[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"POLYSAN Scientific & Technological Pharmaceutical Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":117},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,69,94],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100598057","trial-of-the-efficacy-and-safety-of-use-of-drug-product-reamberin-for-pathogenetic-therapy-of-viral-enteric-infection-in-children-aged-1-6-years-old-100598057",false,"NCT07066540","Trial of the Efficacy and Safety of Use of Drug Product Reamberin® for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old","Open Multicenter Prospective Observational Trial of the Efficacy and Safety of Use of Drug Product Reamberin® Solution for Infusion, 1.5 % (Scientific Technological Pharmaceutical Firm \"POLYSAN\") for Pathogenetic Therapy of Viral Enteric Infection in Children Aged 1-6 Years Old","Inclusion Criteria:\n\n1. Children of both sexes at the age of 1 to 6 years old inclusive;\n2. Diagnosis \"Viral and other specified intestinal infections\" (code according to the International Statistical Classification of Diseases and Related Health Problems 10th Revision(ICD-10): A08),\n3. Clinical signs of endogenous intoxication (nausea, vomiting, hyperthermia, headache, muscle pain, asthenia, adynamia, etc.);\n4. Indication for parenteral rehydratation (infusion therapy);\n5. Decision of a physician on prescribing drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm \"POLYSAN\") in the daily dose of 10 mL\u002Fkg and normal saline NaCl\u002F5 % or 10 % solution of glucose or normal saline NaCl\u002FRinger's solution\u002F5 % or 10 % solution of glucose;\n6. To confirm the diagnosis by laboratory tests, biological material was taken;\n7. Informed Consent Form on Participation in the Observational Program signed and dated by a parent\u002Flegal representative of the patient.\n\nExclusion Criteria:\n\n1. Individual intolerance or known hypersensitivity to sodium meglumine, sodium succinate, and\u002For normal saline (NaCl), solution of glucose, Ringer's solution or excipients of drug product Reamberin® based on data of medical history;\n2. Contraindications to prescription of drug product Reamberin®;\n3. Necessity in surgical interventions during the observational program;\n4. Patients previously enrolled in this trial but discontinued participation due to any any reason;\n5. Administration of antibiotics or succinate-containing drug products (Cytoflavin, Mexidol, etc.) and solutions containing malate;\n6. Other conditions that, according to the Investigator, prevent enrollment of a patient into the observational trial or can result in premature discontinuation of the observational trial by the patient","ALL","1 Year","6 Years",{"count":20,"type":21},300,"ESTIMATED","OBSERVATIONAL","To assess the efficacy and safety of use of drug product Reamberin® solution for infusion, 1.5 % (Scientific Technological Pharmaceutical Firm \"POLYSAN\") for pathogenetic therapy of viral enteric infection in children aged 1-6 years old in routine clinical practice. Trial population: children of both sexes at the age of 1-6 years old inclusive with viral enteric infection.",[25],"Viral Enteric Infection",[27,28],"viral enteric infection","reamberin","RECRUITING","2025-07-12",{"date":32,"type":33},"2025-07-15","ACTUAL",{"date":35,"type":33},"2024-08-01",{"date":37,"type":21},"2026-12",{"name":39,"class":40},"POLYSAN Scientific & Technological Pharmaceutical Company","INDUSTRY",8,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100589515","phase-2-reamberin-15-in-rehydration-therapy-of-diabetic-ketoacidosis-100589515","NCT06955416","REAMBERIN® 1.5% in Rehydration Therapy of Diabetic Ketoacidosis","A Multicenter, Randomized, Double-blind Study of the Safety and Efficacy of REAMBERIN®, 1.5% Solution for Infusions, in Addition to Standard Rehydration Therapy in Patients With Diabetic Ketoacidosis","Inclusion Criteria:\n\n* Signed Informed Consent\n* Male and female patients aged 18-75 years, inclusive.\n* Confirmed diagnosis of type 1 or type 2 diabetes mellitus\n* Established clinical diagnosis of DKA at the time of admission\n* Plasma glucose \\> 13.9 mmol \u002F l\n* Metabolic acidosis (venous blood pH \\\u003C 7.25)\n* Serum bicarbonate \\\u003C 18 mmol \u002F l\n* Ketonuria ≥ ++\n* Possibility of randomizing the patient within 2 hours from admission to the hospital.\n\nExclusion Criteria:\n\n* Known hypersensitivity to any component of the study drug\u002Fstandard therapy p\n* Blood pH ≤ 6.9 or standard bicarbonate level \\\u003C5 mmol\u002Fl\n* Previous use of other solutions containing reserve alkalinity carriers (acetate, lactate, malate, fumarate, etc).\n* Conditions requiring emergency surgical intervention\n* Abdominal surgeries in the last 14 days\n* Traumatic brain injury accompanied by cerebral edema.\n* Chronic treatment with steroids, atypical antipsychotics, cancer chemotherapy.\n* Acute kidney injury\n* Chronic kidney disease stage C5\n* Liver injury (increase in alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels by more than 5 times the established reference values).\n* Acute pancreatitis\n* Sepsis\n* Severe multiple or combined trauma\n* History of malignancy\n* Clinically significant cardiovascular diseases (acute coronary syndrome; acute cerebrovascular accident (CVA) or transient ischemic attack (TIA); chronic heart failure class III - IV according to the NYHA classification; severe uncontrolled arrhythmia).\n* Body mass index \\>=40.0\n* Alcohol abuse, drug use, drug use.\n* Other specific types of diabetes mellitus.\n* Previously diagnosed mental illness\n* Participation in another clinical trial or the use of drugs\u002Fdietary supplements containing succinic acid less than 30 days before inclusion in this study.\n* Pregnancy or breastfeeding.\n* SARS-CoV-2 infection\n* Low systolic blood pressure (BP) (≤70 mmHg) upon admission to hospital or at the time of inclusion in the study.\n* Contraindications to the infusion of REAMBERIN of 0.9% sodium chloride solution.","18 Years","75 Years",{"count":52,"type":21},312,"INTERVENTIONAL",[55,56],"PHASE2","PHASE3","A number of scientific papers have been published on the efficacy and safety of adding REAMBERIN® (meglumin sodium succinate), a 1.5% infusion solution, to standard therapy for patients with diabetic ketoacidosis (DKA), which showed that the addition of the medication to DKA therapy at a dose of 10 ml\u002Fkg\u002Fday or an average of 800.68±151.59 ml on the first day of infusion, leads to a more rapid and successful resolution of DKA, achieving a state of compensation, a more rapid transfer of the patient from the intensive care unit (ICU) and discharge from the hospital.\n\nA combined, two-stage, multicenter, randomized, double-blind, phase II\u002FIII study with an adaptive design is planned. Stage 1 (phase II) will be a sequential evaluation of 2 doses of the study medication (750 ml and 1500 ml) versus placebo. At the 2nd stage of the study (phase III), additional recruitment of patients will be carried out in two groups in a 1:1 ratio to the experimental group or placebo group, to receive the optimal dose in accordance with the result obtained at stage 1.",[59],"Diabetic Ketoacidosis","2025-06-18",{"date":62,"type":33},"2025-06-24",{"date":64,"type":33},"2025-05-01",{"date":66,"type":21},"2027-12-31",{"name":39,"class":40},3,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":76,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},"100555660","observational-study-of-efficiency-of-cytoflavin-in-patients-with-ischemic-stroke-not-receiving-reperfusion-therapy-100555660","NCT06514976","Observational Study of Efficiency of Cytoflavin, in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy","Multi-center International Observational Study of Efficiency of the Drug Cytoflavin®, Solution for Infusions in Patients With Ischemic Stroke Not Receiving Reperfusion Therapy.","Inclusion Criteria:\n\n1. Signed informed consent form\n2. Age from 18 years and older\n3. Diagnosis: Acute cerebrovascular accident of ischemic type (ischemic stroke) developed within 36 hours before enrollment in the study\n4. Motor neurologic deficit measurable using the NIHSS Scale (score for item 5 and\u002For 6 at the time of starting the therapy ≥ 1))\n5. Conservative stroke treatment tactics (without reperfusion therapy thrombolysis\u002Fthrombus extraction)\n6. According to the routine clinical practice, the patient is scheduled to receive the treatment as per one of the following regimens:\n\n   * Cytoflavin® 20-40 ml\u002Fday as a course of not less than 10 days or\n   * another neuroprotector - course of not less than 10 days (or without neuroprotector)\n\nExclusion Criteria:\n\n1. NIHSS 1a (coma) score 3 at the time of enrollment\n2. Initial severe disablement (corresponding to mRS \\> 2) requiring external assistance in everyday life before development of stroke\n3. History of Parkinson's disease, dementia, multiple sclerosis, and other significant diseases accompanied by neurologic deficit\n4. Severe comorbidity with expected lifespan of not more than 6 months\n5. Pregnancy and breastfeeding\n6. Any other concomitant medical or serious psychic conditions, which make the patient ineligible for participation in the study, restrict lawfulness of obtaining the informed consent, or can influence the patient's ability to participate in the study",{"count":77,"type":21},562,"Stroke remains one of the main socially significant problems in the healthcare in the third millennium. The lethality in persons with history of stroke by the end of the 1st year of disease is high. A trend to increased frequency of stroke in the young age is observed during the last decade; third of patients is working-age individuals, out of whom only 15-20% returns to labor, and others remain disabled persons requiring constant medical and social support",[80,81],"Stroke, Acute","Stroke, Ischemic",[83,84],"stroke","сytoflavin","2025-04-15",{"date":87,"type":33},"2025-04-18",{"date":89,"type":33},"2024-03-01",{"date":91,"type":21},"2025-11-01",{"name":39,"class":40},17,{"id":95,"slug":96,"hasResults":11,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":101,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},"100572640","evaluation-of-the-efficacy-of-permanent-course-combined-therapy-with-cytoflavin-intravenous-solution-and-cytoflavin-tablets-at-2-3-stages-of-rehabilitation-of-patients-with-post-intensive-care-syndrome-100572640","NCT06735898","Evaluation of the Efficacy of Permanent Course Combined Therapy With CYTOFLAVIN® Intravenous Solution and CYTOFLAVIN Tablets, at 2-3 Stages of Rehabilitation of Patients With Post Intensive Care Syndrome","Evaluation of the Efficacy of Permanent Course Combined Therapy With CYTOFLAVIN® Intravenous Solution and CYTOFLAVIN® Tablets, at 2-3 Stages of Rehabilitation of Patients With Post Intensive Care Syndrome","Inclusion Criteria:\n\n* Men and women over 18 years of age and older;\n* Stay in the ITU and (or) intensive care unit for at least 3 days;\n* Diagnosed \"post intensive care\" syndrome (PIC syndrome) with moderate-to-severe severity \\>3\\\u003C6 points\n* Diagnosed modalities \"critical illness polyneuropathy, respiratory neuropathy, dysphagia\" of the domain \"Neuromuscular complications\" of PIC syndrome at 2-3 stages of the rehabilitation route at any value of PICS severity index\n* Diagnosed modalities \"decreased gravitational gradient, decreased exercise tolerance\" in the domain \"Vegetative-metabolic complications\" at 2-3 stages of the rehabilitation route at any value of PICS severity index\n\nExclusion Criteria:\n\n* Premorbid level of vital activity when assessed on the rehabilitation routing scale 4-5 points;\n* Hematocrit ≤30%;\n* Hemoglobin level ≤80 g\u002FL;\n* Acute cardiac failure;\n* Acute respiratory failure;\n* Acute renal failure;\n* Acute liver cell failure;\n* Use of drugs from \"metabolic agents\" pharmacotherapeutic group at the time of inclusion in the study\n* Life expectancy of 6 months or less or presence of incurable diseases in decompensation stage",{"count":102,"type":21},90,"Post intensive care syndrome (PIC syndrome) is an important problem in modern intensive care strategy. Understanding the mechanisms of PIC syndrome helps prevent it in patients with respiratory, neuromuscular transmission, and cognitive impairments that require prolonged support of vital functions. Significant role in the formation and severity of PIC syndrome is played by the severity of the systemic inflammatory response, which is an individual reaction of the body, and this determines the degree of neurological and psychological deficits. Chronic diseases such as diabetes mellitus, especially in the context of metabolic syndrome, worsen the course of PIC syndrome and delays recovery. Early initiation of rehabilitation measures in the intensive care unit and subsequent expansion of the individual rehabilitation program contributes to the rapid and successful recovery of not only vital functions, but also cognitive, motor and emotional disorders. This shortens the hospital stay of patient and improves their quality of life after discharge.",[105],"Ischemic Stroke",[107,108],"Post Intensive Care Unit Syndrome","Ischemic stroke","2025-04-04",{"date":111,"type":33},"2025-04-06",{"date":89,"type":33},{"date":114,"type":21},"2026-05-01",{"name":39,"class":40},1,""]