[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"South West Sydney Local Health District\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,46,77,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100615431","phase-2-tirzepatide-combined-with-cognitive-behavioural-therapy-cbt-for-adults-with-alcohol-use-disorder-aud-and-overweightobesity-oob-100615431",false,"NCT07292519","Tirzepatide Combined With Cognitive-Behavioural Therapy (CBT) for Adults With Alcohol Use Disorder (AUD) and Overweight\u002FObesity (OOB)","Inclusion Criteria:\n\n1. Aged 21 to 75 years\n2. Meet DSM-5 criteria for alcohol use disorder (AUD) with at least moderate severity (≥4 symptoms in the past year)\n3. Have an average daily alcohol consumption of:\n\n   * ≥60g ethanol\u002Fday for men\n   * ≥40g ethanol\u002Fday for women (based on the 28 days prior to the baseline visit)\n4. Body mass index (BMI) ≥27 kg\u002Fm²\n5. Currently motivated to reduce or stop drinking but not engaged in formal AUD treatment\n6. Able and willing to attend weekly clinic visits and complete all study procedures\n7. Fluent in English and able to provide informed consent\n8. Stable housing situation (not transient or homeless)\n\nExclusion Criteria:\n\n1. Past-year DSM-5 diagnosis of another substance use disorder (except nicotine or mild cannabis use disorder)\n2. Recent (past 30 days) self-reported illicit drug use (excluding cannabis), or a positive urine drug screen for non-cannabis substances\n3. History of significant alcohol withdrawal, defined by:\n\n   * History of seizure, delirium tremens, or\n   * Hospitalisation for withdrawal, or\n   * CIWA-Ar score \\>9, or\n   * PAWS score \\>4 at screening\n4. Currently engaged in pharmacological or behavioral treatment for AUD, or prior engagement within the past 3 months\n5. History or current diagnosis of:\n\n   * Type 1 or Type 2 diabetes\n   * Diabetic complications (e.g. retinopathy)\n   * HbA1c ≥6.5% at screening\n6. Significant psychiatric illness, including:\n\n   * Current active suicidal ideation (per C-SSRS)\n   * Lifetime history of psychosis or bipolar disorder\n   * Unstable depression or anxiety interfering with daily functioning\n7. Chronic or acute pancreatitis\n8. Significant liver disease or abnormal liver function tests (ALT, AST, ALP, bilirubin \\>3× ULN)\n9. Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia (MEN) type I\u002FII\n10. Estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\n11. Recent significant weight loss (\\>5% of body weight in past 30 days)\n12. Use of any weight loss medication (e.g., orlistat, bupropion-naltrexone) or AUD medication (e.g., naltrexone, acamprosate, topiramate, varenicline) in the past 3 months\n13. Use of tirzepatide or any GLP-1 receptor agonist in the past 6 months\n14. Pregnant or breastfeeding, or not using effective contraception (females of childbearing potential)\n15. Inability to attend weekly visits due to work\u002Ftravel\u002Fschedule conflicts\n16. Participation in another clinical trial involving an investigational product\n17. Shared household with a current or past participant in this trial\n18. Scheduled for surgery requiring anaesthesia within 90 days of enrolment that would interfere with participation or follow-up\n19. History of muscle wasting, bone disorders (e.g. sarcopenia)\n20. Active gastrointestinal conditions that could interfere with treatment (e.g., severe GERD)\n21. Uncontrolled hypertension, recent heart attack or stroke (within 6 months)\n\n    Extra Exclusion criteria for Those Participants Agreeing to Participate in Neuroimaging \\& Psychophysiology Tasks:\n22. Presence of any MRI-incompatible metal implants or devices, including pacemakers, aneurysm clips, insulin pumps, or cochlear implants\n23. History of brain surgery or penetrating head trauma\n24. Prior occupation as a machinist, welder, or metal worker (due to risk of metal fragments)\n25. Non-removable piercings or dental hardware that would interfere with MRI\n26. History of claustrophobia likely to interfere with scanning compliance aa. Neurological disorders (e.g., epilepsy, multiple sclerosis) likely to confound neuroimaging data bb. Inability to lie still or tolerate MRI procedures cc. Patient weighting over 159kg (MRI scan limit) dd. Any other condition or medication judged by the investigator to preclude safe participation","ALL","21 Years","75 Years",{"count":19,"type":20},46,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The investigators approach is to conduct a Phase II Double-Blind randomised controlled trial with individuals with co-occurring Alcohol Use Disorder and overweight\u002Fobesity (AUD-OOB) to receive either a sub-cutaneous injection of Tirzepatide (2.5 mg for 4 weeks followed by 5 mg for 4 weeks) or visually matched sham saline injection, in combination with a structured behavioural intervention (Take Control CBT Module). The primary aim of the study is evaluate the efficacy of the intervention on the number of heavy drinking days (defined as 5+ standard drinks for men, 4+ standard drinks for women) during the final month of treatment (weeks 5 to 8) compared to baseline. The secondary aim of the study is to assess treatment effects on alcohol related (e.g. number drinks consumed per day, abstinent days) and cardio-metabolic outcomes (e.g. body weight in kg, waist circumference, blood pressure, HbA1c, total cholesterol etc...), and summarise safety outcomes associated with use (e.g. frequency and severity of side effects, number of serious adverse events, treatment related discontinuations). The study will also include neurobiological assessments such as functional magnetic resonance imaging (fMRI) and lab-based psychophysiology to assess the impact of tirzepatide on change in brain activity and autonomic responses to alcohol and food cues.",[26,27,28],"Alcohol Use Disorder (AUD)","Overweight or Obese","Comorbidities and Coexisting Conditions",[26,27,30,31,32],"Concurrent Treatment of AUD and overweight\u002Fobesity","Tirzepatide","Phase II Double-blind RCT","NOT_YET_RECRUITING","2025-12-15",{"date":36,"type":37},"2025-12-18","ACTUAL",{"date":39,"type":20},"2026-01-15",{"date":41,"type":20},"2028-01-15",{"name":43,"class":44},"South West Sydney Local Health District","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":45},"100611960","phase-1-ketamine-enhanced-therapy-for-individuals-with-alcohol-use-disorder-and-depression-a-pilot-study-ket-dual-100611960","NCT07247370","Ketamine-Enhanced Therapy for Individuals With Alcohol Use Disorder and Depression: A Pilot Study (KET-DUAL)","An Open-label Pilot Evaluation of Ketamine-Enhanced Psychotherapy in Individuals With Alcohol Use Disorder (AUD) and Co-morbid Major Depressive Disorder (MDD)","KET-DUAL","Inclusion Criteria:\n\n1. Moderate to severe AUD according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria\n2. Presence of current Major Depressive Disorder (MDD), according to the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-V) criteria\n3. Expressed motivation to reduce or cease alcohol consumption.\n4. Consumed at least 21 standard drinks per week or 2 HDD per week (≥5 standard drinks\u002Fday for men; ≥4 for women) in the month prior to screening\n5. Age 18-70\n6. Adequate cognition and English language skills to give valid consent and complete research interviews\n7. Stable housing\n8. Willingness to give written informed consent.\n9. Willingness to comply with study procedures and attend scheduled visits.\n\nExclusion Criteria:\n\n1. DSM-5 diagnosis of current or past psychotic disorder, bipolar I disorder, or substance-induced psychosis.\n2. Current acute suicidality, defined as high risk by the Columbia Suicide Severity Rating Scale (C-SSRS) or clinical judgment or attempts in the past 6 months.\n3. DSM-5 diagnosis of current or past moderate-to-severe ketamine or other dissociative drug use disorder.\n4. Use of ketamine (prescribed or non-prescribed) in the previous 4 weeks.\n5. Enrolment in another interventional clinical trial that may interfere with safety, data quality, or trial participation.\n6. Pregnant or breastfeeding, or planning to become pregnant during the course of the study.\n7. Significant uncontrolled medical conditions, including but not limited to:\n\n   * Severe or poorly controlled hypertension (\\>160\u002F100 mmHg)\n   * Severe cardiovascular disease (e.g., heart failure, recent myocardial infarction, dysrhythmia)\n   * History of stroke, cerebral trauma, or intracranial mass\u002Fhaemorrhage\n   * Severe hepatic impairment (e.g., MELD ≥10) or end-stage liver disease, bladder or kidney disease\n8. Clinically significant alcohol withdrawal at screening (e.g., CIWA-Ar ≥10, history of delirium tremens).\n9. History of heightened intracranial pressure, seizures, or diagnosed seizure disorder (except childhood febrile seizures).\n10. Known hypersensitivity to ketamine or any excipients.\n11. Concurrent use of psychotropic medications (other than stable-dose antidepressants ≥4 weeks).\n12. Active substance use disorder (moderate or severe) other than nicotine or caffeine; stable opioid use disorder permitted if on maintenance therapy (with strict stability criteria).\n13. Inability or unwillingness to comply with study procedures, judged by the principal investigator.\n14. Any clinically significant medical or psychiatric condition that, in the judgment of the Principal Investigator, poses a safety risk or could confound study results or hinder protocol adherence.","18 Years","70 Years",{"count":57,"type":20},20,[59,23],"PHASE1","To assess the safety, feasibility and preliminary efficacy of ketamine-enhanced therapy (KET) for alcohol use disorder (AUD) and comorbid major depressive disorder (MDD) in an open-label, single arm, pilot clinical trial.",[26,62,28],"Major Depressive Disorder (MDD)",[64,65,66,67,68,26,62],"Ketamine-enhanced psychotherapy","Open-label","Single-arm","Ketamine","Concurrent Treatment of AUD and comorbid MDD","2025-11-20",{"date":71,"type":37},"2025-11-25",{"date":73,"type":20},"2025-12-10",{"date":75,"type":20},"2027-12-10",{"name":43,"class":44},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":11,"sex":15,"minAge":85,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":21,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100591415","rehabilitation-in-the-home-after-hip-fracture-100591415","NCT06980129","Rehabilitation in the Home After Hip Fracture","RITH4Hips - Rehabilitation in the Home After Hip Fracture","RITH4Hips","Inclusion Criteria:\n\n* Community-dwelling adults ages ≥ 50 years presenting to Liverpool hospital or Bankstown-Lidcombe hospital with a low-trauma (osteoporotic) hip fracture who undergo surgical management\n* Anticipated to return to community (private) residence\n* Permitted to weight-bear as tolerated post-surgery\n* Suitable for inpatient rehabilitation (i.e., requires multidisciplinary rehabilitation, is considered cognitively suitable by the MDT to participate in the rehabilitation program being examined, and would otherwise be admitted to inpatient rehabilitation)\n* The presence of a carer, if required for mobility or function, is necessary at the time of transfer to the community. The carer must be prepared to manage the patient within 3 days post-randomisation. This time frame is considered necessary as carers will not be able to complete all required preparations before randomisation, and allowing an extended preparation period could bias the length of physical ward bed stay for the RITH group\n* Suitable environment for home-based rehabilitation as assessed by the MDT as per usual practice\n\nExclusion Criteria:\n\n* Presence of a concomitant condition that precludes actively participating in a rehabilitation program at home\n* Residential location outside the Bankstown-Canterbury, Liverpool, and Fairfield Local Government Areas\n* Active end-of-life management or palliative care\n* Previously participated in the HITH4Hips or RITH4Hips trials","50 Years",{"count":87,"type":20},220,[89],"NA","Hip fractures are common, especially in older adults, and they can have a big impact on health and quality of life. In Australia, hip fractures are a significant healthcare challenge. After surgery, patients often need rehabilitation to regain mobility, but this usually involves long hospital stays. The RITH4Hips trial will determine if a program where patients receive rehabilitation at home (instead of in the hospital) is similar to conventional inpatient rehabilitation.\n\nObjectives:\n\nThe main goal of this study is to find out if rehabilitation at home after surgery for a hip fracture works as well as rehabilitation in the hospital. The investigators also want to see if the home rehabilitation program can reduce the time spent in a hospital bed and improve other aspects like quality of life, mobility, and pain management.\n\nMethods:\n\nThis study will involve older adults who have had surgery due to a low-trauma hip fracture. Participants will be randomly assigned to either the usual care inpatient rehabilitation or the Rehabilitation in the Home (RITH) program. The investigators will measure outcomes such as how well patients can move, how much pain they experience, how their quality of life improves, and how much time they spend in the hospital.\n\nExpected Outcomes:\n\nThe investigators expect that the home rehabilitation program will be just similar to inpatient rehabilitation in helping patients recover mobility. The investigators also hope to find that it will reduce the time patients spend in a hospital bed, improve their quality of life, reduce fear of falling, and lessen the burden on carers. Additionally, the investigators aim to show that the home program is more cost-effective than hospital-based rehabilitation.",[92,93],"Hip Fractures (ICD-10 72.01-72.2)","Rehabilitation Program",[95,96],"rehabilitation program","hip fracture","2025-05-11",{"date":99,"type":37},"2025-05-20",{"date":101,"type":20},"2025-06-01",{"date":103,"type":20},"2027-09-20",{"name":43,"class":44},3,{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":112,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":15,"minAge":54,"maxAge":17,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":4,"overallStatus":122,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":45},"100480811","phase-2-viscoelastic-testing-guided-tissue-plasminogen-activator-treatment-in-acute-respiratory-failure-100480811","NCT05540834","Viscoelastic Testing Guided Tissue Plasminogen Activator Treatment in Acute Respiratory Failure","A Phase 2 Safety, Dose-finding and Efficacy Study Evaluating Viscoelastic Testing (VET) Guided Tissue Plasminogen Activator (tPA) Treatment in Critically-ill Pro-thrombotic Acute Respiratory Failure","VETtiPAT-ARF","Inclusion Criteria:\n\n1. Acute respiratory failure of primary pulmonary infectious or extrapulmonary infectious aetiology with severity graded by the arterial oxygen partial pressure to inspired fraction of oxygen ratio (P\u002FF) as per the Berlin definition: acute onset of hypoxemia with an arterial partial pressure of oxygen (PaO2) to inspired fraction of oxygen (FiO2) ratio of less than or equal to 300 mmHg with positive end expiratory pressure (PEEP) of 5 cm of water (H2O) or greater\n2. Requiring admission to Intensive Care\n3. Aged 18 - 75 years of age\n4. Procoagulant profile on ClotPro (TradeMark) fibrinogen (FIB)-test +\u002F- extrinsic coagulation pathway (EX)-test - above normal range for amplitude at 10 minutes (A10) and\u002For maximal clot firmness (MCF) at 30 minutes run time\n5. Lysis Time on ClotPro tissue plasminogen activator (TPA)-test ClotPro equal to or greater than 365 seconds\n\nExclusion Criteria:\n\n1. Platelet count \\\u003C150 x 109\u002FL or a reduction in platelet count of 50% or more in the last 24 hours\n2. Body weight \\\u003C 60 kg\n3. Structural intracranial disease e.g. arterio-venous malformation or aneurysm\n4. Previous intracranial haemorrhage\n5. Ischaemic stroke within 3 months\n6. Traumatic cardiopulmonary resuscitation\n7. Hypoxaemia from traumatic lung injury\n8. Active or recent bleeding\n9. Recent surgery, trauma or invasive procedure\n10. Systolic blood pressure (BP) \\> 180 mm Hg\n11. Diastolic BP \\> 100 mm Hg\n12. Pericarditis or pericardial fluid\n13. Diabetic retinopathy\n14. Currently menstruating\n15. Pregnancy - (beta-human chorionic gonadotropin (HCG) to be performed if of child-bearing age)\n16. Liver failure (known severe liver disease or an alanine aminotransferase or an aspartate aminotransferase level that is 5 times the upper limit of normal)\n17. Kidney failure (estimated Glomerular Filtration Rate (eGFR =\\\u003C30 mL\u002Fhr or receiving renal replacement therapy)\n18. Use of therapeutic anticoagulation or platelet antagonists\n19. Not for active treatment\n20. Unlikely to survive until the day after tomorrow",{"count":115,"type":20},70,[23],"Patients with coronavirus disease (COVID) and non-COVID acute respiratory failure (ARF) may be at an increased risk of thrombosis due to increased clot formation and decreased clot lysis. This two stage study aims to utilise bedside coagulation technology to detect patients at increased risk and guide tPA treatment to maximise efficacy and safety through a personalised approach.",[119,120,121],"Acute Respiratory Failure","Hypercoagulability","Fibrinolysis Shutdown","RECRUITING","2024-04-15",{"date":125,"type":37},"2024-04-17",{"date":127,"type":37},"2022-05-18",{"date":129,"type":20},"2026-12-01",{"name":43,"class":44},""]