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Assessing the Olympus 190 series narrow band imaging for colonic polyp detection rates: A prospective randomised multicentre study
The primary purpose of this trial is to evaluate the efficacy of the Olympus 190 series colonoscope narrow band imaging (NBI) technology for the detection of polyps and adenomas, in comparison to the current standard white light technology used during colonoscopies. Research to date has found no difference between the two technologies of illumination, but with improved technology we believe that NBI may now improve our detection rate of polyps and adenomas- thereby decreasing the overall cancer risk per patient. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been scheduled to undergo a colonoscopy for diagnostic/investigational purposes. Study details All participants in this study will be randomly allocated (by chance) to receive either the NBI or standard white light colonoscopy. All other aspects of the procedure, other than the type of light used during the colonoscope withdrawal will remain the same between each group, as per standard care. NBI is simply a type of light available by pushing a button on the colonoscope, which uses filters to illuminate tissue at a selected wavelength. This may be beneficial for the detection of polyps and adenomas, despite providing less illumination overall than the standard white light. Researchers will then review the colonoscopy procedure and histological notes to assess the detection rates for polyps and adenomas between each type of light. Subsequently, statistical analysis will determine which technology is better for polyp and adenoma detection. It is hoped that the findings of this trial will provide information on which type of light may be the most effective for the detection of polyps and adenomas in patients undergoing colonoscopy.
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A single injection dose study of DUR-928 in patients with impaired kidney function and healthy volunteers
This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intramuscular injection to subjects with chronic kidney disease when compared with healthy control subjects. The study will look at the study drugs effect when given as a single-dose injection at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream). The pharmacodynamics will also be studied; this is done by measuring the amount of selected biomarkers in the blood and/or urine at different times throughout the dosing periods, allowing us to evaluate the effect of DUR-928 on the body.
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Anti-anginal Efficacy of Ticagrelor in Coronary Slow Flow.
The Ticagrelor in Coronary microvascular dysfunction (TIC) program is an extensive research program investigating the potential therapeutic benefits of ticagrelor in patients with a condition referred as slow flow phenomenon, speculating that its benefits extend beyond its anti-platelet effects and suggesting that it may have an important role in the management of these patients. Ticagrelor has been developed as an anti- platelet agent and is currently utilised in the management of heart attack and unstable angina. Slow flow means heart muscle does not receive blood quickly enough and as a consequence patient may experience chest pain. Medical treatment is directed towards controlling the angina pain. Taking Ticagrelor orally twice a day, which has the ability to relax the small microscopic blood vessels in the heart, may lead to better blood flow to the heart muscle and reduce the associated symptoms of chest pain. However, at present, there is no scientific evidence available demonstrating how effective ticagrelor is in patients with slow flow. The aim of this study is to investigate whether taking ticagrelor (90mg twice daily for 4 weeks) can reduce frequency of chest pain in these slow flow patients.
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Central Venous Access Device (CVAD) Registry - an electronic database to monitor the outcomes of patients with CVADs
Treatment 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
There 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
The 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
The 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
The 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
The 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.
The 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.