North Shields

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are evaluating the effectiveness and safety of Afimkibart (RO7790121) as both an induction and maintenance treatment for people with moderately to severely active Crohn's disease in this Phase III, multicenter, double-blind, placebo-controlled study. The goal is to understand how well Afimkibart works compared to placebo in managing symptoms and disease activity over time. Participants will receive either Afimkibart or a matching placebo. Afimkibart is given both as an intravenous infusion and as a subcutaneous injection. This treat-through study means participants continue on the assigned treatment throughout the study period, allowing evaluation of both initial and ongoing therapy effects. During the study, participants will be regularly assessed to measure clinical remission using the Crohn's Disease Activity Index (CDAI) and to check for endoscopic response at week 52. Researchers will monitor safety and treatment effects throughout, with the entire participation lasting up to one year. Assessments include clinical evaluations and endoscopic examinations to track disease changes and treatment impact.

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.

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 studying patients admitted to the hospital with a severe worsening of chronic obstructive pulmonary disease (COPD) to understand blood eosinophil count (BEC) changes during these episodes. Eosinophils are white blood cells involved in inflammation and immune response. The study aims to find factors linked to low eosinophil levels (eosinopenia) on admission and to identify when BEC returns to stable levels after a severe COPD flare-up. This information could improve treatment decisions, especially regarding the use of inhaled corticosteroids (ICS).

Dementia affects millions worldwide, and early diagnosis is crucial for providing proper care and support. Doctors often depend on collateral histories from caregivers to understand memory and cognitive changes, but these accounts can be incomplete, unstructured, or hard to obtain. This research evaluates LUMEN, an AI-powered conversation tool designed to help caregivers describe symptoms more clearly and generate structured reports for memory clinic doctors, potentially making dementia assessments faster, more accurate, and less stressful. Participants include caregivers, patients aged 65 or older attending memory clinics, and experienced dementia clinicians. Caregivers will interact with the LUMEN software on a laptop or tablet to provide structured collateral histories, while clinicians will review these AI-generated reports. The study includes usability assessments using the System Usability Scale and NASA Task Load Index, qualitative interviews, and co-production workshops with community groups to improve accessibility and cultural inclusivity. The study will run over 12 months, with phases for recruitment, data collection, workshops, analysis, and reporting. During participation, caregivers provide collateral histories using LUMEN, followed by clinicians assessing the information's completeness and clinical usefulness. Researchers will measure usability, cognitive workload, and agreement between LUMEN reports and clinician assessments. Community workshops will explore language and cultural issues. The study aims to generate data to refine LUMEN and support a larger clinical validation study, with the goal of integrating AI tools like LUMEN into NHS memory clinics to support dementia diagnosis and reduce caregiver burden.

Researchers are conducting a phase III, randomized, open-label, international trial to compare ruxolitinib with the best available therapy for patients with high-risk polycythemia vera (PV). The best available therapy includes either interferon alpha or hydroxycarbamide, selected by the investigator before randomization. This study aims to evaluate which treatment better prevents major complications like thrombosis, hemorrhage, or progression to more severe blood disorders within approximately three years. Participants will be randomly assigned to receive either ruxolitinib at a dose of 10 mg twice daily or best available therapy consisting of interferon alpha or hydroxycarbamide, administered through standard hospital methods. There will be no crossover between treatment arms during the trial. Interferon formulations, including pegylated-interferon, may be used at the investigator's discretion. During the study, participants will be monitored for event-free survival, defined as the time until the first major thrombosis, hemorrhage, death, or disease transformation. Assessments will include regular clinical evaluations and laboratory tests over the approximately three-year trial period. The trial emphasizes safety and effectiveness by closely observing patient outcomes and treatment tolerability throughout the study.

Researchers are studying patients with chronic lymphocytic leukaemia (CLL) who are treated with acalabrutinib in the United Kingdom. This observational research looks back at real-world clinical outcomes for patients who started acalabrutinib through the UK's Early Access Programme (EAP). The study aims to describe characteristics of these patients and estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. The study focuses on patients who began first-line treatment with acalabrutinib between April 1, 2020, and April 1, 2021. It collects clinical data from patients' medical records in accordance with local laws. This non-interventional study does not assign treatments but observes outcomes from the use of acalabrutinib as provided in routine care. Participants' medical records will be reviewed to assess progression-free survival at multiple time points up to five years, along with other outcomes such as overall survival and treatment responses. The study also evaluates healthcare resource use and post-progression treatments. By gathering this data, researchers aim to provide useful real-world evidence on acalabrutinib's use in the UK for patients with CLL over the course of their treatment.

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.

Researchers are evaluating AIR-DS, a new, non-invasive test designed to improve early detection of lung cancer. This test works by analyzing small biochemical changes in cells collected from the inner cheek using advanced infrared light technology. The goal is to catch lung cancer at its earliest and most treatable stages, which could lead to better patient outcomes and reduce healthcare costs by avoiding more invasive and expensive tests. Participants in the RADICAL REACT trial will provide a cheek swab and basic medical history during a single clinic visit. AIR-DS software will analyze the cheek swab to assess lung cancer risk in individuals suspected of having the disease. The study plans to enroll around 450 participants who are symptomatic or under investigation for lung cancer but have not yet started treatment. During the study visit, participants will provide their medical history and a cheek swab sample for analysis. Researchers will measure the sensitivity of AIR-DS in detecting lung cancer on the first day of testing. The study focuses on evaluating the accuracy of this risk-indicating tool to support early diagnosis. Participant safety and study data quality will be monitored throughout the single visit.