Moscow

This research aims to evaluate the effectiveness and safety of an oral drug called ozanimod (RPC1063) in treating children and teenagers aged 2 to 17 years who have moderate to severe active ulcerative colitis (UC). These young participants have not responded well to standard treatments, and the study focuses on helping them achieve and maintain clinical remission of their condition. Participants will receive specified doses of ozanimod by mouth according to a set schedule. The study is a Phase 2/3, randomized, double-blind trial conducted at multiple centers. The goal is to assess how well ozanimod works and how safe it is in this pediatric population with UC that extends beyond the rectum. During the study, researchers will monitor participants closely through medical assessments, including endoscopy to confirm disease extent and other evaluations to track disease remission. The main outcome measured is the proportion of participants who reach clinical remission by Week 52. Safety and drug behavior in the body will also be observed throughout the trial period.

Researchers are investigating venous outflow from the lower limbs in female patients aged 18 to 40 who have pelvic varicose veins (PVV) and lower limb varicose veins (CVD). The study aims to better understand how pelvic vein dilation, both symptomatic and asymptomatic, affects venous outflow and clinical symptoms of chronic venous disease and pelvic congestion syndrome. This research is important because pelvic varicose veins affect 15 to 30% of women and current treatment options, especially compression therapy, lack clear guidelines for patients with combined pelvic and lower limb vein issues. This single-center, prospective, comparative cohort study will enroll 90 patients divided into three groups: 40 with symptomatic PVV without CVD, 40 with asymptomatic PVV and symptoms of CVD, and 10 with CVD of the lower limb without PVV. The study uses radionuclide venography and single-photon emission computed tomography (SPECT) to assess venous blood flow and pelvic venous congestion. Radionuclide venography involves injecting a radiotracer into foot veins and tracking its movement through leg veins, while SPECT uses labeled red blood cells to image pelvic veins in multiple planes. Participants will undergo detailed imaging and functional tests to measure venous outflow and pelvic venous congestion at the start and after 10 days. Researchers will evaluate the average transport time of the isotope and the coefficient of pelvic venous congestion to understand venous function and disease severity. This information could help guide the use of compression therapy in this patient group. The study runs from April 5, 2023, to January 12, 2023, and includes monitoring symptoms, venous function, and clinical manifestations associated with pelvic pain and lower limb venous disease.

Researchers are evaluating the effectiveness and safety of different venoactive drugs (VADs) in treating pelvic venous disorders (PeVD) in women. PeVD includes conditions like varicose veins in the pelvis and vulva and vein compression, often causing chronic pelvic pain (CPP), which significantly affects quality of life. This Phase 3 study focuses on comparing various diosmin-containing VADs to identify the best option for symptom relief in reproductive-aged women with PeVD. The study involves three groups of 50 female patients each, who will receive one of three VAD 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. All treatments will be taken during breakfast for two months. Before and during treatment, patients will undergo pelvic vein ultrasounds and clinical examinations to confirm diagnosis and assess venous reflux. Participants will rate their chronic pelvic pain weekly using a visual analogue scale (VAS) over eight weeks. Safety will be monitored by recording side effects and adverse events. Patients will report any issues immediately to investigators. The study will also evaluate patient adherence to the medications. The main measure is the severity of pelvic pain weekly throughout the treatment period, with follow-up exams at the end of two months.