ANZCTR search results

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).

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.

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.

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.

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).

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

This study is designed to test the safety and potential benefit of adding an existing drug used for bone protection (denosumab) to a new immune stimulating drug (pembrolizumab). Who is it for? You may be eligible for this study if you have a confirmed unresectable or metastatic clear cell renal carcinoma, and you have adequate liver and bone function. Study details All participants will receive the two study drugs, along with vitamin D and calcium (mode of administration up to the discretion of the treating clinician). Treatment will continue until disease progression or toxicity. Patients will be monitored for tumour response and skeleton health. It is hoped this combination of medications will be as safe, and provide more benefit than the immune stimulating drug alone in treating kidney cancer.

This is the first in human study to evaluate the safety and tolerability of topical treatment, HXP124 in otherwise healthy patients with mild to moderate fungal toenails infections, onychomycosis. The study also aims to evaluate the effectiveness of HXP124 in treating onychomycosis.

The purpose of this study is determine how the lungs start breathing air immediately after birth. We know that during the pregnancy the baby’s lungs are filled with fluid but that immediately after birth the lungs need to very quickly clear the fluid and replace it with air so normal breathing can begin (this is called ‘aeration’). Some babies struggle to do this and develop breathing problems immediately after birth. This is very common in babies born prematurely but also occurs in at least 10% of healthy term babies. It is known from studies in animals that the process of aeration is very complex and breathing problems are most likely if aeration does not occur equally throughout both lungs at birth. At present we don't know how babies lungs aerate at birth, despite this being something every baby needs to do. This is because measuring aeration is hard to do. Recently, our team have developed a special method of measuring aeration at birth, it uses a simple device called electrical impedance tomography or EIT). EIT does not interfere with the normal behaviour of a baby or their clinical care, and is free from radiation (unlike x-rays), meaning that EIT can measure aeration and breathing in a baby for long periods of time. We would like to use EIT describe, for the first time, how healthy term and preterm lungs aerate immediately after birth. This will assist us in determining how we may be able to better understand how to develop treatments for sick babies who cannot achieve aeration properly.

This study is being conducted to evaluate the safety, tolerability, pharmacokinetics of ascending single doses of XW10172 compared to placebo.