ANZCTR search results

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

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31137 results sorted by trial registration date.
  • What is the impact of dousing water on the skin on the rate of dehydration during a simulated heatwave?

    In an extreme heat context, dehydration has been demonstrated to increase cardiovascular strain and exacerbate core temperature rises. Naturally then, when heatwaves strike in areas where access to clean drinking water is limited, human health suffers. Although clean drinking water is often in short supply in these areas, there may be plentiful access to water that is not safe to consume, but can be doused on the skin, taking the place of sweat. We therefore wish to investigate whether dousing of water on the skin may slow an individual’s rate of dehydration, thereby reducing the amount of fluid they must consume to offset any hydration related exacerbations of physiological strain. To achieve this, we will compare resultant dehydration, as well as thermal and cardiovascular outcomes during a four hour passive heatwave exposure (45°C/ 15% relative humidity) during three different interventions: 1. Full fluid replacement, sham dousing (FFR-S) (comparator) 2. Quarter fluid replacement, sham dousing (QFR-S) 3. Quarter fluid replacement, optimal dousing (QFR-F) Participants will complete only one exposure each, and will fit into one of three age brackets: 1. 18-40 years 2. 45-55 years 3. 65 + years The research hypotheses going into this study are: 1. Resultant dehydration will be less in QFR-F than in QFR-S. 2. Heat related thermal and cardiovascular strain will be least inn FFR-S, followed by QFR-F and greatest in QFR-S. 3. During FFR-S and QFR-S the 65+ years age group will have a greater change in core temperature than the 45-55 years age group who will have a greater change in core temperature than the 18-40 years age group. During QFR-F all age groups will have similar changes in core temperature.

  • Exploring the effect of Continuous Positive Airway Pressure (CPAP) treatment withdrawal on markers of brain health and memory and thinking skills

    This feasibility study aims to explore whether the withdrawal of Continuous Positive Airway Pressure (CPAP) therapy affects markers of brain health (such as oxidative stress) and/or memory over a 14-day period. The study will also identify the time point at which CPAP withdrawal has the greatest effect on markers of brain health to facilitate planning for a larger randomized controlled trial. We hypothesize that CPAP withdrawal will result in an increase in oxidative stress in treatment compliant OSA patients. Furthermore, we also hypothesize that increases in oxidative stress will be negatively associated with sleep dependent memory consolidation and greater affective symptom severity over time.

  • Exploring the role of androgen receptor blockade in increasing the expression of prostate specific membrane antigen (PSMA) and enhancing 68Ga-PSMA-11-PET/CT imaging in patients with metastatic prostate cancer

    The purpose of this study is to determine the effect of androgen deprivation therapy, a treatment commonly prescribed in prostate cancer patients, on the effectiveness of medical imaging techniques. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with metastatic prostate cancer. Study details: Participants are required to undergo 2 PSMA Scans, the 1st within 28days prior to starting treatment with the medication enzalutamide and the 2nd 14 days after starting enzalutamide. Participants will be required to undergo a physical exam with the Dr which will include a blood test to assess kidney function. The outcome of this study will have important implications for the diagnostic and therapeutic management of metastatic prostate cancer.

  • Effects of intragastric administration of L-leucine, L-isoleucine and L-valine on gastric emptying, gut hormone release and blood glucose in healthy, lean volunteers.

    This study will investigate the effects of intragastric administration of specific L-amino acids on gastric emptying, gut hormone release, glycaemic control and appetite perceptions in healthy, lean males. We hypothesize that the gastric emptying, gastrointestinal hormone, glycemic and appetite repsonses will be affected by specific L-amino acids in healthy lean males.

  • The association of high plasma potassium levels and high carbon dioxide levels in patients undergoing major laparoscopic abdominal surgery

    A retrospective observational study evaluating the association of hyperkalaemia in normocarbic and hypercarbic patients who have undergone laparoscopic abdominal surgery at Austin health. This observational QI project will be conducted by the department of Anaesthesia at Austin Health. There is very limited research exploring the association between hypercarbia and potassium levels in an adult human population. It is known that hypercarbia detected in blood gas sampling correlates to processes that result in serum acidaemia, and it has also been theorized that an acidosis caused by hypercarbia may be related to changes in plasma potassium levels. As part of routine standard care at Austin Health, blood gas sampling is conducted intra-operatively and analysed in theatre using a blood gas analysis machine. Results of these studies are recorded in Austin Health’s electronic medical record system (CERNER). This retrospective observational study aims to determine the relationship between hypercarbia and hyperkalaemia as there is the potential to developing life-threatening cardiac arrhythmias and cardiac arrest due to electrolyte imbalances. This study aims to achieve the following objectives: 1) Determination of the relationship between hypercarbia and hyperkalaemia 2) Determine the magnitude of hyperkalaemic change from baseline 3) Detail the subsequent potential clinical impact of hyperkalaemia in patients intraoperatively, and post-operatively 4) Identify any patient factors that contribute to changes in serum potassium that may allow future identification of patient populations at risk of hyperkalaemia. 5) Contribute to the limited human data on hyperkalaemia and acidosis. As this is a quality improvement project, data will be collected retrospectively, and there will be no change to anaesthesia or surgical care in any way. All data collected has already been collected by normal hospital anaesthesia and surgical processes. No new data will be collected. There will be no clinical or patient contact involved at any time point for this project.

  • Using Specialised Imaging to Differentiate Incidentally Found Renal Masses

    What is the purpose of this study? The purpose is to investigate the possible role of specialised imaging called Sestamibi SEPC/CT in the diagnosis of renal masses. Who is it for? You are eligible to participate in this study if you are an adult that has had a renal mass detected and are scheduled to undergo a renal biopsy in the near future. Study details All willing and suitable participants will undergo specialised imaging involving a scan that takes approximately 45 minutes. The results of the imaging study will be compared with the results of the renal biopsy to be arranged as per normal by the patients urologist. If proven to be effective in its ability to differentiate renal oncocytomas from renal cell carcinoma the sestamibi imaging technique could be more frequently used in the standard investigation of renal masses detected on abdominal imaging. In doing so the number of invasive renal biopsies may decline.

  • A single-dose, double-blind, placebo-controlled, randomised, crossover study of an oral cannabis-based medicine (ETC120) on sleep, cognition, and next-day function in adults with chronic insomnia disorder

    Anecdotally, cannabis is frequently reported by consumers to promote sleep. Indeed, a recent Australian survey found that sleep disorders were the fourth most indicated reason for using cannabis for medicinal reasons in a community sample of 1,700 users (Lintzeris et al., 2018). While improved sleep is one of the positive effects that cannabis users typically report, there is limited well-designed research using objective measures assessing the effects of cannabis on sleep quality and quantity. Moreover, no study to-date has examined the effects of cannabinoid medicine in people with chronic insomnia disorder. To address this gap, we will investigate the acute effects of a cannabinoid medicine (ETC120) on sleep and next-day function compared to placebo in patients with chronic insomnia disorder. This study will utilise novel high-density 256-channel EEG coupled with structural MRI to examine and localise differences in sleep depth and brain activation during both sleep and wakefulness following a single dose of ETC120 and placebo during an overnight sleep study. Daytime function including cognition, alertness and driving performance will also be assessed. As this is a pilot study, we aim to recruit 20 patients aged 35-60 years inclusive with a diagnosis of chronic insomnia disorder. Participants will be comprehensively screened for eligibility across 1-2 visits at the Woolcock Institute of Medical Research, Sydney. All participants will receive all of the interventions in a randomised and counterbalanced order during two overnight sleep studies at the sleep laboratory at the Woolcock Institute of Medical Research. Each overnight sleep study will take approximately 24 hours to complete and will be scheduled at least one-week apart to avoid any carryover effects. This aim of this study is to provide high-quality pilot data using novel multimodal neuroimaging technologies to comprehensively examine the acute effects of a cannabinoid medicine on sleep in patients with chronic insomnia disorder.

  • Investigating the influence of an oral rinse intervention, containing a taste stimuli, on participants taste perception/sensitivity.

    Investigating factors that influence taste perception provides an insight why individuals may over consume certain foods. There are a number of factors which influence taste perception, including environmental (dietary) and genetic factors. In this study we will be investigating the influence of frequent oral (mouth) exposure to certain taste stimuli on taste perception. As certain genes have been found to be associated with individual differences in taste perception, it is also of interest to investigate the role genetics has in taste perception particularly following oral exposure to certain taste stimuli. It is hypothesised that oral exposure to certain tastants will reduce participants taste sensitivity, that is make them less sensitive, to that specific tastant.

  • App-based brain training for young people with depression

    Subjective and objective cognitive impairments are core features of youth depression. These are experienced as distressing, are associated with poorer functioning and may limit the benefits of psychological treatments such as cognitive behavioural therapy. Based on effectiveness in improving cognitive function in conditions such as schizophrenia and attention-deficit/hyperactivity disorder, research has begun to investigate cognitive training as a potential approach to improving cognitive functioning in depression. A recent meta-analysis of nine trials of cognitive training for adults with depression found significant post-training improvements in attention, working memory and global cognitive function. Nevertheless, few studies have explored the potential effectiveness of cognitive training apps in young people, especially with depression. The aim of this study is to investigate the acceptability, safety and potential effectiveness of app-based cognitive training relative to an active control for young people with depression receiving treatment in a primary health care setting (headspace).

  • WithHolding or continuing Enteral feeds Around blood Transfusion (WHEAT) to prevent necrotising enterocolitis (NEC) in preterm infants

    Necrotising Enterocolitis (NEC) is a devastating neonatal disease associated with high risks of death and disability. The pathogenesis of NEC is incompletely understood but we know there is a temporal association between red cell transfusion and NEC. There is uncertainty about the impact of feeding during red cell transfusions and how this affects the chance of developing NEC. WHEAT aims to answer: In infants born <30 weeks (Patient), does withholding enteral feeds around the time of blood transfusion (Intervention), versus continued feeding around the time of blood transfusion (Comparator), reduce the rate of NEC after the first transfusion (Outcome)? Design/methods: Randomised, controlled, unblinded, multi-centre, comparative effectiveness superiority trial of two clinical care pathways. The two care pathways are: (1) Withholding feeds around transfusion; (2) Continuing feeds around transfusion. Expected outcomes: If withholding or continuing feeds during transfusion reduces the incidence of NEC, adopting this practice will help to improve preterm outcomes.

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