ANZCTR search results

The EDGE Study will focus on measuring the impact of early childhood education on children’s learning and development when it starts earlier (at age 3 years) and is provided for 2 full years (rather than 1 year) prior to school. There is limited evidence internationally that reports on the impact of 2 years of universal early childhood education provided at scale. The Victorian initiative provides a rare chance to collect and link data longitudinally to generate insights and inform policy and practice decisions for the early childhood education sector nationally and internationally. As part of a broad package of early childhood service policy reforms the Victorian state government in Australia is introducing a staggered roll-out of universal provision of funded 3-year-old kindergarten in addition to the existing universal 4-year-old kindergarten program. This project will provide an evaluation of the impact and effectiveness of Victoria’s implementation of universal 3-year-old kindergarten and whether it has measurable benefits to children’s developmental outcomes. There are strong reasons to expect that two years of quality early childhood education prior to schooling is an effective strategy for boosting development, particularly of the most disadvantaged children. This project has the following key objectives: 1) To determine whether 2 years of kindergarten, compared to 1 year, prior to school measurably improves children’s developmental outcomes (cognitive, language, social-emotional and behavioural; at the end of the 4-year-old kindergarten program and up to Year 3 of primary school); 2) To determine the influence of 3-year-old kindergarten by exploring quality and access of programs on children’s developmental pathways and trajectories at the end of the 3- and 4-year-old kindergarten years; 3) To determine the range of 3-year-old kindergarten program design characteristics; how different learning environments influence the experiences of educators and children; and how programs and pedagogy differ for 3- and 4-year olds. We hypothesise that 2 years of universal funded kindergarten, compared to 1 year, prior to school measurably improves children’s developmental outcomes.

To determine in hypertensive subjects of 65-84 years of age whether there is any difference in total cardiovascualr events (fatal and non-fatal) over a five year treatment period between antihypertensive treatment with ACE inhibitor-based regimen and treatment with a diuretic-based regimen.

Atopic dermatitis is a common chronic disorder of the skin that occurs mostly in infants and children. In some cases, this disorder may resolve by itself, however it is common for atopic dermatitis to continue until adolescence and adulthood, where this disorder can exist together with respiratory allergies such as asthma or allergic rhinitis (hay fever). AB-101 Hydrogel contains Crude Plant Latex, which has antibacterial (destroys bacteria or stops its growth), anti-inflammatory (reduces redness, swelling and pain), and anti-pruritic (anti-itching) properties. AB-101 is designed to be used as a single treatment for atopic dermatitis, that can be applied to the skin. The purpose of this study is to gain more information on whether AB-101 Hydrogel works and is safe for the treatment of mild to moderate atopic dermatitis, with or without infection. To test this, the safety and efficacy of AB-101 will be compared to its hydrogel vehicle in participants with mild to moderate AD with or without secondary infection. It is hypothesized that AB-101 Hydrogel is superior to hydrogel vehicle alone.

This research is investigating a naturally occurring compound called N-acetyl-D-mannosamine monohydrate (ManNAc). ManNAc is a sugar (monosaccharide) which is found in humans. Once in the body, ManNAc is converted to another compound called N-acetylneuraminic acid (Neu5Ac) which plays a role in the synthesis and maintenance of muscle; specifically, it facilitates a process called ‘sialylation’. It is being studied as a supplement to treat a condition known as GNE myopathy, a rare genetic disease which is characterised by progressive skeletal muscle wasting (atrophy) caused by a lack of sialylation. In patients with GNE myopathy, this wasting and weakness of muscle affects movement and other bodily functions resulting in disability, wheelchair use and/or incapacitation. Previous studies have shown that the administration of ManNAc can replace the important compounds that patients with GNE myopathy are lacking and therefore may be useful in treating the disease. While supplementation with ManNAc is a promising treatment for patients with GNE myopathy, additional information on how this sugar-like compound is absorbed after oral ingestion is needed. Previous studies suggest that a large proportion of ManNAc remains in the gastrointestinal tract after oral administration and is unabsorbed into the blood. It is thought that this may contribute to gastrointestinal side effects. However, the true extent to which ManNAc is absorbed into the body after oral administration (known as bioavailability) is unknown. This study is therefore being conducted to compare how much ManNAc is absorbed when administered via the oral route (by mouth) compared to when given by the intravenous route (by injection). This information will provide pivotal data to guide the further development of ManNAc treatment strategies for patients with GNE myopathy.

Recent Australian research has shown that physical activity and screen time practices in Outside School Hours Care (OSHC) are varied and ad-hoc; with up to 60% of after school care sessions spent in sedentary behaviours. Recently, physical activity and screen time guidelines for OSHC were developed to help improve children’s activity patterns in this setting and standardise practice. "Activated OSHC" is a program to help implement the newly developed physical activity and screen time guidelines. "Activated OSHC" aims to increase the proportion of time provided for physical activity and reduce recreational screen time in OSHC. OSHC services from metropolitan and regional South Australia (Adelaide), New South Wales (Newcastle) and Western Australia (Perth) will be invited to participate in the study. They will be randomly allocated to either the intervention or control group. The intervention group will receive access to the "Activated OSHC" program including becoming an "Activated OSHC" How-to guide, online training materials, posters, and family communication resources. The control group will receive the same materials after 12 months. Assessments will take place at baseline (before randomisation), 3 months and 12 months. Assessments will include current physical activity and screen time scheduling and observations of staff and children’s physical activity and screen time behaviours during before and after school care sessions. In addition, there will also be surveys of OSHC service characteristics, OSHC staff characteristics, usefulness, and satisfaction of the "Activated OSHC" program and a cost-analysis.

High 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.

Project 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.

COVID-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.

COVID-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.

The 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.