Voronez

Researchers are conducting an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

Researchers are evaluating Raphamin in adults aged 18 to 64 years who have acute bronchitis symptoms lasting less than 72 hours. This randomized, double-blind, placebo-controlled phase 3 trial aims to determine if Raphamin can speed up symptom resolution, reduce disease severity, and prevent complications requiring antibiotics compared to placebo. The study includes both men and women during the seasonal period of acute respiratory viral infections. Participants are randomly assigned to receive either Raphamin or a placebo following a specific oral dosing schedule for 5 days. On the first day, participants take 8 tablets of Raphamin or placebo one tablet every 30 minutes for the first 2 hours total of 5 tablets, then one tablet three times spaced evenly throughout the day. From day 2 onwards, one tablet is taken three times daily. The study uses an electronic patient diary to record daily symptoms, and face-to-face visits are scheduled on days 1, 4, and 7, with a phone visit on day 14. Throughout the study, participants undergo physical exams, vital sign monitoring, pulse oximetry, and laboratory tests including blood counts and PCR for respiratory viruses. Symptom severity is assessed by the Bronchitis Severity Scale and the Integrative Medicine Outcome Scale. Quality of life is evaluated using the EQ-5D instrument. Safety is monitored through recording adverse events and any use of antibacterial medications or hospitalizations. The total duration of participation includes treatment and follow-up over 14 days.

Researchers are studying uncontrolled asthma in adults across Russia to better understand its characteristics and treatment patterns. This large-scale observational registry will include 9,000 patients from 70 outpatient centers in about 50 regions, focusing on those not receiving biologic therapy. The study aims to describe demographic and clinical features, capture complications and comorbidities, and evaluate routine therapies used in real practice. The study has an ambispective design with two main visits. At the first visit, physicians will collect baseline data from the past 52 weeks using medical records and patient interviews. The second visit, conducted 12 weeks later, will gather follow-up information on treatment changes and clinical outcomes. A subgroup of 500 patients using fixed-dose combination budesonidesalbutamol will have an additional third visit 12 weeks after the second to collect further data. Participants will undergo routine clinical assessments during 2 to 3 visits following standard practice. Researchers will examine demographic and clinical data, blood and sputum eosinophil counts, total IgE levels, asthma control status, lung function tests, exacerbation rates, and healthcare resource use. Safety monitoring aligns with routine care, and the study does not involve any experimental treatments or procedures. Total participation spans approximately 24 weeks for those in the extended follow-up group.

The trial investigates the safety and effectiveness of olokizumab compared to a placebo in adults with progressive fibrosing interstitial lung diseases ILD. This phase 23 study uses a double-blind, parallel-group adaptive design to better understand treatment impacts on lung function over time. Participants have progressive fibrosing ILD confirmed by imaging and lung function tests, with disease progression documented within the prior months or years. Participants will be randomly assigned to receive either subcutaneous injections of olokizumab 64 mg or placebo every four weeks during a 48-week treatment period. The study includes a screening period lasting four weeks, followed by a treatment period of 48 weeks, and then a follow-up period of 24 weeks with visits scheduled at 4, 12, and 24 weeks post-treatment. The total duration of participation is approximately 76 weeks. Throughout the study, patients will undergo lung function tests including forced vital capacity FVC and diffusion capacity for carbon monoxide DLCO, as well as imaging assessments to evaluate lung fibrosis. Researchers will monitor symptoms, lung function changes, and quality of life measures using dyspnea scores and health questionnaires. Safety will be closely observed during treatment and follow-up visits, with the main outcome focused on changes in FVC over 48 weeks.

Researchers are studying how surgical treatment for chronic aortic regurgitation affects the hearts left ventricle, especially when combined with correction of functional mitral regurgitation. The study focuses on patients with severe enlargement of the left heart chambers. It aims to assess how mitral regurgitation influences the recovery and remodeling of the left ventricle after surgery, using echocardiography and quality of life measures. Participants are grouped based on the severity of their mitral regurgitation and whether they receive mitral valve repair during surgery. The groups include patients with mild to moderate mitral regurgitation without repair, severe mitral regurgitation without repair, mild to moderate mitral regurgitation with repair, and severe mitral regurgitation with repair. This observational study does not involve additional treatments but monitors outcomes over time. Throughout the study, participants will have their left ventricle volume and function evaluated by echocardiography at 3 and 12 months after surgery. Researchers will also track hospital readmissions within 12 months and assess quality of life at inclusion, 10 days post-surgery, and at 3 and 12 months. The study is sponsored by the Petrovsky National Research Centre of Surgery and will continue until May 2030.

Researchers are evaluating how Lipoproteina Lpa levels vary among patients with Atherosclerotic Cardiovascular Disease ASCVD in Russia and investigating the relationship between elevated Lpa levels and cardiovascular disease risk. The study aims to better understand the distribution of Lpa and its connection to cardiovascular events in this population. The study includes several phases Phase I is a cross-sectional study measuring Lpa levels in ASCVD patients aged 18 and older. Phase II involves a non-interventional, prospective cohort study with these patients and their first-degree relatives, including parents and children with elevated Lpa levels. The study observes patients and relatives over time without altering their treatments. Participants will undergo assessments to measure Lpa levels and cardiovascular events at baseline and during follow-up visits up to 24 months. Researchers will collect clinical data, including disability status, cardiovascular events, hospitalizations, and lipid-lowering therapy usage. The study monitors the percentage of patients with elevated Lpa, occurrence of cardiovascular complications, and treatment outcomes to understand the impact of Lpa levels on ASCVD progression and related health events.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.

Researchers are studying the pharmacokinetics, safety, and long-term effectiveness of olokizumab in children and adolescents aged over 2 and under 18 years who have polyarticular juvenile idiopathic arthritis. This open-label, multicenter study aims to understand how the drug behaves in the body, its effects, and its safety over an extended period. Participants receive subcutaneous injections of olokizumab every 4 weeks, with doses of either 64 mg or 48 mg depending on body weight. The study includes a screening period up to 2 weeks, a main treatment period of 24 weeks, an extended treatment phase lasting up to week 164, and a safety follow-up lasting 22 weeks. The total participation time is about 188 weeks. During the study, participants will undergo assessments of drug concentration levels and response at various timepoints. Researchers will monitor joint activity, inflammation markers like C-reactive protein, and safety measures through laboratory tests. Outcome measures include maximum drug concentration and area under the concentration-time curve over 24 weeks. The study also tracks long-term safety and efficacy with regular evaluations throughout treatment and follow-up.