Ryazan

This research aims to gather long-term safety and effectiveness information for people treated with ibrutinib, a medicine taken by mouth that blocks a specific enzyme called brutons tyrosine kinase. The study focuses on participants who previously took part in ibrutinib studies that have finished and are still receiving ibrutinib treatment, continuing to benefit from it. It is an open-label study, meaning both participants and researchers know the treatment being given. Participants will continue taking ibrutinib capsules daily at the dose they were given in their prior study until the doctor decides the treatment is no longer helpful due to disease progression or side effects, the participant chooses to stop, other treatment options become available, or the study ends. Safety will be monitored throughout, and effectiveness data may be combined with previous study results. No formal testing of hypotheses is planned in this extension. During the study, participants will be regularly monitored for safety and disease status. The main outcome is the number of participants experiencing side effects within 30 days after the last ibrutinib dose or before starting another cancer therapy. Participants may continue treatment until alternative access to ibrutinib is arranged or the study ends, which is planned for December 2029. Researchers will collect ongoing data to understand the long-term effects of ibrutinib treatment.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

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 an observational multicenter cross-sectional study involving 5,000 adult patients in Russia with uncontrolled severe asthma SA who are receiving standard care treatments except biologics. The study aims to describe the characteristics of these patients across about 50 outpatient centers in 50 regions of Russia, addressing the lack of unified data on severe asthma epidemiology, complications, comorbidities, and treatment patterns in the country. Participants will have a single study visit where demographic and clinical data will be collected without any additional interventions or changes to their routine care. The study will gather information on treatment patterns, including the use of oral corticosteroids and various medication classes, and analyze clinical and demographic features such as age at diagnosis, gender distribution, body mass index, lifestyle factors, and presence of comorbidities. During the study, researchers will review medical records and follow-up data from the prior 52 weeks to assess treatment changes, exacerbations, healthcare resource use, and lung function parameters. No extra diagnostic or therapeutic procedures will be performed beyond standard practice. The study will run from June 2024 to June 2027, aiming to provide detailed epidemiological insights into uncontrolled severe asthma in the Russian adult population.

Researchers are evaluating the safety and effectiveness of Indinol Forto 200 mg capsules compared to Visanne 2 mg tablets for treating endometriosis in females aged 18 to 45. This phase 3, open-label, randomized study is designed to test whether Indinol Forto is not less effective than Visanne. Participants have endometriosis confirmed by surgery within the past 60 months and experience moderate pelvic pain. Participants will be randomly assigned to one of two groups one group will take Indinol Forto capsules twice daily, and the other group will take Visanne tablets once daily, both for 24 weeks. Before treatment starts, there is a screening menstrual cycle to confirm eligibility. After completing the 24-week treatment period, participants will be observed for an additional month during a post-treatment follow-up. During the study, participants will daily record pelvic pain using a Visual Analog Scale, noting both cyclic and non-cyclic pain and vaginal bleeding intensity. Researchers will assess changes in average daily pelvic pain after 24 weeks of treatment compared to the screening period. Additional evaluations include quality of life, endometriosis symptoms, menstruation patterns, and lesion size. Safety and symptom changes will be monitored throughout the study and post-treatment period.

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 evaluating the safety and effectiveness of a combination drug containing clotrimazole and lactulose compared to clotrimazole alone in adult women diagnosed with candidal vulvovaginitis. The study aims to determine if the combination drug provides better clinical and microbiological recovery by Day 25 of treatment. This trial uses an adaptive design to assess how lactulose affects fungal infections in the vagina. Participants are randomly assigned to one of three groups one receiving vaginal suppositories with clotrimazole 100 mg and lactulose 300 mg, another receiving vaginal tablets with clotrimazole 100 mg alone, and a third group receiving vaginal suppositories with lactulose 300 mg alone. The study evaluates outcomes at several visits Day 8, Day 15, and Day 25, focusing on symptom improvement, microbiological response, and changes in vaginal bacteria. During the study, participants will undergo clinical assessments and laboratory tests to measure symptom severity and vaginal bacterial content, including molecular analysis of Lactobacillus levels. Patient satisfaction with the therapy will also be recorded. Safety and treatment responses will be monitored throughout the 25-day period, with the main result being the proportion of patients who achieve full clinical and microbiological recovery by Day 25.

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.

Researchers are evaluating the role of markers of endothelial dysfunction in the blood of patients with lower extremity atherosclerotic arterial occlusive disease who are undergoing open reconstructive interventions. The study aims to assess these markers in different stages of the disease and compare various treatment approaches, including conservative therapy and surgical methods. The research will involve 120 patients divided into four groups based on disease severity and treatment type, focusing on understanding how these markers relate to disease progression and treatment outcomes. Participants will be assigned to one of four groups those receiving routine conservative treatment those receiving conservative treatment plus a drug based on vascular polypeptides called Slavinorm4 those undergoing femoral-popliteal bypass grafting surgery combined with conservative treatment and those receiving both surgery and the polypeptide drug treatment. The polypeptide treatment involves intramuscular injections of 5 mg, given twice weekly for a total of 10 injections. Surgical treatment consists of bypass grafting with a synthetic graft above the knee. Throughout the study, participants will be monitored for outcomes such as thrombosis of lower arteries or bypass grafts, disease progression, and restenosis over one year. Secondary measures include limb loss, changes in pain-free walking distance, and ankle-brachial index improvements. Researchers will use instrumental methods like ultrasonography or angiography for diagnosis and follow-up. The study lasts up to one year with assessments of clinical status, walking ability, and vascular function to evaluate the safety and efficacy of the treatments.