Epsom

Researchers are evaluating the safety and effectiveness of a staged hybrid ablation procedure compared to the standard catheter ablation in patients with non-paroxysmal atrial fibrillation AF and heart failure. This randomized controlled trial aims to determine which approach better prevents persistent atrial arrhythmia over a follow-up period extending to 24 months after treatment. Participants will be randomly assigned to one of two treatment groups. One group will undergo a staged convergent hybrid ablation, consisting of a minimally invasive surgical epicardial ablation with optional left atrial appendage exclusion followed by an endocardial catheter ablation. The other group will receive the standard percutaneous endocardial catheter ablation alone. The trial compares these two device-based procedures to assess their impact on heart rhythm and heart function. During the study, participants will be closely monitored for heart rhythm changes, heart chamber remodeling, and quality of life using various assessments before treatment and at 12 and 24 months afterward. The main outcome measured is freedom from persistent atrial arrhythmia after a single procedure without certain medications. Safety is also tracked within 30 days and beyond. Overall, the trial will last at least two years for each participant, including follow-up evaluations at multiple time points.

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 the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

Researchers are evaluating a new blood test called Avantect to detect pancreatic cancer early in people aged 50 to 84 who were recently diagnosed with type 2 diabetes. Pancreatic cancer is often deadly because it is usually found late. This study aims to see if the Avantect test can find signs of cancer sooner, allowing for earlier treatment and better chances of survival. The study is interventional and includes a large group of participants recruited from general practices over three years. Participants will be randomly assigned to one of two groups the intervention arm or the control arm. Those in the intervention arm will have their blood samples tested with the Avantect test quickly, and if cancer markers are found, they will be informed and offered imaging scans like MRI or CT to check for pancreatic cancer. The control group will have their blood samples stored for possible future testing but will receive standard diabetes care. Blood samples and health outcomes will be tracked for three years. Each participant will attend three study visits over 12 months, providing blood samples and completing anxiety questionnaires. Researchers will monitor cancer diagnosis and mortality through registries for three years after consent. They will evaluate the tests sensitivity, specificity, and ability to detect cancer early enough for surgery. The study also measures predictive values and cancer resectability. This design helps understand the tests potential to improve pancreatic cancer detection in people with new diabetes diagnoses.

Researchers are conducting a post-marketing surveillance study to evaluate the SMS femoral stem prosthesis used in patients with severely painful or disabling hip conditions such as osteoarthritis, traumatic arthritis, developmental dysplasia of the hip, or avascular necrosis of the femoral head. The study focuses on observing the performance and safety of this device over a long period to understand its survivorship and patient outcomes. Participants receive the SMS femoral stem as part of their primary total hip replacement surgery. This is an observational study where the devices clinical and radiographic performance will be tracked at multiple intervals including 3, 5, 7, and 10 years. Additional evaluations include bone remodeling, stem migration, patient satisfaction, quality of life, and monitoring of adverse events up to 10 years after implantation. During the study, participants will undergo regular assessments such as radiographic imaging, clinical evaluations, and questionnaires about their satisfaction and quality of life from 6 months through 10 years. Researchers will closely monitor the devices survivorship, bone remodeling patterns, and any complications to gather long-term safety and effectiveness data. The total participation duration can extend up to 10 years, allowing comprehensive long-term follow-up.