ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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33563 results sorted by trial registration date.
  • 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.

  • Safer AnalGEsia (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.

  • Enhancing memory and thinking in Mild Cognitive Impairment: An 18-week feasibility pilot study using brain stimulation and cognitive training in older adults

    This study aims to evaluate the safety, feasibility, and acceptability of combining cognitive training (CT) with intermittent theta burst stimulation (iTBS), a safe and non-invasive form of brain stimulation, in older adults with mild cognitive impairment (MCI). MCI is a condition involving mild memory and thinking difficulties that can increase the risk of developing dementia. Participants will be randomly allocated to one of two groups: CT combined with active iTBS, or CT combined with sham (inactive) iTBS. Both groups receive the same 10-week cognitive training program. iTBS is delivered over 5 consecutive days at the start of the study, targeting a brain region involved in memory and learning. As this is a feasibility pilot study, the primary aim is not to test whether the intervention works, but to assess whether it can be safely and practically delivered, including how well participants can be recruited, how many complete the program, and how acceptable they find it. Any changes in memory, thinking, brain activity, and well-being will also be measured as exploratory outcomes to inform the design of a future larger trial. We hypothesise that the combined CT and iTBS program will be feasible, acceptable, and safe in people with MCI.

  • 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.

  • A Phase 1, Open-label, Single-arm Trial of Intravenously Administered Psilocin (TRP-8803) in Body Dysmorphic Disorder

    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 Body Dysmorphic Disorder. Eligible participants will complete two doses of TRP-8803, administered in conjunction with psychotherapy over a treatment period of 8 weeks, and followed up until 12 weeks post second dose.

  • 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.

  • 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).

  • 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.

  • 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.

  • A retrospective cohort study describing the real-world use of follitropin delta for ovulation induction (prior to intrauterine insemination or frozen embryo transfer) in Australia

    Follitropin delta is a safe and effective medication to use in ovulation induction prior to intrauterine insemination or frozen embryo transfer with acceptable pregnancy, cycle cancellation, ovarian hyperstimulation syndrome and multiple pregnancy rates. The purpose of the retrospective observational cohort study is to report patient and treatment characteristics and outcome for patients where follitropin delta was used.

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