Margate

Researchers are conducting an observational study to explore the relationship between circulating tumour DNA ctDNA and imaging features of extramural venous invasion EMVI in patients with colorectal adenocarcinoma. The study aims to determine if vascular spread contributes to metastatic disease by linking EMVI status with ctDNA levels. Participants include patients with colorectal cancer who have no metastases and are eligible for curative surgery. The study involves collecting two blood samples from each patient one before surgery and another during or within 24 hours after surgery. Patients are grouped based on their EMVI status from MRI scans before and after chemoradiotherapy. The research team monitors ctDNA changes related to EMVI and follows patient survival outcomes over time. Participants undergo a pre-operative staging scan within six weeks before surgery and provide blood samples as described. They are followed annually for up to three years to assess ctDNA, EMVI status, and survival outcomes. The primary outcome is to examine the link between EMVI and ctDNA over two years, with additional measures including ctDNA changes during surgery and survival tracked at 1, 2, and 3 years.

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 evaluating the impact of implantable cardioverter-defibrillators ICDs on patients who have survived a myocardial infarction heart attack and have a severely reduced left ventricular ejection fraction LVEF of 35% or less. This group is at increased risk of sudden cardiac death caused by dangerous heart rhythms. Past landmark trials showed ICDs improved survival, but advances in medical therapy have changed patient outcomes, prompting the need to reassess the benefits and risks of ICDs alongside current optimal treatments. In this randomized trial, participants receive optimal medical therapy OMT based on European Society of Cardiology guidelines for managing heart failure and chronic coronary syndromes. One group will also receive an ICD device, while the other group will not. The study compares outcomes between these two groups to determine if OMT without ICD is not worse than OMT with ICD in preventing death. The trial includes patients with symptomatic heart failure and reduced LVEF after a myocardial infarction. Participants will be followed over time with regular evaluations to monitor health and outcomes. Researchers will measure the time from randomization to death from any cause as the primary outcome, with additional assessments including cardiovascular death, sudden cardiac death, hospital readmissions, length of hospital stays, and quality of life over a year. The study is event-driven and expects to observe outcomes about 15 months after the last participant is enrolled. Safety and effectiveness of treatments will be carefully monitored throughout.

Researchers are evaluating the impact of two different default dialysate sodium concentrations on major cardiovascular events and death in adults receiving maintenance haemodialysis for end-stage kidney disease. This pragmatic, cluster-randomised, open-label Phase 4 study compares sodium levels of 137 mmoll and 140 mmoll in real-world dialysis settings across multiple sites globally. Dialysis sites will be randomly assigned to use either a default dialysate sodium concentration of 137 mmoll or 140 mmoll for at least 90% of dialysis sessions. Other aspects of patient care will follow standard local practices. Sites must consent to participate, and individual patients will provide waiver or opt-out consent. The study expects to enroll sites over 5 to 7 years, with each participant followed for approximately 2 to 5 years until the study endpoints are reached. Participants will receive dialysis at their assigned sites with the designated sodium concentration. Researchers will monitor the time to first occurrence of major cardiovascular events or death as the primary outcome. Secondary outcomes include other cardiovascular events and individual components of the composite outcomes. Data collection and patient monitoring will continue throughout the study period, estimated to last around five years per participant.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

This research aims to evaluate two types of ostomy seals or rings in patients who have recently undergone ostomy surgery. It focuses on preventing and managing complications related to the skin around the stoma, known as peristomal skin complications PSCs. The study is sponsored by Hollister Incorporated and involves post-operative patients with colostomy, ileostomy, or urostomy, assessing how these devices perform in real-world use. Participants will be randomly assigned to use either an absorptive ostomy seal or an ostomy ring containing Aloe. These devices are applied at the first pouch change following surgery or up to four days after the operation. The study treatment period lasts for nine weeks, during which patients use the assigned seal or ring as part of their ostomy care. The trial compares the two devices to monitor skin complications and other related outcomes. During the study, participants will be followed from enrollment through the nine-week treatment phase with regular assessments. Researchers will track skin complications using the Ostomy Complication Severity Index OCSI, including measures of leakage, moisture, skin conditions, and patient and clinician satisfaction. The study also collects data on usage patterns, healthcare visits related to the ostomy, and costs associated with the seals or rings. The overall goal is to understand the devices impact on skin health and patient experience after ostomy surgery.