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The use of 5% tea tree oil for the prevention of infections in renal dialysis patients
"Golden staph" is carried in the noses of 20-50% of people at any given time. People who are having renal dialysis and who carry 'golden staph' in their nose are at a higher risk of infection than those who do not. To minimise this risk renal dialysis patients are given prolonged treatment with mupirocin cream which is applied in their nostrils to kill 'golden staph'. This has lead to resistant strains of 'golden staph' that are not killed by the mupirocin treatment. Tea tree oil ointment has been used to kill 'golden staph' in people's noses and prolonged exposure to tea tree oil has not lead to development of resistance in bacteria. It also kills a wide range of bacteria and fungi, not just 'golden staph and so we believe that tea tree oil would be at least as good as mupirocin at protecting renal patients from infection. So this trial is looking at the use of tea tree oil and comparing it to the use of mupirocin in protecting renal dialysis patients from infection with 'golden staph'.
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effectiveness of local dental anaesthetic in children
The aim of the study is to determine if Articaine was more effective than Lignocaine in achieving local analgesia for dental fillings in the back teeth in the lower jaw among children when using two different techniques of anaesthetic delivery. The null hypothesis is that there is no difference in achieving local analgesia between Articaine 4% and Lignocaine 2%.
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Improving rural cancer outcomes
The project will consist of two intimately-linked phases over a five-year term: a development phase, which will identify health system, doctor and patient factors that affect outcomes in rural patients with cancer of the prostate, breast, colorectum or lung and assess their potential to be modified by a complex intervention; and an implementation/evaluation phase, in which the ‘best prospects’ intervention will be rigorously evaluated by an experimental trial.
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A Phase I study to assess the safety of three formulations of the dermal implant ELAPR
Elastin is a major structural component of the skin which enables the skin to stretch and recoil. The loss or damage of elastin in the skin results in a range of skin abnormalities including, the symptoms of skin aging such as wrinkles, scars and the signs of sun damage. ELAPR is a dermal implant which is made from a synthetic form of human elastin and is being developed as a product which may be injected superficially into the skin using very fine needles to treat skin abnormalities associated with the loss of elastin. The synthetic human elastin which is the basis of the ELAPR dermal implant is a completely new product and the purpose of the current clinical trial is to evaluate the safety of the product in humans. The trial will involve the implantation of a small volume of the product in the skin of the upper arm of study participants. The implant will remain in the skin for a period of up to 29 days. The implant will then be removed by a needle biopsy to allow studies to be carried out on the tissue surrounding the implant to see how the body responded to the presence of the implant in the skin. The results of this study will provide a good understanding of how well the body tolerates this new synthetic human elastin material. If the synthetic elastin is well tolerated by the body then further studies will be undertaken to study its use in the treatment of skin abnormalities resulting from aging, scarring and sun damage.
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Effect of venesection on insulin resistance and oxidative stress in people with non-alcoholic fatty liver disease.
This trial aims to examine the effect of removing iron in people with nonalcoholic fatty liver disease (fatty liver). We hypothesize that removing iron will improve insulin resistance (how the body produces insulin in response to glucose), reduce oxidative stress in the body and reduce the amount of fat in the liver.
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Systematic Termination of Pharmaceutical Agents Trial (STOPAT): a pilot randomised trial of stopping drug therapy
Therapy with several drugs simultaneously entails several hazards related to drug interactions and side effects. Analysis of individual patients often reveals that some drugs are either unnecesary, or at least thought to be so, either because the indication for them no longer exists or because they were injudiciously prescribed in the first place. In support of this point of view, up to 25% of all acute medical admissions to hospital are due to a clinical problem related to drug treatment. It has been shown that withdrawal of some drugs can alleviate a tendency to fall in elderly patients, and there is evidence that antihypertensive medication may be "down—titrated" (i.e. the dose may be reduced) without loss of antihypertensive effect. We wish to undertake a formal trial of drug withdrawal as a therapeutic maneouvre. As a preliminary we wish to establish that such a trial is feasible and safe and therefore propose a pilot study in a limited number of patients. We have also adopted a restricted list of drugs for the purposes of the pilot study in order to enhance the safety aspects of the trial. Participants will be randomised to persist with current therapy or to have the target therapy withdrawn. They will be followed up frequently. The end point for the ultimate study will be efficacy and quality of life measures but in this study we are interested in safety and practicability only, though efficacy and QOL will be assessed.
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Healthy Lifestyles Program for Adults with an Acquired Brain Injury.
Brain injury is defined as “an injury to the brain which results in deterioration of cognitive, physical, emotional or independent functioning (Fortune & Wen, 1999).” Acquired brain injuries (ABI) can occur as a result of trauma, hypoxia, infection, tumour, substance abuse, degenerative neurological disease or stroke. The incidence of ABI in Australia is estimated to range between 100 and 377 per 100,000 individuals per year (Fortune & Wen, 1999). The consequences ABI, together with its relatively high prevalence, make it a disorder of major public health significant in Australia. Physical activity (PA) is defined as “any bodily movement produced by skeletal muscle contracture that increases energy expenditure.” Evidence indicates that PA reduces the risk of all-cause and cardiovascular mortality, and of coronary heart disease, obesity, hypertension, breast and colon cancer, and diabetes mellitus in particular. Physical activity has also been linked to improvements in mental health and is important for the health of muscles, bones and joints (U.S. Department of Health and Human Services, 1996). Based on this evidence, the US Surgeon General recommends that: - Significant health benefits can be obtained by including a moderate amount of PA (e.g., 30 minutes of brisk walking or raking leaves, 15 minutes of running, or 45 minutes of playing volleyball) on most, if not all, days of the week; - Additional health benefits can be gained through greater amounts of PA. People who can maintain a regular regimen of activity that is of longer duration or of more vigorous intensity are likely to derive greater benefit. Currently there is a paucity of evidence regarding PA participation by adults with an ABI. Gordon (1998) reported that, in a sample of 717 people (430 with an ABI and 287 non-disabled), 14.9% of people with an ABI self-reported exercising three times per week for the past six months, compared with 23.0% of people without a disability (Gordon, et al., 1998). It is proposed that people with a disability can also benefit from a physically active lifestyle due secondary health problems and functional limitations that could be prevented or reduced (Cooper, et al., 1999; J. A. Rimmer, et al., 1996) Due to these factors the promotion of PA in adults with an ABI has become a public health priority (Cooper, et al., 1999; J. A. Rimmer, et al., 1996). To date, there have been no studies evaluating the efficacy of a community based intervention for the promotion of PA in adults with an ABI. This study aims to evaluate the efficacy of a novel, stage matched; community based intervention for; increasing habitual physical activity (HPA) counts (measured by the ActiGraph); increasing time spent in moderate intensity PA and; decreasing time spent sedentary in adults with an ABI. The second aim of this study is to evaluate whether the novel stage matched, community based intervention increases; perceived health related quality of life; stage of change (motivational readiness); decisional balance; self efficacy and social support in adults with an ABI. Finally this study aims to qualitatively evaluate the participants and parents/guardians perceived effectiveness and acceptability of a stage matched, community based intervention. In order to evaluate the efficacy of this intervention, the intervention will be compared to a health behaviour intervention comprising of oral health, sun safety and sleep.
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Curing Atrial Fibrillation: A Comparison of 2 Keyhole Techniques
Atrial fibrillation is a common heart rhythm disorder and is associated with heart rhythm irregularity. This trial aims to compare the relative efficacy of 2 different keyhole procedures to cure atrial fibrillation.
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Evaluation of participation restriction in trials of exercise interventions to prevent falls in older people: A systematic review and meta-analysis.
Participation, as defined by the International Classification of Functioning, Disability and Health, reflects the societal consequences of health conditions. Despite being a key component of functioning and an important goal of rehabilitation, participation is not measured consistently in ageing research. Falls are a major public health problem. Fortunately, well-designed exercise interventions have been shown to reduce falls in older people. To date, evaluation of these interventions has focused on rate of falls, impairment of body function and performance of tasks. The consequence of falls prevention programs on functioning at a societal level have not been evaluated. Increased understanding of how falls prevention interventions affect participation may provide opportunities to enhance outcomes for people at risk of falling. The objectives of this study are to: - Evaluate the extent to which measurement of participation has been reported in trials of fall prevention interventions with an exercise component. - Determine whether exercise interventions targeting falls increase ICF participation in older people. We will undertake a systematic review with meta-analysis of randomised controlled trials of interventions including exercise that aimed to reduce falls in older people in the community, aged care facilities or hospital. Studies will be extracted from the Cochrane Review of interventions for preventing falls in older people living in the community(1) and the Cochrane Review of interventions for preventing falls in older people in nursing care facilities and hospitals.(2) We will re-run the search strategies used in these Cochrane Reviews in Medline, EMBASE, AMED, PsychINFO, CINAHL and CENTRAL. The original Cochrane Reviews searched CINAHL via the Ovid platform. As this is no longer available, CINAHL will be accessed via EBESCO. The searches will run from the final date searched by Gillespie et al(1) and Cameron et al,(2) to May 2010. Language restrictions will not be applied. Measurement instruments used in the trials will be linked to the ICF then assessed against instrument classification criteria, to determine whether they measure participation. Trials with published participation data at baseline and at least one follow-up time-point will be included in the meta-analysis. In order to minimise bias, the following methods will be used: - Study selection. One author will independently examine the titles, abstracts and keywords to identify potentially relevant trials from the search results. Full text reports will be obtained for all potentially eligible studies. Based on the full text reports, two authors will independently decide on study inclusion. Differences will be resolved by discussion or, if necessary, arbitrated by an independent third author. Details of discussions will be kept. - Data extraction. Data regarding trial characteristics and estimates of effect of the intervention will be extracted from the included trials by one author and checked by a second author. Disagreement will be resolved by discussion or, if necessary, arbitration by third author. - Duplicate publication bias will be avoided by comparing author names, sample sizes, interventions and outcomes. - Publication bias will be assessed using Egger’s test and observation of the funnel plot. - Assessment of bias of included studies. Two authors will independently assess risk of bias using the Cochrane risk of bias tool, outlined in the Cochrane Handbook for Systematic Reviews of Interventions. Bias will be considered from the study level (assessment of sequence generation and adequacy of allocation concealment) and also the outcome level (evaluation of the methods used to measure the participation outcome in each study: blinding of outcome assessors, completeness of participation data and selective reporting of participation data). Any disagreement will be resolved by consensus or third-party arbitration. (1) Gillespie LD, Robertson MC, Gillespie WJ, Lamb SE, Gates S, Cumming RG, et al. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2009(2):CD007146. (2) Cameron ID, Murray GR, Gillespie LD, Robertson MC, Hill KD, Cumming RG, et al. Interventions for preventing falls in older people in nursing care facilities and hospitals. Cochrane Database Syst Rev. 2010(1):CD005465.
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Nintendo Wii exercise training in adults with cystic fibrosis
Cystic fibrosis (CF) is a chronic hereditary disease affecting respiratory and endocrine systems. There is no cure for this disease but treatment advances have seen increases in life expectancy. Adults with CF have to adhere to a strict life-long regime of self care including chest physiotherapy, antibiotics, vitamins and exercise. Exercise is now a regular treatment tool with benefits including increased respiratory function, fitness and strength. This project seeks to investigate if participating in an exercise program using the recently developed Nintendo Wii is an alternative to a regular exercise program.