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Circuit class therapy for rehabilitation after stroke. A pragmatic randomised controlled trial (CIRCIT).
Expand descriptionLoss of independence is common following stroke, and may lead to reduced quality of life. We will investigate if an increased amount of physical rehabilitation following stroke leads to improvements in walking ability, arm function and independence. Two ways of providing an increased amount of physical rehabilitation will be compared to usual care to find out which leads to improved physical mobility and how they compare economically. The key hypotheses are: 1. Compared to usual care therapy (5 days a week), group circuit class therapy (provided 5 days a week for 3 hours per day) will lead to improvements in walking function and mobility. 2. Compared to usual care therapy (5 days a week) providing physical therapy over 7 days a week will lead to improvements in walking function and mobility. 3. Compared to 7-day a week therapy, group circuit class therapy (5 days a week) will lead to improvements in walking function and mobility. 4. Group circuit class therapy will be more cost-effective than 7-day week therapy.
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Population testing of an internet-based Personalised Decision Support system for Colorectal Cancer screening
Expand descriptionThe purpose of this study is to investigate the effect of utilisation of an internet-based personalised decision support (PDS) tool on screening behaviour for Colorectal Cancer. Our hypothesis is that individuals who are provided access to the PDS will be more likely to participate in screening than those who are not provided access. The study fits in with the aim of improving participation in CRC screening nationally, and if effective the PDS can be implemented on a large scale; for instance, as part of the Department of Health and Ageing's national screening program.
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The distribution and duration of the sensory block after a standard and refined ultrasound guided transversus abdominis plane (TAP) block.
Expand descriptionUltrasound guided Transversus Abominis Plane (TAP) blocks are an effective technique to provide analgesia after lower abdominal surgery. TAP blocks are performed by injecting local anaesthetic around the nerves in the Transversus Abdominis Plane on both sides of the abdomen. This project seeks to examine the duration and distribution of sensory changes over the patient’s abdomen after bilateral TAP blocks. The study will also compare the standard TAP block technique to a refined technique which may provide superior analgesia. Each patient in the study, while anaesthetised will receive a standard and a refined TAP block and then will be assessed by a researcher at 1 hour, 3 hours and then 2 hourly until full sensation returns to the abdomen.
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B2P2M2: Phase II trial of BNC105P as 2nd line chemotherapy for advanced malignant pleural mesothelioma
Expand descriptionAt present there is no standard 2nd line chemotherapy regime for patients with advanced malignant pleural mesothelioma (MPM) who progress after treatment with standard first line chemotherapy (i.e. pemetrexed and a platinum compound). BNC105P is a novel chemotherapy agent which has shown activity in MPM. In this study, BNC105P will be studied in a single arm, 2 stage, multi-centre design to determine its efficacy and safety as 2nd line chemotherapy for patients with MPM. All subjects will receive BNC105P on Day 1 and Day 8 of a 21 day cycle until unacceptable toxicity or disease progression. The primary endpoint will be tumour response, and secondary endpoints include progression-free survival, overall survival, adverse events, and quality of life. Correlative substudies will examine associations between potential biological markers and outcomes.
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AMP: Phase I/II study of AMG 102 and panitumumab in recurrent Glioblastoma Multiforme (GBM)
Expand descriptionThe purpose of this study is to investigate the effectiveness of a combination of two drugs, called AMG 102 and panitumumab, for patients with brain tumours that have returned after previous treatment. In addition, the study will investigate the side-effects that might be associated with the combination of these two drugs when treating brain tumours. Research has shown that AMG 102 is effective at treating brain tumours in a small proportion of patients, and preliminary results in the laboratory show that panitumumab could make AMG 102 more effective at treating brain tumours. Therefore this study will be testing this combination of drugs. The combination of AMG 102 and panitumumab has previously been tested in 8 patients with bowel cancer, and is continuing to be tested in an ongoing bowel cancer study, but has not previously been tested in patients with brain tumours. Because very few patients have been treated with the combination of AMG 102 and panitumumab, the study will be conducted in two phases. Initially 3 patients will be treated at least one week apart. Once these 3 patients have completed 4 weeks of treatment each, and if there are no concerns with side effects, a further 3 patients will be treated at the same dose. If unacceptable side effects are observed, a lower dose will be tested, again treating 3 patients at least one week apart. If unacceptable side effects are still observed at the lower dose, an even lower dose will be tested. Using this system, the dose for the second phase will be identified, or if an acceptable dose cannot be identified, the study will not continue. A total of 6 to 18 patients will participate in the first phase of the study. The second phase of the study will enrol patients until a total of 42 patients have been treated at the dose identified in the first phase.
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Nutrigenomic risk profiles for Mild Cognitive Impairment, Alzheimer's disease and Parkinson's disease
Expand descriptionThe incidence of neurodegenerative diseases such as Alzheimer’s (AD) and Parkinson’s (PD) disease are expected to rise in the next 30 years as a result of Australia’s ageing population. However, conclusive diagnostic tests and impact of dietary status for neurodegenerative disease risk are not clearly defined. Therefore, it is important to identify potential genome damage biomarkers and micronutrients associated with these diseases that may aid in the design of potential preventative measures. The hypothesis is mild cognitive impairment, Alzheimer’s disease, and Parkinson’s disease exhibit increases in genome damage and cell death biomarkers relative to each other, and to healthy age matched controls.
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A randomised controlled trial to assess the efficacy of an intervention to increase the physical activity levels of children attending long day care.
Expand descriptionThe preschool years are considered a critical time in which to establish healthy behaviours in childhood and into the future. One of the best opportunities to support physically active lifestyles among a large number of young children lies in the child care setting. The childcare centre has been shown to account for a significant proportion of the variability in children’s physical activity behaviour while in care and child care centres also have the existing infrastructure to support adequate physical activity. However research suggests children are unlikely to be sufficiently active whilst in care. To date there is little research examining the efficacy of physical activity interventions implemented in the childcare setting therefore the primary aim of this study is to assess the efficacy of a physical activity intervention in increasing physical activity levels among 3 to 6 year old children attending long day care services as assessed by pedometer step counts.
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Nambour Community-based Skin Cancer Prevention Trial
Expand descriptionA randomised trial was conducted to assess whether daily application of a sun protection factor (SPF) 15+ sunscreen to the head, neck, arms and hands, or beta-carotene supplementation (30 mg/day) would prevent skin cancers and related tumours and premature skin ageing in comparison with discretionary use of sunscreen or a daily placebo supplement. The The hypothesis was that regular sunscreen use by adult Caucasians prevents the occurrence of skin cancers and related sun-related degenerative skin conditions
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The CREDO Research Project: Can mood problems be prevented and treated using e-health interventions in patients being treated for cardiovascular disease?
Expand descriptionDepression, cardiovascular disease (CVD) risk factors and cognitive impairment are key causes of disability and poor health outcomes. Comorbidity of these leads to an even worse prognosis. The primary aim of this randomised controlled trial is to determine the effect of an evidence-based internet intervention program for depression on depressive mood symptoms in patients being treated for, or at risk of developing, CVD. Participants will be drawn from the longitudinal cohort study of healthy volunteers, the 45 and Up Study. Participants will be selected on the basis of self-reported history of CVD or multiple risk-factors for developing CVD and positive screen for depressive symptoms, as measured by the Kessler-10. The 12 week intervention will compare the effectiveness of online cognitive behavioural therapy (e-couch) with an attention control placebo (HealthWatch website). Follow-up will occur post-intervention and again at 6 and 12 months. Therefore, secondary aims of this trial are to determine the immediate and 12 month efficacy of the internet intervention on cognitive function and adherence to cardiovascular treatment and exercise.
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Effects of acute dietary restriction on gut motor, hormone and energy intake responses to duodenal fat in obese men
Expand descriptionThis study aimed to investigate the hypothesis that following a 4-day very low calorie diet, the effects of intraduodenal nutrients on antropyloroduodenal motility, gastrointestinal hormone release and appetite in obese subjects, will be enhanced.