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Found 3 Actively Recruiting clinical trials
Actively Recruiting
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.
Actively Recruiting
Researchers are studying how Lipoprotein(a) (Lp(a)) levels are distributed among patients in Russia with Atherosclerotic Cardiovascular Disease (ASCVD) and examining the link between high Lp(a) levels and the risk of cardiovascular disease. The study includes patients with a history of heart attacks, strokes, or other vascular conditions to better understand this relationship. The study has several phases. Phase I involves a cross-sectional study measuring Lp(a) levels in ASCVD patients. Phase II includes a non-interventional, prospective cohort study following the same patients, along with cross-sectional and cohort studies involving their relatives. Various drugs including statins (Atorvastatin, Simvastatin, Rozuvastatin), Ezetimibe, Niacin, fibrates (Ciprofibrate, Fenofibrate, Bezafibrate), PCSK9 inhibitors (Evolocumab, Alirocumab), and small interfering RNA (Inclisiran) are monitored as part of the research. Participants will undergo assessments of their Lp(a) levels and cardiovascular events over 24 months. Researchers will track the percentage of patients with Lp(a) levels above a specific threshold and compare cardiovascular event rates between groups. The study also involves collecting medical history and monitoring safety. The total participation duration includes initial screening and follow-up periods as outlined in the study phases.
Actively Recruiting
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.