Salisbury

Researchers are evaluating the safety and performance of the Polymer Free Sirolimus Eluting Coronary Stent Vivo ISAR in patients with coronary artery disease (CAD). This prospective, observational registry includes patients who have undergone percutaneous coronary intervention (PCI) using this stent and are planned for a short dual antiplatelet therapy (DAPT) regimen lasting up to 3 months. The aim is to assess clinical outcomes in a real-world population across multiple countries and centers. Participants receive the Vivo ISAR stent and follow standard care with a short DAPT treatment of no more than 3 months after PCI. The study does not influence the choice of device or treatment beyond routine care. After the procedure, patients who meet eligibility criteria and provide consent are enrolled and observed over time without additional interventions. Participants will be followed up through routine clinical practice and telephone calls at 30 days, 3 months, and 12 months after PCI. These follow-ups collect information on ongoing medications, any lab tests performed, adverse events, and any further interventions. The main outcomes measured at 12 months include ischemic events and bleeding events related to the treatment and stent use.

This research aims to evaluate the safety and effectiveness of BGB-16673 compared to pirtobrutinib in adults with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously been treated with a covalent Bruton tyrosine kinase inhibitor (cBTKi). The study is a Phase 3, open-label, randomized trial sponsored by BeOne Medicines. The goal is to better understand treatment options for patients whose disease has returned or did not respond to earlier therapies involving cBTKi. Participants will receive either BGB-16673 or pirtobrutinib, both given orally. The study compares these two treatments to assess their safety and efficacy. The treatment period and dosing details are managed as per the trial protocol to evaluate the outcomes of each drug. The study includes ongoing monitoring and assessments to observe treatment effects over time. During the study, participants will be closely followed for up to approximately 3 years to measure progression-free survival, as assessed by an independent review committee. Researchers will conduct regular evaluations including imaging and laboratory tests to track disease status and safety. Participants' health will be monitored throughout the study to identify any side effects or changes in condition.

Researchers are studying an experimental drug called odronextamab in combination with lenalidomide for adults with relapsed or refractory follicular lymphoma (FL) or marginal zone lymphoma (MZL), which are subtypes of Non-Hodgkin's lymphoma. This Phase 3 study has two parts: Part 1 focuses on the safety and tolerability of this drug combination and determining the appropriate odronextamab dose, while Part 2 compares the effectiveness of this combination to the current standard treatment of rituximab plus lenalidomide. The study also explores side effects, drug levels in the blood, antibody development against the study drug, and impacts on quality of life and daily activities. Participants receive either odronextamab plus lenalidomide or rituximab plus lenalidomide according to the study protocol. Part 1 is not randomized, focusing on safety and dose finding, while Part 2 is randomized and controlled to assess efficacy and safety. Treatments are administered per protocol guidelines during these study phases. During the study, participants undergo regular evaluations including imaging scans to measure disease, blood tests, and monitoring for side effects up to two years. The main outcomes measured include dose-limiting toxicities within 35 days, treatment-emergent adverse events over two years, and progression-free survival over five years. Participants are also monitored for quality of life and ability to perform daily activities throughout the trial duration.

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 investigating the use of Magnetic Resonance Tumour Regression Grade (mrTRG) as a new imaging biomarker to guide treatment decisions in patients with locally advanced rectal cancer. This phase III trial in the UK is unique in offering a 'watch and wait' approach for patients who respond well to pre-operative treatment, potentially avoiding surgery and preserving quality of life. The study aims to validate mrTRG to differentiate between good and poor responders to radiotherapy and help tailor ongoing treatment and surveillance accordingly. Participants will be randomly assigned to one of two groups. The control group will receive standard management based on national guidelines and clinical assessments after treatment, including routine MRI scans without mrTRG reporting. The intervention group will have post-treatment MRI scans evaluated by specially trained radiologists to assess mrTRG grades. Patients classified as good responders (mrTRG 1 or 2) will be offered a watch and wait approach to avoid surgery, while poor responders (mrTRG 3 to 5) will have their cases reviewed by a local colorectal multidisciplinary team for further treatment planning. During the study, all participants will undergo routine MRI scans following standardized protocols and complete quality of life questionnaires at registration, 3 years, and 5 years. Researchers will monitor outcomes for up to five years, focusing on whether surgery can be safely avoided in good responders and tracking long-term effects on health and survival. The study does not mandate specific chemotherapy or investigational treatments, allowing local teams to decide additional therapy as needed.

Researchers are studying how to improve the accuracy of MRI scans in identifying early-stage rectal cancer and significant rectal polyps. Early-stage rectal cancers grow partially into the bowel wall and can often be treated with local procedures that preserve the bowel, avoiding major surgery and its risks. Many patients are currently over-treated due to inaccurate MRI staging, leading to unnecessary major surgery or radiotherapy. The study focuses on a new MRI reading method called PRESERVE that has shown higher accuracy in identifying early rectal cancers suitable for local excision. The study involves training radiologists across 20 hospitals in the PRESERVE MRI reading method to better stage early rectal cancers and significant polyps. MRI scans are recommended before removal of rectal polyps that are 20mm or larger or have features suspicious for cancer. Radiologists will be trained to use the PRESERVE system to improve diagnostic accuracy and help guide treatment choices, aiming to increase the number of patients offered organ-preserving surgery. Participants will be monitored by comparing MRI reports before and after the radiologist training over one year. Researchers will measure the impact of the training on the accuracy of tumor staging and whether more patients receive local procedures instead of major surgery. This study will help determine if the new approach can be widely adopted to improve patient outcomes and preserve quality of life.

Researchers are studying patients who have survived a heart attack (myocardial infarction) and are at higher risk for sudden cardiac death caused by dangerous heart rhythms. This study focuses on patients with a severely reduced heart function measured by left ventricular ejection fraction (LVEF) of 35% or less. Previous landmark trials showed that implantable cardioverter-defibrillators (ICDs) improved survival compared to medical therapy alone, but since then, new medications have decreased sudden death rates and the need for ICD therapy. Because ICDs carry risks and costs, this study aims to compare modern optimal medical therapy (OMT) alone versus OMT with ICD implantation to see if medical therapy without ICD is not worse for patient survival. Participants will be divided into two groups: one receiving OMT only and the other receiving OMT plus an ICD device. The ICD options include transvenous ICDs, subcutaneous defibrillators, or a newer extravascular ICD with substernal lead placement. OMT will follow current European guidelines for managing coronary syndromes and heart failure. The study is designed to assess outcomes over time from the point of randomization. During the study, researchers will track survival by measuring the time until death from any cause, expecting about 15 months of follow-up after the last participant joins. Patients must have a history of heart attack at least three months prior, symptomatic heart failure, and have been on OMT for at least three months before enrollment. Safety and effectiveness of treatments will be monitored closely throughout the study period.

Researchers are investigating whether volunteers can be trained to help older adults in hospitals stay active to prevent loss of strength and mobility, a common problem during hospital stays that can reduce quality of life and increase healthcare costs. This feasibility study involves three hospital sites where volunteers will lead physical activity sessions for patients aged 65 and older, compared to a control site receiving usual care. The study will also explore how well the intervention is accepted by patients, volunteers, and staff, and whether it can be implemented effectively across different hospital settings. The intervention consists of twice daily physical activity sessions led by trained volunteers. Patients who can walk independently will be guided through walking exercises, gradually increasing their distance, while those with limited mobility will perform bedside or chair exercises, progressing to walking as they improve. Volunteers receive training by physiotherapists covering safety, exercise techniques, and response to adverse events, with ongoing supervision and competency checks. This program continues from recruitment until the patient’s discharge. Participants will be assessed regularly through interviews, observation, and exercise diaries to monitor adherence, acceptability, and safety. Researchers will collect data on recruitment, retention, physical activity levels, physical function, quality of life, hospital stay length, and readmissions. Volunteer and trainer recruitment and retention will also be tracked. The study aims to gather detailed information over an average of three years to evaluate the feasibility and potential for wider implementation of volunteer-led exercise programs in hospitals.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

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.