Barnsley

Researchers are investigating treatments for obesity or overweight in children and teenagers aged 6 to 17. This phase 3 pediatric chronic weight management study aims to create a framework to evaluate the safety and effectiveness of medicines for managing weight in this young population. The study is designed as a master protocol, allowing multiple interventions to be tested independently as they become available. Participants will be randomly assigned to receive either the drug Orforglipron or a placebo, both given by mouth. Each intervention will follow specific details within the study arms. The study periods include enrollment under the master protocol and independent substudies for each intervention. Results will be reported when all intervention substudies are completed. Throughout the study, participants will have regular assessments to monitor their weight and health. Researchers will track the number of participants assigned to each intervention from the start through week 72. The study includes evaluations of safety and effect on body weight, with ongoing monitoring to understand the impact of the treatments. Total participation may last up to about 72 weeks, with periodic visits and evaluations.

Researchers are evaluating two new treatments compared to the best standard care for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This phase 3 trial includes multiple hospitals across the UK and is led by University College London. The study aims to see if adding targeted radiotherapy or a radioactive drug can slow cancer spread and improve survival. Participants are assigned by computer to one of several groups. One group receives standard care, which includes androgen deprivation therapy ADT plus other hormone therapies, possible chemotherapy with docetaxel, and local radiotherapy. Another group receives standard care plus targeted high-dose radiotherapy SABR to metastatic sites. A third group receives standard care plus a radioactive therapy called 177Lu-PSMA-617, given in cycles with two doses per cycle. Treatments continue unless side effects are severe or participants choose to stop. During the study, participants will have scans and tests to monitor their cancer and side effects. Doctors will check safety and treatment adherence over time. Researchers will measure overall survival, failure-free survival, progression-free survival, prostate cancer-specific survival, and quality of life up to 10 years from randomization. Safety will be closely monitored, and participants health will be followed during and after treatment.

Researchers are studying the effects of orforglipron, taken once daily by mouth, compared to a placebo in adolescents aged 12 to 17 who have obesity or are overweight with related health issues. This Phase 3 trial aims to evaluate how effective, safe, and how the body processes orforglipron in this group. The study is conducted under a master protocol and sponsored by Eli Lilly and Company. Participants will be randomly assigned to receive either orforglipron or a placebo orally. Those who complete the initial study period, including a 4-week safety follow-up, may continue with up to 156 additional weeks of treatment along with ongoing lifestyle interventions. The main treatment and observation period lasts about 18 months. During the study, participants will have their body mass index BMI and other health measures monitored, including body weight, waist size, blood pressure, cholesterol, blood sugar, insulin levels, and body fat through scans. Quality of life related to weight will also be assessed. Researchers will track drug levels in the body and monitor safety throughout. The study includes regular visits and assessments over the full duration to observe changes and effects.

Researchers are evaluating the use of EEG-based Brain-Computer Interface BCI technology to detect awareness and enable communication in people with prolonged disorders of consciousness DoC, such as unresponsive wakefulness syndrome UWS, minimally conscious state MCS, and locked-in syndrome LIS. The study aims to improve diagnosis accuracy where traditional methods relying on motor responses may fail, and to explore if BCI can provide movement-independent communication. The trial also investigates whether training with BCI can enhance brain response consistency and communication ability. Participants undergo three phases Phase I assesses if patients can imagine movements and produce detectable brain activity using EEG. Phase II involves training with motor imagery BCI and real-time auditory feedback to help participants modulate brain signals. Phase III tests participants ability to answer yes-no questions using imagined movement patterns. The study uses specific imagined movement combinations to represent yes or no responses, tailored individually and applied throughout sessions lasting about 1.5 hours each. During the study, participants complete up to 10 sessions including assessments, training, and communication tasks. Researchers monitor changes in BCI performance accuracy, ability to communicate consistently, and clinical scale scores related to consciousness and recovery. The study evaluates how feedback types and timing affect performance and collects data to support clinical diagnosis and potential therapeutic benefits. Participation involves EEG recordings, neurofeedback, and answering structured questions over several weeks.

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.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90 of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are evaluating the efficacy, safety, and tolerability of adding subcutaneous lunsekimig compared with a placebo in adults aged 18 to 80 years who have high-risk asthma and are not currently eligible for biologic treatments. This is a Phase 2, randomized, double-blind, placebo-controlled study with two groups. Participants must have a diagnosis of mild-to-moderate asthma for over 12 months and at least one asthma exacerbation in the previous year. Participants will be randomly assigned to receive either lunsekimig or placebo by subcutaneous injection every 4 weeks. The investigational treatment will last up to approximately 52 weeks. The study includes 18 visits in total and may last about 64 weeks for those not entering the long-term safety study or about 60 weeks for those who do. During the study, participants will have regular assessments including lung function tests, asthma control questionnaires, and measurements of biomarkers like FeNO. Researchers will track asthma exacerbation rates, lung function changes, asthma symptom scores, quality of life, and the presence of antibodies against the study drug. Safety will be monitored through adverse event reporting up to 56 weeks. Participants usual asthma treatments such as inhalers may continue under supervision.

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, especially those over 65 years old, with increasing numbers due to an aging population. This condition often progresses silently until serious symptoms appear, requiring valve replacement surgery AVR or transcatheter aortic valve implantation TAVI. This research aims to compare early valve replacement to regular monitoring in patients with severe AS who have no symptoms, to understand which approach leads to better health outcomes and cost-effectiveness. The study is a large, open, randomized controlled trial conducted in multiple countries, including the UK, Australia, and New Zealand. Participants with severe asymptomatic AS will be randomly assigned to receive either early valve replacement surgery or ongoing regular monitoring without immediate surgery. Those in the surgery group will be placed on a waiting list aiming for surgery within three months and may undergo additional routine tests like coronary angiography. The monitoring group will continue with standard care and regular check-ups. Participants will be followed for at least three years to track outcomes such as cardiovascular death and hospitalizations for heart failure, along with quality of life and health economics measurements. The study includes regular assessments, questionnaires, and record linkages up to five years. Researchers will analyze outcomes based on the group participants were assigned to, regardless of actual treatment received, to provide clear information on the benefits and risks of early surgery versus expectant management.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.