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Assessing the feasibility of microdialysis to monitor vascular endothelial function in paediatric cardiac patients.
The systemic inflammatory response syndrome (SIRS) characterises up to 80% of critical illness in children. The fundamental pathophysiological features underpinning SIRS are changes to the vascular endothelium, which include: 1) increased permeability to fluid and protein ("leaky") and, 2) increased activation ("sticky"). We recently published data which confirms a direct role for Eph/ephrin signalling in endothelial leakage both in a mouse gut ischaemia/reperfusion injury model of systemic inflammation and in vitro in TNF-a induced vascular leakage in human umbilical venous endothelial cells. Based on this data we hypothesise that vascular endothelial function can be monitored in the intensive care unit by: (a) quantifying interstitial protein levels by microdialysis; measuring urinary albumin; and (c) measuring plasma levels of Eph/ephrins a s endothelial activation markers. Positive fluid balance is a poor prognostic sign, but without clear science, opinion on fluid management in the critically-ill patient remains divided. The aim of this project is to determine whether it is feasible to monitor the integrity of the vascular endothelium in critically-ill children by: a) using microdialysis to quantify interstitial protein levels; (b) measuring plasma levels of Eph/ephrin proteins as endothelial activation biomarkers and (c) monitoring urinary albumin (microalbuminuria). This preliminary feasibility study will be undertaken in post-operative paediatric cardiac surgical patients who are routinely admitted to a paediatric intensive care unit for cardiorespiratory support and monitoring. (The control patients undergo an elective cardiac catheterisation without the inflammatory stimulus of cardiopulmonary bypass.) Monitoring the permeability of the vascular endothelium may inform clinicians about the stage and severity of SIRS and assist in clinical decision-making regards fluid resuscitation and fluid balance management. This may improve supportive care in the ICU and result in reduced ventilator days, hospital length of stay and mortality in critically-ill children.
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The respiratory effect of high-flow nasal oxygen in spontaneously breathing or apnoeic adults during general anaesthesia: a randomised controlled trial.
The aim of this study is to define the effect that high-flow nasal oxygen has on ventilation and oxygenation in both apnoeic and spontaneously breathing participants during a 30minute period of general anaesthesia. The use of high-flow nasal oxygen is gaining popularity in anaesthesia due to its benefits on oxygenation and ventilation. The precise effect that high-flow nasal oxygen has on oxygen and carbon dioxide levels during general anaesthesia during spontaneous respiration or apnoea is yet to be defined. Therefore it is not clear which technique may be more suitable for particular patient subgroups. No previous studies have directly compared apnoeic and spontaneously breathing techniques using high-flow nasal oxygen during general anaesthesia. We hypothesise that carbon dioxide levels will be different between spontaneously breathing and apnoeic patients while using high-flow nasal oxygen during a 30minute period of general anaesthesia.
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A Phase I, single centre, open label, escalating dose study to assess the safety, tolerability and immunogenicity of a therapeutic Human Papilloma Virus (HPV) DNA vaccine (AMV002) for HPV-associated head and neck cancer (HNC) after curative treatment.
The aim of this study is to assess the safety and tolerability of ascending doses of the HPV DNA vaccine, and to see if it has any effect on the immune system. Who is it for? You may be eligible for this study if you have previously been diagnosed with HPV-associated oropharyngeal squamous cell carcinoma, and have completed curative treatment at least 12 weeks ago. Study details Participants in the study will receive three doses of the vaccine over the course of 12 weeks. The vaccine is given via injection just below the skin on the forearm(s) depending which dose of the vaccine you are given. Blood and urine samples will be taken at differnet timepoints to measure safety and efficacy of the vaccine. If we are able to show that the vaccine is safe and that it can induce an immune response, it could be used alone or in combination with other drugs to treat HPV-associated oropharyngeal squamous cell carcinoma.
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Enhancing rehabilitation services and quality of life for Aboriginal Australians after brain injury: Healing Right Way
This project involves implementation of the first culturally secure intervention package for Aboriginal survivors of brain impairment in Australia. Aboriginal Australians experience stroke up to three times more frequently than non-Aboriginal Australians, with traumatic brain injury due to assault occurring up to 21 times more often. Yet Aboriginal people remain under-represented in rehabilitation programs. The proposed project follows on from the team's Missing Voices study (NHMRC ID#1046228) that investigated the extent and impact of communication disorders after brain injury in Aboriginal people across Western Australia. Findings suggested significant changes in service delivery are warranted and wanted by Aboriginal brain injury survivors, their families and health service providers. The project aims to improve accessibility to rehabilitation services for all Aboriginal people post brain injury in Western Australia, improve health outcomes for this population, and establish an economic model for the above which will contribute to sustainability and planning of future services. Utilising a stepped wedge cluster randomised control design, the study will involve a complex intervention consisting of a) cultural security training for hospital staff tailored to the delivery of services to Aboriginal people with brain injury, b) use of culturally appropriate educational materials, and c) introduction of a specialist Aboriginal Brain Injury Coordinator to provide an in-reach service to participating hospitals as well as coordination of care and advocacy after hospital discharge. The service and costing models developed in the project will provide a basis for future planning of brain injury services as well as services for a variety of other conditions in WA and nationally.
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The STELAR trial: Intravenous stemetil versus intravenous largactil for the treatment of acute migraine in adults
Lay Summary: Several intravenous (IV) medications have been shown to be effective in alleviating the symptoms of migraine. At this time we do not know which of these medications is the most effective in patients presenting to hospital with persistent migraine, despite oral therapy. This study aims to compare the two common IV migraine medications used in Australasia: chlorpromazine and prochlorperazine. Our current migraine guideline in the Austin Hospital Emergency Department (ED) states that patients can be given either IV chlorpromazine or IV or intramuscular prochlorperazine for the treatment of migraine. Hence, both treatment regimens are considered as standard practice. Although there is a paucity of evidence available, we hypothesise that IV chlorpromazine is superior to IV prochlorperazine for the management of acute migraine in adults. Study design: This is a prospective, randomised, double-blind clinical trial comparing the efficacy of intravenous chlorpromazine versus intravenous prochlorperazine for the management of acute migraine in adults aged 18-65. This will be a single centre study, and will take place at the Austin Hospital. Method/intervention description: Patients age 18-65 years who present to the Austin ED with migraine, and who meet the criteria in the current Acute migraine guidelines for management of adults in the ED will be considered eligible for assessment to participate in this trial. Eligible patients will be randomised to receive either: Chlorpromazine 12.5 mg with 500 mL sodium chloride 0.9% via intravenous infusion over 30 minutes Or, Prochlorperazine 12.5 mg with 500 mL sodium chloride 0.9% via intravenous infusion over 30 minutes. Patients will be assessed at 0, 30, 60 and 120 minutes post infusion of study drug, Basic observations will be recorded, and headache severity score and nausea severity score using a 11-point numerical rating scale will be recorded. Patients will also be asked if photophobia and phonophobia are present. Side effects will be recorded, and at 120 minutes patients will be assessed for postural hypotension, and for akathisia using a modified Prince Henry akathisia rating scale. At 120 minutes the trial is complete, and if patients symptoms have improved they will be discharged home as per the standard discharge protocol. Primary objective: To compare the change in headache severity 60 minutes after infusion of either IV chlorpromazine or IV prochlorperazine. Secondary objectives: 1. To compare the change in headache severity 30 and 120 minutes after infusion of either study drug. 2. To compare the change in nausea severity, photophobia and phonophobia at 30, 60 and 120 minutes after infusion of either study drug. 3. To compare the side effects of both study drugs. 4. To compare the proportion of patients in each group that require rescue therapy (additional medication to manage their symptoms).
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Decision support for colorectal cancer prevention - what is the best way to present access to online information: Frequently Asked Questions (FAQs) targeted to age and gender or a generic information topic list?
Does provision of access to information targeted to certain user segments (age and gender), and presented as a set of FAQs, have a more beneficial effect on attitudes toward reduction of risk for colorectal cancer when compared to a generic information topic list? Aims / Objectives: 1) To determine the impact of different approaches to information provision regarding primary (e.g., diet, lifestyle) and secondary (e.g. screening) prevention of colorectal cancer 2) To assess the usability and acceptance of a web-based decision aid focussing on the strengthening of attitudes toward CRC prevention behaviours. Hypothesis: A website capable of delivering targeted, salient content in the form of FAQs will, when compared with the provision of generic content, improve attitudes toward prevention of colorectal cancer, specifically perceived risk and intention to participate in primary and secondary prevention.
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Westmead Feelings Program Trial for Children with Autism and Intellectual Disability in Special Education Schools
One in 100 children is diagnosed with Autism. Up to 70% of children with Autism also experience mental illnesses including anxiety and depression. In addition to the impact of Autism on children, the mental illnesses they suffer from are of at least the same severity as that of their disability. However, unlike Autism, mental health problems are reversible and preventable. Emotion-based Social Skills Training (EBSST, also known as the Westmead Feelings Program) is a therapy program for children with Autism and co-occurring ID, their parents and teachers and includes a practitioner training and certification program. A controlled trial has demonstrated that school counsellor delivered EBSST improves emotions competence and reduces symptoms of mental disorder in children with ASD/ID. Utilising teachers in the delivery of mental health interventions is important given there are often barriers to therapy (such as cost, time, and travel) that prevent families from accessing much needed services. Additionally, school-based delivery can lead to positive changes within schools such as enhanced relationships between teachers, parents, and children. A pilot study demonstrated that special educator delivered EBSST is feasible and acceptable and results in qualitative improvements in child emotions competence and mental health. The current project extends on these findings by investigating whether EBSST delivered by teachers in eight schools is acceptable and feasible from the perspective of children, parents and teachers. The project will also examine whether EBSST is associated with improvements in child emotions competence, social skills, and mental health symptoms post-treatment and at 3-month follow-up. For a subset of participants, the project will examine whether improvements in emotions competence, social skills, and mental health symptoms are different from a period of treatment-as-usual, compared to a period of EBSST delivery. The current project also examines the impact that EBSST has on the mental health of parents of children with ASD, who have been reported to experience high levels of stress and distress. Sixteen teachers will be recruited to participate in the study to deliver EBSST to children in their classes and their parents. It is expected that approximately 75 children and 40 parents will participate. Teachers will deliver sixteen child EBSST sessions and six parent EBSST sessions across three school terms. Teacher aides and parents will complete questionnaires about child emotions competence and child and parent mental health. Children will complete a questionnaire about how EBSST impacted their learning. It is hypothesised that teacher-delivered EBSST will be acceptable and feasible, and EBSST will be associated with concurrent improvements of child emotions competence, social skills, mental health, and parent mental health.
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The Healthy Youngsters, Healthy Dads Pilot Study: A family-based healthy lifestyles program for fathers and their preschool-aged children.
In Australia, 30% of children are overweight or obese, which increases their lifetime risk of many negative health concerns (e.g., type II diabetes, heart disease, mental illness). Poor health behaviours are also becoming common early in life. For example, 76% of Australian children aged 2-4 years are not meeting physical activity and screen-time guidelines and approximately 25% are developmentally vulnerable when they start school. Family-based lifestyle programs play an important role in improving children’s health behaviours and reducing their risk of obesity. However, a recent review determined that mothers represent an overwhelming majority of participating parents in these programs (93%). This is greatly concerning, as fathers have a key influence on their children’s weight and health behaviours from a young age. Targeting the early childhood period is critical as optimal development at this life stage is very important for future health and wellbeing. Without early intervention, poor health in early childhood will have far-reaching implications for families and communities and worsen inequalities and societal divisions. In addition, childhood obesity is known to track throughout life and poor lifestyle behaviours can be entrenched at a very young age, which makes these outcomes very difficult to reverse later in childhood. In this study, we will develop and pilot test the ‘Healthy Youngsters, Healthy Dads’ intervention, which will be the first father-focused obesity prevention program for preschool-aged children. In the program, fathers will receive the knowledge, parenting skills and motivation to improve their health and become healthy role models for their young children.
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Coordinated Veterans' Care Pilot to improve mental health of Australian veterans
The Australian Government Department of Veterans' Affairs is expanding the current Coordinated Veterans’ Care (CVC) program to address the specific needs of veterans. The existing CVC program uses a team-based model of care led by a general practitioner (GP) and supported by a practice nurse. The GP and practice nurse, in consultation with the patient, develop a personalised care plan for the patient and then work with the patient to improve the management of the patient’s health and quality of life. In the expanded CVC program to address mental health needs, the program will incorporate a digital mental health coaching program to support veterans with mild to moderate anxiety or depression. The digital mental health coaching program is known as Clevertar™ Digital Coaches “app”. Veterans using the “app” will also be supported by a call monitoring facility run by Tunstall Healthcare. The call monitoring facility will provide on-going support for veterans during the time they are using the Clevertar™ Digital Coach program. Staff at the call facility include mental health nurses, allowing participants to access immediate care and support. The aim of this pilot is to evaluate whether the CVC mental health program for veterans with chronic pain who also demonstrate signs of mild to moderate mental health problems can improve mental health (as measured by psychological distress).
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An app-based intervention to improve the packing of healthy food in children’s lunchboxes in childcare.
Early Education and care childcare services are an important setting for interventions to improve child diet as they provide access to large number of children at a critical period in the development of dietary habits. For the majority of childcare centres (approximately 70%), food consumed by children is provided by parents. However research suggests that lunchboxes often contain excessive quantities of “non-core foods” (or energy dense, nutrient poor foods) and inadequate amounts of core foods such as vegetables contributing to poor health outcomes and increasing children’s risk of excessive weight gain which track into adulthood and increase risk of chronic diseases. To date, there has been few studies aiming to improve the nutritional content of lunchbox foods packed in the childcare setting, most reporting limited effect on improving lunchbox contents or improving child nutritional intake. This study explores the use of an app on changing the types of foods packed in young children’s (3-6 years old) lunchboxes while attending childcare service. It aims to measure the impact of the intervention on reducing non-core foods packed and consumed via lunchboxes