[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"The University of Queensland\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":598},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,47,81,105,137,170,208,238,271,298,327,354,387,419,445,476,506,528,549,572],{"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":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100565470","starting-incremental-prescription-of-peritoneal-dialysis-100565470",false,"NCT06642597","STarting incrEmental Prescription of Peritoneal Dialysis","An International, Multi-centre, Randomised Controlled Trial Co-designed With Consumers With Lived Experience of Peritoneal Dialysis (PD) to Determine the Optimal Approach to Starting Patients With Kidney Failure on PD","STEP-PD","Inclusion Criteria:\n\n* adults (≥18 years) commencing PD as their first dialysis therapy (and been on dialysis for \\\u003C1 month)\n* able to give informed consent\n\nExclusion Criteria:\n\n* urine output \\\u003C0.5L\u002Fday\n* previous kidney transplant\n* unlikely to be on dialysis for ≥1 year.\n* known or planned pregnancy during the trial","ALL","18 Years",{"count":20,"type":21},224,"ESTIMATED","INTERVENTIONAL",[24],"NA","Kidney failure is fatal without dialysis. Peritoneal dialysis (PD) completed at home offers greater flexibility and autonomy for patients . However, PD is often prescribed for 24 hours\u002Fday, 7 days\u002Fweek for every patient starting dialysis. This practice is not evidence-informed, may be unnecessary and potentially harmful. The STEP-PD trial aims to determine the optimal approach to commencing patients on PD through starting at low dose PD and incrementing over time.",[27,28],"Peritoneal Dialysis (PD)","Kidney Failure",[30,31,32,33],"Kidney failure","Kidney disease","peritoneal dialysis","incremental start PD","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":38},"2025-09-19",{"date":42,"type":21},"2029-09-30",{"name":44,"class":45},"The University of Queensland","OTHER",9,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":65,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},"100464231","phase-3-a-trial-to-treat-polyomavirus-infections-bkpyv-in-kidney-and-simultaneous-kidney-pancreas-transplant-recipients-100464231","NCT05325008","A Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Simultaneous Kidney Pancreas Transplant Recipients","An Adaptive Randomised Controlled Trial to Treat Polyomavirus Infections (BKPyV) in Kidney and Kidney Pancreas Transplant Recipients","BEAT-BK","Inclusion Criteria:\n\n1. Aged 2 years or above\n2. Have received a kidney or simultaneous pancreas-kidney transplant\n3. Have BKPyV-Viremia (detected by RT-PCR) with a viral count ≥ 5,000 copies per mL, or histological confirmation of BKPyVAN, within 3 weeks prior to randomisation.\n4. Be able to provide informed consent or consent given by a parent or guardian (if age \\\u003C18 years) or other authorised person\n\nExclusion Criteria:\n\n1. Contraindications to receiving IVIG as a treatment\n2. Current active acute rejection (≤ 3 months prior)\n3. Treating clinicians would regard as unsafe to be enrolled\n4. Limited life expectancy (\\\u003C 12 months)\n5. Receiving Belatacept as part of their immunosuppression protocol\n6. Currently undergoing or who have previously received, viral-specific T-cell therapy for BK viremia\n7. Prior infection and treatment for BKPyV-Viremia\n8. Received IVIG treatment in the past with last IVIG treatment \\\u003C 4 weeks prior to randomisation","2 Years",{"count":57,"type":21},280,[59],"PHASE3","BEAT-BK will see the effect of immunosuppression reduction\u002Fmodification with and without IVIG on BKPyV infection, allograft function, allograft loss, acute transplant rejection, immunosuppression load and death in kidney and simultaneous kidney pancreas transplant recipients with polyomavirus infections (BKPyV).",[62,63,64],"BK Viremia","Kidney Transplant Infection","Kidney Transplant Failure and Rejection",[66,67,68,69,70,71],"Kidney transplantation","Intravenous immunoglobulin","Virus","Nephropathy","Clinical trial","Nephrology","2026-06-05",{"date":74,"type":38},"2026-06-08",{"date":76,"type":38},"2023-08-18",{"date":78,"type":21},"2029-06-30",{"name":44,"class":45},13,{"id":82,"slug":83,"hasResults":11,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100434055","incremental-dialysis-to-improve-health-outcomes-in-people-starting-haemodialysis-inch-hd-100434055","NCT04932148","INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD)","The INCremental Dialysis to Improve Health Outcomes in People Starting Haemodialysis (INCH-HD) Study: a Randomised Controlled Trial","Inclusion Criteria:\n\n1. Adults (≥ 18 years of age) and\n2. Commencing HD as their initial dialysis therapy and\n3. Able to give informed consent\n\nExclusion Criteria:\n\n1. Urine output \\\u003C0.5Litres\u002Fday\n2. Unlikely to be on HD for ≥1 year.",{"count":89,"type":21},372,[24],"The INCH-HD trial will test if incremental HD preserves the quality of life of patients and families and is a safe, practical, cost effective treatment option.",[28],[94,95],"Incremental HD","Incident HD","2026-05-10",{"date":98,"type":38},"2026-05-13",{"date":100,"type":38},"2022-07-06",{"date":102,"type":21},"2026-08",{"name":44,"class":45},18,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":112,"targetDuration":4,"studyType":22,"phases":114,"briefSummary":115,"conditions":116,"keywords":121,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":4},"100640666","the-ivcare-adaptive-platform-trial-100640666","NCT07587593","The IVCare Adaptive Platform Trial","Comparative Effectiveness of Interventions to Prevent Infections and Other Complications Arising From Central Venous Access Devices: the IVCare Adaptive Platform Trial.","Core inclusion Criteria:\n\n* The patient has or requires a CVAD, including a PICC, a non-tunnelled or tunnelled CVC, or a totally implanted venous access port.\n* Patient is less than 18 years old and paediatric recruitment has not been approved at the site.\n\nSecurement Domain exclusion criteria:\n\n* Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.\n* CLABSI diagnosed from any vascular access device currently in situ within the past 7 days or being actively treated with antimicrobials.\n* Participants with an estimated life expectancy of \\\u003C30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.\n* Participants who have previously been randomised for the same CVAD.\n* Participants who have been randomised three times.\n* SecurAcath® cannot be applied in accordance with manufacturer instructions and local policy.\n* The participant has compromised skin integrity at the current or intended insertion site, including active infection, inflammation, erosion, ulceration, or pre-existing exit-site injury.\n\nConnectors\u002FCaps Domain exclusion criteria:\n\n* Central line-associated bloodstream infection (CLABSI) currently suspected associated with any vascular access device (peripheral or central) that is in situ.\n* CLABSI diagnosed within the past 14 days or CLABSI being actively treated with antimicrobials, associated with any vascular access device currently in situ.\n* Participants with an estimated life expectancy of \\\u003C30 days OR who have commenced a documented end-of-life, terminal-care, or comfort-care pathway.\n* Participants who have previously been randomised for the same CVAD.\n* Participants who have been randomised three times.\n* Known or suspected hypersensitivity or a confirmed allergy to chlorhexidine or silver-containing products.\n\nCancer stratum inclusion criteria:\n\n* Confirmed diagnosis of a solid tumour OR\n* Confirmed diagnosis of a haematological malignancy. OR\n* Bone marrow failure syndrome requiring systemic therapy, immunosuppression, or haematopoietic stem cell transplantation.\n\nKidney stratum exclusion criteria:\n\n• Confirmed diagnosis of kidney disease.",{"count":113,"type":21},2500,[24],"The IVCare trial is a multicentre adaptive platform study evaluating interventions to prevent infections and other complications associated with central venous access devices (CVADs) in patients with newly inserted or existing devices. The study is organised into domains addressing different aspects of CVAD care and includes patient groups referred to as strata. Domains, strata and interventions may change over time as the study progresses. IVCare also includes an observational cohort study in which patients with CVADs are followed to assess CVAD care practices, infections, and other CVAD-related complications across health services.\n\nThe trial starts with two domains. The Connectors\u002FCaps Domain compares antimicrobial chlorhexidine-containing connectors and caps with standard-of-care connectors and caps used in Australian hospitals. In the cancer stratum, participants are randomised to receive either InVision-Plus CS® or standard-of-care connectors\u002Fcaps. In the kidney disease stratum, participants are randomised to receive either ClearGuard™ HD or standard-of-care connectors\u002Fcaps. Following a predefined stopping decision for ClearGuard™ HD in the kidney disease stratum, Tego™ will be introduced and evaluated in this group.\n\nThe Securement Domain compares the effectiveness of SecurAcath®, a subcutaneous anchor securement system, with standard-of-care securement methods used in Australian hospitals. Participants in both the cancer and kidney disease strata are randomised to receive either SecurAcath® or standard-of-care securement.",[117,118,119,120],"Device Related Infection","Vascular Access Complication","Device Related Sepsis","Catheter Infection",[122,123,124,125,126,127],"Central venous access device","Chlorhexidine cap","Chlorhexidine connector","Subcutaneous anchor","Central line-associated blood stream infection","Adaptive platform trial","NOT_YET_RECRUITING","2026-05-07",{"date":131,"type":38},"2026-05-14",{"date":133,"type":21},"2026-12-01",{"date":135,"type":21},"2031-12-01",{"name":44,"class":45},{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":145,"targetDuration":4,"studyType":22,"phases":147,"briefSummary":149,"conditions":150,"keywords":152,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":164,"completionDateStruct":166,"leadSponsor":168,"locationsCount":169},"100386376","phase-2-finding-the-optimal-regimen-for-mycobacterium-abscessus-treatment-100386376","NCT04310930","Finding the Optimal Regimen for Mycobacterium Abscessus Treatment","Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)","FORMaT","Eligibility criteria for the FORMaT trial can be applied at two levels:\n\n1. Eligibility into the Intervention Program, or;\n2. Eligibility into the Observational Cohort.\n\nPotential participants can only be enrolled in either the Intervention Program or the Observational Cohort at any one time. Provided the eligibility criteria are met, potential participants may either:\n\n1. Enrol directly into the Intervention Program, or;\n2. Enrol into the Observational Cohort and transition into the Intervention Program once they satisfy the inclusion criteria for this program which can occur at any time during the trial.\n\nEligibility into the FORMaT trial will be assessed at screening. Observational Cohort participants who go on to meet the Intervention Program eligibility criteria can transition from the Observational Cohort to the Intervention Program.\n\nINTERVENTION PROGRAM ELIGIBILITY (APPENDIX A) Potential participants are eligible for the Intervention Program (Appendix A) if the criteria below are met. Eligible participants with mixed NTM infections (slow growers + MABS) or with recurrence of MABS infection following completion of previous treatment will be eligible if they meet the inclusion and exclusion criteria listed below. For eligible participants with mixed NTM infections additional therapy combinations are available as detailed in the relevant appendices.\n\nINTERVENTION PROGRAM INCLUSION CRITERIA\n\n1. Positive MABS-PD diagnosis meeting all three American Thoracic Society clinical, radiological and microbiological diagnostic criteria for MABS-PD. Defined as:\n\n   1. Clinical: Pulmonary symptoms and exclusion of other diagnoses.\n   2. Radiological: Nodular or cavitary opacities on chest radiograph or a chest high-resolution computed tomography (HRCT) scan showing multifocal bronchiectasis with multiple small nodules.\n   3. Microbiological: MABS positive culture results from at least two separate expectorated sputum samples.\n\n   or Positive culture results from at least one bronchial wash or lavage. or Transbronchial or other lung biopsy with mycobacterial histopathologic features (granulomatous inflammation or acid-fast bacilli (AFB)) and positive culture for NTM or biopsy showing mycobacterial histopathologic features (granulomatous inflammation or AFB) and one or more sputum or bronchial washes that are culture positive for NTM.\n\n   Screening samples must be collected within the timeframes stated in the relevant appendix.\n2. Male or female participants of any age.\n3. Participant has not received treatment for MABS-PD in the 12 months preceding assessment of eligibility or as specified in the relevant appendix (this includes drugs prescribed for the treatment of other mycobacteria and\u002For other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List Standard Operating Procedure (SOP)).\n4. Informed consent signed by participant or parent\u002Flegal guardian if participant is under 18 years of age.\n5. Ability to comply with study visits, therapies and study procedures as judged by the site investigator.\n\nINTERVENTION PROGRAM EXCLUSION CRITERIA\n\n* Participants receiving current treatment for MABS (this includes drugs prescribed for the treatment of other mycobacteria and\u002For other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List SOP), except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease, or as specified in the relevant appendix.\n* Participants who have a QTc interval of \\>500 milliseconds (QT interval corrected based on Fridericia method).\n* Participants who are pregnant or planning to continue breast feeding.\n* Known hypersensitivity or contraindication to any of the therapies for which no alternative option(s) have been provided.\n\nOBSERVATIONAL COHORT INCLUSION CRITERIA\n\nTo be eligible to participate in the Observational Cohort the following criteria must be met:\n\n1. Male and female participants of any age with at least one positive respiratory culture for MABS.\n2. Informed consent signed by participant or parent\u002Flegal guardian if participant is under 18 years of age.\n3. Ability to comply with study visits and study procedures as judged by the site investigator.\n\nOBSERVATIONAL COHORT EXCLUSION CRITERIA\n\nPotential participants will be ineligible to participate in the Observational Cohort if any of the following criterion are met:\n\n• Receiving active treatment for MABS within the previous 12 months (this includes drugs prescribed for the treatment of other mycobacteria and\u002For other indications that may have activity against MABS, as specified in the FORMaT Prohibited Drug List SOP, except for participants taking azithromycin as part of routine treatment for CF or chronic infection-related pulmonary disease).\n\nADDITIONAL ELIGIBILITY CRITERIA Mixed NTM infections Participants who have cultured slow growing NTM of the same species two or more times in the 24 months prior to screening, with one of those cultures within the 6 months prior to screening, will be considered to have mixed NTM infection at the time of screening. The participants must meet all other inclusion criteria and no exclusion criteria to be eligible for participation. Ethambutol may be used in addition to trial therapies to cover mixed NTM infections considered to require treatment by their clinician.\n\nAppendix specific sub-studies and integrated studies Appendix specific sub-studies and integrated studies may have additional eligibility criteria which are described in each of the relevant appendices.",{"count":146,"type":21},300,[148,59],"PHASE2","Mycobacterium abscessus (MABS) is a group of rapid-growing, multi-drug resistant non-tuberculous mycobacteria (NTM) causing infections in humans. MABS pulmonary disease (MABS-PD) can result in significant morbidity, increased healthcare utilisation, accelerated lung function decline, impaired quality of life, more challenging lung transplantation, and increased mortality. While the overall numbers affected is small, the prevalence of infections is increasing worldwide. The Finding the Optimal Regimen for Mycobacterium abscessus Treatment (FORMaT) trial aims to produce high quality evidence for the best treatment regimens to maximise health outcomes and minimise toxicity and treatment burden, as well as developing biomarkers (serology, gene expression signatures, and radiology) to guide decisions for starting treatment and measuring disease severity in patients with MABS PD.",[151],"Pulmonary Disease Due to Mycobacteria (Diagnosis)",[153,154,155,156,157,158,159,160],"Mycobacterium abscessus","Pulmonary disease","Microbiological","Regimen","Radiological","Quality of life","Health economics","Biomarkers","2026-05-06",{"date":163,"type":38},"2026-05-11",{"date":165,"type":38},"2020-03-02",{"date":167,"type":21},"2030-06-30",{"name":44,"class":45},50,{"id":171,"slug":172,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":176,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":189,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":207},"100594451","chlorhexidine-caps-for-clabsi-prevention-in-hemodialysis-a-pilot-randomized-controlled-trial-100594451","NCT07019610","Chlorhexidine Caps for CLABSI Prevention in Hemodialysis: a Pilot Randomized Controlled Trial","Evaluation of Chlorhexidine Caps for Central Line Associated Blood Stream Infection Prevention in People Needing Hemodialysis: a Pilot Randomised Control Trial","ECHO-HD","Inclusion Criteria:\n\n* Age≥18\n* Able to provide informed consent\n* Kidney failure requiring a tunnelled CVC for treatment (haemodialysis)\n* 21 days BSI free\n* No known allergy to chlorhexidine and\u002For nylon and\u002For polypropylene.\n\nExclusion Criteria:\n\n* Current CLABSI\n* Known allergic to chlorhexidine and\u002For nylon and\u002For polypropylene.\n* Patients on an end-of-life pathway\n* People with a cognitive impairment and\u002For intellectual disability",{"count":179,"type":21},60,[24],"The goal of this clinical trial is to compare a chlorhexidine antimicrobial barrier cap in patients requiring hemodialysis treatment to the standard hemodialysis caps currently used within the Metro North Kidney Health Service.\n\nThe main questions to answer are:\n\n* Study Feasibility\n* Occurrence of infectious complications related to renal central venous catheters\n\nParticipants will be randomly allocated to receive either of the below hemodialysis caps to cover their hemodialysis catheter hub:\n\n* The standard hemodialysis cap used at the Royal Brisbane and Women's Hospital, or\n* The intervention hemodialysis cap containing chlorhexidine inside it\n\nResearchers will compare standard and chlorhexidine hemodialysis caps to see if the presence of chlorhexidine improves the occurrance of infectious complications related to the hemodialysis catheter.",[118,117,119,120,183,184,185,186,187,188],"Catheter Complications","Catheter-Related Infections","Catheter Related Complications","Hemodialysis Catheter Infection","Hemodialysis Catheter-associated Infection","Hemodialysis Complication",[190,191,192,193,194,123,195,196,197,198],"Hemodialysis Catheter","Randomised Controlled Trial","Antimicrobial Barrier Caps","Vascular access device","Hemodialysis catheter caps","Central Venous Catheter","CVC","CLABSI","Central Line Associated Blood Stream Infection","2026-04-27",{"date":201,"type":38},"2026-04-29",{"date":203,"type":21},"2026-06",{"date":205,"type":21},"2028-02",{"name":44,"class":45},1,{"id":209,"slug":210,"hasResults":11,"nctId":211,"briefTitle":212,"officialTitle":213,"acronym":214,"eligibilityCriteria":215,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":216,"targetDuration":55,"studyType":218,"phases":4,"briefSummary":219,"conditions":220,"keywords":222,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":231,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":207},"100636171","load-incorporating-cardiac-assessment-by-echocardiography-in-patients-with-sepsis-liaise-study-100636171","NCT07562217","Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis (LIAISE Study)","Load Incorporating Cardiac Assessment by Echocardiography In Patients With SEpsis: a Prospective Observational Study (LIAISE Study)","LIAISE","Inclusion Criteria:\n\n1. Adults ≥ 18 years old.\n2. Clinically suspected of defined sepsis\n3. Sepsis-induced hypotension or hypoperfusion (arterial or venous blood lactate ≥2.0 mmol\u002FL OR mean artery pressure ≤65 mmHg over 30 mins OR at least one vasoactive or inotropic agent administered).\n4. At least one dose of an IV antimicrobial has been commenced.\n\nExclusion Criteria:\n\n1. Suspected or confirmed pregnancy.\n2. Any severe concomitant diseases with limited life expectancy \\\u003C30 days.",{"count":217,"type":21},200,"OBSERVATIONAL","The LIAISE study is a prospective observational study comparing the performance of load-incorporating echocardiographic parameters and conventional parameters in predicting adverse events among adult patients presenting to the ICU with sepsis. It will be conducted in hospitals in Australia, Hong Kong, South Africa, and Canada, with 199 patients recruited over 2 years. All included patients will receive an regular echocardiographic assessment and their haemodynamic parameters will be simultaneously recorded. Participants will be followed for up to 1 year after enrolment. Load incorporating parameters will be derived from regularly obtained echocardiography and haemodynamic data during offline analysis. The predictive value of cardiac parameters will be evaluated based on their statistical association with clinical outcomes.",[221],"Sepsis",[223,224,225,226,227,228,229,230],"sepsis","echocardiography","strain","speckle-tracking","myocardial work","ICU","echocardiogram","load-independent","2026-04-25",{"date":233,"type":38},"2026-05-01",{"date":233,"type":21},{"date":236,"type":21},"2028-11-30",{"name":44,"class":45},{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":246,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":256,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},"100555331","phase-2-pharmacogenomics-for-better-treatment-of-fungal-infections-clinical-trial-100555331","NCT06510699","Pharmacogenomics for Better Treatment of Fungal Infections Clinical Trial","Randomized Clinical Trial to Evaluate the Use of Genotype-based Dosing of Voriconazole","PRAGMATIC","Inclusion Criteria:\n\n* Age ≥ 2 years.\n* Written informed consent obtained.\n* Decision to prescribe voriconazole.\n* Admitted to a trial site, or sufficient outpatient follow-up appointments are feasible\n\nExclusion Criteria:\n\n* Post-allogeneic haematopoietic stem cell transplant (HCT) patient, without access to pre HCT DNA\n* Death is likely imminent within 7 days.\n* Previously randomised to this trial",true,{"count":248,"type":21},104,[148],"This project aims to address invasive fungal infections in patients, by precision dosing of voriconazole based on CYP2C19 genotype testing with Bayesian dose-forecasting dosing software to develop patient-centric and maximally effective dosing regimens. This study investigates if voriconazole increases the proportion of patients achieving therapeutic exposure at day 8 of dosing compared with standard care; and will assess factors that influence the implementation of genotype testing and dosing software in the healthcare system, including fidelity, feasibility, acceptability and cost-effectiveness. It will recruit at least 104 kids and adults in a parallel-group randomised clinical trial. A hybrid feasibility sub-study will assess the scalability of genotype-directed dosing to ensure sustainable integration of the interventions into the clinical workflow. A health economic sub-study will evaluate the costs, health outcomes and cost-effectiveness of genotype-directed testing compared to standard care.",[252,253,254,255],"Fungal Infection","Haematological Malignancy","Blood Cancer","Infectious Disease",[257,258,259,260,261],"infection","cancer","pharmacogenomic","genotype-based dosing","CYP2C19","2026-04-13",{"date":264,"type":38},"2026-04-16",{"date":266,"type":38},"2025-04-14",{"date":268,"type":21},"2027-03-26",{"name":44,"class":45},7,{"id":272,"slug":273,"hasResults":11,"nctId":274,"briefTitle":275,"officialTitle":276,"acronym":4,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":278,"enrollmentInfo":279,"targetDuration":4,"studyType":22,"phases":281,"briefSummary":282,"conditions":283,"keywords":285,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":289,"lastUpdatePostDateStruct":290,"startDateStruct":292,"completionDateStruct":294,"leadSponsor":296,"locationsCount":297},"100434651","phase-3-implementation-of-metformin-therapy-to-ease-decline-of-kidney-function-in-polycystic-kidney-disease-impede-pkd-100434651","NCT04939935","Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD)","Implementation of Metformin theraPy to Ease Decline of Kidney Function in Polycystic Kidney Disease (IMPEDE-PKD): A Randomised Placebo-Controlled Trial","Inclusion Criteria:\n\nTo be eligible to participate in this trial, patients must satisfy all of the following inclusion criteria:\n\n1. Willing to participate and provide informed consent\n2. Aged 18-70 years\n3. Diagnosis of ADPKD based on radiological +\u002F- genetic criteria as per Kidney Health Australia - Caring for Australians and New Zealanders with Kidney Impairment (KHA-CARI) Guidelines\n4. eGFR equal to or greater than 38 mL\u002Fmin\u002F1.73m2 and \\\u003C90 mL\u002Fmin\u002F1.73m2\n\nAnd have either:\n\n5(a) One or more risk factors of progression from the following:\n\n* Bilateral kidney length equal to or greater than16.5 cm, or\n* Total Kidney Volume (TKV) equal to or greater than 750 mL or height-adjusted TKV (htTKV) equal to or greater than 600 mL\u002Fm2, or\n* Mayo class IC\u002FD\u002FE or Pro-PKD score equal to or greater than 6 OR 5(b) Evidence of Active progression\n* Decline in eGFR equal to or greater than 5 mL\u002Fmin\u002F1.73m2 in one year, or\n* Decline in eGFR equal to or greater than 3 mL\u002Fmin\u002F1.73m2 per year over five years or more. or\n* Increase in htTKV\u002FTKV of equal to or greater than 5% per year on at least 2 measurements in the past year, excluding any initial eGFR effect over the initial 3 months of tolvaptan commencement (if applicable) Note: Tolvaptan therapy must have been in place for at least 6 months with stable dose for at least 3 months.\n\nExclusion Criteria:\n\n1. Diabetes mellitus (as per American Diabetes Association definition), or other systemic conditions that may cause CKD independent of PKD (excluding hypertension)\n2. Uncontrolled hypertension (Systolic BP \\>160 mmHg and\u002For diastolic BP \\>100 mmHg after a period of rest)\n3. Clinically significant heart failure, including but not limited to New York Heart Association Class (NYHA) III or IV\n4. Non-polycystic liver disease, including but not limited to:\n\n   1. Liver enzymes (ALT, AST or Total Bilirubin) \\>2 times the upper limit of normal, except when a diagnosis of Gilbert Syndrome exists and\u002For,\n   2. Child-Pugh classification score equal to or greater than 5\n5. Any contraindication to metformin including abnormal liver function tests or untreated Vitamin B12 deficiency\n6. Currently taking metformin\n7. Pregnancy or breastfeeding, or planning to get pregnant in the next three years.\n8. Comorbidities with potential to contaminate trial outcomes, specifically active cancer, history of other solid organ transplantations, active chronic obstructive pulmonary disease (COPD), active inflammatory bowel disease, and the presence of stoma.\n9. History of dialysis.","70 Years",{"count":280,"type":21},1174,[59],"This study will investigate if a medication (metformin) widely used in the treatment of diabetes could be re-purposed for the treatment of patients with a diagnosis of early stage ADPKD to slow the rate of kidney function decline, reducing morbidity and mortality and improving the quality of life for ADPKD patients.",[284],"Autosomal Dominant Polycystic Kidney Disease",[286,287,288],"Placebo","Metformin","ADPKD","2026-03-26",{"date":291,"type":38},"2026-03-31",{"date":293,"type":38},"2022-11-29",{"date":295,"type":21},"2030-12",{"name":44,"class":45},49,{"id":299,"slug":300,"hasResults":11,"nctId":301,"briefTitle":302,"officialTitle":303,"acronym":304,"eligibilityCriteria":305,"healthyVolunteers":11,"sex":17,"minAge":306,"maxAge":4,"enrollmentInfo":307,"targetDuration":4,"studyType":22,"phases":308,"briefSummary":309,"conditions":310,"keywords":315,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":319,"lastUpdatePostDateStruct":320,"startDateStruct":322,"completionDateStruct":324,"leadSponsor":326,"locationsCount":4},"100630233","phase-2-testing-a-novel-combination-treatment-arm-d-versus-standard-of-care-for-intensive-phase-treatment-for-mycobacterium-abscessus-pulmonary-disease-in-people-with-or-without-cystic-fibrosis-in-the-finding-the-optimal-regimen-for-mycobacterium-abscessus-treatment-format-adaptive-platform-trial-100630233","NCT07485010","Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial","FORMaT-EVOLVE","Inclusion Criteria:\n\n1. Must meet eligibility criteria as per the FORMaT Master Protocol and Appendix A1 Inclusion Criteria (NCT04310930).\n2. Male or female participants aged 12 years and older.\n\nExclusion Criteria:\n\n1. Must not have any exclusion criteria as per the FORMaT Master Protocol and Appendix A1 Exclusion Criteria (NCT04310930).\n2. Participants aged \\\u003C12 years old.\n3. Participants aged between 12 and \\\u003C18years old with clinically significant renal impairment as indicated by an age-appropriate estimated creatinine clearance.\n4. Known hypersensitivity to any of the therapies for which no alternative option(s) have been provided. This includes:\n\n   * Sulbactam\u002Fdurlobactam\n   * Ceftriaxone,\n   * Amoxicillin,\n   * Macrolide antibiotics, and\n   * Clofazimine.","12 Years",{"count":146,"type":21},[148],"The goal of this clinical trial is to learn if a new combination antibiotic treatment (Arm D) works to treat a rare lung condition called mycobacterium abscessus pulmonary disease in people of any age and sex, when compared to the standard treatments. It will also learn about the safety of this new combination antibiotic treatment when compared to the standard treatments. The main questions it aims to answer are:\n\n* How well does Arm D treat mycobacterium abscessus pulmonary disease?\n* What side effects does Arm D cause when used to treat mycobacterium abscessus pulmonary disease? Researchers will compare Arm D to the current standard of care treatments to see if Arm D treats mycobacterium abscessus pulmonary disease better and if it will cause less side effects.\n\nParticipants will:\n\n* Be screened and recruited to the FORMaT adaptive platform trial (NCT04310930)\n* Be given Arm D for 4 weeks or standard of care treatments for 6 weeks.\n* Be reviewed by the study doctors weekly for checkups and tests.\n* Provide respiratory samples (sample coughed up from the chest), respond to quality-of-life questionnaires, have CT lung scans and blood tests.",[311,312,313,314],"Mycobacterium Abscessus Pulmonary Disease","Mycobacterium Abscessus Infection","Non-Tuberculous Mycobacterial (NTM) Infections","Non-Tuberculous Mycobacteria Pulmonary Disease",[316,317,318],"adaptive platform trial","dual beta lactam","sulbactam-durlobactam","2026-03-16",{"date":321,"type":38},"2026-03-20",{"date":323,"type":21},"2027-04",{"date":325,"type":21},"2031-07",{"name":44,"class":45},{"id":328,"slug":329,"hasResults":11,"nctId":330,"briefTitle":331,"officialTitle":332,"acronym":4,"eligibilityCriteria":333,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":334,"targetDuration":4,"studyType":22,"phases":336,"briefSummary":337,"conditions":338,"keywords":341,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":345,"lastUpdatePostDateStruct":346,"startDateStruct":348,"completionDateStruct":350,"leadSponsor":352,"locationsCount":353},"100578085","reducing-blood-culture-contamination-with-the-use-of-a-needle-less-blood-draw-device-the-pivo-trial-100578085","NCT06806709","Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (The PIVO Trial)","Reducing Blood Culture Contamination With the Use of a Needle-less Blood Draw Device (PIVO Pro): An Adaptive Group Sequential Randomized Controlled Trial (The PIVO Trial)","Inclusion Criteria:\n\n* Blood culture requested due to suspected bloodstream infection\n* Patients receiving a 22 gauge short peripheral intravenous catheter (or larger)\n\nExclusion Criteria:\n\n* Patients who have already commenced intravenous antimicrobial medications in the emergency department",{"count":335,"type":21},1148,[24],"Blood cultures (BCs) are a blood test to look for an infection. Two problems with the sample collection are contamination by germs outside of the blood and not collecting enough blood in the tube, resulting in unusable samples. Many patients requiring a BC also have a peripheral intravenous catheter (\"catheter\") but these are not normally used for blood sampling. This means that patients receive many painful needles for both catheter insertion and blood sampling. There is a needle-free blood collection device (PIVO Pro) which can be used with a catheter to collect a blood sample.\n\nThe goal of the PIVO Trial is to see if using the PIVO Pro for blood culture sample collection will have a lower amount of contamination than the usual method of blood sample collection. Patients 18 and older at 3 emergency departments will be included. Research nurses will look for patients in emergency who need a blood culture sample taken and they will be asked if they want to be involved in the trial. Half of the participants will use the PIVO Pro to take their blood sample and half will have the usual way of collecting blood.\n\nParticipants do not have to do anything specifically for the trial. Information about the blood collection and results of the blood culture will be collected from the medical records and recorded for the trial.",[339,340],"Blood Culture Contamination","Infection",[342,343,344],"PIVO Pro","Reducing blood culture contamination","Needle-less blood draw","2026-02-02",{"date":347,"type":38},"2026-02-04",{"date":349,"type":38},"2025-08-18",{"date":351,"type":21},"2026-12-31",{"name":44,"class":45},4,{"id":355,"slug":356,"hasResults":11,"nctId":357,"briefTitle":358,"officialTitle":359,"acronym":360,"eligibilityCriteria":361,"healthyVolunteers":11,"sex":17,"minAge":362,"maxAge":363,"enrollmentInfo":364,"targetDuration":4,"studyType":22,"phases":366,"briefSummary":368,"conditions":369,"keywords":377,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":380,"lastUpdatePostDateStruct":381,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":353},"100592413","phase-4-pasteurised-donor-human-milk-supplementation-for-term-babies-100592413","NCT06993103","Pasteurised Donor Human Milk Supplementation for Term Babies","A Randomised Controlled Trial of Pasteurised Donor Human Milk as Supplementary Nutrition for Infants Born to Women With Diabetes in Pregnancy.","PRESENT","Inclusion Criteria:\n\nEach participant must meet all the following criteria to be enrolled in this trial:\n\n* Mother is \\>18 years at the time of consent\n* Mother has diabetes in pregnancy (type 1, type 2 or gestational diabetes)\n* Mother intends to breastfeed for at least 6 weeks at the time of consent.\n* Infant is born at ≥ 37 weeks and weighs \\> 2.5kg\n* Clinician caring for infant decides that supplementary nutrition (in addition to maternal breast milk) is required within the first 48 hours after birth.\n* Parent\u002Fs provide\u002Fs a signed and dated informed consent form and has a legally acceptable representative capable of understanding the informed consent document and providing consent on the participant's behalf.\n\nExclusion Criteria:\n\nMother\u002Finfant pairs meeting any of the following criteria will be excluded from the trial:\n\n* Multiple pregnancy\n* Mother has a condition that precludes maternal breast milk consumption e.g. HIV, receiving chemotherapy\n* Infant has clinically significant congenital abnormality interfering with effective breastfeeding or breast milk consumption (e.g., cleft lip and palate, metabolic disorder) and\u002For requiring immediate care in a neonatal unit (e.g., congenital heart disease).\n* Infant has received infant formula prior to randomisation.\n* Infant admitted to neonatal intensive care prior to randomisation.\n* More than 48 hours old at the time of recruitment","0 Hours","48 Hours",{"count":365,"type":21},1444,[367],"PHASE4","PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in pregnancy reduces the proportion of infants who are admitted to a neonatal unit for management of hypoglycemia compared with current standard hospital care. The trial will also assess other important outcomes including breastfeeding rates, maternal mental health, and infant cow's milk allergy.\n\nThere will be two treatment arms. In the intervention arm, PDHM will be made available to infants from randomisation until day 5 of life. Infants allocated to the control arm will receive care as per local unit policy, including supplemental nutrition as recommended by the treating clinician. After hospital discharge, participants will be asked to complete an electronic questionnaire at 2 \\& 6 weeks and 6 \\& 12 months after birth. Questionnaires will assess infant feeding practices, maternal quality of life \\[including anxiety and depression symptoms and health-related quality of life\\] along with infant cow's milk allergy symptoms.",[370,371,372,373,374,375,376],"Neonatal Hypoglycemia","Metabolic Complication","Cows Milk Allergy","Hospital Length of Stay","Neonatal Intensive Care Unit","Breastfeeding","Mental Health Issue",[378,379],"Pasteurised donor human milk","Donor breastmilk","2026-01-29",{"date":345,"type":38},{"date":383,"type":38},"2025-12-04",{"date":385,"type":21},"2028-12",{"name":44,"class":45},{"id":388,"slug":389,"hasResults":11,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":11,"sex":17,"minAge":395,"maxAge":4,"enrollmentInfo":396,"targetDuration":4,"studyType":218,"phases":4,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":207},"100610790","is-density-spectral-array-display-along-with-bispectral-index-superior-to-the-display-of-bispectral-index-alone-100610790","NCT07232160","Is Density Spectral Array Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone","Is DSA Display Along With Bispectral Index Superior to the Display of Bispectral Index Alone in Detecting Emergence From Propofol and Opiate Anesthesia? A Prospective Observational Study in Patients Older Than 65 Years?","DSA-Light","Inclusion Criteria:\n\n* Age ≥ 65 years undergoing elective procedures of 1-3 hours' duration requiring GA.\n* Procedures in which a DoA monitor can be applied to the forehead.\n* Patients receiving intravenous propofol and opiate anaesthesia using supraglottic airway device.\n* Patient able to provide informed consent.\n\nExclusion criteria:\n\n* Administration of ketamine\u002Fdexmedetomidine.\n* Administration of inhaled anaesthetic agents or nitrous oxide\n* Administration of muscle relaxation","65 Years",{"count":397,"type":21},70,"A study to evaluate the use of density spectral array display in comparison with Bispectral index in a clinical setting.",[400],"Awareness During General Anesthesia",[402,403,404,405,406,407,408,409,410],"depth of anaesthesia monitoring","processed EEG","EEG","density spectral array","Bispectral index","older adults","patients older than 65 years","general anaesthesia","total intravenous anaesthesia","2025-11-13",{"date":413,"type":38},"2025-11-18",{"date":415,"type":21},"2026-06-30",{"date":417,"type":21},"2029-12",{"name":44,"class":45},{"id":420,"slug":421,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":22,"phases":428,"briefSummary":429,"conditions":430,"keywords":434,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":439,"lastUpdatePostDateStruct":440,"startDateStruct":442,"completionDateStruct":443,"leadSponsor":444,"locationsCount":4},"100601735","enhancing-utility-of-neuropsychological-evaluation-for-earlier-and-effective-diagnosis-of-dementia-in-parkinsons-disease-100601735","NCT07114354","Enhancing Utility of Neuropsychological Evaluation for Earlier and Effective Diagnosis of Dementia in Parkinson's Disease","PDCogniCare","Inclusion Criteria:\n\n* People living with idiopathic Parkinson's disease, one year or more post-diagnosis, attending Movement Disorder Clinics\n\nExclusion Criteria:\n\n* People with severe Parkinson's disease who aren't able to communicate\n* People with comorbid neurological conditions (e.g. Stroke)",{"count":427,"type":21},275,[24],"Dementia is observed in 80% of people living with advanced stage Parkinson's disease, however, there are inadequate opportunities for early and effective diagnosis of dementia in current clinical practice. This study aims to identify whether a new tool called PDCogniCare, can improve detection of dementia in people living with Parkinson's disease, and to explore what factors might influence its use in healthcare services.",[431,432,433],"Dementia (Diagnosis)","Parkinson Disease Dementia (PDD)","Parkinson Disease (PD)",[435,436,437,438],"Parkinson's disease","Dementia","Cognitive evaluation","Implementation","2025-08-03",{"date":441,"type":38},"2025-08-11",{"date":349,"type":21},{"date":351,"type":21},{"name":44,"class":45},{"id":446,"slug":447,"hasResults":11,"nctId":448,"briefTitle":449,"officialTitle":450,"acronym":451,"eligibilityCriteria":452,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":453,"targetDuration":4,"studyType":22,"phases":455,"briefSummary":456,"conditions":457,"keywords":460,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":475},"100329735","pragmatic-randomised-trial-of-high-or-standard-phosphate-targets-in-end-stage-kidney-disease-phosphate-100329735","NCT03573089","Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)","An Investigator-initiated, International, Multi-centre, Prospective, Randomized, Open-label, Parallel-group, Superiority, and Pragmatic Large Simple Trial (LST) to Determine Whether the Currently Recommended Strategy of Intensive Reduction of Serum Phosphate Concentration Towards the Normal Level Results in Significant Patient-centred Benefits in End-stage Kidney Disease (ESKD) Patients Receiving Dialysis.","PHOSPHATE","Inclusion Criteria:\n\n1. Age ≥45 years, or Age ≥18 years with diabetes,\n2. ESKD on haemodialysis or peritoneal dialysis, for at least 3 months,\n3. Currently prescribed at least one phosphate-lowering medication at any dose\n4. Able to provide informed consent\n\nExclusion Criteria:\n\n1. Elective kidney transplantation scheduled,\n2. Concomitant major illness \u002F comorbidity that may result in death in the next 6 months in the view of the treating physician,\n3. Participation in an interventional study that is likely to affect serum phosphate concentration.",{"count":454,"type":21},3600,[24],"During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.",[458,459],"Kidney Failure, Chronic","Hyperphosphatemia",[461,462,463,464,465,466,459],"Renal dialysis","Randomised controlled trial","Bone markers","Cardiovascular risk factors","Phosphate lowering agent","End stage kidney disease","2025-06-29",{"date":469,"type":38},"2025-07-01",{"date":471,"type":38},"2019-12-10",{"date":473,"type":21},"2028-12-31",{"name":44,"class":45},115,{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":482,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":395,"enrollmentInfo":484,"targetDuration":4,"studyType":22,"phases":486,"briefSummary":487,"conditions":488,"keywords":491,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":207},"100583892","spinepass-spine-self-management-techniques-for-persistent-headache-after-concussion-physical-therapy-targeting-autonomic-and-dura-mater-function-100583892","NCT06882239","SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function.","SPINEPASS: SPINE Self-management Techniques for Persistent Headache After Concussion: Physical Therapy Targeting Autonomic and Dura Mater Function","SPINEPASS","Inclusion Criteria:\n\n* Persistent Post-traumatic headache (PPTH) duration =or \\> 4 weeks.\n* No self-reported improvement in headache pattern in the past 3 weeks. (Patients will be asked to determine whether the usual pattern of their headaches has changed for the better over the last 3 weeks.\n* Compass-31 score \\> 21 to select patients who have evidence of ANS dysfunction which SPINEPASS aims to address.\n* Headache Impact Test (HIT6) =\\>50 to capture headache-related disability of \"some impact\" or more.\n* Headache worst intensity \\>3\u002F10 on a numerical rating scale (NRS), at least once per week.\n\nExclusion Criteria:\n\n* Contraindications for spinal or graded general exercise.\n\n  * Contraindications to spinal manual therapy at or below C5-6 level\n* Cognitive impairment\u002F language barriers affecting ability to participate.\n* Redeployment\u002Frelocation or retirement planned within the next 6 months to reduce the chances of dropouts to treatment and follow-up.\n* Rating self-confidence to manage (eliminate and or lower) headaches without abortive medication at baseline of 30% or greater.\n* Inability to attend up to 12 in-person treatment sessions for 4 months.\n* Unwilling to limit commencement of other management for PPTH during the trial period.\n* Botox for headache management within the last 8 weeks or during the trial.",{"count":485,"type":21},120,[24],"This is a prospective randomized controlled trial comparing two different physical therapy approaches to the treatment of posttraumatic headache with autonomic symptoms. AIM 1: To establish the efficacy of SPINEPASS against Standard Physical Therapy to reduce headache disability and impact amongst patients with persistent post-concussion headache. AIM 2: Demonstrate the superiority of SPINEPASS in the efficient self-management of headache. Demonstrate its appropriateness, acceptability, and feasibility and gain patient insights among patients with PPTH compared to standard PT.",[489,490],"Persistent Post-concussive Symptoms","Post Traumatic Headache",[492,493,494,495,496,497],"Persistent post-concussion headache","autonomic","dura","physical therapy","concussion","military","2025-03-11",{"date":500,"type":38},"2025-03-18",{"date":502,"type":21},"2025-05-01",{"date":504,"type":21},"2028-09-30",{"name":44,"class":45},{"id":507,"slug":508,"hasResults":11,"nctId":509,"briefTitle":510,"officialTitle":511,"acronym":4,"eligibilityCriteria":512,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":513,"enrollmentInfo":514,"targetDuration":4,"studyType":22,"phases":515,"briefSummary":516,"conditions":517,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":520,"lastUpdatePostDateStruct":521,"startDateStruct":523,"completionDateStruct":525,"leadSponsor":527,"locationsCount":207},"100460379","a-practice-change-for-patients-with-severe-chronic-clinically-unexplained-gastrointestinal-symptoms-100460379","NCT05274854","A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms","A Practice Change for Patients With Severe Chronic, Clinically Unexplained Gastrointestinal Symptoms: A Randomised, Controlled Intervention to Assess Efficacy and Cost-effectiveness","Inclusion Criteria:\n\n* Patients with relevant, chronic, or relapsing gastrointestinal (GI) symptoms without concerning features and on the wait list for integrated care clinic (ICC) will be included in the study.\n* Patients with severe symptoms as defined by a total Structured Assessment of Gastrointestinal Symptoms (SAGIS) score \\> 35\n* Patients aged 18 years or older to 90 years old\n\nExclusion Criteria:\n\n* Patients with 'alarm' signs or symptoms (significant unexplained weight loss, evidence for gastrointestinal bleeding, iron deficiency anaemia, new onset GI symptoms) will be triaged to undergo urgent clinical work-up before they can be considered for inclusion into the study\n* Patients with mild or moderate symptoms (e.g. not requiring clinical work-up or who will likely spontaneously improve) will not be eligible for inclusion into the study and will be managed as clinically indicated.\n* Patients with any comorbidities that would interfere with the objectives of these interventions will be managed via the routine clinical pathways.\n* Patients with a prior history of any eating disorder, wait listed for bariatric surgery or have had bariatric surgery will be excluded","90 Years",{"count":217,"type":21},[24],"This research project aims to test whether early interventions delivered remotely and prior to integrated care clinic appointments are effective. Patients with chronic unexplained gastrointestinal symptoms will initially undergo structured assessment of symptoms and wheat intolerance delivered remotely. Patients who continue to experience symptoms will then be randomised to a pre-consultation intervention ((a) standardised dietician supervised intervention, b) exercise intervention, c) internet delivered cognitive behavior therapy or d) nothing) followed by randomisation to the consultation intervention ((a) consultant-led outpatient clinic or b) a integrated care clinic depending on their response to the initial intervention.",[518,519],"Gastrointestinal Diseases","Irritable Bowel Syndrome","2024-11-10",{"date":522,"type":38},"2024-11-12",{"date":524,"type":38},"2023-05-01",{"date":526,"type":21},"2025-12-31",{"name":44,"class":45},{"id":529,"slug":530,"hasResults":11,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":4,"eligibilityCriteria":534,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":535,"targetDuration":4,"studyType":22,"phases":536,"briefSummary":537,"conditions":538,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":541,"lastUpdatePostDateStruct":542,"startDateStruct":544,"completionDateStruct":546,"leadSponsor":548,"locationsCount":207},"100464106","the-effects-and-mechanisms-of-brief-mindfulness-meditation-and-hypnosis-for-pain-100464106","NCT05323383","The Effects and Mechanisms of Brief Mindfulness Meditation and Hypnosis for Pain","The Effects and Mechanisms of Brief Training in Mindfulness Meditation and Hypnosis for Pain Management, Relative to an Inert Control","Inclusion Criteria:\n\n* Must be 18 years of age;\n* Experience chronic or recurrent pain;\n* Have access to a computer, phone or tablet with internet capability; and\n* Be able to read and understand English.",{"count":146,"type":21},[24],"The aim of this study is to determine the effects and mechanisms of 1 x 20-min training in mindfulness meditation and self-hypnosis relative to an inert control. Participants will be randomly assigned to condition. The dual primary outcomes will be pre- to post-training changes in current pain intensity and pain unpleasantness. The active treatments are hypothesized to produce greater reductions in pain outcomes than the control. It is also hypothesized that change in mindfulness will be a mediator specific to mindfulness meditation, while change in affect and decentering will be mediators of the hypnosis condition. Moderators of response will also be explored.",[539,540],"Pain","Chronic Pain","2024-09-25",{"date":543,"type":38},"2024-09-27",{"date":545,"type":38},"2022-03-24",{"date":547,"type":21},"2024-12-31",{"name":44,"class":45},{"id":550,"slug":551,"hasResults":11,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":246,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":559,"briefSummary":560,"conditions":561,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":565,"lastUpdatePostDateStruct":566,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":207},"100411882","phase-2-uncovering-a-novel-therapeutic-target-to-reduce-dementia-risk-in-parkinsons-disease-100411882","NCT04643327","Uncovering a Novel Therapeutic Target to Reduce Dementia Risk in Parkinson's Disease","Double-blind Randomised-controlled Within-subject Crossover Trial to Determine Levetiracetam Efficacy for Memory Impairment in Parkinson's Disease: A Proof-of-concept Study","TRIP","Inclusion Criteria:\n\n* Parkinson's Disease patients with amnestic Mild Cognitive Impairment\n* Parkinson's Disease patients with no memory impairment\n* Healthy volunteers\n* All participants must be eligible to take MRI scans\n\nExclusion Criteria:\n\n* Dementia\n* Contraindication to having MRI\n* Bipolar disorder, Schizophrenia, Alcohol or substance abuse\n* Major depression\n* Suicidal Ideation\n* Difficulty complying with protocol requirements\n* Significant non-PD neurological disease\n* Vascular dementia\n* Sensitivity to levetiracetam\n* Use of anticonvulsant medications\n* Use of other excluded medications\n* Severe renal impairment\n* Clinically significant abnormalities in B12 or thyroid function test (below normative range for elderly)\n* Females of childbearing potential",{"count":558,"type":21},28,[148],"The present study is a proof-of-concept clinical trial to test the efficacy of low doses of a repurposed anti-epileptic drug (levetiracetam) in treating memory problems in Parkinson's disease (PD). Neuroimaging techniques will be used to determine the effect of the drug on specific brain regions (hippocampal subfields). Finally, baseline brain activity of PD patients with memory problems will be compared to PD patients without memory problems and healthy older adults to determine if activity in specific brain regions (hippocampal subfields) can be used to predict memory problems in PD. This information will be useful for future clinical trials to target drugs to these brain regions.",[562,563,564],"Parkinson Disease","Mild Cognitive Impairment","Memory Impairment","2024-09-23",{"date":541,"type":38},{"date":568,"type":38},"2021-02-09",{"date":570,"type":21},"2025-12",{"name":44,"class":45},{"id":573,"slug":574,"hasResults":11,"nctId":575,"briefTitle":576,"officialTitle":577,"acronym":578,"eligibilityCriteria":579,"healthyVolunteers":246,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":580,"targetDuration":4,"studyType":218,"phases":4,"briefSummary":582,"conditions":583,"keywords":585,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":593,"completionDateStruct":595,"leadSponsor":597,"locationsCount":207},"100512668","itobos-prospective-data-acquisition-and-feasibility-study-barcelona-100512668","NCT05955443","iToBoS Prospective Data Acquisition and Feasibility Study (Barcelona)","iToBoS Prospective Data Acquisition Study","iToBoS BCN","Inclusion Criteria:\n\n* Over 18\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Unable to stand and hold anatomica pose for 3D total body photography",{"count":581,"type":21},350,"This study is recruiting patients at their regular skin examination appointments to participate in research. Participation involves having 3D total body photography, completing a 10-15 minute questionnaire, and providing a genetic sample. Normally, the total body photography is part of the patients standard care, as is the collection of a genetic sample. Consenting to this study involves consenting to the use of total body photography images (de-identified), questionnaire answers, and genetic risk information to be used for developing AI algorithms for image analysis of skin lesions, and melanoma-risk profiling for patients.",[584],"Skin Cancer",[586,587,588,589],"melanoma","skin examination","artificial intelligence","total body photography","2024-06-21",{"date":592,"type":38},"2024-06-25",{"date":594,"type":38},"2023-01-13",{"date":596,"type":21},"2024-12-20",{"name":44,"class":45},""]