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Randomized Controlled Study of L-Arginine Blood Cardioplegia Administration in Patients with Reduced Left Ventricular Function Undergoing Coronary Artery Bypass Graft Surgery
Aim We aim to detect any significant improvement in myocardial protection when L-arginine is added to standard blood cardioplegia. The study and control populations will consist of patients undergoing coronary artery graft surgery with pre-existing poor myocardial function. This group of individuals often have underlying ischaemia and frequently exhibit low output syndrome (LOS) post-cardiopulmonary bypass. Inadequate myocardial protection resulting in ischaemia-reperfusion injury may be a cause for LOS. As a consequence these patients require a high incidence of pharmacological and mechanical support and frequently experience a protracted stay in the intensive care unit (ICU). L-arginine has been shown to reduce reperfusion injury when added to cardioplegia. Our hypothesis is that effective prevention of ischaemia-reperfusion injury in the jeopardised myocardium leads to an improvement in myocardial preservation and a reduction in the complications that ensue. To prove this, we propose to conduct a randomised, double blind placebo control trial in which L-arginine is added to standard blood cardioplegia. Markers of reperfusion injury, myocyte damage, will be measured. Other markers will include cardiac function, inotrope use and length of ICU stay. Study design A prospective double blind randomised controlled trial of L-arginine cardioplegia administered to patients with known poor myocardial function undergoing coronary artery graft surgery. A minimum of fifty patients in total will be allocated into two groups according to a computer generated random sequence. Once randomization has occurred all participants in the patient’s management will remain blinded to group selection. The control group will receive standard blood cardioplegia technique; while the treatment group will receive L-arginine enriched blood cardioplegia. Endpoints 1. Indicators of cell death – systemic cardiac Troponin I levels pre-cardiopulmonary bypass at 15 min and 12 and 24hrs post aortic clamp removal. Serum Troponin I levels are a measure of myocardial cell death. 2. Markers of myocardial oxidative stress - coronary sinus concentrations of xanthine oxidase, superoxide dismutase and malondialdehyde pre-cardiopulmonary bypass at 5 and 15 minutes post removal of cross clamp. These are a measure of reperfusion injury. 3. Lactic Acid flux at 1 and 5 and 15 minutes post removal of cross clamp as a measure of myocardial aerobic reserve capacity. 3. Effect upon myocardial function - myocardial systolic and diastolic function as measured by intraoperative transoesophageal echocardiography.
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Assessing the risk of heart disease in women with polycystic ovary syndrome
Metformin is a commonly used medication in the management of polycystic ovary syndrome (PCOS). It appears to play an improtant role in the regulation of menstural cycles, fertility and improvement in insulin sensitivity in PCOS. We have recently shown in a small group of young PCOS women the evidence of marked abnormalities in both platelet and endothelial function (surrogate markers of increased cardiovascular risk) when compared to nromal controls. The primary aim is to assess if metformin improves/reverses these anomalies.
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Health and Wellbeing During the Preschool Years
The overall goal of the current project is to conduct a randomised controlled trial (RCT) to measure the effectiveness of the MEND 2-4 program. The intervention will provide information to parents and support them to establish and/or maintain healthy behaviours and attitudes around diet and physical activity for themselves and their preschool child(ren). In comparison to the wait-list control group, at the completion of the 10-week intervention program, and at 6 and 12 months post intervention, the intervention group preschoolers will: (1) demonstrate greater consumption of fruit and vegetables, and a decrease in consumption of high fat, high sugar cordials, soft-drinks and juices and non-essential, energy dense snack foods; (2) exhibit less problematic eating habits, specifically higher responsiveness to satiety, less fussiness, and less neophobia; (3) demonstrate greater increases in physical activity and greater decreases in time spent in sedentary behaviours, specifically TV viewing; (4) exhibit lower BMI-for-age z scores. In comparison to the wait-list control group, at the completion of the intervention program, and at 6 and 12 months post intervention, the intervention group parents will: (1) increase the frequency with which they limit the offering of high fat, high sugar cordials, soft-drinks and juices and non-essential, energy dense snack foods to their child; (2) increase the frequency with which they offer vegetables and fruit, water and milk (rather than cordials, soft-drinks and juices) to their child; (3) demonstrate improved knowledge regarding key aspects of child eating, physical activity and sedentary behaviours relevant to the prevention of obesity and improving child health generally; (4) reduce the frequency with which they use restrictive feeding practices and increase the frequency with which they use covert methods of controlling access to unhealthy foods; (5) increase the frequency with which they model healthy behaviours around diet and physical activity; (6) provide greater opportunities for children to engage in physical activity and reduce their opportunities for engagement in sedentary behaviours.
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Development and evaluation of novel strategies to enhance Internet-based weight loss and weight maintenance programs
Obesity is at epidemic proportions and affects over 7 million Australians with an estimated economic cost of $4 billion. Online weight management programs are widely accessible and have the potential to be a cost effective treatment option. However, the effectiveness of online weight management programs is largely undetermined and there has been no research to date to establish which online program features enhance weight loss outcomes. Using a Randomised Controlled Trial design, this study will provide evidence about the effectiveness of treating overweight and obese people via the Internet. Compared to a standard online program, the impact of enhanced online features, such as personalised feedback and strategies to enhance website use, will be evaluated for their impact on both initial weight loss and the maintenance of lost weight in the longer-term.
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Effect of obesity and diabetes on treatment and outcomes in newly diagnosed breast cancer
Background: Obesity, type 2 diabetes and breast cancer are common diseases. Each of these alone are major health care problems in developed countries such as Australia. As more people acquire these diseases as they get older and as life expectancy increases, the health care costs of these will increase exponentially. Both obesity and diabetes, on its own can cause cancer. A recent study from Queensland and one other reviewing all of the data on this area suggested that both diabetes and obesity can increase death from breast cancer. There is a suggestion that some of this increased death rate may be because obese people and those with diabetes have other medical problems which may lead to reduced dose of chemotherapy being given. For these reasons it is a developing yet urgent area of research interest for patients, clinicians, Governments and policy makers. Aims: To Examine 1) whether obese women with breast cancer are more or less likely to be dosed with appropriate doses of chemotherapy 2) Whether there is a difference in total body exposure for the various chemotherapeutic agents utilised amongst the subgroups classified by obesity and diabetes. Method: A 1 year prospective study of node positive breast cancer patients presenting to the Princess Alexandra Hospital (PAH) will be undertaken to examine total body exposure of chemotherapy drugs. Baseline data on obesity , diabetes and other factors that may influence drug exposure including weight and height at diagnosis; basic biochemistry including glucose, diabetes diagnosis and control; stage of disease; co-morbidities (such as renal impairment); use of hormone replacement therapy, medications, dose and type of chemotherapy will be collected. Total body exposure for the various chemotherapeutic agents used will be calculated by measuring serum drug levels at various points in time points ( 0 hrs,1 hr, 2hrs, 4hrs and 8 hours) during administration of these drugs during the first cylcle of chemotherapy. Results: The total body exposure will be analysed to see if their is a statistical difference in the different obesity and diabetes groupings. We will look at both the relative under-dosing in obese women with breast cancer, and the combined effect of diabetes and obesity on other known risk factors for breast cancer. Ultimately if it can be clearly shown that obesity results in less than optimal chemotherapy treatment and may result in reduced survival, then treatment of obesity and good diabetes control may become an even more important facet of breast cancer management. This is particularly pertinent given our epidemic of obesity and of diabetes.
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A study of patient-specific cutting guides for total knee joint replacement.
Total knee joint replacement is a successful operation for the relief of symptoms such as pain, loss of function and inability to perform daily activities. New techniques are constantly being developed to improve these results even further. This study aims to see how well a very new technique for total knee joint replacement surgery performs in a small number of patients. The technique involves patients having a MRI scan before their operation. This scan enables very detailed 3-D pictures of the bones, cartilage and soft-tissues around the hip, knee and ankle to be obtained. This information is then used to reconstruct a 3-D model of the pre-disease anatomy for that particular patient. This model is used to create two plastic blocks which will be used by the surgeon to perform a total knee joint replacement. Specific questions about how precise the cutting guides can be positioned onto the bone (that is, if the guides are positioned several times, how much does the position vary?) and are there advantages in the recovery and function of patients in the period after their operation will be addressed by this study. The results of this study will be compared to the results obtained using similar total joint replacement components. Patients will be asked to complete surveys to assess their pain, quality of life and knee function before and after their operation. It is hoped that the information collected during this multi-centre study will provide valuable information regarding the use of patient-specific cutting guides for total knee joint replacement.
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Evaluating stress reduction therapy in cardiothoracic surgical patients.
Integrative therapies such as massage have gained support in the literature as methods to improve the overall patient experience. Massage therapy (MT) has been widely accepted as a therapy to help with pain and anxiety and, in fact, many healthcare institutions have integrated massage into their standard of care for patients. Although there are studies that indicate the specific benefits of massage therapy, there are a limited number of studies looking at the specific benefits for cardiac surgical patients. Cardiac surgical patients undergo long surgical procedures and in the immediate post-operative period, commonly complain of back and shoulder pain that may be related to the surgical procedure, bed positioning or general stress and tension. Given the promising, yet insufficiently researched, effects of massage therapy as a symptom relief strategy for alleviating pain and anxiety, we plan to conduct a study to provide evidence of the efficacy and feasibility of massage therapy delivered in a cardiovascular surgery setting. Our planned program of research focuses on the question: Can a massage therapy intervention be delivered within a busy clinical cardiovascular surgery setting in an efficacious manner to alleviate patient pain, anxiety and tension?
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Portaero Pneumostoma System in Patients with Severe Emphysema and Hyperinflation of the Lung
This is the second trial to evaluate the safety and performance of the Portaero Pneumostoma System in patients with severe emphysema and hyperinflation of the lung.
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Evaluation of an instrument for the assessment and management of behavioural and psychological symptoms of dementia in aged care
The study will evaluate the effectiveness of an instrument that has been developed to assist aged care staff in assessing and managing challenging behaviours in residents with dementia. The instrument is a systematic, step by step procedural tool that can be used by care staff to identify or eliminate the various physical, psychological and environmental causes of challenging behaviours in residents with dementia, and provides various strategies for managing these behaviours. It is anticipated that training staff to use the instrument will enable them to implement it within their care routines, and that effective use of the instrument will benefit staff by reducing the occurrence or impact of challenging behaviours in residents with dementia, and by alleviating the stress and strain on staff that care for these residents.
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TROG 99.02 Concurent radiation and chemotherapy for the organ conserving treatment of early anal canal cancer
Anal canal cancer is generally sensitive to both radiation and chemotherapy and these two treatments given together is now the "gold standard treatment for most early anal canal cancers. Our study was designed to see if we could maintain the generally good cure rates using less extensive and lower doses of radiation and chemotherapy than have been given in some centres. We also looked to see if the less intensive treatment would result in a lower risk of serious side effects for the patient.