[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Western Sydney Local Health District\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":327},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,77,102,125,152,178,199,218,238,259,284,309],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100627184","catheter-ablation-versus-anti-arrhythmic-drugs-for-premature-ventricular-complexes-100627184",false,"NCT07445334","Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes","Catheter Ablation Versus Anti-arrhythmic Drugs for Premature Ventricular Complexes (CAAD-PVC): A Randomised Controlled Trial Pilot Study","CAAD-PVC","Inclusion Criteria:\n\n* Premature ventricular complex burden of at least 10%, as determined by multiday (\\>24-hour) heart rhythm monitoring\n* Normal left ventricular ejection fraction\n* Aged ≥18 years.\n\nExclusion Criteria:\n\n* Unable or unwilling to provide informed consent or comply with study requirements including study investigations and follow-up, medical adherence, completion of intervention.\n* Women who are pregnant or breast feeding.\n* Life expectancy ≤ 12 months.\n* Ventricular tachycardia (VT) that is inducible lasting 10 seconds or more; spontaneously occurring lasting 30 seconds or more or not hemodynamically tolerated); or 10 or more episodes of non-sustained ventricular tachycardia (defined as more than five sequential beats, lasting no more than 10 seconds) in 24 hours during ambulatory heart rhythm recording.\n* Structural heart disease including clinically significant coronary artery, valvular disease or clinically significant myocardial replacement.\n* Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome).\n* Responsible primary care or other responsible physician believes it is not appropriate to participate in the study or unable to complete the study procedures, e.g. concomitant illness, physical impairment or mental condition which could interfere with the conduct of the study including outcome assessments.","ALL","18 Years",{"count":20,"type":21},40,"ESTIMATED","INTERVENTIONAL",[24],"NA","Premature ventricular complexes (PVCs) are extra, abnormal heart beats arising from the ventricles of the heart and are the most common ventricular arrhythmia. PVCs can be treated with medication or with a procedure called catheter ablation. It is not known which provides a better cure or provides better quality of life. The purpose of this research project is to study the best way to treat PVCs by comparing the use of medication to catheter ablation to assess which approach is better at reducing symptoms and improving quality of life.",[27,28,29],"Premature Ventricular Complexes","Premature Ventricular Contraction (PVC)","Premature Ventricular Beats",[31,32,27,33,34],"PVC","catheter ablation","anti-arrhythmic medication","beta blocker","NOT_YET_RECRUITING","2026-02-24",{"date":38,"type":39},"2026-03-03","ACTUAL",{"date":41,"type":21},"2026-03-01",{"date":43,"type":21},"2028-03-01",{"name":45,"class":46},"Western Sydney Local Health District","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":64,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":47},"100543828","radiotherapy-vs-catheter-ablation-for-ventricular-tachycardia-in-structural-heart-disease-100543828","NCT06360939","Radiotherapy vs Catheter Ablation for Ventricular Tachycardia in Structural Heart Disease","RadioAblate-VT","Inclusion Criteria:\n\n1. Structural heart disease (including ischaemic cardiomyopathy , non-ischaemic cardiomyopathy or congenital heart disease and defined as any one of\n\n   1. segmental or global decreased ventricular wall motion as defined by TTE, CT or cMRI\n   2. myocardial hypertrophy\n   3. myocardial scar (evidenced by late gadolinium enhancement on cMRI, wall thinning on cardiac CT, low voltage on electrophysiological study or abnormal intracardiac echocardiography)\n2. Recurrent monomorphic VT which can include\n\n   1. at least one episode of VT treated by ICD and\u002For\n   2. sustained VT (lasting \\>30s) and\u002For\n   3. inducible sustained VT on invasive electrophysiological study (EPS) or non-invasive programmed stimulation (NIPS)\n3. PAINESD score of ≥9 points and\u002For at least moderate risk of VT recurrence or death as defined by the I-VT score. Both are validated tools used clinically to identify patient at high risk of VT recurrence and\u002For mortality after CA.\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years\n2. Life expectancy \\\u003C 3 months\n3. Catheter ablation deemed futile or with prohibitive risk by cardiac electrophysiologist.\n4. Unwilling or unable to provide consent\n5. Known cardiac channelopathies (e.g. Catecholaminergic polymorphic ventricular tachycardia (CPVT), long- or short QT syndrome, Brugada syndrome)\n6. Contraindications to radiotherapy as deemed by referring physician and\u002For radiation oncologist\n7. Pregnancy or breast feeding",{"count":56,"type":21},60,[24],"The goal of this randomized clinical trial is to test the efficacy of stereotactic body radiation therapy (SBRT) in treating ventricular tachycardia (VT) in patients with advanced structural heart disease. The main questions it aims to answer are:\n\n* What is the efficacy of SBRT compared to catheter ablation (CA) in achieving a ≥ 75% reduction in VT burden at 6 months\n* What is the comparable safety profile of SBRT vs CA Researchers will compare SBRT and CA (standard of care).",[60,61,62,63],"Ventricular Tachycardia","Cardiomyopathies","Arrhythmias, Cardiac","Ventricular Arrythmia",[32,65,66,67],"stereotactic body radiation therapy","non invasive","radioablation","RECRUITING","2026-02-15",{"date":71,"type":39},"2026-02-18",{"date":73,"type":39},"2025-11-03",{"date":75,"type":21},"2027-12-20",{"name":45,"class":46},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":84,"enrollmentInfo":85,"targetDuration":87,"studyType":88,"phases":4,"briefSummary":89,"conditions":90,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},"100540237","australian-genomics-of-chronic-allograft-dysfunction-study-100540237","NCT06314230","Australian Genomics Of Chronic Allograft Dysfunction Study","AUSCAD","Inclusion Criteria:\n\n* Living or deceased donor kidney transplant candidate.\n* Biological sex: any\n* Ages: 18-75 years.\n* Subject must be able to understand and provide informed consent.\n* Deceased donor individuals where Research Consent has been obtained from the person consenting to organ donation at the time of organ retrieval.\n* Identifiable living donors who have received informed consent and have consented to participate in the project.\n\nExclusion Criteria:\n\n* Presensitization in living donor recipients prior to transplantation, as determined by site-specific standards, OR positive cross match according to site specific technique in cadaveric donor recipients.\n* Recipients of multiple organ transplants, with the exception of kidney\u002Fpancreas transplants.\n* Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n* High risk populations including pregnant women, children less than 18 years and prisoners will not be included in the study.\n* Non English speaking potential participants who do not understand the requirements of the study will not be included.","75 Years",{"count":86,"type":21},500,"2 Years","OBSERVATIONAL","The goal of the Australian Genomics of Chronic Allograft Dysfunction (AUSCAD) study is a single centre (Westmead Hospital), prospective, observational study, which enrols patients at time of kidney (or kidney-transplant) transplant and tracks the post transplant course. The AUSCAD study aims to generate new knowledge and improve outcomes following kidney transplantation. The primary aim is to determine whether important outcomes (including chronic rejection and graft loss) are correlated with patterns of allograft reactivity, gene expression and susceptibility profiles.",[91,92],"Kidney Transplant Rejection","Kidney Transplant; Complications","2025-07-14",{"date":95,"type":39},"2025-07-17",{"date":97,"type":39},"2012-04-26",{"date":99,"type":21},"2040-01-01",{"name":45,"class":46},2,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":110,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":111,"targetDuration":4,"studyType":22,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100511106","white-light-vs-narrow-band-imagingin-the-diagnosis-of-right-sided-colonic-polyps-in-asymptomatic-subjects-undergoing-screening-colonoscopy-100511106","NCT05935124","White Light vs Narrow Band Imagingin the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy","A Randomized Comparison Between White Light Endoscopy (WLE) and Bright Narrow Band Imaging (B-NBI) in the Diagnosis of Right Sided Colonic Polyps in Asymptomatic Subjects Undergoing Screening Colonoscopy","WLEvsB-NBI","Inclusion Criteria:\n\n* Asymptomatic subjects undergoing screening colonoscopy\n* age \\> 50.\n* average risk subjects defined as those without a personal history of inflammatory bowel disease, colon adenoma or cancer or family history of FAP or Familial non-polyposis syndrome or first degree relatives having diagnosed to have colo-rectal carcinoma, no colonoscopy in past 5 years and, ability to provide a written consent to trial participation\n\nExclusion Criteria:\n\n* unable to consent",true,{"count":112,"type":21},600,[24],"A randomized controlled crossover study to determine if narrow band imaging or white light endoscopy is superior in detecting right colonic polyps in average risk subjects undergoing screening colonoscopy",[116],"Adenoma Colon","2025-03-25",{"date":119,"type":39},"2025-03-30",{"date":121,"type":39},"2015-08-01",{"date":123,"type":21},"2025-11",{"name":45,"class":46},{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":129,"acronym":130,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":132,"targetDuration":133,"studyType":88,"phases":4,"briefSummary":134,"conditions":135,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":47},"100501059","the-australia-and-new-zealand-multicentre-upper-gastrointestinal-endoscopic-tissue-resection-study-100501059","NCT05804331","The Australia and New Zealand Multicentre Upper Gastrointestinal Endoscopic Tissue Resection Study","ANZ UGI","Inclusion Criteria:\n\n* UGI neoplastic lesions \\> 10mm\n\n  * Lesions for ESD limited to the mucosal and\u002For submucosal layer OR\n  * Lesions for EFTR limited to the muscularis propria layer OR\n  * Lesions for STER limited to the submucosal and\u002For muscularis propria layer\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Age less than 18\n* Unable to give informed consent\n* Pregnant or lactating patients\n* Patients with bleeding diathesis or who cannot discontinue ADP blockers (e.g. clopidogrel, prasugrel) or antithrombotics (e.g. warfarin, dabigatran) periprocedurally",{"count":86,"type":21},"3 Years","To determine the long term outcomes of Endoscopic Submucosal Dissection (ESD), Endoscopic Full Thickness Resection (EFTR) and Submucosal-Tunnelling Endoscopic Resection (STER) for upper gastrointestinal neoplastic lesions",[136,137,138,139,140,141,142,143,144],"Cancer of Stomach","Oesophageal Cancer","Gastric Cancer","Gastric Adenocarcinoma","GI Cancer","GIST","Neuroendocrine Tumors","Gastric Neoplasm","Esophageal Neoplasms",{"date":146,"type":39},"2025-03-27",{"date":148,"type":39},"2023-03-14",{"date":150,"type":21},"2028-09-14",{"name":45,"class":46},{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":162,"conditions":163,"keywords":167,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":172,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":47},"100442445","cold-snare-endoscopic-mucosal-resection-emr-vs-cold-emr-with-margin-snare-tip-soft-coagulation-stsc-100442445","NCT05041478","Cold Snare Endoscopic Mucosal Resection (EMR) vs Cold EMR With Margin Snare Tip Soft Coagulation (STSC)","Cold Snare Endoscopic Mucosal Resection vs Cold Snare Endoscopic Mucosal Resection With Adjuvant Thermal Therapy to Resection Margins - A Randomised Controlled Trial","Inclusion Criteria:\n\n* Any patient undergoing colonoscopy who is older than 18 years of age, has a written consent for trial participation and has at least one laterally spreading lesion meeting the following description:\n* Localisation in the colon or rectum\n* Benign adenomatous surface features (Kudo III \u002F IV, Japan NBI Expert Team (JNET) 2a)\n* Granular or non-granular topography\n* Paris classification 0-IIa\u002FIIb +\u002F- Is\n* If present, sessile component may be no greater than 10mm in size.\n* Polyp size ranging from 15 to 40mm\n\nExclusion Criteria:\n\n* Current use of antiplatelet (excluding aspirin) or anticoagulants which have not appropriately been interrupted according to the guidelines.\n* Known bleeding disorder or coagulopathy.\n* Pregnancy\n* History of inflammatory bowel disease\n* Previously attempted or otherwise non-lifting lesions\n* Endoscopic features suggestive of submucosal invasion (Kudo Vi\u002Fn, JNET 2b \u002F 3) or concurrent colorectal cancer\n* Lesions involving the ileocaecal valve (ICV), appendiceal oriface or anorectal junction (ARJ)",{"count":160,"type":21},300,[24],"Randomised controlled trial comparing cold snare endoscopic mucosal resection (EMR) with cold snare EMR and adjuvant margin STSC in the complete resection of 15-40mm lateral-spreading adenomas",[164,165,166],"Colorectal Polyp","Colon Adenoma","Colon Cancer",[168,169,170,171],"Colonoscopy","Polypectomy","Adenoma","Colorectal Cancer",{"date":146,"type":39},{"date":174,"type":39},"2023-09-19",{"date":176,"type":21},"2028-10-01",{"name":45,"class":46},{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":184,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":22,"phases":188,"briefSummary":189,"conditions":190,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":193,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":47},"100363145","esd-for-colorectal-lsl-using-a-selective-strategy---a-prospective-cohort-study-100363145","NCT04008407","ESD for Colorectal LSL Using a Selective Strategy - a Prospective Cohort Study","Endoscopic Submucosal Dissection for Sessile Polyps and Laterally Spreading Lesions of the Colorectum Using a Selective Strategy - a Prospective Cohort Study","COVERT","Inclusion Criteria:\n\n* All patients referred for colorectal resection of large laterally spreading lesions in colon.\n* Can give informed consent to trial participation\n\nExclusion Criteria:\n\n* Previous resection or attempted resection of target adenoma lesion\n* Endoscopic appearance of invasive malignancy\n* Age less than 18 years\n* Pregnancy\n* Active Inflammatory colonic conditions (e.g. inflammatory bowel disease)\n* Use of anticoagulant or antiplatelet agents other than aspirin outside of internationally recognised guidelines\n* American Society of Anesthesiology (ASA) Grade IV-V",{"count":187,"type":21},391,[24],"Colonic Laterally spreading lesions (LSL) =\\> 20mm are at high risk to progress to cancer. Overt stigmata of submucosal invasive cancer (SMIC) has been well characterized and includes ulceration and surface pit pattern changes as per the Kudo classification of type V.\n\nIn a recent report, risk factors for LSL with SMIC and no overt stigmata (i.e. covert SMIC) were described. Resection of these lesions 'en-bloc' can allow for better histological staging and potentially reduce the need for surgical resection.",[191,192],"Colorectal Neoplasm","Endoscopic Mucosal Resection",{"date":146,"type":39},{"date":195,"type":39},"2017-08-14",{"date":197,"type":21},"2028-02",{"name":45,"class":46},{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":203,"acronym":204,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":207,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":209,"conditions":210,"keywords":4,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":47},"100321968","the-australian-colonic-large-sessile-lesion-endoscopic-resection-study-100321968","NCT03471793","The Australian Colonic Large Sessile Lesion Endoscopic Resection Study","ACE","Inclusion Criteria:\n\n* Patients referred for endoscopic resection of a large sessile colonic polyp or laterally spreading tumour ≥20mm in size.\n* Able to give informed consent to involvement in the clinical study\n\nExclusion Criteria:\n\n* Unable to provide informed consent for involvement","99 Years",{"count":208,"type":21},5000,"A prospective, multicentre, observational study of all patients referred for endoscopic resection of sessile colorectal polyps sized ≥20 mm conducted with intention to treat analysis",[165,211],"Colon Polyp",{"date":146,"type":39},{"date":214,"type":39},"2017-02-24",{"date":216,"type":21},"2037-02",{"name":45,"class":46},{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":223,"eligibilityCriteria":224,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":206,"enrollmentInfo":225,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":227,"conditions":228,"keywords":230,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":232,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":47},"100321938","cold-snare-polypectomy-for-duodenal-adenomas-in-familial-adenomatous-polyposis-100321938","NCT03471403","Cold Snare Polypectomy for Duodenal Adenomas in Familial Adenomatous Polyposis","COPDA","Inclusion Criteria:\n\n* Patient's diagnosed with a confirmed diagnosis of FAP (genetic testing) and able to give informed consent to involvement in trial. For patients who do not speak English, an interpreter will be asked to translate the informed consent\n* Patients already commenced on endoscopic surveillance for FAP.\n\nExclusion Criteria:\n\n* Patient's with known strictures\u002Fstenosis\n* Pregnancy\n* Patients who did not consent to study\n* Bleeding diathesis",{"count":226,"type":21},100,"The purpose of this study is to collect prospective observational data regarding patients with diagnosed Familial Adenomatous Polyposis (FAP) undergoing cold snare polypectomy for duodenal adenomas",[229],"Familial Adenomatous Polyposis",[231],"Cold snare polypectomy",{"date":146,"type":39},{"date":234,"type":39},"2017-10-10",{"date":236,"type":21},"2028-10-10",{"name":45,"class":46},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":248,"conditions":249,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":251,"lastUpdatePostDateStruct":252,"startDateStruct":254,"completionDateStruct":256,"leadSponsor":258,"locationsCount":4},"100544171","genomic-medicine-in-kidney-transplantation-study-100544171","NCT06365411","GEnomic Medicine in Kidney Transplantation Study","GEM-KiT","Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and\n\n1. able to provide informed consent (interpreter permitted) for enrolment\n2. consenting to longitudinal follow up (can withdraw post enrolment)\n3. consenting to provide samples for biobanking, including blood, urine, faecal and\u002For kidney biopsy tissue (collected prospectively, separate to routine care)\n\nExclusion Criteria: Patients will be excluded from the study if they are\n\n1. unable (or unwilling) to provide consent, or\n2. have life-expectancy less than 6-months, or\n3. have received a haematopoietic stem cell transplant in the past 5 years.","80 Years",{"count":247,"type":21},1000,"Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.\n\n1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation\n2. Derive polygenic risk scores on pre-transplant blood and\u002For kidney biopsy samples which predict kidney allograft dysfunction\n3. Derive polygenic risk scores on post-transplant blood and\u002For kidney biopsy samples which predict kidney allograft dysfunction",[250,91],"Transplant Complication","2025-03-24",{"date":253,"type":39},"2025-03-28",{"date":255,"type":21},"2025-06-03",{"date":257,"type":21},"2035-01-01",{"name":45,"class":46},{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":263,"acronym":264,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":270,"conditions":271,"keywords":273,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":275,"lastUpdatePostDateStruct":276,"startDateStruct":278,"completionDateStruct":280,"leadSponsor":282,"locationsCount":283},"100478375","phase-2-a-randomised-controlled-trial-of-n-acetyl-cysteine-nac-for-premanifest-huntingtin-gene-expansion-carriers-100478375","NCT05509153","A Randomised Controlled Trial, Of N-Acetyl Cysteine (NAC), for Premanifest Huntingtin Gene Expansion Carriers","NAC-preHD","Inclusion Criteria:\n\n* Able to provide informed consent\n* Huntingtin gene expansion carrier with \\>= 39 CAG repeats\n* Absence of unequivocal motor signs of HD - that is, UHDRS\n* Diagnostic Confidence Level needs to be \\\u003C4 upon enrolment\n* Expected to develop clinical HD within 10 years of trial enrolment using the Langbehn formula\n* Availability of an informant for corroborative history\n* Negative serum pregnancy test for women of childbearing potential\n* If of childbearing potential, is able and agrees to remain abstinent or use adequate contraceptive methods\n* Ability to tolerate MRI scans\n* Ability to tolerate blood draws\n* Able to comply with all study protocol requirements, according to the investigators judgement\n* In the opinion of the investigator, medically, psychiatrically and neurologically stable at the time of enrolment\n\nExclusion Criteria:\n\n* Diagnosis of clinical HD\n* Known hypersensitivity to NAC\n* Pregnancy, breastfeeding or intention to do so prior to the end of the study\n* Exposure to any investigational drugs within 30 days of Baseline Visit\n* Use of supplemental NAC\n* Abnormalities in laboratory measurements, ECG or vital signs at screening, which precludes safe participation in the study\n* Current or history of substance abuse within one year of Baseline visit\n* Unstable psychiatric or acute medical illness including cancer, as determined by investigator\n* Current use of antipsychotic medications or Tetrabenazine\n* History of gene therapy, cell transplantation, or any experimental brain surgery\n* History of attempted suicide or suicidal ideation within 12 months prior to screening\n* Pre-existing structural brain lesion as assessed by a centrally read MRI scan during the screening period",{"count":267,"type":21},160,[269],"PHASE2","NAC-preHD is a phase II randomized placebo controlled study of oral NAC among premanifest HD gene expansion carriers, with clinical and radiological outcome at three years.",[272],"Huntington Disease",[274],"N-Acetylcysteine","2025-02-25",{"date":277,"type":39},"2025-02-28",{"date":279,"type":39},"2024-06-01",{"date":281,"type":21},"2027-05-01",{"name":45,"class":46},5,{"id":285,"slug":286,"hasResults":11,"nctId":287,"briefTitle":288,"officialTitle":288,"acronym":289,"eligibilityCriteria":290,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":291,"enrollmentInfo":292,"targetDuration":4,"studyType":22,"phases":294,"briefSummary":295,"conditions":296,"keywords":298,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":308},"100330903","programmed-ventricular-stimulation-to-risk-stratify-for-early-cardioverter-defibrillator-icd-implantation-to-prevent-tachyarrhythmias-following-acute-myocardial-infarction-protect-icd-100330903","NCT03588286","Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction (PROTECT-ICD)","PROTECT-ICD","Inclusion Criteria:\n\n* 2-40 days (inclusive) following a myocardial infarct\n* Impaired left ventricular systolic function (LVEF≤40% or at least moderately impaired)\n\nExclusion Criteria:\n\n1. Age \\\u003C18 or \\>85;\n2. Pregnancy;\n3. Nursing home resident dependent on one or more activities of daily living;\n4. Significant non-cardiac co-morbidity with high likelihood of death within 1 year (this would include any metastatic malignancy, or other terminal disease);\n5. Significant psychiatric illnesses that may be aggravated by device implantation or that may preclude regular follow up;\n6. Intravenous drug abuse (ongoing);\n7. Unresolved infection associated with risk for hematogenous seeding;\n8. Pre-existing implantable cardioverter-defibrillator (ICD);\n9. Secondary prevention indication for an ICD (i.e. sustained ventricular arrhythmias occurring more than 48 hours after qualifying myocardial infarction (patients with ventricular arrhythmias occurring ≤48 hours of myocardial infarction, or with non-sustained ventricular tachycardia at any time, are not excluded));\n10. On the heart transplant list;\n11. Recurrent unstable angina despite revascularisation (defined as ongoing chest pain or ischemic symptoms at rest or with minimal exertion despite adequate treatment with anti-anginal medications);\\*\\*\n12. Congestive heart failure New York Heart Association class IV, defined as shortness of breath at rest, which is refractory to medical treatment (not responding to treatment)\\*\\* \\*\\*NOTE: patients who meet exclusion based on (11) or (12) can be reviewed again in 2-3 days and if symptoms have resolved or treatment performed can be re-considered for inclusion.","85 Years",{"count":293,"type":21},1058,[24],"The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days). The secondary aim is to assess the utility of cardiac MRI (CMR) in analysing cardiac function and viability as well as predicting inducible and spontaneous ventricular tachyarrhythmia when performed early post MI.\n\nFollowing a MI patients are at high risk of sudden cardiac death (SCD). The risk is highest in the first 40 days; however, current guidelines exclude patients from receiving an ICD during this time. This limitation is based largely on a single study, The Defibrillator in Acute Myocardial Infarction Trial (DINAMIT), which failed to demonstrate a benefit of early ICD implantation. However, this study was underpowered and used non-invasive tests to identify patients at high risk. EPS identifies patients with the substrate for re-entrant tachyarrhythmia, and has been found in multiple studies to predict patients at risk of SCD. Contrast-enhanced CMR is a non-invasive test without radiation exposure which can be used to assess left ventricular function. In addition, it provides information on myocardial viability, scar size and tissue heterogeneity. It has an emerging role as a predictor of mortality and spontaneous ventricular arrhythmia in patients with a previous MI.\n\nA total of 1,058 patients who are at high risk of SCD based on poor cardiac function (left ventricular ejection fraction (LVEF) ≤40%) following a ST-elevation or non-STE myocardial infarct will be enrolled in the trial. Patients will be randomised 1:1 to either the intervention or control arm.\n\nIn the intervention arm all patients undergo early EPS. Patients with a positive study (inducible ventricular tachycardia cycle length ≥200ms) receive an ICD, while patients with a negative study (inducible ventricular fibrillation or no inducible VT) are discharged without an ICD, regardless of the LVEF.\n\nIn the control arm patients are treated according to standard local practice. This involves early discharge and repeat assessment of cardiac function after 40 days or after 90 days following revascularisation (PCI or CABG). ICD implantation after 40 days according to current guidelines (LVEF≤30%, or ≤35% with New York Heart Association (NYHA) class II\u002FIII symptoms) could be considered, if part of local standard practice, however the ICD is not funded by the trial.\n\nA proportion of trial patients from both the intervention and control arms at \\>48 hours following MI will undergo CMR to enable correlation with (1) inducible VT at EPS and (2) SCD and non-fatal arrhythmia on follow up. It will be used to simultaneously assess left ventricular function, ventricular strain, myocardial infarction size, and peri-infarction injury. The size of the infarct core, infarct gray zone (as a measure of tissue heterogeneity) and total infarct size will be quantified for each patient.\n\nAll patients will be followed for 2 years with a combined primary endpoint of non-fatal arrhythmia and SCD. Non-fatal arrhythmia includes resuscitated cardiac arrest, sustained ventricular tachycardia (VT) and ventricular fibrillation (VF) in participants without an ICD. Secondary endpoints will include all-cause mortality, non-sudden cardiovascular death, non-fatal repeat MI, heart failure and inappropriate ICD denial. Secondary endpoints for CMR correlation will include (1) the presence or absence of inducible VT at EP study, and (2) combined endpoint of appropriate ICD activation or SCD at follow up.\n\nIt is anticipated that the intervention arm will reduce the primary endpoint as a result of prevention of a) early sudden cardiac deaths\u002Fcardiac arrest, and b) sudden cardiac death\u002Fcardiac arrest in patients with a LVEF of 31-40%. It is expected that the 2-year primary endpoint rate will be reduced from 6.7% in the control arm to 2.8% in the intervention arm with a relative risk reduction (RRR) of 68%. A two-group chi-squared test with a 0.05 two-sided significance level will have 80% power to detect the difference between a Group 1 proportion of 0.028 experiencing the primary endpoint and a Group 2 proportion of 0.067 experiencing the primary endpoint when the sample size in each group is 470. Assuming 1% crossover and 10% loss to follow up the required sample size is 1,058 (n=529 patients per arm). To test the hypothesis that tissue heterogeneity at CMR predicts both inducible and spontaneous ventricular tachyarrhythmias will require a sample size of 400 patients to undergo CMR.\n\nIt is anticipated that the use of EPS will select a group of patients who will benefit from an ICD soon after a MI. This has the potential to change clinical guidelines and save a large number of lives.",[297],"Sudden Cardiac Death",[299],"Myocardial Infarction (MI), Sudden Cardiac Death (SCD), Electrophysiological Study (EPS), Ventricular Tachycardia (VT)","2024-05-06",{"date":302,"type":39},"2024-05-07",{"date":304,"type":39},"2014-02-27",{"date":306,"type":21},"2029-12-06",{"name":45,"class":46},52,{"id":310,"slug":311,"hasResults":11,"nctId":312,"briefTitle":313,"officialTitle":313,"acronym":314,"eligibilityCriteria":315,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":245,"enrollmentInfo":316,"targetDuration":4,"studyType":88,"phases":4,"briefSummary":317,"conditions":318,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":320,"lastUpdatePostDateStruct":321,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":326,"locationsCount":4},"100535657","western-sydney-kidney-injury-biopsy-study-100535657","NCT06254677","Western Sydney Kidney Injury Biopsy Study","WESTKiD","Inclusion Criteria:\n\n1. Had a kidney biopsy (native kidney or transplant kidney included) after year 2000\n2. Kidney biopsy sample sent to Westmead Hospital for clinical interpretation\n\nExclusion Criteria:\n\n1. Patients who have never had a kidney biopsy performed\n2. Biopsy sample not available at Westmead Hospital\n3. No information on kidney function (serum creatinine or eGFR)",{"count":247,"type":21},"The investigators aim to develop a clinically validated, histological acute tubular injury (ATI) scoring system to help improve diagnostic precision and predict clinical outcomes following ATI.\n\nTo use an unbiased, data-driven approach, correlating pathological features (including digital pathology), key signatures using spatial technologies (transcriptomics or proteinomics) with relevant clinical outcomes. Spatial technologies (including spatial transcriptomics and spatial proteinomics) allow the use of 'precision pathology' to study the critical link between molecular characteristics to histological structure.",[319],"Kidney Injury","2024-04-22",{"date":322,"type":39},"2024-04-24",{"date":324,"type":21},"2024-05-01",{"date":99,"type":21},{"name":45,"class":46},""]