ANZCTR search results

This research project is being conducted to investigate the safety, tolerability, and pharmacokinetics of single ascending dose DB-020 when administered via intratympanic injection to healthy adult volunteers.

This study aims to assess the efficacy of action video games (AVGs) in improving reading outcomes in children with dyslexia. Novel research in this area indicates that AVGs may be effective in improving reading because they improve spatial and temporal attention, which are known to be impaired in individuals with dyslexia. This is important because current treatment options do not benefit everyone and are often time-intensive, so alternative strategies are desperately needed. The study will use two AVG training protocols. One intervention group will play AVGs on a PC using a computer mouse. The other intervention group will use eye tracking to play the AVG with their eye movements. The manipulation between AVG training protocols will help us to better identify what processes may assist AVGs in improving reading. It is predicted that text reading skills will improve after only 2 weeks of AVG training, as compared to standard care treatment, in children with dyslexia.

Atrial fibrillation (AF) and other arrhythmias are common medical problems of increasing prevalence which are often identified and managed by General Practitioners (GPs). The aims of the survey and interview are to explore the views, knowledge and practices of GPs with respect to cardiac arrhythmias, and additionally to explore the role of mobile health devices in screening. The information is important to health policy makers, education providers and professional bodies.

MAT is a multicentre, randomised, placebo-controlled trial to assess if 1500 mg of metformin per day will reduce Abdominal Aortic Aneurysm (AAA)-related events in patients with small AAAs who do not have diabetes. In order to allow reliable assessment of any beneficial effects of metformin on important AAA outcomes, including repair or AAA mortality, follow-up will occur until 616 primary outcome events have been accrued (estimated to require a median of ~3.5 years follow-up). In order to study 1,954 people with small AAA for ~3.5 years at low cost, MAT is streamlined to minimise extra work on collaborating doctors and hospitals. Only essential data will be collected and entered directly into a database. If it can be reliably demonstrated that metformin reduces the risk of AAA events in people with small AAA who do not have diabetes, then this would be relevant to some tens of millions of people worldwide who are currently receiving no treatment of their AAA. This important international study is being led by the Central Coordinating Centre at the Queensland Research Centre for Peripheral Vascular Disease.

This study is a multi-centre, randomised, double-blind, placebo-controlled study evaluating safety, tolerability, efficacy and PK of individually established efficacious/tolerated doses of EP1 compared to placebo. EP1 contains Cannabidiol (CBD) and Tetrahydrocannabinol (THC) in a ratio of approximately 20:1. The study will aim to determine if EP1 is an effective treatment for refractory epilepsy in children, adolescents and young adults by comparing different doses of EP1 against a placebo by measuring seizure frequency and character. Safety will also be measured over a long term open-label extension of the study for a year after the double blind phase.

This study aims to test the effectiveness of Transcranial Alternating Current Stimulation (tACS), a gentle non-invasive brain stimulation technique, in treating young people (16-30 years old) with depression. Participants will be randomised into three groups; theta tACS, alpha tACS or sham stimulation and will receive 30 treatment sessions over four-weeks. Depressive symptoms and cognition will be assessed pre-treatment, mid-treatment phase, post-treatment and at 3 month follow-up. It is anticipated that that active tACS will improve both depressive symptoms and cognition compared to sham tACS.

Polycystic ovary syndrome (PCOS) is a common condition which affects up to 18% of young women. It is caused by hormonal disturbances and is associated with significant reproductive, metabolic, and psychological complications. Hirsutism is defined as excessive hair growth in a woman. It is often a key concern for women with PCOS, but is often overlooked by health professionals. Conversely, it is of high importance as it has a deleterious effect on self-esteem, emotional wellbeing and quality of life, especially in women with PCOS. Laser hair removal therapy, is widely used and thought to be effective in reducing severity of hirsutism and improve quality of life but its use in women with PCOS is less well-studied. We intend to conduct a before and after trial to observe the efficacy of laser therapy in treating facial hirsutism in women with PCOS. We will assess changes in hirsutism severity and also its impact on psychological outcomes in women with PCOS.

Some brain aneurysms, when they bleed, are difficult or impossible to treat safely with "conventional" techniques. There is a device similar to a stent which has been used for 10 years to repair some aneurysms, called the Pipeline Embolisation Device, which has previously needed aspirin plus a stronger blood thinner before inserting it to prevent the device clotting and causing a stroke. The latest version of this device Pipeline-Shield), in use in Australia for 3 years now, has a coating which mimics the lining of blood vessels. This means that the stronger blood thinner may not be required to keep the device from clotting. We have been using the Pipeline-Shield with aspirin only to treat some patients with these "impossible" aneurysms under compassionate use for 2 years with very promising results. We hypothesise that using the device in this manner with aspirin only is safe, and that the device will clot only very rarely if used in this manner.

At present, the self-reflective resilience training (Mental Fitness Training) involves a 40-minute training brief and then 15 minutes of guided self-reflection writing activities each week for five weeks. Cadets are required to reflect on their stressor experiences, evaluate their initial approaches to coping with those stressors, and arrive at alternative strategies that could be applied to future demands. However, the research team and RMC leadership believe that the coping and emotion regulatory skills can be integrated into the training of core technical skills. Our objective is to design and test the efficacy of a new integrated self-reflection training involving RMC instructors (instructor Mental Fitness Training). Formally, we proposed three hypotheses for (1) mental health outcomes, (2) performance outcomes, and (3) mediations: H1(a): Indicative of greater expeditiousness of the integrated self-reflection training involving RMC instructors, the intervention group would report lower average mental ill-health symptoms and perceived stress at intermediate time points (T2/T3) compared to the control group, and a more gradual decline in mental ill-health symptoms and perceived stress between T2/T3 to T4 compared to the control H1(b): Indicative of greater efficacy of the integrated self-reflection training involving RMC instructor, the intervention group would report lower average mental ill-health symptoms and perceived stress compared to the control group at T4. H2: Indicative of greater efficacy of the integrated self-reflection training involving RMC instructors, the intervention group would demonstrate higher average performance scores across the four performance measures (foundation warfighting, merit points, command, and leadership and character) than the control group. H3: The effect of training condition on mental ill-health symptoms, perceived stress, and performance will be mediated by (a) perceived instructor support and (b) instructor encouragement of resilience training principles and strategies.

The study aims to evaluate the efficacy of a community-based assertive aftercare follow-up suicide prevention program in reducing repeat suicide attempts for people who have presented to the participating emergency departments following a suicide attempt or with high risk of suicide. A secondary aim of the study is to measure changes in known suicide risk factors (e.g. depressed mood, psychache) for people who participated in the intervention. The assertive follow-up intervention will be delivered by mental health clinicians and peer workers, using both face-to-face interventions and phone follow-up sessions, for a duration of four weeks (with an option of extension to 12 weeks). The intervention is based on the GROW coaching model and will utilise the Suicide Status Form-4 (SSF-4) from the Collaborative Assessment and Management of Suicide (CAMS) model (Jobes, 2016; Jobes, Jacoby, Cimbolic, & Hustead, 1997). Participants will be asked to outline the key issues that are contributing to their suicide risk, and in collaboration with a clinician, will produce a set of goals and objectives for addressing these issues in a set timeframe, and follow a stabilisation plan. Participants will re-rate their suicide risk factors and evaluate their goals and stabilisation plan at each contact with a clinician or peer worker. Quantitative and qualitative measures of progress toward goals, stabilisation plan and suicide risk will be monitored using the SSF-4 at each contact, measuring psychological pain, agitation, stress, hopelessness, self-hate and overall risk. It is hypothesised that; 1. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to re-present to an emergency department for suicide attempt or high risk of suicide. 2. Compared to health consumers who receive TAU following their episode of care in an emergency department for suicide attempt or high risk of suicide, participants of the Aftercare intervention will experience a significant reduction in the number repeat suicide attempts (as measured by re-presentations to an emergency department for a suicide attempt or being deemed to be at high risk of suicide). 3. Compared to health consumers who receive treatment as usual (TAU) following their episode of care in an emergency department as a result of a suicide attempt or high risk of suicide, participants of the Aftercare intervention will be significant less likely to die by any cause in 24 months. 4. Participants of the Aftercare intervention will show significant reductions in suicide risk factors following the intervention.