Volgograd

Researchers are evaluating the pharmacokinetics, safety, and immune response of two drugs, RPH-030 and Vectibix4, in patients with metastatic colorectal cancer mCRC who have wild-type RAS genes. The study aims to show that these treatments are equivalent in how the body processes them and to compare their safety and immune effects. Additionally, the study will explore how effective these drugs are when used as first-line therapy combined with FOLFIRI chemotherapy. Participants will receive either RPH-030 or Vectibix4 intravenously at 6 mgkg every two weeks along with FOLFIRI chemotherapy, which includes irinotecan, calcium folinate, and fluorouracil. Treatment starts with FOLFIRI for 8 cycles, then continues with a modified de Gramont regimen. The study includes several periods a screening phase, a main period lasting up to 6 months, a continued therapy period up to 1 year where all patients receive RPH-030, and a treatment extension period lasting up to 2 years for patients with stable disease or response. Follow-up visits occur after treatment ends to monitor survival and disease status. Participants will undergo regular tumor assessments approximately every 6 to 8 weeks, hospitalizations for drug administration at specific visits, and blood sampling for pharmacokinetic and safety evaluations. Researchers will monitor drug levels over time, adverse events, immune reactions, and tumor responses. Follow-up includes imaging or phone calls to track overall survival and disease progression. The total study participation can last up to about 2 years with additional follow-up to ensure thorough monitoring of outcomes and safety.

Researchers are evaluating the safety and effectiveness of a new bevacizumab drug made by Mabscale, LLC, compared to Avastin, both combined with paclitaxel and carboplatin, for treating adults with advanced or inoperable non-squamous non-small cell lung cancer NSCLC. This phase III trial aims to show that the new bevacizumab works as well and is as safe as Avastin. The study also looks at how the drug is processed in the body. Participants are randomly assigned to one of two groups. One group receives the Mabscale bevacizumab with paclitaxel and carboplatin, and the other gets Avastin with the same chemotherapy drugs. Treatment cycles last about three weeks, with up to six cycles initially. After that, eligible patients continue with bevacizumab alone every three weeks. The study is double-blind, so neither patients nor researchers know who receives which bevacizumab. During the study, patients will undergo regular assessments including tumor measurements and blood tests. Researchers measure the tumor response at 18 weeks and track progression-free and overall survival at 18 and 42 weeks. The duration of response is also evaluated up to 48 weeks. Safety and side effects are closely monitored throughout the trial, which started in 2023 and will continue until 2027. Participants are followed closely to assess the treatments impact and safety.

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 a single bolus dose of non-immunogenic recombinant staphylokinase compared to a placebo in adults with intermediate high-risk pulmonary embolism PE who have stable blood pressure. This phase 3 trial addresses the need for safer thrombolytic treatments in patients who are at risk but do not have shock or low blood pressure, as previous thrombolytics had risks like hemorrhagic stroke. The study aims to improve outcomes while minimizing adverse effects in this patient group. Participants receive either a quick intravenous injection of non-immunogenic recombinant staphylokinase or a matching placebo. The staphylokinase dose is 15 mg given as a single bolus over 10-15 seconds regardless of body weight. The placebo group receives a similar injection with saline solution. This treatment period is followed by monitoring to compare the effects and safety between the two groups. During the study, participants will be assessed for clinical outcomes including death, hemodynamic collapse, and recurrent pulmonary embolism within 30 days. Additional measures include heart function and lung pressure evaluations within 24 hours and 30 days, along with monitoring for bleeding events and other adverse effects. The trial lasts for 30 days after treatment with ongoing safety checks, and participant consent and adherence to contraceptive use are required throughout the study period.

Researchers are evaluating the effectiveness of adjuvant ribociclib combined with hormone therapy using aromatase inhibitors with or without GnRH agonists in patients with hormone receptor-positive HR HER2-negative stage II-III breast cancer. This observational study includes two groups a prospective cohort receiving ribociclib plus aromatase inhibitors, and a retrospective cohort treated with aromatase inhibitor monotherapy. The study aims to analyze outcomes based on tumor grade, lymph node involvement, and hormone therapy response in real-world clinical practice in Russia. Participants in the prospective group receive ribociclib along with aromatase inhibitors GnRH agonists, while the retrospective group includes patients treated with aromatase inhibitor monotherapy. Data collection includes both primary prospective data and secondary retrospective data from medical records. The study does not involve experimental treatment assignments but observes existing treatment patterns and outcomes. Participants will be monitored over several years with assessments at months 36, 48, and 60 to evaluate invasive breast cancer-free survival and other related outcomes. Quality of life questionnaires and safety data including adverse events are collected at multiple time points up to 60 months. The study involves continuous data review to assess treatment adherence, disease recurrence, and patient well-being throughout the observation period.

This research aims to study the safety and effectiveness of a drug called non-immunogenic staphylokinase in patients with massive pulmonary embolism, a serious condition involving blood clots in the lungs. The study builds on previous trials that found this drug to be as effective as alteplase with fewer major bleeding events, making it a promising emergency treatment option. The study is observational and focuses on patients receiving this drug in routine clinical practice. Participants receive a single intravenous bolus dose of 15 mg non-immunogenic staphylokinase Fortelyzin4 regardless of body weight. This drug is easy to administer quickly in emergency situations and is used for treating massive pulmonary embolism since 2024. The study collects information on patients treated with this drug to assess outcomes in a real-world setting. During the study, participants are monitored for outcomes such as all-cause mortality at 7 and 30 days after drug administration, hemodynamic collapse, recurrent pulmonary embolism, and pulmonary artery systolic pressure changes. Safety is closely observed, especially for bleeding events. The study runs from June 2025 to December 2027, with ongoing evaluation of participants following treatment in routine care.

Researchers are studying the quality of primary health care for patients with arterial hypertension, a common condition that significantly impacts population health and mortality. This observational study uses data from a cardiovascular disease registry to analyze how well medical care aligns with current clinical recommendations. The research aims to identify trends and improve treatment approaches for patients with hypertension, including secondary forms. The study collects medical data through a computerized arterial hypertension registry with remote access, allowing online entry of patient information from outpatient records. Doctors received training to reduce data entry errors, and a user guide was provided. Patients aged 18 and older with diagnosed hypertension have their anonymized examination and treatment data added to the registry after giving informed consent. Participants involvement includes the collection of medical data from their outpatient records, which is transmitted securely and anonymously. Researchers will monitor outcomes such as the number of patients achieving blood pressure control below 14090 mm Hg and track histories of related conditions like myocardial infarction, chronic kidney disease, heart failure, and atrial fibrillation. The study also observes the use of antihypertensive medications over the period from 2018 to 2021, with ongoing data collection and analysis.

Researchers are investigating the use of a recombinant non-immunogenic staphylokinase Fortelyzin in patients who have experienced an acute ischemic stroke between 4.5 and 24 hours after symptom onset. This phase III, multicenter, double-blind, randomized, placebo-controlled trial aims to evaluate the efficacy and safety of this drug in restoring blood flow in patients with large vessel occlusion stroke who arrive outside the standard 4.5-hour treatment window. The study focuses on patients with salvageable brain tissue identified by advanced imaging techniques. Participants will be randomly assigned to receive either a single intravenous bolus injection of 10 mg non-immunogenic staphylokinase or a placebo administered rapidly within 5 to 10 seconds regardless of body weight. The trial excludes patients planned for direct thrombectomy. Following treatment, patients will be monitored for up to 90 days to assess outcomes. The trial evaluates functional recovery and reperfusion improvements compared to placebo. Throughout the study, participants will undergo imaging assessments such as CT or MRI perfusion scans to confirm eligibility and monitor brain tissue status. Researchers will evaluate functional outcomes using established stroke scales over 90 days, including the modified Rankin Scale and NIH Stroke Scale. Safety, mortality, and reperfusion rates will also be tracked. Participants will have follow-up visits and assessments designed to measure recovery and treatment impact over the trial 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.