[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"King's College London\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":728},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,89,0,25,[9,56,87,113,137,169,200,225,257,291,318,343,366,392,413,433,461,495,519,553,582,603,624,663,687],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100652166","the-spark-pmdd-study-100652166",false,"NCT07771426","The SPARK-PMDD Study","Studying Psychological Changes And inflammatoRy marKers in Premenstrual Dysphoric Disorder (PMDD)","SPARK-PMDD","Inclusion Criteria:\n\nParticipants must:\n\n* Have been assigned female sex at birth (AFAB), with ovaries\n* Be aged between 18-42 years (inclusive)\n* Be able to provide written informed consent\n* Be premenopausal\n* Have regular menstrual cycles (24-35 days; 5-8 menstrual cycles within the previous 6 months)\n* Have a body mass index (BMI) between 18 and 30 kg\u002Fm².\n* Have access to a computer, tablet or smartphone with an internet connection.\n* Be registered with a UK General Practitioner (GP) and consent to the study team contacting their GP if clinically indicated.\n\nPMDD group only - Participants must additionally:\n\n• Meet DSM-5 diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD), confirmed through prospective symptom ratings and the study diagnostic assessment.\n\nHealthy control group only - Participants must additionally:\n\n* Have no current or previous diagnosis of PMDD.\n* Report no clinically significant premenstrual symptoms on prospective symptom ratings.\n* Have no lifetime psychiatric illness\n* Meet all other study eligibility criteria.\n\nExclusion Criteria:\n\nParticipants will be excluded if they:\n\n* Have a lifetime history of a psychotic disorder (including schizophrenia, schizoaffective disorder or major depressive disorder with psychotic features) or bipolar disorder (past or present)\n* Meet criteria for any other current major psychiatric disorder that would interfere with study participation, as determined by the MINI International Neuropsychiatric Interview.\n* Have a history of drug or alcohol dependence within the previous 12 months.\n* Have a diagnosed intellectual disability, pervasive developmental disorder or significant neurological disorder (e.g. Alzheimer's disease, epilepsy or Parkinson's disease).\n* Are currently pregnant or breastfeeding, or are planning pregnancy during the study period.\n* Have an acute infection, autoimmune disorder, or regularly use anti-inflammatory or antibiotic medication that could influence immune biomarkers.\n* Have a current or previous gynaecological condition (e.g. endometriosis or polycystic ovary syndrome) or have undergone gynaecological surgery within the previous 12 months.\n* Have used hormonal contraception or other steroid hormone treatment within the previous 6 months (except emergency levonorgestrel contraception or temporary hormone treatment for oocyte cryopreservation that has not affected menstrual cycle regularity).\n* Have a significant medical condition that may affect study outcomes (e.g. cancer, inflammatory disease, liver disease, kidney disease or Crohn's disease).\n* Are currently participating in a Clinical Trial of an Investigational Medicinal Product (CTIMP). Eligibility following recent participation in a CTIMP will be considered on a case-by-case basis.\n* Are assessed as presenting an immediate or high risk of suicide requiring urgent clinical intervention. Suicidal ideation alone is not an exclusion criterion because it is recognised as a feature of PMDD; however, participants identified as being at significant risk will be excluded and referred to appropriate clinical services.",true,"FEMALE","18 Years","42 Years",{"count":23,"type":24},120,"ESTIMATED","OBSERVATIONAL","Scientists have found that the immune system, the body's system dedicated to fighting infections, can be in a state of \"hyperactivity\" (i.e., more active than you would normally expect) in some people with depression and postnatal depression, despite the lack of any actual ongoing infection. This response is referred to as inflammation. This discovery has unveiled unique opportunities to identify new medications to help patients with this heightened inflammation who have also not been responding to their antidepressant medications.\n\nThis study aims to explore how inflammation in the body may be linked to symptoms of Premenstrual Dysphoric Disorder (PMDD) across the menstrual cycle, and how thoughts, emotions, and behaviours also may change throughout the cycle. We are recruiting two groups of people: People with a clinical or provisional (suspected) diagnosis of PMDD, and healthy controls who experience mild\u002Fno premenstrual changes.\n\nOver a two-month period, participants will complete daily psychological assessments across two menstrual cycles and will come into King's College Hospital (KCH) twice during one menstrual cycle to provide blood samples to measure their inflammation. By comparing these groups, we hope to gain a better understanding of the biological and psychological factors involved in PMDD, with the long-term goal of improving treatment options.",[28,29,30,31],"Premenstrual Dysphoric Disorder","PMDD","Premenstrual Dysphoric Disorder ( PMDD)","Premenstrual Dysphoric Disorder (PMDD)",[33,34,35,36,37,38,39,40,41,42],"menstrual cycle","pmdd","luteal phase","womens health","reproductive health","reproductive mental health","inflammation","stress","premenstrual","female","NOT_YET_RECRUITING","2026-08-14",{"date":46,"type":47},"2026-08-18","ACTUAL",{"date":49,"type":24},"2027-01-01",{"date":51,"type":24},"2029-10-01",{"name":53,"class":54},"King's College London","OTHER",1,{"id":57,"slug":58,"hasResults":12,"nctId":59,"briefTitle":60,"officialTitle":60,"acronym":61,"eligibilityCriteria":62,"healthyVolunteers":18,"sex":63,"minAge":64,"maxAge":65,"enrollmentInfo":66,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":55},"100651916","arterial-stiffness-in-children-and-young-people-with-hypertension-and-chronic-kidney-disease-100651916","NCT07768865","Arterial Stiffness in Children and Young People With Hypertension and Chronic Kidney Disease","ART-KIDS","Inclusion criteria:\n\nFor CKD participants:\n\n* Aged 10-25 years at study entry.\n* Diagnosis of CKD confirmed on at least two GFR assessments 3-months apart; eGFR will be estimated using routine bedside formulae (modified Schwartz). Participants may include those on dialysis or those with a functioning kidney transplant.\n* Able to tolerate study investigations including 24-hour ABPM, echocardiogram, vascular assessments and MRI.\n\nFor controls:\n\n* Aged 10-25 years at study entry\n* Having completed study measurements as part of other research being completed by the research group and having consented to their anonymised data being used in future research within the same research theme.\n\nExclusion criteria (for all participants):\n\n* Heart abnormalities or pre-existing cardiac disease including congenital heart disease, previous cardiac surgery or heart failure.\n* Cardiac dysrhythmia.\n* Inability to tolerate the required study investigations (out of office BP monitoring, applanation tonometry, cardiac MRI).","ALL","10 Years","25 Years",{"count":67,"type":24},200,"Age related stiffening and hardening of the arteries is often a slow process, but some conditions such as chronic kidney disease (CKD), seem to increase the rate at which the arteries stiffen even during childhood. High blood pressure (BP) is well known to lead to arterial stiffening and is often seen in children and young people (CYP) with CKD.\n\nA greater risk of arterial stiffening has been reported in children CYP with CKD compared to healthy CYP and this is thought to be related to the development of high BP, heart problems, and the worsening of kidney damage. The cause is unknown and is unlikely due to age related changes in the arterial wall seen in older adults. Potential mechanisms contributing to arterial stiffening in CYP with CKD include i) abnormalities in the interaction between the heart and the aorta (the large artery pumping blood away from the heart to the rest of the body), overactivity of the sympathetic nervous system (SNS), the body's \"stress response\", or iii) abnormal metabolism seen in CKD, where there are high levels of phosphate and other waste products circulating in the blood as a result of damage to the kidneys.\n\nIn this study, the investigators will use a variety of non invasive experimental methods to determine if arterial stiffening seen in CYP with CKD is due solely to increased BP, or whether the other potential factors listed above also contribute. This may help to eventually identify how to prevent or treat arterial stiffness in CYP with CKD and prevent its adverse impact on kidney and heart health in later life. The investigators will compare findings between those with CKD and an age, sex and BP matched control group. This control group will comprise CYP both with high BP (primary hypertension) and without high BP (healthy participants).",[70,71],"Chronic Kidney Disease","Hypertension",[73,71,74,75,76,77],"Chronic kidney disease","Arterial stiffness","Children","Pulse wave velocity","Cardiac MRI","RECRUITING","2026-08-12",{"date":81,"type":47},"2026-08-17",{"date":83,"type":47},"2026-06-16",{"date":85,"type":24},"2028-06-16",{"name":53,"class":54},{"id":88,"slug":89,"hasResults":12,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":94,"targetDuration":4,"studyType":96,"phases":97,"briefSummary":99,"conditions":100,"keywords":104,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":55},"100651639","colchicine-and-dialysis-patients-a-feasibility-study-100651639","NCT07762807","Colchicine And Dialysis Patients; a Feasibility Study","CAD","Inclusion Criteria:\n\n1. Anyone who is undergoing haemodialysis.\n2. Aged 18 or over\n3. Able to give informed consent\n\nExclusion Criteria:\n\n1. Already taking colchicine for a clinical indication.\n2. Taking a drug known to increase colchicine levels.\n3. Has a previously documented intolerance of or allergy to colchicine\n4. Has a history of chronic liver disease, or abnormal liver function (i.e. ALT \\> 1.5 x upper limit of normal). Patients with a history of hepatitis are eligible provided these limits are not exceeded.",{"count":95,"type":24},100,"INTERVENTIONAL",[98],"NA","Colchicine is an inexpensive drug that has been available for decades. Trials, which excluded patients with kidney disease, showed that colchicine decreased the number of heart attacks and strokes. The investigators cannot be sure if these results will apply to dialysis patients and a clinical trial exploring the effect of colchicine on heart attacks and strokes specifically in dialysis patients is needed. Colchicine may also be beneficial for dialysis patients as it may help arteriovenous fistulas to last longer. An arteriovenous fistula is a connection made between an artery and a vein in the arm, allowing for access to a person's bloodstream as part of dialysis. Sometimes, these connections can get too narrow in some parts, stopping them from working properly. These narrowings can be treated with a balloon inserted into the vein with the help of an x-ray. Balloons coated with a drug called paclitaxel, which works like colchicine, can be helpful, so the investigators think colchicine may help too.\n\nAt present, colchicine is often avoided in patients receiving dialysis. Patients on haemodialysis take a number of medications already and have significant comorbidity. Therefore, it is possible that a higher proportion would have difficulty tolerating colchicine. These concerns mean that a large trial assessing the potential benefits of colchicine in this population cannot begin without further data on feasibility.\n\nThis feasibility study will establish whether low dose colchicine is tolerated and acceptable to dialysis patients and will help the investigators to plan recruitment to future clinical trials. The investigators will give colchicine to 100 dialysis patients. The investigators will monitor the participants for side effects and see how many continue to take it for the planned period of 3 months. If feasibility is confirmed, there are then strong rationales for large clinical trials exploring the effect of colchicine on both mortality and vascular access outcomes in dialysis patients.",[101,102,103],"Haemodialysis Patients","Colchicine","Feasibility Study",[102,101,103],"2026-08-11",{"date":107,"type":47},"2026-08-13",{"date":109,"type":47},"2025-04-10",{"date":111,"type":24},"2027-11",{"name":53,"class":54},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":96,"phases":122,"briefSummary":123,"conditions":124,"keywords":127,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":55},"100559741","slomo2-implementation-effectiveness-and-cost-effectiveness-study-100559741","NCT06568081","SloMo2: Implementation, Effectiveness, and Cost-effectiveness Study","SloMo2: A Process Evaluation, Effectiveness, and Cost-effectiveness Study of a Digitally Supported Therapy for Psychosis in Routine Care","Inclusion Criteria:\n\n* Meet criteria for ICD-10 psychosis diagnoses (F20-29, F30-39)\n* Seeking therapy for paranoia\n* In contact with secondary care mental health services\n* Capacity to provide informed consent to engage in therapy\n\nExclusion Criteria:\n\n* Acute risk of harm to self or others\n* Unable to engage in therapy due to language barriers\n* Primary diagnosis of alcohol\u002Fsubstance dependence, learning disability, or organic brain injury or illness implicated in psychosis",{"count":121,"type":24},150,[98],"Worries about harm from others (also known as paranoia) are common. Thinking fast or going on gut feelings is natural but can fuel these worries. For some, fast thinking and worries start to get in the way of life. Cognitive behaviour therapy for psychosis (CBTp) is the recommended talking therapy. However, only a minority of people can access CBTp due to limited resources, and even when available, therapy can be difficult to do and use in daily life.\n\nSloMo is a digitally supported therapy that aims to overcome these barriers, and was developed by people with psychosis, designers, and psychologists. It supports people to notice worries and fast thinking habits. During therapy sessions, people learn to slow down and feel safer. Personalised spinning thought bubbles are slowed down using SloMo tips. An app provides access to helpful messages.\n\nSloMo was previously tested in a randomised trial of 361 people attending mental health services. SloMo was found to be safe to use, with no adverse events linked to the software. People in the SloMo group had lower paranoia, and better confidence and wellbeing, over 6 months compared to people who just received their usual care. People found SloMo enjoyable and easy to use.\n\nThe next step is to evaluate if SloMo can be safely and effectively delivered by therapists working in NHS services. If SloMo works in routine care, the therapy will be made more widely available in the NHS.\n\nAn improved version of SloMo has been co-produced based on feedback. At least sixty therapists will be trained and supervised in 3 trusts to deliver SloMo to at least 150 people who fear harm from others. Safety, technical performance, uptake, engagement and acceptability data, alongside interviews with patients, therapists, and managers, will investigate how SloMo is used. Paranoia severity and wellbeing will be measured pre, post therapy, and at 12 months follow up, to find out if SloMo helps. Service use data will evaluate costs and savings.",[125,126],"Schizophrenia Spectrum and Other Psychotic Disorders","Affective Psychoses",[128,129],"Digital health","User-centred design","2026-08-07",{"date":105,"type":47},{"date":133,"type":47},"2024-10-16",{"date":135,"type":24},"2027-12-31",{"name":53,"class":54},{"id":138,"slug":139,"hasResults":12,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":18,"sex":63,"minAge":145,"maxAge":146,"enrollmentInfo":147,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":149,"conditions":150,"keywords":154,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":55},"100610544","cutaneous-biomarkers-in-atopic-eczema-using-a-non-invasive-micro-suction-device-in-babies-100610544","NCT07228962","Cutaneous Biomarkers in Atopic Eczema Using a Non-Invasive Micro-Suction Device in Babies","Using a Non-invasive Micro-suction Biomarker Extraction Device to Understand Atopic Eczema in Babies","CARE","Inclusion Criteria:\n\n1. Healthy babies and babies with atopic dermatitis up to 6 months old.\n2. Ability of parents\u002Fguardians\u002Fcaregivers to provide written informed consent for study participation.\n3. Willingness of parents\u002Fguardians\u002Fcaregivers to comply with all study requirements.\n4. Parents\u002Fguardians\u002Fcaregivers competent use of English language.\n\nExclusion Criteria:\n\n1. Parents\u002Fguardians\u002Fcaregivers unable to give informed consent.\n2. Preterm birth (defined as birth before 37 completed weeks gestation).\n3. Significant inflammatory skin disease at birth.\n4. Baby has any other serious health issue.","0 Months","6 Months",{"count":148,"type":24},30,"This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of eczema and propose new preventative strategies and effective treatments.\n\nSpecifically, it aims to:\n\n1. Demonstrate that the developed ISF device can be used to extract biomarkers from the skin of babies non-invasively and is tolerable (not causing significant discomfort, bruising, or blister formation).\n2. Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema.\n3. Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device.\n4. Compare the microbiome and metabolome profiles from swabs taken from babies with healthy skin and with eczema in lesional and non-lesional skin (exploratory outcome).",[151,152,153],"Eczema","Atopic Dermatitis","Atopic Eczema",[151,152,155,156,157,158,159,160],"Immune System","Skin Barrier","Dermatology","Interstitial Skin Fluid","Microbiome","Early life","2026-08-04",{"date":163,"type":47},"2026-08-05",{"date":165,"type":47},"2026-03-31",{"date":167,"type":24},"2027-06-30",{"name":53,"class":54},{"id":170,"slug":171,"hasResults":12,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":12,"sex":63,"minAge":177,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":180,"conditions":181,"keywords":187,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":199},"100600818","complexity-in-health-education-and-social-support-for-children-and-young-people-with-life-limiting-conditions-100600818","NCT07102433","Complexity in Health, Education, and Social Support for Children and Young People With Life-limiting Conditions.","CHESS - Complexity and Outcomes in Health, Education, and Social Support Among Children and Young People With Life-limiting Conditions: Establishing a Multisectoral Collaboration and Conceptual Framework to Advance Evidence and Practice.","CHESS","Stage 1 - Interviews\n\nInclusion Criteria:\n\n* Children (5-17 years) with any life-limiting condition defined using the UK Together for Short Lives widely adopted 4 categories of life-limiting\u002Flife-threatening conditions among children.\n* Parents\u002Fcarers of children (0-17 years old) with a life-limiting conditions.\n* Bereaved parents of a child who had a life-limiting condition (at least 3 months since bereavement).\n* Healthcare professionals (medicine, nursing, allied health professionals), social care providers, education teaching and therapy staff with \\> 6 months experience of caring for children with life-limiting conditions.\n\nExclusion Criteria:\n\n* Children unable to communicate via an interview, using 'draw and talk' or play methods, Talking MatsTM, or via their parents.\n* Children that speak languages not supported by NHS translation services.\n* Any child or young person for whom the PI believes participation in the study may induce undue psychological distress.\n* Parents\u002Fcarers are unable to provide consent\u002Fassent to participate in interviews.\n* Parents\u002Fcarers that speak languages not supported by NHS translation services.\n* Parents who are recently bereaved (\\\u003C3 months).\n* Any parent\u002Fcarer for whom the PI believes participation in the study may induce undue psychological distress (e.g. parents of children who may be receiving end-of-life care).\n* Professionals with \\\u003C6 months experience of caring for children with life-limiting conditions.\n\nStage 2 - Workshops\n\nInclusion criteria:\n\n* Parents or carers of children with a life-limiting condition (0-17 years old).\n* Bereaved parents of a child who had a life-limiting condition (at least 3 months since bereavement).\n* Researchers working with or in the field of complexity in children with life-limiting conditions.\n* Professionals across child health, social care, and education with experience of working with children with life-limiting conditions for \\>6 months.\n\nExclusion criteria:\n\n* Professionals across child health, social care, and education with \\\u003C6 months of experience working with children with life-limiting conditions.\n* Parents, carers, or professionals that are unable to provide consent or assent.\n* Children with life-limiting\u002Flife-threatening conditions will not be included in the workshops\n* Parents who are recently bereaved (\\\u003C3 months) of a child who had a life-limiting condition.","5 Years",{"count":179,"type":24},170,"Children and young people (CYP) with life-limiting conditions represent a growing population with complex care needs that span health, education, and social care systems. These children often have multiple diagnoses, rely on medical technologies, and experience prolonged trajectories of illness. Despite this, care remains fragmented, services are poorly integrated, and definitions of \"complexity\" are variable, inconsistent, and inadequately reflect the lived experience of families and the perspectives of professionals.\n\nThe CHESS (Complexity in Health, Education, and Social Support) study aims to develop a shared, evidence-informed understanding of \"complexity\" in the context of CYP with life-limiting conditions. The study will be delivered by a multi-disciplinary, multisectoral research team and is funded by a National Institute for Health and Care Research (NIHR) Programme Development Grant. This research will provide the foundational work to inform the design and implementation of a future NIHR Programme Grant focused on the development and testing of a child-centred, nationally applicable case mix classification system to support integrated multisector care and resource allocation.\n\nThis qualitative study involves two stages. Stage 1 consists of semi-structured interviews with (i) CYP aged 5-17 years with a life-limiting condition, (ii) parents\u002Fcarers (including bereaved parents and parents of children aged under 5 years), and (iii) professionals across healthcare, social care, and education sectors. These interviews aim to elicit stakeholder understandings of \"complexity,\" how it is experienced and enacted in care, and the implications for service access, coordination, and outcomes.\n\nStage 2 comprises a series of stakeholder workshops to review, refine, and synthesise findings from Stage 1 and a parallel realist review. Using consensus methods including the Nominal Group Technique, the workshops will co-develop a cross-sectoral conceptual definition of \"complexity\" and produce a logic model to guide integrated care delivery for this population.\n\nThe CHESS study seeks to address a critical evidence gap in how complexity is understood, measured, and supported across systems. By incorporating the voices of children, families, and professionals across sectors, this study will generate new conceptual clarity, build a foundation for improved outcomes, and contribute directly to the national agenda on equity, quality, and integration in paediatric palliative and complex care.",[182,183,184,185,186],"Complex Care","Medical Complexity","Pediatrics","Life-limiting Illness","Life-threatening Illness",[188,189,190,191,192],"Medical complexity","Pediatric palliative care","Life-limiting conditions","Life-threatening conditions","Children and young people",{"date":163,"type":47},{"date":195,"type":47},"2025-12-01",{"date":197,"type":24},"2026-09-30",{"name":53,"class":54},5,{"id":201,"slug":202,"hasResults":12,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":206,"eligibilityCriteria":207,"healthyVolunteers":18,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":210,"conditions":211,"keywords":213,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100546041","teamwork-for-resilient-staff-and-safe-care-in-icu-100546041","NCT06389773","Teamwork for Resilient Staff and Safe Care in ICU","Fostering Teamwork for Resilient Staff and Safe Care: Driving Post-pandemic Recovery and Renewal in Intensive Care Units","FEARLESS_ICU","Inclusion Criteria:\n\n* healthcare professionals\n* work in an intensive care unit\n* work in a selected case study site\n\nExclusion Criteria:\n\n* not a healthcare professional (e.g. patients and their families)\n* not working in an intensive care unit\n* not working in a selected case study site",{"count":209,"type":24},75,"The goal of this ethnographic study is to observe how healthcare professionals work together in an intensive care unit (ICU). The main questions it aims to answer are\n\n* How do healthcare staff work together in everyday ICU settings?\n* What helps people work together in ICUs?\n* What challenges do staff face in working together in ICUs?\n* How have teamwork practices changed since the COVID-19 pandemic?\n\nResearchers will shadow staff during their day-to-day work. Key staff members will also be interviewed about their perceptions and experiences of teamwork.",[212],"Teamwork",[214,215,216],"wellbeing","intensive care","patient safety","2026-08-03",{"date":163,"type":47},{"date":220,"type":47},"2025-03-21",{"date":222,"type":24},"2026-07-31",{"name":53,"class":54},3,{"id":226,"slug":227,"hasResults":12,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":18,"sex":63,"minAge":20,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":96,"phases":235,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":251,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":55},"100533339","investigating-the-effect-of-a-single-dose-of-levetiracetam-on-brain-function-chemistry-and-cognitive-performance-in-psychosis-risk-100533339","NCT06224530","Investigating the Effect of a Single-dose of Levetiracetam on Brain Function, Chemistry and Cognitive Performance in Psychosis Risk","LEVHIPPRO","CHR-P inclusion criteria\n\n1. Age range 18-40 years\n2. Capacity to consent to participation in the study\n3. Inclusion into attenuated psychosis group as assessed by the CAARMS\n4. Scores 3-5 on CAARMS unusual thought content or non-bizarre ideas subscales\n\nCHR-P exclusion criteria:\n\n1. Past episode of psychosis\n2. Current exposure to drugs with strong GABAergic or glutamatergic effects (benzodiazepines, anticonvulsants, mood stabilisers, zopiclone, zolpidem, ketamine, opiates, atomoxetine, memantine)\n3. Current\u002Frecent exposure to any antipsychotic medication\n4. Diagnosis of any neurological disorder, including epilepsy\n5. Current pregnancy\u002Fbreastfeeding\n6. Severe renal impairment\n7. Known allergy to levetiracetam\n8. Contraindication to MRI scanning\n9. IQ\\\u003C70 as determined with WAIS-III\n10. CHR-P individuals are not deemed to have a full-blown mental health disorder. However, in the event that a CHR-P individual is acutely ill and lacking capacity to consent, they will not be approached to take part in this study.\n\nHC inclusion criteria\n\n1. Age range 18-40 years\n2. Capacity to consent to participation in the study\n\nHC exclusion criteria:\n\n1. Personal history of mental health conditions\n2. Any first-degree relative with a psychotic disorder\n3. Diagnosis of any neurological disorder, including epilepsy\n4. Currently pregnant, breastfeeding, or trying to conceive\n5. Current exposure to drugs with strong GABAergic or glutamatergic effects (benzodiazepines, anticonvulsants, mood stabilisers, zopiclone, zolpidem, ketamine, opiates, atomoxetine, memantine)\n6. Current\u002Frecent exposure to any antipsychotic medication\n7. Contraindication to MRI scanning\n8. IQ\\\u003C70 as determined with WAIS-III","40 Years",{"count":234,"type":24},69,[98],"Background\n\nPsychosis is a mental health condition that affects around 3 in 100 people in their lifetime. Most treatments for psychosis target a brain chemical called dopamine but they don't work for everyone and don't address many of the symptoms.\n\nPeople with psychosis and people at risk of developing psychosis show differences in a part of the brain called the hippocampus, such as smaller size and increased activity. This hyperactivity may be associated with cognitive difficulties (thinking and memory).\n\nThe basis of this hippocampal hyperactivity is thought to be a deficit in excitation and inhibition of brain cells. Excitation causes brain cells to send signals more frequently, and inhibition causes cells to send signals less frequently. A balance between these signals is important for the brain, including the hippocampus, to function properly.\n\nApproach\n\nLevetiracetam is a medication that is widely used to treat epilepsy and which helps balance excitation-inhibition in the brain. We will use brain imaging, using Magnetic Resonance Imaging (MRI), to test if levetiracetam can help reduce hippocampal hyperactivity, alter connectivity and change levels of brain chemicals in people who are at risk of developing psychosis.\n\nParticipants (18-40 years), identified as at risk of psychosis through the Outreach and Support in South London (OASIS) teams, will attend an initial visit at the Institute of Psychiatry, Psychology \\& Neuroscience. This will involve questions about experiences and feelings, assessment of thinking and memory, and a blood test. They will then attend two scanning visits at the Centre for Neuroimaging Sciences, during which they will take capsules of either levetiracetam or placebo (in a randomised order) before having a 60 mins MRI scan. The MRI scan will look at blood flow to the hippocampus, resting activity, activity during a cognitive task and levels of brain chemicals.\n\nA case-control sample of 33 healthy individuals aged 18-40 will be recruited from Greater London. We will recruit a healthy control (HC) sample to establish the presence of hippocampal dysfunction in our CHR-P group by comparing the MRI data for CHR-P under the placebo condition with that of the HC sample. The HC individuals will attend the screening visit and one scanning visit. They will not receive any medication.\n\nFunded by the Wellcome Trust and conducted by King's College London researchers, the study spans 2-3 months per participant.\n\nImpact\n\nOur study will provide important evidence about how levetiracetam affects brain function, and how this relates to cognition. This knowledge may lead to innovative approaches for understanding and treating psychosis early.",[238],"Psychosis",[240,241,242,243,244,245,246,247,248,249,250],"Clinical high risk","Levetiracetam","Psychosis risk","Neuroimaging","Hippocampus","GABA","Glutamate","SV2A","Experimental medicine","Magnetic Resonance Spectroscopy","Magnetic Resonance Imaging",{"date":163,"type":47},{"date":253,"type":47},"2024-07-19",{"date":255,"type":24},"2026-08-30",{"name":53,"class":54},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":263,"eligibilityCriteria":264,"healthyVolunteers":12,"sex":63,"minAge":265,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":268,"conditions":269,"keywords":275,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":224},"100647189","early-prediction-of-outcomes-following-optic-neuritis-development-and-acceptability-of-a-prognostic-tool-100647189","NCT07704294","Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool","Early Prediction of Outcomes Following Optic Neuritis: Development and Acceptability of a Prognostic Tool (MS Predictor)","MS Predictor","Inclusion Criteria:\n\n* Aged 16 years and above at time of consent\n* Previous episode of optic neuritis diagnosed at one of the participating sites\n\nExclusion Criteria:\n\n* Patients for whom data relating to the first episode of ON are not available in the medical record at a participating site\n* Children \\\u003C16 years at the time of recruitment","16 Years",{"count":267,"type":24},180,"The goal of this observational study is to determine whether genetic information, together with clinical information, can be used to improve prediction of future multiple sclerosis (MS) diagnosis after a first-time episode of optic neuritis. The study will also investigate visual outcomes, quality of life, healthcare use, and the acceptability of using genetic information to predict future health outcomes in people with optic neuritis.\n\nThe main outcomes that we aim to assess are:\n\n1. Incident diagnosis of MS following a first episode of optic neuritis, including time to MS diagnosis.\n2. Visual outcomes following optic neuritis, including visual acuity, visual field, and colour vision.\n3. Clinical care received following optic neuritis, including specialist review, investigations\u002Ftests\n4. Health-related and vision-related quality of life.\n5. Health economic impacts and healthcare utilisation after experiencing optic neuritis\n6. Knowledge, attitudes, and practices\u002Fbehaviours about using genetic information to predict future MS disease risk.\n\nIf consented, participants will:\n\n1. Allow researchers to review information from their medical records relating to their optic neuritis diagnosis, investigations, treatments, and outcomes.\n2. Be invited to provide a saliva sample for genetic analysis.\n3. Complete questionnaires about their lifestyle\u002Frisk factors, quality of life, and views on genetic risk prediction.\n4. Allow researchers to track long-term health outcomes using information from their NHS records",[270,271,272,273,274],"Optic Neuritis","Multiple Sclerosis","Neuromyelitis Optica Spectrum Disorder","Myelin Oligodendrocyte Glycoprotein (MOG)-Antibody Related Disorders","Sarcoid",[276,277,278,279,280,281,282,272],"Optic neuritis","Multiple sclerosis","MS","Genetic Risk Score","Risk Prediction","Myelin Oligodendrocyte Glycoprotein","MOG Antibody Disease","2026-07-09",{"date":285,"type":47},"2026-07-15",{"date":287,"type":24},"2026-09-01",{"date":289,"type":24},"2027-12-01",{"name":53,"class":54},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":300,"conditions":301,"keywords":308,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":4},"100646634","foot-care-in-care-homes-100646634","NCT07688837","Foot Care in Care Homes","Optimising Foot Care Interventions for Older Adults Living in Care Homes","OPINIONS","Inclusion Criteria:\n\nTask 1 National Survey\n\n* Care staff working in residential care home settings. Care staff will have responsibility for the personal care of residents (aged 65+ years) within the care home setting. This includes agency staff with at least 6-months experience working in care homes.\n* Staff working in the residential care home sector (e.g. care home managers) and in regular contact with care home residents (e.g. nursing staff) will also be eligible to participate.\n* Care homes will be providing 24\u002F7 in-person support, and this is inclusive of residential care home, nursing care homes, specialist dementia care or nursing home, dual-registered care homes and extra care housing (assisted living or very sheltered housing).\n* All geographical regions in England inclusive of multi-ethnic, urban, and rural populations.\n* Aged over 18 years of age.\n\nTask 2 Qualitative interviews\n\n* Care home staff (including carers, care home managers and nursing staff) currently working in the care home environment and with at least 6-months' experience of working in this environment, with experience of providing personal care. This includes agency staff.\n* Care home residents with experience of foot care needs.\n* Family\u002Ffriends of residents who are involved in their care planning\u002Fprovision.\n* Family caregivers will include spousal, sibling, and parent\u002Fchild relations.\n* All participants must have capacity to give informed consent.\n* All participants must be able to take part in an interview in English.\n* Aged over 18 years of age.\n* Where a virtual interview is requested, access to the appropriate technology.\n\nExclusion Criteria:\n\nTask 1 National Survey\n\n* Residents living within care home and\u002For their family members.\n* Care staff working in non-care home sector(s) e.g. domiciliary care.\n* Staff in non- care roles (e.g. catering or maintenance)\n\nTask 2 Qualitative interviews\n\n* Care staff working in non-care home sector(s) e.g. domiciliary care.\n* Staff in non- care roles (e.g. catering or maintenance)\n* Those determined not to have mental capacity to consent to participation, in line with the Mental Capacity Act.\n* Care home residents with communication impairments which would preclude participation in the interview even with reasonable adjustments.\n* Unable to take part in an interview in English language.",{"count":67,"type":24},"The aim of this observational study is to: (1) describe current knowledge and practices related to foot care in care homes; (2) understand how care home staff, residents and\u002For family caregivers perceive foot care knowledge and practices. For the first study, the investigators are conducting a survey, and this will involve recruiting care staff working in care homes, managers of care homes, and staff in regular contact with care home residents (e.g. clinicians). The second study will involve interviews with care home staff (carers, care home managers and health professionals) and care home residents and\u002For their family representative.",[302,303,304,305,306,307],"Foot & Ankle","Foot Care","Foot","Foot Complications","Foot and Ankle Disorders","Foot Deformity",[309],"foot care","2026-07-03",{"date":312,"type":47},"2026-07-07",{"date":314,"type":24},"2026-07-01",{"date":316,"type":24},"2027-08-31",{"name":53,"class":54},{"id":319,"slug":320,"hasResults":12,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":324,"eligibilityCriteria":325,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":96,"phases":328,"briefSummary":329,"conditions":330,"keywords":332,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":4},"100644474","triage-radiology-imaging-assessment-for-greater-effectiveness-100644474","NCT07671664","Triage Radiology Imaging Assessment for Greater Effectiveness","Triage Radiology Imaging Assessment for Greater Effectiveness (TRIAGE): a Cluster-Randomised Crossover Trial Evaluating the Reporting Turn-Around-Time of Brain Magnetic Resonance Images Using an AI-enabled Abnormality Detector for Prioritisation","TRIAGE","Inclusion Criteria:\n\nFor main trial\n\n* Adult patient (≥ 18 years of age) at the time of MRI.\n* Brain MRI scan performed at a participating NHS site during the defined study period (intervention or control arm).\n* Brain MRI scan series will automatically be included if they contain the required scan sequences and are of the required resolution.\n\nFor O3 subgroup ● Radiologists, radiographers, and referring clinicians involved with the use of the MIDI tool at sites who consent to completing the staff survey\n\nFor O7 subgroup\n\n* Adult patient (≥ 18 years of age) at the time of MRI.\n* Brain MRI scan performed at a participating NHS site during the defined study period (intervention or control arm).\n* Brain MRI scan series will automatically be included if they contain the required scan sequences and are of the required resolution.\n* Patient with suspected de novo stroke\u002FTIA in TIA\u002FStroke pathway.\n* Patient with suspected de novo stroke\u002FTIA in Acute Neurology pathway.\n* Patient with suspected de novo stroke\u002FTIA identified via SSNAP review.\n\nFor O8 subgroup\n\n* Adult patient (≥ 18 years of age) at the time of MRI.\n* Brain MRI scan performed at a participating NHS site during the defined study period (intervention or control arm).\n* Brain MRI scan series will automatically be included if they contain the required scan sequences and are of the required resolution.\n* Patient with stage III\u002FIV malignant melanoma undergoing regular surveillance MRI brain scans presenting with de novo brain metastases.\n* Patient with lung cancer undergoing pre-radical treatment staging MRI brain scans presenting with de novo brain metastases.\n* Patients with de novo symptomatic brain metastases secondary to melanoma and\u002For lung cancer and\u002For breast cancer detected on MRI brain scans from all patient pathways.\n\nAdditionally for those completing EORTC questionnaires:\n\n● Able to give consent and likely to be able to complete EORTC questionnaires.\n\nExclusion Criteria:\n\nFor main trial\n\n* Patient is under 18 years of age at the time of MRI.\n* Brain MRI scan not performed at a participating NHS site or outside the defined study period.\n* Data will be excluded for those patients who have opted out of the use of their data for research under the National Data Opt-Out.\n* Brain MRI scan series will automatically be excluded if they do not contain the required scan sequences and\u002For the required resolution.\n\nFor O3 subgroup ● Radiologists, radiographers, and referring clinicians involved with the use of the MIDI tool at sites who do not consent to completing the staff survey\n\nFor O7 subgroup\n\n* Patient is under 18 years of age at the time of MRI.\n* Brain MRI scan not performed at a participating NHS site or outside the defined study period.\n* Data will be excluded for those patients who have opted out of the use of their data for research under the National Data Opt-Out.\n* Brain MRI scan series will automatically be excluded if they do not contain the required scan sequences and\u002For the required resolution.\n* Patient without suspected de novo stroke\u002FTIA or not on TIA\u002FStroke pathway.\n* Patient without suspected de novo stroke\u002FTIA or not on Acute Neurology pathway.\n\nFor O8 subgroup\n\n* Patient is under 18 years of age at the time of MRI.\n* Brain MRI scan not performed at a participating NHS site or outside the defined study period.\n* Data will be excluded for those patients who have opted out of the use of their data for research under the National Data Opt-Out.\n* Brain MRI scan series will automatically be excluded if they do not contain the required scan sequences and\u002For the required resolution.\n* Patient without stage III\u002FIV malignant melanoma, or not undergoing regular surveillance MRI brain scans, or not presenting with de novo brain metastases.\n* Patient without lung cancer undergoing pre-radical treatment staging MRI brain scans, or not presenting with de novo brain metastases.\n* Patients without de novo symptomatic brain metastases secondary to melanoma and\u002For lung cancer and\u002For breast cancer detected on MRI brain scans.\n\nAdditionally for those completing EORTC questionnaires:\n\n● Unable to give consent and unlikely to be able to complete EORTC questionnaires.",{"count":327,"type":24},100800,[98],"The aim of the trial is to understand whether a computerised tool designed to quickly spot problems in brain scans (MIDI) can help doctors diagnose cases faster. This will help patients by getting them the treatment they need sooner. How useful doctors find the tool will also be measured, and whether it is cost-saving for the National Health Service (NHS).",[331],"Brain",[324,333,334],"MIDI","AI Brain MRI","2026-06-25",{"date":337,"type":47},"2026-06-26",{"date":339,"type":24},"2027-03",{"date":341,"type":24},"2030-03",{"name":53,"class":54},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":18,"sex":63,"minAge":350,"maxAge":20,"enrollmentInfo":351,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":353,"conditions":354,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":359,"startDateStruct":361,"completionDateStruct":363,"leadSponsor":365,"locationsCount":4},"100642269","improving-decision-making-for-missing-upper-front-teeth-100642269","NCT07655193","Improving Decision-Making for Missing Upper Front Teeth","Development of a Patient Decision Aid for the Treatment of Maxillary Lateral Incisor Agenesis","Patient Participant Inclusion Criteria:\n\n* Young people with Maxillary Lateral Incisor Agenesis (MLIA) affecting one or both maxillary lateral incisors\n* Young people aged 11-18 years old (attending with an adult with parental responsibility if \\\u003C16 years old)\n* In active orthodontic (space-closure or space-opening) or restorative treatment for MLIA, or completed active dental treatment less than one year ago\n* Attended a multidisciplinary Hypodontia Clinic for treatment planning where both space-closure and space-opening options were offered\n\nPatient Participant Exclusion Criteria:\n\n* Craniofacial anomalies including cleft lip and\u002For palate\n* Unable to communicate in English where no professional translation service is available\n\nClinician Participant Inclusion Criteria:\n\n* Specialists or consultants in orthodontics, restorative dentistry, paediatric dentistry, and oral surgery who provide care as part of the Hypodontia pathway and work within the multidisciplinary hypodontia clinics\n\nClinician Participant Exclusion Criteria:\n\n* Any clinician not providing care as part of the Hypodontia pathway and working within the multidisciplinary hypodontia clinics","11 Years",{"count":352,"type":24},20,"Background: The developmental absence of 1-2 upper front teeth is a common condition, affecting 1 in 50 people worldwide, and affects smile aesthetics and quality-of-life. Treatment is often undertaken in teenagers, but the outcomes have lifelong consequences. Treatment options involve either creating space for a false tooth, or closing space and disguising the adjacent tooth as the missing tooth; both options have their own advantages, disadvantages and long-term considerations, and treatment often requires input from multiple dental specialties. Advances in orthodontic techniques mean more patients can be treated with either approach, therefore, the ideal treatment plan becomes more subjective and based upon the patient's preferences.\n\nAim: To develop a Patient Decision Aid (PDA), a decision-making support tool to help young people (and parents\u002Fguardians) with developmentally missing upper front teeth choose the best treatment option for them.\n\nApproach: First, the investigators will gather information from stakeholders involved in the decision-making process to understand their needs. Interviews will be conducted with young people with developmentally missing upper front teeth and their parents\u002Fguardians about their experiences, expectations, and preferences regarding treatment decision-making. Information will also be sought from clinicians involved in this process about their experiences of the decision-making process, via focus groups. These will be carried out across two NHS hospitals with special clinics for missing teeth. Then, the information obtained from both patient and clinician stakeholder groups will help the investigators to develop a PDA, following international guidelines. PDA development will occur alongside ongoing input and feedback from a Development Panel (which will include patients and clinician representatives) to optimise content, acceptability, and accessibility. The final approved PDA will then be trialled in a later pilot study.",[355,356,357],"Hypodontia","Decision Making ,Shared","Decision Aid","2026-06-15",{"date":360,"type":47},"2026-06-17",{"date":362,"type":24},"2026-08-01",{"date":364,"type":24},"2028-08-31",{"name":53,"class":54},{"id":367,"slug":368,"hasResults":12,"nctId":369,"briefTitle":370,"officialTitle":370,"acronym":371,"eligibilityCriteria":372,"healthyVolunteers":18,"sex":63,"minAge":20,"maxAge":373,"enrollmentInfo":374,"targetDuration":4,"studyType":96,"phases":376,"briefSummary":377,"conditions":378,"keywords":380,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":358,"lastUpdatePostDateStruct":386,"startDateStruct":388,"completionDateStruct":390,"leadSponsor":391,"locationsCount":55},"100641166","challenging-the-endocannabinoid-system-in-sleep-restricted-healthy-volunteers-to-modulate-physiological-arousal-canisleep-study-100641166","NCT07656350","Challenging the Endocannabinoid System in Sleep Restricted Healthy Volunteers to Modulate Physiological Arousal (CANISLEEP) Study","CANISLEEP","Inclusion Criteria:\n\n1. Aged 18-60\n2. Currently experiencing higher than average anxiety (measured by a score of ≥10 on the GAD-7)\n3. Able and willing to restrict their sleep to 4 hours on one occasion\n4. Willing to restrict alcohol and recreational drug intake during time on the study, confirmed by negative urine drug screen on the day of the experimental session\n5. Own a functioning phone and be able to respond to text messages\n6. Willing to provide GP details\n7. Willing to provide an emergency contact\n8. Able to provide written informed consent\n9. Willing to use a highly effective contraceptive method (see Section 5.2.2) for the duration of the study.\n\nExclusion Criteria:\n\n1. Currently receiving any treatment for any psychiatric disorder (medication and\u002For professional psychotherapy for a mental disorder)\n2. Any cannabinoid use in the past 3 months, including CBD oil, medical cannabinoids or recreational cannabis\u002FTHC use\n3. Cannabinoid contraindications: lifetime history of psychosis, 1st degree relative with psychosis, lifetime substance use disorder (that was professionally treated)\n4. History of consistent (\\>12 months) monthly cannabis use\n5. Currently experiencing insomnia or irregular sleep pattern (e.g. night shift work)\n6. Sleep restriction contraindications (sleep apnoea, sleep movement disorder, night shift work, insomnia)\n7. Have excessive daily caffeine intake (\\>4 cups of coffee per day or equivalent)\n8. Unlikely to be able to complete the study procedures for any reason, as judged by the study team\n9. Currently pregnant or lactating\n10. Currently trying to conceive a child\n\nAdditional criteria which must be met on experimental visits:\n\n1. Negative urine drug screen\n2. Negative urine pregnancy test\n3. Negative alcohol breath test","60 Years",{"count":375,"type":24},60,[98],"The goal of this study is to learn about the body's response to cannabis based products in sleep deprived people who are currently experiencing anxiety but are otherwise healthy.",[379],"Healthy Volunteer",[381,382,383,384,385],"THC","CBD","Cannabis","Stress","Anxiety",{"date":387,"type":47},"2026-06-18",{"date":389,"type":47},"2026-06-02",{"date":135,"type":24},{"name":53,"class":54},{"id":393,"slug":394,"hasResults":12,"nctId":395,"briefTitle":396,"officialTitle":397,"acronym":398,"eligibilityCriteria":399,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":389,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":412},"100643586","local-field-potential-correlates-of-neuropsychiatric-symptoms-in-parkinsons-disease-100643586","NCT07633379","Local Field Potential Correlates of Neuropsychiatric Symptoms in Parkinson's Disease","Intracranial Local Field Potential (LFP) Correlates of Neuropsychiatric Symptoms in Parkinson's Disease","LFP-in-PD","Inclusion Criteria:\n\n* Age ≥ 18 years\n* A diagnosis of Parkinson's Disease\n* A diagnosis of hallucinations, impulse control disorder, or panic disorder (episodic anxiety)\n* Previous bilateral DBS implantation with a Medtronic Percept device as part of clinical care\n\nExclusion Criteria:\n\n* Non-English speakers\n* \\\u003C18 years old or \\>75 years old\n* A history of concurrent conditions that could significantly confound the study results, such as other significant neurological condition (e.g., brain injury\u002Finfection, substance abuse) or concurrent severe psychiatric condition (e.g., schizophrenia)\n* Moderate\u002Fsevere Intellectual Disability or inability to understand study procedures\n* Lack of capacity to consent to the study\n* Currently involvement in other studies","75 Years",{"count":352,"type":24},"This prospective observational cohort study aims to investigate whether intracranial Local Field Potentials (LFPs) recorded from implanted Deep Brain Stimulation (DBS) devices are associated with neuropsychiatric symptoms in people with Parkinson's disease (PD). The study will focus on paroxysmal anxiety, impulse control disorders, and hallucinations.\n\nTwenty participants with Parkinson's disease and an implanted Medtronic Percept DBS device will be recruited. Participants will complete behavioural and clinical assessments and will use the event-marking functionality of the DBS device to record symptom episodes over a monitoring period of approximately 120 days. Brain activity will be passively recorded during this period.\n\nThe study will evaluate relationships between LFP signals, symptom occurrence, behavioural task performance, and clinical symptom severity measures. Machine learning approaches will be used to identify electrophysiological patterns associated with neuropsychiatric symptom states at an individual level.\n\nThe findings may improve understanding of the neural mechanisms underlying neuropsychiatric symptoms in Parkinson's disease and support the future development of personalised adaptive neuromodulation approaches.",[404],"PARKINSON DISEASE (Disorder)",{"date":406,"type":47},"2026-06-08",{"date":408,"type":24},"2026-06-01",{"date":410,"type":24},"2028-02-01",{"name":53,"class":54},2,{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":18,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":422,"conditions":423,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":55},"100640928","embrace--bloom---building-literacy-and-outcomes-through-observation-and-monitoring-information-needs-and-wearable-data-in-pregnancy-couples-100640928","NCT07623096","EMBRACE- BLOOM - Building Literacy and Outcomes Through Observation and Monitoring: Information Needs and Wearable Data in Pregnancy Couples","EMBRACE-BLOOM","Inclusion Criteria:\n\nPregnant participants\n\n* Aged 18 years or over;\n* Attending a routine first-trimester ultrasound appointment at the study site;\n* Resident in the UK;\n* Able to provide informed and documented consent;\n* Able to read and understand English sufficiently to complete study questionnaires delivered via the study mobile application;\n* Have access to a compatible smartphone.\n\nPartners\n\n* Aged 18 years or over;\n* Nominated by a participating pregnant participant;\n* Resident in the UK;\n* Able to provide informed and documented consent;\n* Able to read and understand English sufficiently to complete study questionnaires delivered via the study mobile application;\n* Have access to a compatible smartphone.\n\nExclusion Criteria:\n\nPregnant participants and partners:\n\n* Under 18 years of age;\n* Not resident in the UK;\n* Unable to provide informed consent;\n* No access to a compatible smartphone.",{"count":421,"type":24},1000,"The goal of this observational study (a single-site, prospective longitudinal cohort study) is to understand how the health information needs and information-seeking behaviours of pregnant women and their partners change over time, and to identify the factors linked to unmet information needs, in pregnant women aged 18 or over attending routine first-trimester care in the UK, together with one optional nominated partner (also aged 18 or over), followed from early pregnancy (11-13 weeks' gestation) to around 6-8 weeks postpartum. The main questions it aims to answer are:\n\nHow do health information needs and information-seeking behaviours evolve across pregnancy and the postpartum period for women and their partners (measured as longitudinal change in the Information Mismatch Index)? What barriers, facilitators, and sociodemographic factors are associated with unmet information needs, and how do the needs of women and their partners align or diverge?\n\nThis study has no comparison group or intervention; it is non-interventional and does not involve randomisation, treatment allocation, or any change to clinical care. Instead of comparing arms, researchers will examine how needs change over time and will explore differences between women and partners, and associations with health literacy, wellbeing, and optional passive digital data.\n\nParticipants will:\n\nComplete short app-delivered questionnaires at four milestone timepoints (around 11-13 weeks, 20-22 weeks, 35-36 weeks' gestation, and 6-8 weeks postpartum), each taking no longer than about 20 minutes and covering information needs, information-seeking behaviour, trust, health and digital literacy, mental health, quality of life, social support, and relationship satisfaction.\n\nOptionally complete brief biweekly check-in surveys between milestones (about 2-3 minutes each) on recent information needs.\n\nOptionally consent to electronic health record linkage and to sharing passive smartphone- and wearable-derived health metrics (e.g. steps, sleep, heart rate) via their own devices.",[424],"Pregnancy","2026-05-28",{"date":427,"type":47},"2026-06-03",{"date":429,"type":24},"2026-06",{"date":431,"type":24},"2027-12",{"name":53,"class":54},{"id":434,"slug":435,"hasResults":12,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":439,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":96,"phases":443,"briefSummary":444,"conditions":445,"keywords":448,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":455,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":55},"100638199","developing-a-virtual-reality-assisted-intervention-for-emotion-regulation-difficulties-in-psychosis-100638199","NCT07623928","Developing a Virtual Reality-assisted Intervention for Emotion Regulation Difficulties in Psychosis","MANaging emOtions in Everyday Life Using Virtual REality (MANOEUVRE): Developing a VR-assisted Intervention for Emotion Regulation Difficulties in Psychosis","MANOEUVRE","Inclusion Criteria:\n\n* Currently under the care of South London and Maudsley (SLaM) National Health Service (NHS) outpatient services.\n* Clinical diagnosis of psychosis (schizophrenia spectrum disorder) (as assessed by their clinical team)\n* Willing to have the interview audio recorded (if taking part in post therapy interview)\n* Willing and able to provide informed consent to participate in the study (as assessed by their clinical team)\n\nExclusion Criteria:\n\n* Clinical presentation (e.g., immediate serious risk to self) (as assessed by their clinical team)\n* History of photosensitive epilepsy",{"count":442,"type":24},15,[98],"Supporting people with psychosis to manage their emotions using virtual reality\n\nMany people who have experienced psychosis feel overwhelmed by their emotions. Emotions get in the way of doing what matters to them. They want support to manage emotions differently. There is evidence that people with psychosis find talking therapies that teach skills for managing emotions helpful. People said it helped them to understand and manage their emotions. However, they also wanted more help to apply skills they learned to their lives.\n\nIt is hard to help people to use therapy skills in real-life situations. Therapists cannot be present when the skills are needed. One solution is to use virtual reality (VR) to bridge the gap between the clinic and real-life. VR involves using a headset to see and hear a very life-like computer-generated simulation of everyday life situations. People with psychosis find VR therapies engaging and helpful. It can feel safer to try things out in VR.\n\nGuided by the feedback of people with psychosis, this research will evaluate a novel therapy to help people with psychosis manage their emotions. Face-to- face therapy will be combined with VR so that people can practice emotion regulation skills safely with \"live\" coaching from a therapist. This should support people to use these skills when they need them.\n\nFifteen people with psychosis will be offered the therapy. Everyone will be asked what they think of it and complete questionnaires before and after therapy to see what impact it had on their lives.\n\nA lived experience advisory group will support all aspects of the research process.",[238,446,447],"SCHIZOPHRENIA 1 (Disorder)","Schizophrenia and Related Disorders",[449,238,450,451,452,453,454],"Emotion regulation","Virtual reality","Schizophrenia spectrum disorders","Virtual reality exposure therapy","Psychotherapy","Dialectical behaviour therapy",{"date":427,"type":47},{"date":457,"type":24},"2027-09-01",{"date":459,"type":24},"2028-11-01",{"name":53,"class":54},{"id":462,"slug":463,"hasResults":12,"nctId":464,"briefTitle":465,"officialTitle":466,"acronym":467,"eligibilityCriteria":468,"healthyVolunteers":18,"sex":19,"minAge":232,"maxAge":469,"enrollmentInfo":470,"targetDuration":4,"studyType":96,"phases":471,"briefSummary":472,"conditions":473,"keywords":480,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":487,"lastUpdatePostDateStruct":488,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":55},"100638243","impact-of-a-novel-functional-snack-on-perimenopausal-symptoms-and-well-being-100638243","NCT07599930","Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being","Impact of a Novel Functional Snack on Perimenopausal Symptoms and Well-being: a Randomised, Double-blinded, Placebo-controlled, Crossover Trial","SWAP","Inclusion Criteria:\n\n* Adults aged 40 to 55\n* Score 14 or higher on the Menopause Rating Scale\n* For intervention purposes, eligible participants are also required to have a mobile phone and be able to read and speak English.\n\nExclusion Criteria:\n\n* People who consume more than 15g of fibre a day\n* People who consume more than 2 cups of coffee or tea a day\n* People who consume more than 4 portions (portion = 80g) of fruits and vegetables a day\n* People who do not have any intolerances or allergies to the following:\n* Any kinds of nuts including tree nuts, peanuts, hazelnuts and coconuts\n* Chia seeds\n* Pumpkin seeds\n* Sunflower seeds\n* Dates\n* Gluten\n* Dairy\n* Oats\n* Barley\n* Soya\n* People who smoke or vape or have smoked or vaped in the last 2 years\n* People who consume more than 21 drinks a week or have a history of excess alcohol intake\n* People with comorbid conditions that may limit participation in the study, such as a history of an acute cardiovascular event, including coronary artery disease, previous myocardial infarction (heart attack), stroke, peripheral artery disease, diabetes mellitus, chronic kidney disease, metabolic syndrome, malignancies, cardiac arrhythmia, renal failure, cardiac failure, uncontrolled hypertension, cancer or major psychiatric or cognitive problems\n* People receiving drug treatment for lipid metabolisms (e.g., statins)\n* People with a history of long-term use of medicines known to influence glucose metabolism (e.g., corticosteroids) or aspirin\n* People taking antihypertensive drugs\n* People who take antibiotics or bacterial agents (Probiotics) within 1 month\n* People who take vitamin\u002Fdietary supplements within 1 month\n* Pregnant women, women ready for pregnancy, and nursing mothers\n* cardiac arrhythmia\n* renal failure\n* heart failure (NYHA II-IV)\n* diabetes mellitus\n* Malignant disease\n* People who have participated in a biomedical study within the past 3 months\n* Women who require hormone replacement therapy during the development of the protocol.","55 Years",{"count":352,"type":24},[98],"This is a clinical trial aimed to investigate if a novel phytochemical and fibre-rich snack can improve perimenopausal symptoms and well-being in perimenopausal women aged 40-55 and not on hormone replacement therapy.\n\nHypothesis: The investigators hypothesise that the phytochemical and fibre-rich snack will improve perimenopausal symptoms via a gut microbiota mediated mechanism.\n\nMain research questions:\n\nDoes eating the snack every day lower menopause symptoms such as hot flushes, night sweats, mood changes, and sleep problems? Does the snack improve mood, stress, anxiety, sleep, and overall quality of life? Does the snack improve the balance of bacteria in the gut, and could this be part of how it helps symptoms?",[474,475,476,477,478,479],"Perimenopause","Perimenopause-Related Depression","Mood","Sleep","Quality of Life","Gut -Microbiota",[481,482,483,484,485,486],"phytochemical","fibre","mood","sleep","quality of life","gut","2026-05-14",{"date":489,"type":47},"2026-05-20",{"date":491,"type":47},"2026-04-24",{"date":493,"type":24},"2026-12",{"name":53,"class":54},{"id":496,"slug":497,"hasResults":12,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":18,"sex":63,"minAge":503,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":96,"phases":507,"briefSummary":508,"conditions":509,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":514,"completionDateStruct":516,"leadSponsor":518,"locationsCount":55},"100637470","effects-of-plant-foods-on-gastrointestinal-and-cardiometabolic-health-100637470","NCT07586111","Effects of Plant Foods on Gastrointestinal and Cardiometabolic Health","A Randomised Controlled Trial Investigating the Impact of Plant Foods on Gastrointestinal and Cardiometabolic Health","PLANTIFUL","Inclusion Criteria:\n\n* Adults aged 30-70 years of age\n* Capacity to give informed consent in English\n* Consume equal or less than the average UK plant food intake (number and quantity)\n* Consume less than 30 g\u002Fd of fibre\n* BMI 18.50-29.99 kg\u002Fm2\n* Willing to complete the trial by adhering to the diet intervention, complete questionnaires, provide stool, urine and blood samples, record weight and other anthropometric values and record food intake throughout the study\n* Willing and able to adhere to the protocol for the diet intervention for the whole duration of the trial (e.g., appropriate space in freezer to store meals, access to oven\u002Fmicrowave, no planned travelling)\n* Willing to discontinue use of prebiotics and probiotics 4 weeks prior and during the intervention period\n* Willing to consume animal products daily\n* Medication use is stable in women receiving hormone replacement therapy (stable use for the past 3 months)\n\nExclusion Criteria:\n\n* Medical history of any of the following: diabetes, major active or historic psychiatric conditions (e.g., schizophrenia), current eating disorder, alcohol abuse, active treatment for cancer in the last year, severe neurological, endocrine, renal, cardiac or pulmonary disease (or any other chronic medical condition), severe oesophagitis, gastritis or duodenitis, active diverticulitis or intestinal\u002Fcolonic strictures, Coeliac disease, Crohn's disease or Ulcerative colitis, stem cell or organ transplant, gut resection surgery (excluding appendicectomy and cholecystectomy), bleeding disorder, anaphylaxis or any other major or chronic condition known to impact study outcome measures.\n* A current diagnosis of IBS, as defined by the Rome IV criteria.\n* Taking medications known to affect outcomes of interest, including:\n* Prebiotics and probiotics 4 weeks prior to enrolment.\n* Antibiotics within 4 weeks of enrolment.\n* Medications known to affect blood pressure, appetite, gut motility, glucose control, or lipid levels within 4 weeks of enrolment.\n* Taking any dietary supplements, apart from vitamin D or calcium supplements, 4 weeks prior to enrolment.\n* Allergy or intolerance to any study food ingredients.\n* Unable\u002Fdislike\u002Funwilling to consume study foods or adhere to study protocol (e.g., not willing to drink a maximum 9 units of alcohol a week or consume animal products).\n* Currently reported pregnant or lactating.\n* Unwilling or unable to consume non-halal or non-kosher products.\n* Estimated energy requirements of \\\u003C1,500 kcal\u002Fday or \\>3,000 kcal\u002Fday.\n* Unexplained or unintentional weight loss in the past six months.","30 Years","70 Years",{"count":506,"type":24},248,[98],"The aim of this randomised controlled trial is to investigate the effects of plant foods on gastrointestinal and cardiometabolic health in healthy adults aged 30-70 years old. The main question it will answer is \"what is the effect of plant foods on alpha-diversity of the gut microbiota?\".\n\nResearchers will compare two diets containing plant foods to see if they have different effects on gastrointestinal and cardiometabolic health.\n\nParticipants will be asked to replace all their meals, snacks and drinks with those provided by the study team for four weeks (6 days\u002Fweek). Participants will also be asked to attend the research facility on three occasions to:\n\n* Provide a blood sample\n* Provide a urine sample\n* Provide a stool sample\n* Have their body composition assessed\n* Have an ultrasound of their artery (arm)\n* Have their blood pressure measured\n* Answer questionnaires related to dietary intake, mental health, physical activity, quality of life, diet acceptability and adherence",[510,511],"Healthy Adult Volunteers","Nutrition","2026-05-07",{"date":487,"type":47},{"date":515,"type":24},"2026-04",{"date":517,"type":24},"2028-11",{"name":53,"class":54},{"id":520,"slug":521,"hasResults":12,"nctId":522,"briefTitle":523,"officialTitle":524,"acronym":525,"eligibilityCriteria":526,"healthyVolunteers":12,"sex":19,"minAge":232,"maxAge":373,"enrollmentInfo":527,"targetDuration":4,"studyType":96,"phases":528,"briefSummary":529,"conditions":530,"keywords":538,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":545,"lastUpdatePostDateStruct":546,"startDateStruct":548,"completionDateStruct":550,"leadSponsor":552,"locationsCount":55},"100619166","skin-inflammation-in-perimenopause-a-probiotic-intervention-proof-of-concept-trial-100619166","NCT07341087","Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial","Skin Inflammation in (Peri)Menopause: A Probiotic Intervention Proof of Concept Trial (SIPPI)","SIPPI","Inclusion Criteria:\n\n1. Female, aged 40-60 years.\n2. Self-reported or clinician-diagnosed non-infectious, non-autoimmune inflammatory skin condition affecting the face (e.g., rosacea, acne, eczema).\n3. Willing and able to consume a daily oral intervention (2x 65 ml probiotic drinks or skimmed milk) for 8 weeks.\n4. Willing and able to provide sufficient blood, skin and stool samples at baseline and end-of-study (Week 8). Participants unable to provide adequate blood sample volumes will not be able to start the intervention.\n5. Willing and able to provide a photograph of the facial area, with all images anonymised for study purposes.\n6. Able to comply with study procedures, including attending clinic visits at KCL.\n7. Have access to a refrigerator at home and be able to store the study product(s) safely after collection (i.e., travel time allows safe storage).\n8. Capable of providing written informed consent.\n9. Have sufficient proficiency in English to complete study questionnaires and assessments.\n\nExclusion Criteria:\n\n1. Inability or unwillingness to provide informed consent.\n2. Inability or unwillingness to comply with study protocol requirements (e.g., clinic visits, sample provision, daily consumption of study drink)\n3. Unwilling to record dietary intakes using handwritten diet diaries\n4. Not fluent in the English language\n5. Is planning on international travel during the study period\n6. Current participation in another interventional clinical trial or having received an investigational\u002Fpharmaceutical product within the past 3 months.\n7. Known allergy or intolerance to dairy products, skimmed milk, or probiotic drinks containing Lactobacillus species.\n8. Currently pregnant, currently breastfeeding or planning to become pregnant in the next 4 months.\n9. BMI \\\u003C18.5kg\u002Fm2 or \\> 35kg\u002Fm2.\n10. Unintentional weight loss greater than 4 kg in the 3 months prior to enrolment.\n11. History of substance abuse or alcoholism (alcohol intake \\>50 units\u002Fweek) within the last 12 months.\n12. Current smokers, or individuals who quit smoking in the last 6-months.\n13. Fasting glucose \\>7mmol\u002Fl (finger prick test at baseline clinic).\n14. Active skin infection requiring systemic antibiotics, antivirals, or antifungals within the past 4 weeks.\n15. Major gastrointestinal disease (e.g., inflammatory bowel disease, celiac disease, short bowel syndrome) or history of significant gastrointestinal surgery (excluding appendectomy or cholecystectomy).\n16. Known immunodeficiency (e.g., HIV, immunosuppressive therapy, systemic corticosteroids \\>10 mg\u002Fday prednisolone equivalent).\n17. History of malignancy or clinically significant non-malignant skin conditions within the past 5 years (except adequately treated basal cell carcinoma).\n18. Serious medical conditions that, in the opinion of the investigator, would compromise safety or interfere with study outcomes (e.g., uncontrolled diabetes, advanced cardiovascular, hepatic, or renal disease, active cancer, autoimmune conditions).\n19. Women with a history of severe psychiatric illness that would limit adherence to study requirements.\n20. Current use of probiotics, prebiotics, or antibiotics within 4 weeks prior to baseline.\n21. Current use of systemic corticosteroids, or other immunosuppressive\u002Fimmunomodulatory therapies within the past 3 months.\n22. Currently receiving, or having received, phototherapy (e.g., UVB, PUVA, laser\u002Flight-based treatments, including at home treatments) for any skin condition within the past 3 months.\n23. Currently receiving, or having received, systemic dermatology treatments likely to affect skin inflammation or immune response within the past 3 months (e.g., isotretinoin, methotrexate, cyclosporine, biologics such as TNF, IL-17, IL-23 or IL-4\u002FIL-13 inhibitors).\n24. Currently receiving, or having received, topical treatments likely to significantly alter skin inflammation within the past 3 months (e.g., high-potency topical corticosteroids, topical calcineurin inhibitors such as tacrolimus or pimecrolimus, topical retinoids, or photodynamic therapy).\n25. Currently using, or have used, probiotic skincare (e.g., topical creams and serums) within the past 3 months.\n26. Currently receiving, have undergone, or plan to undergo cosmetic skin procedures (e.g., chemical peels, laser therapy, dermal fillers, microneedling) within the 3 months prior to, or within 3 months after the first (baseline) visit.\n27. Currently using, or have used, hormonal contraceptives or treatments known to exacerbate skin conditions, including Mirena (levonorgestrel-releasing intrauterine system), oral progesterone-only contraceptives (e.g., mini-pill), and synthetic progestogens (e.g., norethisterone) within the past 3 months.",{"count":148,"type":24},[98],"This study will explore whether a daily probiotic drink containing Lactobacillus casei Shirota (LcS) can help improve immune function and reduce inflammation in women going through the menopausal transition. Hormonal changes during this stage of life can affect the immune system, gut health, and skin, sometimes leading to increased inflammation or conditions such as eczema, acne or rosacea.\n\nParticipants will consume either a low-sugar LcS probiotic drink or a skimmed milk control drink every day for eight weeks. The study will assess markers of immune ageing, inflammation, skin health, wellbeing, and hormone levels. The results will help determine whether a safe, non-hormonal probiotic approach may support immune and skin health during the menopausal transition.",[531,532,533,534,151,535,536,537],"Skin Inflammation","Immunosenescence","Inflammation","Skin Health","Rosacea","Acne","Menopause",[539,540,541,542,543,544],"Probiotics","Lactobacillus casei Shirota","Immune ageing","Gut-skin axis","Skin health","Menopausal transition","2026-05-05",{"date":547,"type":47},"2026-05-08",{"date":549,"type":47},"2026-04-28",{"date":551,"type":24},"2027-11-01",{"name":53,"class":54},{"id":554,"slug":555,"hasResults":12,"nctId":556,"briefTitle":557,"officialTitle":558,"acronym":559,"eligibilityCriteria":560,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":96,"phases":563,"briefSummary":565,"conditions":566,"keywords":569,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":55},"100636034","phase-2-coronary-artery-stents-in-heart-failure-with-preserved-ejection-fraction-100636034","NCT07560436","Coronary Artery Stents in Heart Failure With Preserved Ejection Fraction","REvascularisation for Heart Failure With PReserved Ejection Fraction and Ischaemia: EValuation of Efficacy and Mechanistic Description","REPRIEVED","Inclusion Criteria:\n\n1\\. A diagnosis of HFpEF, defined by the European Society of Cardiology (ESC) criteria, defined as:\n\n1. Symptoms of heart failure (New York Heart Association (NYHA) class II-IV) and\n2. Left ventricular ejection fraction ≥ 50% and\n3. NT-pro-BNP \\> 125 pg\u002Fml in sinus rhythm or \\> 365 pg\u002Fml in atrial fibrillation and\n4. One or more of the following objective signs of left ventricular diastolic dysfunction:\n\ni. Invasively measured left ventricular end diastolic pressure ≥ 15 mmHg at rest or ≥ 25 mmHg on exercise (directly measured or estimated via pulmonary capillary wedge pressure) ii. Estimated pulmonary artery systolic pressure \\> 35mmHg or tricuspid regurgitation velocity \\> 2.8 m\u002Fs on echocardiography iii. Left atrial volume index \\> 34ml\u002Fm2 in patient in sinus rhythm or left atrial volume index \\> 40ml\u002Fm2 in atrial fibrillation iv. Relative left ventricular wall thickness \\> 0.42 v. Left ventricular mass index ≥ 95 g\u002Fm2 in females or ≥ 115 g\u002Fm2 in males vi. Mitral E\u002FE' ratio \\> 9\n\nExclusion Criteria:\n\n1. Age \\\u003C18 years\n2. People without capacity to provide informed consent\n3. PCI contraindicated or not feasible on coronary angiography or screening CTCA\n4. Contraindication to clopidogrel\u002Fdual antiplatelet therapy\n5. Recent acute myocardial infarction or coronary revascularisation (within 90 days)\n6. Enrolment in another interventional study which may affect study outcomes\n7. Severe chronic obstructive pulmonary disease (GOLD stage ≥3)\n8. Haemoglobin \\\u003C=80 g\u002FL\n9. Other cardiac diagnosis as a cause for HFpEF (hypertrophic cardiomyopathy, untreated severe left sided valvular disease, cardiac amyloidosis)",{"count":562,"type":24},350,[564],"PHASE2","HFpEF (heart failure with preserved ejection fraction) is a condition in which the heart muscle becomes stiff and can't pump blood properly. People living with HFpEF also often have coronary artery disease, where the blood vessels that supply the heart are narrowed or blocked.\n\nIt is not yet know whether opening these arteries with stents improves symptoms or quality of life with HFpEF. REPRIEVED is a randomised clinical trial that aims to find out if heart stents can improve quality of life for people living with heart failure with preserved ejection fraction (HFpEF) and coronary artery disease.\n\nResearchers will compare two groups of people; those who have a stent procedure to those who have a placebo procedure. The placebo procedure feels the same as a stent procedure but does not include a stent.\n\n350 people with HFpEF and coronary artery disease will be asked to take part. Participants will be monitored over a period of 6 months to see if and how quality of life changes.\n\nBefore the procedure, participants will be asked to complete a short health questionnaire, have a blood test, undergo an electrocardiogram (heart tracing) and scans of their heart.\n\nOn the day of the procedure, the participant will come to the hospital for an angiogram and will be randomly allocated to have either treatment with a stent or the placebo procedure without a stent. Participants will not know whether they have received heart stents. This helps researchers know that any improvements in their quality of life are not just related to how they feel about the stenting treatment.\n\nParticipants will then be contacted by a member of the research team at 3 months and 6 months after their procedure.\n\nAt 3 months, participants will complete a short health questionnaire either by phone or during a hospital visit.\n\nAt 6 months, participants will attend the hospital to complete a short health questionnaire, have blood tests, a scan of the heart (echocardiogram) and an electrocardiogram (heart tracing) to measure any changes in the heart.\n\nParticipants will be told whether they received the stent procedure or the placebo procedure.",[567,568],"Heart Failure With Preserved Ejection Fraction (HFPEF)","Coronary Artery Disease",[570,571,559,572,573,92],"HFpEF","Heart failure with preserved ejection fraction","REPRIEVED trial","Placebo PCI","2026-04-27",{"date":576,"type":47},"2026-05-01",{"date":578,"type":47},"2026-03-23",{"date":580,"type":24},"2029-08",{"name":53,"class":54},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":588,"eligibilityCriteria":589,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":590,"targetDuration":4,"studyType":96,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":596,"lastUpdatePostDateStruct":597,"startDateStruct":599,"completionDateStruct":600,"leadSponsor":602,"locationsCount":55},"100635746","a-study-of-home-use-brain-stimulation-to-treat-bipolar-depression-100635746","NCT07556692","A Study of Home-use Brain Stimulation to Treat Bipolar Depression","Home-based Transcranial Direct Current Stimulation in Bipolar Depression: a Randomised, Double-blind, Placebo-controlled Trial","BDEP","Inclusion Criteria:\n\n1. Adults aged 18 years or over.\n2. Diagnosis bipolar disorder in a current depressive episode based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria assessed by structured clinical assessment, Mini-International Neuropsychiatric Interview (MINI) (Sheehan et al.,1998).\n3. Having at least a moderate severity of depressive symptoms as measured by a score of at least 18 in MADRS (Montgomery and Åsberg, 1979).\n4. Either not taking antidepressant medication or taking a stable dose of antidepressant medication for at least 6 weeks before enrolment.\n5. Either not currently in psychotherapy or in ongoing psychotherapy for at least 6 weeks before enrolment.\n6. Being under care of GP.\n7. Agreeable for GP to be regularly informed by research team about participation.\n8. Able to provide written, informed consent.\n\nExclusion Criteria:\n\n1. Significant suicide risk as measured by answering 'yes' to questions 4, 5 or 6 on the Columbia Suicide Severity Rating Scale (C-SSRS) Screen (Posner et al., 2011).\n2. Primary comorbid psychiatric disorder (e.g. obsessive compulsive disorder) based on DSM criteria as assessed in MINI (Sheehan et al., 1998).\n3. Having a Young Mania Rating Scale (Young et al., 1978) score of 20 or more.\n4. Current daily use of medications that affect cortical excitability (e.g. benzodiazepines).\n5. Current illicit drug use or heavy alcohol use with high risk of alcohol use disorder as measured by a score of \\> 8 in Alcohol use disorders identification test consumption (AUDITC) (Khadlesari et al., 2017; NICE, 2023).\n6. History of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), other brain stimulation, or psychosurgery for depression.\n7. History of esketamine \u002F ketamine for treatment of depression.\n8. Medical disorder that may mimic mood disorder (e.g. hormonal disorder).\n9. History of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.\n10. Have cognitive impairment (e.g. dementia).\n11. History of a neurological disorder (e.g., cerebrovascular events, stroke, structural lesion, epilepsy, seizures, Parkinson's disease).\n12. History of migraines or intractable headaches.\n13. Implant in brain, neurocranial defect or active implantable medical device.\n14. Shrapnel or any ferromagnetic material in head.\n15. If female and of child-bearing potential, currently pregnant or planning to become pregnant during the study\n16. Concurrent enrolment in another interventional study.",{"count":591,"type":24},212,[98],"Bipolar depression is a long-lasting and disabling condition, and many people continue to experience depressive symptoms despite standard treatments. Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation that uses a very small electrical current applied through the scalp and has shown promise as a treatment for depression. This study aims to find out whether a home-based tDCS device is effective and safe in reducing symptoms of bipolar depression when compared with a placebo (sham) treatment. The study will also look at how acceptable the treatment is to participants and how well people are able to use the device at home.\n\nWho can participate? Adult patients aged 18 years and over who have a diagnosis of bipolar disorder and are currently experiencing a depressive episode.\n\nWhat does the study involve? Participants must meet specific eligibility criteria, which will be assessed by the research team. People who do not meet the study criteria or for whom tDCS is not suitable will not be able to take part. Participants will be randomly assigned to receive either active tDCS or a placebo (sham) treatment. Neither the participant nor the researchers assessing outcomes will know which treatment has been assigned.\n\nParticipants will use a study device at home over a defined treatment period and will complete a series of assessments at set time points. These include clinician-rated interviews and self-reported questionnaires about mood and well-being. Device use and adherence data will be collected electronically. Participants will also be monitored for any side effects throughout their involvement in the study.\n\nAlthough the study is multi-site, participation is primarily remote, with most study activities completed from the participant's home.\n\nWhat are the possible benefits and risks of participating? Participants may experience an improvement in depressive symptoms. Information gained from this study may help improve future treatments for bipolar depression.\n\ntDCS is generally well tolerated. Possible side effects include mild and temporary sensations such as tingling, itching, headache, or skin irritation at the electrode sites. All participants will be monitored for adverse events, and appropriate support will be available if needed.\n\nWhere is the study run from? The study is run from King's College London in collaboration with NHS research sites across the UK.\n\nWhen is the study starting and how long is it expected to run for? April 2026 to October 2027\n\nWho is funding the study? The National Institute for Health and Care Research (NIHR), UK.\n\nWho is the main contact? Professor Cynthia Fu, the Chief Investigator at King's College London, cynthia.fu@kcl.ac.uk",[595],"Bipolar Disorder (BD)","2026-04-22",{"date":598,"type":47},"2026-04-29",{"date":491,"type":24},{"date":601,"type":24},"2027-11-30",{"name":53,"class":54},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":607,"acronym":608,"eligibilityCriteria":609,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":610,"targetDuration":4,"studyType":96,"phases":611,"briefSummary":613,"conditions":614,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":616,"lastUpdatePostDateStruct":617,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":4},"100633981","phase-3-precise-phenotyping-to-guide-therapies-for-coronary-microvascular-dysfunction-100633981","NCT07533747","PRECISE Phenotyping to Guide Therapies for Coronary Microvascular Dysfunction","PRECISE-CMD","Inclusion Criteria:\n\n* Angina with non-obstructive coronary arteries\n\nExclusion Criteria:\n\n* Significant epicardial coronary stenoses\n* Inability to carry out bike exercise\n* Contra-indication to adenosine administration\n* Insulin usage with frequent hypoglycaemic episodes",{"count":95,"type":24},[612],"PHASE3","Some people experience chest pain and shortness of breath, but when they have tests, no blockages are found in their main heart arteries. The most common cause of symptoms is related to abnormalities in the small blood vessels, also known as 'small vessel angina' or Coronary Microvascular Dysfunction (CMD). Currently, the diagnosis of CMD requires additional measurements of blood flow in the heart vessel during a minimally invasive procedure known as a coronary angiogram.\n\nCMD affects many people and can lead to repeated hospital visits and a lower quality of life, and diagnosing the condition leads to better patient outcomes. However, there are still no widely available, proven treatments for this condition and therefore several patients remain symptomatic.\n\nThis study aims to find better ways to treat CMD, especially by understanding how the heart uses energy and how this might relate to symptoms.",[615],"Coronary Microvascular Dysfunction (CMD)","2026-04-10",{"date":618,"type":47},"2026-04-16",{"date":620,"type":24},"2026-05",{"date":622,"type":24},"2031-05",{"name":53,"class":54},{"id":625,"slug":626,"hasResults":12,"nctId":627,"briefTitle":628,"officialTitle":628,"acronym":629,"eligibilityCriteria":630,"healthyVolunteers":18,"sex":63,"minAge":20,"maxAge":631,"enrollmentInfo":632,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":634,"conditions":635,"keywords":636,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":662,"locationsCount":55},"100568934","immune-mechanisms-of-antipsychotic-treatment-response-100568934","NCT06687694","Immune Mechanisms of Antipsychotic Treatment Response","IMAT","Inclusion Criteria\n\nParticipants with psychosis symptoms:\n\n* Age 18-65\n* Currently experiencing psychosis symptoms warranting treatment by secondary care mental health services, as confirmed by a psychiatrist involved in their treatment.\n* Psychosis symptoms likely to be attributable to a disorder represented by ICD codes F20-F39, in the opinion of the treating clinical team.\n* Due to start or change to a new regular antipsychotic medication. (Participants who are initiating antipsychotic treatment for the first time, transitioning to a different antipsychotic medication, or resuming a formerly prescribed antipsychotic medication that was discontinued for a minimum of two weeks may be recruited.)\n\nControl Participants\n\n* Age 18-65\n* No active autoimmune disorder.\n* No history of psychosis symptoms.\n\nExclusion Criteria\n\nParticipants with psychosis symptoms:\n\n* Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.\n* Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).\n* Inability to have blood tests.\n\nControl participants:\n\n* Unacceptable risk of harm to participant or study staff due to risk of behavioural disturbance.\n* Currently taking or having taken in the last four weeks any medication known to grossly affect the production or function of immune cells (e.g. corticosteroids, methotrexate, cyclophosphamide, mycophenolate mofetil, rituximab or other monoclonal antibody therapies).\n* Inability to have blood tests.\n\nOptional lumbar puncture only:\n\n* Significant lower spinal deformity (such as spina bifida), injury (such as stenosis) or previous lower spinal surgery.\n* Antiplatelet or anticoagulant therapy within the 14 days prior to Lumbar Puncture procedure.\n* Known or suspected clotting disorder.\n* Clinically significant abnormality in full blood count.\n* Known or suspected raised intracranial pressure, assessed by study clinician.\n* Known or suspected allergy to local anaesthetic agent or an ingredient of the anaesthetic solution.\n* History of chronic or recurrent headaches, in the opinion of the investigator.","65 Years",{"count":633,"type":24},500,"The aim of this study is to investigate the role of the immune system in psychotic symptoms and their response to treatment. The investigators will collect blood and cerebrospinal fluid samples from participants with psychosis symptoms who are about to start or change to a new regular antipsychotic treatment as well as a control group for comparison.\n\nParticipants will be assessed at two main timepoints, at visit 1 (Week 0) and at visit 2 (4 +\u002F-2 weeks). For participants with psychosis symptoms visit 1 will take place at the start or change of antipsychotic medication. The studies goal is to identify biomarkers that can aid in diagnosis, prognosis, treatment selection, and tracking treatment response.\n\nThe investigators aim to recruit participants from the following groups:\n\n1. Individuals with psychosis symptoms presenting to acute or outpatient services who are due to be started on or change to a new regular antipsychotic medication.\n2. Age- and sex-matched control participants without neuropsychiatric disease.\n\nFindings could potentially impact the treatment of psychotic illnesses by offering mechanistic insights into targeted immune-based interventions for these disorders through high-resolution immunophenotyping techniques alongside targeted immunological assays. Ultimately, the research aims to contribute valuable resources for future studies exploring the connection between immune processes and neuropsychiatric conditions.",[238],[238,637,638,533,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654],"Antipsychotic","Neuroimmunology","Autoantibody","Schizophrenia","Schizotypal disorder","Persistent delusional disorders","Acute and transient psychotic disorders","Induced delusional disorder","Schizoaffective disorders","Other nonorganic psychotic disorders","Unspecified nonorganic psychosis","Manic episode","Bipolar affective disorder","Depressive episode","Recurrent depressive disorder","Persistent mood [affective] disorders","Other mood [affective] disorders","Unspecified mood [affective] disorder","2026-03-24",{"date":657,"type":47},"2026-03-25",{"date":659,"type":47},"2025-08-06",{"date":661,"type":24},"2031-07",{"name":53,"class":54},{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":668,"acronym":669,"eligibilityCriteria":670,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":671,"enrollmentInfo":672,"targetDuration":4,"studyType":96,"phases":674,"briefSummary":675,"conditions":676,"keywords":678,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":680,"lastUpdatePostDateStruct":681,"startDateStruct":683,"completionDateStruct":685,"leadSponsor":686,"locationsCount":55},"100629182","exploring-the-effect-of-cannabidiol-on-cannabis-tolerance-using-a-novel-vaporiser-device-in-heavy-users-stage-1-100629182","NCT07471347","Exploring The Effect Of Cannabidiol On Cannabis Tolerance Using A Novel Vaporiser Device In Heavy Users (Stage 1)","Exploring The Effect Of Cannabidiol On Cannabis Tolerance Using A Novel Vaporiser Device In Heavy Users: A Randomised Placebo-Controlled Experimental Study (Stage 1)","ENDURANCE","Inclusion Criteria:\n\n1. Adults, between 18 and 45 years old\n2. Heavy and frequent cannabis user: using 7-14 grams of high potency cannabis per week over the past month, and using cannabis on at least 5 days per week over the past month\n3. Positive urine drug screen (UDS) for cannabis\n4. Willing to abstain from cannabis use for 4 hours before any experimental session.\n5. Willing to eat two non-vegan full-fat yoghurts to aid drug absorption\n6. Providing written informed consent.\n\nExclusion Criteria:\n\n1. Dependent use of alcohol or illicit drugs (apart from cannabis or tobacco\u002Fnicotine)\n2. Not able to provide a UDS which is negative for illicit drugs (apart from cannabis)\n3. Not able to provide a negative alcohol breath test\n4. Personal or family history (first-degree) of psychosis or mania\n5. Currently prescribed antidepressant, mood-stabilising, antipsychotic or stimulant medication, or regular medication for a significant medical condition (e.g. antihypertensives, anticonvulsants, anticoagulants, or immunosuppressants)\n6. Diagnosis of a major medical or psychiatric illness that the study doctor considers inappropriate for the purposes of this study\n7. Female participants who are pregnant or mothers who are lactating\n8. Not willing to use an adequate form of contraception for the duration of the study\n9. Participant in another experimental medicine study or clinical trial within the past three months.","45 Years",{"count":673,"type":24},10,[98],"Cannabis contains delta-9-tetrahydrocannabinol (THC), which causes intoxication. People who use cannabis frequently often develop tolerance, meaning they need to use more THC to feel the same effects. Cannabidiol (CBD) is another compound found in cannabis that is not intoxicating and may influence how THC affects the body and brain.\n\nThis study will examine whether taking CBD changes how much THC heavy cannabis users consume to reach their usual level of intoxication. The study will also develop a new laboratory method that allows participants to safely and gradually self-administer THC using a vaporiser, similar to how cannabis is used in real-world settings.\n\nThe study will include around 30 adults who use cannabis heavily. In the first stage, participants will take part in pilot sessions to help refine the THC administration procedure. In the second stage, participants will attend two study sessions and receive a single oral dose of CBD or placebo, in a random order. After this, they will inhale THC using a vaporiser and decide when to stop based on how intoxicated they feel.\n\nResearchers will measure how much THC is used, along with mood, mental health symptoms, thinking abilities, physical measures such as heart rate and blood pressure, and blood levels of THC and CBD. The results will help improve understanding of cannabis tolerance and whether CBD alters responses to THC in heavy cannabis users.",[677],"Cannabis Intoxication",[383,381,679],"Delta-9-tetrahydrocannabinol","2026-03-12",{"date":682,"type":47},"2026-03-13",{"date":684,"type":24},"2026-03",{"date":493,"type":24},{"name":53,"class":54},{"id":688,"slug":689,"hasResults":12,"nctId":690,"briefTitle":691,"officialTitle":692,"acronym":693,"eligibilityCriteria":694,"healthyVolunteers":12,"sex":63,"minAge":20,"maxAge":4,"enrollmentInfo":695,"targetDuration":4,"studyType":96,"phases":697,"briefSummary":698,"conditions":699,"keywords":701,"overallStatus":78,"whyStopped":4,"lastUpdateSubmitDate":719,"lastUpdatePostDateStruct":720,"startDateStruct":722,"completionDateStruct":724,"leadSponsor":726,"locationsCount":727},"100551524","phase-3-a-prospective-faecal-microbiota-transplantation-trial-to-improve-outcomes-in-patients-with-cirrhosis-100551524","NCT06461208","A PROspective Faecal MIcrobiota tranSplantation Trial to Improve outcomEs in Patients With Cirrhosis","PROMISE Trial: A PROspective Randomised Double-blind Parallel Group Placebo-controlled Multicentre Trial of Faecal MIcrobiota tranSplantation to Improve the Primary outcomE (First Hospitalisation Due to Infection) in Patients With Cirrhosis Over 24 Months","PROMISE","Inclusion Criteria:\n\n1. Aged ≥ 18 years\n2. Confirmed Alcohol-related (ALD) or Metabolic dysfunction-Associated Steatotic Liver Disease (MASLD) or MetALD cirrhosis based on clinical, radiological and\u002For histological criteria.\n3. MELD score 8-16\n4. Patients with alcohol-related cirrhosis who must have an active alcohol consumption on average ≤20 grams\u002Fday \\[1 unit of alcohol contains 10mLs or 8g of alcohol\\].\n5. Patients must be deemed to have the capacity to provide written informed consent to participate.\n\nExclusion Criteria:\n\n1. Moderate, severe or life-threatening food allergy (e.g., peanut allergy)\n2. Pregnancy or planned pregnancy\\*. Urine testing will be performed at screening to rule out pregnancy in females.\n3. Breast-feeding\n4. Patients treated for acute variceal bleeding, infection, overt hepatic encephalopathy, bacterial peritonitis or ACLF within 14 days prior to randomisation.\n5. Active alcohol consumption of \\>20 grams\u002Fday \\[1 unit of alcohol contains 10mLs or 8g of alcohol\\]\n6. Had a previous liver transplant\n7. Patients with inflammatory bowel disease.\n8. Patients with coeliac disease.\n9. Patients with a history of prior gastrointestinal resection or surgery that could change the gut microbiome or result in bacterial overgrowth e.g. gastric bypass\n10. Active malignancy including hepatocellular carcinoma\n11. Patients with an expected life expectancy \\\u003C6 months or listed for liver transplantation\n12. Infected with HIV, hepatitis B or C \\[patients who have undetectable hepatitis B or C DNA\u002FRNA can be recruited\\].\n13. Patients who have received antibiotics or probiotics (excluding food stuffs containing 'live bacteria' such as live yoghurts, kefir, fermented vegetables such as sauerkraut\u002Fkombucha or cheese) within 7 days prior to randomisation.\n14. Swallowing disorder, oral-motor dyscoordination or likely inability\u002Funwillingness to ingest study medication.\n15. Patients who have received another investigational drug or device within 4 months prior to randomisation.\n16. Patients, who in the opinion of the PI, have a medical condition, or other relevant psychological, familial, or social factor that may jeopardise their health, compliance, or influence the trial integrity in any way.",{"count":696,"type":24},300,[612],"A feasibility trial called PROFIT has previously shown that FMT administered endoscopically into the jejunum in patients with cirrhosis is safe and feasible and have identified some potential mechanisms of action that warrant further interrogation. The aim of the PROMISE Trial is to evaluate the efficacy and mechanisms of action of encapsulated FMT (versus placebo) to reduce infection and mortality in patients with alcohol-related and metabolic dysfunction-Associated Steatotic Liver (MASLD) cirrhosis.",[700],"Liver Cirrhosis",[702,703,704,700,705,706,707,708,709,710,711,712,693,713,714,715,716,717,718],"Fatty Liver Alcoholic","Alcohol-related Liver Disease","Metabolic dysfunction-Associated Steatotic Liver Disease","MASLD","MASLD-ALD overlap cirrhosis","ALD","Faecal Microbiota Transplant","Metabolic Fatty Liver Disease","Fatty Liver Disease","Gut Microbiota","Cirrhosis","MetALD","Liver Decompensation","Hepatic Encephalopathy","Infection","New Onset Ascites","Variceal Bleeding","2026-02-19",{"date":721,"type":47},"2026-02-24",{"date":723,"type":47},"2023-06-21",{"date":725,"type":24},"2028-06-30",{"name":53,"class":54},23,""]