Ashton Under Lyne

Researchers are evaluating the effects of tirzepatide compared with standard care in adults living with obesity who do not have diabetes. This phase 4 study aims to assess weight loss and the occurrence of type 2 diabetes over a long period in a real-world setting. Participants must have obesity and at least one weight-related health condition to join the study. Participants will receive either tirzepatide, given once weekly by injection under the skin, or continue with standard care as determined by their healthcare providers. The study is designed to reflect real-life treatment and monitoring situations to understand how tirzepatide works outside of tightly controlled clinical trials. The study lasts about 260 weeks, during which participants will be regularly monitored for changes in body weight and the development of type 2 diabetes. Measurements will be taken at the start and throughout the study to track weight changes. Researchers will also observe safety and overall health during this extended follow-up period.

Researchers are evaluating the long-term safety and tolerability of adjunctive KarXT, a combination of xanomeline and trospium chloride, in adults aged 18 to 65 with schizophrenia who did not have sufficient symptom control with their current antipsychotic medications. This Phase 3, open-label extension study involves participants who previously completed the treatment period of the ARISE study (KAR-012). The goal is to monitor how well patients tolerate KarXT over an extended period while assessing related safety concerns. Participants receive fixed doses of KarXT capsules twice daily, with doses ranging from 50 mg/20 mg up to 125 mg/30 mg. The study lasts for 52 weeks as an outpatient program. This open-label extension allows researchers to observe the effects and safety of KarXT when added to stable antipsychotic treatment under real-world conditions. During the study, researchers closely monitor participants for any treatment-emergent adverse events from the initial dose through a safety follow-up visit at 54 weeks or early termination. Participants will undergo regular assessments, including clinical evaluations and reports from reliable caregivers who assist with study activities. The study ensures participants maintain stable living situations and continue their background antipsychotic medications throughout the study period.

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.

Diabetes mellitus requires regular monitoring of blood sugar control to reduce complications. This trial evaluates a new approach to blood testing that allows patients to collect their own blood samples at home for HbA1c, cholesterol, and thyroid function tests. The study compares this home-based self-collection method to the standard venous blood draw done by healthcare professionals in clinics, aiming to assess accuracy, patient acceptance, and cost-effectiveness. Participants first visit the clinic where a nurse collects a venous blood sample. They are then randomly assigned to perform a self-collected capillary blood draw either by finger prick or using a device on the upper arm, both in the clinic and at home within two days. Participants send their home-collected samples to a central lab using prepaid packaging with temperature monitoring. They complete questionnaires about their experience with the blood collection methods at both clinic and home. Throughout the study, researchers monitor sample quality, participant compliance, and any issues with self-collection. They analyze the accuracy of HbA1c, lipids, and thyroid tests from the different collection methods. The study also tracks patient preferences and economic impacts related to home testing, with a total participation time including clinic visits and home sample collection. Participants receive training and support from study nurses to use the self-collection devices.

Researchers are evaluating whether cognitive analytic therapy-guided self-help (CAT-GSH) is as effective and acceptable as cognitive behavioural therapy-guided self-help (CBT-GSH) for people with anxiety or depression who are returning to NHS Talking Therapies services for further treatment. The study aims to compare outcomes for those returning to the service using CAT-GSH or CBT-GSH, considering participant characteristics such as age, and also comparing returning patients to first-time users of CBT-GSH. Participants will choose their preferred treatment between CAT-GSH and CBT-GSH and receive six individual sessions delivered weekly or bi-weekly. Sessions last approximately 35 minutes and can take place face-to-face, online, or by telephone. Psychological wellbeing practitioners (PWPs) trained in CAT-GSH will conduct the sessions. The third session will be recorded for competency checks by the research team, with participant awareness of potential identifiable information in recordings. Participants will complete routine outcome measures before, during, and after the six-session treatment, including scales assessing anxiety, depression, and social adjustment over 6 to 12 weeks. Data will be collected on demographics and therapy outcomes. Researchers will analyze these data to compare the effectiveness and acceptability of CAT-GSH versus CBT-GSH. The study involves follow-up and consent procedures to ensure participant understanding and choice of therapy.

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 investigating the Avantect test, a new blood test designed to detect pancreatic cancer early in patients recently diagnosed with type 2 diabetes. Pancreatic cancer is highly lethal, often detected too late for curative treatment. The study focuses on adults aged 50 to 84 years who were diagnosed with type 2 diabetes within the past six months, as this group has a significantly higher risk of undiagnosed pancreatic cancer. The trial aims to evaluate if the Avantect test can identify pancreatic cancer at a treatable stage, potentially improving survival rates. Participants will be randomly assigned to either an intervention group or a control group. Those in the intervention arm will have their blood samples tested with the Avantect device soon after collection. If the test detects biomarkers suggesting pancreatic cancer, participants will be informed and offered imaging scans such as MRI or CT to confirm diagnosis. Control group samples will be stored for future testing or research. The study will enroll up to 15,000 participants over three years. Each participant will attend three study visits over a 12-month period, providing blood samples and completing anxiety questionnaires at every visit. Researchers will follow all participants remotely via cancer and mortality registries for three years after enrollment to track any cancer diagnoses. The main outcomes measured include the sensitivity and specificity of the Avantect test and the rate at which pancreatic cancer can be surgically removed, with analyses planned at six months and at three years.