There are about 6423 clinical studies being (or have been) conducted in Russian Federation. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This randomized, double-blind, placebo-controlled trial titled "Preventing Weight Regain Post-Semaglutide Treatment with Active Fiber Supplement (Soloways)" evaluated the efficacy of an active fiber supplement in preventing weight regain post-Semaglutide treatment. Participants were adults aged 18-65, with a history of obesity or overweight, and had completed a Semaglutide course. The study involved 160 participants, equally divided into two groups: one receiving the active fiber supplement (glucomannan, inulin, and psyllium) and the other a placebo, both taken 30 minutes before each main meal for 180 days. Co-primary endpoints were the percentage of weight regain from baseline to day 180 and metabolic health markers (blood glucose levels, HbA1c, lipid profile, blood pressure). Secondary endpoints included changes in BMI, body composition, and appetite assessment using VAS ratings and the Control of Eating Questionnaire (CoEQ). Participants also adhered to a reduced-calorie diet and increased physical activity, with all standard assays performed in a central laboratory. The study's objective was to determine the supplement's effectiveness in enhancing satiety, improving digestive health, and thus better managing weight compared to a placebo
This clinical trial investigated the combined effects of Semaglutide and a fiber supplement (glucomannan, inulin, psyllium) on weight loss in adults with overweight or obesity. Participants, aged 18-65 with a BMI ≥30 or ≥27 with comorbidities, were randomized into two groups: one receiving Semaglutide with active fiber supplements and the other with Semaglutide and placebo, over a 180-day period. Key endpoints included percentage change in body weight, BMI, body composition, safety, and appetite control, with a focus on evaluating the additive effects of dietary fibers in enhancing Semaglutide's efficacy.
This randomized, double-blind, placebo-controlled trial assessed the impact of a dietary fiber supplement (glucomannan, inulin, and psyllium) on weight and metabolic parameters in individuals with obesity-related genetic polymorphisms (FTO, MC4R, LEP, LEPR). Participants were adults aged 18-65 with a BMI ≥ 25 and confirmed genetic predispositions. The study, involving 216 participants (108 per group), ran over 12 weeks with assessments at 0, 4, 8, and 12 weeks. Primary outcome was Body-weight change in %. The study aimed to clarify the role of fiber supplements in genetically predisposed obese individuals.
Rheumatoid arthritis (RA) is a chronic disease affecting about 1% of the worldwide population. RA is characterized by inflammation of the synovial membrane joints, which can lead to the destruction of the osteochondral structures of the joint and cause a number of systemic complications. RA represents a serious medical and social problem in the Russian Federation with a high level of disability. Recently, genetically engineered biological drugs (GIBPs) and Janus-kinase inhibitors (JAK-i) have become a popular component in the treatment of the severe RA, which is reflected in Russian and International clinical guidelines (1,2). Despite the widespread use of these drugs, many patients do not adequately respond to the therapy. According to the clinical guidelines, the assessment of treatment effectiveness is carried out in RA within 3 to 6 months from the start of treatment (1,2). Treatment for GIBPs and JAK-i is expensive. The cost of drugs without consideration of the medical personnel services cost is on average RUB 700,000 - 1,000,000 per year. Prescribing GIBP and JAK-i therapy to patients who do not respond well to the proposed drugs lead to significant costs for the national healthcare system. Thus, the development of effective approaches to predicting the response of patients to drugs from the GIBD and JAK-i groups is urgent. The search for molecular predictors of treatment response before drug exposure is a part of personalized medicine purposed at substantiating the most effective treatment strategies for a particular patient at a given time. "Big data" summarizing clinical, biochemical clinical indicators (metadata) in combination with molecular proteomic and metabolic results are characterized by a high diagnostic and prognostic value, and can provide the choice of effective treatment strategy for a particular patient. Up to nowadays, there are no practical methods for predicting the response to treatment with drugs from the GIBD and JAK groups in the clinical practice of RA. In the present study, it is proposed to develop a new approach to identify patients with the insufficiently expressed immunomodulatory effects of drugs from the GIBP and JAK groups and to recommend replacing them with a drug from another group. It is planned to study the response of patients to the most widely used RA therapy in clinical practice: 1) GIBPs from the group of tumor necrosis factor inhibitors (TNF-i) and 2) JAK inhibitors (JAK-i). These groups of drugs differ in their mechanisms of action on the immune system and are characterized by different therapeutic targets. It is proposed to perform a dynamic scientific study of metabolomic-proteomic changes in blood samples from patients with RA with a follow-up period of 12 months. Monitoring of the molecular changes will be carried out within 7 temporary points of blood plasma sampling: before the appointment of treatment, after 2 weeks, and after 1, 3, 6, 9 and 12 months following the appointment of treatment. Two comparison groups will be investigated (GIBP from the TNF-i, and from the JAK-i group). Each comparison group will include 30 patients. Achievement/non-response to the treatment will be assessed using the CDAI index (≤10.0). Secondary evaluation points for the answer will be: 1. achieving remission of the disease according to the CDAI index (≤2.8); 2. achieving a low disease activity according to the DAS28-ESR index (≤3.2). 3. achievement of disease remission according to the DAS28-ESR index (≤2.6). 4. achievement of the minimum clinically significant improvement in the patient's function in daily life - a decrease in the HAQ index by ≥0.22 points. The proposed novelty of the project is to study the molecular basis of the development of the response in RA patients to immunomodulatory drugs with different mechanisms of action, to create a mathematical model for choosing patients who respond to therapy with drugs of a specific group using mathematical algorithms and neural networks. References 1. Nasonov E.L., Karateev D.E. Rheumatoid arthritis. In the book: Russian clinical guidelines. Rheumatology / Under. Ed. E. L. Nasonova - M .: GEOTAR-Media, 2020 .-- 448 p. - ISBN 978-5-9704-5398-8, p. 17-57. 2. G. Chatzidionysiou K., Dougados M., et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis. 2017; 76 (6): 960- 977.doi: 10.1136 / annrheumdis-2016-210715.
This randomized, double-blind, placebo-controlled trial will evaluate the impact of methylfolate, pyridoxal-5'-phosphate (P5P), and methylcobalamin supplementation on homocysteine and LDL-C levels in individuals with low to medium cardiac risk and MTHFR, MTR, and MTRR gene polymorphisms. The study aims to explore the efficacy of these vitamins in reducing homocysteine levels, a critical risk factor for cardiovascular disease (CVD), while also monitoring LDL-C levels. The findings will offer valuable insights into personalized CVD prevention and management, emphasizing the significance of genetic factors in nutritional therapy.
The primary aim of this single-center, prospective, randomized, controlled, pilot study is to test the hypothesis that inhalation of NO 200 ppm prevents the development of nosocomial pneumonia in patients at risk after cardiac surgery with CPB. The study is interventional. Examination and treatment of patients is carried out in accordance with the approved standards of medical care for the relevant diseases. During the study, no experimental or unregistered (not approved for use) medical or diagnostic procedures in the territory of the Russian Federation will be carried out. The study includes patients admitted to the Cardiac Surgery Department of Cardiology Research Institute of Tomsk National Research Medical Center for elective surgery with CPB.
In this study, 102 patients will be evenly randomized into two groups: one set to receive omega-3 fatty acids and the other a placebo. The process will be blinded, ensuring that neither the researchers nor the participants will know which group they are in. Each participant will take two capsules daily for a duration of 90 days, with the active group receiving capsules containing 1000 mg of fish oil each. All participants will be instructed to maintain their usual diet, lifestyle, and medication regimen. At the beginning and end of the study, various health assessments, including lipid panels and C-reactive protein measurements, will be conducted. Additionally, DNA samples will be collected for genotyping to identify patients with specific PPARG gene polymorphisms, leading to the creation of four distinct subgroups: those receiving omega-3 with and without polymorphisms, and those receiving placebo with and without polymorphisms.
The aim of the study is to assess the effect of oral foams on salivary pH changes after Coca-cola consumption in young adults.
Parallel-group, single-blinded controlled clinical trial. The study involved stroke patients (no more than 3 points on a scale Rankin) dived of the control group and experimental group. Control group received daily sessions of conventional physical therapy. In addition to the same conventional physical therapy treatment, the participants of the experimental group underwent repetitive upper limb Functional Proprioceptive Stimulations (FPS) sessions.
The integration of electrocardiography (ECG) functionality into smartwatches is primarily intended to screen for atrial fibrillation, a frequent cause of ischemic stroke, among people aged 50 years and older. However, it should be noted that recommendations for atrial fibrillation screening are controversial, and several organizations and communities do not recommend screening outside of at-risk groups. Some smart device manufacturers do not recommend using the ECG function for anyone under the age of 22. However, young people are frequent users of wearable devices. One of the most common cardiologic diseases at the age of 18-30 is benign heart rhythm disorder, which often does not require diagnosis or treatment and can be considered normal. That said, notification of the detection of atrial fibrillation can affect psycho-emotional well-being, particularly anxiety. This study will assess the level of psycho-emotional health (anxiety level) of the study participants. Participant observation will provide an opportunity to identify associations between the use of the ECG recording function on wearable devices and levels of anxiety and depression. It is hypothesized that the use of smartwatches with the ECG function activated will not lead to a change in anxiety levels on the GAD-7 scale among the study participants. This assumes that after 30 days of use, the mean value of the GAD-7 scale in the intervention group and the control group will be the same.