There are about 6461 clinical studies being (or have been) conducted in Russian Federation. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
In the structure of malignant liver lesions, two main groups are distinguished - primary liver cancer and metastatic liver damage. The five-year survival rate of patients with malignant liver tumors does not exceed 6%. The main and radical method of treatment today is liver resection. However, surgical treatment is possible only in 10-25% of patients. At the same time, recurrence of malignant tumors is observed in 60-80% of cases within five years after surgery, and the number of candidates for repeated liver resection does not exceed 10%. The high toxicity of systemic chemotherapy limits its use in this group of patients. In this connection, minimally invasive and at the same time effective methods of local treatment of malignant liver tumors have been introduced into clinical practice. These methods include: hepatic artery chemoinfusion, chemoembolization and oil chemoembolization. Currently, a large world experience has already been accumulated in the application of the above methods of treatment. However, any, even minimally invasive, surgical manipulation can be associated with the development of complications of varying severity. If complications arise, there is a risk of interruption of palliative care, which entails a significant reduction in life expectancy. According to domestic and foreign literature, the occurrence of complications after intra-arterial chemoembolization occurs in 0.4-10% of patients, and after intra-arterial chemoinfusion - in 5-30% of patients. In the overwhelming majority of scientific works, the description of the complications that have arisen is reduced to listing the latter. Currently, in the Russian and foreign scientific literature there is no systematization of complications, there is no single clinical classification, algorithms for the prevention and treatment of complications arising after local intravascular methods of treatment of patients with malignant liver tumors. The study and systematization of complications arising after intra-arterial chemoembolization and chemoinfusion of the hepatic artery in patients with malignant liver tumors will make it possible to create prevention and treatment algorithms. Thus, it will help prevent interruption of palliative care and increase the life expectancy of this cohort of patients.
Degenerative diseases and traumatic injuries of the shoulder joint, lead to dysfunction of the arm. Arthroplasty has recently become an increasingly popular operation for severe damage to the shoulder joint. In clinical practice, the most effective operation today is the reverse shoulder arthroplasty (RSA), after the installation of which the pain syndrome disappears in patients and a satisfactory range of motion in the shoulder joint resumes. With the increasing use of reverse shoulder arthroplasty and its expanding indications, surgeons today are facing tougher reconstructive challenges while still providing the patient with a good clinical outcome. The damaged joint presents a problem for the surgeon during component positioning. Implants must place the in a location and orientation that optimizes range of motion and stability while minimizing impingement. In order to address this, surgeons can look to the use of 3D imaging in order to better understand each patient's pathology. All patients are performed computed tomography scans (CT) of the shoulder joint. Then, were reconstructed 3D model. To determine the position of the components is mounted a scapular plane was created based on 3 points on the 3D reconstructed scapula: center of the glenoid fossa, most medial point on the spinal border of the scapula, and most distal point on the inferior angle of the scapula. The investigators use a scapular plane for to determine the optimal angles of inclination of the reverse baseplate. Then the position and direction of the pilot pin is determined. The position of the fixing screws and their length are also calculated. A resection line is planned for the humerus. Preoperative virtual templating can be used to translate the preoperative plan into the operating suite in the form of patient specific instrumentation (PSI) and intraoperative navigation. PSI to reference the local anatomy in order to place the guide pin in the desired location, version, and inclination based on the preoperative plan. After surgery, all patients undergo a CT scan of the shoulder joint. These data are compared with CT scan of patients operated on according to the standard method. The range of motion is also assessed and compared.
The study is aimed to find correlation between the assessment of cellularity according to trepanobiopsy data and the results of measuring MRI parameters.
TRICS-IV is an international, multi-centre, open-label randomized controlled trial of two commonly used transfusion strategies in moderate to high risk patients who are 65 years of age or younger undergoing cardiac surgery on cardiopulmonary bypass, using a superiority trial design.
This is a Phase 1/2a, dose-escalation, multicenter, first-in-human, consecutive-cohort, open-label study of BI-1808, as a single agent and in combination with pembrolizumab in subjects with advanced malignancies, whose disease has progressed after standard therapy. For the purpose of this study, subjects with advanced malignancies includes subjects with advanced solid tumors (where iRECIST can be applied for efficacy assessment) and subjects with cutaneous T-cell lymphoma (CTCL), specifically Sézary Syndrome (SS) and mycosis fungoides (MF). The study will consist of 2 phases: a Phase 1 with Parts A and B, and a Phase 2a with Parts A and B. All subjects participating in the trial will complete a follow-up portion of the trial and an End of Treatment (EOT) Visit 30 days (±3 days) after their last dose of BI-1808.
Primary Objective: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): - Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on corticosteroid-treated AECOPD in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on respiratory symptoms in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on Forced Expiratory Volume in 1 second (FEV1) slope in former smokers with moderate-to-severe COPD - Evaluate the efficacy of itepekimab compared with placebo on health-related quality of life (HRQoL) as assessed by St. George's Respiratory Questionnaire (SGRQ) in former smokers with moderate-to-severe COPD - Evaluate the safety and tolerability of itepekimab in former smokers with moderate-to-severe COPD - Evaluate the pharmacokinetic (PK) profile of itepekimab in former smokers with moderate-to-severe COPD - Evaluate immunogenicity to itepekimab in former smokers with moderate-to-severe COPD Secondary population (current smokers cohort) - Estimate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate or severe COPD exacerbations in current smokers with moderate-to-severe COPD - Estimate the efficacy of itepekimab compared with placebo on pulmonary function in current smokers with moderate-to-severe COPD - Estimate the safety and tolerability of itepekimab in current smokers with moderate-to-severe COPD - Estimate the PK profile of itepekimab in current smokers with moderate to severe COPD - Estimate immunogenicity to itepekimab in current smokers with moderate-to-severe COPD
According to clinical guidelines, endoscopic surgery (mono- or bipolar TURBT, laser resection, en bloc resection) is a standard treatment option for patients with primary non-muscle invasive bladder cancer (NMIBC) (excluding carcinoma in-situ). However, more than half of patients will experience local recurrence after surgery. It is believed that one of the main causes for this local recurrence is the reimplantation of tumor cells during endoscopic surgery. It is crucial to limit contact between the resected tumor and the bladder wall during the operation and to extract the specimen as quickly as possible. In the case of a small tumor, the surgeon can immediately remove it using an endoscopic instrument. There are a number of methods available for removing large tumors, but it is not yet clear which one is most optimal. Therefore, comparing the oncological results from evacuating bladder tumors using various methods is very timely. Based on the previously mentioned studies, the investigators assume that the rate of bladder cancer relapse out site of the resection area would be lower in the morcellation group compared with piecemeal resection of the tumor. In order to prove this, the investigators plan to conduct a randomized study comparing the relapse rate in these two groups.
This is a randomized, controlled, parallel study to determine the efficiency and safety of total neoadjuvant therapy in rectal cancer treatment.
This study was designed to assess the safety and efficacy of neoadjuvant therapy with mitomycin C plus cisplatin (MP) in BRCA1-mutated ovarian cancer versus standard regimen (paclitaxel plus carboplatin (TP)).
This is a multicenter non-interventional observational study conducted with a single hand arm to collect real-world data. In this study, commercially available acalabrutinib will be used as prescribed treatment for CLL as per the treating physician's best clinical judgement. No additional procedures besides those already used in the routine clinical practice will be applied to the patients. Treatment assignment will be done according to the current practice. A multi-center collaborative effort in 15 centers selected from regions within Russia will help capture more patients into the database, rather than limiting the data to a single institution. This will be critical for: - increasing database sample size - reducing bias (single institution bias) - increasing result's generalizability to the whole Russian population Being an observational study, only data available from routine clinical practice and standard of care (SoC), in line with national and international laws and regulations, will be recorded. Patients will be treated according to prescribing information, with visit frequency and assessments performed according to routine medical practice and SoC. Only data corresponding to these visits and assessments will be collected as part of the study. Data for the study will be transcribed and entered into an electronic Case Report Form (eCRF) from the patient's medical records. The site investigator will be responsible for ensuring that all required data is collected and entered into the eCRF with the involvement of clinical research organization