ANZCTR search results

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

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32697 results sorted by trial registration date.
  • Randomized Placebo-Controlled Clinical Trial for Recovery from Non-Prescribed Androgen Use

    Investigating whether a short course of treatment with hCG will speed up the recovery of the suppressed reproductive system in men who have been using androgens (“anabolic steroids”) without medical reason or prescription. In men who have previously used androgens but have stopped within the last month or are planning to stop soon. Participants will be randomly allocated to receive either the active drug or an identical placebo.

  • Investigating the impact of heat stress on the gut microbiome, performance and well-being of young adults

    The project aims to identify whether gut microbiota (bacteria) are either disrupted (dysbiotic) or resistant (resilient) to heat stress. The study will also explore how microbiota composition influences cognitive abilities, physical performance, and well-being during heat stress by analysing a range of biological (i.e. stool, blood, and urine) and non-biological (i.e. cognitive assessment and questionnaires, physical function and performance analysis) outcomes. We hypothesize that two days of simulated heat stress will negatively alter the intestinal microbiota composition in healthy adults, reducing diversity, increasing pro-inflammatory taxa, decreasing beneficial taxa, increasing intestinal permeability, and impairing cognitive, physical, and well-being outcomes.

  • Pain after joint steroid injections in children with Juvenile arthritis

    This study is investigating how children with juvenile arthritis experience pain after receiving a steroid injection into their joints. We are testing whether it is practical and reliable to collect information about their pain and recovery directly from children and their parents. The study will also explore how factors like anxiety or previous experiences affect pain perception. We hypothesise that it is feasible to collect meaningful patient- and parent-reported data following intra-articular steroid injections.

  • An examination into the effects of a probiotic and digestive enzyme combination (Weizy and Poolzyme MULTI) in adults experiencing self-reported digestive complaints: a randomised, double-blind, placebo-controlled trial

    In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 75 years with self-reported GI complaints will be randomly assigned to receive a probiotic and digestive enzyme combination (Weizy + Poolzyme MULTI) or a placebo for 4 weeks. Changes in self-reported gastrointestinal symptoms, stool consistency, and general well-being will be assessed for 6 weeks to examine changes in symptoms during and 2 weeks after the cessation of supplementation. It is hypothesised that compared to the placebo, supplementation with the probiotic and digestive enzyme combination (Weizy + Poolzyme MULTI) will result in greater improvement in gastrointestinal symptoms, stool consistency, and general wellbeing.

  • An examination into the effects of Magtein on cognitive performance and sleep quality in adults experiencing subjective cognitive difficulties and sleep dissatisfaction

    In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 70 years with self-reported cognitive and sleep-related difficulties will be randomly assigned to receive magnesium L-threonate (Magtein) or a placebo for 6 weeks. Changes in cognitive performance will be assessed at baseline and week 6 by administering the NIH Toolbox Cognition Battery and related subtests. Moreover, self-report questionnaires will be administered to examine changes in sleep quality and brain fog.

  • SMART-OSA Pilot Study: A Sensor Mat for the Assessment and Remote monitoring of Treatment response in Obstructive Sleep Apnea within primary care

    This project is a pilot study to evaluate whether a contactless Withings sensor mat placed under a patient’s mattress, combined with ‘smart’ blood pressure monitoring, weight scales and a mobile phone app, could be part of a more simple and cost-effective diagnosis and treatment strategy for patients with suspected obstructive sleep apnea (OSA) when used by GPs and practice nurses in the primary care setting. We aim to recruit 20 patients from primary care who are at high risk of OSA who will undergo concurrent single-night full PSG, single-night limited-channel ApneaLink study and 7-night Withings under-mattress sensor mat monitoring, followed by randomisation into either diagnosis and management by their GP using results from the previously-validated limited-channel ApneaLink study (ACTRN12608000514303) versus 7 nights of monitoring using the Withings under-matress sensor and ongoing smart monitoring for 3 months follow-up to assess: (1) the diagnostic accuracy of the Withings sensor for identifying clinically significant OSA, (2) night-to-night variability in OSA parameters; and (3) clinical effectiveness of using the Withings smart system for OSA management.

  • Workforce Related Challenges for Emergency Department Staff: A Prospective, Observational, Multicenter Point Prevalence Study

  • Continuous Glucose Monitoring to support behaviour change in adults with new-onset prediabetes

    Prediabetes is a common condition of slightly high blood sugar levels, before full diabetes occurs. Developing full diabetes can be prevented by losing weight, eating healthy and being physically active. We propose that using continuous glucose monitoring (CGM), a small device that measures sugar levels continuously for 2-weeks, will help people with prediabetes to make healthier lifestyle choices. Participants (24 people) will have standard blood tests and answer questionnaires about their lifestyle (Visit 1). The CGM will be applied/set-up and participants taught how to understand their sugar data (how sugar levels go up or down with different foods, activities, sleep, stress, medicines). The same information will be collected 3-months later (Visit 3). There will be regular telephone (Visit 2/4) and/or email contact. We are interested to see if participants lose weight, have better sugar levels and/or have healthier lifestyles. This study could support use of CGM as a convenient and cheap way to prevent diabetes.

  • Study on RUNX1 mRNA for Safety in Osteoarthritis Patients scheduled for Knee Replacement Surgery

    This study is a first-in-human, Phase 1 trial designed to test the safety and tolerability of RUNX1 mRNA in patients with primary osteoarthritis who are scheduled for knee replacement surgery. Participants will receive a single dose of RUNX1 mRNA or a placebo via intra-articular injection. The study will include up to three dose levels, with four participants in each group. The effects of RUNX1 mRNA will also be explored. The trial uses a staggered dosing schedule to ensure safety, with the first two participants in each group being dosed before the remaining participants. If no significant safety issues are observed, the remaining participants will receive their doses.

  • Efficacy and safety of Fly-In-Fly-Out (FIFO) model of Psilocybin-Assisted Therapy (PAT) for Major Depressive Disorder (MDD)

    This study aims to evaluate whether a six-week program of psilocybin-assisted psychotherapy can more effectively reduce symptoms of major depressive disorder (MDD) compared to standard psychological care (represented by a waitlist control). Adults with MDD will be randomly assigned to either begin the treatment program immediately or after a 10-week delay. The treatment involves one supervised psilocybin dosing session and six psychotherapy sessions, delivered in a standard clinic setting using a fly-in-fly-out model, where specialist staff attend only for the intervention phase. Participants will also be randomly assigned to use either a virtual reality tool or journaling as an adjunct to support their therapy. Mental health outcomes will be tracked for up to 46 weeks. The study aims to test whether this innovative model can safely and effectively improve depression in real-world care settings.

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