ANZCTR search results

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

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32801 results sorted by trial registration date.
  • Fundus EDucation: Analysing the utility of an online education tool in improving the diagnostic accuracy of fundus image interpretation amongst Emergency Doctors and Medical Students

    Non-mydriatic fundus photography (NMFP) has been demonstrated to improve detection of fundus abnormalities in patients presenting to the emergency department (ED). Despite this, there is limited knowledge and education amongst ED doctors and medical students on how to interpret fundus images. This study aims to create an online e-learning program that will improve the diagnostic accuracy of fundus interpretation.

  • The Efficacy and Acceptability of a Remotely Delivered Transdiagnostic Cognitive Behavioural Therapy (CBT) Treatment for Perinatal Anxiety: A Case Series

    The purpose of this project is to assess the efficacy and acceptability of a remotely delivered transdiagnostic cognitive behavioural treatment for perinatal anxiety in an Australian sample. Participants are asked to complete standardised questionnaire measures at pre-treatment, post-treatment, and 3 month follow up, and brief weekly questionnaires throughout treatment to monitor participants’ symptoms and safety throughout treatment. Treatment will consist of 5 x 50-minute weekly sessions, which will be conducted via the secure online platform, Zoom. It is hypothesised that participants self-reported symptoms of perinatal anxiety will reduce from pre-treatment to post-treatment and that participants will no longer meet diagnostic criteria for anxiety.

  • Evaluating a website to help Australians better manage stress, adapt to change and optimise their mental health

    We will test whether an interactive, self-guided, online intervention based on Acceptance and Commitment Therapy (ACT), developed in consultation with mental health professionals and consumers, is perceived as acceptable and helpful by Australian adults (aged 18 years and older), optimises their mental health and wellbeing, and leads to effective coping when faced with future challenges. The icanactnow website contains five short, interactive modules designed to teach users new tools to better manage stress, adapt to change and strengthen their mental wellbeing by fostering the key ACT processes of defusion, acceptance, values, connecting with the present moment and psychological flexibility. Modules are designed to be completed over 10 weeks, with subsequent modules becoming available two weeks after completion of the previous module. We will establish the safety and efficacy of the website using the data that users input as they go through the modules. Users will also be able to opt-in to help us to evaluate the website by completing additional questionnaires. These users will complete questionnaires when they create an account, at the end of the intervention, and 6 months post-intervention so we can examine changes in their mental health and wellbeing over time. We hypothesise that the intervention will lead to a decrease in distress and increase in levels of mental wellbeing and that changes in distress and mental wellbeing will be mediated by the key ACT processes of defusion, acceptance, values, connecting with the present moment and psychological flexibility.

  • Topical magnesium oil for the treatment of neuropathic symptoms in stage IV and V chronic kidney disease

    Neuropathic pain and symptoms are chronic debilitating problems that commonly affect people with advanced kidney disease. Most currently available treatments are taken orally, and may be associated with significant side effects. Also, people with advanced kidney disease are on many medications, and adding additional medications increases the risk of drug interactions. Topical magnesium may represent an alternative treatment for these bothersome symptoms and due to local application, the risk of side effects and drug interactions may be lower. The objective of this study is to determine the effectiveness of daily application of topical magnesium oil for the treatment of neuropathic symptoms (pain, numbness, cramping) in people with stage IV or V chronic kidney disease. The study will also examine the impact of using magnesium oil on quality of life, blood magnesium concentrations and any adverse effects from using magnesium oil. This study will run for a period of 12 weeks, with follow up scheduled every 4 weeks.

  • The Cardiac Return Assist Blanket (CRAB) safely increases central venous pressure.

    The Compressive Redistribution Air Blanket (CRAB) is a recent invention with a primary aim of treating adrenaline resistant anaphylactic shock. Improved understanding of adrenaline resistant anaphylactic shock suggests the primary cause of hypotension is the venodilation, not vasodilation. Venodilation decreases Central Venous Pressure (CVP) resulting in poor cardiac filling and poor cardiac output. Adrenaline is a potent vasoconstrictor but does not significantly effect venodilation. When the CRAB is inflated to the pressures of just 20-40cm H2O the venous system in the abdomen and legs will be compressed and it is believed this will increase the central venous pressure, increase venous return to heart and restore blood pressure. This is a phase 1 clinical trial. The objective is to document the comfort / safety of the CRAB and find the relationship between CRAB Pressure and rise in CVP. In addition, it will be compared to current standard of care which increase CVP, the straight leg raise and Trendelenburg position. Twenty healthy volunteers will arrive fasted on the day of the study and have a midline line catheter inserted under ultrasound guidance in an arm vein to monitor the central venous pressure. A series of 2 minute inflations at 10,20,30 and 40 cmH2O and deflations will be monitored with CVP, ECG, BP & SaO2, and an assessment of comfort after each inflation. The protocol will be repeated after food, drink and IV hydration.

  • The Impact of Light and Odor on Alertness in Management of Sleep Inertia

    The current study will evaluate the impact of sleep inertia on cognitive performance and subjective sleepiness/fatigue, measuring overall impairment and time course, during the first hour after waking at 400h and 1600h, relative to background performance and active control group, across days of sleep restriction. Further, this study will aim to determine the effectiveness of reactive countermeasures (light and odor) to reduce the impact of sleep inertia on cognitive performance and subjective sleepiness/fatigue. It is hypothesised that the impact of sleep inertia on cognitive performance will be greatest upon waking and will dissipate over the first hour of wake. Due to the cumulative effect of sleep restriction, performance will be successively worse upon waking from day one to four and return to a lower baseline each day.

  • Effects of physical activity breaks in secondary school mathematics lessons

    The overall aim of this study is to assess the preliminary efficacy and feasibility of cognitively demanding physical activity breaks in secondary schools. More specifically, this study will assess the effect of cognitively demanding classroom physical activity breaks on adolescents' cognition, and academic achievement. The majority of research in physical activity and cognition has investigated the quantitative aspects of physical activity, such as duration and intensity. Alternatively, the qualitative characteristics of physical activity, such as task complexity, novelty and activity context, have received less attention. Emerging research on cognitively demanding physical activity, using the qualitative characteristics of physical activity, seems to promote changes in cognitive performance. The outcomes from this research will benefit current and future generations of young Australians as physical activity levels decline dramatically during adolescence, and only 15% of Australian adolescents are sufficiently active. Finding ways to promote physical activity in adolescents is particularly important considering that physical inactivity is linked with a range of diseases such as obesity, Type II diabetes, and a range of mental health disorders. Of note, stress and anxiety among youth are increasing in recent decades, particularly among older adolescents. Schools are ideal settings for the promotion of physical activity because they have the necessary facilities, equipment, personnel and are accessible to young people. Our proposed study, focusing on the promotion of physical activity for adolescents has the potential to create new knowledge and reduce the burden of physical inactivity. This project will offer a significant contribution to the field by emphasising the impact of cognitive demanding physical activity. In addition, our proposed intervention may enhance adolescents' cognitive outcomes, as well as their mathematical engagement.

  • A feasibility RCT to assess the usability of the PainChek app to assess pain and scoping of cost implications

    Chronic pain is a common problem but often undiagnosed and untreated in people with dementia due to their cognitive impairment and limited communication ability, leading to reduced quality of life and increased healthcare costs. The efficacy and economic value of interventions to reduce pain in people with dementia remains unclear due to a lack of clinically useful pain assessment tools for this group. This study will (1) determine the feasibility of an artificial intelligence-based application (PainChek) to measure pain in people with dementia; (2) identify the optimal dosage and efficacy of a social robot (PARO) intervention; and (3) develop a checklist of cost-effectiveness measures. A sample of 45 residents with dementia will be randomly allocated to Intervention Group 1 (15-minute PARO intervention, 2×/day) or Intervention Group 2 (15-minute PARO intervention, 1×/day), or the Control Group (15-minute Plush Toy, 1×/day), for 4 weeks and follow-up at week 8. Primary outcomes include the feasibility of using the PainChek to evaluate the intervention efficacy and cost-effectiveness needs within a larger trial. Secondary outcomes are neuropsychiatric symptoms, medication use and participants’ quality of life. This novel project will improve pain management in people with dementia, and potentially reduce treatment costs.

  • Monitoring episodic dizziness outside the clinic

    Prospective randomised study comparing the use of a portable balance testing device prototype versus the currently available clinic-based devices in the diagnosis of vestibular disorders causing vertigo. Patients referred with undiagnosed vertigo will be prospectively randomised into either a control group which will undergo standard vestibular workup or into the interventional group which will use the portable diagnostic device. If a diagnosis is not made in the interventional group, the participant will undergo the standard vestibular workup. The portable device allows to capture the eye movements during the vertigo attacks.

  • Prebiotics, the gastrointestinal microbiome and clinical outcomes post allogeneic stem cell transplantation

    Patients undergoing allogeneic stem cell transplantation frequently require enteral (nasogastric) feeding however the best formula to provide is unclear. Some research has found that the type and diversity of gastrointestinal bacteria (microbiome) may be linked to differences in health outcomes after transplant. Prebiotic fibre may assist in increasing the diversity of the microbiome and the abundance of beneficial bacteria. The aim of this pilot study is to investigate the use of a prebiotic fibre containing enteral feed and its effect on the microbiome and health outcomes after transplantation. This study will recruit 10 participants who are receiving the standard fibre free enteral feed and 20 participants to receive a prebiotic containing feed. Data on clinical outcomes will be collected as well as stool and blood samples before transplant and 2 weeks post, to assess changes in the microbiome. This research will help in improving care for future patients by increasing knowledge on the best enteral feed formula to provide after stem cell transplantation.

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