Lipeck

Researchers are conducting a large, non-interventional observational study to better understand adults with uncontrolled asthma across Russia. This study aims to gather detailed information on the demographic and clinical characteristics of these patients, the treatments they receive, and how their condition is managed in routine clinical practice. The study focuses on patients not treated with biologics and covers a diverse population from about 50 regions in Russia, reflecting differences in ethnicity, climate, and economic status. The study will include 9,000 adult patients with uncontrolled mild to moderate asthma who are receiving standard care. Data will be collected during 2-3 visits that follow routine clinical practice schedules. At the first visit, information from the previous 52 weeks will be gathered from medical records and patient interviews. The second visit will take place about 12 weeks later to collect follow-up data on treatment changes and clinical outcomes. For a subgroup of 500 patients using a fixed-dose combination of budesonide/salbutamol at the second visit, an additional third visit will occur 12 weeks later to further monitor treatment and outcomes. Participants will be monitored through medical record reviews and interviews during these visits. Researchers will assess baseline characteristics such as blood eosinophil counts, sputum eosinophils, and total IgE levels, along with treatment profiles and clinical outcomes. The study does not involve any experimental interventions beyond standard care and aims to provide comprehensive real-world data on uncontrolled asthma management in Russia. The total study duration for participants includes up to 24 weeks of follow-up for some patients.

Researchers are evaluating the efficacy and safety of cariprazine in treating adolescents aged 13 to 17 years with schizophrenia. This Phase 3 study compares cariprazine to a placebo to understand its effects on this population. Participants must have a confirmed diagnosis of schizophrenia based on DSM-5 criteria and meet specific symptom severity requirements. Participants receive either cariprazine or matching placebo capsules once daily by mouth for 6 weeks in a randomized, double-blind, parallel-group design. The study is conducted across multiple international centers to ensure diverse participation and data collection. Throughout the 6-week study, researchers assess changes in schizophrenia symptoms using the PANSS total score from baseline to Week 6. Safety and tolerability are also monitored closely. Participants will undergo clinical evaluations and symptom scoring to track progress and response to treatment during the study period.

Researchers are evaluating the effectiveness and safety of a non-immunogenic recombinant staphylokinase compared to a placebo in patients with intermediate high-risk pulmonary embolism (PE) who have normal blood pressure. This study focuses on patients who have right ventricular dysfunction and an increased risk of early death or hemodynamic collapse but are hemodynamically stable. The goal is to see if this treatment can improve outcomes without the risks seen in other thrombolytic therapies, such as hemorrhagic stroke. Participants receive either a single intravenous bolus of 15 mg of non-immunogenic recombinant staphylokinase or a placebo, both reconstituted in 15 ml of saline and given over 10-15 seconds. This single-dose treatment is compared to understand its safety and efficacy in reducing complications from intermediate high-risk PE. The study is designed as a multicenter, double-blind, randomized, placebo-controlled trial. Throughout the study, participants are monitored for outcomes including death, hemodynamic collapse, or recurrent PE within 30 days. Researchers assess heart function through imaging, blood tests such as troponin I levels, and clinical signs to evaluate treatment effects and safety. Patients must provide informed consent and agree to use reliable contraception during and shortly after the study. The total participation time includes initial diagnosis up to at least 30 days of follow-up to track key health events.