Portsmouth

Researchers are evaluating two different methods of pacing the heart in patients with slow heart rates (bradycardia). This multi-center randomized controlled trial, called PROTECT-HF, aims to compare the standard right ventricular pacing approach with a newer physiological pacing technique, which includes His bundle and left bundle area pacing. The study will enroll 2600 patients to assess differences in outcomes related to heart function and survival. Participants will be randomly assigned to receive either right ventricular pacing or physiological pacing through pacemaker implantation. The physiological pacing method may involve His bundle pacing or left bundle pacing, with biventricular pacing used if these are not possible. Both treatments will be performed at participating centers, with patients and outcome assessors blinded to the treatment allocation. A subgroup of 500 patients will also take part in an optional echocardiographic sub-study to observe heart changes over 24 months. During the study, participants will be monitored from the time of consent for up to 78 months. Evaluations will occur at the start and every six months afterward to track mortality and heart failure-related health events. Researchers will gather data on heart function, treatment effects, and safety. The main analysis will consider all patients as originally assigned, and additional analysis will assess those who received the assigned treatment.

Asthma is a common condition that causes symptoms like difficulty breathing, coughing, and wheezing. Diagnosing asthma can vary because different international guidelines from organizations such as NICE, GINA, and BTS/SIGN use different criteria. This research aims to compare these guidelines and explore additional lung function tests, like impulse oscillometry (IOS), which is not currently included in standard guidelines but may help improve diagnosis accuracy. The study will analyze routine lung function test data from patients attending the severe asthma service at Queen Alexandra Hospital in Portsmouth. The main intervention involves pulmonary function tests, including IOS, to assess their usefulness in diagnosing asthma. The study uses an "opt-out" consent process and includes patients who have had full asthma evaluations since November 2021. Participants will have their lung function data reviewed, and the study will compare results using international asthma guideline scores and non-guideline physiologic criteria. Researchers will measure how well these tests identify asthma and airway disease to improve diagnostic methods. The study focuses on adults aged 18 and older and includes patients with common asthma-related conditions. Safety monitoring involves ensuring patient understanding and consent for data use.

Researchers are evaluating the long-term safety and tolerability of dazodalibep in adults with Sjögren's Syndrome. This phase 3 open-label extension study focuses on participants who have previously received dazodalibep or placebo in earlier phase 3 trials and completed those studies through Week 48. Participants will receive dazodalibep intravenously during this long-term extension study. The first dose is administered around Week 48 (+28 days) following the prior phase 3 studies. The study monitors safety and tolerability over an extended period to assess treatment-emergent adverse events up to 152 weeks. During the study, participants will undergo regular evaluations to monitor their health and any side effects. Researchers will collect data on adverse events that emerge during treatment. The overall goal is to gather long-term safety information to better understand how participants tolerate dazodalibep when used over an extended time frame.

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating new treatments for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This Phase 3 trial compares two additional therapies with the best standard care to see if they slow cancer spread and improve survival. Participants from diverse backgrounds across multiple UK hospitals are involved, and the study is managed by University College London. The trial has two main comparisons. In Comparison S, participants receive either standard care alone or with added targeted high-dose radiotherapy (Stereotactic Ablative Body Radiotherapy or SABR) aimed at metastatic lesions. In Comparison P, participants receive standard care alone or with a radioactive drug (177Lu-PSMA-617) that targets prostate cancer cells. Standard care includes long-term hormone-reducing therapy and may include other approved medications or treatments. Treatments are given according to specific schedules: SABR is delivered in 3-5 sessions over 1-2 weeks, while 177Lu-PSMA-617 is given in up to three 6-week cycles. Participants are randomly assigned to either standard care or the new treatment with equal chance. During the study, participants undergo regular scans and tests to monitor cancer and side effects. Doctors track treatment safety and may stop treatment if side effects become serious or participants choose to stop. The main outcome measured is overall survival, with final results expected around 5 to 7 years after the first patient starts treatment. Participants' health status and response to treatment are closely observed throughout the study period.

Researchers are evaluating treatments for adults with relapsed or refractory multiple myeloma who have previously received an anti-CD38 antibody and lenalidomide. The study compares the effectiveness of talquetamab combined with pomalidomide (Tal-P), talquetamab combined with teclistamab (Tal-Tec), and investigator's choice between two standard regimens: elotuzumab with pomalidomide and dexamethasone (EPd), or pomalidomide with bortezomib and dexamethasone (PVd). This Phase 3 trial aims to understand which combination best controls the disease progression. Participants will receive talquetamab as a subcutaneous injection, pomalidomide orally, teclistamab as a subcutaneous injection, elotuzumab intravenously, dexamethasone either orally or intravenously, and bortezomib as a subcutaneous injection. The study involves comparing these combinations with varying administration routes. The trial includes multiple treatment arms to assess different drug combinations in patients who have undergone 1 to 4 prior therapies. During the study, participants will be monitored for progression-free survival up to 3 years and 5 months. Researchers will regularly assess disease status, treatment response, and safety. Participants' performance status will be evaluated, and adherence to treatment and potential side effects will be carefully tracked. This long-term observation will help determine how well each treatment combination controls the disease over time.

This research aims to evaluate the effectiveness and safety of two different dose schedules of pegozafermin compared to a placebo in adults with metabolic dysfunction-associated steatohepatitis (MASH) who have liver fibrosis at stage F2 or F3. This phase 3 study focuses on improving liver fibrosis and steatohepatitis in this patient group, which involves chronic liver disease associated with metabolic dysfunction. Participants will receive either pegozafermin or a placebo through subcutaneous injections. The study compares two doses of pegozafermin to assess their impact on liver fibrosis and steatohepatitis. The treatment period lasts up to 52 weeks, with outcomes measured at this time point. During the study, participants will be monitored for improvements in liver fibrosis and resolution of steatohepatitis without worsening fibrosis by week 52. Researchers will also track the time until any disease progression occurs, up to 5 years. Throughout the trial, safety and efficacy will be carefully assessed through clinical evaluations and laboratory tests to ensure participant well-being.

Lung cancer is the leading cause of cancer-related deaths in the UK, with over 35,000 deaths yearly, mostly diagnosed late. Current screening uses low-dose CT scans but misses about 30% of cases, including many women and never-smokers. There is a need for a simple, non-invasive tool to triage patients with persistent respiratory symptoms who do not meet formal screening criteria. Inflammacheck4 measures hydrogen peroxide and other breath markers linked to airway inflammation and oxidative stress. Previous studies showed promising results distinguishing lung cancer from other respiratory diseases. This study, VICTORY 2, aims to validate and improve the AI model behind Inflammacheck4 for quick and accurate triage in NHS settings. This is a multi-center observational study without intervention or randomization. It uses data analysis and AI development based on breath measurements, patient demographics, and clinical diagnosis. Participants include healthy volunteers and people with various respiratory conditions such as confirmed or suspected lung cancer, pneumonia, asthma, COPD, and other non-malignant lung diseases. Breath samples are collected using the Inflammacheck4 device to assess biomarkers. Participants will perform a breath test and provide clinical and demographic data for disease classification. Researchers will analyze breath biomarkers alongside existing clinical information to refine the AI diagnostic model. The primary outcome is to improve this AI model from the first participant enrollment through study completion, expected by December 30, 2026. The study includes monitoring for safety, data quality, and participant compliance throughout the observational period.

The purpose of this study is to assess the anti-tumor activity and safety of amivantamab which will be administered as a co-formulation with recombinant human hyaluronidase PH20 (rHuPH20) (subcutaneous co-formulation \[SC-CF\]) in combination treatment (all cohorts except Cohort 4) and to characterize the safety of amivantamab SC-CF (Cohort 4).

Researchers are evaluating Risvutatug rezetecan (Ris-Rez), a new medicine that targets specific proteins called B7-H3 on cancer cells to reduce the cancer's ability to grow and spread. This study focuses on participants with relapsed extensive-stage small cell lung cancer (ES-SCLC) who have previously received platinum-based systemic therapy combined with a PD-(L)1 inhibitor. The trial aims to compare how well Ris-Rez works versus the standard treatment topotecan in shrinking tumors or making them disappear, and whether Ris-Rez helps participants live longer. The study also assesses the safety and tolerability of Ris-Rez compared to topotecan and gathers information on side effects of both treatments. Participants will be randomly assigned to receive either Ris-Rez, administered as a biological treatment, or topotecan, given as a drug treatment. The study is a phase 3, multicenter, randomized, open-label clinical trial. Both treatments will be provided according to the study protocol, and participants will be monitored carefully throughout the treatment period. During the study, participants will undergo assessments to monitor tumor response using RECIST 1.1 criteria and overall survival for up to approximately 113 weeks. Researchers will also evaluate participants' organ function, performance status, and side effects. Safety monitoring includes checking for cardiovascular health, infections, bleeding, and lung conditions. The study requires participants to provide informed consent and comply with study procedures and restrictions throughout their involvement.