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A First-in-Human Study of a new Controlled Release Formulation of Octreotide acetate in healthy male volunteers
This study will determine the pharmacokinetics and safety of the controlled released formulation of Octreotide acetate in healthy male volunteers Who is it for? You may be eligible to join this study if you are male, aged 18-45, and in good general health. Study details After a screening period beginning up to 28 days before admission to the Clinical Research Unit (CRU), all participants in this study will receive one injection of Octreotide acetate. As part of the study, participants will undergo safety assessments, pharmacokinetic, pharmacodynamic and global local tolerance assessment. Participants will be admitted to the CRU until day 2. This new formulation of Octreotide will provide a significant reduction of the volume of administration and deliver an immediate onset of action. Additionally the long-acting release is intended to potentially result in less frequent dosing which could improve treatment compliance and quality of life in patients.
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The Healthy Optimal Australian Microbiome (HOAM) Study
Researchers at the Microbiome Research Centre, UNSW Sydney are inviting healthy and active adults to join in a study to help them discover what is the optimal human microbiome-state. The microbiome is the population of microbes occupying various sites on our bodies, and is already known to have a major impact on human health. If we can determine what the normal microbiome of a the supremely healthy person is made up of, then we have the potential to positively change health outcomes for many future generations by using the microbiome as a target for clinical therapies.
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Support After Stroke with group-based classeS: The SASS study
Stroke is the leading cause of disability from physical, social and mental health impacts (e.g. 1 in 3 survivors have depression after stroke) and affects over 420,000 Australians, with 50,000 new events each year. Community-based options for preventing comorbidity and supporting recovery after stroke are limited. We are proposing to test whether a mindfulness-based intervention (MBI), specifically designed for survivors of stroke that uses movement and meditation to focus on body awareness and breathing is acceptable and feasible. Prior studies of MBIs in older adults, cardiac and cancer populations provide evidence of reduced stress, fatigue, mood disorders such as anxiety and depression, lower blood pressure and improved quality of life. Our aim is to perform a feasibility trial among people within 3-12 months of a stroke who are living at home. Participants will either receive the SASS intervention (12 week MBI program includes weekly group class and home practice) or attention control intervention (12 week social group). This research project will provide important pilot data for work that will have the potential to impact on a large number of survivors of stroke living in the community who need support with managing the consequences of their stroke. If successful this pilot data will provide the rationale for future related work which has the potential to save lives and improve the quality of life of thousands of survivors of stroke.
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A study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MET642 in healthy subjects.
MET642 is a tablet that is taken once daily. This study will look at the safety of single and multiple doses of MET642 when compared to placebo. This study will also determine the PK and PD of MET642 in healthy subjects.
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Examining whether receiving optimal messages influences attitudes, intentions and take-up of pre-commitment among monthly sports/race bettors.
Rationale. Most Australian licensed online wagering operators already offer voluntary pre-commitment through setting deposit limits. However, uptake of this tool is reportedly quite low and it is often associated with problem gambling, rather than being considered a useful tool for all online bettors to monitor their betting expenditure over time. Therefore, substantial trialling and testing is required to determine how to increase the uptake of voluntary opt-out precommitment for online wagering. Aim. This project will examine whether receiving optimal messages influences attitudes, intentions and take-up of pre-commitment. Methodology. The proposed evaluation methodology is a Randomised Control Trial to be conducted with 600 Australian monthly sports/race bettors.
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Getting Back on Track after a cardiac event: Trial of an online patient self-management program comparing self-directed and health-professional supported delivery options
The Australian Centre for Heart Health (ACHH) developed the Back on Track online program to help patients manage their health behaviours and emotional wellbeing after a cardiac event. This project will trial the Back on Track program, and test two methods of program delivery – one self-directed by the patient, and one including two telephone sessions with a health psychologist. The project aims to assess whether patients obtain enhanced benefit through psychologist support, over and above benefit obtained through completing the online program alone. We anticipate that Back on Track will assist patients' recovery, and represents a flexible, easily accessible, user-friendly and effective alternative or adjunct to centre-based programs.
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Biomarker Use in Evidence of Neuronal Damage in Response to Anaesthesia and Surgery (The BOUNDARY Study)
This study aims to investigate if markers of neuronal damage (neurofilament light and tau) are associated with general anesthesia and surgery. Specifically, we wish to confirm and expand our recent preliminary findings that this damage is associated with anesthetic type and with clinical outcomes of delirium and postoperative cognitive dysfunction. To establish this, patients undergoing major elective non-cardiac surgery will be randomly allocated to receive sevoflurane maintenance anaesthesia or propofol maintenance anaesthesia. Cognitive and memory testing will take place prior to surgery, at 7 days after surgery and at 3 months after surgery. Tests for delirium and collection of blood samples will also be conducted during the participants' time in hospital.
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Coronary Atherosclerosis Progression with Testosterone InterVEntion (CAPTIVE)
The first aim of CAPTIVE is to determine in a randomised double-blind, placebo-controlled trial whether two years treatment with intramuscular testosterone undecanoate is non-inferior to placebo in its effect on non-calcified coronary plaque burden. The second aim is to determine whether testosterone treatment is superior to placebo in slowing progression of coronary atherosclerosis. This study will be conducted in 558 men aged 50-74 years with central adiposity (waist 95 cm or more) and low-normal baseline testosterone (14 nmol/L or less). The primary outcome will be normalised non-calcified coronary plaque volume as measured on computed tomography coronary angiography (CTCA) at baseline and 2 years, with secondary outcomes of high risk plaque characteristics and pericoronary adipose tissue attenuation.
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Assistive technology for people with early dementia
In this study, we will randomly assign 80 people living with dementia into two groups, an intervention or a control group. Forty participants in the intervention group will receive a range of low cost, adaptable, user-centric technologies installed in their homes, while 40 participants in the control group will continue to receive usual care. These technologies include a wearable falls detector, a communication tablet, personalised reminders for medication taking and other routine activities, and motion sensors installed around the home. The study aims to see whether these technologies will help people living with dementia better manage their routine activities of daily living, and examine the impact of these technologies on the people living with dementia and their informal carers. The intervention will be provided for six months.
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A social media nutrition promotion program to improve calcium intakes in young adults
This project will recruit young adults (18-25 years) to a social media intervention that aims to improve calcium intake of young adults. Our previous research indicates most fail to meet the recommended dietary intake. The CAN-DO (CAlcium Nutrition- Dietary Opportunities) study will have three arms, one intervention group will be exposed to Facebook; one will be exposed to Facebook with text messages groups while the control group will be emailed once with an e-leaflet. Participants will be asked to complete a baseline and end of intervention questionnaire to assess change in dietary calcium intake.