Tver

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 conducting a national, multicenter, prospective study in the Russian Federation to collect real-world data on patients with aggressive, advanced endometrial cancer (stages III-IV). The study aims to understand the prevalence of molecular markers such as POLE mutations, dMMR/pMMR, p53 abnormalities, HER2, and PD-L1, as well as to observe first-line postoperative treatment approaches in these patients. Approximately 500 female patients with newly diagnosed aggressive subtypes of advanced endometrial cancer will be enrolled across about 30 sites. The study involves two visits aligned with routine clinical practice. At the first visit, demographic and clinical information will be collected from medical records or patient interviews, along with biopsy or archival tumor samples for molecular testing using immunohistochemistry and genetic sequencing methods. The second visit occurs six months after baseline or at disease progression, whichever is earlier, to gather follow-up data on treatments and disease status. No additional procedures beyond standard care are applied. Participants' data will be securely entered into electronic case report forms by study physicians. Researchers will monitor the rates of molecular markers such as POLE mutation positivity, mismatch repair status, p53 abnormalities, PD-L1 expression, and HER2 expression over 24 months. The overall study duration, from first patient enrollment to final data analysis, is expected to be about 27 months or until all data from 500 patients are collected, including follow-up information.

Researchers are evaluating the safety and effectiveness of two treatments, Indinol Forto400 mg capsules and Visanne 2 mg tablets, for women with endometriosis. This phase 3 study compares these treatments to see if Indinol Forto400 mg is not less effective than Visanne. The study includes females aged 18 to 45 who were diagnosed with endometriosis by surgery within the past 60 months and have experienced at least moderate pelvic pain for at least 2 months. Participants are randomly assigned to take either Indinol Forto 200 mg capsules twice daily or Visanne 2 mg tablets once daily for 24 weeks. Before treatment, there is a one menstrual cycle screening period to assess eligibility. After 24 weeks of treatment with monthly visits, participants enter a one-month post-treatment observation period. Daily pelvic pain, both cyclic and non-cyclic, and vaginal bleeding intensity are recorded using a Visual Analog Scale (VAS). During the study, participants complete daily diaries on pain and bleeding, and their pain scores are closely monitored. The main measure of success is the change in average daily pelvic pain after 24 weeks compared to the screening period. Safety and tolerability are also assessed throughout. The whole study lasts about 7 months, including screening, treatment, and follow-up periods.

Researchers are conducting a multi-center, non-interventional study to observe routine diagnostic and treatment practices for patients with unresectable or inoperable locally advanced non-small cell lung cancer (NSCLC) and limited-stage small cell lung cancer (LS-SCLC) in 50 major oncology centers across Russia. The study will collect data from 2000 patients receiving chemo-radiation therapy (CRT) over two years. The aim is to understand demographic and clinical characteristics, diagnostic procedures, treatment approaches, and short-term outcomes of CRT in these patients, without collecting information on treatments following CRT such as durvalumab. The study involves collecting data at two main points: at the start of CRT (either concurrent or sequential chemo-radiation) and after the last dose of radiation therapy, including results from computed tomography (CT) scans. Data collection will be done from patients' medical records in routine clinical practice, and the second data collection is expected to occur within six months after the first visit. The study follows local regulations for adverse event reporting and does not involve additional interventions or treatments. Participants will be adults aged 18 years or older who have locally advanced NSCLC or LS-SCLC and are currently undergoing radiation therapy as part of CRT. Researchers will gather information on patient demographics, disease stage, histology, and clinical status at baseline. The study will monitor treatment details and short-term outcomes after CRT. All data is collected from existing medical records, ensuring no extra procedures for participants. The total participation duration aligns with routine treatment schedules and follow-up visits.

Researchers are studying the effects of Mexidol®, given both as an intravenous solution and as oral tablets, on patients who have recently experienced ischemic stroke. This pilot, randomized, multicenter, open-label study aims to better understand how Mexidol® works during the early and acute phases of stroke and to assess its impact on clinical symptoms and brain imaging outcomes. It also compares Mexidol® treatment to Glycine tablets while monitoring safety and effectiveness in both patients and healthy volunteers. Participants with acute ischemic stroke are randomly assigned to two groups. The first group receives Mexidol® solution intravenously twice daily for 10 days, followed by Mexidol® FORTE 250 mg tablets three times daily for 60 days, alongside standard stroke care. The second group receives Glycine sublingual tablets once daily for 5 days, also with standard care. Healthy volunteers will not receive treatment but will provide baseline biomarker data. The total treatment and observation period lasts up to 70 days for patients. During the study, participants undergo clinical evaluations, laboratory tests, and brain imaging such as CT or MRI scans to assess stroke damage and recovery. Researchers measure outcomes including infarct volume at day 11 and monitor safety throughout the trial. Both patients and healthy volunteers provide informed consent, and adherence to treatment and contraception requirements is tracked. The study includes follow-up assessments to evaluate the effects of the treatments over time.

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.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy (aromatase inhibitors with or without GnRH agonists) in patients with hormone receptor-positive, HER2-negative stage II-III breast cancer in Russia. The study includes both a prospective cohort receiving ribociclib plus hormone therapy and a retrospective cohort treated with hormone therapy alone. The goal is to assess treatment outcomes in different patient subgroups defined by tumor grade, lymph node involvement, and hormone therapy response. Participants in the prospective group receive ribociclib alongside aromatase inhibitors, with or without GnRH agonists, as part of their adjuvant therapy. The retrospective group includes patients treated with aromatase inhibitors alone during a specific period from July 2019 to July 2020. The study collects new data from the prospective group while also analyzing existing patient records from the retrospective group. Throughout the study, researchers monitor invasive breast cancer-free survival at 36, 48, and 60 months following treatment according to standardized criteria. Patient information is gathered from clinical records, including hormone therapy start dates and treatment responses. Safety and effectiveness are assessed by tracking outcomes over several years to better understand ribociclib's role in routine clinical practice for this type of breast cancer.