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Central Venous Access Device (CVAD) Registry - an electronic database to monitor the outcomes of patients with CVADs
Expand descriptionTreatment today is unthinkable without vascular access devices for the management of patients. CVADs are essential for the administration of intravenous medications and blood sampling. This registry will collect information about the patients requiring CVADs, the type of CVADs being inserted, any complications experienced and the reasons for removal. The registry will provide clinicians and researchers with first-hand information about CVADs for patients receiving treatment and over time will increase our understanding of the complications associated with CVADs. The CVAD Registry will provide clinicians and researchers with an increased understanding of device failure, therefore improving clinical outcomes for patients with CVADs. The CVAD Registry will prospectively collect clinical data on device characteristics, adverse outcomes and risk factors. The Registry will: 1. Store existing clinical data pertaining to patients with CVADs in one database. 2. Facilitate quality improvement and research projects about patients with CVADs.
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Group metacognitive therapy for repetitive negative thinking: Evaluation in a transdiagnostic adolescent sample
Expand descriptionThere is evidence to suggest that it may be of benefit to look at the common (transdiagnostic) processes that appear to exist across psychological disorders, rather than the typical approach of splitting into discrete disorders. Suggested processes include metacognition (beliefs about our thinking, which can be both positive and negative) and repetitive negative thinking (RNT), which includes worry and rumination. Metacognitive therapy has been used as a treatment approach across a range of mental disorders to target these proposed common underlying processes of metacognition and repetitive negative thinking and has shown promising results in studies with adult participants. There is evidence to suggest that similarities may also outweigh differences between psychological disorders in youth, particularly adolescents. Support is growing for an extension of models related to transdiagnostic processes of metacognition and repetitive negative thinking from adults to adolescents, although studies of the benefits of metacognitive therapy in adolescents have been limited. New research coming from the adult literature has shown that group metacognitive therapy is as beneficial as individual treatment protocols, but is delivered in a much briefer time frame and is found to be benefit individuals with a range of mental health diagnoses. The aim of the proposed study is to provide a preliminary evaluation of the acceptability and efficacy of brief group metacognitive therapy (MCT) targeting repetitive negative thinking for adolescents with a diagnosed emotional disorder.
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The SHAKE IT pilot study: Shakes and meal replacements to Help children and Adolescents Kick-start healthy Eating In Type 2 diabetes
Expand descriptionThe aim of this pilot study is to investigate the effectiveness of a very low energy diet (VLED), consisting primarily of meal replacements, to resolve the metabolic abnormalities underlying type 2 diabetes in children and adolescents. We hypothesise that children and adolescents who achieve rapid weight loss through short-term use of a VLED will reverse the metabolic abnormalities underlying their type 2 diabetes. Our approach to cure type 2 diabetes is innovative and is in contrast to current practice which is aimed at managing type 2 diabetes. To our knowledge this study will be a world's first with the aim of curing diabetes in youth.
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Topical estradiol add-back in hypogonadal men: dose-finding study
Expand descriptionThe primary purpose of this trial is to determine the ideal dose of estradiol to give to men receiving androgen deprivation therapy (ADT) for prostate cancer, in order to replace the normal estradiol levels that they would have if they were not taking ADT. Who is it for? You may be eligible to participate in this trial if you are aged 55 to 80 years of age, and have been diagnosed with non-metastatic Prostate Cancer (T1-3NxM0) for which you are receiving treatment with GnRH agonists to suppress androgen production with a planned duration of further treatment of greater than 4 weeks. Study details All participants enrolled in this trial will be randomly allocated (by chance) to one of three groups. The first group will receive 0.9mg per day of estradiol, the second group will receive 1.8mg per day of estradiol, and the third group will receive a placebo (sham) treatment which contains no active ingredient. All three treatments are given as a gel which is rubbed into the skin once per day for 4 weeks. Researchers will take weekly blood samples from baseline to the end of the 4 week treatment period to determine the impact of each treatment on the level of estradiol in the blood as well as some indicators of bone health and diabetes, and a diary of hot flushes will be completed by all participants. It is hoped that this trial will provide information on the optimal dose of estradiol to give to men with prostate cancer on ADT, to replace the normal blood (serum) level of estradiol that they would have had were they not taking ADT. A subsequent study will investigate whether this treatment is effective in reducing some of the side effects of ADT.
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Effects of high-intensity exercise training among women with previous gestational diabetes
Expand descriptionThe aim of our study is to investigate the effects of a novel intervention - high-intensity aerobic interval training - on aerobic fitness, heart volumes and function, metabolic control, substrate utilization, nerve function and cardiovascular risk factors among women with previous gestational diabetes mellitus (pGDM). Women with pGDM have an exceptionally high (at least a 7-fold higher risk) risk of developing type 2 diabetes mellitus compared with women without pGDM. Previous GDM is associated with subclinical atherosclerosis prior to the development of the metabolic syndrome or T2D. There may also be subclinical heart dysfunction, however this has rarely been examined and responses to exercise training have not been investigated. It has been demonstrated recently that peripheral nerve dysfunction precedes the development of neuropathy in T2D and given that pGDM is associated with subclinical atherosclerosis prior to the development of the metabolic syndrome or T2D, nerve dysfunction may also be evident among women with pGDM, however, this has not been examined. There is an inverse relationship between physical activity and risk of type 2 diabetes mellitus (T2D) among women with pGDM. In fact, achieving the minimum recommended exercise targets (150 min of moderate-intensity exercise per week) halved the risk of developing T2D among women with pGDM. No studies have examined effects of high-intensity exercise training among women with pGDM.
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Effects of high-intensity exercise training among people with early-onset type 2 diabetes mellitus
Expand descriptionThe aim of our study is to investigate the effects of a novel intervention - high-intensity aerobic interval training - on aerobic fitness, heart volumes and function, metabolic control, substrate utilization and cardiovascular risk factors among patients with early-onset type 2 diabetes. Diabetes prevalence in Australia is amongst the highest in the developed world and increasingly affects younger people. Early-onset type 2 diabetes mellitus (EOT2D) is a very aggressive form of diabetes - evidenced by poor metabolic control, the appearance of severe cardiovascular disease about three decades earlier than in later-onset type 2 diabetes and early mortality – primarily from cardiovascular causes. Multiple stressors, including management of aggressive diabetes and the burden of obesity and other co-morbidities contribute to impaired quality of life among people with EOT2D. Among adults with later-onset type 2 diabetes, exercise training improves physical fitness, metabolic control, cardiovascular risk factors and quality of life and may reduce early mortality. The gold standard for assessing whole body (aerobic) fitness is peak oxygen uptake (VO2peak) which has both central (heart) and peripheral (skeletal muscle) components. There is a very robust inverse relationship between whole body fitness and mortality: the higher the fitness, the lower the risk of early mortality. The only intervention (other than blood doping which is inherently dangerous) that increases VO2peak is regular aerobic exercise training. However, the only previous study to examine the effects of exercise training in EOT2D found no significant change in whole body fitness or metabolic control after three months of traditional moderate-intensity aerobic exercise training. In contrast to the group with EOT2D, the obese control group without diabetes experienced substantial improvement in whole body fitness. This raises the question of whether a different training strategy would be effective in improving whole body fitness in EOT2D. Randomized controlled trials in older patients groups with cardiovascular disease, e.g. heart failure, demonstrated that an exercise strategy that is novel among people with chronic disease - high intensity aerobic interval training - was safe and was more effective in improving aerobic fitness, heart volumes and function and skeletal muscle capacity than traditional moderate-intensity continuous exercise. Aerobic interval training requires less time than traditional continuous exercise, and thus time-efficiency may render this form of exercise more sustainable for people with chronic disease who are required to cope with many stressors. The proposed study will provide the first evidence of the effects of high intensity aerobic interval training on fitness, metabolic control, heart volumes and function, nerve function and cardiovascular risk among people with early-onset type 2 diabetes.
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The evaluation of telehealth technologies to facilitate clinical outcomes improvements in eye care, diabetes and cardiovascular disease management for Indigenous Australians.
Expand descriptionThe TEAMSnet study is a research project which aims to improve diabetes and cardiovascular healthcare in Aboriginal and Torres Strait Islander communities. The project is developing and testing the use of internet and mobile technologies to provide diabetic retinopathy screening and coordinated diabetes and CVD care in three Aboriginal communities in remote and very remote parts of the Northern Territory. The primary hypothesis is that participation in a culturally appropriate retinal imaging programme that includes education, care coordination and management will improve clinical outcomes, adherence to eye care and clinical visits, reduce hospitalizations and patient stress in dealing with self-management and that additional analyses of the retinal images will add value in indicating potential care plans that may impact on decreasing the risk for diabetic retinopathy progression. Thus, in collaboration with Northern Territory Indigenous communities and their health care providers, we propose the overall goal of implementing and evaluating a telemedicine-supported diabetes and CVD assessment and care program to facilitate optimal healthcare delivery for Indigenous Australians. The project plans to implement an established primary care-based teleretinal eye assessment programme that acquires digital images of the retina, assesses visual acuity, and transmits, via secure telecommunication links, the data to a grading centre (at the Centre for Eye Research Australia [CERA]) for assessment of clinical retinopathy. The project will also implement a telecommunications infrastructure that supports health information exchange between participating sites, CERA retinal grading centre and investigators. This includes a web-based telehealth Chronic Disease Management Program (CDMP), a clinical data repository that incorporates eye diagnoses and management recommendations, and a telehealth program for diabetes and CVD prevention and management. The potential benefits include increased rates of timely eye screening for diabetic eye disease, the development an eye screening software technology that integrates within the primary care environment through integration with software based electronic decision support for facilitating optimal diabetes, cardiovascular disease and lifestyle management with the ultimate improvement in clinical outcomes such as blood glucose control (Haemoglobin A1c), lipid levels and blood pressure.
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Sleep health management for healthcare workers
Expand descriptionThis study aims to develop and assess the effectiveness of an individual based intervention for sleep problems in shift workers, and will be conducted in operational settings (i.e., Austin Hospital and Flinders Medical Centre). The targeted sleep problems include poor shift work responsiveness, insomnia and obstructive sleep apnoea/sleep disordered breathing. The effectiveness of the treatment will be based on whether or not shift work responsiveness, insomnia, obstructive sleep apnoea, sick and carers leave, RiskMan data (e.g., staff and patient related incidents), symptoms of mental health problems (depression and anxiety), sleepiness and functionality decrease from before the treatment to after the treatment. The project will also determine whether or not those who have been randomly assigned to the intervention group (labeled program 1) have lower levels of the aforementioned than those randomly assigned to the control group (labeled program 2). The labels “program 1” and “program 2” will be used to help blind the participants to the intervention and control group. While laboratory and clinical studies demonstrate benefits from the proposed interventions, research has yet to assess the impact of comprehensive sleep health management for shift workers in an operational setting. Developing an individual-level treatment method to improve sleep health and to identify and manage sleep problems in hospital staff will lead to better health outcomes for staff, improved alertness and patient outcomes, and in turn reduced costs of days lost (e.g., from sick leave) within the workplace. Participants will be allocated to Program 1 or Program 2. Both groups will receive an educational presentation; the talk for Program 1 will focus on sleep health, circadian rhythms and scheduling, whereas the talk for program 2 will be designed to seemingly but not actually assist in improving sleep or scheduling. From here, both groups will be given a questionnaire that will take approximately 30 minutes. For those in the intervention group, the answers to the questionnaire will then be used to identify those who are at risk for poor shift work responsiveness, insomnia and obstructive sleep apnoea. Those who are identified with a potential sleep problem will then receive further treatment. Follow-up questionnaires that are identical to those answered originally will then be completed directly after the treatment procedures end for those in the intervention group. Sick leave data will be collected at the end of each financial year with help from the Austin Hospital and Flinders Medical Centre.
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Appetite control and body composition in breastfed infants
Expand descriptionBackground: Obesity is considered to be at epidemic proportions yet data is limited for the mechanisms of breastfeeding that reduce risk of obesity later in life. In particular the influence of breastmilk components on gastric emptying rate, appetite control and body composition in term infants is largely poorly understood. Furthermore an accurate non-invasive methodology to measure infant body composition is required to identify infants at risk of obesity. Aims: This study aims to investigate the relationship between infant gastric emptying rate and the composition of the consumed breastmilk, with the focus on milk proteins (whey and casein fractions), appetite hormones such as leptin and adiponectin and POPs. Further associations between breastmilk components and infant body composition will be investigated with the accent on longitudinal study. New methods of measuring infant body composition (ultrasound skinfolds) will be developed. Objectives: 1. To establish possible longitudinal associations between breastmilk macronutrients and components and both infant and maternal body composition. 2. To investigate and describe gastric emptying of term fully breastfed infants feeding on demand and establish possible associations with breastmilk composition. 3. To establish effect of milk intake and extracellular fluid reservoirs on bioimpedance in term breastfed infants I order to evaluate the possibility to use pre- and post-breastfeed measurements interchangeably. 4. To determine body composition (percent fat mass, %) of breastfed infants using bioimpedance spectroscopy and ultrasound skinfolds and to compare performance of these two methods in term breastfed infants. 5. To determine pesticide residues concentration in human milk during the first year of lactation and establish possible associations between pesticide residues in breastmilk and demographic factors of breastfeeding dyads.
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A pilot study of gabapentin for managing pain in children with dystonic cerebral palsy
Expand descriptionThe primary objective of this feasibility pilot study is to gather preliminary data on the use of gabapentin to reduce pain in children with dystonic CP to inform a future RCT including trialling the recruitment process and retention rate, the outcome measures, and to identify complications and side effects from the medication which could impact on the design of an RCT. The study will specifically examine the variability of results for different outcome measures to determine effect sizes that will be used to inform the planning of a future trial (choice of primary outcome measure, sample size planning).