[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"University of Melbourne\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":580},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,20,0,[8,41,73,104,144,174,202,234,265,291,313,341,367,395,423,448,469,496,522,552],{"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":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100564645","implementing-surgery-school-prehabilitation-using-telehealth-100564645",false,"NCT06631872","Implementing Surgery School Prehabilitation Using Telehealth","Implementing Tele-prehabilitation Education Into Cancer Care Pathways","STTARRS","Inclusion Criteria:\n\n* Preparing for lung cancer (open or video assisted) or major abdominal cancer surgery (e.g. upper GI, hepatobiliary or colorectal, open or video assisted).\n* Provide consent\n* Have primary treating surgeon approval\n* Proficient in English to understand testing, video interventions as well as outcome assessments.\n\nExclusion Criteria:\n\n* Concurrent, actively treated other malignancy or history of other malignancy treated within the past year.\n* Severe or unstable psychiatric, cognitive or substance abuse disorders, such that precludes informed consent or interferes with cooperation with trial requirements or current inpatients.\n* Current inpatients or incarcerated\n* Surgery date booked \\\u003C7 days from consent","ALL","18 Years",{"count":20,"type":21},515,"ESTIMATED","INTERVENTIONAL",[24],"NA","The physiological challenge of major surgery has been likened to running a marathon. In both cases, preparation is critical. Yet, many patients undergo major surgery without understanding the potential consequences.\n\nThe STTARRS trial aims to test the effect of an education program delivered via telehealth in people preparing for lung or major abdominal cancer surgery , compared with usual care on the development of a respiratory complications after surgery.\n\nThe secondary aims will be to determine the effect of the online education program for people preparing for lung or major abdominal cancer surgery compared to usual care on the following outcomes; acute hospital length of stay, surgical recovery, physical function and activity, self-efficacy, behaviour change, symptoms, health-related quality of life, number of days alive and out of hospital and health service usage and survival.\n\nThis trial includes one sub-study. The sub-study will recruit eligible people preparing for lung cancer surgery. In the sub-study, 35 participants will receive an individualised inspiratory muscle training and walking program delivered and monitored by telehealth in addition to the main STTARRS trial intervention before surgery.",[27],"Adults Waiting to Undergo Lung Cancer or Major Abdominal, Open or Video Assisted Cancer Surgery","RECRUITING","2026-06-08",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2025-01-22",{"date":36,"type":21},"2028-07",{"name":38,"class":39},"University of Melbourne","OTHER",9,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":53,"conditions":54,"keywords":59,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100507832","phase-2-post-thrombectomy-intra-arterial-tenecteplase-for-acute-management-of-non-retrievable-thrombus-and-no-reflow-in-emergent-stroke-100507832","NCT05892510","Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke","Post-thrombectomy Intra-arterial Tenecteplase for Acute manaGement of Non-retrievable Thrombus and No-reflow in Emergent Stroke (EXTEND-AGNES TNK)","Inclusion Criteria:\n\n* Adult participants (age≥18 years) presenting with ischemic stroke with arterial LVO on CT\u002FMR Angiogram of the intracranial internal carotid or middle cerebral artery (MCA) first segment (M1) or proximal second segment (M2) committed to thrombectomy using standard criteria within 24 hours of onset:\n* For 0-6 hours of symptom onset: Presence of arterial occlusion as defined above and ASPECTS≥3 on NCCT\n* For 6-24 hours of symptom onset: Additional imaging criteria on CTP or MRI perfusion of core volume \\\u003C100ml.\n* Qualifying CT\u002FMR within 4hrs of randomisation (repeat CT for transferred participants required if \\>4hr)\n* Pre-stroke Modified Rankin Scale (mRS) score of ≤2 (mild pre-existing disability permitted)\n* Local legal requirements for consent have been satisfied.\n\nExclusion Criteria:\n\n* Intracranial hemorrhage identified by CT or MRI\n* ASPECTS 0-2 on NCCT\n* CTP or MRI perfusion ischemic core volume \\>100ml if presenting within 6-24 hours from symptoms onset\n* Anticipated endovascular stenting required for intracranial or extracranial atherosclerotic stenosis\u002Focclusion.\n* More than six retrieval attempts in the same vessel\n* Alteplase being infused within 30 minutes (\\~5x half-life) of anticipated trial drug administration\n* Contraindication to imaging with contrast agents\n* Any condition (eg.mid-arterial phase early venous filling) that in the judgment of investigators could impose hazards if study therapy is initiated\n* Pregnant women.\n* Current participation in another intervention research study that includes experimental interventions beyond standard-of-care.\n* Anticoagulation. INR ≤1.7 if on warfarin, and dabigatran reversal by idarucizumab are permitted.\n* Other standard contraindications to thrombolysis apart from time window.\n* Known terminal illness such that the participants would not be expected to survive a year.\n* Planned withdrawal of care or comfort care measures.",{"count":49,"type":21},462,[51,52],"PHASE2","PHASE3","Multicentre, prospective, Multi-arm Multi-stage (MAMS) seamless phase 2b\u002F3 interventional randomized placebo-controlled double-blinded parallel-assignment (2 arms with 1:1 randomization) efficacy and safety trial to test intra-arterial tenecteplase at the completion of thrombectomy versus best practice in participants with anterior circulation LVO receiving mechanical thrombectomy within 24 hours of symptoms onset.",[55,56,57,58],"Ischemic Stroke, Acute","Cerebrovascular Disorders","Brain Disorder","Central Nervous System Diseases",[60,61,62,63],"Tenecteplase","Fibrinolytic agents","Thrombectomy","No-reflow","2026-05-14",{"date":66,"type":32},"2026-05-18",{"date":68,"type":32},"2024-06-01",{"date":70,"type":21},"2027-11-30",{"name":38,"class":39},12,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":17,"minAge":81,"maxAge":82,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},"100589586","cross-bracing-protocol-versus-surgery-for-acute-anterior-cruciate-ligament-rupture-100589586","NCT06956339","Cross Bracing Protocol Versus Surgery for Acute Anterior Cruciate Ligament Rupture","Evaluating Non-surgical Management of Acute Anterior Cruciate Ligament Rupture With a Novel BRACE Protocol Versus Early Surgical Reconstruction - a Comparative Effectiveness Randomised Controlled Trial","EMBRACE","Inclusion Criteria:\n\n* Aged 16 to 40 years;\n* Have a primary and acute ACL rupture (complete tear) confirmed by MRI scan;\n* At least moderately active before the ACL injury (a score of 5 to 10 on the Tegner Activity Scale before the injury);\n* Willing and able to give informed consent and participate fully in the interventions and assessment procedures;\n* Willing and able to cover the out-of-pocket costs associated with ACLR surgery.\n\nExclusion Criteria:\n\n* Have not completed the baseline questionnaire within 16 days of their initial ACL injury;\n* Inability to read and speak English\n* Concomitant knee injury diagnosed on MRI that requires surgical opinion and\u002For alterative treatment:\n\n  i) Loose body ii) Unstable osteochondral defect iii) Intra-articular fracture that extends into the articular surface and requires reduction iv) Displaced and\u002For unstable meniscal tear v) Grade 2 and 3 posterolateral corner injury vi) High-grade medial collateral ligament (MCL) injury that requires treatment with a knee brace and\u002For surgery vii) Posterior cruciate ligament (PCL) injury (partial discontinuity with some preserved fibers or complete disruption)\n* Severe disruption of ACL tissue visible on MRI:\n\n  i) Gap distance ≥8mm and ≥ 25% of tissue displaced outside of intercondylar notch ii) Gap distance ≥8mm and ≥ 25% of femoral footprint avulsed iii) ≥ 25% of femoral footprint avulsed and ≥ 25% of tissue displaced outside of intercondylar notch iv) Complete femoral or tibial avulsion\n* Concomitant patellofemoral joint dislocation diagnosed on MRI and\u002For self-reported history of recurrent patellofemoral joint instability or ≥1 patellofemoral joint dislocation;\n* Self-reported episode of instability (i.e. 'giving way') since initial MRI that resulted in increased pain, swelling and reduced function (without a subsequent MRI to re-determine eligibility);\n* Open growth plate of the femur and\u002For tibia visible on MRI;\n* Past history of ACL injury on the ACL-injured knee;\n* Past history of any surgery on ACL-injured knee;\n* Breastfeeding, pregnancy or planned pregnancy within the first 12 weeks of the trial;\n* Health conditions\u002Fmedications that are contraindications for ACLR, CBP and\u002For use of anticoagulant (rivaroxaban) medication:\n\n  i) Current deep vein thrombosis (DVT); ii) Past history of DVT and\u002For pulmonary embolism; iii) Diagnosed hypercoagulable disease (e.g., Protein C and Protein S deficiency, Factor 5 Leiden); iv) Significant renal\u002Fhepatic impairment (creatinine clearance \\\u003C15mL\u002Fmin, Child-Pugh score 10-15 (Class C)); v) Restless Legs Syndrome; vi) Current use of contraindicated medication (such as other anticoagulants, antiviral or oral anti-fungal medications); vii) Clinically significant active and\u002For recent bleeding (e.g., gastrointestinal, intracranial or haematuria); viii) At increased risk of clinically significant bleeding (e.g., significant inherited bleeding disorders, uncontrolled high blood pressure); ix) Other conditions requiring significant medical monitoring while anticoagulated, such as rheumatoid arthritis, type I or type II diabetes, autoimmune diseases; x) Self-reported body mass index (BMI) ≥40kg\u002Fm2, except in competitive athletes (defined as a pre-injury Tegner Activity Scale score of 7-10 and\u002For undertakes strength training\u002Fweightlifting two or more times per week); xi) Any known cardiovascular disease (history of stroke, coronary vascular disease); xii) Chronic obstructive pulmonary disease and\u002For chronic respiratory disease, except for controlled asthma; xiii) Acute infection of the knee or affected limb; xiv) Inflammatory arthropathy\u002Farthritis; xv) knee osteoarthritis in the ACL-injured knee (assessed on acute knee MRI, defined as focal partial thickness cartilage loss or greater (at least ACLOAS grade 2 cartilage lesion2626) plus one or more definite osteophyte (at least ACLOAS grade 2 osteophyte26 xvi) Concurrent immunosuppressive illness (e.g., AIDS, cancer) and\u002For immunosuppressant usage; xvii) Connective tissue disorders (such as Ehlers-Danlos syndrome); xviii) Current systemic steroid usage; xix) Intravenous drug users and\u002For substance addiction.","16 Years","40 Years",{"count":84,"type":21},180,[24],"The aim of the EMBRACE clinical trial is to compare outcomes (knee pain, symptoms, function and quality of life) between people with anterior cruciate ligament (ACL) rupture who are managed with either a novel bracing protocol (Cross Bracing Protocol), or with ACL reconstruction surgery. The main question that the trial aims to answer is:\n\nIn individuals with acute ACL rupture, is management with the Cross Bracing Protocol more clinically effective and cost effective compared to early ACL reconstruction surgery?\n\n180 people across five Australian cities, with a recent ACL injury, will be randomly allocated to one of two treatments.\n\n1. Cross Bracing Protocol\n\n   People who are allocated to the bracing treatment will:\n   * wear a knee brace for 12 weeks\n   * see a sports doctor\n   * have 23 visits to a physiotherapist who will supervise their knee rehab over 12 months.\n   * have two knee scans; 3 and 18 months after they enrol\n2. Anterior Cruciate Ligament Reconstruction Surgery\n\nPeople who are allocated to the surgery group will:\n\n* have surgery within 8 weeks of enrolling in the study\n* have 15 visits to a physiotherapist for their knee rehab over 12 months after surgery.\n* have one knee scan 18 months after they enrol.\n\nAll participants will:\n\n* complete surveys at the beginning and 3, 6, 12 and 18 months later so the main trial outcomes can be collected, as well as additional information about their knee.\n* have knee imaging (Magnetic Resonance Imaging or MRI scan) so the overall condition of their knee can be assessed, as well as whether their ACL has healed.",[88],"Anterior Cruciate Ligament Rupture",[90,91,92,93,94],"anterior cruciate ligament","cross bracing","ACL healing","ACL","ACL reconstruction surgery","2026-05-06",{"date":97,"type":32},"2026-05-07",{"date":99,"type":32},"2025-08-07",{"date":101,"type":21},"2030-03",{"name":38,"class":39},1,{"id":105,"slug":106,"hasResults":11,"nctId":107,"briefTitle":108,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":22,"phases":116,"briefSummary":117,"conditions":118,"keywords":125,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},"100597211","creating-a-risk-assessment-tool-for-thunderstorm-asthma-the-carista-study-100597211","NCT07055542","Creating A Risk Assessment Tool for Thunderstorm Asthma: the CARISTA Study","Creating A RIsk Assessment Biomarker Tool to Prevent Seasonal and Thunderstorm Asthma: The CARISTA Study","CARISTA","Inclusion Criteria:\n\nConsenting adults aged 18 to 70 years with seasonal allergic rhinitis\n\nwilling to undertake:\n\n* Lung function testing\n* Blood sample collection for risk factor identification, -Prospectively logging their symptoms and medications through the springtime season using the CARISTA symptom monitoring platform . -\n\nExclusion Criteria:\n\n* Individuals unable to provide informed consent\n* Individuals who do not suffer from symptoms of seasonal allergic rhinitis\n* Individuals who do not consent to lung function testing and blood sample collection - Individuals with unstable asthma (FEV1 by spirometry less than 70% predicted), a recent exacerbation or change of asthma preventive medication use (within one month) would be excluded, although re-screening would be permitted after one month, time permitting.\n* Individuals with severe asthma requiring the use of continuous oral corticosteroids or biological medication for severe asthma.\n* The presence of any medical illness, such as cardiac disease, pre-existing illness or immunomodulatory therapy that, in the opinion of the Investigators, would compromise participant safety or the derivation of biomarkers during the study.",true,"70 Years",{"count":115,"type":21},530,[24],"Thunderstorm asthma is a recurring public health emergency in South-Eastern Australia which occurs in springtime. The major identified risk factors for thunderstorm asthma is hay fever and allergy to ryegrass pollen. The goal of the CARISTA study is to identify the risk of springtime allergic and thunderstorm asthma in allergic adults living in South-Eastern Australia. To do this the investigators will recruit 530 people who have hay fever and test them for allergy to ryegrass pollen and undertake simple lung function testing. The investigators will ask study participants to complete a customised symptom tracker over the springtime pollen season for 2 consecutive years. The outcome the investigators are looking for is an asthma exacerbation or worsening asthma symptoms. This study will enable the investigators to identify indicators (biomarkers) of severe and moderate asthma exacerbations in order to identify those at risk of thunderstorm and seasonal asthma so protective treatments and strategies can be advised.",[119,120,121,122,123,124],"Allergic Asthma","Thunderstorm Asthma","Seasonal Allergic Rhinitis","Grass Pollen Allergy","Asthma Exacerbation Due to Thunderstorm","Asthma Acute",[126,127,128,129,130,131,132,133,134,135],"asthma","allergy","grass pollen allergy","ryegrass pollen","prospective symptom monitoring","seasonal allergic rhinitis","hay fever","seasonal allergic rhinoconjunctivitis","serum specific IgE","spirometry","2026-04-29",{"date":95,"type":32},{"date":139,"type":32},"2025-08-27",{"date":141,"type":21},"2030-12-31",{"name":38,"class":39},6,{"id":145,"slug":146,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":154,"conditions":155,"keywords":159,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":168,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":103},"100588376","exclude-or-expose-in-irritable-bowel-syndrome-what-works-for-whom-and-how-100588376","NCT06940596","Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom and How?","Exclude or Expose in Irritable Bowel Syndrome: What Works for Whom, and How? A Randomized Controlled Trial of Internet-Delivered FODMAP Diet Versus Exposure-Based Cognitive Behavioral Therapy","Inclusion Criteria: Each participant must meet all of the following criteria to be enrolled in this trial:\n\n* Living in Australia or the United States\n* Aged 18 years or older\n* Body Mass Index (BMI) \\[Equation\\]18.5kg\u002Fm2 and \\[Equation\\] 34.9kg\u002Fm2\n* Diagnosed with IBS by a General Practitioner, Family Physician, or Gastroenterologist, or Advanced Specialist Dietitian\n* Currently fulfill Rome IV criteria for IBS\n* Symptomatic at the time of recruitment (IBS-SSS \\> 175)\n* Access to a computer and internet\n* Sufficient English language and computer skills to complete a text-based online treatment\n* Willing to make dietary or behavioral changes in line with the allocated treatment program\n* Ability to provide informed consent\n\nExclusion Criteria:Patients meeting any of the following criteria will be excluded from the trial:\n\n* Presence or known history of other GI disease (e.g. coeliac disease, Inflammatory Bowel Disease) or history of gastrointestinal cancer\n* History of major gastrointestinal surgery (not appendectomy, cholecystectomy or hemorrhoidectomy)\n* Individuals who report alarm symptoms (e.g., blood in stool, recent unexplained\u002Funintentional weight loss \\>5% body weight, a recent change in bowel habits if \\>50 years, family history of gastrointestinal cancer or gastrointestinal diseases, large volumes of diarrhea occurring at night, fever associated with gut symptoms, recurrent vomiting, persistent unexplained iron deficiency) will be excluded if appropriate medical investigations have not been conducted, unless written medical approval is provided from a general practitioner, family physical, or gastroenterologist.\n* Diagnosis of major disease that could explain current gastrointestinal symptoms such as severe diabetic, cardiac, liver, neurological, neuropathy disease\n* History or current diagnosis of psychotic disorder or bipolar disorder\n* Current diagnosis of substance abuse disorder or major depressive disorder or active suicidal ideation\n* History or current diagnosis of an eating disorder\n* Current enteral\u002Fparenteral feeding or use of supplemental feeds (e.g. Ensure)\n* Pregnant or lactating or planning to become pregnant during the 12-week intervention period\n* Commenced or change in dose of antibiotics and medications that potentially affect the gastrointestinal transit (e.g. anti-diarrheals and laxatives) in the 3 months preceding study commencement.\n* Commenced taking or changed dose of probiotics, prebiotics, fibre supplements and digestive enzymes in the 3 months preceding study commencement\n* Commenced or change dose in psychotropic medication in the 3 months preceding study commencement\n* Are currently undertaking behavioral therapy for IBS (including cognitive behavioral therapy, CBT), or have undertaken clinician-delivered behavioral therapy for the treatment of IBS\n* Are currently undertaking or have undertaken a dietitian-prescribed and delivered restrictive diet for IBS (e.g., FODMAP diet).",{"count":152,"type":21},235,[24],"This research project will assess how two treatments for irritable bowel syndrome (one dietary and one behavioral) work and for whom. This will be done by assessing moderators (what treatment works for who and in what context) and mediators (how treatment works). Investigators will also assess how the diet and behavioral treatments affect IBS symptoms during treatment. Participants will be randomized to either: i. A FODMAP diet online program that focuses on modifying the consumption of foods high or moderate in fermentable carbohydrates (FODMAPS) to manage IBS symptoms. or, ii. An Exposure-based Cognitive Behavioral Therapy (E-CBT) online program for IBS that focuses on changing symptom-related behaviors which are known to worsen IBS symptoms.",[156,157,158],"Irritable Bowel Syndrome (IBS)","Intestinal Diseases","Gastrointestinal Disease",[160,161,162,163,164,165,157,166,167],"Irritable Bowel Syndrome","FODMAP Diet","Behavior Therapy","Gastrointestinal Diseases","Cognitive Behavioral Therapy","Exposure Based Cognitive Behavioral Therapy","Digestive System Diseases","Low FODMAP Diet",{"date":95,"type":32},{"date":170,"type":32},"2025-05-22",{"date":172,"type":21},"2028-04",{"name":38,"class":39},{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":181,"targetDuration":4,"studyType":22,"phases":183,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":195,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":201},"100449794","phase-4-staphylococcus-aureus-network-adaptive-platform-trial-100449794","NCT05137119","Staphylococcus Aureus Network Adaptive Platform Trial","SNAP","PLATFORM Inclusion Criteria:\n\nPatients must fulfil all of the following criteria to be eligible to enter the SNAP trial:\n\n1. Staphylococcus aureus complex grown from ≥1 blood culture\n2. Admitted to a participating hospital at the time of eligibility assessment (OR if patient has died, they were admitted to this site anytime from the time of blood culture collection until the time of eligibility assessment)\n\nPLATFORM Exclusion Criteria:\n\nPotentially eligible participants meeting any of the following criteria at the time of eligibility assessment for platform entry will be excluded from the randomised platform (but may still participate in the registry):\n\n1. Time of anticipated platform entry is greater than 72 hours post collection of the index blood culture (Where the time of culture collection is not recorded, the time of laboratory registration of the sample will be used as an alternative)\n2. Polymicrobial bacteraemia, defined as more than one organism (at species level) in the index blood cultures OR in any subsequent blood culture reported between the collection of the index blood culture and platform eligibility assessment, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician.\n3. Known previous participation in the randomised SNAP platform\n4. Known positive blood culture for S. aureus (of the same silo: PSSA, MSSA or MRSA) between 72 hours and 180 days prior to the time of eligibility assessment\n5. Treating team deems enrolment in the study is not in the best interest of the patient\n6. Treating team believes that death is imminent and inevitable\n7. Patient is for end-of-life care and antibiotic treatment is considered not appropriate\n8. Patient \\\u003C18 years of age and paediatric recruitment not approved at recruiting site\n9. Patient has died since the collection of the index blood culture\n\nTo be included in any of the following DOMAINS the participant must met eligible for the PLATFORM (as listed above)\n\nADJUNCTIVE TREATMENT DOMAIN\n\nInclusion Criteria:\n\n1. All participants that met the PLATFORM eligible are eligible to be included in this domain unless they meet any of the following exclusions listed.\n2. Patients are eligible for this domain regardless of S. aureus susceptibility testing results to clindamycin.\n\nExclusion criteria:\n\n1\\. Previous type 1 hypersensitivity reaction to lincosamides 2. Currently receiving clindamycin (lincomycin) or linezolid which cannot be ceased or substituted 3. Necrotising fasciitis 4. Current C. difficile associated diarrhoea (any severity) 5. Current severe diarrhoea from any cause (defined as Grade 3 or higher) 5. Known CDAD (C.Difficile Associated Diarrhoea) in the past 3 months, or CDAD relapse in the past 12 months 6. At the time of domain eligibility assessment, more than 4 hours has elapsed since platform entry 7. Treating clinician deems enrolment in this domain is not in the best interest of the patient\n\nPSSA, MSSA TREATMENT DOMAIN (backbone)\n\nInclusion Criteria:\n\n1. For PSSA silo: Index blood culture isolate is penicillin-susceptible as per the Microbiology Appendix. In short, this will require phenotypic disc testing with EUCAST (a P1 disc diffusion with zone \\>=26mm OR a P1 disc diffusion with zone \\>=26mm and the zone edge is NOT sharp) OR CLSI (a P10 disc diffusion) defined criteria.\n2. For MSSA silo: Index blood culture isolate is methicillin-susceptible as per the Microbiology Appendix.\n\nNote that where trial sites are not testing for penicillin-susceptibility, patients with MSSA\u002FPRSA can be included in the MSSA silo, but those with MSSA\u002FPSSA (but not confirmed with a P-disc) will be excluded from the backbone domain. The rationale for this is that patients with MSSA but not tested with a P-disc may be truly PSSA (with no blaZ). If the cefazolin inoculum effect (CIE) is a clinically relevant entity, then including patients with an organism without blaZ (and hence cannot have a CIE phenotype), will bias towards non-inferiority of cefazolin compared to (flu)cloxacillin.\n\nFor PSSA, the requirement for laboratories to use an accredited phenotypic test for a penicillin-susceptible phenotype, is to ensure clinical safety according to internationally accepted guidelines. The automated antimicrobial susceptibility testing, and other phenotypic tests, have poor sensitivity for detection of blaZ compared to a gold standard of blaZ PCR. Therefore, patients could be placed at risk of treatment with benzylpenicillin when the infecting isolate is actually blaZ positive, unless these guidelines are followed.\n\nExclusion Criteria (PSSA \\& MSSA):\n\n1. \\>72 hours have elapsed since the collection of the index blood culture (i.e. the time of collection of the first positive blood culture from the patient during this episode)\n2. History of type I hypersensitivity reaction (i.e. anaphylaxis or angioedema) to any penicillin or cephalosporin\n3. History of severe delayed reaction (e.g. allergic interstitial nephritis, cutaneous vasculitis, Stevens-Johnson, DRESS, etc.) to any penicillin or cephalosporin\n4. PSSA silo: Non-severe rash to any penicillin (unless patient has been subsequently de-labelled; this criteria does not include criteria 2 and 3 above), or MSSA silo: Non-severe rash to cefazolin or any penicillin (unless patient has been subsequently de-labelled); (Nausea, diarrhoea, headache, and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of unclear nature, or a family history of allergy are not exclusions.)\n5. Treating team deems enrolment in this domain is not in the best interest of the patient\n6. Currently receiving maintenance dialysis (haemodialysis or peritoneal dialysis); (Acute renal replacement therapy (including CRRT, haemodialysis or peritoneal dialysis) are not exclusions. Such patients are eligible as long as appropriate vascular access is available or can be arranged.)\n7. Polymicrobial bacteraemia (defined as more than one organism \\[at species level\\] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician) reported between collection of the index blood culture and backbone domain eligibility assessment\n8. Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)\n\nMRSA TREATMENT DOMAIN (backbone)\n\nInclusion Criteria:\n\n1\\. MRSA confirmed microbiologically\n\nExclusion Criteria:\n\n1. Time to allocation reveal is \\>72 hours from time of index blood culture collection\n2. Severe allergy to any beta-lactam (including cefazolin) Immediate severe allergy: Anaphylaxis\u002Fangioedema Severe delayed allergy: Severe cutaneous adverse reaction (SCAR; including Steven Johnson Syndrome, Toxic Epidermal Necrolysis, Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) and acute generalised exanthematous pustulosis (AGEP)), severe drug induced liver injury, proven allergic interstitial nephritis, immune-mediated haemolytic anaemia and other severe cytopenia.\n3. Non-severe rash to cefazolin Nausea, diarrhoea, headache and other non-specific symptoms are NOT allergies, they are drug intolerance, and they are not exclusion criteria. Similarly, a vague history of an allergy of unclear nature, or a family history of allergy are not exclusions.)\n\n3\\. Severe allergy or non-severe rash to both vancomycin AND daptomycin Vancomycin infusion reaction (formerly known as \"red man syndrome\") is due to direct histamine release and is not generally an allergy, and therefore is not considered an exclusion.\n\n5\\. Treating team deems enrolment in the domain is not in the best interest of the patient 6. Polymicrobial bacteraemia (defined as more than one organism \\[at species level\\] in blood cultures, excluding those organisms judged to be contaminants by either the microbiology laboratory or treating clinician) reported between collection of the index blood culture and backbone domain eligibility assessment.\n\n7\\. Patient currently being treated with a systemic antibacterial agent that cannot be ceased or substituted for interventions allocated within the platform (unless antibiotic is listed in Table 1 of the DSA, which specifies allowed antibiotics with limited absorption from the gastrointestinal tract or negligible antimicrobial activity against S. aureus)\n\nEARLY ORAL SWITCH DOMAIN\n\nInclusion Criteria:\n\nDay 7 (+\u002F- 2 days):\n\n1. Clearance of SAB by platform Day 2: blood cultures negative for S. aureus from platform Day 2 onwards AND no known subsequent positive blood cultures\n2. Afebrile (\\\u003C37.8°C) for the past 72 hours (at time of judging eligibility)\n3. Primary focus is either line related (either central or peripheral IV cannula) or skin and soft tissue, AND source control achieved (for 'line-related' this means line removed; for 'skin and soft tissue' means site PI considers source control to have been achieved and any abscess more than 2cm diameter has been drained)\n4. No evidence of metastatic foci (on clinical or radiological examination, but radiological imaging is not required to exclude metastatic foci if not clinically indicated)\n\nDay 14 (+\u002F- 2 days):\n\n1. Clearance of SAB by platform Day 5: blood cultures negative for S. aureus from platform Day 5 (+\u002F-1 day) AND no known subsequent positive blood cultures. If the most recent blood culture from Day 2-4 is negative for S. aureus, blood cultures do not need to be repeated on Day 5 to fulfil eligibility criteria (Day 5 blood cultures will be assumed to be negative in this situation)\n2. Afebrile (\\\u003C37.8°C) for the past 72 hours (at time of judging eligibility)\n3. Site Principal Investigator has determined that source control is adequate\n\nExclusion Criteria:\n\nWhen judging eligibility at platform Day 7 (+\u002F- 2 days) and at Day 14 (+\u002F- 2 days), exclusion criteria are:\n\n1. Adherence to oral agents unlikely (as judged by site PI in consultation with the treating team)\n2. Unreliable gastrointestinal absorption (e.g. vomiting, diarrhoea, nil by mouth, anatomical reasons)\n3. There are no appropriate oral antibiotics due to contraindications, drug availability, or antibiotic resistance\n4. Ongoing IV therapy unsuitable e.g. no IV access\n5. Clinician deems not appropriate for early oral switch\n6. Patient no longer willing to participate in domain In the lead-up to judging eligibility, it may be helpful to discuss with the patient the potential for continued IV treatment versus oral switch, to allow hospital discharge planning\n7. Clinical team deems that sufficient duration of antibiotic therapy has already been provided\n\nExclusions when judging eligibility for early oral switch at trial Day 7 (+\u002F- 2 days):\n\n1. Presence of prosthetic cardiac valve, pacemaker or other intracardiac implant\n2. Presence of intravascular clot, graft, or other intravascular prosthetic material Intravascular clot excludes superficial peripheral IV line-related thrombophlebitis. Intravascular prosthetic material excludes coronary artery stents)\n3. Intravascular\u002Fintracardiac infections (e.g. endocarditis, mycotic aneurysm)\n4. Presence of other intracardiac abnormalities felt to put patient at increased risk of endocarditis (e.g., bicuspid aortic valve)\n\nPET\u002FCT DOMAIN\n\nInclusion Criteria:\n\n1. PET\u002FCT participating site\n2. Patient is accessible for PET\u002FCT - a patient is considered accessible if the site team are able to access the participant medical records, arrange for a PET\u002FCT scan for the patient, and discuss this domain with the patient and their treating healthcare providers.\n\nExclusion Criteria:\n\n1. Pregnant - patients of childbearing potential should be assessed for pregnancy status and a pregnancy test performed (if not performed within the past 10 days)\n2. Currently breastfeeding\n3. \\\u003C 18 years of age\n4. Patient has had PET\u002FCT in the past 7 days\n5. Patient needs PET\u002FCT in the next 7 days (in the opinion of the clinical team, at the time of eligibility assessment)\n6. Clinically unstable for PET\u002FCT (as judged by the treating clinical team, taking into account need for organ support (including inotropes) and capacity to lie flat for the PET\u002FCT)\n7. Contraindication to PET\u002FCT (e.g., claustrophobia, persistently elevated blood sugar levels \\[\\>12.5mmol\u002FL\\] that cannot be corrected).\n8. Patient no longer willing to participate in the domain - in the days leading up to judging eligibility, it may be helpful to discuss with the patient the potential for PET\u002FCT vs no PET\u002FCT to allow imaging planning\n9. Clinician deems participation in this domain is not in the patient's best interests",{"count":182,"type":21},8000,[184],"PHASE4","The Staphylococcus aureus Network Adaptive Platform (SNAP) trial is an International Multi-Centered Randomised Adaptive Platform Clinical Trial to evaluate a range of interventions to reduce mortality for patients with Staphylococcus Aureus bacteraemia (SAB).",[187],"Staphylococcus Aureus Bacteremia",[189,190,191,192,193,194],"Methicillin-resistant Staphylococcus aureus (MRSA)","Methicillin-susceptible Staphylococcus aureus (MSSA)","Penicillin-susceptible Staphylococcus aureus (PSSA)","Staphylococcus aureus","S. aureus","Staph Aureus Bacteremia (SAB)",{"date":95,"type":32},{"date":197,"type":32},"2022-02-16",{"date":199,"type":21},"2028-12-01",{"name":38,"class":39},161,{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":207,"acronym":208,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":210,"targetDuration":4,"studyType":22,"phases":212,"briefSummary":213,"conditions":214,"keywords":216,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":227,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},"100447376","phase-2-extending-the-time-window-for-tenecteplase-by-recanalization-of-basilar-artery-occlusion-in-posterior-circulation-stroke-100447376","NCT05105633","Extending the Time Window for Tenecteplase by Recanalization of Basilar Artery Occlusion in Posterior Circulation Stroke","Extending the Time Window for Tenecteplase by Effective RecanalizatioN of bAsilar Artery occLusion in Patients With POSTerior Circulation Stroke (POST-ETERNAL)","POST-ETERNAL","Inclusion Criteria:\n\n* Patients presenting with posterior circulation ischemic stroke symptoms due to partial or complete basilar artery occlusion within 24 hours from symptom onset (or clinical deterioration\u002Fcoma) or the time the patient was last known to be well.\n* Patient's age is ≥18 years\n* Presence of basilar artery occlusion, proven by CT Angiography or MR Angiography. Basilar artery occlusion is defined as 'potentially retrievable' occlusion at the basilar artery. This can be a partial or complete occlusion.\n* Premorbid mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).\n* Local legal requirements for consent have been satisfied.\n\nExclusion Criteria:\n\n* Intracerebral hemorrhage (ICH) or other diagnosis (e.g. tumour) identified by baseline imaging.\n* Posterior circulation Acute Stroke Prognosis Early CT score (pc-ASPECTS) \\\u003C7 on non-contrast CT, CT Angiography source images or DWI MRI.\n* Significant cerebellar mass effect or acute hydrocephalus.\n* Established frank hypodensity on non-contrast CT indicating subacute infarction.\n* Bilateral extensive brainstem ischemia.\n* Strong suspicion of underlying intracranial atherosclerotic disease (e.g diffuse arterial calcifications, basilar stenosis) or dissection which may require immediate neuro-interventional procedure with intracranial stenting and not benefit from intravenous thrombolysis at investigator's discretion.\n* Pre-stroke mRS of ≥4 (indicating moderate to severe previous disability).\n* Other standard contraindications to intravenous thrombolysis.\n* Contraindication to imaging with contrast agents.\n* Clinically evident pregnant women.\n* Current participation in another research drug treatment protocol.\n* Known terminal illness such that the patients would not be expected to survive a year.\n* Planned withdrawal of care or comfort care measures.\n* Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.",{"count":211,"type":21},688,[51,52],"Patients presenting to the emergency department with an acute ischemic stroke due to basilar artery occlusion within 24 hours of stroke onset will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomised 50:50 using a central computerised allocation process to either standard of care (no intravenous thrombolytic treatment or intravenous alteplase 0.9mg\u002Fkg) or tenecteplase 0.25mg\u002Fkg before undergoing mechanical thrombectomy as required at treating clinician's discretion. The trial is Multi-arm, Multi-stage, prospective, randomised, open-label, blinded endpoint (PROBE) design with seamless phase 2b\u002F3 transition if the intermediate endpoint (recanalization without symptomatic intracerebral hemorrhage) is met in analysis of the first 202 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 240 patients have completed 3 month follow-up (minimum sample size 320, maximum sample size 688).",[215],"Basilar Artery Occlusion",[217,218,219,60,220,56,221,58,222,223,224,225,226],"ischemic stroke","basilar artery occlusion","Stroke","Tissue Plasminogen Activator","Brain Diseases","Nervous System Diseases","Vascular Diseases","Cardiovascular Diseases","Fibrin Modulating Agents","Molecular Mechanisms of Pharmacological Action",{"date":95,"type":32},{"date":229,"type":32},"2021-11-29",{"date":231,"type":21},"2029-05",{"name":38,"class":39},17,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":22,"phases":245,"briefSummary":247,"conditions":248,"keywords":250,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":264},"100453660","phase-1-low-dose-nivolumab-in-adults-living-with-hiv-on-antiretroviral-therapy-100453660","NCT05187429","Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy","Safety, Immunogenicity and Efficacy of Low Dose Nivolumab in Adults Living With HIV on Antiretroviral Therapy (ART)","NIVO-LD","Inclusion Criteria:\n\n* Documented HIV-1 infection;\n* Viral load \\> 400 copies\u002FmL prior to initiation of ART;\n* Weight ≥ 50 kg;\n* Ability and willingness to provide informed consent and to continue ART throughout the study;\n* Receiving combination ART for at least 2 years and being on the same ART regimen for at least 4 weeks at the screening visit;\n* HIV-1 plasma RNA \\\u003C50 copies\u002FmL for \\>2 years (documented on at least 2 occasions within the 2 years) and \\\u003C50 copies\u002FmL at screening. Episodes of a single HIV plasma RNA 50-500 copies\u002FmL will not exclude participation if the subsequent HIV plasma RNA was \\\u003C50 copies\u002FmL;\n* CD4+ T cell counts \\>500 cells\u002FμL at screening;\n* Female participants if they meet one of the following criteria:\n\n  * Is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and ≥ 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,\n  * Is of child-bearing potential with a negative pregnancy test at both Screening and Day 0 and agrees to use one of the following methods of contraception to avoid pregnancy from 14 days prior to the first infusion until the end of the study:\n\n    * Complete abstinence from penile-vaginal intercourse;\n    * Double barrier method (male condom\u002Fspermicide, male condom\u002Fdiaphragm, diaphragm\u002Fspermicide);\n    * Any intrauterine device (IUD) with published data showing that the expected failure rate is \\\u003C1% per year;\n    * Male partner sterilization confirmed prior to the female participant's entry into the study, and this male is the sole partner for that participant;\n    * Approved hormonal contraception (Where other medications to be used in the study (e.g., efavirenz and darunavir) are known, or are likely, to significantly interact with systemic contraceptives, resulting in decreased efficacy of the contraceptive, then alternative methods of non-hormonal contraception are recommended);\n    * Any other method with published data showing that the expected failure rate is \\\u003C1% per year. Note: If using one of the described contraception methods it must be used consistently, in accordance with the approved product label and all female participants must be willing to undergo urine pregnancy tests as specified in the Schedule of Procedures.\n* All participants must agree not to participate in a conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) during the study;\n* Heterosexually active male if they are;\n\n  * willing to use an effective method of contraception (anatomical sterility in self that is confirmed prior to study entry) or\n  * agree on the use of an effective method of contraception with an effective failure rate of \\\u003C 1% by his partner (hormonal contraception, intra-uterine device (IUD), or anatomical sterility) from the day of the first infusion until the end of study (as long as plasma viral load \\\u003C20c\u002FmL).\n* Singapore only: all participants must understand and agree to abide by the Infectious Diseases Act, in particular Part 4 'Control of HIV infection' inclusive of section 23 'Sexual activity by person with HIV infection'\n\nExclusion Criteria:\n\n* Active, known and suspected autoimmune disease (including but not limited to including but not limited to inflammatory bowel diseases, scleroderma, severe psoriasis, myocarditis, uveitis, pneumonitis, systemic lupus erythematosus, rheumatoid arthritis, optic neuritis, myasthenia gravis, adrenal insufficiency, hypothyroidism and\u002For hyperthyroidism, autoimmune thyroiditis, sarcoidosis, and vitiligo);\n* History of interstitial lung disease;\n* History of chronic obstructive pulmonary disease (COPD);\n* Type I diabetes mellitus;\n* Active malignancy or history of malignancy requiring systemic chemotherapy or surgery in the preceding 24 months; exception -history of excised localized non-melanomatous skin cancers (squamous cell carcinoma, basal cell carcinoma);\n* History of solid organ transplant. Note Individuals with prior corneal transplants may be allowed to enroll after discussion with and approval from the study principal investigator;\n* Active or previously treated active TB;\n* History of HIV-related opportunistic infection within the last years prior to study entry;\n* Prior history of immune reconstitution syndrome (IRIS);\n* Current, chronic, acute or recurrent bacterial, fungal or viral (other than HIV) infections that are serious, in the opinion of the investigator, and require systemic therapy within 30 days prior to study entry;\n* Immune deficiency other than that caused by HIV infection;\n* Received investigational drug or device within 6 months prior to study entry\n* Treatment for hepatitis C virus (HCV) within 6 months prior to study entry;\n* History of previous treatment with an immune checkpoint inhibitor;\n* History of prior immunoglobulin (IgG) therapy;\n* Use of immunomodulators (e.g., interleukins, interferons, cyclosporine), systemic cytotoxic chemotherapy, experimental vaccines or investigational therapy within 60 days prior to study entry or intent to use immunomodulators during the study. NOTE: Participants receiving stable physiologic glucocorticoid doses, defined as prednisolone less than or equal to 10 mg\u002Fday or the equivalent, will not be excluded. Stable physiologic glucocorticoid doses should not be discontinued for the duration of the study. In addition, participants receiving inhaled or topical corticosteroids will not be excluded;\n* Any other current or prior therapy which, in the opinion of the investigators, would make the individual unsuitable for the study or influence the results of the study;\n* Participants with severe hepatic impairment (Class C) as determined by Child-Pugh classification;\n* Unstable liver disease (as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones);\n* Participants who intend to modify their ART regimen within the study period;\n* Active alcohol or substance use that in the opinion of the investigator will prevent adequate compliance with study procedures;\n* Any acute or chronic psychiatric problems that, in the opinion of the investigator, make the participant ineligible for participation;\n* Any active, clinically significant medical condition not otherwise covered;\n* Women who are pregnant or breastfeeding or Women of Child Bearing Potential (WOCBP) who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria;\n* Men of reproductive potential who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy as specified in the inclusion criteria;\n* Specific exclusion criteria for Cohort A (Fine Needle Biopsy):\n\n  * prothrombin time (PTT) \\>2x ULN\n  * international normalized ratio (INR) \\>1.5\n  * Platelets \\\u003C50,000\u002Fmm3\n  * Chronic venous stasis of lower extremities\n  * Lower extremity lymphedema\n  * Allergies to local anesthetic\n  * Blood coagulation disorder.\n* The following laboratory abnormalities (lab tests may be repeated to obtain acceptable values before failure at screening is concluded);\n\n  * Hematology:\n\n    * Hemoglobin \\\u003C 14.0 g\u002FdL for men and \\\u003C12.0 g\u002FdL for women;\n    * Absolute Neutrophil Count (ANC) ≤ 1,500 \u002Fmm\\^3 (≤ 1 x 10\\^9\u002FL);\n    * Platelets ≤ 150,000 \u002Fmm\\^3\n  * Biochemistry:\n\n    * Aspartate aminotransferase (AST) \\> 1.25 x ULN;\n    * Alanine aminotransferase (ALT) \\> 1.25 x ULN;\n    * Bilirubin ≥1.5 x ULN (if on atazanavir ≥5 x ULN);\n    * Interferon-gamma release assay (IGRA) for tuberculosis (TB) with negative results within 90 days prior to study entry\n    * Thyroid stimulating hormone (TSH) outside the normal reference range;\n    * Free thyroxine (T4) outside the normal reference range\n    * Presence of Anti-thyroid peroxidase (TPO) antibodies;\n    * Presence of anti-glutamic acid decarboxylase (GAD) antibodies\n    * Antinuclear antibody (ANA) \\>1:80 at screening\n    * Early morning (8-9 am) cortisol outside the normal reference range. Note: female participants on estrogen-containing oral contraception or other exogenous estrogen treatment may repeat the AM cortisol as part of screening to determine eligibility;\n    * Fasting blood sugar \\> 7.0 mmol\u002FL (unless already diagnosed with Type 2 Diabetes Mellitus);\n  * Microbiology:\n\n    * Positive for hepatitis B surface antigen;\n    * Positive for hepatitis C antibody, unless confirmed clearance of HCV infection (spontaneous or following treatment) by polymerase chain reaction (PCR) testing.","65 Years",{"count":244,"type":21},42,[246,51],"PHASE1","The purpose of this study is to evaluate whether a single dose of Nivolumab in people living with HIV can reduce the latent reservoir. The latent HIV reservoir is a group of immune system cells in the body that are infected with HIV but are not actively producing new virus. This is the reason why people living with HIV are unable to stop their antiretroviral treatment.",[249],"HIV I Infection",[251,252,253,254,255],"HIV","Antiretroviral interruption","ATI","Low dose Nivolumab","Clinical Trial","2025-12-15",{"date":258,"type":32},"2025-12-22",{"date":260,"type":32},"2023-01-24",{"date":262,"type":21},"2029-01",{"name":38,"class":39},2,{"id":266,"slug":267,"hasResults":11,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":271,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":22,"phases":275,"briefSummary":276,"conditions":277,"keywords":279,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},"100395877","ultra-early-minimally-invasive-intracerebral-haemorrhage-evacuation-versus-standard-treatment-100395877","NCT04434807","Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment","Ultra-Early, Minimally inVAsive intraCerebral Haemorrhage evacUATion Versus Standard trEatment (EVACUATE)","EVACUATE","Inclusion Criteria:\n\n1. Patients with an acute supratentorial intracerebral hemorrhage (ICH) ≥20mL in volume\n2. Age ≥18 years\n3. Surgery can commence within 8 hours of symptom onset (the time the patient was last known to be well) or, in patients with wake-up onset, within 8 hours of the time the patient awoke with symptoms. Patients presenting with small ICH (volume \\\u003C20mL) with clinical deterioration judged due to ICH hematoma expansion meeting volume criteria may be randomized if surgery can commence within 8 hours of clinical deterioration\n4. Moderate neurological deficit (NIHSS≥6)\n5. Pre-stroke mRS ≤3 (independent function or requiring only minor domestic assistance and able to manage alone for at least 1 week).\n6. CTA or MRA is performed and does not show an underlying vascular lesion\n\nExclusion Criteria:\n\n1. Brainstem ICH\n2. ICH secondary to trauma, where brain injury is judged more likely to be due to the broad effects of trauma rather than the focal ICH.\n3. Hereditary or acquired hemorrhagic diathesis or coagulation factor deficiency (in liver disease, INR\\>1.4).\n4. Platelet count \\\u003C75,000\n5. Unreversible heparinization or anticoagulation. If reversing warfarin, INR should be ≤1.4 before procedure commences. Reversal of heparin by protamine, dabigatran by idarucizumab and rivaroxaban, apixaban and enoxaparin by andexanet (where available) is permitted. Unreversed anticoagulation with a last dose within 48 hours is an exclusion.\n6. Recent (\\\u003C12 hours) parenteral GPIIb\u002FIIIa antagonist.\n7. Recent (\\\u003C1 hour) thrombolysis. If the ICH has occurred between 1 and 12 hours following thrombolysis, cryoprecipitate (1U per 10kg) and tranexamic acid must be administered prior to treatment.\n8. Participation in any investigational study in the last 30 days\n9. Pregnant women (clinically evident)\n10. Co-morbidities or advance care directive preventing general anaesthesia for the procedure.\n11. Known terminal illness such that the patients would not be expected to survive a year.\n12. Planned withdrawal of care or comfort care measures.\n13. Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.",{"count":274,"type":21},240,[24],"A randomized controlled trial of ultra-early, minimally invasive, hematoma evacuation versus standard care within 8 hours of intracerebral hemorrhage. Patients presenting to the emergency department with stroke due to supratentorial, spontaneous intracerebral hemorrhage \\>20mL volume will be assessed to determine their eligibility for randomization into the trial. If the patient gives informed consent they will be randomized 50:50 using central computerized allocation to minimally invasive hematoma evacuation using the Aurora surgiscope and evacuator (Integra Lifesciences) versus standard medical therapy. The trial is prospective, randomized, open-label, blinded endpoint (PROBE) design with seamless phase 2b-3 transition if the intermediate endpoint (successful hematoma evacuation) is met in analysis of the first 52 patients. Adaptive sample size re-estimation (Mehta and Pocock) will be performed when 160 patients have completed 6 month follow-up (minimum sample size 240, maximum sample size 434).",[278,219],"Intra Cerebral Hemorrhage",[280,281],"neurosurgery","minimally invasive","2025-10-24",{"date":284,"type":32},"2025-10-28",{"date":286,"type":32},"2020-11-15",{"date":288,"type":21},"2028-12",{"name":38,"class":39},13,{"id":292,"slug":293,"hasResults":11,"nctId":294,"briefTitle":295,"officialTitle":296,"acronym":297,"eligibilityCriteria":298,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":299,"targetDuration":4,"studyType":22,"phases":301,"briefSummary":302,"conditions":303,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":305,"lastUpdatePostDateStruct":306,"startDateStruct":308,"completionDateStruct":310,"leadSponsor":312,"locationsCount":103},"100583048","spinal-cord-injury-neurorecovery-collaboration-100583048","NCT06871254","Spinal Cord Injury Neurorecovery Collaboration","Spinal Cord Injury Neurorecovery Collaboration (SCINC) Master Protocol","SCINC","SCINC Inclusion Criteria:\n\n\\- Person with SCI\n\nSCINC Exclusion Criteria:\n\n\\- Proven contraindication to intervention\n\nRRULI: Appendix 1 (TIH + ET) study-specific inclusion criteria:\n\n* Adults \\> 18 years of age\n* Able to independently ventilate\n* Chronic SCI (\\>1 years post-injury or impairment onset)\n* Tetraplegia (C2-T1 level of injury)\n* Evidence of motor incomplete paralysis in the upper limb below the neurological level of injury\n* Have a documented management plan for their AD if it occurs.\n\nRRULI: Appendix 1 (TIH + ET) study-specific exclusion criteria:\n\n* Pregnancy\n* Medical instability, including current or recent (within the previous 6 weeks) infection or inflammation\n* Current or recent (within the previous 6 weeks) pressure ulcers or cutaneous lesions\n* Poorly controlled diabetes\n* An episode of AD in the previous 6 months that required medical intervention to resolve\n* Significant other neurological, psychiatric, pulmonary, cardiovascular, orthopaedic, or oncological conditions.\n* Currently taking part in another clinical trial\n* Upper limb contracture",{"count":300,"type":21},24,[24],"SCINC is an adaptive design Master protocol that seeks to determine if there is \"sufficient promise\" of beneficial effect of treatment combinations to enhance motor recovery in pre-specified strata of people with a spinal cord injury.",[304],"Spinal Cord Injuries","2025-08-04",{"date":307,"type":32},"2025-08-08",{"date":309,"type":32},"2025-03-01",{"date":311,"type":21},"2027-12-31",{"name":38,"class":39},{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":319,"eligibilityCriteria":320,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":321,"targetDuration":4,"studyType":22,"phases":323,"briefSummary":324,"conditions":325,"keywords":327,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":333,"lastUpdatePostDateStruct":334,"startDateStruct":336,"completionDateStruct":338,"leadSponsor":340,"locationsCount":4},"100551541","platform-for-adaptive-trials-in-perinatal-units---core-protocol-100551541","NCT06461429","PLatform for Adaptive Trials In Perinatal UnitS - [Core Protocol]","Platform for Adaptive Trials in Perinatal Units (Core Protocol)","PLATIPUS","Potential participants with core platform eligibility AND who meet all domain-specific inclusion criteria and none of the domain-specific exclusion criteria for at least one PLATIPUS domain, will be eligible to 'enrol' in the PLATIPUS trial and randomised to all eligible domains, for which consent has been provided.\n\nCORE PLATFORM ELIGIBILITY - PREGNANCY DOMAINS\n\nInclusion Criteria: Pregnant women and people must fulfil the following inclusion criteria to be eligible to participate in PLATIPUS:\n\n1. Pregnant and at risk of preterm birth\n2. Receiving care at a participating site at the time of eligibility assessment.\n3. Meets the eligibility criteria for at least one domain.\n\nExclusion Criteria: Pregnant women and people who meet the following criteria will be excluded from participation in this trial:\n\n1. Circumstances where death (pregnant woman or person\u002Ffetal) is deemed to be imminent and inevitable. The treating team may however decide that providing an opportunity for the pregnant woman or person to participate would be in their and\u002For their fetus\u002Finfant's interest. OR\n2. Inability to consent, unless a waiver of consent has been deemed appropriate at domain-level.\n\nCORE PLATFORM ELIGIBILITY - NEONATAL DOMAINS\n\nInclusion Criteria: Preterm infants must fulfil the following criteria to be eligible to participate in PLATIPUS, infants must be:\n\n1. Born preterm (\\\u003C37 weeks' gestational age)\n2. Receiving care at a participating site at the time of eligibility assessment.\n3. Meet the eligibility criteria for at least one domain.\n\nExclusion Criteria: Preterm infants who meet the following criteria will be excluded from participation in this trial:\n\n1. Circumstances where death (neonatal) is deemed to be imminent and inevitable. The treating team may however decide that providing an opportunity for the infant to participate is in the infant's interest. OR\n2. Parental\u002Fguardian inability to consent, unless a waiver of consent has been deemed appropriate at domain-level.\n\nDOMAIN-SPECIFIC ELIGIBILITY CRITERIA\n\nPotential participants who meet core platform eligibility criteria will be assessed for eligibility to participate in trial domains available at their hospital. Domain-specific eligibility criteria are outlined in the related Domain-Specific Appendices.",{"count":322,"type":21},100000,[24],"PLATIPUS is an adaptive platform trial aimed at improving the health of infants born preterm (before 37 weeks' gestation). PLATIPUS will compare how different treatments and care provided to pregnant women and people at risk of preterm birth and infants born preterm affect infant health.\n\nThe main questions PLATIPUS aims to answer are:\n\n1. What effect\u002Fs do different treatments\u002Fcare provided to pregnant women and people at risk of preterm birth have on the health of their infants? (Pregnancy domains)\n2. What effect\u002Fs do different treatments\u002Fcare given to infants born preterm have on their health ? (Neonatal domains).\n\nThis registration record relates to the PLATIPUS Core (or 'master') protocol which provides guidance for the overall running of the trial. Additional appendices will outline the aims, questions, treatments, and activities for each separate research question (domain). Each Domain-Specific Appendix will be registered separately on ClinicalTrials.gov and will link to this record.",[326],"Preterm Birth",[328,329,330,331],"Preterm infant","Pregnancy","Neonatal complications","Preterm labor","NOT_YET_RECRUITING","2025-06-10",{"date":335,"type":32},"2025-06-13",{"date":337,"type":21},"2025-11-01",{"date":339,"type":21},"2050-12-31",{"name":38,"class":39},{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":347,"eligibilityCriteria":348,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":349,"enrollmentInfo":350,"targetDuration":4,"studyType":22,"phases":352,"briefSummary":353,"conditions":354,"keywords":356,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":4},"100590855","caffeine-citrate-to-improve-neonatal-outcomes-100590855","NCT06972849","Caffeine Citrate to Improve Neonatal Outcomes.","BabyCCINO: Caffeine Citrate to Improve Neonatal Outcomes. A Neonatal Domain Within PLATIPUS.","BabyCCINO","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Born before 37 weeks gestation\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* (Parent) Inability to consent for their infant, unless a domain-level waiver of consent is deemed appropriate.\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening), including if neonatal intensive care is not being provided to the infant.\n\nInfants who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for BabyCCINO-specific eligibility.\n\nBabyCCINO-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all BabyCCINO-specific inclusion criteria:\n\n1. Very preterm infants born \\\u003C32 weeks' gestation\n2. \\\u003C72 hours old\n3. Very preterm infants born at \\\u003C32 weeks' gestation, \\\u003C72 hours of age, with any clinical indication for commencing caffeine, as determined by the treating clinician, including:\n\n   * Prevention or treatment of apnoea\n   * Facilitating extubation from mechanical ventilation\n   * Prevention of BPD\n   * For longer-term benefit.\n\nParticipants will be excluded from participation if they meet any BabyCCINO-specific exclusion criteria:\n\n1. Prior treatment with caffeine, other methylxanthines, or doxapram\n2. Major congenital anomalies: major congenital cardiac disease (not including patent ductus arteriosus or isolated atrial\u002Fventricular septal defects), major gastrointestinal malformations, congenital diaphragmatic hernia, known genetic syndromes, known brain malformations\n3. Death considered to be imminent in the next 24 hours, or intensive care not going to be offered or continued\n4. Pre-existing tachyarrhythmia (e.g., antenatal or postnatal supraventricular tachycardia)\n5. Pre-existing seizures\n6. No parental\u002Fcaregiver consent or not satisfying the principles and criteria for waiver with consent to continue, as approved in the relevant jurisdiction\n\nPlatform-eligible participants who meet all BabyCCINO-specific inclusion criteria and none of the BabyCCINO-specific exclusion criteria will be eligible to participate in BabyCCINO.","32 Weeks",{"count":351,"type":21},3900,[24],"The goal of this clinical trial to learn what dose\u002Fs of caffeine citrate works to treat preterm born babies who have episodes where they stop breathing. It will also learn about the safety of different doses of caffeine citrate for the variety of preterm-born babies that are prescribed this.\n\nThe main question it aims to answer is: Which dose is the optimal dose of caffeine citrate for very preterm babies to prevent short-term death and disease?\n\nResearchers will compare three different doses of caffeine citrate, which are already used in clinical practice to treat breathing stoppages in preterm babies, to see which dose works best. No placebo will be used.\n\nParticipants will be given a 'loading' dose of caffeine citrate \\\u003C72 hours of life, and a smaller 'maintenance' dose once a day, for as long as the baby needs this.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[355],"Apnea of Prematurity",[328,355,357,358],"Apnoea of Prematurity","Caffeine citrate","2025-05-06",{"date":361,"type":32},"2025-05-15",{"date":363,"type":21},"2025-10",{"date":365,"type":21},"2050-12",{"name":38,"class":39},{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":373,"eligibilityCriteria":374,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":22,"phases":377,"briefSummary":378,"conditions":379,"keywords":383,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":386,"lastUpdatePostDateStruct":387,"startDateStruct":389,"completionDateStruct":391,"leadSponsor":393,"locationsCount":394},"100530827","phase-4-subcutaneous-tirzepatide-once-weekly-in-patients-with-obesity-and-knee-osteoarthritis-stop-knee-oa-100530827","NCT06191848","Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA)","Effect of Subcutaneous Tirzepatide Once-weekly in Patients With Obesity and Knee Osteoarthritis (STOP KNEE-OA): A Randomized, Double-Blind, Placebo-Controlled Trial","STOP KNEE-OA","Inclusion Criteria:\n\n* Have a body mass index of ≥ to 30 kg\u002Fm2.\n* Report one or more previous unsuccessful attempt to lose body weight via lifestyle modification.\n* Have been deemed eligible to enter the waiting list for primary knee replacement for the treatment of osteoarthritis in the target joint by an orthopaedic surgeon at one of the participating study sites.\n* Have moderate-to-severe knee osteoarthritis in the target joint, defined as a Kellgren-Lawrence grade two or greater.\n* Be willing to and capable of learning how to self-inject the study drug and follow study procedures for the duration of the trial.\n* Provide informed consent to study participation in line with the requirements of the human research ethics committee of the study site.\n\nFemale participants must:\n\n* Not be currently pregnant or breastfeeding AND\n* Not be of reproductive potential, defined as:\n* Infertile due to surgical sterilization or congenital anomaly, OR\n* Post-menopausal defined as:\n* A woman over the age of 40 years with spontaneous cessation of menses for at least 12 consecutive months (in the absence of medications known to induce amenorrhea), with a follicle-stimulating hormone ≥40mIU\u002FmL, and a negative pregnancy test prior to study entry, OR\n* A woman over the age of 55 years with cessation of menses for at least 12 consecutive months (in the absence of medications known to induce amenorrhea), OR\n* A woman over the age of 55 years that has commenced hormone replacement therapy after a documented diagnosis of menopause.\n\nExclusion Criteria:\n\nParticipant will be ineligible for inclusion if they meet any of the following criteria:\n\n* Have been deemed eligible to enter the waiting list for knee replacement in the contralateral knee by an orthopaedic surgeon at one of the participating study sites.\n* Have used any prescription medications intended to promote weight loss (e.g., tirzepatide, liraglutide, semaglutide) in the three months prior to screening.\n* Have previously undergone any surgical or endoscopic procedure intended to promote weight loss.\n* Have been diagnosed with type 1 diabetes mellitus (T1DM) or T2DM\n* Have laboratory evidence indicative of diabetes mellitus during screening.\n* Have personal or family history of medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)\n* Have an active malignancy (excluding basal or squamous cell skin cancer).\n* Have had a transplanted organ or awaiting an organ transplant\n* Have received chronic systemic glucocorticoid therapy (for more than 14 days) in prior 3 months or have a significant, active autoimmune abnormality (e.g., lupus or rheumatoid arthritis) that the study doctor deems likely to require systemic glucocorticoid therapy during the next 18 months.\n* Have any other medical conditions, abnormal laboratory tests or concomitant medications that make them unsuitable for participation:\n\n  * Have a clinically significant gastric emptying abnormality.\n  * Have had a history of acute or chronic pancreatitis.\n  * Have obesity induced by other endocrinologic disorders\n  * Have an unstable psychiatric disorder\n  * Have a Patient Health Questionnaire (PHQ-9) score of \\>15 during screening\n  * Have been deemed by the study doctor to be actively suicidal,\n* Have answered \"yes\" to questions 4 or 5 on the \"Suicidal Ideation\" section of the Columbia-Suicide Severity Rating Scale (C-SSRS) during screening, OR\n* Have answered yes to any questions in the \"Suicidal Behaviour\" section of the C-SSRS during screening. AND\n* The behaviour or ideation occurred in the last month\n\n  * Have uncontrolled hypertension (systolic blood pressure above or equal to 160 mmHg and\u002For diastolic blood pressure above or equal to 100 mmHg)\n  * Have had within the past 6 months prior to randomisation any of the following: acute myocardial infarction, cerebrovascular accident, unstable angina, or hospitalisation due to congestive cardiac failure (are also exclusion criteria for elective knee replacement)\n  * Have severe renal impairment defined as an eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 at screening visit.\n  * Have thyroid-stimulating hormone outside of the range of 0.4 to 6.0 mIU\u002FL at screening visit\n  * Have acute or chronic hepatitis or abnormal liver function tests as measured by either alanine aminotransferase or alkaline phosphatase \\>200 IU.\n  * Have any other known contraindication to any glucagon-like peptide-1 receptor agonists.\n* Are study site personnel, or immediate family of a member of the study site.\n* Have been enrolled in any other study of an investigational product within the past ninety days or are currently enrolled in such a study.",{"count":376,"type":21},352,[184],"This is a trial of tirzepatide in people with obesity and knee osteoarthritis. The main purpose of this study is to see if tirzepatide can reduce number of these participants who require a knee replacement. Participants will be randomized to take a weekly injection of tirzepatide or a placebo for a total of 72 weeks.",[380,381,382],"Obesity","Knee Osteoarthritis","Osteoarthritis, Knee",[384,380,385],"Osteoarthritis","Total knee replacement","2025-04-27",{"date":388,"type":32},"2025-04-30",{"date":390,"type":32},"2024-11-19",{"date":392,"type":21},"2037-05",{"name":38,"class":39},4,{"id":396,"slug":397,"hasResults":11,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":403,"targetDuration":4,"studyType":22,"phases":405,"briefSummary":406,"conditions":407,"keywords":409,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":103},"100571145","prehabilitation-for-patients-undergoing-lung-cancer-surgery-100571145","NCT06716437","Prehabilitation for Patients Undergoing Lung Cancer Surgery","Digitally Enabled Prehabilitation in a Community-based Setting for Patients Undergoing Lung Cancer Surgery","DIGI-Lung","Inclusion Criteria:\n\n* Diagnosis of lung cancer and scheduled for lung resection surgery\n* Ability to understand and speak English to follow instructions and complete the intended assessments.\n* Age ≥ 18 years at the point of baseline screening\n* Provide written informed consent for the trial\n* Sufficient digital literacy to use a smartphone and mobile app\n* No contraindications for exercise\n\nExclusion Criteria:\n\n* Other cancer diagnoses than lung cancer\n* Surgery scheduled in less than one week\n* Unstable psychiatric, cognitive or substance abuse disorders that would interfere with cooperation with the requirements of the trial",{"count":404,"type":21},25,[24],"Major surgery has been linked to running a marathon as in both represent large endeavours where the body will experience an increase in demands to supply the necessary energy. It has been alledged that, as one would train to prepare for a marathon, the same should be applied to surgery. The process of getting ready and\u002For fitter for surgery is frequently referred to as prehabilitation and it usually involves interventions on improving nutrition and diet, getting fit and improve emotional wellness. Prehabilitation can improve the recovery after surgery and reduce the time spent in hospital afterwards. This research seeks to determine whether a home based program of increased physical activity and breathing training can improve patients' physical and respiratory function in preparation for lung cancer surgery.",[408],"Lung Cancer (NSCLC)",[410,411,412,413,414],"Prehabilitation","Inspiratory Muscle Training","Exercise Therapy","Lung Cancer","Telehealth","2025-04-16",{"date":417,"type":32},"2025-04-22",{"date":419,"type":32},"2025-01-24",{"date":421,"type":21},"2025-06-30",{"name":38,"class":39},{"id":424,"slug":425,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":11,"sex":431,"minAge":4,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":22,"phases":433,"briefSummary":434,"conditions":435,"keywords":438,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":447,"locationsCount":4},"100585775","preterm-rupture-of-membranes-optimising-antibiotics-trial-100585775","NCT06906757","Preterm Rupture of Membranes Optimising Antibiotics Trial","Preterm Rupture of Membranes Optimising Antibiotics Trial (PROMOAT). A Pregnancy Domain Within PLATIPUS.","PROMOAT","PLATFORM ELIGIBILITY\n\nParticipants must meet all core PLATIPUS platform inclusion criteria:\n\n* Considered to be at risk of birth before 37 weeks gestation (spontaneous and provider-initiated)\n* Receiving pregnancy care at a participating site (hospital) at the time of eligibility assessment and\n* Meet eligibility criteria for one or more platform domains.\n\nParticipants will be excluded from participation if they meet any core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nPregnant women and people who meet ALL of the core platform inclusion criteria and none of the exclusion criteria will be considered for PROMOAT-specific eligibility.\n\nPROMOAT-SPECIFIC ELIGIBILITY\n\nPlatform-eligible participants must meet all PROMOAT-specific inclusion criteria:\n\n1. Women with singleton or multiple pregnancies complicated by preterm prelabour rupture of membranes (PPROM) \\\u003C 37+0 weeks' gestation as determined by the treating clinician and standard criteria:\n\n   * Maternal history consistent with loss of fluid per vagina\n   * Evidence of a pool of fluid in the vagina on sterile speculum examination\n   * +\u002F- positive testing for IGFBP-1 (Actim PROM) or PAMG-1 (Amnisure) AND\n2. Are eligible for at least two treatment arms within the domain\n3. The fetus\u002Ffetuses are alive at randomisation\n4. The pregnancy is continuing and active neonatal management is planned.\n\nParticipants will be excluded from participation if they meet core PLATIPUS platform exclusion criteria:\n\n* Inability to consent for themselves OR\n* Perinatal death is deemed to be imminent and inevitable during the next 24 hours (at time of screening).\n\nParticipants will be excluded from participation if they meet any PROMOAT-specific exclusion criteria:\n\n1. Antibiotic treatment for \\> 24 hours administered with the aim of preventing infection from PPROM\n2. Suspected maternal or fetal infection (chorioamnionitis)\n3. Maternal or fetal indication for immediate birth\n4. Established preterm labour (cervical dilatation ≥ 3cm AND regular contractions)\n5. No appropriate antibiotic available within domain intervention arms due to allergy, contraindications, drug interactions, drug availability, or previous history of antibiotic-resistant infection\u002Fs\n6. Women with a previous infant affected by GBS sepsis\n7. Major congenital fetal anomaly.\n\nPlatform-eligible participants who meet all PROMOAT-specific inclusion criteria and none of the PROMOAT-specific exclusion criteria will be eligible to participate in PROMOAT.","FEMALE",{"count":351,"type":21},[24],"The goal of this clinical trial is to learn which antibiotic regimen works best to prevent infection in pregnant women whose waters break early (preterm, pre-labour rupture of membranes, or PPROM) and assess the health outcomes of babies born to pregnant women who have received these antibiotics.\n\nPROMOAT aims to answer the question: Which antibiotic or combined antibiotic regimen most effectively prevents infection in pregnant women with PPROM \\\u003C 37+0 weeks' gestation.\n\nResearchers will compare three antibiotic regimens already used in clinical practice to prevent infection in pregnant women with PPROM.\n\nParticipants will be randomly allocated to the antibiotic regimen they will follow for seven days, or until birth (whichever is earlier). All antibiotics will be taken orally.\n\nNeonatal health outcomes will be collected at 42 weeks postmenstrual age and maternal birth and postpartum care outcomes assessed at 42 days postpartum.\n\nQuestionnaires will capture maternal mood at time of consent and at 42 days postpartum. Antibiotic tolerance will be assessed at the time antibiotic treatment is ceased.\n\nThis trial will be undertaken as part of the PLATIPUS trial (NCT06461429).",[436,437],"PPROM","Preterm",[439,440],"Pregnancy, Preterm, PPROM, Antibiotics","chorioamnionitis","2025-03-31",{"date":443,"type":32},"2025-04-02",{"date":445,"type":21},"2025-09",{"date":365,"type":21},{"name":38,"class":39},{"id":449,"slug":450,"hasResults":11,"nctId":451,"briefTitle":452,"officialTitle":453,"acronym":4,"eligibilityCriteria":454,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":242,"enrollmentInfo":455,"targetDuration":4,"studyType":22,"phases":457,"briefSummary":458,"conditions":459,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":465,"completionDateStruct":467,"leadSponsor":468,"locationsCount":103},"100545173","dose-response-effects-of-mindfulness-meditation-100545173","NCT06378450","Dose-Response Effects of Mindfulness Meditation","Examining Dose-Response Effects of Mindfulness Meditation Interventions on Wellbeing: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Reside in Australia, with no plans to relocate or travel overseas during the intervention period;\n* Sufficient comprehension of the English language to complete measures;\n* Register for an account and agree to the Terms and Conditions of Unforgettable.Me;\n* If suffering anxious or depressive symptoms of moderate severity (defined by \\> 19 on the Patient-Reported Outcomes Measurement Information System \\[PROMIS\\] Level 2 Anxiety or \\> 22 on the PROMIS Level 2 Depression), must agree to continue recommended routine medical treatment for eligible underlying mental and\u002For physical health conditions or the duration of the study and to seek additional treatment if indicated by deterioration of symptoms;\n* No or minimal experience with meditation, defined as less than 25 hours over the past 6 months; never attended a multi-day mindfulness course (e.g., Mindfulness-Based Stress Reduction, Vipassana). If 50% of our target sample size has not bee recruited within the first three months of active recruitment, the inclusion criteria will be broadened to include participants with up to 100 hours in the past 6 months.\n\nExclusion Criteria:\n\n* Self-reported current or lifetime serious mental illness (e.g., neurodevelopmental, schizophrenia spectrum, bipolar, obsessive-compulsive, trauma-related, dissociative or personality disorder);\n* Anxious and depressive symptoms in the severe range (defined by \\>27 on the PROMIS Level 2 Anxiety or \\> 32 on the PROMIS Level 2 Depression);\n* Psychological distress symptoms in the severe range (Kessler Psychological Distress Scale \\[K10\\] \\>= 30);\n* Threshold scores on pre-screening and follow-up measures exceeded for Mania, Suicidal Ideation, Psychosis, Repetitive Thoughts \\& Behaviors, Dissociation\n* Moderate alcohol, tobacco, or drug use;\n* Self-reported diagnosis of neurological condition (e.g., traumatic brain injury, amnesia, epilepsy, stroke, etc.);\n* Self-reported presence of any serious medical condition (e.g., cancer, thyroid disorder, multiple sclerosis, etc.);\n* Recent bereavement or major loss;\n* History of unexplored, untreated traumatic experiences or adverse childhood events.",{"count":456,"type":21},860,[24],"The goal of this randomized controlled trial is to test for evidence of dose-response effects in a sample of healthy adults with little to no prior experience with meditation.\n\nThe main question it aims to answer is whether larger doses of mindfulness meditation yield greater positive changes in wellbeing than smaller doses.\n\nOur hypotheses are that (1) larger doses of mindfulness training will yield significantly larger effects, and (2) different doses will be significantly associated with variation in participant engagement, with lower engagement associated with higher doses.\n\nResearchers will compare each of three dose conditions, 10-min, 20-min, 30-min, against a minimal dose condition of 3-4 min.\n\nParticipants will take a 28-day mindfulness meditation course, with guided audio instructions provided daily throughout the intervention period (excluding one rest day per week). They will also be asked to respond to surveys before, during, and after the intervention.",[460,461],"Well-Being, Psychological","Depression","2025-03-25",{"date":464,"type":32},"2025-03-30",{"date":466,"type":32},"2024-05-01",{"date":421,"type":21},{"name":38,"class":39},{"id":470,"slug":471,"hasResults":11,"nctId":472,"briefTitle":473,"officialTitle":473,"acronym":474,"eligibilityCriteria":475,"healthyVolunteers":112,"sex":17,"minAge":18,"maxAge":476,"enrollmentInfo":477,"targetDuration":4,"studyType":22,"phases":478,"briefSummary":479,"conditions":480,"keywords":484,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":491,"completionDateStruct":493,"leadSponsor":495,"locationsCount":103},"100583853","phase-1-experimental-malaria-infection-of-healthy-malaria-naive-adults-by-mosquito-bite-with-the-genetically-modified-plasmodium-falciparum-nf54igp3-gap-100583853","NCT06881732","Experimental Malaria Infection of Healthy Malaria-Naive Adults by Mosquito Bite With the Genetically Modified Plasmodium Falciparum NF54\u002FiGP3 GAP","iGP3-SWITCH","INCLUSION CRITERIA:\n\n* Able and willing to complete the informed consent process\n* Available for the entire planned study duration\n* Male or Female\n* Aged 18 to 55 years\n* Willing to have blood samples collected, stored indefinitely and used for research purposes\n* Willing to defer blood donations for at least six months after the EoS visit (D180)\n* Agreement to adhere to specific Lifestyle Considerations throughout study duration\n\nClinical Criteria:\n\n* Total body weight ≥ 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg\u002Fm2 (inclusive)\n* In good general physical and mental health as evaluated through a comprehensive clinical assessment\n* Vital signs at screening and pre-inoculation within normal clinical range\n* Electrocardiograph (ECG) without significant abnormalities, including: QTcF ≤450 ms for males, QTcF ≤470 ms for females, PR interval ≤210 ms\n\nLaboratory Criteria:\n\n* O negative blood type\n* Haemoglobin, white cell count and platelet levels within normal laboratory ranges\n* Ferritin, creatinine and alanine aminotransferase (ALT) within normal laboratory ranges\n* No clinically significant abnormality in coagulation or clotting\n* Normal G6PD enzyme activity levels as defined by the parameters of the specific quantitative G6PD test performed at screening\n* Negative for blood borne viruses, including Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), Human T-lymphotropic virus type 1 (HTLV); and other blood borne pathogens including West Nile Virus (WNV), Babesia species, Treponema pallidum, and Trypanosoma cruzi\n\nCriteria specific to female participants:\n\n* Post-menopausal for at least 1 one year, post-hysterectomy, or bilateral oophorectomy with a correlating follicle stimulating hormone (FSH) level.\n\nOR\n\n* Females of childbearing age have a negative beta-human chorionic gonadotrophin (b-HCG) pregnancy test (urine or serum) on day of enrolment and prior to CHMI inoculation and agreement to use effective birth control through the duration of the study.\n\nEXCLUSION CRITERIA:\n\n* Participant lives alone and is unable provide contact details of a support person who is aware of the individual's participation in the study and is available to provide assistance if required\n* Participation in any investigational product study within the 12 weeks preceding inoculation\n* Positive urine drug test at screening or on the day of malaria inoculation unless there is an explanation acceptable to the Investigator (e.g. the volunteer has stated in advance that they consumed a prescription or over-the-counter product which contained the detected drug) and\u002For the volunteer has a negative urine drug screen on retest by the pathology laboratory\n* Positive alcohol breath test at screening or on the day of malaria inoculation\n\nMalaria History:\n\n* Any previous history of malaria infection, including participation in a malaria research study\n* Receipt of a malaria vaccination at any time, including as part of a research study\n* Travelled to or lived (more than two weeks) in a malaria-endemic region during the past 12 months or planned travel to a malaria-endemic region over the course of the study\n* Lived for more than one year in a malaria-endemic region in the past 10 years\n* Lived in a malaria-endemic region for more than 10 years inclusive\n\nClinical History:\n\n* Anyone who is pregnant, breastfeeding or planning pregnancy during the study period\n* History of severe allergic reaction, including angioedema or anaphylaxis\n* Receipt of any live attenuated vaccines within 21 days prior to enrolment\n* Has ever received a blood transfusion\n* Use of blood products or immunoglobulins within the previous 6 months\n* Without good peripheral venous access\n* Clinical history of: Sickle cell disease, sickle cell trait or other haemoglobinopathies; Splenectomy or fuctional asplenia; Skeeter syndrome or anaphylactic response to mosquito bites\n* Known intolerance, hypersensitivity or other contraindication to artemether or other artemisinin derivatives, lumefantrine, atovaquone, proguanil, primaquine, or artesunate or any of its excipients\n* Use or planned use of any drug, including antibiotics, with antimalarial activity four weeks prior to inoculation\n* Use of any of the following drugs: Anticoagulants (within 14 days of enrolment); Systemic corticosteroids (within 3 months of enrolment); Any prescription or non-prescription drugs, and or supplements that in the opinion of the investigator would jeopardise the safety of the volunteer\n* Any other chronic or clinically significant medical condition that in the opinion of the investigator would jeopardize the safety or rights of the volunteer, including but not limited to: diabetes mellitus type I, chronic hepatitis; OR clinically significant forms of: drug or alcohol abuse, asthma, autoimmune disease, infectious diseases, psychiatric disorders, heart disease, or cancer\n\nClinical Risk:\n\n* Evidence at screening of increased cardiovascular disease risk (defined as \\>10%, 5-year risk for those greater than 35 years of age), as determined by the Australian Absolute Cardiovascular Disease Risk Calculator","55 Years",{"count":264,"type":21},[246],"The goal of this clinical trial is to learn if the genetically-modified malaria parasite NF54\u002FiGP3 will safely infect humans with malaria. The investigators will also determine how the parasite grows in humans, and the effect of anti-malarial drugs.\n\nResearchers will use a controlled human malaria infection (CHMI) model to infect participants with malaria to observe the development of the disease, collect malaria-infected blood, and then treat the participants to cure the malaria infection.\n\nThe collected malaria-infected blood will be used to create a frozen stock of malaria parasites for use in future research.",[481,482,483],"Malaria Falciparum","Malaria Infection","Malaria Transmission",[485,486,487],"SWITCH","NF54\u002FiGP3","Plasmodium falciparum","2025-03-11",{"date":490,"type":32},"2025-03-18",{"date":492,"type":21},"2025-07",{"date":494,"type":21},"2026-07",{"name":38,"class":39},{"id":497,"slug":498,"hasResults":11,"nctId":499,"briefTitle":500,"officialTitle":500,"acronym":501,"eligibilityCriteria":502,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":503,"targetDuration":505,"studyType":506,"phases":4,"briefSummary":507,"conditions":508,"keywords":509,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":103},"100556604","electronic-capturing-of-activities-during-rehabilitation-for-upper-limb-after-stroke-100556604","NCT06527261","Electronic Capturing of Activities During REhabilitation for Upper Limb After Stroke","eCARE4Stroke","Group 1: Stroke patients\n\nInclusion Criteria:\n\n* Adults (≥18 years) with a new, first or consecutive stroke, confirmed on CT or MRI.\n* Motor upper limb impairment defined by a Shoulder Abduction and Finger Extension (SAFE) score of 0 through 9.\n* Able to consent for themselves.\n* Likely to receive at least one upper limb intervention session as determined by the treating clinical team.\n\nExclusion Criteria:\n\n* Existing co-morbidities that limit upper limb function and usual care treatment provided as determined by the treating clinical team e.g., neural or orthopeadic\n* Receiving palliative care or have a limited life expectancy\n* Deemed unable or unnecessary to participate in upper limb intervention by the treating clinical team\n* Treating Occupational Therapist and local allied health assistant declined to participate in the research preventing recording of usual care data\n* Unable to follow basic instructions in English\n\nGroup 2: Clinicians\n\nInclusion criteria\n\n* Occupational therapist or allied health assistant working with the stroke population in an acute or subacute settings within Austin Health.\n* At least four months of clinical experience\n\nExclusion criteria:\n\n• Clinicians expected to move into another clinical area within one month.",{"count":504,"type":21},146,"4 Months","OBSERVATIONAL","This is a prospective cohort study to determine the feasibility of accurate, complete, and timely real-time electronic capturing of upper limb motor intervention sessions during usual care. In clinical trials accurate reporting of usual care for people with stroke is scarce, thus understanding the control group compared to the experimental group is poor. The unit of measure in this study is therapy sessions, where a clinician is providing usual care to a patient.\n\nThe observed sessions will occur in two Austin Health settings: Acute at Austin Hospital; subacute, across Royal Talbot Rehabilitation Centre or the Heidelberg Repatriation Hospital. For each session, patient characteristics, dose and content of upper limb interventions will be electronically captured in REDCap. Additionally, the sessions will be video recorded to allow a second rater to assess feasibility. The secondary aim is to determine if there is an association between the dose and content of upper limb intervention sessions and the contextual factors of stroke patients. Two participant groups will be recruited: Stroke patients and Clinicians (Occupational Therapists and Allied Health Assistants).",[219],[510,511,512,513],"Usual care","Upper extremity","Dose","Rehabilitation","2024-07-24",{"date":516,"type":32},"2024-07-30",{"date":518,"type":21},"2024-07",{"date":520,"type":21},"2026-12",{"name":38,"class":39},{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":22,"phases":532,"briefSummary":533,"conditions":534,"keywords":536,"overallStatus":332,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":551},"100554175","australasian-nanoparticle-mediated-magnetically-enhanced-diffusion-for-ischemic-stroke-100554175","NCT06495671","Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke","Australasian Nanoparticle-mediated Magnetically Enhanced Diffusion for Ischemic Stroke (AusNanoMED)","AusNanoMED","Inclusion Criteria:\n\n* Patients presenting with ischemic stroke within 24 hours of the time they were last known to be well\n* Patient's age is ≥18 years\n* Legal requirements for consent as per local legislative requirements are satisfied.\n* Distal medium vessel intracranial arterial occlusion visible on CT-angiography, MR-angiography or catheter digital subtraction angiography (DSA) in the middle cerebral, anterior or posterior cerebral artery. The occlusion may be primary or secondary (ie following initial mechanical thrombectomy of a large vessel occlusion)\n\nExclusion Criteria:\n\n* Intracranial hemorrhage (ICH) identified by CT or MRI\n* Rapidly improving symptoms at the discretion of the investigator\n* Pre-stroke mRS score of ≥ 3 (indicating functional dependence)\n* Frank hypodensity in \\>1\u002F3 of the affected arterial territory on non-contrast CT\n* CT Perfusion ischemic core volume \\> 100 ml\n* Known automated implantable cardiac defibrillator, pacemaker, cerebral aneurysm clip, cochlear implant, cranial neurostimulator or other device implant that is incompatible with the external magnetic field\n* Known allergy or sensitivity to iron\n* Known hemochromatosis, or known liver disease such as cirrhosis.\n* Known aortic dissection\n* Suspected septic embolization\n* Contra indication to imaging with contrast agents\n* Pregnant or lactating women\n* Any terminal illness such that patient would not be expected to survive more than 6 months\n* Current participation in another investigational drug or device treatment study\n* Any condition that, in the judgment of the investigator could impose hazards to the patient if study therapy is initiated or affect the participation of the patient in the study.",{"count":531,"type":21},30,[24],"Rapidly restoring blood flow to the brain in patients with stroke caused by a blocked blood vessel in the brain is the key to reducing disability. Current treatments often leave small blocked arteries that cannot be safely opened with mechanical clot removal devices. Furthermore, stagnant flow limits access of clot-dissolving medication to the clot. This trial tests iron nanoparticles (similar to iron infused to replace low body stores but injected directly into the brain artery upstream of the blockage) combined with an external rotating magnet that draws the nanoparticles towards the clot, overcoming stagnant blood flow. The aim is to bring fresh blood which contains naturally-occurring clot-dissolving substances, and any clot-dissolving medication that may be circulating, to the surface of the clot with the aim of restoring blood flow to the brain. The trial will recruit up to 30 patients. All will receive injection of nanoparticles via an angiogram (small tube inserted into a leg or arm artery and fed up into the brain artery under Xray control). The procedure takes 30min and the degree of success in opening the artery at the end of procedure is the primary outcome, combined with an absence of symptomatic brain bleeding at 24h.",[535,219],"Ischemic Stroke",[537,538,539,540,541,542],"thrombolysis","thrombolytic","endovascular thrombectomy","nanoparticle","magnetically enhanced diffusion","digital subtraction angiography","2024-07-07",{"date":545,"type":32},"2024-07-11",{"date":547,"type":21},"2024-08-01",{"date":549,"type":21},"2027-03-31",{"name":38,"class":39},7,{"id":553,"slug":554,"hasResults":11,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":560,"targetDuration":4,"studyType":22,"phases":562,"briefSummary":563,"conditions":564,"keywords":566,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":572,"lastUpdatePostDateStruct":573,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":290},"100449725","polysomnographic-titration-of-non-invasive-ventilation-in-motor-neurone-disease-100449725","NCT05136222","Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease","A Multi-centre Randomised Controlled Trial of Polysomnographic Titration of Non-invasive Ventilation in Motor Neurone Disease (PSG4NIVinMND; 3, Three Letter Acronyms [3TLA])","3TLA","Inclusion Criteria:\n\n* Age \\>18 years\n* Clinical indication to commence long term NIV\n* Confirmed clinical diagnosis of underlying condition\n\nExclusion Criteria:\n\n* Medically unstable\n* Hypoventilation attributable to medications with sedative\u002Frespiratory depressant side- effects\n* Use of NIV for more than 1 month in the previous 3 months\n* Inability to provide informed consent\n* Previous intolerance of NIV",{"count":561,"type":21},244,[24],"A two-arm, individual participant randomised controlled, assessor-blinded trial in 7 MND care centres across Australia will be undertaken.",[565],"Motor Neuron Disease \u002F Amyotrophic Lateral Sclerosis",[567,568,569,570,571],"Non-invasive ventilation","Polysomnography","Sleep study","Amyotrophic lateral sclerosis","Chronic respiratory failure","2022-06-19",{"date":574,"type":32},"2022-06-23",{"date":576,"type":32},"2021-12-15",{"date":578,"type":21},"2028-02-28",{"name":38,"class":39},""]