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A randomised controlled trial of 'arthritis relief plus' for osteoarthritis of the knee
Expand descriptionThis study aims to determine the efficacy of arthritis relief plus for knee osteoarthritis pain. THis is a mix of 20 natural therapies. The design is randomised and double blind for 3 months followed by a one month wash out in 140 patients with significant knee pain due to arthritis.
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Using Nintendo Wii following an acquired brain injury
Expand descriptionThis study is aiming to determine if playing the Nintendo Wii is potentially a useful addition to a therapy program in adults with an acquired brain injury
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The use of 5% tea tree oil for the prevention of infections in renal dialysis patients
Expand description"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
Expand descriptionThe 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
Expand descriptionThe 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
Expand descriptionElastin 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.
Expand descriptionThis 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
Expand descriptionTherapy 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.
Expand descriptionBrain 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
Expand descriptionAtrial 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.