Luton

Researchers are evaluating the safety and effectiveness of the study drug IPN10200 compared with a placebo for treating adults with Cervical Dystonia (CD). CD causes abnormal movements and symptoms in the head and neck, including pain, stiffness, and headaches. The condition may be influenced by brain function, genetics, and environmental factors. Current treatments involve botulinum toxin (BoNT) injections lasting about three months, but IPN10200 is designed to provide longer-lasting relief. Participants will receive a single intramuscular injection of IPN10200 at one of several doses or a placebo on the first day of the 36-week treatment period. The injections will be given into muscles in the head, neck, and shoulders. Before treatment, there is a screening period lasting up to four weeks to confirm eligibility. Some participants may continue other medications during the study, with all treatments recorded. The study involves about 40 weeks of participation, including screening and treatment. Participants will attend 10 to 12 in-person clinic visits plus one remote phone visit. During these visits, they will undergo blood and urine tests, physical and neurological exams, and clinical assessments. Questionnaires will also be completed to evaluate symptoms and treatment effects. The main outcome measured is the change in cervical dystonia severity four weeks after treatment based on a standardized rating scale.

Researchers are evaluating the effect and safety of efgartigimod PH20 SC compared to placebo in adults diagnosed with systemic sclerosis (SSc). This phase 2 randomized, double-blinded, placebo-controlled study aims to understand how this treatment impacts skin involvement measured by the modified Rodnan Skin Score (mRSS) in affected individuals. The study includes participants with diffuse or limited SSc who meet specific classification criteria and antibody test requirements. Participants will be randomly assigned in a 2:1 ratio to receive either subcutaneous efgartigimod PH20 SC via prefilled syringe or a matching placebo. The study consists of a screening period, followed by a treatment period lasting up to 48 weeks, and then a safety follow-up phase. The total duration of participation may be approximately 15 months. During the study, participants will have regular evaluations including assessments of skin thickness using the mRSS to measure changes from baseline at week 24. Researchers will monitor safety, tolerability, pharmacodynamics, pharmacokinetics, and immunogenicity throughout the trial. Additional assessments may include disability and patient global assessment scores, antibody testing, and skin evaluations at injection sites.

Researchers are studying AZD1163, a new bispecific antibody, to assess its effectiveness and safety in adults with moderately-to-severely active rheumatoid arthritis (RA) who test positive for anti-citrullinated peptide antibodies (ACPA). This Phase II, randomized, double-blind, placebo-controlled trial involves participants already receiving standard treatments such as conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) or tumor necrosis factor inhibitors (TNFi). Participants will be randomly assigned to one of four groups to receive subcutaneous injections of either one of three doses of AZD1163 or a placebo, alongside their standard care, for 24 weeks. Following this treatment period, there will be a 28-week safety follow-up to monitor participants. Throughout the study, researchers will evaluate changes from baseline in disease activity scores using C-reactive protein levels at 12 weeks. Participants will undergo regular assessments including joint counts and laboratory tests to monitor disease status and safety. The total involvement in the study spans over 52 weeks, including treatment and follow-up periods.

This trial studies adults aged 18 years and older with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not shown lung function improvement after standard immunosuppressant treatment. It evaluates how the medicine nerandomilast affects lung disease associated with these conditions. The study is a phase 3, double-blind, randomized, placebo-controlled trial designed to test nerandomilast's safety and efficacy over at least 26 weeks. Participants are randomly assigned to receive either nerandomilast tablets or placebo tablets twice daily for a period of at least 26 weeks and up to 1 year. Alongside this, participants continue their ongoing immunosuppressant treatments for their rheumatic disease. The study involves two groups receiving either the active drug or placebo to compare outcomes between them. During the 7.5 to 13 months of participation, individuals visit the study site about 9 to 10 times for lung function tests, chest imaging at select visits, and to complete questionnaires about symptoms and quality of life. Researchers monitor changes in lung disease using high-resolution CT scans and assess safety by recording any side effects. The main outcome is the change in lung fibrosis score after 26 weeks of treatment.

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 evaluating the safety and effectiveness of whole-body hypothermia treatment in newborn babies diagnosed with mild hypoxic ischaemic encephalopathy (HIE). This phase III randomized controlled trial aims to determine whether cooling babies to 33.57b0C within six hours of birth for 72 hours improves cognitive development at two years of age compared to maintaining normal body temperature (normothermia). The study also assesses the cost-effectiveness of cooling therapy to help guide national and international treatment guidelines and standardize care across the NHS. Babies born at or after 36 weeks with specific signs of birth asphyxia or acidosis are randomly assigned to either whole-body hypothermia or targeted normothermia groups. The hypothermia group will have their body temperature lowered and maintained at 33.57b0C using a cooling machine for 72 hours in a neonatal intensive care unit. The normothermia group will have their temperature maintained at 377b0C with treatment for any fever using standard protocols. If babies in the normothermia group develop seizures and worsen to moderate HIE, they may receive cooling treatment as part of clinical care. Conventional MRI scans will be performed before discharge. Participants will be followed up at 24 months of age (7 months) using the Bayley Scales of Infant and Toddler Development IV to measure cognitive, language, and motor skills. Additional neurological exams, including assessments for cerebral palsy, vision, and hearing, will be conducted. Parents will complete questionnaires about their child's development. Researchers will collect detailed clinical data from birth through follow-up to evaluate safety and developmental outcomes. Babies who die or cannot complete assessments due to severe disability will be assigned specific scores to reflect outcomes.

Researchers are evaluating two surgical approaches for patients with low risk differentiated thyroid cancer in this multi-center, randomized, phase III study. The study aims to determine if hemithyroidectomy, which removes part of the thyroid, is an acceptable and cost-effective alternative to total thyroidectomy, which removes the entire thyroid. Patients are identified through oncology multidisciplinary team meetings and divided into two groups based on their treatment history and diagnosis method. Patients in Group 1 have already had a hemithyroidectomy for thyroid problems and are then diagnosed with low risk differentiated thyroid cancer. They will be randomized to either surveillance only or a second surgery to remove the rest of the thyroid gland (two-stage total thyroidectomy). Group 2 patients are diagnosed by cytology with low risk cancer and have not yet had surgery; they will be randomized to either hemithyroidectomy or a single-stage total thyroidectomy. The study plans to recruit 456 patients who will be followed after surgery and then every 12 months for 6 years. During the study, participants will undergo regular assessments to monitor for any signs or symptoms of cancer recurrence, with a primary outcome measure of the 3-year recurrence rate after surgery. Follow-up visits will include clinical evaluations to check for cancer return or progression. Researchers will also observe overall patient outcomes and safety throughout the 6-year follow-up period.

Researchers are studying the occurrence, treatment, and outcomes of complications that may happen after bariatric surgery in patients across the United Kingdom. This observational study seeks to understand how often unplanned interventions are needed due to these complications and to evaluate current management practices and their effects on patient results. The study also aims to identify best practices for emergency bariatric care and factors influencing why patients come in as emergencies. Patients who experience complications following bariatric surgery and present for unplanned interventions at hospitals in the UK will be included. Data will be collected on their demographics, surgical history, type and site of bariatric surgery, existing health conditions, complications, treatments given, and outcomes. The study will use a combination of electronic health records and manual data extraction to gather information, with ongoing quality checks to maintain data accuracy and completeness. Participants' data will be analyzed to compare different treatment approaches and their impacts on patient outcomes. The study will measure outcomes such as mortality within 30 days of the procedure or admission, length of hospital stay up to 100 weeks, and complication severity classified by the Clavien-Dindo system over approximately one year. Statistical analyses will explore demographic effects and healthcare engagement, aiming to improve emergency care quality and patient results following bariatric surgery.

Researchers are assessing the prevalence and severity of Periodontal Disease (PD) in people who are obese, focusing on those attending a bariatric care clinic. The study also aims to explore inflammatory markers linked to PD in saliva, examine genetic variations related to obesity (FTO gene) and PD, and analyze the types of bacteria found beneath the gums and in saliva of obese patients with PD. This is a cross-sectional study involving one visit per participant. Participants will undergo routine medical evaluations including measurements of age, gender, smoking status, body composition, ethnicity, and body mass index (BMI). A blood sample will be taken for genetic testing unless DNA data is already available. All participants will receive a basic periodontal examination (BPE). If signs of serious PD are found, additional detailed assessments of dental plaque, gum bleeding, and full mouth periodontal probing will be performed. Each visit will last up to two hours and include collection of dental and saliva samples, genetic analysis, and clinical periodontal measurements. Researchers are mainly measuring how common PD is in this group. They will also monitor safety by reviewing medical histories and ensuring participants meet all criteria. The study involves only one visit and thus no long-term follow-up is required.

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.