[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Queen Mary University of London\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":667},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,56,0,25,[9,42,76,108,138,167,200,221,241,259,283,306,327,352,373,403,439,458,485,513,541,564,581,612,640],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100601526","artificial-intelligence-assisted-magnetic-resonance-imaging-for-quality-efficiency-and-equity-in-the-national-health-service-nhs-care-of-multiple-sclerosis-100601526",false,"NCT07111637","Artificial Intelligence-Assisted Magnetic Resonance Imaging for Quality, Efficiency and Equity in the National Health Service (NHS) Care of Multiple Sclerosis","AssistMS","Inclusion Criteria:\n\n* Clinically Isolated Syndrome suggestive of demyelination (CIS) or definitive diagnosis of MS.\n* Undergoing MRI head investigation.\n* On an MS DMT pathway.\n* Access to a smartphone, tablet or computer.\n\nExclusion Criteria:\n\n* patients with Multiples Sclerosis participating in a randomised controlled CTIMP (participating in a single arm study may be included, provided this is in line with the other protocol).","ALL","18 Years","99 Years",{"count":21,"type":22},1336,"ESTIMATED","INTERVENTIONAL",[25],"NA","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.\n\nMagnetic 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.\n\nIn 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.",[28],"Multiple Sclerosis","RECRUITING","2026-08-11",{"date":32,"type":33},"2026-08-12","ACTUAL",{"date":35,"type":33},"2025-06-14",{"date":37,"type":22},"2027-04-14",{"name":39,"class":40},"Queen Mary University of London","OTHER",1,{"id":43,"slug":44,"hasResults":12,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":70,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":41},"100595687","new-biomarkers-to-stratify-colorectal-cancer-referrals-100595687","NCT07035691","New bioMarkers tO straTIfy cOlorectal caNcer Referrals","Plasma Biomarkers in Stratifying Patients Referred Via the Lower Gastro-intestinal (LGI) Suspected Cancer Two-week Wait (2WW) Pathway","MOTION","Inclusion Criteria:\n\n* Adult, lower GI 2WW and or Straight to Test (STT) referral patients with suspected lower GI cancer.\n* Male and Female patients aged \\>18 years.\n* 2WW referral patients with no history of inflammatory bowel disease.\n* Performance status (ECOG 0-2; and 3 pending clinical assessment of fitness).\n* Patients with capacity to consent to the study.\n\nExclusion Criteria:\n\n* Any patients referred outside of the 2WW and or STT referral pathways with suspected Lower GI cancer or those referred as an emergency with or suspected CRC.\n* Age \\\u003C 18 years.\n* Patients not fit for standard investigations (e.g. not fit for gastroscopy, colonoscopy or CT colonography) in the 2WW pathway.\n* Patients with no capacity to consent or who declined consent for participation.\n* Patients with untreated solid organ cancers.\n* Patients with known inflammatory bowel disease.\n* Patients with documented familial type CRC.",{"count":51,"type":22},582,"OBSERVATIONAL","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.\n\nThe main questions it aims to answer are:\n\nCan 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?\n\nParticipants will:\n\nProvide a 20ml blood sample during a routine hospital visit for their 2WW diagnostic test (e.g., colonoscopy, CT Colon).\n\nUndergo standard clinical investigations as determined by their treating clinicians.\n\nHave their final diagnosis (cancer, polyp, or normal) correlated with their plasma hPG80 levels.\n\nFor a subset of 100 participants (25 with confirmed CRC, 75 non-cancer), have their plasma analyzed for circulating signatures using RNAseq and DNAseq.\n\nComplete an electronic post-study questionnaire to explore their preferences and experiences with different CRC diagnostic tests used within the 2WW pathway.",[55,56,57],"Colorectal Carcinoma","Polyp","Colorectal Adenoma",[59,60,56,61,62,63,64,65,66,67,68,69],"Colorectal cancer","Cancer","Adenoma","Cancer surveillance","Flag symptoms","Liquid biopsy","Progastrin","Circulating biomarkers","Biomarkers","Risk stratification","Early diagnosis",{"date":32,"type":33},{"date":72,"type":33},"2025-06-30",{"date":74,"type":22},"2026-10-01",{"name":39,"class":40},{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":83,"sex":17,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":4,"studyType":23,"phases":88,"briefSummary":89,"conditions":90,"keywords":95,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},"100550507","the-barts-charity-childrens-environmental-health-clinic-100550507","NCT06447974","The Barts Charity Children's Environmental Health Clinic","BCCEHC","Inclusion Criteria:\n\n* Parent\u002FGuardian able to provide written informed consent\n\nReferral made by paediatric asthma team\n\nChild aged 4-17 years at the time of consent to study\n\nA diagnosis of a chronic respiratory condition (diagnosis by a medical professional)\n\nContactable for regular follow up by the research team\n\nReasonable level of English language\n\nAbility to engage with technology and devices used in the study\n\nExclusion Criteria:\n\n* Inability to use the tools and devices in the research study\n\nInability to visit the hospital for the initial hospital visit\n\nInability to allow home environmental assessment",true,"4 Years","17 Years",{"count":87,"type":22},200,[25],"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.",[91,92,93,94],"Environmental Exposure","Health Behavior","Asthma in Children","Environmental Illness",[96,97,98,99],"asthma","Air pollution","environmental","Environmental health clinic",{"date":101,"type":33},"2026-08-13",{"date":103,"type":33},"2025-07-24",{"date":105,"type":22},"2027-06",{"name":39,"class":40},2,{"id":109,"slug":110,"hasResults":12,"nctId":111,"briefTitle":112,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":83,"sex":17,"minAge":115,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":23,"phases":119,"briefSummary":120,"conditions":121,"keywords":125,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":135,"leadSponsor":137,"locationsCount":107},"100594013","fructose-is-a-metabolic-and-inflammatory-pathogenic-factor-in-metabolic-dysfunction-associated-steatohepatitis-mash-100594013","NCT07013916","Fructose is a Metabolic and Inflammatory Pathogenic Factor in Metabolic Dysfunction-associated Steatohepatitis (MASH)","FLOURISH","Inclusion Criteria:\n\n* Able and willing to give written informed consent\n* Age 45-65 at consent\n* HbA1c \\\u003C 48 mmol\u002Fmol\n* Overweight and stage I obesity using BMI thresholds adjusted for ethnicity:\n\n  * 23.0kg\u002Fm2 - 32.4kg\u002Fm2 in South Asian, Chinese, other Asian, Middle Eastern, Black African or African-Caribbean populations\n  * 25kg\u002Fm2 - 34.9kg\u002Fm2 in White populations\n\nMASH Patients:\n\nClinical diagnosis of MASH and F2 - F3 fibrosis:\n\nEither:\n\nLiver biopsy within 12 months of baseline\n\nOr:\n\n• History of histologically-diagnosed MASH with current evidence of fatty liver, AST\\>20 and Fibroscan CAP≥248 dB\u002Fm and stiffness 9.5kPa -14kPa\n\nOr:\n\n• FAST score \\>0.67\n\nPatients with steatosis:\n\n• defined by Fibroscan CAP≥248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nHealthy controls:\n\n• defined by Fibroscan CAP\\\u003C248dB\u002Fm and stiffness \\\u003C7.9kPa.\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Age \\\u003C45 or \\>65\n* Any form of diabetes mellitus\n* Currently pregnant\n* Known fructose intolerance or food allergy\n* Diagnosis of cirrhosis or Fibroscan stiffness \\>14kPa\n* Current Child-Pugh B\u002FC or episode of decompensation in last year\n* Non-MASLD liver disease known to participant (including viral hepatitis, auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, sarcoidosis, cystic fibrosis, sickle cell disease)\n* Regular alcohol intake \\> 14 units a week for females and \\>21 units a week for males (participant-reported)\n* Smoking, vaping or use of nicotine-containing products within the last month\n* Taking prohibited medication:\n\n  * Probiotic or antibiotic use within last 4 weeks (Note: participants will be considered eligible if they have undergone a 4-week washout from probiotics or 4-weeks after discontinuing antibiotic use)\n  * any oral steroids within the last 6 weeks\n  * current, or within 3 months, use of immunosuppressive medication\n  * Amiodarone, nitrofurantoin, or anti-fungals within 3 months\n  * Use of anti-obesity medication - orlistat or GLP-1 receptor agonist-containing treatments within 6 months\n  * Use of vitamin E, pioglitazone or other medication for MASH including current or within 3 months enrolment in clinical trial unless documented to have been on placebo\n* History of malignancy (except basal cell carcinoma), or medication for malignancy within the last 2 years\n* Any major organ transplant (excluding corneal or hair)\n* Clinical diagnosis of chronic kidney disease 3 or above, or of heart failure (NYHA 3 or 4)\n* COPD requiring home oxygen\n* Known eating disorder (e.g. anorexia nervosa) or severe mental illness (e.g. schizophrenia)\n* Investigator opinion that study is unsuitable for patient","45 Years","65 Years",{"count":118,"type":22},72,[25],"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.\n\nIt 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.\n\nTo 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\u002FMASH.",[122,123,124],"MASH - Metabolic Dysfunction-Associated Steatohepatitis","MASH With Fibrosis","Steatosis of Liver",[126,127,128,129,130],"fructose","MASH","MASLD","liver","inflammation","2026-07-30",{"date":133,"type":33},"2026-07-31",{"date":72,"type":33},{"date":136,"type":22},"2027-04-01",{"name":39,"class":40},{"id":139,"slug":140,"hasResults":12,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":4,"eligibilityCriteria":144,"healthyVolunteers":12,"sex":17,"minAge":145,"maxAge":116,"enrollmentInfo":146,"targetDuration":4,"studyType":23,"phases":148,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":41},"100648048","psychosocial-support-for-nitrous-oxide-misuse-100648048","NCT07716293","Psychosocial Support for Nitrous Oxide Misuse","Development and Evaluation of a Psychosocial Intervention for Nitrous Oxide Misuse in East London","Inclusion Criteria:\n\n* Confirmed clinical neurological diagnosis related to N₂O use.\n* Experiencing mild to moderate psychological distress.\n* Aged 16-65 years.\n* Able to communicate in English.\n* Able and willing to give informed consent.\n\nExclusion Criteria:\n\n* Other causes of neurological symptoms.\n* Currently receiving another structured psychosocial intervention.\n* Severe psychiatric distress.","16 Years",{"count":147,"type":22},10,[25],"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.\n\nSome 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.\n\nOur 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.\n\nIn 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.",[151],"Brief Psychosocial Intervention",[153,154,155,156,157],"Feasibility study","Mixed methods","Nitrous oxide","Psychological intervention","Addiction and dependence","NOT_YET_RECRUITING","2026-07-16",{"date":161,"type":33},"2026-07-21",{"date":163,"type":22},"2026-09-14",{"date":165,"type":22},"2027-09-13",{"name":39,"class":40},{"id":168,"slug":169,"hasResults":12,"nctId":170,"briefTitle":171,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":12,"sex":17,"minAge":174,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":177,"conditions":178,"keywords":183,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100647301","artificial-intelligence-based-parkinsons-disease-risk-assessment-ai-pra-study-100647301","NCT07706829","Artificial Intelligence-based Parkinson's Disease Risk Assessment (AI-PRA) Study","AI-PRA","Inclusion Criteria:\n\n1. Age ≥ 50 years.\n2. At least one of the following clinical markers for PD risk:\n\n   1. REM sleep behaviour disorder (RBD) confirmed with polysomnography.\n   2. Neurogenic orthostatic hypotension (nOH) defined as a drop in systolic \u002F diastolic blood pressure ≥ 20\u002F10mmHg within 3 minutes of active standing or tilt-table test, and with a blunted heart rate response (ΔHeart rate\u002FΔSBP ratio \\\u003C 0.5 bpm\u002FmmHg).\n   3. Objective hyposmia defined as University of Pennsylvania Smell Identification Test (UPSIT) score ≤ 15th percentile for age and sex.\n3. Able and willing to give informed written consent.\n4. Use of compatible smartphone (mobile operating system Android version 11 or newer). A smartwatch will be provided to each participant for the duration of the study.\n\nExclusion Criteria:\n\n1. Clinical diagnosis of Parkinson's disease (PD) according to MDS clinical diagnostic criteria.\n2. Currently taking levodopa, dopamine agonists, MAO-B inhibitors, amantadine or another PD medication, except for low-dose treatment of restless leg syndrome (with permission of investigator).\n3. Dementia defined as deterioration of cognitive function severe enough to impair functioning on daily activities.\n4. Active treatment with neuroleptics, reserpine or metoclopramide (these drugs should be discontinued for at least 6 months before screening visit) due to their interference with dopamine transporter SPECT imaging acquisition and interpretation.\n5. Pregnant women.\n6. Concomitant participation in interventional studies.\n7. Unwilling or unable to give informed written consent.\n8. Vulnerable individuals as defined by the HRA.\n9. Inability to use the smartwatch and\u002For the mAI-Health app for the purpose of the study as judged by the investigator.","50 Years",{"count":176,"type":22},60,"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.",[179,180,181,182],"Parkinson Disease (PD)","REM Sleep Behavior Disorder (iRBD)","Neurogenic Orthostatic Hypotension","Hyposmia",[184,185,186,187,188,189,190,191],"prodromal Parkinson's disease","neurogenic orthostatic hypotension","REM sleep behaviour disorder","hyposmia","Digital biomarkers","AI-PROGNOSIS","Smartwatch","Wearable electronic devices",{"date":193,"type":33},"2026-07-20",{"date":195,"type":22},"2026-07-01",{"date":197,"type":22},"2027-09-30",{"name":39,"class":40},3,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":220},"100590142","left-ventricular-thrombus-registry-100590142","NCT06963567","Left Ventricular Thrombus Registry","Observational Registry to Determine the Predictors and Outcomes of Patients at Risk of and Diagnosed With Left Ventricular Thrombus","LVT Registry","Inclusion Criteria:\n\n* Patients with LV thrombus or;\n* Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Unable to consent",{"count":209,"type":22},1500,"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.\n\nHaving 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.\n\nA 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.",[212],"Left Ventricular Thrombus","2026-07-15",{"date":159,"type":33},{"date":216,"type":33},"2024-05-17",{"date":218,"type":22},"2027-01-31",{"name":39,"class":40},8,{"id":222,"slug":223,"hasResults":12,"nctId":224,"briefTitle":225,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":12,"sex":17,"minAge":145,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":229,"conditions":230,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":41},"100549437","barts-endocarditis-research-registry-100549437","NCT06434012","Barts Endocarditis Research Registry","Inclusion Criteria:\n\n* • Patients aged 16 and over (Patients under 16 years of age are not admitted to Barts Heart Centre)\n\n  * Patients admitted to Barts Heart Centre with confirmed Endocarditis (see above)\n  * Patients attending outpatients with confirmed\u002Fsuspected Endocarditis\n  * Patients with possible IE who complete treatment for endocarditis\n  * Patients with cardiac device related Endocarditis\n  * Patients with the ability to provide informed consent\n\nExclusion Criteria:\n\n* • Patients with pacemaker pocket infection with no evidence of pacemaker lead or valve infection\n\n  * Patients who refuse consent to be included in the research database\n  * Patients with \"rejected\" endocarditis",{"count":228,"type":22},1000,"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",[231,232,233],"Infective Endocarditis","Endocarditis","Endocarditis, Bacterial",{"date":235,"type":33},"2026-07-17",{"date":237,"type":33},"2019-04-24",{"date":239,"type":22},"2029-04-30",{"name":39,"class":40},{"id":242,"slug":243,"hasResults":12,"nctId":244,"briefTitle":245,"officialTitle":245,"acronym":246,"eligibilityCriteria":247,"healthyVolunteers":83,"sex":17,"minAge":145,"maxAge":4,"enrollmentInfo":248,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":253,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":41},"100387888","longitudinal-population-based-observational-study-of-covid-19-in-the-uk-population-100387888","NCT04330599","Longitudinal Population-based Observational Study of COVID-19 in the UK Population","COVIDENCE UK","Inclusion Criteria:\n\n* UK resident\n* Age ≥16 years\n\nExclusion Criteria: none",{"count":249,"type":22},13000,"COVIDENCE UK is a population-based observational longitudinal study that has the following objectives:\n\n1. To determine risk factors for incident COVID-19 and for adverse outcomes of COVID-19 in the UK population\n2. To characterise the natural history of COVID-19 in the UK population\n3. To evaluate the impact of COVID-19 on the physical and mental health of the UK population\n4. 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.",[252],"COVID-19",{"date":235,"type":33},{"date":255,"type":33},"2020-04-27",{"date":257,"type":22},"2026-07-27",{"name":39,"class":40},{"id":260,"slug":261,"hasResults":12,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":12,"sex":17,"minAge":145,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":23,"phases":269,"briefSummary":271,"conditions":272,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":275,"startDateStruct":277,"completionDateStruct":279,"leadSponsor":281,"locationsCount":282},"100544545","phase-3-thromboprophylaxis-in-lower-limb-immobilisation-100544545","NCT06370273","Thromboprophylaxis in Lower Limb Immobilisation","Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.","TiLLI","Inclusion Criteria:\n\n* Age \\>\u002F= 16 years\n* Placed in temporary lower limb immobilisation (rigid cast or brace) as a result an injury that occurred within the last 7 calendar days\n\nExclusion Criteria:\n\n* Hospital admission is required direct from the emergency department, minor injuries unit, or fracture clinic setting with an expected length of stay \\>2 calendar days.\n* Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR \\\u003C20ml\u002Fmin\u002F1.73m2), hepatic failure or use of concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g. ritonavir) or active substances strongly inhibiting elimination pathways such as CYP3A4 or P-gp (such as clarithromycin, erythromycin or dronaderone) or a history of heparin induced thrombocytopenia.\n* Pregnancy, actively seeking conception, or active breastfeeding.\n* Preceding use of anticoagulant treatment for \\>3 calendar days at prophylactic or therapeutic dose.\n* Prior enrolment in the TiLLI study.\n* Non-rigid immobilisation (crepe bandage, tubigrip support, strapping).\n* Time since prescription of rigid immobilisation \\>3 calendar days\n* Co-enrolment onto a CTIMP where an anticoagulant is administered\n* People lacking the capacity to consent\n* Inability or refusal to use acceptable contraception up until after the last administration of IMP. Only applicable for women of childbearing potential who have been randomised to receive apixaban or rivaroxaban",{"count":268,"type":22},10044,[270],"PHASE3","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.\n\nThe main questions it aims to answer are:\n\n* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)\n* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.\n\nParticipants 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.\n\nDrug 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.",[273,274],"Thrombosis","Injury Leg",{"date":276,"type":33},"2026-07-02",{"date":278,"type":33},"2024-11-12",{"date":280,"type":22},"2028-08-31",{"name":39,"class":40},5,{"id":284,"slug":285,"hasResults":12,"nctId":286,"briefTitle":287,"officialTitle":288,"acronym":4,"eligibilityCriteria":289,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":290,"targetDuration":4,"studyType":23,"phases":292,"briefSummary":293,"conditions":294,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":300,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":107},"100539890","hyaluronic-acid-and-polynucleotides-for-supra-bony-defects-100539890","NCT06309719","Hyaluronic Acid and Polynucleotides for Supra-bony Defects","Characterizing the Healing of Periodontal Supra-bony Defects Treated With Hyaluronic Acid and Polynucleotides","Inclusion Criteria:\n\n* Systemically healthy males and females ≥18 years old\n* Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)\n* Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) \\> 5 mm, following non-surgical periodontal therapy (NSPT). If \\>4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.\n\nIf defect presents with an intrabony component, this should be ≤2 mm.\n\n* Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months\n* Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%\n\nExclusion Criteria:\n\n* Teeth with degree III mobility\n* Multi-rooted teeth with grade ≥2 furcation involvement\n* Heavy smokers (≥10 cigarettes a day)\n* Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery\n* Previous periodontal surgery in the area selected for the study\n* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)\n* Antibiotic or anticoagulant therapy during the month preceding the baseline exam.\n* History of alcohol or drug abuse\n* Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition\n* In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)\n* Self-reported pregnancy or lactation.",{"count":291,"type":22},24,[25],"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.",[295,296,297,298,299],"Periodontal Diseases","Wound Heal","Periodontal Inflammation","Periodontal Pocket","Periodontal Attachment Loss",{"date":276,"type":33},{"date":302,"type":33},"2024-10-21",{"date":304,"type":22},"2026-12",{"name":39,"class":40},{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":312,"eligibilityCriteria":313,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":314,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":316,"conditions":317,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":320,"startDateStruct":321,"completionDateStruct":323,"leadSponsor":325,"locationsCount":326},"100427857","periodontal-assessment-of-a-bariatric-care-population-100427857","NCT04851470","Periodontal Assessment of a Bariatric Care Population","Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.","Bariatric","Inclusion Criteria:\n\nEach subject must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Subject must be over 18 years of age.\n2. Subject must have a BMI of higher or equal to 30 kg\u002F m2\n3. Subject must have voluntarily given written informed consent.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n1. Subject is currently involved in other research involving the use of antibiotics or novel or unknown medications.\n2. Self-reported pregnancy.\n3. Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit.\n4. Subject knowingly has HIV or Viral Hepatitis.\n5. Patients are completely edentulous.\n6. Subject with uncontrolled systemic illnesses.\n7. Subject is not capable to give informed consent.\n8. Subjects on chronic antibiotic therapy (ie two weeks or more in the previous month).",{"count":315,"type":22},394,"Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients.\n\nOur secondary objectives are to:\n\nInvestigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients.\n\nInvestigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population.\n\nInvestigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.",[318,319],"Bariatric Surgery Candidate","Obesity",{"date":276,"type":33},{"date":322,"type":33},"2014-01-31",{"date":324,"type":22},"2027-12-31",{"name":39,"class":40},4,{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":335,"enrollmentInfo":336,"targetDuration":4,"studyType":23,"phases":338,"briefSummary":339,"conditions":340,"keywords":341,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":345,"startDateStruct":347,"completionDateStruct":349,"leadSponsor":351,"locationsCount":41},"100382071","autologous-platelet-concentrate-apc-in-intrabony-defects-100382071","NCT04254861","Autologous Platelet Concentrate (APC) in Intrabony Defects","Regenerative Treatment of Intrabony Defects With GTR and PRGF: A Randomised, Single-blind, Parallel-group Clinical Trial","Inclusion Criteria:\n\n* Systemically healthy males and females ≥25 years old\n* Willingness to read and sign a copy of the Informed Consent Form after reading the Patient Information Sheet, and after the nature of the study has been fully explained\n* Clinical evidence of periodontitis, with one interdental area of PPD ≥6mm, BOP, and attachment loss ≥6mm, with associated intrabony defect ≥3mm in any area of their mouth (excluding third molars and distal of second molars)\n* Full mouth bleeding and plaque scores (FMBS and FMPS) \\\u003C25%recorded within the previous 6 weeks\n* Non-surgical treatment completed within 6 months prior to assessment for eligibility\n\nExclusion Criteria:\n\n* Medical history that includes diabetes type 1 or hepatic or renal disease, or other serious medical conditions or transmittable diseases (e.g. cardiovascular disease or AIDS).\n* Antibiotic or anti-inflammatory therapy during the month preceding the baseline exam.\n* In chronic treatment (\\>2 weeks) with anticoagulants, corticosteroids or other medications that can severely impact on bone formation\n* History of alcohol or drug abuse.\n* Smoking ≥10 cigarettes a day\n* Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing, which can affect interpretation of study results).\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.\n* Periodontal surgery in the same area selected for the study within the past 12 months.","25 Years","80 Years",{"count":337,"type":22},74,[25],"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.",[295],[342,343,344],"Intrabony defect","Periodontitis","PRGF",{"date":346,"type":33},"2026-07-06",{"date":348,"type":33},"2021-03-02",{"date":350,"type":22},"2026-12-31",{"name":39,"class":40},{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":12,"sex":17,"minAge":334,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":23,"phases":361,"briefSummary":362,"conditions":363,"keywords":4,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":4},"100644690","autologous-platelet-concentrates-on-the-healing-of-extraction-sockets-100644690","NCT07673848","Autologous Platelet Concentrates on the Healing of Extraction Sockets","The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.","Eligibility criteria\n\nAll of the following criteria must be fulfilled for inclusion:\n\n* Patient must be willing to read and sign a copy of the Informed Consent Form\n* Males and females ≥ 25 years old;\n* Patients who are currently or previously treated with antiresorptive therapy alone or in combination with immune modulators or antiangiogenic medications for the management of cancer;\n* Patients who are treated with antiresorptive therapy, bisphosphonates, for osteoporosis for more than 5 years;\n* Patients who have been treated with antiresorptive therapy, bisphosphonates, for osteoporosis for less than 5 years and being concurrently treated with a systemic glucocorticoid;\n* Patients who are treated with denosumab in the last nine months and being concurrently treated with a systemic glucocorticoid;\n* Patients who are on the high-risk category to develop MRONJ based on the SDCEP guidance;\n* Patients who require dental extractions (one per quadrant per patient) of premolar or molar teeth which are irrational to treat for any reason;\n* Patients with a history of MRONJ.\n\nThe following patients will be excluded:\n\n* Patients with MRONJ at the area of extraction;\n* Patients with history of radiotherapy in the area of treatment;\n* Patients with metastatic bone disease in the area of treatment;\n* Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;\n* Dental extractions in people who are systemically unwell and who require hospital admission;\n* Patients with poor glycaemic control (uncontrolled diabetes);\n* Current smokers or smokers who have quit less than 10 years ago (including e-cigarettes)",{"count":360,"type":22},44,[25],"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.",[364],"Medication-related Osteonecrosis of the Jaw","2026-06-24",{"date":367,"type":33},"2026-06-29",{"date":369,"type":22},"2026-06-01",{"date":371,"type":22},"2029-06-01",{"name":39,"class":40},{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":381,"maxAge":382,"enrollmentInfo":383,"targetDuration":4,"studyType":23,"phases":385,"briefSummary":386,"conditions":387,"keywords":390,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":397,"startDateStruct":398,"completionDateStruct":400,"leadSponsor":402,"locationsCount":41},"100562228","slow-speed-uk-a-double-blind-randomised-feasibility-trial-100562228","NCT06600438","Slow-SPEED UK: A Double-Blind Randomised Feasibility Trial","Slow-SPEED-United Kingdom: A Double-Blind Randomised Feasibility Trial of a Remote Gamified Physical Activity Programme in Adults With Hyposmia.","Slow-SPEED","Inclusion criteria\n\n* Age ≥ 40 years\n* Objective hyposmia, defined as scoring below the 15th percentile (adjusted for age\u002Fsex) on UPSIT\n* Ability and willingness to provide written informed consent\n* Proficiency in written and spoken English sufficient to complete study procedures.\n* Willingness and ability to attend baseline (in-person), 9-month (remote), and 18-month (in-person) assessments.\n* Access to telephone or internet for interim communication. Specifically, in possession of a suitable smartphone (screen size minimum 4.6 inch; Android version 9 or iOS version 15 or newer).\n* Physical activity threshold: During the 4-week eligibility run-in, the mean daily step count must be \\\u003C7,000 steps\u002Fday, calculated over ≥21 valid days (a valid day = ≥10 hours wear time or ≥1,000 steps). If recruitment after the first 2 months is \\\u003C60-70% of target, and subject to TSC\u002FSponsor approval and REC amendment, eligibility may be broadened to \\\u003C10,000 steps\u002Fday (i.e. participants averaging 7,000-9,999 steps\u002Fday become eligible).\n\nExclusion criteria\n\n* Clinical diagnosis of PD, dementia, or other neurodegenerative conditions\n* Severe or unstable medical or psychiatric illness likely to impair participation\n* Use of agents known to alter olfaction (e.g. intranasal zinc, chronic corticosteroids)\n* Current enrolment in an interventional study within the past 3 months (standard research retention guidance).\n* Inability to complete study procedures in English, per investigator assessment\n* Unable to give consent\n* Participants not living independently in the community. Participants in nursing homes, hospitalised persons on in a non-institutionalised setting are excluded.\n* Subject's personal smartphone is Fitbit-incompatible i.e. Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite\n* Activity level above threshold during eligibility run-in: mean daily step count ≥7,000 steps\u002Fday (or ≥10,000 steps\u002Fday if the broadened threshold is activated).","40 Years","100 Years",{"count":384,"type":22},110,[25],"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.\n\nParticipants 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.",[182,388,389],"Olfactory Dysfunction","Anosmia",[182,391,392,393,394,395,396],"Physical activity","Feasibility randomized controlled trial","Wearable technology","Smartphone application","Olfactory dysfunction","Digital health intervention",{"date":367,"type":33},{"date":399,"type":33},"2026-05-27",{"date":401,"type":22},"2027-10-31",{"name":39,"class":40},{"id":404,"slug":405,"hasResults":12,"nctId":406,"briefTitle":407,"officialTitle":407,"acronym":408,"eligibilityCriteria":409,"healthyVolunteers":83,"sex":17,"minAge":410,"maxAge":411,"enrollmentInfo":412,"targetDuration":4,"studyType":23,"phases":414,"briefSummary":415,"conditions":416,"keywords":419,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":432,"startDateStruct":434,"completionDateStruct":436,"leadSponsor":438,"locationsCount":41},"100626083","childrens-health-respiratory-inflammation-and-short-term-air-pollution-100626083","NCT07431021","Children's Health, Respiratory Inflammation and Short-term Air Pollution","CHERISH","Inclusion Criteria:\n\n* Attending schools in Central and East London that have been recruited to the study\n\nExclusion Criteria:\n\n* Not able to engage with PE lessons on safety grounds, reported by their parents.\n* Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures","7 Years","11 Years",{"count":413,"type":22},330,[25],"The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.",[417,418],"Asthma Acute","Respiratory",[420,421,422,423,424,425,426,427,428,429,430],"air pollution","physical activity","children","exercise","no2","Public health","air quality","pollution","paediatric","exposure","environment","2026-06-12",{"date":433,"type":33},"2026-06-15",{"date":435,"type":33},"2025-10-20",{"date":437,"type":22},"2027-07-01",{"name":39,"class":40},{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":446,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":448,"conditions":449,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":431,"lastUpdatePostDateStruct":452,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":41},"100498094","diagnosing-variable-primary-aldosteronism-100498094","NCT05765786","Diagnosing Variable Primary Aldosteronism.","Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?","Inclusion Criteria:\n\n* People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity \\\u003C0.5 nmol\u002Fh\u002FL or renin mass \\\u003C5 ng\u002FL), plasma sodium \\> 140mmol\u002FL or plasma potassium \\\u003C 4mmol\u002FL.\n* Patients who have been diagnosed with PA and had previous aldosterone samples \\\u003C277 pmol\u002FL, a level which would normally not qualify for confirmatory testing.\n* Patients with aldosterone results done at different times that indicate variability in production.\n* Willing to consent and participate in the study.\n\nExclusion Criteria:\n\n* Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.\n* People on end of life treatment.",{"count":447,"type":22},100,"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.",[450,451],"Primary Aldosteronism","High Blood Pressure",{"date":433,"type":33},{"date":454,"type":33},"2023-02-24",{"date":456,"type":22},"2027-07-24",{"name":39,"class":40},{"id":459,"slug":460,"hasResults":12,"nctId":461,"briefTitle":462,"officialTitle":463,"acronym":464,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":17,"minAge":145,"maxAge":4,"enrollmentInfo":466,"targetDuration":4,"studyType":23,"phases":468,"briefSummary":470,"conditions":471,"keywords":475,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":479,"startDateStruct":481,"completionDateStruct":482,"leadSponsor":484,"locationsCount":4},"100643542","early-phase-1-clinical-evaluation-of-an-ai-risk-prediction-system-ai-trips-100643542","NCT07634185","Clinical Evaluation of an AI Risk Prediction System (AI-TRiPS)","Clinical Evaluation of an AI Risk Prediction and Decision Support System for Early Management of Injured Patients: a Stepped-wedge Cluster Randomised Trial","AI-TRiPS","Inclusion Criteria:\n\nClinician Participants\n\n* Senior clinical decision-maker involved in the initial trauma resuscitation (e.g. consultant or senior trainee in emergency medicine, anaesthesia, intensive care medicine, or surgery).\n* Based at one of the four participating Major Trauma Centres.\n* Able and willing to provide informed consent.\n* Completed the required study-specific training.\n\nTrauma Patients\n\n* Aged 16 years and above.\n* Treated and transported to a participating Major Trauma Centre by London's Air Ambulance.\n* Managed by one or more participating trauma clinicians during the resuscitation.\n\nExclusion Criteria:\n\nClinician Participants\n\n● Decline or withdraw informed consent at any stage.\n\nTrauma Patients\n\n* Aged under 16\n* Not treated by London's Air Ambulance.\n* Transported to a non-participating hospital.\n* Not managed by any participating clinicians.\n* Presenting with injuries resulting from burns, hangings, drownings, or isolated psychiatric emergencies.\n* Have registered a national NHS data opt-out or otherwise requested that their routine clinical data not be used for research.",{"count":467,"type":22},1200,[469],"EARLY_PHASE1","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.\n\nThe investigators will use a Stepped Wedge Cluster Randomised Controlled study design with an integrated process evaluation.\n\nThe 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).\n\nPrimary Outcome: Clinician behaviour, assessed via the accuracy of risk prediction and clinician confidence.\n\nSecondary Outcome: Clinician acceptability, care process metrics, patient outcomes, and safety endpoints.\n\nPrimary study population: Hospital trauma clinicians, following initial resuscitation of each eligible trauma patient, who will complete electronic questionnaires.\n\nSecondary 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.",[472,473,474],"Trauma","Injury","Decision Support Systems, Clinical",[476,477],"Device trial, prediction tool, trauma","clinical decision support","2026-06-03",{"date":480,"type":33},"2026-06-08",{"date":369,"type":22},{"date":483,"type":22},"2027-12-01",{"name":39,"class":40},{"id":486,"slug":487,"hasResults":12,"nctId":488,"briefTitle":489,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":83,"sex":17,"minAge":18,"maxAge":492,"enrollmentInfo":493,"targetDuration":4,"studyType":23,"phases":495,"briefSummary":496,"conditions":497,"keywords":501,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":41},"100606197","evaluation-of-adding-nitrate-into-foods-for-regulating-nitric-oxide-bioavailability-in-healthy-individuals-100606197","NCT07172425","Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals","An Open-Label, Randomised, Crossover Study to Investigate the Feasibility of Nitrate Fortification in Commonly Consumed Foods for Regulating Nitric Oxide Metabolism in Healthy Individuals","Inclusion Criteria:\n\n1. Healthy volunteer.\n2. Aged ≥18 years and ≤ 60 years.\n3. Willing to provide informed consent.\n4. Able to understand and comply with protocol requirements, instructions, and stated restrictions.\n\nExclusion Criteria:\n\nA volunteer will not be eligible for inclusion in this study if any of the following criteria are met:\n\n1. Unwilling to provide consent.\n2. People with chronic health conditions requiring medication.\n3. Pregnant females, or those with a possibility of being pregnant.\n4. History of hypertension and \u002For diabetes.\n5. History of any serious illnesses, including recent infections or trauma.\n6. History of symptomatic coronary artery disease, stroke, or other known atherosclerotic diseases.\n7. People who will commence or who are likely to commence treatment with non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin, from screening until study completion.\n8. Self-declared alcohol or drug abuse within the past 6 months.\n9. Three-month prior history of regular alcohol consumption exceeding an average weekly intake of \\> 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of \\> 21 units (or an average daily intake of greater than 2 units) for females. One unit is equivalent to a half pint (284mL) of beer\u002Flager; 25mL of spirits, or 125mL of wine.\n10. Taking systemic medication (other than the oral contraceptive pill).\n11. Recent (within 2 weeks) self-reported use of mouthwash or tongue scrapers.\n12. Recent (within 2 weeks) or current antibiotic use.\n13. Recent (within 1 week) use of NO3- or NO2- supplements.\n14. History, or recent treatment of (within the last 3 months) for any oral condition (excluding caries), including gingivitis, periodontitis and halitosis.\n15. History of, or recent treatment for, any blood-borne infectious disease such Hepatitis B or C virus, or HIV.\n16. Current smokers (including vaping) or have smoked within the last 6 months.\n17. Diagnosis of rheumatoid arthritis, connective tissue disorders, and other conditions known to be associated with chronic inflammation (e.g., Inflammatory Bowel Disease).\n18. People who have donated more than 500mL of blood within 56 days prior to the study commencement.\n19. Known allergy to celery, gluten, crustaceans, eggs, lupin, milk, mustard, peanuts, sesame, soybeans, tree nuts, oats, palm oil, sugar, cranberries, sunflower oil, invert syrup, sodium bicarbonate.","60 Years",{"count":494,"type":22},30,[25],"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.\n\nThe 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.\n\nThis 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.",[498,499,500],"Healthy Volunteers","Nitric Oxide","Vascular Function",[502,503,504,505],"Blood pressure","Oral microbiome profiling","Nitric oxide bioavailability","Inorganic nitrate fortification",{"date":507,"type":33},"2026-06-04",{"date":509,"type":33},"2025-10-15",{"date":511,"type":22},"2027-02",{"name":39,"class":40},{"id":514,"slug":515,"hasResults":12,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":4,"eligibilityCriteria":519,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":520,"targetDuration":4,"studyType":23,"phases":521,"briefSummary":522,"conditions":523,"keywords":525,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":41},"100605681","ctca-prior-to-invasive-angiography-in-post-bypass-patients-bypass-ctca-2-100605681","NCT07165678","CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2)","A Multi-Centre, Randomised Trial Assessing the Value of Computed Tomography Coronary Angiography Prior to Invasive Coronary Angiography in Patients With Previous Coronary Artery Bypass Grafts in Reducing Cardiac Events","Inclusion Criteria:\n\n* Aged ≥18\n* Previous coronary artery bypass grafting (CABG)\n* An indication for coronary angiography\n\n  * Angina\n  * Ischaemia on perfusion imaging\n  * Acute coronary syndrome\n* Patients are able and willing to give their written informed consent\n\nExclusion Criteria:\n\n* Subjects presenting with ST segment myocardial infarction within window for primary PCI\n* Patients considered unsuitable to participate by the research team (e.g. due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures)\n* Life expectancy less than 1 year",{"count":228,"type":22},[25],"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:\n\n* Can CTCA reduce major adverse cardiovascular events compared to standard invasive coronary angiography?\n* 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.\n\nParticipants will:\n\n* Be randomly assigned to either CTCA-guided care or standard angiography\n* Undergo coronary imaging and follow-up assessments\n* Complete questionnaires on quality of life and healthcare resource use",[524],"Coronary Heart Disease",[526,527,528,529,530,531,532,533],"Coronary Artery Bypass Graft","Angina","Coronary Artery Disease","CABG","percutaneous coronary intervention","coronary angiograms","Computerised Tomography Coronary Angiography","CTCA",{"date":535,"type":33},"2026-06-05",{"date":537,"type":33},"2026-04-16",{"date":539,"type":22},"2029-07-31",{"name":39,"class":40},{"id":542,"slug":543,"hasResults":12,"nctId":544,"briefTitle":545,"officialTitle":545,"acronym":546,"eligibilityCriteria":547,"healthyVolunteers":83,"sex":17,"minAge":381,"maxAge":382,"enrollmentInfo":548,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":550,"conditions":551,"keywords":553,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":41},"100591947","trans-and-non-binary-prostate-specific-antigen-reference-interval-determination-study-100591947","NCT06987045","Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study","TransPRIDE","Inclusion Criteria:\n\n* • Aged \\>40\n\n  * Transgender or non-binary (identify with a gender other than the one assigned at birth)\n  * With a prostate\n  * Fulfills at least one of the following 3 criteria with regards to gender-affirming medical care:\n\n    * Taking oestradiol for at least the last 3 months\n    * Taking anti-androgens for at least the last 3 months\n    * Ever had bilateral orchidectomy\n  * Eligible for National Health Service (NHS) treatment\n\nExclusion Criteria:\n\n* • History of prostate cancer (Prostate cancer) at any time\n\n  * History of prostate surgery at any time\n  * History of prostate radiotherapy at any time\n  * History of benign prostatic hypertrophy (enlarged prostate) at any time\n  * Vaginoplasty within 12 months\n  * Orchidectomy or vulvoplasty within three months\n  * Sexually Transmitted Infection (STI) within 6 weeks of blood sample\n  * Active urinary infection or within 6 weeks of blood sample\n  * Prostatitis within 6 weeks of blood sample\n  * Urological intervention (e.g. prostate biopsy) within 6 weeks of blood sample\n  * Unwilling to give consent\n  * Lacking capacity to give consent\n  * In the secure estate",{"count":549,"type":22},500,"The prostate specific antigen (PSA) blood test can help diagnose prostate problems, including cancer.\n\nThe prostate is an organ in the pelvis. It is found in cisgender men, transgender (trans) women and some non-binary people.\n\nAnyone 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\n\nTransPRIDE is a research study that will help us find the normal levels of PSA in trans women and non-binary people with prostates.\n\nResearchers 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.\n\nKnowing the normal PSA level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.",[552],"Prostate CA",[554,555,556,557],"Prostate Cancer","Transwomen","Non-binary","prostate",{"date":507,"type":33},{"date":560,"type":33},"2026-04-04",{"date":562,"type":22},"2028-03-31",{"name":39,"class":40},{"id":565,"slug":566,"hasResults":12,"nctId":567,"briefTitle":568,"officialTitle":569,"acronym":4,"eligibilityCriteria":570,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":571,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":573,"conditions":574,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":478,"lastUpdatePostDateStruct":576,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":41},"100373374","investigating-pathological-mechanisms-in-non-alcoholic-fatty-liver-disease-100373374","NCT04141592","Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease","Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)\n* If diabetic, Diagnosed with Type 2 Diabetes Mellitus\n\nOR\n\n• Healthy Control: no diagnosis of any liver condition including NAFLD\n\no NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of \\\u003C222 dB\u002Fm\n\nExclusion Criteria:\n\n* Unwilling or unable to give informed consent\n* Type 1 Diabetes Mellitus\n* Other form of liver disease (other than NAFLD)\n\n  o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease\n* Taking medication associated with liver dysfunction (except methotrexate)\n* Auto-immune disease which in the investigator's opinion may confound immune profiling\n* Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)\n* Currently pregnant\n* Any major organ transplant (excluding corneal or hair transplant)\n* Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants",{"count":572,"type":22},153,"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",[575],"Non-Alcoholic Fatty Liver Disease",{"date":535,"type":33},{"date":578,"type":33},"2019-03-05",{"date":133,"type":22},{"name":39,"class":40},{"id":582,"slug":583,"hasResults":12,"nctId":584,"briefTitle":585,"officialTitle":585,"acronym":586,"eligibilityCriteria":587,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":588,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":590,"conditions":591,"keywords":598,"overallStatus":158,"whyStopped":4,"lastUpdateSubmitDate":604,"lastUpdatePostDateStruct":605,"startDateStruct":607,"completionDateStruct":609,"leadSponsor":611,"locationsCount":4},"100638250","prep-lana-pre-exposure-prophylaxis--long-acting-novel-antiviral-agent-100638250","NCT07620730","PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)","PrEP-LANA","Inclusion Criteria:\n\nParticipants of any gender, ethnicity or socio-economic group who meet all the following criteria are eligible for inclusion in this study:\n\n* Adults who are aged \\> 18 years at time of consent (including people of child-bearing capacity and age, non-pregnant or pregnant adults)\n* Attending a participating NHS sexual healthcare service\n* Prescribed LA CAB for PrEP according to NICE and NHS eligibility criteria (including those newly prescribed and those already using LA CAB)\n* Non-reactive \u002F negative HIV Antigen\u002FAntibody test and HIV RNA test at time of LA CAB for PrEP initiation (performed under routine care)\n* Able and willing and able to give informed consent to all study procedures prior to inclusion\n\nExclusion Criteria:\n\nPrEP user participants who meet any of the following criteria are ineligible for inclusion in this study:\n\n* One or more reactive or positive HIV test results at enrolment visit, even if HIV infection is not confirmed.\n* Currently enrolled in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.\n* Plan to relocate out of the area during the study period. Note: \"Plan to relocate out of the area\" is defined as a stated intention at enrolment to move residence outside the catchment area of a participating study site during the study period, such that ongoing clinical management would likely transfer to a non-participating team.",{"count":589,"type":22},220,"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).\n\nThe main questions it aims to answer are:\n\n* What do healthcare providers think about the feasibility of delivering LA CAB PrEP within sexual health services in the NHS?\n* How many participants stay on\u002Fremain consistent with LA CAB PrEP injections at Month 12 (PrEP persistence)?\n\nParticipants (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.\n\nA 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:\n\n* 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),\n* 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\\\u003C25 yrs, OR sex workers OR people who inject drugs OR racially minoritised heterosexual men.",[592,593,594,595,596,597],"PrEP","PrEP Adherence Experiences","PrEP Adherence Perspectives","PrEP Uptake","Equity","Community Setting",[592,599,586,600,601,602,596,603],"Patient and public involvement and engagement","LA CAB","Cabotegravir","Long-acting PrEP","community setting","2026-05-28",{"date":606,"type":33},"2026-06-02",{"date":608,"type":22},"2026-10",{"date":610,"type":22},"2028-06",{"name":39,"class":40},{"id":613,"slug":614,"hasResults":12,"nctId":615,"briefTitle":616,"officialTitle":617,"acronym":618,"eligibilityCriteria":619,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":620,"targetDuration":4,"studyType":23,"phases":622,"briefSummary":623,"conditions":624,"keywords":627,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":107},"100625492","monitoring-respiratory-muscle-function-in-acute-respiratory-failure-patients-on-non-invasive-respiratory-support-100625492","NCT07423338","Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients on Non Invasive Respiratory Support","Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients Requiring Non-invasive Respiratory Support (MONITOR-NIV): A Prospective Observational Study","MONITOR-NIV","Inclusion Criteria:\n\n* Adult (≥18 years old)\n* with acute respiratory failure with hypoxia (i.e. arterial oxygen tension (PaO2) of \\\u003C8.0 kPa), and\u002For with or without hypercapnia (i.e. arterial carbon dioxide tension (PaCO2) of \\>6.0 kPa) from any underlying disease or cause\n* requiring any non-invasive respiratory support (i.e. HFNO, CPAP, BiPAP)\n* Multidisciplinary critical care staff involved in the management of those recruited patients with acute respiratory failure requiring non-invasive respiratory supports. Staff will possibly have an interview and are also required to complete a questionnaire.\n\nExclusion Criteria:\n\n* Patients in respiratory arrest defined as the total cessation of airflow and breathing effort and absent ventilation (24,25)\n* Patients requiring immediate intubation\n* Patients with Glasgow Coma Scale (GCS) \\\u003C 8\n* Patients with severe facial trauma or burns\n* Patients with fixed upper airway obstruction or inability to protect the airway\n* Patients with severe agitation and\u002For confusion that prevent use of the device mask\n* Patients with severe vomiting\n* Pregnancy\n* Patients with pacemakers and other electronic devices in the thorax\n* Patients on end-of-life care or palliative care (defined as expected to die and\u002For not receiving active treatment)\n* Contra-indication to EIT or ultrasound monitoring (e.g. burns, severe obesity, thoracic wounds limiting instrument placement, and thoracic drain)",{"count":621,"type":22},50,[25],"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.\n\nA 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.\n\nThis study aims to find out whether two advanced but non-invasive, radiation-free bedside monitoring tools can be used effectively in routine care:\n\n1. Ultrasound, which can measure breathing muscle thickness, movement, and lung aeration\n2. 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\n\nThese 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.\n\nWhat the study will involve:\n\nUp 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.\n\nIn 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.\n\nWhat the study is trying to learn:\n\nThe 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.\n\nSecondary aims include understanding:\n\n* how the respiratory muscles and lungs change over time during NRS\n* whether these changes are linked to treatment settings (e.g., flow rate, pressure support)\n* whether certain patterns are associated with treatment success or failure (intubation or death)\n* whether these tools could help identify patients at risk of deterioration earlier\n\nRisks and benefits:\n\nBoth 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.\n\nBy 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.",[625,626],"Acute Respiratory Failure (ARF)","Non Invasive Ventilation",[628,629,630,631],"acute respiratory failure","non-invasive respiratory support","ultrasonography","electrical impedance tomography","2026-05-20",{"date":634,"type":33},"2026-05-22",{"date":636,"type":33},"2026-02-26",{"date":638,"type":22},"2027-05-02",{"name":39,"class":40},{"id":641,"slug":642,"hasResults":12,"nctId":643,"briefTitle":644,"officialTitle":645,"acronym":646,"eligibilityCriteria":647,"healthyVolunteers":12,"sex":648,"minAge":18,"maxAge":4,"enrollmentInfo":649,"targetDuration":4,"studyType":23,"phases":651,"briefSummary":653,"conditions":654,"keywords":656,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":661,"startDateStruct":662,"completionDateStruct":664,"leadSponsor":666,"locationsCount":107},"100589443","phase-2-investigating-datopotamab-deruxtecan-plus-durvalumab-versus-datopotamab-deruxtecan-in-patients-with-pdl1-negative-metastatic-triple-negative-breast-cancer-100589443","NCT06954480","Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer","An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer","DIAMOND","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Ability to comply with the protocol.\n3. Female ≥ 18 years of age.\n4. Triple-negative disease, defined as tumour cells being:\n\n   * Negative for ER with \\\u003C10% of tumour cells positive for ER on IHC or IHC score (Allred) of ≤3.\n   * Negative for PR with \\\u003C10% of tumour cells positive for PR on IHC or IHC score (Allred) of ≤3 or PR unknown, and\n   * Negative for HER2 with 0, 1+ or 2+ intensity on IHC and no evidence of amplification on ISH.\n5. PDL1 negative, defined as 22C3 CPS\\\u003C10.\n6. Patients must have:\n\n   * at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computed tomography (CT) or magnetic resonance imaging (MRI) performed within 28 days prior to randomisation which is suitable for accurate repeated measurements, or\n   * lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above; patients with sclerotic\u002Fosteoblastic bone lesions only in the absence of measurable disease are not eligible. Patient that cannot be assessed by the CT or MRI should be excluded from the study.\n7. Representative formalin-fixed paraffin embedded (FFPE) breast tumour samples with an associated pathology report from the primary or recurrent cancer that are determined to be available and sufficient for central testing OR tumour accessible for biopsy.\n8. ECOG performance status 0-1.\n9. Life expectancy ≥12 weeks.\n10. Adequate haematologic and end-organ function within 28 days prior to the first study treatment defined by the following:\n\n    * Absolute neutrophil count ≥ 1500 cells\u002FμL (1.5 x 109\u002FL) (without granulocyte) colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1).\n    * WBC \\> 2500\u002FμL (2.5 x 109\u002FL).\n    * Platelet count ≥ 100,000\u002FμL (100 x 109\u002FL) (transfusion not permitted within 28 days of study medication).\n    * Haemoglobin ≥ 9.0 g\u002FdL (90g\u002FL) with no blood transfusions (packed red blood cells).\n    * Serum albumin ≥ 3g\u002FdL.\n    * AST (SGOT) or ALT (SGPT) and ALP ≤ 2.5 times the institutional upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (patients with liver metastases who have AST or ALT ≤ 5 x the institutional ULN may be enrolled).\n    * aPTT ≤ 1.5 × the institutional ULN, INR \\\u003C1.5 and absence of evidence of impaired hepatic synthesis function. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n    * Serum Creatinine ≤ 1.5 x institutional ULN.\n    * Glomerular filtration rate ≥ 40mL\u002Fmin as assessed by standard methodology at the investigating center (i.e., Cockcroft Gault, MDRD or CKD-EPI formulae, EDTA clearance or 24 h urine collection).\n    * No evidence of haematuria: +++ on microscopy or dipstick.\n11. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Cycle 1, Day 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible. Patients must agree to use adequate contraception, defined as those methods with a failure rate of \\\u003C 1 % per year beginning 14 days before the first dose of study drug and for 7 months after the last dose of study drug. Also, participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of treatment. Preservation of ova should be considered prior to randomisation or the first dose of study intervention.\n12. Body Weight \\> 30 kg.\n\nExclusion Criteria:\n\n1. Prior chemotherapy, immunotherapy (including durvalumab) or treatment with PARP inhibitors for advanced or metastatic breast cancer.\n2. Prior treatment with immune checkpoint inhibitors (eg atezolizumab, pembrolizumab) or DNA topoisomerase I or TROP2- or HER2-targeting ADCs and TROP2 targeted therapy in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation into this study.\n3. Patients with prior allogeneic stem cell or solid organ transplantation.\n4. Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent), or had oral or IV steroids for 14 days prior to the first dose of study drug; the use of intranasal, inhaled corticosteroids topical steroids, or local steroid injections, physiologic replacement doses of glucocorticoids (i.e. for adrenal insufficiency) and mineralocorticoids (e.g. fludrocortisone) or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication is allowed.\n5. Administration of a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Active or prior documented autoimmune or inflammatory disorders including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, , rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis , Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following are exceptions to this criterion:\n\n   * Patients with vitiligo or alopecia\n   * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy\n   * Any chronic skin condition that does not require systemic therapy\n   * Patients without active disease in the last 5 years may be included\n   * Patients with celiac disease controlled by diet alone\n7. History of idiopathic pulmonary fibrosis (including pneumonitis or interstitial lung disease), drug-induced pneumonitis, radiation pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia) requiring steroids, or evidence of active pneumonitis on screening chest CT scan.\n8. Active infection requiring systemic therapy.\n9. History of HIV infection.\n10. Known active hepatitis infection (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n11. Known history of active tuberculosis (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n12. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study protocol.\n14. Concurrent treatment with other experimental drugs or participation in another clinical trial with therapeutic intent within 28 days prior to randomisation.\n15. Pregnant and lactating female patients.\n16. Major surgical procedure within 4 weeks prior to randomisation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n17. Malignancies other than breast cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent).\n18. Severe infections within 28 days prior to randomisation in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.\n19. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\n    * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n    * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n20. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, situations that would limit compliance with study requirement, substantially increase risk of incurring AEs.\n21. History of leptomeningeal carcinomatosis.\n22. Has clinically significant corneal disease.\n23. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n24. History of active primary immunodeficiency.\n25. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n26. Brain metastases or neoplastic spinal cord compression. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression. In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤10mg\u002Fday of prednisone or its equivalent and anticonvulsants for at least 14 days prior to the start of treatment. Brain metastases will not be recorded as RECIST Target Lesions at baseline.\n27. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n28. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    * Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.","FEMALE",{"count":650,"type":22},140,[652],"PHASE2","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.",[655],"Triple Negative Breast Cancer",[655,657,658,659,660],"breast cancer","PDL1-negative","Datopotamab Deruxtecan","Durvalumab",{"date":634,"type":33},{"date":663,"type":33},"2025-10-27",{"date":665,"type":22},"2030-02",{"name":39,"class":40},""]