Moscow

Researchers are evaluating the safety and effectiveness of ozanimod RPC1063 in helping children and teenagers with moderate to severe active ulcerative colitis UC who have not responded well to standard treatments. The study focuses on whether ozanimod can help achieve and maintain clinical remission in this young population. This research is conducted as a phase 2 and phase 3 trial sponsored by Bristol-Myers Squibb. Participants will receive ozanimod orally in either a high dose or low dose as part of the study. The treatment is given on specified days, and participants are randomly assigned to one of these dosing groups. The study uses a quadruple masking design, meaning that participants, caregivers, investigators, and assessors do not know which dose is given. The main study period will last up to 52 weeks, with ongoing assessments for up to 6 years to monitor longer-term outcomes and safety. During the study, participants will be monitored regularly for clinical remission, symptomatic remission, clinical response, and endoscopic improvement at various time points including weeks 10 and 52. Researchers will also track corticosteroid-free remission and measure blood levels of the drug and its metabolites. Safety is closely observed by recording adverse events, serious adverse events, and events leading to treatment discontinuation. The study involves clinical visits, endoscopic exams, and laboratory tests throughout the treatment and follow-up periods.

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 investigating the effects of pelvic varicose veins PVV and pelvic congestion syndrome PCS on venous outflow from the lower limbs in women with chronic venous disease CVD. This observational study aims to understand how symptomatic and asymptomatic PVV impact the clinical course of CVD and the potential role of compression therapy. The study addresses the relationship between pelvic and lower limb varicose veins, including their frequency, symptoms, and hemodynamic disturbances, to improve treatment strategies and develop targeted compression products. The study includes three groups 40 women with symptomatic PVV without signs of CVD, 40 women with asymptomatic PVV showing signs of CVD, and 10 women with varicose veins of the lower limb without PVV or PCS. Participants undergo diagnostic tests including radionuclide venography and single-photon emission computed tomography SPECT to assess venous outflow and pelvic venous congestion. The study duration is from May 2023 to January 2024, focusing on measuring isotope transport time and the coefficient of pelvic venous congestion. Participants will be monitored through imaging studies and clinical assessments at baseline and after 10 days. Researchers will evaluate venous blood flow, pelvic vein reflux, and symptoms related to pelvic congestion. The main outcomes include the average transport time of an injected isotope and a quantitative pelvic venous congestion coefficient. These results will help clarify the role of compression therapy and venous outflow disorders in women with PVV and CVD, aiming to improve conservative treatment options and clinical management.

Researchers are evaluating the effectiveness and safety of different venoactive drugs VADs in treating female patients with pelvic venous disorders PeVD, which include conditions like varicose veins in the pelvis and vulva and compression of certain veins. PeVD causes chronic pelvic pain CPP, which greatly affects quality of life, daily activities, and emotional well-being in women. This study aims to compare three diosmin-containing VADs in their ability to relieve CPP and assess patient adherence and side effects. The trial involves 150 women aged 18 to 45 with symptomatic PeVD. Participants are randomly assigned into three groups of 50 each to receive one of the following treatments micronized purified flavonoid fraction MPFF 1000 mg once daily, diosmin 600 mg once daily, or a combination of hesperidin and diosmin 1000 mg once daily. Each treatment lasts for two months, with patients taking their medication every morning during breakfast. Diagnosis and disease characteristics are confirmed using transabdominal and transvaginal duplex ultrasound scans. During the study, participants will record their pelvic pain weekly using a 10-point visual analogue scale VAS. Researchers will monitor pain levels, side effects, and adherence throughout the 8-week treatment. Clinical exams and data collection will occur before and after treatment. Patients are instructed to report any side effects immediately. The main outcome measure is the severity of chronic pelvic pain, assessed weekly. Secondary outcomes include monitoring side effects and adverse events. The study duration for each participant is approximately two months of treatment.