Astana

Researchers are evaluating the safety and effectiveness of three different doses of MORF-057 in adults with moderately to severely active Crohn's disease (CD). This Phase 2 study is randomized, double-blind, placebo-controlled, and conducted at multiple centers. It aims to compare MORF-057 to placebo to see how well it works in reducing disease activity and symptoms in this patient population. Participants will first go through a 14-week induction period where they receive one of three doses of MORF-057 or a matching placebo, all given orally. After this, all participants will enter a 38-week maintenance phase where they receive open-label MORF-057. Those who complete these 52 weeks of treatment may continue in a 52-week long-term extension to further monitor treatment effects and safety. Throughout the study, participants will have evaluations to assess their response to treatment using endoscopic scoring at Week 14. Researchers will monitor safety, symptom changes, and disease activity over the full treatment and extension periods. Study visits will include assessments, questionnaires, and clinical monitoring to track participants' health and treatment adherence over time.

Researchers are evaluating whether the medicine tenecteplase helps adults recover from an acute ischemic stroke when given more than 4.5 hours after they were last seen well. This study focuses on people who had a stroke caused by a clot blocking blood flow in the brain and who have imaging showing brain tissue that can still be saved. Participants should not be planning to receive a procedure to remove the clot and must have a pre-stroke disability level of 0 or 1 on the modified Rankin Scale. Participants are randomly placed into two groups. One group receives a single injection of tenecteplase into a vein, while the other group receives standard medical care. The study includes adults aged 18 and over who had an acute stroke or woke up with stroke symptoms more than 4.5 hours ago. Imaging with MRI or CT is used to confirm eligibility. The study lasts about three months, starting with a hospital stay of about one week. During the study, participants have seven clinical examinations or visits to monitor their recovery and health. The last two visits may be done from home to allow remote assessments. Researchers use the modified Rankin Scale to measure disability or dependence in daily activities at 90 days after treatment. They also monitor for any side effects or health changes to compare the effects of tenecteplase against standard care.

Researchers are evaluating the clinical effectiveness of Ustekinumab in patients with Crohn's Disease through an observational study that includes both retrospective and prospective components. The study aims to assess the reduction in disease activity with a focus on the Crohn's Disease Activity Index over 24 weeks of therapy. The study involves patients who have been prescribed Ustekinumab for the first time between January 1 and December 31, 2024. Participants receive the usual care with Ustekinumab as prescribed, and the study observes their response to treatment without additional experimental interventions. Participants will be monitored for changes in their disease activity using the Crohn's Disease Activity Index at week 24. The study also involves collection of clinical data, monitoring for safety, and evaluating adherence to treatment. The total duration and detailed follow-up procedures are based on observing the patients through their routine care during the study period.

Researchers are evaluating the effectiveness of pharmacologic, surgical, and diet-based weight loss methods on lifespan and health in adults with metabolic syndrome, type 2 diabetes (T2D), and hypertension. This phase 4 clinical trial seeks to compare how these weight loss strategies impact glycemic control, lipid metabolism, quality of life, and cost-effectiveness over 24 weeks in patients aged 35 to 65 years with a BMI of 27 kg/m2 or higher for Asian ethnicity. The study addresses the growing prevalence of T2D complicated by hypertension and obesity, focusing on reducing cardiovascular risks associated with metabolic syndrome. The trial includes three treatment groups: one receiving a combination of subcutaneous Semaglutide (1 mg weekly) and oral Empagliflozin (25 mg daily) alongside standard care; another undergoing laparoscopic minigastric bypass surgery to reduce nutrient absorption; and a third following a very-low-calorie diet with fat-free vegetables, controlled salt intake, physical activity, and sexual self-restraint. Additionally, participants follow specific fasting and dietary rules during the Ramadan fasting period, including eating one meal daily after sunset and avoiding meat and fatty foods. The study involves preoperative evaluations for surgery patients and continuous support through in-person and phone consultations during the intervention. Participants are involved for 24 weeks, with assessments at baseline and study end measuring weight, body mass index, fat mass, fat-free mass, fasting blood glucose, blood insulin levels, and blood pressure. Additional evaluations include lipid profiles, bone mineral density, ejection fraction, quality of life questionnaires, and cost-effectiveness analyses. Physical activity is tracked by step counts using pedometers or digital devices. Blood samples are collected for laboratory tests and telomere length measurement using polymerase chain reaction methods. Safety and treatment effects are monitored closely throughout the study period.

Researchers are evaluating the effects of adding Anifrolumab to the usual treatment for Systemic Lupus Erythematosus (SLE) in a real-world setting. This international study, called INTERSTELLAR, aims to provide important evidence on how Anifrolumab helps patients with SLE, including those with skin symptoms related to the disease. The study uses standardized criteria and measures across multiple countries such as Qatar, Saudi Arabia, Mexico, Costa Rica, Panama, Dominican Republic, Colombia, Argentina, Taiwan, and Egypt to allow comparisons between different populations. INTERSTELLAR is a multi-country, single-arm observational study that includes both retrospective data from the year before starting Anifrolumab and prospective follow-up for one year after treatment begins. Patients join the study when they receive their first prescription and infusion of Anifrolumab, following the approved country-specific guidelines. The study will collect data until the patient dies, stops participating, or the study ends. Clinical assessments and patient-reported outcomes related to lupus activity, skin involvement, fatigue, and quality of life will be gathered throughout the study. Participants will be assessed at various times including before treatment and at 1, 3, 6, and 12 months after starting Anifrolumab. Researchers will monitor lupus disease activity, skin symptoms, fatigue, and quality of life using standardized tools. Data will continue to be collected even if patients stop the treatment, as long as they agree to stay in the study. This approach helps provide a comprehensive understanding of Anifrolumab's impact in routine clinical practice over a full year.

Researchers are evaluating the effectiveness of PD-1 inhibitors as maintenance therapy after autologous hematopoietic stem cell transplantation (auto-HSCT) in patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This phase II study aims to improve progression-free survival by preventing relapse and disease progression following this intense treatment. Despite existing therapies like brentuximab vedotin, many patients still face disease progression within two years after auto-HSCT, highlighting the need for better maintenance options. Participants will receive one of two PD-1 inhibitors as maintenance therapy: nivolumab or pembrolizumab. Nivolumab may be given either as a fixed 40 mg dose or 3 mg/kg intravenously every 14 days for up to 12 cycles, while pembrolizumab is administered as a fixed 200 mg dose intravenously every 21 days for up to 8 cycles. Treatment should start within 60 days after the transplant, with some flexibility allowed based on clinical judgment. Throughout the study, patients will be closely monitored for disease status and safety. The main outcome measure is progression-free survival at 24 months after starting the study treatment, tracking the time until disease relapse, progression, or death from any cause. Researchers will also evaluate adverse events, blood counts, performance status, and other clinical assessments to ensure participant safety and treatment adherence. The study focuses on patients aged 18 to 70 years with high-risk relapsed or refractory cHL who have responded to transplant treatment.

This research aims to evaluate the effectiveness of Pirfenidone, an oral anti-fibrotic drug, in treating patients with Acute Respiratory Distress Syndrome (ARDS), a serious lung condition causing severe inflammation and lung injury. ARDS leads to significant ICU admissions and high mortality rates, with many patients developing lung fibrosis even after the acute phase. Despite many clinical trials, no specific drug treatment has proven clearly effective for ARDS, making this randomized controlled trial important to explore new options. Participants will be randomly assigned to receive either Pirfenidone or a placebo. Pirfenidone will be given through a nasogastric tube in increasing doses: 801 mg per day from days 1 to 7, 1602 mg per day from days 8 to 14, and 2403 mg per day from day 15 until discharge from the ICU. The placebo group will receive a matching treatment schedule via nasogastric tube. The study is designed as a multicenter phase 3 trial to assess the drug's impact on ARDS. During the study, researchers will monitor participants closely, focusing on the number of days they are free from mechanical ventilation within 28 days. The study will include assessments of lung function and inflammation, with ongoing safety monitoring throughout ICU stay. Participants must meet specific criteria, including confirmed moderate to severe ARDS and an inflammatory phenotype. The study seeks to provide clear evidence on whether Pirfenidone can reduce lung fibrosis and improve outcomes in ARDS patients.

Gastric cancer is a common and deadly disease, ranking fifth in occurrence worldwide and third in cancer-related deaths. For patients with locally advanced gastric cancer, combining treatments like chemotherapy before and after surgery has improved survival. However, many patients still develop peritoneal carcinomatosis (PC), a serious condition where cancer spreads to the lining of the abdomen, occurring in about 60% of cases after surgery and linked to poor outcomes and limited treatment options. This research compares a new treatment method called pressurized intraperitoneal aerosolized chemotherapy (PIPAC) with standard care. PIPAC delivers chemotherapy drugs as an aerosol directly to the abdominal lining before surgery, which may better target cancer cells while reducing side effects. Patients in the intervention group receive preventive PIPAC with cisplatin and doxorubicin, combined with perioperative chemotherapy (FLOT regimen) and surgery to remove the stomach and lymph nodes. The control group receives standard perioperative chemotherapy and surgery without PIPAC. Throughout the study, researchers will monitor patients to see if preoperative PIPAC lowers the chance of developing peritoneal carcinomatosis within 12 and 24 months after surgery. They will also assess overall survival, disease progression, quality of life, serious side effects, postoperative complications, and pathological response. Participants will be closely followed after treatment to measure these outcomes and safety over time.

This research aims to describe the rate of chronic kidney disease (CKD) diagnosis in patients with arterial hypertension (high blood pressure) and markers of CKD in Kazakhstan. The study is a multicenter, non-interventional, prospective observational study that also includes retrospective analysis. It focuses on patients with hypertension and markers such as albuminuria or reduced kidney filtration rate (GFR below 60 ml/min/1.73 m2). Participants are adults diagnosed with hypertension according to clinical guidelines, with specific laboratory markers of CKD measured within the last 12 months and persisting for at least 3 months. The study does not involve any interventions or treatments and observes patients' existing conditions and therapies. It evaluates the proportion of patients with CKD markers among those with hypertension and further assesses demographic and clinical characteristics as well as routine therapies before and after CKD diagnosis. During the study, researchers will collect data on patient medical records, laboratory test results, and diagnoses. The primary outcome is the proportion of patients with CKD markers within 16 months. Secondary outcomes include further evaluation of patients with confirmed CKD diagnoses. The study spans prospective observation and retrospective review, focusing on real-world clinical information without altering patient care.

Researchers are evaluating the safety and effectiveness of a new treatment for patients with ischemic heart failure (iHF) who have a left ventricular ejection fraction (LVEF) of 40% or less despite receiving the best medical care. This Phase 2 study compares a single injection of fresh, uncultured, autologous adipose-derived regenerative cells (UA-ADRCs) isolated from a patient's own fat tissue using the Transpose RT / Matrase System, delivered through a small balloon catheter into a coronary vein, with continued best guideline-based medical treatment alone. The goal is to determine if this cell therapy can improve heart function more than standard care. The study involves 36 patients randomly assigned to either receive the UA-ADRCs injection (24 patients) or continue their best medical treatment (12 patients). The injection is performed retrogradely via the coronary sinus to the site of interest in the heart. Follow-up visits occur at 1, 3, and 6 months after treatment, including MRI or CT scans of the heart, physical exams, echocardiography, questionnaires about symptoms and quality of life, medication review, and monitoring for adverse events. After completing these visits, control group patients may also receive the cell therapy, and all participants are offered the chance to join a registry study with longer-term follow-up up to 24 months. Participants will undergo multiple assessments including measurement of left ventricular ejection fraction by cardiac MRI or CT at baseline and 6 months to determine treatment success, defined as a 15% or greater improvement in LVEF. Additional outcomes include blood tests, walking tests, heart failure questionnaires, hospitalizations, and adverse event monitoring. Safety is closely tracked through reporting of major adverse cardiac events and other side effects. The total study duration includes enrollment and 6 months of individual follow-up, with longer-term data collection for interested patients.