Clinical trials

Background and study aims The retina is the layer at the back of the eye that allows us to see. Sometimes, it can detach from the wall of the eye, causing a condition called rhegmatogenous retinal detachment (RRD), which leads to vision loss and requires surgery. The most common surgery for RRD is vitrectomy, but this can lead to complications like cataracts, which worsen over time and need to be removed with another surgery. Cataract surgery involves replacing the cloudy lens with a clear artificial one. Currently, it's unclear whether it's better to perform both surgeries at the same time or separately. The COMBAT study aims to find out which approach is best by comparing the outcomes of patients who have vitrectomy alone versus those who have both surgeries (vitrectomy and cataract surgery by phacoemulsification and intraocular lens \[IOL\] implantation) together. Who can participate? Adults aged 50 and older who have RRD but are not highly myopic (less than -6 diopters or an axial length of 26.5 mm or less) and have not had previous vitreoretinal surgery. Participants must be scheduled for a pars plana vitrectomy to repair their RRD. What does the study involve? Participants will be randomly assigned to one of two groups: one group will have vitrectomy first and, if needed, cataract surgery later; the other group will have both surgeries at the same time. The study will compare their vision, the number of successful retina reattachments, health related and visual related quality of life, patient satisfaction, complications, additional surgeries and procedures, and costs.

The goal of this clinical trial is to understand the feasibility of a co-designed, pre-radiotherapy exercise programme for people with stage I-III non-small cell lung cancer. This involves people with lung cancer engaging in 20 minutes exercises sessions performed within the radiotherapy department and immediately before each treatment at a personalised intensity. The main questions it aims to answer are: To understand the acceptability of the exercise programme through monitoring recruitment rates, attendance of the exercise sessions, and adherence to prescribed exercise intensities. Adverse events will also be monitored to understand programme safety. Follow-up qualitative interviews will be conducted with participants, their family members, and health care professionals (HCP) to further explore the acceptability of the exercise programme. In total, participants will be invited to perform twenty, supervised exercise sessions scheduled immediately before each treatment within the radiotherapy department. Each exercise session will be twenty minutes in duration and will be performed on a stationary exercise bike. Regarding exercise intensity, there are four levels which may be prescribed depending on people's exercise history, baseline exercise experience, and personal preference. Participants may progress or regress exercise intensity levels throughout the programme depending on their adherence and preference.

Background: Heart failure (HF) is widespread in the United Kingdom (UK). Many of these patients rely on support from family carers who are ill-prepared and supported for this role. These carers often experience poor mental and physical health because of their caring role. HEart faiLure carer support Programme (HELP) is the first intervention in the UK developed with carers of patients with HF to support them with looking after themselves and the patients they care for. Aim: To identify the best way of delivering HELP to all carers across the UK and evaluate its impact on carers and patients. Methods: HF Nurses will deliver HELP across 3 sites in the UK to approximately 180 carers of patients with HF. The carers targeted will be those who require additional support (caring for a patient who has HF symptoms). These carers will be nominated for the project by patients identified by nurses at in- and out-patient HF appointments. These patients (around 180) will also be invited to provide information for the project. HELP includes 6 online educational support sessions (1 hour each) delivered weekly, along with an educational booklet and website that provide additional support and advice. We will evaluate the impact of HELP on outcomes for patients (i.e., hospital admissions, GP visits, and quality of life) and carers (i.e., burden, preparedness, and quality of life). Interviews and logs / questionnaires will be completed by participants and staff, which will help us understand how best to deliver HELP. Information for the project will be collected at baseline, during HELP, immediately post-HELP (6 weeks), and 6 months after finishing HELP. Impact: The findings will allow us to develop a plan for giving HELP to all carers throughout the UK to provide them with the education and support they need.

Controversy remains around the role of ultra-processed food (UPF) consumption and health outcomes. A key question that remains to be answered is: when diet quality is the same, does food processing itself have any independent health effects? The current application aims to isolate the health effects of food processing from those of diet quality through the conduct of a dietary intervention study.

This study is a single-arm feasibility trial designed to evaluate the implementation, acceptability, and preliminary effects of a culturally adapted Compassionate Mindful Resilience (CMR) intervention among adolescents in Thailand. The study is conducted in a secondary school setting and targets students aged 16 to 18 years. Adolescence is a critical developmental period associated with increased emotional vulnerability, academic pressure, and exposure to mental health risks. In Thailand, recent evidence indicates rising levels of stress, anxiety, and reduced psychological well-being among young people. School-based preventive interventions that strengthen internal coping skills are therefore a public health priority. While mindfulness-based interventions have demonstrated benefits in Western contexts, there is limited evidence regarding compassion-focused mindfulness programs that are culturally adapted for Thai adolescents. The CMR intervention is a structured, manualized behavioral program that integrates mindfulness, self-compassion, and resilience-building skills. The program was originally developed by MindfulnessUK and subsequently adapted for the Thai adolescent context through a co-production process involving students, teachers, and school counselors. Cultural adaptations focused on language use, contextual relevance of examples, and alignment with the Thai educational environment, while maintaining fidelity to the core theoretical framework. All participants enrolled in the study will receive the CMR intervention. The program consists of four weekly group sessions, each lasting approximately 90 minutes, delivered after school hours to minimize disruption to academic activities. Sessions include guided mindfulness practices, group discussions, and practical exercises aimed at increasing present-moment awareness, cultivating self-compassion, improving emotional regulation, and strengthening resilience. Home practice activities are encouraged between sessions to support skill integration into daily life. The primary objective of the study is to assess feasibility. Feasibility outcomes include recruitment rate, retention rate, session attendance, intervention fidelity, and participant acceptability. These indicators will inform whether the intervention can be delivered as planned in a Thai school setting and whether progression to a larger-scale trial is justified. Secondary objectives explore preliminary changes in mental health-related outcomes. These include mindfulness, self-compassion, resilience, and overall well-being, measured using validated Thai-language instruments before and after completion of the intervention. Although the study is not powered to test effectiveness, these data will provide estimates of variability and potential effect sizes to inform the design of a future randomized controlled trial. Participant safety is addressed through a predefined distress protocol. A school counselor is available during all intervention sessions to provide immediate support if participants experience emotional distress. Ethical approval has been obtained from the relevant institutional ethics committee, and written assent from participants, along with parental or guardian consent, is required prior to enrollment. Overall, this feasibility study will generate critical information on the practicality, acceptability, and preliminary impact of the Compassionate Mindful Resilience program for adolescents in Thailand. The findings will guide the development of a future definitive trial and contribute to the evidence base for culturally appropriate, school-based mental health promotion interventions in low- and middle-income settings.

The goal of this clinical trial is to determine whether the sequence of macronutrient consumption affects post-prandial glycaemia in women with gestational diabetes mellitus. The main questions it aims to answer are: * The difference in the magnitude of postprandial rise in blood glucose between the two test meals. * The difference in the magnitude of postprandial change in serum levels of gut hormones between the two test meals. * The difference in mean change in pre-post ingestion satiety scores between the two test meals. * The difference in 24 hour energy and macronutrient intake following the two test meals. Participants will attend two study visits at the Centre for Public Health, with an interval of at least two days between the visits and complete the following, anthropometric measurements, demographic and appetite questionnaires, glucose measurements, two food diaries and fasting blood samples and the consumption of the study breakfast. Participants will be asked to eat either the protein/fat-based component of the meal (scrambled egg) before or after the carbohydrate-based component (wholemeal toast) on their first visit and on the other visit they will be asked to eat the meal in the reverse order. The order in which this occurs will be randomised and each participant will act as their own control. Researchers will compare the results from participants between the two test meals to see if the order of macronutrient consumption has any effect on post-prandial glycaemia, gut hormones, satiety scores and energy and macronutrient intake.

The investigators aim to conduct a mixed-method study in which a randomised controlled trial (RCT) and a descriptive qualitative study will be conducted. The RCT aims to determine whether free near and distance glasses provided to residents in Hyderabad, India, aged ≥ 60 years, with under- or un- corrected refractive error and normal baseline hearing and cognition (HMSE \> 18), can improve quality of life, reduce falls, reduce depression, improve social interaction and physical activity cost-effectively over 36 months. The primary qualitative research aim is to a) contextualize the RCT with information on the milieu and culture in which the trial will be conducted; b) provide data on the lived experiences of older adults with reduced vision in the study area, and c) conduct a process evaluation of the trial. The primary outcome measure is the three-year change in cognition measured by LASI- DAD (Longitudinal Aging Study in India(LASI)- Diagnostic Assessment of Dementia(DAD) global cognitive score. Secondary Outcome Measures: Three year change in Quality of Life score measured by WHO QOL-BREF; Visual functioning from the RASCH-scaled version of INDVFQ(Indian Visual Functioning(INDVFQ);self-reported physical activity score measured using IPAQ questionnaire; PHQ9 score; domain specific cognitive score (orientation, executive function, language/fluency, memory) measured by HMSE; Total cost of care including direct and indirect costs; Quality adjusted life years; Incremental Cost Effectiveness Ratio; Number of falls measured by Quick Screen score over the three years; Social network density at 3 years (SNI 1-3 represents a "limited" social network, 4-5 is a "medium" social network, and SNI ≥6 is a "diverse" social network) measured by the SNI score; An additional secondary outcome will be LASI-DAD global cognitive score analysed by excluding any tests determined pre-hoc to depend on visual acuity.

The COVID-19 pandemic has highlighted the critical need for evidence-based interventions to support the psychological wellbeing of healthcare staff, particularly within Occupational Health settings. Recent research has documented significant mental health challenges among healthcare professionals, including high rates of burnout and stress. Fostering self-compassion has emerged as a key area for intervention. This study aims to pilot and assess the effectiveness of an online compassion-based intervention for healthcare staff, using a randomised Treatment As Usual (TAU) control group. The intervention will be grounded in Compassion Focused Therapy (CFT) and Compassionate Mind Training (CMT). CFT aims to shift focus from self-blame and shame to self-compassion, while CMT involves specific techniques to cultivate compassionate attitudes. The four-week online intervention, led by a CMT expert, will include mindfulness practices such as attention training, imagery, and behaviour-based exercises designed to foster an identity grounded in compassion. The sample will consist of healthcare professionals accessing Occupational Health service in Belfast Health and Social Care Trust (BHSCT) for psychological assessment. Participants who meet inclusion criteria will be randomly assigned to either the intervention group or the TAU control group. Questionnaires will be administered online at four time points: pre-intervention,mid intervention, post-intervention, and at one-month follow-up. The measures will assess mental health, burnout, self-compassion, fear of self-compassion and credibility and expectancy of treatment. Participants will be recruited through BHSCT Occupational Health Service and will be screened to meet inclusion criteria by the clinician completing psychological assessment. If the client agrees to be contacted by the researcher their name will be added to a study spreadsheet by their clinician and they will be contacted by the researcher to provide further information and obtain informed consent. Data will be collected electronically using Microsoft Forms and stored securely on an encrypted Trust-based database.

This lay description has been written in conjunction with, and the content approved by our Patient and Public Involvement collaborators. Patients with kidney cachexia will experience extreme muscle loss, reduced strength and symptoms including fatigue, reduced appetite and lower quality of life. Patients are also at an increased risk of hospitalisation and shortened life expectancy. Previous research suggests that treatments that target several causes of the muscle wasting syndrome (known as cachexia), show better outcomes for patients than treatments using just one method (for example only exercise). We want to see if combining different treatments (exercise, dietary advice and anti-inflammatory supplements) will improve outcomes for patients with kidney failure receiving haemodialysis at risk of developing kidney cachexia, compared to patients who only receive routine kidney care alone. However, there is currently no routine treatment for kidney cachexia. Individual treatments, such as exercise, have not been successful to slow the progression of wasting in chronic diseases. Our recent review of scientific literature highlighted dual treatments of exercise and dietary advice is effective to varying degrees. Combined treatments which include anti-inflammatory supplements (including those found in fish oils), alongside exercise and dietary advice, have been successfully trialled in other chronic illnesses, such as cancer for the treatment of cachexia. However, this bundle of three treatments has not been tested in patients with kidney cachexia. It is important to test whether such a combination of treatments will be practical for patients and clinicians. Our study will assess how well this intervention works in the healthcare system and if it shows potential to help patients with kidney cachexia. Patients at risk of kidney cachexia who are receiving haemodialysis at two renal departments have been assigned to the treatment group (Multi-Modal Integrated intervention combining Exercise, Anti-inflammatory \& Dietary advice plus routine care) and two have been assigned to the control group (routine care). Over 12 weeks, those in the treatment group will receive an individualised exercise programme, dietary advice and anti-inflammatory (fish oil) nutritional supplements. We will collect data on how successful the trial is (e.g., how many patients took part, completed all components of the study). Additionally, we will collect data on physical functioning, muscle mass, body weight, quality of life and survival. After 12 weeks, we will interview patients and clinicians to evaluate, if any, changes can be made to improve the intervention within what is called a 'process evaluation'.

STABLE is a stepped-wedge cluster randomised controlled trial and its primary aim is to determine whether the provision of spectacles for the correction of myopia can reduce the average number of crash-near-crash (CNC) events among eligible motorcycle drivers in Vietnam as measured under naturalistic driving conditions with the Data Acquisition System (DAS). STABLE is designed to assess the impact of vision correction on the safety of road users in a a Low and Middle income countries (LMIC) setting. A positive trial outcome would demonstrate the safety benefits of vision correction and would create pressure for tighter regulation of drivers' vision and the promotion of vision correction. The study will be conducted in the peri-urban universities in Ho Chi Minh City, Vietnam and 625 students from five universities will be recruited into the trial. Before conducting the main trial, a pilot of 35 students will be recruited to test DAS and build CNC dictionary. Duration of the trial is 33 months from enrolment to completion of primary analysis, with 18 months for data collection. Study participants can be both male and female motorcycle drivers aged 18 to 23 years years with at least one year of driving experience; they must use their motorcycle as their primary means of transport; drive at least 25 km per week and present with un- or under-corrected myopia that can be corrected with spectacles. Participants with any ocular or systemic abnormality affecting vision, other than un-or under-corrected myopia will be excluded from the trial. STABLE's primary outcome is CNC events per 1,000 km driven the DAS mounted to the motorcycles of trial participants. An interim analysis of the primary outcome will take place 9 months after data collection begins. The interim analysis will be reviewed by the trial's Data Monitoring and Ethics Committee. Unless a change is needed because of this review, the trial's primary analysis will take place 18 months after the DAS units are fitted to participants' motorcycle). Compliance with study glasses; self-reported visual function (driving-adapted Visual Function Questionnaire-25 \[VFQ-25\]); Dula Dangerous Driving Index (DDDI), for all crashes; self-reported CNC events for comparison with recorded CNC events and total delivery cost per CNC event avoided with the intervention (indicator of cost-effectiveness).

Young children frequently attend the emergency department (ED) with wheeze which is usually triggered by a virus infection, such as the common cold. Wheeze can be treated with inhaled medications and sometimes oral steroid medicines are also given to reduce swelling within the lungs. Unfortunately, oral steroids can have side effects. Despite lots of research there is no clear evidence that oral steroids work in young children with a wheeze attack. It is likely that some children get better quicker with oral steroids but deciding who to treat is difficult. This results in differences in care with some children receiving unnecessary oral steroids and others not receiving them when they could benefit. The investigators hypothesise that in a subgroup of children with mild-to-moderate acute wheeze attacks, the viral trigger can predict their response to steroid medications. Previously, respiratory virus testing was too slow to be used to inform treatments in the ED. Now, point-of-care (POC) viral tests can provide results within 30 minutes. There is a research gap regarding the role of these tests in determining steroid responsiveness and outcomes in children presenting with acute wheeze in the pre-school population. In order to address the hypothesis in a future definitive trial, the feasibility of using (POC) viral tests to randomise steroid treatments for children in a clinical study in the ED setting must be ascertained. The PRECISE Study will therefore be a single centre randomised, feasibility study enrolling approximately 60 pre-school aged children to inform a future definitive multi-centre Randomised Controlled Trial.

Chinese children are some of the most short-sighted in the world, but only one in five children in poor areas who needs glasses has them. Our team has already shown in other trials that giving children free glasses leads to better grades and that free glasses have a bigger impact on grades than factors like parents' education level and the amount of money a family has. The effect on grades from glasses is greater than from other health services in school, like giving vitamins. Only about one in three children in rural China goes on to a regular, non-vocational high school. The investigators would like to show the Chinese government strong evidence of what glasses can do to help children continue their education, in order to help convince the government to carry out national programs to provide free glasses for children who need them. Study Plan: The investigators will choose 111 middle schools at random in Liaoning, northern China, and all children in Year 1 at each school will go at random into one of two groups: either a group getting free glasses, with support from teachers to push them to wear the glasses ("Intervention") or a group getting just glasses prescriptions ("Control.") The main study outcome will be the proportion of children going on to academic (as opposed to vocational) high school, and the study is powered to detect a 10% difference in this figure between groups.The study will also assess whether children wear their glasses at school and how often they use blackboards (which disadvantage short-sighted children) vs textbooks to learn from. These other outcomes will help us to better understand the causal pathway between vision and high school attendance. We will also study the total cost of providing glasses and the teacher support to wear them per additional student attending academic high school, as well as student mental health outcomes. We will also collect data on the progression of nearsightedness. The hypothesis of this study is that providing glasses will increase academic high school attendance.