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A Randomised trial assessing Efficacy and safety of Mineralocorticoid receptor Antagonist therapy compared to Standard antihypertensive Therapy in hypErtension with low Renin (REMASTER)
Expand descriptionHigh blood pressure, or hypertension, is a major cause of death worldwide and affects over 6 million Australians. Many people with high blood pressure do not achieve good blood pressure control even with more than one medication. The purpose of this trial is to find out whether personalising treatment by measuring a hormone called renin with a blood test can select people who will benefit from early treatment with a widely used blood pressure medication called spironolactone, an aldosterone blocker. We will do this by randomly assigning individuals with high blood pressure and low renin to either spironolactone or standard blood pressure lowering medications. Participants will be assessed every 12 weeks for 48 weeks. Medication doses will be slowly increased until blood pressure is controlled. At the end of the trial, we will compare individuals who received aldosterone blockers to standard blood pressure-lowering medications and see if there is a difference in blood pressure control and markers of heart and kidney health.
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Project Twenty21 Australia- A Prospective Observational Study Investigating Medicinal Cannabis in Four Clinical Conditions
Expand descriptionProject Twenty21 Australia is an observational study which will follow patients prescribed medicinal cannabis who have been diagnosed with either chronic pain, anxiety, post-traumatic stress disorder or multiple sclerosis. They will be followed for up to 6 months. The purpose is to investigate whether medicinal cannabis products are efficacious in alleviating the symptoms associated with these conditions, and if they are safe and tolerable.
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Investigating the effect of 3D printed facial guards on leak from P2/N95 respirators
Expand descriptionCOVID-19 is a major global pandemic. A current major issue in countries dealing with COVID-19 is the availability of safe and effective masks for health care workers. The current recommended gold standard mask is the P2/N95 mask for health care workers in high exposure environments. Unfortunately, for many health care workers, there continues to be residual peri-mask leak with existing off-the-shelf standard mask designs. In this project, we develop customized 3D-printed facial shields that could be worn by health care workers as a supplementary barrier to prevent peri-mask leak.
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Therapies to prevent progression of COVID-19 in outpatients: The 'Primary Care Australian COVID-19 Therapeutics' (PACT) Trial
Expand descriptionCOVID-19 is a global pandemic and has limited cost-effective early treatments. There is some evidence that the use of Vitamin C, Vitamin D and Zinc may be of benefit in conjunction with Ivermectin and Doxycycline. The second phase of the illness is inflammatory and it is possible that Famotidine may help this phase and reduce people needing hospitalisation. This randomised multi-centre outpatient trial aims to ascertain whether therapy with Ivermectin, Doxycycline, Vitamin C, Vitamin D, and Zinc with or without Famotidine reduces hospitalisation.
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Effects of physical activity and exercise on glycaemic control in cystic fibrosis
Expand descriptionThe RPAH Cystic Fibrosis Service will be conducting an Exercise and Glucose (blood sugar) Control study, comparing glucose levels during supervised exercise at the RPA Exercise Lab and unsupervised exercise that participants perform on their own. We will assess the frequency of low glucose levels during exercise before and after TrikaftaTM, for those who are eligible for this drug if/when it becomes available on the PBS. The study is to elicit whether low glucose after exercise is a common feature in patients with cystic fibrosis with existing glucose metabolism abnormalities, and whether this is changed when starting potent gene modulators in the form of Trikafta.
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A pilot study of safety, tolerability and pharmacokinetics of cannabidiol therapy in symptomatic kidney failure
Expand descriptionPeople with kidney failure suffer a variety of symptoms and poor quality of life. Common symptoms include pain, itch, nausea, anorexia, restless legs, difficulty sleeping and fatigue. There are few treatments available, and many symptoms do not respond or go untreated. Cannabinoids, derived from cannabis, have a wide range of therapeutic effects, including showing promise as treatments for pain, itch, and nausea. This makes them promising treatments for some symptoms of kidney failure. Also, cannabinoids are predominantly hepatically metabolized, with the limited available data suggesting their pharmacokinetics may not be substantially affected by reduced kidney function. However, no studies testing these agents in people with kidney failure have been published. The two best studied, and most widely used cannabinoids are tetrahydrocannabinol (THC), which has psychoactive and muscle relaxing actions and may also be analgesic and antiemetic, and cannabidiol (CBD), which has anti-convulsant, anti-inflammatory, and anxiolytic actions. CBD is typically better tolerated and minimises the potentially adverse psychoactive actions of THC. Combined formulations of the two cannabinoids are common in clinical practice. Before embarking on studies of the efficacy of cannabinoids on symptoms in people with kidney failure it is important to first show that they are safe and well tolerated. Hence, the aim of the present study is to determine the safety and tolerability, and pharmacokinetic parameters of cannabinoids in people with kidney failure. The staggered initiation of CBD, is designed to permit assessment of the safety and tolerability of CBD alone, in a manner that minimises the potential for adverse effects in this vulnerable population. The experience gained with this canabidiol will inform the design of future studies.
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Drawing Out Care: Using animation and digital technologies in different languages in family carers and people living with dementia - a randomised controlled trial.
Expand descriptionThe Draw-Care study aims to improve the lives of culturally and linguistically diverse (CALD) family carers and people living with dementia using animations, digital fact sheets, and a multilingual chat-bot, collectively titled “The Draw-Care Intervention”. The three primary objectives of the study are addressed in three interconnected components comprising the overall trial. In Study 2, the intervention will be trialled and tested for effectiveness in reducing care burden experienced by carers of people living with dementia -- both of a CALD background up to 12 weeks after they receive the resources and will be compared with an active control group who won't receive the resources at the same time. The third component of the trial overall is to evaluate cost-effectiveness of the intervention from a societal perspective compared to a control which models usual standard care. The outcomes of the Draw-Care study are significant and measurable in terms of effectiveness of the resources developed, that is, 1) whether care burden is reduced 2) whether there are improvements in family carer's mood and quality of life 3) whether there are improvements in the quality of life for the person living with dementia. A range of online questionnaires including previously validated tools and interviews with carers and people living with dementia will be used to capture exposures and views and experiences using the Draw-Care intervention complement of resources.
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Type 1 Diabetes National Screening Pilot: Feasibility and Acceptability Study
Expand descriptionChildren are often diagnosed with type 1 diabetes (T1D) too late, with 1 in 3 admitted to ICU with life-threatening diabetic ketoacidosis (DKA). This start to disease is traumatic and has lifelong implications for cognitive impairment, long-term blood glucose levels, and the risk of serious complications. Early diagnosis and starting treatment are essential to prevent DKA, reduce trauma and improve long-term health. Up to 90% of those who will develop T1D have no family history of the condition. Therefore, the only way to identify most children early is through general population screening. Our overarching vision is that general population screening for T1D will be implemented in Australia to decrease the burden of DKA and its health consequences. Australia is ideally suited to screening programs, given our centralised healthcare system with screening federally mandated, funded and managed. Several screening models have been proposed in research trials internationally, however, the optimal model for the Australian setting is unclear. The National Type 1 Diabetes Screening Pilot: Feasibility and Acceptability Study will compare three different models to determine the most appropriate model for routine screening of the Australian paediatric general population. Model 1) Newborn Screening via genetic analysis of a dried bloodspot taken in hospital at the same time as the current newborn screening sample. Genetically ‘at-risk’ children will be offered follow-up autoantibody bloodspot testing from 12 months of age. Model 2) Infants aged 6-12 months will be screened via genetic analysis of a saliva sample. Genetically ‘at-risk’ children will be offered follow-up autoantibody bloodspot testing from 12 months of age. Model 3) Children aged 2, 6 or 10 years old will be screened for islet autoantibodies using a dried bloodspot sample. Children with two or more autoantibodies are considered to have early stage T1D. We are aiming to recruit 9,000 children, with 3,000 children in each group from across Australia. Each screening model will run in a unique geographical area with public awareness and engagement campaigns, and targeted mail-out invitations to participate. The three screening models will be compared to see which was the most feasible, acceptable, and cost-effective. Collectively, this is a pivotal first step in achieving our overarching vision for general population screening for T1D to be implemented into routine healthcare across Australia, with the principal aim of reducing the burden of DKA and its lifelong health consequences for children.
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Move Your Mind: Preliminary efficacy of a small group exercise intervention for older adults with dementia.
Expand descriptionWe aim to investigate the efficacy of a small group exercise program, which consists of two 45-minute sessions twice per week for 12 weeks, for improving cognition in older adults with dementia.
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The feasibility, safety, and efficacy of GRoup Exercise for people with type 2 diAbetes using Telehealth: The GREAT Study
Expand descriptionAlmost 1million Australian adults (5.3% of the population aged over 18years) have type 2 diabetes (T2D). The benefits of exercise for people with T2D include improved glycaemic control, reduced body fat, increased fitness, and reduced pain. These benefits can be observed even with once weekly supervised sessions. Medicare subsidises eight group exercise classes annually for people with T2D. However, barriers such as lack of transport, financial cost and living in regional centres can preclude people from participating in-person. Telehealth may be an alternative approach to overcome these barriers. In response to COVID-19, Medicare are now subsidising one-on-one videoconference exercise services; this funding has not been extended to group services. In people with T2D, being physically active with others is an important motivator; specifically, the accountability, increased enjoyment, and sense of community that accompanies group training improves adherence, which ultimately improves health outcomes. The feasibility and efficacy of group services delivered via telehealth have not been evaluated in T2D, though a small study in liver transplant recipients has shown it to be an appropriate alternative to in-person services. Given the unique provision of care in T2D with the availability of subsidised group exercise sessions, investigating the application of telehealth in this context is crucial. Therefore, the aims of this study are to: 1. Establish the feasibility (i.e., practicality, recruitment, attendance, retention, safety, and acceptability) of delivering group exercise interventions via telehealth, compared with in-person, in people with T2D 2. Evaluate the preliminary efficacy of an 8week telehealth group exercise intervention on behavioural (physical activity levels) and clinical (bloods, body composition, physical function) outcomes, compared with an in-person group intervention, in people with T2D 3. Evaluate the impact of the mode of service delivery on behavioural and clinical outcomes 16weeks following an 8week group exercise intervention in people with T2D 4. Determine the validity and reliability of in-person clinician-measured versus telehealth-supervised participant self-measured assessments