Uxbridge

Researchers are evaluating the Acorai Heart Monitor, a handheld electronic device designed to non-invasively measure pressures inside the heart by placing it on the chest. This study focuses on patients hospitalized with heart failure who are medically ready to be discharged. The study aims to assess how well data from this device can predict survival, hospitalizations, and major cardiac events over one year, offering a safer alternative to invasive right heart catheterization procedures which carry risks such as bleeding and infection. Participants will have the Acorai ICPM system placed on their chest for five minutes while lying down, during which the device collects sensor data using multiple technologies to measure intracardiac pressures. This observational, single-center study follows a single-arm design without randomization or significant risk. The collected data will be used to evaluate the feasibility of the device in predicting patient outcomes after discharge. During the study, participants will undergo this non-invasive monitoring before discharge. Researchers will track survival and hospitalizations over one year to assess the device's predictive ability. The study includes monitoring patients' health status and collecting relevant clinical information to support outcome measurement. Participants' involvement includes consenting, compliance with evaluations, and the monitoring procedure using the Acorai device.

Researchers are evaluating the safety and effectiveness of brenipatide compared to placebo for people with opioid use disorder. This study focuses on participants who are also using buprenorphine, with or without naloxone, as part of their treatment. The trial includes two parts, each with separate groups of participants, to better understand how brenipatide works alongside current therapies in early recovery from opioid use disorder. The study has two parts: Part A involves a double-blind treatment phase followed by an open-label extension, while Part B offers an open-label treatment only. Brenipatide and placebo are given as subcutaneous injections, and buprenorphine is administered either sublingually or buccally. Participants will be enrolled in only one part of the study, with treatment durations potentially lasting up to 144 weeks in Part A and 116 weeks in Part B, depending on enrollment timing and study progress. Participants will regularly attend study visits where they will be assessed through urine drug screens and self-reports to measure abstinence from opioid use. They will also maintain study diaries and complete questionnaires to track adherence and effects. The main outcomes measured include the percentage of weeks participants remain abstinent from opioids between weeks 13 and 24, verified by negative drug tests and no self-reported opioid use. Safety and long-term effectiveness will be monitored throughout the study duration.

Researchers are evaluating the safety and effectiveness of advanced external beam radiotherapy called stereotactic body radiotherapy (SBRT) in men with high risk localized prostate cancer. This cancer is limited to the prostate but has a high chance of growing quickly or spreading. The study compares SBRT given to the prostate alone versus SBRT given to both the prostate and surrounding lymph nodes. It is a Phase III trial involving 1128 participants to see which treatment option is better and safer over at least three and a half years of follow-up. Participants receive radiotherapy in 5 visits over two weeks. Half of the men will have SBRT targeted only to the prostate, while the other half will have it directed to both the prostate and pelvic lymph nodes. The treatments are delivered at NHS radiotherapy centers experienced with SBRT and pelvic node radiotherapy. Quality assurance ensures the treatments are administered properly. During the study, men will undergo scans including multi-parametric MRI and various types of PET-CT or MRI to stage their cancer before treatment. Researchers will monitor side effects and cancer outcomes to assess safety and effectiveness. The main outcome measured is the time until biochemical or clinical failure, with a minimum follow-up of 3.5 years after randomization. Participants will be closely followed for side effects and cancer control throughout the study period.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

Severe diabetic macular oedema (DMO) is a condition where fluid builds up in the macula, the central part of the retina responsible for detailed vision, leading to sight loss. This trial studies people over 18 years old with type 1 or type 2 diabetes who have severe DMO, defined by a thickened macula (400 microns or more). Researchers are comparing the current standard treatment of anti-VEGF eye injections alone to a new approach where patients start with anti-VEGF injections and switch to subthreshold micropulse laser (SML) treatment once the macula thickness decreases below 400 microns. Participants will be randomly assigned to receive either ongoing anti-VEGF injections or to switch to SML treatment after initial anti-VEGF therapy. Anti-VEGFs such as ranibizumab, aflibercept, faricimab, and brolucizumab are given as monthly injections at first, then every 1-3 months. The SML procedure, which does not damage the macula, will be applied based on the trial guidelines once the macula is less than 400 microns thick. This study aims to see if the combined treatment is as effective and more cost-efficient than anti-VEGF injections alone. Participants will attend regular clinic visits for eye exams including optical coherence tomography (OCT) scans to measure macula thickness and assessments of visual acuity over 104 weeks after randomization. Researchers will monitor best-corrected visual acuity, side effects, participant experience, and cost-effectiveness. The trial includes follow-up for two years with safety monitoring and evaluation of how this approach might be adopted in routine care. The study is conducted at multiple hospital eye services across the UK.

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.

Researchers are evaluating depemokimab as a treatment for adults aged 40 to 80 years with moderate to severe chronic obstructive pulmonary disease (COPD) who have type 2 inflammation and frequent exacerbations. This Phase 3 study aims to assess the safety and effectiveness of depemokimab when added to optimized inhaler therapy compared to placebo in participants whose COPD is uncontrolled despite current treatment. Participants must have an elevated blood eosinophil count and a history of COPD symptoms and exacerbations. Participants will receive depemokimab, a sterile liquid drug, or a placebo consisting of a sterile 0.9% sodium chloride solution. The treatments are administered as an add-on to their usual inhaler therapies, which include inhaled corticosteroids, long-acting muscarinic antagonists, and long-acting beta2-adrenergic agonists. The study is randomized, double-blind, placebo-controlled, and takes place across multiple centers. Treatment duration and detailed dosing schedules are not specified but participants are monitored up to 104 weeks. Throughout the study, participants will be monitored for the annual rate of moderate to severe COPD exacerbations. Researchers will also assess safety and other clinical outcomes related to lung function and COPD symptoms. Participants will have regular visits for evaluation of their disease status, treatment adherence, and any side effects. The total duration of participation includes baseline screening and follow-up visits over the study period to ensure comprehensive data collection for efficacy and safety analysis.

Researchers are evaluating the use of biparametric MRI (bpMRI) and image-fusion targeted biopsies to detect prostate cancer in men at risk. The study aims to determine if bpMRI can be recommended as an alternative to the longer multiparametric MRI (mpMRI) for identifying clinically significant prostate cancers. It also compares image-fusion targeted biopsy with visual-registration targeted biopsy to see which method better detects significant prostate cancer in patients with suspicious MRI findings. Participants will undergo one of two types of MRI scans: a longer 30-40 minute MRI that uses a contrast dye called gadolinium (commonly used in the NHS), or a shorter MRI without contrast. If the MRI shows suspicious areas, participants may then have a prostate biopsy. Biopsies are performed either by visual registration, where the biopsy needle placement is guided by the operator’s judgment using MRI and ultrasound images, or by image fusion, where MRI images are overlaid on live ultrasound using software to guide the biopsy needle more precisely. During the study, patient scans and biopsy results will be closely monitored and analyzed to measure how many clinically significant cancers are detected within 12 weeks of enrollment. Researchers will collect MRI images, perform biopsies if indicated, and evaluate the biopsy samples under a microscope. The study includes safety monitoring and aims to inform future NHS practices for prostate cancer diagnosis. Male participants aged 18 and older who are referred for prostate MRI due to abnormal exams or elevated PSA levels are eligible to join.

Researchers are investigating inherited cardiac conditions in children, focusing on cardiomyopathies, which are progressive heart muscle diseases. This study aims to understand the genetic and environmental factors that influence the development, severity, and progression of these conditions to help identify new personalized treatments. The study collects data from children diagnosed with inherited cardiac conditions before age 16, their unaffected parents, and other family members, using an online platform called The Heart Hive to connect participants with researchers. Participants with confirmed inherited cardiac conditions and their parents will provide samples for whole genome sequencing and biomarker analysis. The study also includes subsets of patients with other rare inherited cardiovascular diseases with onset before age 16. Family members of deceased patients may be invited to donate stored samples, and some participants may be asked to provide tissue samples collected during their clinical care. Throughout the 5-year study period, demographic, imaging, and genetic data will be collected primarily from routine clinical care, with additional samples obtained through blood or saliva collection. Researchers will monitor participants' clinical progress and analyze genetic data to identify variants linked to disease outcomes. The study includes careful consent procedures, minimal risk sample collections, and access to health information to improve understanding and treatment of pediatric inherited cardiac conditions.

Researchers are studying how to improve the accuracy of MRI scans in identifying early-stage rectal cancer and significant rectal polyps. Early-stage rectal cancers grow partially into the bowel wall and can often be treated with local procedures that preserve the bowel, avoiding major surgery and its risks. Many patients are currently over-treated due to inaccurate MRI staging, leading to unnecessary major surgery or radiotherapy. The study focuses on a new MRI reading method called PRESERVE that has shown higher accuracy in identifying early rectal cancers suitable for local excision. The study involves training radiologists across 20 hospitals in the PRESERVE MRI reading method to better stage early rectal cancers and significant polyps. MRI scans are recommended before removal of rectal polyps that are 20mm or larger or have features suspicious for cancer. Radiologists will be trained to use the PRESERVE system to improve diagnostic accuracy and help guide treatment choices, aiming to increase the number of patients offered organ-preserving surgery. Participants will be monitored by comparing MRI reports before and after the radiologist training over one year. Researchers will measure the impact of the training on the accuracy of tumor staging and whether more patients receive local procedures instead of major surgery. This study will help determine if the new approach can be widely adopted to improve patient outcomes and preserve quality of life.