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The effect of a carbohydrate oral rinse on energy expenditure in a fed state in individuals with high and low sensitivity to carbohydrate taste
Expand descriptionThe purpose of this research is to determine if the ability and sensitivity of adults to carbohydrate and sweet taste can modify how their body uses carbohydrate as an energy source. In this project, study participants will attend three morning sessions in total, separated by 3 or more days, after they have fasted overnight. Upon arrival to the research facility, participants will have their weight and body composition measured using a weighing scale, then asked to rest for 30 minutes before their resting energy expenditure is assessed with a machine that measures oxygen usage and carbon dioxide produced. This measurement involves the placement of a clear hood over the participant’s upper body. After the initial measurement, participants will drink a carbohydrate beverage, followed by the rinsing of their mouth with a carbohydrate solution, a sugar solution or water. After the oral rinsing, participants will continue the measurement of energy expenditure using the same machine for 90 minutes.
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Red plunger syringes for muscle relaxant drug safety: brilliant or bothersome? A survey of anaesthetists and anaesthetic trainees in Australia and New Zealand, and review of incident report data involving muscle relaxant drug errors
Expand descriptionA 5ml slip-lock syringe with a fluorescent red plunger was introduced in Australia and New Zealand in the mid-1990s for use with muscle relaxants. Its aim was to reduce drug errors involving muscle relaxants in anaesthesia. To our knowledge, the impact of this syringe has not previously been formally evaluated. Reporting of drug errors is not mandatory in Australia and New Zealand, so it would be very difficult to determine if introducing the syringe has reduced patient deaths and suffering. The use of the syringe is not mandated. Our hypothesis is that most anaesthetists and trainees in Australia and New Zealand value the red plunger syringe as a drug safety intervention, and choose to use it voluntarily. We aim to test this hypothesis by surveying a large stratified random sample of anaesthetists and trainees across Australia and New Zealand. The survey will ask participants about availability, patterns of use, and attitudes towards the syringe. Suggestions for improving the syringe to better meet the needs of anaesthetists and trainees will also be sought. We also intend to undertake a retrospective analysis drug errors involving muscle relaxants that have been voluntarily reported to the WebAIRS recording system in Australia and New Zealand. The purpose of this is to determine if and how the red plunger syringe was used in each case.
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Personalised 3D printed ankle-foot orthoses for children and adolescents with Charcot-Marie-Tooth disease (printhotics™ trial)
Expand descriptionThe aim of this project is to evaluate 3D printed AFOs compared to traditional handmade AFOs in children and adolescents with Charcot-Marie-Tooth disease (CMT) during walking. Three AFO designs will be evaluated traditional AFO, replicated 3D printed AFO and optimised 3D printed AFO and compared to a shoe only condition. Traditional AFOs will be handmade by an Orthotist from plaster casting methods of the participant’s lower limb followed by thermoplastic vaccum forming. The positive plaster cast mould will then be digitised using a 3D surface scanner to create a 3D model. Computer aided models of a replicated AFO and optimised AFO will then be generated from the 3D model and manufactured using the state of the art 3D printer. 3D gait analysis and inshoe plantar pressure data will be collected to assess differences in walking.
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A study to determine the safety, maximum tolerable dose and ability to provoke an immune response of the Codavax Influenza Vaccine in healthy volunteers. Part 2
Expand descriptionCodaVax, the study drug being researched in this project, is an experimental vaccine being developed by Codagenix, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. CodaVax is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax influenza vaccine compared to placebo controls when administered to healthy adults.
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Does inflating a balloon in the aorta (to reduce blood flow) stop severely injured adults from bleeding to death at a Level 1 Australian Trauma Centre (The ACE Study)?
Expand descriptionNon-compressible torso haemorrhage is a leading cause of preventable trauma death. Although Trauma Systems have optimised access to surgery and interventional radiology for definitive haemorrhage control, a significant proportion of deaths occur before this can be achieved. Resuscitative thoracotomy with aortic compression is a means of temporary haemorrhage control. This procedure is effective in patients with a thoracic source of haemorrhage that can be directly controlled, but is invasive and has poor outcomes in those with sub-diaphragmatic haemorrhage. Temporary occlusion of the aorta with an endovascular balloon is a technique used to control haemorrhage in shocked patients with ruptured aortic aneurysms. This technique has also been described in other forms of non-compressible haemorrhage such as gastro-intestinal bleeding and post-partum haemorrhage. Resuscitative endovascular balloon occlusion of the aorta (REBOA) as an adjunct for hemorrhagic shock has recently been promoted. REBOA provides a means of temporary haemorrhage control in patients with severe non compressible haemorrhage - potentially enabling these patients to access means of definitive haemorrhage control and survive. However, the procedure requires specific technical expertise as well as integration into current models of trauma reception and resuscitation - and there are conflicting reports about whether REBOA contributes to survival. This pilot study involved the introduction of Balloon Occlusion for Aortic Control of Exsanguinating Trauma Related Haemorrhage (The ACE Study) at an Australian Adult Major Trauma Centre, to determine whether REBOA would be a feasible and effective strategy to provide temporary circulatory support to trauma patients with critical, refractory, hypovolaemic shock and hypovolaemic cardiac arrest - allowing transfer to an operating theatre for definitive haemorrhage control surgery. The primary purpose was to determine if the introduction of REBOA outcome was feasible and, if so, it would improve survival of blunt or penetrating trauma patients aged 18-60 years with exsanguinating sub-diaphragmatic haemorrhage.
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The Dementia Lifestyle Coach: a pilot study of a support and coaching program for people recently diagnosed with early dementia
Expand descriptionThe Dementia Lifestyle Coach aims to test the feasibility of delivering and evaluating the Dementia Lifestyle Coach program for people newly diagnosed with early dementia The Dementia Lifestyle Coach fills a gap in dementia care in Australia and internationally by supporting people with early dementia to adjust psychologically to having the condition, stay active and involved in their community. If shown to be efficacious in a fully-powered trial, the availability of an early support program for people with dementia may increase the motivation of general practitioners to make earlier diagnoses of dementia. The Dementia Lifestyle Coach program is a 14 session psychoeducation, counselling and coaching program for people recently diagnosed with dementia. Sessions are hour-long and held weekly for the first 2 months, then fortnightly for 2 months, then monthly for the last 2 months (14 sessions in total). Sessions are delivered by a registered psychologist or rehabilitation counsellor. In addition, participants receive support (monthly conversations) from a trained peer who lives with dementia. This parallel group design will have an intervention group and a wait-list control group. The wait-list control group will receive the intervention after 6 months. A wait-list control group was selected rather than no-treatment control group because the study investigators considered it unethical to offer no support to participants, further offering the intervention to the control group would allow a greater sample with which to test acceptability of and fidelity to the intervention.
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A Randomised, Double Blind, Placebo-Controlled Trial of Medicinal Cannabis in Adults with Tourette's Syndrome
Expand descriptionTourette’s syndrome (TS) is a neurological disorder that develops in childhood and often continues into adulthood. Individuals with TS make involuntary movements and vocalisations (known as tics), which may be painful, embarrassing and functionally impairing. There is no cure for TS, but certain medications (particularly antipsychotics) are effective at suppressing tics when taken continuously. Unfortunately, these medications have significant and independently-disabling side effects, which limit their acceptability for many sufferers. The human body has its own (‘endogenous’) cannabinoid neurotransmitter system, which facilitates communication between nerve cells in the brain. This system is implicated in the control of normal movement and the development of movement disorders such as TS. The ‘endocannabinoid’ system could therefore be a new therapeutic target for tic suppression. There is some early evidence to support the effectiveness of cannabinoids in TS, but well-designed clinical trials have yet to be conducted. We plan to use an oral formulation of medicinal cannabis containing two cannabinoids: tetrahydrocannabinol and cannabidiol. This formulation does not intoxicate or cause the unpleasant psychiatric effects of ‘street’ cannabis. We predict that treatment with tetrahydrocannabinol and cannabidiol will significantly reduce tics, when compared to placebo, as well as improving psychiatric and cognitive symptoms associated with TS. We also predict that this formulation will be well tolerated, without psychiatric side effects, and will not lead to craving or intoxication. Therefore, this study may support the development of a new, safe and effective treatment for TS, with potential applications to other neurological disorders.
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Stoma closure using bio-absorbable reinforcement (SCUBAR).
Expand descriptionThe rate of incisional hernia formation following closure of a temporary intestinal stoma is approximately 30%. Hernias following abdominal surgery are a significant cause of morbidity and may adversely affect a patient's quality of life and may require emergent repair. Currently closure of the abdominal fascia is accomplished with sutures however, newer surgical materials are now available to reinforce fascial closure which have shown promise in their abilities to reduce IH formation and tolerate bacterial contamination that is present in these contaminated wounds. We propose a randomised clinical trial in patients undergoing reversal or resiting of an intestinal stoma to have placement of a new synthetic tissue reinforcement material or standard repair to determine if this material can reduce incisional hernia formation with low morbidity, specifically surgical site infection which has prohibited the use of existing materials.
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A Phase 1 clinical trial to assess the safety, tolerability and pharmacokinetics of PBT434 in healthy volunteers.
Expand descriptionThis is a Phase 1 Single and Multiple Ascending Dose Study of PBT434 in Healthy Volunteers. The first in human study consists of two parts, both of which are randomised, double-blind, and placebo-controlled: The single ascending dose (SAD) and the multiple ascending dose (MAD) parts of the study will be conducted in sequential stages. Key safety and PK data from the SAD portion will be reviewed before progressing to the MAD part of the study.
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Meaningful Engagement in Nutritional Understanding (MENU): Best choices for aged care
Expand descriptionResearch suggests that the majority of Australians with dementia in residential aged care are malnourished or at risk of malnourishment. This project seeks to change this unacceptable situation by trialling a practical multi-component nutrition support intervention (MENU: Meaningful Engagement in Nutritional Understanding) that arose from suggestions from staff in a Tasmanian aged care home on how to improve care and support of people with dementia. The project will trial MENU in two Wicking-partner aged care facilities. The impact of MENU on raising staff awareness of best nutrition care and support for residents with dementia and reducing malnutrition prevalence will be evaluated. There are two specific objectives: 1. raise awareness (knowledge and practice change) among care facility staff/care volunteers/family of best nutrition care for residents with dementia; 2. reduce residents’ malnutrition risk. The project findings, outputs and the MENU approach will be disseminated across Tasmania.