Newport

Researchers are investigating whether encapsulated faecal microbiota transplantation (FMT) can help reduce infections and mortality in adults with alcohol-related or metabolic dysfunction-associated steatotic liver disease (MASLD) cirrhosis. Cirrhosis, a severe scarring of the liver, is a growing health crisis, leading to high rates of early death, with infections being a major complication. Previous trials showed that FMT delivered endoscopically is safe, and this study aims to test a capsule form of FMT to improve patient outcomes without the need for invasive procedures. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical. They will take five capsules every three months for up to 21 months or until they develop an infection requiring hospital admission. This double-blind trial will follow participants for up to 24 months to compare infection rates and time to hospitalization between the two groups. The study will also explore if FMT improves liver function, immune response, and reduces harmful bacteria linked to cirrhosis complications. During the study, participants will be closely monitored for infections and other cirrhosis-related complications through hospital visits and assessments. Researchers will measure the time until the first infection or decompensation leading to emergency or hospital admission. Laboratory tests will evaluate immune system changes and the presence of antibiotic-resistant bacteria. The trial will last up to two years, aiming to provide insights into new, antibiotic-free treatments for cirrhosis and influence future care and policy.

This research aims to evaluate the long-term safety and tolerability of pelacarsen (TQJ230) in adults with established cardiovascular disease and elevated Lipoprotein(a) who have completed the parent trial CTQJ230A12301. The study is an open-label extension following the phase 3 parent study, providing participants continued access to pelacarsen after the initial trial. Participants will receive pelacarsen 80 mg by subcutaneous injection once a month during this open-label extension. The study is single-arm and multicenter, focusing on continued treatment with pelacarsen for up to 36 months after completion of the parent study. Throughout the study, participants will be monitored regularly to assess safety and tolerability, with particular attention to adverse events occurring up to 36 months. Researchers will collect data on health status throughout this period to understand the long-term effects of pelacarsen in this patient population.

Severe diabetic macular oedema (DMO) is a condition where fluid builds up in the macula, the central part of the retina responsible for detailed vision, leading to sight loss. This trial studies people over 18 years old with type 1 or type 2 diabetes who have severe DMO, defined by a thickened macula (400 microns or more). Researchers are comparing the current standard treatment of anti-VEGF eye injections alone to a new approach where patients start with anti-VEGF injections and switch to subthreshold micropulse laser (SML) treatment once the macula thickness decreases below 400 microns. Participants will be randomly assigned to receive either ongoing anti-VEGF injections or to switch to SML treatment after initial anti-VEGF therapy. Anti-VEGFs such as ranibizumab, aflibercept, faricimab, and brolucizumab are given as monthly injections at first, then every 1-3 months. The SML procedure, which does not damage the macula, will be applied based on the trial guidelines once the macula is less than 400 microns thick. This study aims to see if the combined treatment is as effective and more cost-efficient than anti-VEGF injections alone. Participants will attend regular clinic visits for eye exams including optical coherence tomography (OCT) scans to measure macula thickness and assessments of visual acuity over 104 weeks after randomization. Researchers will monitor best-corrected visual acuity, side effects, participant experience, and cost-effectiveness. The trial includes follow-up for two years with safety monitoring and evaluation of how this approach might be adopted in routine care. The study is conducted at multiple hospital eye services across the UK.

Researchers are evaluating the use of Bearing nsPVA Embolization Particles in a prospective, multicenter, observational study for women with symptomatic uterine fibroids. The study focuses on collecting data about the safety and performance of these particles when used for uterine artery embolization over a period of six months. The study involves treating participants with Bearing nsPVA Embolization Particles, which are irregularly shaped, biocompatible, hydrophilic, and nonresorbable particles made from polyvinyl alcohol. These particles are designed to block or reduce blood flow in target vessels during uterine artery embolization, aiming to treat symptomatic uterine fibroids. Participants will be monitored for safety over 30 days and for effectiveness over six months. Data collection will include assessments related to the treatment's safety and performance. Participants will provide written informed consent and will be observed for any adverse events or changes in their condition during the follow-up period.

Researchers are evaluating the effectiveness and safety of bomedemstat compared to hydroxyurea in people diagnosed with essential thrombocythemia (ET) who have not yet received cytoreductive therapy but need it. This Phase 3 study aims to determine if bomedemstat leads to a better lasting clinicohematologic response than hydroxyurea in these patients. Participants will receive either oral bomedemstat capsules or oral hydroxyurea capsules, with placebos used to maintain the study's double-blind design. The study compares these two treatments to see which better manages ET with a focus on sustained treatment response. The treatments are taken as capsules, but specific dosing schedules are not detailed in the available information. During the study, researchers will monitor participants up to 52 weeks to measure their durable clinicohematologic response. Participants will undergo regular assessments to evaluate treatment effects and safety. The study includes safety monitoring and collects data on how well patients respond to the therapies over time, ensuring comprehensive evaluation of both treatments.

This research aims to evaluate different ways of giving an antibiotic called cefuroxime to patients having bowel surgery, which carries a high risk of infection. It builds on a previous smaller study that tested a single dose versus a single dose plus a continuous infusion of antibiotic during surgery. The current trial is larger and conducted in three hospitals to see if the study design works across different settings and to compare if one treatment method leads to fewer infections within 30 days after surgery. Participants will receive cefuroxime either as a single dose before surgery or as a single dose plus a continuous infusion throughout the operation. All patients will have elective colorectal surgery expected to last more than two hours. The study will follow a double-blind design, meaning the staff caring for patients and those counting infections will not know which treatment was given unless necessary. During the study, up to 180 patients will be monitored for infections occurring up to 30 days post-operation. Researchers will track recruitment and retention rates over 24 months and 90 days, respectively. Patients will be assessed for eligibility, consented, and monitored for safety, with infection rates as the main outcome. This trial is a Phase 2 feasibility study aimed at testing the study methods and gathering data to inform larger future trials.

Researchers are evaluating the optimal duration of antibiotic treatment for adults with complicated intra-abdominal infections (cIAI). This Phase 3 trial aims to compare a fixed extended duration of 28 days of antibiotics to the current standard care durations, which typically range from 7 to 18 days. The study will assess clinical outcomes, quality of life, and cost effectiveness over a 180-day follow-up period to determine which approach may better reduce treatment failure and improve patient care while considering antimicrobial resistance concerns. Participants will be randomly assigned to one of two groups: the standard care group, where antibiotic type and duration are determined by their clinician, or the fixed extended-duration group, which receives antibiotics for a set 28-day period. The study includes a total of 1166 adult patients recruited from intensive care units and hospital wards across approximately 30 NHS trust hospitals. The treatment period is followed by monitoring up to 180 days after randomization. During the study, patients or their personal consultees will complete quality of life questionnaires at baseline and at 30, 60, and 180 days post-randomization. They will also provide information about antibiotic use and healthcare resource utilization. Researchers will collect hospital records on admissions, relapses, and further infections. The main outcome measured is treatment failure within 180 days of randomization, with safety and effectiveness assessed throughout the follow-up period.

Researchers are studying patients with known or suspected angina who do not have obstructive coronary artery disease to see if a special diagnostic test can help guide personalized treatment. This condition includes ischaemic heart disease, microvascular angina, and vasospastic angina. The trial builds on earlier research suggesting that tailoring treatment based on coronary vascular function tests may improve symptoms and quality of life. This large, multicentre, blinded, randomized study aims to confirm these findings and assess effects on health and wellbeing over a longer period. Participants undergo invasive coronary angiography along with an adjunctive interventional diagnostic procedure (IDP) that measures coronary vascular function using a guidewire technique. Patients with no significant artery blockage are randomized into two groups: one where IDP results are disclosed to guide treatment decisions, and a control group with concealed results receiving standard care. Those with abnormal vascular function in the intervention group may have repeated assessments to tailor medications, such as calcium channel blockers. Patients with obstructive artery disease or other exclusions may join a registry for follow-up and assessment. Throughout the study, participants complete questionnaires about angina symptoms, quality of life, activity levels, treatment satisfaction, and pain. Researchers monitor clinical outcomes for at least 12 months, including major cardiovascular events. The study also evaluates the safety and usefulness of the diagnostic procedure in multiple hospitals across Europe. Blood samples are collected to explore disease mechanisms. Participants and their doctors remain blinded to group assignments, but diagnoses are shared to help guide care following current guidelines.

Researchers are conducting a phase III, randomized, open-label, international trial to compare ruxolitinib with the best available therapy for patients with high-risk polycythemia vera (PV). The best available therapy includes either interferon alpha or hydroxycarbamide, selected by the investigator before randomization. This study aims to evaluate which treatment better prevents major complications like thrombosis, hemorrhage, or progression to more severe blood disorders within approximately three years. Participants will be randomly assigned to receive either ruxolitinib at a dose of 10 mg twice daily or best available therapy consisting of interferon alpha or hydroxycarbamide, administered through standard hospital methods. There will be no crossover between treatment arms during the trial. Interferon formulations, including pegylated-interferon, may be used at the investigator's discretion. During the study, participants will be monitored for event-free survival, defined as the time until the first major thrombosis, hemorrhage, death, or disease transformation. Assessments will include regular clinical evaluations and laboratory tests over the approximately three-year trial period. The trial emphasizes safety and effectiveness by closely observing patient outcomes and treatment tolerability throughout the study.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.