Luton

Researchers are evaluating the study drug Corabotase IPN10200 for treating Cervical Dystonia CD in adults. This condition causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches, possibly related to brain and genetic factors. The study compares Corabotase to a placebo to assess its safety and effectiveness, aiming for a longer-lasting treatment than current botulinum toxin injections. This is a Phase II, randomized, double-blind, placebo-controlled trial. Participants will be randomly assigned to receive one of several doses of Corabotase Dose A, Dose B, or possibly Dose C or placebo. The study drug is given by intramuscular injection into different muscles in the head, neck, and shoulders in a single treatment cycle on Day 1 of the treatment period. The study includes a screening period of up to 4 weeks followed by a 36-week treatment period with 10 in-clinic visits and one remote phone visit 12 visits for those receiving Dose C. During the study, participants will undergo physical and neurological exams, blood and urine sample collections, and clinical assessments. They will complete questionnaires to track symptoms and treatment effects. Researchers will measure changes in the Toronto Western Spasmodic Torticollis Rating Scale TWSTRS scores and other pain and disability scales at multiple time points up to week 36. Safety, antibody formation, and adverse events will also be closely monitored. Total participation lasts about 40 weeks.

Researchers are evaluating the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis, a chronic autoimmune disease. This phase 2, randomized, double-blinded, placebo-controlled study aims to assess how well the treatment works and its safety profile. Participants have systemic sclerosis with specific skin involvement and meet classification criteria, with the study sponsored by argenx. Eligible participants will be randomly assigned in a 21 ratio to receive either subcutaneous efgartigimod PH20 SC or a placebo, both given by prefilled syringe. The treatment period lasts up to 48 weeks, followed by a safety follow-up period. The total duration of the study can be up to approximately 15 months, including screening, treatment, and follow-up. Participants will undergo screening to confirm eligibility and then receive regular doses of the study drug or placebo during the treatment phase. Assessments include changes in skin thickness measured by the modified Rodnan Skin Score mRSS at 24 and 48 weeks, safety monitoring for adverse events, and evaluations of disability, patient and clinician assessments, lung function, and antibody levels. The study also tracks pharmacokinetics, immunogenicity, and antibody responses throughout the treatment and follow-up periods.

This research aims to evaluate the effectiveness and safety of AZD1163, a new bispecific antibody, in adults with moderately-to-severely active rheumatoid arthritis RA who are positive for anti-citrullinated peptide antibodies ACPA. The study focuses on patients who have had an inadequate or lost response or intolerance to certain standard treatments. The trial is a Phase II, randomized, double-blind, placebo-controlled study conducted at multiple centers to assess AZD1163s impact on RA disease activity. Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a matching placebo. All participants will continue their standard care treatments, which may include conventional synthetic disease-modifying antirheumatic drugs csDMARDs or tumor necrosis factor inhibitors TNFi with or without csDMARDs. The treatment period lasts 24 weeks, followed by a 28-week safety follow-up phase. Throughout the study, participants will undergo assessments including disease activity scores such as DAS28-CRP, American College of Rheumatology response criteria ACR20 and ACR50, and clinical disease activity indexes. Researchers will also evaluate the pharmacokinetics and immunogenicity of AZD1163. Safety monitoring continues during the follow-up period, and total participation spans approximately 52 weeks.

This research aims to evaluate how the medicine nerandomilast affects lung fibrosis in adults with systemic autoimmune rheumatic diseases who have lung fibrosis. The study includes adults 18 years and older who have not shown improvement in lung function after standard immunosuppressant treatment. Participants have interstitial lung disease related to rheumatic diseases such as rheumatoid arthritis, systemic sclerosis, idiopathic inflammatory myopathy, Sjgrens disease, or mixed connective tissue disease. Participants are randomly divided into two groups one group receives nerandomilast tablets and the other receives placebo tablets that look identical but contain no medicine. Tablets are taken twice daily for at least 26 weeks and up to 1 year. Participants continue their usual immunosuppressant treatments during the study. Participants stay in the study for about 7.5 to 13 months and visit the study site 9 to 10 times. During visits, lung function tests and chest imaging are performed, and participants complete questionnaires about symptoms and quality of life. Researchers compare results between the groups to assess the effects of nerandomilast while monitoring health and any side effects throughout the study.

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 evaluating the safety and effectiveness of whole-body hypothermia for newborn babies with mild hypoxic ischaemic encephalopathy. This phase III randomised controlled trial aims to determine whether cooling the whole body to 33.5.5C within six hours after birth and continuing for 72 hours improves cognitive development at around two years of age compared with maintaining normal body temperature. The study also seeks to assess the economic value of cooling therapy for mild encephalopathy within the healthcare system. Babies born at or after 36 weeks with signs of birth asphyxia or acidosis will be randomly assigned to receive either whole-body hypothermia or targeted normothermia. Cooling will be applied using a servo-controlled machine in neonatal intensive care units, maintaining a rectal temperature of about 33.5C for 72 hours. The control group will have their body temperature kept at normal levels 37C for the first 80 hours, with any fever carefully treated. Babies born at non-cooling centers will be transferred to specialized units for treatment. During the study, participants will undergo brain monitoring, MRI scans before discharge, and follow-up developmental assessments at 24 months using the Bayley Scales of Infant and Toddler Development IV. Additional evaluations will include neurological exams, motor function assessments, vision and hearing tests, and parent-completed questionnaires. Researchers will collect detailed clinical data from birth through hospital stay, aiming to compare cognitive outcomes and safety measures between the two groups over the study period.

Researchers are evaluating surgical options for patients with low risk differentiated thyroid cancer. This phase III study aims to determine if hemithyroidectomy, which removes part of the thyroid gland, is an acceptable and cost-effective alternative to total thyroidectomy, which removes the entire gland. The trial includes two groups of patients based on their prior surgery status and diagnosis method, focusing on recurrence risk and prognosis. Participants are randomly assigned to different surgical treatments depending on their group. Group 1 patients who have had prior thyroid surgery will either have a second operation to remove the remaining thyroid tissue or undergo surveillance without further surgery. Group 2 patients who have not had surgery will be randomized to receive either hemithyroidectomy or total thyroidectomy in a single operation. The trial plans to recruit 456 participants and follow them regularly for six years after surgery. During the study, patients will attend follow-up visits post-surgery and then annually for six years. Researchers will monitor cancer recurrence rates at three and five years, assess the site and risk of recurrence, and record additional investigations and procedures after surgery. They will also evaluate surgical complications, voice function, hormone replacement needs, quality of life, and healthcare resource use at multiple time points. This comprehensive monitoring aims to compare outcomes between the different surgical approaches and understand their impact on patients health and well-being over time.

This research aims to investigate how often complications occur after bariatric surgery in patients across the United Kingdom and how these complications are managed. It seeks to understand the prevalence of unplanned interventions, current management practices, and their effects on patient outcomes. By examining these factors, the study hopes to identify the best ways to provide emergency bariatric care and understand influences such as patient demographics and previous engagement with NHS weight management services. Participants will be identified when they present at hospitals with complications following bariatric surgery. Data will be collected on their demographics, surgical history, the type and site of their bariatric surgery, complications, treatments, and outcomes. This observational study will gather information through electronic health records and manual extraction over a six-month period at each center, without assigning any treatments or interventions. During the study, researchers will analyze patient information to compare different treatment approaches and their impact on outcomes like 30-day mortality, length of hospital stay, and complication severity. They will also track secondary outcomes such as nutritional support use, surgeries or procedures performed, critical care admissions, and engagement with specialized weight management services. Data quality will be ensured through checks, and missing information will be requested from participating centers. Overall, the study will provide insights over about a year on these key outcomes following bariatric surgery complications.

Researchers are investigating the prevalence and severity of Periodontal Disease PD in adults with obesity who are receiving bariatric care. The study also aims to explore inflammatory biomarkers linked to PD in saliva, examine the association of FTO gene polymorphisms with PD prevalence, and analyze the subgingival microbial flora in this population. This is a cross-sectional observational study conducted at a bariatric clinic. Participants will undergo routine care including medical examination with recording of various parameters such as age, gender, smoking status, body composition, ethnicity, and body mass index. Blood samples will be taken for genetic analysis if DNA samples are not already available. All participants will receive a basic periodontal examination, and if signs of destructive periodontitis are detected, more detailed periodontal assessments and microbial sampling will be performed. During the single study visit, participants will have periodontal evaluations, saliva and subgingival plaque samples collected, and possibly blood samples taken. These assessments will take up to two hours from consent. Researchers will measure the prevalence of PD, inflammatory biomarkers in saliva, genetic polymorphisms, and microbial flora. There is no additional follow-up, and the study duration for each participant is limited to this single visit.

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.