[{"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:":327},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,39,70,108,130,157,186,206,232,256,281,303],{"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":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100598323","ai-guided-af-treatment-100598323",false,"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","ALL","18 Years",{"count":19,"type":20},60,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26],"Atrial Fibrillation (AF)","NOT_YET_RECRUITING","2025-07-07",{"date":30,"type":31},"2025-07-17","ACTUAL",{"date":33,"type":20},"2025-07-15",{"date":35,"type":20},"2028-05-26",{"name":37,"class":38},"East and North Hertfordshire NHS Trust","OTHER_GOV",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":47,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":55,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"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":49,"type":20},100,[23],"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.",[53,54],"Post Surgical Pain","Analgesia",[56,57,58,59],"Post-tonsillectomy pain","Tonsil surgery","Manuka honey","Honey","RECRUITING","2025-04-28",{"date":63,"type":31},"2025-04-29",{"date":65,"type":31},"2023-09-04",{"date":67,"type":20},"2025-09-04",{"name":37,"class":38},1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":77,"minAge":17,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":21,"phases":81,"briefSummary":82,"conditions":83,"keywords":90,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":69},"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":80,"type":20},40,[23],"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.",[84,85,86,87,88,89],"Prostate Cancer (Adenocarcinoma)","Prostate Cancer (Post Prostatectomy)","Prostate Cancer Surgery","Prostate Cancers","Prostate Neoplasm","Prostatectomy",[91,92,93,94,95,96,97,98,99],"prostate cancer","prostatectomy","robotic prostatectomy","post-operative pain","pain","Stryker PneumoClear insufflator","AirSeal Insufflation System","intra-operative pain","Medasense","2025-03-31",{"date":102,"type":31},"2025-04-08",{"date":104,"type":20},"2025-04-01",{"date":106,"type":20},"2025-07-01",{"name":37,"class":38},{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":118,"conditions":119,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":69},"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":116,"type":20},20,"OBSERVATIONAL","The main study aim is the investigate the clinical use of in vivo dosimeters (small measurement devices) for brachytherapy (internal radiotherapy).",[120,121],"Prostate Cancer","Gynaecological Cancer","2025-03-07",{"date":124,"type":31},"2025-03-11",{"date":126,"type":20},"2025-03-03",{"date":128,"type":20},"2026-03-01",{"name":37,"class":38},{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":137,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":139,"conditions":140,"keywords":143,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":69},"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":138,"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.",[141,142],"Perspective of Healthcare Professionals Haemodialysis Needling","Dialysis",[144,145,146,147,148],"Haemodialysis","Haemodialysis needling","End-Stage Renal Disease","Fistula","Cannulation","2025-02-24",{"date":151,"type":31},"2025-02-25",{"date":153,"type":31},"2024-10-30",{"date":155,"type":20},"2025-05",{"name":37,"class":38},{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":4,"eligibilityCriteria":163,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":21,"phases":166,"briefSummary":168,"conditions":169,"keywords":171,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":69},"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":165,"type":20},160,[167],"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.",[170],"Tinnitus",[172,173,174,175,176,177],"tinnitus","therapeutics","telemedicine","outcomes","otology","otolaryngology","2024-10-01",{"date":180,"type":31},"2024-10-02",{"date":182,"type":31},"2024-06-20",{"date":184,"type":20},"2025-06-20",{"name":37,"class":38},{"id":187,"slug":188,"hasResults":11,"nctId":189,"briefTitle":190,"officialTitle":191,"acronym":4,"eligibilityCriteria":192,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":193,"targetDuration":4,"studyType":21,"phases":194,"briefSummary":195,"conditions":196,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":69},"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":19,"type":20},[23],"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.",[197],"Heart Failure","2024-07-26",{"date":200,"type":31},"2024-07-29",{"date":202,"type":31},"2024-05-07",{"date":204,"type":20},"2027-09-13",{"name":37,"class":38},{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":213,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":69},"100555731","association-of-middle-molecules-clearance-with-hdf-volume-100555731","NCT06515899","Association of Middle Molecules Clearance With HDF Volume","Association of Middle Molecules Clearance and Clinical Parameters With Haemodiafiltration Convection Volume","Inclusion Criteria:\n\n* Age 18 years or above.\n* Ability to give informed consent.\n* End stage renal failure treated by dialysis for at least 3 months.\n* Established on hemodiafiltration for \\>4 weeks.\n* Prognosis more than 6 months as assessed by PI\n\nExclusion Criteria:\n\n* Age less than 18 years.\n* Inability to give informed consent.\n* Prognosis less than 6 months as assessed by PI",{"count":214,"type":20},400,"HDF is a dialysis technique which involves diffusion and convection. HDF with high convection volume has consistently shown to improve survival in dialysis patients in number of robust RCTs. The precise reason of this survival benefit remains unclear.\n\nThe investigators hypothesize that this survival benefit with high volume HDF is related to enhanced middle molecule clearance and hemodynamic stability. However, this relationship has not been studied so far.\n\nThis observational study is aimed to understand the relationship between HDF convection volume with middle molecules (Beta 2-Microglobulin) clearance during HDF.\n\nExploring the relationship of HDF volume with middle molecules clearance has significant clinical ramifications. Only a minority of patients are able to achieve target convection volume. Understanding these relationships can rationalize the HDF prescription from convection volume-based prescription to β2-Microglobulin clearance-based prescription which may be applicable to wider range of patients.\n\nThe relationship between pre-dialysis β2-Microglobulin levels and RKF offers the prospect of dispensing with pre- and post-dialysis urea and creatinine measurements and interdialytic urine collections, currently necessary for estimating RKF, thus simplifying its estimation.\n\nβ2-Microglobulin reduction ratio and its component pre and post-dialysis β2-Microglobulin levels could therefore provide a composite estimate of small and middle molecule clearance and RKF.",[217],"End Stage Renal Disease",[219,220,221,222,223],"Middle Molecules clearance in HDF","HDF","Middle molecules","beta 2 microglobulin","HDF convection volume","2024-07-17",{"date":226,"type":31},"2024-07-23",{"date":228,"type":31},"2024-01-19",{"date":230,"type":20},"2025-07",{"name":37,"class":38},{"id":233,"slug":234,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":238,"eligibilityCriteria":239,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":240,"targetDuration":4,"studyType":21,"phases":242,"briefSummary":243,"conditions":244,"keywords":246,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":69},"100554606","capsule-sponge-study-in-eosinophilic-oesophagitis-100554606","NCT06501274","Capsule Sponge Study in Eosinophilic Oesophagitis","A Pragmatic Interventional Study to Assess the Clinical Value of Capsule Sponge in the Assessment of Response to Treatment of Non-stenotic Eosinophilic Oesophagitis in a Single District General Hospital","Cosie","Inclusion Criteria:\n\n• patients diagnosed with non -stenotic eosinophilic oesophagitis who have a change in treatment\n\nExclusion Criteria:\n\n* Strictures or rings at most recent endoscopy that prevent passage of adult gastroscope\n* Previous oesophageal dilatation\n* Previous oesophageal perforation or surgical resection\n* Oesophago-gastric malignancy\n* Oesophageal varices\n* Bolus obstruction since last endoscopy requiring hospital visit\n* Previous fundoplication or complicated hiatus hernia\n* Patient on Warfarin with INR\\>=3\n* Suspected new diagnosis of EOE without prior endoscopic confirmation",{"count":241,"type":20},140,[23],"Open pragmatic, descriptive single site study in adult patients with non-stenotic eosinophilic oesophagitis.\n\nTo assess the clinical value of Capsule sponge in the assessment of treatment response in patients with known non-stenosing eosinophilic oesophagitis, as an alternative to gastroscopy in a real world setting.\n\nTo assess patient preference for Capsule sponge or gastroscopy. All patients with non-stenosing eosinophilic oesophagitis who are reviewed in clinic that have not had reassessment of their oesophagus post treatment initiation or change in treatment will be offered Capsule sponge as an alternative to gastroscopy.\n\nA standardised clinical symptom questionnaire will be self-administered for 2w prior to clinic visits and Capsule sponge.\n\nTelephone triage for safety check and exclusion criteria by Capsule sponge nurse.\n\nA patient symptom questionnaire at the time of procedure by research nurse. A patient satisfaction survey will be delivered after the Capsule sponge procedure by Capsule sponge nurse.\n\nCytological assessment of the Capsule sponge and eosinophil count and other markers of inflammation will be reported by Cyted.\n\nClinic follow up will occur at approximately 6-8 weeks post Capsule sponge. Descriptive Changes in management as a result of the Capsule sponge findings and \u002For symptoms will be recorded by clinician.",[245],"Eosinophilic Esophagitis",[247],"capsule sponge","2024-07-08",{"date":250,"type":31},"2024-07-15",{"date":252,"type":31},"2023-07-31",{"date":254,"type":20},"2025-07-31",{"name":37,"class":38},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":260,"acronym":261,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":263,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":265,"conditions":266,"keywords":269,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":69},"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":264,"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",[267,268],"Atherosclerosis","Aortic Valve Disease",[270,271,272],"Lipoprotein (a)","Global thrombosis test","Endogenous fibrinolysis","2023-11-06",{"date":275,"type":31},"2023-11-13",{"date":277,"type":31},"2023-10-20",{"date":279,"type":20},"2027-10-01",{"name":37,"class":38},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":289,"conditions":290,"keywords":292,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":302},"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":49,"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.",[291],"Atrial Fibrillation",[293,272,271],"Atrial fibrillation","2023-11-05",{"date":296,"type":31},"2023-11-09",{"date":298,"type":20},"2023-11-03",{"date":300,"type":20},"2026-09-17",{"name":37,"class":38},2,{"id":304,"slug":305,"hasResults":11,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":117,"phases":4,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":69},"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":312,"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.",[315],"Aortic Stenosis",[317,318],"TAVI","SAVR","2020-01-16",{"date":321,"type":31},"2020-01-21",{"date":323,"type":20},"2020-02-01",{"date":325,"type":20},"2028-01",{"name":37,"class":38},""]