Chelmsford

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.

Researchers are evaluating whether combining the investigational drug PF-06821497 with enzalutamide works better than enzalutamide alone in men with metastatic castration-resistant prostate cancer mCRPC who have not yet received certain advanced anti-cancer treatments. This global, multicenter, randomized Phase 3 study focuses on participants who have not been treated with androgen receptor signaling inhibitors like enzalutamide or abiraterone before, except for androgen deprivation therapy or first-generation anti-androgen agents. The study is sponsored by Pfizer and aims to assess treatment effects in this patient population. Participants will be randomly assigned to one of two groups one group will receive PF-06821497 875 mg twice daily combined with enzalutamide 160 mg once daily, while the other will receive a placebo twice daily plus enzalutamide 160 mg once daily. The study includes several phases screening, randomization, treatment, safety follow-up, and long-term follow-up. Treatment continues over a period of up to approximately three years for primary outcomes, with ongoing assessments for up to five years for some secondary outcomes. During the study, participants will undergo various assessments including scans to monitor disease progression, blood tests to measure prostate-specific antigen levels and circulating tumor DNA, patient-reported pain and quality of life questionnaires, and evaluations of adverse events. The primary outcome is radiographic progression-free survival measured from randomization up to about three years. Safety and long-term effects will be monitored through follow-up visits lasting up to five years. Participants will be followed closely throughout the study duration to track treatment impact and side effects.

Researchers are evaluating 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, called the BECOME Study, aims to find which type of collagen is most effective at improving outcomes such as skin elasticity, nail strength, hair thickness, and other health markers related to skin and whole body wellness. Participants will take 10 grams of either bovine collagen, marine collagen, or a placebo powder daily throughout the study period. The study includes three groups receiving these supplements to compare their effects directly. The intervention lasts for 12 weeks, with assessments at the start, week 6, and week 12. During the study, participants will be evaluated on changes in nail growth and strength, skin elasticity and wrinkles, hair thickness and strength, skin pigmentation, and hydration. Subjective assessments of skin health and digestive quality of life will also be collected at baseline and follow-up visits. The trial includes safety monitoring and aims to capture both objective and personal perceptions of health improvements over the 12-week period.

Blastic Plasmacytoid Dendritic Cell Neoplasm BPDCN is a very rare blood cancer with no agreed-upon best treatment. Researchers are working internationally to gather detailed information on how BPDCN presents, how it is diagnosed, the treatments patients receive, and their outcomes. The study aims to build a large database to better understand the disease and to develop treatment recommendations based on collected data. This study is an international registry collecting information from multiple centers about patients diagnosed with BPDCN. It includes both retrospective and prospective data from patients worldwide. The data collected covers patient details, disease characteristics, treatment information, outcomes, causes of death, and the conclusion of data collection. Consent will be obtained from prospective patients, and quality control is managed by the Immune Oncology Research Institute. Participants will provide information through questionnaires completed by their treatment centers. Researchers will analyze overall survival, complete remission rates, duration of first remission, and event-free survival over five years. This observational study does not involve treatment but gathers and monitors detailed clinical data to improve understanding and guide future therapies for BPDCN.

Researchers are evaluating the effects of a medicine called BI 690517 combined with empagliflozin in adults with chronic kidney disease CKD who are at risk of their kidney condition getting worse. The study includes people with or without type 2 diabetes and those who may already be taking medicines like angiotensin converting enzyme inhibitors ACEi, angiotensin receptor blockers ARB, or sodium-glucose cotransporter-2 inhibitors SGLT2i. The goal is to understand if adding BI 690517 can help delay worsening kidney function, hospitalizations due to heart failure, or cardiovascular death. After a run-in period where all participants take empagliflozin and other standard medications, participants are randomly assigned to receive either BI 690517 tablets or placebo tablets once daily alongside empagliflozin. The run-in period confirms that participants are stabilized on empagliflozin before randomization. The treatment phase continues for about three to four years until enough kidney or heart-related events have occurred to compare outcomes between the two groups. During the study, participants visit the study site about five times in the first six months and then every six months thereafter. At these visits, health is regularly checked through blood and urine tests, blood pressure and weight measurements, kidney function monitoring, and collection of any side effect information. The main outcome measured is the time until the first occurrence of kidney disease progression, hospitalization for heart failure, or cardiovascular death.

Researchers are conducting a randomized phase III clinical trial to evaluate treatments for patients with unilateral malignant pleural mesothelioma MPM. The study aims to compare progression-free survival and overall survival between two groups. It also assesses safety, tolerability, quality of life, and local disease control. Patients are grouped based on tumor histology, treatment center, tumor location, and time since diagnosis. Participants are randomly assigned to one of two groups. The experimental group receives proton beam therapy PBT to the hemithorax 50 Gy in 25 daily fractions over five weeks, with a boost to 60 Gy for visible tumors. The control group follows standard care with active surveillance and no immediate treatment. Both groups are monitored for two years after randomization, with clinic visits every three months in the first year and every four months in the second year. If disease progresses in the control group, patients may receive immunotherapy or chemotherapy based on doctor recommendation. During the study, patients undergo evaluations including scans, pulmonary function tests, and quality of life questionnaires. Researchers track adverse events related to proton therapy and collect data on healthcare resource use and informal care. Follow-up occurs at local centers for two years after treatment start. The main outcomes measured are time to disease progression and overall survival, assessing the potential benefits and risks of proton beam therapy for MPM.

This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.

Researchers are evaluating treatment options for patients with localized renal cell carcinoma RCC who have undergone nephrectomy and are at intermediate or high risk of disease recurrence. This phase III randomized controlled platform trial, called RAMPART, aims to assess whether durvalumab alone or combined with tremelimumab can improve disease-free survival or overall survival compared to the current standard care of active monitoring. The study includes patients with Leibovich scores between 3 and 11, focusing on those at intermediate and high risk of relapse after surgery. Participants will be randomly assigned to one of three groups active monitoring for one year, durvalumab monotherapy given as 1500 mg infusions every four weeks for up to 13 cycles, or a combination of durvalumab same dosing with tremelimumab administered twice during the first month. The trial monitors patients over several years to compare outcomes between these groups, including disease-free survival, overall survival, and metastasis-free survival. During the study, participants will undergo clinical and radiological assessments, including post-operative CT scans before randomization and routine follow-ups during treatment and observation. Researchers will collect tissue samples and blood for future research. Safety and health will be closely monitored through laboratory tests, ECGs, and performance status evaluations. The study may last up to 20 years for the longest follow-up on overall survival and other outcomes.

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.

Researchers are evaluating the efficacy of perioperative dostarlimab compared with the standard of care in participants with untreated T4N0 or Stage III resectable colon cancer that shows defective mismatch repair or high microsatellite instability dMMRMSI-H. This phase 3, open-label, randomized study focuses on these specific colon cancer patients to assess if dostarlimab can improve outcomes compared to current treatments. Participants are randomly assigned to receive either dostarlimab before and after surgery or the standard of care treatments, which include FOLFOX or CAPEOX chemotherapy or post-surgery observation. Dostarlimab is given as monotherapy during the perioperative period. The study carefully monitors participants for up to approximately 5 years to evaluate long-term effects. During the trial, participants undergo regular assessments including event-free survival reviewed by blinded independent central review, overall survival, and pathological response evaluations. Safety is closely monitored by tracking adverse events, immune-related effects, and serum concentrations of dostarlimab across treatment cycles. The study involves frequent follow-ups to understand treatment impact and ensure participant well-being throughout the extended observation period.