[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Queen Mary University of London\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":632},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,57,0,25,[9,43,69,91,114,146,183,202,229,257,286,309,327,358,386,413,434,459,479,501,521,542,562,582,611],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100544545","phase-3-thromboprophylaxis-in-lower-limb-immobilisation-100544545",false,"NCT06370273","Thromboprophylaxis in Lower Limb Immobilisation","Thromboprophylaxis in Lower Limb Immobilisation (TiLLI): a Multicentre Study Comprising Two Linked Open Label Phase III Randomised Controlled Trials Evaluating the Effectiveness and Cost Effectiveness of Different Methods of Pharmacological Prophylaxis for Patients With Temporary Lower Limb Immobilisation.","TiLLI","Inclusion Criteria:\n\n* Age \\>\u002F= 16 years\n* Placed in temporary lower limb immobilisation (rigid cast or brace) as a result an injury that occurred within the last 7 calendar days\n\nExclusion Criteria:\n\n* Hospital admission is required direct from the emergency department, minor injuries unit, or fracture clinic setting with an expected length of stay \\>2 calendar days.\n* Absolute contraindication or known hypersensitivity to anticoagulants, including history of end stage renal failure (eGFR \\\u003C20ml\u002Fmin\u002F1.73m2), hepatic failure or use of concomitant systemic treatment with azole-antimycotics (such as ketoconazole, itraconazole, voriconazole and posaconazole), HIV protease inhibitors (e.g. ritonavir) or active substances strongly inhibiting elimination pathways such as CYP3A4 or P-gp (such as clarithromycin, erythromycin or dronaderone) or a history of heparin induced thrombocytopenia.\n* Pregnancy, actively seeking conception, or active breastfeeding.\n* Preceding use of anticoagulant treatment for \\>3 calendar days at prophylactic or therapeutic dose.\n* Prior enrolment in the TiLLI study.\n* Non-rigid immobilisation (crepe bandage, tubigrip support, strapping).\n* Time since prescription of rigid immobilisation \\>3 calendar days\n* Co-enrolment onto a CTIMP where an anticoagulant is administered\n* People lacking the capacity to consent\n* Inability or refusal to use acceptable contraception up until after the last administration of IMP. Only applicable for women of childbearing potential who have been randomised to receive apixaban or rivaroxaban","ALL","16 Years",{"count":21,"type":22},10044,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","The goal of this clinical trial is to find out the clinical and cost effectiveness of Thromboprophylaxis in participants who have been placed in a plaster cast or splint after injury.\n\nThe main questions it aims to answer are:\n\n* whether giving tablets to people at high risks of clots after a leg injury is as good as injections (standard care)\n* whether giving any medication after a leg injury is better than standard care (advice only) for people at low risk of clots.\n\nParticipants will be assessed to be high risk (TiLLI High) or low risk (TiLLI Low). People who are at high risk of clots will have either tablets or injections to reduce their risk. People at low risk will receive tablets, injections or no medication.\n\nDrug treatments will be provided for the duration of immobilisation or up to 42 days (whichever is earlier), in accordance with current NICE guidelines. The participants will be followed up for 90 days following randomisation.",[28,29],"Thrombosis","Injury Leg","RECRUITING","2026-07-01",{"date":33,"type":34},"2026-07-02","ACTUAL",{"date":36,"type":34},"2024-11-12",{"date":38,"type":22},"2028-08-31",{"name":40,"class":41},"Queen Mary University of London","OTHER",5,{"id":44,"slug":45,"hasResults":12,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":23,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":62,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"100539890","hyaluronic-acid-and-polynucleotides-for-supra-bony-defects-100539890","NCT06309719","Hyaluronic Acid and Polynucleotides for Supra-bony Defects","Characterizing the Healing of Periodontal Supra-bony Defects Treated With Hyaluronic Acid and Polynucleotides","Inclusion Criteria:\n\n* Systemically healthy males and females ≥18 years old\n* Stage III or IV periodontitis (Papapanou, Sanz et al. 2018)\n* Presence of supra-bony periodontal defects (i.e., defects where the base of the pocket is located coronal to the alveolar crest and characterized by a predominantly horizontal pattern of tissue destruction) confirmed clinically and radiographically at a minimum of two and a maximum of four adjacent teeth and with a probing pocket depth (PPD) \\> 5 mm, following non-surgical periodontal therapy (NSPT). If \\>4 adjacent teeth exhibited the above clinical and radiographic conditions, the four adjacent teeth showing the greatest overall loss of periodontal attachment were included. Wisdom teeth and second molars will not be considered for the study.\n\nIf defect presents with an intrabony component, this should be ≤2 mm.\n\n* Non-surgical periodontal treatment (step 1 and 2) completed within the previous 4 months\n* Full-mouth bleeding score (FMBS) and full-mouth plaque score (FMPS) ≤20%\n\nExclusion Criteria:\n\n* Teeth with degree III mobility\n* Multi-rooted teeth with grade ≥2 furcation involvement\n* Heavy smokers (≥10 cigarettes a day)\n* Untreated caries or endodontic lesions or abscesses on the teeth involved in the surgery\n* Previous periodontal surgery in the area selected for the study\n* History of conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures (e.g., mitral valve prolapse, artificial heart)\n* Antibiotic or anticoagulant therapy during the month preceding the baseline exam.\n* History of alcohol or drug abuse\n* Medical history that includes uncontrolled diabetes or hepatic or renal diseases, or other serious medical conditions that can have a negative impact on the periodontal condition\n* In treatment with medications that can severely affect bone metabolism and blood clot formation (e.g., anticoagulants, long-term corticosteroids, bisphosphonates, immunosuppressants)\n* Self-reported pregnancy or lactation.","18 Years",{"count":52,"type":22},24,[54],"NA","The goal of this pilot study is to describe the early wound healing molecular events and the vascularization pattern associated with the treatment of supra-bony defects with access flap alone or in association with a combined formulation of hyaluronic acid and polydeoxyribonucleotides gel.",[57,58,59,60,61],"Periodontal Diseases","Wound Heal","Periodontal Inflammation","Periodontal Pocket","Periodontal Attachment Loss",{"date":33,"type":34},{"date":64,"type":34},"2024-10-21",{"date":66,"type":22},"2026-12",{"name":40,"class":41},2,{"id":70,"slug":71,"hasResults":12,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":84,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},"100427857","periodontal-assessment-of-a-bariatric-care-population-100427857","NCT04851470","Periodontal Assessment of a Bariatric Care Population","Periodontal Assessment of a Bariatric Care Population, Clinical, Genetic and Microbiological Characteristics. A Cross-sectional Study.","Bariatric","Inclusion Criteria:\n\nEach subject must meet all of the following inclusion criteria to be enrolled in the study:\n\n1. Subject must be over 18 years of age.\n2. Subject must have a BMI of higher or equal to 30 kg\u002F m2\n3. Subject must have voluntarily given written informed consent.\n\nExclusion Criteria:\n\nSubjects meeting any of the following exclusion criteria are not to be enrolled in the study:\n\n1. Subject is currently involved in other research involving the use of antibiotics or novel or unknown medications.\n2. Self-reported pregnancy.\n3. Subject is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit.\n4. Subject knowingly has HIV or Viral Hepatitis.\n5. Patients are completely edentulous.\n6. Subject with uncontrolled systemic illnesses.\n7. Subject is not capable to give informed consent.\n8. Subjects on chronic antibiotic therapy (ie two weeks or more in the previous month).",{"count":78,"type":22},394,"OBSERVATIONAL","Our primary aim is to investigate the prevalence and severity of Periodonotal Disease (PD) in a population of obese patients.\n\nOur secondary objectives are to:\n\nInvestigate inflammatory biomarkers that have been associated with PD in the saliva of obese patients.\n\nInvestigate the association of FTO gene (Obesity) polymorphisms with the prevalence of PD in this population.\n\nInvestigate and describe the subgingival microbial flora in obese patients with PD from subgingival dental plaque samples as well as the salivary samples.",[82,83],"Bariatric Surgery Candidate","Obesity",{"date":33,"type":34},{"date":86,"type":34},"2014-01-31",{"date":88,"type":22},"2027-12-31",{"name":40,"class":41},4,{"id":92,"slug":93,"hasResults":12,"nctId":94,"briefTitle":95,"officialTitle":96,"acronym":4,"eligibilityCriteria":97,"healthyVolunteers":12,"sex":18,"minAge":98,"maxAge":4,"enrollmentInfo":99,"targetDuration":4,"studyType":23,"phases":101,"briefSummary":102,"conditions":103,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":4},"100644690","autologous-platelet-concentrates-on-the-healing-of-extraction-sockets-100644690","NCT07673848","Autologous Platelet Concentrates on the Healing of Extraction Sockets","The Role of Autogenous Platelet Concentrates (APCs) in Post-extraction Early Wound Healing of High-risk Medication Related Osteonecrosis of the Jaw (MRONJ) Patients.","Eligibility criteria\n\nAll of the following criteria must be fulfilled for inclusion:\n\n* Patient must be willing to read and sign a copy of the Informed Consent Form\n* Males and females ≥ 25 years old;\n* Patients who are currently or previously treated with antiresorptive therapy alone or in combination with immune modulators or antiangiogenic medications for the management of cancer;\n* Patients who are treated with antiresorptive therapy, bisphosphonates, for osteoporosis for more than 5 years;\n* Patients who have been treated with antiresorptive therapy, bisphosphonates, for osteoporosis for less than 5 years and being concurrently treated with a systemic glucocorticoid;\n* Patients who are treated with denosumab in the last nine months and being concurrently treated with a systemic glucocorticoid;\n* Patients who are on the high-risk category to develop MRONJ based on the SDCEP guidance;\n* Patients who require dental extractions (one per quadrant per patient) of premolar or molar teeth which are irrational to treat for any reason;\n* Patients with a history of MRONJ.\n\nThe following patients will be excluded:\n\n* Patients with MRONJ at the area of extraction;\n* Patients with history of radiotherapy in the area of treatment;\n* Patients with metastatic bone disease in the area of treatment;\n* Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial;\n* Dental extractions in people who are systemically unwell and who require hospital admission;\n* Patients with poor glycaemic control (uncontrolled diabetes);\n* Current smokers or smokers who have quit less than 10 years ago (including e-cigarettes)","25 Years",{"count":100,"type":22},44,[54],"This study will evaluate the effect of A-PRF, a second-generation APC, on early wound healing in high-risk MRONJ patients following dental extractions, utilising advanced non-invasive methods to assess and associate molecular and blood flow changes during early healing. The early healing events of the post-extraction socket will also be characterised in terms of volumetric changes in relation to intra-oral thermographic changes, blood flow changes, in tandem with clinical measures of soft tissue healing and post-operative pain assessment. The early healing events will be analysed up to 15 days, and the final recall will be 180 days after extraction.",[104],"Medication-related Osteonecrosis of the Jaw","NOT_YET_RECRUITING","2026-06-24",{"date":108,"type":34},"2026-06-29",{"date":110,"type":22},"2026-06-01",{"date":112,"type":22},"2029-06-01",{"name":40,"class":41},{"id":115,"slug":116,"hasResults":12,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":12,"sex":18,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":4,"studyType":23,"phases":126,"briefSummary":127,"conditions":128,"keywords":132,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},"100562228","slow-speed-uk-a-double-blind-randomised-feasibility-trial-100562228","NCT06600438","Slow-SPEED UK: A Double-Blind Randomised Feasibility Trial","Slow-SPEED-United Kingdom: A Double-Blind Randomised Feasibility Trial of a Remote Gamified Physical Activity Programme in Adults With Hyposmia.","Slow-SPEED","Inclusion criteria\n\n* Age ≥ 40 years\n* Objective hyposmia, defined as scoring below the 15th percentile (adjusted for age\u002Fsex) on UPSIT\n* Ability and willingness to provide written informed consent\n* Proficiency in written and spoken English sufficient to complete study procedures.\n* Willingness and ability to attend baseline (in-person), 9-month (remote), and 18-month (in-person) assessments.\n* Access to telephone or internet for interim communication. Specifically, in possession of a suitable smartphone (screen size minimum 4.6 inch; Android version 9 or iOS version 15 or newer).\n* Physical activity threshold: During the 4-week eligibility run-in, the mean daily step count must be \\\u003C7,000 steps\u002Fday, calculated over ≥21 valid days (a valid day = ≥10 hours wear time or ≥1,000 steps). If recruitment after the first 2 months is \\\u003C60-70% of target, and subject to TSC\u002FSponsor approval and REC amendment, eligibility may be broadened to \\\u003C10,000 steps\u002Fday (i.e. participants averaging 7,000-9,999 steps\u002Fday become eligible).\n\nExclusion criteria\n\n* Clinical diagnosis of PD, dementia, or other neurodegenerative conditions\n* Severe or unstable medical or psychiatric illness likely to impair participation\n* Use of agents known to alter olfaction (e.g. intranasal zinc, chronic corticosteroids)\n* Current enrolment in an interventional study within the past 3 months (standard research retention guidance).\n* Inability to complete study procedures in English, per investigator assessment\n* Unable to give consent\n* Participants not living independently in the community. Participants in nursing homes, hospitalised persons on in a non-institutionalised setting are excluded.\n* Subject's personal smartphone is Fitbit-incompatible i.e. Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite\n* Activity level above threshold during eligibility run-in: mean daily step count ≥7,000 steps\u002Fday (or ≥10,000 steps\u002Fday if the broadened threshold is activated).","40 Years","100 Years",{"count":125,"type":22},110,[54],"Slow-SPEED UK is an 18-month randomised, double-blind feasibility trial evaluating the delivery, adherence, and acceptability of a digitally supported physical activity programme in community-dwelling adults aged 40 and over with objectively confirmed hyposmia (reduced sense of smell) and low baseline physical activity.\n\nParticipants are randomly assigned 1:1 to either a full-dose activity-support programme (targeting a 100% increase in daily step count) or a very low-dose active control (targeting a 10% increase). Both arms are delivered via a smartphone application linked to a wearable activity monitor (Fitbit Charge 6), with personalised weekly goals expressed as relative percentages to maintain blinding. The study is not designed to test clinical efficacy.",[129,130,131],"Hyposmia","Olfactory Dysfunction","Anosmia",[129,133,134,135,136,137,138],"Physical activity","Feasibility randomized controlled trial","Wearable technology","Smartphone application","Olfactory dysfunction","Digital health intervention",{"date":108,"type":34},{"date":141,"type":34},"2026-05-27",{"date":143,"type":22},"2027-10-31",{"name":40,"class":41},1,{"id":147,"slug":148,"hasResults":12,"nctId":149,"briefTitle":150,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":153,"sex":18,"minAge":154,"maxAge":155,"enrollmentInfo":156,"targetDuration":4,"studyType":23,"phases":158,"briefSummary":159,"conditions":160,"keywords":163,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":145},"100626083","childrens-health-respiratory-inflammation-and-short-term-air-pollution-100626083","NCT07431021","Children's Health, Respiratory Inflammation and Short-term Air Pollution","CHERISH","Inclusion Criteria:\n\n* Attending schools in Central and East London that have been recruited to the study\n\nExclusion Criteria:\n\n* Not able to engage with PE lessons on safety grounds, reported by their parents.\n* Children with learning or physical disabilities sufficient for them to be unable to give informed assent to the study, or to carry out study procedures",true,"7 Years","11 Years",{"count":157,"type":22},330,[54],"The goal of this study is to see if physical activity in high air pollution is worse than rest in high air pollution.",[161,162],"Asthma Acute","Respiratory",[164,165,166,167,168,169,170,171,172,173,174],"air pollution","physical activity","children","exercise","no2","Public health","air quality","pollution","paediatric","exposure","environment","2026-06-12",{"date":177,"type":34},"2026-06-15",{"date":179,"type":34},"2025-10-20",{"date":181,"type":22},"2027-07-01",{"name":40,"class":41},{"id":184,"slug":185,"hasResults":12,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":190,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":192,"conditions":193,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":196,"startDateStruct":197,"completionDateStruct":199,"leadSponsor":201,"locationsCount":145},"100498094","diagnosing-variable-primary-aldosteronism-100498094","NCT05765786","Diagnosing Variable Primary Aldosteronism.","Do we Miss a Common Subset of Primary Aldosteronism in Which There is Cyclical or Exaggerated Diurnal Variation in Secretion?","Inclusion Criteria:\n\n* People with clinically suspected PA but have not met criteria for diagnosis. Suspicion based on low-renin (renin activity \\\u003C0.5 nmol\u002Fh\u002FL or renin mass \\\u003C5 ng\u002FL), plasma sodium \\> 140mmol\u002FL or plasma potassium \\\u003C 4mmol\u002FL.\n* Patients who have been diagnosed with PA and had previous aldosterone samples \\\u003C277 pmol\u002FL, a level which would normally not qualify for confirmatory testing.\n* Patients with aldosterone results done at different times that indicate variability in production.\n* Willing to consent and participate in the study.\n\nExclusion Criteria:\n\n* Inability to withdraw β-adrenoceptor antagonist therapy for 2 weeks.\n* People on end of life treatment.",{"count":191,"type":22},100,"The goal of this observational study is to see if there is a cyclical or exaggerated diurnal variation in aldosterone production in people with Primary Aldosteronism.",[194,195],"Primary Aldosteronism","High Blood Pressure",{"date":177,"type":34},{"date":198,"type":34},"2023-02-24",{"date":200,"type":22},"2027-07-24",{"name":40,"class":41},{"id":203,"slug":204,"hasResults":12,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":23,"phases":212,"briefSummary":214,"conditions":215,"keywords":219,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100643542","early-phase-1-clinical-evaluation-of-an-ai-risk-prediction-system-ai-trips-100643542","NCT07634185","Clinical Evaluation of an AI Risk Prediction System (AI-TRiPS)","Clinical Evaluation of an AI Risk Prediction and Decision Support System for Early Management of Injured Patients: a Stepped-wedge Cluster Randomised Trial","AI-TRiPS","Inclusion Criteria:\n\nClinician Participants\n\n* Senior clinical decision-maker involved in the initial trauma resuscitation (e.g. consultant or senior trainee in emergency medicine, anaesthesia, intensive care medicine, or surgery).\n* Based at one of the four participating Major Trauma Centres.\n* Able and willing to provide informed consent.\n* Completed the required study-specific training.\n\nTrauma Patients\n\n* Aged 16 years and above.\n* Treated and transported to a participating Major Trauma Centre by London's Air Ambulance.\n* Managed by one or more participating trauma clinicians during the resuscitation.\n\nExclusion Criteria:\n\nClinician Participants\n\n● Decline or withdraw informed consent at any stage.\n\nTrauma Patients\n\n* Aged under 16\n* Not treated by London's Air Ambulance.\n* Transported to a non-participating hospital.\n* Not managed by any participating clinicians.\n* Presenting with injuries resulting from burns, hangings, drownings, or isolated psychiatric emergencies.\n* Have registered a national NHS data opt-out or otherwise requested that their routine clinical data not be used for research.",{"count":211,"type":22},1200,[213],"EARLY_PHASE1","The goal of this clinical study is to evaluate a software device and its impact on clinician behaviour during the initial management of trauma patients in a real-world clinical setting. Known as the AI-TRiPS Device this software uses real-time prehospital data and machine learning-based risk predictions which are displayed digitally for hospital trauma teams prior patient arrival.\n\nThe investigators will use a Stepped Wedge Cluster Randomised Controlled study design with an integrated process evaluation.\n\nThe Device will be deployed across the London Major Trauma System where the Major Trauma Centres will be the clusters. Each cluster will transition from control (standard care) to intervention at a pre-specified time (time of transition is randomised).\n\nPrimary Outcome: Clinician behaviour, assessed via the accuracy of risk prediction and clinician confidence.\n\nSecondary Outcome: Clinician acceptability, care process metrics, patient outcomes, and safety endpoints.\n\nPrimary study population: Hospital trauma clinicians, following initial resuscitation of each eligible trauma patient, who will complete electronic questionnaires.\n\nSecondary study population: Adult trauma patients, data will be collected for the duration of their index admission to hospital, to assess outcomes and enable comparison with clinician risk predictions.",[216,217,218],"Trauma","Injury","Decision Support Systems, Clinical",[220,221],"Device trial, prediction tool, trauma","clinical decision support","2026-06-03",{"date":224,"type":34},"2026-06-08",{"date":110,"type":22},{"date":227,"type":22},"2027-12-01",{"name":40,"class":41},{"id":230,"slug":231,"hasResults":12,"nctId":232,"briefTitle":233,"officialTitle":234,"acronym":4,"eligibilityCriteria":235,"healthyVolunteers":153,"sex":18,"minAge":50,"maxAge":236,"enrollmentInfo":237,"targetDuration":4,"studyType":23,"phases":239,"briefSummary":240,"conditions":241,"keywords":245,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":250,"startDateStruct":252,"completionDateStruct":254,"leadSponsor":256,"locationsCount":145},"100606197","evaluation-of-adding-nitrate-into-foods-for-regulating-nitric-oxide-bioavailability-in-healthy-individuals-100606197","NCT07172425","Evaluation of Adding Nitrate Into Foods for Regulating Nitric Oxide Bioavailability in Healthy Individuals","An Open-Label, Randomised, Crossover Study to Investigate the Feasibility of Nitrate Fortification in Commonly Consumed Foods for Regulating Nitric Oxide Metabolism in Healthy Individuals","Inclusion Criteria:\n\n1. Healthy volunteer.\n2. Aged ≥18 years and ≤ 60 years.\n3. Willing to provide informed consent.\n4. Able to understand and comply with protocol requirements, instructions, and stated restrictions.\n\nExclusion Criteria:\n\nA volunteer will not be eligible for inclusion in this study if any of the following criteria are met:\n\n1. Unwilling to provide consent.\n2. People with chronic health conditions requiring medication.\n3. Pregnant females, or those with a possibility of being pregnant.\n4. History of hypertension and \u002For diabetes.\n5. History of any serious illnesses, including recent infections or trauma.\n6. History of symptomatic coronary artery disease, stroke, or other known atherosclerotic diseases.\n7. People who will commence or who are likely to commence treatment with non-steroidal anti-inflammatory drugs (NSAIDs) other than aspirin, from screening until study completion.\n8. Self-declared alcohol or drug abuse within the past 6 months.\n9. Three-month prior history of regular alcohol consumption exceeding an average weekly intake of \\> 28 units (or an average daily intake of greater than 3 units) for males, or an average weekly intake of \\> 21 units (or an average daily intake of greater than 2 units) for females. One unit is equivalent to a half pint (284mL) of beer\u002Flager; 25mL of spirits, or 125mL of wine.\n10. Taking systemic medication (other than the oral contraceptive pill).\n11. Recent (within 2 weeks) self-reported use of mouthwash or tongue scrapers.\n12. Recent (within 2 weeks) or current antibiotic use.\n13. Recent (within 1 week) use of NO3- or NO2- supplements.\n14. History, or recent treatment of (within the last 3 months) for any oral condition (excluding caries), including gingivitis, periodontitis and halitosis.\n15. History of, or recent treatment for, any blood-borne infectious disease such Hepatitis B or C virus, or HIV.\n16. Current smokers (including vaping) or have smoked within the last 6 months.\n17. Diagnosis of rheumatoid arthritis, connective tissue disorders, and other conditions known to be associated with chronic inflammation (e.g., Inflammatory Bowel Disease).\n18. People who have donated more than 500mL of blood within 56 days prior to the study commencement.\n19. Known allergy to celery, gluten, crustaceans, eggs, lupin, milk, mustard, peanuts, sesame, soybeans, tree nuts, oats, palm oil, sugar, cranberries, sunflower oil, invert syrup, sodium bicarbonate.","60 Years",{"count":238,"type":22},30,[54],"Inorganic nitrate, found in leafy green vegetables and beetroot, can help lower blood pressure and support heart health. Early experimental work has suggested that dietary nitrate supplementation, in the form of beetroot juice or potassium nitrate capsules, can reduce blood pressure and improve endothelial function. Consequently, concentrated nitrate supplements like beetroot juice have become popular. However, these supplements can be expensive, high in sugar, and not to everyone's taste. Since more than three-quarters of adults with high blood pressure live in low- and middle-income countries, it is important to find safe, affordable ways to add nitrate to commonly eaten foods.\n\nThe team at Queen Mary University of London has been developing nitrate-fortified products that may be more appealing to a wider population. With support from the food manufacturer Reading Scientific Services Ltd. (RSSL), they have successfully added nitrate to three oat-based products: cereal bar, porridge, and biscuits.\n\nThis study aims to explore whether adding nitrate to commonly eaten foods can improve nitric oxide levels in the body and help lower blood pressure in healthy volunteers. Participants will receive the three nitrate-fortified food products in a randomised, crossover design. Nitrate and nitrite concentrations in biological samples, along with blood pressure, will be measured before and at multiple time points after supplementation with the nitrate-fortified products.",[242,243,244],"Healthy Volunteers","Nitric Oxide","Vascular Function",[246,247,248,249],"Blood pressure","Oral microbiome profiling","Nitric oxide bioavailability","Inorganic nitrate fortification",{"date":251,"type":34},"2026-06-04",{"date":253,"type":34},"2025-10-15",{"date":255,"type":22},"2027-02",{"name":40,"class":41},{"id":258,"slug":259,"hasResults":12,"nctId":260,"briefTitle":261,"officialTitle":262,"acronym":4,"eligibilityCriteria":263,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":264,"targetDuration":4,"studyType":23,"phases":266,"briefSummary":267,"conditions":268,"keywords":270,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":145},"100605681","ctca-prior-to-invasive-angiography-in-post-bypass-patients-bypass-ctca-2-100605681","NCT07165678","CTCA Prior to Invasive Angiography in Post-Bypass Patients (BYPASS CTCA 2)","A Multi-Centre, Randomised Trial Assessing the Value of Computed Tomography Coronary Angiography Prior to Invasive Coronary Angiography in Patients With Previous Coronary Artery Bypass Grafts in Reducing Cardiac Events","Inclusion Criteria:\n\n* Aged ≥18\n* Previous coronary artery bypass grafting (CABG)\n* An indication for coronary angiography\n\n  * Angina\n  * Ischaemia on perfusion imaging\n  * Acute coronary syndrome\n* Patients are able and willing to give their written informed consent\n\nExclusion Criteria:\n\n* Subjects presenting with ST segment myocardial infarction within window for primary PCI\n* Patients considered unsuitable to participate by the research team (e.g. due to medical reasons, laboratory abnormalities, or subject's unwillingness to comply with all study related procedures)\n* Life expectancy less than 1 year",{"count":265,"type":22},1000,[54],"The goal of this clinical trial is to evaluate whether a coronary computed tomography angiography (CTCA)-guided strategy can reduce the risk of death, heart attack, stroke, and hospital admissions in patients experiencing angina or myocardial infarction following coronary artery bypass graft (CABG) surgery. The main questions it aims to answer are:\n\n* Can CTCA reduce major adverse cardiovascular events compared to standard invasive coronary angiography?\n* Is CTCA a cost-effective and safer alternative that improves patient quality of life? Researchers will compare outcomes between patients receiving CTCA prior to angiography and those undergoing standard angiography alone to determine if CTCA improves clinical outcomes and procedural safety.\n\nParticipants will:\n\n* Be randomly assigned to either CTCA-guided care or standard angiography\n* Undergo coronary imaging and follow-up assessments\n* Complete questionnaires on quality of life and healthcare resource use",[269],"Coronary Heart Disease",[271,272,273,274,275,276,277,278],"Coronary Artery Bypass Graft","Angina","Coronary Artery Disease","CABG","percutaneous coronary intervention","coronary angiograms","Computerised Tomography Coronary Angiography","CTCA",{"date":280,"type":34},"2026-06-05",{"date":282,"type":34},"2026-04-16",{"date":284,"type":22},"2029-07-31",{"name":40,"class":41},{"id":287,"slug":288,"hasResults":12,"nctId":289,"briefTitle":290,"officialTitle":290,"acronym":291,"eligibilityCriteria":292,"healthyVolunteers":153,"sex":18,"minAge":122,"maxAge":123,"enrollmentInfo":293,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":145},"100591947","trans-and-non-binary-prostate-specific-antigen-reference-interval-determination-study-100591947","NCT06987045","Trans and Non-binary Prostate-Specific Antigen Reference Interval Determination Study","TransPRIDE","Inclusion Criteria:\n\n* • Aged \\>40\n\n  * Transgender or non-binary (identify with a gender other than the one assigned at birth)\n  * With a prostate\n  * Fulfills at least one of the following 3 criteria with regards to gender-affirming medical care:\n\n    * Taking oestradiol for at least the last 3 months\n    * Taking anti-androgens for at least the last 3 months\n    * Ever had bilateral orchidectomy\n  * Eligible for National Health Service (NHS) treatment\n\nExclusion Criteria:\n\n* • History of prostate cancer (Prostate cancer) at any time\n\n  * History of prostate surgery at any time\n  * History of prostate radiotherapy at any time\n  * History of benign prostatic hypertrophy (enlarged prostate) at any time\n  * Vaginoplasty within 12 months\n  * Orchidectomy or vulvoplasty within three months\n  * Sexually Transmitted Infection (STI) within 6 weeks of blood sample\n  * Active urinary infection or within 6 weeks of blood sample\n  * Prostatitis within 6 weeks of blood sample\n  * Urological intervention (e.g. prostate biopsy) within 6 weeks of blood sample\n  * Unwilling to give consent\n  * Lacking capacity to give consent\n  * In the secure estate",{"count":294,"type":22},500,"The prostate specific antigen (PSA) blood test can help diagnose prostate problems, including cancer.\n\nThe prostate is an organ in the pelvis. It is found in cisgender men, transgender (trans) women and some non-binary people.\n\nAnyone with a prostate can get prostate cancer. The prostate remains after genital (lower) surgery. The hormones and surgeries that trans women and non-binary people might have can lower the PSA. We do not have good data on the normal PSA levels are for this group\n\nTransPRIDE is a research study that will help us find the normal levels of PSA in trans women and non-binary people with prostates.\n\nResearchers will ask 500 trans women and non-binary people with prostates to take part. They will need to be aged 40 or over. They will need to be on hormones or have had lower surgery. They will be called after 6 months to recheck their health. If a person has a high PSA, they may be sent for more tests.\n\nKnowing the normal PSA level for trans women and non-binary people will help doctors to find and treat their prostate cancer more quickly.",[297],"Prostate CA",[299,300,301,302],"Prostate Cancer","Transwomen","Non-binary","prostate",{"date":251,"type":34},{"date":305,"type":34},"2026-04-04",{"date":307,"type":22},"2028-03-31",{"name":40,"class":41},{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":318,"conditions":319,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":321,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":145},"100373374","investigating-pathological-mechanisms-in-non-alcoholic-fatty-liver-disease-100373374","NCT04141592","Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease","Investigating Pathological Mechanisms in Non-alcoholic Fatty Liver Disease: Cross-sectional Comparative Study Between Patients and Healthy Controls","Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed non-alcoholic Fatty liver disease (diagnosed clinically, radiologically or histologically)\n* If diabetic, Diagnosed with Type 2 Diabetes Mellitus\n\nOR\n\n• Healthy Control: no diagnosis of any liver condition including NAFLD\n\no NAFLD excluded by Fibroscan Controlled Attenuation Parameter (CAP) score of \\\u003C222 dB\u002Fm\n\nExclusion Criteria:\n\n* Unwilling or unable to give informed consent\n* Type 1 Diabetes Mellitus\n* Other form of liver disease (other than NAFLD)\n\n  o Viral hepatitis, Auto-immune hepatitis, primary sclerosing cholangitis, primary biliary cholangitis, haemochromatosis, Sarcoidosis, cystic fibrosis, sickle cell disease\n* Taking medication associated with liver dysfunction (except methotrexate)\n* Auto-immune disease which in the investigator's opinion may confound immune profiling\n* Concomitant immunosuppressive medications (except methotrexate, short course oral steroids or inhaled corticosteroids)\n* Currently pregnant\n* Any major organ transplant (excluding corneal or hair transplant)\n* Regular alcohol intake greater than 14 units a week for female participants and 21 units a week for male participants",{"count":317,"type":22},153,"To identify key characteristics of the tissue resident and peripherally circulating immune-phenotype in addition to blood markers, metabolic profile, faecal and oral microbiota in non-alcoholic fatty liver disease",[320],"Non-Alcoholic Fatty Liver Disease",{"date":280,"type":34},{"date":323,"type":34},"2019-03-05",{"date":325,"type":22},"2026-07-31",{"name":40,"class":41},{"id":328,"slug":329,"hasResults":12,"nctId":330,"briefTitle":331,"officialTitle":331,"acronym":332,"eligibilityCriteria":333,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":336,"conditions":337,"keywords":344,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":350,"lastUpdatePostDateStruct":351,"startDateStruct":353,"completionDateStruct":355,"leadSponsor":357,"locationsCount":4},"100638250","prep-lana-pre-exposure-prophylaxis--long-acting-novel-antiviral-agent-100638250","NCT07620730","PrEP-LANA (Pre-exposure Prophylaxis- Long-acting Novel Antiviral Agent)","PrEP-LANA","Inclusion Criteria:\n\nParticipants of any gender, ethnicity or socio-economic group who meet all the following criteria are eligible for inclusion in this study:\n\n* Adults who are aged \\> 18 years at time of consent (including people of child-bearing capacity and age, non-pregnant or pregnant adults)\n* Attending a participating NHS sexual healthcare service\n* Prescribed LA CAB for PrEP according to NICE and NHS eligibility criteria (including those newly prescribed and those already using LA CAB)\n* Non-reactive \u002F negative HIV Antigen\u002FAntibody test and HIV RNA test at time of LA CAB for PrEP initiation (performed under routine care)\n* Able and willing and able to give informed consent to all study procedures prior to inclusion\n\nExclusion Criteria:\n\nPrEP user participants who meet any of the following criteria are ineligible for inclusion in this study:\n\n* One or more reactive or positive HIV test results at enrolment visit, even if HIV infection is not confirmed.\n* Currently enrolled in interventional trial of PrEP agents, HIV vaccine trial or experimental medication.\n* Plan to relocate out of the area during the study period. Note: \"Plan to relocate out of the area\" is defined as a stated intention at enrolment to move residence outside the catchment area of a participating study site during the study period, such that ongoing clinical management would likely transfer to a non-participating team.",{"count":335,"type":22},220,"The goal of this 12-month implementation science study is to generate the evidence required to ensure long-acting cabotegravir (LA CAB) as pre-exposure prophylaxis (PrEP) can be delivered in an equitable manner within the NHS. This study will recruit both PrEP users and healthcare professionals (HCPs).\n\nThe main questions it aims to answer are:\n\n* What do healthcare providers think about the feasibility of delivering LA CAB PrEP within sexual health services in the NHS?\n* How many participants stay on\u002Fremain consistent with LA CAB PrEP injections at Month 12 (PrEP persistence)?\n\nParticipants (200 PrEP users) will be followed for 12-months and asked to complete surveys at 3 study visits. A subset of 20 participants will also be asked to complete interviews about their experiences. We will also ask 20 HCPs at participating locations to complete surveys and interviews at both baseline and month 12.\n\nA core principle of equity (understanding any difference in impact on underserved populations) will be applied throughout the study. To ensure representation of a diverse group of participants that reflects the demographic groups most affected by incident HIV and most underserved by PrEP in the UK, enrolment targets will be applied and meticulously managed by the central study team, as follows:\n\n* A cap of 30% (n=60) will be applied to recruitment of White cisgender men who have sex with men who are not otherwise part of other under-represented groups (as defined below),\n* At least 70%% (n=140) of participants will represent groups currently underserved by PrEP and fall into one (or more) of the following socio-demographic categories: women (defined cisgender or transgender) OR as transgender men OR non-binary individuals OR age\\\u003C25 yrs, OR sex workers OR people who inject drugs OR racially minoritised heterosexual men.",[338,339,340,341,342,343],"PrEP","PrEP Adherence Experiences","PrEP Adherence Perspectives","PrEP Uptake","Equity","Community Setting",[338,345,332,346,347,348,342,349],"Patient and public involvement and engagement","LA CAB","Cabotegravir","Long-acting PrEP","community setting","2026-05-28",{"date":352,"type":34},"2026-06-02",{"date":354,"type":22},"2026-10",{"date":356,"type":22},"2028-06",{"name":40,"class":41},{"id":359,"slug":360,"hasResults":12,"nctId":361,"briefTitle":362,"officialTitle":363,"acronym":364,"eligibilityCriteria":365,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":366,"targetDuration":4,"studyType":23,"phases":368,"briefSummary":369,"conditions":370,"keywords":373,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":68},"100625492","monitoring-respiratory-muscle-function-in-acute-respiratory-failure-patients-on-non-invasive-respiratory-support-100625492","NCT07423338","Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients on Non Invasive Respiratory Support","Monitoring Respiratory Muscle Function in Acute Respiratory Failure Patients Requiring Non-invasive Respiratory Support (MONITOR-NIV): A Prospective Observational Study","MONITOR-NIV","Inclusion Criteria:\n\n* Adult (≥18 years old)\n* with acute respiratory failure with hypoxia (i.e. arterial oxygen tension (PaO2) of \\\u003C8.0 kPa), and\u002For with or without hypercapnia (i.e. arterial carbon dioxide tension (PaCO2) of \\>6.0 kPa) from any underlying disease or cause\n* requiring any non-invasive respiratory support (i.e. HFNO, CPAP, BiPAP)\n* Multidisciplinary critical care staff involved in the management of those recruited patients with acute respiratory failure requiring non-invasive respiratory supports. Staff will possibly have an interview and are also required to complete a questionnaire.\n\nExclusion Criteria:\n\n* Patients in respiratory arrest defined as the total cessation of airflow and breathing effort and absent ventilation (24,25)\n* Patients requiring immediate intubation\n* Patients with Glasgow Coma Scale (GCS) \\\u003C 8\n* Patients with severe facial trauma or burns\n* Patients with fixed upper airway obstruction or inability to protect the airway\n* Patients with severe agitation and\u002For confusion that prevent use of the device mask\n* Patients with severe vomiting\n* Pregnancy\n* Patients with pacemakers and other electronic devices in the thorax\n* Patients on end-of-life care or palliative care (defined as expected to die and\u002For not receiving active treatment)\n* Contra-indication to EIT or ultrasound monitoring (e.g. burns, severe obesity, thoracic wounds limiting instrument placement, and thoracic drain)",{"count":367,"type":22},50,[54],"Acute respiratory failure is a common, life-threatening condition where the lungs cannot provide enough oxygen to the body. Many patients are treated with non-invasive respiratory support (NRS) such as high-flow nasal oxygen (HFNO), continuous positive airway pressure (CPAP), or bilevel positive airway pressure (BiPAP). However, up to half of patients receiving NRS still deteriorate and require intubation and invasive ventilation, which is linked to longer hospital stays, more complications, and slower recovery.\n\nA major challenge in caring for these patients is that clinicians currently cannot directly see how well the breathing muscles (especially the diaphragm and parasternal intercostal muscles) and the lungs are working while the patient is using NRS. Existing bedside measures, such as respiratory rate or oxygen levels, only show part of the picture. They do not indicate how hard the patient is working to breathe or whether their respiratory muscles are becoming fatigued. This lack of information may delay important decisions about adjusting NRS settings or switching to other treatments.\n\nThis study aims to find out whether two advanced but non-invasive, radiation-free bedside monitoring tools can be used effectively in routine care:\n\n1. Ultrasound, which can measure breathing muscle thickness, movement, and lung aeration\n2. Electrical impedance tomography (EIT), which uses a soft belt of small electrodes around the chest to measure changes in air and blood flow within different regions of the lungs in real time\n\nThese tools have shown promise in earlier research, and interviews with patients and clinicians suggest they are comfortable, well-tolerated, and potentially useful. However, they have not yet been evaluated together in a real-world hospital environment where many acute respiratory failure patients are cared for outside the ICU.\n\nWhat the study will involve:\n\nUp to 100 adults with acute respiratory failure requiring any type of non invasive respiratory support will be recruited with the goal of obtaining complete data from at least 50 patients. Each participant will undergo ultrasound and EIT assessments up to seven times during the first 72 hours after starting NRS, plus an additional measurement if they improve enough to stop NRS or if they deteriorate and require intubation. These assessments take place at the bedside, require brief exposure of the upper chest, and last approximately 15-45 minutes. Routine clinical data-such as heart rate, oxygen levels, and breathing measures-will also be recorded.\n\nIn parallel, clinical staff caring for these patients will complete a short Healthcare System Usability Scale questionnaire to rate how useful, understandable, and practical they find the information generated by ultrasound and EIT. Some staff may also take part in optional interviews to explore usability in more depth.\n\nWhat the study is trying to learn:\n\nThe primary aim is to determine the usability of these monitoring methods meaning understanding if they are practical, easy to use, and helpful for clinicians making decisions about NRS treatment.\n\nSecondary aims include understanding:\n\n* how the respiratory muscles and lungs change over time during NRS\n* whether these changes are linked to treatment settings (e.g., flow rate, pressure support)\n* whether certain patterns are associated with treatment success or failure (intubation or death)\n* whether these tools could help identify patients at risk of deterioration earlier\n\nRisks and benefits:\n\nBoth ultrasound and EIT are widely used, safe, and non-invasive. They involve no radiation, needles, or harmful exposure. Minor temporary discomfort from the gel or belt placement is possible. Participation will not change any clinical treatments. Although patients may not directly benefit, the study may help future patients by improving understanding of breathing muscle function and supporting more personalised respiratory care.\n\nBy contributing to this research, patients and clinicians will help determine whether advanced monitoring can be realistically implemented in busy hospital settings and whether it could lay the groundwork for future trials aimed at improving outcomes for people with acute respiratory failure.",[371,372],"Acute Respiratory Failure (ARF)","Non Invasive Ventilation",[374,375,376,377],"acute respiratory failure","non-invasive respiratory support","ultrasonography","electrical impedance tomography","2026-05-20",{"date":380,"type":34},"2026-05-22",{"date":382,"type":34},"2026-02-26",{"date":384,"type":22},"2027-05-02",{"name":40,"class":41},{"id":387,"slug":388,"hasResults":12,"nctId":389,"briefTitle":390,"officialTitle":391,"acronym":392,"eligibilityCriteria":393,"healthyVolunteers":12,"sex":394,"minAge":50,"maxAge":4,"enrollmentInfo":395,"targetDuration":4,"studyType":23,"phases":397,"briefSummary":399,"conditions":400,"keywords":402,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":68},"100589443","phase-2-investigating-datopotamab-deruxtecan-plus-durvalumab-versus-datopotamab-deruxtecan-in-patients-with-pdl1-negative-metastatic-triple-negative-breast-cancer-100589443","NCT06954480","Investigating Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer","An Open-label Randomised, Phase II Trial of Datopotamab Deruxtecan Plus Durvalumab Versus Datopotamab Deruxtecan in Patients With PDL1-negative Metastatic Triple-negative Breast Cancer","DIAMOND","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Ability to comply with the protocol.\n3. Female ≥ 18 years of age.\n4. Triple-negative disease, defined as tumour cells being:\n\n   * Negative for ER with \\\u003C10% of tumour cells positive for ER on IHC or IHC score (Allred) of ≤3.\n   * Negative for PR with \\\u003C10% of tumour cells positive for PR on IHC or IHC score (Allred) of ≤3 or PR unknown, and\n   * Negative for HER2 with 0, 1+ or 2+ intensity on IHC and no evidence of amplification on ISH.\n5. PDL1 negative, defined as 22C3 CPS\\\u003C10.\n6. Patients must have:\n\n   * at least one lesion, not previously irradiated, that can be measured accurately at baseline as ≥ 10mm in the longest diameter (except lymph nodes which must have short axis ≥ 15mm) with computed tomography (CT) or magnetic resonance imaging (MRI) performed within 28 days prior to randomisation which is suitable for accurate repeated measurements, or\n   * lytic or mixed (lytic + sclerotic) bone lesions in the absence of measurable disease as defined above; patients with sclerotic\u002Fosteoblastic bone lesions only in the absence of measurable disease are not eligible. Patient that cannot be assessed by the CT or MRI should be excluded from the study.\n7. Representative formalin-fixed paraffin embedded (FFPE) breast tumour samples with an associated pathology report from the primary or recurrent cancer that are determined to be available and sufficient for central testing OR tumour accessible for biopsy.\n8. ECOG performance status 0-1.\n9. Life expectancy ≥12 weeks.\n10. Adequate haematologic and end-organ function within 28 days prior to the first study treatment defined by the following:\n\n    * Absolute neutrophil count ≥ 1500 cells\u002FμL (1.5 x 109\u002FL) (without granulocyte) colony-stimulating factor support within 2 weeks prior to Cycle 1, Day 1).\n    * WBC \\> 2500\u002FμL (2.5 x 109\u002FL).\n    * Platelet count ≥ 100,000\u002FμL (100 x 109\u002FL) (transfusion not permitted within 28 days of study medication).\n    * Haemoglobin ≥ 9.0 g\u002FdL (90g\u002FL) with no blood transfusions (packed red blood cells).\n    * Serum albumin ≥ 3g\u002FdL.\n    * AST (SGOT) or ALT (SGPT) and ALP ≤ 2.5 times the institutional upper limit of normal (ULN), bilirubin ≤ 1.5 x ULN (patients with liver metastases who have AST or ALT ≤ 5 x the institutional ULN may be enrolled).\n    * aPTT ≤ 1.5 × the institutional ULN, INR \\\u003C1.5 and absence of evidence of impaired hepatic synthesis function. This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.\n    * Serum Creatinine ≤ 1.5 x institutional ULN.\n    * Glomerular filtration rate ≥ 40mL\u002Fmin as assessed by standard methodology at the investigating center (i.e., Cockcroft Gault, MDRD or CKD-EPI formulae, EDTA clearance or 24 h urine collection).\n    * No evidence of haematuria: +++ on microscopy or dipstick.\n11. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Cycle 1, Day 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible. Patients must agree to use adequate contraception, defined as those methods with a failure rate of \\\u003C 1 % per year beginning 14 days before the first dose of study drug and for 7 months after the last dose of study drug. Also, participants must not donate, or retrieve for their own use, ova at any time during this study and for at least 7 months after the last dose of treatment. Preservation of ova should be considered prior to randomisation or the first dose of study intervention.\n12. Body Weight \\> 30 kg.\n\nExclusion Criteria:\n\n1. Prior chemotherapy, immunotherapy (including durvalumab) or treatment with PARP inhibitors for advanced or metastatic breast cancer.\n2. Prior treatment with immune checkpoint inhibitors (eg atezolizumab, pembrolizumab) or DNA topoisomerase I or TROP2- or HER2-targeting ADCs and TROP2 targeted therapy in the (neo)adjuvant setting within 6 months from the end of treatment and randomisation into this study.\n3. Patients with prior allogeneic stem cell or solid organ transplantation.\n4. Patients must not have a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent), or had oral or IV steroids for 14 days prior to the first dose of study drug; the use of intranasal, inhaled corticosteroids topical steroids, or local steroid injections, physiologic replacement doses of glucocorticoids (i.e. for adrenal insufficiency) and mineralocorticoids (e.g. fludrocortisone) or steroids as premedication for hypersensitivity reactions (e.g., CT scan premedication is allowed.\n5. Administration of a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n6. Active or prior documented autoimmune or inflammatory disorders including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, , rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis , Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. The following are exceptions to this criterion:\n\n   * Patients with vitiligo or alopecia\n   * Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement therapy\n   * Any chronic skin condition that does not require systemic therapy\n   * Patients without active disease in the last 5 years may be included\n   * Patients with celiac disease controlled by diet alone\n7. History of idiopathic pulmonary fibrosis (including pneumonitis or interstitial lung disease), drug-induced pneumonitis, radiation pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia) requiring steroids, or evidence of active pneumonitis on screening chest CT scan.\n8. Active infection requiring systemic therapy.\n9. History of HIV infection.\n10. Known active hepatitis infection (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n11. Known history of active tuberculosis (clinical evaluation that may include clinical history, physical examination and radiographic findings, or tuberculosis testing in line with local practice).\n12. Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that, in the investigator's opinion, gives reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, may affect the interpretation of the results, render the patient at high risk from treatment complications or interferes with obtaining informed consent.\n13. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the study protocol.\n14. Concurrent treatment with other experimental drugs or participation in another clinical trial with therapeutic intent within 28 days prior to randomisation.\n15. Pregnant and lactating female patients.\n16. Major surgical procedure within 4 weeks prior to randomisation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.\n17. Malignancies other than breast cancer within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent).\n18. Severe infections within 28 days prior to randomisation in the study including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia.\n19. Any unresolved toxicity NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria:\n\n    * Patients with Grade ≥2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.\n    * Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.\n20. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, situations that would limit compliance with study requirement, substantially increase risk of incurring AEs.\n21. History of leptomeningeal carcinomatosis.\n22. Has clinically significant corneal disease.\n23. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n24. History of active primary immunodeficiency.\n25. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients.\n26. Brain metastases or neoplastic spinal cord compression. Patients whose brain metastases have been treated may participate provided they show radiographic stability (defined as 2 brain images, both of which are obtained after treatment to the brain metastases. These imaging scans should both be obtained at least four weeks apart and show no evidence of intracranial progression. In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be stable either, without the use of steroids, or are stable on a steroid dose of ≤10mg\u002Fday of prednisone or its equivalent and anticonvulsants for at least 14 days prior to the start of treatment. Brain metastases will not be recorded as RECIST Target Lesions at baseline.\n27. Mean QT interval corrected for heart rate using Fridericia's formula (QTcF) ≥470 ms calculated from 3 ECGs (within 15 minutes at 5 minutes apart).\n28. Patients who have received prior anti-PD-1, anti PD-L1 or anti CTLA-4:\n\n    * Must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.\n    * All AEs while receiving prior immunotherapy must have completely resolved or resolved to baseline prior to screening for this study.\n    * Must not have experienced a ≥Grade 3 immune related AE or an immune related neurologic or ocular AE of any grade while receiving prior immunotherapy. NOTE: Patients with endocrine AE of ≤Grade 2 are permitted to enroll if they are stably maintained on appropriate replacement therapy and are asymptomatic.\n    * Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently require maintenance doses of \\> 10 mg prednisone or equivalent per day.","FEMALE",{"count":396,"type":22},140,[398],"PHASE2","The DIAMOND study is being carried out to evaluate if Datopotamab deruxtecan (Dato-DX) in combination with Durvalumab is more effective than Dato-DXd alone in treating PDL1-negative advanced or metastatic triple negative breast cancer (TNBC). Globally, breast cancer is the most common malignancy in women and the second most common cancer overall. The term TNBC is used to define tumours that do not express oestrogen receptors, progesterone receptors and HER2 receptors. TNBC comprises 10 -15% of all breast cancers. It remains the subtype with poorest outcome and there is a significant need to develop new therapies for this group of patients especially. Moreover, the PDL1-negative tumour has demonstrated no benefit from standard 1st line treatment of chemotherapy plus immune checkpoint inhibitors.",[401],"Triple Negative Breast Cancer",[401,403,404,405,406],"breast cancer","PDL1-negative","Datopotamab Deruxtecan","Durvalumab",{"date":380,"type":34},{"date":409,"type":34},"2025-10-27",{"date":411,"type":22},"2030-02",{"name":40,"class":41},{"id":414,"slug":415,"hasResults":12,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":420,"targetDuration":422,"studyType":79,"phases":4,"briefSummary":423,"conditions":424,"keywords":426,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":428,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":145},"100438894","mechanism-of-chronic-pain-in-patients-with-ibd-100438894","NCT04995224","Mechanism of Chronic Pain in Patients With IBD","Psychophysiological and Biological Profiling of Chronic Pain in Patients With Inflammatory Bowel Disease","Inclusion Criteria :\n\n* Males or females who are over 18 years old.\n* Patients who are diagnosed with UC or CD within 6 months before the enrolment.\n* Patients who have access to the internet and have the IT skills to perform basic tasks e.g. operate emails and fill out questionnaires.\n* Patients who are willing and able to participate in the study for the required duration, can understand and are willing to sign the consent forms and agree to undergo all protocol-related tests and procedures.\n\nExclusion Criteria:\n\n* Patients who have severe extensive colitis and are at imminent risk of colectomy.\n* Patients who already have the presence of a stoma or history of a fistula or stricture due to another diagnosis.\n* Patients who are pregnant, lactating or thinking of becoming pregnant during the study period\n* Patients who have unstable acute illness or exacerbation of an unstable chronic illness or chronic disease (other than IBD) that may affect assessments for this study as determined by previous physical examination, medical history, vital signs, ECG, and laboratory (serum biochemistry, hematology, urinalysis) assessments.\n* Patients with a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection that are not in remission and are on medication that can affect gastrointestinal function.\n* Patients who have known or suspected to have a severe cardiac disease (e.g., symptomatic coronary artery disease, prior myocardial infarction, congestive heart failure (CHF) and chronic arrhythmia such as atrial fibrillation\n* Patients who have known or suspected cerebrovascular disease (e.g. prior stroke or transient ischemic attack, symptomatic carotid artery disease, prior carotid endarterectomy or other vascular neck surgery)\n* Patients who have a known history or suspected history of substance abuse or addiction (within the last five years).",{"count":421,"type":22},25600,"18 Months","Abdominal pain is a common symptom in patients with inflammatory bowel disease (IBD). Up to 70 % of IBD patients experience pain when the disease is active. Even when patients with IBD are in remission, 20-50 % experience ongoing pain. The precise mechanism of developing chronic abdominal pain in patients with IBD in remission remains unknown.\n\nThe aim of this study is to identify psychophysiological and biological risk factors for the development of chronic abdominal pain in patients with newly diagnosed IBD (ulcerative colitis and Crohn's disease).\n\nThis study consists of 4 sections (Study 1A, 1B, 2, and 3):\n\nStudy 1A: We perform a longitudinal study in 150 patients with new-onset IBD over 18 months to identify risk factors related to the brain-gut axis for the development of chronic pain. This is a collaborative study with IBD BioResourse Inception study. We administer online questionnaires, collect stool and blood samples, and record heart rate. Other physiological data collected by the Inception study will be also used for the analysis.\n\nStudy 1B: This is also a collaborative study with the Inception study. We will apply for our detailed questionnaires for 7 days (as per study 1A) to be administered to all the new patients (n=450) that are included in the Inception study on a voluntary basis. Patients will be followed for 12 months.\n\nStudy 2 and 3: Study 2 and 3 are a questionnaire-based cross-sectional study in patients with IBD. The participants for study 2 are patients registered in IBD BOOST study and those for study 3 are patients registered in IBD BioResource (but not in IBD Boost study). Detailed online questionnaires will be administered to them. These studies are just one-day assessment.",[425],"Inflammatory Bowel Diseases",[427],"inflammatory bowel diseases, IBD",{"date":380,"type":34},{"date":430,"type":34},"2021-07-26",{"date":432,"type":22},"2027-09-30",{"name":40,"class":41},{"id":435,"slug":436,"hasResults":12,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":4,"eligibilityCriteria":440,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":441,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":443,"conditions":444,"keywords":449,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100640618","human-tendon-tissue-collection-100640618","NCT07606092","Human Tendon Tissue Collection","Human Tendon Tissue Collection for In Vitro Models and Tissue Analysis","Inclusion Criteria:\n\n* 18 years or older\n* Scheduled to undergo orthopaedic lower limb surgery that involve tendon tissue waste\n* Have provided informed consent to take part in the study\n\nExclusion Criteria:\n\n* Under the age of 18\n* Unable or unwilling to give informed consent (including those with limited English proficiency)\n* Cases where tendon tissue is required for clinical care and therefore not surplus.",{"count":442,"type":22},400,"The goal of this study is to improve understanding of tendon health and disease by using surplus tendon tissue that is routinely removed during planned orthopaedic surgeries in adults. The main questions it aims to answer are:\n\n\\- What can tendon tissue and tendon cells tell us about how healthy and diseased tendons function?\n\nParticipants will not undergo any extra procedures. Instead, researchers will use only tissue that is already being removed as part of normal surgical care and would otherwise be discarded.\n\nParticipants will:\n\n* Be asked for permission (consent) before their surgery to donate any surplus tendon tissue.\n* Have a small piece of tendon tissue (normally waste material) collected during their planned operation.\n* Allow the research team to access some non-identifiable medical information (such as age, reason for surgery, and relevant medical history) to help interpret research findings.\n\nWhat the researchers will do with the donated tissue:\n\n* Isolate different types of human tendon cells.\n* Build advanced laboratory cellular models to study how tendon diseases develop.\n* Analyse whole tendon tissue sections to understand cell types, tissue organisation, and disease-related changes.\n\nThis study does not involve testing treatments, and it does not change any aspect of a participant's clinical care. Although there is no direct benefit to participants, the donated tissue may help researchers develop better ways to study tendon injuries and improve future treatment options for tendon disease.",[445,446,447,448],"Tendinopathy","Musculoskeletal Diseases or Conditions","ACL Surgery","Achilles Tendon Surgery",[450],"Tendon tissue collection","2026-05-18",{"date":453,"type":34},"2026-05-26",{"date":455,"type":22},"2026-06",{"date":457,"type":22},"2031-06",{"name":40,"class":41},{"id":460,"slug":461,"hasResults":12,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":4,"eligibilityCriteria":465,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":466,"targetDuration":468,"studyType":79,"phases":4,"briefSummary":469,"conditions":470,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":145},"100584288","wearable-devices-for-patient-monitoring-in-long-qt-syndrome-100584288","NCT06887387","Wearable Devices for Patient Monitoring in Long QT Syndrome","Application of Wearable Devices for Remote QT Interval Monitoring and Symptom Investigation for Patients With Long QT Syndrome","Inclusion Criteria:\n\n* Clinical diagnosis of Long QT Syndrome\n* Aged 18 years or over\n* Phone with iOS version 15 or Android OS 9.0 or higher\n* Able and willing to provide informed consent\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent\n* Ventricular pacing at recruitment\n* Bundle branch block or pre-excitation at baseline",{"count":467,"type":22},80,"3 Months","The main research question of this study is whether wearable devices have utility in monitoring patients with Long QT syndrome.",[471],"Long QT Syndrome",{"date":473,"type":34},"2026-05-19",{"date":475,"type":34},"2025-04-01",{"date":477,"type":22},"2026-09-04",{"name":40,"class":41},{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":484,"acronym":4,"eligibilityCriteria":485,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":486,"targetDuration":4,"studyType":23,"phases":488,"briefSummary":489,"conditions":490,"keywords":4,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":494,"lastUpdatePostDateStruct":495,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":500,"locationsCount":145},"100592936","the-effect-of-ipd-on-lateral-bone-augmentation-100592936","NCT06999915","The Effect of IPD on Lateral Bone Augmentation","Influence of Individual Phenotypical Dimension (IPD) on Hard Tissue Stability Following Lateral Bone Augmentation: a Two-centre Clinical Study","Inclusion Criteria:\n\n* Adult (\\>18 years old) patients\n* Good medical and psychological health\n* Engaged patients presenting with a Full Mouth Plaque Score (FMPS) of ≤ 20% within the 6 weeks prior to enrolment\n* Need of a tooth\u002Fteeth replacement in the incisor, canine or premolar maxillary region that could be provided with an implant-supported fixed prosthesis\n* A relatively symmetrical maxillary arch\n* A nearly intact contra-lateral alveolar ridge\n* At least one neighbouring natural tooth present with healthy periodontal conditions\n* After implant placement, presence of a buccal bone dehiscence\u002F fenestration or buccal bone plate thickness of ≤ 1.5 mm requiring GBR (Monje et al., 2022; Jensen et al.,2023, Group 1 ITI Consensus Report).\n* At least 4 weeks of post-extraction socket healing and no ridge preservation prior to implant placement.\n* No acute infection at the site; adequate availability of bone apical and palatal to obtain implant primary stability\n* A functional occlusion with a minimum of 4 occlusal units (i.e., pairs of occluding posterior teeth)\n* Willingness to read and sign a copy of the Informed Consent Form (ICF) after reading the Patient Information Sheet (PIS), and after the nature of the study has been fully explained and potential questions fully answered.\n\nExclusion Criteria:\n\n* Any known systemic disease severely affecting bone metabolism (e.g., Cushing's syndrome, Crohn's disease, rheumatoid arthritis, osteoporosis or diabetes type I and uncontrolled diabetes type II).\n* Self-reported HIV or other severe immunosuppression.\n* Self-reported alcoholism or chronic drug abuse.\n* Heavy smokers ( \\> 10 cigarettes\u002Fday)\n* Patients reporting use of vape\u002Fe-cigarettes\n* Self-reported pregnancy or lactation\n* Chronic treatment (i.e., 2 weeks or more) with any medication known to affect oral status or bone metabolism (e.g., bisphosphonates, hormone replacement therapy, immunosuppressants) within 1 month before baseline visit.\n* Chronic treatment with anticoagulants (including Aspirin), corticosteroids, immunosuppressants or other medications that may influence blood coagulation\u002Fcount.\n* Untreated caries lesions in neighbouring teeth and untreated\u002Funcontrolled periodontal disease; If patients require periodontal treatment (non-surgical and\u002For surgical), this will be arranged outside the study protocol and completed prior to enrolment;\n* Physical handicaps that would interfere with the ability to perform adequate oral hygiene in the area of implant placement.\n* Patients requiring maxillary sinus lift surgery before implant placement or presenting bone dimensions (at any time point of the study) that do not allow implant placement or there is no clinical indication to perform study procedures (i.e. bone augmentation, implant placement).\n* Patients not willing to receive animal-derived biomaterials for GBR.\n* Patients suffering from a known psychological disorder or with limited mental capacity or language skills such that study information could not be understood, informed consent could not be obtained, or simple instructions could not be followed.\n* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgement of the investigator, would make the subject inappropriate for entry into this trial.",{"count":487,"type":22},28,[54],"Guided Bone Regeneration (GBR) is a widely used technique during dental implant surgery to help rebuild bone around the implant and improve its long-term appearance and stability. This study investigates whether the amount of bone that regrows depends on a person's original bone shape, known as the Individual Phenotypical Dimension (IPD). The aim is to compare the bone stability and overall results between two approaches: adding bone only up to the original bone line (IPD) or adding bone beyond it (over-contour augmentation). Over the course of a year, the study will assess not only bone and soft tissue healing, but also gum blood flow, implant success, and patient satisfaction.\n\nThere will be two treatment groups in this study - one group will receive bone grafting just up to their natural bone shape, while the other group will receive a slightly larger graft that extends about 3 mm beyond it. Throughout the study CBCT scans will be taken to assess bone changes around the implant area in order to measure how the bone shape and thickness change over time after surgery.",[491,492,493],"Guided Bone Regeneration","Bone Resorption","Diagnostic Imaging","2026-05-06",{"date":496,"type":34},"2026-05-07",{"date":455,"type":22},{"date":499,"type":22},"2029-06",{"name":40,"class":41},{"id":502,"slug":503,"hasResults":12,"nctId":504,"briefTitle":505,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":153,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":511,"conditions":512,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":516,"completionDateStruct":518,"leadSponsor":520,"locationsCount":145},"100590142","left-ventricular-thrombus-registry-100590142","NCT06963567","Left Ventricular Thrombus Registry","Observational Registry to Determine the Predictors and Outcomes of Patients at Risk of and Diagnosed With Left Ventricular Thrombus","LVT Registry","Inclusion Criteria:\n\n* Patients with LV thrombus or;\n* Patients at risk for developing LV thrombus (e.g severe LV dysfunction, LV aneurysm, MI.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Unable to consent",{"count":510,"type":22},1500,"Left Ventricular Thrombus (LVT) is a blood clot that can develop in a poorly functioning heart. In around 1 in 6 patients who have had a heart attack or diagnosed with heart failure tend to develop blood clots in their main heart chamber.\n\nHaving a blot clot in the main heart chamber can lead to serious complications such as stroke. Treatment for blood clots is blood thinning medications, which if taken for a prolonged period of time can result in bleeding which further complicates treatment. We hope to gather information to better understand the factors associated with blood clot formation and management in the lower left chamber of the heart. This understanding will hopefully enable us and others to improve management of this condition in the future and therefore help the wider population. As part of this study, bloods and scan results will be recorded and we will complete a short quality of life questionnaire. When participants come in for routine MRI scan, we may capture additional images for further research analysis.\n\nA sample of blood no more than one tablespoon will be collected for research analysis at the same time as routine blood test. This will occur at baseline and at around 6 months. At 12 months we will repeat the quality of life questionnaire and collect final data.",[513],"Left Ventricular Thrombus","2026-05-05",{"date":494,"type":34},{"date":517,"type":34},"2024-05-17",{"date":519,"type":22},"2027-01-31",{"name":40,"class":41},{"id":522,"slug":523,"hasResults":12,"nctId":524,"briefTitle":525,"officialTitle":526,"acronym":527,"eligibilityCriteria":528,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":529,"targetDuration":4,"studyType":23,"phases":531,"briefSummary":532,"conditions":533,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":535,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":541},"100584708","phase-2-comparing-3-vs-6-cycles-of-platinum-based-chemotherapy-prior-to-maintenance-avelumab-in-advanced-urothelial-cancer-100584708","NCT06892860","Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer","A Randomised Phase II Study Comparing 3 vs 6 Cycles of Platinum-based Chemotherapy Prior to Maintenance Avelumab in Advanced Urothelial Cancer","DISCUS","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent.\n2. Ability to comply with the protocol, including but not limited to, the repeated completion of the EORTC QLQ-C30 questionnaires.\n3. Age ≥ 18 years.\n4. Histologically confirmed, unresectable locally advanced or metastatic urothelial carcinoma (i.e., cancer of the bladder, renal pelvis, ureter, or urethra). Patients with squamous or sarcomatoid differentiation or mixed cell types are eligible but a component of urothelial cancer is required.\n5. Measurable disease by RECIST v1.1.\n6. Eligible for gemcitabine\u002F cisplatin or gemcitabine\u002Fcarboplatin. The following criteria are established for the use of carboplatin (patients not fulfilling the following carboplatin criteria should be considered for gemcitabine\u002F cisplatin):\n\n   1. GFR \\\u003C60 mL\u002Fmin but ≥30 mL\u002Fmin (measured by the Cockcroft-Gault formula or by local accepted standards). Subjects with a GFR ≥50 mL\u002Fmin and no other cisplatin ineligibility criteria may be considered cisplatin-eligible based on the investigator's clinical judgement.\n   2. ECOG or WHO performance status of 2.\n   3. NCI CTCAE Grade ≥2 audiometric hearing loss.\n   4. NYHA Class III heart failure.\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1 or 2.\n8. Adequate haematologic and organ function as defined below:\n9. Negative serum or urine pregnancy test within 2 weeks of Day 1 Cycle 1 for female patients of childbearing potential only.\n10. Agreement to use adequate contraceptive measures\n\nExclusion Criteria:\n\n* 1\\. Prior treatment with a PD-(L)-1 inhibitor for any advanced malignancy. Treatment with PD-(L)-1 inhibitors in the neoadjuvant or adjuvant setting for UC are permitted.\n\n  2\\. Prior systemic therapy for locally advanced or metastatic urothelial carcinoma with the following exceptions: a platinum containing regimen (cisplatin or carboplatin) in the neoadjuvant or adjuvant setting if more than 6 months since last cycle have occurred. Patients who received adjuvant or neoadjuvant immune therapy for muscle invasive or non-muscle invasive disease are eligible.\n\n  3\\. Pregnant and lactating female patients. 4. Known history of active CNS metastases. Patients with treated CNS metastases are permitted on the study if all of the following are true: 5. Prior allogeneic stem cell or solid organ transplantation. 6. Administration of a live, attenuated vaccine within 4 weeks prior to enrolment or anticipation that such a live, attenuated vaccine will be required during the study.\n\n  7\\. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \\[IL\\]-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to enrolment (see section 11.26).\n\n  8\\. Concurrent treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to enrolment.\n\n  9\\. Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome).\n\n  10\\. Malignancies other than urothelial carcinoma within 3 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, or ductal carcinoma in situ treated surgically with curative intent) or localized prostate cancer treated with curative intent and absence of prostate-specific antigen (PSA) relapse or incidental prostate cancer (Gleason score ≤ 3 + 4 and PSA \\\u003C 10 ng\u002FmL undergoing active surveillance and treatment naive). .\n\n  11\\. Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction or cerebral vascular accident\u002Fstroke within 6 months prior to enrolment, unstable arrhythmias, or unstable angina.\n\n  12\\. Radiotherapy within 2 weeks prior to C1D1. Patients must have recovered adequately from toxicities resulting from the intervention prior to starting study treatment.\n\n  13\\. Major surgery (defined as requiring general anaesthesia and \\>24-hour inpatient hospitalization) within 4 weeks prior to randomisation. Patients must have recovered adequately from complications from the intervention prior to starting study treatment.\n\n  14\\. History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).\n\n  15\\. Active hepatitis infection (defined as having a positive hepatitis B surface antigen \\[HBsAg\\] test at screening) or hepatitis C. Patients with past hepatitis B virus (HBV) infection or resolved HBV infection (defined as having a negative HBsAg test and a positive antibody to hepatitis B core antigen \\[anti-HBc\\] antibody test) are eligible.\n\n  16\\. Positive HIV test. 17. Active tuberculosis. 18. Active autoimmune disease including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.\n\n  19\\. History of autoimmune-related hypothyroidism, unless on a stable dose of thyroid replacement hormone.\n\n  20\\. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies.\n\n  21\\. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of avelumab.\n\n  22\\. Active infection requiring systemic therapy. 23. Persisting toxicity related to prior therapy (NCI CTCAE Grade \\> 1); however, alopecia, sensory neuropathy Grade ≤ 2, or other Grade ≤ 2 not constituting a safety risk based on investigator's judgment are acceptable.\n\n  24\\. Any condition that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results 25. Participants with previous or known history of allergic reaction to cisplatin, gemcitabine, carboplatin or other platinum containing compounds, or any component of the chemotherapy formulations.\n\n  26\\. Patients with bleeding tumours 27. Any other contraindication for gemcitabine\u002F cisplatin or gemcitabine\u002Fcarboplatin treatment as per SmPC.",{"count":530,"type":22},320,[398],"This is an adaptive, open-label, randomised phase II trial that aims to evaluate the impact of 3 vs 6 cycles of first-line platinum-based chemotherapy followed by maintenance avelumab in the quality of life of patients with locally advanced or metastatic urothelial cancer. Initially, 224 eligible and evaluable patients (112 in each arm) will receive 3 cycles vs 6 cycles of 3-weekly gemcitabine plus cisplatin\u002Fcarboplatin, followed by 2-weekly maintenance avelumab until disease progression or intolerable toxicities. Avelumab treatment will be given up to a maximum of 2 years from the end of chemotherapy.",[534],"Urinary Bladder Neoplasms",{"date":494,"type":34},{"date":537,"type":34},"2021-12-16",{"date":539,"type":22},"2027-12-22",{"name":40,"class":41},3,{"id":543,"slug":544,"hasResults":12,"nctId":545,"briefTitle":546,"officialTitle":547,"acronym":548,"eligibilityCriteria":549,"healthyVolunteers":12,"sex":18,"minAge":122,"maxAge":550,"enrollmentInfo":551,"targetDuration":4,"studyType":23,"phases":553,"briefSummary":554,"conditions":555,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":557,"startDateStruct":558,"completionDateStruct":560,"leadSponsor":561,"locationsCount":145},"100369616","increasing-the-use-of-an-anti-snoring-mouth-guard-mandibular-advancement-appliance-to-prevent-upper-airway-collapse-during-sleep-in-patients-with-obstructive-sleep-apnoea-100369616","NCT04092660","Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.","Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial","IPOSAT","Inclusion Criteria:\n\n* Adult (≥ 40 years old)\n* Confirmed diagnosis of OSA (AHI ≥ 5)\n* Referred for MAA therapy\n* Must be able to understand, read and write English; with the assistance of a translator\n\nExclusion Criteria:\n\n* Insufficient teeth for MAA fabrication\n* Poor dental and\u002For periodontal health\n* Symptomatic Temporomandibular Disorder (TMD)\n* Previously used an MAA\n* Patients with Epilepsy","90 Years",{"count":552,"type":22},56,[54],"Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement Appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient's acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care.\n\nThe investigators also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index \\>5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA.\n\nPatients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and\u002For prevents their adherence.",[556],"Obstructive Sleep Apnea",{"date":494,"type":34},{"date":559,"type":34},"2019-12-06",{"date":110,"type":22},{"name":40,"class":41},{"id":563,"slug":564,"hasResults":12,"nctId":565,"briefTitle":566,"officialTitle":567,"acronym":4,"eligibilityCriteria":568,"healthyVolunteers":153,"sex":18,"minAge":50,"maxAge":569,"enrollmentInfo":570,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":571,"conditions":572,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":581,"locationsCount":68},"100492674","cutaneous-squamous-cell-carcinoma-staging-study-100492674","NCT05695222","Cutaneous Squamous Cell Carcinoma Staging Study","Comparison of the Prognostic Capacity of Existing Staging Systems for Cutaneous Squamous Cell Carcinoma","Inclusion Criteria:\n\n* Over 18 years old with diagnosis of CSCC\n\nExclusion Criteria:\n\n* Patients who decline for their data to be used for research purposes","120 Years",{"count":510,"type":22},"Cutaneous squamous cell carcinoma (CSCC) is the second most common form of skin cancer, and one of the most common cancers worldwide. The majority of CSCCs are easily removed by surgery and have excellent prognosis. However, a small subset has poor outcomes, including secondary spread in the body (metastasis) and death.\n\nThe investigators will look at existing CSCC in people from two UK dermatology centres. The investigators will then evaluate the accuracy of current staging systems in predicting risk of poor outcomes in people. The investigators hope that this project will improve the management of patients with CSCC by validating the predictive power of currently available histological staging classifications for cSCC. In the second stage of the study, The investigators will see whether better prediction tools can be found.",[573],"Cutaneous Squamous Cell Carcinoma","2026-04-01",{"date":576,"type":34},"2026-04-02",{"date":578,"type":34},"2023-05-01",{"date":580,"type":22},"2028-06-05",{"name":40,"class":41},{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":586,"acronym":587,"eligibilityCriteria":588,"healthyVolunteers":153,"sex":394,"minAge":50,"maxAge":4,"enrollmentInfo":589,"targetDuration":4,"studyType":23,"phases":591,"briefSummary":592,"conditions":593,"keywords":597,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":603,"lastUpdatePostDateStruct":604,"startDateStruct":606,"completionDateStruct":608,"leadSponsor":610,"locationsCount":145},"100631296","population-based-germline-testing-for-early-detection-and-prevention-of-cancer-100631296","NCT07498829","Population Based Germline Testing for Early Detection and Prevention of Cancer","PROTECT-C","Inclusion Criteria:\n\n* Women, trans men, and non-binary people with female reproductive organs\n* ≥18 years at consent\n\nExclusion Criteria:\n\n* Individuals who have previously undergone genetic testing for one or more of the following CSGs: BRCA1, BRCA2, PALB2, RAD51C, RAD51D, BRIP1, MLH1, MSH2, MSH6\n* One or more first- or second-degree relative with a PV in any of above CSGs\n* Inability to provide informed consent",{"count":590,"type":22},6000,[54],"PROTECT-C is a research study offering genetic testing to people to see whether they have a genetic change that increases their risk of breast, ovary, bowel, and\u002For womb cancer. This is regardless of whether they or their families have had cancer.\n\nBreast, ovary, bowel, and womb cancers make up half of all cancers in women. Around 15-20% (15 to 20 in 100 cases) of ovary and 3-4% (3 to 4 in 100 cases) of breast, womb, and bowel cancers are linked to cancer genes and may be prevented. People with a genetic change that puts them at increased risk of any of these cancers have ways to help them manage their risk through the NHS. This may include screening to find cancers earlier when they are easier to treat, and surgery or medication to prevent cancers from developing. This can save lives.\n\nCurrently, genetic testing is only available on the NHS to people who meet certain criteria. For example, those who have had certain cancers, have a strong family history of cancer, or those with Jewish ancestry. But many people may not have a strong family history or meet NHS testing criteria. This means that this system of testing misses 50% to 80% of people (50 to 80 in 100 people) who have a genetic change. It is thought that only around 3 in 100 people overall who have a genetic change that increases their risk of cancer know about it. Given the effective screening and preventive options that are available, this represents a huge, missed opportunity to prevent cancers or find them earlier.\n\nThe PROTECT-C study aims to evaluate the option of offering genetic testing to everyone who may want it. This is regardless of whether they or their families have had cancer. We will offer genetic testing to 5000 people. People may take part if they:\n\n* Are over the age of 18 years and\n* Are a woman, trans man, or non-binary person with female reproductive organs (ovaries, fallopian tubes, and\u002For a uterus) and\n* Have never had genetic testing for the cancer genes tested for in the study and\n* Do not have first-degree family members (e.g.: parent, sibling, child) or second-degree family members (e.g.: aunt, uncle, niece, nephew, grandchild, grandparent, half-sibling) with genetic changes in the cancer genes tested for in the study\n\nPROTECT-C is a completely digital study. The study team will give participants access to an app developed specifically for this study. They can download this app using a smartphone or tablet or access it on any internet browser using a computer or laptop. Before they can access the app, participants will need to complete a consent form. They will also be asked to fill in a short questionnaire about themselves and their health. The PROTECT-C app contains information to help participants decide if they would like to have genetic testing. If they decide to have genetic testing, they will complete a consent form for genetic testing on the app. The study team will send them a saliva based test kit in the post.\n\nThe study will look at how many people decide to have genetic testing and how many of them are found to have a genetic change. It will evaluate their experience with using the app and how this approach to genetic testing affects their quality-of-life, satisfaction, and mental well-being. This will give us a better understanding of how well the app works as a way of offering genetic testing to people. The study is interested to see how people found to be at increased risk decide to manage their risk. We will assess the uptake of screening and prevention options. Few participants will be invited to have 1:1 interviews by the study team. This will evaluate their experience of making a decision about genetic testing and taking part in the study. Taking part in these interviews is optional. The study will also assess if this way of offering genetic testing to people is affordable for the NHS.",[594,595,596],"Breast Cancer Risk","Ovarian Cancer Risk","Cancer Gene Mutation",[598,599,600,601,602],"Population based genetic testing","BRCA","Lynch Syndrome","breast cancer risk","ovarian cancer risk","2026-03-23",{"date":605,"type":34},"2026-03-27",{"date":607,"type":34},"2025-12-18",{"date":609,"type":22},"2040-12",{"name":40,"class":41},{"id":612,"slug":613,"hasResults":12,"nctId":614,"briefTitle":615,"officialTitle":616,"acronym":617,"eligibilityCriteria":618,"healthyVolunteers":12,"sex":18,"minAge":50,"maxAge":4,"enrollmentInfo":619,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":621,"conditions":622,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":624,"lastUpdatePostDateStruct":625,"startDateStruct":627,"completionDateStruct":629,"leadSponsor":631,"locationsCount":145},"100467619","investigate-and-predict-aortic--thoracic-surgery-persistenet-postsurgical-pain-100467619","NCT05369130","Investigate and Predict Aortic & Thoracic Surgery Persistenet Postsurgical Pain","Characterising the Phenotype for Persistent Postoperative Pain Following Repair of the Thoraco-abdominal Aorta","ImPARTonPPP","Inclusion Criteria:\n\n* Adults (over 18 years of age) undergoing elective repair of the thoraco-abdominal aorta. Able to adequately understand and respond to verbal instructions\n\nExclusion Criteria:\n\n* Unwilling or unable to give consent, Age \\\u003C18 years",{"count":620,"type":22},60,"This is an observational clinical study aiming to further the wider understanding of patients who develop persistent pain after Thoracoabdominal Aorta surgery, a surgical cohort who are disproportionately affected. This will be undertaken through a prospective biopsychosocial characterisation of the phenotype of patients undergoing this operation.\n\nIncreasing numbers of patients are undergoing surgery on the chest for treatment of heart or lung cancer disease. Over the last twenty years, the medical community has become increasingly aware of the long-term effect of this surgery in producing persistent pain, approximately half of all survivors are still in pain around their surgical incision at three months postoperatively and beyond. There is currently no accepted method for preventing this phenomenon.\n\nThe nervous system mechanisms for the development of persistent pain after surgery are unclear. Some studies suggest it may involve the patient's ability to dampen down pain signals travelling from the incision site to the brain.\n\nHumans have an in-built system that produces opiates as well as other pain-relieving molecules in response to injury, e.g. surgery. However, this response varies hugely from person to person and may even be impacted by the psychological state of the individual at the time of surgery. Some of these pain modulating mechanisms can be measured before and after surgery in patients using sensory testing, a robust and established objective method to assess patients'.\n\nIdentifying patients who are most at risk of a persistent pain state will allow both academics and clinicians to investigate and better target appropriate treatments.\n\nUndertaking these longitudinal observational assessments will facilitate an improved mechanistic insight of the transition from acute to pathological pain, with the ultimate goal of improving outcomes for patients'.",[623],"Persistent Postsurgical Pain","2026-03-13",{"date":626,"type":34},"2026-03-16",{"date":628,"type":34},"2022-06-12",{"date":630,"type":22},"2029-02",{"name":40,"class":41},""]