Bolton

Researchers are evaluating tirzepatide in adults with obesity who do not have diabetes but have at least one weight-related health condition. The study aims to assess body weight loss and the development of type 2 diabetes over a long period in a real-world setting. This is a Phase 4 clinical trial sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either weekly subcutaneous injections of tirzepatide in addition to standard care or standard care alone. The study uses a parallel design to compare these two groups and lasts about 260 weeks 5 years. The focus is on long-term effects and real-world treatment outcomes. During the study, participants will have regular assessments including measurements of body weight, blood sugar control HbA1c, waist circumference, blood pressure, cholesterol, kidney function, quality of life, and healthcare resource use. The primary outcome is the percent change in body weight from baseline to 24 months. Secondary outcomes cover diabetes onset, metabolic changes, obesity-related complications, and quality of life over 60 months. Participants will be monitored throughout the study duration for safety and health changes.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are evaluating the safety and effectiveness of whole-body hypothermia for newborn babies with mild hypoxic ischaemic encephalopathy. This phase III randomised controlled trial aims to determine whether cooling the whole body to 33.5.5C within six hours after birth and continuing for 72 hours improves cognitive development at around two years of age compared with maintaining normal body temperature. The study also seeks to assess the economic value of cooling therapy for mild encephalopathy within the healthcare system. Babies born at or after 36 weeks with signs of birth asphyxia or acidosis will be randomly assigned to receive either whole-body hypothermia or targeted normothermia. Cooling will be applied using a servo-controlled machine in neonatal intensive care units, maintaining a rectal temperature of about 33.5C for 72 hours. The control group will have their body temperature kept at normal levels 37C for the first 80 hours, with any fever carefully treated. Babies born at non-cooling centers will be transferred to specialized units for treatment. During the study, participants will undergo brain monitoring, MRI scans before discharge, and follow-up developmental assessments at 24 months using the Bayley Scales of Infant and Toddler Development IV. Additional evaluations will include neurological exams, motor function assessments, vision and hearing tests, and parent-completed questionnaires. Researchers will collect detailed clinical data from birth through hospital stay, aiming to compare cognitive outcomes and safety measures between the two groups over the study period.

Researchers are evaluating the efficacy and safety of intravenously administered fosfomycin in treating severely infected patients across Europe. This prospective, multicenter, non-interventional study focuses on infections such as osteomyelitis, complicated urinary tract infections, nosocomial lower respiratory tract infections, bacterial meningitis or central nervous system infections, bacteraemia or sepsis, skin and soft tissue infections, endocarditis, and other infections covered by national guidelines. Patients receive fosfomycin intravenously according to the respective national Summary of Product Characteristics SmPC. The study is observational and does not involve randomization or placebo. It includes monitoring during treatment and follow-up periods, with evaluations up to six months for treatment outcomes and up to one year for osteomyelitis follow-up. The study documents clinical and microbiological cure rates, clinical improvements, and sodium and potassium serum levels during hospital stays. Participants are assessed for clinical success at multiple points, including initial response within 7 days, end of treatment up to 6 months, test of cure, and follow-up up to one year for osteomyelitis. Safety monitoring includes daily recording of adverse events, serious adverse events, adverse drug reactions, and deaths during treatment and follow-up. The study tracks dropouts due to treatment failure or adverse events. Overall, participation duration varies depending on treatment and follow-up schedules.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

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.

This research aims to collect and analyze information about babies born at 22 weeks of pregnancy in the UK to better understand their clinical care and outcomes. Since survival-focused care for these extremely premature babies has only been offered since 2019, there is limited data on how they respond to treatment and what challenges they face. The study gathers data from multiple neonatal intensive care units NICUs across the UK to improve knowledge for future care and support families. Data collection involves medical staff entering selected, anonymized information from babies medical records into a secure database. The study observes babies who are attended by neonatal teams at birth or admitted to NICUs within the first 72 hours of life. No changes are made to the babies care during the study, and a one-time survey of NICUs will assess unit approaches and equipment used for 22-week babies. Participants data, including clinical care details and short-term outcomes such as survival to discharge, are analyzed. Researchers will report on interventions across various care areas and outcomes like brain injury or infections. Parents receive information about data use, and individual babies cannot be identified in results. The study runs from admission until death or discharge from neonatal care, aiming to inform future research and improve care practices.