Gateshead

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

Researchers are studying patients with cirrhosis caused by alcohol-related or metabolic dysfunction-associated steatotic liver disease MASLD. The trial aims to evaluate whether taking capsules containing faecal microbiota from healthy donors can reduce infections and mortality in these patients. This Phase 3 trial follows earlier research that showed faecal microbiota transplantation FMT delivered via endoscopy was safe and feasible, leading to the development of capsules for easier treatment administration. Participants will be randomly assigned to receive either encapsulated FMT or placebo capsules that look identical but contain no active treatment. They will take five capsules every three months over a total period of 21 months or until they develop an infection requiring hospital admission. This double-blind trial means neither participants nor study staff will know which treatment is given. The study will last up to 24 months including follow-up, monitoring effects on infection rates, liver health, immune system function, and antibiotic resistance. Throughout the trial, participants will be regularly assessed for infections, liver disease progression, hospital admissions, quality of life, mental health, alcohol use, and safety of FMT treatment. Laboratory tests will examine immune response and bacterial resistance. The primary outcome is the time until first infection needing hospital care. The study involves detailed monitoring and follow-up visits for up to two years to understand the treatments impact and safety in patients with cirrhosis.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

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.

Acute respiratory infections ARI are a common cause of hospital admissions and antibiotic use, caused by various pathogens including viruses like influenza and coronaviruses. This observational study aims to describe routine diagnostic and treatment practices for ARI and to characterize the adult patient population presenting with ARI in acute hospital settings across Europe. The study also seeks to understand the causes of ARI in these patients and variations in clinical outcomes. The study collects data from adults with ARI who visit emergency rooms or acute medical assessment units, including those admitted to hospital and those discharged the same day. Diagnostic methods such as laboratory and point of care tests, as well as pharmacological treatments like antibiotics and antivirals, are recorded. A subset of participants will have a respiratory sample taken within 24 hours to identify pathogens using molecular methods. Participants will undergo data collection about their clinical condition, laboratory tests, and treatments received. Researchers will track the use of microbiology and virology tests, antibiotic and antiviral treatments, clinical outcomes, hospital and ICU stays, and mortality up to 28 days after admission or discharge. Patient demographics, symptoms, comorbidities, physiological measurements, and ARI causes will also be studied. The study is ongoing and observational, with no direct interventions beyond data collection.

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.

Chronic obstructive pulmonary disease COPD is a common lung condition affecting many adults worldwide, with exacerbations leading to worsening health and hospital admissions. This trial focuses on patients recently discharged after a hospital stay for a COPD exacerbation, aiming to reduce the risk of readmission and improve outcomes during the critical 90-day high-risk period after discharge. The study is a phase 3, multicenter randomized controlled trial addressing an important healthcare challenge and potential cost savings for the NHS. The trial compares a supported rescue pack management plan to standard care. Participants in the supported rescue pack group receive a 5-day rescue pack of prednisolone and antibiotics, a written self-management plan based on the Asthma-Lung UK plan, and twice-weekly automated phone or text symptom assessments for 90 days. Those in the standard care group do not receive rescue packs on discharge but may access them through community care. The trial will monitor the use of rescue packs and support provided during the 90-day period. Participants will be involved in regular symptom monitoring through automated calls or texts and follow-up assessments. Researchers will measure time to first hospital readmission within 90 days as the primary outcome, along with secondary outcomes including readmission frequency, days alive and out of hospital, corticosteroid and antibiotic use, healthcare contacts, quality of life, and cost-effectiveness. Safety monitoring will include adverse events and antimicrobial resistance over an average of 4 years, with participant involvement lasting up to one year for some assessments.

Aortic stenosis AS affects many older adults, with a rising number of people over 65 and 75 years old experiencing moderate to severe disease. This study aims to compare the benefits of early aortic valve replacement AVR versus expectant management in patients with severe asymptomatic AS. It addresses a significant gap, as no randomized controlled trials have yet compared these approaches to determine which leads to better outcomes and cost-effectiveness. Participants will be randomly assigned to either early AVR, where surgery or transcatheter AVR TAVI is planned within six months, or to expectant management, involving regular monitoring according to standard hospital practice. The study will be conducted across multiple centers in the UK, Australia, and New Zealand, with an internal pilot phase to confirm recruitment feasibility. Those in the AVR group may undergo additional tests such as coronary angiography, with further treatment decisions made by their care team. During the study, participants will be followed for a median of 5.5 years, with assessments including cardiovascular events, hospitalizations, quality of life questionnaires, and health economics evaluations. Researchers will measure a combined outcome of cardiovascular death, heart failure hospitalization, and stroke, along with other health and disability measures. The study will use intention-to-treat analysis, ensuring participants are evaluated in their assigned groups regardless of treatment received.

Researchers are studying Non-Alcoholic Fatty Liver Disease NAFLD and Non-Alcoholic Steatohepatitis NASH through the European NAFLD Registry, an observational study aimed at understanding how the disease varies among patients, its natural progression, and underlying causes. The study focuses on identifying and validating biomarkers that can help detect and monitor disease progression from NAFL through NASH to fibrosis and cirrhosis. This international collaboration involves major European universities and ongoing projects funded by European health initiatives. The study collects detailed clinical data and biological samples from adult patients suspected of having NAFLD. Data includes clinical biochemistry, liver histology, imaging, medication use, and comorbidities. Biological samples include blood, liver tissue, urine, and stool. Participants are recruited primarily from hepatology, diabetology clinics, and bariatric surgery units across Europe. The registry also supports nested sub-studies with additional imaging and data collection, such as MR-PDFF and MR-Elastography, under separate consent. Participants provide informed consent and are assigned unique identifiers to protect privacy. The study involves detailed characterization of the NAFLD patient phenotype in a single day, with follow-up over an average of five years to track disease natural history, lifestyle factors like diet and exercise, and health-related quality of life using various assessment tools. Data collection and monitoring support collaborative research and biomarker development to improve understanding and management of NAFLD and related conditions.

Researchers are investigating the use of the Risk of Malignancy Algorithm ROMA, which combines two blood tests, CA125 and Human epididymis protein 4 HE4, to improve the diagnosis of ovarian cancer in women showing symptoms in primary care. This observational study aims to compare how accurately ROMA detects ovarian cancer, especially in early stages, against the current standard CA125 test, and to evaluate the cost-effectiveness of using ROMA in general practice settings. The study involves testing blood samples collected when a general practitioner orders a CA125 test for a woman suspected of having ovarian cancer. Along with CA125, the blood will also be tested for HE4, and the ROMA score will be calculated. By comparing the diagnostic accuracy of ROMA and CA125, researchers hope to determine whether ROMA could help identify more cases of ovarian cancer earlier and more cost-effectively. This research is part of a wider NHS programme called SONATA that aims to improve ovarian cancer diagnosis pathways. Participants will be women who present to primary care with symptoms that may indicate ovarian cancer and who are tested for CA125. The study will monitor sensitivity and specificity of ROMA versus CA125 in detecting ovarian cancer over 12 months, focusing on early-stage cases. Cost-effectiveness will also be assessed. The study uses existing blood samples and routine clinical data, without changing participants care, and aims to provide evidence for improving diagnostic testing in primary care.