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An experimental study of the influence of choice (versus no choice) of placebo treatment on reported side effects (nocebo effects) in healthy participants
Expand descriptionThis study will use sham placebo treatments, ostensibly a benzodiazepine medicines being tested to assess their effectiveness for experimentally-induced anxiety, to assess the influence of choice of treatment (no choice, choice of 2 treatments, choice of 10 treatments) on the nocebo effect (assessed via self-reported physical symptoms that are described as benzodiazepine side effects). To assess the development and magnitude of the nocebo effect, placebo-treated participants will be compared to a no treatment control condition. It is hypothesised that a nocebo effect will be seen across the three groups of placebo-treated participants. It is also hypothesised that, compared to the no choice group, the 2 choice group will report lower physical symptoms scores, and the 10 choice group will report higher or at least equivalent physical symptoms scores.
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GoodForm: An intervention to enhance body image and prevent doping and supplement use in adolescent boys
Expand descriptionThe overall aim for this project is to conduct a randomised controlled trial to examine the efficacy of GoodForm, an education program that aims to reduce body dissatisfaction, appearance and performance enhancing substance [APES] use, and lenient attitudes towards doping in sport) in 600 boys aged 14-5. This program will run within the Health and Physical Education curriculum. Boys have typically been overlooked in body image research, and there are no effective intervention programs for boys. There is evidence that body image, the use of supplements, and attitudes towards doping in sport are interrelated and contribute to anabolic steroid use in adolescent boys. The theoretical frameworks underpinning body image and intentions to use supplements are very different for boys and girls. We will focus only on boys in order to confirm approaches that can be used to target these behaviours in a single sex setting to fill this gap in the literature. In this research, we will ask teachers of grade 9 and 10 boys to implement GoodForm, the 4 session program that we have developed. We will measure body image, use and intentions to use APES, and attitudes towards doping in sport before and after boys receive the program to determine impact. This is the first trial of an antidoping program that targets the behaviours that might lead to boys using muscle-building supplements in the world.
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Lifestyle Intervention: Pilot Study for people with schizophrenia treated with either clozapine or another antipsychotic medication
Expand descriptionMost people who have schizophrenia and are treated with either clozapine or another antipsychotic medication, are at increased risk of getting metabolic syndrome and cardiovascular disease. The research study is looking at whether a simple change in lifestyle including engaging in regular physical activity and modifying diet can help to improve the quality of physical and mental health of people with schizophrenia.
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What is the impact of dousing water on the skin on the rate of dehydration during a simulated heatwave?
Expand descriptionIn 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.
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Exploring the effect of Continuous Positive Airway Pressure (CPAP) treatment withdrawal on markers of brain health and memory and thinking skills
Expand descriptionThis 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.
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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
Expand descriptionThe 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.
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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.
Expand descriptionThis 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.
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The association of high plasma potassium levels and high carbon dioxide levels in patients undergoing major laparoscopic abdominal surgery
Expand descriptionA 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.
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Using Specialised Imaging to Differentiate Incidentally Found Renal Masses
Expand descriptionWhat 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.
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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
Expand descriptionAnecdotally, 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.