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How does heart disease affect cognition and brain structural integrity in diabetes?
Expand descriptionType 2 diabetes mellitus and dementia are two of the commonest and most disabling conditions worldwide, responsible for an enormous and growing burden of disease. There is increasing awareness that the two conditions are linked, with cognitive impairment (worsening memory, thinking, perception) common in patients type 2 diabetes, and a strong association between type 2 diabetes and Alzheimer’s disease, the most common form of dementia. Better markers are needed for the prediction of cognitive decline in people with diabetes. Left ventricular hypertrophy (LVH) is an enlargement and thickening (hypertrophy) of the walls of the hearts main pumping chamber, which is common in type 2 diabetes. To date there have been no studies on the association between LVH and cognitive decline in type 2 diabetes. The purpose of this study is to establish whether people with type 2 diabetes and LVH have increased rates of brain volume changes and cognitive impairment. An understanding of whether LVH is contributing to cognitive decline will allow us to identify patients at particular risk.
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Efficacy of the Facilitation Intervention for Practice (FLIP) program for increasing adherence to clinical practice guidelines (CPG) relating to the management of the clinical deterioration of patients.
Expand descriptionThis knowledge translation (KT) study uses a pragmatic cluster randomised controlled trial (C-RCT) design that will measure the effectiveness and cost effectiveness of a facilitation intervention to improve nurses’ vital sign (VS) measurement, interpretation, treatment and escalation of patients with abnormal VS. We will compare outcomes and costs from standard implementation of clinical practice guidelines (CPGs) with facilitated implementation. This study will include both process and health economic evaluations.
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Compassionate Mind: Evaluation of a Positive Psychology Psycho-educational workshop series for Middle School Students
Expand descriptionBackground & Project Aims Mental health disorders form a substantial proportion of overall disease burden in young people in all societies (Patel, Flisher, Hetrick, & McGorry, 2007). Internalising disorders, such as anxiety and depression, are consistently reported as the most common mental health problems amongst Australian children aged between 7 and 14 years and are often less likely to be detected compared to externalising disorders (Australian Institute of Health, 2012; Klein, Jacobs, & Reinecke, 2007; Letcher, Sanson, Smart, & Toumbourou, 2012; Seligman, Ernst, Gillham, Reivich, & Linkins, 2009). Poor mental health often begins in early adolescence (12 years of age), and a shift toward early intervention has seen some promise in preventing the trajectory of later diagnosable conditions as well as enabling adolescents to fulfil their potential (Klein, et al., 2007; McGorry, Bates, & Birchwood, 2013). Within this context of rising mental health disorder incident rates, early interventions which target underlying contributors to poor mental health are likely to prevent later trajectories of disorders. Perfectionism has recently gained attention as is a transdiagnositic entity. This means it underlies many other series pathologies such as depression, social anxiety, generalized anxiety disorder, eating disorders and even personality disorders (Dimaggio et al., 2015; Holland, Bodell, & Keel, 2013). Perfectionism refers to a tendency to strive for flawlessness and set exceedingly high standards for performance, accompanied by tendencies for overly critical evaluations (Stoeber, Eklund, & Tenenbaum, 2014). Its transdiagnostic nature positions perfectionism to be an ideal target for early intervention in addition to low mood and social worry to prevent the longitudinal development of future mental health disorders. Self-compassion is a construct gaining prominence over recent years and may directly target the key features of perfectionism, low mood and social worry (Neff, 2011; Neff & Germer, 2013; Neff, 2010). Self-compassion refers to an adaptive way of relating to ones self when considering personal inadequacies or difficult life circumstances. Self-compassion has also been shown to be an effective intervention target for adolescents suffering from negative world views (Neff, 2010). When working with a non-clinical high school population, it is important to ensure content is relevant and engaging, and appropriate for this population. Thus the combined framework of ACT, CBT and positive psychology approaches have been adopted in developing a psycho-educational workshop series, COmpassionate Mind. In addition, high schools are an appropriate target for early intervention programs given their access to a large group and capacity for the provision of ongoing support. The current study seeks to evaluate the effectiveness of the Compassionate Mind program which targets self-compassion and mindfulness.
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A randomised controlled trial of the use of a respiratory function monitor to teach neonatal mask ventilation to healthcare professionals in a simulation setting
Expand descriptionThe purpose of the study is to improve how we teach doctors, nurses and midwives how to breath for babies not breathing at birth. The primary objective is to compare the leak from mask ventilation performed on a mannequin, after learning using a respiratory function monitor and after learning without using a respiratory function monitor. The design is a single centre, randomised controlled trial. The participants will be randomised to either the intervention group (neonatal mask ventilation taught with a respiratory function monitor) or control (standard teaching of neonatal mask ventilation). Adult health care professionals attending the Victorian Neonatal Resuscitation training program (a structured simulation training program, NeoResus) in the Royal Children’s Hospital during the study period will be eligible to participate. 382 (191 in each arm) participants are expected, over 2 years 3 months. The primary outcome is the difference in leak measured after neonatal mask ventilation training between the control and intervention groups. Secondary outcomes are difference in the volume of breaths, the stability of breaths and the number of obstructed breaths.
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Study of the role of bacterial infection as the predominant cause for back pain
Expand descriptionIntroduction Degenerate intervertebral disc can cause back pain or neck pain and /or arm or leg pain (if compressing on the nerve root). Correlation between MRI scan findings of degenerate disc and back pain is poor. It is not uncommon to find poor correlation between arm or leg pain symptoms and degree of compression of the nerve root (on MRI scan). Inflammatory mediators have been implicated as the cause for this discrepancy. A few investigators have found infection of disc by low virulent organisms in these degenerate discs and in sciatica in a surprising 45% of cases. The organisms found are skin commensals and there is a high likelihood that these are contaminants. Treating all back pain or sciatica patients with long-term antibiotics is unreasonable and harmful without a strong proof of infection. Unfortunately these studies are underpowered and do not have a stringent contaminant control arm. Aims Primary: To find the rate of true infection in degenerate discs Secondary: To find the risk factors for true infection Proposal research design This is a case control study comparing incidence of true infection of intervertebral disc in degenerate disc disease patients undergoing spine surgery to patients undergoing spine surgery without degenerate disc (trauma/scoliosis/tumour). Methods All patients undergoing discectomy for various indications will be eligible to participate. At the time of surgery, disc removed as a part of the intended procedure (discectomy or fusion) will be sent for culture. A small amount of tissue generally removed as a part of the procedure (fat/muscle/ligamentum) will serve as contamination control and will also be sent for culture. Prolonged cultures will be performed to identify low virulent organisms. Data collected will include demographic data (age, sex, pre-existing health problems, diabetes, smoking, medications, immunocompromised status, smoking, family history etc), radiological data and type of surgery. If the disc culture is positive and other tissue culture is negative it will be assumed to be infected. But if the other tissue is also positive then it is presumed to be contamination. Two other arms were added to the original study: . 1. Contamination (Sham) arm: paraspinal cultures were also undertaken in patients undergoing spinal surgery without discectomy. We aim to obtain contamination rate from this cohort. 2. Histopathological arm: A subset of patients also underwent histopatholgical evaluation to review inflammatory changes in the disc samples. this was planned to augment the notion of disc infection in degenerated discs
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Goal-directed Therapy for Patients Undergoing Pancreaticoduodenectomy
Expand descriptionThis study aims to evaluate if patients undergoing pancreaticoduodenectomy (Whipple’s procedure) managed by intraoperative goal directed therapy with the Flotrac/Vigileo deviceTM will have a shorter length of hospital stay with fewer post-operative complications compared to patients managed by standard care. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo pancreaticoduodenectomy (Whipple procedure). Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will have their haemodynamic variables (fluid dynamic and blood flow) managed by intraoperative goal directed therapy (GDT) using the Flotrac/Vigileo deviceTM (FloTrac/Vigileo Version 3.02, Edwards Lifesciences, Irvine, CA, USA). This minimally invasive device automatically calculates key flow parameters every 20 seconds and recognizes and allows for adjustments in haemodynamic variables in patients undergoing major surgery. Importantly, it enables the anaesthetist to make a differential diagnosis leading to either a volume or cardiovascular intervention (preload, afterload and contractility), by providing continuous information on the patients cardiac output, stroke volume, and systemic vascular resistance. Participants allocated to the control group will have fluid management and inotropic use guided by the routine cardiovascular monitoring in place i.e. arterial line, and central venous catheter, which will be at the discretion of the anaesthetist, who will be blinded to Flotrac data. The Control group anaesthetist will be allowed to have the Flotrac haemodynamic data unblinded if needed for clinical decision making but patients will be removed from analysis if this occurs. There is now compelling evidence that fluid optimization and GDT in patients undergoing colorectal surgery leads to better outcomes, particularly in high risk patients. This study will contribute to understanding if similar benefit of GDT is also observed in patients undergoing major pancreatic surgery - pancreaticoduodenectomy (Whipples Procedure).
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The Target-D Study: An individually randomised controlled trial of a clinical prediction tool to triage and target treatment for depressive symptoms in general practice.
Expand descriptionUp to 55% of patients who see a GP have problems with stress, worries or depression, however it’s not always clear which patients will naturally recover and which ones would benefit from treatment. Researchers from the University of Melbourne have developed the Target-D Toolkit which identifies patients that might benefit from treatment and helps GPs to more effectively manage their patients’ emotional well-being. This study will improve people’s health and well-being and make better use of GPs time at less cost to the healthcare budget. It is funded by the National Health and Medical Research Council (NHMRC No: 1059863).
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Fostering Effective Early Learning (FEEL) study: Effect of a professional development program for early childhood educators on children's cognitive, social and self-regulatory development
Expand descriptionThe aim of this study is to provide a model of sustainable and effective professional development for the early childhood education and care sector to improve staff understanding and competencies, as well as child outcomes. The overall design is a cluster randomized controlled trial with an intervention group (45 early childhood education centres) receiving a professional development intervention in 2016 and a control group (45 early childhood education centres) receiving this intervention on completion of the research evaluation in 2017. Pre- and post-intervention measures of centre quality (involving observation of typical centre operations) and child outcomes (involving direct and indirect assessment of participating children’s academic/cognitive, self-regulatory and social development) will permit estimation of effects of the intervention on both staff behaviour and child outcomes.
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Long Term Intervention with Pravastatin in Ischaemic Disease
Expand descriptionThis multicentre, double-blind, placebo-controlled clinical trial is designed to determine whether prolonged reduction in blood cholesterol with pravastatin, one of the class of 3-hydroxy-3-methylglutaryl-coenzyme-A reductase (HMG-CoA reductase) inhibitors, will reduce mortality from coronary heart disease in patients with a history of myocardial infarction or unstable angina pectoris. To qualify for entry, a patient must have a blood cholesterol level in the range 4.0 to 7.0 mmol/L, and must have suffered a myocardial infarction or have been admitted to hospital with unstable angina, within three months to three years prior to screening. The primary study outcome will be death due to coronary heart disease. Secondary analyses will be of death from all causes, combined incidence of non fatal myocardial infarction and fatal coronary heart disease, stroke (total and non-haemorrhagic), cardiovascular mortality, coronary revascularisation (CABG and coronary angioplasty), and number of days in hospital during the follow-up period. The goal of intervention is to reduce total blood cholesterol by an average of 25% in patients allocated pravastatin compared with those allocated placebo. To detect reliably the expected effect of such a cholesterol difference on the primary endpoint requires about 9,000 patients be randomised in equal numbers to pravastatin or placebo, and that follow-up of these patients continues for a minimum 5 years for each surviving patient.
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An evaluation of the role of Magnetic resonance Imaging (MRI) in Mucosal Primary Head and Neck Cancer
Expand descriptionThis study will evaluate the role of magnetic resonance imaging (MRI) in the treatment of Mucosal Primary Head and Neck Cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with histologically-proven invasive primary squamous cell carcinoma of mucosal primary head and neck region or suspect tumours for mucosal primary head and neck cancer. Study details: Imaging studies are not routinely performed during radiotherapy for head and neck cancer. In this study, all participants will receive multiple additional MRI sequences before, during and after radiotherapy treatment (with or without chemotherapy). MRI sequences used include DWI, R2*, and DCE. The results from all scans will be evaluated with respect to tumour response, local control, disease free survival and overall survival. The main purpose of this study is to see whether new MRI techniques during and after radiotherapy treatment provides the doctors with accurate information which predicts the later response of mucosal primary head and neck cancer to the treatment and also evaluates tumour recurrence following treatment.