Macclesfield

This research aims to evaluate how well brenipatide (LY3537031) is tolerated, what side effects may occur, and its safety and effectiveness in adults with Irritable Bowel Syndrome-Diarrhea (IBS-D). The study focuses on participants who meet specific IBS-D criteria related to bowel movement patterns and abdominal pain. It is a Phase 2, randomized, double-blind, placebo-controlled trial lasting approximately 35 weeks. Participants will receive either brenipatide or a placebo, both administered under the skin through subcutaneous injection. The treatments are compared to assess their impact on IBS-D symptoms. The study involves careful monitoring of patients' responses to the medication over the treatment period, with no changes in diet allowed in the four weeks before screening. During the study, participants will track their symptoms daily using an electronic diary, including abdominal pain and stool consistency. Researchers will measure the percentage of days participants have a positive composite response between weeks 9 and 16. Safety and side effects will be monitored throughout the study, ensuring participants are closely observed during the full duration of about 35 weeks.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

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 evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

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.

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease that causes scarring, leading to coughing and breathlessness. Many people with IPF also have reflux disease, where stomach acid may enter the lungs and cause damage. This research is evaluating whether using proton pump inhibitors (PPIs), medicines that reduce stomach acid like lansoprazole, can slow the progression of IPF. The study is a phase 3 clinical trial involving 298 IPF patients from about 37 UK hospitals to determine if treating with PPIs affects IPF outcomes and cough, reflux, and sleep symptoms. Participants will be randomly assigned to take either lansoprazole 30 mg capsules or matching placebo capsules twice daily, about 12 hours apart, for 12 months. They will be asked to start weekly home breathing tests using equipment provided, and some with a cough will use a device to count coughs over 24 hours. Questionnaires on cough, breathlessness, sleep, and general health will be completed. A sub-study involves additional cough and sleep monitoring sessions. Participants may reduce the dose if side effects occur. Throughout the study, participants will complete home spirometry assessments weekly, provide blood samples for safety checks at set intervals, and answer questionnaires at 3, 6, 9, and 12 months. Visits may be remote or in person. Researchers will monitor medication adherence, medical history changes, and side effects. The main outcome measured is the change in lung function, specifically forced vital capacity, 12 months after randomization. Additional blood samples may be collected for future research with consent.