ANZCTR search results

This is Part B of a 2-part, Phase 2, Clinical Trial Evaluating the Efficacy, Safety, Tolerability, and Pharmacokinetics of PRAX-944 in Adults with Essential Tremor. Each participant will complete 3 study periods: Screening, Treatment Period (21 or 28 days) and Safety Follow-up.

In recent years significant interest has been shown in the role of contact heat evoked potentials (CHEPs) in the assessment of spinal cord damage. A single study comparing CHEPs with dermatomal somatosensory evoked potential (dSSEP) and clinical sensory testing found CHEPs to be the most sensitive measure of spinal cord damage. In subjects with spinal cord injury (SCI), peripheral sensitisation with topical capsaicin was found to improve the detection of “silent” fibres using quantitative sensory testing (QST). Given that QST is a psychophysical test (dependent on patient report) more objective neurophysiological tests would be valuable. Several methods have been explored to improve the acquisition of potentials in patients with and without nerve damage. The two most promising methods are the use of chemicals to achieve peripheral afferent sensitisation and raising the baseline temperature of the stimulation. This study assesses whether increased baseline temperatures and peripheral sensitisation using topical capsaicin improves the detection of “silent” spinal cord fibre tracts using contact heat evoked potentials (CHEPs) in people with spinal cord injury (SCI) and below-level neuropathic pain (BLNP). Given the onset of SCI BLNP is often delayed identification of partially preserved fibres may be a risk factor that can be identified early in an individual. The detection of a potential peripheral contributor to the pain will also influence the treatment options pursued. Primary Objective: Determine whether CHEPs are able to detect subclinical spinothalamic fibre (STT) preservation following SCI. Secondary Objective: Determine whether CHEPs taken from an area of pain (below the SCI) are more frequently observed when peripheral sensitisation with capsaicin and baseline temperatures up to 42°C are used in subjects with clinically complete spinal cord injuries and BLNP.

The aim of this randomised controlled trial is to increase adoption of the lunchbox nutrition program ‘SWAP IT ’ in primary schools located in the Mid North Coast Local Health District. This trial will evaluate whether a theory-based multi-component dissemination strategy targeting barriers to adoption can improve the adoption rates of the nutrition program. Schools will be randomly allocated to receive either a multi-component dissemination strategy over a four month period, or a minimal intervention control group. Intervention effectiveness will be determined by comparing, relative to control, the absolute difference in the proportion of schools adopting the program at 6-month follow up. The trial aims to generate evidence regarding the effectiveness of strategies to inform broader dissemination of the lunchbox nutrition program.

Peripheral vasopressors are safe and effective to use in pre-hospital and retrieval medicine with a similar risk profile to administration in Emergency departments Prospective data collection on the use of peripheral vasopressors in prehospital and retrieval medicine. Studying patients transported by Lifeflight retrieval medicine who operate across Queensland in Australia. Primary outcome is safety with secondary endpoints including monitoring and indication as well as site and type of access.

Undiagnosed or unrecognised Coeliac disease is associated with a 3-fold increased risk of autoimmune disease (such as type 1 diabetes), osteoporosis and malignancy (such as lymphoma), decreased quality of life and a 2 to 4-fold increase in mortality. Early diagnosis and treatment of Coeliac disease reduces or avoids many of these complications and reduces health care expenditure. In Australia it is estimated that Coeliac disease affects 1 in 60 females and 1 in 80 males based on serological testing. Despite this, the rate of diagnosis through routine medical care is very low, resulting in 4 out of 5 Australians with Coeliac disease remaining undiagnosed. There is currently insufficient data to support population-wide screening for Coeliac disease. As such, screening is based on active case finding of high-risk individuals, such as first-degree relatives of Coeliac disease sufferers and other high-risk populations such as those with developmental defects of enamel in the teeth. Coeliac disease is known to be associated with dental developmental defects of enamel in children. They appear as bilateral, symmetrical and chronologic white or yellow opacities with or without grooves and structural defects. It is thought to be caused by an immune mediated reaction affecting the cells that form enamel and possible nutritional disturbances. Delayed diagnosis and increased exposure to gluten is likely to result in more significant enamel defects over time. Therefore, screening for Coeliac disease in high-risk individuals with developmental defects of enamel could decrease the amount of future enamel and structural defects. This research study is a prospective exploratory study which aims to assess how many children with developmental defects of enamel have undiagnosed Coeliac disease . The study is being conducted at the Paediatric Dental Group, Wesley Medical Research (WMR) and St Andrew’s War Memorial Hospital (SAWMH) in Brisbane, Australia

There are many types of orthodontic appliances with the most common fixed appliance consists of brackets bonded onto the enamel of the teeth and wires that provide the force for tooth movement. The more recent method is with a series of customized clear appliances, called "aligners". The purpose of the study is to compare the outcomes Invisalign® System to the fixed orthodontic appliance; and especially for subjects who have moderate malocclusion (greater than 5mm of crowding in either the maxilla or the mandible). The secondary outcome measures are treatment efficiency and patient satisfaction.

The purpose of this study is to identify if AR technology is a practical approach within this clinical setting, Considering both the acceptability of this resource along with participant usability. The team is trying to identify if it is an age-appropriate tool to reduce procedural anxiety through education and self-management. The study will be done using one-on-one interviews accompanied by a short questionnaire that has been developed using the Theoretical Framework of Acceptability (TFA), the Theoretical Domains Framework (TDF) and the System Usability Scale (SUS). Currently, there are minimal resources for this cohort within the cystic fibrosis community experiencing procedural anxiety. The topic of procedural anxiety may cause emotional distress in participants. Should this be bought to the attention of the researcher through observation within the interviews or a participant coming forward, they will be offered the support systems that are in place for this study. A deductive thematic analysis of the semi-structured moderator guide responses accompanied by a comparison of mean and standard deviation from the questionnaire which will be used only for hypothesis generation, reporting and comparison of results. A narrative synthesis will be used to gather results and collate multiple forms of data allowing comparison of the different data collection methods. For the purpose of the research honours project, data will only be analysed through the TFA and the SUS. The TDF responses will be used for a separate paper associated with this study.

The overall aim of the study is to examine and compare the physiological and non-invasive haemodynamic responses during the sit-to-stand test in one-minute (1min-STST) and the six-minute walk test (6MWT) in individuals with stable heart failure with reduced ejection fraction In addition, there are several objectives that are to be examined in this study. The first objective would be to examine and compare the physiological/non-invasive haemodynamic responses during the 1min-STST with the 6MWT in HFrEF patients. The corresponding hypothesis is that the 1min-STST will generate similar physiological/non-invasive haemodynamic responses to that achieved during the 6MWT. In contrast, the null hypothesis is that 1min-STST will generate a significantly different physiological noninvasive haemodynamic responses to that achieved during the 6MWT. Objective 2: To determine the relationship between quadriceps muscle strength and lower limb lean muscle mass and the 1min-STST performance and physiological/non-invasive haemodynamic responses. Hypothesis 2: Greater lower limb muscle strength and higher skeletal muscle mass will be positively related to the 1min-STST performance and physiological/non-invasive haemodynamic responses i.e., those individuals with the greatest skeletal muscle mass and strength will perform a greater number of sit-to-stand (STS) activities in 1-minute. Null Hypothesis 2: There will be no significant relationship between lower limb muscle strength/skeletal muscle mass and the 1min-STST performance and physiological/non-invasive haemodynamic responses.

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.