ANZCTR search results

People with PWS and severe behaviour disturbance had significantly lower brain gamma-aminobutyric acid (GABA) levels than typically developing controls. GABA is the major inhibiting neurotransmitter in the brain, meaning it helps turn brain activity off. Unfortunately, there are currently no effective treatments for the core behaviours associated with PWS. We aim to address this issue by examining whether people with PWS show an increase in brain GABA levels in response to the medication acamprosate (a GABA modulator). If we find that they do, then this then this will help identify a new potential target for treatment in PWS.

Cognitive decline including delirium is known to follow anaesthesia and surgery in the elderly and may have long term consequences including increased risk of dementia. There is evidence that lifestyle interventions may reduce the risk of delirium and slow the progression of cognitive decline. This study will implement a care program to reduce the incidence of perioperative delirium and in turn, reduce postoperative neurocognitive disorder. To achieve these aims participants randomised to our specialised care group will receive perioperative optimisation strategies (e.g. medications, pain management) in accordance with the expert opinion for delirium prevention in Australia (ACSQHC, 2016). In addition, these patients will receive lifestyle interventions targeting modifiable cardiovascular risk factors (e.g. diabetes, inactivity, smoking). Our control group will receive current standard of care. Primary outcomes include mild or major neurocognitive disorder at 3 and 12 months, assessed with a battery of neuropsychological tests. Secondary outcomes include days alive and out of hospital, QoL and functional independence.

Stillbirth directly affects over 2,000 families in Australia each year. Stillbirth is a personal tragedy for the families involved and a serious public health problem with far reaching social, emotional and financial burdens on all involved. In many cases stillbirth is preventable and research shows 20-30% of late gestation stillbirths could be avoided with better care. The Safer Baby Bundle (SBB) was developed to address priority evidence practice gaps in stillbirth prevention. This before and after study evaluates the impact of this healthcare improvement initiative across maternity services in three states; Queensland, Victoria and New South Wales. By implementing the SBB elements of care, the goal is to reduce stillbirth in Australia by 20% for women from 28 weeks’ gestation and beyond.

A randomised controlled proof of concept and feasibility study will investigate whether virtually embodying hyper-muscular and hyper-capable avatars in virtual reality (VR) can augment body image as it relates to the perception of bodily integrity and vulnerability, and whether these changes relate to short-term improvements in clinical outcomes. Thirty adults with chronic low back pain will be recruited from the Metro South Health Persistent Pain Management Service and randomised to receive a single session VR intervention targeting body image ‘Body Image-VR’ (n=20), or single session of general virtual reality ‘General-VR’ (n=10). Primary outcome measures of body image, pain, and strength, will be assessed: (1) Immediately pre- and post-intervention, and (2) At one week follow-up to assess carry-over effects. A qualitative interview will be conducted with Intervention participants to investigate VR experience, acceptability, feasibility, and tolerability. We hypothesise that embodying hyper-capable avatars in VR will improve body image, pain and strength. We expect outcomes to inform future research and clinical implementation.

As a person ages there is a gradual decline in bone health and an increased risk of falling which, when combined, increases the risk of fractures. Weight gain is common after menopause, however weight loss leads to even greater bone loss and greater risk of fractures. This study will help to determine whether the high-load resistance training or home-based exercise are effective strategies for maintaining bone strength and physical function during weight loss.

A multi-armed randomised control trial to assess the effectiveness of sleep education and wrist-activity monitors that provide daily feedback on sleep . These interventions were selected as they are frequently used by shiftwork organisations as part of a systematic approach to manage fatigue risk. However, the effectiveness of these interventions is somewhat unknown. An assessment of sleep quality, quantity, and cognitive performance will follow these interventions using both subjective and objective measures.

The primary outcome of this study is to examine whether there is an observable reduction in post operative opioid analgesia required in patients who received a fascia iliaca block in the emergency department for their fractured neck of femur, compared to patients who did not. Secondary outcomes of this study will examine whether a discernible difference between rates of infection and thromboembolic complications exists between these groups of patients.

Patients who require the creation of a new arteriovenous fistula for future haemodialysis will be recruited for this study. They will have a 50/50 chance of being assigned to receive either a brachial plexus block or a general anaesthetic technique for this operation. The main aim of this small trial is to determine if it will be feasible to perform a future larger trial comparing the effects of these two techniques on arteriovenous fistula patency. Therefore, the dual key outcomes for this trial are the proportion of eligible patients successfully recruited and the ability to complete the desired data collection for all recruited patients.

The aim of this clinical trial is to find out whether combination treatment with nivolumab and entinostat is safe and effective for children and adolescents with high-risk cancer. Who is it for? You may be eligible for this study if you are aged 2-21 years old and have been diagnosed with a relapsed or refractory high-risk cancer or high grade glioma with a repair defect of the genetic material. Study details: If you are eligible to participate, you will always receive the drugs nivolumab and entinostat in combination. There will be no placebo or control group with any other medication. Before treatment starts, there will be a screening phase. Molecular profiling (DNA sequencing of the tumour) will be performed and the molecular results will indicate if you are eligible for this study. You will be allocated to one of three biomarker groups and continue with screening. Routine tests will also be performed to confirm whether you are eligible for this study, and if you can start treatment. These include medical history, physical exam, CT or MRI scans of the tumour, ECG, blood tests and urine tests. During study treatment: Entinostat is a tablet or liquid taken once a week. Nivolumab is given at the hospital every two weeks, as an intravenous drip over 30 minutes. Routine tests will be performed during treatment to monitor your health. These include medical history, physical exam, CT or MRI scans of the tumour, ECG, blood tests and urine tests. Additional blood samples are collected for this study to measure the levels of drugs and examine how they are working the body. You will be in this study for up to 4 years. This includes the screening phase, study treatment (12 cycles for about 1 year), follow-up visits (every 4 weeks up to 100 days) and long term observation (every 3 months until the study closes).

This study evaluates the addition of three components (music distraction, distraction via gaming and reappraisal) designed to augment Graduated Extinction for infant sleep problems. Participants will be parents of infants with pediatric insomnia. They will be randomized into 4 groups: (1) Control group, receiving Graduated Extinction alone; (2) Music distraction group receiving Graduated Extinction with a music distraction technique; (3) Distraction via gaming group, receiving Graduated Extinction with a gaming distraction technique; and (4) Reappraisal group receiving Graduated Extinction with a reappraisal technique. Infant sleep and maternal sleep and compliance will be assessed at baseline, and 1- and 6-weeks later. Parental cry tolerance, driving performance, sleepiness and fatigue will also be assessed at these 3 time points.