Tyumen

This research aims to provide continued access to study treatments for participants with pulmonary hypertension who have completed previous clinical studies but have no other way to receive these treatments. It focuses on assessing the long-term safety of the study drugs macitentan, selexipag, and a fixed dose combination of macitentan and tadalafil. The study is designed for participants who benefited from these treatments during parent studies and have no alternative approved therapies available. Participants will continue receiving oral study drugs macitentan once daily with doses adjusted for children by weight, selexipag twice daily with dosing based on previous maintenance dose and body weight for children, or a fixed dose combination of macitentan and tadalafil once daily. Adults will have study visits every six months, while pediatric participants will have visits every three months. These visits will collect information on the treatments safety and effectiveness until the participant stops treatment, the drug becomes commercially available, or the study ends prematurely. During the study, participants will undergo regular assessments to monitor safety, including tracking treatment-emergent adverse events, serious adverse events, events leading to discontinuation, and deaths for up to 84 months. Visits will include collecting efficacy and safety data to ensure ongoing monitoring. The overall participation duration may extend for several years, allowing careful observation of long-term effects and safety of these treatments in people with pulmonary hypertension.

Researchers are studying aggressive high-volume metastatic hormone-sensitive prostate cancer mHSPC in male patients in the Russian Federation. This observational study focuses on treatment patterns and the evaluation of homologous recombination repair mutations HRRm in circulating tumor DNA ctDNA. The study aims to better understand demographic and clinical characteristics along with how patients with different HRR gene statuses are treated. The study enrolls about 400 male patients with high-aggressive Gleason 8-10 and high-volume mHSPC who have known tumor HRRm status from routine tumor samples. No additional procedures beyond routine clinical care are performed. Data are collected during two visits a baseline visit where medical history and treatment approaches since diagnosis are recorded, and a final visit at disease progression or after about 12 months to gather follow-up treatment and progression information. Blood samples for ctDNA and HRRm testing are collected from routine blood draws and analyzed centrally. Participants contribute data through medical record reviews and, if needed, patient interviews. Researchers collect information on treatments received, disease progression, lab tests, and mutation presence. The study evaluates various outcomes including treatment proportions, therapy durations, progression times, and mutation rates over 36 months. Data are entered into electronic forms, and follow-up may occur by phone if in-person visits are not possible. The total study duration is about 38 months or until all data are collected.

Researchers are evaluating the dietary supplement Gepaktiv compared to standard medications ursodeoxycholic acid UDCA and ademetionine in adults with metabolic-associated fatty liver disease MAFLD and liver enlargement hepatomegaly. The study aims to determine if Gepaktiv can improve liver function and reduce liver size and fat accumulation as effectively as these established treatments. This is a randomized, open-label study involving 90 patients. Participants will be randomly assigned to one of three groups Gepaktiv taken as 2 capsules three times daily before meals UDCA dosed at 10-15 mgkgday or ademetionine at 800-1600 mgday. The treatment period lasts 15 days, with an optional 60-day follow-up to observe longer-term effects. Doctors will monitor liver health using blood tests, ultrasound scans, and FibroScan to assess liver enzymes, size, and fat or fibrosis levels. During the study, patients will provide daily diaries to track treatment adherence. Evaluations include blood tests for liver enzymes ALT, AST, GGT, bilirubin, lipid profile, albumin, protein levels, and quality of life questionnaires. Ultrasound and FibroScan will be performed by blinded assessors following standardized protocols. The main outcomes measured are a 30% or greater reduction in ALT, liver size decrease, and improvement in liver fat and fibrosis after 15 days, with additional follow-up assessments if participants continue. The total participation duration may extend up to 75 days including follow-up.

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.

This research evaluates the long-term safety and effectiveness of pembrolizumab in participants with advanced tumors or hematologic malignancies who have previously taken part in Merck pembrolizumab-based studies. This phase 3 extension study includes participants currently on treatment or in follow-up from parent trials. The study has three phases based on participants prior treatment status First Course Phase, Survival Follow-up Phase, and Second Course Phase, allowing continuation or observation depending on prior participation. Participants receive pembrolizumab alone or combined with other treatments such as standard of care therapies, lenvatinib, olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Dosing schedules vary by phase and regimen, including intravenous infusions of pembrolizumab every 3 or 6 weeks, oral lenvatinib capsules daily, oral olaparib tablets twice daily, and other biologics administered intravenously or subcutaneously. The study allows up to 35 doses in the First Course Phase and fewer doses in the Second Course Phase, with treatment durations adjusted for crossover eligibility and combination therapies. Participants are monitored through regular treatment visits involving drug administration and follow-up assessments. Researchers evaluate overall survival up to approximately 10 years, along with progression-free survival, event-free survival, and adverse events including serious and clinically significant side effects. The study includes ongoing safety monitoring up to around 40 months post-treatment. Participants remain under observation for long-term outcomes and potential treatment effects for many years after enrollment.

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 quality of primary health care for patients with arterial hypertension, a common condition that significantly impacts population health and mortality. This observational study uses data from a cardiovascular disease registry to analyze how well medical care aligns with current clinical recommendations. The research aims to identify trends and improve treatment approaches for patients with hypertension, including secondary forms. The study collects medical data through a computerized arterial hypertension registry with remote access, allowing online entry of patient information from outpatient records. Doctors received training to reduce data entry errors, and a user guide was provided. Patients aged 18 and older with diagnosed hypertension have their anonymized examination and treatment data added to the registry after giving informed consent. Participants involvement includes the collection of medical data from their outpatient records, which is transmitted securely and anonymously. Researchers will monitor outcomes such as the number of patients achieving blood pressure control below 14090 mm Hg and track histories of related conditions like myocardial infarction, chronic kidney disease, heart failure, and atrial fibrillation. The study also observes the use of antihypertensive medications over the period from 2018 to 2021, with ongoing data collection and analysis.

Researchers are investigating how other existing health conditions affect the risk of complications after abdominal surgery. This observational study aims to understand the frequency and types of additional diseases among surgical patients and identify key factors that predict postoperative problems. The goal is to help better assess and manage risks for patients undergoing planned abdominal operations. The study collects information about patients age, gender, physical status by the ASA scale, presence of various diseases such as heart, lung, kidney, neurological, and metabolic conditions, and treatments they receive. It also records details about the type and severity of surgery, anesthesia methods, and uses various assessment scales related to cognition, respiratory and cardiovascular risk, liver and kidney function. Data is gathered before surgery and patients are monitored until hospital discharge. Participants provide informed consent and their data is entered into a secure database. Researchers evaluate factors influencing complications within 7 days after surgery, as well as mortality within 30 days. Statistical analysis includes regression models to identify independent risk predictors. The study involves multiple centers and follows patients throughout the hospital stay, aiming to improve understanding of postoperative risks and guide preventive strategies.

Researchers are conducting a multicenter observational study in Russia to examine treatment methods and the prevalence of HER2-positive status in various stages of bladder cancer, including PD-L1-positive status in metastatic bladder cancer. The study aims to collect and analyze epidemiologic data without changing routine clinical care. Approximately 600 adult patients with urothelial bladder cancer will be enrolled from about 30 specialized oncology centers, divided into three equal groups based on cancer stage high-risk non-muscle-invasive, muscle-invasive, and metastatic bladder cancer. Participants will be observed during a single routine clinical visit where demographic, clinical, and treatment information will be recorded. Tumor tissue samples collected during standard care will be sent to a central laboratory for testing. No interventions or additional diagnostic procedures will be performed as part of the study. Enrollment is expected to continue for about 18 months or until 600 patients have been included and all necessary data and test results are collected. Participants provide their medical data, including treatment history, during their routine visits, and tumor samples are analyzed centrally. Researchers will measure various outcomes related to treatment patterns and biomarker prevalence over a 24-month period. The study focuses on proportions of patients receiving different treatments, relapse rates, progression timelines, and biomarker status. There is no follow-up planned beyond the single visit, and safety monitoring is not part of this observational study.