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Primary school Physical Education and Physical Literacy (PEPL) support system: a quasi randomised controlled trial
Expand descriptionThe Physical Education Physical Literacy (PEPL) project evaluates a support system designed to assist primary schools to create a physically active culture, increase student opportunities for physical activity, and to enhance the content and delivery of physical education. This study continues on from a previous research project conducted in Victoria (ACTRN12615000066583) The system is guided by a PEPL coach - an expert physical educator working in a network of 8 schools who tailors the support system to meet individual school needs. The objectives of the PEPL coach include: 1) Develop a school climate that understands the benefits of PEPL for student learning and development 2) Provide in-class lesson modelling and professional development for the generalist classroom teacher 3) Increase opportunities for students to take part in physical education and physical literacy activities outside of physical education time 4) To develop relationships between schools, community organisations and sporting clubs
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The effect of high carbohydrate and low carbohydrate suppers on fasting blood glucose levels (BGLs) in gestational diabetes mellitus (GDM): GDM Supper Study
Expand descriptionDiabetes in pregnancy is the most common metabolic dysfunction in pregnancy. Many women are managed with diet control alone. It is therefore essential that women are receiving accurate nutritional advice. Current practice at our hospital is to advise women to have a bedtime snack to help meet the caloric requirements of pregnancy, and with the expectation that it may suppress hepatic gluconeogenesis thus achieving lower fasting blood glucose levels (BGLs). Recommending supper in GDM is widely practiced across Australia and is contained in the Dietitians Association of Australia resources, and supported by the Canadian and American Diabetes Associations’ Guidelines; however, there is no strong or recent evidence to support this. This study aims to recruit 66 women and measure the effect of two different snacks: a higher carbohydrate snack (apple and yoghurt) and a lower carbohydrate snack (nuts and dark chocolate) as compared to no snack, to see what influence each of these has on fasting BGLs. Each snack will be consumed for five consecutive days. Women will be randomly allocated an order in which to consume each snack. Women will also be required to record their activity levels each day, in order to monitor the effect that this has on fasting BGLs It is expected that women will have lower fasting BGLs when consuming either snack than when they are not having a snack. It is also expected that those women with higher physical activity levels will have lower fasting BGLs.
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Measuring the effects of the Silence is Deadly program on mental help-seeking attitudes in young men
Expand descriptionThe largest mortality risk facing young men is suicide, and their unwillingness to seek help for their mental health troubles greatly exacerbates this problem. Rather than blame men for their poor attitudes, some organisations are changing the nature of the public health message directed at young men to make it more male friendly. It is not known whether these interventions are having a positive effect on mens help-seeking attitudes and intentions, particularly among young men with indicated mental health problems, those with more stigmatising attitudes, or those who conform more strongly to gender norms. The current research project seeks to evaluate one such existing intervention, the Silence is Deadly Program, which has been delivered in ACT schools since 2014. This intervention is delivered by not-for-profit organisation Menslink in partnership with the state representative rugby league team (the Canberra Raiders) and uses role-modelling and social norming, as well as male-tailored vocabulary, to influence young mens help-seeking attitudes and intentions. The proposed research project will be conducted in 2017-2018, and will comprise a cluster randomised wait-list control trial that involves 8 ACT schools, totalling 800 male students who will be surveyed pre, post and three months after the intervention. The primary aim of the study is to determine the effectiveness of this tailored approach to suicide prevention and identify if it is differentially effective for participants with different levels of mental health symptoms, suicidal thoughts, stigmatizing attitudes towards seeking help and adherence to gender role norms. This analysis will be complemented by a qualitative investigation into the interventions effect on the culture of helping seeking in the school through semi-structured interviews with staff members. The research team has a strong track record of research in schools, service evaluation, stigma and help-seeking for mental health issues and suicide.
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Lisdexamfetamine for the treatment of methamphetamine addiction
Expand descriptionAustralia has one of the highest rates of methamphetamine dependence in the world. While counselling is effective for many people with less severe dependence, there is no proven medication treatment for severe dependence. Lisdexamfetamine is a stimulant of the brain and is approved in Australia for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). It is a once-daily oral medication converted to dexamphetamine in the blood. The aim of the LiMA study is to test if lisdexamfetamine is effective in reducing methamphetamine use, cravings and withdrawal symptoms in people who are dependent on methamphetamine. This will be a randomised double-blind placebo-controlled study which means that one group will receive lisdexamfetamine and another will receive a placebo (a medication with no active ingredients), in addition to counselling. Participants, clinicians and researchers involved in the study will not know to which group they have been allocated. The two groups will be compared and the findings will contribute to evidence for the future use of lisdexamfetamine in the treatment of methamphetamine dependence. 180 people will be recruited to the LiMA study which will be conducted in specialist treatment centres in Sydney, Newcastle and Adelaide. It is anticipated that recruitment will start in early 2017.
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Validation of Whole Blood Point of Care B-hCG Testing for Pregnancy Using Urine Pregnancy Assay in Women of Reproductive Age Presenting to the Emergency Department
Expand descriptionAnecdotally, whole blood can be used on point of care cartridges for rapid determination of a patient's pregnancy status. Early identification of pregnancy status is important in the case of females of reproductive age with abdominal pain, as the possibility of a pregnancy (including an ectopic pregnancy) can be quickly included or excluded. The manufacturers of the point of care testing cartridges, however, state that these can only be used with urine or serum, both of which there is often a delay in obtaining. This study aims to validate the use of whole blood for rapid point of care investigation for pregnancy. The hypothesis is that the whole blood point of care testing will have similar sensitivity and specificity to lab serum testing for detection of pregnancy.
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Dynamic and static functional imaging and morphological imaging in Neuroendocrine Tumour (NET) with known liver metastases.
Expand descriptionThe aim of this study is to compare the accuracy of novel, dynamic and static functional imaging, and also morphological imaging, with standard of care imaging for the detection of liver metastases in patients with neuroendocrine tumour (NET). Who is it for? You may be eligible to join this study if you aged 18 years or above and have been diagnosed with histologically proven WHO Grade I or Grade II NET with known liver metastases. Study details All participants in this study will receive three scans on a single day: an initial PET-MRI Scan, followed by a PET-CT Scan, and then a final PET-MRI Scan. For the initial PET-MRI scan a qualified Nuclear Medicine Technologist will ask you to lie on the scanner bed. They will insert a tube into your vein and inject a radioactive substance called Ga-68-DOTATATE as well as a special dye called contrast. The scan involves lying flat with knees supported and arms resting by your side. You will be scanned from the top of your head to the middle of your thighs. The scan time for the PET-MRI will be approximately 45 minutes. The PET-CT scan involves lying flat and takes approximately 30 minutes to scan you from the top of your head to the middle of your thighs. The final PET-MRI scan will not require any further injections. This scan will go from the top of your head to the middle of your thighs and should take approximately 30 minutes. This scan is performed to directly compare the PET-CT images to the PET-MRI images. The images generated will be independently reviewed by trained Nuclear Medicine physicians partaking in the study to count the number of liver metastases. It is hoped that additional dynamic PET may further increase the sensitivity of detecting liver metastases. This may potentially influence treatment options in individual patients, including possibly avoiding futile surgery in patients with more extensive disease burden than detected on current standard imaging
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A prospective validation study of the Glasgow-Blatchford score
Expand descriptionThe Glasgow-Blatchford score (GBS) has been shown to be superior to other scoring systems, such as the Rockall score, in predicting clinical outcomes and the need for endotherapy in hospitalised patients with upper gastrointestinal (UGI) bleeding. Specifically, our prospective observational study in 708 patients has recently found that a score of three or less identifies patients who do not require endoscopic intervention, blood transfusion, or surgery, and thus, could potentially be discharged early with conservative management and outpatient endoscopy. Despite the clinical implication of these findings, the use of the GBS in the management of UGI bleeding has not been adopted in practice at the Royal Adelaide Hospital. In order to further evaluate the use of the GBS to triage patients, we would like to prospectively validate the cut-off GBS of three or less in the outcome and management of patients with UGI haemorrhage (UGIH). More specifically, we would like to examine whether the GBS cut-off of three can determine the need for urgent endoscopy (within 24 hours), endotherapy, blood transfusion or surgery in these patients.
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Effect of cognitive behaviour therapy on anxiety, depression and breathlessness in patients with Chronic Obstructive Pulmonary Disease
Expand descriptionThe aim of the current study, is to investigate the efficacy of an 8 session Cognitive Behaviour Therapy intervention as an adjunct to a breathlessness clinic intervention on mastery of breathlessness and anxiety/depression scores compared to a waitlist control. Participants will have recently completed the breathlessness clinic at Westmead Hospital and still have high scores for depression and anxiety related to their disease symptoms. They will then be invited to participate in this study. They will be randomised to one of two groups, immediate enrolment in cognitive behaviour therapy or to an 10 week waitlist control group. This will allow comparison between the two groups. The cognitive behaviour therapy will be identical for each group. Questionnaires, lung function and activity tracker will be completed by all participants, at baseline and end of 10 week.
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The impact of Sulpiride (600mg; a dopamine antagonist) on behavioural and electrophysiological measures of visuospatial attention and inhibition
Expand descriptionThis study will investigate whether temporarily reducing dopamine transmission in the healthy brain affects an individual’s spatial selective attention, that is, the direction in space (left or right) in which an individual’s visual attention naturally falls. By combining this investigation with measures of electrical activity in the brain and genetic testing, we hope to gain a deeper understanding of the mechanisms involved in spatial attention and the influence on these mechanisms of genes implicated in the structure and function of the dopamine system in the brain. Uncovering the mechanisms of spatial attention may help us better understand and treat disorders involving spatial attention deficits, including Attention Deficit Hyperactivity Disorder, which involves an impaired awareness of, and ability to respond to, objects and information in a particular area of visual space.
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BCT 1702 (CHARIOT): Patients with high-risk primary triple negative breast cancer who have had anthracycline-based chemotherapy will receive Ipilimumab and Nivolumab with weekly paclitaxel, followed by definitive surgery and further treatment with Nivolumab to evaluate the safety, feasibility and efficacy of this treatment.
Expand descriptionThis study aims to find out if treatment with a combination of Ipilimumab and Nivolumab, with weekly paclitaxel before surgery, and treatment with Nivolumab after surgery, is safe and effective in women and men diagnosed with triple negative breast cancer. Who is it for? You may be eligible for this study if you are 18 years or older, have been diagnosed with triple negative breast cancer, will be having neoadjuvant treatment (treatment with anthracycline-based chemotherapy before surgery) and your tumour is >= 15mm in size after anthracycline-based chemotherapy. Trial Details. Participants may have commenced anthracycline based chemotherapy prior to signing consent to this study. Tumour block/sections from the initial diagnostic core biopsy must be available. Up to 3 weeks before starting study treatment, all participants will have a breast and axillary ultrasound, and provide research core biopsies and research blood tests. The tumour must be biopsied prior to the start of neoadjuvant study therapy and a primary tumour size of >= 15 mm on imaging (mammogram or ultrasound) is required for eligibility. Participants will have clinic visits every 2 weeks during pre-surgery treatment (nivolumab, ipilimumab and paclitaxel) for 12 weeks. They will receive nivolumab every 2 weeks (6 doses), ipilimumab every 6 weeks (2 doses) and paclitaxel every week (12 doses). Participants will have a breast and axilla ultrasound repeated before surgery. If tumour is available at surgery, research biopsies will be collected. Nivolumab will re-start when safe to do so 3-6 weeks post-surgery. All participants will have clinic visits with the first dose of nivolumab after surgery, and then every 4 weeks for 9 visits (36 weeks). Nivolumab is dosed every 4 weeks post-surgery for up to 9 doses. The total duration of study treatment is 1 year. Participants will be followed as per local investigator standard of care (SOC) at 6 months, 12 months, 24 months and 36 months following start of study treatment by phone or SOC visits.