[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University Hospital Southampton NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":671},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,44,73,99,123,148,182,211,237,267,293,322,352,382,412,437,457,481,504,524,552,577,606,626,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100553634","pilot-study-of-nitrate-rich-beetroot-juice-supplementation-in-patients-with-idiopathic-pulmonary-fibrosis-ipf-100553634",false,"NCT06488638","Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)","BEET-IPF","IPF Patients: Inclusion Criteria\n\n1. Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on current established consensus guidelines.\n2. Medical Research Council (MRC) breathlessness grade 1-3\n3. Judged clinically stable for 3 months prior to recruitment by the investigator.\n\nIPF Patients: Exclusion Criteria\n\n1. Baseline spirometry with FEV1\u002FFVC ratio \\\u003C 0.7.\n2. Neoplastic disease undergoing treatment or active follow up.\n3. Presence of infection or exacerbation requiring hospitalization, within last 3 months.\n4. Current tobacco smoker or use of nicotine containing vapes (within 3 months)\n5. Current use of ambulatory or long-term oxygen therapy (LTOT).\n6. Peripheral oxygen saturations \\\u003C85% during 6-minute walk-test.\n7. Any condition which would prevent completion of cycle-ergometer testing, pulmonary function testing (PFT) or 6-minute walk testing as judged by the investigator.\n8. Participation in a pulmonary rehabilitation (PR) program in the last 3 months.\n9. Any condition excluding CPET based on the absolute contraindication as the ACCP\u002FATS guidelines 2003\n10. Positive pregnancy test in females of childbearing age.\n11. Symptomatic peripheral vascular disease\n12. Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors\n\nControls: Inclusion Criteria\n\n1\\) Age and sex-matched to participants in the IPF cohort. Note: the participants will be age-matched within a 5-year age bracket.\n\nControls: Exclusion Criteria\n\n1. Inability to give informed written consent.\n2. Malignancy (except localised squamous or basal cell skin carcinoma) undergoing active investigation, treatment, or follow-up.\n3. Significant cardiorespiratory disease as judged by the investigator.\n4. Diabetes mellitus requiring treatment with pharmacology therapy.\n5. Current tobacco smoker or use of nicotine containing vapes (within three months).\n6. Symptomatic peripheral vascular disease.\n7. Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors.",true,"ALL","18 Years","85 Years",{"count":22,"type":23},16,"ESTIMATED","INTERVENTIONAL",[26],"NA","Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients. In previous research the investigators identified that an interval-based exercise programme led to significant improvements in exercise capacity (Wallis et al Antioxidants. 2023).\n\nAn unexpected finding was that in patients with IPF, exercise led to a reduction in blood nitrite concentrations an observation the investigators did not see in non-affected individuals. Research has identified that nitrite concentrations are expected to increase after exercise and the size of this increase is related to an individual's exercise capacity. There is also evidence from healthy individuals and patients with chronic obstructive pulmonary disease (COPD) that nitrate supplementation (a source of nitrite) improves response to exercise training. However, in both these groups an exercise-induced fall in blood nitrite concentrations has not been observed. Hence our finding of an exercise-induced fall in blood nitrite levels in IPF patients suggest that they may be especially sensitive to supplementation with nitrate, commercially available as nitrate-rich beetroot juice (NRBJ).\n\nThis current study investigates this in a pilot placebo-controlled, double-blind, randomised, cross-over study of NRBJ on exercise capacity in IPF patients.\n\nAims In patients with IPF\n\n* Quantify the effect of nitrate supplementation on exercise capacity\n* Determine the effect of nitrate supplementation on blood markers of nitric oxide production\u002Fmetabolism.\n* Determine the effect of nitrate supplementation on forearm blood flow. Sample size: n=8 IPF patients, aged 18-85years and medical research breathlessness scale 1-3 Intervention: 3-days (two-times daily) NRBJ or nitrate-depleted placebo juice (both commercially available) with subsequent constant-load exercise test (Primary outcome). Following at least 1 week wash-out period participants will cross-over and repeat.\n\nA cohort (n=8) of age, sex-matched controls without IPF will be enrolled for comparison of forearm blood flow and pre-exercise venous blood samples for biomarkers comparison only.\n\nNumber of sites: 1",[29,30],"Idiopathic Pulmonary Fibrosis","Interstitial Lung Disease","RECRUITING","2026-06-26",{"date":34,"type":35},"2026-06-30","ACTUAL",{"date":37,"type":35},"2026-02-13",{"date":39,"type":23},"2027-06-03",{"name":41,"class":42},"University Hospital Southampton NHS Foundation Trust","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":24,"phases":54,"briefSummary":55,"conditions":56,"keywords":58,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100482902","rct-of-implantable-defibrillators-in-patients-with-non-ischemic-cardiomyopathy-scar-and-severe-systolic-heart-failure-100482902","NCT05568069","RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure","Using Cardiovascular Magnetic Resonance Identified Scar as the Benchmark Risk Indication Tool for Implantable Cardioverter Defibrillators in Patients With Non-Ischemic Cardiomyopathy and Severe Systolic Heart Failure","BRITISH","Inclusion Criteria:\n\n1. A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging\n2. LV scar on routine CMR (patient without scar can enter the registry)\n3. New York Heart Association (NYHA) Heart Failure (HF) functional class I-III and severely impaired left ventricular function (LVEF ≤ 35% on any imaging modality) after a minimum of 3 months of treatment with optimal medical therapy (OMT) as recommended by National Institute for Health and Care Excellence (NICE)\n4. Able and willing to provide informed consent\n\nExclusion Criteria:\n\n1. New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT)\n2. Acute decompensated heart failure\n3. Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD)\n4. Ischemic cardiomyopathy (ICM) is defined as segmental wall motion abnormalities or wall thinning in a particular coronary territory with subendocardial or transmural late gadolinium enhancement (LGE). Patients with an LVEF ≤35% and a small amount of ischemic LGE (i.e. an infarct out of keeping with the amount of LV dysfunction) will not be excluded (so-called dual pathology patients)\n5. Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy)\n6. Known Lamin gene mutation or a positive family history of a Lamin gene mutation\n7. Valve disease is considered likely to require surgery during the 3 years follow-up period\n8. Complex congenital heart disease\n9. Any secondary prevention ICD indication\n10. Heart transplant recipient or admitted for cardiac transplantation\u002F left ventricular assist device\n11. Clinically apparent myocardial ischemia which requires revascularization\n12. Intracardiac mass which requires surgery\n13. Active endocarditis\n14. Active Septicaemia\n15. Pregnancy\n16. Life expectancy \\\u003C2 years secondary to any other cause (i.e. malignancy)\n17. Active treatment with chemotherapy\n18. Severe renal failure (GFR \\\u003C30)\n19. Actively participating in another study without prior agreement between both Chief Investigators",{"count":53,"type":23},2504,[26],"BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries. Participants will be randomised into two groups. Half the participants will receive an Implantable Cardioverter-Defibrillator (ICD) and the other half will not. The aim of the study will be to compare all-cause mortality (death from any cause) between these two groups at 36 months, and longer-term to 10 years. The study has the potential to change international heart failure treatment guidelines and to improve how patients with this condition are managed.",[57],"Heart Failure",[59,60,61,62,63],"Cardiac Magnetic Resonance Imaging (CMR)","Implantable Cardioverter Device","Implantable Loop Recorder","Left ventricular ejection fraction (LVEF)","Myocardial scar","2026-06-12",{"date":66,"type":35},"2026-06-16",{"date":68,"type":35},"2023-04-12",{"date":70,"type":23},"2032-02-28",{"name":41,"class":42},47,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":80,"minAge":19,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":43},"100639185","vaginal-fluid-derived-biomarkers-in-the-early-detection-and-evolution-of-gynaecological-cancers-100639185","NCT07622953","Vaginal Fluid Derived Biomarkers in the Early Detection and Evolution of Gynaecological Cancers","VIOLET","Inclusion Criteria:\n\n* Suspected cohort: Individuals undergoing investigations for suspected gynaecological cancer. This includes patients undergoing surgery to reduce their risk of the development of gynaecological cancers in the future\n* Confirmed treatment cohort: Individuals with a confirmed gynaecological cancer diagnosis undergoing anti-cancer treatment including surgical resection, chemotherapy or radiotherapy as part of their routine clinical care\n* Confirmed palliative cohort: Individuals with a confirmed gynaecological cancer diagnosis undergoing palliative procedures including ascitic drainage as part of their routine clinical care\n\nExclusion Criteria:\n\n* Patients under 18 years old\n* Individuals who lack capacity to consent to trial participation\n* Pregnant or breastfeeding patients\n* Patients with active vaginal infection\n* Patients currently on or having received antibiotics within the previous week\n* History of prior malignancy or chronic inflammatory disease","FEMALE",{"count":82,"type":23},250,"OBSERVATIONAL","This study will investigate vaginal secretions in those patients with cancer versus those who are cancer free and compare changes in specific markers that change when a cancer first develops.\n\nPatients who are being investigated for any gynaecological cancer, undergoing surgery to reduce their risk of gynaecological cancer and those with confirmed gynaecological cancer undergoing anti-cancer treatment will be approached to take part in this study.\n\nParticipants will be asked to provide an extra blood test, urine sample and high vaginal swab in addition to surplus primary tissue and ascitic fluid that is left over from routine surgical procedures. Specific markers will be compared in patients who have evidence of gynaecological cancer versus those that do not. Changes in these markers during anti-cancer treatment will also be compared to see how these change over time. This could improve the detection and monitoring of gynaecological cancers in those people at highest risk of developing it by using non-invasive multi-cancer early detection tests developed at the University of Southampton.",[86],"Gynaecological Cancers",[88,89,90],"Gynaecological cancers","Biomarker","Multi-Cancer Early Detection","2026-05-26",{"date":93,"type":35},"2026-06-03",{"date":95,"type":35},"2026-01-14",{"date":97,"type":23},"2030-07-02",{"name":41,"class":42},{"id":100,"slug":101,"hasResults":12,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":18,"minAge":107,"maxAge":4,"enrollmentInfo":108,"targetDuration":110,"studyType":83,"phases":4,"briefSummary":111,"conditions":112,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},"100549908","understanding-the-variation-of-modern-endoscopic-ultrasound-use-in-patients-with-oesophageal-cancer-value-100549908","NCT06440174","Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE)","Understanding the Variation of Modern Endoscopic Ultrasound Use in Patients With Oesophageal Cancer (VALUE): a Multi-methods Study","VALUE","Inclusion Criteria:\n\n1. Patients aged 16 or above with first diagnosis of biopsy-confirmed oesophageal cancer.\n2. Referred for EUS examination as part of standard of care investigations.\n3. Tumour location in the oesophagus, or gastro-oesophageal junction (Siewert types I-III)\n4. MDT decision that patient is potentially curable with radical treatment (e.g., endoscopic treatment, surgery +\u002F- neoadjuvant therapy, or definitive chemoradiotherapy)\n5. Prior staging with CT and PET-CT\n6. Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n7. Clinical staging of T1-T4, N0-N3, M0 disease\n8. Adenocarcinoma or squamous cell carcinoma (SCC) histopathological cell type\n\n   Exclusion Criteria:\n9. Recurrent or residual disease\n10. Distant metastatic disease detected before EUS.\n11. Previous oesophagectomy or oesophageal radiotherapy\n12. Unable to undergo EUS examination.\n13. Concurrent malignancy e.g., second primary tumour\n14. Other histopathological cell type","16 Years",{"count":109,"type":23},160,"6 Months","This is an observational trial that will look at patients undergoing endoscopic ultrasound (EUS) in patients with oesophageal cancer and to determine the proportion of cases in which EUS changes disease management in these patients.",[113],"Oesophageal Cancer","2026-04-24",{"date":116,"type":35},"2026-04-30",{"date":118,"type":35},"2024-06-27",{"date":120,"type":23},"2026-12-31",{"name":41,"class":42},14,{"id":124,"slug":125,"hasResults":12,"nctId":126,"briefTitle":127,"officialTitle":127,"acronym":128,"eligibilityCriteria":129,"healthyVolunteers":17,"sex":80,"minAge":19,"maxAge":130,"enrollmentInfo":131,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":43},"100635846","reframing-endometrial-physiology-by-advanced-integrated-research-100635846","NCT07557992","Reframing Endometrial Physiology by Advanced Integrated Research","REPAIR","Inclusion Criteria:\n\n* 18-45\n* Having Periods\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding.\n* Known uterine malignancy, severe anaemia requiring urgent treatment, or other acute gynaecological emergencies.\n* Inability to undergo MRI (e.g., pacemaker, severe claustrophobia).\n* Inability to provide informed consent.\n* Current use of hormonal treatment, or use in the last 2 months","45 Years",{"count":132,"type":23},100,"Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the uterus linked with HMB. The investigators aim to recruit approximately 130 participants across two study sites over three years, including people with and without HMB.",[135],"Menorrhagia Due to Benign Causes",[137,138,139,140],"menorrrhagia","heavy menstrual bleeding","electrophysiology","uterine contractility","2026-04-22",{"date":116,"type":35},{"date":144,"type":35},"2026-02-06",{"date":146,"type":23},"2030-02-01",{"name":41,"class":42},{"id":149,"slug":150,"hasResults":12,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":4,"eligibilityCriteria":154,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":155,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":157,"conditions":158,"keywords":164,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":175,"startDateStruct":177,"completionDateStruct":179,"leadSponsor":181,"locationsCount":43},"100620234","immuno-fit-observational-study-100620234","NCT07354971","IMMUNO-FIT Observational Study","The Immuno-FIT Observational Study: A Phase II Window Observational Study Investigating the Effects of Immunotherapy on Cardiopulmonary Fitness, Quality of Life, and Treatment Outcomes in Patients With Advanced Cancer","Inclusion Criteria:\n\n* Age ≥18 years\n* Histologically confirmed solid malignancy\n* Receiving immune checkpoint inhibitors in one of the following settings:\n\n  * Adjuvant: Single-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4\n  * Metastatic\u002FPalliative: Single-agent or dual-agent anti-PD-1, anti-PD-L1, or anti-CTLA-4\n* ECOG Performance Status 0-2\n* Able to perform cardiopulmonary exercise testing\n* Able to provide written informed consent\n* Willing and able to comply with study procedures and follow-up schedule\n\nExclusion Criteria:\n\n* Age \\\u003C18 years\n* Prior systemic anti-cancer immunotherapy for unresectable or metastatic disease, EXCEPT:\n* Prior adjuvant or neoadjuvant immunotherapy if all treatment-related adverse events have returned to baseline or stabilized\n* Prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy with at least 6 months since last dose and date of disease recurrence\n* Absolute contraindications to cardiopulmonary exercise testing:\n* Acute myocardial infarction within 6 weeks\n* Unstable angina\n* Uncontrolled cardiac arrhythmias causing symptoms or hemodynamic compromise\n* Active endocarditis\n* Symptomatic severe aortic stenosis\n* Uncontrolled heart failure\n* Acute pulmonary embolism or pulmonary infarction\n* Acute myocarditis or pericarditis\n* Suspected or known dissecting aneurysm\n* Acute systemic infection\n* Inability to perform cardiopulmonary exercise testing (e.g., severe lower limb dysfunction, severe peripheral vascular disease)\n* Inability to provide informed consent\n* Currently enrolled in another interventional clinical trial that would confound study outcomes\n\nADDITIONAL EXCLUSION CRITERIA FOR RESEARCH BIOPSY SUB-STUDY:\n\n* Severe cardiopulmonary disease precluding safe sedation (for endoscopic biopsies)\n* Suspected bowel obstruction or perforation (for gastrointestinal biopsies)\n* Uncorrectable severe coagulopathy (INR \\>1.5, platelet count \\\u003C50,000\u002FµL)\n* Severe portal hypertension with high-risk varices (for upper endoscopy)\n* Lesion inaccessible for safe biopsy as determined by a performing clinician",{"count":156,"type":23},67,"This observational study will investigate how immunotherapy affects physical fitness, quality of life, and treatment tolerance in adults with solid cancers. Immunotherapy can cause a range of side effects that impact daily functioning and may lead to treatment delays or early discontinuation. Physical fitness may influence how well patients cope with treatment, yet little is known about how fitness changes during immunotherapy or whether baseline fitness is linked to outcomes.\n\nParticipants will complete fitness testing using cardiopulmonary exercise testing (CPET) and quality-of-life questionnaires before starting immunotherapy and again 12 weeks later. Blood samples will also be taken, and long-term outcomes including survival, disease progression, and quality of life will be followed for up to 24 months. All cancer treatment will remain standard of care.\n\nA small number of participants will be invited to take part in an optional research biopsy at week 12 to explore how physical fitness relates to changes in the tumour's immune environment.\n\nThe study will help researchers understand natural changes in fitness during immunotherapy, identify whether baseline fitness is associated with treatment tolerance or outcomes, and generate information needed to design future trials testing exercise-based interventions during immunotherapy.",[159,160,161,162,163],"Neoplasms","Immunotherapy","Physical Fitness","Quality of Life","Drug-Related Side Effects and Adverse Reactions",[160,165,161,166,162,167,168,169,170,171,172,173,174],"Immune Checkpoint Inhibitors","Cardiopulmonary Exercise Testing","Immune-Related Adverse Events","Cancer","Exercise Physiology","Tumour Microenvironment","PD-1","PD-L1","CTLA-4","Observational Study",{"date":176,"type":35},"2026-04-28",{"date":178,"type":35},"2026-03-26",{"date":180,"type":23},"2028-12-31",{"name":41,"class":42},{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":18,"minAge":190,"maxAge":191,"enrollmentInfo":192,"targetDuration":4,"studyType":24,"phases":194,"briefSummary":195,"conditions":196,"keywords":199,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":210},"100577859","surveillance-of-pancreatic-health-after-diabetes-diagnosis-100577859","NCT06803771","Surveillance of Pancreatic Health After Diabetes Diagnosis","A Randomised Trial to Evaluate the cfDNA Pancreatic Cancer Test (Avantect) in the Early Detection of Pancreatic Cancer in Patients With Newly Diagnosed Diabetes Mellitus","SAFE-D","Inclusion Criteria:\n\n* 50 - 84 years of age at the time of enrolment (within year of birth, not month of birth)\n* Haemoglobin A1c (HbA1c) ≥ 48 or 6.5% and\u002For confirmed type II DM diagnosed within the last 180 days (+20 days flexibility allowance)\n* Willing to provide up to 30 mL of blood for each study visit\n* Willing and eligible to undergo MRI scan (or CT scan if MRI is contraindicated)\n* Understands the study process and is willing to take part in the study and sign the informed consent form\n\nExclusion Criteria:\n\n* Prior type I or type II DM diagnosis \\> 6 months\n* A history of pancreatic cancer, pancreatic neuroendocrine tumour (pNET) or Pancreatitis\n* Under investigation for pancreatic cancer \u002F pancreatic cyst\n* Any known pancreatic surgery (not including ERCP), or other major surgery requiring anaesthesia within 3 months\n* Any invasive solid or haematological cancer in the past 3 years, including cancer recurrence after treatment in the last 3 years\n* Current chronic or acute oral or systemic steroid use within 3 months of initial HbA1c or diabetes diagnosis (estimate rather than accurate)\n* Blood transfusion within 1 month\n* Solid organ transplant recipient\n* Currently pregnant\n* Needing dialysis","50 Years","84 Years",{"count":193,"type":23},15000,[26],"The goal of this interventional study is to evaluate if the novel diagnostic blood test, called Avantect can early detect pancreatic cancer in patients diagnosed with type 2 diabetes within the last 6 months.\n\nParticipants will:\n\n* attend 3 study visits over 12 months time\n* provide a blood sample at each study visit\n* complete an anxiety questionnaire at each visit.",[197,198],"Diabetes Mellitus","Pancreatic Cancer, Adult",[200,201],"Type 2 diabetes","pancreatic cancer","2026-03-20",{"date":204,"type":35},"2026-03-23",{"date":206,"type":35},"2025-05-21",{"date":208,"type":23},"2029-02",{"name":41,"class":42},31,{"id":212,"slug":213,"hasResults":12,"nctId":214,"briefTitle":215,"officialTitle":215,"acronym":4,"eligibilityCriteria":216,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":217,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":229,"lastUpdatePostDateStruct":230,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":43},"100620433","a-qualitative-study-investigating-the-lived-experiences-and-impact-of-reproductive-issues-in-adults-with-primary-ciliary-dyskinesia-100620433","NCT07357558","A Qualitative Study Investigating the Lived Experiences and Impact of Reproductive Issues in Adults With Primary Ciliary Dyskinesia","Inclusion Criteria:\n\n* Lives in United Kingdom\n* 'likely' or 'confirmed' diagnosis of PCD\n* able and willing to sign the consent form\n\nExclusion Criteria:\n\n* unwilling to participate in the study\n* not meeting inclusion criteria",{"count":218,"type":23},30,"Study involving undertaking research interviews with adults who have primary ciliary dyskinesia in the UK about their views and experiences of fertility, pregnancy and parenthood",[221],"Primary Ciliary Dyskinesia (PCD)",[223,224,225,226,227,228],"fertility","pregnancy","reproduction","parenthood","qualitative","interviews","2026-01-21",{"date":231,"type":35},"2026-01-22",{"date":233,"type":35},"2025-09-02",{"date":235,"type":23},"2026-07-31",{"name":41,"class":42},{"id":238,"slug":239,"hasResults":12,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":12,"sex":18,"minAge":245,"maxAge":19,"enrollmentInfo":246,"targetDuration":4,"studyType":24,"phases":248,"briefSummary":249,"conditions":250,"keywords":253,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":263,"leadSponsor":265,"locationsCount":266},"100581546","improving-quality-of-life-for-teenagers-with-asthma-100581546","NCT06851715","Improving Quality of Life for Teenagers With Asthma","Can the Quality of Life of Adolescents With Asthma be Improved by Focusing on Improving Their Asthma Self-management","IMPAQT","Inclusion Criteria:\n\n* Adolescent aged 12-18 years\n* Attending a paediatric respiratory clinic\n* Informed consent from adolescent aged ≥16 years, and assent plus parent\u002Fguardian consent for adolescents aged ≤16 years\n* Paediatric Asthma Quality of Life Questionnaire score ≤5.5 points\n\nExclusion Criteria:\n\n* Aged 0-11 or over 18 years\n* Other significant long-term medical condition that has a day-to-day impact on their lives (except for co-existing allergic conditions, breathing pattern disorder, dysfunctional breathing, or intermittent laryngeal obstruction)\n* Adolescent or parent\u002Fguardian unable to communicate sufficiently to complete consent forms.","12 Years",{"count":247,"type":23},98,[26],"BACKGROUND: Asthma is a long-term lung condition affecting 1 in 11 children and young people in the UK. Many teenagers have well controlled asthma, but a significant number continue to experience regular symptoms and asthma attacks leading to hospitalisations. While non-adherence to medication is a factor, teenagers also face challenges like changing relationships with parents and peers, avoiding triggers like smoking, and fitting in treatment with daily life demands. Healthcare professionals (HCPs) also face difficulties in managing teenagers with asthma.\n\nA previous study, funded by Asthma + Lung UK, developed a new approach to manage teenage asthma by focusing on self-efficacy, which is how confident one feels about performing a task. Teenagers completed the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ), which identified areas where they needed more support. HCPs then tailored their consultations to address these needs. This approach improved the teenagers' confidence in self-managing their asthma.\n\nImproving quality of life (QoL) is a key goal in asthma care. Therefore, the aim of this study is to determine if the self-efficacy approach improves QoL for teenagers with asthma.\n\nMETHODS: Teenagers aged 12-18 years with asthma will be recruited from hospital clinics. They will be randomly assigned to one of two groups:\n\n1. Teenager will complete the AASEQ at the start of their appointment. The HCPs will use this to focus the consultation on areas where the teenager needs support in self-managing their asthma.\n2. Teenager will have their usual consultation with the HCP.\n\nThree months after the appointment, the QoL will be compared between the two groups using a standardised questionnaire.\n\nIMPACT: If the self-efficacy approach proves to be beneficial, it could help HCPs to empower teenagers to better manage their asthma and ultimately improve their quality of life.",[251,252],"Asthma in Children","Asthma",[252,254,255,256,257],"Adolescent","Self-efficacy","Quality of life","Asthma control","2025-12-30",{"date":260,"type":35},"2026-01-05",{"date":262,"type":35},"2025-08-26",{"date":264,"type":23},"2027-11-01",{"name":41,"class":42},2,{"id":268,"slug":269,"hasResults":12,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":4,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":274,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":276,"conditions":277,"keywords":281,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":292,"locationsCount":43},"100615491","the-pneumorator-study-100615491","NCT07293299","The PneumoRator Study","Clinical Validation of the PneumoRator Respiratory Rate Sensor in a Perioperative Cohort","Inclusion Criteria:\n\n1. Have undergone or are referred for CPET\n2. are scheduled for elective surgery and expected to have \\>24 hours postoperative hospital stay\n3. Will be admitted to the Surgical High Dependancy Unit (SHDU) as part of their planned care\n4. will receive invasive arterial pressure monitoring as part of routine care\n5. are aged 18 or over\n6. have the capacity to give consent to participate\n\nExclusion Criteria:\n\n1. do not proceed to surgery following CPET referral\n2. are aged less than 18 years\n3. do not have capacity to consent\n4. decline to consent\n5. have sensitivity or allergy to medical adhesives\n6. patients with fragile, erythematous, or broken skin at the site of PnemoRator attachment or any other condition which, in the view of the clinical research team, may mean that the use of the PnemoRator device and adhesive is likely to cause patient harm.\n7. patients with implantable electronic medical devices (e.g. pacemakers, nerve stimulators)",{"count":275,"type":23},50,"Healthcare workers measure heart rate, blood pressure, temperature, oxygen levels and breathing rate to monitor how unwell a patient is. All these apart from breathing rate are now normally measured by machines. But there still isn't a machine that does this well enough for breathing rate to be used in most places. The machines that do exist are either uncomfortable or don't work well on patients who are moving. Instead, a healthcare worker will count the number of breaths a patient takes. This needs staff time and isn't very accurate.\n\nIt is known that changes in breathing rate can happen any time. But healthcare systems normally only measure it every few hours because it takes time. Breathing rate could be monitored all the time, we might pick up people getting sick earlier and be able to treat them more quickly, which could save lives.\n\nA team at the University of Southampton has made a small device, called a PneumoRator, that gets stuck to onto a person's chest. Once stuck there it can measure their breathing rate and store or send that information wirelessly. The device has been tested on healthy volunteers but has never been tested on patients in hospital.\n\nIn this study the team will put the device on patients having major operations. The investigators will record information already collected about patients during normal care. This includes their breathing rate using the best measurement we have, where a patient's breathing is measured by a gas they breathe out. The gas is carbon dioxide, and the measurement is called capnography. This way of measuring is only used in operating theatres and intensive care units but is a good way to check if the PneumoRator is accurate.\n\nThe investigators want to attach the PneumoRator to patient's chests before they go to sleep for their operation and leave it there for the first few days after their operation. This will let them see how the PneumoRator compares to capnography and manual breath counting. It will also let them see how the device works at different times in the patient's journey. The investigators will look at the time when patients are asleep, when breathing is controlled by a machine. Then when patients wake up investigators can measure with both capnography and the PneumoRator. Finally, when patients go to the high dependency ward, investigators will compare it against manual counting. The study team will also ask patients how they found wearing the device and any problems they found.\n\nWith this information the investigators hope to show the PenumoRator is accurate at measuring breathing rate and comfortable for patients. This will help them get the device approved for use in hospitals and other places where breathing rate needs to be measured accurately.",[278,279,280],"Respiratory","Monitored Anaesthesia Care","Perioperative",[282,283,284,285],"monitoring","respiratory rate","sensor","wearable","2025-12-16",{"date":288,"type":35},"2025-12-19",{"date":290,"type":35},"2025-04-25",{"date":114,"type":23},{"name":41,"class":42},{"id":294,"slug":295,"hasResults":12,"nctId":296,"briefTitle":297,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":24,"phases":303,"briefSummary":304,"conditions":305,"keywords":310,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":319,"leadSponsor":321,"locationsCount":43},"100614363","virtual-group-prehabilitation-education-surgery-school-feasibility-trial-100614363","NCT07278622","Virtual Group Prehabilitation Education (Surgery School) Feasibility Trial","Feasibility Testing and Process Evaluation of a Virtual Group Preoperative Prehabilitation Education Intervention (GoPREPARE)","GoPREPARE","Inclusion Criteria:\n\n* Adults undergoing elective surgery for any body cavity cancer with curative intent.\n* Adults with more than 3 weeks before planned surgery\n* Adults without previous experience of prehabilitation.\n\nExclusion Criteria:\n\n* Children\n* Adults who lack mental capacity.\n* Adults who do not understand spoken English.\n* Previous experience of prehabilitation.\n* Previous surgery for cancer\n* Pregnancy",{"count":302,"type":23},24,[26],"One in four patients requiring planned major surgery have complications. Prehabilitation; which involves increasing physical activity, improving nutrition and supporting emotional well-being prior to surgery can reduce these complications and improve recovery. Group preoperative prehabilitation classes (surgery schools) are advocated by the Centre for Perioperative Care and are standard care in many hospitals, despite a lack of evidence for their effectiveness in improving patient outcomes. In phase 1 an 2 of this research investigators used patient experiences and co-participatory methods to optimise an existing intervention to make it as acceptable and as engaging as possible. The resulting education package is called 'GoPREPARE'\n\nInvestigators now intend to test the practicalities of trialing GoPREPARE on preoperative patients with cancer. 24 patients awaiting surgery will be recruited from University Hospital Plymouth and randomly allocated equally to: Group - GoPREPARE and Group 2- standard care. Participants will complete lifestyle questionnaires before during and after their hospital stay. To evaluate the experience, \\~8 participants will be interviewed. 5 clinical staff involved in the trial will also take part in a focus group. The information collected will be analysed to assess if it is feasible to conduct a larger trial.",[306,307,308,309],"Cancer Surgery","Elective Surgery","Patient Education","Prehabilitation",[311,312,313,314],"surgery school","prehabilitation","patient education","perioperative care","2025-12-11",{"date":317,"type":35},"2025-12-12",{"date":233,"type":35},{"date":320,"type":23},"2026-07-01",{"name":41,"class":42},{"id":323,"slug":324,"hasResults":12,"nctId":325,"briefTitle":326,"officialTitle":327,"acronym":328,"eligibilityCriteria":329,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":330,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":332,"conditions":333,"keywords":335,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":351},"100555004","risk-characterization-of-non-culprit-vessels-in-patients-undergoing-primary-pci-for-st-elevation-mi-in-multivessel-disease-100555004","NCT06506448","Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease","Anatomical, Physiological and Inflammatory Characterization of the Non-Culprit Vessels in Patients Undergoing Primary PCI for ST-Elevation Myocardial Infarction in the Presence of Multivessel Disease Toward a Personalised Approach to Complete Revascularisation After Primary PCI","PICNIC","Inclusion Criteria:\n\n1. Ability to provide written informed consent (post PPCI)\n2. Age 18 years to 85 years\n3. Presentation of acute STEMI within 12 hours of symptom on-set\n4. Culprit artery PPCI\n5. Coronary stenosis of \\> 50% diameter stenosis by visual estimation in NIRA with a minimum diameter of 2.5mm\n\nExclusion Criteria:\n\n1. Cardiogenic shock\n2. Decompensated heart failure requiring intubation, inotropes, or intra-aortic balloon counter pulsation\n3. Refractory ventricular arrhythmia\n4. Previous coronary artery bypass surgery (CABG)\n5. Stent thrombosis and in stent restenosis\n6. An intention before inclusion into the study to revascularize a non-culprit lesion\n7. Active malignancy or inflammatory disorders such as rheumatoid arthritis or inflammatory bowel disease\n8. Severe valvular heart disease requiring surgery\n9. Planned surgical revascularisation\n10. Active participation in another study\u002Ftrial\n11. \\\u003C 12 months life expectancy\n12. Contraindication to CTCA\n\n    * Presence of internal defibrillator\n    * Known allergy to iodinated contrast\n    * Pregnancy\n    * Contraindication to intravenous beta blockade\n    * Contraindication to acute sublingual nitrate administration\n    * Mechanical prosthetic heart valve\n    * Advanced renal impairment (creatinine \\>200)\n    * Significant valve disease (sever aortic stenosis or regurgitation; severe mitral regurgitation)\n\nAngiographic exclusion criteria\n\n1. NIRA stenosis of 50% or more in the left main stem or the ostia of both the left anterior descending and circumflex arteries\n2. \\\u003C TIMI (thrombolysis in myocardial infarction) flow grade 3 in the NIRA,\n3. Evidence of thrombus in the NIRA.",{"count":331,"type":23},320,"Most heart attacks occur because a clot forms in a coronary artery blocking blood flow. Without blood heart muscle dies. Untreated, clots can cause a specific type of heart attack -ST-elevation myocardial infarction (STEMI). STEMI patients are treated immediately by finding the blocked artery (\"culprit\" lesion) using a dye injected into the coronary arteries and then by unblocking the artery using balloons and stents. This procedure - primary angioplasty - is offered 24\u002F7 and limits the size of heart attacks and saves lives.\n\nCardiologists know how to treat STEMI patients but it's less clear what to do about narrowings in other coronary arteries (\"bystander\" disease). This is important - if they're left alone some bystander lesions can cause future events including heart attacks or angina. Recent trials compared stenting ALL the bystander narrowings after primary angioplasty, with stenting none and showed some benefit from stenting all of them (\"complete revascularisation\").\n\nHowever, complete revascularisation carries extra risk, putting patients through more complicated procedures and using up resource. A blanket strategy of complete revascularisation of ALL bystander narrowings in ALL STEMI patients is unlikely to be the correct answer as only a small minority of these patients have further events.\n\nIn PICNIC the investigators want to identify bystander narrowings most likely to cause a future event, and those unlikely to do so. The study can then test the hypothesis that only the high-risk bystander narrowings need stenting, and the others can be treated with tablets only. Investigators will study patients using specialised imaging techniques from coronary artery CT scans and levels of inflammation to see which narrowings cause future events and which do not. If this can be done, a case can be made to test complete revascularisation only in bystander narrowings that look high risk.",[334],"ST Elevation Myocardial Infarction",[336,337,338,339,340,341,342],"Primary percutaneous coronary intervention","Infarct related artery","Non-infarct related artery","Computerised Tomography Coronary Angiography CTCA","Fractional Flow Reserve from CT (FFRct)","Fat Attenuation Index (FAI)","Inflammation","2025-09-17",{"date":345,"type":35},"2025-09-23",{"date":347,"type":35},"2025-01-20",{"date":349,"type":23},"2029-01",{"name":41,"class":42},3,{"id":353,"slug":354,"hasResults":12,"nctId":355,"briefTitle":356,"officialTitle":357,"acronym":4,"eligibilityCriteria":358,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":359,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":361,"conditions":362,"keywords":369,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":374,"lastUpdatePostDateStruct":375,"startDateStruct":377,"completionDateStruct":379,"leadSponsor":381,"locationsCount":43},"100602250","validation-of-a-parent-administered-symptom-score-for-unsettled-infants-every-baby-is-unique-100602250","NCT07121062","Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)","Validation Of A Parent Administered Symptom Score For Unsettled Infants","Inclusion Criteria:\n\n1. Consent to complete the anonymous questionnaire\n2. Parent 18 years old or over\n3. Parent of an infant aged under 12 months old at time of questionnaire completion\n\nExclusion Criteria:\n\n1. Parent does not consent to complete the anonymous questionnaire\n2. Parent under 18 years old\n3. Parent of an infant aged 12 months or older at time of questionnaire completion",{"count":360,"type":23},350,"It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas.\n\nTo address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething.\n\nThis study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues.\n\nParents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided.\n\nBy validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.",[363,364,365,366,367,368],"Colic, Infantile","Milk Allergy, Cow's","Gastro Oesophageal Reflux Disease","Atopic Dermatitis (Eczema)","Constipation - Functional","Congential Hip Dysplasia",[370,371,372],"Infantile colic","Cows milk allergy","Unsettled behaviour","NOT_YET_RECRUITING","2025-08-06",{"date":376,"type":35},"2025-08-13",{"date":378,"type":23},"2025-09",{"date":380,"type":23},"2026-08",{"name":41,"class":42},{"id":383,"slug":384,"hasResults":12,"nctId":385,"briefTitle":386,"officialTitle":387,"acronym":388,"eligibilityCriteria":389,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":390,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":392,"conditions":393,"keywords":395,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":43},"100594392","mitochondrial-assessment-in-critical-ill-patients-in-intensive-care-100594392","NCT07018843","Mitochondrial Assessment in Critical Ill Patients in Intensive Care","Metabolic Characterisation of Critically Ill Patients: An Observational Study Focusing on Mitochondria","MitoICU","Inclusion Criteria:\n\n* Adults ≥ 18 years\n* Mechanically ventilated at time of recruitment\n* Defined as critically ill by the responsible clinician\n* Recruited within 48-hours of intubation\n* Likely to remain intubated and ventilated for \\> 72-hours\n\nExclusion Criteria:\n\n* Patients \\\u003C 18 years\n* Patient is being treated on an end-of-life pathway or active treatment is likely to be withdrawn within 24-hours\n* Patient has significant liver dysfunction (Child-Pugh ≥ class 3)\n* Patient is not absorbing enterally (defined as 2 x NG aspirates of \\> 500ml)\n* Known pregnancy or positive urinary pregnancy test on testing\n* Specific exclusion criteria for the muscle biopsy component of the study: Patients taking treatment dose anticoagulation, antiplatelet agents or with severe coagulopathy (or disease process leading to increased risk of bleeding) will be excluded from having a muscle biopsy taken as part of data collection.",{"count":391,"type":23},20,"Critically ill patients often require admission to the intensive care unit (ICU). When patients develop organ failures and end up on a ventilator, there are changes in the body's cell function that can increase the risk of poor outcomes. All cells, in order to function normally, have mitochondria, which help them generate energy and transfer vital messages between cells. However, during critical illness, the mitochondria in the cells can function less effectively and die prematurely, or their new synthesis and regeneration can be severely affected. This can result in continuous multi-organ failure with a lack of recovery and muscle wasting, causing severe weakness and an inability to function normally.\n\nIn this study, the investigators aim to assess mitochondrial capacity using three methods with varying levels of invasiveness. The investigators are planning to recruit 20 patients in the ICU who are on a ventilator for breathing support. The investigators plan to measure mitochondrial capacity from a breath test, blood cells, and muscle cells.\n\nThe investigators will collect breath samples after consuming an amino acid, which is a component of protein in our body and is commonly found in food. This amino acid is only broken down by the mitochondria. This safe test allows us to measure how much mitochondrial capacity remains in the body after the modified amino acid is broken down by the mitochondria. In comparison, the investigators will use standard methods which includes blood tests and muscle biopsy to examine the mitochondrial function of platelets (blood cells) and muscle cells. The investigators will also use non-invasive techniques (ultrasound and 'MyotonPRO') to assess muscle.\n\nThis study will help us determine the best way to assess mitochondrial function and capacity in critically ill patients and to understand strengths and weaknesses of different approaches.\n\nWhen patients' mitochondrial function or capacity is impaired, the investigators can provide them with particular nutrition to improve mitochondrial activity. Because evaluating this at the bedside is challenging, it is impossible to tell which patients may benefit from specific therapies that improve mitochondrial function. If this breath test provides an assessment similar to the standard, sophisticated mitochondrial testing, the investigators could use it at the bedside in the future, which may improve patient outcomes and help design large clinical trials.",[394],"Critical Illness",[396,397,398,399,400,401,402,403],"Mitochondria","Critical illness","Respirometry","Muscle biopsy","Breath test","Oroboros","MyotonPRO","Muscle ultrasound","2025-06-04",{"date":406,"type":35},"2025-06-13",{"date":408,"type":23},"2025-07",{"date":410,"type":23},"2026-03",{"name":41,"class":42},{"id":413,"slug":414,"hasResults":12,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":422,"conditions":423,"keywords":425,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":430,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":4},"100592732","ethnography-of-hospital-care-for-adults-with-learning-disabilities-100592732","NCT06997250","Ethnography of Hospital Care for Adults With Learning Disabilities","Improving the Care People With Learning Disabilities Receive in Hospital: an Ethnographic Study Examining the Experiences of People With Learning Disabilities and the Organisation and Delivery of Their Care","Care4Me","Inclusion Criteria:\n\n* Adults with a learning disability (over the age of 18)\n* Receiving inpatient care in the hospital site during the data collection period\n\nExclusion Criteria:\n\n* Children and young people with learning disabilities (under 18 years of age).\n* People living with other kinds of cognitive impairment (not learning disability) e.g. head injury\n* People not receiving inpatient care in the hospital sites during the recruitment period\n* Patients on the end-of-life care pathway at the point of recruitment into the study\n* Patients in intensive care units at the point of recruitment into the study",{"count":421,"type":23},96,"This study will:\n\n1. explore care experiences during a hospital admission from the perspectives of adults with learning disabilities (including people with profound learning disabilities) and their carers.\n2. Examine how care is organised and delivered for adults with learning disabilities during a hospital admission.\n3. Use the findings to co design guidance with people with learning disabilities, carers, and ward staff to improve care.\n\nThis study will follow the care of 8 adults with learning disabilities (including people with profound learning disabilities) during a hospital admission, in two hospitals in England. The researcher will use tailored communication to support people in sharing their experiences, including Talking Mats, Makaton and photos. The researcher will spend time with people with profound learning disabilities, learning how they communicate and carefully interpreting their non-verbal communications with their carers' support. The researcher will also talk to people's carers. The researcher will observe people's care, meetings about their care, talk to staff about their care, and read care notes (if the person agrees). The researcher will write this down and analyse it to learn how care could be improved.\n\nThe research team will work with people with learning disabilities, carers, and hospital staff to co design resources to improve ward care for people with learning disabilities. This will include:\n\n1. recommendations to the NHS on adapting ward care;\n2. a masterclass on ward care for participating hospitals;\n3. a briefing to the NHS in England and the Care Quality Commission on improving how ward care is checked and managed; and\n4. guidance and a toolkit on making co design more inclusive, including for people with profound learning disabilities.\n\nThe research team includes a person with a learning disability and a family carer, who will steer this project. The research team are working with people with learning disabilities and carers throughout our study to make sure it reflects their needs.",[424],"Learning Disability, Adult",[426,427,428,429],"Learning disabilities","Hospital care","Acute care","Ward care",{"date":431,"type":35},"2025-05-30",{"date":433,"type":23},"2025-06",{"date":435,"type":23},"2025-09-30",{"name":41,"class":42},{"id":438,"slug":439,"hasResults":12,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":444,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":449,"lastUpdatePostDateStruct":450,"startDateStruct":452,"completionDateStruct":454,"leadSponsor":456,"locationsCount":4},"100571733","artificial-intelligence-to-detect-early-total-knee-replacement-implant-failure-100571733","NCT06724094","Artificial Intelligence to Detect Early Total Knee Replacement Implant Failure","Using Machine Learning to Detect and Predict Loosening NexGen Total Knee Replacement","Inclusion Criteria:\n\n* Had a NexGen TKR between 2003 and 2022.\n\nExclusion Criteria:\n\n* Below 18 yrs old.\n* Revision surgery for any reason other than aseptic loosening\n* patients who have not had a revision but who do not have a well functioning TKR.",{"count":445,"type":23},2105,"The goal of this trial is to investigate whether Machine Learning (ML) can be used to detect small degrees of loosening, lucent zones, or any other changes on radiographs that might predict early failure following NexGen total knee replacement.\n\nResearchers will identify plain AP and lateral plain film radiographs from two groups of patients. Those who has NexGen total knee replacements (TKRs) that went on to failure, and those who has well performing TKRs. Radiographs from these two groups will be labelled as 'failure' and 'well performing' and will be processed through a machine learning algorithm.\n\nThe algorithm will be successful if it is able to detect a NexGen TKR that went on to failure or went on to perform well. This will be determined by using a test set.\n\nThe population will be adults who had the recalled a NexGen Total Knee Replacement with a standard tibial tray. It will include adults only, who has the TKR at University Hospitals Southampton between 2003 and 2022.\n\nFailure will be defined as revision of tibial or femoral components which is likely due to aspectic loosening. It will exclude washouts, exchange of poly, peri-prosthetic fractures, microbiologically confirmed infection.\n\nWell performing TKRs will be defined as patients who have had their TKR in situ for 10 years and have reported no significant symptoms.",[448],"Aseptic Loosening of Prosthetic Joint","2025-05-12",{"date":451,"type":35},"2025-05-13",{"date":453,"type":23},"2025-08",{"date":455,"type":23},"2025-12",{"name":41,"class":42},{"id":458,"slug":459,"hasResults":12,"nctId":460,"briefTitle":461,"officialTitle":462,"acronym":463,"eligibilityCriteria":464,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":465,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":467,"conditions":468,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":480},"100456090","reconstruction-in-extended-margin-cancer-surgery-100456090","NCT05219058","Reconstruction in Extended MArgin Cancer Surgery","REMACS - Understanding the Impact of Perineal Reconstruction After Extended MArgin Cancer Surgery on Longer-term Quality of Life, Morbidity and Health Economic Outcomes - a Prospective Longitudinal Cohort Study","REMACS","Inclusion Criteria:\n\n* Male and female patients aged 18 or older\n* Patients that have undergone pelvic exenteration or abdominoperineal excision at participating sites, at any time, that have complete data (work package 1 - Colorectal Surgery Database)\n* Patients undergoing pelvic exenteration or abdominoperineal excision at participating sites (work package 2 - prospective study)\n* Patients that have already had pelvic exenteration or abdominoperineal resection that can speak English (work package 3 - mixed-methods study)\n\nExclusion Criteria:\n\n* Patients eligible for, but that are unfit, decline or are not offered abdominoperineal excision or pelvic exenteration surgery\n* Patients that undergo surgery by an intersphincteric abdominoperineal resection approach\n* Patients that are unable to complete the questionnaire over the telephone or online with a researcher\n* Patients unable or unwilling to provide informed consent\n* Patients that are prisoners in the custody of HM Prison Service or who are offenders supervised by the probation service",{"count":466,"type":23},236,"Advanced pelvic cancers are uncommon, with treatment being challenging. Around 4000 patients every year need treatment in the UK. Cancers can involve multiple organs and often need radiotherapy and chemotherapy before surgery. Surgery usually requires removal of multiple pelvic organs, including muscles, bone, and skin around the anus (the perineum). This can lead to complications relating to both the empty pelvis syndrome and closure of the perineal defect.\n\nReconstruction is challenging, with frequently occurring complications, reducing speed of recovery and quality of life. This study investigates complication frequency, quality of life and expenses following different reconstruction techniques. The investigators hope to improve patient and doctor decision-making in this area and find the best methods of reconstruction to improve outcomes.\n\nREMACS has three work packages:\n\n1. Maintenance of a database of patients undergoing colorectal surgery at Southampton and Salisbury Hospitals, including those undergoing extra-levator abdominoperineal excision and pelvic exenteration. This includes all routinely collected clinical data, imaging, health resource use, and patient reported outcome measures.\n2. A collaborative national prospective cohort study investigating morbidity, health resource use, longitudinal quality of life outcomes (EORTC QLQ-C30 and disease-specific modules) and quality adjusted life years. The investigators will also assess financial toxicity using the comprehensive score for financial toxicity.\n3. A qualitative study using semi-structured interviews to undertake a more complex evaluation of quality of life and patient experiences in patients that have recovered from their surgeries.\n\nThe last two work packages have now been funded by an NIHR Research for Patient Benefit Grant",[469,470,471,162],"Surgery--Complications","Pelvic Cancer","Abdominal Cancer","2025-01-29",{"date":474,"type":35},"2025-01-31",{"date":476,"type":35},"2022-05-17",{"date":478,"type":23},"2028-01-01",{"name":41,"class":42},18,{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":486,"acronym":487,"eligibilityCriteria":488,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":490,"briefSummary":491,"conditions":492,"keywords":494,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":503,"locationsCount":43},"100577858","teicoplanin-allergy-testing-using-autologous-serum-tatas-100577858","NCT06803758","Teicoplanin Allergy Testing Using Autologous Serum (TATAS)","Improving The Sensitivity of Teicoplanin Allergy Testing By Using Autologous Serum","TATAS","Inclusion Criteria:\n\n* Adult patients 18 years old and above who have suffered suspected anaphylaxis under anaesthesia (the 'index episode'), where teicoplanin has been given\n\nExclusion Criteria:\n\n* Patients unable to stop drugs that would interfere with skin tests prior to study- e.g. antihistamines or certain anti-psychotics\n* Pregnancy\n* Patients under age 18 years\n* Patients with elevated baseline mast cell tryptase requiring further investigation\n* Patients with blood-borne viruses such as Hep B, C and HIV",{"count":391,"type":23},[26],"Allergy testing for Teicoplanin is much more unreliable than for other similar drugs. This means that we run the risk of missing serious Teicoplanin allergy, and these patients will be given another dose in future, not knowing that they are seriously allergic. Serious allergic reactions, also known as anaphylaxis, can be life threatening.\n\nThe patients which we recruit to our study will come to us through the perioperative allergy service. They will have had a reaction to a general anaesthetic, but will also have had teicoplanin as part of the anaesthetic.\n\nWe are not sure why allergy skin testing, which is fairly reliable for most other drugs, is so unreliable in detecting teicoplanin allergy. We do know that some drugs need to mix with proteins in the blood before they trigger an allergy. We would like to replicate this by mixing the teicoplanin with the patients' own blood and using this for the skin testing, to see if we get a more reliable result compared with the plain drug. Using the patient's own serum to do skin testing is an established test (the 'autologous serum test') used in certain immunological conditions, we are simply going to use it as a vehicle to test our theory.\n\nWe will recruit 20 adult patients referred with a recent history of anaphylaxis under anaesthesia, where teicoplanin has been given and is one of the drugs under suspicion of having caused the allergy. In addition to the usual allergy skin testing, which would be done anyway as part of standard allergy investigation, we will perform extra tests using autologous serum for this trial.\n\nWe hope to find a better way of testing for Teicoplanin allergy, so that patients are not put at risk where the allergy has been missed because of an unreliable test.",[493],"Drug Allergy",[495,496],"Teicoplanin allergy testing","Autologous Serum","2025-01-27",{"date":474,"type":35},{"date":500,"type":35},"2025-01-08",{"date":502,"type":23},"2026-12",{"name":41,"class":42},{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":512,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":514,"conditions":515,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":523,"locationsCount":43},"100535553","early-detection-of-at-risk-septic-patients-100535553","NCT06253325","Early Detection of At-risk Septic Patients","An Observational Pilot Study for the Multi-Modality Risk Prediction and Early Identification of Critically Ill Septic Patients in the Emergency Department","MMICS","Inclusion Criteria:\n\n1. Differential diagnosis which includes infection\n2. Change in the quick Sequential Organ Failure Assessment (qSOFA) ≥2 or National Early Warning Score 2 (NEWS2) score ≥5\n3. Aged ≥18 years\n\nExclusion Criteria:\n\n1. Traumatic injury\n2. Rockwood frailty score ≥6\n3. Critical care therapy previously believed to not be in patient's best interests\n4. Critical care therapies-initiated pre-hospital. Critical care therapies defined as:\n\n   4.1 Mechanical ventilation 4.2 Vasopressor\u002Finotrope therapy 4.3 Sedation or a general anaesthetic 4.4 Pre-hospital transfusion of blood products 4.5 Extra-corporeal support\n5. Advanced directive refusing critical care therapies.\n6. Acute cardiac failure\n7. Active gastrointestinal bleed\n8. Massive pulmonary embolism\n9. ICU admission declined by critical care team\n10. Treated in an acute hospital \\\u003C6 hours before presentation to the Emergency Department",{"count":513,"type":23},60,"The purpose of this study is to determine whether additional investigations used in other parts of healthcare can be used in the Emergency Department to identify critically ill patients quicker than usual care.",[516],"Sepsis","2024-11-27",{"date":519,"type":35},"2024-12-02",{"date":521,"type":35},"2024-01-12",{"date":374,"type":23},{"name":41,"class":42},{"id":525,"slug":526,"hasResults":12,"nctId":527,"briefTitle":528,"officialTitle":529,"acronym":530,"eligibilityCriteria":531,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":532,"enrollmentInfo":533,"targetDuration":4,"studyType":24,"phases":535,"briefSummary":536,"conditions":537,"keywords":541,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":546,"startDateStruct":547,"completionDateStruct":549,"leadSponsor":551,"locationsCount":43},"100509767","cardiac-arrest-bundle-of-care-trial-100509767","NCT05917717","Cardiac Arrest Bundle of cARE Trial","Cardiac Arrest Bundle of Care Trial","CABARET","Inclusion Criteria:\n\n1. Adult patients (\\>18 year of age) who have suffered a cardiac arrest\n2. Body habitus is compatible with the bundle devices.\n3. Witnessed event\n4. Time of collapse was known with reasonable certainty to have been to be within 20 minutes.\n\nExclusion Criteria:\n\n1. Visibly pregnant women\n2. Prisoners\n3. Traumatic cardiac arrest\n4. Drowning\n5. Hanging\n6. DNACPR\n7. Have been in witnessed cardiac arrest for an estimated time of 21 minutes or more","120 Years",{"count":534,"type":23},32,[26],"An out-of-hospital cardiac arrest is a sudden event where the heart stops beating and a person becomes unresponsive. During this event, vital organs in the body receive no blood flow, causing them to shut down. Without intervention to restart the heart, a person effectively dies. In the UK, around 60,000 people experience cardiac arrests each year, with most occurring at home. Despite prompt emergency service response, survival rates are typically low.\n\nThere is technology available that has the potential to improve survival rates for out-of-hospital cardiac arrests. The intervention involves three devices used together: head-up position CPR (Elegard), active compression-decompression mechanical CPR (Lucas-3), and the Impedance Threshold device (Resqpod-16). When combined, these devices can enhance blood flow during resuscitation, potentially leading to improved initial resuscitation rates and higher rates of survival with normal brain function after a cardiac arrest.\n\nA pilot study is planned to test the feasibility of using these devices. The results will inform the design of a larger study to determine if this technology can indeed improve survival rates in out-of-hospital cardiac arrests.",[538,539,540],"Cardiopulmonary Resuscitation","Cardiac Arrest","Out of Hospital Cardiac Arrest",[539,542,538,543,544,545],"Mechanical CPR","Impedance threshold device","Active compression decompression CPR","Head up cardiopulmonary resuscitation (HUP-CPR)",{"date":519,"type":35},{"date":548,"type":35},"2024-05-24",{"date":550,"type":23},"2025-08-30",{"name":41,"class":42},{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":559,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":561,"conditions":562,"keywords":566,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":569,"lastUpdatePostDateStruct":570,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":576,"locationsCount":43},"100565703","utilisation-of-health-services-and-quality-of-life-in-patients-with-atypical-parkinsonian-syndromes-100565703","NCT06645626","Utilisation of Health Services and Quality of Life in Patients With Atypical Parkinsonian Syndromes","UHSQOLAPS","Inclusion Criteria:\n\nPatients and their carers must:\n\n* Be aged 18 or over\n* Have capacity to consent at the beginning of their involvement\n* Have a diagnosis of a neurodegenerative disease which includes progressive supranuclear palsy, corticobasal syndrome and multiple system atrophy but may include other closely related diseases where the presentation is similar, such as Alzheimer's disease where they present with a corticobasal syndrome\n\nExclusion Criteria:\n\n* Patients or carers not meeting the inclusion criteria\n* Patients with static deficits only who do not have a neurodegenerative syndrome.\n* Patients who the principal investigator feels are not suitable to take part due to co-morbidities or participation in other trials.",{"count":560,"type":23},198,"The study will compare health care utilisation and quality of life for patients with progressive supranuclear palsy, corticobasal syndrome and multiple system atrophy in different parts of the region that our specialist clinic operates in with different services as well as in other regions with no specialist clinics. This study aims to investigate which aspects of the service are most beneficial for the patients and to determine the influence of support services and specialty clinics on patients and their carers.",[563,564,565],"Progressive Supranuclear Palsy","Cortico Basal Degeneration","Multiple System Atrophy",[567,568],"quality of life","health economics","2024-10-15",{"date":571,"type":35},"2024-10-17",{"date":573,"type":35},"2022-10-10",{"date":575,"type":23},"2027-07-15",{"name":41,"class":42},{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":83,"phases":4,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":43},"100557800","ironheart-intravenous-iron-in-non-ischaemic-heart-failure-100557800","NCT06542822","IRONHEART: Intravenous Iron in Non-ischaemic Heart Failure","Immediate Effects of Intravenous Iron Therapy in Patients With Systolic Heart Failure and Iron Deficiency as Evaluated by Cardiac Magnetic Resonance Imaging: An Observational Prospective Study","IRONHEART","Inclusion Criteria:\n\n* Participants capable of giving informed consent.\n* Aged 18yrs and above.\n* Diagnosed with heart failure and a reduction of their ejection fraction \\\u003C 40% by any modality.\n* Non ischaemic cardiomyopathy as determined by baseline cardiac magnetic resonance imaging.\n* Iron deficient per this definition: Transferrin saturations \\\u003C 20%.\n* Established on Heart failure therapy including SGLT2i therapy for a minimum of four weeks prior to recruitment.\n* New York Heart Association score of I - III class.\n\nExclusion Criteria:\n\n* New York Heart Association classification Score \\>IV\n* Ischaemic cardiomyopathy\n* Chronic kidney stage: Estimated Glomerular Filtration Rate (eGFR) \\\u003C 30\n* Requirement for renal dialysis\n* Atrial fibrillation \u002F atrial flutter\n* Non cardiac and cardiac palliative diagnosis\n* Active cancer diagnosis\n* Moderate to severe valvular heart disease\n* Cardiac electronic implantable device: Cardiac resynchronization therapy, Implantable cardioverter-defibrillator, left ventricular assist device\n* Cardiac \\& non cardiac transplant participants\n* Myocardial infarction, Percutaneous Coronary Intervention, Coronary Artery Bypass Graft surgery in the last 30 days\n* Complex congenital heart disease\n* Pregnancy",{"count":22,"type":23},"The aim of this study is to observe the effect of intravenous ferric derisomaltose in participants with non-ischaemic heart failure (LVEF\\\u003C40%), iron deficiency (TSATS\\\u003C20%) and established on heart failure therapy including Sodium-glucose cotransporter 2 inhibitors (SGLT2i). Participants will undergo baseline laboratory blood tests, cardiac magnetic resonance imaging (cMRI), six-minute walk test, musculoskeletal function test and Kansas City Cardiomyopathy Questionnaire (KCCQ). These investigations will be repeated at 24 hours and 30 days after the administration of intravenous ferric derisomaltose.",[57,588],"Iron Deficiencies",[590,591,592,593,594,595,596,597],"Ferric derisomaltose","Non-ischaemic heart failure","Chronic heart failure","Iron deficiency","Left ventricular failure","Iron homeostasis","Cardiac MRI","Cardiac Magnetic resonance imaging","2024-08-05",{"date":600,"type":35},"2024-08-07",{"date":602,"type":35},"2024-04-15",{"date":604,"type":23},"2027-02",{"name":41,"class":42},{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":610,"acronym":611,"eligibilityCriteria":612,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":613,"targetDuration":4,"studyType":24,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":4},"100557002","evaluating-the-feasibility-of-high-volume-low-risk-penicillin-allergy-de-labelling-to-maximise-efficiency-in-a-resource-limited-setting-100557002","NCT06532448","Evaluating the Feasibility of High-volume, Low-risk Penicillin Allergy De-labelling to Maximise Efficiency in a Resource-limited Setting","De-Label Me","Inclusion Criteria:\n\n1. Penicillin allergy label\n2. Age ≥18\n3. Registered as a patient with University Hospital Southampton NHS Foundation Trust (with a UHS medical record)\n4. Able and willing to consent to penicillin de-labelling\n\nExclusion Criteria:\n\n1. Penicillin allergy previously confirmed via positive blood, skin, BAT or challenge testing\n2. PEN-FAST score \\>2 (indicating a moderate or high risk of a positive challenge)\n3. Anaphylaxis, angioedema, wheeze, shortness of breath or suspected hypotension linked to treatment with penicillin\n4. Received treatment in hospital for a reaction linked to penicillin (unless already an inpatient at onset)\n5. Itchy or urticarial rash within 1 hour of starting a new course of treatment with penicillin\n6. Severe cutaneous adverse reaction (SCAR) linked to penicillin exposure (e.g. SJS\u002FTEN, DRESS), including symptoms suggestive of SCAR without a formal diagnosis (e.g. skin blistering or peeling, mucosal involvement)\n7. History of other serious, non-immediate reactions linked to penicillin (e.g. haemolytic anaemia, transaminitis, nephritis)\n8. Currently pregnant or breastfeeding\n9. Poorly controlled asthma\n10. Severe COPD\n11. Severe or critical aortic stenosis\n12. Clinically unstable secondary to other organ failure\n13. Unwell or unstable on the day of proposed penicillin challenge (including acute febrile illness)\n14. Prescribed other antibiotics on the day of proposed challenge, unless taken as a long-term treatment\u002Fprophylaxis",{"count":614,"type":23},36,[26],"Plenty of studies have now established the safety of low-risk penicillin allergy de-labelling, but few have addressed how to organise de-labelling at the clinic level. This study will test the real world practicalities of running a de-labelling clinic optimised for maximum patient volume. The sheer number of patients with a penicillin allergy label, in contrast to relatively few allergy centres, makes demonstrating that such an approach can work extremely important for future antimicrobial stewardship.",[618],"Penicillin Allergy","2024-08-01",{"date":598,"type":35},{"date":622,"type":23},"2024-10",{"date":624,"type":23},"2025-10",{"name":41,"class":42},{"id":627,"slug":628,"hasResults":12,"nctId":629,"briefTitle":630,"officialTitle":631,"acronym":4,"eligibilityCriteria":632,"healthyVolunteers":17,"sex":18,"minAge":633,"maxAge":190,"enrollmentInfo":634,"targetDuration":4,"studyType":24,"phases":636,"briefSummary":637,"conditions":638,"keywords":4,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":648,"locationsCount":43},"100553446","preemie-milk-analyser-validation-study-100553446","NCT06486194","Preemie Milk Analyser Validation Study","Analytical Validation and Clinical Testing of the Preemie System for Analysis and Calculation of Targeted Fortification of Mother's Breast Milk for Preterm Infants","Inclusion criteria Phase 1A For University Hospital Southampton (UHS) milk bank donors\n\n* Approved as a donor for the UHS milk bank through the usual process\n* Be providing milk to UHS donor milk bank For mothers of infant inpatients\n* Have an infant who is currently an inpatient in the neonatal unit, paediatric wards, paediatric cardiac ward, or paediatric intensive care unit\n* Be providing breastmilk for their preterm or term born infant\n* Have sufficient breast milk available such that providing 120ml breast milk for the study does not impact on the needs of their infant.\n\nInclusion criteria Phase 1B\n\n* Approved as a donor for the UHS milk bank through the usual process\n* Be providing milk to UHS donor milk bank\n\nExclusion criteria Phase 1A and 1B For mothers of infant inpatients\n\n\\- Mothers whose infants are inpatients and where there is a concern about adequacy of maternal milk supply to feed their infant\n\nInclusion Criteria Phase 2\n\n* Birth weight ≥1kg and \\\u003C1.8 kg (so meet the ESPGHAN criteria for breast milk fortification)\n* Be taking fully fortified enteral breast milk feeds (≥150 ml\u002Fkg\u002Fday of mothers or donor breast milk containing breast milk fortifier as per the manufacturer's instructions)\n* Tolerating fully fortified breast milk feeds≥150 ml\u002Fkg\u002Fday for 48 hours\n* No longer on parenteral nutrition.\n\nExclusion Criteria Phase 2\n\n* Infants where there is a concern about mother's supply of breast milk being insufficient to meet demands (where donor milk is not being used to make up any shortfall);\n* Known congenital metabolic disorder;\n* Infant formula fed;\n* Bilateral grade III or IV intraventricular haemorrhage;\n* Any infant who has had gastrointestinal tract surgery;\n* Refusal of consent;\n* Refusal for the use of breast milk fortifier\n* Birthweight \\\u003C1 kg","0 Days",{"count":635,"type":23},180,[26],"This study aims to test and validate the Preemie Ecosystem- a new device and associated software package for measuring the nutrient (fat, protein and carbohydrate) content of the breast milk of the mothers of premature babies. This is potentially useful, as premature babies have higher nutritional requirements than babies born at term near their due date. At the moment, a nutritional supplement called breast milk fortifier is added to breast milk in standard amounts to improve its nutritional content and help premature babies grow. However, we know that each mother's breast milk is different, and varies from day to day, so each mother's milk may require more or less of such supplements in order to meet European recommendations for the nutrient intake.\n\nThe aim of this study is to first test and validate the accuracy of the Preemie device for measuring the nutritional content of mother's breast milk, using milk donated to the local donor milk bank and from mothers of babies currently on the neonatal unit. Next, once this is complete, the aim is to demonstrate it is feasible to use the Preemie device to enable fortification of mother's milk on an individualised basis for a small group of premature babies. The growth and nutrient intakes of these babies will be compared to another group who are cared for using the standard fortification approach.\n\nThe results of this study will be used to gain \"Conformité Européenne\" (CE) certification of the Preemie device and software.",[639,640,641],"Pre-Term","Breast Milk Expression","Nutrition Disorder, Infant","2024-06-26",{"date":644,"type":35},"2024-07-03",{"date":646,"type":23},"2024-07-01",{"date":320,"type":23},{"name":41,"class":42},{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":654,"acronym":655,"eligibilityCriteria":656,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":657,"enrollmentInfo":658,"targetDuration":4,"studyType":24,"phases":659,"briefSummary":660,"conditions":661,"keywords":4,"overallStatus":373,"whyStopped":4,"lastUpdateSubmitDate":663,"lastUpdatePostDateStruct":664,"startDateStruct":666,"completionDateStruct":668,"leadSponsor":670,"locationsCount":4},"100544803","haemoglobin-and-vancomycin-pharmacokinetics-in-the-cerebrospinal-fluid-following-subarachnoid-haemorrhage-100544803","NCT06373640","Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage","HAPTO Study: Haemoglobin And Vancomycin Pharmacokinetics in the Cerebrospinal Fluid Following Subarachnoid Haemorrhage: Therapeutic Optimisation of Haptoglobin","HAPTO","Inclusion Criteria:\n\n* aSAH on pre-repair CT scan graded 2, 3, or 4 on Modified Fisher Scale (diffuse \\[clot present in both hemispheres\\] thick or thin, or local thick).\n* Ruptured saccular aneurysm confirmed by angiography (CT angiogram, MR angiogram, or digital subtraction angiography)\n* EVD in situ in the lateral ventricle (or anticipated to have an EVD inserted)\n* Scheduled for surgery to clip the aneurysm (or has had surgery to clip the aneurysm with a proximal Sylvian fissure\u002Fbasal cistern drain left in situ)\n* CT scan completed after aneurysm repair to confirm EVD position and exclude major post-repair complications\n* Aged 18 years to 80 years (inclusive) at the time of providing written informed consent.\n* Capable of providing written (or electronic) informed consent and willing and able to adhere to all protocol requirements or informed consent provided by the subject's legally authorized representative if the subject lacks capacity at the time of screening.\n* Haemodynamically stable after resuscitation, with systolic blood pressure ≥ 90 mm Hg at screening\n\nExclusion Criteria:\n\n* SAH due to giant aneurysm (i.e., size ≥ 2.5 cm) or causes other than a saccular aneurysm (e.g., rupture of infective aneurysm, traumatic head injury \u002F traumatic SAH).\n* Bilateral blown pupils\n* Isolated intraventricular haemorrhage or intracerebral haemorrhage without SAH\n* aSAH diagnosed on LP with no evidence of blood on CT\n* Bleeding disorder\n* Decompressive hemicraniectomy at screening\n* Contraindications to vancomycin: known hypersensitivity to vancomycin or teicoplanin, documented history of hearing impairment, wearing a hearing aid, or renal insufficiency (estimated glomerular filtration rate \\\u003C60 ml\u002Fmin\u002F1.73m2)\n* Pregnant, planning to become pregnant, or breastfeeding\n* Underwent prophylactic hypertension or balloon angioplasty between admission to hospital for aSAH and screening\n* Given therapeutic magnesium infusion, and other intrathecal or intraventricular vasodilators or thrombolytics between admission to hospital for aSAH and screening\n* Given IV or intrathecal \u002F intraventricular nicardipine between admission to hospital for aSAH and screening\n* Given antifibrinolytics (e.g., tranexamic acid) or intrathecal thrombolytics between admission to hospital for aSAH and screening\n* Current participation in an interventional clinical study\n* Direct involvement in the planning and \u002F or conduct of this study (e.g., Sponsor employees, study site staff, as well as their immediate family members \\[i.e., spouse, parent, child, or sibling, whether biological or legally adopted\\]).\n* Any medical condition or other issue that, in the opinion of the Investigator and \u002F or Sponsor, would render the subject unsuitable for participation in the study (ie, issue may compromise subject safety or compliance, impede study conduct, or interfere with interpretation of study results).\n* Subject met eligibility criteria but was not needed for enrolment \u002F randomization.","80 Years",{"count":122,"type":23},[26],"The HAPTO study will recruit adult patients with aSAH due to a burst aneurysm. These patients must be scheduled to have their aneurysm treated surgically to prevent further bleeds, and need an external ventricular drain for clinical reasons (to drain fluid and relieve pressure on the brain). At the end of their surgery for their aneurysm, a further drain will be left at the site of the surgery (which is in the basal cisterns) and they will additionally have a drain sited in their lumbar spine. Vancomycin will be given through these drains. Additionally, these drains will allow the fluid in the brain to be collected to measure how haemoglobin levels and vancomycin levels differ between compartments and change over time. Patients will participate in the study over a period from recruitment at three days after aSAH to a maximum of ten days after aSAH. The data will be analysed to determine the relationship in haemoglobin concentrations between different areas of the brain and spine after aSAH, and how vancomycin distribution is related to its route of administration.",[662],"Subarachnoid Hemorrhage","2024-04-16",{"date":665,"type":35},"2024-04-18",{"date":667,"type":23},"2024-11",{"date":669,"type":23},"2028-01",{"name":41,"class":42},""]