Clinical trials

Coronary artery disease occurs when fatty deposits (plaques) build up inside the arteries that supply blood to the heart. Some plaques remain stable, while others continue to grow or become more likely to rupture, which can lead to a heart attack. Identifying plaques that are at higher risk of progression could help doctors provide earlier and more personalized treatment. The purpose of this study is to determine whether combining information about blood flow within the coronary arteries with information about a person's biological response to blood flow can improve prediction of plaque growth. Participants undergoing treatment for coronary artery disease will have a specialized heart scan to assess blood flow patterns around plaques in their coronary arteries. Researchers will also collect blood samples to study cells that line blood vessels and investigate how these cells respond to blood flow forces. The study will follow participants over time to determine whether plaques are more likely to progress in individuals who show a stronger biological response to abnormal blood flow. The findings may help researchers develop new ways to identify patients at higher risk of future heart problems and support the development of more personalized approaches to prevention and treatment of coronary artery disease.

Coronary artery disease, caused by the furring up of the heart arteries by atherosclerosis, is a major cause of death in the UK. Despite existing therapies, adverse cardiovascular events remains high, especially in patients who have already had a heart attack, as some of these patients have aggressive atherosclerotic disease. If we could identify these vulnerable patients, then in wider clinical practice in the future we might be able to treat them better with new therapies that can otherwise be expensive or come with a risk of side-effects. Traditionally, the assessment of atherosclerotic disease and the identification of the plaques that will cause heart attacks is performed using invasive imaging - imaging taken by passing a wire into the arteries of the heart that has a camera on its tip. Invasive imaging, however, can be used only in patients with symptoms and has risks. Photon counting (PC) CT is a new CT system that has image quality comparable to invasive imaging and can be used in the community to examine individuals with stable angina symptoms. In this study we aim to compare how well PC-CT detects high-risk plaques compared with invasive imaging and in due course develop a platform that will expedite the analysis of CT images to allow its broad use in the clinical practice.

The goal of this study is to improve understanding of tendon health and disease by using surplus tendon tissue that is routinely removed during planned orthopaedic surgeries in adults. The main questions it aims to answer are: \- What can tendon tissue and tendon cells tell us about how healthy and diseased tendons function? Participants will not undergo any extra procedures. Instead, researchers will use only tissue that is already being removed as part of normal surgical care and would otherwise be discarded. Participants will: * Be asked for permission (consent) before their surgery to donate any surplus tendon tissue. * Have a small piece of tendon tissue (normally waste material) collected during their planned operation. * Allow the research team to access some non-identifiable medical information (such as age, reason for surgery, and relevant medical history) to help interpret research findings. What the researchers will do with the donated tissue: * Isolate different types of human tendon cells. * Build advanced laboratory cellular models to study how tendon diseases develop. * Analyse whole tendon tissue sections to understand cell types, tissue organisation, and disease-related changes. This study does not involve testing treatments, and it does not change any aspect of a participant's clinical care. Although there is no direct benefit to participants, the donated tissue may help researchers develop better ways to study tendon injuries and improve future treatment options for tendon disease.

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.

Despite the year-on-year decrease, coronary artery disease (CAD) still remains one of the leading cause of mortality worldwide. With advances in technology and our understanding of cardiac disease, we can now treat CAD using minimally invasive interventional techniques. This has revolutionised treatment for and improved the lives of many patients with CAD. Although trials have assessed various therapeutic strategies in various populations, real-world evidence of intervention and medical treatment among patients with CAD is increasingly recognised as an important part of providing safety and efficacy data and improving the care we provide. This data will add to that literature by assessing the characteristics and outcomes of patients with CAD. It will also identify and characterise predictors of outcomes, improve risk stratification and diagnostic evaluation.

Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction. There will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.

What is the Study About? The DIRECT study (Delivery and Implementation of a Randomised Crossover Trial on Thrombosis) is a large research project investigating the best way to prevent blood clots (thrombosis) in people who break their hip. The study will compare two common treatments: aspirin (a tablet) and low molecular weight heparin (LMWH, an injection). Every year, thousands of people in the UK suffer a hip fracture, which often requires surgery and hospital care. After a hip fracture, patients are at risk of developing serious blood clots in their legs (deep vein thrombosis, DVT) or lungs (pulmonary embolism, PE), which can be life-threatening. Currently, doctors prescribe different medications to prevent these clots, but there is uncertainty about which treatment is best for people with hip fractures. Why is This Study Needed? Blood clot prevention is vital for hip fracture patients, but the current recommended treatment (LMWH) involves daily injections for 28 days, which some patients find uncomfortable and difficult to manage at home. Aspirin, a tablet taken by mouth, is a much simpler alternative, but there is not enough evidence to confirm whether it is as effective and safe as LMWH in this group of patients. The DIRECT study will help doctors and the NHS understand whether aspirin could be a safe and cost-effective alternative to LMWH. If aspirin is found to be just as effective, it could make treatment easier for patients and save millions of pounds for the NHS. How Will the Study Work? The study will involve 96 hospitals across the UK and will include over 21,000 patients aged 60 and older who have broken their hip. Hospitals will be randomly assigned to use either aspirin or LMWH as their standard treatment for a set period. After this, they will switch to the other treatment. This approach allows researchers to compare the two treatments fairly. All data will be collected from national NHS databases, which routinely record patient care and outcomes. This means patients will not need to do anything extra or attend additional follow-ups. What Are the Expected Benefits? This study will provide clear evidence on which treatment is better for preventing blood clots while minimising risks like bleeding. If aspirin is shown to be as effective as LMWH, it could: * Reduce the need for daily injections, making treatment more comfortable for patients. * Lower NHS costs, as aspirin is much cheaper than LMWH. * Provide a simple, widely available treatment option for older adults with hip fractures. How Will Patient Data Be Protected? The study will use anonymised patient data from NHS records. This means that all personal details will be kept confidential and protected according to strict NHS and research regulations. Patients who do not want their data to be used can opt out via NHS data-sharing policies. Summary The DIRECT study is an important project that will help improve care for hip fracture patients by determining whether aspirin can be a safe and effective alternative to injections for preventing blood clots. The results will help shape future NHS guidelines, ensuring patients receive the best possible treatment while reducing unnecessary costs and discomfort.

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.

There is a lack of understanding of how Coronary Artery Disease (CAD) - meaning the blocking or furring up of the arteries of the heart - starts and progresses in women. In both men and women, CAD is the most common cause of heart attacks, which occur when the blood supply in the heart is interrupted (these are also known medically as 'acute coronary syndromes'). Before the menopause women appear to be protected from CAD; however, after the menopause that protection is lost. Also, those women who do suffer a heart attack have twice the risk of further heart attacks compared to men despite having the same treatment that works well in men. Biological differences between men and women are probably playing an important role in the way CAD develops. However, due to a lack of research there is currently little understanding of how the female body works in this area. Inflammation is the body's natural response to injury or infection. Importantly it is also involved in the development of CAD. Hormones such as oestrogen and testosterone are also likely to be contributory factors. The investigators think the differences between the way these hormones and inflammation play a part in CAD in both men and women are important, but the role they play is not yet fully understood. In this study the investigators wish to measure the 'markers' of inflammation in the blood of patients attending Barts Heart Centre with chest pain. The investigators will also conduct questionnaires with these patients, to understand their hormone status and how parts of their medical history may be a contributory factor. For patients who have previously attended Barts Heart Centre will will contact them to conduct the questionnaire over the telephone only. The investigators will combine this data with the data that is routinely collected during hospital admission. In this way the investigators hope to understand whether inflammation together with hormone status plays an important role in CAD. Our hope is that through this research the investigators will address an under researched area and find new ways of treating women and men with coronary artery disease.

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 study seeks to investigate safety and efficacy of ixazomib (NINLARO), a proteasome inhibitor, in multiple sclerosis (MS). Participants will receive either ixazomib capsules or placebo capsules for up to 24 months.

The goal of this clinical trial is to find out whether treatment with baxdrostat changes aldosterone-producing activity in the adrenal glands of people with primary aldosteronism. The study will use specialised imaging to measure changes in the adrenal glands before and after treatment. Participants will receive baxdrostat for 24 weeks and will be followed for changes in their adrenal imaging, blood pressure and hormone levels. The study will also investigate whether changes caused by treatment continue after baxdrostat is stopped. This is a single-group study, meaning that all participants receive baxdrostat and there is no placebo or comparison group.

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.

Dental implants have been on the market for several years and they are routinely used to replace single/multiple missing teeth with a high success rate. However, there is still a limited number of studies comparing the influence of timing of implant placement on wound healing. In addition, there is no data available on the signaling pathways and the expression of healing biomarkers involved in the early stages of osseointegration after immediate implant placement (IP) or delayed implant placement (DP). The primary objective of this study is to describe changes in the expression of inflammatory, angiogenesis and osseous biomarkers of saliva at 1, 3, 7, 15 and 30 days and of PICF at 3, 7, 15 and 30 days after immediate implant placement (IP) compared with delayed placement (DP).

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 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.

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.