Pyatigorsk

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 conducting a multicenter, double-blind, placebo-controlled, randomized clinical trial to study children aged 3 to 12 years with acute respiratory viral infection ARVI. This trial aims to evaluate the safety and effectiveness of Raphamin in treating ARVI symptoms during the seasonal incidence of the illness. Enrollment starts with children aged 6 to 12 years and may expand to include those aged 3 to 12 years based on interim safety and efficacy results. Participants will be randomly assigned to receive either Raphamin or a placebo. Raphamin is given orally as tablets that dissolve in the mouth, with a specific dosing schedule over five days eight tablets on the first day taken at intervals, then one tablet three times daily on days two through five. The placebo group follows the same dosing regimen using placebo tablets. The treatment period lasts five days, followed by monitoring and follow-up visits. During the study, parents or caregivers will record their childs symptoms and body temperature twice daily in an electronic diary, including any use of fever-reducing medications and changes in health. Children will have several visits with healthcare providers on days 1, 5, and 7, plus a phone visit on day 14 for safety and symptom assessment. Laboratory tests and physical exams will be conducted to monitor progress and safety. The primary outcome is the time until ARVI symptoms resolve within 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.

Researchers are studying the effects of dapagliflozin, a medication taken daily, on heart function in patients who have reduced left heart pumping and have undergone off-pump coronary artery bypass grafting OPCAB. The study focuses on measuring the right ventricular-pulmonary artery coupling by using a specific ratio called TAPSEPASP. This observational study includes 72 patients with left ventricular ejection fraction less than 50%, aiming to understand how dapagliflozin influences heart function after surgery. Participants begin dapagliflozin treatment at a dose of 10 mg once daily starting one month after their surgery. Heart function is assessed through echocardiography at three points before surgery, one month after surgery before starting dapagliflozin, and seven months after surgery following six months of dapagliflozin therapy. The study also evaluates other heart-related measures such as pulmonary artery pressure, pulmonary vascular resistance, right and left ventricular function, blood biomarkers, and quality of life. During the study, patients undergo echocardiograms and blood tests to monitor heart function and biomarkers at the specified time points. Researchers measure changes in heart function and quality of life scores between one month and seven months post-surgery. The study lasts for seven months after surgery, with close monitoring of heart measurements to evaluate the medications impact on cardiac health.

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 evaluating the efficacy and safety of Raphamin in treating acute rhinosinusitis in adult patients aged 18 to 75 years. This multicenter, double-blind, placebo-controlled, randomized clinical trial focuses on adults experiencing symptoms within 48 hours of disease onset during the seasonal peak of acute respiratory viral infections. The study aims to compare Raphamin against placebo in improving symptoms and quality of life. Participants will be randomly assigned to one of two groups at the first visit. One group receives Raphamin tablets dissolved in the mouth following a specific dosing schedule over 5 days, starting with multiple doses on day 1 and three times daily thereafter. The other group receives a placebo on the same schedule. The study includes a treatment period of 5 days and follow-up visits up to 14 days. Participants will attend three visits on days 1, 4, and 7, either at a medical center or at home, with a phone visit on day 14. They will complete symptom severity scales and quality of life questionnaires, record daily temperature and symptoms in an electronic diary, and report any worsening condition or adverse events. Researchers will monitor symptom improvement, safety, antibiotic use, hospitalizations, and vital signs throughout the study and follow-up period.