ANZCTR search results

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

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30977 results sorted by trial registration date.
  • Point Of Care Hepatitis C testing and subsequent treatment uptake in Addiction Medicine residential withdrawal unit (POCAM): a pilot study

    This prospective cohort study will recruit consecutive clients attending the withdrawal unit and offer them rapid point-of-care testing for hepatitis C viral load by fingerstick. This will be compared to current standard-of-care hepatitis C testing through a retrospective analysis of testing and treatment over the preceding 12 month period. The study will aim to evaluate the uptake and acceptability of point-of-care testing of hepatitis C amongst individuals with substance dependence presenting to a residential withdrawal unit along with the rates of direct acting antiviral treatment initiation and adherence for individuals with confirmed hepatitis C. The study will be undertaken at Depaul House, a residential withdrawal unit attached to St Vincent's Hospital Melbourne.

  • Optimising outcomes for people with knee pain through food: the FEAST randomised controlled trial

    Osteoarthritis is the most common form of arthritis and is a leading cause of global disability. This study will evaluate the effects of two different nutrition programs in individuals with knee OA delivered over 12 weeks. We hypothesise that the anti-inflammatory dietary intervention will result in greater improvements in pain, function, quality of life, inflammatory biomarkers and body composition after 12 and 26 weeks compared to a standard care control group.

  • The Felix Study: Assessing the Felix™ System vs Swim-Up and Discontinuous Gradient Centrifugation to isolate spermatozoa for use in assisted reproductive technology

    The aim of the study is to prove that the Felix™ System is just as good as either or both the Density Gradient Centrifugation (DGC) and Swim-up (SU) methods of spermatozoa separation when using Intracytoplasmic Spermatozoa Injection (ICSI) fertilisation. This will be measured based on how many embryos could be immediately transferred, 5 or 6 days post fertilisation or retained and frozen for later transfer.

  • Effects of cannabidiol in children with autism

    Autism spectrum disorder (ASD) is a highly prevalent neurodevelopmental disorder with no validated biomedical treatments for the core social and behavioural symptoms. The current study is a randomised crossover trial to assess whether cannabidiol (CBD) can promote behavioural and neurophysiological improvements in 5- to 12-year-old children. Several recent studies have investigated acute CBD administration on neurophysiological processes in the adult autistic brain (Pretzsch, Freyberg, Voinescu, et al., 2019a; Pretzsch, Voinescu, Lythgoe, et al., 2019a, 2019b; Pretzsch et al., 2021a). Others have documented behavioural outcomes following chronic (long-term) administration of the compound (Aran et al., 2019, 2021; Bar-Lev Schleider et al., 2019). To date, no investigation has explored effects of long-term CBD administration on glutamate and GABA concentrations alongside social communication outcomes. With a specific focus on the Research Domain Criteria (RDoC) ‘social processes’ domain (Cuthbert & Insel, 2013), which is heavily implicated in ASD, this study will utilise electroencephalography (EEG) to measure neurophysiological changes after chronic administration of CBD over a 12-week period. EEG will be used to acquire resting-state, social task-related processing, and mismatch negativity (MMN) data. MMN is a recognised measure of glutamatergic NMDA receptor function, and thus, neuronal excitation (Kompus et al., 2015). The study is designed to address the following aims: Behavioural: to measure the effect of CBD on the RDoC social processes domain in children with autism. More specifically, to observe a change in Social Responsiveness Scale (SRS) scores from baseline to Week 12. Neurophysiological: to observe whether CBD ‘shifts’ cortical excitation/inhibition during a social task, measured using EEG.

  • Impact of incorporating a polygenic risk score into cardiovascular disease examinations on the identification of subclinical coronary artery disease (CAD)

    To assess whether incorporation of a polygenic risk score (PRS) into cardiovascular disease examinations (e.g., Heart Health Check), through the PPP-CAD clinical pathway, identifies subclinical CAD in participants considered to be at low or moderate 5-year absolute cardiovascular disease (CVD) risk (Absolute CVD Risk).

  • Investigating the effect of French bark extract, Pycnogenol, as a supplement to improve exercise performance in a population of AFL footballers.

    Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. While the mechanisms for adaptations can be varied and can include increased energy expenditure, reduced catabolism, and increased protein synthesis, the intended outcome is an increase in the intended adaptations to training. Pycnogenol, a herbal dietary supplement extracted from French maritime pine bark, is widely marketed for its antioxidant effects. Health benefits purported for Pycnogenol include improved cognitive function, endothelial function, and blood pressure regulation. However, the effect of Pycnogenol on exercise performance, or exercise-induced oxidative stress and inflammatory responses is less clear. Consumption of Pycnogenol has been shown to increase serum NAD+ levels and more recently a study demonstrated that French maritime pine bark extract reduced markers of oxidative stress 48 hours post exercise. Substantially more investigation into the influence of Pycnogenol on exercise performance is required to confirm these results, to examine the optimal timing and dose amount of this supplement, as well as to establish the physiological mechanisms that explain the increased time to exhaustion during intense endurance exercise. Therefore, we hypothesize that Pycnogenol, could be a supplement that increases endurance and with greater adaptations when consumed in addition to training. Here we propose a study designed to establish whether Pycnogenol can improve endurance in highly trained AFL footballers.

  • The effects of running gait retraining using wearable sensors in healthy runners

    Providing feedback to runners outside of laboratory settings may be more advantageous than traditional laboratory-based feedback due to reduced associated costs and improved accessibility. With advancements in wearable technology, it is now possible to use small wireless sensors, called inertial measurement units (IMU), to provide runners with real-time feedback on variables associated with injury in their usual running environment. This project will determine the effects of field-based gait retraining using real-time biofeedback from wearable sensors in high impact runners and assess whether any biomechanical effects are retained at 1-month post retraining. To assess our project aims we plan to recruit 30 healthy runners with high landing impacts. Participants will be randomised into an intervention group that will receive real-time feedback to lower their landing impacts or a control group that be provided with a sham IMU and not receive any feedback during field-based running sessions. Groups will be compared post-training and at 1-month post-training. The expected findings may provide an IMU-based method of running gait retraining and allow for large-scale translation of the results to field settings and reduce the reliance on laboratory-based gait retraining.

  • Change in health outcomes for Aboriginal children with chronic wet cough: a multi-centre implementation study

    Overview: Chronic wet cough in children can be a sign of underlying lung disease such as protracted bacterial bronchitis (PBB) or bronchiectasis. In the absence of pointers to alternative diagnoses, chronic (>4 weeks duration) wet cough that responds to antibiotic treatment typically indicates a diagnosis of PBB. Timely recognition and management of PBB can potentially prevent progression of disease to irreversible bronchiectasis with lifelong consequences3. However, detection and management requires both timely health seeking by parents/families and optimal management by clinicians. Our study’s overall aim is to improve (a) parent/family health seeking for chronic wet cough in their children and (b) clinician management of chronic wet cough in First Nations children. We hypothesize that implementation of a culturally integrated strategy, which is informed by barriers and facilitators identified by parents and health care providers, will improve respiratory health of First Nations children and thereby reduce the burden of bronchiectasis by preventing the progression of protracted bacterial bronchitis to bronchiectasis in First Nations children. Methods The trial is a multi-center, pseudorandomized stepped wedge design where the implementation of the intervention (a strategy) is adapted to each site through a combined Participatory Action Research and Implementation Science approach informed by the Consolidated Framework of Implementation Research. Outcome measures will consist of three categories related to (i) health (ii) economics and (iii) implementation. Health seeking will be measured as the proportion of parents seeking help for their child in a 6-month period before and the same 6-month period after the intervention. The Cough-specific Quality of Life (PC-QoL) will be the primary health related outcome measure. Discussion We hypothesise that tailored intervention based on identified barriers and facilitators identified through engagement with parents and health service providers will result in improved health seeking for parents of children with chronic wet cough and improved clinician management of chronic wet cough. We expect this will result in improve lung health outcomes for children with chronic wet cough.

  • Using oxytocin in individuals with body dysmorphic disorder (BDD)

    BDD is one of the most debilitating chronic mental health conditions, with impacts across multiple domains of functioning. Approximately 2% of the Australian population live with this serious disorder. Reappropriated pharmacological and psychological treatments (developed for mental health disorders with some similar symptoms, i.e. social anxiety disorder (SAD)) have efficacy for some people with BDD; however, most patients remain symptomatic and impaired, and many fail to respond at all. Thus, there is an urgent and immediate need for new BDD-targeted treatments given this significant clinical gap. There are only a few researchers worldwide attempting to improve the knowledge gaps in our understanding of BDD in a bid to develop novel interventions. Our CI team represents one of these groups. We have pilot data using a single dose of intranasal oxytocin (OXT) that restored activity in the ‘social brain’ (i.e. amygdala) in a double-blind placebo-controlled trial of BDD patients (d=0.78). This study seeks funding to extend and expand this world-leading work. Patients with BDD have a chronic illness course that has a major negative impact on social engagement, leading to social isolation and a quality of life that is worse than that associated with many chronic physical illnesses, let alone other psychiatric disorders (e.g. SAD). People with BDD are socially anxious, fear negative evaluations, hide their perceived appearance “flaws” from others, disconnect from family and friends, become depressed and are often suicidal. Despite these prominent social impacts, no treatments for BDD address social affiliation directly. We postulate (supported by our pilot data) that treatments which directly address social aspects of BDD, that is intranasal OXT, will have the potential to achieve symptom reduction/remission as well as substantially improve social functioning (i.e. reduced isolation and a better quality of life). Thus, we are proposing to conduct an innovative phase II randomised-controlled trial (RCT) to investigate whether daily intranasal OXT compared to placebo is an effective intervention for the treatment of BDD symptoms as well as related social impairments.

  • A Phase I Clinical Trial comparing Pharmacokinetics of EMD-RX5 Cannabidiol (CBD) capsules to Epidyolex CBD oil in Healthy Volunteers.

    This is a study of EMD-RX5, an experimental new treatment for stress. EMD-RX5 is a cannabidiol (CBD) capsule which is hoped to be absorbed more effectively than other approved CBD products. Some research indicates that CBD affects receptors (a group of cells that control the movement of chemicals and molecules) in the brain, that may alter a key hormone (serotonin) relating to mood, happiness and feelings of well-being. In this study, we are investigating whether EMD-RX5 capsules are safe and how the body breaks down and absorbs the new drug in comparison to approved CBD (Epidyolex).

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