Bryansk

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are evaluating the effectiveness and safety of Vespireit, prolonged-release tablets (15 mg), compared to Arlevert tablets (40 mg + 20 mg) in patients who have autonomic dysfunction syndrome along with functional vertigo. This Phase 4 trial focuses on adults aged 18 to 65 diagnosed with these conditions. The study addresses chronic functional vertigo symptoms measured by specific scoring systems and aims to provide new insights into treatment options for this population. Participants will be randomly assigned to receive either Vespireit, containing buspirone, or Arlevert, containing dimenhydrinate and cinnarizine. The study medication will be administered during an initial treatment phase lasting 28 days, with precise timing of visits and evaluations. Both drugs are oral tablets, and the comparison includes monitoring the response to therapy over this period. During the study, participants will undergo various assessments including measurement of vertigo scores to track changes from baseline. Safety and efficacy will be closely monitored through scheduled visits, with attention to any adverse events or therapy effectiveness. The primary outcome is the change in mean vertigo score from the start to the end of the initial treatment phase. Participants will be observed and evaluated throughout the treatment period with follow-up as needed, ensuring comprehensive data collection on treatment impact and safety.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy (aromatase inhibitors with or without GnRH agonists) in patients with hormone receptor-positive, HER2-negative stage II-III breast cancer in Russia. The study includes both a prospective cohort receiving ribociclib plus hormone therapy and a retrospective cohort treated with hormone therapy alone. The goal is to assess treatment outcomes in different patient subgroups defined by tumor grade, lymph node involvement, and hormone therapy response. Participants in the prospective group receive ribociclib alongside aromatase inhibitors, with or without GnRH agonists, as part of their adjuvant therapy. The retrospective group includes patients treated with aromatase inhibitors alone during a specific period from July 2019 to July 2020. The study collects new data from the prospective group while also analyzing existing patient records from the retrospective group. Throughout the study, researchers monitor invasive breast cancer-free survival at 36, 48, and 60 months following treatment according to standardized criteria. Patient information is gathered from clinical records, including hormone therapy start dates and treatment responses. Safety and effectiveness are assessed by tracking outcomes over several years to better understand ribociclib's role in routine clinical practice for this type of breast cancer.