Clinical trials

Multiple Sclerosis (MS) is a long-term disease that affects over 150,000 people in the UK. Starting treatment early is important for managing Multiple Sclerosis (MS). It is also essential to monitor the treatment to see if it is working and to switch treatments if needed. Magnetic resonance imaging (MRI) is the only accepted tool to monitor how well the treatment is working. Current evaluation of brain Magnetic resonance imaging (MRI) scans requires visual inspection, of which sensitivity is degraded by human, and technical factors, such as lack of time, fatigue of radiologists, and lack of standardization of image acquisition protocols across the National Health Service (NHS). MRI-readings can be significantly enhanced by artificial intelligence (AI)-assistive software. Evidence suggests the rate of new lesion detection to be 3 - 4 times higher when using assistive software compared to visual inspection of MRI scans. In this study, an Artificial Intelligence (AI) software called "icobrain ms." developed by the company "icometrix" (Leuven, Belgium) is tested. This tool helps track MS by measuring changes in the brain using MRI scans. The AI can highlight problem areas and create reports that doctors can use to make better decisions about participants' treatment. The aim of the study is to prove that icobrain ms can be used to assist the neuro-radiologist with their visual assessment of MRI scans by a radiologist, and that it will help clinicians make more informed decisions about participants' current MS treatment.

The goal of this observational study is to evaluate if a blood test for circulating progastrin (hPG80) and transposable elements (TEs) can accurately predict colorectal cancer (CRC) or polyps in adult patients referred to the 2-week wait (2WW) or Straight to Test (STT) pathways for suspected lower gastrointestinal cancer. The main questions it aims to answer are: Can plasma hPG80 levels accurately predict a diagnosis of CRC or polyps in patients undergoing standard 2WW investigations? Can transposable elements (TEs) in the plasma serve as predictive biomarkers for CRC diagnosis in these patients? What are the patient preferences for different diagnostic tests for CRC, particularly a blood-based test compared to more invasive methods? Participants will: Provide a 20ml blood sample during a routine hospital visit for their 2WW diagnostic test (e.g., colonoscopy, CT Colon). Undergo standard clinical investigations as determined by their treating clinicians. Have their final diagnosis (cancer, polyp, or normal) correlated with their plasma hPG80 levels. For a subset of 100 participants (25 with confirmed CRC, 75 non-cancer), have their plasma analyzed for circulating signatures using RNAseq and DNAseq. Complete an electronic post-study questionnaire to explore their preferences and experiences with different CRC diagnostic tests used within the 2WW pathway.

The study will be based from a newly formed NHS service, the children's environmental health service. Participants will be children with a known chronic respiratory condition. Participants will undergo personal environmental exposure monitoring as well as home environmental assessments, before personalised exposure reports will be provided including a summary of their exposure and advising mitigation strategies based on exposure patterns and behaviours. The monitoring will be repeated after introduction of mitigation strategies. This will allow a comparison of the effectiveness of each method of mitigation.

MASLD (Metabolic dysfunction-associated steatotic liver disease) is a condition where fat builds up in the liver. It is the most common cause of liver disease worldwide. In some people, the fat can irritate the liver (inflammation) and cause damage. This is a more serious condition called MASH (Metabolic dysfunction-associated steatohepatitis). People with MASH more at risk of liver cirrhosis (advanced scarring in the liver) and liver cancer. It is not fully understood why MASLD becomes MASH, or why this happens in some people but not in others. However, it is known that our diet plays a role. Research shows a diet high in a type of sugar called fructose might make MASLD worse. Fructose is found in fruit, honey and table sugar, and lots of processed food and drinks. The body deals with fructose differently to other sugars, which is why fructose may be a problem. Although scientists have studied the effects of fructose in healthy people, no studies so far have included people with MASH, so it is not known if fructose might make the condition worse. To answer this question, the researchers will conduct a four-week randomised, double-blind study to compare the effects of fructose with another sugar called glucose in 36 people with MASH, 18 people with 'simple' MASLD, and 18 controls without liver disease. Participants will follow a low-sugar diet and, after 14 days on this diet, they will add either a glucose or fructose supplement for another 14 days. Participants will attend 3 study visits, where blood, urine, stool, and saliva samples will be taken. The main question is whether fructose causes more inflammation in people with MASH compared to those with MASLD, or people without liver disease. The researchers will also investigate how fructose affects liver fat content, the gut microbiota, and other processes relevant to MASLD/MASH.

Nitrous oxide (laughing gas, N₂O) is the third most commonly used recreational drug among young people in the UK. Although it may seem harmless, frequent use can damage the nerves and spinal cord. Vitamin B12 injections can help treat these neurological complications, but continued N₂O use can reduce how effective this treatment is. Some people use N₂O to cope with stress or emotional difficulties, while others may find it hard to stop because of cravings or habits. These emotional and social difficulties can negatively affect recovery, wellbeing, and quality of life. Our team has developed a new brief support programme for people experiencing mild to moderate emotional and social difficulties related to N₂O use. The programme provides information and practical strategies to help people cope, manage emotions, and prevent problems from worsening. It is delivered by a trained facilitator over up to four weekly sessions, either in-person or remotely. In this study, the support programme will be introduced to patients attending the Royal London Hospital clinic for N₂O related neurological harms. Ten participants will receive the programme alongside their usual care. Participants will complete questionnaires before and after the programme to monitor mental health, quality of life, and dependence on N₂O. The research team will evaluate whether the programme was delivered as intended and whether participants remained engaged. Participants will be invited to take part in an interview to feedback on their experiences and suggest improvements before the programme is tested in a larger study. Participation will last up to 8 hours in total over approximately 9 weeks.

The study aims to provide initial proof-of-concept validation data of an artificial intelligence-based model to estimate individual Parkinson's disease risk using demographic, clinical, genetic information and digital biomarker data collected via a smartwatch and a mobile application.

Left Ventricular Thrombus (LVT) is a blood clot that can develop in a poorly functioning heart. In around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber. Having a blot clot in the main heart chamber can lead to serious complications such as stroke. Treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. We hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. This understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. As part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. When participants come in for routine MRI scan, we may capture additional images for further research analysis. A sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. This will occur at baseline and at around 6 months. At 12 months we will repeat the quality of life questionnaire and collect final data.

The Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis (IE) in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies. The endocarditis research registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment. We have a series of studies planned that we believe will influence the management of endocarditis (we are working up proposals for genomic and therapeutic trials that will subsequently be presented for ethical and hospital approval). The registry will be generic to all our planned studies, and will allow us to capture data to assess treatment effectiveness

COVIDENCE UK is a population-based observational longitudinal study that has the following objectives: 1. To determine risk factors for incident COVID-19 and for adverse outcomes of COVID-19 in the UK population 2. To characterise the natural history of COVID-19 in the UK population 3. To evaluate the impact of COVID-19 on the physical and mental health of the UK population 4. To provide a resource from which to identify potential participants for future clinical trials, and to use data collected in COVIDENCE as comparison or control data for trial participants who have been randomised to receive one or more interventions.

The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury. The main questions it aims to answer are: * whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care) * whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots. Participants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication. Drug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.

The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.

Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients. Our secondary objectives are to: Investigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients. Investigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population. Investigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.

The aim of this 12-month clinical study is to treat patients affected by gum disease (periodontitis) by a minor gum surgery that aims to reduce the depth of the gum pockets. In particular, the study will compare two types of gum surgery, one based on the use of a product derived from the patients' own blood (PRGF, platelet autologous concentrate), and the other based on the use of an animal-derived bone graft and membrane that have been in the market for the past 30 years. Both procedures aim to regenerate bone and gum tissue that is damaged by the disease. 74, ≥ 25-year-old, otherwise healthy, patients affected by gum disease will be recruited at the Barts and The London Dental Hospital. Participants will be randomly (by chance) assigned to receive one of the two treatments. Throughout the study, we will assess gum's health by taking some measurements around teeth and gums. In addition, we will use non-invasive technologies to assess changes in temperature, blood flow and face's swelling at different time-points. Patients will be given specific questionnaires to evaluate their preferences and the impact that each surgical treatment had in their everyday life. One intra-oral x-ray will be performed before the surgery and after 12 months to assess if new bone has formed around the teeth involved in the surgery, as per standard procedure.

This study will evaluate the effect of A-PRF, a second-generation APC, on early wound healing in high-risk MRONJ patients following dental extractions, utilising advanced non-invasive methods to assess and associate molecular and blood flow changes during early healing. The early healing events of the post-extraction socket will also be characterised in terms of volumetric changes in relation to intra-oral thermographic changes, blood flow changes, in tandem with clinical measures of soft tissue healing and post-operative pain assessment. The early healing events will be analysed up to 15 days, and the final recall will be 180 days after extraction.

Slow-SPEED UK is an 18-month randomised, double-blind feasibility trial evaluating the delivery, adherence, and acceptability of a digitally supported physical activity programme in community-dwelling adults aged 40 and over with objectively confirmed hyposmia (reduced sense of smell) and low baseline physical activity. Participants are randomly assigned 1:1 to either a full-dose activity-support programme (targeting a 100% increase in daily step count) or a very low-dose active control (targeting a 10% increase). Both arms are delivered via a smartphone application linked to a wearable activity monitor (Fitbit Charge 6), with personalised weekly goals expressed as relative percentages to maintain blinding. The study is not designed to test clinical efficacy.

The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.

The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.

The goal of this clinical study is to evaluate a software device and its impact on clinician behaviour during the initial management of trauma patients in a real-world clinical setting. Known as the AI-TRiPS Device this software uses real-time prehospital data and machine learning-based risk predictions which are displayed digitally for hospital trauma teams prior patient arrival. The investigators will use a Stepped Wedge Cluster Randomised Controlled study design with an integrated process evaluation. The Device will be deployed across the London Major Trauma System where the Major Trauma Centres will be the clusters. Each cluster will transition from control (standard care) to intervention at a pre-specified time (time of transition is randomised). Primary Outcome: Clinician behaviour, assessed via the accuracy of risk prediction and clinician confidence. Secondary Outcome: Clinician acceptability, care process metrics, patient outcomes, and safety endpoints. Primary study population: Hospital trauma clinicians, following initial resuscitation of each eligible trauma patient, who will complete electronic questionnaires. Secondary study population: Adult trauma patients, data will be collected for the duration of their index admission to hospital, to assess outcomes and enable comparison with clinician risk predictions.

Inorganic nitrate, found in leafy green vegetables and beetroot, can help lower blood pressure and support heart health. Early experimental work has suggested that dietary nitrate supplementation, in the form of beetroot juice or potassium nitrate capsules, can reduce blood pressure and improve endothelial function. Consequently, concentrated nitrate supplements like beetroot juice have become popular. However, these supplements can be expensive, high in sugar, and not to everyone's taste. Since more than three-quarters of adults with high blood pressure live in low- and middle-income countries, it is important to find safe, affordable ways to add nitrate to commonly eaten foods. The team at Queen Mary University of London has been developing nitrate-fortified products that may be more appealing to a wider population. With support from the food manufacturer Reading Scientific Services Ltd. (RSSL), they have successfully added nitrate to three oat-based products: cereal bar, porridge, and biscuits. This study aims to explore whether adding nitrate to commonly eaten foods can improve nitric oxide levels in the body and help lower blood pressure in healthy volunteers. Participants will receive the three nitrate-fortified food products in a randomised, crossover design. Nitrate and nitrite concentrations in biological samples, along with blood pressure, will be measured before and at multiple time points after supplementation with the nitrate-fortified products.

The goal of this clinical trial is to evaluate whether a coronary computed tomography angiography (CTCA)-guided strategy can reduce the risk of death, heart attack, stroke, and hospital admissions in patients experiencing angina or myocardial infarction following coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are: * Can CTCA reduce major adverse cardiovascular events compared to standard invasive coronary angiography? * Is CTCA a cost-effective and safer alternative that improves patient quality of life? Researchers will compare outcomes between patients receiving CTCA prior to angiography and those undergoing standard angiography alone to determine if CTCA improves clinical outcomes and procedural safety. Participants will: * Be randomly assigned to either CTCA-guided care or standard angiography * Undergo coronary imaging and follow-up assessments * Complete questionnaires on quality of life and healthcare resource use

The prostate specific antigen (PSA) blood test can help diagnose prostate problems, including cancer. The prostate is an organ in the pelvis. It is found in cisgender men, transgender (trans) women and some non-binary people. Anyone with a prostate can get prostate cancer. The prostate remains after genital (lower) surgery. The hormones and surgeries that trans women and non-binary people might have can lower the PSA. We do not have good data on the normal PSA levels are for this group TransPRIDE is a research study that will help us find the normal levels of PSA in trans women and non-binary people with prostates. Researchers will ask 500 trans women and non-binary people with prostates to take part. They will need to be aged 40 or over. They will need to be on hormones or have had lower surgery. They will be called after 6 months to recheck their health. If a person has a high PSA, they may be sent for more tests. Knowing the normal PSA level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.

To identify key characteristics of the tissue resident and peripherally circulating immune-phenotype in addition to blood markers, metabolic profile, faecal and oral microbiota in non-alcoholic fatty liver disease

The goal of this 12-month implementation science study is to generate the evidence required to ensure long-acting cabotegravir (LA CAB) as pre-exposure prophylaxis (PrEP) can be delivered in an equitable manner within the NHS. This study will recruit both PrEP users and healthcare professionals (HCPs). The main questions it aims to answer are: * What do healthcare providers think about the feasibility of delivering LA CAB PrEP within sexual health services in the NHS? * How many participants stay on/remain consistent with LA CAB PrEP injections at Month 12 (PrEP persistence)? Participants (200 PrEP users) will be followed for 12-months and asked to complete surveys at 3 study visits. A subset of 20 participants will also be asked to complete interviews about their experiences. We will also ask 20 HCPs at participating locations to complete surveys and interviews at both baseline and month 12. A core principle of equity (understanding any difference in impact on underserved populations) will be applied throughout the study. To ensure representation of a diverse group of participants that reflects the demographic groups most affected by incident HIV and most underserved by PrEP in the UK, enrolment targets will be applied and meticulously managed by the central study team, as follows: * A cap of 30% (n=60) will be applied to recruitment of White cisgender men who have sex with men who are not otherwise part of other under-represented groups (as defined below), * At least 70%% (n=140) of participants will represent groups currently underserved by PrEP and fall into one (or more) of the following socio-demographic categories: women (defined cisgender or transgender) OR as transgender men OR non-binary individuals OR age\<25 yrs, OR sex workers OR people who inject drugs OR racially minoritised heterosexual men.

Acute respiratory failure is a common, life-threatening condition where the lungs cannot provide enough oxygen to the body. Many patients are treated with non-invasive respiratory support (NRS) such as high-flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP). However, up to half of patients receiving NRS still deteriorate and require intubation and invasive ventilation, which is linked to longer hospital stays, more complications, and slower recovery. A major challenge in caring for these patients is that clinicians currently cannot directly see how well the breathing muscles (especially the diaphragm and parasternal intercostal muscles) and the lungs are working while the patient is using NRS. Existing bedside measures, such as respiratory rate or oxygen levels, only show part of the picture. They do not indicate how hard the patient is working to breathe or whether their respiratory muscles are becoming fatigued. This lack of information may delay important decisions about adjusting NRS settings or switching to other treatments. This study aims to find out whether two advanced but non-invasive, radiation-free bedside monitoring tools can be used effectively in routine care: 1. Ultrasound, which can measure breathing muscle thickness, movement, and lung aeration 2. Electrical impedance tomography (EIT), which uses a soft belt of small electrodes around the chest to measure changes in air and blood flow within different regions of the lungs in real time These tools have shown promise in earlier research, and interviews with patients and clinicians suggest they are comfortable, well-tolerated, and potentially useful. However, they have not yet been evaluated together in a real-world hospital environment where many acute respiratory failure patients are cared for outside the ICU. What the study will involve: Up to 100 adults with acute respiratory failure requiring any type of non invasive respiratory support will be recruited with the goal of obtaining complete data from at least 50 patients. Each participant will undergo ultrasound and EIT assessments up to seven times during the first 72 hours after starting NRS, plus an additional measurement if they improve enough to stop NRS or if they deteriorate and require intubation. These assessments take place at the bedside, require brief exposure of the upper chest, and last approximately 15-45 minutes. Routine clinical data-such as heart rate, oxygen levels, and breathing measures-will also be recorded. In parallel, clinical staff caring for these patients will complete a short Healthcare System Usability Scale questionnaire to rate how useful, understandable, and practical they find the information generated by ultrasound and EIT. Some staff may also take part in optional interviews to explore usability in more depth. What the study is trying to learn: The primary aim is to determine the usability of these monitoring methods meaning understanding if they are practical, easy to use, and helpful for clinicians making decisions about NRS treatment. Secondary aims include understanding: * how the respiratory muscles and lungs change over time during NRS * whether these changes are linked to treatment settings (e.g., flow rate, pressure support) * whether certain patterns are associated with treatment success or failure (intubation or death) * whether these tools could help identify patients at risk of deterioration earlier Risks and benefits: Both ultrasound and EIT are widely used, safe, and non-invasive. They involve no radiation, needles, or harmful exposure. Minor temporary discomfort from the gel or belt placement is possible. Participation will not change any clinical treatments. Although patients may not directly benefit, the study may help future patients by improving understanding of breathing muscle function and supporting more personalised respiratory care. By contributing to this research, patients and clinicians will help determine whether advanced monitoring can be realistically implemented in busy hospital settings and whether it could lay the groundwork for future trials aimed at improving outcomes for people with acute respiratory failure.

The DIAMOND study is being carried out to evaluate if Datopotamab deruxtecan (Dato-DX) in combination with Durvalumab is more effective than Dato-DXd alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC). Globally, breast cancer is the most common malignancy in women and the second most common cancer overall. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises 10 -15% of all breast cancers. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially. Moreover, the PDL1-negative tumour has demonstrated no benefit from standard 1st line treatment of chemotherapy plus immune checkpoint inhibitors.