[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospitals, Leicester\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":247},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,9,0,[8,53,89,109,133,158,179,202,227],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100644861","ai-timing-in-chest-x-ray-interpretation-using-eye-tracking-100644861",false,"NCT07675694","AI Timing in Chest X-ray Interpretation Using Eye-Tracking","A Within-Subject Eye-Tracking Study Examining How the Timing of AI Decision Support Influences Visual Search Behaviour, Diagnostic Accuracy, and Trust During Chest X-ray Interpretation","CREAITED","Inclusion Criteria:\n\nMain reader study:\n\n* Healthcare professionals aged 18 years or over\n* Registered to practise in the UK\n* Employed by the NHS or another healthcare service operating in the UK\n* Current or recent, within the last 3 years, clinical experience involving chest X-ray interpretation, review, or use in clinical practice\n* Able to attend two onsite study sessions at University Hospitals of Leicester NHS Trust at mutually agreed times\n* Able and willing to provide written informed consent\n* Compatible with the eye-tracking equipment\n\nSupplementary survey:\n\n* Adults aged 18 years or over\n* Live in the UK or have used the NHS or another UK healthcare service within the last 5 years\n* Able to provide informed electronic consent\n* Belong to one of the following respondent groups: healthcare professionals or healthcare staff, patients or carers, or members of the public\n* Healthcare professional respondents may include adults involved in requesting, interpreting, checking, or acting on chest X-ray findings in clinical practice\n\nExclusion Criteria:\n\nMain reader study:\n\n* Inability to attend both onsite study sessions at University Hospitals of Leicester NHS Trust\n* Eye-tracking incompatibility, such as visual, neurological, or physical conditions preventing adequate gaze tracking or participant comfort\n* Direct involvement in selection, adjudication, or preparation of the chest X-rays used in the study\n* Conflicts of interest, including direct involvement in development of the AI system under evaluation\n* Prior participation in a closely related AI chest X-ray study where overlap in image sets or study procedures may compromise validity, assessed on a case-by-case basis\n\nSupplementary survey:\n\n* Aged under 18 years\n* Does not live in the UK and has not used the NHS or another UK healthcare service within the last 5 years\n* Unable to provide informed electronic consent\n* Does not meet one of the eligible respondent groups for the survey",true,"ALL","18 Years",{"count":21,"type":22},24,"ESTIMATED","INTERVENTIONAL",[25],"NA","Chest X-rays are commonly used to help diagnose and manage chest conditions. Artificial intelligence (AI) tools are increasingly being used to support chest X-ray interpretation. However, it is not yet clear whether the timing of AI information affects how clinicians review images, make decisions, and use AI support.\n\nThis study will look at whether showing AI information before or after a clinician first reviews a chest X-ray changes how they look at the image, how long they take, their interpretation decisions, their confidence, and their trust in AI support.\n\nHealthcare professional participants will complete two chest X-ray interpretation sessions in a controlled NHS research setting. During each session, participants will review de-identified chest X-ray images while wearing eye-tracking equipment. Eye-tracking will record where a participant looks on the image and how long they spend looking at different areas.\n\nIn one session, AI information will be shown before the participant reviews the chest X-ray. In the other session, AI information will be shown after the participant has first reviewed the chest X-ray. The order of these two sessions will be balanced across participants.\n\nThe study uses de-identified chest X-ray images from existing examinations. It does not involve patients directly, does not change clinical care, and no clinical decisions will be made from the study readings. Participants will also complete a short questionnaire about their experience of using AI support. A separate anonymous survey will collect wider views from clinicians, patients, members of the public, and healthcare staff about the use of AI in chest X-ray interpretation.",[28,29,30],"Diagnostic Imaging","Eye Tracking","Artificial Intelligence (AI)",[32,33,34,35,36,37,38,39,40],"Artificial intelligence timing","Chest X-ray interpretation","Visual search behaviour","Diagnostic accuracy","Trust in automation","Automation bias","Clinician confidence","Decision support systems","Human-AI interaction","NOT_YET_RECRUITING","2026-06-29",{"date":44,"type":45},"2026-06-30","ACTUAL",{"date":47,"type":22},"2026-06",{"date":49,"type":22},"2026-12",{"name":51,"class":52},"University Hospitals, Leicester","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":72,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},"100642831","breathlessness-perceptions-within-respiratory-diseases-100642831","NCT07648082","Breathlessness Perceptions Within Respiratory Diseases","Exploring Differences in Breathlessness Perceptions Within Respiratory Diseases","BiRD","Inclusion Criteria:\n\n* • Aged 18 or over up to 100\n\n  * Known respiratory diagnosis\\* OR Healthy control\\*\\*\n  * Ongoing symptoms of breathlessness defined as ≥2 MRC dyspnoea scale\n  * Able to communicate in English\n  * Able to attend two study visits\n  * Able to provide written informed consent\n\n    * Known respiratory diagnosis could include, but is not limited to, COPD, Asthma, Bronchiectasis or ILD.\n    * Healthy controls are required to have an absence of a functionally limiting condition such as respiratory, cardiovascular, or musculoskeletal.\n\nExclusion Criteria:\n\n* • Unstable disease or undergoing investigations for unexplained symptoms\n\n  * Undergone a surgery within past six weeks\n  * Contraindications for exercise outlined by ACSM guidelines (Unstable CVD, hypertension etc)\n  * BMI ≥ 35kg\u002Fm2\n  * Unable to communicate in English\n  * Unable to provide written informed consent\n  * Unable to abstain from smoking for 8 hours prior to testing","100 Years",{"count":63,"type":22},75,"OBSERVATIONAL","Breathlessness is a complex symptom that results in poor quality of life, increased hospitalisations and increased mortality. Breathlessness is influenced by physiological, psychological and functional factors but these are poorly explored. There are also unexplored phenomenon's such as breathing pattern. Therefore, this study aims to understand the influences of physiology, psychology, function and breathing pattern on health related quality of life in those with a respiratory disease compared to healthy controls. This project is a cross-sectional cohort study including those with a known respiratory disease and experiencing breathlessness, compared to non-breathless healthy controls. The investigators will measure your physiology through spirometry (a breathing test that tells us about their lung function), psychology through questionnaires, function through an exercise test and breathing pattern using opto-electrictronic plethysmography (markers are placed on your chest to see how participants breathe while exercising). This will be conducted over two visits. The investigators will recruit participants from clinics at the University Hospitals of Leicester NHS Trust. The investigators are aiming to recruit 50 participants with a respiratory disease and 25 healthy controls. The results of this study will help us understand breathlessness in more detail in order to be able to develop better treatments.",[67,68,69,70,71],"Chronic Obstructive Pulmonary Disease (COPD)","Asthma (Diagnosis)","Interstitial Lung Disease (ILD)","Bronchiectasis","Breathing Pattern Disorder",[73,74,75,76,77,78],"Breathlessness","OEP","Cardiopulmonary Exercise Testing","Respiratory diseases","Heart rate variability","Breathing patterns","RECRUITING","2026-06-10",{"date":82,"type":45},"2026-06-15",{"date":84,"type":45},"2025-06-06",{"date":86,"type":22},"2026-07-01",{"name":51,"class":52},1,{"id":90,"slug":91,"hasResults":11,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":98,"conditions":99,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":88},"100392357","biomedical-research-informatics-centre-for-cardiovascular-sciences-the-briccs-study-100392357","NCT04388943","Biomedical Research Informatics Centre for Cardiovascular Sciences (The BRICCS Study)","Inclusion Criteria:\n\n* All outpatients and inpatients with cardiovascular disease, of either gender\n* Aged 18-90 years old\n* Examples of conditions include: coronary artery disease, heart failure, heart attacks (myocardial infarction), valve disease, cardiac surgery, dysrhythmias (including atrial fibrillation), aneurysms, embolism, strokes, peripheral vascular disease, hypertension (and its complications, such as left ventricular hypertrophy) or those presenting with chest pain\n* Healthy volunteers\n* Aged 18-90 years old\n* From the community without cardiovascular or other diseases\n\nExclusion Criteria:\n\n* Any patient who is unable to give consent\n* Any patient with non-cardiovascular comorbidity likely to cause death within 6 months\n* Patients know to be infected with HIV, Hepatitis B or any other agent posing an infection risk from unfixed material","90 Years",{"count":97,"type":22},9500,"This project will examine the diagnosis and prognosis of patients with cardiovascular disease in hospital in- and outpatients and compare their characteristics with normal controls from the community. The cardiovascular diseases studied include coronary artery disease, heart failure, heart attacks, valve disease, cardiac surgery, dysrhythmias, aneurysms, embolism, strokes, peripheral vascular disease and hypertension. Current methods for diagnosis and predicting outcome in patients are limited and may lack accuracy. This study will collect clinical details, and blood and urine samples from patients for analysis of proteins, chemicals and genetic biomarkers which will enable an examination of the pathological mechanisms involved in cardiovascular disease. The data will also be used to improve diagnosis and also improve prediction of outcome in patients (future clinical events such as death, further hospitalisation with cardiovascular disease and the effects of any therapy given to the patients). In this way, we can develop accurate ways of assessing a patient's condition and how it could be effectively managed. The study will last for 20 years.",[100,101],"Cardiovascular Diseases","Cardiovascular Risk Factor",{"date":103,"type":45},"2026-06-11",{"date":105,"type":45},"2010-06-17",{"date":107,"type":22},"2027-03-31",{"name":51,"class":52},{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":18,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":4,"studyType":23,"phases":120,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":128,"completionDateStruct":130,"leadSponsor":132,"locationsCount":88},"100437385","phase-4-rotator-cuff-tears-repair-with-or-without-dermal-patch-augmentation-100437385","NCT04975581","Rotator Cuff Tears Repair With or Without Dermal Patch Augmentation","CUFFPATCH","Inclusion Criteria:\n\n1. Patient aged at least 50 years to 75 years.\n2. Degenerative cuff tear.\n3. Large Full thickness rotator cuff tear (≥ 3cm and \\\u003C 5 cm ) that is fully repairable.\n4. Tears diagnosed using MRI scan.\n5. Ability to consent.\n6. Agreement to use of human dermal matrix allograft as augmentative patch\n\nExclusion Criteria:\n\n1. Previous surgery on the affected shoulder.\n2. Osteoarthritic changes.\n3. Unable to have MRI Scans.\n4. Significant neck pathology.\n5. Cognitive problems or language issue.\n6. Systemic arthritis\n7. Significant dual pathology in the involved shoulder\n8. Acute Traumatic tears (\\\u003C 6 months since injury).","50 Years","75 Years",{"count":119,"type":22},40,[121],"PHASE4","The Investigators are planning to conduct a Pilot study of 40 patients of Pragmatic randomised controlled trial comparing rotator cuff tendons repair (small tendons around the shoulder ) with or without augmentative patch. It includes patients between age groups 50 to 75 years with large (≥ 3cm and \\\u003C 5 cm ) rotator cuff tear that can be fully repaired using open or mini open repair with or without an augmentation with a human dermal matrix allograft (processed skin graft from a human donor ). The main aim is to examine whether the addition of the patch helps to reduce the rate of re-tear of the rotator cuff tendons at one year following surgery. Patients are randomized to receive either a repair with addition of an augmentative patch or a repair without a patch and have an identical follow-up after surgery. Patients are followed up in outpatient at 6 weeks , 3 months and 12 months after randomization and receive an Magnetic Resonant Imaging (MRI) scan 12 months after surgery. The primary outcome measure is to assess the Re-tear rate of rotator cuff at 12 months after surgery. The secondary outcome measure is to assess functional scores of the shoulder at 12 months . The tertiary outcome measures are to check the cost effectiveness of each procedure.",[124],"Rotator Cuff Tears","2026-05-06",{"date":127,"type":45},"2026-05-11",{"date":129,"type":45},"2021-12-03",{"date":131,"type":22},"2026-12-31",{"name":51,"class":52},{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":139,"eligibilityCriteria":140,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":141,"enrollmentInfo":142,"targetDuration":4,"studyType":23,"phases":143,"briefSummary":144,"conditions":145,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":88},"100529899","pilot-study-on-ha380-column-use-in-critically-ill-patients-receiving-extracorporeal-support-100529899","NCT06179771","Pilot Study on HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support.","HA380 Column Use in Critically Ill Patients Receiving Extracorporeal Support for Acute Critical Illness; a Prospective, Randomised, Interventional, Feasibility, Pilot Study (HACEC)","HACEC","Inclusion Criteria\n\n* Consent obtained\n* Male or Female, aged 18 years - 65 years.\n* Admitted with a diagnosis of sepsis (according to sepsis-3 definition), trauma, ARDS of infectious or non-infectious aetiology, trauma or after major surgery\n* Need for extracorporeal support and specifically renal replacement therapy (RRT) and\u002For ECMO.\n* Vasopressor or inotropic therapy requirement at the time of RRT or ECMO support\n* Within 72 hours of requiring extracorporeal support\n* At least one of:\n* CRP \\> 100 mg\u002FL (in the absence of immunosuppressive therapy\u002Fimmunomodulation)\n* Lactate \\>2 mmol\u002FL\n\nExclusion Criteria\n\n* The participant may not enter the trial if ANY of the following apply:\n* Unable to obtain consent.\n* Expected to die in the next 24 hours.\n* Pre-existing chronic kidney disease - requiring dialysis \u002FeGFR \\\u003C 30ml\u002Fmin\u002F1.73m2\n* Pre-existing severe respiratory failure - e.g., requiring home oxygen\u002F home nebulisers\u002F poor exercise tolerance\n* Chronic heart failure - NYHA class III and above\n* Pregnancy\n* Requirement for immediate immune modulation e.g., plasma exchange, high dose steroids , IV immunoglobulins (does not include vasoplegic dose of steroids or immune modulation for COVID 19)\n* Participants who have participated in another research trial involving an investigational product in the past 12 weeks.","65 Years",{"count":119,"type":22},[25],"Patients who are very ill either due to a severe infection, major organ injury, trauma or a major operation may require significant support with devices such as a dialysis machine for the kidneys or Extracorporeal Membrane Oxygenation (ECMO) for the heart and lungs. This is often due to a reaction of the body to the insult which is termed inflammation. The investigators would like to assess if the use of a device that can remove the agents driving this reaction can lead to a quicker recovery form the illness. The device is a blood filter called HA380 and it would be connected to either the dialysis machine or the ECMO circuit. The investigators want to assess the feasibility of conducting a study with the HA380 column. We will also evaluate if the use of the HA380 column has an effect on the time spent on dialysis or ECMO, time spent on the breathing machine, time spent requiring drugs to support blood pressure and time spent in the intensive care unit.",[146,147,148,149],"Acute Kidney Injury","ARDS","Inflammation","Extracorporeal Circulation; Complications","2026-02-27",{"date":152,"type":45},"2026-03-02",{"date":154,"type":45},"2024-09-02",{"date":156,"type":22},"2026-10-31",{"name":51,"class":52},{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":18,"minAge":166,"maxAge":167,"enrollmentInfo":168,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":170,"conditions":171,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":178},"100401991","the-brave-study--the-identification-of-genetic-variants-associated-with-bicuspid-aortic-valve-using-a-combination-of-case-control-and-family-based-approaches-100401991","NCT04514445","The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.","Bicuspid aoRtic vAlVe gEnetic Research - BRAVE Study","BRAVE","Inclusion Criteria:\n\n\\- 1. All outpatients and inpatients with diagnosed BAV, of either gender, aged 10 and above.\n\n2\\. Affected and unaffected first degree relatives meeting the age criteria.\n\nExclusion Criteria:\n\n* 1\\) Patients unable to give informed consent.\n\n  2\\) Patients known to be infected with HIV, Hepatitis B, Hepatitis C or any other agent posing an infection risk from unfixed material.\n\n  3\\) Patient with known cytogenetic disorders e.g. aneuploidia, chromosomal abnormalities and known karyotype abnormalities.\n\n  4\\) Patients with diagnosed or suspected Mendelian syndromes (e.g. Marfan syndrome, Loeys-Dietz syndrome, Ehlers-Danlos syndrome).","10 Years","99 Years",{"count":169,"type":22},700,"Bicuspid aortic valve (BAV) is the most common congenital heart anomaly in the general population (1-2% of all individuals). In affected people, the aortic valve (the structure ensuring one way blood flow between the heart's left pumping chamber, the left ventricle and the main body artery, the aorta) consists of 2 rather than 3 leaflets. This arrangement can cause the affected valve to have restricted opening or cause it to leak. Both situations put strain on the heart and patients with BAV across the age range may require surgery to replace the affected valve. BAV is therefore a condition associated with significant ill health and early mortality.\n\nBAV is known to cluster in families and is likely to have a genetic cause. We don't fully understand the inheritance of BAV or the specific genes involved in its development. Learning more about this is the basis of the BRAVE study.\n\nWe will ask patients with BAV and their relatives (who may or may not have BAV) to take part in the study. Blood samples obtained from the participants will be used for analyses of their genetic composition. This information, linked with the clinical data concerning who does and does not have BAV, will potentially enable the identification of the gene changes responsible for the disease. This, we hope, will give us a much better understanding of the mechanisms leading to this serious and common condition.",[100],{"date":152,"type":45},{"date":174,"type":45},"2015-09-08",{"date":176,"type":22},"2027-12-01",{"name":51,"class":52},4,{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":61,"enrollmentInfo":186,"targetDuration":4,"studyType":23,"phases":188,"briefSummary":189,"conditions":190,"keywords":193,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":195,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":88},"100527795","ablate-and-pace-his-study-100527795","NCT06152406","Ablate and Pace HIS Study","Safety and Efficacy of Distal His Bundle Pacing Compared to Right Ventricular Pacing in Patients With Symptomatic Atrial Fibrillation Undergoing AV Node Ablation With Evidence of Heart Failure, a Randomised Control Study","Inclusion Criteria:\n\n* Aged 18 or above\n* Symptomatic AF, New York Heart Association (NYHA) class II-IV\n* Willing to consent for the study\n* AF regardless type, deemed not suitable for rhythm control strategy that has been referred for AVN ablation with one of the following:\n\n  1. Impaired LV function, EF \\\u003C50 %. And or\n  2. Raised N-Terminal Pro B-type Natriuretic Peptide ( NT-ProBNP) \\>365 ng\u002FL\n\nExclusion Criteria:\n\n* Patient who has already got a pacemaker in situ\n* Known severe LVSD when biventricular device is the thought to be the preferred pacing modality\n* Females in child bearing period\n* Lack of capacity to consent\n* Other serious medical condition with life expectancy of less than 1 year\n* Less than 18 years\n* Unwilling to consent for the study",{"count":187,"type":22},100,[25],"Atrial fibrillation (AF) is the most common sustained cardiac arrhythmia, and estimates suggest its prevalence is increasing. Despite the advances in AF ablation strategies, the outcome of ablation procedures in persistent AF is still unsatisfactory. In addition, many patients are not candidates for ablation due to advanced age, comorbidities and previous failed ablation procedures.\n\nIt is well known that there is no mortality benefit from rhythm versus rate control strategy in AF, therefore the increased number of AV node ablation and pacemaker insertion for patients with symptomatic AF with uncontrolled heart rate. Following AV node ablation, it is understandable that these patients will be paced 100% of the time where the value of physiological pacing will be at its most.\n\nThe current standard practice is to pace the right ventricle for this cohort of patients unless they have severe LV systolic dysfunction when a biventricular pacing might be recommended. Previous data showed that RV pacing only can lead to deterioration of LV function, worsening of heart failure symptoms and increased mortality.\n\nHIS bundle pacing is a novel technique of pacing through placing the pacemaker lead on the junction box between the top and bottom chamber of the heart. This will allow the utilisation of the normal\u002Fintrinsic HIS Purkinjie (eclectic cables) to stimulate the ventricles. This can offer a physiological pacing modality and reduce pacing induced cardiomyopathy specially in pacing dependent pacing.\n\nThe Ablate and Pace HIS Study proposes that the new method of HIS pacing is safe, effective and superior to the existing method of RV pacing in patients with atrial fibrillation who demonstrate signs of heart failure.",[191,192],"HIS Bundle Pacing","Atrial Fibrillation",[191,192],"2025-12-31",{"date":196,"type":45},"2026-01-05",{"date":198,"type":45},"2023-10-24",{"date":200,"type":22},"2028-02-29",{"name":51,"class":52},{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":18,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":214,"conditions":215,"keywords":217,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":88},"100436169","covid-19-impact-on-rsv-emergency-presentations-100436169","NCT04959734","COVID-19 Impact on RSV Emergency Presentations","Impact of Covid-19 on Respiratory Syncytial Virus Seasonality and Disease Severity in UK Children (BronchStart)","BronchSTART","Inclusion Criteria:\n\ni) Children under two years of age presenting to participating emergency departments with clinical features of:\n\n* Bronchiolitis (cough, tachypnoea or chest recession, and wheeze or crackles on chest auscultation) or\n* Lower Respiratory Tract infection or\n* Afirst episode of acute viral wheeze.\n\nExclusion Criteria:\n\ni) Children with previous episodes of wheeze responsive to bronchodilator (suggesting an underlying diagnosis of recurrent wheeze of early childhood)","0 Years","2 Years",{"count":213,"type":22},3000,"Bronchiolitis is a very common winter disease that normally affects children less than one year of age. It is a common reason for parents and carers to bring their child to an Emergency Department (ED) and the frequent need for hospital admission means that paediatric units are at their capacity each winter.\n\nDuring the COVID19 pandemic the virus that causes bronchiolitis (Respiratory Syncytial Virus; RSV) disappeared meaning this winter there have been virtually no cases of bronchiolitis in the United Kingdom. This phenomenon has been observed in many other countries around the world. Evidence from Australia suggests as restrictions such as social distancing for COVID19 are relaxed bronchiolitis returns, even in the summer. At the release of lockdown the return has been so dramatic in some areas of Australia the summer time numbers are above a typical winter. There is also evidence it may affect older children up to 2 years of age.\n\nIt is likely the Australian experience will be mirrored in the UK. The ability to track, anticipate and respond to a surge in bronchiolitis is important. There is a need to understand:\n\n1. the onset of RSV spread at the earliest opportunity. This is important as some children are at higher risk of hospitalisation, intensive care admission or death if they contract RSV; knowing when to passively immunise these children is a public health priority.\n2. whether the population at risk is a wider age range than normal and whether disease severity is greater as these will both effect service planning;\n\nThere are currently no existing studies or surveillance systems fully able to address these questions. This study will use staff in Emergency Department to report, in real time, case of bronchiolitis that they see and record essential, but non-identifying, information about them.\n\nIn 2022\u002F23 the study evolved from a prospective surveillance study into a genomic analysis study with sites collecting positive respiratory samples for RSV genomic review.\n\nIn 2024\u002F25 the study was amended in light of the introduction of the Bivalent Prefusion F Vaccine in Pregnancy in the United Kingdom to undertake a Vaccine Effectiveness study.\n\nThe main inclusion criteria remains the same but mothers who would have been eligible for the vaccine, and deliver an infant during the RSV season, were consented to obtain vaccination details so these could be linked to BronchSTART records.",[216],"Bronchiolitis; Respiratory Syncytial Virus",[218,219,220],"Bronchiolitis","RSV","Vaccine Effectiveness",{"date":196,"type":45},{"date":223,"type":45},"2021-06-25",{"date":225,"type":22},"2026-03-27",{"name":51,"class":52},{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":231,"acronym":232,"eligibilityCriteria":233,"healthyVolunteers":17,"sex":234,"minAge":235,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":194,"lastUpdatePostDateStruct":241,"startDateStruct":242,"completionDateStruct":244,"leadSponsor":246,"locationsCount":88},"100348978","bioimpedance-in-pregnancy-and-labour-a-fluid-balance-concept-study-100348978","NCT03823820","Bioimpedance In Pregnancy and Labour: A Fluid Balance Concept Study.","BiPAL","Inclusion Criteria: pregnant women at age of 16 or over with a viable pregnancy and who will fulfil the following:\n\n* Group I: Women attending for elective CS.\n* Group II: Women admitted for induction of labour and expected to stay stay in hospital for more than 24 hours.\n* Group III: Maternal condition that could have direct impact on body fluid including:\n\n  1. Pre-eclampsia requiring hospital admission.\n  2. Hyperemesis gravidarum requiring hospital admission.\n  3. Major postpartum haemorrhage (equal or greater than 1000 ml following delivery).\n* Group IV: gestational age matched controls.\n\nExclusion criteria:\n\n* Maternal age less than 16 years at booking.\n* Women who are not capable of giving consent.\n* Women with learning disabilities\u002Fdifficulties.\n* Unable to speak or read English to the appropriate level.\n* Prisoners.\n* Any others deemed to belong to a vulnerable group.\n* Women who require pace maker or defibrillators.","FEMALE","16 Years",{"count":237,"type":22},900,"The purpose of our study is to find out if using a simple bed side test can tell us information about changes that occur in women's body water content. We would like to check if certain medical conditions could affect body water contents.",[240],"Hydration",{"date":196,"type":45},{"date":243,"type":45},"2019-04-08",{"date":245,"type":22},"2029-02-14",{"name":51,"class":52},""]