Vladivostok

Researchers are conducting a national, multi-center, prospective study to collect real-world data on patients in the Russian Federation with advanced and aggressive endometrial cancer, specifically stage III-IV disease. The study focuses on molecular profiling markers such as POLE mutations, dMMRpMMR, p53 abnormalities, HER2 expression, and PD-L1 status, alongside demographic and clinical characteristics. It aims to understand first-line postoperative treatment approaches in these patients. The study involves no additional procedures beyond routine clinical practice. Patients provide archival tumor tissue samples obtained from biopsy or post-operative formalin-fixed paraffin-embedded FFPE blocks for molecular testing. Testing uses immunohistochemistry IHC for certain markers and next-generation sequencing NGS or polymerase chain reaction PCR for POLE mutations. Data will be collected at two visits a baseline visit to gather clinical and demographic information and tissue testing results, and a final visit 6 months later or at disease progression to collect follow-up treatment and progression data. Participants data and outcomes will be recorded in an electronic case report form. The study measures include rates of positive molecular markers and various clinical and treatment-related outcomes over 24 to 33 months. Approximately 500 patients will be enrolled across about 30 sites. The overall study duration is about 27 months or until data collection for all patients is complete.

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 the efficacy, safety, pharmacokinetics, pharmacodynamics, and immunogenicity of the study drug BCD-261 in patients with moderate to severe active Crohns Disease. This study involves adult men and women aged 18 to 75 years who have had an inadequate response to previous treatments such as glucocorticoids, immunosuppressants, or biologics. The trial is designed to better understand the dose-response relationship of BCD-261 compared to a placebo in this patient group. Participants are randomly assigned to one of five groups receiving different dosing regimens of BCD-261 or placebo. Four groups receive varying doses of BCD-261 low, medium, high during induction weeks 0-12 and maintenance phases, with some groups transitioning between doses. The fifth group receives placebo until the primary endpoint assessment at week 14, after which they switch to the medium dose of BCD-261. During the study, participants will be closely monitored for clinical remission and endoscopic response at week 14, with additional remission assessments at week 24. The study includes comprehensive evaluations such as safety monitoring and pharmacokinetic and pharmacodynamic assessments. Participants will be involved throughout the induction and maintenance periods with scheduled visits and assessments to track treatment effects and safety over time.

This research aims to understand brain network problems and how they recover during rehabilitation with spinal cord stimulation SCS in people with spinal cord injuries. It focuses on recording resting-state EEG to track brain function changes and explore how brain neuroplasticity plays a role when effective SCS programs are used with implanted electrodes. The study includes participants with either partial or complete spinal cord injuries at various levels. Participants first have resting-state EEG recordings before and after implanting multichannel electrodes into the epidural space below the injury. The spinal cord stimulator is then activated, and optimal stimulation programs are selected to either reduce spasticity or improve voluntary muscle control. Throughout the rehabilitation, EEG recordings are taken before, during, and after stimulation, including a final recording before discharge. The stimulation parameters are adjusted systematically over about two weeks to maximize effectiveness and comfort. During the study, participants follow motor imagery exercises imagining and then performing limb movements while EEG is recorded with the stimulator both off and on. Researchers monitor changes in EEG rhythms and connectivity, focusing on measures like mu rhythm desynchronization. The study also uses clinical scales for neurological function and quality of life at baseline. Postoperative monitoring continues for up to two weeks to ensure safety and track progress. The collected data aims to improve rehabilitation strategies and personalize recovery after spinal cord injury.

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.

Researchers are evaluating postoperative pain relief methods in patients undergoing coronary artery bypass grafting CABG. This clinical trial compares the effects of tafalgin tyrosyl-D-arginyl-phenylalanyl-glycine amide with morphine to see if tafalgin reduces pain scores similarly to morphine. The study also monitors the medical problems participants may experience while using tafalgin. This trial is interventional and randomized with a single-blind design. Participants are assigned to one of two groups one group receives a single subcutaneous dose of morphine 10 mg based on a pain score greater than 3 within 24 hours after CABG. The other group receives a single subcutaneous dose of tafalgin 0.4 mg under the same pain score condition and timeframe. The trial focuses on early postoperative pain control in the first 24 hours after surgery. During the study, researchers assess pain using the Visual Analogue Scale VAS 24 hours after CABG. They also evaluate arterial blood gases, including pH, oxygen levels PaO2, and carbon dioxide levels PaCO2, as well as hemodynamic parameters like intra-arterial blood pressure and heart rate. Participants are monitored closely for safety and efficacy during this period. The study is scheduled to start in December 2025 and continue until March 2026.

Researchers are studying pain management in patients undergoing cardiac surgery, specifically focusing on the use of intrapleural analgesia with ropivacaine. This method involves delivering local anesthetics directly into the pleural cavity through drainage tubes placed after surgery. The study aims to evaluate whether ropivacaine improves the quality of recovery from anesthesia compared to a placebo, especially when traditional pain treatments might pose risks. Participants will receive either 0.2% ropivacaine or a 0.9% sodium chloride placebo infused into the pleural cavity during surgery before closing the chest bone. The infusion starts at 10 ml per hour and continues through a microcatheter placed in the pleural cavity. This randomized, double-blind, placebo-controlled trial monitors patients after surgery to compare these treatments. During the study, participants will be assessed for their recovery quality 24 hours after surgery using the QoR15 questionnaire. Additional measures include oxygenation levels at 6, 12, and 24 hours, morphine use within 24 hours, and pain levels at multiple time points up to 48 hours after surgery. Safety and response to treatment will be closely monitored throughout the recovery period.

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 conducting a national multicenter observational study to develop a Russian national calculator for predicting the risk of postoperative complications and mortality. The study focuses on adult patients undergoing elective and emergency surgeries in various surgical fields including obstetrics, gynecology, urology, orthopedics, and more. The aim is to identify risk factors that lead to unfavorable postoperative outcomes and to create a comprehensive database for better understanding and prediction of surgical risks. The study includes two cohorts Cohort A will assess the incidence of primary outcomes such as 30-day mortality and complications, and Cohort B will identify risk factors and develop a risk calculator validated across different surgical specialties. Data collection involves filling out basic and additional checklists quarterly across centers to capture detailed surgical and postoperative information. The study period spans from 2024 to 2028 with monitoring of outcomes up to one year after surgery. Participants will be followed for various outcomes including 30-day and 90-day mortality and complications, length of stay in intensive care and hospital, multiple organ failure, ICU syndrome, readmission rates, and one-year mortality. Researchers will analyze long-term results and the influence of factors such as anesthesia type, urgency of surgery, age, comorbidities, and oncological conditions. The study is organized by the Russian Federation of Anesthesiologists and Reanimatologists and aims to improve postoperative care through validated risk assessment tools integrated into a national calculator.