[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Cambridge University Hospitals NHS Foundation Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":691},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,26,0,25,[9,47,75,104,128,153,182,206,235,262,291,320,343,373,404,423,442,468,497,525,547,568,603,635,666],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100645333","phase-2-an-experimental-study-of-belzutifan-impact-on-catecholamine-metabolism-100645333",false,"NCT07680205","An Experimental Study of Belzutifan Impact on Catecholamine Metabolism","An Experimental Pilot Study to Investigate Changes in Catecholamine Synthesis and Metabolism in Patients With Molecularly Profiled Phaeochromocytoma and Paraganglioma Taking Belzutifan","Inclusion Criteria:\n\n* Adult patients \\> 18 years\n* Patients must have a biochemically confirmed diagnosis of a phaeochromocytoma or paraganglioma using plasma metanephrines or 24- hour urinary metanephrines and plasma or urinary metanephrines should be at least 1.5 times the upper limit of the normal reference range.\n* Female patients of child-bearing potential must have a negative serum pregnancy test result within 3 days before first administration of study drug\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Has hypoxia, or requires intermittent supplemental oxygen, or requires chronic supplemental oxygen.\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass graft surgery (CABG) ≤6 months from Day 1 of study drug administration, or New York Heart Association Class III or IV congestive heart failure. Medically controlled arrhythmia stable on medication is permitted.\n* Has a co-existing malignancy (in addition to PPGL)\n* Has a Hb \\\u003C 100g\u002FdL\n* Is on medications which may interfere with belzutifan pharmacokinetics and that cannot be stopped for the duration of the study and for 7 days after the study period (everolimus, omeprazole, esomeprazole, Fluconazole, fluoxetine, Voriconazole, Sirolimus)\n* Has a known diagnosis of HIV, hepatitis B or hepatitis C","ALL",{"count":19,"type":20},12,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To investigate the impact of a medication called Belzutifan on the production and subsequent metabolism of adrenaline and noradrenaline collectively termed 'catecholamines'. The study aims to identify changes in the production and metabolism of catecholamines by measuring the substance which starts the chain of catecholamine metabolism called tyrosine in patients before, during and after 5 days of taking Belzutifan 120mg daily.",[26,27,28,29,30],"Pheochromocytoma and Paraganglioma (PPGL)","Pheochromocytoma Malignant","Pheochromocytoma, Metastatic","Pheochromocytoma\u002FParaganglioma","Pheochromocytoma",[32,33],"Belzutifan","catecholamine synthesis","RECRUITING","2026-06-29",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2026-04-27",{"date":42,"type":20},"2027-12",{"name":44,"class":45},"Cambridge University Hospitals NHS Foundation Trust","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},"100446422","phase-2-pembrolizumab-with-olaparib-as-combined-therapy-in-metastatic-pancreatic-cancer-100446422","NCT05093231","Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer","A Phase II Study Combining Pembrolizumab With Olaparib in Metastatic Pancreatic Adenocarcinoma (PDA) Patients With Mismatch Repair Deficiency or Tumour Mutation Burden > 4 Mutations\u002FMb","Inclusion Criteria:\n\n* Aged ≥ 18 years old\n* Written informed consent\n* Histologically or cytologically confirmed PDA\n* Confirmation that the PDA has TMB \\>4 mutations\u002FMb, or dMMR gene mutation, or MSI-H by IHC. TMB status and dMMR can be obtained from either tissue, or blood.\n* Radiologically confirmed stage 4 mPDA, with measurable disease\n* Received no more than 1 prior systemic therapy regimen for unresectable (stage 3 or 4) PDA is allowed\n* Measurable disease which has not been irradiated in prior radiotherapy\n* Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1\n* Life expectancy \\>12 weeks from the date of screening assessment\n* Adequate bone marrow function:\n\n  * Absolute neutrophil count (ANC) ≥1.5 x 109 \u002FL\n  * Haemoglobin (Hb) ≥ 90 g\u002FL\n  * Platelets ≥100 x 109 \u002FL\n* Adequate liver function:\n\n  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 x upper limit of normal range (ULN), or \\\u003C5 x ULN in the presence of liver metastases\n  * Total bilirubin \\\u003C1.5 x ULN\n* Adequate renal function defined as a calculated creatinine clearance by Cockcroft - Gault of ≥50 mL\u002Fmin\n\nExclusion Criteria:\n\n* Patients with resectable or locally advanced PDA\n* Other invasive malignancies diagnosed within the last 2 years which have not been treated with curative intent\n* Prior immune checkpoint inhibitors or PARP inhibitors. This includes any prior therapy with an anti-PD-1, or anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g, CTLA-4, OX 40, CD137)\n* Requirement for non-physiological dose of daily oral steroids, or regular use of any other immunosuppressive agents; prednisolone dose of \\\u003C 10mg (or equivalent steroid dose) is allowed. Use of inhaled or topical steroids is allowed.\n* Significant acute or chronic medical or psychiatric condition, disease or laboratory abnormality, which in the judgment of the investigator would place the patient at undue risk or interfere with the trial. Examples include, but are not limited to:\n\n  * A history of chronic obstructive pulmonary disease, interstitial lung disease, sarcoidosis, idiopathic pulmonary fibrosis, pulmonary hypersensitivity pneumonitis, cystic fibrosis or bronchiectasis affecting pulmonary function, causing breathlessness at rest\n  * Uncontrolled ischaemic heart or other cardiovascular event (myocardial infarction, new angina, stroke transient ischaemic attack, or new congestive cardiac failure) within the last 2 months\n  * Stable but significant cardiovascular disease defined by heart failure (New York Heart Association Functional Classification III or IV) or frequent angina\n  * Presence of active infection\n  * Cirrhotic liver disease, known HIV, chronic active or acute hepatitis B, or hepatitis C\n  * History of severe allergy or hypersensitivity reactions\n  * Autoimmune disease requiring chronic use of immunosuppressive agents.\n  * Replacement therapy using physiological doses for adrenal or pituitary insufficiency is allowed.\n  * Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded.\n  * Has known brain metastases and\u002For carcinomatous meningitis\n  * Has myelodysplastic syndrome (MDS)\u002Facute myeloid leukaemia (AML) or with features suggestive of MDS\u002FAML.\n* Women who are pregnant, or plan to become pregnant or are lactating.\n* Women of child-bearing potential and male patients who are unwilling to adhere to the contraception requirement from informed consent until the last dose of the trial treatment and for 120 days after the last dose of trial treatment.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication.\n* Concomitant use of known potent CYP3A4 inhibitors and inducers. Restrictions relating to concomitant medications are described in section 10.9. Please consider wash-out periods.\n* Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to screening.\n* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and\u002For any of its excipients\n* Has received prior radiotherapy within 2 weeks of start of study intervention. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.\n* Has received a live vaccine or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.\n* Participant received colony-stimulating factors (e.g., granulocyte colony-stimulating factor \\[G-CSF\\], granulocyte-macrophage colony-stimulating factor \\[GM CSF\\] or recombinant erythropoietin) within 28 days prior to the first dose of study intervention.\n* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention.\n* Participant has persistent toxicities (\\>CTCAE Grade 2) caused by previous cancer therapy, excluding alopecia.\n* Has had an allogenic tissue\u002Fsolid organ transplant\n* Judgment by the Investigator that the patient should not participate in the trial.","18 Years",{"count":56,"type":20},20,[23],"A phase II study combining pembrolizumab with olaparib in metastatic pancreatic adenocarcinoma patients with high tumour mutation burden",[60],"Pancreatic Cancer",[62,63,64,65],"High tumour burden","molecular profiling","confirmed MMRD or MSI-H IHC","pancreatic cancer","2026-06-16",{"date":68,"type":38},"2026-06-17",{"date":70,"type":38},"2025-02-26",{"date":72,"type":20},"2028-01-01",{"name":44,"class":45},17,{"id":76,"slug":77,"hasResults":12,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":12,"sex":17,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":4,"studyType":21,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":46},"100605070","phase-2-a-trial-to-test-the-use-of-dapansutrile-an-anti-inflammatory-medication-in-people-with-parkinsons-disease-100605070","NCT07157735","A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease","Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial","DAPA-PD","Inclusion Criteria:\n\nTo be included in the trial, the potential participant must:\n\n* Have given written informed consent to participate.\n* Be aged between 50 and 80 years (inclusive) at the time of the screening visit.\n* Be a fluent English speaker.\n* Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for Clinically Established Early Parkinson's Disease.\n* Have a disease duration of less than 5 years at the time of screening visit.\n* Have early-stage PD, defined as Hoehn and Yahr stage ≤2.\n* Be PD drug naïve or be receiving a stable dose of dopaminergic therapy for at least 3 months prior to screening visit, or between screening and baseline.\n* Have hsCRP ≥ 1 mg\u002FL on a blood test done within 2 years prior to, or at, the screening visit.\n* Have adequate organ function, as defined below (to be rechecked prior to baseline\u002Finvestigational medicinal product \\[IMP\\] initiation if \\>42 days from screening visit): Haemoglobin ≥ 110 g\u002FL; Platelet count ≥ 130 × 109\u002FL; Neutrophil count ≥ 1.5 × 109\u002FL; Renal function: estimated glomerular filtration rate (eGFR) \\>45 mL\u002Fmin\u002F1.73m2; Hepatic function: alanine aminotransferase (ALT) and bilirubin \\\u003C 1.5 times the institutional upper limit of normal; Thyroid function: thyroid stimulating hormone (TSH) within normal range; or if TSH is abnormal, free T4 within normal range; Corrected calcium ≤ institutional upper limit of normal; Alkaline phosphatase (ALP) \\\u003C 1.5 times the institutional upper limit of normal\n\nExclusion Criteria:\n\nThe presence of any of the following will preclude inclusion:\n\n* Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.\n* Any use of immunomodulatory drugs or biologic agents (such as azathioprine, mycophenolate, methotrexate, ciclosporin, cyclophosphamide etc.) within 12 months prior to screening visit, or between screening and baseline.\n* Any previous use of rituximab or alemtuzumab at any time.\n* Treatment with oral corticosteroids for greater than 2 weeks within 12 months prior to screening visit, or any oral or injected steroid use within 3 months prior to screening visit, or between screening and baseline.\n* Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \\> 75 mg, naproxen, ibuprofen and meloxicam - on more than 2 days per week.\n* Clinically significant inflammatory or autoimmune disease.\n* Chronic or latent infection.\n* Severe infection requiring the use of parenteral antimicrobial agents within 2 months prior to screening visit, or between screening and baseline.\n* Skin, solid organ or haematological malignancy which is active\\* at screening, or between screening and baseline (\\*defined as cancer which is under active management, with the exception of low-grade malignancy under observation of hormonal treatment).\n* The inability to take or swallow oral medication.\n* Parkinson's Disease Dementia according to Movement Disorder Society (MDS) PD Dementia criteria.\n* A known genetic mutation associated with PD.\n* A positive test for human immunodeficiency virus (HIV), hepatitis B (HBV)\u002FC (HCV) or syphilis.\n* Chronic liver disease.\n* Any concurrent medical or psychiatric condition or disease that is likely to interfere with the trial procedures or results, or that in the opinion of the investigator, would constitute a hazard for participating in this trial.\n* Women of childbearing potential - female participants must be surgically sterile or be post-menopausal. (A post-menopausal state is defined as no menses for 12 months without an alternative medical cause).\n* Male participants must be surgically sterile or must agree to use effective contraception during the period of therapy and for 6 months after the last dose of the trial treatment.\n* Known hypersensitivity to dapansutrile or its excipients.\n* Received an investigational drug or used an invasive investigational medical device within 12 weeks before the screening assessment, or is currently enrolled in another interventional investigational trial. Participants currently enrolled in other observational studies may be recruited.\n* Contraindications to PET-magnetic resonance imaging (MRI) scanning including metal implants, claustrophobia or inability to lie flat for 90 minutes.\n* Concomitant treatment with any medications that could interfere with \\[18F\\]-DPA714 binding (e.g., certain benzodiazepines), with the exception of medications which can be safely withheld for an appropriate washout period prior to imaging at the investigator's discretion.\n* Current use of any drugs of abuse or average alcohol intake of \\>21units per week over the last 3 months.\n* Any other significant disease, disability or investigation result which, in the opinion of the Chief Investigator (CI), may either put the participant at risk, or may influence the result of the trial, or the participant's ability to participate in the trial.","50 Years","80 Years",{"count":86,"type":20},36,[23],"In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease.\n\nDapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects.\n\nThe goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are:\n\n1. is dapansutrile safe and well-tolerated in people with Parkinson's?\n2. does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial.\n\nResearchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms.\n\nParticipants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.",[90],"Parkinson Disease",[92,93,94,95,96],"Dapansutrile","Neurodegeneration","Neuroinflammation","Inflammation","NLRP3 inflammasome","2026-06-12",{"date":66,"type":38},{"date":100,"type":38},"2026-02-02",{"date":102,"type":20},"2028-06",{"name":44,"class":45},{"id":105,"slug":106,"hasResults":12,"nctId":107,"briefTitle":108,"officialTitle":108,"acronym":109,"eligibilityCriteria":110,"healthyVolunteers":111,"sex":17,"minAge":54,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":4},"100642598","neonatal-wireless-transmission-system-hospital-adoption-and-planning-for-implementation-study-100642598","NCT07650045","Neonatal Wireless Transmission System: Hospital Adoption and Planning for Implementation Study","NEWTS HAPI-1","Inclusion Criteria:\n\n* staff with experience of working or supporting NICU care Informed consent\n\nExclusion Criteria:\n\n* no informed consent",true,"65 Years",{"count":114,"type":20},50,"OBSERVATIONAL","To explore the feasibility, acceptability, and implementation considerations associated with the adoption of the NeWTS system within NHS neonatal services.",[118,119],"Preterm Infants","Vital Sign Monitoring","NOT_YET_RECRUITING","2026-06-11",{"date":66,"type":38},{"date":124,"type":20},"2026-07-01",{"date":126,"type":20},"2026-12-31",{"name":44,"class":45},{"id":129,"slug":130,"hasResults":12,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":111,"sex":17,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":21,"phases":139,"briefSummary":141,"conditions":142,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":46},"100505824","the-effect-of-time-restricted-eating-in-cardiometabolic-health-100505824","NCT05866406","The Effect of Time-Restricted Eating in Cardiometabolic Health","TRE","Inclusion Criteria:\n\n* must be able to grant voluntary informed consent and comply with the study instructions\n* aged 25-75 years\n* men and women\n* body mass index 27-45 kg\u002Fm2\n* fasting plasma glucose 5.6-6.9 mmol\u002FL, or 2h oral glucose tolerance test plasma glucose 7.8-11.1 mmol\u002FL or haemoglobin A1C 39-46 mmol\u002Fmol or homeostasis model assessment-insulin resistance (HOMA-IR) score ≥2.73\n* self-reported habitual eating period ≥ 13 h per day\n\nExclusion Criteria:\n\n* shift worker\n* fasting \\>12 h\u002Fday more than once a week\n* vegan\n* \\> once a week no food intake after \\~1800 h\n* habitually waking up before \\~0400 h and sleeping before \\~2100 h\n* unstable weight (\\>5% change the last 2 months)\n* Clinical diagnosis of type 1 or 2 diabetes\n* Clinical diagnosis of sleep disorder\n* Clinical diagnosis of eating disorder\n* Clinical diagnosis of cancer in last 5 years\n* conditions that render subject unable to complete all testing procedures (including individuals with known allergies or contraindications to the medications used in this study)\n* use of medications that affect the study outcome measures or increase the risk of study procedures and that cannot be temporarily discontinued (e.g., steroids, alpha- or beta-adrenergic blockers or agonists, etc.)\n* smoking and illegal drug use\n* pregnant or lactating\n* gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)\n* individuals with electromedical devises\n* prisoners\n* alcohol abuse","25 Years","75 Years",{"count":138,"type":20},100,[140],"NA","Time-restricted eating (TRE) is a dietary manipulation that involves restricting food intake to 6-12 h\u002Fday with no energy intake the rest of the day. In rodents, TRE improves metabolic function without caloric restriction, potentially by activating nutrient sensing mechanisms and effects on circadian oscillations. However, an understanding of the effect of TRE on cardiometabolic health in people is not clear and few studies have evaluated this issue. Accordingly, the investigators propose to conduct a randomized controlled trial in people with obesity and prediabetes to determine the effect of 9 h TRE for 12 weeks, without a change in body weight, on key metabolic outcomes that are risk factors for cardiovascular disease (CVD): 1) multi-organ insulin sensitivity; 2) 24 h metabolic homeostasis and diurnal rhythm; and 3) adipose tissue and skeletal muscle biology. The proposed studies will elucidate the cardiometabolic implications of TRE in people with obesity and prediabetes.",[143,144],"Obesity","PreDiabetes","2026-05-27",{"date":147,"type":38},"2026-05-28",{"date":149,"type":38},"2023-11-01",{"date":151,"type":20},"2028-08-31",{"name":44,"class":45},{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":21,"phases":162,"briefSummary":163,"conditions":164,"keywords":168,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":174,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":181},"100638546","low-dose-interleukin-2-after-myocardial-infarction-to-investigate-effects-on-tissue-resident-regulatory-t-cells-100638546","NCT07610538","Low-dose Interleukin-2 After Myocardial Infarction to Investigate Effects on Tissue-resident Regulatory T Cells","Leuk-ALIVE","Inclusion Criteria:\n\n* Aged over 18 years old\n* Undergoing CABG surgery\n\nExclusion Criteria:\n\n* Critical left main stem coronary disease\n* Severe valvular disease (for example 'severe' aortic stenosis as classified on echocardiogram report)\n* Haemodynamic instability caused by arrhythmia requiring cardioversion in the current admission\n* Non-sustained ventricular tachycardia of \\>10 beats in the last 48 hours\n* Autoimmune disease\n* Any regular immunosuppressive treatment \\[Inhaled or topical steroids are permissible\\]\n* Known active hepatic disease or alanine aminotransferase (ALT) \\> 3xULN\n* Severe chronic kidney disease (defined as eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m2)\n* Allergy or intolerance to aldesleukin\n* Signs and symptoms of active infection\n* History of human immunodeficiency virus (HIV), hepatitis B or C\n* Current malignancy requiring active treatment\n* Vaccine within 4 weeks prior to screening\n* Women of child-bearing potential and pregnancy (women must be either postmenopausal (defined as being amenorrhoeic for greater than 2 years with an appropriate clinical profile (e.g. age appropriate (\\>55 years old), history of vasomotor symptoms) or having documented hysterectomy and\u002For bilateral oophorectomy)\n* Women who are breast-feeding\n* Clinically relevant medical or surgical conditions that, in the opinion of the investigator, would put the subject at risk by participating in the study",{"count":161,"type":20},24,[140],"The primary goals of this study are to compare the differences in tissue-resident Treg gene signature for activation, proliferation, and suppressive function using single-cell\u002F-nucleus RNA sequencing in patients treated with ld-IL-2 compared to control grouped by individual tissue beds from in and around the heart. Additionally, tissue-resident Tregs will be compared to peripheral blood Tregs from the same patient to assess the differential effect of ld-IL-2 on the two compartments.",[165,166,167],"Coronary Artery Disease","Myocardial Infarction (MI)","CABG",[169,170,171,172,167,173],"Interleukin-2","IL-2","MI","Myocardial infarction","Coronary artery bypass graft","2026-05-20",{"date":147,"type":38},{"date":177,"type":38},"2026-03-31",{"date":179,"type":20},"2028-12-01",{"name":44,"class":45},2,{"id":183,"slug":184,"hasResults":12,"nctId":185,"briefTitle":186,"officialTitle":186,"acronym":187,"eligibilityCriteria":188,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":189,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":191,"conditions":192,"keywords":194,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":46},"100558794","utilising-ai-analysis-of-sounds-to-predict-heart-failure-decompensation-100558794","NCT06555757","Utilising AI Analysis of Sounds To prEdict heaRt failurE decOmpensation","STEREO","Inclusion Criteria:\n\n* Male or Female, aged 18 years or above.\n* Diagnosed with chronic stable heart failure NYHA Class 3 or 4 (either during most recent cardiology\u002Fheart failure clinic visit, or ADHF during recent\u002Fcurrent hospitalization).\n* Participant is willing and able to give informed consent for participation in the study.\n* Participant has a smartphone device and can download a purposely designed mobile application on their phone (with guidance from the study investigators) or is willing to have sound recordings via a smartphone device loaned for the purpose of the study.\n\nExclusion Criteria:\n\n* Unable to provide consent\n* Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula\n* Patients with currently known pneumonia\n* Patients with known significant pulmonary disease including asthma, COPD, pulmonary fibrosis\u002Finterstitial lung disease, pulmonary hemorrhage.\n* Patients with current Pulmonary embolus\n* Patients with other intercurrent acute symptomatic illness (e.g., viral\u002Fbacterial infection) at time of recording\n* Patients requiring continuous oxygen therapy at flow rates that cannot be provided through nasal cannula\n* Patients with tracheostomy or who have undergone a surgical procedure to the head\u002Fneck\u002Flarynx which would affect the normal functioning of the vocal cords.\n* Aphasic\n* Patients excluded at PI discretion",{"count":190,"type":20},250,"Heart failure impacts more than 2% of people in the UK (United Kingdom) and leads to about 5% of emergency hospital visits. Patients might have slowly worsening symptoms or suddenly face acute decompensated heart failure (ADHF), marked by intense difficulty in breathing due to fast-developing lung congestion. This is a serious emergency requiring in-hospital treatment and monitoring. Once stable, patients usually have a phase where symptoms remain constant. But as time goes on, those with heart failure often face more frequent and prolonged episodes of ADHF.\n\nFluid build-up (pulmonary congestion) in the lungs is a key issue in heart failure, and catching it early helps avoid unexpected hospital stays. Spotting these early signs outside the hospital can be tough, as symptoms aren't always clear. Study investigators are working on a new, non-invasive way to identify these early signs using AI (artificial intelligence) to analyse subtle changes in a patient's voice, cough, and breathing sounds. This tool will act as an early warning for patients and their heart care teams, allowing quicker treatment. This could make heart failure episodes less severe and reduce the need for hospital visits.\n\nThis research has two parts. First, a small pilot trial with up to 50 patients. The findings will guide and inform a larger study involving up to 200 patients. From this larger study, investigators will develop the final version of the AI algorithm. The results from the Part A and Part B of this research will guide the investigators in planning a future clinical trial. This trial will confirm if the AI algorithm can be effectively used as a medical tool for heart failure care within the NHS (National Health Service). Study investigators will seek the necessary ethical approval before starting this trial.",[193],"Heart Failure",[195,196,197],"heart failure","cardiovascular","artificial intelligence","2026-05-07",{"date":200,"type":38},"2026-05-12",{"date":202,"type":38},"2024-09-18",{"date":204,"type":20},"2027-08-15",{"name":44,"class":45},{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":111,"sex":17,"minAge":54,"maxAge":214,"enrollmentInfo":215,"targetDuration":217,"studyType":115,"phases":4,"briefSummary":218,"conditions":219,"keywords":223,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":46},"100632654","metabolic-phenotyping-in-veds-100632654","NCT07516496","Metabolic Phenotyping in vEDS","Metabolic Phenotyping in Individuals With Vascular Ehlers-Danlos Syndrome (vEDS)","MPEDS","Inclusion Criteria:\n\n* Age over 18 years\n* Confirmed pathogenic or likely pathogenic COL3A1 mutation with vascular Ehlers-Danlos syndrome\n* Capacity to provide informed consent\n\nExclusion Criteria for those with vEDS:\n\n* Current corticosteroid use\n* Pregnancy or lactation\n* Acute illness at the time of assessment\n\nExclusion criteria for control participants\n\n* Current corticosteroid use\n* Pregnancy or lactation\n* Acute illness at time of assessment\n* Confirmed COL3A1 mutation\n* Gastrointestinal or bariatric surgery (except cholecystectomy and appendectomy)","85 Years",{"count":216,"type":20},15,"2 Days","This research study will investigate whether people with vascular Ehlers-Danlos syndrome (vEDS), a rare inherited condition, have problems with the way their body stores and uses fat (adipose tissue). vEDS is caused by changes in a gene called COL3A1, which makes a protein important for the structure of many tissues. While vEDS is best known for making blood vessels fragile, there is some early evidence that it may also affect fat tissue and increase the risk of problems such as insulin resistance (where the body does not respond properly to insulin) and diabetes.\n\nFat tissue is important for keeping the body healthy. It stores extra energy, but it also sends signals to other organs. If fat tissue cannot expand or work properly, fat can build up in the liver or muscles instead, leading to high blood sugar, high cholesterol, and greater risk of diabetes and heart disease.\n\nIn this study, we will invite 12-17 adults with genetically confirmed vEDS to take part, along with a group of age-, sex-, and weight-matched controls without vEDS. Participants will attend a research visit at Addenbrooke's Hospital, Cambridge. They will have measurements of body fat distribution (using a DEXA scan), a liver scan, blood tests, and a standard oral glucose tolerance test (drinking a sugary drink with blood samples before and after). Some participants may also choose to provide a small fat biopsy under local anaesthetic to allow more detailed analysis of tissue structure.\n\nThe main aim is to see whether people with vEDS show changes in fat distribution and insulin sensitivity compared to those without vEDS.",[220,221,222],"Vascular Ehlers-Danlos Syndrome","Vascular Ehlers Danlos Syndrome","Vascular EDS (vEDS)",[224,225,226],"vascular Ehlers Danlos syndrome","insulin resistance","partial lipodystrophy","2026-04-01",{"date":229,"type":38},"2026-04-08",{"date":231,"type":38},"2026-03-05",{"date":233,"type":20},"2031-04-04",{"name":44,"class":45},{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":111,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":243,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":245,"conditions":246,"keywords":248,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":257,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100631138","cardiovascular-acoustics-for-early-disease-detection-100631138","NCT07496775","Cardiovascular Acoustics for Early Disease Detection","ACOUTECT: Cardiovascular Acoustics for Early Disease Detection","ACOUTECT","Inclusion Criteria:\n\n* Participants aged ≥18 years\n* Able to provide written, informed consent\n* Has undergone angiography in the previous 6 months and scheduled to undergo transthoracic echocardiography, or has undergone transthoracic echocardiography in the previous 6 months and scheduled to undergo angiography, or is scheduled to undergo transthoracic echocardiography and angiography within 6 months.\n* Angiography and echocardiography performed within Cambridge University Hospitals NHS Foundation Trust.\n\nExclusion Criteria:\n\n* Haemodynamic instability\n* STEMI or high risk NSTEMI\n* Anginal symptoms at rest\n* Heart failure symptoms with NYHA 4\n* Cardiovascular related admission or event occurring between imaging studies\n* Uncontrolled symptomatic arrhythmia\n* Acute pulmonary embolism\n* Acute aortic dissection\n* Previous valve intervention\n* Suspected endocarditis",{"count":244,"type":20},500,"There are many types of heart disease. Two of the most common causes are narrowings within the blood vessels that supply the heart (known as coronary artery disease), or valves within the heart becoming narrowed (stenosed) or leaky (regurgitation), known as heart valve disease.\n\nThere are two main types of imaging used to test for these conditions. Coronary artery disease can be diagnosed by taking X-ray pictures of a dye when injected into the blood vessels. In some cases the dye is injected into the veins and a CT scanner is used (CT coronary angiography), in others the dye is injected via a tube placed in the artery (invasive coronary angiography). Valvular heart disease is normally diagnosed using an echocardiogram (ultrasound of the heart).\n\nIn this study the investigators are looking for subtle changes in the sounds that come from the heart, which may allow heart disease to be detected earlier. The investigators are using a novel device, similar to a digital stethoscope, that has excellent sensitivity for heart sounds. Ultimately this may be used in community settings including GP surgeries, in this study the investigators are collecting sounds from patients undergoing routine scans as part of their workup for heart disease.",[247,165],"Valvular Heart Disease",[249,250,251,252,253,254],"coronary artery disease","valvular heart disease","ischemic heart disease","cardiovascular acoustics","heart sounds","cardiac auscultation","2026-03-27",{"date":227,"type":38},{"date":258,"type":20},"2026-05-01",{"date":260,"type":20},"2029-12-31",{"name":44,"class":45},{"id":263,"slug":264,"hasResults":12,"nctId":265,"briefTitle":266,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":111,"sex":17,"minAge":54,"maxAge":83,"enrollmentInfo":269,"targetDuration":4,"studyType":21,"phases":271,"briefSummary":273,"conditions":274,"keywords":276,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":46},"100630140","phase-4-decode---haemodynamic-effects-of-semaglutide-and-tirzepatide---a-series-of-pilot-studies-100630140","NCT07483801","DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies","DECODE","Inclusion Criteria:\n\n1. Inclusion Criteria - Participants with normal weight and normal blood pressure\n\n   * Have given written informed consent to participate\n   * Aged 18 to 50 years (inclusive)\n   * Females must be post\u002Fperi-menopausal or if of child-bearing potential they are required to use adequate contraception and to have a negative pregnancy test (performed at each visit)\n   * Current non-smoker\n   * Body mass index (BMI) in range 18.5-24.9 kg\u002Fm2\n   * Clinic brachial systolic blood pressure \\\u003C140 mmHg and diastolic blood pressure \\\u003C90 mmHg\n2. Inclusion Criteria - Obese participants with normal blood pressure\n\n   * Have given written informed consent to participate\n   * Aged 18 to 50 years (inclusive)\n   * Male or female\n   * Females must be post\u002Fperi-menopausal or if of child-bearing potential they are required to use adequate contraception and to have negative pregnancy test (performed at each visit)\n   * Current non-smoker\n   * BMI ≥30 kg\u002Fm2\n   * Clinic brachial systolic blood pressure \\\u003C140 mmHg and diastolic blood pressure \\\u003C90 mmHg\n3. Inclusion Criteria - Obese participants with high blood pressure\n\n   * Have given written informed consent to participate\n   * Aged 18 to 50 years (inclusive)\n   * Male or female\n   * Females must be post\u002Fperi-menopausal or if of child-bearing potential they are required to use adequate contraception and to have negative pregnancy test (performed at each visit)\n   * Current non-smoker\n   * BMI ≥30 kg\u002Fm2\n   * Diagnosis of stage 1 essential hypertension\n\nExclusion Criteria:\n\n* Regular use of medications with vasoactive or cardiac effects in normotensive individuals; inability or unwillingness to omit anti-hypertensive medications on the morning of the study visits in hypertensive individuals\n* Hypersensitivity to any of the study drugs or excipients\n* Known clinically significant valvular heart disease\n* Implanted pacemaker or implantable cardioverter defibrillator (ICD)\n* Known active malignancy\n* Known renal impairment (creatinine \\>150µmol\u002FL)\n* Clinically significant neurological disease\n* History of scleroderma\n* Current pregnancy, breastfeeding\n* Current involvement in the active treatment phase of other research studies (excluding observational\u002Fnon-interventional)\n* Second or third-degree AV block, sino-atrial block, sick sinus syndrome\n* Known HIV, hepatitis B or C\n* Needle phobia\n* Participants treated with formal anticoagulant therapy such as, but not limited to, heparin or warfarin\n* Diagnosis of Type 1 or Type 2 Diabetes Mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP-1 and GIP receptor agonists\n* BMI \\\u003C18.5 kg\u002Fm2\n* Known heart failure\n* Currently taking drugs likely to have interactions with semaglutide or tirzepatide\n* Family history of multiple endocrine neoplasia\n* Known thyroid cancer\n* Known history of pancreatitis\n* History of gall stones (unless the gall bladder has been removed)\n* Any other clinical reason which may preclude entry in the opinion of the investigator",{"count":270,"type":20},112,[272],"PHASE4","What is the research question? Semaglutide and tirzepatide cause weight loss and blood pressure reduction. However, weight loss only partially explains the blood pressure reduction. Based on previous studies, there might be direct effects in the cardiovascular system. In forearm blood flow studies, semaglutide and tirzepatide will be infused into the brachial artery to investigate their effects on the function of blood vessels. In systemic studies, semaglutide and tirzepatide will be infused into systemic circulation to investigate their effects on heart and blood vessels.\n\nThere are three different populations being looked at for this study: participants with normal weight and normal blood pressure, participants with obesity and normal blood pressure, and participants with obesity and high blood pressure.\n\nThere are six sub-studies each with different visit schedules. The minimum participant study duration (including follow-up phone call) would be 2 days, while the maximum participant study duration would be approximately 2 - 2.5 months. The overall study duration is expected to be approximately 18 months.",[275],"Cardiovascular Diseases",[277,278,279,280,281,282],"Metabolic","Endocrine","Semaglutide","tirzepatide","weight loss","hypertension)","2026-03-17",{"date":285,"type":38},"2026-03-19",{"date":287,"type":20},"2026-03",{"date":289,"type":20},"2028-04",{"name":44,"class":45},{"id":292,"slug":293,"hasResults":12,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":299,"enrollmentInfo":300,"targetDuration":4,"studyType":21,"phases":302,"briefSummary":303,"conditions":304,"keywords":307,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":46},"100620942","a-trial-within-cohort-feasibility-study-design-comparing-standard-of-care-versus-weight-loss-achieved-through-tirzepatide-for-obesity-related-hypertension-in-young-adults-100620942","NCT07364175","A Trial Within Cohort Feasibility Study Design Comparing Standard of Care Versus Weight Loss (Achieved Through Tirzepatide) for Obesity-related Hypertension in Young Adults","Standard of Care or Weight Loss Drug Therapy in Obesity-related Hypertension - Pilot Study","SOLUTION-Pilot","Eligibility criteria for randomisation\n\nInclusion Criteria:\n\n* Aged 18 to 40 years (inclusive)\n* Body mass index (BMI) ≥27 kg\u002Fm2\n* Clinical diagnosis of primary (essential) hypertension as per NICE guidance\n* Unattended brachial SBP ≥135 and\u002For DBP ≥85 mmHg and \\\u003C160\u002F100 mmHg\n* Maximum of one antihypertensive medication\n\nExclusion Criteria:\n\n• Anything in medical notes suggesting unsuitable in the opinion of the investigator\n\nEligibility criteria for participation in weight loss arm\n\nInclusion criteria:\n\n* Written informed consent\n* Aged 18 to 40 years (inclusive)\n* Body mass index ≥27 kg\u002Fm2\n* Clinical diagnosis of primary (essential) hypertension as per NICE guidance\n* Unattended brachial SBP ≥135 and\u002For DBP ≥85 mmHg and \\\u003C160\u002F100 mmHg\n* Maximum of one antihypertensive medication\n\nExclusion criteria:\n\nThe presence of any of the following will preclude participant inclusion:\n\n* Known or suspected secondary hypertension\n* Hypersensitivity to any of the study drugs or excipients\n* Currently taking drugs likely to have interactions with tirzepatide\n* Diagnosis of type 1 or type 2 diabetes mellitus or current usage of insulin or other injectable drugs for the treatment of diabetes such as but not limited to GLP-1 and GIP receptor agonists\n* Prior or planned surgical, endoscopic and\u002For device-based therapy treatment for obesity\n* Self-reported, intentional or unintentional, change in body weight (over \\~10%) within \\~three months of screening\n* Known heart failure or clinically significant valvular heart disease\n* Implanted pacemaker or implantable cardioverter defibrillator (ICD)\n* Second or third-degree AV block, sino-atrial block, sick sinus syndrome\n* Known active malignancy including thyroid cancer\n* Known renal impairment (creatinine \\>150µmol\u002FL)\n* Clinically significant neurological disease\n* History of scleroderma\n* Participants on anticoagulant therapy\n* Known history of pancreatitis\n* Known inflammatory bowel disease\n* History of gallstones (unless previous cholecystectomy)\n* Severe gastroparesis or gastric emptying abnormality\n* Family history of multiple endocrine neoplasia\n* Needle-phobia\n* Planned pregnancy, current pregnancy, or breastfeeding\n* Current involvement in the active treatment phase of other research studies\n* Any other clinical reason which may preclude entry in the opinion of the investigator","40 Years",{"count":301,"type":20},60,[140],"Hypertension is the leading risk factor for death globally, affecting approximately 30% of adults in the United Kingdom. Obesity is also a serious and ongoing epidemic, with global obesity rates having more than tripled in men and doubled in women, since 1975. In the United Kingdom, 64% of the adult population are overweight or obese. Hypertension and obesity share a well-established association, with obesity being responsible for the development of hypertension in 40-78% of cases. In young adults, this link between body size and blood pressure (BP) is much stronger that in older adults. Since overweight and obesity are among the most common and modifiable causes of high BP, weight loss induced by lifestyle-changes is recommended for overweight or obese patients with hypertension. However, lifestyle interventions, even when successful, result in only moderate weight loss, which is not maintained in the majority of cases. A meta-analysis of randomised controlled trials demonstrated that lifestyle-interventions lead to an average net weight reduction of 5.1 kg, accompanied by a significant, but modest, \\~4 mmHg reduction in BP. Weight loss interventions could play a crucial role in the treatment of obesity-related hypertension in young adults.\n\nGlucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists, originally developed for the treatment of type 2 diabetes, are safe and clinically effective anti-obesity drugs. Recent data show a 10-20% placebo-adjusted reduction in body weight in overweight or obese adults without diabetes using the GLP-1 analogue semaglutide or the dual GLP-1\u002FGIP receptor agonist tirzepatide, with the majority of weight loss achieved within the initial six months. The substantial weight loss induced by these drugs is accompanied by a significant reduction in BP. Two recent meta-analyses showed that semaglutide is associated with a \\~5 mmHg placebo-adjusted reduction in clinic systolic BP (SBP). A sub-study of the SURMOUNT-1 trial reported a \\~10 mmHg reduction in 24-h ambulatory SBP with tirzepatide. Most participants in these studies were normotensive or had well-controlled hypertension. Furthermore, antihypertensive medication use declined amongst those receiving anti-obesity drugs meaning the BP-lowering effect of weight loss, elicited by these drugs, is probably underestimated. These data suggest that the new anti-obesity drugs could be effective in managing overweight or obesity-related hypertension. Furthermore, it may be possible to cure hypertension in at least some young adults, removing the need for life-long antihypertensive treatment. However, the magnitude and time course of BP reduction elicited by these new anti-obesity drugs remain uncertain.\n\nThe primary aim of this feasibility study is to assess the extent and trajectory of BP reduction achieved through intensive weight loss in overweight or obese adults with stage 1 hypertension and compare this to current standard of care measures which uses anti-hypertensive medications and lifestyle advice. The study will utilise a modified trial within cohort approach, using patients based within the clinical pharmacology\u002Fhypertension service at Addenbrooke's Hospital, Cambridge.",[305,306],"Hypertension","Obesity & Overweight",[308,309,310,280,311],"hypertension","obesity","overweight","GLP-1","2026-01-28",{"date":314,"type":38},"2026-01-29",{"date":316,"type":20},"2026-01",{"date":318,"type":20},"2029-01",{"name":44,"class":45},{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":326,"eligibilityCriteria":327,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":328,"enrollmentInfo":329,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":331,"conditions":332,"keywords":4,"overallStatus":120,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":4},"100602904","point-of-care-testing-in-emergency-departments-after-mild-traumatic-brain-injury-100602904","NCT07129577","Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury","Point of Care Testing in Emergency Departments After Mild Traumatic Brain Injury (POCkET)","POCkET","Inclusion Criteria:\n\n* Adult patients (≥ 18 years of age)\n* Glasgow Coma Score \\>12\n* Presentation within 24 hours of head injury\n* Meet criteria to be assessed using NICE NG232 clinical decision support tool (CDST).\n* Patients with a prior history of TBI may still be included.\n\nExclusion Criteria:\n\n* Participant without capacity and no available patient legal representative or professional consultee.\n* Participant with capacity unwilling to provide informed consent\n* Unable to adequately understand written and verbal English.\n* Prisoners currently in custody of HM Prison Service","100 Years",{"count":330,"type":20},400,"Traumatic brain injury (TBI) is estimated to have the highest incidence of all common neurological disorders, affecting 50 to 60 million people worldwide each year. In the UK, approximately one million people attend an Emergency Department (ED) annually following a head injury, and 80-90% of these are classified as mild TBI (mTBI), also referred to as concussion. In the acute setting, mTBI is typically defined by a Glasgow Coma Scale (GCS) score of 13-15 on presentation.\n\nCurrent acute management focuses primarily on identifying which patients require a CT head scan to detect life threatening injuries that may need neurosurgical intervention, observation, or neurocritical care. However, there is increasing recognition that the term \"mild\" can be misleading. Many patients, including those with normal CT scans,experience persistent functional, cognitive, and symptomatic deficits that may benefit from further intervention and follow-up care.\n\nBlood biomarkers offer significant potential to improve the early diagnosis, risk stratification, and prognostication of mTBI in the ED setting. While these biomarkers are increasingly being developed and evaluated in moderate and severe TBI, their clinical utility in mild TBI has not yet been definitively demonstrated.\n\nTo fully assess their potential value, it is essential to understand the current care pathways for mTBI in the ED, how they are implemented in practice, and where biomarker information could meaningfully enhance clinical decision making and improve patient outcomes.\n\nThe POCKET study will use a systems engineering approach, in combination with health economic evaluation, to assess the potential role and utility of point-of-care blood biomarkers in the management of mild TBI in UK emergency departments. This research will be conducted using the Abbott biomarker platform.",[333,334],"Injuries, Head","Traumatic Brain Injuries","2025-08-12",{"date":337,"type":38},"2025-08-19",{"date":339,"type":20},"2025-09-01",{"date":341,"type":20},"2026-08-29",{"name":44,"class":45},{"id":344,"slug":345,"hasResults":12,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":4,"eligibilityCriteria":349,"healthyVolunteers":12,"sex":350,"minAge":54,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":21,"phases":353,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":372},"100453987","phase-2-therapeutics-in-early-prostate-cancer-taps02-100453987","NCT05191680","TherApeutics in Early ProState Cancer (TAPS02)","Targeted Drug Intervention in Men at Risk of Progression on Active Surveillance for Early Prostate Cancer: A Randomised Trial - Therapeutics in Active Prostate Cancer Surveillance (TAPS02).","INCLUSION CRITERIA\n\nTo be included in the trial the patient must:\n\n* Have given written informed consent to participate.\n* Be aged 18 or over.\n* Have an Eastern Cooperative Oncology Group (ECOG) status 0-2.\n* Have selected active surveillance as a management option.\n* Have an MRI detectable lesion with an M score of ≥ 3 using Likert scale OR PI-RADS (version 2.1) reporting criteria. If M score is 3 then lesion size (single or combined) of ≥10mm.\n* Have prostate cancer from a combination of image guided targeted + systematic biopsies and MRI lesion and biopsy are concordant for a prostate cancer diagnosis.\n* Not anticipated to require bladder outlet surgery during IMP treatment or for up to 12 months of follow-up.\n* Meet all of the following clinical laboratory assessment criteria:\n\n  * Haemoglobin ≥ 9.0 g\u002FdL, independent of transfusion and\u002For growth factors within 3 months prior to randomisation.\n  * Platelet count ≥ 100 x 109\u002FL independent of transfusion and\u002For growth factors within 3 months prior to randomisation.\n  * Absolute neutrophil count (ANC) ≥ 1.0 x 109\u002FL within 21 days prior to randomisation.\n  * Serum albumin ≥ 3.0 g\u002FdL within 21 days prior to randomisation.\n  * Glomerular filtration rate (GFR) ≥ 30 ml\u002Fmin AND Serum creatinine ≤ 3 times the ULN (calculated by Cockcroft and Gault equation using actual body weight) within 21 days prior to randomisation.\n  * Serum potassium ≥3.5 mmol\u002FL within 21 days prior to randomisation.\n  * Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5 × ULN AND Serum total bilirubin ≤1.5 × ULN within 21 days prior to randomisation (Note: In patients with confirmed Gilbert's syndrome, if total bilirubin is \\>1.5 × ULN, measure direct and indirect bilirubin and if direct bilirubin is ≤1.5 × ULN, patient may be eligible in consultation with their physician).\n* Have prostate cancer with any one or more of the following:\n\n  * CPG2 (based on Grade Group 2 on histology)\n  * CPG1 (based on Grade Group 1 on histology) with PSA high density (PSAd \\>0.15) and LIKERT or PI-RADS 4\u002F5 lesion (individual or combined) of ≥10mm size.\n  * CPG1 with PSA high density (PSAd \\>0.15) and ≥50% biopsy core involvement (number of positive cores\u002Fall cores taken) with target biopsies counted as one if LIKERT or PI-RADS 3 lesion\n\nEXCLUSION CRITERIA\n\nThe presence of any of the following will preclude patient inclusion:\n\n* Contraindications to apalutamide or its excipients.\n* Pelvic metalwork interfering with MRI prostate interpretation.\n* Any prior or concurrent use of androgen deprivation therapy (ADT) or androgen receptor targeting agents (not including established and continued use of 5-ARIs for urinary symptoms).\n* Systemic therapy for prostate cancer.\n* Inability for patient to have prostate MRI scan.\n* Concurrent involvement in a Clinical Trial of Investigational Medicinal Product (CTIMP); participation in an observational trial\u002Fstudies is acceptable.\n* Seizure or known condition that may pre-dispose to seizure (including but not limited to the following within 1 year prior to randomisation: prior stroke, transient ischemic attack, loss of consciousness, brain arteriovenous malformation; or intracranial masses such as schwannomas and meningiomas that are causing oedema or mass effect).\n* Medications known to lower the seizure threshold or cause seizures must be discontinued or substituted at least 28 days prior to randomisation.\n* In the opinion of investigator, patient is at increased risk of falls or fractures.\n* Severe\u002Funstable angina, myocardial infarction, symptomatic congestive heart failure, arterial or venous thromboembolic events (e.g., pulmonary embolism, cerebrovascular accident including transient ischemic attacks), or clinically significant ventricular arrhythmias within 6 months prior to randomisation. Cardiovascular risk factors should be optimised i.e. hypertension, diabetes, dyslipidaemia.\n* Uncontrolled hypertension (SBP ≥ 160 mmHg or DBP ≥ 90 mmHg). Patients with a history of uncontrolled hypertension are allowed provided blood pressure is controlled by anti-hypertensive treatment.\n* Gastrointestinal disorder affecting absorption.\n* Medicinal products known to prolong the QT interval or medicinal products able to induce Torsade de pointes such as class IA (e.g., quinidine, disopyramide) or class III (e.g., amiodarone, sotalol, dofetilide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics (e.g. haloperidol). Alternative therapy, for the prohibited medication known to prolong the QTc, may be inistigated. A minimum washout for the discontinued medication of ≥ 4 half-lives is required prior to starting IMP.\n* Symptoms suggestive of Stevens-Johnson syndrome (SJS)\u002Ftoxic epidermal necrolysis (TEN).","MALE",{"count":352,"type":20},90,[23],"This is a phase 2, randomised, multicentre, double-blind, placebo-controlled trial investigating the use of short term androgen deprivation therapy in the form of apalutamide (Erleada) in men on active surveillance for prostate cancer.",[356],"Prostate Cancer",[358,359,360,361,362,363],"active surveillance","prostate cancer","therapeutics in prostate cancer","apalutamide","short term androgen deprivation therapy","androgen receptor inhibitor","2025-06-17",{"date":366,"type":38},"2025-06-20",{"date":368,"type":38},"2023-04-24",{"date":370,"type":20},"2029-10",{"name":44,"class":45},6,{"id":374,"slug":375,"hasResults":12,"nctId":376,"briefTitle":377,"officialTitle":378,"acronym":379,"eligibilityCriteria":380,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":381,"targetDuration":4,"studyType":21,"phases":383,"briefSummary":384,"conditions":385,"keywords":390,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":396,"lastUpdatePostDateStruct":397,"startDateStruct":399,"completionDateStruct":401,"leadSponsor":403,"locationsCount":46},"100589846","armstrong---air-entrainment-vs-standard-treatment-in-non-expandable-lung-100589846","NCT06959719","ARMSTRONG - Air entRainMent vS sTandard tReatment in nOn-expandable luNG","Air Entrainment vs. Standard Treatment in Non-Expandable Lung With Persistent Pleural Effusion: A Randomised Controlled Double-Blind Trial","ARMSTRONG","Inclusion Criteria:\n\n* Adults aged 18 years or older with a suspected or confirmed diagnosis of NEL and persistent pleural effusion.\n* Patients who are scheduled for pleural effusion drainage as part of their standard care.\n* Ability to adequately understand verbal or written information in English and provide informed consent in English.\n\nExclusion Criteria:\n\n* Patients with a history of pleurodesis or other procedures that may affect pleural dynamics.\n* Patients with active infections or other acute medical conditions that could interfere with the study.\n* Patient with multifactorial pain and high baseline score pain defined as VAS \\>= 5\n* Patients requiring IPC\n* Individuals with known contraindications to pleural drainage or air entrainment.\n* Patients who cannot provide informed consent in English, do not adequately understand verbal or written information in English or have special communication needs.",{"count":382,"type":20},41,[140],"This is a randomised controlled trial evaluating whether controlled air introduction into pleural space (air entrainment) during pleural effusion drainage reduces pain, improves patient satisfaction, and facilitates more effective drainage in patients with non-expandable lung (NEL).\n\nNEL lung is a common complication in patients with malignant or chronic pleural effusions, where the lung fails to fully re-expand after fluid removal due to pleural disease or fibrosis. In these patients, drainage often creates excessive negative pressure within the pleural cavity, leading to pain, vasovagal episodes, early termination of drainage, and the need for repeated procedures.\n\nThis study investigates a simple, safe, and low-cost intervention using a standard 3-way tap attached to the drainage system. By intermittently opening the tap to atmospheric air during drainage, air enters the pleural cavity in a controlled fashion, reducing negative pressure and potentially reducing pain, improving drainage tolerance, and minimising the need for repeated procedures.\n\nPleural effusion drainage is a common procedure in patients with advanced malignancy or chronic pleural disease. In patients with NEL, fluid removal creates a vacuum effect within the pleural space due to the inability of the lung to fully re-expand. This negative pressure is a key driver of severe procedural pain, vasovagal symptoms, and premature cessation of drainage. It may also necessitate multiple drainage procedures over a short period.\n\nCurrently, there are limited strategies to mitigate this problem, often relying on stopping the procedure prematurely or on analgesia, which does not address the underlying cause.\n\nThis trial evaluates the introduction of atmospheric air into the pleural space during drainage as a pragmatic, low-cost solution. The technique uses standard equipment - a 3-way tap - allowing air to be introduced safely and intermittently during drainage to reduce the vacuum effect.\n\nPatients undergoing therapeutic pleural drainage with an indwelling catheter or chest drain will be randomised in a 2:1 ratio to:\n\nStandard drainage care (control group)\n\nDrainage with intermittent controlled air introduction (intervention group)\n\nAir entrainment will be performed by briefly opening the 3-way tap to atmospheric air during drainage up to five times, based on patient discomfort and operator discretion. This aims to equalise pleural pressures, reduce pain, and improve drainage outcomes.\n\nRandomisation is weighted 2:1 towards the intervention group to maximise the number of patients who may benefit, following favourable preliminary data. Both patients and outcome assessors will be blinded to group allocation.\n\nOutcomes collected\n\nPrimary Outcomes:\n\nPatient-reported pain scores during drainage - Pain will be assessed using the Visual Analogue Scale (VAS), ranging from 0 to 10 cm, where 0 indicates \"no pain\" and 10 indicates \"worst imaginable pain.\" Higher scores represent a worse outcome.\n\nSecondary Outcomes:\n\nVolume of pleural fluid drained Number of pleural drainage procedures required Time interval between drainage procedures Incidence of complications (e.g., pneumothorax, re-expansion pulmonary oedema, infection) Reasons for incomplete drainage, including the presence and characteristics of non-expandable lung Patient-reported satisfaction with the drainage procedure",[386,387,388,389],"Non-expandable Lung","Trapped Lung","Pleural Effusion","Malignant Pleural Effusions (Mpe)",[391,392,393,394,395],"air entrainment","trapped lung","non-expandable lung (NEL)","pleural effusion","malignant pleural effusion","2025-05-04",{"date":398,"type":38},"2025-05-07",{"date":400,"type":38},"2025-04-14",{"date":402,"type":20},"2026-10-30",{"name":44,"class":45},{"id":405,"slug":406,"hasResults":12,"nctId":407,"briefTitle":408,"officialTitle":408,"acronym":409,"eligibilityCriteria":410,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":411,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":413,"conditions":414,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":417,"startDateStruct":419,"completionDateStruct":421,"leadSponsor":422,"locationsCount":46},"100426302","monitoring-key-activity-and-physiology-of-neonates-in-intensive-care-100426302","NCT04831242","Monitoring Key Activity and Physiology of Neonates in Intensive Care","Meerkat","Inclusion Criteria:\n\n* written informed parental consent\n\nExclusion Criteria:\n\n\\-",{"count":412,"type":20},48,"To optimise and evaluate a novel non-contact physiological monitoring system in the neonatal intensive care unit (NICU)",[415],"Neonatal Seizure","2025-04-15",{"date":418,"type":38},"2025-04-18",{"date":420,"type":38},"2021-08-01",{"date":126,"type":20},{"name":44,"class":45},{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":431,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":432,"conditions":433,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":416,"lastUpdatePostDateStruct":436,"startDateStruct":438,"completionDateStruct":440,"leadSponsor":441,"locationsCount":46},"100377276","digestnewborn-study-100377276","NCT04192422","DiGESTnewborn Study","Glucose Control and Metabolic Adaptation in Offspring of Women With Gestational Diabetes Recruited to the DiGest Study","DiGESTnewborn","Inclusion Criteria:\n\n* mothers and their babies who have been enrolled in DiGest Trial and who have provided informed consent\n\nExclusion Criteria:\n\n* none",{"count":301,"type":20},"We wish to study the effect of a mothers sugar (glucose) control during pregnancy on her baby's sugar control after birth.",[434,435],"GDM","Hypoglycemia",{"date":437,"type":38},"2025-04-17",{"date":439,"type":38},"2020-09-01",{"date":126,"type":20},{"name":44,"class":45},{"id":443,"slug":444,"hasResults":12,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":111,"sex":17,"minAge":450,"maxAge":4,"enrollmentInfo":451,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":453,"conditions":454,"keywords":456,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":461,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":467,"locationsCount":181},"100511572","co-designing-and-evaluating-a-real-world-implementation-model-for-remote-consultation-with-vision-self-testing-100511572","NCT05941182","Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing.","Co-designing and Evaluating a Real-world Implementation Model for Remote Consultation with Vision Self-testing. the ReVise Study.","ReVise","Inclusion Criteria:\n\n* Patients 4 years and older scheduled by their clinician for a follow up remote eye clinic consultation following an initial face-to face consultation.\n\nExclusion Criteria:\n\n-Patients refusing remote consultation or converted to a face-to-face appointment following scheduling.","4 Years",{"count":452,"type":20},200,"This study aims to involve the public, patients and National Health Service (NHS) staff in co-designing a scalable, inclusive and sustainable implementation model for ophthalmic remote consultation with vision self-testing (the intervention). The main study questions are:\n\nWhat are the barriers to uptake of the intervention and how can these be mitigated by the design of the implementation model.\n\nHow do implementation outcome measures compare before and after real world application of the model.",[455],"Ophthalmic Disorders",[457,458,459,460],"Remote consultation","visual acuity testing","self-testing applications","home-testing applications","2025-02-09",{"date":463,"type":38},"2025-02-12",{"date":465,"type":38},"2023-09-03",{"date":100,"type":20},{"name":44,"class":45},{"id":469,"slug":470,"hasResults":12,"nctId":471,"briefTitle":472,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":12,"sex":476,"minAge":54,"maxAge":4,"enrollmentInfo":477,"targetDuration":479,"studyType":115,"phases":4,"briefSummary":480,"conditions":481,"keywords":487,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":489,"lastUpdatePostDateStruct":490,"startDateStruct":492,"completionDateStruct":494,"leadSponsor":496,"locationsCount":46},"100572073","partial-breast-reconstruction-with-chest-wall-perforator-flap-100572073","NCT06728527","PARTial BREast RECONstruction With Chest Wall Perforator Flap","PartBreCon-Pro Study: PARTial BREast RECONstruction With Chest Wall Perforator Flap, a PROspective Study of Clinical and Patient Reported Outcomes","PartBreCon","Inclusion Criteria:\n\n* Patients undergoing partial breast reconstruction using CWPF for primary breast cancer\n* Delayed correction of breast deformity following previous BCS\n* Each surgeon is to have performed a minimum of 10 CWPFs\n* Each centre anticipates completing a minimum of 10\u002Fyear\n\nExclusion Criteria:\n\n* Patients undergoing volume displacement BCS\n* Patients undergoing mastectomy +\u002F- immediate breast reconstruction","FEMALE",{"count":478,"type":20},1001,"6 Months","The goal of this observational study is to ascertain the outcomes following partial breast reconstruction using chest wall perforator flaps after breast conservation surgery.",[482,483,484,485,486],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Carcinoma","Breast Neoplasms","Breast Surgery","Breast Reconstruction Surgery",[488],"breast oncoplastic, recon, chest wall perforator flap, PROMS","2024-12-07",{"date":491,"type":38},"2024-12-11",{"date":493,"type":38},"2023-06-01",{"date":495,"type":20},"2026-05-31",{"name":44,"class":45},{"id":498,"slug":499,"hasResults":12,"nctId":500,"briefTitle":501,"officialTitle":502,"acronym":4,"eligibilityCriteria":503,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":504,"enrollmentInfo":505,"targetDuration":4,"studyType":21,"phases":506,"briefSummary":507,"conditions":508,"keywords":512,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":517,"lastUpdatePostDateStruct":518,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":46},"100354850","low-energy-diet-and-familial-partial-lipodystrophy-100354850","NCT03900286","Low Energy Diet and Familial Partial Lipodystrophy","Evaluating the Therapeutic Efficacy and Metabolic Impact of a Low Energy Diet (LED) in People With Familial Partial Lipodystrophy and Diabetes","Inclusion Criteria:\n\n* Familial Partial Lipodystrophy\n* Age \\>= 18 yrs\n* T2DM\n* Willingness to check daily blood sugars\n* HbA1c between 53mmol(7%)- 108 mmol(12%)\n* Weight stable for 3 months\n* Capacity to consent\n\nExclusion Criteria:\n\n* Pregnancy\n* Untreated thyroid dysfunction (patients who have been euthyroid on medication for at least 3 months can be included)\n* Use of medication adversely that affects diabetes control (e.g. steroids\u002F immunosuppressants\u002F certain antipsychotics)\n* Incapacity to give informed consent\n* History of an eating disorder\u002F purging behaviour\n* Previous gastric bypass\u002F banding\n* Use of Leptin Therapy\n* Untreated retinopathy","99 Years",{"count":56,"type":20},[140],"To evaluate the therapeutic efficacy and metabolic impact of a low energy diet (LED) in people with familial partial lipodystrophy and diabetes. Participants will be provided with a LED (total diet replacement) for 12 weeks, before the introduction of a stepped food transition. Metabolic effects will continue to be assessed for 1 year. In order to better understand why this intervention changes insulin sensitivity, we will also collect adipose and muscle tissue samples at baseline and 12 weeks into the intervention in participants willing to have these procedures performed. These samples will be used for histological, metabolite, gene expression and protein expression analyses.",[509,510,511],"Lipodystrophy","Diabetes","Diet Modification",[513,514,515,516,510],"Familial Partial Lipodystrophy","FPLD","Diet","Total Diet Replacement","2024-12-03",{"date":519,"type":38},"2024-12-05",{"date":521,"type":38},"2020-01-16",{"date":523,"type":20},"2025-05",{"name":44,"class":45},{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":530,"acronym":531,"eligibilityCriteria":532,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":533,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":534,"conditions":535,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":538,"lastUpdatePostDateStruct":539,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":546},"100304243","gaucherite---a-study-to-stratify-gaucher-disease-100304243","NCT03240653","Gaucherite - A Study to Stratify Gaucher Disease","Predictive Measures to Stratify Clinical Outcomes in Children and Adults With Gaucher Disease and Responses to Specific Therapies","Gaucherite","Inclusion Criteria:\n\nEach patient must meet all of the following criteria to be enrolled in this study:\n\n1. Confirmed biochemical diagnosis of Type I, Type II or Type III Gaucher disease\n2. Written Ethics Committee (EC) approved informed consent obtained from the patient, or patient's parent or legal guardian and patient assent if appropriate\n3. Male or Female patients, no age limitation\n4. Willing and able to comply with study schedule and procedures\n5. Deceased patients for whom the EC determines that patient data can be collected without a new consent from the patient\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be excluded from the study:\n\n1. Unrelated co-morbid condition limiting life expectancy to less than 6 months\n2. Patient or if applicable, parent or legal guardian is unable to comprehend, sign and date the EC approved informed consent form and patient assent as appropriate\n3. If determined unsuitable for the study by the investigator",{"count":190,"type":20},"The purpose of this research is to review data already collected and to collect new data from adults and children in England with Gaucher Disease to determine clinical factors which predict severity and response to therapy of Gaucher disease especially in the areas of bone, cancer and brain conditions.",[536,537],"Gaucher Disease, Type I","Gaucher Disease, Type III","2024-08-05",{"date":540,"type":38},"2024-08-06",{"date":542,"type":38},"2014-01-01",{"date":544,"type":20},"2028-12-31",{"name":44,"class":45},8,{"id":548,"slug":549,"hasResults":12,"nctId":550,"briefTitle":551,"officialTitle":552,"acronym":553,"eligibilityCriteria":554,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":214,"enrollmentInfo":555,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":556,"conditions":557,"keywords":559,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":560,"lastUpdatePostDateStruct":561,"startDateStruct":563,"completionDateStruct":565,"leadSponsor":567,"locationsCount":46},"100548953","low-dose-il-2-for-the-reduction-of-vascular-inflammation-in-acs--clinical-outcomes--follow-up-study-100548953","NCT06427694","Low-Dose IL-2 For The Reduction Of Vascular Inflammation In ACS -Clinical Outcomes & Follow-up Study","The Low-Dose Interleukin-2 For The Reduction Of Vascular Inflammation In Acute Coronary Syndromes -Clinical Outcomes And Follow-up Study","IVORY-FINALE","Inclusion Criteria:\n\n* Participants who completed the full per-protocol treatment regime of low-dose IL2 or placebo having attended the final dosing visit in the IVORY trial. IVORY patients who previously consented to have their medical records inspected in the IVORY trial and who have already passed away at the commencement of IVORY-FINALE will also be included in analyses\n\nExclusion Criteria:\n\n* Patients who decline participation\n* Patients who did not consent to being contacted about future research\n* Patients who were withdrawn from the IVORY trial for any reason",{"count":301,"type":20},"The preceding IVORY trial (NCT04241601) has completed. As atherosclerosis and its complications are driven by inflammation the investigators hypothesise that treatment with low-dose IL2 may reduce adverse cardiovascular outcomes compared to placebo.\n\nIn this follow-up study, the investigators aim to collect cardiovascular clinical outcome data for patients who completed the IVORY clinical trial and will look at major adverse cardiovascular events (MACE), defined as cardiovascular death, non-fatal myocardial infarction, resuscitated cardiac arrest, ischaemic stroke, or unplanned coronary revascularization. In addition, data on adverse events such as all cause death, haemorrhagic stroke, new atrial fibrillation, ventricular arrhythmias, hospitalisation due to cardiovascular causes (e.g. stable and unstable angina, TIAs, heart failure), amputations and revascularisation due to peripheral vascular disease.",[558],"Acute Coronary Syndromes",[558],"2024-06-07",{"date":562,"type":38},"2024-06-10",{"date":564,"type":38},"2024-06-01",{"date":566,"type":20},"2030-02-11",{"name":44,"class":45},{"id":569,"slug":570,"hasResults":12,"nctId":571,"briefTitle":572,"officialTitle":573,"acronym":574,"eligibilityCriteria":575,"healthyVolunteers":111,"sex":476,"minAge":54,"maxAge":576,"enrollmentInfo":577,"targetDuration":4,"studyType":115,"phases":4,"briefSummary":579,"conditions":580,"keywords":585,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":594,"lastUpdatePostDateStruct":595,"startDateStruct":597,"completionDateStruct":599,"leadSponsor":601,"locationsCount":602},"100505052","cardiometabolic-health-in-first-time-pregnancy-100505052","NCT05856318","Cardiometabolic Health in First Time Pregnancy","Preconception to pOst-partum Study of Cardiometabolic Health in Primigravid PregnancY","POPPY","Pregnancy Arm Inclusion Criteria:\n\nTo be included in the trial the participant must:\n\n* Nulliparous (no previous pregnancy beyond 20 weeks' gestation)\n* Actively considering pregnancy within approximately 12 months\n* Aged between 18 and 45 years\n* Ability to consent and willing to participate\n\nPregnancy Arm Exclusion Criteria:\n\nThe presence of any of the following will preclude participant inclusion:\n\n* Currently pregnant\n* Established infertility\n* Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)\n* Assigned male sex at birth\n* Autoimmune disease (e.g. rheumatoid arthritis, lupus)\n* Thrombophilia\n* Type 1 diabetes\n* Known advanced chronic kidney disease (stages 4-5)\n* Malignant hypertension\n* Clinically manifest CVD (e.g. previous myocardial infarction, stroke)\n* Active cancer\u002Fbeing treated for cancer currently (other than skin cancer)\n* Any other condition preventing full participation in the study\n\nNon-Pregnancy Arm Inclusion criteria\n\nTo be included in the trial the participant must:\n\n* Nulliparous (no previous pregnancy beyond 20 weeks' gestation)\n* Not planning to conceive during next 18 months\n* Aged between 18 and 45 years\n* Ability to consent and willing to participate\n\nNon-Pregnancy Exclusion Criteria\n\nThe presence of any of the following will preclude participant inclusion:\n\n* Currently pregnant\n* Planning or actively using fertility treatments (e.g. IVF, ICSI, FET, IUI)\n* Assigned male sex at birth\n* Autoimmune disease (e.g. rheumatoid arthritis, lupus)\n* Thrombophilia\n* Type 1 diabetes\n* Known advanced chronic kidney disease (stages 4-5)\n* Malignant hypertension\n* Clinically manifest CVD (e.g. previous myocardial infarction, stroke)\n* Active cancer\u002Fbeing treated for cancer currently (other than skin cancer)\n* Any other condition preventing full participation in the study","45 Years",{"count":578,"type":20},3500,"Women who experience placental complications (syndromes) during pregnancy, such as pre-eclampsia (high blood pressure and kidney problems), gestational hypertension (high blood pressure during pregnancy) and fetal growth restriction (baby being small) have twice the risk of developing heart disease and diabetes later in life, compared to women who have a healthy pregnancy.\n\nThis study aims to assess risk factors for heart disease and diabetes in women who are actively trying to conceive, before and during their pregnancy, and 9-12 months after delivery of their baby, to see whether placental syndromes make a difference to their heart health. This will allow us to understand, if, and how, placental syndromes increase the risk of heart disease and diabetes, and, therefore, how best to reduce this risk and potentially prevent placental syndromes in the future. The investigators will also recruit women who are NOT planning pregnancy, as a control group.",[581,582,510,583,584],"Cardiometabolic Health","Pregnancy Related","Placental; Syndrome, Dysfunction","Heart Diseases",[586,587,588,589,590,591,592,593,196],"cardiometabolic","pregnancy","diabetes","childbirth","placental syndrome","heart disease","nulliparous","CVD risk","2024-04-05",{"date":596,"type":38},"2024-04-09",{"date":598,"type":38},"2023-05-24",{"date":600,"type":20},"2052-12",{"name":44,"class":45},7,{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":609,"eligibilityCriteria":610,"healthyVolunteers":12,"sex":17,"minAge":611,"maxAge":612,"enrollmentInfo":613,"targetDuration":4,"studyType":21,"phases":615,"briefSummary":617,"conditions":618,"keywords":620,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":626,"lastUpdatePostDateStruct":627,"startDateStruct":629,"completionDateStruct":631,"leadSponsor":633,"locationsCount":634},"100297328","phase-2-platinum-and-polyadenosine-5diphosphoribose-polymerisation-inhibitor-for-neoadjuvant-treatment-of-triple-negative-breast-cancer-andor-germline-brca-positive-breast-cancer-100297328","NCT03150576","Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and\u002For Germline BRCA Positive Breast Cancer","Randomised, Phase II\u002FIII, 3 Stage Trial to Evaluate the Safety and Efficacy of the Addition of Olaparib to Platinum-based Neoadjuvant Chemotherapy in Breast Cancer Patients With TNBC and\u002For gBRCA.","PARTNER","Inclusion Criteria:\n\n* Aged between 16 and 70.\n* Written informed consent, willing and able to comply with the Protocol for the duration of the trial including undergoing treatment and scheduled visits and examinations.\n* Histologically confirmed invasive breast cancer.\n* ER-negative\\*, and HER2-negative\\*\\* breast cancer (TNBC). Patients will be eligible with any PR status but PR expression must be scored.\n\nOR\n\n* Germline BRCA (gBRCA) mutation positive, HER2 negative, and PgR \u002F ER of any status.\n* T1, T2 or T3 tumours.\n* T4 tumour of any size with direct extension to (a) chest wall or (b) skin. OR Inflammatory carcinoma with tumour of any size. OR\n\nOther Locally Advanced Disease:\n\n* Involvement of ipsilateral large or fixed axillary lymph nodes, or infra or supraclavicular nodes (\\>10mm diameter or clinical N2 or N3) and primary breast tumour of any diameter.\n* Involvement of ipsilateral large or fixed axillary lymph nodes, or infra or supraclavicular nodes (\\>10mm diameter, or clinical N2 or N3), without a primary breast tumour identified, the presence of breast cancer in a Lymph Node (LN) must be histopathologically confirmed by LN biopsy.\n\nOR\n\nMultifocal tumour:\n\n\\- with at least one tumour with a size\\>10mm.\n\n* Patients with bilateral disease are eligible to enter the trial provided that both breast disease meets the above criteria.\n* Be fit to receive the trial chemotherapy regimen in the opinion of the responsible clinician:\n\nAdequate bone marrow, hepatic, and renal function. ECOG performance status of 0, or 1.\n\n* Treatment should be commenced within 6 weeks of the diagnostic biopsy. In uncommon circumstances, where medically acceptable, treatment is permitted to start within a maximum of 9 weeks of the diagnostic biopsy.\n* Availability of the Tumour Infiltrating Lymphocytes score is required.\n* Availability of CK 5\u002F6 and EGFR +\u002F- Androgen Receptor IHC score.\n* Availability of slides and paraffin embedded tissue blocks from pre-chemotherapy core biopsy and from primary surgical resection is required.\n* Women of child-bearing potential (WCBP), defined as not surgically sterilized or not post-menopausal for at least 24 consecutive months if age ≤55 year or 12 months if age \\>55 years, must have a negative serum or urine pregnancy test within 14 days prior to randomisation.\n* All WCBP and all sexually active male patients as well as their partners must be aware that they should not conceive during the treatment period and therefore should routinely use effective forms of contraception, throughout their participation in the trial and for at least 6 months after the last dose of trial treatment. Please follow the olaparib contraception guidelines.\n\nExclusion Criteria:\n\n* T0 tumour in absence of axillary node \\>10mm.\n* TNBC with a non-basal phenotype which strongly expresses Androgen Receptor.\n* Previous or concomitant chemotherapy or biological agents used for the treatment of cancer in the last 5 years.\n* Malignancy within the last 5 years except: adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ (DCIS); Stage 1, grade 1 endometrial carcinoma; or other solid tumours including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years.\n* Patients with myelodysplastic syndrome\u002Facute myeloid leukaemia.\n* Evidence of distant metastasis apparent prior to randomisation.\n* Patients with uncontrolled seizures.\n* Pre-existing sensory or motor neuropathy of CTCAE v4.03, grade ≥2.\n* Concomitant use of known potent CYP3A4 inhibitors and inducers. Consider wash-out periods.\n* Pregnant or breast feeding women.\n* Not suitable for neoadjuvant chemotherapy in the opinion of the responsible clinician.\n* Major surgery within 14 days of starting trial treatment and patients must have recovered from any effects of any major surgery.\n* Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment or follow-up. For example:\n\nEvidence of severe or uncontrolled cardiac disease Uncontrolled ventricular arrhythmia Recent myocardial infarction (within 12 months) Active infection including Hepatitis B, Hepatitis C and Human Immunodeficiency virus (HIV). Screening for chronic conditions is not required.\n\n* ECG with mean resting QTc \\>470 msec on 2 or more time points within a 24 hour period or family history of long QT syndrome.\n* Patients unable to swallow orally administered medication and patients with gastrointestinal disorders likely to interfere with absorption of the trial medication\n* Known hypersensitivity to olaparib, carboplatin, paclitaxel or their excipients (including cremophor).\n* Whole blood transfusions in the last 120 days prior to blood sampling for BRCA test as it may interfere with the results (packed red blood cells and platelet transfusions are acceptable).","16 Years","70 Years",{"count":614,"type":20},780,[23,616],"PHASE3","This neoadjuvant trial for patients with TNBC and\u002For gBRCA breast cancer, aims to investigate the safety and efficacy (improvement in pathological Complete Response at surgery) of concurrent platinum-based chemotherapy with olaparib an inhibitor of the PARP enzyme (PARPi).",[619],"Breast Cancer",[621,622,623,624,625],"Triple negative breast cancer","germline BRCA","platinum and PARP inhibitor","neoadjuvant chemotherapy","olaparib","2022-11-09",{"date":628,"type":38},"2022-11-14",{"date":630,"type":4},"2016-05",{"date":632,"type":20},"2034-06",{"name":44,"class":45},30,{"id":636,"slug":637,"hasResults":12,"nctId":638,"briefTitle":639,"officialTitle":640,"acronym":641,"eligibilityCriteria":642,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":54,"enrollmentInfo":643,"targetDuration":645,"studyType":115,"phases":4,"briefSummary":646,"conditions":647,"keywords":651,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":657,"lastUpdatePostDateStruct":658,"startDateStruct":660,"completionDateStruct":662,"leadSponsor":664,"locationsCount":665},"100377155","european-paediatric-non-alcoholic-fatty-liver-disease-registry-eu-pnafld-100377155","NCT04190849","European Paediatric Non-Alcoholic Fatty Liver Disease Registry (EU-PNAFLD)","The European Paediatric Non-alcoholic Fatty Liver Disease Registry (EU-PNAFLD): a Prospective, Longitudinal Follow-up of Children With Non-alcoholic Fatty Liver Disease","EU-PNAFLD","Inclusion Criteria:\n\n* Diagnosis made under 18 years of age.\n* Diagnosis of NAFLD spectrum disease (simple steatosis (NAFL), steatosis with abnormal transaminases, NASH ± fibrosis or cirrhosis)\n* Diagnosis established by:\n\n  * Radiological evidence of hepatic steatosis (e.g. increased hepatic echogenicity on ultrasound), with\n  * Exclusion of secondary causes (negative serological liver screen for HBV\u002FHCV, caeruloplasmin \\>0.20g\u002FL, no history of excess alcohol consumption, no evidence of iron overload, and no clinically significant alpha-1 antitrypsin (A1AT) phenotype (i.e. SZ, ZZ, SS), with or without\n  * Histology (\\>5% steatosis and histology consistent with paediatric NAFLD)\n\nExclusion Criteria:\n\n* Secondary fatty liver disease (e.g. glycogen storage diseases, Wilson disease, viral hepatitis, drug-related, autoimmune hepatitis, type 1 diabetes mellitus)\n* Post-transplant fatty liver\n* \\>20g\u002Fday ethanol intake",{"count":644,"type":20},2000,"30 Years","The EU-PNAFLD (The European Paediatric NALFD Registry) will be a network composed of European centres involved in the care of children with NAFLD, and will include Hepatologists, Endocrinologists, and Scientists, supported by relevant international specialists. This collaboration will build on existing infrastructure (local databases and bio-repositories) and will align with the adult European NAFLD Registry (\"EPoS\", Elucidating Pathways of Steatohepatitis study) to allow long-term follow-up supported by translational studies. Through an international, well-characterised large-scale cohort, we hope to: facilitate multi-centre clinical trials; extend our understanding of the key disease mechanisms of NAFLD; and establish the natural history of paediatric NAFLD.",[648,649,650],"Non-Alcoholic Fatty Liver Disease","Non-alcoholic Fatty Liver","Non-alcoholic Steatohepatitis",[652,653,654,655,656],"Cirrhosis","Liver disease","Hepatocellular carcinoma","Type 2 diabetes","Atherosclerosis","2022-02-17",{"date":659,"type":38},"2022-03-04",{"date":661,"type":38},"2017-11-14",{"date":663,"type":20},"2047-11",{"name":44,"class":45},3,{"id":667,"slug":668,"hasResults":12,"nctId":669,"briefTitle":670,"officialTitle":671,"acronym":672,"eligibilityCriteria":673,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":84,"enrollmentInfo":674,"targetDuration":4,"studyType":21,"phases":675,"briefSummary":676,"conditions":677,"keywords":680,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":683,"lastUpdatePostDateStruct":684,"startDateStruct":686,"completionDateStruct":688,"leadSponsor":690,"locationsCount":46},"100410973","phase-3-regeneration-in-cervical-degenerative-myelopathy-100410973","NCT04631471","Regeneration in Cervical Degenerative Myelopathy","Regeneration in Cervical Degenerative Myelopathy - a Multi-centre, Double-blind, Randomised, Placebo Controlled Trial Assessing the Efficacy of Ibudilast as an Adjuvant Treatment to Decompressive Surgery for Degenerative Cervical Myelopathy","RECEDE","Inclusion Criteria:\n\n* Patients suffering from degenerative cervical myelopathy as per established criteria who have granted informed consent to participate in the trial\n* Have a preoperative mJOA score ≥8 and ≤14\n* Scheduled for first surgical decompression as part of usual NHS clinical practice\n\nExclusion Criteria:\n\n* Previous surgery for DCM\n* DCM symptoms due to cervical trauma (at the discretion of the investigator)\n* Hypersensitivity to Ibudilast or any of the formulation components\n* Evidence of acute hepatitis, clinically significant chronic hepatitis, or evidence of clinically significant impaired hepatic function through clinical and laboratory evaluation including ALP\\> 1.5x ULN; ALT or AST \\> 2x ULN; GGT \\> 3x ULN\n* Active malignancy defined as history of invasive malignancy, except if the patient has received treatment and displayed no clinical signs and symptoms for at least five years\n* Recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance that may impact the outcome or study participation\n* Female patients with child bearing potential who are unwilling or unable to use reliable methods of contraception\n* Female patients who are pregnant, lactating or planning pregnancy during the course of the trial\n* Inability to comply with study procedures, IMP regime or follow-up schedule\n* Unable to take a gelatin based product\n* Participation in another CTIMP or device within the past 30 days from the time of recruitment\n* Functional disability from a commitment neurological disease that would mask the symptoms of DCM (at the discretion of the investigator). Including but not limited to stroke with residual disability, cerebellar ataxia, Parkinson's disease, symptomatic lumbar stenosis and multiple sclerosis\n* Resting pulse \\\u003C 50 bpm, SA or AV block, uncontrolled hypertension, or QTcF \\> 450 ms\n* History of stomach or intestinal surgery or any other condition that could interfere with or is judged by the Investigator to interfere with absorption, distribution, metabolism, or excretion of study drug\n* Unable to converse, read or write English at primary school level",{"count":330,"type":20},[616],"Degenerative (wear and tear arthritis of the spine) Cervical (concerning the neck) Myelopathy (injury to the spinal cord), DCM, is the most common spinal cord disorder of adulthood. In DCM, arthritis of the spine causes compression of the spinal cord.\n\nThe symptoms of DCM are often mistaken for natural consequences of ageing, including numb and clumsy hands, loss of coordination, imbalance, bladder and bowel problems. The weakness can progress to severe paralysis. Every year approximately 4 individuals in 100,000 undergo surgery for DCM; however, many more individuals are thought to suffer from DCM.\n\nThe main treatment for DCM is surgery. The aim of surgery is to create space and remove the compression of the spinal cord. This is known to prevent further injury. Unfortunately, the post-operative improvements are often incomplete and many patients remain severely disabled. Improving outcome after surgery represents an important unmet clinical need.\n\nClinical and preclinical findings indicate that the drug Ibudilast can stimulate neuroprotective and regenerative processes in the spinal cord. Ibudilast is well-tolerated and used to treat asthma and post-stroke dizziness in Japan and is currently being investigated for use in treating other neurological diseases.\n\nThis study will investigate whether daily oral administration of Ibudilast for a maximum of 34 weeks can improve hand function, strength, balance, urinary problems and reduce pain.\n\nThe study will initially be conducted at three sites in the UK, with more sites added as necessary. Individuals between 18-80 years old, diagnosed with DCM and scheduled for an operation for the first time will be invited to participate in the trial. The study will entail patient questionnaires and clinical assessments before surgery, shortly after surgery and 3, 6, and 12 months after surgery. Moreover, patients will undergo MRI scans pre-operatively and at 6-months postoperatively to determine whether the treatment was successful.",[678,679],"Myelopathy","Spinal Cord Diseases",[681,682,678],"Degenerative","Cervical","2021-12-24",{"date":685,"type":38},"2022-01-13",{"date":687,"type":38},"2021-12-22",{"date":689,"type":20},"2026-09-01",{"name":44,"class":45},""]