[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Russia\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":698},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,420,0,25,[9,48,74,98,130,174,202,235,264,286,314,333,361,388,417,445,465,497,520,547,573,606,627,648,670],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100603701","spontaneous-correction-of-sagittal-imbalance-after-isolated-lumbar-decompression-100603701",false,"NCT07139938","Spontaneous Correction of Sagittal Imbalance After Isolated Lumbar Decompression","Multicenter Study of Spontaneous Correction of Sagittal Imbalance After Isolated Decompression Surgery Without Corrective Fusion Procedure for Lumbar Spinal Stenosis","Inclusion Criteria:\n\n* 1\\. Age 45 and over;\n* 2\\. Radicular leg pain and\u002For neurogenic claudication with\u002Fwithout back pain, caused by single- or multi-level degenerative lumbar stenosis with\u002Fwithout spodylolisthesis, confirmed by MRI;\n* 3\\. Planned isolated decompression of the spinal canal without implantation of any devices;\n* 4\\. Symptoms persisting for at least 3 months prior to surgery;\n* 5\\. Given written Informed Consent;\n* 6\\. Able and agree to fully comply with the clinical protocol and willing to adhere to follow-up schedule and requirements.\n\nNon-Inclusion Criteria:\n\n* 1\\. Prior any lumbar surgery;\n* 2\\. Scoliosis of any non-degenerative etiology (due to vertebral fractures, idiopathic, etc.);\n* 3\\. Degenerative scoliosis \\> 20 degrees;\n* 4\\. Any contraindication or inability to undergo baseline and\u002For follow up MRI or X-ray as required per protocol;\n* 5\\. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study;\n\nExclusion Criteria:\n\n* 1\\. Performed intraoperative discotomy;\n* 2\\. Performed intraoperative iatrogenic instability of the lumbar segment (facetectomy, foraminotomy, etc.)","ALL","18 Years",{"count":20,"type":21},165,"ESTIMATED","INTERVENTIONAL",[24],"NA","Sagittal spinal imbalance may be caused by orthopedic problems, compression of the neural structures of the spinal canal, and pain syndrome (functional imbalance). Sagittal imbalance in combination with appropriate clinical symptoms may require surgical correction of the spine with fixation. However, in some cases, patients experience spontaneous correction of sagittal balance after isolated decompression without any correction or fusion. Therefore, it is necessary to clarify whether isolated decompression may cause spontaneous correction of sagittal imbalance in patients with degenerative lumbar stenosis.",[27,28,29,30],"LUMBAR STENOSIS","Sagittal Imbalance","Degeneration Lumbar Spine","Lumbar Decompression",[32,33,34],"lumbar stenosis","sagittal imbalance","lumbar decompression","RECRUITING","2026-07-01",{"date":38,"type":39},"2026-07-02","ACTUAL",{"date":41,"type":39},"2025-10-06",{"date":43,"type":21},"2027-10-06",{"name":45,"class":46},"N.N. Priorov National Medical Research Center of Traumatology and Orthopedics","OTHER",3,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":17,"minAge":56,"maxAge":57,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100442302","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-obinutuzumab-in-adolescents-with-active-class-iii-or-iv-lupus-nephritis-and-the-safety-and-pk-of-obinutuzumab-in-pediatric-participants-100442302","NCT05039619","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants","A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to \u003C 12)","POSTERITY","Inclusion Criteria:\n\n* Participants who are age 12 to \\\u003C18 years at the time of randomization\n* Participants who are age 5 to \\\u003C12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)\n* International Society of Nephrology and the Renal Pathology Society (ISN\u002FRPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening\n* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible\n* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria\n* Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening\n* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg\u002Fkg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.\n\nExclusion Criteria:\n\n* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia\n* Sclerosis in \\>50% of glomeruli on renal biopsy\n* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions\n* Presence of rapidly progressive glomerulonephritis\n* Pure Class V LN\n* Intolerance or contraindication to study therapies\n* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization\n* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders\n* History of serious recurrent or chronic infection\n* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years\n* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation\n* Currently active alcohol or drug abuse or history of alcohol or drug abuse","5 Years","17 Years",{"count":59,"type":21},40,[61],"PHASE2","This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\\u003C12 with LN.",[64],"Lupus Nephritis",{"date":38,"type":39},{"date":67,"type":39},"2022-05-12",{"date":69,"type":21},"2030-06-14",{"name":71,"class":72},"Hoffmann-La Roche","INDUSTRY",42,{"id":75,"slug":76,"hasResults":12,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":90,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":97},"100354763","phase-2-pan-tumor-rollover-study-100354763","NCT03899155","Pan Tumor Rollover Study","Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies","Inclusion Criteria\n\n* Signed Written Informed Consent.\n* Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.\n* On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.\n* WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.\n\nExclusion Criteria\n\n* Participant is not eligible for study treatment per the Parent Study eligibility criteria.\n* Participants not receiving clinical benefit as assessed by the Investigator.\n* Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.\n* Other protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":82,"type":21},1500,[61],"Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.",[86],"Cancer",[88,89],"Rollover","pan-tumor",{"date":38,"type":39},{"date":92,"type":39},"2019-08-09",{"date":94,"type":21},"2029-08-25",{"name":96,"class":72},"Bristol-Myers Squibb",399,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":106,"enrollmentInfo":107,"targetDuration":4,"studyType":22,"phases":109,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":122,"completionDateStruct":124,"leadSponsor":126,"locationsCount":129},"100641441","hemoadsorpion-in-patients-with-septic-shock-efficacy-and-safety-evaluation-100641441","NCT07661303","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation","Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial","HAdSS","Inclusion Criteria:\n\n* Septic shock according to SEPSIS-3 criteria\n* Age: 18-80 years\n* SOFA ≥9 points\n* Diagnosis of septic shock established \\\u003C12 hours ago\n* Invasive hemodynamic monitoring\n* Norepinephrine dose \\>0.2 mcg\u002Fkg\u002Fmin\n\nExclusion Criteria:\n\n* Absolute neutrophil count less than 500 cells\u002FμL\n* Pregnancy\n* End-stage heart failure (NYHA stage IV)\n* Pulmonary embolism with obstructive shock\n* Ongoing bleeding\n* Atonic coma\n* More than 30 points on the MELD scale, class C on the Child-Pugh scale\n* HIV infection\n* Burns over 10% of the body surface area\n* Patients with oncohematological diseases\n* Patients with a recognized palliative status or the definition of \"metastatic cancer\"\n* RRT using membranes with a high cutoff point and increased adsorption capacity within 72 hours from the initiation of the first hemoadsorption procedure\n* Use of plasma exchange within 72 hours from the initiation of the first hemoadsorption procedure","80 Years",{"count":108,"type":21},76,[24],"Hemoadsorpion in Patients With Septic Shock: Efficacy and Safety Evaluation. A Pilot Multicenter Randomized Controlled Trial.\n\nThe goal of this clinical trial is the estimation of the efficacy and safety of hemoadsorption procedures (LPS (Lipopolysaccharide) and inflammatory mediators adsorption) in participants with septic shock.\n\nThe main questions it aims to answer are:\n\nDoes hemoadsorption decrease the severity of MODS (multiple organ disfunction syndrome)?\n\nThe study will include participants aged 18 to 80 years with a verified diagnosis of septic shock according to SEPSIS 3 criteria, diagnosed within 12 hours, and a SOFA (sequential organ failure assessment) score of 9 or more.\n\nIn addition to Standard of Care (SOC), blood purification, including hemoadsorption, will be used. The minimum waiting time after diagnosis of septic shock and initiation of basic therapy before inclusion of the patient in the study therapy is 4 hours.\n\nThe choice of procedure will be based on the EAA (Endotoxin Activity Assay) result:\n\n* for an EAA level of 0.6-0.9, selective lipopolysaccharide (LPS) adsorption with duration from 2 to 10 hours;\n* for an EAA level less than 0.6, inflammatory mediator adsorption with duration from 6 to 12 hours.\n\nThe choice of a specific adsorbers within the LPS and inflammatory mediator adsorption group will be based on randomization.\n\nThe use of LPS adsorption is planned based on randomization: Toramyxin R-20 or Efferon LPS. The use of inflammatory mediator adsorption is planned based on randomization: Jafron (HA 330) or CytoSorb.",[112],"Septic Shock",[114,115,116,117,118],"Septic shock","hemoadsorption","blood purification","MODS","Endotoxemia","NOT_YET_RECRUITING","2026-06-30",{"date":38,"type":39},{"date":123,"type":21},"2026-06-25",{"date":125,"type":21},"2027-12-25",{"name":127,"class":128},"Moscow Multidisciplinary Clinical Center \"Kommunarka\"","OTHER_GOV",7,{"id":131,"slug":132,"hasResults":12,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":141,"conditions":142,"keywords":146,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":165,"lastUpdatePostDateStruct":166,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100321141","phase-1-a-study-of-mevrometostat-for-treatment-of-relapsedrefractory-sclc-castration-resistant-prostate-cancer-and-follicular-lymphoma-100321141","NCT03460977","A Study of Mevrometostat for Treatment of Relapsed\u002FRefractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma","A PHASE I DOSE ESCALATION AND EXPANDED COHORT STUDY OF PF 06821497 (MEVROMETOSTAT) IN THE TREATMENT OF ADULT PATIENTS WITH RELAPSED\u002FREFRACTORY SMALL CELL LUNG CANCER (SCLC), CASTRATION RESISTANT PROSTATE CANCER (CRPC) AND FOLLICULAR LYMPHOMA (FL)","Part 1 and Part 2 (Closed for enrollment).\n\nPart 3 Key Inclusion Criteria:\n\n* Histological or cytological diagnosis of castration resistant prostate cancer.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-2 with expected life expectancy of at least 6 months.\n* Adequate bone marrow, renal, and liver function\n\nPart 3 Key Exclusion Criteria:\n\n* Prior irradiation to \\>25% of the bone marrow.\n* QTcF interval \\>480 msec at screening.\n* Hypertension that cannot be controlled by medications (\\>150\u002F90 mmHg despite optimal medical therapy).\n* Known or suspected hypersensitivity to PF 06821497 or any components or enzalutamide (CRPC)\n* Active inflammatory gastrointestinal disease, chronic diarrhea, known diverticular disease or previous gastric resection or lap band surgery.\n* Current use or anticipated need for food or drugs that are known strong and moderate CYP3A4\u002F5 inducers or inhibitors\n* Prior enzalutamide within the last 4 weeks\n* DDI SUBSTUDY:\n* history of CHF or evidence of ventricular dysfunction\n* fructose intolerance\n* coadministration of CYP3A4 substrates",{"count":138,"type":21},453,[140],"PHASE1","The purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed\u002F Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment.\n\nPart 3, which is open for enrollment is seeking men who:\n\n* have Castration Resistant Prostate Cancer (CRPC) and\n* have previously received treatment for CRPC and have progressed from the last treatment\n\nAll participants in Part 3 of this study will receive mevrometostat and\u002F or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort).\n\nIn the assessment phase:\n\n* participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods.\n* participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and\u002For itraconazole 1 time a day based on a present schedule.\n* participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and\u002For itraconazole 1 time a day based on a present schedule.\n\nAfter completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding.\n\nThe study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.",[143,144,145],"Metastatic Castration Resistant Prostate Cancer (mCRPC)","Small Cell Lung Cancer (SCLC)","Follicular Lymphoma (FL)",[147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164],"EZH2","enhancer of zeste homolog 2","castrate resistant prostate cancer","prostatecancer-study.com","mCRPC","efficacy","safety","pharmacokinetics","pharmacodynamics","dose escalation","dose expansion","open-label","small cell lung cancer","SCLC","follicular lymphoma","FL","relapsed","refractory","2026-06-29",{"date":36,"type":39},{"date":168,"type":39},"2018-04-17",{"date":170,"type":21},"2029-07-07",{"name":172,"class":72},"Pfizer",83,{"id":175,"slug":176,"hasResults":12,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":4,"eligibilityCriteria":180,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":184,"conditions":185,"keywords":188,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":47},"100645298","etiologic-diagnosis-algorithm-in-infective-endocarditis-100645298","NCT07682389","Etiologic Diagnosis Algorithm in Infective Endocarditis","Development and Validation of An Algorithm of Etiological Diagnosis of Infective Endocarditis in Adults: An Open-Label Multicenter Randomized Clinical Trial","Inclusion Criteria:\n\n* Informed consent,\n* Age ≥ 18,\n* IE (definite or possible per the 2023 Duke-International Society for Cardiovascular Infectious Diseases Criteria for Infective Endocarditis)\n\nExclusion Criteria:\n\n* Pregnancy\u002Fbreastfeeding\n* Unconfirmed or rejected IE diagnosis,\n* Very high risk of death within 14 days due to severe complications of the main or concomitant disease(s), according to the physician's opinion;\n* Prior use of antibiotic therapy (except documented treatment failure).",{"count":182,"type":21},128,[24],"The goal of this study is to evaluate the impact of a diagnostic algorithm combining culture-based and molecular methods on the frequency of etiotropic antibiotic therapy prescription within 14 days of diagnosis of infective endocarditis",[186,187],"Infective Endocarditis","Microbiology",[189,190,191,192,193],"Infective endocarditis","PCR","Antibiotic therapy","Etiological diagnosis","Sequencing","2026-06-28",{"date":38,"type":39},{"date":197,"type":39},"2026-01-20",{"date":199,"type":21},"2027-02-20",{"name":201,"class":46},"I.M. Sechenov First Moscow State Medical University",{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":4,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":213,"conditions":214,"keywords":220,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":229,"completionDateStruct":230,"leadSponsor":232,"locationsCount":234},"100643941","reliability-and-reproducibility-of-facet-joint-measurements-in-the-thoracolumbar-spine-100643941","NCT07670039","Reliability and Reproducibility of Facet Joint Measurements in the Thoracolumbar Spine","Reliability and Reproducibility of Pathria Scale-Based Grading of Facet Joint Degeneration and Facet Joint Morphometric Measurements in the Thoracolumbar Spine","Inclusion Criteria:\n\n* availability of CT scans covering the T9-L3 vertebrae;\n* absence of imaging artifacts at the level of interest.\n\nExclusion Criteria:\n\n* bone mineral density of the vertebrae of \\\u003C100 HU;\n* systemic diseases of bone or joints associated with changes in the FJs and IvDs (including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, etc.);\n* previous spinal surgery, including procedures performed without instrumentation;\n* spinal fractures involving injury to the posterior structures;\n* participation in other clinical studies related to the treatment of spinal disorders or spinal trauma.","65 Years",{"count":211,"type":21},12,"OBSERVATIONAL","The purpose is to determine how reliably degenerative changes in the facet joints (FJs) and intervertebral discs (IvDs) can be assessed on computed tomography (CT) scans.\n\nAt least six raters, including neurosurgeons and CT specialists, will independently evaluate anonymized CT scans covering the T9-L3 levels. The study will assess reproducibility of the Pathria grading scale for FJ degeneration and of quantitative measurements such as FJ space width and FJ angulation.",[215,216,217,218,219],"Facet Joint Arthritis","Facet Joints; Degeneration","Facet Joint Disease","Intervertebral Disk Degeneration","Pathria Classification",[221,222,223,224,225,226],"Thoracolumbar Spine","Facet Joint","Intervertebral Disc","Computed Tomography","interobserver reliability","intraobserver reliability","2026-06-27",{"date":36,"type":39},{"date":36,"type":21},{"date":231,"type":21},"2026-11-01",{"name":233,"class":128},"Sklifosovsky Institute of Emergency Care",1,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":4,"eligibilityCriteria":241,"healthyVolunteers":242,"sex":17,"minAge":18,"maxAge":243,"enrollmentInfo":244,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":246,"conditions":247,"keywords":251,"overallStatus":119,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":259,"startDateStruct":260,"completionDateStruct":261,"leadSponsor":263,"locationsCount":234},"100644645","degenerative-changes-after-treatment-of-thoracolumbar-junction-fractures-100644645","NCT07672184","Degenerative Changes After Treatment of Thoracolumbar Junction Fractures","Degenerative Changes in Injured and Adjacent Spinal Motion Segments After Conservative and Surgical Treatment of AOSpine Type A2, A3, and A4 Thoracolumbar Junction Fractures","Inclusion Criteria:\n\nConservative Treatment Cohort:\n\n* Age 18 to 50 years.\n* Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.\n* AOSpine type A2, A3, or A4 fracture.\n* No clinical evidence of nerve root or spinal cord compression at the injured level.\n* Conservative treatment of the thoracolumbar junction fracture.\n* Minimum follow-up period of 1 year.\n* Written informed consent for prospective follow-up or additional study procedures, when applicable.\n\nSurgical Treatment Cohort:\n\n* Age 18 to 50 years.\n* Acute or subacute traumatic fracture of the thoracolumbar junction at the start of treatment.\n* AOSpine type A2, A3, or A4 fracture.\n* No clinical evidence of nerve root or spinal cord compression at the injured level.\n* Surgical treatment performed without disruption of the posterior supporting column.\n* Surgical treatment may include anterior fusion, transpedicular fixation, or combined surgery without direct posterior decompression.\n* Minimum follow-up period of 1 year.\n* Written informed consent for prospective follow-up or additional study procedures, when applicable.\n\nControl Cohort:\n\n* Age 18 to 50 years.\n* At least two computed tomography examinations covering the Th9-L4 vertebral levels.\n* Interval of at least 1 year between computed tomography examinations.\n* Computed tomography performed for reasons unrelated to traumatic or degenerative thoracolumbar junction disease.\n* No imaging artifacts at the spinal levels included in the study assessment.\n\nExclusion Criteria:\n\nConservative Treatment Cohort:\n\n* Severe combined trauma.\n* Severe concomitant disease.\n* Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.\n* Verified osteoporosis.\n* Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.\n* Previous spine surgery.\n* American Society of Anesthesiologists physical status class 4 or 5.\n* Participation in another clinical study related to treatment of spinal disease or spinal trauma.\n* Withdrawal of informed consent, when applicable.\n\nSurgical Treatment Cohort:\n\n* Severe combined trauma.\n* Severe concomitant disease.\n* Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.\n* Verified osteoporosis.\n* Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.\n* Previous spine surgery.\n* Direct posterior decompression or other surgery disrupting the posterior supporting column.\n* American Society of Anesthesiologists physical status class 4 or 5.\n* Participation in another clinical study related to treatment of spinal disease or spinal trauma.\n* Withdrawal of informed consent, when applicable.\n\nControl Cohort:\n\n* Complicated fracture of any spinal region.\n* Combined trauma or severe concomitant disease limiting patient mobility.\n* Systemic bone or joint disease associated with changes in facet joints or intervertebral discs, including diffuse idiopathic skeletal hyperostosis, ankylosing spondylitis, rheumatoid arthritis, or similar disorders.\n* Grade 4 facet joint degeneration according to the Pathria classification at the studied levels.\n* Bone density of thoracolumbar vertebrae less than 100 Hounsfield units.\n* Previous spine surgery, including surgery without implants.\n* Spinal fracture with injury to the posterior supporting column.\n* Participation in another clinical study related to treatment of spinal disease or spinal trauma.",true,"50 Years",{"count":245,"type":21},150,"This observational study will evaluate how degenerative changes in the facet joints and intervertebral discs develop over time after treatment of AOSpine type A2, A3, and A4 fractures of the thoracolumbar junction. Patients treated conservatively and patients treated surgically will be compared with each other and with a control group of patients who underwent repeated computed tomography examinations for reasons unrelated to traumatic or degenerative spinal disease.\n\nThe study will assess computed tomography findings at the injured spinal motion segment and adjacent segments, including facet joint degeneration, intervertebral disc degeneration, signs of ankylosis, facet joint space parameters, and facet joint angle. Clinical outcomes in the fracture cohort will be evaluated using pain scores and validated questionnaires. The purpose of the study is to identify factors associated with progression of degenerative changes after thoracolumbar junction fractures and to clarify whether treatment method is associated with long-term degeneration of the injured and adjacent spinal motion segments.",[248,249,250],"Thoracolumbar Spine Fracture","Facet Joint Degeneration","Intervertebral Disc Degeneration",[252,253,254,255,256,249,250,257,258,224],"Thoracolumbar Junction Fracture","AOSpine Classification","AOSpine Type A2 Fracture","AOSpine Type A3 Fracture","AOSpine Type A4 Fracture","Adjacent Segment Degeneration","Spinal Motion Segment",{"date":36,"type":39},{"date":231,"type":21},{"date":262,"type":21},"2027-12-31",{"name":233,"class":128},{"id":265,"slug":266,"hasResults":12,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":274,"conditions":275,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":277,"startDateStruct":279,"completionDateStruct":281,"leadSponsor":283,"locationsCount":285},"100595936","treatment-approaches-and-biomarkers-prevalence-in-bladder-cancer-in-russian-federation-100595936","NCT07038928","TReatment Approaches and bIomarkers preValence in bladdEr Cancer in RuSsian Federation","A Multicentre Observational Study on Treatment Approaches and HER2 Positive Status Prevalence in Different Stages of Bladder Cancer and PD-L1-positive Status in Metastatic Bladder Cancer in Russian Federation","RIVERS","Inclusion Criteria:\n\n* Age ≥ 18 years;\n* Signed ICF, including consent for FFPE tumor tissue sample testing;\n* Confirmed diagnosis of urothelial bladder cancer at NMIBC, MIBC, or mBC stage at study entry;\n* For patients with NMIBC: 1. TURBT performed at least 1 month but not more than 12 months prior to study entry; 2. Presence of ≥1 high-risk feature:\n\n  * T1 tumor\n  * High grade\u002FG3 tumor\n  * CIS (carcinoma in situ)\n  * Multiple and recurrent and large (with diameter of largest tumor ≥3 cm) tumors (all conditions must be met in this point);\n* For patients with MIBC: Сystectomy performed at least 2 months but not more than 12 months prior to study entry;\n* For patients with mBC: mBC diagnosed during 12 months prior to study entry;\n* Availability of medical history data;\n* Availability of FFPE tumour tissue sample obtained during biopsy and\u002For surgery.\n\nExclusion Criteria:\n\n• Participation in any interventional trial since the urothelial bladder cancer diagnosis.",{"count":273,"type":21},600,"A multicentre observational study on treatment approaches and HER2 positive status prevalence in different stages of bladder cancer and PD-L1-positive status in metastatic bladder cancer in Russian Federation",[276],"Bladder Cancer",{"date":278,"type":39},"2026-06-26",{"date":280,"type":39},"2025-06-30",{"date":282,"type":21},"2026-12-31",{"name":284,"class":72},"AstraZeneca",22,{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":57,"enrollmentInfo":294,"targetDuration":4,"studyType":22,"phases":296,"briefSummary":297,"conditions":298,"keywords":300,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":306,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":313},"100433542","phase-1-study-to-determine-the-dose-and-safety-of-asciminib-in-pediatric-patients-with-chronic-myeloid-leukemia-100433542","NCT04925479","Study to Determine the Dose and Safety of Asciminib in Pediatric Patients With Chronic Myeloid Leukemia","A Multi-center, Open-label Study to Determine the Dose and Safety of Oral Asciminib in Pediatric Patients With Philadelphia Chromosome Positive Chronic Myeloid Leukemia in Chronic Phase (Ph+ CML-CP), Previously Treated With One or More Tyrosine Kinase Inhibitors","Inclusion Criteria:\n\n* Male or female participants:\n\n  * Pediatric formulation group: ≥ 1 and less than 18 years of age at study entry.\n  * Adult formulation group: ≥ 14 and less than 18 years of age and body weight of ≥ 40 kg at study entry.\n* Participants with Ph+ CML-CP must meet all of the following laboratory values at the screening visit. In the case where bone marrow blast and promyelocyte counts are available, these will be accepted if done within 56 days prior to the screening visit, to avoid unnecessary repetition of this test.\n\n  1. \\\u003C 15% blasts in peripheral blood and bone marrow\n  2. \\\u003C 30% combined blasts plus promyelocytes in peripheral blood and bone marrow\n  3. \\\u003C 20% basophils in the peripheral blood\n  4. Neutrophils ≥ 1.5 x 10\\^9\u002FL (or WBC ≥ 3 x 10\\^9\u002FL if neutrophils are not available) and platelet count ≥ 100 x 10\\^9\u002FL\n  5. No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly\n* Prior treatment with a minimum of one TKI\n* Failure (adapted from the 2020 European Leukemia Net (ELN) Guidelines Hochhaus et al 2020 and 2013 ELN Guidelines Baccarani et al 2013) or intolerance to the most recent TKI therapy at the time of screening.\n* Performance status: Karnofsky ≥ 50% for patients ≥ 16 years of age, and Lansky ≥ 50 for patients \\\u003C 16 years of age at the time of screening\n* Participants must have adequate renal, hepatic, pancreatic and cardiac function\n* Participants must have electrolyte values within normal limits or corrected to be within normal limits with supplements prior to first dose of study medication:\n* Evidence of typical BCR::ABL1 transcript \\[e14a2 and\u002For e13a2\\] at the time of screening which are amenable to standardized RQ-PCR quantification.\n\nExclusion Criteria:\n\n* Known presence of the T315I mutation prior to study entry or a BCR::ABL mutation with known resistance to study treatment any time prior to study entry.\n* Known second chronic phase of CML after previous progression to AP\u002FBC.\n* Previous treatment with a hematopoietic stem-cell transplantation.\n* Patient planning to undergo allogeneic hematopoietic stem cell transplantation.\n* Cardiac or cardiac repolarization abnormality\n* Severe and\u002For uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol\n* History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis.\n* History of acute or chronic liver disease.\n* Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of study drug\n* Pregnant or nursing (lactating) females.\n\nOther protocol-defined inclusion\u002Fexclusion may apply.","1 Year",{"count":295,"type":21},34,[140,61],"The aim of this study is to support development of asciminib in the pediatric population (1 to \\\u003C18 years) previously treated with one or more TKIs. Full extrapolation of the efficacy of asciminib from adult to pediatric patients will be conducted. Full extrapolation is based on the concept that CML in the pediatric population has the same pathogenesis, similar clinical characteristics and progression pattern as in adults.",[299],"Myeloid Leukemia, Philadelphia Positive",[301,302,303,304,305],"Asciminib","pediatric patients","Philadelphia chromosome positive chronic myeloid leukemia in chronic phase","Ph+ CML-CP","ABL001",{"date":120,"type":39},{"date":308,"type":39},"2021-12-27",{"date":310,"type":21},"2031-11-01",{"name":312,"class":72},"Novartis Pharmaceuticals",39,{"id":315,"slug":316,"hasResults":12,"nctId":317,"briefTitle":318,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":12,"sex":17,"minAge":320,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":327,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":331,"locationsCount":234},"100396438","the-study-of-biological-prosthetic-heart-valves-with-the-easy-change-system-100396438","NCT04442100","The Study of Biological Prosthetic Heart Valves With the \"Easy Change\" System","Inclusion Criteria:\n\n1. aortic valve disease requiring surgical disease patients without symptoms with severe aortic stenosis - indexed area of the opening less than 0.5 cm2 \u002F m2, average gradient more than 40 mm RT. Art;\n\n   o patients who require coronary artery bypass grafting with moderate aortic stenosis - indexed area of the hole 0.5 - 1 cm2 \u002F m2, the average gradient is more than 20 mm RT. Art., Regardless of symptoms;patients with symptoms of aortic stenosis, regardless of the severity of stenosis)\n2. mitral valve disease requiring surgical disease\n\nExclusion Criteria:\n\n1. the need for prosthetics of two or more valves\n2. patients with a decrease in LVEF of less than 45%;\n3. the presence of a competing disease or concomitant pathology that significantly affects the prognosis of quality of life or the likelihood of death\n4. high pulmonary hypertension (SDJ above 60 mm Hg. Art.);\n5. the diameter of the ascending aorta is more than 45 mm;\n6. unwillingness of the patient to participate in the study.","60 Years",{"count":322,"type":21},500,[24],"The study of new biological heart valves with the \"easy change\" system, including an assessment of the basic hemodynamic characteristics of the prosthesis, complications associated with valve implantation, and general mortality",[326],"Heart Valve Diseases",{"date":278,"type":39},{"date":329,"type":39},"2016-11-29",{"date":282,"type":21},{"name":332,"class":46},"Tomsk National Research Medical Center of the Russian Academy of Sciences",{"id":334,"slug":335,"hasResults":12,"nctId":336,"briefTitle":337,"officialTitle":338,"acronym":4,"eligibilityCriteria":339,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":340,"targetDuration":4,"studyType":22,"phases":342,"briefSummary":344,"conditions":345,"keywords":348,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":353,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":360},"100323125","phase-3-long-term-safety-and-efficacy-extension-study-for-participants-with-advanced-tumors-who-are-currently-on-treatment-or-in-follow-up-in-a-pembrolizumab-mk-3475-study-mk-3475-587keynote-587-100323125","NCT03486873","Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587\u002FKEYNOTE-587)","A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab","Inclusion Criteria:\n\n* Treated on the parent pembrolizumab studies established by the Sponsor as MK-3475-587 ready.\n* Currently receiving pembrolizumab, pembrolizumab based combinations or lenvatinib from parent studies or in a follow-up phase.\n\nAdditional eligibility criteria for participants who enter Second Course Phase once they are enrolled on MK-3475-587:\n\n* Has not received any anticancer systemic treatment since the last dose of pembrolizumab or a pembrolizumab-based combination in First Course Phase.\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Demonstrates adequate organ function.\n* Have resolution of any toxic effect(s) of First Course Phase trial treatment with pembrolizumab or a pembrolizumab-based combination to Grade 1 or less (except alopecia) before trial treatment in Second Course Phase is started. If participant received major surgery or radiation therapy of \\>30 Gray (Gy), they must have recovered from the toxicity and\u002For complications of the intervention.\n* A female participant is eligible to enroll if she is not pregnant, not breastfeeding, and ≥1 of the following conditions applies: A woman of childbearing potential (WOCBP) who agrees to use contraception during the study treatment period and for ≥120 days (corresponding to time needed to eliminate any study combination treatment(s) plus 30 days (a menstruation cycle) for study treatments with risk of genotoxicity.\n\nAdditional eligibility criteria for participants who enter dosing with Lenvatinib:\n\n* Adequately controlled blood pressure (BP) to \\\u003C150\u002F90 mmHg, with or without antihypertensive medications.\n* For male agrees to be abstinent from penile-vaginal intercourse OR agrees to use a highly effective contraceptive method while receiving study drug and for 7 days after the last dose of lenvatinib.\n* Is female and not pregnant\u002Fbreastfeeding and at least one of the following applies during the study and for ≥4 days after: is not a woman of childbearing potential (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency method OR a user dependent hormonal method in combination with a barrier method) or is a WOCBP who is abstinent from heterosexual intercourse.\n\nExclusion Criteria:\n\n-There are no exclusion criteria to participate in MK-3475-587.\n\nParticipants are excluded from entering Second Course trial treatment once they are enrolled on MK-3475-587 if any of the following criteria applies:\n\n* Has severe hypersensitivity (≥ Grade 3) to pembrolizumab and\u002For any of its excipients.\n* Has received a live vaccine within 30 days prior to the first dose of Second Course Phase trial treatment.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the Cycle 1 Day 1 of Second Course Phase.\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include early stage cancers (carcinoma in situ or Stage 1) treated with curative intent, melanoma (non-ulcerated, thin primary), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, in situ cervical cancer, or in situ breast cancer that has undergone potentially curative therapy.\n* Has known active central nervous system metastases and\u002For carcinomatous meningitis.\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis. Note: Participants that experienced pneumonitis during First Course that did not meet the criteria for permanent discontinuation are eligible.\n* Non-small cell lung cancer (NSCLC) participants only: Has interstitial lung disease.\n* Has an active infection requiring systemic therapy.\n* Has a known history of human immunodeficiency virus (HIV) infection.\n* Has a known history of or is positive for hepatitis B or hepatitis C. For parent studies where inclusion of participants with hepatitis was permitted, MK-3475-587 will follow the parent study eligibility criteria for hepatitis.\n* Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the Second Course Phase eligibility Visit through 120 days after the last dose of study treatment.\n* Has severe cardiovascular disease, i.e., arrhythmias, requiring chronic treatment, congestive heart failure (New York Heart Association Class III or IV) or symptomatic ischemic heart disease.\n* Has hepatic decompensation (Child-Pugh score \\>6 \\[class B and C\\]).\n* Has uncontrolled thyroid dysfunction.\n* Has uncontrolled diabetes mellitus.\n* Has had an allogeneic tissue\u002Fsolid organ transplant.\n* Has a known history of active tuberculosis (TB; Bacillus tuberculosis).\n\nAdditional exclusion criteria for participants who enter dosing with Lenvatinib:\n\n* Has had major surgery within 3 weeks prior to first dose of study intervention(s).\n* Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.\n* Has urine protein ≥1 g\u002F24 hours.\n* Has LVEF below the institutional (or local laboratory) normal range, as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO).\n* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation.\n* Prolongation of QT intervals corrected for heart rate using Fridericia's (cube root) correction (QTcF) interval to \\>480 ms.\n* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention, including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or cardiac arrhythmia associated with hemodynamic instability.\n* Gastrointestinal malabsorption or any other condition that might affect the absorption of lenvatinib.\n* Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug.\n* Has a history of any contraindication or has a severe hypersensitivity to any components of lenvatinib.",{"count":341,"type":21},3500,[343],"PHASE3","The purpose of this study is to evaluate the long-term safety and efficacy of pembrolizumab (MK-3475) in participants from previous Merck pembrolizumab-based parent studies who transition into this extension study.\n\nThis study will consist of three phases: 1) First Course Phase, 2) Survival Follow-up Phase or 3) Second Course Phase. Each participant will transition to this extension study in one of the following three phases, depending on the study phase they were in at the completion of the parent study. Participants who were in the First Course Phase of study treatment with pembrolizumab or lenvatinib in their parent study will enter the First Course Phase of this study and complete up to 35 doses or more every 3 weeks (Q3W) or 17 doses or more every 6 weeks (Q6W) of study treatment with pembrolizumab or a pembrolizumab-based combination or lenvatinib according to arm assignment. Participants who were in the Follow-up Phase in the parent study (post-treatment or Survival Follow-up Phase) will enter the Survival Follow-up Phase of this study. Participants who were in the Second Course Phase in their parent study will enter Second Course Phase of this study and complete up to 17 doses Q3W or 8 doses Q6W of study treatment with pembrolizumab or a pembrolizumab-based combination according to arm assignment.\n\nAny participant originating from a parent trial where crossover to pembrolizumab was permitted upon disease progression may be eligible for 35 doses as Q3W or 17 doses Q6W of pembrolizumab (approximately 2 years), if they progress while on the control arm and pembrolizumab is approved for the indication in the country where the potential eligible crossover participant is being evaluated.",[346,347],"Solid Tumors","Hematologic Malignancies",[349,350,351,352],"PD1","PD-1","PDL1","PD-L1",{"date":278,"type":39},{"date":355,"type":39},"2018-08-21",{"date":357,"type":21},"2043-08-04",{"name":359,"class":72},"Merck Sharp & Dohme LLC",782,{"id":362,"slug":363,"hasResults":12,"nctId":364,"briefTitle":365,"officialTitle":366,"acronym":4,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":368,"enrollmentInfo":369,"targetDuration":4,"studyType":22,"phases":371,"briefSummary":372,"conditions":373,"keywords":376,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":387},"100641959","phase-3-clinical-trial-of-the-efficacy-and-safety-of-raphamin-in-the-treatment-of-acute-bronchitis-in-adult-patients-100641959","NCT07650227","Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients","Multicenter, Double Blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients","Inclusion Criteria:\n\n1. Male and female patients aged 18 to 64 years, inclusive.\n2. Confirmed diagnosis of acute bronchitis (AB) based on the presence of productive cough and one or more symptoms (wheezing in the lungs, chest \"discomfort\", shortness of breath, fever).\n3. The BSS score of at least 5 and no more than 15 points.\n4. Duration of AB symptoms does no more than 72 hours.\n5. Seasonal incidence of acute respiratory viral infections.\n6. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.\n7. Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).\n\nExclusion Criteria:\n\n1. History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.\n2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.\n3. Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.\n4. History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.\n5. Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964).\n6. Metabolic disorders (obesity grades 2-3).\n7. History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy.\n8. Primary and\u002For secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.).\n9. Surgery of any localization within the last 3 months.\n10. Clinical symptoms of severe influenza\u002FARI requiring hospitalization .\n11. Acute respiratory failure.\n12. History\u002Fsuspected oncological disease of any location (except for benign neoplasms).\n13. Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus.\n14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.\n15. Pregnancy, breastfeeding, and childbirth less than 3 months prior to study inclusion.\n16. Hypersensitivity to any component of the medications used in the treatment.\n17. Patients who have taken medications listed in the \"Prohibited Concomitant Medication\" section in the previous 1 month prior to study inclusion or who require medications prohibited for use in this study.\n18. Patients who, in the investigator's opinion, will not comply with study monitoring requirements or with the study drugs administration schedule.\n19. History of mental illness, alcoholism, or drug abuse that, in the investigator's opinion, will interfere with successful compliance with study procedures.\n20. Participation in other clinical trials within 3 months prior to study inclusion.\n21. The patient is a member of the center's research staff directly involved in the study and is an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted.\n22. The patient is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or a designated official responsible for the study, or is an immediate family member of one of these individuals..","64 Years",{"count":370,"type":21},308,[343],"The goal of this clinical trial is to learn if Raphamin works to treat acute bronchitis in adults. It will also learn about the efficacy and the safety of Raphamin. The main questions it aims to answer are:\n\nWill treatment with Rafamine contribute to a faster resolution of acute bronchitis symptoms, reduce the severity of the disease, and prevent the development of complications requiring antibacterial therapy compared to placebo therapy? Investigators will compare Raphamin to a placebo (a look-alike substance that contains no drug) to see if Raphamin works to treat acute bronchitis.\n\nParticipants will:\n\nTake Raphamin or a placebo for 5 days. On the first day of treatment 8 tablets of Raphamin or a placebo should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day.\n\nFace-to-face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3 (Day 7±1), and a phone Visit 4 (day 14±1). The study uses an electronic patient diary (EPD) in which symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily.",[374,375],"Bronchitis","Acute Bronchitis",[374,377,378],"Acute","Adults","2026-06-24",{"date":165,"type":39},{"date":382,"type":39},"2025-12-09",{"date":384,"type":21},"2028-12-31",{"name":386,"class":72},"Materia Medica Holding",33,{"id":389,"slug":390,"hasResults":12,"nctId":391,"briefTitle":392,"officialTitle":393,"acronym":4,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":395,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":22,"phases":398,"briefSummary":399,"conditions":400,"keywords":406,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":410,"startDateStruct":411,"completionDateStruct":413,"leadSponsor":415,"locationsCount":416},"100433434","phase-2-belzutifanmk-6482-for-the-treatment-of-advanced-pheochromocytomaparaganglioma-ppgl-pancreatic-neuroendocrine-tumor-pnet-von-hippel-lindau-vhl-disease-associated-tumors-advanced-gastrointestinal-stromal-tumor-wt-gist-or-solid-tumors-with-hif-2-related-genetic-alterations-mk-6482-015-100433434","NCT04924075","Belzutifan\u002FMK-6482 for the Treatment of Advanced Pheochromocytoma\u002FParaganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Solid Tumors With HIF-2α Related Genetic Alterations (MK-6482-015)","A Phase 2 Study to Evaluate the Efficacy and Safety of Belzutifan (MK-6482, Formerly PT2977) Monotherapy in Participants With Advanced Pheochromocytoma\u002FParaganglioma (PPGL), Pancreatic Neuroendocrine Tumor (pNET), Von Hippel-Lindau (VHL) Disease-Associated Tumors, Advanced Gastrointestinal Stromal Tumor (wt GIST), or Advanced Solid Tumors With HIF-2α Related Genetic Alterations","The main inclusion criteria include but are not limited to the following:\n\n* Male and female participants at least 12 years of age (at least 18 years of age for Cohort B1)\n* Diagnosis of one of the following: Advanced\u002Fmetastatic pheochromocytoma\u002Fparaganglioma (PPGL), pancreatic neuroendocrine tumors (pNET), von Hippel-Lindau (VHL) disease associated localized tumors, or advanced wild-type gastrointestinal stromal tumor (wt GIST) or advanced solid tumors with Hypoxia Inducible Factor- 2 alpha subunit (HIF-2α) related genetic alterations\n* Cohort B1: VHL Disease-associated tumors:\n\n  * Have a diagnosis of VHL disease as determined by a germline test locally and\u002For clinical diagnosis\n  * Must be ≥18 years of age\n* Has a life expectancy of at least 3 months\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Unable to swallow orally administered medication or has a disorder that might affect the absorption of belzutifan\n* History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* Any of the following: A pulse oximeter reading \\\u003C92% at rest, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen\n* Clinically significant cardiac disease, including unstable angina, acute myocardial infarction, or arterial bypass (CABG) or Percutaneous transluminal coronary angioplasty (PTCA) ≤6 months from study entry, or New York Heart Association Class III or IV congestive heart failure\n* Received prior treatment (except somatostatin analogs) with chemotherapy, targeted therapy, biologics, or other investigational therapy within the past 4 weeks of first dose of study intervention","12 Years",{"count":397,"type":21},355,[61],"This is a study to evaluate the efficacy and safety of belzutifan monotherapy in participants with advanced pheochromocytoma\u002Fparaganglioma (PPGL), pancreatic neuroendocrine tumor (pNET), von Hippel-Lindau (VHL) disease-associated tumors, advanced wt (wild-type) gastrointestinal stromal tumor (wt GIST), or advanced solid tumors with hypoxia inducible factor-2 alpha (HIF-2α) related genetic alterations. The primary objective of the study is to evaluate the objective response rate (ORR) of belzutifan per response evaluation criteria in solid tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR).",[401,402,403,404,405],"Pheochromocytoma\u002FParaganglioma","Pancreatic Neuroendocrine Tumor","Von Hippel-Lindau Disease","Advanced Gastrointestinal Stromal Tumor","HIF-2α Mutated Cancers",[407,408,409],"HIF-2α","Pheochromocytoma\u002Fparaganglioma","Pancreatic NET",{"date":278,"type":39},{"date":412,"type":39},"2021-08-12",{"date":414,"type":21},"2029-12-27",{"name":359,"class":72},84,{"id":418,"slug":419,"hasResults":12,"nctId":420,"briefTitle":421,"officialTitle":422,"acronym":423,"eligibilityCriteria":424,"healthyVolunteers":12,"sex":17,"minAge":425,"maxAge":57,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":433,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":437,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":442,"locationsCount":444},"100422171","phase-3-a-study-to-assess-change-in-disease-activity-and-adverse-events-aes-with-cariprazine-in-the-treatment-of-depressive-episodes-in-pediatric-participants-participants-10-to-17-years-of-age-with-bipolar-i-disorder-100422171","NCT04777357","A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.","A 6-week, Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of the Efficacy and Safety of Cariprazine in Pediatric Subjects (10 to 17 Years of Age) in the Treatment of Depressive Episodes Associated With Bipolar I Disorder","3112 Ped BPD","Inclusion Criteria:\n\n* Participants with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) primary diagnosis of bipolar I disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL).\n* Current depressive episode is more than 2 weeks and less than 12 months in duration.\n* Participant has a lifetime history of at least one manic episode.\n* Children's Depression Rating Scale - Revised (CDRS-R) score \\> = 45 at Visit 1 and Visit 2.\n* Young-Mania Rating Scale (YMRS) score \\\u003C = 12 with YMRS Item 1 (elevated mood) score \\\u003C = 2 at Visit 1 and Visit 2.\n* Clinical Global Impression-Severity (CGI-S) scale score of \\> = 4 (moderately ill) at Visit 1 and Visit 2.\n\nExclusion Criteria:\n\n* Participants with DSM-5 diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, brief psychotic disorder, psychotic disorder due to another medical condition, PTSD, antisocial personality disorder, or borderline personality disorder.\n* Participant has a history of meeting DSM-5 diagnosis for any substance-related disorder (except caffeine- and tobacco-related) within the 3 months before Screening Visit 1.\n* History of serotonin syndrome or neuroleptic malignant syndrome.\n* Four or more episodes of a mood disturbance within the 12 months before Visit 1.\n* DSM-5 diagnosis of intellectual disability (IQ \\\u003C 70), autism spectrum disorders, or documented history of chromosomal disorder with developmental impairment.\n* History of seizures, with the exception of febrile seizures.\n* Significant head trauma, history of tumor of the CNS, or any other condition that predisposes to seizures.\n* Participant requires concomitant treatment with moderate or strong CYP3A4 inhibitors or with any CYP3A4 inducers.\n* Participant requires concomitant treatment with any prohibited medication, supplement, or herbal product, including any psychotropic drug or any drug with psychotropic activity or with a potentially psychotropic component.\n* Use of a depot antipsychotic within 2 cycles of their respective dosing interval prior to Screening Visit 1.\n* Treatment with clozapine in a dose of \\>= 50 mg\u002Fd in the past 2 years.\n* History of or any current ocular disease including, but not limited to, retinal detachment, intraocular surgery, laser treatment, glaucoma, cataracts, or clinically significant ocular trauma (with the exception of refractive errors).","10 Years",{"count":427,"type":21},380,[343],"Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States. The treatment of the depressive episodes of bipolar disorder in the pediatric population has not been as widely studied as the treatment of depressive episodes in bipolar disorder in adults, therefore pharmacotherapeutic options are limited. Given the change in disease state and safety demonstrated in adults with depressive episodes associated with bipolar I disorder, the purpose of this study is to evaluate the change in disease state and safety of cariprazine in the treatment of depressive episodes associated with bipolar I disorder in the pediatric population.\n\nCariprazine is an approved drug for the treatment of depressive episodes in adult participants with bipolar I disorder. Study doctors put participants in 1 of 2 groups, called treatment arms. There is a 1 in 2 chance that a participant will be assigned to placebo. Around 380 Participants ages 10-17 years with bipolar I disorder will be enrolled in approximately 60 sites worldwide.\n\nParticipants receiving the study drug will receive Dose A or B of Cariprazine based on age and weight. At Week 3, participants with insufficient response will have their dose increased to Dose B or Dose C, while participants with sufficient response will continue receiving the Dose A or B for the remainder of the treatment period. The treatment period will be followed by a safety follow-up (SFU) period for 4 weeks.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[431,432],"Depression","Bipolar I Disorder",[431,434,432,435,436],"RGH-188","Vraylar","Cariprazine",{"date":278,"type":39},{"date":439,"type":39},"2021-04-28",{"date":441,"type":21},"2027-03",{"name":443,"class":72},"AbbVie",81,{"id":446,"slug":447,"hasResults":12,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":242,"sex":17,"minAge":425,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":455,"conditions":456,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":458,"startDateStruct":459,"completionDateStruct":461,"leadSponsor":463,"locationsCount":234},"100399906","registry-for-chronic-venous-disease-incidence-and-natural-course-100399906","NCT04487314","Registry for Chronic Venous Disease Incidence and Natural Course","Russian Registry for Chronic Venous Disease Incidence and Natural Course","RRCVD","Inclusion Criteria:\n\n* A family members of the researcher (spouse, childrens, brothers and sisters, parents) or the researcher himself\n* The possibility of annual clinical and ultrasound assessment of the venous system of the observed individuals\n\nExclusion Criteria:\n\n* Any invasive treatment of the chronic venous disorder in anamnesis\n* Venous thrombosis in the anamnesis or at the time of inclusion",{"count":454,"type":21},10000,"A prospective cohort study of patients with primary varicose veins to assess the morbidity, risk factors and development of chronic lower limb vein disease.",[457],"Varicose Veins of Lower Limb",{"date":165,"type":39},{"date":460,"type":39},"2020-08-20",{"date":462,"type":21},"2050-09-01",{"name":464,"class":46},"Russian Phlebological Association",{"id":466,"slug":467,"hasResults":12,"nctId":468,"briefTitle":469,"officialTitle":470,"acronym":4,"eligibilityCriteria":471,"healthyVolunteers":12,"sex":472,"minAge":473,"maxAge":474,"enrollmentInfo":475,"targetDuration":4,"studyType":22,"phases":477,"briefSummary":478,"conditions":479,"keywords":481,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":496},"100644768","phase-1-a-study-to-evaluate-the-tolerability-safety-and-efficacy-of-gnr-097-gene-therapy-in-pediatric-patients-with-duchenne-muscular-dystrophy-100644768","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":476,"type":21},32,[140,61],"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.",[480],"Duchenne Muscular Dystrophy",[480,482,483,484,485,486,487],"DMD","Ambulatory","Gene Therapy","Micro-dystrophin","AAV","AAV9","2026-06-23",{"date":165,"type":39},{"date":491,"type":39},"2025-09-30",{"date":493,"type":21},"2029-08-02",{"name":495,"class":72},"AO GENERIUM",6,{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":503,"eligibilityCriteria":504,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":505,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":507,"conditions":508,"keywords":510,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":519},"100552378","clinical-and-demographic-features-of-patients-with-uncontrolled-severe-asthma-in-russia-corsar-100552378","NCT06472310","Clinical and demOgRaphic Features of Patients With Uncontrolled Severe Asthma in Russia (CORSAR)","An Observational Multicenter Cross-sectional Study of Patients With Uncontrolled Severe Asthma in the Population of the Russian Federation","CORSAR","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of inclusion;\n2. Signed and dated written informed consent in accordance with ICH GCP and local law prior to inclusion in the study;\n3. Patients with diagnosis of uncontrolled SA (Asthma Control Questionnaire-5 (ACQ-5) score \\> 1,5) established no less than 52 weeks prior to inclusion; Severe asthma is defined as asthma, that is controlled due to treatment with ICS in medium or high doses plus LABA and\u002For ALP, and\u002For LAMA, and\u002For systemic corticosteroids (sCS), and\u002For immunobiological therapy, while attempts to reduce the volume of therapy lead to a loss of symptom control, or asthma remains uncontrolled despite this treatment. Such therapy should be carried out at least 3 months before inclusion.\n\n   Uncontrolled asthma is defined as ACQ-5\\>1.5.\n4. Patients with the availability of at least 52 weeks of follow-up data (prior to inclusion) in the medical records.\n\nExclusion Criteria:\n\n1. Patients receiving any biological therapy currently or within 52 weeks prior to inclusion;\n2. Presence of chronic obstructive pulmonary disease (COPD) or idiopathic pulmonary fibrosis (ILF) currently or in the anamnesis;\n3. The participation in any clinical study currently or within 52 weeks prior to inclusion;\n4. An acute or chronic disease that, as deemed by Investigator, limits the ability of patients to participate in this study or could influence the interpretation of the results.",{"count":506,"type":21},5000,"This study is an observational multicenter cross-sectional study. Planned study population consists of 5 000 adult patients with uncontrolled SA receiving treatment according to standard of care (except biologics). Planned number of study site is 50 outpatient centers with experience of uncontrolled SA treatment in about 50 regions of Russia (in order to describe characteristics of patients with uncontrolled SA in different regions in the most comprehensive way). This non-interventional study does not imply any intervention into a routine clinical practice, and does not provide for any diagnostic and therapeutic procedures other than those used in routine practice.",[509],"Severe Asthma",[511,512],"uncontrolled severe asthma","SA",{"date":379,"type":39},{"date":515,"type":39},"2024-06-06",{"date":517,"type":21},"2027-06-30",{"name":284,"class":72},37,{"id":521,"slug":522,"hasResults":12,"nctId":523,"briefTitle":524,"officialTitle":525,"acronym":526,"eligibilityCriteria":527,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":528,"targetDuration":4,"studyType":22,"phases":530,"briefSummary":532,"conditions":533,"keywords":536,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":541,"startDateStruct":542,"completionDateStruct":544,"leadSponsor":546,"locationsCount":234},"100500264","phase-4-the-prevalence-of-iron-deficiency-and-the-effectiveness-of-ferinject-in-patients-with-hfpef-id-hfpef-100500264","NCT05793996","The Prevalence of Iron Deficiency and the Effectiveness of Ferinject® in Patients With HFpEF (ID-HFpEF)","Study of the Prevalence of Iron Deficiency Among Hospitalized Patients With HFpEF and the Impact of Ferinject® on Indicators of Quality of Life, Functional Status in Patients With Iron Deficiency","ID-HFpEF","Inclusion Criteria:\n\n* Signed informed consent to participate in the study;\n* In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF);\n* Left ventricular ejection fraction (LVEF) ≥50%; objective signs of structural and\u002For functional disorders of the heart consistent with the presence of LV diastolic dysfunction\u002Fincreased LV filling pressure, including elevated levels of natriuretic peptide;\n* Screening ferritin below 100 µg\u002FL, or below 300 µg\u002FL when transferrin saturation (TSAT) is below 20%;\n* Screening haemoglobin (Hb) at the time of switching on ( 90-150 g\u002Fl).\n\nExclusion Criteria:\n\n* Uncontrolled arterial hypertension;\n* Аnemia not related to iron deficiency;\n* Аnemia with a hemoglobin level of less than 90 g\u002Fl;\n* Less than 1 year after acute myocardial infarction;\n* Less than 1 year after acute cerebral circulation disorder;\n* Less than 1 year after surgical interventions, including non-cardiac operations and myocardial revascularization (coronary bypass surgery, coronary artery stenting), operations for valvular pathology;\n* Chronic alcoholism (including alcoholic heart disease), mental disorders;\n* Severe hepatic (increased transaminase levels above the upper three limits of normal) and renal insufficiency (glomerular filtration rate less than 15 ml\u002Fmin\u002F1.73 m2);\n* Known active infection, clinically significant bleeding, active malignancy;\n* Severe autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc.);\n* Severe bronchial asthma, COPD in the acute stage;\n* Allergic reactions to medications in the anamnesis, eczema, atopic allergic reaction;\n* Blood transfusions and taking erythropoiesis-stimulating drugs during the previous three months.",{"count":529,"type":21},100,[531],"PHASE4","Observational cohort randomized controlled study to study the influence of correction of ID by intravenous injection of ferric carboxymaltose (Ferinject®) on quality of life indicators, functional status in a cohort of patients with HFpEF.",[534,535],"Chronic Heart Failure","Iron Deficiency, Latent",[537,538,539,540],"HFpEF","iron deficiency","ferric carboxymaltose","Ferinject",{"date":379,"type":39},{"date":543,"type":39},"2023-04-28",{"date":545,"type":21},"2026-12",{"name":332,"class":46},{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":555,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":557,"conditions":558,"keywords":560,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":568,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":572,"locationsCount":234},"100465120","pim-incidence-in-older-cardiovascular-patients-during-covid-19-pandemics-100465120","NCT05336565","PIM Incidence in Older Cardiovascular Patients During COVID-19 Pandemics","Incidence of Prescribing Potentially Inappropriate Medications to Older Cardiovascular Patients During COVID-19 Pandemics According to Medical Information System BARS","PIM-BARS","Inclusion Criteria:\n\n* established diagnosis of cardiovascular disease\n* age of 18 years and older\n* enrollment in the reimbursement program in Tomsk Region\n\nExclusion Criteria:\n\n* age of 17 years and younger",{"count":556,"type":21},1000,"The aim of the study is to assess the incidence of potentially inappropriate medication (PIM) administration, polypharmacy, and potential drug-drug-interactions (PDDIs) in cardiovascular patients enrolled in the reimbursement program in the time of coronavirus disease (COVID-19) pandemic. Medical information system (MIS) \"BARS\" will be used for inclusion and retrieval of relevant data of cardiovascular patients enrolled in the reimbursement programs in the Tomsk Region. The incidence rates of PIM prescriptions will be assessed in patients aged 75 years and older. Potentially inappropriate medications will be defined according to 2015 Beers criteria. Polypharmacy will be defined as being administered five or more medications at the same time. PDDIs will be checked with Medscape Drug Interaction Checker and rated as 'Contraindicated', 'Serious', and 'Requiring Monitoring'. Combined analysis of retrospective and prospective occurrences of study parameters will be performed. PIM-BARS will evaluate the incidence rates and patterns of PIM prescriptions, polypharmacy, and PDDIs in elderly cardiovascular patients enrolled in the reimbursement program in the time of COVID-19 pandemic.",[559],"Potentially Inappropriate Medications",[561,562,563,564,565,566,567],"Potentially inappropriate medication","Drug-drug-interaction","Polypharmacy","Cardiovascular","Electronic medical record","Medical information system","Prevention",{"date":379,"type":39},{"date":570,"type":39},"2022-07-01",{"date":262,"type":21},{"name":332,"class":46},{"id":574,"slug":575,"hasResults":12,"nctId":576,"briefTitle":577,"officialTitle":578,"acronym":579,"eligibilityCriteria":580,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":320,"enrollmentInfo":581,"targetDuration":4,"studyType":22,"phases":583,"briefSummary":584,"conditions":585,"keywords":590,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":599,"lastUpdatePostDateStruct":600,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":234},"100644473","comparison-of-focal-cryoablation-vs-radiofrequency-cardioneuroablation-for-bradyarrhythmias-100644473","NCT07671898","Comparison of Focal Cryoablation vs. Radiofrequency Cardioneuroablation for Bradyarrhythmias","Prospective Non-Randomized Comparison of Point-by-Point Cryoablation Using Freezor™ Xtra Versus Radiofrequency Ablation Using TactiFlex™ SE of Parasympathetic Ganglia (Cardioneuroablation) in Patients With Vagally-Mediated Bradyarrhythmias","CRYO-CNA vs RF","Inclusion Criteria:\n\n* Age 18 to 60 years;\n* Symptomatic bradycardia (sinus bradycardia or bradycardia due to atrioventricular block, including transient);\n* Severe asymptomatic sinus bradycardia (heart rate less than 30 beats per minute);\n* Transient second- or third-degree atrioventricular block;\n* Persistent second-degree atrioventricular block;\n* Rhythm pauses greater than 6 seconds;\n* Recurrent syncope or presyncope with documented association with bradycardia (without trauma);\n* Positive response to atropine (heart rate increase ≥25% from baseline or \\>90 beats per minute) OR positive response to exercise (heart rate increase ≥25% from baseline or \\>90 beats per minute, OR conversion of second- or third-degree atrioventricular block to first-degree block or complete normalization of atrioventricular conduction during sinus rhythm);\n\nExclusion Criteria:\n\n* Chronic antiarrhythmic drug therapy (ongoing);\n* Presence of implanted pacemaker, cardiac resynchronization therapy device, or implantable cardioverter-defibrillator;\n* Bradyarrhythmia secondary to medications;\n* Bradyarrhythmia secondary to electrolyte imbalance (hyperkalemia);\n* Bradyarrhythmia secondary to hypothyroidism;\n* Bradyarrhythmia secondary to obstructive sleep apnea syndrome;\n* Absence of response to pharmacological denervation (no heart rate increase after atropine administration up to maximum dose of 0.2 mg\u002Fkg);\n* Clinically significant coronary artery disease;\n* Post-myocardial infarction cardiosclerosis;\n* Hemodynamically significant congenital heart disease (including surgically corrected);\n* Stable ventricular tachycardia in the setting of bradycardia;\n* History of stroke or transient ischemic attack;\n* Prior open-heart surgery;\n* Prior catheter-based coronary artery intervention or percutaneous coronary intervention;\n* Pregnancy or breastfeeding; Age less than 18 years Age greater than 60 years",{"count":582,"type":21},60,[24],"Bradyarrhythmias are conditions where the heart beats too slowly, causing symptoms like dizziness, fainting, and fatigue. In some patients, these slow heart rhythms are caused by overactivity of the vagus nerve (the part of the nervous system that slows the heart down).\n\nCardioneuroablation (CNA) is a catheter-based procedure that targets and reduces the effect of these overactive nerves on the heart. It is an alternative to permanent pacemaker implantation, especially for younger patients.\n\nTraditionally, CNA is performed using radiofrequency (RF) energy to create small burns in specific areas of the heart. This study investigates whether focal cryoablation (freezing technology using the Freezor™ Xtra catheter) is as safe and effective as standard RF ablation for CNA.\n\nThis is a prospective, non-randomized study. Participants will receive either RF ablation (N=30) or cryoablation (N=30). The study will evaluate the recurrence of slow heart rhythms and fainting episodes, as well as any complications, over 12 months of follow-up.",[586,587,588,589],"Bradycardia","Syncope, Vasovagal","Sick Sinus Syndrome","Atrioventricular Block",[591,592,593,594,595,596,597,598,588,589],"Cardioneuroablation,","Cryoablation","Radiofrequency Ablation","Ganglionated Plexi","Parasympathetic Nervous System","Bradyarrhythmias","Functional Bradycardia","Vasovagal Syncope","2026-06-22",{"date":278,"type":39},{"date":602,"type":39},"2024-09-01",{"date":604,"type":21},"2028-12-25",{"name":332,"class":46},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":612,"eligibilityCriteria":613,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":614,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":626},"100599784","clinical-and-demographic-characteristics-of-adult-p-atients-with-neurofibromatosis-in-russia-100599784","NCT07088991","Clinical and Demographic Characteristics of Adult p Atients With NEurofibromatosis in RUSsia","Clinical and Demographic Characteristics of Adult Patients With NEurofibromatosis in RUSsia","NEREUS","Inclusion Criteria:\n\n1. Age ≥ 18 years at the time of inclusion.\n2. Signed and dated written informed consent in accordance with ICH-GCP and local law prior to inclusion in the study.\n3. NF1 diagnosed (according to the international consensus criteria for evaluating NF1 \\[18\\]), see Appendix A.\n4. Confirmed PN by clinical assessment, USI, MRI, biopsy; one method is sufficient (histologic confirmation of PN is not necessary in the presence of radiographic findings).\n5. Existing of PN-associated symptoms.\n6. Adult patients (≥18 years) with newly diagnosed PN or established PN naïve to MEK-inhibitor therapy verified by medical records\u002Fhistories (e.g., prior prescriptions, hospitalization data).\n\nExclusion Criteria:\n\n1. The participation in any clinical study currently (patients participating in other non-interventional studies may be included);\n2. Patients with the evidence of a malignant glioma, malignant peripheral nerve sheath tumor, or other cancer, requiring treatment with chemotherapy or radiation therapy.\n3. In the opinion of the investigator the patient is not able to return for follow-up visits or obtain required follow-up studies.\n4. Individuals who are pregnant or breast feeding or who become pregnant while enrolled on this trial, if they are unable to undergo radiographic evaluations or MRI scans requested for research purposes, or other studies which might negatively impact on the pregnancy.\n5. Prior receipt of any MEK-inhibitor for PN therapy within 4 months before screening or initiation of therapy prior to age 18 verified by medical records\u002Fhistories (e.g., prior prescriptions, hospitalization data).\n6. Patients who modify their index pathogenetic therapy regimen during the study (for example, pathogenetic antitumor therapy of PN; switching to a different therapy), as determined by the investigator at any protocol-specified visit during the a study, will be excluded from the primary efficacy analysis population from the point of modification onward and will not continue study participation.",{"count":615,"type":21},200,"Clinical and Demographic Characteristics of Adult Patients with NEurofibromatosis in RUSsia (NEREUS)",[618],"Neurofibromatosis","2026-06-19",{"date":488,"type":39},{"date":622,"type":39},"2025-06-06",{"date":624,"type":21},"2028-03-31",{"name":284,"class":72},14,{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":631,"acronym":632,"eligibilityCriteria":633,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":634,"enrollmentInfo":635,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":637,"conditions":638,"keywords":640,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":642,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":59},"100587628","non-interventional-study-to-assess-the-effectiveness-and-safety-of-ribociclib-in-the-adjuvant-therapy-of-hormone-receptor-positive-hr-her2-negative-stage-ii-and-iii-breast-cancer-in-real-clinical-practice-in-russia-100587628","NCT06930859","Non-interventional Study to Assess the Effectiveness and Safety of Ribociclib in the Adjuvant Therapy of Hormone Receptor Positive (HR+) HER2-negative Stage II and III Breast Cancer in Real Clinical Practice in Russia","ELEGANCE","Inclusion Criteria:\n\nPatients from the prospective cohort of the study must meet all of the following criteria:\n\n1. Signed and dated Informed Consent Form (ICF) not later than 28 days after the initiation of adjuvant therapy with ribociclib in combination with aromatase inhibitors (±GnRH agonists).\n2. Age ≥18 years at the time of signing the ICF.\n3. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.\n4. The adjuvant hormone therapy with aromatase inhibitors (±GnRH agonists) may be started not earlier than 12 months before initiation of therapy with ribociclib.\n5. ECOG performance status 0-1\n\nPatients from the retrospective cohort of the study must meet all of the following criteria:\n\n1. Age ≥18 years at the initiation of hormone therapy.\n2. Histologically verified HR+ HER2-negative stage II-III breast cancer, for which radical treatment was carried out.\n3. Initiation of adjuvant hormone monotherapy with aromatase inhibitors (±GnRH agonists) in the index period from July 1, 2019 to July 1, 2020.\n4. Presence of the necessary information in the source documentation.\n\nExclusion Criteria:\n\nPatients enrolled in the study in prospective cohort should not meet any of the following criteria.\n\n1. History of therapy with abemaciclib or palbociclib\n2. Therapy with ribociclib in combination with AI for more than 28 days at the time of signing the Informed Consent Form\n3. Active therapy for other malignant neoplasms\n4. Participation in interventional clinical studies at the time of signing the Informed Consent Form\n\nPatients enrolled in the study in retrospective cohort should not meet any of the following criteria.\n\n1. Neoadjuvant or adjuvant therapy with CDK4\u002F6 inhibitors\n2. A history of another concomitant malignant neoplasm requiring active therapy\n3. Participation in interventional clinical studies at the time of treatment for breast cancer\n4. Patients experiencing a recurrence during adjuvant hormone therapy can participate if they meet the other inclusion and exclusion criteria.","99 Years",{"count":636,"type":21},2766,"This prospective, observational, multicenter study aims at evaluating the efficacy of adjuvant ribociclib in combination with hormone therapy (aromatase inhibitor ± GnRH aginost) in various subgroups of patients with HR+HER2- stage II-III breast cancer in real clinical practice in Russia. Subgroup division will be based on the tumor grade, lymph node involvement, and the response to test hormone therapy. The study will consist of two cohorts: a prospective one with patients receiving adjuvant therapy with ribociclib combined with Aromatase inhibitors (AI), and a retrospective one with patients receiving adjuvant therapy with AI alone. Thus, both primary data collection and secondary use of data will be organized.",[639],"Breast Cancer",[641],"Breast cancer",{"date":488,"type":39},{"date":644,"type":39},"2025-12-03",{"date":646,"type":21},"2032-12-31",{"name":312,"class":72},{"id":649,"slug":650,"hasResults":12,"nctId":651,"briefTitle":652,"officialTitle":652,"acronym":653,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":655,"maxAge":4,"enrollmentInfo":656,"targetDuration":4,"studyType":212,"phases":4,"briefSummary":658,"conditions":659,"keywords":661,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":664,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":234},"100535464","registry-of-acute-myocardial-infarction-100535464","NCT06252168","Registry of Acute Myocardial Infarction","RAMI-Tomsk","Inclusion Criteria:\n\n* age of at least 20 years;\n* being a resident or visitor of the city of Tomsk at a time of AMI onset;\n* the presence of definite AMI or possible AMI. Definite AMI is diagnosed in the presence of characteristic ECG changes, regardless of clinical course and changes in serum enzymes; or the presence of typical pain syndrome, \"ambiguous\" ECG changes, and definite increase in the activity of serum enzymes i.e. exceeding the upper limit of normal by 25% or more; or macroscopically detected focus of myocardial necrosis and (or) fresh thrombotic occlusion of the coronary artery. Possible AMI is registered in the presence of typical pain syndrome with ambiguous ECG changes and an ambiguous (up to 25%) increase in the levels of serum enzymes; or the presence of obstruction in the lumen of at least one coronary artery by at least 50% and (or) the presence of a post-infarction scar in the myocardium with a diameter of 0.5 cm or more, while simultaneously excluding a non-coronary cause of death. In case of atypical clinical picture, ambiguous or absent ECG changes, when the enzyme levels are not determined or their activity does not reach a pathological level, AMI case is considered unconfirmed. In the absence of data that could confirm or not confirm AMI, the case is interpreted as \"insufficient data\"\n\nExclusion Criteria:\n\n* none.","20 Years",{"count":657,"type":21},97500,"The Registry of Acute Myocardial Infarction (RAMI) aims at regular and centralized acquiring and processing standard information about verified and suspected cases of acute myocardial infarction (AMI), monitoring of AMI cases, and establishing AMI diagnosis based on standard diagnostic criteria by doctors involved in the registry. The RAMI obtains data from all medical institutions, which could potentially document any cases of suspected AMI.",[660],"Myocardial Infarction, Acute",[662,663],"Acute Myocardial Infarction","Acute Coronary Syndrome",{"date":379,"type":39},{"date":666,"type":39},"1984-01-01",{"date":668,"type":21},"2050-12-31",{"name":332,"class":46},{"id":671,"slug":672,"hasResults":12,"nctId":673,"briefTitle":674,"officialTitle":675,"acronym":676,"eligibilityCriteria":677,"healthyVolunteers":12,"sex":17,"minAge":293,"maxAge":18,"enrollmentInfo":678,"targetDuration":4,"studyType":22,"phases":680,"briefSummary":681,"conditions":682,"keywords":684,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":690,"startDateStruct":691,"completionDateStruct":693,"leadSponsor":695,"locationsCount":697},"100345151","phase-3-a-study-of-baricitinib-in-participants-from-1-year-to-less-than-18-years-old-with-juvenile-idiopathic-arthritis-100345151","NCT03773965","A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis","A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to \u003C18 Years of Age With Juvenile Idiopathic Arthritis (JIA)","JUVE-X","Inclusion Criteria:\n\n* Participants must have completed a previous study of baricitinib for the treatment of JIA.\n\nExclusion Criteria:\n\n* Participants must not have had a permanent discontinuation of baricitinib in the prior study.\n* Participants must have not developed an allergy to baricitinib.",{"count":679,"type":21},190,[343],"The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.",[683],"Juvenile Idiopathic Arthritis",[685,686,687,688,689],"Polyarticular JIA","Oligoarthritis","Juvenile psoriatic arthritis (JPsA)","Enthesitis-related juvenile idiopathic arthritis (ERA)","Systemic JIA with and without systemic features",{"date":488,"type":39},{"date":692,"type":39},"2019-04-05",{"date":694,"type":21},"2031-07",{"name":696,"class":72},"Eli Lilly and Company",80,""]