Stavropol

Bipolar disorder is a serious, long-lasting mood condition affecting both adults and children. This research focuses on studying the effects and safety of cariprazine, a medication approved for adults, in treating depressive episodes linked to bipolar I disorder in children and adolescents aged 10 to 17. The study aims to better understand how this drug impacts the pediatric population, where treatment options are currently limited. Participants will be randomly assigned to one of two groups one receiving cariprazine at flexible doses adjusted by age and weight, and the other receiving a placebo. The treatment lasts six weeks, with dose adjustments at week 3 depending on response. Following treatment, there is a four-week safety follow-up period. Weekly visits at clinics or hospitals will support monitoring and treatment. During the study, participants will undergo medical assessments, blood tests, questionnaires, and side effect checks to evaluate the drugs impact. Researchers will track changes in mood symptoms using scales like the Childrens Depression Rating Scale and monitor safety through vital signs, lab tests, and movement assessments. The total study participation spans around 10 weeks, including treatment and follow-up.

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 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 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 efficacy and safety of cariprazine in treating schizophrenia among adolescents aged 13 to 17 years. This international, multicenter study is designed as a randomized, double-blind, placebo-controlled trial to understand how cariprazine affects symptoms of schizophrenia in this younger population. Participants will be randomly assigned to receive either cariprazine capsules at doses of 1.5 mg or 4.5 mg once daily, or matching placebo capsules once daily. The treatment phase lasts for six weeks, during which participants take the assigned capsules orally every day. During the study, participants will be monitored regularly to assess changes in their schizophrenia symptoms using the Positive and Negative Syndrome Scale PANSS. Researchers will also evaluate safety and tolerability throughout the trial. The main measurement is the change in PANSS total score from the start to the end of the six-week period. The study is designed to last until December 2026.

Researchers are studying the pharmacokinetics, safety, and long-term effectiveness of olokizumab in children and adolescents aged over 2 and under 18 years who have polyarticular juvenile idiopathic arthritis. This open-label, multicenter study aims to understand how the drug behaves in the body, its effects, and its safety over an extended period. Participants receive subcutaneous injections of olokizumab every 4 weeks, with doses of either 64 mg or 48 mg depending on body weight. The study includes a screening period up to 2 weeks, a main treatment period of 24 weeks, an extended treatment phase lasting up to week 164, and a safety follow-up lasting 22 weeks. The total participation time is about 188 weeks. During the study, participants will undergo assessments of drug concentration levels and response at various timepoints. Researchers will monitor joint activity, inflammation markers like C-reactive protein, and safety measures through laboratory tests. Outcome measures include maximum drug concentration and area under the concentration-time curve over 24 weeks. The study also tracks long-term safety and efficacy with regular evaluations throughout treatment and follow-up.

Researchers are evaluating the long-term safety and effectiveness of RPH-104 in adults with familial Mediterranean fever FMF who do not respond well to or cannot tolerate colchicine treatment. This study focuses on patients who have already participated in an earlier core trial and received at least one dose of RPH-104. The goal is to understand how well RPH-104 works to prevent recurrent fever attacks in this specific patient group over an extended period. The study includes a screening phase lasting 2 weeks to confirm eligibility and unblind previous treatment assignments. Following this, participants receive open-label RPH-104 injections every two weeks for up to 198 weeks. The doses studied are either 80 mg or 160 mg administered subcutaneously. Patients may receive their injections at the study site or at home if trained to self-administer. Safety and effectiveness are regularly assessed through scheduled visits and phone contacts. If patients experience attacks on the lower dose, an increase to 160 mg may occur. After completing treatment, an 8-week safety follow-up with two visits monitors participants. Participants will visit the study site frequently for drug administration and evaluations, including assessments of side effects and disease activity. Researchers collect data on adverse events, inflammatory markers, symptom severity, and kidney function. Telephone follow-ups also support patient monitoring. The primary outcomes focus on tracking side effects, while secondary outcomes assess disease control and symptom changes. Overall, the study lasts nearly four years, combining treatment and follow-up to provide detailed long-term information on RPH-104 use in colchicine-resistant or intolerant FMF patients.

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.

Researchers are investigating how other existing health conditions affect the risk of complications after abdominal surgery. This observational study aims to understand the frequency and types of additional diseases among surgical patients and identify key factors that predict postoperative problems. The goal is to help better assess and manage risks for patients undergoing planned abdominal operations. The study collects information about patients age, gender, physical status by the ASA scale, presence of various diseases such as heart, lung, kidney, neurological, and metabolic conditions, and treatments they receive. It also records details about the type and severity of surgery, anesthesia methods, and uses various assessment scales related to cognition, respiratory and cardiovascular risk, liver and kidney function. Data is gathered before surgery and patients are monitored until hospital discharge. Participants provide informed consent and their data is entered into a secure database. Researchers evaluate factors influencing complications within 7 days after surgery, as well as mortality within 30 days. Statistical analysis includes regression models to identify independent risk predictors. The study involves multiple centers and follows patients throughout the hospital stay, aiming to improve understanding of postoperative risks and guide preventive strategies.