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Effect of a sugar-sweetened beverage price increase on healthiness of purchases and business outcomes in an Australian university
This 2 year randomised controlled trial (RCT) aims to test the effect of two interventions (i) a 20% ‘red’ drink price increase, and (ii) prominent price labelling, on healthiness of vending purchases (‘red’, ‘amber’, and ‘green’ volume sales) and vending revenue in a university. We hypothesise that the price increase and combined price and prominent price labelling, will be associated with a decrease in 'red' drinks purchases. This study will help inform vending machine pricing interventions and potential policies for universities and other institutions who wish to promote customers’ health, while considering the business outcomes for retailers.
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BrightHearts RCT: procedural pain management during botulinum toxin-A injections.
Many children with neurological physical disabilities routinely receive intramuscular botulinum toxin-A (BoNT-A) injections for the management of spastic muscle tone. There are limited non-pharmacological strategies for pain management during this medical procedure. This study compares distraction therapy vs. BrightHearts (a relaxation training application) for the management of procedural pain in children and adolescents undergoing BoNT-A injections.
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A Phase 1, Healthy Volunteer Study to Evaluate the Effect of Differing Bonding Strengths on the Adhesion of a Patch Delivery System for Alzheimer's type Dementia
This is a single-site phase 1, randomized, crossover study to assess the effects of 4 different bond strengths on the performance of a patch delivery system to be used in Alzheimer's type dementia. The study will enroll 36 participants. The total study duration is 98 days which includes a 42-day screening window, 4 consecutive treatment periods, and 3 follow-up visits over 28 days.
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Lignocaine for the prevention of chronic pain after caesarean section
Chronic postsurgical pain (CPSP) after caesarean section surgery occurs in approximately one in five women. In Australia about one-third of women who give birth have caesarean section surgery. This means that in Australia over the next five years nearly 105,000 young women will be affected by CPSP. The impacts of this condition are significant with reduction in quality of life, reduced maternal-baby bonding, decreased mobility, and social isolation, and present an added burden for women facing the physical and emotional challenges of motherhood. The problem of chronic pain also has other complications including the risk of dependence on morphine-based medications, poor mental health and loss of work productivity. Due to the far-reaching implications of chronic pain, there is an ongoing search for ways to prevent this. Data suggests that different types of anaesthesia and management around the time of surgery may minimise the risk of patients developing chronic pain following surgery. A local anaesthetic drug, lignocaine, which has a long history of use and is safe in pregnancy and breastfeeding, has shown promising benefits in reducing chronic pain when it is given with an anaesthetic during other types of abdominal surgery. It has not been used in caesarean section surgery however we hope that it could be used in this surgery to reduce CPSP. Before conducting a large study in this area, we need to collect information about the safety of lignocaine in women having caesarean section, information about whether a study is feasible on a large scale, and what the rate of CPSP is in women in contemporary Australia.
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Effects of a topical botanical cream on subcutaneous fat loss in athletes
Weight – notably fat - reduction is commonly undertaken by athletes to improve locomotive efficiency and power-to-weight ratio, aesthetic appearance or to reach a target weight class. While energy restriction - or "dieting" - is typically implemented to achieve desired fat loss, this practice is accompanied by compensatory metabolic and hormonal responses that cause attenuation of weight loss, undesirable changes in appetite and mood, performance impairment, and an increase in the likelihood of weight rebound. Thus, novel strategies to achieve fat loss while minimising reliance on ER would be highly advantageous to athletes. This study will be the first to investigate the effects of a topical fat loss agent in a cohort of resistance trained athletes. This study will also be the first to investigate the effects of the popular topical fat loss agent, Subcut. If our hypothesis were to be supported, Subcut would be of extreme value to athletes desiring to lose fat locally without the need of energy restriction. If our hypothesis were to be refuted, consumers would be provided with information that would allow them to allocate their money and time into other, more effective fat loss strategies. Irrespective of the outcome, there is a benefit to the athletic community, as well as to the general population wanting to lose fat.
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Glucagon-like peptide 1 (GLP-1) for lowering plasma glucose in type 2-diabetic patients: A systematic comparison of intravenous and subcutaneous routes.
Certain gut hormones, like Glucagon like peptide 1 (GLP-1), have been proven to play a major role in the control of blood glucose. GLP-1 Receptor Agonists (GLP-1RAs) have been developed to treat type 2 diabetes mellitus (T2DM). So far, all GLP-1RAs that are marketed in Australia must be applied subcutaneously (SC). GLP-1RAs can cause gastrointestinal (GI) side-effects. In early studies on GLP-1 action through intravenous (IV) application, GI side-effects were less common or even absent. We want to compare the SC and the IV administration of GLP-1 regarding the potency of lowering BG and GI side-effects. 20 patients with T2DM managed by long-acting insulin will be studied. The study involves 2 study visits. Patients will be asked to withhold their long-acting insulin on the day before each visit. Patients will then, in a double-blind manner, receive continuous GLP-1 infusion. GLP-1 will be applied SC or IV on each study day. Infusion rate will be raised every 2 hours (max. 4 x per study day). Blood glucose and GI symptoms will be monitored closely. This experimental setup will allow to clarify the impact of the application route of GLP-1 on blood glucose and provocation of GI side-effects.
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A Phase 1, Healthy Volunteer Study to Assess a Patch Delivery System for Alzheimer's type Dementia
This is a single-site, phase 1, randomized bioavailability study to assess a patch delivery system with and without crystals to be used in Alzheimer's type dementia. The study will enroll 48 healthy volunteers with approximately equal distribution of male and female volunteers. The total study duration is 133 days and includes a 42-day screening window and 2 treatment periods of 36 days each. There will be a washout period between Period 1 and Period 2. In the first treatment period, each participant will receive a single application of once weekly Corplex Donepezil TDS (with or without crystals), applied to either the left or right side of the back according to his or her randomization. After the washout period, the participant will have the other Corplex Donepezil TDS type applied on the opposite side of the back during Treatment Period 2.
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Improving the ways we put patients to sleep (anaesthesia) for weight loss surgery
Obesity is a major public health problem in both the developed and the developing world. A therapeutic approach that includes both bariatric surgery and medical management is more effective than medical management alone. However, bariatric patients are more prone to post operative complications that include post operative nausea and vomiting (PONV) and obstructive sleep apnea (OSA) both of which are caused by opiate administration. Despite the potential for both total intravenous anaesthesia (TIVA) and lignocaine infusions to reduce both of these morbidities there are few published reports in the literature on their use in bariatric patients. We propose to perform a pilot study in which patients are randomised to opiate free TIVA (Dexmedetomidine, Ketamine, Lignocaine and Propofol) or standard volatile-opiate based general anaesthesia and post operative care. We postulate that opiate free TIVA will provide improved analgesia, reduce PONV, cause less respiratory adverse events and lead to better post surgical rehabilitation. Ultimately we seek to establish a program of research which assesses the best method of Anaesthesia in Bariatric Patients. Pilot data will be used in grant applications to the Australian and New Zealand College of Anaesthetists (ANZCA) and the National Health and Medical Research Council (NHMRC).
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Evaluation of the role of an artificial intelligence system (iDA) in embryo selection.
The project is a randomised controlled trial to evaluate the clinical effects of a deep learning system, (IVY). IVY studies the images of each embryo during culture. Previous work shows that it is a good predictor of which embryo has highest chance of implanting. This project aims to investigate what effects, if any, this has on the success rate from IVF.
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Association between diet quality, lipid profile and body weight in participants with spinal injury
Given the wide spectrum of metabolic consequences post SCI in conjunction with age-related co- morbidities with increased life expectancy in recent years, it is imperative to implement timely and targeted risk modification strategies. There is evidence that dietary and lifestyle modifications minimise several CVD risk factors in individuals with SCI and good evidence in the role of physical activity in improving cardio-metabolic outcomes in the population. Therefore, this study aims to examine the association between diet quality on lipid profile and body weight of spinal cord injury patients. Hypothesis: Compliance with a Mediterranean style dietary pattern is associated with lower CVD risk in adults with SCI.