Worthing

Researchers are evaluating two different pacing methods for patients with slow heart rates, called bradycardia. This study compares the common right ventricular pacing approach with a newer physiological pacing method that includes His bundle and left bundle area pacing. The trial aims to better understand how these pacing techniques affect patient outcomes, including mortality and heart failure morbidity, in a large group of 2600 patients. Participants will receive a pacemaker implant and be randomly assigned to either right ventricular pacing or physiological pacing. The physiological pacing may involve His bundle pacing or left bundle pacing, but if these are not successful, biventricular pacing will be used. A subgroup of 500 participants will take part in an optional echocardiographic sub-study to assess heart function changes over a 24-month period. Throughout the study, patients will be assessed at baseline and every six months after randomization, with follow-up lasting up to 78 months. Researchers will monitor outcomes such as mortality, heart failure events, device-related safety issues, patient quality of life, symptoms, and pacemaker-derived data like arrhythmias and activity levels. The echocardiographic sub-study will measure specific heart function changes to understand pacing-induced cardiomyopathy. Participants involvement includes implantation, regular follow-up visits, questionnaires, and optional imaging assessments.

Researchers are evaluating whether less frequent dosing of pembrolizumab after six months of standard treatment is safe and effective for patients with advanced non-small cell lung cancer NSCLC. Pembrolizumab, an immunotherapy targeting the PD-1 receptor, has improved outcomes in NSCLC, but current dosing every six weeks for up to two years may result in overtreatment. This UK phase III trial aims to find if reducing dose frequency can maintain effectiveness while improving quality of life and lowering costs. Participants who have received six months of pembrolizumab, with or without chemotherapy, and plan to continue treatment will be randomized to receive pembrolizumab intravenously every six weeks control or every twelve weeks initially. If the 12-week dosing is found to be not less effective, additional groups receiving doses every nine, fifteen, and eighteen weeks will be included. Patients who experience disease progression while on reduced frequency dosing can return to the standard six-week schedule. Throughout the study, participants will be monitored for overall survival at 18 months from randomization, along with other outcomes such as progression-free survival, response rate, duration of response, and adverse events over two years. The study involves regular hospital visits for treatment and assessments, and the results may lead to safer, more convenient treatment options for NSCLC patients. The total participation time varies depending on individual treatment and follow-up schedules.

Researchers are evaluating the combination of bleximenib, venetoclax VEN, and azacitidine AZA compared to placebo with VEN and AZA in treating adults with newly diagnosed Acute Myeloid Leukemia AML who have mutations in the NPM1 or KMT2A genes. This Phase 3 study focuses on participants who are not eligible for intensive chemotherapy due to age or other health conditions. The goal is to understand how these treatments work in this specific AML population. Participants receive treatment in 28-day cycles, either with bleximenib plus VEN and AZA or placebo plus VEN and AZA. Bleximenib, VEN, and placebo are taken orally, while AZA is given intravenously or under the skin. Treatment continues until disease progression or unacceptable side effects occur. During the study, participants will be monitored for response to treatment including complete remission and overall survival for up to over four years. Researchers will track event-free survival, duration and timing of remission, transfusion independence, and other health outcomes. Safety is also closely observed through adverse events and lab tests. Participation involves regular visits for treatment and assessments over the study period.

Researchers are evaluating the long-term outcomes of the ACE Acetabular Cup System, a device used in total hip replacement surgery. This procedure replaces both the hip ball and socket to relieve pain and help patients return to normal activities. The study aims to monitor the safety and performance of this CE-marked device over 10 years by assessing clinical, functional, and radiological results in patients with hip disease. The ACE Acetabular Cup System offers three options for socket liners ceramic, polymer, or dual mobility, allowing surgeons to choose the best fit for each patient. Participants in the study have received a primary elective total hip replacement using this system combined with a JRI femoral stem and head. The study is observational and follows patients over a decade to gather data on device function and patient health. Participants will be followed through questionnaires, reviews of X-rays, and monitoring of any complications. Key measurements include the Oxford Hip Score at 3 years post-operation, along with implant survivorship and other hip function assessments at multiple time points up to 10 years. Radiological assessments will also be conducted at 1, 5, and 10 years. This comprehensive follow-up helps researchers understand how well the device performs long-term and supports patient safety.

This research aims to assess the effectiveness and safety of adding oral anticoagulation OAC to background antiplatelet therapy in patients who develop new-onset post-operative atrial fibrillation POAF after isolated coronary artery bypass graft CABG surgery. The study is a prospective, multicenter, open-label, randomized trial comparing OAC with no OAC to evaluate the prevention of thromboembolic events and the risk of major bleeding. Participants are randomly assigned to either an OAC-based strategy using vitamin K antagonists or approved direct oral anticoagulants alongside antiplatelet therapy, or to an antiplatelet-only strategy. The anticoagulation treatment lasts for 90 days, with option for crossover to OAC if recurrent atrial fibrillation occurs after 30 days in the control group. Up to 500 patients may also participate in a digital health substudy using a wearable heart rhythm monitor for 30 days post-discharge. During the study, participants have follow-up visits at 30, 60, 90, and 180 days after randomization, including phone contacts and clinical assessments. Researchers will monitor outcomes such as death, stroke, transient ischemic attacks, myocardial infarction, thromboembolism, and bleeding events up to 180 days. Data from patients who decline randomization are collected in a parallel registry to compare baseline risk and treatment strategies.

Researchers are evaluating the safety and effectiveness of whole-body hypothermia for newborn babies with mild hypoxic ischaemic encephalopathy. This phase III randomised controlled trial aims to determine whether cooling the whole body to 33.5.5C within six hours after birth and continuing for 72 hours improves cognitive development at around two years of age compared with maintaining normal body temperature. The study also seeks to assess the economic value of cooling therapy for mild encephalopathy within the healthcare system. Babies born at or after 36 weeks with signs of birth asphyxia or acidosis will be randomly assigned to receive either whole-body hypothermia or targeted normothermia. Cooling will be applied using a servo-controlled machine in neonatal intensive care units, maintaining a rectal temperature of about 33.5C for 72 hours. The control group will have their body temperature kept at normal levels 37C for the first 80 hours, with any fever carefully treated. Babies born at non-cooling centers will be transferred to specialized units for treatment. During the study, participants will undergo brain monitoring, MRI scans before discharge, and follow-up developmental assessments at 24 months using the Bayley Scales of Infant and Toddler Development IV. Additional evaluations will include neurological exams, motor function assessments, vision and hearing tests, and parent-completed questionnaires. Researchers will collect detailed clinical data from birth through hospital stay, aiming to compare cognitive outcomes and safety measures between the two groups over the study period.

Atrial fibrillation AF is a common heart rhythm disorder that can cause strokes due to blood clots. Despite treatment with direct oral anticoagulants DOACs, patients with AF still face a significant risk of stroke. This trial investigates whether adding a procedure called left atrial appendage occlusion LAAO to DOAC therapy is better than DOAC therapy alone in preventing stroke and other cardiovascular problems in people who have had a recent ischemic stroke despite being on anticoagulants. Participants will be randomly assigned to one of two groups one group will receive the LAAO procedure along with DOAC therapy, while the other will continue DOAC therapy alone. The choice of DOAC is determined by the treating doctor. The trial uses a randomized design with blinded assessment of outcomes. Treatment and follow-up will continue for a minimum of 6 months and up to 48 months, with visits every 6 months to monitor health and outcomes. During the study, participants will undergo regular assessments including monitoring for recurrent ischemic stroke, systemic embolism, cardiovascular death, bleeding events, procedure-related complications, and overall health status. Functional neurological outcomes and patient-reported measures will also be evaluated. The study aims to enroll 482 patients and follow them closely to compare the effects of the two treatment strategies over time.

Researchers are evaluating the efficacy, safety, and tolerability of a subcutaneous drug called lunsekimig compared to placebo in adults aged 40 to 80 years who have inadequately controlled Chronic Obstructive Pulmonary Disease COPD with an eosinophilic phenotype. This Phase 2b3 study aims to better understand how lunsekimig might affect COPD symptoms and exacerbations in this specific group. Participants will be randomly assigned to one of three groups lunsekimig dose regimen A, lunsekimig dose regimen B, or a matching placebo. All treatments are given by subcutaneous injection during a 48-week intervention period. The study includes a screening period up to 4 weeks before treatment and an approximately 8-week follow-up after the intervention, for a total duration of up to 60 weeks. During the study, participants will have regular assessments including lung function tests and symptom questionnaires. Researchers will monitor the annual rate of moderate-to-severe COPD exacerbations as the primary outcome. Secondary measures include changes in lung function and quality of life scores, along with safety evaluations such as monitoring adverse events and laboratory tests. Blood samples will be collected to measure drug levels and antibody responses. Participants are observed throughout the treatment and follow-up periods to assess the effects and tolerability of lunsekimig.

This research aims to find out if adding a special rehabilitation program to usual care can improve the quality of life for patients with incurable solid cancers like lung, colorectal, breast, prostate, or others. It focuses on people aged 18 or older who have advanced cancer that cannot be cured and who may be experiencing disability and loss of function. The study is conducted across several European countries and looks at how this rehabilitation fits alongside current healthcare services. Participants are randomly assigned to one of two groups one receiving the Integrated Short-term Palliative Rehabilitation plus usual care, and the other receiving usual care alone. The rehabilitation involves up to three sessions with a trained practitioner, either face-to-face or remotely, focusing on symptom management, physical activity, and social participation. The first session occurs within two weeks of joining the trial, with follow-up sessions around weeks 4 and 6. Usual care continues without change for all participants. During the 16-week study period, participants complete questionnaires on health-related quality of life and other outcomes at weeks 4, 8, and 16. Those in the rehabilitation group may also have an optional interview. Medical history and demographic data are collected and securely stored. Researchers will monitor participants progress through medical records at 28 weeks without requiring participant action. The main outcome measured is quality of life at 8 weeks, with additional assessments of symptoms, disability, and goal attainment.

Researchers are evaluating a medicine called elranatamab in people with multiple myeloma MM, a type of cancer. This study compares elranatamab to other commonly used combination therapies for MM that has returned or not responded to previous treatments. Participants must be 18 years or older and have received prior treatments, including an anti-CD38 antibody and lenalidomide. The study is a phase 3, randomized trial sponsored by Pfizer. Participants will be randomly assigned to receive either elranatamab alone or one of several combination therapies chosen by the study doctor. Elranatamab is given as a shot under the skin at the study clinic about once a week, with possible adjustments later. The combination therapies include two to three medicines taken by mouth or given by injection or infusion at the clinic. Treatment continues until the multiple myeloma stops responding. During the study, participants attend regular visits to monitor their response and side effects. Follow-up continues after treatment ends through telephone contacts or visits. Researchers will measure outcomes such as progression-free survival, overall survival, response rates, duration of response, and quality of life over approximately five years. Safety monitoring includes tracking adverse events and laboratory results throughout and after treatment.