Bangor

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are evaluating a digital monitoring approach for adult cancer survivors to improve their quality of life and symptom management. The study focuses on using routine patient-reported outcomes collected through questionnaires combined with continuous smart watch monitoring. This pilot aims to assess the feasibility of this method and identify factors that might affect participant engagement or satisfaction. Participants will receive a smart watch and either a smart phone or an app on their own phone. The watch will continuously track physical activity, sleep patterns, heart rate, and other data while participants wear it for about 4 months. They will complete weekly symptom questionnaires via MS Forms and attend hospital research appointments at the beginning and end of their involvement. After their participation, a focus group will gather feedback on their experience. The study lasts 18 months overall, with each participant involved for approximately 4 months. Researchers will measure the feasibility of routine self-assessment during this period. Participants health status will be monitored through patient-reported outcomes and smart watch data. The goal is to better understand how digital tools can support cancer survivors during their active surveillance or after treatment completion.

Researchers are conducting a multi-centre prospective observational study to evaluate patients with solid and part-solid pulmonary nodules detected on routine CT chest scans. The goal is to assess whether the use of an AI-based Lung Cancer Prediction LCP tool influences physician decision-making and leads to clinical and health-economic benefits compared to the current standard care for these patients. This study focuses on nodules sized between 5 and 30 mm that meet specific imaging criteria. Participants will be observed without any assigned treatments as this is an observational study. The study involves evaluating baseline CT scans that meet defined quality standards and include nodules with a solid component of at least 80. Training will be provided on the CT scan requirements. No experimental interventions are administered, but the impact of the AI tool on clinical management, use of scans and procedures, adherence to guidelines, and patient outcomes will be studied over up to one year. During the study, researchers will collect data on patient care and outcomes related to pulmonary nodules, including discharge rates and health economics. Assessments will include reviewing clinical decisions, imaging usage, and adherence to guidelines over a one-year period. Participants will be followed through their routine care with no additional treatments required, and their progress will be monitored to measure the potential effects of the AI tool on service utilization and patient outcomes.

Researchers are evaluating an online program based on Compassionate Mind Training CMT designed for adults living with Type 1 and Type 2 Diabetes Mellitus. This pilot randomized controlled trial aims to assess the feasibility and acceptability of this four-week self-compassion course tailored to reduce diabetes distress, self-criticism, and shame while improving physical health. The study compares participants receiving the compassion training with a waitlist control group who will be offered the intervention after the study. Participants in the intervention group will engage in a four-week online self-compassion course developed with input from diabetes experts and based on Compassionate Mind Training. Each week includes a 30-minute video on a compassionate topic, a daily 10-minute compassionate exercise, and a summary to support learning. Control group participants receive no intervention during the study but can access the course after its completion. Participants will complete self-report measures online at the start weeks 0-1 and after the intervention weeks 9-10. Researchers will track recruitment ease, retention rates in the intervention and study, intervention acceptability, and completion of outcome measures. The primary focus is on changes in diabetes distress, while secondary measures assess self-criticism, shame, and compassionate engagement. The study will run from baseline through 10 weeks with monitoring of adherence and effects.

Researchers are evaluating the study medicine called elranatamab in people with multiple myeloma MM that has returned or not responded to previous treatments, including prior anti-CD38 antibody and lenalidomide therapies. This Phase 3 trial aims to compare elranatamab with other commonly used combination therapies to understand its safety and how well it works for people with relapsed or refractory MM. Participants will be randomly assigned to receive either elranatamab alone or an investigators choice of combination therapies. Elranatamab is given as a weekly shot under the skin at the study clinic, which may become less frequent later. The combination therapies include various medicines taken by mouth and given as shots or intravenous infusions at the clinic. Treatment continues until the MM no longer responds. During the study, participants will visit the clinic regularly for monitoring and assessments, including evaluations of disease progression and response to treatment. Follow-up contacts by telephone or visits will continue after treatment ends. The main measure is progression-free survival, and other outcomes include overall survival, response rates, quality of life, and safety. The study may last up to about five years for some measures.

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 the accuracy and performance of a new method to measure respiratory rate derived from the plethysmography waveform using Philips FAST Pulse Oximetry technology. This observational study includes adult and pediatric inpatients who are breathing room air and undergoing routine spot-check vital sign monitoring. The goal is to compare respiratory rates obtained from this new noninvasive method with those measured by capnography, a reference standard, to see how well the new algorithm performs without affecting patient care. Participants will undergo noninvasive physiological monitoring during a single study visit using age- and weight-appropriate Philips SpO2 sensors finger, nasal alar, ear along with capnography sensors. Adults will complete two separate 20-minute recording cycles with different sensor combinations, while pediatric participants will complete one or two 20-minute cycles depending on age and weight. Capnography data will be collected simultaneously to serve as the reference for respiratory rate. During the study visit, waveform data will be annotated by clinicians to identify normal breathing and exclude artifacts. Researchers will measure respiratory rate accuracy using metrics such as Accuracy Root Mean Square ARMS, mean bias, and precision during continuous and spot-check monitoring. They will also assess the time to first valid respiratory rate value and adult participant satisfaction with the CO2 cannula. All data collection occurs in a single visit, and no device outputs will be used for clinical decisions.