[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Second Affiliated Hospital of Soochow University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":445},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,45,68,90,110,139,165,186,210,235,258,281,303,326,353,375,401,423],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100640100","early-phase-1-an-open-label-single-arm-multicenter-phase-ii-clinical-study-of-azacitidine-chidamide-combined-with-pd-1-monoclonal-antibody-in-the-treatment-of-refractoryrelapsed-peripheral-t-cell-lymphoma-100640100",false,"NCT07598578","An Open-label, Single-arm, Multicenter Phase II Clinical Study of Azacitidine, Chidamide Combined With PD-1 Monoclonal Antibody in the Treatment of Refractory\u002FRelapsed Peripheral T-cell Lymphoma.","Inclusion Criteria:\n\n1. Age ≥18 years and ≤75 years, male or female.\n2. Histologically confirmed peripheral T-cell lymphoma (PTCL) by the investigating center, including: peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS); anaplastic large cell lymphoma (ALK-negative or ALK-positive); angioimmunoblastic T-cell lymphoma; enteropathy-associated T-cell lymphoma; NK\u002FT-cell lymphoma; and other PTCL subtypes deemed eligible by the investigator.\n3. Relapsed or refractory disease after at least one prior line of systemic therapy. Relapse is defined as disease recurrence after complete response (CR) or progression after partial response (PR) or stable disease (SD). Refractory disease is defined as progressive disease (PD) after 2 cycles of therapy, or SD after 4 cycles of therapy, or failure to achieve response after adequate last-line therapy (e.g., at least 2-3 cycles of systemic chemotherapy without remission), or progression during treatment.\n4. Patients considered ineligible for autologous hematopoietic stem cell transplantation by the investigator, or those who refuse such treatment.\n5. At least one measurable or evaluable lesion according to the Lugano 2014 classification. Measurable lesion: nodal lesion with longest diameter \\>1.5 cm and shortest diameter \\>1.0 cm on CT\u002FPET-CT or MRI; or extranodal lesion with longest diameter \\>1.0 cm. Evaluable lesion: nodal or extranodal focal uptake on 18F-FDG\u002FPET higher than liver with PET and\u002For CT features consistent with lymphoma.\n6. ECOG performance status 0-2.\n7. Life expectancy ≥3 months.\n8. Adequate organ and bone marrow function defined as:\n\n   1. Hematology: WBC ≥2.0×10⁹\u002FL (≥1.0×10⁹\u002FL if with bone marrow involvement), ANC ≥1.0×10⁹\u002FL (≥0.5×10⁹\u002FL if with bone marrow involvement), PLT ≥50×10⁹\u002FL (≥30×10⁹\u002FL if with bone marrow involvement), HGB ≥7.0 g\u002FdL; no granulocyte growth factor support, platelet or RBC transfusion within 7 days prior to testing.\n   2. Liver function: TBIL ≤1.5×ULN (≤3.0×ULN with liver involvement); ALT and AST ≤2.5×ULN (≤5.0×ULN with liver involvement).\n   3. Renal function: Serum Cr ≤1.5×ULN.\n   4. Coagulation: INR ≤1.5×ULN; PT and APTT ≤1.5×ULN (unless on anticoagulant therapy with PT\u002FAPTT within therapeutic range at screening).\n   5. Thyroid function: TSH, FT4, and FT3 within ±10% of normal range (Note: TSH abnormalities due to non-autoimmune causes are acceptable).\n   6. Cardiac function: Left ventricular ejection fraction ≥50%, no organic arrhythmia, no significant abnormalities in cardiac enzymes.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past 5 years, except for those treated with curative intent (e.g., basal cell carcinoma of the skin, carcinoma in situ).\n2. Patients with significant dysfunction of major organs.\n3. Known involvement of central nervous system (CNS) lymphoma.\n4. History of active bleeding or newly diagnosed thrombotic disease, or those with bleeding tendency receiving anticoagulant therapy.\n5. Known history of Human Immunodeficiency Virus (HIV) infection and\u002For Acquired Immunodeficiency Syndrome (AIDS).\n6. Patients with active chronic hepatitis B or active hepatitis C.\n7. Systemic corticosteroid therapy or other immunosuppressive therapy required for any condition within 14 days prior to initiation of study treatment.\n8. Active autoimmune disease requiring systemic treatment within the past two years. Patients with autoimmune diseases not requiring systemic treatment in the past two years may be enrolled.\n9. Major surgery within 28 days prior to enrollment, or less than 6 weeks after major organ surgery.\n10. Administration of live attenuated vaccines within 4 weeks prior to enrollment or planned during the study period (influenza vaccines excluded).\n11. Pregnant or lactating women, and subjects of childbearing potential unwilling to use effective contraception.\n12. Psychiatric disorders or individuals unable to provide informed consent.\n13. Active infection, except for tumor-related B-symptom fever.\n14. Poorly controlled cardiac symptoms or diseases, including:\n\n    i. NYHA Class III or higher heart failure ii. Unstable angina iii. Myocardial infarction within the past year iv. Clinically significant arrhythmias\n15. Any other condition deemed by the investigator to make the subject unsuitable for study participation.","ALL","18 Years","75 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","An Open-Label, Single-Arm, Multicenter Phase II Clinical Study to Evaluate the Efficacy of Azacitidine, Chidamide, and PD-1 Monoclonal Antibody in the Treatment of Refractory\u002FRelapsed Peripheral T-Cell Lymphoma.",[26],"Peripheral T-Cell Lymphoma Refractory",[28,29,30,31],"therapy","Azacitidine","Chidamide","PD-1","RECRUITING","2026-05-19",{"date":35,"type":36},"2026-05-20","ACTUAL",{"date":38,"type":20},"2026-06-01",{"date":40,"type":20},"2030-01-31",{"name":42,"class":43},"Second Affiliated Hospital of Soochow University","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":44},"100612790","phase-2-evaluation-of-the-effect-of-cordycepin-on-cd8-lymphocytopenia-in-patients-with-solid-tumors-100612790","NCT07258160","Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors","Evaluation of the Effect of Cordycepin on CD8+ Lymphocytopenia in Patients With Solid Tumors: A Randomized Withdrawal Trial","Inclusion Criteria:\n\n1. Age ≥ 18 years;\n2. Participants with solid malignant tumors, with confirmed pathological diagnosis or medical history; they have completed radiotherapy and\u002For chemotherapy more than six months ago; and peripheral blood CD8+ absolute count (blood drawn before 10:00 AM) below the lower reference limit (LRL);\n3. No treatment with immunomodulatory or immunosuppressive agents within the past 2 weeks prior to enrollment;\n4. ECOG performance status score of 0-1, with an estimated life expectancy of ≥ 3 months;\n5. AST and ALT ≤ 3.0 times the upper limit of normal (ULN) within one week prior to study enrollment; serum creatinine ≤ 2 times ULN;\n6. Ability to understand the study and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. History of uncontrolled epilepsy, central nervous system (CNS) disease, or mental disorders, as determined by the investigator to be clinically significant and potentially interfere with the participant's ability to provide informed consent or comply with medication;\n2. Significant (i.e., active) cardiovascular disease, including symptomatic coronary heart disease, congestive heart failure classified as New York Heart Association (NYHA) Class II or worse, or serious arrhythmias requiring pharmacological intervention, or history of myocardial infarction within the past 12 months;\n3. Known active serious infections, or in the investigator's opinion, presence of major hematological, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious, uncontrolled comorbidities;\n4. History of allergy to fungi, or to any of the following components: Cordyceps militaris extract powder, D-mannitol, maltitol, microcrystalline cellulose, or magnesium stearate;\n5. History of immunodeficiency, including HIV positive status, or diagnosis with other acquired or congenital immunodeficiencies, or a history of organ transplantation, or immunological disorders requiring long-term oral corticosteroid treatment;\n6. Acute gout flare\n7. Any other condition deemed unsuitable for enrollment by the investigator.",{"count":53,"type":20},127,[55],"PHASE2","The goal of this clinical trial is to evaluate the effectiveness of PRaG-1 in improving CD8+ lymphocytopenia in patients with solid tumors who are tumor-free for more than six months after completing radiotherapy and\u002For chemotherapy. It will also assess the safety of PRaG-1 Cordycepin in these patients. The main questions it aims to answer are:\n\nDoes PRaG-1 increase CD8+ lymphocyte counts by more than 25% in this patient population? Does the effect of PRaG-1 maintain when treatment is discontinued? What are the safety and tolerability profiles of PRaG-1 during and after the treatment period? Participants will receive open-label PRaG-1 (one tablet in the morning and one in the evening) for 14 days, and those who show a response (CD8+ lymphocytes increase by more than 25%) will enter a 14-day randomized withdrawal period, where they will be assigned to continue PRaG-1 or switch to a placebo.\n\nThroughout the study, participants will:\n\nHave their peripheral blood lymphocyte subpopulations tested at baseline and on Days 7 and 14 Undergo safety monitoring for adverse events according to CTCAE 5.0 criteria Provide information on their quality of life during the treatment period Researchers will compare the outcomes of those who continue PRaG-1 to those who receive a placebo to determine if the observed improvement in CD8+ lymphocytes is sustained, which would indicate that the drug is effective in maintaining immune response.",[58,59],"Solid Cancer","Lymphopenia","2026-01-07",{"date":62,"type":36},"2026-01-09",{"date":64,"type":36},"2025-12-01",{"date":66,"type":20},"2026-09",{"name":42,"class":43},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":44},"100618114","phase-2-cetuximab--combined-with-prag-regimen-in-the-treatment-of-egfr-positive-advanced-refractory-solid-tumors-100618114","NCT07327411","Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors","A Single-arm, Multi-center, Prospective Clinical Study of Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors","Inclusion Criteria:\n\n* Voluntarily sign a written informed consent form;\n* Age ≥18 years, male or female;\n* Eligible patients must have recurrent or metastatic advanced solid malignancies, with a confirmed pathological diagnosis or medical history, and pathology showing EGFR positivity (IHC 1, 2, or 3; for colorectal cancer, RAS\u002FBRAF wild-type patients can be enrolled if EGFR is negative), with no clear guideline-recommended standard treatment or intolerance to standard therapy, and with measurable metastatic lesions (\\>1 cm);\n* Patient performance status is scored 0-3 according to the Eastern Cooperative Oncology Group (ECOG) criteria;\n* Estimated life expectancy ≥3 months;\n* No history of severe hematopoietic, cardiac, pulmonary, hepatic, or renal dysfunction or immunodeficiency;\n* Good compliance.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women；\n* Individuals with a history of other malignant diseases within the past 5 years, except for cured skin cancer and carcinoma in situ of the cervix；\n* Individuals with uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, where the investigator judges that the clinical severity may hinder the signing of informed consent or affect patient compliance with medication；\n* Clinically severe (i.e., active) heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or more severe congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months；\n* Individuals requiring immunosuppressive therapy due to organ transplantation；\n* Known significant active infection, or if the investigator judges there is a significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other severe uncontrolled comorbid conditions；\n* Individuals allergic to any component of the study drug；\n* Individuals with a history of immunodeficiency, including HIV positive, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immune-related diseases requiring long-term oral corticosteroid treatment；\n* Individuals currently with acute or chronic tuberculosis infection (positive T-spot test, chest X-ray showing suspicious tuberculosis lesions)；\n* Other situations deemed unsuitable for enrollment by the investigator.",{"count":76,"type":20},40,[55],"This study is a single-arm, multi-center, prospective clinical study aimed at exploring the efficacy and safety of cetuximab β combined with PRaG regimen in rescuing patients with EGFR-positive advanced refractory solid tumors.",[80],"Advanced Refractory Solid Tumors","NOT_YET_RECRUITING","2025-12-25",{"date":84,"type":36},"2026-01-08",{"date":86,"type":20},"2025-12-27",{"date":88,"type":20},"2027-11-10",{"name":42,"class":43},{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":94,"acronym":4,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":96,"targetDuration":4,"studyType":21,"phases":98,"briefSummary":99,"conditions":100,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":107,"leadSponsor":109,"locationsCount":4},"100613487","phase-2-prag-1-plus-prag-therapy-in-advanced-solid-tumors-a-prospective-clinical-trial-prag-100-100613487","NCT07267234","PRaG-1 Plus PRaG Therapy in Advanced Solid Tumors: A Prospective Clinical Trial (PRaG 10.0)","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Histologically confirmed treatment-naïve or relapsed\u002Fmetastatic advanced solid malignancies with no standard treatment option per current clinical guidelines or intolerance to standard therapy; measurable metastatic lesions ≥1 cm (by RECIST criteria); absolute lymphocyte count (ALC) below lower limit of normal (LLN).\n3. No history of congestive heart failure, unstable angina, or unstable cardiac arrhythmias within the past 6 months.\n4. ECOG performance status 0-3; estimated life expectancy ≥3 months.\n5. No history of significant hematologic, cardiac, pulmonary, hepatic, or renal dysfunction.\n6. Baseline AST ≤3×ULN and ALT ≤3×ULN (≤5×ULN for hepatocellular carcinoma or liver metastases); creatinine ≤3×ULN.\n7. Capacity to comprehend study procedures and voluntarily provide written informed consent.\n\nExclusion Criteria:\n\n1. History of other malignancies within the past 5 years, except for adequately treated non-melanoma skin cancer or cervical carcinoma in situ.\n2. Uncontrolled epilepsy, central nervous system disorders, or psychiatric disorders that, in the investigator's judgment, may interfere with informed consent or treatment adherence.\n3. Clinically significant active cardiac disease, including symptomatic coronary artery disease, NYHA Class II or higher congestive heart failure, severe arrhythmias requiring pharmacological intervention, or myocardial infarction within the past 12 months.\n4. History of solid organ transplant requiring ongoing immunosuppressive therapy.\n5. Known significant active infection, or significant hematologic, renal, metabolic, gastrointestinal, or endocrine dysfunction, or other serious uncontrolled comorbidities as determined by the investigator.\n6. Allergy to any component of the study drug(s).\n7. History of immunodeficiency, including HIV infection, acquired or congenital immunodeficiency disorders, solid organ transplant, or chronic immunosuppressive therapy for immune-related conditions.\n8. Active or latent tuberculosis infection confirmed by positive T-SPOT.TB test or chest X-ray findings suggestive of tuberculosis.\n9. Any other condition that, in the investigator's clinical judgment, may compromise study participation or safety.",{"count":97,"type":20},65,[55],"The goal of this clinical trial is to learn if a combination treatment using PRaG-1 Cordycepin Tablets with radiation therapy, immune-boosting injections, and immunotherapy drugs can help patients with advanced solid tumors. It will also assess safety. The main questions it aims to answer are:\n\nDoes this treatment improve immune function and slow tumor growth? What side effects or risks occur during treatment?\n\nParticipants will:\n\nTake PRaG-1 Cordycepin Tablets (a natural compound derived from Cordyceps fungus) orally: higher dose for 7 days before radiation, then lower daily dose for 2 weeks Receive targeted radiation therapy to the tumor area (5-12 Gy total in 2-3 sessions) Get daily immune-boosting injections (GM-CSF) for 7 days starting with radiation Receive immunotherapy drugs (PD-1\u002FPD-L1 inhibitors) within one week after radiation Have blood drawn and small tumor tissue samples taken before and after the first two treatment cycles for immune analysis All participants will receive this combination treatment; there is no placebo or alternative treatment group in this study.",[58,59,101,102],"Radiotherapy","Immune Checkpoint Inhibitor","2025-11-24",{"date":105,"type":36},"2025-12-05",{"date":64,"type":20},{"date":108,"type":20},"2027-09-01",{"name":42,"class":43},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":15,"minAge":117,"maxAge":17,"enrollmentInfo":118,"targetDuration":4,"studyType":21,"phases":120,"briefSummary":122,"conditions":123,"keywords":126,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":44},"100611539","phase-3-dpp4-inhibitor-intervention-on-post-stroke-cognitive-impairment-in-ischemic-stroke-patients-with-type-2-diabetes-100611539","NCT07241897","DPP4 Inhibitor Intervention on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes","DPP4 Inhibitor on Post-stroke Cognitive Impairment in Ischemic Stroke Patients With Type 2 Diabetes Mellitus (DISC-DM): Multicentre, Double Blind, Randomised, Placebo Controlled Trial","Inclusion Criteria:\n\n1. Mild ischemic stroke, defined as a National Institutes of Health Stroke Scale (NIHSS) score ≤ 5.\n2. Coexisting type 2 diabetes with a disease duration of less than 5 years.\n3. Ability to complete the MoCA, MMSE, and the NINDS-CSN-recommended 1-hour standardized neuropsychological test for VCI.\n4. Age between 40 and 75 years.\n5. Onset of stroke within the last 2 weeks.\n6. Glycated hemoglobin (HbA1c) between 6.5% and 8.5%.\n7. More than 9 years of education.\n8. Informed consent signed by the patient or their family.\n\nExclusion Criteria:\n\n1. Coexisting dementia or severe cognitive impairment (MoCA \\\u003C 17).\n2. Coexisting severe depression, defined as a Hamilton Depression Rating Scale (HAMD) score ≥ 20.\n3. Prior use of cognitive-enhancing drugs, such as donepezil or memantine.\n4. Allergy to DPP4 inhibitors.\n5. Past or current use of DPP4 inhibitors.\n6. Past or current use of GLP-1 agonists.\n7. Type 1 diabetes, latent autoimmune diabetes in adults, secondary diabetes, malignant tumors, autoimmune diseases, or other endocrine-related diseases.\n8. Moderate or severe liver or kidney dysfunction.\n9. Chronic or acute pancreatitis.\n10. Pregnancy or lactation.\n11. Severe infection or severely impaired immune response.\n12. Participation in other clinical trials.\n13. Past or current use of insulin therapy.","40 Years",{"count":119,"type":20},312,[121],"PHASE3","Post-stroke cognitive impairment (PSCI) increases the risk of disability and mortality in stroke patients, thereby exacerbating the disease burden of stroke. Type 2 diabetes is a major risk factor for PSCI, and stroke patients with type 2 diabetes have a higher risk of developing PSCI. Despite the high incidence and severe impact of PSCI, effective intervention methods are still lacking. Identifying safe and effective drugs to improve cognitive function in stroke patients and reduce the risk of PSCI, especially for those with type 2 diabetes, is of significant importance and could help reduce the burden of stroke.\n\nDipeptidyl peptidase-4 (DPP4) inhibitors are first-line antidiabetic drugs, and several studies have shown that DPP4 inhibitors provide benefits beyond glucose control, including significantly improving cognitive function in patients with type 2 diabetes or slowing the progression of cognitive impairment. Our previous research found a significant negative correlation between baseline plasma soluble DPP4 (sDPP4) levels and the 90-day PSCI risk in ischemic stroke patients. Moreover, some studies indicate that DPP4 inhibitors can increase plasma sDPP4 levels. Based on this, we hypothesize that DPP4 inhibitors could be effective for PSCI intervention and may improve cognitive function post-stroke.\n\nThis project aims to conduct a multicenter, randomized, double-blind, placebo-controlled study. We will include patients with mild ischemic stroke combined with type 2 diabetes and provide continuous intervention with DPP4 inhibitors or a placebo for 180 days. Cognitive function in both groups will be assessed before and after intervention to determine if DPP4 inhibitors can improve cognitive function and reduce the risk of PSCI in ischemic stroke patients with type 2 diabetes. Clinical blood samples and imaging data will also be used to preliminarily explore potential mechanisms.",[124,125],"Ischemic Stroke","Diabete Mellitus",[127,124,128,129,130],"DPP4 inhibitors","PSCI","Diabetes Mellitus","RCT","2025-11-18",{"date":133,"type":36},"2025-11-21",{"date":135,"type":20},"2025-12-15",{"date":137,"type":20},"2028-04-30",{"name":42,"class":43},{"id":140,"slug":141,"hasResults":11,"nctId":142,"briefTitle":143,"officialTitle":144,"acronym":145,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":147,"enrollmentInfo":148,"targetDuration":4,"studyType":21,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":157,"lastUpdatePostDateStruct":158,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":5},"100600307","phase-4-tirofiban-with-sequential-dual-antiplatelet-therapy-in-mild-stroke-100600307","NCT07095790","Tirofiban With Sequential Dual Antiplatelet Therapy in Mild Stroke","Tirofiban With Sequential Dual Antiplatelet Therapy Versus Dual Antiplatelet Therapy Alone in Mild Acute Ischemic Stroke (TiMIS): A Multicenter, Open-Label, Blinded-Endpoint, Parallel-Controlled, Randomized Clinical Trial","TiMIS","Inclusion Criteria:\n\n1. Age: 18-80 years old.\n2. Acute mild non-cardioembolic stroke.\n3. NIHSS score ≤5.\n4. Time from onset to randomization of ≤48 hours; if the time of onset is unknown, time from the last known time of being well to randomization of ≤48 hours.\n5. The investigational drug can be administered within 48 hours of symptom onset.\n6. Signed informed consent by the patient or legally authorized representative.\n\nExclusion Criteria:\n\n1. Received or planned to receive intravenous thrombolysis or bridging therapy (with subsequent endovascular treatment)\n2. Intracranial hemorrhage confirmed by imaging.\n3. Pre-stroke modified Rankin Scale (mRS) score ≥2.\n4. Any confirmed cardioembolic source, including chronic or paroxysmal atrial fibrillation, sick sinus syndrome, mitral stenosis, mechanical heart valve, infective endocarditis, intracardiac thrombus or vegetation, myocardial infarction within 3 months, dilated cardiomyopathy, left atrial spontaneous echo contrast, ejection fraction \\\u003C30%.\n5. History of primary intracerebral hemorrhage.\n6. History of other intracranial hemorrhage (intraventricular, subarachnoid, epidural, or subdural hemorrhage).\n7. Untreated or inadequately treated intracranial aneurysm or vascular malformation.\n8. Major systemic bleeding within 30 days.\n9. Active bleeding, including laboratory evidence of coagulopathy (platelet count \\\u003C100 × 10⁹\u002FL, activated partial thromboplastin time \\>50 seconds, or international normalized ratio \\>1.7), or treatment with direct oral anticoagulants within the preceding 48 hours.\n10. Major surgery within 14 days.\n11. Persistently elevated blood pressure (systolic \\>180 mmHg or diastolic \\>110 mmHg) despite treatment.\n12. Baseline platelet count \\\u003C100 × 10⁹\u002FL.\n13. Severe renal dysfunction (glomerular filtration rate \\\u003C30 mL\u002Fmin or serum creatinine \\>220 μmol\u002FL \\[2.5 mg\u002FdL\\]).\n14. Known allergy or contraindication to tirofiban or aspirin.\n15. Current pregnancy or lactation.\n16. Any intracranial tumor (except asymptomatic meningiomas ≤1.5 cm in diameter).\n17. Any terminal illness with life expectancy \\\u003C6 months.","80 Years",{"count":149,"type":20},580,[151],"PHASE4","This study aims to evaluate whether initiating intravenous tirofiban within 48 hours of onset (with a 48-hour infusion), followed by sequential DAPT, can improve the likelihood of excellent functional outcomes (modified Rankin Scale score 0-1) in mild stroke patients, compared with standard DAPT therapy based on current guidelines.",[154],"Mild Stroke",[156],"Tirofiban; Dual Antiplatelet Therapy; Mild Stroke","2025-07-23",{"date":159,"type":36},"2025-07-31",{"date":161,"type":20},"2025-08-30",{"date":163,"type":20},"2027-05-31",{"name":42,"class":43},{"id":166,"slug":167,"hasResults":11,"nctId":168,"briefTitle":169,"officialTitle":170,"acronym":4,"eligibilityCriteria":171,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":172,"targetDuration":4,"studyType":21,"phases":174,"briefSummary":175,"conditions":176,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":4},"100593135","phase-2-immune-modulation-with-prag-1-treatment-100593135","NCT07002502","Immune Modulation With PRaG-1 Treatment","Immune Modulation and Efficacy Assessment of PRaG-1 in Patients With Advanced Solid Malignancies: A Prospective, Multicenter, Open-Label Clinical Trial","Inclusion Criteria:\n\nPatients with a history of other malignant diseases within the past 5 years, except for curatively treated skin cancer and cervical carcinoma in situ; Patients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders, which, in the judgment of the investigator, may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment; Clinically significant (i.e., active) cardiovascular disease, such as symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, or severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months; Patients currently receiving immunosuppressive therapy; Known active major infections, or significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator; Patients with hypersensitivity to any component of the investigational drugs; History of immunodeficiency, including positive HIV test results or other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy; Other conditions deemed unsuitable for enrollment by the investigator.\n\nExclusion Criteria:\n\nPatients with a history of any other malignant diseases within the past 5 years are excluded, except for curatively treated skin cancer and cervical carcinoma in situ.\n\nPatients with a history of uncontrolled epilepsy, central nervous system diseases, or psychiatric disorders are excluded if, in the judgment of the investigator, these conditions may impair the ability to sign the informed consent form or affect the patient's compliance with drug treatment.\n\nClinically significant (active) cardiovascular disease is excluded, including symptomatic coronary artery disease, New York Heart Association (NYHA) Class II or worse congestive heart failure, severe arrhythmias requiring medication, or a history of myocardial infarction within the past 12 months.\n\nPatients currently receiving immunosuppressive therapy are excluded. Known active major infections are excluded, as are significant hematological, renal, metabolic, gastrointestinal, endocrine dysfunction, or other serious uncontrolled comorbid conditions, as determined by the investigator.\n\nPatients with hypersensitivity to any component of the investigational drugs are excluded.\n\nHistory of immunodeficiency is excluded, including positive HIV test results, other acquired or congenital immunodeficiency diseases, history of organ transplantation, or other immunologically related conditions requiring long-term oral steroid therapy.\n\nOther conditions deemed unsuitable for enrollment by the investigator are excluded.",{"count":173,"type":20},19,[55],"The study is a single-center, prospective, single-arm, Phase II clinical trial. Eligible patients with advanced solid malignant tumors will sign the informed consent form and undergo screening for enrollment. After enrollment, patients will receive oral administration of \"PRaG-1\" twice daily (morning and evening) for a total of 10 days. Peripheral blood lymphocyte tests will be performed before treatment, on day 5 post-treatment, and at the conclusion of treatment.",[177,58],"Cancer","2025-06-08",{"date":180,"type":36},"2025-06-10",{"date":182,"type":20},"2025-06-15",{"date":184,"type":20},"2026-06-26",{"name":42,"class":43},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":190,"acronym":4,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":192,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":198,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":44},"100593104","phase-2-selinexor-high-dose-methotrexate-and-rituximab-combined-with-radiotherapy-for-newly-diagnosed-transplant-ineligible-patients-with-central-nervous-system-lymphoma-an-open-label-single-arm-multicenter-phase-ii-study-100593104","NCT07002099","Selinexor, High-dose Methotrexate, and Rituximab Combined With Radiotherapy for Newly Diagnosed, Transplant-ineligible Patients With Central Nervous System Lymphoma: An Open-label, Single-arm, Multicenter Phase II Study","Inclusion Criteria:\n\n1. Age ≥ 18 years, male or female.\n2. Histologically confirmed primary CNS lymphoma (PCNSL) or secondary CNS lymphoma (SCNSL) with CNS-only involvement.\n3. Ineligible for autologous stem cell transplantation based on clinical assessment or patient refusal.\n4. At least one measurable brain lesion ≥1 cm in diameter, or positive cerebrospinal fluid (CSF) cytology\u002Fflow cytometry for patients with leptomeningeal disease.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-3.\n6. Adequate organ function, including:\n\n   * Absolute neutrophil count (ANC) ≥ 1.0 × 10⁹\u002FL\n   * Platelets ≥ 75 × 10⁹\u002FL\n   * Hemoglobin ≥ 80 g\u002FL\n   * Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if liver involvement)\n   * ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN if liver involvement)\n   * Creatinine clearance ≥ 30 mL\u002Fmin (Cockcroft-Gault formula)\n   * INR ≤ 1.5 × ULN; APTT within 10 seconds of normal\n7. Estimated life expectancy of ≥ 3 months.\n8. Negative serum pregnancy test for women of childbearing potential.\n9. Ability to understand and willingness to sign a written informed consent form.\n\nExclusion Criteria:\n\n1. CNS involvement limited to intraocular lymphoma only.\n2. Prior systemic therapy for CNS lymphoma.\n3. SCNSL with active systemic (non-CNS) disease involvement.\n4. Uncontrolled intracranial hypertension.\n5. Clinically significant or unstable cardiovascular disease, including:\n\n   * Myocardial infarction within 6 months\n   * Unstable angina within 3 months\n   * Uncontrolled arrhythmias (e.g., ventricular tachycardia\u002Ffibrillation)\n   * Congestive heart failure NYHA class ≥ III\n   * LVEF \\\u003C 50% by echocardiography\n6. Other severe uncontrolled medical conditions, including active infections requiring systemic therapy.\n7. Known active hepatitis B (HBV), hepatitis C (HCV), or HIV infection.\n8. Active gastrointestinal dysfunction that interferes with the ability to swallow or absorb oral medication.\n9. Prior treatment with selective inhibitor of nuclear export (SINE) compounds, including selinexor.\n10. Concurrent malignancy, except for adequately treated basal\u002Fsquamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ of the cervix, prostate, or breast.\n11. Pregnant or breastfeeding women, or subjects unwilling to use medically accepted effective contraception during the study and for 6 months after the last dose.\n12. Any condition which, in the investigator's judgment, would make the patient unsuitable for study participation.",{"count":193,"type":20},26,[55],"This phase II clinical trial is designed to evaluate a novel combination treatment for patients with newly diagnosed central nervous system lymphoma (CNSL) who are not candidates for stem cell transplantation. The study will assess the safety and effectiveness of combining selinexor (an oral selective nuclear export inhibitor) with high-dose methotrexate and rituximab chemotherapy, followed by low-dose whole-brain radiotherapy (WBRT). Selinexor has shown promise in enhancing the effects of chemotherapy and radiation in blood cancers.\n\nPatients enrolled in this open-label, single-arm, multicenter study will receive up to six 21-day treatment cycles. Those who respond well will undergo reduced-dose WBRT and continue selinexor as maintenance therapy. The study will measure how many patients respond to the treatment (overall response rate), how long the response lasts (progression-free survival), overall survival, and safety.\n\nThis research aims to provide a less toxic and more effective option for treating CNSL in patients who are older or medically unfit for transplantation.",[197],"Lymphomas",[199,200,201],"Selinexor","central nervous system lymphoma","WBRT","2025-05-23",{"date":204,"type":36},"2025-06-03",{"date":206,"type":20},"2025-06-01",{"date":208,"type":20},"2028-12-31",{"name":42,"class":43},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":218,"targetDuration":220,"studyType":221,"phases":4,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":44},"100580524","evaluation-of-the-effect-of-finerenone-on-renal-function-in-patients-with-type-2-diabetes-and-chronic-kidney-disease-100580524","NCT06838416","Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease","Evaluation of the Effect of Finerenone on Renal Function in Patients With Type 2 Diabetes and Chronic Kidney Disease: A Prospective, Single-Arm, Multicenter Clinical Study","KSD-01","Inclusion Criteria:\n\n* Diagnosed with Type 2 diabetes according to the 1999 WHO criteria\n* Aged ≥18 years\n* UACR ≥30 mg\u002Fg and eGFR ≥30 ml\u002Fmin\u002F1.73 m² sustained for over 3 months\n* Stable ARB\u002FACEI treatment for ≥4 weeks prior to enrollment\n* Willing to sign a written informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n* Chronic kidney disease diagnosed before Type 2 diabetes\n* Serum potassium \\>4.8 mmol\u002FL\n* Ineffective blood pressure control at screening (systolic BP ≥160 mmHg and\u002For diastolic BP ≥100 mmHg, average of three measurements in the supine position)\n* HbA1c \\>9%\n* Acute urinary tract infection or conditions affecting urine tests\n* Primary or secondary adrenal insufficiency\n* Use of mineralocorticoid receptor antagonists\n* Use of medications with clear effects on urine protein and eGFR within 4 weeks (except kininogenase)\n* Use of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, ritonavir, nelfinavir, cobicistat, clarithromycin, telithromycin, nefazodone, carbamazepine)\n* ALT or AST \\>2.5 × ULN, total bilirubin (TBIL) \\>2 × ULN\n* Use of systemic glucocorticoids for more than 7 days within 12 weeks prior to screening, or use of systemic glucocorticoids (intravenous\u002Foral or intra - articular) or need for systemic immunosuppressive treatment within the past 14 days\n* Any organ system cancer within the past 5 years, whether treated or untreated\n* Known pregnancy (positive pregnancy test), breastfeeding, recent plans for conception, or not using adequate contraception\n* Participation in other interventional clinical trials within 3 months prior to screening",{"count":219,"type":20},300,"1 Year","OBSERVATIONAL","Research Objectives To evaluate the impact of finerenone on renal function, diabetic complications, and safety in patients with Type 2 diabetes and chronic kidney disease.\n\nStudy Design Type: Prospective, single-arm, multicenter clinical trial. Sample Size: 300 patients. Intervention: Finerenone added to existing treatment regimen (10-20 mg once daily, dose adjusted based on eGFR), for 48 weeks.\n\nData Collection Time Points: Baseline, 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks.\n\nPrimary Endpoint: Change in urine albumin-to-creatinine ratio (UACR). Secondary Endpoints: Changes in eGFR, 24-hour urine protein, serum uric acid, retinopathy markers, pulse wave velocity (PWV), ankle-brachial index (ABI), etc.\n\nSafety Endpoints: Changes in serum potassium, sodium, and blood pressure.",[224,225,226],"Type 2 Diabetes Mellitus","Chronic Kidney Disease","Renal Function","2025-04-01",{"date":229,"type":36},"2025-04-04",{"date":231,"type":36},"2023-11-17",{"date":233,"type":20},"2026-12-31",{"name":42,"class":43},{"id":236,"slug":237,"hasResults":11,"nctId":238,"briefTitle":239,"officialTitle":239,"acronym":4,"eligibilityCriteria":240,"healthyVolunteers":11,"sex":15,"minAge":241,"maxAge":17,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":244,"briefSummary":246,"conditions":247,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":257,"locationsCount":44},"100577360","the-impact-of-light-electrical-and-magnetic-neuroregulation-interventions-on-sleep-wake-disorders-100577360","NCT06797284","The Impact of Light, Electrical, and Magnetic Neuroregulation Interventions on Sleep-wake Disorders","Inclusion Criteria:\n\n\\- Patients with insomnia, narcolepsy,and RBD that have been clearly diagnosed by specialists should sign the informed consent form.\n\nExclusion Criteria:\n\n1. Patients with major neurological diseases such as multi-infarct dementia, Huntington\\'s disease, normal pressure hydrocephalus, brain tumors, progressive supranuclear palsy, epilepsy, subdural hematoma, multiple sclerosis, or those who have sustained neurological dysfunction or known structural brain abnormalities after significant head trauma are excluded.\n2. A history of major depressive disorder or bipolar disorder within the past year, as defined in DSM-IV criteria. A history of schizophrenia (meeting DSM-IV criteria).\n3. History of severe drug or alcohol abuse within the past year;\n4. Any significant systemic illness or unstable medical condition that may make it difficult to comply with the protocol, such as severe autoimmune diseases or a history of cancer.\n5. Have significant hearing, visual, or cognitive impairments, or are unable to participate in interviews in a meaningful way.","8 Years",{"count":243,"type":20},20,[245],"NA","Carry out precise and effective neuromodulation interventions, and develop new neuromodulation technologies for sleep disorders. Use phototherapy, transcranial electrical\u002Fmagnetic stimulation and other therapies to conduct self-controlled intervention studies on insomnia, narcolepsy, and rapid eye movement sleep behavior disorder .",[248,249,250],"Insomnia Chronic","Narcolepsy","REM Sleep Behavior Disorder","2025-02-11",{"date":253,"type":36},"2025-02-14",{"date":255,"type":36},"2025-02-01",{"date":233,"type":20},{"name":42,"class":43},{"id":259,"slug":260,"hasResults":11,"nctId":261,"briefTitle":262,"officialTitle":263,"acronym":4,"eligibilityCriteria":264,"healthyVolunteers":11,"sex":15,"minAge":265,"maxAge":147,"enrollmentInfo":266,"targetDuration":4,"studyType":21,"phases":268,"briefSummary":269,"conditions":270,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":44},"100526069","light-therapy-in-parkinsons-disease-100526069","NCT06129942","Light Therapy in Parkinson's Disease","Light Therapy in Parkinson's Disease: a Prospective, Observational Study","Inclusion Criteria:\n\n* According to the criteria of PD diagnosis of the MDS, PD patients were selected as the research object. The clinical symptoms of PD patients were consistent with Hoehn and Yahr stages 2-3.\n* All PD patients have maintained stable drug treatment for at least one month, signed clinical informed consent and agreed not to adjust drugs throughout the light test and follow-up period.\n\nExclusion Criteria:\n\n* Using hypnotic or stimulating drugs.\n* Using antidepressants, except stable drugs maintained for more than three months;\n* Visual impairment, such as cataract, glaucoma, blindness, etc;\n* Cognitive impairment (MMSE \\\u003C 24);\n* There are uncontrollable hallucinations and mental diseases;\n* There are sleep phase delay \u002F advance syndrome, shift work, jet lag, etc","50 Years",{"count":267,"type":20},50,[245],"The aim of this randomized controlled trial (RCT) is to clarify the effect of bright light therapy on motor symptoms and sleep disorders in patients with Parkinson's disease.",[271,272,273],"Parkinson Disease","Sleep Disorder","Circadian Rhythm Disorders",{"date":275,"type":36},"2025-02-12",{"date":277,"type":36},"2021-09-01",{"date":279,"type":20},"2026-05-16",{"name":42,"class":43},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":285,"acronym":4,"eligibilityCriteria":286,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":287,"enrollmentInfo":288,"targetDuration":4,"studyType":21,"phases":290,"briefSummary":291,"conditions":292,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":295,"lastUpdatePostDateStruct":296,"startDateStruct":298,"completionDateStruct":300,"leadSponsor":302,"locationsCount":44},"100576744","the-impact-of-thoracic-paravertebral-nerve-block-at-different-positions-on-pain-relief-in-patients-undergoing-single-port-thoracoscopic-partial-lung-resection-100576744","NCT06789276","The Impact of Thoracic Paravertebral Nerve Block At Different Positions on Pain Relief in Patients Undergoing Single-Port Thoracoscopic Partial Lung Resection","Inclusion Criteria:\n\n* Age ≥ 18 and ≤ 70 years old\n\n  * BMI ≥ 18 and ≤ 28\n\n    * American Society of Anesthesiologists (ASA) physical status classification I-II ⑷ Patients scheduled for elective thoracoscopic lung resection (including lobectomy, segmentectomy, and wedge resection) ⑸ Patients who agree to participate in this study and sign the informed consent form\n\nExclusion Criteria:\n\n* Patients who refuse to undergo nerve block\n\n  * Patients with severe cardiac, pulmonary, hepatic, or renal insufficiency requiring postoperative admission to the ICU for continued treatment (EF \\\u003C 40%, FEV1\u002FFVC \\\u003C 40%)\n\n    * Abnormal coagulation function ⑷ History of allergy to anesthetic drugs\n\n      * History of chronic alcohol use, chronic pain, or long-term use of psychotropic medications ⑹ Scars, infections, or tumors at the puncture site ⑺ History or family history of malignant hyperthermia ⑻ Refusal to participate in this study or inability to cooperate with follow-up or poor compliance\n\nTermination criteria:\n\n* Failure to comply with the predetermined study protocol ⑵ Occurrence of local anesthetic adverse reactions, puncture needle entering the pleural cavity, or other complications during puncture\n\n  * Changes in the patient's condition ⑷ The patient's unwillingness to continue participating in the study","70 Years",{"count":289,"type":20},200,[245],"Thoracic surgery is widely recognized as one of the most painful surgical procedures. Compared to open thoracotomy, video-assisted thoracoscopic surgery (VATS) offers similar therapeutic outcomes with less invasiveness, significantly reducing postoperative pain and promoting recovery. Despite the use of video-assisted thoracoscopic surgery (VATS), a significant proportion of patients still experience considerable discomfort. Specifically, 78% of patients report moderate to severe pain, with 27% experiencing moderate pain, 34% severe pain, and 17% very severe pain.\n\nMultiple studies have shown that the use of regional anesthesia, such as thoracic paravertebral nerve block (TPVB), in these surgeries can block the transmission of nociceptive signals via the intercostal nerves, producing good analgesic effects. This can reduce the consumption of postoperative opioids, decrease inflammatory responses, and improve patient survival rates after surgery.\n\nBy comparing the differences in hemodynamic parameters, inflammatory stress indicators, and intraoperative and postoperative analgesic effects of thoracic paravertebral nerve block in different preoperative positions for patients undergoing thoracoscopic surgery, we aim to identify the optimal nerve block position, thereby promoting patient recovery.",[293,294],"Lung Nodules","Lung Cancer","2025-01-22",{"date":297,"type":36},"2025-01-23",{"date":299,"type":20},"2025-01-18",{"date":301,"type":20},"2025-12-31",{"name":42,"class":43},{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":4,"eligibilityCriteria":309,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":310,"targetDuration":220,"studyType":221,"phases":4,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":44},"100557757","clinical-study-on-the-effect-of-cpap-on-af-recurrence-after-catheter-ablation-in-patients-with-af-and-osa-100557757","NCT06542263","Clinical Study on the Effect of CPAP on AF Recurrence After Catheter Ablation in Patients with AF and OSA","Clinical Study on the Effect of Continuous Positive Airway Pressure Ventilation on Atrial Fibrillation Recurrence After Catheter Ablation in Patients with Atrial Fibrillation and Obstructive Sleep Apnea","Inclusion Criteria:\n\n1. Clinical diagnosis of AF combined with moderate to severe OSA (OSA diagnostic criteria: apnea hypopnea index (AHI) greater than 15\u002Fhour, and at least 80% of all events are respiratory sleep obstructive events; AF includes persistent atrial fibrillation and paroxysmal atrial fibrillation)\n2. Age ≥ 18 years old\n3. The patient voluntarily participates in the project and signs informed consent\n4. All patients undergo overnight sleep pressure titration at the sleep center to determine the minimum pressure value for continuous positive airway pressure ventilation at home. All patients are required to undergo CPAP treatment at home at least 5 days a week, with each session lasting at least 4 hours\n\nExclusion Criteria:\n\n1. Patients with neuromuscular disorders, pulmonary hypopnea, and severe lung diseases\n2. Preoperative confirmation of thrombus in the left atrium\n3. The patient has no desire for conversion\n4. Secondary atrial fibrillation (hyperthyroidism, tumors, etc.)\n5. Individuals with contraindications to anticoagulants\n6. Left atrial diameter (LAD) exceeding 60mm (2D echocardiography long axis section data)\n7. Pregnant women\n8. History of myocardial infarction, percutaneous coronary intervention, and cardiac surgery in the past three months\n9. Stroke or transient ischemic attack in the past six months\n10. After artificial valve implantation surgery\n11. Severe renal insufficiency (creatinine Cr\\>2.5mg\u002Fdl or\\>221umol\u002FL, or glomerular filtration rate eGFR\\\u003C30ml\u002Fmin\u002F1.73m2)\n12. Acute diseases or active infections that occur before surgery, recorded as pain, fever, positive blood culture, and\u002For leukocytosis, or have been treated with antibiotics.\n13. Expected survival period\\\u003C1 year",{"count":311,"type":20},224,"Atrial fibrillation (AF) is the most common sustained arrhythmia in clinical practice, significantly increasing the risks of death, stroke, heart failure, cognitive impairment, and dementia, thus severely impacting patients' quality of life. However, for AF patients with concomitant cardiovascular risk factors, particularly those with obstructive sleep apnea (OSA), the success rate of catheter ablation is significantly reduced. Continuous positive airway pressure (CPAP) is currently an effective treatment for OSA, effectively correcting nocturnal intermittent hypoxia and fragmented sleep caused by OSA. However, the effect of CPAP therapy on AF recurrence in patients with OSA undergoing catheter ablation remains controversial. Faced with conflicting research findings, our team recently conducted a meta-analysis (registration number CRD42023398588) to assess the impact of CPAP on AF recurrence post catheter ablation in patients with AF and OSA, suggesting that CPAP significantly reduces AF recurrence post catheter ablation (RR = 0.58, P \\\u003C 0.01). However, considering the limited number of included studies, potential bias risks, and confounding factors, our meta-analysis results await further confirmation through real-world studies by our team. Therefore, our team plans to conduct further research on the impact of CPAP on AF recurrence post catheter ablation in patients with moderate to severe OSA, aiming to provide clinical guidance for the treatment of AF in patients with moderate to severe OSA.",[314,315,316,317,318],"Atrial Fibrillation","Continuous Positive Airway Pressure","Obstructive Sleep Apnea","Recurrence","Observational Study","2025-01-20",{"date":297,"type":36},{"date":322,"type":36},"2024-08-09",{"date":324,"type":20},"2026-08-01",{"name":42,"class":43},{"id":327,"slug":328,"hasResults":11,"nctId":329,"briefTitle":330,"officialTitle":331,"acronym":4,"eligibilityCriteria":332,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":333,"targetDuration":4,"studyType":21,"phases":335,"briefSummary":337,"conditions":338,"keywords":340,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":4},"100542648","phase-1-prag-therapy-in-combination-with-locally-advanced-pancreatic-ductal-adenocarcinoma-pdac-neoprag-study-100542648","NCT06345599","PRaG Therapy in Combination With Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study)","Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study)","Inclusion Criteria:\n\n* Age ≥ 18 ≤ 75 years；no gender limitations\n* Histopathologically and\u002For cytologically confirmed ductal adenocarcinoma of the pancreas, the patient has fresh pathological tissue and the tumour is located in the head and neck or body of the pancreas\n* Locally advanced pancreatic cancer, borderline resectable or unresectable, without metastases.\n* Life expectancy \\>= 3 months.\n* ECOG score 0-1.\n* Have at least 1 measurable lesion according to RECIST 1.1 criteria.\n* No prior treatment with abdominal radiotherapy, chemotherapy and PD-1\u002FPD-L1 antibody.\n* Adequate organs functions as defined by the following laboratory values (completed within 14 days prior to registration): (1) haemoglobin \\>= 90 g\u002FL (no blood transfusion within 14 days)； (2) neutrophil count \\> 1.5x10\\^9\u002FL； (3) platelet count \\>= 100x10\\^9\u002FL； (4) total bilirubin \\\u003C= 1.5xULN (upper limit of normal)； (5) blood glutamic transferase (ALT) or blood glutamic transferase (AST) \\\u003C= 2.5xULN (6) endogenous creatinine clearance \\>= 60 ml\u002Fmin (Cockcroft's AST). (ALT) or blood albumin transaminase (AST) \\\u003C= 2.5xULN； (6) endogenous creatinine clearance \\>= 60 ml\u002Fmin (Cockcroft-Gault formula)； (7) cardiac Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) \\>= 50%. (8) International normalised ratio (INR) of prothrombin time ≤ 1.5 and partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal in patients who have not received anticoagulation. Patients receiving full or parenteral anticoagulant therapy may enter a clinical trial as long as the dose of anticoagulant has been stable for at least 2 weeks prior to entry into the clinical study and the results of coagulation assays are within the limits of local therapy.\n* No congestive heart failure, unstable angina, unstable arrhythmia in the last 6 months.\n* No previous severe haematopoietic, cardiac, pulmonary, hepatic or renal abnormalities or immunodeficiencies.\n* Patient must be able to understand the potential risks and benefits associated with this study. Patient able to give informed consent and would likely to comply with the study parameters.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients with a history of other malignant diseases in the last 5 years, except cured skin cancer and cervical cancer in situ.\n* Patients with a history of uncontrolled epilepsy, central nervous system disease or psychiatric disorders whose clinical severity, in the judgement of the investigator, may prevent the signing of informed consent or affect the patient's adherence to drug therapy.\n* Severe heart disease, such as symptomatic coronary heart disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmia requiring pharmacological intervention, or a history of myocardial infarction within the last 12 months.\n* Organ transplants requiring immunosuppressive therapy\n* Active infection or, in the investigator's judgement, significant haematological, renal, metabolic, gastrointestinal, endocrine function or metabolic disorders, or other serious uncontrolled concomitant disease\n* Allergy to any of the study drug ingredients\n* History of immunodeficiency, including HIV-positive or other acquired or congenital immunodeficiency diseases, or history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy\n* During acute or chronic tuberculosis infection (patients with a positive T-spot test and suspicious tuberculosis foci on chest radiographs).\n* Other conditions considered by the investigator to be unsuitable for enrolment.",{"count":334,"type":20},66,[336,55],"PHASE1","The goal of this clinical trial is to learn about Phase I+Phase II Clinical Study of PRaG Therapy in Combination With Chemotherapy (AG Regimen) for Neoadjuvant Treatment of Locally Advanced Pancreatic Ductal Adenocarcinoma (PDAC) (NeoPRAG Study).The main question it aims to answer is to investigate the safety and efficacy of the PRaG treatment modality combined with chemotherapy neoadjuvant therapy for locally advanced pancreatic cancer.",[339],"Pancreatic Ductal Adenocarcinoma",[341,342,343,344],"Locally Advanced Pancreatic Ductal Adenocarcinoma","Chemotherapy","Neoadjuvant Treatment","PRaG Therapy","2024-03-26",{"date":347,"type":36},"2024-04-03",{"date":349,"type":20},"2024-05-01",{"date":351,"type":20},"2027-01-10",{"name":42,"class":43},{"id":354,"slug":355,"hasResults":11,"nctId":356,"briefTitle":357,"officialTitle":358,"acronym":4,"eligibilityCriteria":359,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":360,"targetDuration":4,"studyType":21,"phases":361,"briefSummary":362,"conditions":363,"keywords":365,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":367,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":44},"100538371","plasma-cfdna-testing-guiding-the-treatment-decisions-of-dlbcl-100538371","NCT06289959","Plasma cfDNA Testing Guiding the Treatment Decisions of DLBCL","A Prospective, Single-Center, Randomized, Controlled Study Guiding the Treatment of Diffuse Large B-Cell Lymphoma Patients Based on Plasma cfDNA Testing","Inclusion Criteria:\n\n* Age ≥ 18 years, gender not specified.\n* Newly diagnosed patients with diffuse large B-cell lymphoma (DLBCL) confirmed by histopathological examination. Patients should test positive for plasma cfDNA before treatment (defined as positive for point mutations, CNV, IgH-related fusion, or IG clonal rearrangement) and achieve complete metabolic remission after 6 cycles of R-CHOP chemotherapy (evaluated by Lugano response assessment criteria).\n* Patients for whom the researcher predicts a life expectancy of \\>6 months.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* Patients who have undergone autologous stem cell transplantation.\n* Patients with a history of other malignant tumors, except for basal cell carcinoma of the skin or in situ cervical cancer.\n* Patients with uncontrolled cardiovascular diseases, coagulation disorders, connective tissue diseases, severe infectious diseases, and other such conditions;\n* Primary central nervous system lymphoma.\n* Patients with mental illness or others known or suspected to be unable to fully comply with the study protocol.\n* Pregnant or lactating women.\n* HbsAg-positive patients who need to undergo HBV-DNA testing and can only be included if they seroconvert. Additionally, if the HbsAg test is negative but the HBcAb test is positive (regardless of HbsAb status), HBV-DNA testing is also required. If the result is positive, inclusion is possible only after seroconversion.\n* HIV-infected individuals.\n* Other concurrent and uncontrolled diseases that researchers believe may affect the medical condition of patients participating in the study.",{"count":19,"type":20},[245],"A prospective, single center, randomized, clinical controlled study to evaluate the efficacy and prognosis differences between precision treatment based on plasma cfDNA testing results and the current conventional diagnostic and treatment practices for DLBCL patients.",[364],"Lymphoma, Large B-Cell, Diffuse",[366,28],"cfDNA","2024-03-01",{"date":369,"type":36},"2024-03-04",{"date":371,"type":20},"2024-02-25",{"date":373,"type":20},"2029-01-01",{"name":42,"class":43},{"id":376,"slug":377,"hasResults":11,"nctId":378,"briefTitle":379,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":382,"minAge":383,"maxAge":4,"enrollmentInfo":384,"targetDuration":4,"studyType":21,"phases":386,"briefSummary":387,"conditions":388,"keywords":390,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":394,"lastUpdatePostDateStruct":395,"startDateStruct":397,"completionDateStruct":398,"leadSponsor":400,"locationsCount":44},"100534215","a-clinical-study-of-darcilil-combined-with-ai-combined-with-pyrrotinib-in-the-treatment-of-tpbc-100534215","NCT06235931","A Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of TPBC","Prospective, Single-arm, Single-center Clinical Study of Darcilil Combined With AI Combined With Pyrrotinib in the Treatment of Elderly Advanced Triple-positive Breast Cancer.","Inclusion Criteria:\n\n* 1.Age: ≥65 years old; 2. Histologically confirmed stage IV TPBC; 3. Without prior treatment, adjuvant endocrine therapy and anti-HER2 therapy should be completed for more than one year; 4.TPBC is defined as HER2-positive (3+ by immunohistochemistry, or 2+ by fluorescence in situ hybridization), ER-positive (more than 10% of tumor cells expressed estrogen receptor by immunohistochemistry), and PR-positive (at least 1% of tumor cells expressed progesterone receptor by immunohistochemistry) breast cancer; 5.ECOG score is 0-3 points; 6. Expected survival ≥12 weeks; 7. Normal function of major organs:\n\n  1. Blood routine:\n\n     Neutrophil (ANC) ≥1.5×109\u002FL; Platelet count (PLT) ≥75×109\u002FL; Hemoglobin (Hb) ≥90 g\u002FL;\n  2. Blood biochemistry:\n\n     Total bilirubin (TBIL) ≤1.5× upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0×ULN; Alkaline phosphatase ≤2.5×ULN; Urea or urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;\n  3. Heart color ultrasound:\n\nLeft ventricular ejection fraction (LVEF) ≥50%.\n\nExclusion Criteria:\n\n* 1\\. Breast cancer with no evaluable lesions such as inflammation or occult; 2. Other malignancies within five years 3. Received other tyrosine kinase inhibitors, anti-HER2 treatment and T-DM1 treatment less than one year ago; 4. Patients with intestinal obstruction or fasting, gastrointestinal history, with diarrhea as the main symptom; 5. Suffering from mental illness or psychotropic substance abuse, unable to cooperate; 6. Pregnant or lactating women; 7. Participants considered unsuitable for inclusion by the researchers.","FEMALE","65 Years",{"count":385,"type":20},34,[245],"Elderly patients with advanced triple-positive breast cancer have the characteristics of low physical status and poor treatment tolerance. Therefore, such patients are often unable to tolerate more toxic chemotherapy regimen, and it is particularly important to choose a highly effective and low-toxic treatment regimen. However, few studies have paid attention to the treatment of such patients in the past.\n\nPyrrotinib is a small molecule, irreversible, panerbb receptor tyrosine kinase inhibitor, which was independently developed by our country and has shown excellent efficacy in second-line anti-HER2 treatment of breast cancer, and has become the second-line standard treatment choice for advanced HER2-positive breast cancer. In addition, PHILA study results showed that the mPFS of pyrrotinib group reached 24 months. Compared with the control group, the duration of 10 months was significantly extended, indicating the significant efficacy of pyrrotinib in the first-line treatment of advanced HER2-positive breast cancer.\n\nDarsili is a CDK4\u002F6 inhibitor independently developed in China, which has been reconstructed and optimized in molecular structure, and has become a new CDK4\u002F6 inhibitor with more powerful modification by introducing piperidine structure through replacement of classical electronic and other panbody. The results of DAWNA-2 study indicated that the mPFS of Dalsily combined AI group reached 30.6 months, which was significantly longer than 18.2 months of the control group, and was the longest in similar studies.\n\nMUKDEN01 study, for the first time, tried the efficacy of pyrrotinib + letrozole + Dalsily regimen in the new adjuvant therapy of TPBC patients, and the results showed that ORR reached 87.4%, CR rate was 30.4%, and pCR rate was 35.4%. Therefore, to further confirm the efficacy and safety of this protocol in elderly patients with advanced triple positive breast cancer, we intend to conduct this study. This is a prospective, single-arm, single-center clinical trial in which participants were treated with darcilide +AI (letrozole\u002Fanastrozole\u002Fexemestane) + pyrrotinib until disease progression, toxicity became intolerable, informed consent was withdrawn, or investigator judgment required discontinuation. The successful development of this study provides a new direction for the first-line treatment of elderly advanced triple-positive breast cancer.",[389],"Breast Neoplasms",[391,392,393],"Triple-positive breast cancer","Dalsillie","Pyrrolizinib","2024-01-31",{"date":396,"type":36},"2024-02-01",{"date":396,"type":20},{"date":399,"type":20},"2026-12-01",{"name":42,"class":43},{"id":402,"slug":403,"hasResults":11,"nctId":404,"briefTitle":405,"officialTitle":406,"acronym":407,"eligibilityCriteria":408,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":147,"enrollmentInfo":409,"targetDuration":4,"studyType":21,"phases":410,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":44},"100527297","repetitive-transcranial-magnetic-stimulation-therapy-in-essential-tremor-100527297","NCT06145932","Repetitive Transcranial Magnetic Stimulation Therapy in Essential Tremor","the Effects of Repetitive Transcranial Magnetic Stimulation and Mechanisms in Clinical Function of Essential Tremor","rTMS","Inclusion Criteria:\n\n1. Diagnosed as essential tremor conforming to the diagnostic criteria for essential tremor in the tremor group of the International Parkinson's and Movement Disorders Society (IPMDS).\n2. Signed informed consent form.\n\nExclusion Criteria:\n\n1. Complicated with brain organic diseases, epilepsy, other mental diseases, family history of dementia, metal devices implanted in the body and any contraindications to TMS;\n2. History of craniocerebral surgery;\n3. TMS cannot cooperate;\n4. TMS-EEG examination artifacts are obvious, or cannot be analyzed due to other technical reasons.",{"count":76,"type":20},[245],"The purpose of this study is to evaluate the efficacy and electrophysiology of repetitive transcranial magnetic stimulation in the treatment of essential tremor.",[413],"Essential Tremor",[413,415],"Transcranial magnetic stimulation","2023-11-16",{"date":418,"type":36},"2023-11-24",{"date":420,"type":36},"2023-11-07",{"date":233,"type":20},{"name":42,"class":43},{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":15,"minAge":17,"maxAge":4,"enrollmentInfo":430,"targetDuration":4,"studyType":21,"phases":432,"briefSummary":433,"conditions":434,"keywords":4,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":44},"100524692","phase-2-the-prospective-clinical-study-of-precision-prag-therapy-in-elderly-patients-with-advanced-solid-malignant-tumors-prag90-100524692","NCT06112041","The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors (PRaG9.0)","The Prospective Clinical Study of Precision PRaG Therapy in Elderly Patients With Advanced Solid Malignant Tumors(PRaG9.0)","Inclusion Criteria:\n\n* Aged 75 years and above\n* Standard treatment is ineffective (disease progresses after treatment) or locally advanced or metastatic malignant solid tumor patients who cannot tolerate standard therapy, cannot receive or do not have standard therapy\n* ECOG(Eastern Cooperative Oncology Group) performance is 0-3\n* Life expectancy greater than 3 months\n* serum aspartate transaminase (AST) and serum alanine transaminase (ALT) ≤3.0\\*ULN, or AST and ALT≤5\\*ULN with hepatic metastasis; Total serum creatinine ≤1.5\\*ULN\n* Signed informed consent form\n\nExclusion Criteria:\n\n* Current pregnancy or lactation\n* History of other malignant tumors within 5 years prior to dose administration, expect for#malignancies that can be cured after treatment (including but not limited to adequately treated thyroid cancer, cervical carcinoma in situ, basal or squamous cell skin cancer)\n* Uncontrolled epilepsy, central nervous system diseases or mental illness\n* arrhythmia, congestive heart failure, or greater than or equal to Class 2 congestive heart failure as defined by the New York Heart Association Functional Classification, or history of myocardial infarction unstable angina, or acute coronary syndrome within 6 months prior to enrollment in the study\n* Received allogeneic hematopoietic stem cell transplantation or solid organ transplantation\n* Other serious, uncontrolled concomitant diseases that may affect protocol compliance or interpretation of outcomes, including active opportunistic infections or advanced (severe) infections, uncontrolled diabetes\n* Allergic to any of the ingredients used in the study\n* A history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency disease, or a history of organ transplantation, or other immune-related disease requiring long-term oral hormone therapy\n* Acute and chronic tuberculosis infection\n* Other disorders with clinical significance according to the researcher's judgment",{"count":431,"type":20},29,[55],"This is an open-label, single-arm, Phase II investigator-initiated trial of hypofractionated radiotherapy combined with PD-L1 inhibitor sequential GM-CSF and thymopentin for treatment of elderly patients with advanced solid tumors, when the HER-2 positive patients are treated with extra antibody-drug conjugate.",[435,436],"Carcinoma","Solid Tumor","2023-10-26",{"date":439,"type":36},"2023-11-01",{"date":441,"type":20},"2023-10-25",{"date":443,"type":20},"2026-10-30",{"name":42,"class":43},""]