Veliky Novgorod

Researchers are evaluating the safety and effectiveness of a new biosimilar drug called bevacizumab (made by Mabscale, LLC) compared to the existing drug Avastin4 in treating patients with advanced non-squamous non-small cell lung cancer (NSCLC) that cannot be removed by surgery or has recurred or spread. This is a phase III randomized, double-blind trial designed to show that the new bevacizumab works as well and is as safe as Avastin4. The study also includes assessments of how the body processes the drug (pharmacokinetics). Participants will receive treatment with bevacizumab at 15 mg/kg or Avastin4, combined with chemotherapy drugs paclitaxel (175 mg/m2) and carboplatin (AUC 6). This combination is given as the first-line therapy for advanced NSCLC. The study is conducted across multiple centers and participants are randomly assigned to one of the two treatment groups without knowing which they receive. Throughout the study, participants will be monitored for their response to treatment, specifically measuring the Objective Response Rate at 18 weeks after starting therapy. Researchers will also assess safety and side effects. Various tests including tumor measurements, blood tests, and other evaluations will be done to ensure participants meet criteria and to track treatment effects. The total duration includes screening, treatment, and follow-up visits to monitor health and outcomes.

Researchers are evaluating the effectiveness, safety, and tolerability of the drug 4-MUST at different doses compared to a placebo in adults aged 18 to 70 years with chronic cholecystitis and biliary dyskinesia. This Phase 2 study focuses on patients experiencing pain or discomfort in the upper abdomen along with other digestive symptoms such as heartburn, nausea, bloating, or changes in bowel habits. The goal is to see how well 4-MUST reduces upper abdominal pain and improves gastrointestinal symptoms. Participants receive either 4-MUST tablets containing 128 mg of trimebutine 4-methylumbelliferyl sulfate or placebo tablets. The study compares various doses of 4-MUST to placebo in parallel groups under double-blind conditions, meaning neither doctors nor patients know which treatment is given. The treatments are administered over a period that allows assessment of pain relief and safety. During the study, participants will be assessed for changes in upper abdominal pain severity using a visual analog scale by day 29 compared to baseline. Researchers will monitor safety and tolerability through questionnaires and clinical evaluations. Women must use effective contraception or meet specific reproductive criteria, and all participants will provide informed consent. The study includes careful monitoring for compliance, adverse events, and other health conditions that might affect participation or outcomes.

Researchers are evaluating the effectiveness and safety of varying doses of Grammidin with anesthetic, a metered dose topical spray, in treating acute infectious and inflammatory diseases of the throat. This Phase 2 study compares Grammidin with anesthetic to Septolete Total lozenges in adults aged 18 to 75 who experience sore throat symptoms due to conditions like acute pharyngitis, nasopharyngitis, or exacerbation of chronic pharyngitis. Participants receive different doses of Grammidin with anesthetic spray or Septolete Total lozenges. The study involves a randomized, parallel-group design to compare these treatments. The primary measure of success combines pain intensity and throat assessment scores over the first 8 days of treatment, with visits scheduled accordingly. During the study, participants report sore throat severity using the Visual Analog Scale and other clinical symptom scales. Researchers monitor symptom changes from Day 1 to Day 8 and assess safety throughout. Patients must meet specific criteria such as symptom duration and pregnancy testing, and they are followed closely to measure treatment effects and any adverse events during this period.