Aylesbury

Researchers are evaluating whether the introduction of dedicated hospital-based HIV teams can improve HIV testing rates among patients with HIV indicator conditions across ten European countries. This real-world, multicenter, stepped-wedge cluster randomized effectiveness-implementation trial spans four years and involves hospitals in the Netherlands, Belgium, United Kingdom, Germany, Spain, France, Italy, Romania, Poland, and Ukraine. The study aims to address the current gap in HIV testing and improve early diagnosis by comparing testing rates before and after the implementation of HIV teams. The intervention involves creating local HIV teams led by HIV specialists, supported by nurses and data collectors. These teams focus on auditing and providing feedback to healthcare professionals to encourage HIV testing when indicated, reducing stigma, educating staff on HIV prevention and care, and improving linkage to local prevention services. The HIV teams use electronic health records to identify patients with HIV indicator conditions and integrate their activities into routine hospital care. Participants' data are collected retrospectively from routine care and prospectively at the healthcare professional level. Researchers measure changes in HIV testing rates, new HIV diagnoses, and variations across countries and specialties. They also assess the HIV diagnosis and care cascade, healthcare professionals' knowledge and stigma levels, and implementation outcomes such as resource use and cost-effectiveness. Monitoring includes feedback loops and evaluation of barriers and facilitators to implementation, aiming to improve HIV testing and care sustainability in hospitals.

Researchers are looking for ways to treat germinal center B-cell-like diffuse large B-cell lymphoma (GCB DLBCL). DLBCL is a fast-growing blood cancer that affects B-cells. GCB is a type of DLBCL that affects young B-cells that are still maturing. The goal of this study is to learn if more people who receive zilovertamab vedotin (MK-2140) and R-CHP have the cancer respond (go away) than those who receive polatuzumab vedotin and R-CHP.

This research aims to understand the genetic factors that contribute to the risk of giant cell arteritis (GCA) and polymyalgia rheumatica (PMR). GCA is a serious inflammatory disease affecting blood vessels, mainly in people over 50, which can cause severe complications like vision loss or stroke if untreated. PMR causes pain and stiffness in the limbs with signs of inflammation. The study involves both patients recently suspected of having GCA and those with confirmed diagnoses from the past. It seeks to provide new insights into disease causes and improve diagnosis and treatment approaches. Participants are observed in a multi-center study collecting clinical and genetic data. The study includes both prospective patients with suspected GCA and retrospective patients with confirmed GCA or PMR diagnoses. Some retrospective participants receiving tocilizumab for recurring or difficult-to-treat GCA are also included in a safety monitoring registry. Data collected include clinical features, imaging, tissue and blood samples, and advanced genetic testing. The study also follows patients over time to assess disease impact, quality of life, and long-term outcomes. During the study, participants provide medical information, biological samples, and complete questionnaires about their symptoms and quality of life. Researchers monitor disease activity and treatment effects, especially among those starting certain immune-modifying drugs. The main measurements focus on genetic susceptibility at the study start, with ongoing evaluation of diagnosis, prognosis, and disease progression. The study is designed to improve understanding and management of GCA and PMR over time.

Researchers are evaluating whether adding duroplasty, a surgical procedure that expands the dura (the tough membrane around the spinal cord), to standard spinal surgery improves muscle strength and outcomes after severe traumatic spinal cord injury in the neck. This condition often causes permanent disabilities like paralysis and loss of bladder and bowel control, and currently, no treatments have proven to improve recovery. The study focuses on adults with severe cervical spinal cord injury who need surgery within 72 hours of injury. Participants will be randomly assigned to receive either standard spinal surgery, which includes laminectomy (removal of part of the vertebra), or spinal surgery plus duroplasty. The duroplasty involves opening the dura and stitching a patch to relieve pressure on the swollen cord. A subgroup of patients will also take part in a smaller mechanistic study using probes at the injury site to monitor pressure, blood flow, metabolism, and inflammation. The study will recruit 222 adults over 4 years from major trauma centers in the UK. During the study, patients will be assessed at baseline, 3, 6, and 12 months after surgery for muscle strength, hand function, walking ability, bladder and bowel control, quality of life, complications, and survival. Some patients will have additional monitoring at the injury site. The main outcome measured is the change in motor function at 6 months compared to baseline. Participants will be followed for one year to evaluate recovery and safety.

Researchers are evaluating the optimal duration of antibiotic treatment for adults with complicated intra-abdominal infections (cIAI). This Phase 3 trial aims to compare a fixed extended duration of 28 days of antibiotics to the current standard care durations, which typically range from 7 to 18 days. The study will assess clinical outcomes, quality of life, and cost effectiveness over a 180-day follow-up period to determine which approach may better reduce treatment failure and improve patient care while considering antimicrobial resistance concerns. Participants will be randomly assigned to one of two groups: the standard care group, where antibiotic type and duration are determined by their clinician, or the fixed extended-duration group, which receives antibiotics for a set 28-day period. The study includes a total of 1166 adult patients recruited from intensive care units and hospital wards across approximately 30 NHS trust hospitals. The treatment period is followed by monitoring up to 180 days after randomization. During the study, patients or their personal consultees will complete quality of life questionnaires at baseline and at 30, 60, and 180 days post-randomization. They will also provide information about antibiotic use and healthcare resource utilization. Researchers will collect hospital records on admissions, relapses, and further infections. The main outcome measured is treatment failure within 180 days of randomization, with safety and effectiveness assessed throughout the follow-up period.

Researchers are studying patients with chronic lymphocytic leukaemia (CLL) who are treated with acalabrutinib in the United Kingdom. This observational research looks back at real-world clinical outcomes for patients who started acalabrutinib through the UK's Early Access Programme (EAP). The study aims to describe characteristics of these patients and estimate progression-free survival, overall survival, response rates, treatment patterns, and healthcare resource use. The study focuses on patients who began first-line treatment with acalabrutinib between April 1, 2020, and April 1, 2021. It collects clinical data from patients' medical records in accordance with local laws. This non-interventional study does not assign treatments but observes outcomes from the use of acalabrutinib as provided in routine care. Participants' medical records will be reviewed to assess progression-free survival at multiple time points up to five years, along with other outcomes such as overall survival and treatment responses. The study also evaluates healthcare resource use and post-progression treatments. By gathering this data, researchers aim to provide useful real-world evidence on acalabrutinib's use in the UK for patients with CLL over the course of their treatment.

Researchers are evaluating ABBV-RGX-314, a novel one-time gene therapy, for treating neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD causes vision loss due to abnormal blood vessel growth in the retina and affects millions in the United States, Europe, and Japan. Current treatments require frequent eye injections, which can be burdensome and may lead to reduced vision over time. This Phase 3 study aims to compare the effectiveness and safety of two doses of ABBV-RGX-314 against the standard anti-VEGF drug, aflibercept, in people with wet AMD. Participants will be randomly assigned to receive one of two doses of ABBV-RGX-314 gene therapy or aflibercept injections. The gene therapy involves a one-time subretinal injection delivering a gene that produces an anti-VEGF protein to help control abnormal blood vessels. In addition, a bilateral treatment substudy will examine safety and effectiveness when both eyes are treated in participants with wet AMD in both eyes. This substudy will enroll up to 15 participants for at least 50 weeks of follow-up. During the study, participants will have their vision measured regularly to assess changes in best-corrected visual acuity (BCVA). Safety will be monitored by recording any eye-related adverse events and serious side effects. Participants will be followed for up to 54 weeks or more to evaluate how well the gene therapy maintains or improves vision compared to aflibercept and to assess overall treatment safety and tolerability.

Researchers are investigating colorectal cancer (CRC) patients with newly diagnosed stage I, II, and III cancers to evaluate whether mutations in circulating tumor DNA (ctDNA) can predict disease relapse earlier than current methods. This study includes two parts: Part B focuses on analyzing tumor tissue, serial blood samples, and clinical data to detect minimal residual disease (MRD) and predict relapse, while Part C is a randomized study comparing ctDNA-guided adjuvant chemotherapy to standard care in high-risk stage II or III CRC patients post-surgery. In Part B, the study collects serial blood samples from patients who have undergone potentially curative surgery to detect and quantify ctDNA, aiming to identify MRD and predict relapse. Part C randomizes patients after surgery into two groups: one receiving standard adjuvant chemotherapy and the other receiving ctDNA-guided chemotherapy, where those testing ctDNA negative may have chemotherapy reduced. The goal is to assess if ctDNA-guided treatment can safely reduce chemotherapy use without compromising disease-free survival. Participants will undergo tumor tissue collection, blood sampling at multiple time points, and clinical assessments over several years. Researchers will monitor ctDNA levels and clinical outcomes, measuring disease-free survival up to 3 to 6 years. Safety and treatment effects will be evaluated, with follow-up visits to track relapse and treatment response. Total participation includes long-term monitoring for relapse prediction and chemotherapy guidance.

This research investigates treatment options for rhegmatogenous retinal detachment (RRD), a serious eye condition where the retina detaches from the eye wall, potentially causing vision loss. The study compares two surgical approaches: vitrectomy alone versus combined vitrectomy and cataract surgery (phacovitrectomy). The goal is to determine which method offers better vision outcomes, fewer complications, and improved patient satisfaction. This is a phase 3 randomized equivalence trial focused on adults aged 50 and older with non-highly myopic phakic RRD who have not had previous vitreoretinal surgery. Participants will be randomly assigned to either have vitrectomy alone or combined phacovitrectomy. Vitrectomy involves removing the vitreous gel to repair the retinal detachment, while phacovitrectomy adds cataract removal and lens replacement during the same surgery. Vitrectomy can be performed with various gauge sizes at the surgeon's discretion, along with the choice of tamponade agent. Those in the vitrectomy-only group may have cataract surgery later if needed, following standard clinical practice. The combined surgery group will follow a specific procedure to determine the appropriate intraocular lens when the macula is detached. During the study, participants’ vision will be assessed, including Best-Corrected Visual Acuity at 52 weeks after surgery. Researchers will also evaluate retinal reattachment success, quality of life related to vision and health, patient satisfaction, complications, additional treatments, and costs. The study includes multiple hospital sites across the UK, with careful monitoring of recruitment, safety, and patient experiences. Total participation includes pre-surgery assessment, surgery, and follow-up evaluations over approximately one year.

Heart failure occurs when the heart cannot pump blood properly, causing symptoms like breathlessness, swelling, and tiredness. About half of heart failure patients have a normal ejection fraction, known as heart failure with preserved ejection fraction (HFpEF). HFpEF is complex and varies between patients, with unclear causes, severity factors, and limited treatment options. This research aims to better understand HFpEF by studying many patients over time to discover why it develops, improve diagnosis, and find new treatments. The study will create a UK-wide registry collecting detailed information from patients diagnosed with HFpEF by heart failure experts. This registry will include clinical data and outcomes from many centers, enabling advanced analysis to identify different HFpEF subgroups. The platform will support the development of personalized diagnostics and targeted treatment trials, improving how HFpEF is managed. It also facilitates collaboration with industry and enhances patient recruitment for future studies. Participants will provide consent and be diagnosed with HFpEF confirmed by a specialist. Their health data will be collected and linked to long-term outcomes, including measurement of natriuretic peptides. Researchers will monitor and analyze patient information over many years to identify distinct HFpEF groups, understand causes, and improve risk prediction. The study excludes patients with certain heart conditions or very reduced heart function. This long-term approach aims to improve personalized care for people living with HFpEF.