Saransk

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 immune response, side effects, and safety of a vaccine called GNG-DE compared to a reference vaccine for preventing meningococcal infections. This phase 3 trial is conducted by NPO Petrovax and involves healthy volunteers aged 3 to 55 years. The study is divided into three stages to include adults, adolescents, and children sequentially, with each stage beginning after safety review of the previous stage. Participants are randomly assigned to one of two groups to receive either GNG-DE or the reference vaccine Menactra, both given as 0.5 mL injections into the muscle of the upper arm. The study starts with adults aged 18 to 55 years, then moves to adolescents aged 11 to 17 years, and finally to children aged 3 to 10 years. Each group includes 80 participants, and the dosing and administration are consistent across all age groups. Throughout the study, volunteers undergo screening before enrollment and attend scheduled visits for safety and immune response assessments. The main outcome measured is the primary immune response 29 days after vaccination. Additional immune markers and safety data are also collected. Participants will be monitored closely to track any reactions or side effects, with all procedures conducted under medical supervision until the study ends in late 2025.

Researchers are evaluating the effectiveness, safety, how the body processes, and immune response to BCD-236 combined with chemotherapy in women with relapsed or metastatic triple negative breast cancer TNBC who have received previous treatments. This is a Phase 2 study that compares BCD-236 plus chemotherapy versus chemotherapy alone in patients whose cancer has returned or progressed after earlier therapies. Participants will be randomly assigned to one of two groups one receiving BCD-236 by intravenous infusion plus chemotherapy chosen by the investigator, and the other receiving chemotherapy alone. Treatment continues until the cancer worsens, side effects become intolerable, or the study ends. During the study, participants will undergo regular assessments including tumor measurements and health evaluations to monitor response and side effects. The main outcome measured is the overall response rate at 24 weeks, with secondary outcomes including progression-free survival, overall survival, disease control rate, time to response, and duration of response assessed at various times up to 102 weeks. Participants will be monitored closely throughout their treatment and follow-up periods.

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 evaluating the efficacy and safety of a liquid form of Rengalin for treating cough caused by acute viral upper respiratory tract infections in children aged 6 months to 3 years during the epidemic growth of influenza and ARVI. This randomized, double-blind, placebo-controlled trial compares Rengalin with a placebo to determine its effect on cough severity in young children. Participants will be randomly assigned to receive either 5 ml of Rengalin or a placebo orally three times a day for 7 days. The study includes initial screening and consent, followed by treatment and monitoring visits on days 1, 4, and 8, with a phone follow-up on day 14. On day 4, if needed, mucolytic ambroxol may be added while continuing the assigned study treatment. Parents will use an electronic diary to record cough severity twice daily throughout the study. During the study, researchers will assess symptoms, perform physical exams, and conduct laboratory tests including blood and urine analyses in at least half the participants. Safety and treatment adherence are closely monitored through visits and diaries. The main outcome is the percentage of patients responding to treatment by day 3, with secondary outcomes including changes in cough severity by day 7. The total study duration for participants is up to 14 days with ongoing observation.

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 effects of Ingavirin Forte capsules at different doses compared to the standard Ingavirin capsules and placebo in adults with influenza or other acute respiratory viral infections ARVIs. This Phase 2 trial aims to evaluate how well these treatments work, their safety, and how well patients tolerate them. Participants include adults aged 18 to 65 with confirmed influenza or ARVIs, showing significant symptoms and meeting specific clinical criteria. Participants are randomly assigned to one of five groups three groups receive Ingavirin Forte capsules at varying doses 90 mg plus either 5 mg, 10 mg, or 20 mg, one group receives standard Ingavirin 90 mg capsules, and one group receives a placebo. All treatments are taken as one capsule twice daily morning and evening for five consecutive days under double-blind conditions. During the 10-day study period, participants are monitored closely with visits on Days 3 and 6 to assess symptom severity, use of nasal sprays and pain medications, and viral elimination. Researchers measure the time until all symptoms resolve without additional medications and evaluate treatment effectiveness through clinical assessments and patient feedback. Safety and tolerability are also assessed throughout the trial, which may continue until the end of 2027.