[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Belarus\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":662},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,49,76,104,126,152,178,203,222,250,274,301,328,361,383,413,435,455,484,511,548,574,598,614,636],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100644768",false,"NCT07673809","A Study to Evaluate the Tolerability, Safety and Efficacy of GNR-097 Gene Therapy in Pediatric Patients With Duchenne Muscular Dystrophy","Multicenter, Single-blind, Randomized, Placebo-controlled Study of a Single Intravenous Infusion of a Gene Therapy Product GNR-097 in Pediatric Patients With Duchenne Muscular Dystrophy","Inclusion Criteria:\n\n1. Written informed consent for participation in the trial.\n2. Ambulatory boys aged 4-9 years with a documented diagnosis of DMD and clinical manifestations of the disease.\n3. A frameshift mutation or nonsense mutation in the DMD gene.\n4. Сreatine phosphokinase level \\>5000 U\u002FL.\n5. Binding antibody titer to AAV9 ≤1:50 \\[method: ELISA\\].\n6. The patient is able to interact with the study physician and perform tests to assess functional activity.\n7. Results of functional activity assessment tests at screening (at least in one of the two attempts performed on different days):\n\n   * NSAA ≥22;\n   * time to rise from a supine position without using surrounding objects or furniture \\\u003C5 sec;\n   * 6MWT distance ≥350 m.\n8. The patient received oral glucocorticosteroids at a stable dose for ≥12 weeks prior to signing the Informed Consent Form, and it is planned that glucocorticosteroids will be continued during the screening stage and after the patient's inclusion in the study.\n9. For patients receiving deflazacort at study entry: switching the patient from deflazacort to prednisolone, in the opinion of the investigator, will not result in a significant deterioration in the patient's health.\n10. The patient has been immunized with a vaccine against meningococcal serotypes A, C, Y, W135 (and B, if available) no later than 4 weeks prior to administration of GNR-097\u002Fplacebo, and the immunization period expires no more than three months after the expected date of administration of GNR-097\u002Fplacebo.\n\nExclusion Criteria:\n\n1. Hypersensitivity to any component of GNR-097 or placebo.\n2. Patient with cognitive impairment or a sedentary lifestyle that, in the opinion of the investigator, may interfere with the development or manifestation of motor activity.\n3. Mutations in exons 8 and\u002For 9 of the DMD gene; for patients planned for inclusion in Cohort A, additionally: mutations in exons 1-17 and\u002For 59-71 of the DMD gene.\n4. Clinical signs of cardiomyopathy, including left ventricular ejection fraction (Simpson) \\\u003C40% based on echocardiography performed during screening.\n5. Contraindications to magnetic resonance imaging.\n6. History of any autoimmune disease, with the exception of drug-compensated autoimmune thyroiditis.\n7. History of tuberculosis; positive or indeterminate result of Diaskintest® TigraTest® or T-SPOT.TB screening.\n8. Positive results of tests for hepatitis B, hepatitis C, or HIV screening.\n9. Acute infectious diseases that resolved less than 4 weeks before administration of GNR-097\u002Fplacebo.\n10. Immunization with a live attenuated vaccine less than 3 months before administration of GNR-097\u002Fplacebo OR immunization with any inactivated vaccine less than 4 weeks before administration of GNR-097\u002Fplacebo.\n11. Abnormal laboratory parameters:\n\n    * GGT level is more than three upper limits of normal;\n    * total bilirubin \\>50.0 μmol\u002FL (except for patients with a confirmed diagnosis of Gilbert's syndrome);\n    * creatinine \\>160.0 μmol\u002FL;\n    * hemoglobin \\\u003C80 or \\>180 g\u002FL;\n    * white blood cell count \\>18,500\u002FμL;\n    * platelet count below the lower limit of normal.\n12. History of taking antisense oligonucleotides, ataluren, gene therapy using vector constructs, or cell therapy.\n13. Use of immunosuppressive drugs other than glucocorticosteroids less than 12 weeks prior to signing the Informed Consent Form.\n14. Participation in clinical trials less than 6 months prior to signing the Informed Consent Form.\n15. Unwillingness or inability of the patient and\u002For their parent\u002Flegal guardian to comply with the protocol requirements and\u002For the trial procedures.\n16. Other diseases or conditions not listed above that, in the opinion of the physician investigator and\u002For the Sponsor, prevent the patient from participating in the trial, including for safety reasons.","MALE","4 Years","9 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","The study will evaluate the tolerability, safety and efficacy of gene therapy product in boys with Duchenne muscular dystrophy (DMD). In Phase I the participants will be included in two sequential dose cohorts with increasing doses of the investigational product. Based on the results of Phase I, the dose of the investigational product for use in Phase II will be determined. Phase II is a randomized, single-blind, placebo-controlled study. The participants who are randomized to the placebo arm will have an opportunity for treatment with gene therapy at the beginning of the second year.",[28],"Duchenne Muscular Dystrophy",[28,30,31,32,33,34,35],"DMD","Ambulatory","Gene Therapy","Micro-dystrophin","AAV","AAV9","RECRUITING","2026-06-23",{"date":39,"type":40},"2026-06-29","ACTUAL",{"date":42,"type":40},"2025-09-30",{"date":44,"type":21},"2029-08-02",{"name":46,"class":47},"AO GENERIUM","INDUSTRY",6,{"id":50,"slug":4,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100615123","NCT07288515","Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in Belarus","Observational Prospective Study of Acalabrutinib in Chronic Lymphocytic Leukemia Therapy in Real Clinical Practice in Belarus.","ALICIA(BY)","Inclusion Criteria:\n\n* Age ≥18 years.\n* Confirmed diagnosis of CLL.\n* Newly prescribed acalabrutinib monotherapy within the previous four weeks preceding study enrolment. Monotherapy is defined as acalabrutinib prescribes without concomitant administration (or planned initiation) of other anti-leukemic agents (e.g. obinutuzumab, venetoclax, bendamustine) within ± 30 days of acalabrutinib initiation.\n* Treatment-naïve or R\u002FR CLL.\n* Ability and willingness to provide informed consent for study participation.\n\nExclusion Criteria:\n\n* Patients not satisfying any of the inclusion criteria.\n* Prior treatment with any BTK inhibitor.\n* Participation in other ongoing clinical trials.\n* Pregnant or breastfeeding females","ALL","18 Years",{"count":59,"type":21},50,"OBSERVATIONAL","to address critical gap in knowledge, providing essential data on the real-world effectiveness, safety, associated with acalabrutinib treatment in patients with CLL",[63],"Chronic Lymphocytic Leukemia",[65],"CLL","2026-06-12",{"date":68,"type":40},"2026-06-15",{"date":70,"type":40},"2025-12-31",{"date":72,"type":21},"2029-12-31",{"name":74,"class":47},"AstraZeneca",1,{"id":77,"slug":4,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":56,"minAge":83,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":22,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":103},"100453081","NCT05179876","A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option","A Prospective, Open-label, Platform Study for Long-term Follow-up of Participants Using Study Intervention in Pulmonary Hypertension Parent Studies","PLATYPUS","Inclusion Criteria:\n\n* Participant must sign an informed consent form (ICF) (or their legally designated representative must sign) indicating that participant understands the purpose of, and procedures required for, the study and is willing to participate in the study\n* Participant treated with oral macitentan or selexipag or fixed dose combination (FDC) of macitentan 10 milligrams (mg) and tadalafil 40 mg at the end of a sponsor parent study and: a) the indication of the parent study is included in the intervention-specific appendices (ISA) (pulmonary arterial hypertension \\[PAH\\]; b) participant has completed the parent study; c) no alternative means of access to study intervention (or equivalent approved therapy) have been identified; d) participant may continue to benefit from treatment with the study intervention; e) Participant is at least 18 years old for macitentan\u002Ftadalafil FDC, and at least 2 years old for macitentan or selexipag\n* A female participant of childbearing potential must: a) have a negative urine or serum pregnancy test prior to first intake of study intervention; b) agree to perform monthly urine pregnancy test up to the end of the safety follow-up period; c) If heterosexually active, agree to follow contraceptive methods until 30 days after the last intake of the study intervention. For pediatric female participants: It is the responsibility of the investigator to ensure appropriate counselling, including consultation with a specialist (if needed), to the participant and\u002For parent(s)\u002F legally designated representative (LDR)(s) on the acceptable method of contraception\n\nExclusion Criteria:\n\nGeneral:\n\n* Participants prematurely discontinued from the study intervention in their parent study\n* Female participant being pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study\n* Planned or current treatment with another investigational treatment\n\nMacitentan-specific:\n\n* Known allergies, hypersensitivity, or intolerance to macitentan or its excipients\n* Hemoglobin less than (\\\u003C) 80 grams per liter (g\u002FL)\n* Serum aspartate (AST) and\u002For alanine aminotransferases (ALT) greater than (\\>) 3\\* upper limit of normal (ULN)\n* Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening\n\nSelexipag-specific:\n\n* Known allergies, hypersensitivity, or intolerance to selexipag or its excipients\n* Suspected or known pulmonary veno-occlusive disease (PVOD)\n* Uncontrolled thyroid disease\n* Severe coronary heart disease or unstable angina, myocardial infarction within the last 6 months, decompensated cardiac failure (if not under close medical supervision), severe arrhythmia, cerebrovascular events (for example, transient ischemic attack, stroke) within the last 3 months, or congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension (PH)\n* Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class (Child-Pugh score) should be fully assessed and documented in the source documents at screening\n* Children only: (a) Current suspicion of intussusception or ileus or gastrointestinal obstruction, per the investigator's judgment; (b) hemoglobin or hematocrit \\\u003C75 percent (%) of the lower limit of normal range\n\nMacitentan\u002Ftadalafil FDC-specific:\n\n* Known allergies, hypersensitivity, or intolerance to macitentan or tadalafil or their excipients\n* Hemoglobin \\\u003C80 g\u002FL\n* Serum aspartate (AST) and\u002For alanine aminotransferases (ALT) \\>3\\* ULN range\n* Known and documented severe hepatic impairment that is, Child-Pugh Class C. For participants with hepatic impairment, Child-Pugh Class should be fully assessed and documented in the source documents at screening\n* Severe renal impairment (estimated glomerular filtration rate \\[eGF\\]\u002Fcreatinine clearance \\\u003C30 milliliter per minute \\[mL\u002Fmin\\])","2 Years",{"count":85,"type":21},280,[87],"PHASE3","The purpose of the study is to enable participants with pulmonary hypertension (PH) currently treated with study intervention(s) in a clinical study (parent studies \\[NCT03422328, NCT03904693,NCT04565990, NCT02932410, NCT03492177, and NCT04175600\\]), to continue to benefit from the intervention after closure of the parent study in case they have no alternative means of access to the study intervention. This study will allow assessment of the long-term safety of each study intervention.",[90],"Hypertension, Pulmonary",[92,93],"Chronic thromboembolic pulmonary hypertension (CTEPH)","pulmonary arterial hypertension (PAH)","2026-06-04",{"date":96,"type":40},"2026-06-05",{"date":98,"type":40},"2022-05-04",{"date":100,"type":21},"2030-09-30",{"name":102,"class":47},"Actelion",45,{"id":105,"slug":4,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":125},"100339167","NCT03695978","Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia A Patients","Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia A Patients Entering Routine Clinical Treatment With Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW","Protect-NOW","Inclusion Criteria:\n\n* Male and female patients of any age and ethnicity\n* Severe haemophilia A (FVIII:C\\\u003C1%)\n* Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study\n* Either\n* No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR\n* Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if\n* data are available on all previous treatment, AND\n* they did not develop an inhibitor at any time point, OR\n* they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).\n* Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent\u002Flegal guardian)\n\nExclusion Criteria:\n\n* Diagnosis with a coagulation disorder other than haemophilia A\n* Concomitant treatment with any systemic immunosuppressive drug\n* Participation in an interventional clinical trial during the time period evaluated\n* Participation in another non-interventional study of Octapharma",{"count":112,"type":21},200,"International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.",[115],"Haemophilia A","2026-05-29",{"date":118,"type":40},"2026-06-02",{"date":120,"type":40},"2018-02-13",{"date":122,"type":21},"2030-06",{"name":124,"class":47},"Octapharma",59,{"id":127,"slug":4,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":132,"minAge":57,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":75},"100629244","NCT07472153","PD-1 (Programmed Death-1) Versus PD-L1 (Programmed Death-ligand 1) Immune Check Point Inhibitors Combined With Chemotherapy, With or Without Bevacizumab, In Patients With Metastatic, Persistent Or Recurrent Cervical Cancer","To Validate, Develop and Implement The Scope of Medical Care for Metastatic, Persistent and Recurrent Cervical Cancer Using The Method of Chemoimmunotargeted Therapy","Inclusion Criteria:\n\n* Age ≥18-≤75 years.\n* Histologically confirmed diagnosis.\n* One of the forms of the cervical cancer:\n\n  1. Metastatic cervical cancer (stage IVB according to FIGO (International Federation of Gynaecology and Obstetrics) 2018);\n  2. Persistent cervical cancer (primary incurability after radical treatment for stages IIB-IVA cervical cancer according to FIGO 2018);\n  3. Reccurent cervical cancer (first recurrence after completed radical treatment for IA-IVB cervical cancer according to FIGO 2018).\n* Availability of material for determining PD-L-1 expression for immunotherapy candidates.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* No contraindications to chemotherapy, immunotherapy, or bevacizumab.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of another active malignant invasive neoplasm.\n* Pregnancy or lactation period.","FEMALE","75 Years",{"count":135,"type":21},120,[25,87],"This is a randomized trial evaluating the results of using of PD-1 and PD-L1 immune checkpoint inhibitors combined with chemotherapy, with or without bevacizumab, in patients with metastatic, persistent, and recurrent cervical cancer.",[139,140,141],"Metastatic Cervical Cancer","Persistent Cervical Cancer","Recurrent Cervical Cancer","2026-05-26",{"date":144,"type":40},"2026-05-28",{"date":146,"type":40},"2025-07-01",{"date":148,"type":21},"2033-06-30",{"name":150,"class":151},"N.N. Alexandrov National Cancer Centre","OTHER_GOV",{"id":153,"slug":4,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":158,"enrollmentInfo":159,"targetDuration":161,"studyType":60,"phases":4,"briefSummary":162,"conditions":163,"keywords":165,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":75},"100633294","NCT07524816","Real World Practice With Academic Anti CD19 CAR-T Cell Therapy in Relapse\u002FRefractory B-cell Lymphoma","Treatment Method of Patients With Refractory and Relapsed CD-19 Positive Leukemia and Lymphoma Using Academic Anti-CD19 CAR-T Human Cells","Inclusion Criteria:\n\n* age ≥18 years,\n* relapsed or refractory LBCL,\n* confirmed CD19 expression in tumor tissue,\n* prior exposure to at least one line of anti-tumor therapy\n\nExclusion Criteria:\n\n* pregnancy,\n* active hepatitis B or C infection, HIV infection,\n* naïve T-lymphocyte count (CD3+CCR7+CD45RO-) ≤ 0,5%","80 Years",{"count":160,"type":21},76,"3 Months","Chimeric antigen receptor (CAR) T-cell therapy has been the standard of care for relapsed\u002Frefractory large B-cell lymphomas (R\u002FR LBCLs) since 2018. However, high cost of commercial products limits their application in real-world clinical practice. Academic approach to manufacturing CAR-T cell products can reduce the costs and improve availability and affordability of this therapy option. The aim of the present study is assess the efficacy and safety of the use of academic CAR-T cell products in r\u002Fr LBCL patients.This prospective observational study with r\u002Fr LBCL patients treated in the NN Alexandrov National Cancer Centre of Belarus. The CAR-T cell product was manufactured using lentiviral vector encoding anti-CD19 CAR.",[164],"Large B-Cell Lymphoma (LBCL)",[166,167,168,169],"academic CAR-T cell products","r\u002Fr large B-cell lymphomas","efficacy","safety","2026-04-09",{"date":172,"type":40},"2026-04-13",{"date":174,"type":40},"2021-06-01",{"date":176,"type":21},"2029-01-01",{"name":150,"class":151},{"id":179,"slug":4,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":75},"100629687","NCT07477912","Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma","Phase I\u002FII Open-label Study Evaluating The Safety And Efficacy of Anti BCMA CAR-T Cell Therapy in Adults With R\u002F R Multiple Myeloma","MSTH-CAR001","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. Willing and able to give written, informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 2.\n4. Relapsed or refractory multiple myeloma according to IMWG criteria with two previous lines of therapy and resistance to proteosome inhibitors and immunomodulators.\n5. Adequate organ system function including\n\n   \\- Creatinine clearance ≥30 cc\u002Fmin.\n\n   \\- Serum alanine aminotransferase \u002F aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).\n\n   \\- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.\n\n   \\- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \\[ECHO\\] or\n\n   \\- Baseline oxygen saturation \\>92% on room air and ≤Grade 1 dyspnoea.\n6. Have no active GVHD (Grade 2-4)\n7. Adequate bone marrow (BM) function\n\n   * Absolute neutrophil count ≥1.0 × 10\\^9\u002FL.\n   * Absolute lymphocyte count ≥0.3 × 10\\^9\u002FL (at enrolment and prior to leukapheresis).\n   * Haemoglobin ≥80 g\u002FL.\n   * Platelets ≥50 × 10\\^9\u002FL\n\nExclusion Criteria:\n\n1. Females who are pregnant or lactating.\n2. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.\n3. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).\n4. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.\n5. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.\n6. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 24 months.\n\n6\\. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.\n\n7\\. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).\n\n8\\. The following medications are excluded:\n\n* Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.\n* Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.\n* Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.\n* Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.\n* Live vaccine ≤4 weeks prior to enrolment.\n* Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.\n\nPrior limited radiation therapy within 2 weeks of CAR-T cells infusion. 9. Prior anti BCMA therapy 10. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab.\n\n11\\. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.",{"count":186,"type":21},30,[24,25],"The mail purpose of this study is to estimate the safety and the efficacy of anti-BCMA CAR- T cell immunotherapy for adults with relapsed or refractory multiple myeloma",[190],"Multiple Myeloma Refractory",[192,193],"CAR-T therapy","multiple myeloma","2026-03-13",{"date":196,"type":40},"2026-03-17",{"date":198,"type":40},"2025-02-01",{"date":200,"type":21},"2030-02-01",{"name":202,"class":151},"Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology",{"id":204,"slug":4,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":132,"minAge":57,"maxAge":133,"enrollmentInfo":209,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":216,"lastUpdatePostDateStruct":217,"startDateStruct":219,"completionDateStruct":220,"leadSponsor":221,"locationsCount":75},"100629243","NCT07472140","PARP (Poly (ADP-ribose) Polymerase) Inhibitor With or Without Angiogenesis Inhibitor in Homologous Recombination Deficient Primary Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer","To Develop and Implement The Scope of Medical Care for Homologous Recombination Deficient Ovarian Cancer, Fallopian-Tube Cancer, or Primary Peritoneal Cancer of the III-IV Stages Using Maintenance Therapy With PARP Inhibitor Combined With Angiogenesis Inhibitor.","Inclusion Criteria:\n\n* Age ≥18-≤75 years.\n* Histologically confirmed diagnosis of serous or endometrioid high-grade ovarian cancer, fallopian-tube cancer or primary peritoneal cancer.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Possibility of performing diagnostic laparoscopy or cytoreductive surgery.\n* Presence of homologous recombination deficiency (HRD).\n* No contraindications to chemotherapy, or bevacizumab.\n* Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n* Presence of another active malignant invasive neoplasm.\n* Pregnancy or lactation period.\n* Disease progression during treatment.",{"count":135,"type":21},[25,87],"This is a randomized trial evaluating the results of using of PARP inhibitor combined with angiogenesis inhibitor. in patients with homologous recombination deficient primary ovarian cancer, fallopian-tube cancer, or primary peritoneal cancer of the III-IV stages.",[213,214,215],"Ovarian Cancer","Fallopian Tube Cancers","Primary Peritoneal Cancer","2026-03-11",{"date":218,"type":40},"2026-03-16",{"date":146,"type":40},{"date":148,"type":21},{"name":150,"class":151},{"id":223,"slug":4,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":229,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":231,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":247,"locationsCount":75},"100628366","NCT07460700","Mesenteric Ischemia Markers Study","Mesenteric Ischemia Markers Study In The Presence Of Mesenteric Arteries Disease","MESMARK","Inclusion Criteria:\n\n* 18 years or older, all sex\n* Initial decision, the presence of angio-visualisation of the MA and suspicion of mesenteric arteries diseases\n* Patient's consent to participate in the study\n* No pregnancy, no history of major operations on MA, the gastrointestinal tract and digestive organs (except appendectomy, endoscopic polypectomy).\n\nExclusion Criteria:\n\n* Consent declined by patient or relatives\n* Failure to meet inclusion criteria",true,{"count":135,"type":21},[232],"NA","Vascular bowel disease remains a socially significant and potentially fatal condition (if it develops into AMI), primarily due to delayed diagnosis. Blood biomarkers are theoretically ideal for early risk stratification (like troponins in myocardial infarction). However, the existing evidence base is characterized by low quality and high heterogeneity, which hinders their use in clinical practice. Therefore, there is an urgent and unmet clinical need for high-quality, methodologically rigorous research to validate biomarkers in MI. A current study (MESMARK) is to be undertaken to identify combinations of biomarkers that can reliably identify mesenteric ischemia (MI) and distinguish between non-transmural and transmural clinical relevant ischemia.",[235],"Mesenteric Vascular Disease",[237,238,239],"Mesenteric arteries disease","Mesenteric Ischemia","Blood biomarkers","2026-03-04",{"date":242,"type":40},"2026-03-10",{"date":244,"type":40},"2025-12-22",{"date":246,"type":21},"2026-12-12",{"name":248,"class":249},"Belarusian State Medical University","OTHER",{"id":251,"slug":4,"hasResults":11,"nctId":252,"briefTitle":253,"officialTitle":254,"acronym":4,"eligibilityCriteria":255,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":256,"targetDuration":4,"studyType":22,"phases":258,"briefSummary":259,"conditions":260,"keywords":262,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":75},"100616698","NCT07308990","Limited Versus Extended Lymph Node Dissection During Radical Prostatectomy in Patients With Localized or Locally Advanced Prostate Cancer","To Develop and Implement a Method for Optimizing the Volume of Lymph Node Dissection in Radical Surgical Treatment of Localized or Locally Advanced Prostate Cancer","Inclusion Criteria:\n\n1. Age over 18 years.\n2. Histologically confirmed localized or locally advanced prostate cancer (adenocarcinoma without a neuroendocrine component).\n3. No evidence of metastatic spread of the tumor\n4. Local resectability of the tumor according to digital rectal examination and\u002For CT and\u002For MRI of the pelvis\n5. Patients are suitable for radical prostatectomy based on their comorbidities and life expectancy.\n6. Signed informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Presence of another active malignant invasive neoplasm.\n2. Contraindication to pelvic lymph node dissection (e.g., history of radiation therapy to the pelvis).\n3. The evidence of metastases in regional lymph nodes according to preoperative examination data (including PET\u002FCT with PSMA).\n4. Severe concomitant disease limiting participation in the study.",{"count":257,"type":21},800,[232],"This is a randomized controlled study assessing outcome of low (no or limited) versus high (limited or extended) extent of lymph node dissection in addition to radical prostatectomy in patients with operable localized or locally advanced prostate cancer.",[261],"Prostate Cancer Patients Undergoing Radical Prostatectomy",[263,264,265],"prostate cancer","lymph node dissection","radical prostatectomy","2025-12-15",{"date":268,"type":40},"2025-12-30",{"date":270,"type":40},"2025-10-29",{"date":272,"type":21},"2032-05-30",{"name":150,"class":151},{"id":275,"slug":4,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":56,"minAge":279,"maxAge":158,"enrollmentInfo":280,"targetDuration":4,"studyType":60,"phases":4,"briefSummary":282,"conditions":283,"keywords":288,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":75},"100500789","NCT05800821","Prediction of Cerebral Hyperperfusion Syndrome After Carotid Revascularization Using Deep Learning","Inclusion Criteria:\n\n1. Age between 30 and 80 years.\n2. Occlusive-stenotic lesion of the carotid arteries with indications for carotid revascularization.\n\nExclusion Criteria:\n\n1. Systemic vasculitis.\n2. Cerebral vessel aneurysms.\n3. Arteriovenous malformation of the brain.\n4. Primary brain tumor (including metastatic lesions).\n5. Epilepsy.\n6. History of traumatic brain injury.\n7. Demyelinating diseases of the central nervous system.\n8. History of neuroinfection.\n9. Atrial fibrillation.\n10. Frequent supraventricular or ventricular extrasystoles.\n11. Chronic heart failure with left ventricular ejection fraction less than 40%.\n12. Chronic kidney disease with estimated glomerular filtration rate less than 45 mL\u002Fmin\u002F1.73 m².\n13. Presence of an implanted cardioverter-defibrillator or pacemaker.\n14. Presence of contraindications to the medical use of iodine-containing radiographic contrast agents.\n15. Patient's unwillingness to continue participating in the study.\n16. Absence of a temporal acoustic window for transcranial Doppler ultrasonography.","30 Years",{"count":281,"type":21},500,"Cerebral hyperperfusion syndrome (CHS) was initially described as a clinical complication following carotid endarterectomy (CEA), but it may occur after both CEA and carotid artery stenting. It is characterised by throbbing ipsilateral frontotemporal or periorbital headache, and sometimes diffuse headache, eye and facial pain, vomiting, confusion, macular oedema, visual disturbances, focal motor seizures with frequent secondary generalisation, focal neurological deficits, and intracerebral or subarachnoid haemorrhage.\n\nKnowledge of CHS among physicians remains limited. Most studies report an incidence of 1-3% after carotid endarterectomy. CHS is most common in patients with increases of more than 100% in cerebral perfusion compared with baseline after carotid revascularization, and is rare in patients with perfusion increases of less than 100% compared with baseline.\n\nThe pathophysiological mechanism of CHS is only partially understood. The chronic low-flow state induced by severe carotid disease results in compensatory dilation of cerebral vessels distal to the stenosis, as part of the normal autoregulatory response to maintain adequate cerebral blood flow (CBF). In this chronically dilated state, the vessels lose their ability to autoregulate vascular resistance in response to changes in blood pressure. Dysautoregulation has been shown to be proportional to the duration and severity of chronic hypoperfusion. After revascularization and reperfusion, impaired cerebral autoregulation may contribute to a cascade of intracranial microcirculatory changes, with an inability to respond adequately to the augmentation of CBF following carotid recanalization.\n\nAlthough most patients present with mild symptoms and signs, progression to severe and life-threatening complications can occur if CHS is not recognised and treated promptly. Because CHS is diagnosed on the basis of several non-specific signs and symptoms, patients may be misdiagnosed as having one of the better-known causes of perioperative complications, such as thromboembolism.",[284,285,286,287],"Carotid Artery Diseases","Carotid Atherosclerosis","Carotid Artery Stenosis","Cerebral Hyperperfusion Syndrome",[287,289,290,291],"Carotid Stenosis","Stroke","Deep Learning","2025-11-20",{"date":294,"type":40},"2025-11-25",{"date":296,"type":40},"2023-05-03",{"date":298,"type":21},"2030-05-03",{"name":300,"class":249},"State Institution \"Republican Scientific and Practical Center\" Cardiology, Belarus",{"id":302,"slug":4,"hasResults":11,"nctId":303,"briefTitle":304,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":308,"targetDuration":4,"studyType":22,"phases":310,"briefSummary":311,"conditions":312,"keywords":315,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":75},"100605442","NCT07162571","This is a Phase I\u002FII Interventional, Open-label Treatment Study Designed to Evaluate the Safety and Efficacy of Anti CD 19\u002F22 CAR- T Cells Immunotherapy for Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia\u002FLymphoma.","Phase I\u002FII Open-label Study Evaluating The Safety And Efficacy of Anti CD19\u002F22 CAR-T Cells Therapy Adults With R\u002F R Leukemia\u002F Lymphoma","MSTH-CAR002","Inclusion Criteria:\n\n1. Male or female, aged ≥18 years.\n2. Willing and able to give written, informed consent.\n3. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 to 1.\n4. Relapsed or refractory lymphoblastic leukemia\u002Flymphoma.\n\n   \\- Chemotherapy-refractory disease after ≥1 lines of therapy\n\n   \\- Relapse after chemotherapy or after ASCT\u002FAllo-HSCT.\n5. Adequate organ system function including - Creatinine clearance ≥40 cc\u002Fmin.\n\n   \\- Serum alanine aminotransferase \u002F aspartate aminotransferase ≤2.5 x upper limit of normal (ULN).\n\n   \\- Total bilirubin ≤1.5 x ULN, except in subjects with Gilbert's syndrome.\n\n   \\- Left ventricular ejection fraction (LVEF) ≥50% (by echocardiogram \\[ECHO\\] or\n\n   \\- Baseline oxygen saturation \\>92% on room air and ≤Grade 1 dyspnoea.\n6. Have no active GVHD (Grade 2-4)\n7. Adequate bone marrow (BM) function - Absolute neutrophil count ≥1.0 × 10\\^9\u002FL.\n\n   * Absolute lymphocyte count ≥0.3 × 10\\^9\u002FL (at enrolment and prior to leukapheresis).\n   * Haemoglobin ≥80 g\u002FL.\n   * Platelets ≥75 × 10\\^9\u002FL\n\n7\\. The expression of CD19 and\u002For CD22 on the tumor cells are reported as positive by either immunohistochemistry or flow cytometry\n\nExclusion Criteria:\n\n1. Females who are pregnant or lactating.\n2. History or presence of clinically relevant CNS pathology such as epilepsy, paresis, aphasia, stroke within prior 3 months, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis.\n3. Patients with active CNS involvement by malignancy. Patients with history of central nervous system (CNS) involvement with malignancy may be eligible if CNS disease has been effectively treated and provided treatment was at least 4 weeks prior to enrolment (at least 8 weeks prior to CAR-T infusion).\n4. Clinically significant, uncontrolled heart disease or a recent (within 12 months) cardiac event.\n5. Active bacterial, viral or fungal infection requiring systemic treatment. Active or latent hepatitis B infection or hepatitis C infection. Testing positive for human immunodeficiency virus, human T cell lymphotropic virus (HTLV1 and 2) or syphilis.\n6. History of autoimmune disease resulting in end organ injury or requiring systemic immunosuppression\u002Fsystemic disease modifying agents within the last 24 months.\n\n6\\. Evidence of active pneumonitis on chest computed tomography (CT) scan at screening or history of drug-induced pneumonitis, idiopathic pulmonary fibrosis, organising pneumonia, or idiopathic pneumonitis.\n\n7\\. History of other malignant neoplasms unless disease free for at least 24 months (carcinoma in situ, non-melanoma skin cancer, breast or prostate cancer on hormonal therapy allowed).\n\n8\\. The following medications are excluded:\n\n* Steroids: Therapeutic doses of corticosteroids within 7 days of leukapheresis or 72 hours prior to CAR-T administration. However, physiological replacement, topical, and inhaled steroids are permitted.\n* Immunosuppression: Immunosuppressive medication must be stopped ≥2 weeks prior to leukapheresis or CAR-T cells infusion.\n* Cytotoxic chemotherapies within 1 week of CAR-T cellsinfusion and 1 week prior to leukapheresis.\n* Antibody therapy use including anti-CD20\u002F19\u002F22 therapy within 2 weeks prior to CAR-T cells infusion.\n* Granulocyte-colony stimulating factor less than 14 days prior to leukapheresis.\n* Live vaccine ≤4 weeks prior to enrolment.\n* Prophylactic intrathecal therapy: Methotrexate within 4 weeks and other intrathecal chemotherapy (e.g. Ara-C) within 2 weeks prior to starting pre-conditioning chemotherapy.\n\nPrior limited radiation therapy within 2 weeks of CAR-T cells infusion. 9. Known allergy to albumin, dimethyl sulphoxide (DMSO), cyclophosphamide or fludarabine or tocilizumab.\n\n10\\. Any other condition that in the Investigator's opinion would make the patient unsuitable for the clinical trial.",{"count":309,"type":21},17,[24,25],"The purpose of this study is to estimate the safety and the efficacy of anti-CD19\u002F22 CAR- T cells immunotherapy for adults with relapsed or refractory acute lymphoblastic leukemia\u002Flymphoma.",[313,314],"Acute Lymphobkastic Leukemia","B Cell Lymphoma",[316,313,317,318],"CD19\u002F22 CAR-T cells","B Cell lymphoma","dual targeting CAR-T therapy","NOT_YET_RECRUITING","2025-09-06",{"date":322,"type":40},"2025-09-09",{"date":324,"type":21},"2026-01-01",{"date":326,"type":21},"2031-12",{"name":202,"class":151},{"id":329,"slug":4,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":133,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":343,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100602120","NCT07119372","Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","A Randomized, Open-label, Comparative Clinical Study of the Efficacy and Safety of BCD-131 and Mircera® in the Treatment of Anemia in Patients With Chronic Kidney Disease on Dialysis","Inclusion Criteria:\n\n* The patient signed a written ICF for participation in the study.\n* Men and women aged 18 to 75 years inclusive at the time of signing the ICF.\n* End stage kidney disease (documented).\n* The need for dialysis sessions within at least the last 90 days prior to signing the ICF.\n* For patients on hemodialysis - hemodialysis procedures should be at least 3 times a week, for a total duration of at least 12 hours a week.\n* Documented use of recombinant erythropoietin (epoetin alfa, epoetin beta or darbepoetin alfa) for at least 90 days prior to signing the ICF.\n* The dose of recombinant erythropoietins (epoetin alfa or epoetin beta received 1, 2 or 3 times a week, or darbepoetin alfa received once a week\u002Fonce every 2 weeks) should be stable for at least 90 days prior to signing the ICF and the entire screening period (documented).\n* Target hemoglobin level (100-120 g\u002FL inclusive) based on the results of screening examination (two measurements).\n* The efficacy of dialysis established at screening or not more than 14 days before signing the ICF (dialysis dose index (Kt\u002Fv) ≥1.2 in patients on long-term hemodialysis, and weekly Kt\u002Fv ≥1.7 for patients on peritoneal dialysis).\n* Transferrin saturation ≥20%, ferritin level \\>100 ng\u002FmL at screening.\n* Cyancobalamine (vitamin B12) and folic acid levels within the laboratory reference values at screening.\n* Willingness of patients of both sexes and their sexual partners of childbearing potential to use methods of contraception in accordance with the protocol, starting from signing the informed consent form, throughout the study and for up to 90 days after receiving the last dose of the drug in the clinical study, as well as to refrain from donation of eggs for female subjects or sperm for male subjects during this period.\n* The ability of the patient to comply with the Protocol requirements, in the Investigator's opinion.\n\nExclusion Criteria:\n\n* Any other diagnosed forms of anemia, except for anemia of renal disease, including anemia in chronic diseases (C-reactive protein level \\>20 mg\u002FL at screening).\n* Diagnosed lupus nephritis or chronic kidney disease due to systemic vasculitis.\n* Platelet count \\\u003C100×109\u002FL based on the results of screening examination.\n* A high probability of early withdrawal from the study, in particular a planned (i.e., available information about a planned date and\u002For a suitable donor) kidney transplant surgery during the estimated period of participation in the study.\n* A history of severe allergic reactions (anaphylactic shock or multiple drug allergy) according to the patient, and hypersensitivity to recombinant erythropoietins, polyethylene glycol or any components of the study drugs, or to iron (III) hydroxide sucrose complex.\n* Vaccination less than 8 weeks before signing the ICF (according to the patient).\n* Diagnosed liver cirrhosis.\n* HIV infection.\n* ALT, AST \\>3хULN at screening.\n* Decompensated heart disease (NYHA Class IV CHF).\n* Resistant hypertension.\n* Unstable angina.\n* History of acute hemolysis episodes.\n* Documented hemoglobinopathy, myelodysplastic syndrome, hematological malignancy, pure red cell aplasia.\n* Severe secondary hyperparathyroidism (intact PTH\\>1000 pg\u002FmL at screening) or biopsy-confirmed bone marrow fibrosis (myelofibrosis).\n* Documented episodes of gastrointestinal or other bleeding within less than 90 days prior to signing the ICF.\n* Documented history of episodes of thrombosis (acute myocardial infarction, stroke, transient ischemic attacks, deep vein thrombosis, pulmonary thromboembolism within less than 6 months before the signing of the ICF, as well as long-term vascular access thrombosis within 30 days before the signing of the ICF.\n* Seizure syndrome, including a history of or epilepsy during the screening period.\n* Documented major surgery less than 30 days before signing the ICF.\n* Documented blood transfusion within less than 90 days prior to signing the ICF.\n* Any acute or chronic infections in the stage of exacerbation, as well as other chronic diseases that at the time of signing the informed consent, may adversely affect the patient's safety while using the study therapy in the opinion of the investigator.\n* A history of severe depression, suicidal ideation, or attempted suicide.\n* Documented malignancies other than cured basal-cell carcinoma and\u002For cervical carcinoma in situ with a remission duration of more than 5 years at the time of signing the ICF.\n* Known alcohol or drug addiction, or current signs of alcohol\u002Fdrug addiction, which, according to the investigator, is contraindication for the treatment with the test drug\u002Freference drug or limits the treatment adherence.\n* Participation in other clinical studies of medicinal products within less than 90 calendar days prior to signing the informed consent form for participation in this study.\n* Pregnancy or breastfeeding.",{"count":335,"type":21},228,[87],"BCD-131 is pegylated darbepoetin beta. This clinical study BCD-131-3 is a randomized, open-label, phase III study of the efficacy and safety of BCD-131 and Mircera used for the treatment of anemia in end-stage chronic kidney disease (CKD) patients on dialysis.",[339,340,341,342],"Anemia","Chronic Kidney Disease","Chronic Kidney Disease Patients on Hemodialysis","Chronic Kidney Disease 5D",[340,344,339,345,346,347,348,349,350],"CKD","Erythropoietin","Darbepoetin","Erythropoiesis-stimulating agent","Dialysis","Hemodialysis","Renal anemia","2025-08-07",{"date":353,"type":40},"2025-08-13",{"date":355,"type":40},"2025-03-01",{"date":357,"type":21},"2026-11",{"name":359,"class":47},"Biocad",2,{"id":362,"slug":4,"hasResults":11,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":11,"sex":132,"minAge":57,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":382},"100601270","NCT07108309","BCD-236 in Combination With Chemotherapy in Patients With Relapsed and\u002For Metastatic Triple Negative Breast Cancer","A Randomized, Open-label, Comparative Clinical Study of the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BCD-236 in Combination With Chemotherapy in Patients With Relapsed and\u002For Metastatic Triple Negative Breast Cancer","AREAL","Main Inclusion Criteria:\n\n* Signed informed consent and the subject's ability to comply with the requirements of the Clinical Study Protocol.\n* Age ≥18 years and \\\u003C75 years at the time of signing the informed consent form.\n* Histologically verified diagnosis (there are documented results of relevant studies) of TNBC: ER 0-2 points, PR 0-2 points or ER \\\u003C1%, PR \\\u003C1% (ASCO\u002FCAP); HER2 (≤1+) or HER2 (2+) in the absence of amplification of the Her-2-neu gene by ISH.\n* TNBC is progressive or relapsing on or after systemic therapy.\n* The subject received at least 1 line of systemic therapy for locally advanced unresectable or metastatic TNBC, or she experienced a relapse \u002F progressive disease during or within 6 months after completion of post-operative (adjuvant) chemotherapy.\n* Confirmed AXL expression in tumor cells according to immunohistochemistry.\n* Availability of fresh (obtained as part of screening or before its start, but after disease progression or relapse on the last line of therapy) and archival (obtained before disease progression or relapse on the last line of therapy, if available) tumor material samples suitable for immunohistochemical examination to determine AXL expression.\n* Presence of at least 1 measurable tumor lesion according to RECIST 1.1. criteria for CIR.\n* ECOG score 0-1.\n* Life expectancy ≥ 4 months from the date of signing of the informed consent form in the opinion of the Investigator.\n\nMain Exclusion Criteria:\n\n* Indications for radical therapy or radiotherapy (excluding minor surgery or radiation therapy for palliative purposes).\n* Active CNS metastases and\u002For carcinomatous meningitis. Subjects with brain metastases may participate in the study provided that the metastases have been adequately treated with surgery or radiotherapy, and if they have been clinically stable for at least 4 weeks prior to randomization (i.e. no neurological symptoms, no need for corticosteroids, and no lesions \\>1.5 cm) and no evidence of new or increasing CNS metastases. Patients with newly diagnosed CNS metastases during screening may not be included in the study.","74 Years",{"count":370,"type":21},124,[25],"To study the efficacy, safety, pharmacokinetics and immunogenicity of BCD-236 in combination with chemotherapeutic agents (CHT) in 2nd and subsequent lines of therapy of subjects with relapsed and\u002For metastatic triple negative breast cancer (TNBC).",[374],"Triple Negative Breast Cancer","2025-08-04",{"date":351,"type":40},{"date":378,"type":40},"2024-07-15",{"date":380,"type":21},"2027-05",{"name":359,"class":47},47,{"id":384,"slug":4,"hasResults":11,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":390,"enrollmentInfo":391,"targetDuration":4,"studyType":22,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":319,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":360},"100533945","NCT06232421","Clinical Study in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues, Phase I-II of the Wound Process","A Prospective, Parallel, Single-blind Clinical Study Using Stratified Randomization of the Effectiveness, Tolerability and Safety of the Medicinal Product \"Foscelantan, Medicinal Plate 4.0x5.0 cm in Package No. 1\" Produced by UNITEKHPROM BSU, Republic of Belarus, in Comparison With the Medicinal Product Povidone- Iodine Produced by BelAseptika JSC, in Adult Patients With Purulent-inflammatory Processes of the Skin and Soft Tissues Due to the Neuropathic Form of Diabetic Foot Syndrome or Chronic Venous Insufficiency, Phase I-II of the Wound Process","OLENKRON-01","Inclusion Criteria:\n\n* The presence of purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome (Main diagnosis: Diabetes mellitus type I or II, clinical metabolic compensation\u002Fsubcompensation, class I - II according to the Wagner classification) or chronic venous insufficiency (Main diagnosis: Varicose veins dilatation of the veins of the lower extremities, class C6 according to the CEAP classification), phase I-II of the wound process\n* The size of the ulcerative defect is from 1 cm² to 20 cm²\n* Secondary type of wound healing\n* Absence of exposed bones and tendons in the wound\n* Absence of severe concomitant diseases in the stage of decompensation, oncological diseases, as well as diseases requiring steroid therapy\n* Availability of written informed consent from the patient to participate in the study\n* The patient's ability to follow the instructions of the research physician and comply with the study regimen\n\nExclusion Criteria:\n\n* Individual intolerance or hypersensitivity reactions to the components of the drug Foscelantan\n* Neuroischemic form of diabetic foot syndrome\n* The presence of serious concomitant pathology (severe form of renal and hepatic failure, systemic connective tissue diseases, severe cardiovascular insufficiency), history and current mental illness\n* The need to constantly take drugs from the list of prohibited therapies\n* Participation of the patient in another clinical trial within 3 months before the current clinical trial\n* Acute bleeding\n* Level of peripheral blood leukocytes less than 1.5 × 109 per l, platelets less than 75.0 × 109 per l.\n* Hemoglobin less than 80g per l.\n* Positive tests for syphilis, human immunodeficiency virus (HIV), hepatitis B, or hepatitis C\n* Severe liver dysfunction - AST or ALT levels exceed the upper limit of normal by 5 times or more, bilirubin ≥ 2.0 mg\u002FdL (34.2 µmol\u002FL).\n* Severe renal dysfunction - creatinine 2 times higher than reference values\n* Diabetes mellitus in a state of clinical and metabolic decompensation\n* Pregnant and breastfeeding women\n* At one\\'s own request without explaining the reasons for the action.\n* At the request of the research physician, if the research subject violates the protocol requirements for diet, consumption of alcoholic beverages, and medications without the prescription of the research physician.\n* For reasons independent of the study subject and the research physician, when a study subject develops drug intolerance and other life-threatening or requiring emergency pharmacotherapy adverse reactions to the administration of the study drug.\n* The need to prescribe drugs from the list of prohibited treatments.","70 Years",{"count":392,"type":21},224,[25,87],"The purpose of this study is to estimate efficiency, tolerance, safety of \"Foscelantan, medicinal plate 4.0x5.0 cm in package No. 1\" among adult patients who have purulent-inflammatory processes of the skin and soft tissues due to the neuropathic form of diabetic foot syndrome or chronic venous insufficiency, phase I-II of the wound process.",[396,397],"Diabetic Foot Infections","Chronic Venous Insufficiency",[399,400,401,402,403],"diabetic foot infection","chronic venous insuffiency","lidocaine","cellulose","miramistin","2025-07-22",{"date":406,"type":40},"2025-07-25",{"date":408,"type":21},"2025-11",{"date":410,"type":21},"2026-05",{"name":412,"class":249},"Research Institute for Physical Chemical Problems of the Belarusian State University",{"id":414,"slug":4,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":416,"acronym":417,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":133,"enrollmentInfo":419,"targetDuration":4,"studyType":22,"phases":420,"briefSummary":421,"conditions":422,"keywords":424,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":432,"leadSponsor":434,"locationsCount":75},"100533946","NCT06232434","An Open Prospective Randomized Clinical Study of the Effectiveness, Tolerability and Safety of a Single Intraperitoneal Use of the Drug \"Prospidelong, Powder for the Preparation of a Gel for Topical Use, 1000 mg in Vials, Package No. 1\" in Patients With Disseminated Gastric Cancer, Phase I-II","ИНТЕЛОН-02","Inclusion Criteria:\n\n* Gastric cancer without transition to the esophagus with peritoneal dissemination sT1-4N0-3M1.\n* Life expectancy of at least 6 months\n* Physical status on the ECOG scale 0 - 1.\n* The age of patients is from 18 to 75 years.\n* Absence of severe concomitant diseases in the decompensation stage.\n* Availability of written informed consent from the patient to participate in the study.\n* The ability of the patient and the personnel caring for him to comply with the instructions of the research physician and comply with the study design.\n\nExclusion Criteria:\n\n* Pregnancy and lactation.\n* The presence of a primary multiple (synchronous or metachronous) malignant tumor. The exception is for patients who were treated for basal cell or squamous cell skin cancer, cervical cancer in situ, or other tumors more than 5 years ago and are expected to be completely cured.\n* Presence of severe concomitant diseases in the stage of decompensation;\n* Family relationships between the patient and the center staff.\n* Allergy to components of the study drug.\n* Refusal of the patient from the proposed treatment method.\n* Presence of heart disease class III or IV according to the New York Heart Association classification or a history of myocardial infarction within 6 months before the 1st day of the study.\n* Any history of epileptic seizures.\n* Severe diseases, including those with severe symptoms, untreated inflammatory and infectious processes, due to which the patient cannot receive treatment in accordance with the study protocol.\n* Chronic liver and\u002For kidney failure.\n* Legal incapacity or other circumstances due to which the patient or his immediate family are unable to understand the nature, scope and possible consequences of the treatment being carried out\n* Socioeconomic or geographic circumstances that cannot guarantee adequate compliance with protocol requirements for treatment and follow-up.\n* History of abuse of alcohol or any chemical substances for 2 years up to the 10th day before the start of the study.\n* Patient participation in another clinical trial.\n\nNon-inclusion criteria based on survey data:\n\n* Acute bleeding from the tumor.\n* Level of peripheral blood leukocytes less than 1.5 × 109 per l, platelets less than 75.0 × 109 per l.\n* Hemoglobin less than 80g per l.\n* Positive tests for human immunodeficiency virus (HIV), hepatitis B or hepatitis C.\n* Severe liver dysfunction - AST and ALT levels exceed the upper limit of normal by 5 times or more, bilirubin greater than or equal to 2.0 mg per dL (34.2 µmol per L).\n* Severe renal impairment - creatinine clearance less than 30 ml per minute, calculated using the Cockcroft-Gault formula - or the CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula.\n* Diabetes mellitus in a state of clinical and metabolic decompensation.\n\nCriteria for exclusion (dropout) from the study:\n\n* Individual intolerance to drugs included in the treatment regimen.\n* The patient's desire to stop participating in the study.\n* Serious adverse events occurring in the patient during the study.\n* Violation by the patient of the research conditions of the investigational medicinal product (non-compliance).\n* Pregnancy.\n* Detection of a second malignant tumor",{"count":135,"type":21},[25,87],"It is planned to conduct an open-label, prospective, randomized clinical study of the efficacy, tolerability and safety of a single intraperitoneal administration of the investigational drug Prospidelong at a dose of 4000 mg (2000 mg in terms of prospidium chloride) in patients with disseminated gastric cancer.\n\nIn total, the study plans to include 120 patients aged 18 to 75 years inclusive, including 60 patients in the study group and 60 in the comparison group. The study consists of daily examination of patients throughout the entire period of hospitalization and subsequent visits.",[423],"Gastric Cancer With Peritoneal Dissemination",[425,426,427],"gastric cancer with peritoneal dissemination","prospidin","dextran phosphate","2025-06-20",{"date":430,"type":40},"2025-06-22",{"date":428,"type":40},{"date":433,"type":21},"2025-12",{"name":412,"class":249},{"id":436,"slug":4,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":11,"sex":16,"minAge":57,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":22,"phases":443,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":447,"lastUpdatePostDateStruct":448,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":309},"100525349","NCT06120582","Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B (SAFRAN)","An Open-label, Non-comparative, Single Dose-Escalation Study of the Safety, Pharmacodynamics and Efficacy of ANB-002 in Patients With Hemophilia B","Inclusion Criteria:\n\n1. Male with hemophilia B.\n2. Age ≥18 years.\n3. FIX activity at screening ≤2% without FIX inhibitor.\n4. ≥150 previous exposure days of treatment with FIX concentrates.\n\nExclusion Criteria:\n\n1. Previous gene therapy.\n2. Other blood or hematopoietic disorders.\n3. Positive Anti-AAV5 antibodies (for Cohorts 1-3).\n4. Diagnosed HIV-infection, not controlled with anti-viral therapy.\n5. Hepatitis B (for Cohorts 1-3), acute or chronic hepatitis C.\n6. Any active systemic infections or recurrent infections requiring systemic therapy at screening.\n7. Any other disorders associated with severe immunodeficiency.\n8. Significant hepatic disorders (liver cirrhosis, liver fibrosis, etc).\n9. Malignancies with remission \\\u003C5 years.",{"count":442,"type":21},28,[24,25],"The goal of this multicenter, two-stage, open-label study is to investigate the safety, immunogenicity, and efficacy of ANB-002 in subjects with hemophilia В. The study will have a dose-escalation design with elements of phase I\u002FII seamless adaptive design.",[446],"Hemophilia B","2025-06-10",{"date":449,"type":40},"2025-06-13",{"date":451,"type":40},"2023-05-02",{"date":453,"type":21},"2029-11",{"name":359,"class":47},{"id":456,"slug":4,"hasResults":11,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":4,"eligibilityCriteria":460,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":461,"enrollmentInfo":462,"targetDuration":4,"studyType":22,"phases":464,"briefSummary":465,"conditions":466,"keywords":468,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":483},"100590718","NCT06971068","Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins","Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)","Inclusion Criteria:\n\n* Age over 18 years\n* Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position\n* Informed consent\n\nExclusion Criteria:\n\n* pregnancy or lactation\n* malignant neoplasms\n* inability or unwillingness of any patient to wear compression stockings\n* hypersensitivity to lidocaine\n* concomitant diseases: diabetes mellitus, bronchial asthma, severe liver and kidney diseases, acute thrombosis and thrombophlebitis, skin and\u002For soft tissue infection, infectious diseases, obliterating peripheral arteriosclerosis, diabetic angiopathy, heart defects requiring surgical intervention, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, blood cell composition disorder, all diseases requiring bed rest, heart disease with decompensation, known hereditary thrombophilia\n* period after treatment for alcohol addiction\n* sedentary lifestyle\n* history of acute deep vein thrombosis\n* history of superficial thrombophlebitis\n* history of drug or other addiction\n* use of oral contraceptives or other hormonal drugs","90 Years",{"count":463,"type":21},184,[232],"Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalization.1-5 The use of vacuum evacuation of the remaining intraluminal blood during endovenous laser ablation allows to decrease the risk of intraoperative (carbonization and destruction of the fiber lens) and postoperative complications (EHIT, hyperpigmentation, \"string\" feeling) and leads to reduction of recovery because of short period of vein resorption. The aim of the study is to evaluate the safety and effectiveness of endovenous thermal ablation with or without vacuum evacuation for the treatment of incompetent large saphenous veins (\\>15 mm).",[467],"Varicose Veins",[469,470,471,472],"Vacuum-assisted Laser Ablation","large saphenous veins","varicose veins","EVLA","2025-05-10",{"date":475,"type":40},"2025-05-14",{"date":477,"type":40},"2025-03-15",{"date":479,"type":21},"2026-02-15",{"name":481,"class":482},"Center Of Phlebology","NETWORK",9,{"id":485,"slug":4,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":22,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":501,"lastUpdatePostDateStruct":502,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":510},"100383674","NCT04275726","LANDMARK Trial: a Randomised Controlled Trial of Myval THV","A Prospective, Multinational, Multicentre, Open-label, Randomised, Non-inferiority Trial to Compare Safety and Effectiveness of Meril's Myval Transcatheter Heart Valve (THV) Series vs. Contemporary Valves (Edwards's Sapien THV Series and Medtronic's Evolut THV Series) in Patients With Severe Symptomatic Native Aortic Valve Stenosis","LANDMARK","Inclusion Criteria:\n\n1. Patient ≥18 years of age.\n2. Patient or their legal representative has provided written informed consent as approved by the Institutional Review Board (IRB)\u002FInstitutional Ethics Committee (IEC) of the investigational site to participate in the study.\n3. As per local Heart Team assessment, patient is eligible for TAVI and the patient is suitable for implantation with all three study devices.\n\nExclusion Criteria:\n\n1. Patients who are not willing to provide informed consent form, or whose legal heirs object to their participation in the study.\n2. Any condition, which in the Investigator's opinion, would preclude safe participation of patient in the study.",{"count":492,"type":21},988,[232],"The primary objective of this study (LANDMARK) is to compare the safety and effectiveness of the Myval THV Series with Contemporary Valves (Sapien THV Series and Evolut THV Series) in patients with severe symptomatic native aortic valve stenosis.\n\nThis study will be done in total 768 subjects (384:384, Myval THV Series vs. Contemporary Valves)\n\nThe randomisation will be carried out with an allocation ratio of 1:1 between Myval THV Series vs. Contemporary Valves (Sapien THV Series and Evolut THV Series)",[496],"Aortic Valve Stenosis",[498,499,500],"LANDMARK Trial","Trial to evaluate safety & effectiveness of Myval THV","CE Approved Myval THV Series","2025-04-01",{"date":503,"type":40},"2025-04-04",{"date":505,"type":40},"2020-11-04",{"date":507,"type":21},"2033-12-31",{"name":509,"class":47},"Meril Life Sciences Pvt. Ltd.",54,{"id":512,"slug":4,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":4,"eligibilityCriteria":516,"healthyVolunteers":11,"sex":132,"minAge":57,"maxAge":517,"enrollmentInfo":518,"targetDuration":4,"studyType":22,"phases":520,"briefSummary":521,"conditions":522,"keywords":525,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":547},"100580289","NCT06835361","Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis\u002FVulvovaginitis","International Open-label Randomized Comparative Clinical Study of Efficacy and Safety of Clotrimazole+Lactulose, Vaginal Suppositories (AVVA RUS JSC, Russia) Vs. a Clotrimazole Monocomponent Product in Adult Female Patients with Candidal Vaginitis\u002Fvulvovaginitis","Inclusion Criteria:\n\n* Women aged 18 to 60 years.\n* Clinically and microbiologically confirmed diagnosis of candidal vulvovaginitis.\n* Negative pregnancy test at screening.\n* Agreement to use reliable contraception throughout the study and for 30 days after its completion.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding.\n* Diagnosed bacterial vaginosis.\n* Chronic inflammatory or atrophic diseases of the female genital organs.\n* History of malignant neoplasms.\n* Use of systemic antibiotics or antifungal drugs within 2 weeks prior to screening.","60 Years",{"count":519,"type":21},264,[25,87],"This study aims to compare the efficacy and safety of the combination drug Clotrimazole+Lactulose with the monocomponent product Canesten® (clotrimazole) in adult women diagnosed with candidal vulvovaginitis. The primary objective was to confirm the superiority of the combination drug in terms of clinical and microbiological response on Day 25 of the study.",[523,524],"Candidal Vulvovaginitis (ICD-10 Code: B37.3)","Vulvovaginal Candidiasis (VVC)",[526,527,528,529,530,531,532,533,534,535,536,537],"Clotrimazole+Lactulose","Candidal Vulvovaginitis","Vulvovaginal Candidiasis","Clotrimazole","Lactulose","Antifungal Therapy","Prebiotic","Vaginal Suppositories","Canesten","Microbiological Recovery","Women's Health","Vaginal Microbiota","2025-02-14",{"date":540,"type":40},"2025-02-19",{"date":542,"type":40},"2024-02-29",{"date":544,"type":21},"2025-11-30",{"name":546,"class":47},"AVVA Pharmaceuticals Ltd.",7,{"id":549,"slug":4,"hasResults":11,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":4,"eligibilityCriteria":553,"healthyVolunteers":11,"sex":56,"minAge":554,"maxAge":555,"enrollmentInfo":556,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":562,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":568,"completionDateStruct":570,"leadSponsor":572,"locationsCount":75},"100464976","NCT05334693","Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children\u002FYoung Adults With AML","Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells as Consolidation Strategy for Children\u002FYoung Adults With AML","Inclusion Criteria:\n\nPatients:\n\n* primary intermediate risk AML in molecular complete remission;\n* primary high risk AML in molecular complete remission awaiting unrelated HSCT;\n* Karnofsky or Lansky performance scale greater or equal to 70;\n* written informed consent.\n\nDonors:\n\n* haploidentical family donor;\n* donor suitable for cell donation and apheresis according to standard criteria;\n* written informed consent.\n\nExclusion Criteria:\n\nPatients:\n\n* uncontrolled infection;\n* severe hepatic dysfunction: SGOT or SCPT \\>=5x upper limit of normal for age;\n* positive serology for human immunodeficiency virus (HIV).\n\nDonors:\n\n* pregnancy;\n* positive serology for HIV, hepatitis B or C.","6 Months","21 Years",{"count":557,"type":21},15,[24,25],"The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells as consolidation therapy for children\u002Fyoung adults with intermediate risk AML.",[561],"Acute Myeloid Leukemia",[563,564],"Natural killer cells","Immunotherapy","2024-08-27",{"date":567,"type":40},"2024-08-28",{"date":569,"type":40},"2021-11-01",{"date":571,"type":21},"2026-06",{"name":573,"class":249},"Belarusian Research Center for Pediatric Oncology, Hematology and Immunology",{"id":575,"slug":4,"hasResults":11,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":4,"eligibilityCriteria":579,"healthyVolunteers":11,"sex":56,"minAge":580,"maxAge":279,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":588,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":592,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":75},"100464869","NCT05333302","Pilot CAR-T Cells Therapy for Children\u002FYoung Adults With CD19+ R\u002FR Leukemia\u002FLymphoma","Pilot Study of CD19 CAR-T Cells Therapy for Relapsed or Refractory Acute Lymphoblastic Leukemia\u002FLymphoma in Children\u002FYoung Adults","Inclusion Criteria:\n\n* CD19+ relapsed or refractory lymphoblastic leukemia\u002Flymphoma;\n* Karnofsky or Lansky performance scale greater or equal to 70;\n* T-cells count in peripheral blood \\>150 cells\u002FµL;\n* Written informed consent.\n\nExclusion Criteria:\n\n* primary immunodeficiencies or genetic syndromes;\n* neurologic diseases;\n* autoimmune diseases or polyallergie;\n* transfusion of donor lymphocyte less than 6 week before CAR-T cells infusion;\n* GvHD grade 2-4;\n* uncontrolled systemic infection;\n* hypoxia (Sp02\\\u003C90%)\n* severe hepatic dysfunction: ALT or AST \\>=3x upper limit of normal for age;\n* renal dysfunction: serum creatinine level \\>=3x upper limit of normal for age;\n* positive serology for human immunodeficiency virus (HIV), active hepatite C or B;\n* pregnancy.","1 Year",{"count":582,"type":21},10,[24],"The purpose of this study is to estimate the safety and the efficacy of CAR- T cells immunotherapy for children\u002Fyoung adults with relapsed or refractory acute lymphoblastic leukemia\u002Flymphoma.",[586,587],"B-cell Acute Lymphoblastic Leukemia","Lymphoblastic B-Cell Lymphoma",[589,590,591],"immunotherapy","CAR-T cells","CD19",{"date":567,"type":40},{"date":594,"type":40},"2020-10-26",{"date":596,"type":21},"2025-06",{"name":573,"class":249},{"id":599,"slug":4,"hasResults":11,"nctId":600,"briefTitle":601,"officialTitle":602,"acronym":4,"eligibilityCriteria":603,"healthyVolunteers":11,"sex":56,"minAge":554,"maxAge":279,"enrollmentInfo":604,"targetDuration":4,"studyType":22,"phases":605,"briefSummary":606,"conditions":607,"keywords":608,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":610,"startDateStruct":611,"completionDateStruct":612,"leadSponsor":613,"locationsCount":75},"100460182","NCT05272293","Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children\u002FYoung Adults With AML","Immunotherapy With ex Vivo Expanded Haploidentical Natural Killer Cells for Children\u002FYoung Adults With High-risk, Refractory or Relapsed AML","Inclusion Criteria:\n\nPatients:\n\n* primary high risk AML\n* primary refractory AML\n* relapsed AML\n* Karnofsky or Lansky performance scale greater or equal to 70\n* written informed consent\n\nDonors:\n\n* haploidentical family donor\n* donor suitable for cell donation and apheresis according to standard criteria\n* written informed consent\n\nExclusion Criteria:\n\nPatients:\n\n* uncontrolled infection\n* severe hepatic dysfunction: SGOT or SCPT \\>=5x upper limit of normal for age\n* positive serology for human immunodeficiency virus (HIV)\n\nDonors:\n\n* pregnancy\n* positive serology for HIV, hepatitis B or C",{"count":557,"type":21},[24,25],"The purpose of this study is to estimate the efficacy of immunotherapy with ex vivo expanded haploidentical NK cells for children\u002Fyoung adults with primary high risk or refractory AML and relapsed AML.",[561],[609],"Natural killer cells, immunotherapy",{"date":567,"type":40},{"date":569,"type":40},{"date":571,"type":21},{"name":573,"class":249},{"id":615,"slug":4,"hasResults":11,"nctId":616,"briefTitle":617,"officialTitle":618,"acronym":619,"eligibilityCriteria":620,"healthyVolunteers":11,"sex":56,"minAge":4,"maxAge":621,"enrollmentInfo":622,"targetDuration":4,"studyType":22,"phases":624,"briefSummary":625,"conditions":626,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":628,"lastUpdatePostDateStruct":629,"startDateStruct":631,"completionDateStruct":633,"leadSponsor":635,"locationsCount":547},"100496671","NCT05747261","Study of the Safety and Efficacy of an Adeno-Associated Viral Vector Carrying the SMN Gene After a Single Intravenous Administration of Escalating Doses in Children With Spinal Muscular Atrophy (BLUEBELL)","An Open-Label, Non-Comparative Clinical Study of the Safety and Efficacy of an Adeno-Associated Viral Vector Carrying the SMN Gene (ANB-004 (JSC BIOCAD, Russia)) After a Single Intravenous Administration of Escalating Doses in Children With Spinal Muscular Atrophy","BLUEBELL","Inclusion Criteria:\n\n1. Informed consent form for participation in the study signed by the subject's legal representative;\n2. Subjects of either sex under the age of 240 days at the time of signing the Information Sheet for the Legal Representative of the Clinical Study Subject with Informed Consent Form;\n3. A diagnosis of 5q-SMA (homozygous deletion of exon 7 of the SMN1 gene or heterozygous deletion of exon 7 + confirmed point mutation of the SMN1 gene) and 2 or 3 copies of the SMN2 gene established based on molecular genetic testing;\n4. Subjects with 2 copies of the SMN2 gene can be included in the study both at the presymptomatic stage of the disease and in the presence of SMA symptoms. If symptoms are present, the age of onset of the disease should be up to 180 days from birth.\n5. Subjects with 3 copies of the SMN2 gene can be included in the study if they have symptoms of SMA type 1 and the disease began before the age of 180 days.\n6. The ability of the subject's legal representative, in the Investigator's opinion, to perceive information and follow the Protocol procedures\n\nExclusion Criteria:\n\n1. A diagnosis of HIV infection, hepatitis B, hepatitis C, congenital syphilis in the study subject, as well as a documented diagnosis of HIV infection in the study subject's mother. Note: documented hepatitis B and\u002For hepatitis C and\u002For syphilis in the mother of a study subject is not an exclusion criterion in this clinical study, provided that standard breastfeeding rules are followed or the subject is not breastfed due to the low risk of transmission of hepatitis B and C viruses and Treponema pallidum from mother to child with breast milk;\n2. Unwillingness of the legal representative to use alternative feeding methods (nasogastric tube, gastrostomy) in case of swallowing disorders and a risk of aspiration;\n3. Anti-AAV9 antibody titer \\>1:50 determined by ELISA. Note: if a subject's screening anti-AAV9 antibody titer is \\>1:50, the anti-AAV9 antibody titer may be determined again. Subjects with anti-AAV9 antibody titers ≤1:50 in the second test may be included in the study;\n4. Need for respiratory support for ≥16 hours per day or tracheostomy ;\n5. Treatment with nusinersen, risdiplam, branaplam, onasemnogene abeparvovec or other antisense oligonucleotides\u002Fselective SMN2 splicing modifiers or gene therapy drugs for SMN1 transduction or other AAV-based gene therapy drugs regardless of serotype used previously (from birth) or planned for the main study period, i.e., within 12 months after the administration of the investigational product.\n6. A need to use any medications for the treatment of myopathy or neuropathy, drugs for the treatment of diabetes, ongoing immunosuppressive therapy, or the need for immunosuppressive therapy after the start of the study (for example, glucocorticoids (except for premedication and post-medication), cyclosporine, tacrolimus, methotrexate, cyclophosphamide, intravenous immunoglobulin, rituximab, etc.);\n7. Subjects with the following laboratory test results at screening:\n\n   * increased activity of transaminases (ALT, AST) or GGT \\>2×ULN;\n   * total bilirubin level ≥34 µmol\u002FL;\n   * creatinine level ≥160 µmol\u002FL;\n   * hemoglobin \\\u003C80 g\u002FL and \\>180 g\u002FL;\n   * WBC count \\>20x109\u002FL;\n   * Troponin I level \\> ULN.\n8. Any concomitant diseases that, in the Investigator's opinion, may affect the safety of ANB-004 in the subject or have a significant impact on the assessment of the outcomes of SMA therapy;\n9. A diagnosis of acute or chronic hepatic failure at screening;\n10. A known allergy or intolerance to any components of the investigational product or pre- and post-medication drug (glucocorticoids);\n11. Simultaneous participation of the subject in other clinical studies or previous participation in another clinical study using an experimental therapy.","240 Days",{"count":623,"type":21},40,[24,25],"The goal of this multicenter, open-label, non-comparative, cohort study is to investigate the safety, immunogenicity, and efficacy of ANB-004 in children with spinal muscular atrophy. The study will have a standard 3+3 dose-escalation design.",[627],"Spinal Muscular Atrophy (SMA)","2024-02-21",{"date":630,"type":40},"2024-02-22",{"date":632,"type":40},"2023-02-02",{"date":634,"type":21},"2030-08",{"name":359,"class":47},{"id":637,"slug":4,"hasResults":11,"nctId":638,"briefTitle":639,"officialTitle":639,"acronym":4,"eligibilityCriteria":640,"healthyVolunteers":11,"sex":56,"minAge":641,"maxAge":57,"enrollmentInfo":642,"targetDuration":4,"studyType":22,"phases":644,"briefSummary":645,"conditions":646,"keywords":648,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":652,"lastUpdatePostDateStruct":653,"startDateStruct":655,"completionDateStruct":657,"leadSponsor":659,"locationsCount":661},"100205295","NCT01949129","Allogeneic Stem Cell Transplantation for Children and Adolescents With Acute Lymphoblastic Leukaemia","Inclusion Criteria:\n\nPatients with ALL (except for patients with B-ALL) who fulfil the following criteria:\n\n* age at diagnosis ≤ 18 years. Age at HSCT ≤ 21 years\n* indication for allogeneic HSCT\n* complete remission (CR) before HSCT\n* written consent of the parents (legal guardian) and, if necessary, the minor patient via \"Informed Consent Form\"\n* no pregnancy\n* no secondary malignancy\n* no previous HSCT\n* HSCT is performed in a study participating centre\n\nExclusion Criteria:\n\n* patients who do not fulfil the inclusion criteria\n* Non Hodgkin-Lymphoma\n* the whole protocol or essential parts are declined either by patient himself\u002Fherself or the respective legal guardian\n* no consent is given for saving and propagation of anonymous medical data for study reasons\n* severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders)\n* Karnofsky \u002F Lansky score \\\u003C 50%\n* subjects unwilling or unable to comply with the study procedures","1 Month",{"count":643,"type":21},1800,[25,87],"The ALL SCTped 2012 FORUM is a multinational, multi-centre, controlled, prospective phase III study for the therapy and therapy optimisation for children and adolescents with ALL in complete morphological remission (CR, less than 5% bone marrow blasts, no blasts in cerebrospinal fluid, no other extramedullary leukemia), who have an indication for HSCT with a myeloablative conditioning regimen.\n\nThe stratification of patients in first and following remissions according to the individual transplantation modalities rests upon an indication for allogeneic HSCT and the availability of a suitable donor within the individual transplantation groups.",[647],"Acute Lymphoblastic Leukaemia",[649,650,651],"stem cell transplantation","children and adolescents","high risk acute lymphoblastic leukaemia","2024-01-12",{"date":654,"type":40},"2024-01-16",{"date":656,"type":4},"2013-04",{"date":658,"type":21},"2030-04",{"name":660,"class":249},"St. Anna Kinderkrebsforschung",119,""]