ANZCTR search results

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

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31913 results sorted by trial registration date.
  • A green tea-pazopanib pharmacokinetic interaction study in healthy participants

    This study aims to investigate whether the pharmacokinetics of pazopanib (i.e., the amount of pazopanib in the blood) changes when pazopanib is given alone and when given with a green tea extract tablet. Pazopanib is an anti-cancer drug that is approved by the Australian Therapeutic Goods Administration and has been used clinically in Australia since 2010. Many patients living with cancer are reported to use complementary and alternative medicines in conjunction with their anti-cancer treatment, with green tea commonly used. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 60 years old and are of European ancestry. Please note that this study will NOT be enrolling patients with cancer. Study details Participants will receive a single oral tablet of pazopanib on 2 separate occasions, separated by 14 days. The first dose is on Day 1 and the second dose is on Day 15. Participants will also be asked to take a single daily green tea extract tablet for 9 days (from Day 10 to Day 18). All participants will provide blood samples over a 96-hour period after each pazopanib dose for the measurement of pazopanib pharmacokinetics. All participants will be monitored to check for changes to their health, questioned about their wellbeing and will have their vital signs checked (e.g., heart rate, blood pressure, temperature). An electrocardiogram (ECG) will also be performed and blood samples will be collected for safety testing. It is hoped that this research will help to understand whether the effectiveness and safety of pazopanib could be impacted in patients consuming green tea with their anti-cancer medication.

  • The effects of FloraSMART on gastrointestinal symptoms and health in older adults

    The composition, diversity, and function of gut bacteria collectively referred to as the gut microbiome undergo notable changes with ageing. These changes can have significant impacts on overall health. For example, ageing is associated with an increased abundance of potentially harmful bacteria, such as Enterobacteriaceae, while certain beneficial bacteria such as Bifidobacterium often decline. These shifts can contribute to chronic low-grade inflammation and adverse health outcomes. The gut microbiome can be influenced through the use of supplements called prebiotics, probiotics and postbiotics. Multiple health benefits have been reported in response to supplementation with postbiotics in adults, however, most of the existing work has been done in assessing the health benefits in young adults, with very few studies specifically targeting older adults. The aim of this study is to identify whether supplementation with FloraSMART A17 blend reduces gastrointestinal symptoms and improves quality of life in older adults.

  • 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.

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