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Defining a Randomised, Controlled Study of Ortho-ATI (Trademark) vs Corticosteroid Injection for Treatment of Rotator Cuff Tendinopathy and Tear.
Expand descriptionThe objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Conservative treatments include rest, NSAIDs, glucocorticoid injections and physical therapy. While specific exercise therapy may be beneficial, most of these treatments often only temporarily relieve the patients’ symptoms, and do not address the underlying tendon pathology. A combination of an increased understanding of pathological processes involved in tendinopathy as well as the success of other autologous therapies for tissue repair has highlighted the potential for tendon repair by delivery of tenocytes to the site of injury. Tendon-derived cells, including tendon progenitor cells (TPCs), possess the potential for tendon regeneration as they have the capacity for collagen synthesis, proliferate rapidly and are self-renewable. The efficacy of tenocyte implantation for stimulation of tendon repair has been verified in a number of in vitro and animal studies. Animal studies have revealed that implantation of in vitro expanded autologous tenocytes improved the tendon structure and facilitated the healing process in both an acute tendon tear model and a chronic degenerative tendon disease model . Based on these studies, it was proposed that restoration of functional cells capable of synthesizing extracellular matrix and repairing the damaged tissue within the tendon may be an effective therapeutic strategy for tendon repair. This method is the basis of the Ortho-ATI (Trademark) tenocyte therapy product developed by Orthocell. Imaging studies of rotator cuff tear indicate that injury to the supraspinatus tendon is most likely to be the cause of rotator cuff disease. The majority of supraspinatus tendon tears occur within a zone close to the tendon insertion. This is most likely due to lack of vascularity within that portion of tendon, and/or increased tensile loading. Furthermore, concealed lesions within the substance of the tendon (interstitial or intrasubstance tears) account for approximately one third of rotator cuff tears detected at the tendon insertion. These lesions present an unmet area of clinical need, as they are not suitable for surgical correction, should non-surgical treatments fail. Ortho-ATI (Trademark) is a minimally-invasive treatment which, unlike other conservative treatments, directly addresses the underlying pathology of rotator cuff tendinopathy and tear. This randomised, controlled study has been designed to investigate the feasibility of Ortho-ATI (Trademark) as an alternative treatment for patients with partial, intrasubstance rotator cuff tear and tendinopathy.
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Do Australian orthodontists’ need a lateral cephalometric radiograph to diagnose malocclusions?
Expand descriptionLateral head radiographs are routinely prescribed to every patient who is willing to have braces to correct their abnormal teeth positions (malocclusion). However, the information gathered during a clinical examination of the patient is fundamental to determine the diagnosis of a given malocclusion. The aim of the present investigation is to test the null hypothesis that lateral head radiographs will not alter Australian Orthodontists’ diagnosis and treatment planning decisions. If the results are consistent with our hypothesis and lateral head radiographs are not a ‘must have’ diagnostic record in orthodontics, we can suggest that lateral head radiographs should not be prescribed routinely to all patients. This would alter the conventional prescription of lateral head radiographs required for orthodontic diagnosis. The omission of the lateral head radiograph from a susceptible age group would limit the amount of ionising radiation exposure.
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Implementation trial of the BeUpstanding Champion Toolkit in desk-based workers: evaluation of uptake, implementation, effectiveness, and costs.
Expand descriptionThe aim of this three-year project is to evaluate, in the context of a national implementation trial, an evidence-informed intervention to reduce workplace sitting – the BeUpstanding Champion Toolkit. Primary outcomes are: 1) Uptake of the Toolkit overall and within the partner-determined priority sectors 2) Implementation of the Toolkit by workplace teams 3) Effectiveness of the Toolkit in reducing employee workplace sitting time Hypothesis (two-tailed): the Toolkit will elicit significant changes in workplace sitting time following exposure to the program (at 3 months) and in the long term (at 12 months) Target is 20 minute reduction per 8-h workday
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Physical Activity for Everyone (PA4E1) Implementation Trial: supporting secondary schools in low-income communities to prevent the decline in adolescent physical activity.
Expand descriptionTo address adolescent PA, Physical Activity 4 Everyone (PA4E1) is a multi-component secondary school PA intervention recently trialled in New South Wales (NSW), Australia in a study involving 10 disadvantaged secondary schools (5 intervention schools, 5 control schools). The program involved schools implementing seven PA strategies, which schools were supported to implement. The intervention delivered over two years resulted in significant improvements in adolescents’ daily minutes of moderate-to-vigorous physical activity (MVPA) and adiposity at 24 months. The program was cost-effective and acceptable to stakeholders. There is currently little evidence to guide the successful scale-up of effective programs, such as PA4E1, to a larger number of secondary schools. Without adequate implementation ‘at scale’ of such programs, their benefits cannot be realised. A larger trial of the PA4E1 intervention will be conducted in secondary schools located in disadvantaged areas in four NSW Local Health Districts. The primary aim of this study is to assess the effectiveness of the intervention in increasing school implementation of seven practices designed to facilitate student PA levels (PA practices). The effectiveness of the intervention in improving adolescent PA and preventing adiposity, and its cost effectiveness in doing so, will also be assessed in a sub-sample of schools (secondary outcome). The study will employ a cluster randomised controlled trial (RCT) design (24 intervention schools and 25 control schools). An implementation support intervention adapted for scale up from the support provided to schools in the PA4E1 effectiveness trial has been designed using the Theoretical Domains Framework (TDF). A nested sample of 30 schools (15 per group) will collect student level measures to assess the secondary outcomes.
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An e-health delivered trial to test the efficacy of a combined physical activity and sleep intervention to improve sleep quality in Australian adults with poor sleep quality: The Refresh Study
Expand descriptionThis study will be a 3-arm randomised-control trial to examine the efficacy of a combined physical activity and sleep health intervention to improve sleep quality in mid-aged adults, compared with a sleep health only intervention and a wait-list control group. The study will also compare the groups by physical activity, depressive symptoms and health-related quality of life. These outcomes will be assessed after 3 months (primary time point) and 6 months (follow-up). The interventions will be delivered using an internet-enabled app as well as email and text message support, using goal setting, action planning, self-monitoring, and feedback in relation to progress towards goals, as behaviour change strategies. The combined physical activity and sleep health group will use these strategies to change both physical activity and sleep behaviours while the sleep health only group will only change their sleep behaviours. The wait-list control will be asked not to change their behaviours for the duration of the intervention but will be offered the combined physical activity and sleep intervention at the completion of the study. Poor sleep health is associated with an increased risk of non-communicable diseases, decreased work productivity and high health care costs. Approximately 30-50% of adults worldwide report poor sleep quality. Only about half of these people have a diagnosable sleep disorder, yet most interventions to date are targeted at those with a sleep disorder. Additionally, although physical activity has been shown to be effective at improving sleep quality, none of the studies included in a review of sleep health interventions provided participants with specific strategies and behaviour change techniques to foster changes in physical activity. Consequently, sleep health interventions that do not provide participants with targeted strategies to change physical activity may not maximise change in physical activity, nor the resulting flow on effects that physical activity may have on sleep health. The 3-arm design will allow us to determine whether the addition of physical activity enhances the effectiveness of a sleep intervention to improve sleep quality. The combination of a physical activity intervention with a sleep intervention is likely to further reduce the risk of chronic diseases associated with poor sleep such as cardiovascular disease and type 2 diabetes, by synergistically enhancing the effectiveness of the sleep intervention.
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Magnet Resonance to Manage Breast Disease
Expand descriptionBackground Breast cancer is the most common cancer in women in Australia and the second most common cancer to cause death in women, after lung cancer. The symptoms of breast disease include new lumps, thickening in the tissues including under the arm, nipple sores, nipple discharge, dimpling of the skin and red or swollen breasts. The cause of breast cancer is unknown, but risk factors include; increasing age, family history, inheritance of mutation in the genes BRCA1 and BRCA2, exposure to female hormones and obesity. Study Aims: This study aims to identify biochemical markers associated with breast cancer using Magnetic Resonance Spectroscopy. You will undergo vivo MR spectroscopy to identify the pathology of any lesions identified by MR through looking at the biochemical deregulation of the tumour. This information will ascertain if in vivo MR spectroscopy combined with contrast-enhanced MRI can distinguish DCIS from invasive cancer. This will be achieved by comparison with post-operative pathology. Through collecting this information we aim to develop an approach to improve diagnostic timeframes and pre-operative planning of breast disease management by combining MRI, MRS and the current imaging approaches. Moreover, we aim to produce technology that can identify the spread of malignant disease to the surrounding nodes. Study details If you are scheduled for surgery: A biopsy or a small piece of tissue will be collected by your surgeon prior to surgery for the purpose of this study. This tissue will be examined under Magnetic Resonance Spectroscopy. If you are a volunteer who is identified as a carrier of BRCA1 and/or BRCA2 mutations:([Blood samples will be used to confirm BRCA1 and/or BRCA2 mutations) If you are a healthy volunteer or do not carry the gene(s) or have not been diagnosed with breast cancer BRCA1 and BRCA2 genetic status will first be determined with a blood test to confirm absence of BRCA mutations. All study participants will be provided an appointment at the imaging facility closest to them to complete an MRI and MRS of breasts. During your visit to the imaging facility you will be required to undergo two non-invasive imaging procedures with a clinical scanner used for routine testing. Your two scan procedures will be done in a single visit on the same day with a short break in between. For the 1st MRS scan you will require to lie in the scanner for approximately 40 minutes. During this scan images of your breast and information on its chemistry will be obtained. The 2nd MRI scan is a functional MRI and will assess the blood flow in different areas of your breast. This scan will take approximately 45 minutes. These are additional MR scans which you would not be undergoing unless you were part of the study.
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Magnetic Resonance Spectroscopy of Post Traumatic Stress Disorder.
Expand descriptionPost-Traumatic Stress Disorder (PTSD) is a complex condition where sufferers are affected by a varying range of symptoms following an exposure to a traumatic situation or event. Sufferers may experience symptoms such as recurrent and intrusive thoughts, nightmares, flashbacks, or distress and avoidance of situations that are similar to the event that first occurred. It is not yet known why some people experience PTSD following a traumatic event and others do not. This research study aims to try to determine if the chemicals that allow the brain to carry out its normal functions are different in a person who suffers from PTSD when compared to a person who does not. In this study researchers will use a technique called Magnetic Resonance Spectroscopy (MRS) to look for any changes in the normal chemistry of the brain. The researchers will then compare the images obtained from participants who have PTSD with those who do not. The researchers conducting this study hope that by using MRS to look for and isolate any abnormalities in the brain chemicals of those with PTSD this may lead to improvements in the diagnosis and treatment for PTSD suffers in the future. MRS is a non-invasive medical test. It is conducted on the same machine as conventional Magnetic Resonance Imaging (MRI) scans. The MRI scan uses a powerful magnet, radio waves, and a computer to create detailed images. MRS is a series of tests that are added to an MRI scan to measure the chemical properties of molecules in cells and tissues. In this study MRI will be used to take anatomical images of your brain and MRS will be used to provide detailed information about the nature and chemical environment of the molecules in your brain.
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Compassion at the heart of well-being: an inter-disciplinary study to evaluate the effect of a meditation intervention and a positive psychology intervention on well-being and compassionate care among healthcare employees
Expand descriptionThis RCT compares two interventions designed to enhance nurse well-being and compassion with a control group. Nursing teams will be randomized into one of three conditions: a) a meditation training program, b) a positive psychology training program and c) a wait list control group. Pre-, post- and 4-month follow-up self-report measures of nurse well-being, compassionate care and related measures will be administered along with physiological measures of nurse heart-rate variability. In addition, ethnographic interviews and ethnographic observations will be undertaken along with semi-structured interviews with nurses regarding their experiences of compassionate care, Lastly, the study will explore the effects of the interventions on compassionate care among nurse-patient dyads and among nurses' broader social networks.
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The relationship between changes in the neural mechanisms associated with pain and the improvement in clinical symptoms of Achilles tendon pain.
Expand descriptionThe proposed research aims to provide insight into the mechanism(s) behind the improvement patients with Achilles tendon pain experience from rehabilitation. Specifically is there an association between the neural mechanisms associated with pain. Therefore this body of work may enable clinicians to more effectively understand the mechanisms which drive improvement in pain and function in people with Achilles tendon pain. Investigating these mechanisms of action may serve to refine and optimise rehabilitation strategies to improve outcomes.
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What are the effects on carbohydrate digestion and absorption of variations in the salivary amylase gene in healthy adults?
Expand descriptionThe aim of this study is to identify the variation of the salivary amylase (AMY1) gene copy number in the Australian population and to investigate the effect of AMY1 copy number on carbohydrate digestion, acute metabolic and satiety responses, and potential associations with obesity and diabetes risk. This project will screen Australian adults for their number of copies of the AMY1 gene. This gene produces a protein, salivary amylase, which is secreted in the mouth and begins starch breakdown. Individuals with varying AMY1 copy numbers will be asked to perform a series of starch challenge tests during which they will consume different high carbohydrate foods. Fingerprick blood samples will be taken at regular intervals over 2 hours to measure their metabolic responses to starchy foods. To assess the efficiency of starch digestion, salivary amylase activity, breath hydrogen and methane responses, and postprandial glucose and insulin responses will also be assessed over an 8 hour period following the consumption of different high carbohydrate meals. Information on how AMY1 copy number influences carbohydrate metabolism and usual dietary intake may have important implications for the dietary management of diabetes and obesity and/or identify those at greater risk of developing these conditions.