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.
This study will be a non-interventional prospective study. Assessment of parameters will be carried out as if the patient is treated in a real-life clinical setting. The patients should be enrolled into this project after evaluation of eligibility criteria by the investigator in clinical sites who have an experience in management of patients with SLE. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. The purpose of this study is to estimate prevalence of confirmed SLE in patients in rheumatological settings who has the reproductive issues and certain clinical and laboratory manifestations specific for immunoinflammatory diseases in Russia. We will follow all the local regulatory requirements regarding adverse event reporting (pharmacovigilance). It is planned to enrol 2000 patients in clinical sites in Russian Federation (N ≤ 15). The study will include two visits. During the screening visit women who meet the inclusion/non-inclusion criteria will be offered to participate and sign the informed consent form (ICF). Initial patient's data input will be done retrospectively (case report forms [CRF] will be filled in, a patient's visit will be conducted in accordance with the routine practice and healthcare professionals (HCPs) recommendations on an individual basis). An experienced rheumatologist will collect the baseline patient's characteristics such as demographic data, clinical profile, detailed obstetric/reproductive history. Women who had pregnancies in the past will be asked about the course of all pregnancies and their outcomes. Women will be asked to provide the corresponding medical records or discharge summaries, if possible, in order to input the data from them into the CRFs (the documents will be given back to women at the same visit). The immunologic blood test will be conducted in the reference laboratory. According to clinical examination and laboratory test results (ANA, immunoassay for specific antibodies (anti-Sm, and-dsDNA), antiphospholipid antibodies (anticardiolipin antibodies, anti-β3GP1 antibodies, lupus anticoagulant, complement components C3, C4, etc.) SLE diagnosis will be made or rejected. One follow-up visit will be conducted for those women who were referred to a laboratory testing for SLE. The visit will include the laboratory analyses assessment by an experienced rheumatologist with a subsequent confirmation or rejection of the SLE diagnosis. The last date of enrolment - Dec 2023. Last patient last visit (approximately 4 months from the study start): patient's data input will be done for enrolled patients.
The study attempts to quantify the relative risks for mortality, anastomotic leakage and other early and late postoperative complications, recurrence rate, cancer-specific survival, recurrence-free survival after colorectal surgery for patients with colorectal cancer depending on the localization of the tumor.
An interventional prospective randomised clinical trial (RCT) in parallel groups is planned. The sample size was 30 patients who will be randomly divided into two groups based on the surgical procedure. The first group is the healing of the donor zone after SCTG harvesting without filling the wound with collagen matrix. The second group is the wound defect closure in the donor area using the collagen matrix "FibroMATRIX" (LLC "Cardioplant", Russia; registration in Russia 20/05/2019 No FSZ 2019/83671). Changes in volumetric parameters of the maxillary tuberosity area after CTG harvesting, severity of pain, postoperative edema, bleeding, analgesic intake and quality of life in the postoperative period will be assessed.
The goal of this open, prospective, multicenter study is analyze long-term outcomes of aortic/mitral valve replacement using the "UniLine" bioprosthesis in patients with acquired aortic or mitral valve diseases. Main research objectives: To analyze long-term (up to 12 years) outcome of aortic or mitral valve replacement using the "UniLine" bioprosthesis. To study the hemodynamic characteristics of normally functioning "UniLine " prostheses in the mitral or aortic valve position based on the transthoracic echocardiography data. To assess the number, type, time frames of dysfunctions of UniLine bioprostheses and the results of their treatment. To analyze the frequency of major serious adverse events associated with the "UniLine" bioprosthesis or procedure.
The Impact of the "Stone MD" Mobile App on the Prevention of Forgotten Ureteral Stents
The frequency of women presenting with a combination of uterine fibroids and pregnancy is in-creasing nowadays. Uterine fibroids in pregnancy are an unfavorable condition in themselves and being reactive to hormonal stimuli, tending to grow, can generate symptoms of different lev-els of severity. Obstetrics and gynecologists are increasingly faced with the problem of clarifying the management tactics of pregnant patients with symptomatic fibroids, who may see their preg-nancy put at risk by these masses.
MABPS-3/2020 is a double-blind randomized multicenter clinical trial comparing efficacy, immunogenicity and safety profiles of Adalimumab (manufactured by Mabscale, LLC) compared to Humira®. The purpose of the study is to demonstrate efficacy, immunogenicity and safety of Adalimumab (manufactured by Mabscale, LLC) to Humira ® in adult patients with chronic plaque psoriasis of moderate and severe degree.
The goal of this multicenter prospective cohort study is to evaluate the long-term safety and efficacy of clinical outcomes of aortic valve replacement using the "TiAra" prosthesis with or without concomitant procedures. Main research objectives: 1. To analyze the short and mid-term (up to 3 years) outcome of aortic valve replacement using the "TiAra" prosthesis. 2. To study the hemodynamic characteristics of normally functioning "TiAra" prostheses in the aortic position, as well as the condition of the heart chambers in short and long-term period (up to 10 years) after the implantation. 3. To assess complications of the early and mid-term follow-up periods of aortic valve replacement using the "TiAra" prosthesis. This study does not presuppose implementation of comparison groups.
At the moment, the invasive strategy for the infarct-associated coronary artery in patients with ST-segment elevation myocardial infarction (STEMI) necessary to save the myocardium and reduce the size of the necrosis zone remains the leading one. However, despite the high efficiency of providing medical care to patients with acute coronary syndrome (ACS), there remains a high mortality and disability of this group of patients. In this regard, the search for new drug and non-drug strategies for the treatment of patients with ACS is actively continuing. Over the past decade, it has been shown that transcutaneous vagus nerve stimulation (TENS) has a cardioprotective effect both in chronic heart failure and in coronary heart disease, improves cardiac function, prevents reperfusion injury, weakens myocardial remodeling, increases the effectiveness of defibrillation and reduces the size of a heart attack. One of the methods of noninvasive stimulation of the afferent fibers of the vagus nerve is percutaneous electrical stimulation of the auricular branch of the vagus nerve. However, further studies are needed to determine whether stimulation of the tragus can improve the long-term clinical outcome in this cohort of patients.
In the prospective part of the study, patients diagnosed with PID will receive replacement therapy with Cutaquig for at least 6 months and will be randomised with the help of physicians of the Russian PID Registry. At the beginning of the study, data on the prior intravenous immunoglobulin (IVIG) therapy efficacy will be extracted from patients' medical records (retrospective part of study). Also, at the beginning of the study, patients or their parents will be asked to complete Quality of Life Questionnaire for children, version 4.0; short form in Russian - Pediatric Quality of Life Inventory Russian, Version 4.0 (Russia), PedSQL (Appendix 14.1). During the 6 months of treatment with Cutaquig, investigators will enter information on infectious episodes, IgG levels (at least 3 times during the study period), and definition of an adverse drug reaction / serious adverse drug reaction, in the database. After 6 months, patients/their parents will be asked to complete the PedSQL, Quality of Life Questionnaire again. If the patient continues to receive the drug, and patient and his/her legally acceptable representatives (for patients under 14 years of age) agree to continue participating in the study, similar information will be collected for another 6 months. The first 6 months are planned for the main study period, 6-12 months for an extended study period. Data obtained in the prospective phase of the study will be compared with similar data obtained in the retrospective phase in the same patients