There are about 6461 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.
Influenza and other acute respiratory viral infections remain practically uncontrollable diseases due to the high variability of the antigenic structure of influenza viruses and the heterogeneity of pathogens of acute respiratory infections. Therefore, for the prevention and treatment of influenza, acute respiratory viral infections and herpes infections, it is relevant to develop drugs - immunomodulators that mobilize the reserves of nonspecific and specific immune systems and enhance the effects of these systems against the pathogens. The drug CYCLOFERON, 150 mg, enteric-coated tablets, contains the active substance meglumine acridone acetate, which is an interferon inducer. Interferons are the most important system of innate immunity, which has antiviral and immunomodulatory effects, and can protect the body from infection with a virus, and in case of infection, fight the causative agent of the disease. The planned clinical trial of the efficacy and safety of the drug CYCLOFERON in the dosage form of a tablet will study its ability to prevent influenza and other respiratory viral infections in adults who have already had close contact with patients with manifest disease.
This is a prospective case-control single center observational non-randomized study. It is carried out to evaluate the diagnostic accuracy of functional tests with physical load under the control of a 12-channel ECG together with analysis of the parameters of volatile organic compounds of the exhaled breath, and single-channel ECG data.
Hypotension is a significant precursor to unfavorable clinical outcomes. To determine whether infusion therapy can positively impact the management of hypotension, several evaluative tests can be utilized. These include assessing the collapsibility and distensibility indices of the inferior vena cava, conducting a passive leg raising (PLR) test, and performing a fluid challenge (FC). Technologically advanced methods leveraging dynamic testing are capable of real-time prediction of a patient's response to infusion therapy. Nonetheless, the use of systolic pressure variability (SPV), pulse pressure variability (PPV), and stroke volume variability (SVV) is often limited by the prohibitive costs of the necessary equipment. In contrast, the PLR test and FC are not subject to this limitation. Despite being deemed unreliable by numerous clinical protocols, static measurements of central venous pressure (CVP) or pulmonary capillary wedge pressure (PCWP) persist in usage among certain traditionalists within the medical community. It must be noted that the patient's baseline state and the unique clinical context are pivotal in determining the precision of these methodologies. For example, the PLR test may yield limited information in fully conscious patients, and the prognostic value of CVP measurements is significantly diminished in cases of pneumothorax and hydrothorax. Regrettably, there is a paucity of data on the prognostic utility of these tests in patients with altered levels of consciousness, despite their growing presence in intensive care units. This gap underscores the necessity for comprehensive studies that evaluate the predictive efficacy of infusion therapy responsiveness in patients with concurrent hypotension and impaired consciousness. Purpose of the study: to investigate the sensitivity and specificity of methods for assessing fluid responsiveness in patients with hypotension and decreased level of consciousness.
Postoperative pulmonary complications (PPC) are a common problem in patients undergoing surgery using one-lung invasive ventilation. Major pulmonary complications such as atelectasis, bronchospasm, and pneumonia can lead to respiratory failure. PPC are the main cause of mortality in the postoperative period in patients after thoracic surgery. The study aimed to compare the effectiveness of using a mechanical insufflator-exsufflator after video-assisted thoracoscopic surgery using one-lung ventilation to reduce postoperative pulmonary complications as compared to standard therapy.
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.
Evaluation effectiveness and safety of TMS in subjects with catatonia
Treatment of reticular veins with a 1064 nm long-pulsed Nd:YAG laser and combination of a 1064 nm Nd:YAG long pulse laser and sclerotherapy should be no less effective than sclerotherapy alone, and have a frequency of adverse events less then sclerotherapy alone.
The study is planned to evaluate the effectiveness and safety of two types of anesthesia (regional and general) for carotid endarterectomy in 100 patients with acute stage of stroke: 50 patients will be operated under regional anesthesia and the remaining 50 patients under general anesthesia. Patient inclusion criteria: 1. Ischemic stroke in the middle cerebral artery territory 2. Ipsilateral stenosis of the internal carotid artery more than 50% 3. Neurological deficit at the time of surgical treatment: the modified Rankin scale (mRs) score of 0-4 and the US National Institutes of Health (NIHSS) stroke scale score no more than 12 4. The size of the ischemia focus: no more than 1/3 in the territory of the middle cerebral artery brain supply 5. Terms of operation: from 1 to 28 days from the moment of ischemic stroke The primary intra-hospital and/or 30-day study endpoints: 1. Perioperative ipsilateral ischemic stroke. 2. Any stroke: contralateral ischemic or any hemorrhagic stroke. 3. Myocardial infarction. 4. Hemorrhagic complications that required surgical revision of the operating wound or transfusion of blood components. 5. Surgical site infection 6. Death 7. Main adverse cardiovascular events (stroke + myocardial infarction + death).
Aim of study is to investigate the optimal duration and daily regimen of compression treatment in patients with chronic venous disease
This study will compare results of different intestinal decompression techniques in patients with small bowel obstruction.