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A supervised exercise programme following hospitalisation for heart failure: does it add to disease management?
Expand descriptionHeart failure is a common, disabling condition. Research has shown that a disease management programme for patients recently in hospital with heart failure, including education, attention to diet, exercise and medications, and regular review by trained staff can reduce death and hospital admissions. There is some evidence to suggest benefits of a supervised programme of exercise in improving fitness and well-being in this patient group. This study will show whether adding regular supervised gym-based exercise to a disease management programme can further improve important outcomes including death, hospital use and depression in a cost-effective manner.
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The Work Outcomes Research Cost-benefit project
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Is a peer-led strength training program beneficial for adolescents with Down syndrome?
Expand descriptionThis trial has now been completed and recruited 20 adoelcents with Dwon syndrome who were randomly allocation to either a progressive resistance training intervention group or a wait list control group.
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Immunogenicity and duration of immunity in immunosuppressed children vaccinated with Human papillomavirus vaccine
Expand descriptionGenital HPV is the necessary cause for cervical cancer, as well as a major contributing cause of several other cancers and conditions. There are now effective vaccines against the main oncogenic HPV types, HPV16 and 18; most research and discussion has focussed around targeting the vaccine to young women and older adolescents. Based on this, a national free HPV vaccination program for adolescent girls will commence in 2007. There is no research on the use of this vaccine in immunosuppressed. Therefore, information on the immunogenicity, safety and duration of efficacy of HPV vaccine when administered to immunosuppressed children is needed.
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Clinical study to assess the efficacy and safety of a new antiretroviral drug (MPC-4326) in patients with Human immunodeficiency virus-1 (HIV-1) infection over a period of 14 days to 72 weeks.
Expand descriptionThe main purpose of this research study is to evaluate the antiretroviral (how effective the drug is at reducing the amount of HIV in the blood) activity of two different doses of MPC-4326 in HIV-1 positive participants and what, if any, side effects there may be through 14 days of dosing. This study will also evaluate the antiretroviral activity and safety of bevirimat in participants who continue treatment with bevirimat as part of combination highly active antiretroviral therapy for up to 72 weeks. We also want to know how much of the drug gets into your blood stream following oral administration. We are asking participants who will start their treatment for the first time (so called naïve (exposed to treatment for the first time) participants) and who are already on treatment (treatment experienced participants) to participate. If you choose to participate in this study and do not intend to continue MPC-4326 treatment past 14 days, you should not expect any medical benefits from taking part in this study and it is even possible that your HIV could worsen during the study. The potential benefit to society may be information gained on the safety and effectiveness of the study treatment for patients in the future. However, if you choose to participate in this study and intend to continue MPC-4326 treatment past 14 days should your viral load reduction in those first 14 days be at least two-thirds or 66.6% as compared with your viral load value at baseline, then you may have medical benefits from taking part in this study. These possible benefits include a persistent viral load reduction and an improvement in the CD4 count (a blood marker of immune system health) that may occur. As this is an experimental medication, the likelihood of these benefits occurring for you is not yet known.
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The effects of multivitamin supplementation on memory and brain function in elderly women experiencing memory decline.
Expand descriptionThis study is a 16 week, double blind, placebo controlled investigation of the effects of a Women’s 50+ multivitamin antioxidant supplement on memory and brain function in women aged 65 to 80 years who are experiencing memory decline. Additionally, this study aims to investigate the possible mechanisms which underlie memory impairment in older adults including cardiovascular risk factors, oxidative stress and brain activity (EEG).
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Aprepitant for Germ Cell Chemotherapy: A phase II multi-centre trial of a seven day Aprepitant schedule for the prevention of chemotherapy induced nausea and vomiting in patients receiving five day cisplatin-based chemotherapy for germ cell tumours.
Expand descriptionThis is a trial of the drug Aprepitant for the prevention of chemotherapy-induced nausea and vomiting in people being treated for germ cell tumours with cisplatin-based chemotherapy. Who is it for? You can join this study if you: - have germ cell cancer that is at early or local, locally advanced or locally recurrent stage - are being treated with cisplatin-based chemotherapy. Trial details All participants receive anti-emetic (anti-vomiting or dry retching) treatment with Aprepitant for seven days while they are receiving their first cycle of Cisplatin-based chemotherapy. The study will measure the number of participants with no emesis during day 1 to 8 of chemotherapy. Chemotherapy-induced nausea and vomiting is an unpleasant side effect of chemotherapy for germ cell tumours, and this study hopes to minimise this.
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A study to establish whether further study of sertraline in relieving severe breathlessness is warranted.
Expand descriptionBreathlessness continues to be a major clinical problem for many people with advanced progressive illnesses such as cancer, end-stage cardiac failure or chronic obstructive pulmonary disease, even when they are receiving the best treatment for the underlying disease. Although there are some interventions that may offer benefit (oxygen therapy, sustained release low dose morphine), there is still a need for a wider range .of interventions to meet the needs of people with refractory breathlessness. Study design: This is a phase II (pilot) double blind randomised controlled multi-site study of sertraline (titrated to a mid-range dose) or placebo. It will run for 28 days and draw participants from across the services participating. Objectives: To establish feasibility of the study design and inform adequate power calculations for a definitive study of this intervention in the same sites in mid 2008.
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Cancer care after surgery – the CONNECT study
Expand descriptionPatients with colorectal cancer are often required to navigate a complex system involving a diverse range of medical, nursing and allied health practitioners in both hospital and community settings. Improving care coordination, patients’ experience of care and patient outcomes are widely recognised as priorities for the improvement of cancer services. A simple strategy that could have wide application for patients in regional and rual Australia as well as those in metropolitan centres is a centralised telephone-based ‘remote access’ cancer care coordination intervention, administered by a cancer nurse. This strategy will be implemented and evaluated in this study to determine whether it improves care coordination and patient outcomes in the six months following cancer surgery. Over a period of 2 years, 720 patients who undergo surgery for a newly diagnosed colorectal cancer will be recruited. Participants will be randomised to the intervention or control (usual care) group. Those in the intervention group will receive the nursing care coordination and support service telephone calls from the cancer nurse at 3 days, 10 days, 1 month, 3 months and 6 months after discharge from hospital. Those in the control group will receive courtesy calls only from the research team in the first week following discharge from hospital, and then again at 1 month, 3 months and 6 months following discharge. All participants will be asked to complete questionnaires relating to quality of life and psychological distress at baseline (just prior to, or in the days following, surgery for colorectal cancer). They will then complete these questionnaires, as well as additional questions relating to satisfaction with treatment, health service utilisation and care coordination at 1, 3 and 6 months after discharge.
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Frailty Intervention Trial
Expand descriptionFrailty is a term in common use amongst health care professionals and in the general community. It has often been used to describe the condition of an older person who has chronic health problems, has lost functional abilities and is likely to deteriorate further. However despite its common use, only a small number of studies have attempted to define the syndrome of frailty and measure its prevalence. Attempts been made to improve clinical outcomes for frail older people using general interventions such as comprehensive geriatric assessment, and specific interventions such as exercise programs or nutritional supplementation, but no interventions have been developed to specifically reverse the syndrome of frailty. A definition of frailty has been formulated allowing more precise identification of frail older people and this has been used in a number of subsequent studies. This empirically derived and validated definition for frailty is based on the presence of at least three or more defined characteristics (the “Fried frailty criteria”). These characteristics are shrinking (unintentional weight loss of more than 4.5 kg or greater than 5% of body weight in the previous year), weakness (grip strength in the lowest quintile adjusted for age and gender), self-reported exhaustion, poor endurance (in lowest quintile for walking speed adjusted for age and gender), and low activity (weekly energy expenditure of less than 380kcal/1600kJ in men and 270kcal/1130kJ in women). The presence of frailty as defined was independently predictive, over a three year period, of incident falls, worsening mobility, deteriorating function in activities of daily living, hospitalisation, and death. The low activity criterion is relatively complex to measure and alternatives have been described. This project aims to identify older people who are seen by the aged care service of a metropolitan hospital and who are frail and therefore at risk of hospitalisation and admission to residential aged care facilities, falls, and deteriorating mobility and function. These older people may be seen in the Emergency Department, as inpatients in the hospital wards, in the outpatient clinics, or in the community by the Aged Care Assessment Team. They will be offered the opportunity to participate in this project, when treatment from the hospital Rehabilitation and Aged Care service has been completed. Those who consent to participate will be assessed for frailty according to the Fried frailty criteria. Those who meet the definition of frailty will be randomised to receive either usual care or the multifactorial, multidisciplinary frailty intervention. The intervention will involve nursing, medical, physiotherapy, occupational therapy, dietetic and psychology input. In this intervention, functional limitations will be addressed through the use of exercise and supply of appropriate aids, nutritional status through the use of nutritional assessment and supplementation if necessary, falls risk through the use of a validated screening instrument and assessment of cause, psychological state through the use of neuropsychological assessment and cognitive behavioural therapy as necessary, and appropriate management of chronic health conditions will be facilitated. The primary outcome sought is a reduction in the rate of functional decline. The primary outcome measurements are the time required to complete the “Timed Up and Go” test, and the Short Physical Performance Battery, at three and 12 months after randomisation. Secondary outcomes, also measured at 3 and 12 months, are frailty assessment score, unplanned hospitalisation or admission to residential care facility, activities of daily living status (using Barthel Index), health related quality of life (using the EQ-5D), psychological status (using the GDS), satisfaction with service provision and incremental cost effectiveness. This project will confirm whether the Fried frailty criteria are able to be used in an aged care service setting, whether an intervention specifically targeting frailty can be implemented, and whether it is effective when compared to usual care. If this intervention is shown to be effective, there are major potential benefits to the frail older population in terms of decreased disability and improved quality of life, and significant cost savings for government if hospitalisation or institutionalisation can be postponed or avoided. The interventions being examined are readily transferable to routine clinical practice and can be applied in aged care services throughout Australia.