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"Wiihabilitation": Can active gaming systems be used to improve recovery after stroke?
Expand descriptionDeficits in balance are common and debilitating following stroke. Active gaming systems, such as the Nintendo Wii(TM), may provide a means of promoting physical activity to improve recovery post-stroke. We hypothesise that the Nintendo Wii(TM) gaming system, when used in addition to standard inpatient rehabilitation therapy will result in improved balance outcomes in a sub-acute stroke population. We also hypothesise that this system will be a feasible tool for use in an inpatient rehabilitation setting.
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The Type 2 Diabetes PULSE study: a research trial to determine the effectiveness of a multi-component prevention program (diet, aerobic exercise, resistance training) for men at high risk of Type 2 Diabetes
Expand descriptionThe Type 2 Diabetes PULSE (Prevention Using LifeStyle Education) study, is a 6 month research study evaluating the effectiveness of a men only Type 2 Diabetes prevention study that focuses on diet and home-based exercise (aerobic and resistance exercise). Aims: To determine the feasibility and efficacy of a novel multi-component Type 2 Diabetes prevention program (diet + aerobic exercise + resistance exercise) Hypotheses: 1. Compared to the wait-list control, the diet + aerobic training + RT intervention will result in a significant and a clinically meaningful reduction in weight as well as improvements in important secondary outcomes such as plasma biomarkers at 3 and 6 months post-baseline. The Type 2 Diabetes PULSE intervention will consist of a diet and exercise (aerobic and resistance training) program. Men in the intervention group will receive a resource pack with information regarding Type 2 Diabetes prevention. The dietary intervention will consist of a resource manual with information/tips to improve diet quality and reduce Type 2 Diabetes risk such reducing overall energy intake, reading food labels, reducing portion size, reducing alcohol and sugared beverages, improving quality of diet (low GI carbohydrates, high fibre, low saturated fat), achieving an ideal macronutrient (carbohydrates-fat-protein) profile, reducing salt intake, and increasing fruit and vegetable intake. The exercise intervention will consist of both aerobic and resistance training and will be self-administered over the duration of the 6-month intervention. Men will be asked to perform at least 150 mins/wk (5 x 30 min sessions) of moderate intensity aerobic exercise (e.g., walking, jogging, swimming, cycling) and at least 60 mins/wk (2 x 30 min sessions) of resistance training using body weight and Gymstick (an elastic tubing) exercises. Men will be assessed at baseline, 3- and 6-months on a range of health outcomes. Primary outcomes for the study are weight and fasting plasma glucose. Secondary outcomes will include anthropometric, plasma biomarker, and diet and exercise/fitness measures. The wait-list control group will receive the intervention after the 6-month time-point and will be followed up for a further 6 months.
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Haematological Cancer Web Program Randomised Controlled Trial (RCT)
Expand descriptionKey challenges faced by patients with cancer and their families include coping with a potentially life threatening disease, making decisions about cancer treatment, and managing the side effects of cancer and its treatment. In particular, those diagnosed with haematological cancers may be at high risk for psychosocial distress. Communicating treatment options, the likely impact of treatments, preparing patients for cancer treatments and providing them with information about how to manage side effects of treatment are likely to be key to helping patients and their families cope with a diagnosis of cancer. The purpose of this study is to examine whether an integrated approach (including access to a web-based program and nurse-delivered telephone support) to helping haematological patients with key psychosocial challenges is effective in reducing depression, anxiety, and unmet information needs among patients and their support persons. Participants will be assigned to either a 12-week period of accessing a web-based program designed to provide effective communication, decisional support and adjustment via research staff-provided iPads, or your usual standard of care normally provided by your care team. Who is it for? 10 tertiary referral hospitals that treat at least 15 patients per year will be invited to participate. In order to be eligible for this trial, you will need to be aged 18 years or older; English speaking; newly diagnosed with acute myeloid leukaemia, acute lymphoblastic leukaemia, Burkitt lymphoma, Lymphoblastic lymphoma (B or T cell), Diffuse large b cell lymphoma, potentially making a decision regarding treatment; have a life expectancy of 2 months or more as judged by their clinician; and be able to provide informed consent. This study will also include participation by a sample of support persons, where each patient will be asked to nominate a designated support person. Eligible support persons will be aged 18 or older, able to provide informed consent, and considered by the patient to be an important source of support in relation to the demands of their cancer diagnosis and treatment. Trial Details Consenting eligible patients will be consented into the study by the clinician in their first consultation. Each patient will be given an information statement and consent form to pass onto their nominated support person. Patients and support persons will then be block randomised by week to either the experimental or usual care group. Experimental group: Patients and support persons randomly allocated to the experimental group will be provided with access to a web-based program designed to provide effective communication, decisional support and adjustment. The website provides tailored information on a range of topics including information about diagnosis, treatment options, what is involved in each treatment, side effects, self-management strategies, impact of cancer on day to day life, available support, complementary and alternative therapies. Patients will be able to access the website through iPads provided by the research team. The intervention will also include access to a telephone helpline staffed by an experienced cancer nurse. Usual care: Patients and significant others allocated to the usual care group will receive care normally provided by their care team. Follow-up: Patient and support person follow-up surveys will be completed at approximately 2, 4, 8 and 12 weeks post-recruitment into the study.
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Effects of Acupuncture on Cognitive Function in Healthy Adults
Expand descriptionThe purpose of this study is aim to determine whether acute acupuncture intervention can improve cognitive functionality in a cohort of relatively healthy participants. We hypothesize that there will be a statistically significant increase in both behavioural and physiological measures of cognitive performance in comparison to untreated control after six acupuncture treatments.
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Feasibility of a computer training intervention for novice drivers with Attention Deficit Hyperactivity Disorder or Autism Spectrum Disorder: pilot randomized controlled trial.
Expand descriptionThere is good quality evidence that a link exists between negative driving outcomes and ADHD, yet reducing crash and traffic infringement risk for this group of drivers remains problematic. The pilot study aims are to: 1) Determine the magnitude of the between-group and within-subject change in hazard perception skills, reaction time and risk-taking propensity in young drivers with ADHD or ASD exposed to Drive Smart training. 2) Determine if any between-group or within-subject change in hazard perception, risk-taking propensity or reaction time is maintained over time. 3) Estimate the variance of the primary outcome variable to enable sample size calculation. 4) Determine the rate of recruitment and retention of participants in order to establish if a full-scale evaluation of Drive Smart is feasible. Young drivers aged between 16 and 25 years will be randomised to an intervention or control group. Participants in the intervention group will receive a computer training session using a PC-based CD-ROM interactive training program. A second phase is included, in which the control group will receive Drive Smart training as a delayed intervention. This is intended to maximise resources and data collection within the reduced number of participants recruited. This will facilitate investigation of the potential benefits of Drive Smart training beyond the current exposure with participants acting as their own control. An additional benefit of including a second phase is that all participants receive the intervention. This research will contribute to the evidence-base regarding the efficacy of interventions for improving the hazard perception skills of young novice drivers.
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Fluid restriction compared to fluid optimisation with the oesophageal doppler in colorectal surgery: a randomized clinical trial of efficacy
Expand descriptionDuring surgery on the bowel it is routine to replace blood and fluid loss with intravenous fluids. However, it is still unclear what the optimal amount and method is to replace this loss. This study compares giving a smaller amount of fluid, called fluid restriction, to giving fluid guided by a cardiac output monitor, called targetted fluid administration. We will assess the impact these two methods have on patient's recovery and also the effect on observed clinical signs such as cardiac output at the end of the operation.
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Evaluation of an online system for health, called Healthy.me, in patients with asthma
Expand descriptionThe aim of this project is to assess the efficacy of an online system designed for patients and health care consumers, called Healthy.me, to support health management. Healthy.me provides patients and consumer condition specific information, as well as online tools to manage their care including a personal health record. Our primary hypothesis is that use of Healthy.me for patients with asthma will increase possession and uptake of a written asthma action plan. This randomized controlled trial will also specifically test whether system use is associated with the following secondary outcome measures: i) significant improvement in asthma control, ii) increased compliance according to written asthma action plan, iii) reduced unplanned utilization of health services, iv) reduced frequency of exacerbations, and iv) improved quality of life over 12 months. Patients and consumers are increasingly using online systems to make health decisions and manage their health but we still know little about their patterns of use and impact. This study will make a specific and significant contribution to our understanding of the effectiveness of online systems for patients and healthcare consumers.
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Prospective Evaluation of Vibrynt’s Single Port Access Restrictive Therapy to Improve Life for the Morbidly Obese – United States Pivotal Study
Expand descriptionTo evaluate the safety and effectivness of the VIBRYNT PREVAIL Paragastric Implant System for the treatment of morbid obesity. Efficacy will be demonstrated if the average percent excess weight loss (%EWL) among those participants implanted with the PREVAIL System is found to be not inferior to the %EWL observed amoung participants implanted with the REALIZE Adjustable Gastric Band-C.
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A study to evaluate the safety, tolerability, and pharmacokinetics of a single dose of the drug F-652 in healthy male volunteers.
Expand descriptionF-652 is intended for the treatment for Alcoholic Hepatitis which results in the inflammation of the liver. This is a single dose escalation study testing evaluating dose levels of 2.0, 8.0, 30.0, 120.0 and 250.0 microgram/kg. This is the first time F-652 is tested in humans and that is to establish safety and tolerability, to evaluate how the body handles the drug (pharmacokinetics) and what the drug does to the body (pharmacokinetics) compared to when the drug was tested in animal models.
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"Smiles not Tears" an Aboriginal Health Worker Led Dental Health Education Program.
Expand descriptionEarly dental decay causes much pain and suffering to very young Aboriginal children. Unfortunately dental services for many of these communities are very limited, so it is vital to utilise local health care workers to give parents advice on how to prevent dental decay. Simple dietary changes,especially night time bottle use and ealy introduction of fluoride toothpaste can greatly reduce dental decay. We wish to recruit Aboriginal Health Workers to take on this educaton program as they are well known in their communities and have an existing committment to health promotion. In addition we will be teaching them how to screen for ealy signs of decay, so children with dental problems can be fast tracked for the appropriate care. Our pilot work has led to the development of a culturally acceptable program which the AHWs feel is practical and sustainable. This trial seeks to determine whether the program will actually reduce the prevalence of dental decay in young Aboriginal children and is acceptable to parents and the AHWs.. If successful Aboriginal Medical Services will have evidence based information on which to base their dental preventive programs.