Clinical trials

Calorie labelling in out-of-home (OOH) settings was introduced by the government in England as part of a wider strategy to 'tackle obesity' (DHSC, 2020). The OOH sector encompasses outlets where food and drinks are prepared for immediate consumption, on or off the premises (DHSC, 2021). Increased consumption of OOH food is associated with greater intake of energy and nutrients of concern; therefore, is implicated in poorer dietary quality and ill-health (Gesteiro et al., 2022). The key ambition for the calorie labelling policy was to inform consumers of the calorie content of their food choices, making it easier to select healthier food choices (DHSC, 2020). An additional potential benefit of the policy was to prompt reformulation by the food industry to either reduce the calorie content of foods on offer or provide new lower calorie options (DHSC, 2021). The calorie labelling policy in England was criticised at the time of implementation in the media for its potential to cause harm in individuals with eating disorders (Polden et al., 2023). However, limited research had explored effects on individuals with eating disorders (Robinson et al., 2023). It is estimated that over a million individuals in the UK are living with an eating disorder (Beat Eating disorders, 2026). Therefore, it is important for research to understand the impact of food labelling interventions on mental health outcomes in individuals with eating disorders and other mental health conditions, and whether alternative nutritional labelling practices that are not focused on calories alone could have positive health impacts without unintended negative consequences. One alternative form of nutritional labelling that could be considered in OOH settings is Nutri-score. Nutri-score provides food items with a label from A (dark green, healthiest) to E (Red, least healthy) according to the content of both positive (e.g. fibre, protein) and negative (e.g. saturated fat, salt, sugar) nutrients. Nutri-score has been implemented as a front-of-pack label in several countries across Europe, with positive impacts on the healthiness of food purchasing in supermarkets (Andreani et al., 2025). Two studies have assessed Nutri-score in OOH settings, also finding associations between Nutri-score and healthier food choices (Chandon \& Indaburu, 2026; Julia et al., 2021). However, Nutri-score on food menus has not previously been examined in terms of the potential impact on individuals with eating disorders and other mental health outcomes. Nutri-score encompasses the nutritional quality of a food product, by accounting for both positive and negative components. This may be less harmful to individuals with eating disorders as it would remove the focus on calorie content. Previous qualitative research has shown that individuals with eating disorders may support labelling strategies that provide more holistic approaches to nutrition (Trompeter et al., 2026). It could also be of benefit to general population health to focus on helping individuals to consume a well-rounded diet higher in positive nutrients (fibre, protein), with high fruit, vegetable and nut content, and lower in negative nutrients that contribute to ill health (salt, sugar, fats). To date, limited research has compared Calorie labelling to Nutri-score in the general population or among those living with mental health conditions, like eating disorders. OBJECTIVES This new study will explore the impact of Nutri-score labelling vs Calorie labelling vs no labelling (Control) in a simulated OOH food delivery ordering platform (common setting for food purchasing and calorie labelling is required by law in England) on participants' perceived effectiveness of nutritional labelling, healthiness of food choices, positive and negative affect, and perceived impacts on mental health. We will examine effects in a general population sample (no eating disorder diagnosis), a sample of participants with a past or current diagnosis of an eating disorder by a medical practitioner and a sample of participants with a common mental health condition diagnosed by a medical practitioner without eating disorder (e.g., anxiety), in order to understand potential effects across groups of participants who may differ in their risk of poorer mental health in response to nutritional labelling. (references in attached protocol)

This study evaluates the effectiveness and safety of infliximab in the treatment of acute pancreatitis in adults. A third of participants will receive one single dose of infliximab via infusion, another third will receive a higher dose of infliximab via infusion and the final third of participants will receive a placebo infusion.

The AGILE platform master protocol allows incorporation of a range of identified and yet-to-be-identified candidates as potential treatments for adults with COVID-19 into the trial. Candidates will be added into the trial via candidate-specific trial (CST) protocols of this master protocol as appendices. Having one master protocol ensures different candidates are evaluated in the same consistent manor and opening up new trials for new candidates is more efficient. Inclusion of new candidates will be based on pre-clinical data, evidence in the clinical setting and GMP capabilities.

This study aims to ensure that assays that measure drug concentrations are accurate and precise in different matrices when quantified using high performance liquid chromatography -tandem mass spectrometry (HPLC-MS/MS). The study involves collecting samples of various bodily fluids to quantify antimicrobials, antivirals, oral contraceptives and erectile dysfunction agents. Samples will also be obtained from individuals not receiving these medications for quality control purposes.

The goal of this prospective, cross-sectional study is to test the strength of the soleus muscle in participants who have a ACL tear confirmed by MRI. Previous studies have shown that the soleus muscle, which one of the muscles situated in the calf, decreases mechanical loading on the ACL. Therefore, we aim to test soleus muscle strength using a seated plantar flexor test. The main questions we aim to answer are: * Do patients with ACL tears demonstrate inter-limb soleus strength asymmetry (\>10%) * Do patients with ACL tears have soleus muscle weakness compared with uninjured (normative) participants? * Do changes in soleus strength values correlate with patient reported outcomes and stability, as measured by the IKDC questionnaire? To achieve this the VALD force frame will be used as the testing device for plantar flexor strength testing. This device records the force generated by the movement. This will be repeated three times on each leg as part of the testing procedure. Furthermore, as part of the testing procedure participants will be required to fill out an IKDC form to assess their knee stability. Interrater reliability of the force frame will be investigated. Further data from participants without ACL tears will be used to compare results. Thus allowing us to see if people with ACL tears have a weakness in the soleus muscle.

This study is designed to investigate differences between people living with HIV (PLWHIV) and general populations on how the body utilises and stores energy. This study uses magnetic resonance imaging (MRI) to measure fat around the body organs including the heart and liver. The fat around body organs, also known as visceral fat, is known to be associated with metabolic syndrome and a risk factor for developing heart attacks and strokes. MRI scans are used frequently in hospitals to diagnose a range of conditions. These scans use radio waves to measure protons in body tissues. The machines can reconstruct tissues using complex algorithms to form composite images of body structures. MRI scans do not use ionising radiation and there is no risk to undertaking an MRI in terms of radiation. We often use MRI scans to assess the hearts' structure and function. In addition, we can use specific MRI sequences to assess the integrity of heart muscle. Heart MRI is often considered the gold standard imaging technique to assess the heart and heart muscle disease. This sub-study will use multiple MRI sequences to assess the heart and the liver. We are aiming to investigate any changes in heart and liver fat. In addition, we will assess any changes in fat levels within the heart muscle cells whilst also assessing for any change in the way the heart is functioning. PLWHIV have roughly double the risk of heart attacks compared to general populations. Previous studies have demonstrated that this increased risk may arise from the way in which fat is stored and metabolised in the body. We hope this study will give insight into why HIV-positive individuals have increased risks of heart attacks and how reducing visceral fat may reduce risk. It may lead to further medicines or treatment strategies to reduce the risk of heart attacks in HIV-positive individuals.

A randomised, open label, controlled PK standard of care vs doravirine plus 2 nucleoside reverse transcriptase inhibitors backbone in pregnant women initiating combination antiretroviral therapy in the second trimester of pregnancy.

ASPIRE is a nutrition study focusing on the effect of arginine supplementation on immune function in postoperative infants. The investigators will explore the effect of current intravenous feeding (parenteral nutrition (PN)) formulations and oral arginine supplementation on blood arginine levels and the genes that are involved in body nutrition and fighting infection in babies who have had major bowel surgery or been diagnosed with necrotising enterocolitis. The investigators will undertake an exploratory physiological study across two sites under which are part of a single neonatal partnership. 48 infants will be recruited; 24 preterm infants and 24 term/near term infants. 16 of these infants (8 preterm and 8 term/near term) will be supplemented with arginine in both oral and parenteral form, 16 infants will receive arginine supplementation in oral form alone and 16 infants will receive standard nutrition with no arginine supplement. The investigators will record nutritional intake and routine biochemical testing data (which includes amino acid levels) collected over the first 30 days post surgery or post NEC diagnosis. The investigators will take blood for analysis at prespecified intervals for RNA sequencing, ammonia and metabolomics. RNA sequencing findings will allow the investigators to describe the effect of arginine on gene activity in postoperative infants The investigators hypothesise that arginine supplementation will result in changes in gene expression that are consistent with changes in T-cell function and associated inflammatory pathways.

Rehabilitation robotics has the potential to facilitate rehabilitation at home and empower people with spinal injuries to self-manage increasing their independence and improving their quality of life. The objective of this study is to assess for the first time in the NHS the efficacy of a commercial robotic orthosis for upper limb rehabilitation in patients with spinal cord injury. The device is produced by Myomo (myomo.com) which is an American company. We will be assessing the wearable robotic orthosis also known as robotic exoskeleton in two different neuro-rehabilitation centres: National Spinal injuries Unit in Glasgow (Scotland) and The Robert Jones and Agnus Hunt Orthopaedic Hospital in Oswestry (England). The study will involve nine spinal cord injured tetraplegic inpatients in total. Patients will follow a twelve-week rehabilitation programme with three to four sessions per week in addition to their usual care and rehabilitation. Each session lasts for approximately 45 minutes. Participants arm function, range of motion, spasticity level will be measured before, half-way and at the end of the programme to assess change in these and other parameters. Training will focus on the dominant arm of the patient and compared to the other arm at every assessment stage. We shall evaluate therapists' and patients' satisfaction with the commercial device in addition to assessing various clinical measures to evaluate the efficacy of using the robotic orthosis in rehabilitation and recovery of arm function.

Generating bespoke biosampling protocols for individual tumour specific translational projects is onerous, cumbersome and inefficient. This study aims to provide a broad platform to maximise the unique access to biopsy and resected tumour specimens available from cancer patients to provide a high-quality and efficient source of biosamples for specific translational projects. Access to historical FFPE samples and clinical data, as well as prospective fresh tissue samples, will allow interrogation of the underlying biology of these cancers. Matched pseudoanonymised clinical and radiological data will allow the development of rich high-yield datasets.