ANZCTR search results

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

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31301 results sorted by trial registration date.
  • 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.

  • Studies in Autosomal Dominant Polycystic Kidney Disease (ADPKD): Observational study on the impact of ADPKD on quality and activities of daily life

    Autosomal Dominant Polycystic Kidney Disease (ADPKD) is a lifelong condition that causes fluid-filled cysts to grow in the kidneys and other organs, which can lead to pain and kidney failure. It affects about 25,000 Australians and is responsible for 1 in 10 people starting dialysis each year. People with ADPKD often experience abdominal swelling, pain, poor sleep, and other symptoms that aren't always well understood or addressed in clinical care. Women with ADPKD may face unique challenges related to hormones, pregnancy, and contraception, which are not always discussed with healthcare providers.

  • The effect of gastric surgeries (anti-reflux or bariatric) on symptoms and gastric activity using Gastric Alimetry in patients indicated for gastric surgery

    This study aims to investigate how gastric surgeries, such as anti-reflux or bariatric surgery, affect stomach function and related symptoms. A non-invasive test called body surface gastric mapping (BSGM) will be used before and after surgery to measure changes in stomach activity. Participants will also complete questionnaires about their symptoms, quality of life, and psychological health. The study will follow participants for 12 months after surgery to assess changes over time. Researchers hope to better understand how these surgeries influence symptoms and identify which patients may benefit most from them.

  • Heat Outcome Trial (HOT) Text – Pilot Randomised Controlled Trial of a tailored text messaging intervention for heat adaptation in older Australians

    Extreme weather events attributable to climate change are occurring with increasing frequency and intensity. Whilst extreme temperatures can affect people of all ages and health status, certain populations are more vulnerable, especially older adults (65 years and older). Age is considered the most critical risk factor for morbidity and mortality associated with heatwave exposure. As population exposure to extreme heat rises and our population ages, the associated health burden will continue to grow. The trial purpose is to evaluate whether a tailored text messaging intervention can reduce patient-reported heat symptoms, increase adoption of heat adaptive behaviours and reduce utilisation of health services during and after extreme heat days for older Australians (65 years and older).

  • Pain Smart: Integrating pain education and case management for adolescents with pain at schools. Part 2 of a Protocol for a Combined Cluster Randomised Controlled Trial and Individually-Randomised Controlled Trial.

    This is part a combined cluster randomized controlled trial and individually-randomized controlled trial with embedded clinimetric study. Trial Part 2 is an individually-randomized controlled trial delivering biopsychosocial case management to adolescents with bothersome pain attending Australia secondary schools. The individually-randomized controlled trial (1:1 ratio) will be conducted in adolescents in grades 7-10 attending Australian secondary schools. Adolescents reporting bothersome pain at baseline will be randomized to receive a) biopsychosocial case management and facilitated referral, or 2) no intervention. Participants in Trial Part 2 will be recruited from schools in Trial Part 1.

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