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COARCT: Evaluation of COmpression Therapy in Addition to Regular Cellulitis Therapy (Internal Pilot Phase)
Expand descriptionCellulitis is a common bacterial infection of the skin and underlying tissue. Acutely, it causes pain and swelling that significantly hinder daily activities. Longer-term, persistent oedema predisposes patients to recurrent cellulitis, creating a relentless cycle of swelling and infection. Our trial will evaluate whether adding compression therapy to standard antibiotic care at the onset of acute cellulitis can hasten can hasten resolution, avoid complications, minimise antibiotic use, and prevent recurrence. An initial internal pilot will refine procedures and support trial expansion. Our vision is to transform cellulitis management by targeting infection and oedema together, enabling faster recovery, reducing long-term disability, saving healthcare resources, and promoting antibiotic stewardship.
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A Study to Test the Safety and How Well a New Medicine (SAT-3247) Works in Children with Duchenne Muscular Dystrophy Who Can Walk Unassisted – BASECAMP
Expand descriptionThis is a phase 2a trial of SAT-3247 in ambulatory DMD patients aged from 7 and less than 10 years. The trial will study two doses of SAT-3247 in a randomized, double-blind, placebo-controlled weekday regimen for 12 weeks to determine the optimal dose, safety, tolerability, and preliminary efficacy. Enrollment of up to 51 ambulatory DMD participants aged from 7 and less than 10 years of age is planned. Randomization will be stratified by baseline corticosteroid regimen and prior DMD concomitant medications. Each participant will receive once daily doses of SAT-3247 or matched placebo for 12 weeks. Participants will be screened within 28 days before initiating dosing of investigational product at Baseline. Following the Screening period, participants will complete a Baseline visit (Visit 2), Week 4 (Visit 3), Week 8 (Visit 4), and Week 12 (Visit 5) follow-up visits.
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Examining Diet, Immune Function, and Fatigue in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis patients
Expand descriptionCFS/ME is a debilitating disease characterised by severe, unexplained fatigue lasting for more than 6 months with additional symptoms affecting the entire body. CFS/ME has no known causes, no definitive diagnostic biomarkers, and very limited treatment options. Dysfunction of the immune system is common in CFS/ME and while many people with CFS/ME find that dietary modification can improve symptoms, the research behind this is lacking. This study therefore aims to determine whether diet and immune function differ between CFS/ME patients compared to healthy controls, and whether they possibly interact to affect symptoms of CFS/ME.
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Path-OUD: Psilocybin-Assisted Therapy for people living with Opioid Use Disorder.
Expand descriptionThis study explores whether a single 30mg dose of Psilocybin - when given as part of Psychedelic-Assisted Therapy - can assist people who are living with Opioid Use Disorder reduce their use of non-prescribed opioids. The study will also use functional Magnetic Resonance Imaging (fMRI) to observe any changes in participants’ brain, thinking and mood.
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Assessing Hand Hygiene Practices and Infectious Disease Outcomes in Preschools
Expand descriptionThis study will evaluate whether a structured hand hygiene program in preschools can reduce respiratory and gastrointestinal infections in children. Preschools will adopt the program in a stepped-wedge sequence over 12 months. The intervention includes teacher training, visual prompts, and routine-based handwashing practices. We hypothesise that structured hand hygiene will reduce infection incidence and illness-related absenteeism.
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Placebo controlled study testing safety and tolerability of BEL536 in healthy adults.
Expand descriptionThe purpose of this study is to find out if BEL536is safe and tolerable in healthy adults. BEL536 is a synthetic protein called a bispecific antibody which can recognise and block pathways to help reduce inflammatory responses in the body. Bispecific means that BEL536 can attach to two different targets at the same time. This is the first time BEL536 has been tested in humans and aims to assess the effects of BEL536 on healthy volunteers.
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Resuscitation of term or near term infants at birth with air or 100% oxygen (Resair 3) A Randomised Controlled Trial
Expand descriptionResair 3 is a phase 3 pragmatic multicentre, consent waiver, cluster randomised cross-over study of 51 hospitals in 9 countries that will recruit 481,774 term or near term infants (gestation >35 weeks) within 12 months to initial respiratory support with either air (21% O2) or pure (100% O2). O2 concentrations will be titrated according to preductal O2 saturations (SpO2) of healthy, full-term infants (1). The primary outcome is the need for advanced resuscitation interventions (one or more of the following: 1. Endotracheal intubation/supraglottic airway 2. Cardiac compressions 3. Adrenaline) and death before hospital discharge. Resair 3 will use interventions and data collection methods that are part of routine care. The hypothesis is that initiating resuscitation of term/near term infants with 100% oxygen and then titrating according to clinical condition and oxygen saturations will lead to reduction in the need for advanced resuscitation interventions and death before hospital discharge, compared to initiating resuscitation with 21% oxygen and then titrating upwards.
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A Follow-on, Ascending, Single and Multiple Dose(s), Double-Blind, Randomized, Placebo Controlled Study Assessing the Safety, Tolerability, and Pharmacokinetics of OV329 in Healthy Male and Female Participants
Expand descriptionOV329 [(S)-3-amino-4-(difluoromethylene) cyclopent-1-ene-1-carboxylic acid hydrochloride salt] is a gamma aminobutyric acid (GABA) aminotransferase (GABA-AT) inhibitor that is being developed as an antiseizure medication for seizure disorders in adults and pediatric patients. Part A will consist of up to 2 cohorts, comprising 8 participants each. Dosing will be initiated at 7 mg/day. Subsequent cohorts will be dosed as recommended by the Data Review Committee (DRC) based on the safety, tolerability and PK of OV329 from the previous cohort. Part B will consist of 2 planned cohorts comprising 8 participants each. Subsequent cohorts will be dosed as recommended by the DRC based on the safety, tolerability and PK of OV329 from the previous cohort (based on review of the Day 30 data, including ophthalmological assessments). Participants will be dosed for a total of 7 days.
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Phase 1 trial of a novel antibody-targeted radiotherapy in patients with metastatic castrate-resistant prostate cancer (mCRPC)
Expand descriptionThis study aims to understand how a new anti-cancer drug ATNM-400 ([²²5Ac]-barecetamab-DOTA) behaves in the body, to determine a safe dose range, and to assess its early signs of anti-tumour activity. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with metastatic prostate cancer that has not responded to surgery and you have undergone at least one previous round of chemotherapy. Study details Participants who choose to enrol in this study may be invited to participate in one of three parts. Part A - participants will have a dose of [89Zr]-barecetamab-DFO injected into a vein and will then undergo PET-CT imaging. These participants will also be asked to provide blood samples for up to 6 hours after their injection. Part B - participants will be given a dose of ATNM-400 ([²²5Ac]-barecetamab-DOTA) injected into a vein once every 6 weeks. If participants don't experience any extreme side effects, they may have this treatment repeated up to 4 times. Different groups of participants will be enrolled to assess higher doses of ATNM-400 ([²²5Ac]-barecetamab-DOTA) for this part. Part C - participants will be give a dose of ATNM-400 ([²²5Ac]-barecetamab-DOTA) injected into a vein once every 6 weeks. If participants don't experience any extreme side effects, they may have this treatment repeated for up to 1 year. Participants in Part B and C will also be asked to provide further blood samples while receiving ATNM-400 and to undergo additional PET-CT and possibly MR imaging. It is hoped this research will determine if ATNM-400 anti-cancer treatment could be developed further for patients with advanced prostate cancer who have limited treatment options.
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The Impact of Vitamin C Supplementation in Hospitalised Patients with Community - Acquired Pneumonia - VitCAP Trial
Expand descriptionCommunity acquired pneumonia is a common cause of hospital admission and can be life-threatening. Despite effective antibiotics, some patients develop complications, need intensive care, or die. Vitamin C is a natural antioxidant important for immune function and healing. Patients who require hospitalisation with infections like pneumonia often have low vitamin C levels. Giving vitamin C may help recovery, but this has not been tested in a large clinical trial in pneumonia. The purpose of this study is to determine whether vitamin C supplementation improves outcomes in patients hospitalised with pneumonia. We believe that Vitamin C supplementation in people who have pneumonia will lead to improvement in outcomes. We will be studying if the use of Vitamin C will reduce the time to recovery, affect length of hospital stay and improve post-discharge quality of life.