Astana

Researchers are evaluating the safety and effectiveness of three different dose regimens of MORF-057, a small molecule drug, in adults with moderately to severely active Crohns disease CD. This Phase 2, randomized, double-blind, placebo-controlled, multicenter study aims to compare these doses with a matching placebo during an induction treatment period. The study includes adult participants who have active symptoms of CD and have not adequately responded to other treatments. Participants will first undergo a 14-week induction period where they receive either one of the three blinded MORF-057 dose regimens or a matching placebo, all taken orally. Following this, all participants enter a 38-week maintenance period receiving open-label MORF-057. Those who complete this 52-week treatment phase may have the chance to continue treatment for an additional 52 weeks during a long-term extension. MORF-057 is designed to selectively inhibit integrin 47. During the study, participants will have their disease activity monitored using endoscopic assessments and clinical symptom scores, such as the Simple Endoscopic Score for Crohns Disease SES-CD and the Crohns Disease Activity Index CDAI. Researchers will assess the proportion of participants showing endoscopic response and clinical remission at Week 14. Safety and adherence will be closely followed throughout the treatment and extension phases. The entire study spans up to 6 years, allowing for long-term evaluation.

This trial is for adults who have had an acute ischemic stroke caused by a blood clot blocking a brain vessel. It focuses on people whose stroke occurred or was discovered more than 4.5 hours ago, including those who woke up with stroke symptoms. The study aims to find out if the medicine tenecteplase helps recovery when given after this 4.5-hour window, compared to standard medical care. Tenecteplase is already used within 4.5 hours after stroke onset, but this study tests its effect when given later. Participants are randomly assigned to one of two groups one receives a single injection of tenecteplase into a vein, and the other receives the usual standard treatment. Both groups have an equal chance of receiving either treatment. The study lasts about three months, starting with approximately one week of hospital stay. During the study, participants have seven clinical examinations or visits, with the final two visits conducted remotely from home to allow for easier participation. Throughout the study, doctors regularly assess participants recovery using a scale that measures disability and dependence in daily activities. They also monitor overall health and record any side effects. The main outcome measured is the level of recovery 90 days after treatment, comparing the two groups. This includes neurological improvement, bleeding events, and survival over the study period.

Researchers are evaluating the safety and effectiveness of the CorWave Left Ventricular Assist System LVAS for treating patients with advanced heart failure. This prospective, multi-center, non-randomized trial focuses on adults aged 18 to 75 years who have advanced left ventricular heart failure and meet specific heart function criteria. The study is sponsored by CorWave and aims to assess survival and freedom from adverse events related to the device. Participants will receive implantation of the CorWave LVAS device to support heart function. The study follows a single group design where all participants receive this advanced device to treat their condition. The treatment period includes monitoring for survival and device-related complications, with outcome measurements extending up to two years after implantation. During the study, participants undergo regular assessments including evaluations of survival 30 days post-implant, adverse events, quality of life, neurocognitive function, and functional status up to two years. Researchers will also track freedom from bleeding, infection, stroke, and other complications at various time points. The total participation duration spans up to two years with ongoing safety and health monitoring throughout the study.

Researchers are investigating different ways to reduce weight in adults aged 35 to 65 years who have metabolic syndrome, including type 2 diabetes and hypertension. This study aims to compare the effects of drug treatment, surgery, and diet on lifespan, blood sugar control, blood fat levels, quality of life, and cost-effectiveness over 24 weeks. The study includes patients with obesity and metabolic syndrome complications, examining how these approaches influence health outcomes. The study has four groups one receives a combination of medications including Semaglutide and Empagliflozin alongside standard treatments another undergoes a surgical procedure called minigastric bypass to reduce food absorption a third follows a very-low-calorie diet with fat-free vegetables and controlled salt intake combined with physical activity and the fourth group practices fasting during the Ramadan period following specific dietary rules. Treatments and lifestyle changes are monitored over 24 weeks with ongoing support through in-person and phone consultations. Participants will have regular assessments including weight, blood sugar, insulin levels, blood pressure, cholesterol, and bone density measured at the start and end of the study. Other evaluations include body composition analysis, ultrasound, electrocardiograms, and quality of life questionnaires. The study also measures telomere length as a marker of cellular health. Safety, treatment adherence, and cost-effectiveness are tracked throughout, with all participants continuing their standard care during the trial.

Researchers are conducting the INTERSTELLAR study to gather important real-world evidence about adding anifrolumab to the usual treatment for systemic lupus erythematosus SLE. This observational study is taking place across multiple countries, including regions like GCC, Mexico, Central America, Colombia, Argentina, Taiwan, and Egypt. It aims to provide data useful for doctors, payers, and patients by using consistent criteria and measures for SLE and skin symptoms related to lupus. Participants will be observed for one year before starting anifrolumab and followed for one year after beginning treatment. The study starts after anifrolumabs commercial launch in each country and includes patients from the time of their first anifrolumab prescription and infusion. Data collection continues even if participants stop taking anifrolumab, unless they withdraw their consent. During the study, clinical assessments and patient-reported outcomes will be collected at baseline and at months 1, 3, 6, and 12. These include disease activity scores PGA, SLEDAI-2K, skin involvement measures CLASI, fatigue assessments FACIT-Fatigue, and quality of life questionnaires LupusQoL, EQ-5D-5L. The study monitors participants until death, loss to follow-up, withdrawal, or study end, aiming to reflect real-world use and outcomes of anifrolumab in routine care.

Researchers are evaluating the clinical 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 focuses on preventing relapse and disease progression in patients who often experience these within two years after auto-HSCT. Current treatments like brentuximab vedotin have improved outcomes but still show limitations, making PD-1 inhibitors a promising alternative due to their favorable toxicity profile and potential for durable remission. Participants will receive maintenance therapy using PD-1 inhibitors, either nivolumab or pembrolizumab, as decided by the study center. Nivolumab is given intravenously either as a fixed 40 mg dose every two weeks for up to 12 cycles or at 3 mgkg every two weeks for up to 12 cycles. Pembrolizumab is administered as a fixed 200 mg dose intravenously every three weeks for up to 8 cycles. Treatment should begin within 60 days after transplantation, with some exceptions allowed under study leadership guidance. Throughout the study, participants will be closely monitored with assessments including imaging scans, blood tests, and evaluation of adverse events. The main outcome measured is progression-free survival at 24 months after starting maintenance therapy, alongside secondary measures such as survival rates and relapse incidence at 12, 18, and 24 months. Safety and tolerability will also be tracked during therapy and for one year after treatment completion. The overall study duration extends to September 2030.

Acute respiratory distress syndrome ARDS is a serious lung condition causing inflammation and fluid buildup, leading to severe breathing problems and high mortality in intensive care units worldwide. Despite many clinical trials, no specific drug has yet proven effective in treating ARDS. The study aims to evaluate the anti-fibrotic medication Pirfenidone, previously used for idiopathic pulmonary fibrosis, to see if it can prevent lung fibrosis and improve outcomes in ARDS patients. Participants will be randomly assigned to receive either Pirfenidone or a placebo. Pirfenidone dosing starts at 801 mg per day for the first week, increases to 1602 mg per day for the second week, and then to 2403 mg per day until ICU discharge. The medication or placebo is given through a nasogastric tube in three divided doses daily. This is a phase 3 randomized controlled trial conducted across multiple centers. Throughout the study, researchers will monitor the number of days participants are free from ventilators within 28 days, length of ICU stay, lung imaging changes, mortality rates, lung function tests, heart function, and quality of life up to one year. Samples from the lungs will also be collected to study inflammation. Safety and any adverse effects will be closely tracked. The study will continue until December 2026.

Gastric cancer is a common and serious disease, ranking as the fifth most frequent cancer worldwide and the third leading cause of cancer-related deaths. Patients with locally advanced gastric cancer often face the challenge of peritoneal carcinomatosis PC, a condition occurring in 60% of cases after surgery and linked to poor outcomes. Researchers are evaluating whether adding a new preoperative treatment called pressurized intraperitoneal aerosolized chemotherapy PIPAC can reduce the occurrence of PC compared to standard treatment alone. The study compares two groups one receiving PIPAC with the chemotherapy drugs cisplatin and doxorubicin before standard perioperative chemotherapy FLOT regimen and surgery including gastrectomy with lymphadenectomy the other group is a retrospective cohort receiving only the standard chemotherapy and surgery. PIPAC delivers chemotherapy as an aerosol directly to the peritoneal surface, aiming to penetrate tumor implants more deeply while minimizing side effects. Participants will be monitored through scheduled assessments, including evaluations of survival rates, disease progression, quality of life using the EORTC QLQ-C30 questionnaire, and safety events. The main outcome is the incidence of peritoneal carcinomatosis at 12 and 24 months after surgery. Secondary outcomes include overall and disease-free survival, adverse events, and pathological response. The study begins in January 2025 and will follow participants over multiple years to gather these results.

Researchers are investigating 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 study compares a single injection of fresh, uncultured, autologous adipose-derived regenerative cells UA-ADRCs isolated from a patients own fat tissue, delivered through a small balloon catheter into a coronary vein, against the continuation of the best guideline-based medical treatment. The goal is to see if this cell-based therapy improves heart function more than standard treatment. The study involves two groups one group of 24 patients will undergo a liposuction procedure to collect fat tissue, from which UA-ADRCs will be isolated using the Transpose RT Matrase System and then injected into the heart veins using a balloon catheter. The other group of 12 patients will continue with their regular medical treatment without the cell therapy. Follow-up visits are scheduled at 1, 3, and 6 months after treatment, and patients in the control group may later receive the stem cell therapy if they complete these visits. Additionally, all participants may join a long-term registry study with follow-ups at 12 and 24 months. During follow-up visits, participants will undergo cardiac MRI or CT scans, physical exams including echocardiography, answer questionnaires about their quality of life, and have their medication use and hospitalizations monitored. The primary measure of treatment success is a 15% or greater improvement in LVEF at 6 months. Secondary assessments include blood tests, a 6-minute walk test, scar tissue evaluation for MRI patients, heart failure symptom scores, and monitoring for any serious heart-related adverse events. The total study duration includes 6 months of individual follow-up after enrollment.

Researchers are studying bronchiectasis in adults and adolescents aged 12 to under 18 who produce sputum and have experienced flare-ups. The trial aims to evaluate whether the medicine BI 1291583 can help reduce these flare-ups compared to a placebo. Participants are randomly assigned to receive either BI 1291583 or a placebo in a phase III, double-blind study. Participants take one tablet of either BI 1291583 or placebo once daily for up to 1 year and 6 months. The study includes two groups one receiving the active medication and the other receiving placebo tablets that look identical but contain no medicine. The study period lasts up to 1 year and 8 months, during which participants attend up to 10 site visits and receive about 13 phone calls. During the study, participants regularly record their bronchiectasis symptoms in a smartphone diary. Study doctors monitor participants health, note any flare-ups, and check for unwanted effects. Researchers compare the number of flare-ups between the two groups as the primary measure. Secondary measures include time to first flare-up, quality of life changes, lung function changes, and rates of severe flare-ups.