Tyumen

Researchers are evaluating the long-term safety of study treatments for participants with pulmonary hypertension (PH) who were treated with specific medications in earlier clinical studies and have no other way to access these treatments. This study is designed for people who have finished their previous parent studies and may continue to benefit from the treatment. It is an open-label, phase 3 platform study that follows participants over an extended period to monitor safety. Participants will receive one of the study drugs they used in their parent study, including oral macitentan, selexipag, or a fixed-dose combination of macitentan and tadalafil. Adults take standard doses, while children aged 2 to under 18 years receive doses adjusted for their body weight to match adult exposure levels. Selexipag is given twice daily with dosing adjusted for body weight in children. This treatment continues as in the parent studies, providing ongoing access to these medications. During the study, participants will be regularly monitored for treatment-emergent adverse events, serious adverse events, and any events leading to discontinuation or death, with follow-up lasting up to 84 months. Female participants of childbearing potential will undergo monthly pregnancy testing and agree to contraceptive use during the study and safety follow-up. The study involves ongoing safety assessments to ensure participant well-being while providing access to the study treatments over the long term.

This research investigates treatment patterns and the evaluation of homologous recombination repair mutations (HRRm) in circulating tumor DNA (ctDNA) among patients with aggressive high-volume metastatic hormone-sensitive prostate cancer (mHSPC) in the Russian Federation. The study focuses on patients with high-aggressive disease characterized by Gleason scores 8-10 and high-volume disease as defined by specific criteria for bone and visceral metastases. Approximately 400 male patients aged 18 years and older with known tumor HRRm status will participate to better understand demographic and clinical characteristics and treatment approaches in routine practice. The study does not introduce new treatments but observes and collects data as patients receive standard care. Two study visits will occur: the first at baseline to gather medical history, demographic data, and treatment information from diagnosis to enrollment, including routine blood samples for ctDNA and HRRm testing. The second visit will happen at disease progression or after about 12 months to collect follow-up data on progression to metastatic castration-resistant prostate cancer (mCRPC) and subsequent treatments. Blood samples will be analyzed centrally. Participants will have their medical records reviewed and may be interviewed to complete missing information. Data will be entered into electronic records by the study physician. Outcome measures include the proportion of patients receiving various treatments (such as androgen deprivation therapy, chemotherapy, radiation, surgery, and specific inhibitors), duration of therapies, time to progression, mutation presence in ctDNA, testosterone levels, and sites of disease progression over 36 months. Follow-up may be completed by phone if in-person visits are not possible, with the total study duration lasting about 38 months or until data from 400 patients are collected.

Researchers are comparing the effects of the dietary supplement Gepaktiv with standard medications ursodeoxycholic acid (UDCA) and Ademetionine in adults aged 18 to 65 who have metabolic-associated fatty liver disease (MAFLD) and an enlarged liver (hepatomegaly). This study aims to evaluate if Gepaktiv can improve liver function and reduce liver size as effectively as the standard treatments. It involves 90 participants divided equally into three treatment groups. Participants will receive one of three treatments for 15 days: Gepaktiv capsules taken 2 capsules three times daily before meals, UDCA at 10-15 mg per kilogram per day, or Ademetionine at doses between 800 and 1600 mg daily. An optional follow-up period of up to 60 days is available to monitor ongoing effects. The study uses a randomized, open-label design with standardized ultrasound scans and FibroScan measurements to assess liver fat and fibrosis. During the study, doctors will monitor liver health through blood tests measuring enzyme levels such as ALT and AST, ultrasound scans to measure liver size, and FibroScan to evaluate fat accumulation and fibrosis. Participants will keep daily diaries to track treatment adherence. Researchers will also assess changes in lipid profiles, protein levels, and quality of life using questionnaires. All assessments are conducted by blinded evaluators to ensure unbiased results.

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.

Researchers are evaluating the long-term safety and effectiveness of pembrolizumab (MK-3475) in participants with advanced solid tumors or blood cancers who have previously taken part in other pembrolizumab-based studies. This phase 3 study includes participants who are either currently on treatment or in follow-up from prior parent studies. It aims to understand how well pembrolizumab works over an extended period, up to approximately 10 years, by observing overall survival and safety outcomes. The study has three phases: First Course Phase, Survival Follow-up Phase, and Second Course Phase. Participants who were receiving pembrolizumab, pembrolizumab-based combinations, or lenvatinib in their parent studies will continue treatment in the First Course Phase, completing up to 35 doses every 3 weeks or 17 doses every 6 weeks. Those in the Follow-up Phase will enter the Survival Follow-up Phase without additional treatment but will be monitored. Participants eligible for a Second Course Phase, who have not received other anticancer treatments since their prior pembrolizumab dose and meet health criteria, may receive up to 17 doses every 3 weeks or 8 doses every 6 weeks of pembrolizumab or its combinations. Some may also receive other study drugs such as olaparib, MK-4280, MK-4280A, or pembrolizumab with berahyaluronidase alfa. Participants will be involved in regular treatment visits, safety checks, and long-term monitoring for up to about 10 years to assess overall survival. Researchers will evaluate clinical outcomes, monitor any side effects, and check organ function and physical health status. The study includes detailed eligibility screening, including physical assessments and adherence to contraception requirements for women of childbearing potential. Safety follow-up is ongoing to ensure participant well-being throughout the study.

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.

Researchers are studying the quality of primary health care for patients with arterial hypertension, focusing on how timely, accessible, and modern the medical care is. The study aims to evaluate how well doctors follow current clinical recommendations for diagnosis and treatment. It uses a cardiovascular disease registry system established at a federal clinical hospital in Russia to analyze patient data and improve care practices. The study collects medical data from outpatient records of patients aged 18 to 99 years with diagnosed arterial hypertension. This information is entered into an arterial hypertension registry, a computer program with remote access designed for online data collection from primary care. Doctors were trained to minimize errors, and patient data is transmitted anonymously through a secure channel after informed consent is obtained. Participants' medical examination and treatment data will be analyzed to observe trends in care quality from 2018 to 2021. The main outcome measured is the number of patients achieving blood pressure below 140/90 mm Hg. The registry allows ongoing monitoring and comparison with clinical guidelines to identify areas for improvement in managing arterial hypertension.

Researchers are studying the presence and types of other health conditions in patients having abdominal surgery to better understand and categorize the risk of complications after surgery. The goal is to identify which existing diseases independently predict such risks, as this knowledge is important for informed consent and planning preventive care. The study focuses on adults with certain physical health statuses undergoing planned operations, noting that while anesthesia risks have decreased, complications remain a significant concern worldwide. The study collects detailed information before surgery about patient age, gender, physical status (ASA classification), various chronic diseases like heart, lung, kidney, neurological disorders, and diabetes, as well as treatments the patient is receiving. It also records the type and severity of different abdominal surgeries and anesthesia methods used. Data is gathered uniformly from multiple centers and entered into an electronic database. The study includes patients operated on within defined days and monitors them until hospital discharge. Participants will have their health and surgical data collected and tracked, including cognitive function, respiratory and cardiac risk scales, and kidney and liver function. Postoperative complications occurring within 7 days of surgery are the main outcomes measured. The study plans to enroll a large number of patients to develop reliable risk prediction models, with ongoing data analysis using statistical methods to identify significant predictors. Results will be validated with additional patient groups to improve accuracy and clinical usefulness.

Researchers are conducting a multicenter observational study in the Russian Federation to understand treatment approaches and the prevalence of HER2 positive status in different stages of bladder cancer, as well as PD-L1 positive status in metastatic bladder cancer. This study includes approximately 600 adult patients diagnosed with urothelial bladder cancer at various stages: high-risk non-muscle invasive bladder cancer (NMIBC), muscle-invasive bladder cancer (MIBC), and metastatic bladder cancer (mBC). The study does not involve any intervention but collects primary and secondary clinical data for descriptive and epidemiologic analysis. Patients will be grouped into three cohorts based on their bladder cancer stage at enrollment. Data collection involves one routine clinical visit where demographic information, clinical characteristics, medical history, and treatment approaches are recorded. Formalin-fixed paraffin-embedded (FFPE) tumor tissue samples collected during routine care will be sent to a central laboratory for immunohistochemistry testing. The study plans to enroll patients over approximately 18 months across about 30 oncology centers in Russia. During the single study visit, investigators will enter patients' medical data into electronic case report forms from medical records. No follow-up visits are planned. The study will measure outcomes such as proportions of patients receiving various treatments over 24 months, number and timing of cancer relapses, progression to metastatic disease, and treatment responses. Safety monitoring or additional interventions are not part of this observational study.

Researchers are conducting a multicenter observational study in the Russian Federation to examine treatment approaches, patient characteristics, and biomarker prevalence in men with newly diagnosed high-aggressive metastatic hormone-sensitive prostate cancer (mHSPC). The study focuses on patients with Gleason scores between 8 and 10 who were diagnosed within two years before enrollment. It aims to collect information on demographic and clinical features, treatment methods, and biomarker status, including PTEN loss, HER2-positive status, HRR mutations, and HRD positivity. Participants will not receive any additional procedures beyond their routine clinical care. Data will be collected during a single visit and include medical history, treatment received, and outcomes. Tumor tissue samples taken during standard care will be tested centrally for biomarkers using immunohistochemistry and next-generation sequencing. Approximately 400 patients across around 30 sites will be enrolled over about 27 months or until the target number is reached. During the study visit, researchers will gather information from medical records and patient interviews, entering data into an electronic case report form. No follow-up visits are planned. Key outcomes measured include the types and proportions of treatments patients have received over 24 months, such as hormone therapy, chemotherapy, radiation, surgery, and combination therapies, as well as biomarker test results. The study duration includes enrollment and data collection until database lock.