Frimley

Researchers are conducting a multinational, multicenter observational study to understand the real-world use of garadacimab in patients with hereditary angioedema HAE. The study includes patients who are newly starting garadacimab treatment as part of their regular clinical care. The main goal is to evaluate the effectiveness of garadacimab by comparing the rate of HAE attacks before and after treatment over a 24-month period, along with assessing safety and quality of life. Participants will receive garadacimab as prescribed by their doctors in routine practice, without any additional interventions from the study. There is one study group consisting of patients treated with garadacimab. Data collection includes information from patient medical records, electronic diaries, and routine clinical visits. Retrospective and prospective data on HAE attacks, prior treatments, safety, and healthcare resource use will be gathered throughout the study. Each participant will be followed for 48 months from the first garadacimab dose. During this time, researchers will collect data through electronic diaries, medical record reviews, and scheduled clinical assessments. Outcome measures include attack rates, adverse event monitoring, angioedema control, and quality-of-life questionnaires. This long-term follow-up helps capture the real-world experience and safety of garadacimab in routine care.

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 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 exploring whether trained volunteers can help older adults in hospitals stay active to prevent loss of strength and mobility, a common issue that can lower quality of life and increase healthcare costs. This study is a feasibility trial conducted in three hospitals of varying sizes, aiming to see if volunteer-led physical activity is practical and accepted by patients, volunteers, and staff. The study will compare outcomes in patients who receive usual care with those who receive the volunteer-led intervention. Trained volunteers will deliver tailored physical activities twice daily to hospitalised older adults starting from recruitment until discharge. Patients who can walk independently will perform walking exercises progressing over time, while those with mobility impairments will do bedside or chair exercises, advancing as they improve. Volunteers receive training and are monitored by hospital therapists to ensure safety and correct exercise delivery. Control patients receive usual care without the volunteer-led activities. Participants will be assessed at baseline and discharge for physical function, muscle strength, quality of life, and physical activity levels using various tests and monitors. Data on hospital stay length and readmissions will also be collected. Researchers will track the number of trainers and volunteers recruited, trained, and retained, as well as adherence to the intervention. Interviews and observations will explore how well the program is accepted and identify any barriers or facilitators to its implementation. The study runs for about three years and aims to inform wider use of volunteer-led activity programs in hospitals.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Idiopathic pulmonary fibrosis IPF is a progressive lung disease causing scarring that leads to coughing and breathlessness. Many IPF patients also have reflux disease, where stomach acid can damage the lungs. This research aims to find out if treating IPF patients with proton pump inhibitors PPIs, which reduce stomach acid, can slow down the progression of IPF. The trial is a randomized, placebo-controlled study involving 298 IPF patients across about 37 UK hospitals. Participants will be randomly assigned to take either lansoprazole a PPI or dummy tablets twice daily for 12 months. They will start weekly breathing tests at home using equipment provided and, if they have a cough, use a device to count coughs over 24 hours. Participants will complete questionnaires about coughing, breathlessness, sleep habits, and overall health. Some will also wear activity and sleep monitors during cough monitoring sessions. Dose reduction is allowed if side effects occur. During the study, patients will complete regular questionnaires and provide blood samples for safety checks at 3, 6, 9, and 12 months. Weekly home spirometry will continue for the full year. Researchers will track lung function, cough frequency and severity, breathlessness, quality of life, sleep quality, reflux symptoms, and hospital-free survival. Remote and in-person visits are possible, and participants will receive training on study procedures. The primary outcome is the change in lung function 12 months after starting treatment.