Voronez

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 olokizumab (OKZ) compared to a placebo in patients with progressive fibrosing interstitial lung diseases (ILD). This phase 2/3 study uses a double-blind, parallel-group, adaptive design to assess treatment impact on lung function. Progressive fibrosing ILD is confirmed by imaging and lung function tests, with disease progression criteria including declines in lung capacity and worsening symptoms. Participants will receive subcutaneous injections of either 64 mg olokizumab or placebo every 4 weeks during a 48-week double-blind treatment period. The study begins with a 4-week screening period before treatment starts. After completing treatment, all participants enter a 24-week follow-up phase with visits at weeks 52, 60, and 72 to monitor ongoing effects and safety. Throughout the study, patients will undergo lung function tests, imaging reviews, and assessments of respiratory symptoms. Researchers will measure changes in forced vital capacity (FVC) over 48 weeks as the primary outcome. Safety and adverse events will be monitored during treatment and follow-up. The total participation time is about 76 weeks, including screening, treatment, and follow-up periods.

Researchers are evaluating how surgical correction for functional mitral regurgitation during surgery for chronic aortic regurgitation affects the recovery and remodeling of the left ventricle (LV) in patients with severe enlargement of the heart chambers. The study explores the idea that functional mitral regurgitation may cause extra volume overload in the left ventricle, which might help improve LV volume and function in the early postoperative period. The focus is on monitoring LV volume, and systolic and diastolic function through echocardiography, as well as assessing the quality of life in patients with varying degrees of functional mitral regurgitation related to severe chronic aortic insufficiency after surgery. This is an observational study with no active treatment given to participants. The study tracks patients who undergo primary elective surgery for chronic aortic regurgitation with concurrent functional mitral regurgitation and a left ventricular end-diastolic volume of 250 ml or more. The study observes how the LV remodels after the surgical treatment without introducing additional interventions. Participants will be monitored using echocardiography to measure changes in left ventricular end-diastolic volume at 3 and 12 months after surgery. The study also tracks freedom from hospital readmission within 12 months post-surgery. Researchers will evaluate heart function, volume changes, and patient quality of life throughout the follow-up period to understand the effects of surgery on heart remodeling and recovery.

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.

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.

Stroke continues to be a major healthcare challenge, especially due to its high death rate within the first year after occurrence. There has been an increase in stroke cases among younger adults over the past decade, with about one-third of patients being of working age. Unfortunately, only 15-20% of these patients return to work, while the rest require ongoing medical and social support due to disability. This study examines the use of Cytoflavin, a drug provided through intravenous infusion, in patients who have had an ischemic stroke but are not receiving reperfusion therapy such as thrombolysis or thrombus extraction. Patients in this study receive Cytoflavin infusions dosed between 20 to 40 ml per day, delivered over 10 days. The infusion involves 10 ml doses given every 8 to 12 hours, with the possibility of increasing to 20 ml per dose for severe cases. The drug is diluted in sodium chloride solution and administered at a rate of 3 to 4 ml per minute. The study observes patients treated with Cytoflavin or other neuroprotective treatments for at least 10 days as part of routine clinical care. Participants undergo assessments of their neurological function using scales such as the Modified Rankin Scale and the NIH Stroke Scale at several points: baseline, day 14, day 21, and day 90. The main outcome measured is the percentage of patients who achieve a favorable functional outcome by the day of hospital discharge and again at 90 days post-stroke. The study also monitors safety and effectiveness during this period, capturing data on recovery and disability progression throughout the follow-up.

Researchers are evaluating the pharmacokinetics, pharmacodynamics, long-term efficacy, and safety of olokizumab in children and adolescents aged over 2 and under 18 years with polyarticular juvenile idiopathic arthritis. This open-label, multicenter Phase 2 study aims to better understand how olokizumab behaves in the body and its effects in this young patient population. Participants receive subcutaneous injections of olokizumab every 4 weeks, with doses adjusted by weight (either 64 mg or 48 mg). The study includes a screening period of up to 2 weeks, followed by 24 weeks of open-label treatment, then an extended open-label treatment period lasting up to 140 weeks, and finally a safety follow-up period of 22 weeks. The total study duration for participants is approximately 188 weeks. During the study, up to 50 patients will be closely monitored through scheduled visits and assessments. Researchers will measure olokizumab concentration levels in the blood, track clinical outcomes, and evaluate safety throughout the treatment and follow-up periods. They will also assess disease activity, laboratory tests, and adverse events to gather comprehensive data on the medication's performance and participant health over time.

Researchers are evaluating the rate of chronic kidney disease (CKD) diagnosis in adults with arterial hypertension (AH) who have laboratory markers indicating possible CKD but no prior recorded CKD diagnosis. The study focuses on patients without diabetes mellitus or symptomatic chronic heart failure and aims to better understand CKD prevalence in this specific population in Russia. This multi-center, non-interventional, observational study includes both prospective and retrospective data analysis involving about 10,000 adult outpatients from approximately 50 outpatient sites across 20 regions of Russia. The study will not involve any new diagnostic or treatment procedures beyond routine clinical practice. Retrospective data will be collected from medical records to identify CKD markers measured within 12 months before study inclusion. Patients with adequate retrospective data may have CKD diagnosis confirmed based on two evaluations at least 3 months apart. Those without sufficient retrospective data will undergo laboratory testing during the prospective study period, which will last up to 18 months or until data from 10,000 patients are collected. Participants will be monitored and treated by cardiologists or internal medicine specialists during routine visits. Researchers will collect demographic and clinical information, including medical history and CKD markers, from both retrospective and prospective records. The main outcome is the rate of new CKD diagnoses over the 18-month follow-up. No additional interventions or procedures beyond usual care will be performed, and the study aims to support earlier CKD detection and improved clinical outcomes in patients with hypertension.