Aylesbury

This research aims to evaluate whether creating dedicated HIV teams in hospitals across ten European countries can increase HIV testing rates among patients showing signs of HIV-related conditions. The study uses a stepped-wedge design, where hospitals switch from routine care to the new intervention in sequence. This approach compares outcomes before and after the teams are in place, helping to understand the impact of the intervention across various locations and medical specialties. The intervention involves establishing local HIV teams led by specialists and supported by nurses and data experts. These teams identify patients needing HIV tests through electronic health records, provide feedback to doctors to encourage testing, offer education to healthcare staff about HIV, reduce stigma, and improve connections to prevention and care services. This program integrates smoothly into regular hospital routines and aims to close gaps in HIV diagnosis. Participants HIV testing rates will be monitored by reviewing records before and after the intervention. Researchers will also assess new HIV diagnoses, changes in testing patterns by country and specialty, and healthcare professionals knowledge and attitudes toward HIV. The study includes ongoing evaluation of how well the teams operate, resource use, and cost-effectiveness. Data collection extends up to several years to observe long-term effects, with continuous monitoring of care access and prevention services.

Researchers are evaluating treatments for germinal center B-cell-like diffuse large B-cell lymphoma GCB DLBCL, a fast-growing blood cancer affecting immature B-cells. The study compares two treatment combinations to see if more people respond to zilovertamab vedotin MK-2140 plus R-CHP versus polatuzumab vedotin plus R-CHP. This Phase 2 trial aims to assess the effectiveness and safety of these regimens in participants with newly diagnosed GCB DLBCL. Participants receive either zilovertamab vedotin along with rituximab, cyclophosphamide, doxorubicin, and prednisone R-CHP, or polatuzumab vedotin combined with R-CHP. Treatments are given by intravenous infusion on Day 1 of each 3-week cycle for up to 6 cycles, approximately 4 months, with prednisone or prednisolone taken orally for 5 days of each cycle. For participants with high-risk DLBCL, up to 2 additional cycles of rituximab or biosimilar are given. During the study, participants are monitored for response to treatment using Lugano Response Criteria, with follow-up lasting up to about 31 months for the primary outcome. Secondary outcomes include progression-free survival, overall survival, event-free survival, duration of complete response, adverse events, and quality of life assessments. Safety and health status are regularly checked through exams, lab tests, and questionnaires over several years, with total study participation extending up to 7 years.

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 investigating whether adding duroplasty, a surgical procedure that expands the tough membrane around the spinal cord, improves outcomes after severe cervical spinal cord injury. This trial focuses on adults with acute, severe injuries in the neck area who require surgery within 72 hours. The study aims to determine if duroplasty combined with standard bony decompression surgery enhances muscle strength and functional recovery compared to bony decompression alone. Participants will be randomly assigned to receive either standard spinal surgery including laminectomy alone or the same surgery plus duroplasty. Some patients may also join an optional mechanistic sub-study where probes and microdialysis catheters monitor spinal cord pressure, blood flow, metabolism, and inflammation at the injury site. The study will recruit around 222 to 260 patients over four years, including sites in the UK and internationally. During the study, participants will be assessed at baseline, 3, 6, and 12 months after surgery using questionnaires and physical examinations to measure muscle strength, hand function, walking ability, bladder and bowel control, and quality of life. Some will have MRI scans at 2 weeks and 6 months, and safety outcomes such as complications, additional surgeries, and mortality will be tracked up to 12 months. Follow-up lasts one year to evaluate recovery and treatment impact.

Researchers are evaluating the Heartfelt device, a new passive monitoring system that detects early signs of fluid build-up in patients with heart failure by measuring changes in foot and lower leg volume using 3D images. The study aims to see if adding this device to standard NHS care improves quality of life and reduces heart failure-related events compared to standard care alone. The trial involves 300 participants from multiple NHS hospitals and GP practices across the UK and uses a randomized crossover design. Participants will be randomly assigned to receive either standard NHS care, which includes regular weight checks and symptom monitoring, or standard care plus the Heartfelt device installed at home. The device captures daily images of the feet to track swelling without extra effort from the user. Alerts triggered by important changes are sent to the clinical team for prompt action. Both groups receive a patient booklet from the British Heart Foundation to support self-monitoring and understanding of heart failure. During the study, participants quality of life will be assessed using questionnaires at baseline and at 3, 6, 9, and 12 months. The study will also monitor hospitalizations, deaths, medication adherence, and the availability of daily device data. Researchers will evaluate how the clinical teams respond to alerts, the ease of device use, and its cost-effectiveness. The total participation period covers 12 months of monitoring and data collection.

Researchers are studying patients with chronic lymphocytic leukaemia CLL who have been treated with acalabrutinib in the United Kingdom. This observational study aims to describe the characteristics and real-world clinical outcomes of these patients, especially those who started acalabrutinib treatment as part of the UK Early Access Programme. The study seeks to provide UK-specific data on how patients respond to and tolerate acalabrutinib in typical clinical settings. The study involves reviewing clinical records of treatment-naefve CLL patients who began acalabrutinib between April 1, 2020, and April 1, 2021. The focus is on patients treated in the first-line setting with acalabrutinib under the Early Access Programme. This non-interventional study does not involve new treatments but collects and analyzes existing data to estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. Participants medical information will be gathered from their clinical records following local laws. Researchers will track outcomes such as progression-free survival at various time points up to 60 months, overall survival, response rates, and treatment interruptions. The study design allows for long-term observation of how patients fare with acalabrutinib, providing valuable real-world evidence. The study is expected to continue through April 2027.

Researchers are studying patients with newly diagnosed stage I, II, and III colorectal cancer CRC to understand how circulating tumor DNA ctDNA in the blood can predict disease relapse. The study evaluates whether using ctDNA to guide adjuvant chemotherapy decisions after surgery is as effective as standard chemotherapy, aiming to reduce unnecessary treatments and side effects. This multi-center, prospective research includes both observational and randomized components to better manage early-stage CRC. The study has two parts Part B focuses on collecting tumor tissue, serial blood samples, and clinical data to detect minimal residual disease MRD using ctDNA after curative surgery. Part C is a randomized trial comparing ctDNA-guided adjuvant chemotherapy versus standard care in patients with high-risk stage II or III CRC. Patients are randomized post-surgery to either standard chemotherapy or a ctDNA-guided approach where those testing negative for ctDNA may receive less chemotherapy. Participants will undergo regular blood sampling and clinical assessments to monitor ctDNA levels and disease status. Researchers will measure outcomes such as 3-year disease-free survival and the relationship between ctDNA detection and treatment response over several years. The study includes follow-up periods of 4 to 8 years to evaluate long-term outcomes and safety. Participants need to consent, adhere to follow-up schedules, and be suitable for chemotherapy if randomized to Part C.

Rhegmatogenous retinal detachment RRD is a condition where the retina detaches from the back wall of the eye, causing vision loss that requires surgery. This trial evaluates two surgical approaches for adults aged 50 and older with non-highly myopic RRD who have not had previous vitreoretinal surgery. It compares vitrectomy alone, the standard care, with combined vitrectomy and cataract surgery phacovitrectomy to determine which offers better outcomes, safety, and patient experience. Participants are randomly assigned to one of two groups. One group undergoes vitrectomy to repair the retina and may have cataract surgery later if needed. The other group receives both vitrectomy and cataract removal with intraocular lens implantation during the same surgery. The surgeries follow standard care procedures, including vitrectomy with various gauge sizes and tamponade agent choice at the surgeons discretion. A special protocol guides lens selection when the macula is detached during combined surgery. During the 52 weeks after surgery, participants are monitored for vision quality using best-corrected visual acuity, success of retinal reattachment, complications, additional surgeries, quality of life, patient satisfaction, and healthcare costs. Assessments include visual tests, patient questionnaires, and safety monitoring. Interviews are also conducted to understand patient experiences and acceptability of each surgical approach. The trial aims to provide evidence on clinical and cost-effectiveness to guide treatment decisions for RRD.

Heart failure with preserved ejection fraction HFpEF occurs when the hearts pumping function is normal but the heart cannot pump blood properly. This condition causes symptoms like breathlessness, swollen feet and ankles, and tiredness. HFpEF is complex and varies widely among patients, making it poorly understood with limited treatment options. The UK HFpEF study aims to improve understanding of why people develop HFpEF, create better diagnostic tests, identify new treatments, and follow participants health over many years. This observational study involves creating a large registry by collaborating across many centers in the UK. The registry will collect detailed information from thousands of patients with HFpEF, enabling researchers to classify the condition more precisely and develop personalized treatment approaches. This platform will support future research trials targeting specific patient groups and enable efficient patient recruitment. Participants will undergo detailed assessments including clinical evaluations, measurements of natriuretic peptide levels, and long-term health monitoring. Researchers will analyze data to identify distinct HFpEF subgroups, understand causes, and improve risk prediction over a 10-year period. This study is designed to provide important insights for better care and treatment strategies, with ongoing follow-up to track health outcomes.

The trial investigates whether stopping or continuing milk feeding around the time of blood transfusion in very premature infants born before 30 weeks gestation affects the risk of developing Necrotizing Enterocolitis NEC, a serious intestinal disease. NEC can cause severe damage or death in preterm infants, and this study aims to find out which feeding approach during transfusion may reduce this risk. The trial is conducted in neonatal intensive care units across Canada and the UK and compares two standard care methods currently in use. Participants are randomly assigned to one of two groups one group will stop all enteral feeds for 4 hours before, during, and 4 hours after packed red cell transfusions, with hydration maintained by intravenous nutrition or glucose the other group will continue feeding as usual throughout the transfusion period. Infants stay in their assigned feeding group until they reach 34 weeks and 6 days gestational age. This approach follows practices identified as acceptable in prior surveys and studies. During the study, infants will be closely monitored for the development of NEC and other health outcomes from randomization until 40 weeks postmenstrual age. Researchers will track serious complications like severe NEC, infections, growth, lung disease, eye problems, brain injury, and hospital stay duration. The study collects detailed information about feeding, infections, nutrition, and clinical status to evaluate the safety and effects of each feeding strategy during transfusion.