ANZCTR search results

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

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30818 results sorted by trial registration date.
  • A study to test the feasibility for adding a home-based Prehabilitation program prior to having total hip or knee surgery in older patients.

    The aim of this study is to address the knowledge gaps relating to prehabilitation in older frail patients having hip or knee surgery, and to explore the opportunities of delivering home-based preoperative care through digital technology. Patients will be randomly allocated to a treatment group. One group will receive standard preoperative care before their surgery. The other group will receive standard care plus the prehabilitation program before their surgery. This study also acts to inform future research in frail patients undergoing these surgeries to optimise post-operative outcomes.

  • A phase 1, Randomised, placebo-controlled, single-blind, single-ascending dose study, to determine the safety and tolerability of intravenous Gemini in healthy volunteers.

    Gemini is being developed as a potential new drug as a treatment for reducing the incidence, duration, and severity of acute kidney injury following cardiac surgery and for surgical site infection. The purpose of this research study is to evaluate safety, tolerability, how the body uses the drug and how the drug affects the body in healthy participants. The study drug works by stimulating a protein called toll-like receptor, which plays an important role in activating the natural immune response. The immune system is the body's first line of defence against invaders such as viruses, bacteria, parasites or toxins entering the body, or to detect wounds in trauma.

  • A trial of a virtual reality treatment to improve social functioning in young people experiencing hallucinations

    Psychotic illness tends to emerge during adolescence, which is a stage of critical social development. One of the earliest signs of psychotic illness is social difficulties, which can cause young people to become withdrawn from everyday life. Psychotic symptoms like paranoia and hallucinations (hearing or seeing things that aren’t there) can make it hard for young people to function around others. These symptoms are usually triggered in social situations, which can make young people want to avoid them, ultimately making the problem worse and causing them to become more withdrawn. Psychological treatments like cognitive behavioural therapy can be effective for helping young people feel comfortable in social situations. However, these treatments are delivered in clinics, removed from the social situations where they need the most help, and are therefore have limited effectiveness. Virtual reality (VR) is a technology that involves wearing a headset which projects 3D images of real world environments onto a screen so the user feels like they are immersed in that environment. Users can interact with the virtual environment using hand controllers, and virtual characters (‘avatars’) are often present to simulate social interactions. Research has found that VR can be used to support treatment of social difficulties by guiding people to learn and practice social skills in virtual environments. This technology therefore has potential to help young people who experience symptoms of psychosis, which is yet to be explored. This research aims to evaluate a new VR treatment based on cognitive behavioural therapy for young people experiencing hallucinations (a common and distressing symptom of psychosis) to understand whether it is feasible and safe to deliver, and whether it has potential to improve social functioning.

  • Integration of Cloud Based Artificial Intelligence Assisted Medical Image and Clinical Data Analysis into Stroke Patient Workflows

    The aim is to use Artificial Intelligence based tools for automated measurement of lesions/areas of ischemia in stroke patients. This data will be used for patient outcome prediction.

  • Eating nuts while breastfeeding – the Nuts For Babies Study.

    Australia has the highest prevalence of food allergy in the world, with at least one in every 32 (3.1%) infants developing peanut allergy and one in every 66 (1.5%) infants developing a cashew nut allergy, which are usually lifelong. Nut allergies place individuals and their families under enormous stress and have been shown to decrease quality of life. This trial aims to determine if the risk of developing peanut and cashew nut allergy during infancy can be reduced by a maternal diet rich in peanuts and cashew nuts during breastfeeding. A finding from our recent Western Australian pilot randomised controlled trial (ACTRN12617001465347) with 109 mother-infant pairs discovered that a maternal high-peanut diet, compared to a low-peanut diet, during the first six months of lactation may reduce the risk that her infant will develop a peanut allergy. We now propose a definitive efficacy randomised controlled trial, in order to provide high-quality evidence to inform maternal diet guidelines for peanut and cashew nut allergy prevention. If the hypothesis is correct, this will be a simple strategy to reduce nut allergies. If incorrect, this information will be paramount for informing breastfeeding women about food choices. Participating mothers will be randomly allocated into either a high-nut (minimum of 60 peanuts and 40 cashew nuts per week), or a low-nut (maximum of 20 peanuts and 12 cashew nuts per week) group, for 6 months from the birth of their baby. From six months of age after commencement of solid foods, both groups will be encouraged to include smooth peanut butter and cashew nut spread in their baby’s diet as per our current Australian infant feeding and allergy prevention guidelines. Infant peanut and cashew nut allergy outcomes will be assessed at 12 months of age. This trial has been co-designed with consumers who will continue to be involved in all stages.

  • Can non-invasive electrical brain stimulation improve exercise rehabilitation outcomes in people with hip osteoarthritis?

    The primary objective of this randomised controlled trial is to quantify the effect of tDCS and exercise on pain, disability and QoL in people with hip OA. Our secondary objectives include: 1) quantifying the influence of motor cortex excitability and CPM on treatment effects, and 2) quantifying the economic cost/ benefit of tDCS for improving health-related QoL in people with hip OA.

  • Re-building bone with exercise in multiple myeloma

    This study will determine the effect of highly targeted exercise on the bone health of people with multiple myeloma. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with multiple myeloma and you are currently taking bisphosphonates (bone active medication). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be given an individual exercise program that consists of two supervised sessions and one at-home session per week. Participants in this group will be asked to complete these weekly sessions for 9 months. Participants allocated to the second group will be asked to continue with their current care program which may include exercise but will not include the weekly program described above. Participants in the second group will also be given information sheets to review from Myeloma Australia. All participants will be asked to undergo a series of assessments, including bone scans and exercise assessments at 3-months and 9-months after enrolment. It is hoped this research will demonstrate that bone-targeted exercise will not only maintain bone health but may delay the progression of bone tumours by altering the behaviour of bone cells. It is also hoped that this exercise program can increase muscle strength and physical function, and reduce pain, improving quality of life in people with multiple myeloma.

  • Evaluating the effectiveness of a custom-built digital program blended with specialist telehealth treatment on burnout in Australian doctors

    Currently, there is a critical lack of established mental health services or treatment programs for burnout, let alone services or programs tailored specifically for health professionals. Burnout is a work-related syndrome characterised by emotional exhaustion, disengagement from work, and a reduced sense of accomplishment. Burnout is notably prevalent among health professionals, especially due to the COVID-19 pandemic. Burnout is a cause for concern as it is related to poor mental health among health professionals, increased staff turnover, and reduced patient safety. To help address this, the Black Dog Institute (BDI) created an online self-guided cognitive behavioural program designed to support health professionals experiencing burnout. The “Navigating Burnout” program sits within BDI’s dedicated health professional support service – The Essential Network (TEN) – where health professionals can access a both digital and person-to-person services. In this study, we will conduct a 10-week randomised-controlled trial to examine the effectiveness and acceptability of a “blended care” version of Navigating Burnout in supporting doctors experiencing burnout, in which a clinical psychologist will work through Navigating Burnout with the participant. This blended care Navigating Burnout will be compared to (a) a self-guided version of the digital program where the participant will work through the program online by themselves and (b) an active attention control where participants will be provided with digital self-care.

  • Evaluating the effect of an online game on depression symptoms in trans young people

    Trans and gender diverse young people face an alarming rate of mental health difficulties. Due to their unique experiences, the lack of available tailored mental health interventions, and their preference for trans-informed digital delivery formats, there is a pressing need for an engaging and effective, evidence-based prevention intervention, designed with and for trans youth specifically. The aim of this project is to evaluate the efficacy, acceptability and feasibility of a mobile serious game adapted specifically for and with trans young people (SPARX-T) in preventing the onset and exacerbation of depressive symptoms, compared to a waitlist control.

  • A feasibility randomised control trial of prolonged virtual reality cycling in people with knee osteoarthritis

    Despite all treatment guidelines recommending exercise, 9 of 10 Australians with knee osteoarthritis (OA) are inactive. Most undergo surgery without trying exercise, despite evidence that exercise can delay/prevent surgery. However, exercise often hurts, reducing initial/sustained exercise engagement. Clinicians promise that pain will reduce over time as fitness increases/weight reduces. While evidence supports this promise, sustaining exercise is difficult. Arthritis Australia's Exercise Report identifies improving exercise engagement as key to improving osteoarthritis outcomes and Australia's National Arthritis Strategic Action Plan calls for new ways to increase uptake of exercise in people with arthritis. New virtual reality technology holds promise and may assist with reducing exercise barriers to increase exercise uptake/engagement. Using a parallel-group, randomised controlled trial, participants will be randomised to one of two active treatment groups. Both groups will receive 2 weekly in-person treatment sessions with a physiotherapist for a period of 6 weeks. Primary outcomes include the WOMAC and perceptually-regulated exercise.

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