Yeovil

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study. This trial focuses on patients with established atherosclerotic cardiovascular disease ASCVD or those at high risk for a first ASCVD event. The study aims to assess how AZD0780 compares to placebo in reducing the risk of major adverse cardiovascular events, also known as MACE-PLUS, over the course of the trial. Participants are randomly assigned to receive either oral AZD0780 once daily or a matching placebo once daily. The study continues until a primary analysis censoring date, which may be up to approximately 54 months from randomization. After this, a study closure visit will be conducted as the final visit for each participant. During the study, participants will be regularly monitored for cardiovascular events including heart attacks, strokes, urgent coronary revascularizations, and other related outcomes. Researchers will track the time to first occurrence of these events as the primary outcome. Safety and other secondary outcomes like all-cause mortality will also be assessed. The total participation time can last up to about 54 months, with ongoing evaluations throughout this period.

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 studying metastatic breast cancer in a program aiming to recruit 1300 patients from hospitals across Europe. Eligible participants are adults aged 18 or older, male or female, with a recent diagnosis of metastatic or locally advanced breast cancer or disease relapse who have not received more than one type of treatment for metastases. The goal is to better understand genetic changes in metastatic breast cancer and discover how tumors respond or resist therapy to eventually identify the most suitable treatment for each patient. The study is sponsored by the Jules Bordet Institute and focuses on molecular analysis of cancer samples. Participants will undergo a biopsy of a metastatic lesion either at program entry or up to six months before inclusion, and a sample of the primary tumor must be available. Blood, serum, and plasma samples will also be collected. These samples will be analyzed centrally, and any unused samples will be stored in a bio-repository for future research. The study offers the possibility for patients with certain genetic changes to join related clinical trials if available and approved in their country. Throughout the study, participants provide blood samples at screening and regular intervals during follow-up. Researchers will evaluate genetic alterations, identify exceptional responders and rapid progressors, and assess patient prognosis over up to 10 years. The study will also monitor the feasibility of molecular screening and correlate molecular findings with standard measures of treatment response. The total study duration extends to March 2031, with primary outcome review planned one year after recruitment ends.

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Researchers are collecting and evaluating long-term clinical and X-ray data to better understand the safety and performance of shoulder arthroplasty over time. This observational study follows patients for at least 10 years to observe outcomes without a set limit on follow-up duration. The study includes people with various shoulder conditions such as osteoarthritis, rotator cuff tears, fractures, and infections. Participants in this study have undergone or are indicated for shoulder arthroplasty surgery. The study tracks their progress over time through regular clinical and radiographic assessments. Various outcome scores like the Constant score, ASES, Oxford Score, TESS, and MSTS are measured approximately once per year throughout the study period to evaluate shoulder function and recovery. During the study, participants will attend scheduled visits where clinical exams and imaging are performed to monitor their shoulder health and prosthesis performance. They will complete questionnaires related to their condition and function. The study aims to gather comprehensive long-term data on shoulder arthroplasty outcomes, with follow-up lasting at least 10 years from enrollment.

Researchers are evaluating the prevention of venous thromboembolism VTE, a serious condition that can occur after a stroke, in immobile patients. This study compares the current standard treatment, Intermittent Pneumatic Compression IPC, with a medical device called the geko device, which uses neuromuscular electrostimulation to increase blood circulation. The study focuses on whether the geko device can better prevent VTE during a 90-day follow-up period after stroke. Participants will be randomly assigned to one of two groups one receiving the geko device and the other receiving standard IPC treatment. The geko devices will be applied to both legs and changed every 24 hours, used continuously for up to 30 days or until the patient regains mobility. The IPC devices will also be applied to both legs and used up to 30 days or until recovery or discharge. Treatment will start soon after randomization. During the study, participants will have leg Doppler ultrasound exams at 7 days optional and 14 days mandatory to check for blood clots. At 14 days, patients will complete a questionnaire about device comfort and health information. At 30 days, medical records will be reviewed for any symptomatic deep vein thrombosis or pulmonary embolism. A final phone follow-up at 90 days will assess recovery, health, mobility, quality of life, and survival. Safety and device effectiveness will also be monitored throughout the study period.

Researchers are evaluating whether using MRI imaging for staging sigmoid colon adenocarcinoma can change treatment plans by detecting more high-risk tumors compared to standard CT imaging. This randomized phase II multicenter trial aims to improve radical treatment decisions and provide better prognostic information to patients. The study involves patients eligible for curative treatment whose MRI can be reviewed before surgery without a prior treatment decision. Participants are assigned randomly to one of three groups standard preoperative CT imaging with multidisciplinary team discussion, standard CT plus an additional preoperative MRI scan with team discussion, or observation only. The MRI provides supplementary diagnostic information that may alter treatment strategies based on local protocols. During the study, patients are followed up at 1 and 3 years with quality of life questionnaires. Researchers assess differences in cancer staging between CT and MRI, treatment changes, recurrence rates, disease-free survival, surgery quality, pathology outcomes, morbidity and mortality, and permanent stoma rates. The total follow-up extends up to 5 years after treatment, with outcomes measured at multiple time points to understand the impact of MRI staging on patient care.

Researchers are studying advanced pelvic cancers, which are rare and often require complex treatment involving radiotherapy, chemotherapy, and surgery. Surgery typically involves removing multiple pelvic organs and surrounding tissues, which can lead to complications affecting recovery and quality of life. This study aims to investigate the frequency of these complications, quality of life, and related costs following different reconstruction techniques to help improve decision-making for patients and doctors. This observational study has three parts maintaining a database of patients undergoing colorectal surgery, conducting a national prospective cohort study to assess morbidity, quality of life, and healthcare resource use, and a qualitative study using interviews to explore patient experiences after surgery. Patients undergoing surgeries like abdominoperineal excision or pelvic exenteration will be followed, with reconstruction methods chosen by the surgeon. Data such as surgery details, complications, and resource use will be collected and analyzed. Participants will complete quality of life and financial impact questionnaires at baseline, 3, 6, and 12 months after surgery, either by telephone or email. Clinical data, imaging, and hospital resource use will also be recorded. The qualitative study will involve interviews with selected patients at 3 and 12 months post-surgery to deepen understanding of recovery and long-term outcomes. The study will analyze these data to evaluate the impact of different reconstruction methods on patient health and healthcare costs over time.

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.

This research aims to understand how healthcare professionals collaborate in intensive care units ICUs, focusing on teamwork practices, challenges, and changes since the COVID-19 pandemic. The study observes daily work and explores factors influencing teamwork to support staff resilience and patient safety. It is an observational ethnographic study conducted in multiple ICUs. Participants include healthcare professionals working in selected ICU sites. Researchers will shadow staff during their shifts, observing various interactions such as handovers, ward rounds, and team meetings. Observations occur in 20-minute blocks to reduce burden. In addition, one-on-one interviews with at least 15 healthcare professionals per site will be conducted to gather detailed insights into teamwork experiences. During the study, researchers will collect and analyze fieldnotes and interview transcripts using thematic analysis to identify patterns in teamwork. Observations and interviews will be recorded with consent and anonymized for privacy. The main outcome is to examine changes in teamwork over 12 months after the pandemic. Participants contribute through observation and interviews over four weeks, supporting a comprehensive understanding of ICU teamwork.