Vladivostok

Researchers are conducting an observational multicenter cross-sectional study to better understand the characteristics of adults with uncontrolled severe asthma in Russia who are not receiving biological therapy. The study aims to collect detailed information on the epidemiology, clinical features, treatment patterns, and demographics of these patients across different regions of the Russian Federation, which vary widely in population composition and environmental factors. The study will help fill the gap in data about severe asthma in Russia, especially in patients treated according to standard care but excluding biologics. The study plans to include 5,000 adult patients from about 50 outpatient centers across 50 regions of Russia. It will collect routine clinical data without altering standard medical care or introducing any new diagnostic or therapeutic procedures. The study design includes one visit per patient to gather demographic, clinical, and treatment information, focusing on patients with uncontrolled severe asthma receiving standard treatments like inhaled corticosteroids with other medications but not biological agents. Participants will provide data through medical records and assessments such as the Asthma Control Questionnaire. Researchers will analyze patterns of drug use, clinical characteristics including comorbidities, blood counts, immunoglobulin levels, and lifestyle factors. The study will characterize patients' demographics, treatment trends, and asthma control status from June 2024 to June 2027. Safety monitoring is observational, with no intervention beyond routine care, and the total participation involves a single study visit.

Researchers are evaluating the effectiveness, safety, how the body processes and responds to the drug BCD-261, and immune reactions in adults aged 18 to 75 with moderate to severe active Crohn's Disease. This Phase 2 study focuses on patients who have not responded well to previous treatments like glucocorticoids, immunosuppressants, or biologic therapies. The goal is to understand how different doses of BCD-261 affect the disease and to compare these results to a placebo group. Participants will be randomly assigned to five groups, receiving one of four dose levels of BCD-261 (low, medium, high) or a placebo, all given by injection. The study includes an induction phase and a maintenance phase for treatment. After the main assessment at week 14, those initially receiving placebo will switch to the medium dose of BCD-261. This design helps evaluate both short-term and longer-term effects of the drug. Throughout the study, researchers will track clinical remission and endoscopic response at week 14 as primary outcomes. Participants will undergo regular evaluations including symptom assessments and endoscopic exams to monitor disease activity. The study also monitors safety, drug levels, immune responses, and how the drug affects the body over time. Total involvement includes screening, treatment periods, and follow-up assessments to gather comprehensive data on BCD-261 in Crohn's Disease.

Researchers are investigating brain network dysfunctions and their recovery by recording resting-state electroencephalography (EEG) during rehabilitation with spinal cord stimulation (SCS) in people with partial or complete spinal cord injuries. The study aims to understand the role of brain neuroplasticity during effective SCS programs using implanted electrodes. Researchers expect that successful SCS will cause progressive changes in EEG measures throughout the rehabilitation period, which may help optimize rehabilitation and create personalized recovery plans after spinal cord injury. Participants undergo implantation of multichannel electrodes in the epidural space below the injury level, guided by X-ray and neurophysiological monitoring. EEG recordings are taken before implantation, after implantation but before stimulation, and repeatedly during and after stimulation sessions. SCS begins two days post-surgery, with the stimulation program adjusted for spasticity suppression or voluntary motor control by changing frequency, intensity, and electrode configuration. Participants also engage in motor imagery tasks involving imagining and performing limb movements with the stimulator on and off. Throughout the study, continuous EEG monitoring captures brain activity during resting states and motor imagery tasks with eyes open and closed, both with stimulation on and off. Researchers measure EEG spectral characteristics, spatial distribution of rhythms, functional connectivity, and mu rhythm desynchronization during the neurostimulation period of up to two weeks. Scheduled postoperative monitoring continues for up to two weeks, including final EEG recordings before discharge to assess the physiological effects of spinal cord stimulation and support rehabilitation planning.

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 pain relief options for patients undergoing coronary artery bypass grafting (CABG). The study aims to find out if tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amide) can reduce pain as effectively as morphine, and to identify any medical issues participants may experience when taking tafalgin. This comparison focuses on the early postoperative period after CABG surgery. Participants will be divided into two groups. One group will receive a single subcutaneous dose of morphine (10 mg) if their pain score on the Visual Analogue Scale (VAS) is higher than 3 within 24 hours after surgery. The other group will receive a single subcutaneous dose of tafalgin (0.4 mg) under the same conditions. The effectiveness of each treatment will be measured by how much it lowers the VAS pain score, along with monitoring hemodynamic parameters and arterial blood gases. During the study, participants' pain levels will be assessed using the VAS scale 24 hours after CABG. Researchers will also monitor vital signs and blood gas levels to evaluate safety and treatment effects. The study includes adults aged 18 to 75 years with coronary artery disease undergoing CABG, and will track any side effects or complications related to the treatments.

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.

This research aims to evaluate the feasibility, safety, and effectiveness of dendritic cell (DC) vaccines designed to treat patients with multiple myeloma (MM) or plasmacytoma. These conditions involve malignant plasma cells in the bone marrow and damage to bones, along with abnormal immunoglobulin production. Immunotherapy, including therapies like CAR-T cells and monoclonal antibodies, has shown promise in treating MM, but relapses remain a challenge. This study focuses on using immune-modified DC vaccines (DCvac) to maintain remission in patients who have achieved very good partial or complete remission after prior treatments. Participants will receive multiple injections of DC vaccines made from their own dendritic cells, which have been modified to present tumor antigens and activate anti-cancer immune responses. These vaccines are administered to patients who have previously undergone a combination of anti-cancer treatments, including CAR-T therapy. The study is designed as a Phase 1 trial assessing the safety, feasibility, and potential efficacy of this personalized immunotherapy approach. During the study, patients will be closely monitored for safety outcomes one month after DC vaccine injections. Researchers will conduct regular assessments including blood tests and follow-up visits to evaluate the immune response and disease status. Participation involves consenting to treatment and follow-up visits, with the goal of preventing disease relapse and achieving prolonged remission. The total study duration and additional monitoring details are guided by the trial protocol and patient condition.

Researchers are evaluating a new frontline treatment for patients with high-risk multiple myeloma or plasmacytoma, which are cancers involving plasma cells in the bone marrow. The study focuses on assessing the safety, feasibility, and effectiveness of CAR-T cell therapy targeting multiple cancer cell antigens, including BCMA and GPRC5D. These targets are chosen because they are highly expressed on malignant plasma cells, and combining treatments against them may improve therapy outcomes and potentially offer a revolutionary approach for this difficult-to-treat disease. The treatment involves infusing multi-CAR-T cells that are engineered to attack the cancer cells by targeting BCMA and GPRC5D antigens. This combination therapy is given as part of frontline management, meaning it is used early in the treatment process, and it may be combined with other well-established therapies. The study includes a period where patients receive the CAR-T cell infusion and researchers monitor the persistence and function of these cells in the body. Participants will be closely monitored for safety and treatment effects, including tracking any treatment-related side effects one month after therapy. The study will also include assessments of how long the CAR-T cells remain active and functional. The total participation duration and follow-up periods are designed to gather detailed information about treatment response and patient safety in this high-risk population.

Many patients experience pain after cardiac surgery due to pleural drains placed during the operation, which remain for 1 to 3 days. Traditional pain management methods like systemic opioids or epidural anesthesia can have risks and limitations. Researchers are studying interpleural analgesia, which uses local anesthetics directly in the pleural cavity to target chest pain receptors, potentially providing effective pain relief with fewer systemic effects. This randomized, double-blind, placebo-controlled Phase 4 study aims to evaluate whether ropivacaine improves recovery quality after anesthesia compared to placebo in cardiac surgery patients. Participants will receive either 0.2% ropivacaine or a 0.9% sodium chloride solution injected into the pleural cavity during surgery before closing the sternum. Both groups will have a continuous infusion through a microcatheter into the drained pleural cavity, starting at 10 ml per hour, with the infusion rate adjusted as needed. This treatment targets pain relief during the immediate postoperative period. During the study, participants' recovery quality will be assessed using the Quality of Recovery (QoR15) questionnaire 24 hours after surgery. Researchers will monitor participants closely to compare the effects of ropivacaine versus placebo on postoperative pain and anesthesia recovery. The study focuses on safety and effectiveness within the early recovery phase following cardiac surgery involving pleural cavity opening.

Researchers are studying how Lipoprotein(a) (Lp(a)) levels are distributed among patients in Russia with Atherosclerotic Cardiovascular Disease (ASCVD) and examining the link between high Lp(a) levels and the risk of cardiovascular disease. The study includes patients with a history of heart attacks, strokes, or other vascular conditions to better understand this relationship. The study has several phases. Phase I involves a cross-sectional study measuring Lp(a) levels in ASCVD patients. Phase II includes a non-interventional, prospective cohort study following the same patients, along with cross-sectional and cohort studies involving their relatives. Various drugs including statins (Atorvastatin, Simvastatin, Rozuvastatin), Ezetimibe, Niacin, fibrates (Ciprofibrate, Fenofibrate, Bezafibrate), PCSK9 inhibitors (Evolocumab, Alirocumab), and small interfering RNA (Inclisiran) are monitored as part of the research. Participants will undergo assessments of their Lp(a) levels and cardiovascular events over 24 months. Researchers will track the percentage of patients with Lp(a) levels above a specific threshold and compare cardiovascular event rates between groups. The study also involves collecting medical history and monitoring safety. The total participation duration includes initial screening and follow-up periods as outlined in the study phases.