Chelmsford

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.

Researchers are evaluating the combination of the investigational drug PF-06821497 (mevrometostat) with enzalutamide compared to enzalutamide alone in men with metastatic castration-resistant prostate cancer (mCRPC) who have not previously received androgen receptor signaling inhibitors (ARSi) or abiraterone. This global, multicenter Phase 3 study focuses on participants whose cancer has progressed despite androgen deprivation therapy (ADT) or first-generation anti-androgens but who have not started other systemic anti-cancer treatments for mCRPC. The study excludes those with prior treatment using enzalutamide, darolutamide, apalutamide, or abiraterone in any setting, though chemotherapy is allowed in the hormone-sensitive setting. The study includes a Screening Phase, followed by randomization where participants are assigned equally to one of two groups: one receiving PF-06821497 plus enzalutamide, and the other receiving placebo plus enzalutamide. All treatments are taken orally on a continuous basis. After the treatment phase, participants enter a Safety Follow-up and a Long-Term Follow-up period to monitor ongoing effects. Participants will undergo assessments during the study to evaluate radiographic progression-free survival over about three years. Researchers will collect imaging data such as bone scans and CT or MRI scans to monitor disease progression. Additional evaluations include performance status, life expectancy assessments, and safety monitoring for adverse events. The study duration spans from screening through treatment and follow-up phases to gather comprehensive data on the combination therapy's impact on mCRPC.

The BECOME Study investigates the effects of bovine and marine collagen supplements compared to a placebo on skin, hair, nails, and overall body health in healthy adult women aged 35 to 55 years. This randomized controlled trial aims to identify which collagen source is most effective and whether both types provide similar benefits. Researchers are focusing on improvements in skin elasticity, joint and digestive health, and general well-being over the course of the study. Participants receive either bovine collagen, marine collagen, or a placebo as dietary supplements. The study evaluates changes at baseline, week 6, and week 12 to monitor how these supplements influence various health markers. The trial is designed to compare the efficacy of these collagen types in a controlled setting. During the study, women will be assessed for nail strength and growth, skin elasticity, hair thickness and strength, skin wrinkles, perceived skin health, pigmentation, and hydration at specified intervals. These measurements help researchers understand the impact of collagen supplementation on physical health attributes. Participants are closely monitored for adherence and safety throughout the 12-week period.

Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN) is a very rare blood cancer recognized as a distinct disease since 2008. There is currently no agreed-upon best treatment for BPDCN, and because the disease is so uncommon, international collaboration is needed to collect detailed information on how BPDCN presents, is diagnosed, and responds to different treatments. The study aims to build a large global database of BPDCN patients, examine disease characteristics and outcomes across various treatments, identify factors that affect prognosis, and develop treatment recommendations based on collected data. This study is an international registry collecting both past and new patient data from multiple centers worldwide. Participating centers gather detailed patient information through questionnaires, including patient and disease characteristics, treatment details, outcomes, causes of death, and the timing of data collection. The registry does not involve any experimental treatments but focuses on collecting comprehensive clinical data to better understand BPDCN. Participants provide informed consent if enrolled prospectively, and data quality is managed by the Immune Oncology Research Institute. Researchers will analyze overall survival over five years as a key outcome. This registry supports ongoing monitoring and data collection to improve knowledge about BPDCN and guide future treatment strategies.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating a phase III randomized clinical trial for patients with unilateral malignant pleural mesothelioma (MPM). The study aims to compare progression-free survival and overall survival between two approaches: proton beam therapy and standard surveillance. Patients will be stratified based on tumor histology, treatment center, tumor side, and time since diagnosis to assess these outcomes. Participants in the experimental group will receive proton beam therapy targeted at the hemithorax, delivering a total dose of 50Gy in 25 daily fractions over five weeks, with an additional boost to 60Gy for visible tumors. The control group will undergo standard care surveillance without immediate treatment, with immunotherapy or chemotherapy offered if disease progression occurs. Both groups will be followed for two years from randomization. During the study, patients will have regular follow-up visits at their local trial sites for assessments including safety, tolerability, quality of life questionnaires, and disease monitoring. The main outcomes measured are progression-free survival and overall survival up to two years. The study plans to recruit 148 patients across 20 UK centers, with additional interim analyses to evaluate treatment efficacy and safety throughout the trial period.

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

Researchers are investigating treatments for patients with localized renal cell carcinoma (RCC) who have undergone nephrectomy, focusing on those at high or intermediate risk of the cancer returning. The study evaluates whether durvalumab alone or combined with tremelimumab can improve disease-free survival or overall survival compared to the current standard of care, which is active monitoring. This phase III multi-arm, multi-stage randomized controlled trial includes patients with specific risk scores, and recruitment of intermediate risk patients will be limited based on time and accrual targets. Participants will be randomly assigned to receive either durvalumab alone, the combination of durvalumab and tremelimumab, or active monitoring. The drugs are given via controlled infusion through a pump into a vein. The trial includes a screening phase and treatment period, with careful monitoring of patients' disease status and side effects throughout the study. During the study, participants will undergo clinical and radiological assessments, including post-operative scans and laboratory tests like blood counts and ECGs. Researchers will track disease-free survival and overall survival over several years, including specific time points up to 20.5 years for some comparisons. Participants will also provide tissue and blood samples for future research. Safety and treatment effects will be closely monitored to understand how the therapies impact long-term outcomes.

Researchers are evaluating if using additional liver diffusion weighted MRI (DW-MRI) scans at diagnosis can find more synchronous liver 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 scans. The goal is to improve detection and management of liver metastases by sharing MRI findings with multidisciplinary teams for treatment decisions. Participants will undergo additional breath hold T1, T2, and DW-MRI liver scans without intravenous contrast every six months for three years after surgery. Any liver metastases detected on these scans will be reviewed by the local multidisciplinary team and treated following local protocols. This ongoing monitoring aims to identify metastases early and guide appropriate therapy. During the study, participants will have regular imaging assessments and clinical evaluations as part of their post-surgery surveillance. The researchers will measure the presence of liver metastases through these MRIs and track treatment responses. Findings will be discussed in multidisciplinary team meetings, and participants will be followed for five years after the last recruitment to assess long-term outcomes and management of liver metastases.

Researchers are evaluating the effectiveness of perioperative dostarlimab compared to the standard of care in adults with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability. This is a Phase 3, open-label, randomized study aiming to improve treatment outcomes for this specific type of colon cancer. Participants will receive either dostarlimab alone or standard chemotherapy regimens such as CAPEOX or FOLFOX. The treatments are given around the time of surgery (perioperative) to address the cancer before and after surgical removal. The study compares the new treatment approach with the current standard therapies to see which is more effective and safe. During the study, participants will be monitored for up to approximately 5 years to assess event-free survival, meaning the length of time they remain free from cancer recurrence or other related events. Researchers will perform regular evaluations, including imaging and clinical assessments, to track the participant’s progress and treatment response. Safety and side effects will also be closely observed throughout the study duration.