Newport

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease MASLD. The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation FMT delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatments impact and safety in patients with cirrhosis.

This study evaluates the long-term safety and tolerability of pelacarsen TQJ230 in people with established cardiovascular disease and elevated Lipoproteina who completed a previous related study. It is an open-label extension trial, meaning all participants receive the study drug without placebo comparison. The trial is sponsored by Novartis Pharmaceuticals and focuses on continued treatment after the completion of the parent study. Participants receive monthly injections of pelacarsen 80 mg subcutaneously for up to 36 months during this extension phase. This phase is designed to provide access to the study drug after the initial trial and to monitor participants closely. The study does not involve randomization or blinding, and all enrolled participants receive the active drug. During the study, participants will undergo regular assessments including monitoring for adverse events and cardiovascular events, as well as measuring Lipoproteina levels at baseline and several time points over 36 months. Safety and tolerability will be closely tracked throughout the treatment period. The total duration of participation corresponds to the length of the extension phase, up to three years.

Severe diabetic macular oedema DMO affects the central part of the retina called the macula, leading to sight loss due to fluid buildup from leaking blood vessels. This condition mainly occurs in adults with type 1 or type 2 diabetes and is measured by how thick the macula becomes in microns. This trial evaluates and compares the current standard treatment of anti-vascular endothelial growth factor anti-VEGF injections alone with a new approach where patients start with anti-VEGF injections and then switch to subthreshold micropulse laser SML treatment once the macula thickness decreases below 400 microns. Participants are randomly assigned to receive either continued anti-VEGF monotherapy or a combination where anti-VEGF treatment is followed by SML applied every 2-3 months after the macula thickness drops below 400 microns. Anti-VEGFs used include ranibizumab, aflibercept, faricimab, and brolucizumab, administered monthly initially and then spaced out as needed. SML is applied according to the study guidelines once the macula thins, aiming to reduce the number of injections required. During their participation, individuals will undergo regular optical coherence tomography OCT scans to measure macular thickness and visual acuity tests up to 104 weeks after randomization. Researchers will assess vision changes, macular thickness, quality of life, safety, treatment use, and participant experience. The study also includes follow-up questionnaires and qualitative interviews to understand patient preferences and the potential for wider implementation of the laser treatment strategy.

Researchers are conducting a prospective, multicenter observational study to follow up on individuals treated with Bearing nsPVA Embolization Particles for uterine fibroid embolization. The study focuses on collecting data regarding the safety and performance of these particles over a six-month period. The study is sponsored by Merit Medical Systems, Inc. and involves adult women with symptomatic uterine fibroids suitable for embolization. The intervention being observed is the use of Bearing nsPVA Embolization Particles, which are irregularly-shaped, biocompatible particles made from polyvinyl alcohol. These particles are designed to block or reduce blood flow in targeted blood vessels through selective catheter placement. The study tracks outcomes following the use of this device in treating uterine fibroids, with no comparison groups or placebo treatments. Participants will be monitored for safety outcomes up to 30 days and effectiveness outcomes through six months after treatment. Data collection will include evaluations related to the devices performance and participant health status during follow-up visits. The overall participation duration includes the initial treatment and subsequent monitoring over half a year to assess treatment impact and safety.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

Researchers are evaluating treatments for high-risk polycythemia vera PV, a blood condition. This phase III international trial compares the drug ruxolitinib against the best available therapy, which includes hydroxycarbamide or any form of interferon alpha, chosen by the doctor before randomization. The study aims to determine which treatment better prevents serious complications and improves patient outcomes over about three years. Participants will be randomly assigned to one of two groups one receiving oral ruxolitinib 10 mg twice daily, and the other receiving either hydroxycarbamide or interferon alpha via standard hospital care. There is no switching between treatments during the study. The trial is open-label, meaning both doctors and participants know which treatment is given. During the trial, participants will have regular assessments including blood tests, symptom and quality of life questionnaires, and monitoring for events like thrombosis, bleeding, or disease progression. Researchers will track treatment side effects, blood markers, spleen size, and time between blood removal procedures. The study duration is approximately three years per participant, with some outcomes followed up to eight years to assess long-term effects and health economics.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating whether adding diffusion weighted MRI scans of the liver at diagnosis can detect more synchronous metastases than CT scans alone in patients with high risk colorectal cancer. This phase II multicenter study focuses on patients with advanced primary colorectal tumors who have no evidence of liver metastases on CT. The liver metastases found through the additional DW-MRI scans will be reviewed by a multidisciplinary team to determine appropriate management based on local protocols. Participants will undergo additional liver DW-MRI scans including T2-weighted, diffusion weighted imaging, and apparent diffusion coefficient sequences. These scans will be performed six months after surgery and then every six months for three years to monitor for liver metastases. If liver metastases are detected, treatment decisions will be made by the local multidisciplinary team following their standard procedures. During the study, participants will have regular imaging assessments to track the presence and progression of liver metastases. Researchers will analyze baseline tumor risk factors, patterns of metastatic relapse, and survival outcomes over time. The primary outcome is the detection and treatment of liver metastases as guided by local protocols, with follow-up to five years after the last patient is recruited. This study aims to improve understanding of liver disease progression in high risk colorectal cancer and assess the accuracy of DW-MRI as a screening tool.