Wishaw

Crohns disease CD is a long-lasting condition causing inflammation in the gut. This research aims to find out if replacing a normal diet with specialized milkshakes for 6 weeks can help improve treatment response and maintain remission in children and young adults with active CD receiving biologic therapies. The study focuses on patients aged 6 to 18 years who are starting biologic treatment with TNF alpha inhibitors, aiming to compare diet approaches alongside these medications to better manage CD symptoms and disease activity. Participants will be randomly assigned or choose to follow either their usual unrestricted diet or replace varying amounts of their diet with a liquid formula called enteral nutrition for 6 weeks while receiving biologic treatments such as infliximab or adalimumab. Additional groups receiving exclusive enteral nutrition alone or combined with biologics will also be observed to compare different treatment outcomes. The study uses a proprietary liquid formula to replace energy intake and tracks effects during biologic induction therapy. Throughout the study, participants will be monitored for improvements in symptoms and disease markers over 10 to 12 weeks, with follow-up up to a year to assess sustained remission. Researchers will evaluate nutritional status, body composition, quality of life, immune markers, and gut and oral microbiome changes. Safety and treatment adherence will also be tracked, with various blood tests, questionnaires, and physical assessments included. Overall, the study spans over a year to assess both immediate and long-term treatment effects in pediatric CD patients.

Researchers are conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

Researchers are evaluating the long-term effects of lidocaine infusions given during and after surgery to reduce moderate or severe chronic post-surgical pain in adult women undergoing elective breast cancer surgery. This large, international, randomized, double-blind trial aims to detect a meaningful reduction in chronic pain one year after surgery and also assesses safety, pain relief, opioid use, nerve-related pain symptoms, psychological health, and quality of life. Participants receive either a lidocaine infusion starting with an intravenous bolus after anesthesia induction, continuing with an intraoperative intravenous infusion, and followed by a post-operative subcutaneous infusion for up to 24 hours. The lidocaine dosing is adjusted by lean body weight with a cap, while the comparison group receives a saline placebo infusion following the same schedule. Day-case surgeries receive only the intraoperative treatments without the post-operative infusion. During the trial, participants will be monitored for pain severity, opioid consumption, nerve-related symptoms, psychological distress, physical functioning, quality of life, safety events, and health care costs up to one year after surgery. The primary outcome is the incidence of moderate or severe chronic post-surgical pain reported at one year. Assessments include patient-reported outcomes, pain scores at 24 hours postoperatively, and opioid use at various timepoints. The total participation duration extends up to one year after surgery.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.

This research aims to collect and analyze information about babies born at 22 weeks of pregnancy in the UK to better understand their clinical care and outcomes. Since survival-focused care for these extremely premature babies has only been offered since 2019, there is limited data on how they respond to treatment and what challenges they face. The study gathers data from multiple neonatal intensive care units NICUs across the UK to improve knowledge for future care and support families. Data collection involves medical staff entering selected, anonymized information from babies medical records into a secure database. The study observes babies who are attended by neonatal teams at birth or admitted to NICUs within the first 72 hours of life. No changes are made to the babies care during the study, and a one-time survey of NICUs will assess unit approaches and equipment used for 22-week babies. Participants data, including clinical care details and short-term outcomes such as survival to discharge, are analyzed. Researchers will report on interventions across various care areas and outcomes like brain injury or infections. Parents receive information about data use, and individual babies cannot be identified in results. The study runs from admission until death or discharge from neonatal care, aiming to inform future research and improve care practices.