Yeovil

Researchers are evaluating AZD0780, an oral PCSK9 inhibitor, in a phase 3, randomized, placebo-controlled study to see if it can reduce the risk of major adverse cardiovascular events (MACE-PLUS) in adults with established atherosclerotic cardiovascular disease (ASCVD) or those at high risk for a first ASCVD event. The study compares AZD0780 to a placebo and monitors participants from randomization until the primary analysis censoring date, followed by a final study closure visit. Participants will be randomly assigned to receive either oral AZD0780 or an oral placebo once daily. The treatment period lasts until the primary analysis censoring date, after which a study closure visit will occur. The study is event-driven and designed to assess the time to the first major cardiovascular event during treatment. During the study, participants will be closely monitored with various assessments to evaluate cardiovascular outcomes and safety over approximately 54 months. Researchers will track the time to first event of any component of MACE-PLUS and collect data to assess the effect of AZD0780 compared to placebo. The study includes regular visits and evaluations to ensure participant safety and adherence to treatment.

Researchers are evaluating whether reducing the frequency of pembrolizumab treatment after six months of standard therapy is safe and effective for patients with advanced non-small cell lung cancer (NSCLC). Pembrolizumab, an immunotherapy targeting the PD-1 receptor on T cells, has improved outcomes for this condition. Because pembrolizumab remains bound to its target for a long time and dosing frequency may not affect outcomes, this study aims to find out if less frequent dosing can maintain effectiveness while reducing overtreatment and side effects. This phase III study also considers potential benefits like cost savings and improved quality of life due to fewer hospital visits. Participants who have completed six months of pembrolizumab treatment without disease progression and are continuing therapy will be randomly assigned to receive pembrolizumab at the standard six-week interval or at a reduced frequency of 12 weeks. If early results show that the 12-week schedule is not less effective, later participants may be randomized to even longer intervals of 9, 15, or 18 weeks. Pembrolizumab is given intravenously at 400 mg per dose. Patients whose disease progresses on a reduced frequency schedule may return to the standard six-week treatment. During the study, researchers will monitor overall survival at two years after randomization. Participants will undergo regular assessments to track disease status, treatment tolerability, and overall health. The study aims to confirm that less frequent dosing does not reduce survival while potentially improving patient experience. The trial is open to adults aged 18 and older with advanced NSCLC who have already completed six months of pembrolizumab therapy and intend to continue treatment.

This research aims to demonstrate the acceptable performance and assess the safety of the HARMONIC 700 Shears device when used as instructed in both pediatric and adult surgical procedures. The study focuses on its use in general pediatric surgeries as well as general, gynecological, urological, and thoracic surgeries in adults. It evaluates the device in a post-market setting to ensure its reliability across these types of surgeries. The study involves using the HARMONIC 700 Shears for vessel transection according to the device's instructions for use. There is no additional intervention beyond the necessary clinical care during the procedures. The device is applied in surgeries where at least one vessel is planned to be transected, covering a range of general and specialized surgical procedures for both children and adults. Participants will be monitored during surgery to measure the number of vessel transections achieving effective hemostasis and to track any device-related adverse events up to approximately 1 year and 7 months after the procedure. The study assesses both the intraoperative performance of the device and its longer-term safety, involving follow-up assessments to evaluate outcomes and any potential complications.

Researchers are studying metastatic breast cancer by recruiting 1300 patients from many hospitals across Europe. This study focuses on patients aged 18 or older, both female and male, who have been diagnosed with metastatic breast cancer or a relapse and have not received more than one systemic treatment since the discovery of metastases. The main goal is to better understand the genetic changes in metastatic breast cancer and how patients respond or resist therapies, aiming to find the right treatment for each patient. Patients with genetic changes that match new drug trials may have the option to participate in those trials if available. Participants undergo a biopsy of the metastatic lesion to collect tissue samples, performed by a surgeon or radiologist. Biopsy samples, along with blood, serum, and plasma, are collected both at the start and during follow-up. Some samples are analyzed immediately, while others are stored in a bio-repository for future research. Biopsies can be from bone or brain tissue under specific conditions, and must be collected before starting or changing systemic treatment lines, following precise timing rules. Throughout the study, participants provide regular blood samples and allow collection of tissue samples from both primary and metastatic tumors. Researchers monitor participants' health status and treatment responses. The primary outcome is to improve understanding of metastatic breast cancer over the year following the end of patient recruitment. This research aims to enhance treatment outcomes for all patients diagnosed with metastatic breast cancer by using detailed molecular analyses and offering access to clinical trials when possible.

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Researchers are collecting and evaluating long-term data on clinical and radiographic outcomes to better understand the safety and performance of shoulder arthroplasty over time. This study includes people with various shoulder conditions such as osteoarthritis, osteonecrosis, rotator cuff tears, rheumatoid arthritis, fractures, and infections. The trial will follow participants for at least 10 years, with no early limit on follow-up duration. The study includes patients who are either scheduled for shoulder arthroplasty or have already undergone the procedure. Participants must be skeletally mature and expected to survive at least two years beyond surgery. The study is open-label and multi-center, involving both retrospective and prospective data collection. There are no specific interventions or treatments being compared, as the focus is on observing outcomes after shoulder arthroplasty. Participants will undergo assessments including clinical and radiographic evaluations at an average of once per year throughout the study. Outcome measures include the Constant score, ASES (American Shoulder and Elbow Surgeons) score, Oxford Score (optional in the UK), TESS, and MSTS scores related to pre-operative conditions. Researchers will monitor participants for safety and implant performance during the long-term follow-up, which can last a minimum of 10 years.

Researchers are evaluating the prevention of venous thromboembolism (VTE), which can be a serious complication after an acute stroke. This study is focused on immobile stroke patients who cannot walk without help and aims to compare two methods to prevent VTE during a 90-day follow-up period. The study compares the current standard treatment, Intermittent Pneumatic Compression (IPC), with a medical device called the geko17; device, which uses neuromuscular electrical stimulation to improve blood flow and potentially reduce VTE risk. Participants will be randomly assigned to receive either the IPC treatment, which involves air-filled cuffs squeezing the lower legs, or the geko17; device stimulating the peroneal nerve. Both treatments will be applied until the patient can walk independently or for up to 30 days. Leg compression Doppler scans will be done at 7 days (optional) and 14 days (mandatory) after randomisation. At 14 days, patients will also complete a questionnaire about device comfort and provide health information. Additional data on symptomatic deep vein thrombosis (DVT) or pulmonary embolism (PE) will be collected from medical records at 30 days. During the study, participants will be monitored through scans, questionnaires, and medical record reviews to track any occurrences of DVT or PE. A final follow-up call at 90 days will assess the patient's recovery, health status, mobility, and quality of life. The main outcome measured is the frequency of symptomatic or asymptomatic DVT in the leg veins or any PE from randomisation up to 30 days. This comprehensive monitoring aims to provide clear information about which prevention method may better support immobile stroke patients.

This research aims to assess whether adding MRI imaging to the standard CT imaging for patients with suspected or confirmed sigmoid colon adenocarcinoma influences treatment decisions. The study compares standard preoperative CT and multidisciplinary team discussions against adding MRI scans to see if MRI identifies more high-risk tumors, potentially changing treatment plans and prognosis information. Participants are randomly assigned to either the control group receiving standard care with CT imaging or the intervention group receiving an additional MRI scan before surgery. Both groups undergo multidisciplinary team reviews based on their imaging results. The intervention involves extra radiological and pathological assessments and reporting that might affect treatment choices following local protocols. Participants are followed up at 1 and 3 years after recruitment, including quality of life questionnaires. The study measures differences in cancer staging on CT versus MRI and how these differences impact treatment strategies. The total follow-up duration extends up to three years after the last participant is recruited, ensuring long-term observation of outcomes and treatment effects.

Researchers are studying advanced pelvic cancers, which are complex and require treatments like radiotherapy, chemotherapy, and extensive surgery involving multiple pelvic organs. These surgeries often result in complications related to the empty pelvis syndrome and perineal wound closure, affecting recovery and quality of life. The study aims to evaluate how different reconstruction methods after surgery influence complication rates, patient quality of life, and healthcare costs, to improve decision-making for patients and doctors. The study has three parts: first, maintaining a database of patients undergoing colorectal surgeries including pelvic exenteration and abdominoperineal excision, collecting detailed clinical data, imaging, complications, and patient outcomes. Second, a national prospective study where patients undergoing these surgeries complete quality of life and financial impact questionnaires before surgery and at 3, 6, and 12 months after surgery. The surgical reconstruction method is chosen by the surgeon. Third, a qualitative study involving interviews with patients at 3 and 12 months post-surgery to explore experiences and quality of life in depth. Participants provide clinical information and complete various patient-reported outcome measures including quality of life and financial toxicity questionnaires. Researchers monitor surgical details, complications, healthcare use, and survival. Follow-ups involve telephone or email contacts for questionnaire completion. Data analysis includes statistical modeling and health economic evaluation. The qualitative interviews are recorded, transcribed, and analyzed to identify themes over time. The study lasts up to 12 months of follow-up after surgery, with patient involvement throughout.

Chronic obstructive pulmonary disease (COPD) is a common lung condition affecting about 10% of adults worldwide, with a prevalence of 4.5% in those aged 40 years and older in the UK. Exacerbations, or sudden worsening episodes often triggered by infections, can lead to hospital admissions and carry risks of increased illness and death. This trial focuses on the high-risk 90-day period after hospital discharge, during which patients have a 43% chance of readmission and 12% risk of mortality. The study aims to test whether a supported rescue pack management plan can reduce readmissions by 20%. This is a Phase 3, open-label, multicenter randomized controlled trial involving 1400 patients across 30 NHS trusts.