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Coronary Artery Stenosis in Anti-Resorptive Users (CAESAR) Imaging Study
This study is a follow-up to the original CAESAR study to further establish a stronger relationship between coronary artery calcification (CAC) and osteoporosis with the use several scans. It involves a two-part set-up, including an invitation for patients to return for a questionnaire to be asked in-person, and a comprehensive skeletal and cardiovascular assessment. The aim of this study is to identify pre-existing or new comorbidities for the patient group, medication compliance and patient well-being. Additionally, we aim to re-establish the effectiveness of anti-resorptive treatment and side-effect profile of these medications, whilst also establishing a correlation between changes in CAC score over time and changes in bone mineral density (BMD) over time. It is hypothesised that CAC may alter the efficacy of anti-resorptive therapy in patients with osteoporosis due to shared metabolic pathways, and that due to poor efficacy of these drugs, different therapies such as an anabolic therapy may be more effective.
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Evaluation of the National Roll-out of the Triple P Online System across four new online variants; Family Transitions Triple P Online, Stepping Stones Triple P Online, Resilience Triple P Online, and Teen Triple P Online.
Research Aims: 1. To determine the effectiveness of individual Triple P Online System (TPOS) variants (Family Transitions Triple P Online, Stepping Stones Triple P Online, Resilience Triple P Online and Teen Triple P Online) on child and parent outcomes. 2. To examine the relationship between pre-intervention characteristics (moderators) and program outcomes (child and parent effects, module completion, and program satisfaction). The Triple P Online System has been disseminated in Australia since 2014 and randomized controlled trials have shown that the system is effective in improving parenting practices, enhancing parenting efficacy and reducing child behavioural and emotional problems. Little is known however about its efficacy in a practice-as-usual context and about parents’ interaction with the program and the mediators and moderators that influence program outcomes. This study will take advantage of a roll-out of TPOS within Australia, funded for dissemination to all eligible Australian parents by the Commonwealth Government, to collect data on effectiveness in a practice-as-usual context. A mix of routinely collected TPOS process data, mapped against parent and child characteristics and parent questionnaire responses pre, during and post program completion will track program effectiveness and allow rapid identification of specific areas for improvement.
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Safer AnalGEsis (SAGE) Trial
SAGE is a pragmatic cluster randomised controlled trial to reduce the use of high-risk medicines in people with chronic back and/or neck pain. The SAGE intervention provides GPs with support to help their patients with chronic back and/or neck pain to safely reduce or cease the use of high-risk medicines (benzodiazepine, gabapentinoid or opioid) for pain. It will be compared to the usual care control group. We hypothesise that: i) more patient-participants treated by study GPs in the SAGE intervention will have their target high-risk medicine ceased than patient-participants in the usual care control group; ii) patient-participants receiving care from study GPs in the SAGE intervention will experience fewer medicines-related harms and have no worse clinical outcomes, including pain, function and quality of life, than patient-participants in the usual care control group; iii) the SAGE intervention will be cost-effective (concerning medicine dispensations and health care use) compared with usual care control group.
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Enhancing memory and thinking in Mild Cognitive Impairment: An 18-week study using brain stimulation and cognitive training in older adults
This study will investigate whether combining computerised cognitive training (CT) with intermittent theta burst stimulation (iTBS), a non-invasive brain stimulation technique, can improve memory, executive function, and brain function in older adults with mild cognitive impairment (MCI). Participants will be randomly allocated to receive CT with iTBS, CT with sham (inactive) iTBS, or a waitlist control. We hypothesise that CT combined with iTBS will lead to greater improvements in cognitive function and brain activity compared to CT alone or no intervention.
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Human Factors and Clinical Validation of the iHealth Labs Inc. Flu A&B/COVID-19/Respiratory syncytial virus (RSV) Rapid Test in Anterior Nares Nasal Samples For Over the Counter (OTC) Use. IH-018
This study will take place at several locations designed to look and feel like a home setting. It aims to check how well the new iHealth rapid test can identify influenza A, influenza B, COVID-19, and RSV using nasal swabs taken by people with symptoms, by comparing the results to those from highly accurate laboratory tests. The study will include over 500 people with cold or flu-like symptoms, making sure to include both young children (6-23 months) and older adults (above 60 years) with RSV.
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Testing the Safety and Effects of the Psychedelic Psilocin on Wellbeing and Anxiety in People with Ongoing Physical and Mental Health Conditions
Psychedelic medicine has emerged as a safe and promising therapeutic approach for a wide range of mental and physical health conditions. Psychedelics like psilocin facilitate profound psychological experiences that can interrupt rigid, maladaptive thought patterns commonly underlying chronic and treatment-resistant mental illnesses. This open-label study will evaluate the safety and preliminary effects of a novel intravenous (IV, i.e. into the vein) formulation of the psychedelic psilocin (TRP-8803) in 10 different mental and physical health conditions (Anorexia Nervosa, Body Dysmorphic Disorder, Chronic Fatigue, Fibromyalgia, Generalized Anxiety Disorder, Irritable Bowel Syndrome, Long COVID, Major Depressive Disorder, Obsessive Compulsive Disorder, Post Traumatic Stress Disorder). Eligible participants will complete two doses of TRP-8803, administered in conjunction with psychotherapy over a treatment period of 6 weeks, and followed up until 12 weeks post second dose.
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Evaluating the Safety and Efficacy of the ROMAX Resurfacing System in patients undergoing hip resurfacing.
This study will evaluate the safety and clinical effectiveness of the ROMAX Resurfacing System in primary hip resurfacing. This will be achieved by assessing survivorship and collecting patient reported outcome measures from patients receiving the ROMAX resurfacing system. Patient clinical and radiographic outcomes will be analysed pre-implantation and post-implantation through to 3 years. The hypothesis is that the 2-year cumulative percent revision of the ROMAX resurfacing system is not inferior to the performance of other resurfacing systems currently on the Australian market.
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Development and Evaluation of a Mental Health Podcast for Men: A Pilot Study
A pilot randomised trial that will test the feasibility and preliminary efficacy of the podcast-based intervention in a group of Australian men (aged 18-70 years) that are experiencing at least mild psychological distress (e.g., depression, anxiety and stress). Online assessments will collect data for primary outcomes (e.g., feasibility such as, podcast listenership & satisfaction) and secondary outcomes (e.g., psychological distress, attitudes towards help-seeking) at baseline, and 10-weeks (post-intervention, primary endpoint).
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Exploring the functionality and feasibility of Spatialist VR gamified immersive virtual reality rehabilitation programme for patients with acquired brain injury and visuospatial neglect: Phase 2 a mixed-methods pilot study
This study aims to explore the functionality and acceptability and feasibility of a novel immersive virtual reality gamified rehabilitation therapy programme, the Spatialist VR (SVR) for adult patients with an acquired brain injury and visuospatial neglect. The study will be completed in two phases. This phase will evaluate the acceptability of the SVR therapy programme and explore the feasibility of a future larger RCT, including sample size calculation by using a pilot RCT model.
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Exploring the functionality of Spatialist VR gamified immersive virtual reality rehabilitation programme for healthy adults and patients with acquired brain injury and visuospatial neglect:- phase 1 alpha/beta testing.
This study aims to explore the functionality and acceptability of a novel immersive virtual reality gamified rehabilitation therapy programme, the Spatialist VR (SVR) for adult patients with an acquired brain injury and visuospatial neglect.