[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"East and North Hertfordshire NHS Trust\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":342},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,39,68,87,110,149,177,199,220,246,275,295,320],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100652978","bicarbonate-hd-study-100652978",false,"NCT07779200","Bicarbonate HD Study","Factors Affecting Bicarbonate Levels In Patients On Haemodialysis","Inclusion Criteria:\n\n* Age 18 years and above.\n* Ability to give informed consent.\n* End Stage Renal Disease established on maintenance dialysis for at least 3 months.\n* Patients on dialysis 3 times a week\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Patients with acute kidney injury\n* Patients with severe COPD","ALL","18 Years",{"count":19,"type":20},100,"ESTIMATED","OBSERVATIONAL","The primary goal of this single centre observational study is to look at factors that affect serum bicarbonate levels in patients on maintenance dialysis. This will be done by collecting demographic information, relevant medical history, dialysis history, potential renal acid load from diet by recording different foods consumed over 2 days in a food diary and bicarbonate levels at 3 intervals, pre and post dialysis session 1 and pre dialysis session 2.\n\nBicarbonate levels are of significant interest as an indicator of metabolic acidosis in CKD dialysis patients. This study will allow us to understand the efficacy of different dialysis modalities in controlling bicarbonate levels. It will also enable us to understand the idea of individualizing dialysis for patients in terms of not using a standard concentration of dialysate for all patient undergoing dialysis in this center.",[24,25],"Metabolic Acidosis","CKD on Hemodialysis Patients","RECRUITING","2026-08-20",{"date":29,"type":30},"2026-08-21","ACTUAL",{"date":32,"type":30},"2026-05-12",{"date":34,"type":20},"2026-08",{"name":36,"class":37},"East and North Hertfordshire NHS Trust","OTHER_GOV",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":45,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":47,"conditions":48,"keywords":55,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":38},"100648108","adequacy-of-haemodiafiltration-middle-molecules-clearance-patients-reported-outcomes-and-sodium-balance-100648108","NCT07717255","Adequacy of Haemodiafiltration: Middle Molecules Clearance, Patients Reported Outcomes and Sodium Balance","Inclusion Criteria:\n\n* Age 18 years or above.\n* Ability to give informed consent.\n* End stage kidney disease (ESKD) treated by haemodialysis for at least 3 months.\n* Prognosis \\> 6 months as assessed by principal investigator (PI)",{"count":46,"type":20},300,"The goal of this observational study is to understand the differences in terms of middle molecules clearance and patient outcomes in High (\\>23Litres (L)) vs Low (\\\u003C23 L) convection volume (CV) Hemodiafiltration (HDF) and to understand the effect of dialysate fluid sodium concentration (137 vs 140 mmol\u002FL) on overhydration volume in patients on HD and HDF.",[49,50,51,52,53,54],"Haemodiafiltration","Haemodialysis","Patient Reported Outcome Measurements","Nutrition","Malnutrition (Calorie)","Fluid Balance Outcomes",[56,57,58,59],"Middle molecules clearance in haemodiafiltraion","Effect of dialysis clearance on nutritional status","Effect of dialysis clearance on patient reported outcome measure","Effect of dialysate sodium on fluid status","2026-07-16",{"date":62,"type":30},"2026-07-21",{"date":64,"type":30},"2025-01-09",{"date":66,"type":20},"2030-11-01",{"name":36,"class":37},{"id":69,"slug":70,"hasResults":11,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":77,"conditions":78,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":86,"locationsCount":38},"100647963","2m-post-hd-rebound-prediction-100647963","NCT07713680","β2M Post-HD Rebound Prediction","Predicting the Post-dialysis Rebound of β2-microglobulin","Inclusion Criteria:\n\n* Age 18 years or above.\n* Ability to give informed consent.\n* End Stage Renal Disease established on maintenance haemodialysis for at least 3 months\n\nExclusion Criteria:\n\n* Inability to give informed consent.\n* Acute infection in last 2 weeks.",{"count":76,"type":20},30,"β2-Microglobulin is small 11.8 kDa protein presents on the surface of all nucleated cell in the human body, it forms part of the non-variable chain of Major Histocompatibility Complex class I. β2-Microglobulin production is constant and it is continuously released into the bloodstream. Its production increases during active infections, inflammation or blood cancers. The Kidneys are the main route of its elimination. It accumulates in patients with kidney disease and levels can rise significantly in patients with end-stage renal failure. Studies have shown that its accumulation in dialysis patients contributes to dialysis-related amyloidosis.\n\nHaemodialysis is a significant contributor to removal of β2-microglobulin in those on dialysis. It removes β2-microglobulin from the blood rather than directly from tissues. Blood levels fall during dialysis. However, after haemodialysis, β2-microglobulin gradually moves from tissues into the bloodstream until equilibrium is reached (post-dialysis rebound). Our own published data and unpublished data suggest this rebound occurs by two hours post-dialysis approximately but is significant in magnitude. β2-Microglobulin is increasingly recognized as an important marker of middle-molecule solute clearance.\n\nThe investigators plan to recruit thirty haemodialysis patients. During two dialysis sessions blood samples will be taken to measure β2-microglobulin. During the first session, samples will be taken pre-dialysis and at intervals during the session. Post-dialysis samples will be taken at 1 and 2 hour time points. The investigators will perform a physical examination, fluid\u002Fnutrition assessment. Dialysis prescription and routine monthly blood and urine results will also be recorded, and patients will be asked to complete questionnaires about dialysis symptoms, fatigue and post-dialysis recovery time. At the start of the next dialysis, one final β2-microglobulin sample will be taken.\n\nβ2-microglobulin removal may be a useful marker of dialysis quality. The investigators aim to develop a predictive model to estimate the equilibrated β2-microglobulin to allow its dialysis clearance to be accurately assessed.",[79],"Renal Disease, End Stage","2026-07-14",{"date":82,"type":30},"2026-07-20",{"date":84,"type":30},"2026-02-24",{"date":34,"type":20},{"name":36,"class":37},{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":93,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":38},"100380534","avr-thrombosis-outcome-study-100380534","NCT04234841","Avr Thrombosis OutcoMe Study","Can Thrombosis and Fibrinolysis Markers in Patients Undergoing Aortic Valve Replacement Predict Outcome","ATOM","Inclusion Criteria:\n\n1. Male and female patients aged 18 years or over.\n2. Patients diagnosed with aortic valve disease, undergoing surgical or transcatheter AVR and free of exclusion criteria below.\n3. The patient is willing and able to understand the Patient Information Sheet and provide informed consent.\n4. The patient agrees to comply with the study protocol, including phlebotomy and imaging as required at pre-specified time points.\n\nExclusion Criteria:\n\n1. Inability to provide valid informed consent.\n2. Male and female patients aged \\\u003C 18 years of age.\n3. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses.\n4. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or active psychiatric disease that may result in non-compliance with visits or inability to obtain venous access.\n5. Alcohol consumption above recommended safe levels (i.e. more than 14 units per week owing to the potential effects of high alcohol levels on platelet reactivity).\n6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study such as sepsis.\n7. Any major bleeding diathesis or blood dyscrasia (platelets \\\u003C 70 x 109\u002Fl, Hb \\\u003C 8 g\u002Fdl, INR \\> 1.4, APTT \\> x 2 UNL, leucocyte count \\\u003C 3.5 x 109\u002Fl, neutrophil count \\\u003C 1 x 109\u002Fl).\n8. Currently enrolled in an investigational device or drug trial.\n9. Active or disseminated malignancy at the time of recruitment.\n\n   Additionally, for those patients taking part in the additional 4D CT angiography substudy:\n10. Any contraindications to CT angiography: renal failure (Cr\\>250 μmol\u002FL or eGFR\\\u003C30 mL\u002Fmin) due to the additional risk of contrast medium nephrotoxicity; or allergy to iodine.\n11. Women of childbearing age who have not had a hysterectomy and\u002For who may be breastfeeding.",{"count":96,"type":20},750,"This study aims to utilise novel biomarkers assessing thrombosis and thrombolysis (through a blood test), to identify patients undergoing either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI) who are at risk of thrombosis, and relate this to clinical thrombotic and thromboembolic adverse events and subclinical valve thrombosis, and identify the timeframe of greatest risk for valve thrombosis.",[99],"Aortic Stenosis",[101,102],"TAVI","SAVR",{"date":104,"type":30},"2026-07-15",{"date":106,"type":30},"2020-02-01",{"date":108,"type":20},"2028-01",{"name":36,"class":37},{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":120,"phases":121,"briefSummary":123,"conditions":124,"keywords":131,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":38},"100586479","robotic-prostatectomy-artificial-intelligence-low-pressure-pain-ralp-trial-100586479","NCT06915909","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain (RALP) Trial","Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial - \"The Monitoring of Patients Outcomes Intraoperatively and Perioperatively Using the Airseal and Stryker Insufflator Undergoing Robotic Assisted Laparoscopic Prostatectomy at a Pressure and Stability of Pneumoperitoneum of 8 mmHg\"","Inclusion Criteria:\n\n* Patient indicated for non-emergent robotic Prostatectomy surgery\n* Patients (or appropriate legal representatives) able to provide written informed consent to participate in the study\n* Males, aged 18 to 75 years\n* Have no significant psychopathology that could limit the subject's ability to understand the procedure, comply with medical, surgical, and\u002For behavioural recommendations and office visits\n* Are American Society of Anaesthesiologists (ASA) Class I, II, or III);\n\nExclusion Criteria:\n\n* Patient participation in a different investigational clinical study within 90 days before screening and for the duration of this trial (unless previously approved by the investigator and Sponsor);\n* Patients requiring any surgical procedure in addition to Prostatectomy and or \u002F Pelvic Lymph node dissection\n* Previous pelvic surgery or previous malabsobtion or restrictive procedures performed for the treatment of obesity\n* Inability to provide informed consent\n* Unable or unwilling to attend follow-up visits and examinations\n* Uncontrolled hypertension (=\u002F\\>Systolic: 180 mmHg\u002FDiastolic: 120 mmHg) and\u002For diabetes mellitus (Blood sugar level: \\>200 mg\u002FdL)\n* Patients who fall into American Society of Anesthesiologists (ASA) Class ≥ IV\n* History of chronic alcohol or drug abuse within 2 years of the screening visit\n* Chronic renal failure or on dialysis\n* Significant complicating medical history or immunocompromised\n* History or presence of pre-existing autoimmune connective tissue disease, e.g., systemic lupus erythematosus or scleroderma\n* Immunocompromised such as that resulting from chronic oral steroid use, chemotherapeutic agents, or immune deficiency disorders;\n* Any medical condition which precludes compliance with the study\n* Subjects with any other clinically significant unstable medical disorder, life threatening disease, or conditions that, in the opinion of the investigator, may jeopardize the subject's well-being and\u002For the soundness of this clinical study or which would contra-indicate a surgical procedure.\n* Previous or current history of being on regular analgesia \u002F pain killers","MALE","75 Years",{"count":19,"type":20},"INTERVENTIONAL",[122],"NA","The 'Robotic Prostatectomy Artificial Intelligence Low Pressure Pain Study Trial' aims to assess the feasibility of being able to review operative outcomes such as pain when comparing two commonly used surgical devices for the removal of prostate cancers. The data collected will inform methodologies for future, larger, multi-center trials investigating pain in patients undergoing prostate cancer surgery.\n\nA robotic prostatectomy is a commonly performed surgery used to treat prostate cancer by removing the prostate gland. In order to perform the procedure, the surgeon must 'inflate' (technical term pneumoperitoneum) the patients abdomen with carbon dioxide gas using a device called an insufflator. Adequate 'inflation' of the abdomen ensures the surgeon can clearly visualise the prostate. Unfortunately, higher pressures of abdominal 'inflation' are a large contributor to intra and post-operative pain in patients having prostatectomies. The type of insufflator device used to maintain inflation pressures in the abdomen are thought to be a variable contributing to differing levels of intra and post-operative pain. Therefore, the purpose of this trial is to compare intra and post-operative pain when using two different insufflator devices when performing robotic prostatectomies. Both insufflators are already commonly used across multiple NHS Trusts.\n\n40 patients awaiting a robotic prostatectomy at the urology department at the Lister hospital, Stevenage, will be randomised to use either the Conventional Insufflator System (CIS) {Stryker PneumoClear Insufflator} or the AIRSEAL® Insufflation System (AIS) to 'inflate' their abdomens during their prostatectomies. Data relating to various intra and post-operative outcomes will be collected in the 30 days following the patient's operation. Outcomes include levels of intra and post-operative pain, medication use, procedure time, recovery room time, length of hospital stay, post operative nausea and vomiting and adverse events. This data can be analysed to identify trends in differences in outcomes between the AIS and CIS insufflators.\n\nAn amendment has been approved to recruit an additional 60 participants, total overall recruitment is 100.",[125,126,127,128,129,130],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Surgery","Prostate Cancers","Prostate Neoplasm","Prostatectomy",[132,133,134,135,136,137,138,139,140],"prostate cancer","prostatectomy","robotic prostatectomy","post-operative pain","pain","Stryker PneumoClear insufflator","AirSeal Insufflation System","intra-operative pain","Medasense","2026-07-03",{"date":143,"type":30},"2026-07-08",{"date":145,"type":30},"2025-04-22",{"date":147,"type":20},"2027-08-17",{"name":36,"class":37},{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":120,"phases":159,"briefSummary":160,"conditions":161,"keywords":164,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":38},"100537274","honey-for-the-treatment-of-post-tonsillectomy-pain-100537274","NCT06275698","HONEY for the Treatment of POst-Tonsillectomy Pain","HONEY for the Treatment of POst-Tonsillectomy Pain - a Double-blind, Randomised, Placebo Controlled, Single Site Trial","HONEY-POT","Inclusion Criteria:\n\n* Adult (≥18years old at the time of giving consent)\n* Consented and listed for bilateral tonsillectomy or adenotonsillectomy\n* Tonsillectomy performed within the trial study period\n\nExclusion Criteria:\n\n* Any concurrent Head \\& Neck (H\\&N) malignancy\n* Unilateral tonsillectomy\n* Pregnancy\n* Concurrent pharyngeal or upper aerodigestive tract biopsy\n* Robotic tonsillectomy\n* Previous H\\&N malignancy\n* Previous H\\&N radiotherapy\n* Type 1\u002F2 diabetes mellitus\n* Known allergy to bee related products\n* Known allergy to golden syrup\n* History of chronic pain\n* History of fibromyalgia\n* Current usage of chronic (\\>6weeks) analgesia\n* High-risk anaesthetic patients\n* Children or adolescents \\\u003C18years old\n* Adults unable to consent for themselves",true,{"count":19,"type":20},[122],"Double-blind, randomised, placebo controlled, single-site trial in adults to compare the effect of Manuka honey with standard of care compared to placebo with standard of care on post-tonsillectomy pain and postoperative outcomes.\n\nMain aim is to investigate a potential improvement in post-tonsillectomy pain control, with a low cost and freely available alternative to conventional analgesics. Recent systematic review and multidisciplinary consensus suggest a potential role for the inclusion of honey for this purpose. Clinical efficacy over placebo remains to be conclusively demonstrated in robust clinical trials.",[162,163],"Post Surgical Pain","Analgesia",[165,166,167,168],"Post-tonsillectomy pain","Tonsil surgery","Manuka honey","Honey","2026-07-02",{"date":171,"type":30},"2026-07-07",{"date":173,"type":30},"2023-09-04",{"date":175,"type":20},"2027-07-31",{"name":36,"class":37},{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":4,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":120,"phases":186,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":190,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":4},"100598323","ai-guided-af-treatment-100598323","NCT07069998","AI-guided AF Treatment","Artificial Intelligent Guided Treatment of Atrial Fibrillation: A Randomized Controlled Pilot Study","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Documented diagnosis of AF within the last 6 months\n3. Patient is at least mildly symptomatic. Presence of at least one of the symptoms like palpitation, dizziness, breathlessness, pre-syncope, and syncope with at least mild intensity\n4. Ability to understand and comprehend the study rationale, design, and process.\n\nExclusion Criteria:\n\n1. Severe comorbidities (such as physical impairment, cognitive impairment, and hearing loss) that could affect protocol adherence, in the opinion of the investigator\n2. Chronic Kidney Disease (CKD) stage 4-5 or on dialysis\n3. Medical illness with a life expectancy of less than 1 year\n4. Alternative potentially reversible causes of AF (such as surgery, sepsis, or thyroid dysfunction)\n5. Dementia or other cognitive impairment\n6. Currently involved in another AF interventional clinical trial\n7. Being pregnant",{"count":185,"type":20},60,[122],"Two-centre, prospective, randomized, open-label, controlled pilot study to examine whether integrating an artificial intelligence virtual assistant (VA), instructed with the latest international guidelines on optimal patient management into the outpatient management of patients diagnosed with atrial fibrillation (AF) in the last 6 months, is feasible, acceptable and effective in reducing the need for regular medical assessment and the healthcare burden, reduce variability, and meets with participant satisfaction, without compromising participant safety and overall care quality.",[189],"Atrial Fibrillation (AF)","NOT_YET_RECRUITING","2025-07-07",{"date":193,"type":30},"2025-07-17",{"date":195,"type":20},"2025-07-15",{"date":197,"type":20},"2028-05-26",{"name":36,"class":37},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":206,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":208,"conditions":209,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":38},"100582421","in-vivo-dosimetry-for-brachytherapy-study-100582421","NCT06863090","In Vivo Dosimetry for Brachytherapy Study","A Single-centre Feasibility Study Investigating the Use of in Vivo Dosimetry in Patients Receiving High Dose Rate (HDR) Brachytherapy for Gynaecological and Prostate Cancers","Inclusion Criteria:\n\n* Patients aged 18 years and above\n* Patients receiving HDR brachytherapy using iridium-192 (192Ir) radioactive source either as a monotherapy or in combination with external beam radiotherapy for:\n\n  1. histologically\u002Fradiologically proven primary or locally recurrent prostate cancer\n  2. locally advanced gynaecological malignancy in the primary and recurrent setting\n\n     * primary cervix carcinoma (squamous, adenocarcinoma, adenosquamous) FIGO IB2-IVA\n     * primary vulval FIGO I-IVA\n     * primary vaginal FIGO I-IVA\n     * primary endometrial cancer FIGO Stage I-IVA (not suitable for surgery)\n     * endometrial cancer receiving adjuvant vaginal vault brachytherapy\n     * recurrent cervix, vulval, vaginal or endometrial cancer suitable for brachytherapy as discussed in a regional gynae-oncology multidisciplinary meeting.\n* World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) performance status 0-2\n\nExclusion Criteria:\n\n* Previous brachytherapy exposure to the treatment site\n* Patients unable to give informed consent\n* Patients unable to have a regional or general anaesthetic\n* Patients with the following medical conditions: coagulopathies, history of another primary malignancy, known allergy or sensitivity to study materials; previous or current fistulae\n* Not able to understand the implications of participating in the study in English\n* Patients with recent (within the last 6 months) or currently participating in interventional research",{"count":207,"type":20},20,"The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).",[210,211],"Prostate Cancer","Gynaecological Cancer","2025-03-07",{"date":214,"type":30},"2025-03-11",{"date":216,"type":20},"2025-03-03",{"date":218,"type":20},"2026-03-01",{"name":36,"class":37},{"id":221,"slug":222,"hasResults":11,"nctId":223,"briefTitle":224,"officialTitle":225,"acronym":4,"eligibilityCriteria":226,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":227,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":229,"conditions":230,"keywords":233,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":238,"lastUpdatePostDateStruct":239,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":38},"100581076","behind-the-needle-healthcare-professionals-perspectives-on-hd-needling-100581076","NCT06845605","Behind the Needle: Healthcare Professionals' Perspectives on HD Needling","A Qualitative Exploration Study of Healthcare Professionals' Perspectives in Haemodialysis Needling to Enhance Patients' Overall Experience","Inclusion Criteria:\n\n* Participants must be registered nurses or Band 3 healthcare assistants who perform needling procedures in a haemodialysis unit.\n* Participants must be employed at the renal dialysis units of East and North Hertfordshire NHS Trust (ENHT), including both the main unit and its satellite units.\n* Participants must be willing to participate in the study and share their experiences.\n* Participants must be able to speak English fluently to ensure they can communicate effectively, providing rich and comprehensive information.\n\nExclusion Criteria:\n\n•Registered nurses or healthcare assistants who do not perform needling procedures in a haemodialysis unit will not be eligible to participate.",{"count":228,"type":20},16,"Haemodialysis is essential for patients with End-Stage Renal Disease (ESRD), requiring consistent vascular access through arteriovenous fistulas or grafts. This involves frequent needling, a procedure that is painful and distressing for many patients, causing significant emotional and physical demands on healthcare professionals working in the dialysis units. In the UK, about 30,000 patients receive haemodialysis, involving over 300 needling procedures annually.\n\nHealthcare professionals (Registered nurses and healthcare assistants) play a crucial role, with their expertise directly affecting patient outcomes. However, 60% of HCPs (healthcare professionals) report high job-related stress, particularly due to needling demands. Effective needling requires not only technical proficiency but also managing patient pain and anxiety. Strong staff-patient relationships, characterized by empathy and understanding, can enhance the needling experience. Challenges for dialysis unit staff includes the technical difficulty of needling and the emotional burden of patient care. Studies highlight the need for better training and support systems to help them cope with these demands.\n\nUnderstanding healthcare professionals' perspectives can identify areas for improvement, inform training programs, and improve experiences in dialysis units. Research by Rahmah et al. (2018) and Duncanson (2023) emphasizes the importance of HCPs skills and the psychological toll on them, suggesting further exploration of this area is needed. The primary aim of this research is to examine HCPs perspectives on the needling experience in haemodialysis, aiming to identify improvement areas and inform targeted training programs to enhance patient experiences. The study will utilize a qualitative exploratory design with semi-structured interviews to gather in-depth insights from HCPs. Data will be collected from renal dialysis units at East and North Hertfordshire NHS Trust, involving 12 to 16 registered nurses performing needling procedures. Thematic analysis will be used to analyse interview transcripts and identify key themes related to technical skills, communication barriers, and patient-related factors. The study will run for 10 months.",[231,232],"Perspective of Healthcare Professionals Haemodialysis Needling","Dialysis",[50,234,235,236,237],"Haemodialysis needling","End-Stage Renal Disease","Fistula","Cannulation","2025-02-24",{"date":240,"type":30},"2025-02-25",{"date":242,"type":30},"2024-10-30",{"date":244,"type":20},"2025-05",{"name":36,"class":37},{"id":247,"slug":248,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":253,"targetDuration":4,"studyType":120,"phases":255,"briefSummary":257,"conditions":258,"keywords":260,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":268,"startDateStruct":270,"completionDateStruct":272,"leadSponsor":274,"locationsCount":38},"100563973","phase-3-oto-smartphone-app-in-treating-tinnitus-amongst-adult-patients-compared-with-standard-talking-therapies-100563973","NCT06623123","Oto Smartphone App in Treating Tinnitus Amongst Adult Patients Compared with Standard Talking Therapies","Multimodality Smartphone App Delivered Therapy for Tinnitus - a Protocol for a Randomised Controlled Trial","Inclusion Criteria:\n\n* Adult patients (male or female) aged over 18 years of age presenting to NHS ENT and hearing services with primary non-pulsatile tinnitus irrespective of hearing.\n* Patients must be suffering from tinnitus for a minimum of 3 months\n* Patients that have a willingness to use as well as have access to a smartphone device capable of running Oto.\n* Willing and able to provide written informed consent.\n* Those that would be offered tinnitus retraining therapy (TRT) as management for their primary tinnitus\n\nExclusion Criteria:\n\n* Patients with secondary tinnitus as confirmed by magnetic resonance imaging (MRI).\n* Patients undergoing any other tinnitus therapies concurrently (including hearing aids \u002F implants). Previous tinnitus therapies including CBT in the past are accepted.\n* Patients who are not willing to use the app due to not having a suitable phone to download the application or due to own limitations in working Oto.",{"count":254,"type":20},160,[256],"PHASE3","A study that looks at treating tinnitus and its associated burden, insomnia and quality of life effects with a smartphone app when compared with the talking therapies already offered on the national health service. Three separate questionnaires will be used to collect this data from patients at regular time intervals.",[259],"Tinnitus",[261,262,263,264,265,266],"tinnitus","therapeutics","telemedicine","outcomes","otology","otolaryngology","2024-10-01",{"date":269,"type":30},"2024-10-02",{"date":271,"type":30},"2024-06-20",{"date":273,"type":20},"2025-06-20",{"name":36,"class":37},{"id":276,"slug":277,"hasResults":11,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":282,"targetDuration":4,"studyType":120,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":287,"lastUpdatePostDateStruct":288,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":38},"100546896","safety-of-ai-powered-virtual-assistant-in-outpatient-management-of-heart-failure-100546896","NCT06400927","Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure","Safety of AI-Powered Virtual Assistant in Outpatient Management of Heart Failure: A Randomized Controlled Pilot Study: ASSIST-HF SIRIO","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Newly diagnosed HF with New York Heart Association class II-III symptoms at discharge\n\nExclusion Criteria\n\n* Known prior history of HF\n* Severe comorbidities that could affect protocol adherence, in the opinion of the investigator\n* Alternative diagnosis for symptoms such as chronic obstructive pulmonary disease\n* Dementia or other cognitive impairment\n* Currently involved in another interventional clinical trial",{"count":185,"type":20},[122],"The aim of this pilot randomized study is to examine whether integrating the SIRIO-HF virtual assistant (VA) into the outpatient management of participants recently discharged from hospital with a new diagnosis of heart failure (HF), may reduce the need for regular medical assessment and the healthcare burden, reduce variability in healthcare, and meet with participant satisfaction, without compromising participant safety and overall care quality.",[286],"Heart Failure","2024-07-26",{"date":289,"type":30},"2024-07-29",{"date":291,"type":30},"2024-05-07",{"date":293,"type":20},"2027-09-13",{"name":36,"class":37},{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":302,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":304,"conditions":305,"keywords":308,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":312,"lastUpdatePostDateStruct":313,"startDateStruct":315,"completionDateStruct":317,"leadSponsor":319,"locationsCount":38},"100525794","assessment-of-lipoproteina-and-endogenous-fibrinolysis-in-atherosclerotic-cardiovascular-diseaseaortic-valve-disease-100525794","NCT06126367","Assessment of Lipoprotein(a) and Endogenous Fibrinolysis in Atherosclerotic Cardiovascular Disease\u002FAortic Valve Disease","ALFA","Inclusion Criteria:\n\n1\\) Male and female patients aged 18 years or over\n\n2\\) i) Patients identified as eligible for treatment with either a PCSK9i or inclisiran ii) Patients diagnosed with moderate or severe calcific aortic stenosis based on non-enhanced Cardiac CT scan\n\n3\\) Willing and able to understand the Participant Information Sheet and provide informed consent\n\n4\\) The patient must agree to comply with the drawing of blood samples for the assessments\n\n5\\) The patient does not meet any of the exclusion criteria\n\nExclusion Criteria:\n\n1. Inability to provide valid informed consent\n2. Male and female patients aged \\\u003C 18 years of age\n3. The patient has, in the opinion of the investigator, significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses\n4. The patient has a history of substance abuse or demonstrates signs or clinical features of active substance abuse or psychiatric disease\n5. Alcohol consumption above recommended safe levels (i.e., more than 14 units per week) due to the potential effects of high alcohol levels on platelet reactivity\n6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study\n7. Any major bleeding diathesis or blood dyscrasia (platelets \\\u003C 70 x 109\u002Fl, Hb \\\u003C 8 g\u002Fdl, INR \\> 1.4, APTT \\> x 2 upper normal limit, leucocyte count \\\u003C 3.5 x 109\u002Fl, neutrophil count \\\u003C 1 x 109\u002Fl)\n8. Currently enrolled in an investigational device or non-licensed drug trial",{"count":303,"type":20},180,"Prior studies have shown that impaired endogenous fibrinolysis is a novel, independent cardiovascular risk factor in patients with myocardial infarction and there is currently no known chronic treatment to enhance endogenous fibrinolysis.\n\nTo date, no therapies have been able to sufficiently reduce Lp(a) and therefore it was considered to be a non-modifiable cardiovascular risk factor. New data, however, has shown that PCSK9 inhibitors and inclisiran (medication that you have been deemed eligible for in order to help further reduce your cholesterol levels) to reduce Lp(a) levels by approximately 20-25%.\n\nThe aim of this study to is to assess:\n\n1. if there is an association between raised Lp(a) level in blood and the effectiveness of endogenous fibrinolysis (lysis time).\n2. whether lowering Lp(a) with PCSK9i or inclisiran can enhance endogenous fibrinolysis",[306,307],"Atherosclerosis","Aortic Valve Disease",[309,310,311],"Lipoprotein (a)","Global thrombosis test","Endogenous fibrinolysis","2023-11-06",{"date":314,"type":30},"2023-11-13",{"date":316,"type":30},"2023-10-20",{"date":318,"type":20},"2027-10-01",{"name":36,"class":37},{"id":321,"slug":322,"hasResults":11,"nctId":323,"briefTitle":324,"officialTitle":325,"acronym":4,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":328,"conditions":329,"keywords":331,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":341},"100525659","an-investigator-initiated-linked-study-to-oceanic-af-100525659","NCT06124612","An Investigator-initiated Linked Study to OCEANIC-AF","Assessing the Effect of Asundexian on Thrombotic Status, in Particular Endogenous Fibrinolysis, in Patients With Atrial Fibrillation","Inclusion Criteria:\n\n1. Patients aged 18 years or over\n2. Patients enrolled in OCEANIC-AF study\n3. Free from the exclusion criteria below\n4. The patient is willing and able to understand the Patient Information Sheet and provide written informed consent\n5. The patient agrees to comply with the drawing of blood samples for the assessments.\n\nExclusion Criteria:\n\n1. Inability to provide valid informed consent\n2. Patients aged \\\u003C 18 years of age\n3. Patients with significant neurological, hepatic, renal, endocrine, gastrointestinal, pulmonary, haemorrhagic, metabolic or other disease likely to confound the study requirements or analyses\n4. Patients with a history of substance abuse or signs or clinical features of active substance abuse or psychiatric disease\n5. Alcohol consumption above 21 units per week\n6. Any illness deemed significant by the investigator during the four (4) weeks preceding the screening period of the study\n7. Any major bleeding diathesis or blood dyscrasia (platelets \\\u003C70 x 109\u002Fl, Hb \\\u003C80 g\u002Fdl, INR \\>1.4, APTT \\>x 2 UNL, leucocyte count \\\u003C3.5 x 109\u002Fl, neutrophil count \\\u003C1 x 109\u002Fl)",{"count":19,"type":20},"Impaired endogenous fibrinolysis is a recently recognised risk factor for thrombotic events in patients with cardiovascular disease. Enhancing endogenous fibrinolysis in such individuals represents a way of reducing thrombosis risk. However, the optimal pharmacotherapy to enhance fibrinolysis is unclear.\n\nThe aim of this study is to assess the effect of asundexian on endogenous fibrinolysis and compare this to apixaban. If asundexian can enhance endogenous fibrinolysis, this could be used as targeted treatment for patients who despite optimal antithrombotic therapy, demonstrate impaired endogenous fibrinolysis.",[330],"Atrial Fibrillation",[332,311,310],"Atrial fibrillation","2023-11-05",{"date":335,"type":30},"2023-11-09",{"date":337,"type":20},"2023-11-03",{"date":339,"type":20},"2026-09-17",{"name":36,"class":37},2,""]