ANZCTR search results

The aim of the trial is to conduct the first study of the impact of Phenytoin administration (4mg) on key mechanisms involved in social communication in youth aged 16 years and older with Autism Spectrum Disorders. We hypothesize that Phenytoin will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.

The Research Team recently conducted a randomised controlled trial demonstrating that a capacity building intervention (‘Good Sports’) was effective in increasing compliance of licensed community football clubs with liquor licensing laws, and reducing excessive alcohol consumption by club members. If the benefits of such interventions are to be ongoing, the changes adopted by sporting clubs need to be sustained over time. Research that describes the sustainability of health promoting policies and practices in community settings generally, and in sports clubs specifically, is limited. The proposed research will be the first randomised trial investigating the effectiveness of web-based intervention in sustaining best-practice alcohol management practices by community sport clubs.

Living with a child who has Autistic Spectrum Disorder (ASD) is challenging for all families. Despite growing evidence on the effectiveness of educational and behavioural treatment strategies in addressing the core features of ASD, access to and availability of therapy services in rural communities is sparse. The overall aim of this research project is to test the effectiveness of the Therapy Outcomes By You (TOBY) playpad application as an early intervention complementary therapy, for 2-6 year olds living in rural WA, who have received an ASD diagnosis within the past 12 months The outcomes of the research will provide evidence on the effectiveness of the TOBY playpad application as a complement to existing therapy for recently diagnosed 2-6 year old children with ASD, living in rural communities.

Background: Fluid bolus therapy (FBT) is common in critically ill patients. With the exception of traumatic brain injury, FBT with human albumin solution appears safe and perhaps superior in severe sepsis/septic shock patients. However, 4% and 20% albumin solutions have different chloride contents and deliver different volumes. Objective: To compare the physiological and biochemical effects of FBT with 4% vs. 20% human albumin solution. Design: Retrospective observational study Setting: Tertiary intensive care unit Subjects: Critically ill patients receiving FBT with either 4% or 20% human albumin solution according to clinician preference Measurements and Main Results: We recorded demographic and clinical data for 202 patients (101 patients in each group). We obtained biochemical and hemodynamic data at baseline and at 1, 2 and 4 hours after the administration of either 4% or 20% human albumin solution. We compared the effect of FBT with the two solutions. Patients receiving 20% albumin had a higher incidence of pre-existing liver disease (P=0.003), were more likely to be on renal replacement therapy (P=0.005) and had higher APACHE III scores and predicted risk of death on admission (P=0.007 and <0.0001 respectively). Patients in the 4% group received a median volume of 500mls of albumin compared to 100mls in the 20% group (P<0.0001). There was a trend in higher mean arterial pressure values in the 20% group at 2 and 4 hours following the fluid bolus (P=0.056). There were no significant differences in absolute or percentage change of any haemodynamic parameters over the four hours following fluid bolus. Patients receiving 4% albumin demonstrated higher serum chloride levels and more negative bass excess (P =0.027 and 0.017, respectively). The difference in base excess was greater following post-hoc adjustment for risk of death (P=0.003/ 0.004) . Conclusions: FBT with 100 ml of 20% human albumin solution is hemodynamically equivalent to FBT with 500 ml of 4% human albumin solution but has a lesser effect on chloride levels and delivers 80% less fluid.

The aims of our study are to: 1. Determine the frequency of NTHi infection (defined by >10E4 cfu/ml BAL) in the lower airways of children who have received PHiD-CV; 2. Determine the frequency of NTHi carriage in the upper airways of children who have received PHiD-CV; and 3. Evaluate the influence of PHiD-CV on the systemic adaptive immunity to NTHi in`children with chronic suppurative lung disease.

This study aims to establish the validity and precision of continuous glucose monitors (CGM's) for determining glycemia in response to diet and exercise. CGM's are a new, minimally invasive technology that provide greater insight into the direction, magnitude and frequency of daily glucose fluctuations. Postprandial glycemia is a significant determinant of glycemic control in individuals with impaired glucose tolerance. Given the prevalence of diabetes, it is important to identify effective lifestyle interventions to treat and manage pre-diabetes, and quantify the capacity to monitor daily variations in glucose control. We hypothesise that CGM precision will be reduced during high glucose excursions and strenuous exercise, and that high intensity exercise will be superior for promoting the return of glycemia to basal levels.

This study will compare the chemotherapy drug, Pacritinib, against the best available treatment for Thrombocytopenia and Myelofibrosis. You may be eligible to join this study if you aged 18 years or above and have been diagnosed with thrombocytopenia and/or myelofibrosis. Participants in this study are randomly allocated (by chance) to one of three groups. Participants in the first group will receive one dose of 400mg of oral Pacritinib for 24 weeks or until progression has occurred. Participants in the second group will receive two doses of 200mg of oral Pacritinib daily for up to 24 weeks or until progression occurs. Participants in the third group will receive best available treatment - which will be chosen by your treating physician. Participants will undergo magnetic resonance imaging (MRI) or computed tomography (CT) scans to determine spleen volume and will be assessed for total symptom score using the Myeloproliferative Neoplasm Symptom Assessment Form 2.0. These assessments will occur 12 weekly. Patients may crossover from the BAT (Best available treatment) arm to Pacritinib at the discretion of the Investigator.

Despite the development of anaesthesia management guidelines, PRAE remain a major cause of morbidity and mortality during paediatric anaesthesia, accounting for more than three quarters of critical incidents and nearly one third of all perioperative cardiac arrests. It is known that the rate of PRAE is approximately 2-folds higher in children undergoing tonsillectomy procedures compared to adults and that the rate of complications is also inversely proportional to age. Younger children are at a higher risk for PRAE compared with older children with a decrease in PRAE of 11% with each yearly increase in age. In recent studies and audits in our institution looking at children undergoing tonsillectomies, we found that approximately half the patients suffer from PRAE. Such a high rate of complications inevitably generates a cascade of linked events such as delays in theatre, with the potential for cancellation of other children due to the lack of theatre time and consecutive increases in waitlist time, unplanned hospital admissions, prolonged hospital stay and additional treatment. Even though most PRAE are not associated with long-term sequelae, it also creates more stress for the child and parents. Furthermore, data from closed malpractice claims in the United States of America (USA) show that nearly half of all claims were due to PRAE with higher incidents of death and brain damage as well as higher compensation payments in children as compared with adults. The development of preventative strategies, incorporated into an optimised anaesthesia management, would help reduce the occurrence of PRAE and address the previously cited issues. Salbutamol is a commonly used drug in the treatment of asthma which is available as an over the counter medication in Australia. A previous observational trial showed that premedication with inhaled salbutamol reduced the incidence of respiratory adverse events and in particular reduced bronchospasm and persistent cough by up to 50% in children with a recent upper respiratory tract infection. This current study aims to test the efficacy of inhaled salbutamol to prevent PRAE in young children undergoing tonsillectomies, who are at a particularly high risk for PRAE in a randomised controlled setting. The secondary objectives are to reduce the delays in theatre and the time spent in PACU due to PRAE, the number of unplanned admissions, prolonged hospital stays and delays in the waiting lists due to sequelae following PRAE. Hypothesis We hypothesise that, in children undergoing tonsillectomy (+/- adenoidectomy, +/- grommets) procedures, the incidence of overall PRAE will be significantly reduced by the preoperative treatment with inhaled salbutamol as compared with placebo.

There is now a substantial evidence base for a range of treatment strategies that target the core features of autism spectrum disorders (ASD). Educational and behavioural interventions in particular have been the focus of several well-designed studies that have reported benefits of intense and sustained therapy. However, the effectiveness of these interventions depends on significant therapy time with trained clinicians, and come at considerable financial cost. Thus, a significant proportion of families are unable to access these therapies. Any activities that can improve the time- and cost-effectiveness of early intervention, and are proven to enhance the longer-term outcomes among individuals with ASD, will provide enormous benefit to the community. TOBY (Therapy Outcomes By You) Playpad, an iPad App developed by a team of computer scientists, psychologists and speech pathologists, is one such tool that may enable a more cost-effective way to provide therapy to children with ASD. The TOBY curriculum covers social skills, language, sensory discrimination, and cognitive skills, using Applied behavioural analysis (ABA) principles. While TOBY was not designed to replace one-on-one therapy with clinicians, it may provide an affordable (RRP: $27.99AUD) and easily accessible intervention method to complement existing therapy. Anecdotal reports suggest that TOBY may be an effective intervention method for children with ASD, and also a means of positively empowering parents by giving them greater control over their child’s therapy. However TOBY is yet to be subjected to a randomized controlled trial. 1.To determine the effectiveness of the TOBY Playpad app as a complement to early behavioural intervention using a multi-site single-blind, randomized controlled design. 2.To examine whether the use of TOBY influences parental empowerment in relation to therapy. Further information on TOBY Playpad, can be found at: http://tobyplaypad.com/

In recent years the, role of physical activity in healthy brain ageing has also been a major topic of investigation. Observational studies have shown that adults who are physically active are more likely to have better performance on several cognitive test tasks, including those involving higher order executive functions. Regular physical activity during midlife has also been associated with a significantly slower rate of cognitive decline and reduced risk of developing dementia in later adulthood. Such evidence has prompted calls to investigate the potential role of regular exercise as a protective factor against cognitive decline and dementia. Traditionally, the physical activity public health focus has been directed at purposeful exercise for health benefits, at a moderate to vigorous-intensity. Emerging evidence suggests that targeting the adoption of moderate to vigorous exercise in the population should not be the only consideration; a focus on reducing sedentary behaviour may be equally important for health outcomes. Previous work has provided epidemiological and experimental evidence on the independent associations of sedentary behaviour with metabolic health. Together, with The University of Western Australia, we propose to undertake a randomised cross-over trial in 48 older overweight adults involving three experimental conditions. All participants will complete each of the three (one-day) experimental conditions, separated by a 7-day washout period to account residual physiological effects of the acute exercise. We will examine whether, compared to uninterrupted sitting, there are acute effects of a single bout of moderate-intensity exercise, with or without intermittent (3 min) light-intensity activity breaks from prolonged sitting, on cognitive function and metabolic function in overweight adults aged between 55 and 80 years of age. We hypothesise that (1) a continuous 30 minute bout of moderate-intensity exercise will lead to improvements in cognitive function relative to uninterrupted sitting, and (2) that the magnitude of the improvement in cognitive function resulting from the exercise bout, compared to uninterrupted sitting, will be greater when an exercise bout is combined with a series of brief intermittent light-intensity breaks from prolonged sitting. Furthermore, we aim to examine an exploratory hypothesis that the improvement in cognitive function associated with both the continuous 30 minute bout of exercise and the brief intermittent breaks from prolonged sitting will be associated with mechanisms which increase cerebral blood flow and glucose uptake.