiety Depression","2025-07-14",{"date":222,"type":35},"2025-07-23",{"date":224,"type":20},"2025-08-01",{"date":226,"type":20},"2026-12-31",{"name":41,"class":42},{"id":229,"slug":230,"hasResults":11,"nctId":231,"briefTitle":232,"officialTitle":233,"acronym":4,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":235,"enrollmentInfo":236,"targetDuration":4,"studyType":80,"phases":237,"briefSummary":239,"conditions":240,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":248,"locationsCount":43},"100597489","phase-2-multicenter-study-of-combined-chemotherapy-and-transplantation-for-adult-all-100597489","NCT07059156","Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL","Multicenter Study on Integrated Treatment Regimen of Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Lymphoblastic Leukemia","Inclusion Criteria:\n\n1. Age: 18 to 60 years；\n2. Diagnosis must comply with the Chinese Guidelines for Diagnosis and Treatment of Adult Acute Lymphoblastic Leukemia (2024 Edition), requiring MICM (Morphology, Immunology, Cytogenetics, and Molecular genetics) integration and WHO 2022 (5th edition) classification standards. The minimal diagnostic workup must include morphological assessment and immunophenotyping to differentiate ALL from acute myeloid leukemia (AML). All patients shall undergo bone marrow aspiration plus biopsy at initial diagnosis. A definitive ALL diagnosis requires ≥20% blasts\u002Fimmature lymphocytes in bone marrow (Note: Patients with \\\u003C20% blasts due to fever or glucocorticoid pretreatment require comprehensive evaluation incorporating medical history and ancillary tests for differential diagnosis)；\n3. ECOG Performance Status: 0-2\n\nExclusion Criteria:\n\n1. Intracranial hemorrhage\n2. Pregnancy\n3. Psychiatric disorders or other conditions compromising protocol compliance\n4. Severe cardiac arrhythmia with ECG abnormalities (QTc \\>500 ms)","60 Years",{"count":194,"type":20},[196,238],"PHASE3","This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.",[241],"Acute Lymphoblastic Leukemia, Adult","2025-07-01",{"date":244,"type":35},"2025-07-10",{"date":246,"type":35},"2025-06-01",{"date":183,"type":20},{"name":41,"class":42},{"id":250,"slug":251,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":256,"enrollmentInfo":257,"targetDuration":4,"studyType":80,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":43},"100590053","hybrid-closed-loop-in-diabetes-post-kidney-transplant-a-randomized-trial-100590053","NCT06962410","Hybrid Closed-Loop in Diabetes Post-Kidney Transplant: A Randomized Trial","Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Diabetes After Kidney Transplantation: An Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged 18 - 70 years;\n* Meets the diagnostic criteria in the \"Guidelines for Prevention and Control of Diabetes in China (2024 Edition)\": A patient can be diagnosed with diabetes if he\u002Fshe presents typical symptoms of diabetes (including polydipsia, polyuria, polyphagia, and unexplained weight loss) and meets one of the four criteria: ① random blood glucose ≥ 11.1 mmol\u002FL; ② fasting blood glucose ≥ 7.0 mmol\u002FL; ③ 2 - hour post - load blood glucose during an oral glucose tolerance test ≥ 11.1 mmol\u002FL. For patients without typical symptoms, the diagnosis requires two abnormal test results obtained either simultaneously or at two different time points.\n* Able to correctly use insulin pumps and CGM devices, and has certain learning and operational abilities;\n* Agrees to participate in the study and signs the informed consent form.\n\nExclusion Criteria:\n\n* The patient has experienced acute diabetic complications within the past month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.\n* The patient has severe symptoms of hypoglycemic intolerance.\n* The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function.\n* The patient has diseases related to glucose metabolism, such as uncontrolled hyperthyroidism, uncontrolled hypothyroidism, Cushing's syndrome, etc.\n* The patient has severe diseases of the liver, kidneys, gastrointestinal tract, hematopoietic system, brain, circulatory system, etc.\n* Patients with malignant tumors (including solid tumors and hematological malignancies).\n* The patient has impaired consciousness or mental illness, lacks self-control, and is unable to express clearly.\n* Lactating women, pregnant women, or women who plan to become pregnant during the trial period.\n* The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan.\n* The patient is currently using other closed-loop systems.\n* Populations not suitable for conventional insulin pump therapy and contraindications.\n* The patient has known or suspected insulin allergy, or is allergic to adhesive tape, insulin pumps, or CGM devices.\n* Other situations where the investigator deems the patient unfit to participate in the clinical trial.","70 Years",{"count":258,"type":20},30,[82],"Objective: To evaluate the short-term blood glucose control effect of the closed-loop system combined with a regular insulin pump and continuous glucose monitoring (CGM) in hospitalized patients with diabetes after kidney transplantation, explore its clinical application value, and provide precise and personalized blood glucose management plans. Methods: A clinical comparative study will be conducted. This will be the first study focusing on hospitalized patients with diabetes after kidney transplantation. The advanced closed-loop system technology will be introduced. Expected Results: The study aims to fill the gap in this field, offer new ideas and solutions for clinical blood glucose management of these patients, and promote the development of diabetes treatment technologies by comparing the short-term blood glucose control effects of the closed-loop system and the regular insulin pump combined with CGM.",[262],"Diabetes Mellitus Patients With Kidney Transplantation","2025-04-30",{"date":265,"type":35},"2025-05-08",{"date":267,"type":35},"2025-04-01",{"date":269,"type":20},"2027-08-31",{"name":41,"class":42},{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":256,"enrollmentInfo":278,"targetDuration":4,"studyType":80,"phases":279,"briefSummary":280,"conditions":281,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":287,"leadSponsor":288,"locationsCount":43},"100588459","hybrid-closed-loop-system-in-lada-patients-a-randomized-trial-100588459","NCT06941675","Hybrid Closed-Loop System in LADA Patients: A Randomized Trial","Application of a Hybrid Closed-Loop Artificial Pancreas System in Patients With Latent Autoimmune Diabetes in Adults (LADA): An Open-Label, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Age between 18 and 70 years old.\n2. Meet the diagnostic criteria for LADA in the \"Chinese Expert Consensus on the Diagnosis and Treatment of Latent Autoimmune Diabetes in Adults (2021 Edition)\":\n\n   * The onset age of diabetes is ≥ 18 years old.\n   * Positive for islet autoantibodies or islet autoimmunity T cells.\n   * Do not rely on insulin therapy for at least 6 months after the diagnosis of diabetes.\n3. Patients are able to correctly use insulin pumps and CGM devices and have a certain learning ability and operational ability.\n4. Baseline HbA1c \\> 7.0% or HbA1c \\> 6.0% combined with hypoglycemia.\n5. Patients agree to participate in the study and sign the informed consent form.\n\nExclusion Criteria:\n\n1. The patient has been clearly diagnosed with type 2 diabetes or special types of diabetes.\n2. The patient has experienced acute diabetic complications within the past 1 month, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.\n3. The patient has severe symptoms of hypoglycemia intolerance.\n4. The patient has skin diseases such as rashes and prurigo, or abnormal coagulation function.\n5. The patient has diseases related to impaired glucose metabolism, such as uncontrolled hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.\n6. The patient has comorbid severe liver, kidney, gastrointestinal, hematological, brain, circulatory system diseases, etc.\n7. The patient has other severe chronic diseases (such as malignant tumors, end-stage organ failure, etc.).\n8. The patient has impaired consciousness or mental illness, lacks self-control, and cannot express clearly.\n9. Lactating women, pregnant women, or women who plan to become pregnant during the trial period.\n10. The patient is currently using or has used glucocorticoids or other drugs that interfere with glucose metabolism within 1 month before screening.\n11. The patient is allergic to the drugs involved in the clinical diagnosis and treatment plan.\n12. The patient is currently using other closed-loop systems.\n13. People who are not suitable for conventional insulin pump treatment and those with contraindications.\n14. The patient is known or suspected to have an insulin-allergic constitution and is allergic to adhesive tape, insulin pumps, or CGM devices.\n\nOther situations where the researcher deems the patient unfit to participate in the clinical trial.",{"count":194,"type":20},[82],"Based on the difficulties in blood glucose control among the Latent Autoimmune Diabetes in Adults (LADA) population and the deficiencies of previous studies, this research aims to conduct a clinical comparative study. The short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and Continuous Glucose Monitoring (CGM) in hospitalized LADA patients will be evaluated to explore the clinical application value of these methods in LADA patients. Moreover, this study aims to provide a more precise and personalized blood glucose management plan for LADA patients. As a slowly progressive subtype of autoimmune type 1 diabetes mellitus (T1DM), LADA patients have significant differences in pathological characteristics, clinical needs, and treatment effects compared with classical T1DM patients. However, they also face huge challenges in blood glucose management. This study will focus on LADA patients for the first time, especially the group of hospitalized patients, to fill the gap in this field. Meanwhile, by introducing the cutting-edge closed-loop system technology, it will provide new ideas and solutions for the clinical blood glucose management of LADA patients. Through a comparative analysis of the short-term blood glucose control effects of the closed-loop system and the combination of a conventional insulin pump and CGM, this study aims to provide more precise and personalized treatment strategies for LADA patients and promote the further development of diabetes treatment technologies.",[282],"Latent Autoimmune Diabetes in Adults (LADA)","2025-04-22",{"date":285,"type":35},"2025-04-24",{"date":267,"type":35},{"date":269,"type":20},{"name":41,"class":42},{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":51,"enrollmentInfo":296,"targetDuration":4,"studyType":80,"phases":298,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":307,"locationsCount":43},"100585953","hybrid-closed-loop-system-in-neurosurgical-perioperative-hyperglycemia-an-open-rct-100585953","NCT06909071","Hybrid Closed-Loop System in Neurosurgical Perioperative Hyperglycemia: An Open RCT","Application of the Hybrid Closed-Loop Artificial Pancreas System in Neurosurgical Perioperative Hyperglycemic Patients: An Open, Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged between 18 and 75 years old.\n2. Patients who have undergone neurosurgical procedures for intracranial hemorrhage (including subdural hemorrhage, basal ganglia hemorrhage, and subarachnoid hemorrhage), have a Glasgow Coma Scale score of 12 or higher after leaving the intensive care unit, receive enteral nutrition postoperatively, and have a previously established diagnosis of type 2 diabetes mellitus, or meet the diagnostic criteria for type 2 diabetes mellitus in the \"Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes\" (2020 edition) .\n3. Fasting blood glucose ≥ 7.0 mmol\u002FL or random blood glucose ≥ 11.1 mmol\u002FL.\n4. Those who have signed the informed consent form and are willing to participate in this clinical trial voluntarily.\n\nExclusion Criteria:\n\n1. Patients with diabetic emergencies, such as diabetic ketoacidosis, hyperglycemic hyperosmolar coma, etc.\n2. Patients with type 1 diabetes or other special types of diabetes.\n3. Patients with severe cardiac and renal dysfunction: those with cardiac function above grade III; those with serum creatinine exceeding 442 μmol\u002FL.\n4. Patients with diseases that affect glucose metabolism, such as hyperthyroidism, hypothyroidism, Cushing's syndrome, etc.\n5. Patients who are allergic to the drugs involved in the clinical diagnosis and treatment plan.\n6. Populations and contraindications that are not suitable for insulin pump treatment.\n7. Patients with allergic constitution and those who are allergic to adhesive tape.\n8. Patients with skin diseases such as rashes and prurigo, or those with abnormal coagulation function.\n9. Patients with impaired consciousness or mental diseases, who lack self-control and cannot express themselves clearly.\n10. Other situations that the researcher deems inappropriate for participating in the clinical trial.\n11. Patients who develop severe complications during or after surgery and are judged by the researcher as unfit for enrollment.",{"count":297,"type":20},40,[82],"In this study, we plan to use an open-source hybrid closed-loop artificial pancreas system and a combination of a traditional insulin pump and continuous glucose monitoring (CGM) respectively to conduct short-term intensive insulin treatment for patients with type 2 diabetes mellitus (T2DM) during the perioperative period who are hospitalized in the Department of Neurosurgery of Shanxi Bethune Hospital. By comparing the blood glucose control status of patients under different intensive insulin treatment regimens and other clinical indicators such as postoperative complications, we will comprehensively evaluate the clinical efficacy and safety of the hybrid closed-loop artificial pancreas system.",[301],"T2DM Patients With Traumatic Brain Injury",{"date":303,"type":35},"2025-04-23",{"date":305,"type":20},"2025-04-15",{"date":269,"type":20},{"name":41,"class":42},{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":313,"acronym":4,"eligibilityCriteria":314,"healthyVolunteers":11,"sex":16,"minAge":315,"maxAge":213,"enrollmentInfo":316,"targetDuration":4,"studyType":80,"phases":318,"briefSummary":319,"conditions":320,"keywords":322,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":331,"locationsCount":43},"100581436","cd30-car-t-in-the-treatment-of-cd30-positive-relapsedrefractory-lymphoma-100581436","NCT06850285","CD30 CAR-T in the Treatment of CD30 Positive Relapsed\u002FRefractory Lymphoma","Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed\u002FRefractory Lymphoma","Inclusion Criteria:\n\n* Age≥15 years and ≤80years，female and male；\n* CD30+ lymphocyte malignancies;\n* CD30 expression \\>10% by immunohistochemistry；\n* At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria;\n* Not suitable for autologous hematopoietic stem cell transplantation or recurrence after autologous hematopoietic stem cell transplantation;\n* Not suitable for BV treatment or relapse after BV treatment, and the expression of CD30 was confirmed by histology;\n* The estimated survival time ≥3 months;\n* ECOG performance status 0-2，KPS\\>60%;\n* Sufficient organ function：ALT，AST≤2.5×ULN，patients with liver invasion can be relaxed to ≤ 5 x ULN；serum total bilirubin\\\u003C34 μmol\u002FL；creatinine clearance rate\\>30 mL\u002Fmin；EF≥40%；No pericardial effusion and obvious arrhythmia；SpO2≥92%；\n* ALC ≥0.5×109\u002FL，PLT\\>30×109\u002FL，Hb\\>80 g\u002FL and subjects had apheresis venous access and no contraindications for blood cell separation;\n* MRI showed no central involvement of lymphoma;\n* Patients with fertility must be willing to be able to use reliable contraceptive measures ;\n* The subject or legal guardian can understand and voluntarily sign the written informed consent.\n\nExclusion Criteria:\n\n* Lymphoma-associated hemophagic cell syndrome;\n* Pregnant or lactating women, and women who have a pregnancy plan within six months;\n* Hepatitis B（HBsAg、HBsAb、HBeAg、HBeAb、HBcAb），Hepatitis C（Anti-HCV），Anti-HIV Ⅰ\u002FⅡ and anti-TP positive（Hepatitis B DNA test is negative except）;\n* Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment;\n* Received Anti-CD30 Ab therapy within 4 weeks before enrollment;\n* Unresolved \\> Grade 1 non-hematologic toxicity associated with any prior treatments;\n* Active uncontrolled bleeding or a known bleeding diathesis;\n* Autologous hematopoietic stem cell transplantation was performed within 6 weeks;\n* Uncontrollable active bacterial or fungal infection；\n* Known allergy to the study drug and its components;\n* Suffer from active autoimmune diseases that require systemic treatment ;\n* Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation;\n* Participated in other clinical studies within 1 months prior to this study;\n* History of allogeneic hematopoietic stem cell transplantation;\n* patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.","15 Years",{"count":317,"type":20},15,[82],"The is a prospective, open-label, dose-climbing clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r\u002Fr CD30+ lymphoma. Plan to recruit 15 subjects with r\u002Fr CD30+ lymphoma。",[321],"Lymphoma, B-Cell",[323],"CD30 CAR-T; lymphoma;","2025-02-23",{"date":326,"type":35},"2025-02-27",{"date":328,"type":20},"2025-09-05",{"date":330,"type":20},"2028-06-01",{"name":41,"class":42},{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":80,"phases":341,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":356,"locationsCount":43},"100576324","a-novel-car-t-combined-expression-of-il-15-in-the-treatment-of-malignant-hematological-tumors-100576324","NCT06783816","A Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors","A Multicenter, Single Arm, Open Label Clinical Study on the Novel CAR-T Combined Expression of IL-15 in the Treatment of Malignant Hematological Tumors","Inclusion Criteria:\n\n* I (or the authorized representative\u002Flegal guardian) agree and have signed an informed consent form, and am willing and capable of following the planned visits, research treatments, laboratory tests, and other research procedures;\n* Histopathological or flow cytometric diagnosis of CD19 and\u002For CD22, BCMA-positive hematological malignancies;\n\n  -≥15 years old, ≤80 years old;\n* If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies treated with one standard chemotherapy regimen and one salvage regimen;-Minimal residual lesions persist after treatment with one standard chemotherapy regimen and one salvage regimen;-Patients with recurrence after hematopoietic stem cell transplantation;\n* Estimated survival ≥12 weeks;\n* Good heart, liver and kidney function:\n* Serum creatinine ≤ 1.5 mg\u002FdL (1mg\u002Fdl=88.4umol\u002FL); Serum ALT\u002FAST ≤ 2.5 ULN; Total bilirubin ≤ 1.5 mg\u002Fdl (1mg\u002Fdl=17.1umol\u002FL):\n* Cardiac ejection fraction ≥50%, cardiac ultrasound showed centropericardial effusion:\n* Eastern Oncology Collaborative Group Activity Status Score (ECOG)0-3;\n* Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent.\n\nIf the answer to any of the above is \\"no\\", the subject will not be allowed to participate in this study.\n\nExclusion Criteria:\n\n* Have a New York Heart Association (NYHA) classification \\> Class III heart failure or myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically prominent heart disease within one year prior to signing the consent form, or have a QTC interval \\>480ms at the time of screening (QTC interval is calculated using the Fridericia formula);\n* Have active GVHD, or need immunosuppressants;\n* Other malignancies were present within 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, and breast ductal carcinoma in situ after radical resection of local prostate cancer;\n* The presence of an active or uncontrolled infection requiring systemic treatment (except for mild genitourinary and upper respiratory tract infections) in the 7 days prior to screening;\n* If HBSAg or HbCAb positive peripheral blood hepatitis B virus (HBV)DNA is higher than the lower limit of detection, it should be excluded. If hepatitis C virus (HCV) antibody positive, peripheral blood HCVRNA positive should be excluded; (HIV) antibody-positive; -Cytomegalovirus (CMV)DNA test positive for human immunodeficiency virus; Those who test positive for Treponema pallidum specific antibody (TPPA) should be excluded;\n* Participating in another clinical trial within 4 weeks prior to the signing of the informed consent, or the signing date of the informed consent is still within 5 half-lives of the drug (whichever is longer) since the last drug used in the last clinical trial;\n* A history of severe allergy to biological products;\n* Systemic diseases that are considered unstable by the investigator: including but not -limited to severe liver, kidney, or metabolic diseases requiring medical treatment;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partner plans pregnancy within 2 years after cell transfusion;\n* Conditions that the investigator believes may increase the risk to the subject or interfere with the test results.",{"count":340,"type":20},45,[82],"The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.",[85,344,345],"Lymphoma,Non-Hodgkin","Relapsed Refractory Multiple Myeloma",[347,348,349],"CAR-T","IL-15","malignant hematological tumors","2025-01-15",{"date":352,"type":35},"2025-01-20",{"date":354,"type":35},"2023-12-01",{"date":330,"type":20},{"name":41,"class":42},{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":4,"eligibilityCriteria":363,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":364,"enrollmentInfo":365,"targetDuration":4,"studyType":80,"phases":367,"briefSummary":368,"conditions":369,"keywords":4,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":372,"lastUpdatePostDateStruct":373,"startDateStruct":375,"completionDateStruct":377,"leadSponsor":379,"locationsCount":4},"100568225","sugammadex-on-laparoscopic-bariatric-surgery-100568225","NCT06678451","Sugammadex on Laparoscopic Bariatric Surgery","Effect of Sugammadex on Quality of Recovery Following Laparoscopic Bariatric Surgery","Inclusion Criteria:\n\n* Age 18-50 years\n* Body Mass Index (BMI) ≥ 40kg\u002Fm²\n* American Society of Anesthesiologists (ASA) grade I to III classification\n* NYHA cardiac function grade I - II\n\nExclusion Criteria:\n\n* Patients with neuromuscular disease or respiratory system disease\n* Patients with severe abnormal liver and renal function\n* Perioperative use of drugs known to interact with rocuronium\n* Patients with unstable mental illness or refusal to participate","50 Years",{"count":366,"type":20},60,[82],"Laparoscopic bariatric surgery has been recognized as the most effective treatment for obesity and related metabolic diseases. Because obesity patients often associated with sleep apnea syndrome or obesity hypoventilation syndrome, combined with the residual effect of muscle relaxants during the operation is easy to lead to respiratory obstruction and respiratory insufficiency, and hypoxemia and carbon dioxide retention are easy to occur after surgery, Post-extubation is prone to upper respiratory tract obstruction such as retrolingual fall, thus increase the risk of perioperative respiratory complications. Therefore, it is very important to achieve a rapid and effective antagonistic muscle relaxant effect, reduce the postoperative muscle relaxation residue, and maintain the patency of the patient's airway.\n\nCompared with the traditional cholinesterase inhibitor neostigmine, sugammadex is a specific antagonist of novel aminosteroid muscle blockers, which rapidly reverses moderate and deep neuromuscular block by combining with rocuronium or vecuronium 1:1,without compatibility with due to its no effect on muscarinic receptors or plasma cholinesterase. The absence of cholinergic and cardiovascular effects during awakening from anesthesia would be significant benefit for patients with cardiovascular or respiratory diseases.\n\nThe pharmacological effect of sugammadex is its ability to form a tight 1:1 complex with amino steroid neuromuscular blockers, which causes a lower plasma concentration of free neuromuscular blockers and promotes the transfer of neuromuscular blockers from the peripheral compartment (including the neuromuscular junction) to the plasma gradient. A meta-analysis by Vaghiri et al showed that reversal of neuromuscular block by sugammadex accelerated postoperative recovery of intestinal peristalsis in patients undergoing colorectal surgery compared with acetylcholinesterase inhibitors. Deljou et al confirmed that reversal of neuromuscular blockade with sugammadex shortened the time to first postoperative defecation in patients compared with neostigmine \u002F glononium bromide. The study will investigate the effect of sugammadex in patients undergoing laparoscopic bariatric surgery.",[370,371],"Laparoscopic Bariatric Surgery","Sugammadex","2024-11-05",{"date":374,"type":35},"2024-11-07",{"date":376,"type":20},"2024-12",{"date":378,"type":20},"2025-05",{"name":41,"class":42},{"id":381,"slug":382,"hasResults":11,"nctId":383,"briefTitle":384,"officialTitle":385,"acronym":4,"eligibilityCriteria":386,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":256,"enrollmentInfo":387,"targetDuration":4,"studyType":80,"phases":389,"briefSummary":390,"conditions":391,"keywords":394,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":43},"100559622","thoracic-paravertebral-block-in-daytime-laparoscopic-partial-adrenalectomy-100559622","NCT06566521","Thoracic Paravertebral Block in Daytime Laparoscopic Partial Adrenalectomy","Effect of Thoracic Paravertebral Block on Analgesia and the Quality of Recovery Following Daytime Laparoscopic Partial Adrenalectomy","Inclusion Criteria:\n\n* Aged 18 to70 years\n* Body Mass Index (BMI) 18.5 to 30 kg\u002Fm²\n* American Society of Anesthesiologists (ASA) grade I to II classification\n* unilateral non-functional adrenal adenoma with a tumor diameter greater than 20mm\n\nExclusion Criteria:\n\n* Patients with peripheral nervous system disease\n* Patients with spinal deformity or surgery\n* Patients with puncture site infection or coagulation abnormalities\n* Patients with history of postoperative nausea and vomiting or allergy to local anesthetics\n* Patients with unstable mental illness or refusal to participate",{"count":388,"type":20},80,[82],"Day surgery refers to the entire diagnostic and therapeutic process completed within 24-48 h, including patient admission, surgery, and discharge. Research by Shariq et al suggested that daytime laparoscopic adrenalectomy was a safe and effective alternative to traditional inpatient treatment. Li et al demonstrated that daytime surgery for laparoscopic partial adrenalectomy could reduce hospital stays, lower medical costs, and optimize healthcare resource utilization.\n\nThe day surgery has put forward higher requirements for the management of perioperative anesthesia, in which the postoperative multimodal analgesia is particularly important.Thoracic paravertebral block (TPVB) is a regional block technique in which local anaesthetics can be injected into paravertebral space to block the ipsilateral sympathetic and somatosensory nerves. TPVB single point injection can achieve sensory block of 3-6 spinal ganglia on one side, with minimal impact on respiratory, gastrointestinal and bladder function. Especially, TPVB does not affect motor nerve, which enable patients to perform painless functional exercise shortly after surgery, promote rapid recovery, and enhance satisfaction and comfort.\n\nA large number of previous studies have shown that TPVB had become increasingly popular for postoperative analgesia after thoracic or breast surgery. However, to our knowledge, few studies to date have investigated the application of TPVB in daytime adrenal surgery. Therefore, we conducted this randomized clinical trial to examine the effect of TPVB on postoperative analgesia and the quality of recovery in patients following daytime laparoscopic partial adrenalectomy.",[392,393],"Laparoscopic Adrenalectomy","Day Surgery",[395,396,397,398,399],"laparoscopic partial adrenalectomy","thoracic paravertebral block","daytime mode","analgesia","recovery quality","2024-10-28",{"date":402,"type":35},"2024-10-31",{"date":404,"type":35},"2024-08-23",{"date":406,"type":20},"2024-11-15",{"name":41,"class":42},{"id":409,"slug":410,"hasResults":11,"nctId":411,"briefTitle":412,"officialTitle":413,"acronym":4,"eligibilityCriteria":414,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":235,"enrollmentInfo":415,"targetDuration":4,"studyType":80,"phases":416,"briefSummary":417,"conditions":418,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":420,"lastUpdatePostDateStruct":421,"startDateStruct":423,"completionDateStruct":425,"leadSponsor":427,"locationsCount":43},"100495048","phase-3-selinexor-in-combination-with-had-or-cag-rregimens-in-relapsed-or-refractory-acute-myeloid-leukemia-100495048","NCT05726110","Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia","A Single-arm Open-label Multicenter Clinical Study of Selinexor in Combination With HAD or CAG Rregimens in Relapsed or Refractory Acute Myeloid Leukemia","Inclusion Criteria:\n\n1. Age:18-60 years old;\n2. Except for patients with AML-M3 with acute myeloid leukemia；\n3. Meet the diagnostic criteria for refractory AML (2011 Chinese guidelines for the diagnosis and treatment of acute myeloid leukemia (relapsed or refractory)):(1) The standard regimen did not achieve complete remission after 2 courses of induction chemotherapy;(2) Relapse within 6 months after the first complete remission; (3) Patients who relapse after 6 months after the first complete remission, and those who fail to induce chemotherapy after the original program; (4) 2 or more recurrences; (5) Extramedullary leukemia persists；\n4. Meet the diagnostic criteria for recurrent AML (refer to the 2014 NCCN guidelines): after complete remission, (1) naive cells appear in peripheral blood; (2) \\>5% of bone marrow naive cells; (3) Extramedullary recurrence；\n5. The bone marrow image indicates active hyperplasia or hypoproliferation；\n6. Eastern Oncology Collaborative Group Physical Status Assessment (ECOG-PS) with a score of 0-2.\n\nExclusion Criteria:\n\n1. Accompanied by cerebral hemorrhage；\n2. Pregnancy；\n3. Have a mental illness or other condition that cannot proceed as planned；\n4. Severe arrhythmia, abnormal ECG (QT\\>500ms).\n\nEarly withdrawal from test criteria：\n\nParticipants have the right to withdraw from the study at any time from the trial. Exit Criteria:\n\n1. The subject or the subject's legally authorized representative requests to withdraw from the study;\n2. Participant loss to follow-up.\n\nDoctor\u002FInvestigator required subjects to terminate the trial early:\n\n1. Subjects who are unable to carry out follow-up treatment due to adverse events (serious irreversible organ function damage during treatment) who are judged by the investigator to be unsuitable for continuing the research;\n2. The subject does not adhere to the protocol, such as the use of chemotherapy drugs, etc., which affects the effectiveness and safety judgment.\n\nFor participants who withdrew early from the study (except subjects who were lost to follow-up), the reason for their early withdrawal should be recorded, and the time of the last study's medication\u002Ftreatment should be recorded, and the examination items at the time of early withdrawal from the study should be completed at the last visit, if possible.",{"count":194,"type":20},[238],"This clinical trial studies the efficacy and safety of selinexor combined with HAD or CAG regimen in the treatment of relapsed or refractory acute myeloid leukemia",[419],"Relapsed or Refractory Acute Myeloid Leukemia","2024-10-20",{"date":422,"type":35},"2024-10-22",{"date":424,"type":35},"2023-01-29",{"date":426,"type":20},"2024-12-31",{"name":41,"class":42},{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":434,"eligibilityCriteria":435,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":126,"enrollmentInfo":436,"targetDuration":4,"studyType":80,"phases":437,"briefSummary":439,"conditions":440,"keywords":442,"overallStatus":86,"whyStopped":4,"lastUpdateSubmitDate":444,"lastUpdatePostDateStruct":445,"startDateStruct":447,"completionDateStruct":449,"leadSponsor":450,"locationsCount":43},"100534771","early-phase-1-jy231internal-clinical-drug-code-injection-for-the-treatment-of-refractory-autoimmune-diseases-100534771","NCT06243159","JY231(Internal Clinical Drug Code) Injection for the Treatment of Refractory Autoimmune Diseases","JY231 Injection for the Treatment of Refractory Autoimmune Diseases (ADs) Early Exploratory Clinical Studies on Safety, Tolerability, and Initial Efficacy","JY231、ADs","Inclusion Criteria:\n\n1. Age 18-65 years old, regardless of gender, signed with informed consent (ICF).\n2. Diagnosed as one of the following diseases: Systemic lupus erythematosus (SLE)；Sjogren's syndrome (SS) ; Systemic Scleroderma (SSc); Dermatomyositis (DM); Anti neutrophil cytoplasmic antibody associated vasculitis (ANCA-AAV).\n3. Patients who have been treated with ≥ 2 immunosuppressive agents for 3 months, or require ≥ 15mg glucocorticoids to maintain stable condition, or are intolerant to standard treatment, or have relative contraindications, and whose disease activity meets the following criteria:\n\n   1. For SLE patients, SLEDAI ≥ 8 points;\n   2. For SS patients, Sjogren's syndrome disease activity index(ESSDAI )≥ 14 points;\n   3. For SSc patients, the modified Rodnan skin score (mRSS) score ranges from 10 to 35 (including cutoff values) and is associated with interstitial pneumonia (ILD);\n   4. For DM patients, diagnosed for at least 1 year;\n   5. For ANCA-AAV patients, Birmingham Vasculitis Activity Score(BVAS) score ≥ 15 and ANCA antibodies.\n4. Eastern Cooperative Oncology Group(ECOG) 0-1 points;\n5. The evaluation of important organ functions meets the following conditions:\n\n   1. Blood count: hemoglobin ≥ 60g\u002FL, platelet count ≥ 30 × 109\u002FL;\n   2. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 55%, no significant abnormalities observed on electrocardiogram;\n   3. Renal function: estimated glomerular filtration rate(eGFR) ≥ 30 mL\u002Fmin\u002F1.73m2;\n   4. Liver function: Aspartate Aminotransferase(AST) and Alanine Transaminase(ALT) ≤ 3.0 upper limit of normal(ULN), total bilirubin ≤ 2.0 ULN;\n   5. Pulmonary function: diffusion capacity of the lung for carbon monoxide(DLCO) ≥ 40% expected value; forced vital capacity(FVC) ≥ 50% of expected value;\n   6. Having single or intravenous blood collection standards and no other contraindications for cell collection;\n6. The urine pregnancy test results of subjects of childbearing age are negative, and they agree to take effective contraceptive measures during the trial period, until one year after infusion;\n7. The patient or their guardian agrees to participate in this clinical trial and signs an informed consent form, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study.\n\nExclusion Criteria:\n\n1. Previously received Chimeric Antigen Receptor T cell(CAR-T) therapy;\n2. Suffering from severe diseases of the heart, liver, lungs, blood system, and endocrine system, the researcher has determined that the risk of participating in the trial is higher than the benefit;\n3. Active or uncontrollable infections that require systemic treatment within the first week of screening;\n4. Previously received hematopoietic stem cell transplantation or solid organ transplantation (excluding corneal and hair transplantation), or screened for acute graft-versus-host disease (GVHD) with grade 2 or above in the first two weeks;\n5. Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus(HBV) DNA titer in peripheral blood is greater than the normal reference value; Or hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA titer detection greater than the normal reference range; Or positive for human immunodeficiency virus (HIV) antibodies; Or those who test positive for syphilis; Or positive for cytomegalovirus (CMV) DNA detection;\n6. Received live vaccine within 4 weeks prior to screening;\n7. Pregnancy test positive individuals;\n8. Patients with malignant tumors and other malignant diseases before screening, in addition to fully treated cervical cancer in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery;\n9. Screening patients who have participated in other clinical trials within the first three months;\n10. Other researchers believe that it is not suitable to participate in this study.",{"count":148,"type":20},[438],"EARLY_PHASE1","Early exploratory clinical study of the safety, tolerability and initial efficacy of JY231 injection in the treatment of refractory autoimmune diseases",[441],"Autoimmune Diseases",[443],"JY231 injection","2024-02-05",{"date":446,"type":35},"2024-02-06",{"date":448,"type":20},"2024-02-08",{"date":226,"type":20},{"name":41,"class":42},""]