Frimley

Researchers are studying the real-world use of garadacimab in patients aged 12 years and older who have hereditary angioedema (HAE). This multinational, multicenter observational study follows patients newly starting garadacimab as part of their routine clinical care. The goal is to assess how effective garadacimab is at reducing the number of HAE attacks over 24 months, complementing existing clinical trial data on its safety, effectiveness, and impact on quality of life. No specific intervention is administered by the study team since garadacimab treatment is prescribed by the patients' doctors according to local approved guidelines. Participants will be followed for 48 months after starting garadacimab. Data will be collected from patients' medical records, a digital diary for HAE attacks, and routine clinical visits. These sources will provide information on HAE attack frequency, prior treatments, safety, and healthcare use before and during the study. Participants will record their HAE attacks and treatment details using an electronic device such as a smartphone or computer. Researchers will collect retrospective data for 3 to 12 months before enrollment and prospectively monitor patients for up to 48 months. The main outcome measured is the rate of HAE attacks over 24 months. Safety, quality of life, and healthcare resource use will also be assessed throughout the study to understand the longer-term effects of garadacimab in everyday clinical practice.

Researchers are conducting a Phase 3 multicenter, randomized, double-blind, placebo-controlled trial to assess the safety and effectiveness of navenibart in preventing attacks in adults and adolescents with type 1 or type 2 hereditary angioedema (HAE). This study compares navenibart to a placebo to determine its ability to reduce the frequency of HAE attacks. Participants will receive either navenibart or a placebo as subcutaneous injections. The study treatment period lasts for 6 months, during which the number of investigator-confirmed HAE attacks will be tracked and analyzed to evaluate the treatment's impact. During the trial, participants will be closely monitored for HAE attack frequency and safety. Researchers will collect data on the number of attacks from Day 1 through Day 181 to measure treatment efficacy. Safety assessments will also be conducted throughout the study to ensure participant well-being.

This research aims to gather real-world information on using intravascular lithotripsy (IVL) with the Shockwave IVL system to treat calcified lesions in the femoropopliteal and crural arteries of patients with chronic limb-threatening ischemia (CLTI). The main goal is to understand how effective IVL is in helping wounds heal and avoiding amputations. The study also looks at how well the treatment restores blood flow immediately, its safety, and its effect on patients' quality of life. Participants receive treatment with the Shockwave Medical IVL System, a comprehensive device that includes a generator, connector cable, and a single-use catheter with an integrated balloon designed to break up artery calcification. The study is observational and collects data on patients who undergo this treatment for their calcified arterial lesions. During the study, researchers will monitor wound healing and whether participants avoid amputation over 12 months. They will also assess how well the blood vessels open after treatment and track safety and quality of life outcomes. Participants will be followed to collect this information over the course of a year to understand the impacts of IVL treatment for CLTI.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are evaluating the use of an AI-based Lung Cancer Prediction (LCP) tool in patients with solid or part-solid pulmonary nodules detected on CT chest scans during routine care. This prospective observational study aims to understand whether using the AI tool in physician decision making can provide clinical and health-economic benefits compared to current standard care. The study focuses on patients aged 35 and older with specific types and sizes of lung nodules. Participants must have at least one solid or part-solid pulmonary nodule between 5 and 30 mm detected on a baseline CT scan that meets certain technical quality standards. The study observes how the AI tool influences healthcare service use and patient outcomes without altering the usual diagnostic or treatment process. The study does not involve investigational treatments but follows participants prospectively to monitor clinical decisions and effects. During the study, researchers will track patient outcomes and healthcare utilization for up to one year after discharge. Assessments include reviewing imaging quality, nodule characteristics, and physician decisions guided by the AI tool. The main goal is to determine the potential impact of the AI solution on clinical outcomes and resource use over this period, providing insight into its value in managing lung nodules.

Researchers are investigating whether volunteers can be trained to help older adults in hospitals stay active to prevent loss of strength and mobility, a common problem during hospital stays that can reduce quality of life and increase healthcare costs. This feasibility study involves three hospital sites where volunteers will lead physical activity sessions for patients aged 65 and older, compared to a control site receiving usual care. The study will also explore how well the intervention is accepted by patients, volunteers, and staff, and whether it can be implemented effectively across different hospital settings. The intervention consists of twice daily physical activity sessions led by trained volunteers. Patients who can walk independently will be guided through walking exercises, gradually increasing their distance, while those with limited mobility will perform bedside or chair exercises, progressing to walking as they improve. Volunteers receive training by physiotherapists covering safety, exercise techniques, and response to adverse events, with ongoing supervision and competency checks. This program continues from recruitment until the patient’s discharge. Participants will be assessed regularly through interviews, observation, and exercise diaries to monitor adherence, acceptability, and safety. Researchers will collect data on recruitment, retention, physical activity levels, physical function, quality of life, hospital stay length, and readmissions. Volunteer and trainer recruitment and retention will also be tracked. The study aims to gather detailed information over an average of three years to evaluate the feasibility and potential for wider implementation of volunteer-led exercise programs in hospitals.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease that causes scarring, leading to coughing and breathlessness. Many people with IPF also have reflux disease, where stomach acid may enter the lungs and cause damage. This research is evaluating whether using proton pump inhibitors (PPIs), medicines that reduce stomach acid like lansoprazole, can slow the progression of IPF. The study is a phase 3 clinical trial involving 298 IPF patients from about 37 UK hospitals to determine if treating with PPIs affects IPF outcomes and cough, reflux, and sleep symptoms. Participants will be randomly assigned to take either lansoprazole 30 mg capsules or matching placebo capsules twice daily, about 12 hours apart, for 12 months. They will be asked to start weekly home breathing tests using equipment provided, and some with a cough will use a device to count coughs over 24 hours. Questionnaires on cough, breathlessness, sleep, and general health will be completed. A sub-study involves additional cough and sleep monitoring sessions. Participants may reduce the dose if side effects occur. Throughout the study, participants will complete home spirometry assessments weekly, provide blood samples for safety checks at set intervals, and answer questionnaires at 3, 6, 9, and 12 months. Visits may be remote or in person. Researchers will monitor medication adherence, medical history changes, and side effects. The main outcome measured is the change in lung function, specifically forced vital capacity, 12 months after randomization. Additional blood samples may be collected for future research with consent.