ANZCTR search results

The study is designed to look at the effect of supplementation with low dose mixed vitamin E and sesame, either alone on in combination on blood pressure in people who already have elevated blood pressure. The study will be double-blinded with both the study co-ordinator and participants blinded to the tocopherol treatment. However, because of a noticeable taste difference between the placebo spread and the sesame spread, this will not be able to be blinded

A crossover trial of mifepristone for the treatment of depression in Parkinson's disease. Participants will be randomly assigned to either mifepristone or placebo during the first part of the study and then assigned to the other during the second part of the study. The trial will be double blinded - the placebo and mifepristone are to be dispensed by a hospital pharmacy according to a code generated by a statistician. Participants and investigators will not know which has been dispensed until the completion of the trial.

Infants born preterm have an increased risk of mortality and cerebral palsy. Evidence from recent case controlled studies support animal research that suggests maternal administration of magnesium sulphate may reduce the risk of cerebral palsy and mortality in infants born very preterm. It is important that these findings are tested in large randomised controlled trials as soon as possible to assess whether prophylactic treatment should be recommedned for clinical practice in the case of women who are at risk of preterm delivery. Trial participants, trial research staff and all involved in clinical care of participants were blinded. Trial treatment packs of identical appearance, labelled only with unique study number.

We will determine the contribution of Plane Trees to the respiratory symptoms of inner-Sydney residents. We will measure the allergic symptoms of groups of patients over the Spring and Summer, while sampling air at 2 city locations and also specific locations related to exacerbations of symptoms (attacks) in individuals. The results of this study will help people manage their allergies, and provide information for policy-makers.

This project aims to developing a performance test battery that can be utilised by sleep physicians in order to assess an obstructive sleep apnea (OSA) subject's performance and sleepiness level after they have been treated with continuous positive airway pressure (CPAP). To facilitate this OSA subjects' performances will be assessed by a number of psychomotor tasks, cognitive tasks and objective measures of sleepiness. OSA subjects and also controls will be tested during their normal state and also during a sleep deprived state so that comparisons can be made between the two groups and across the two different conditions.

AIMS: The aim is to test whether a 10-week progressive resistance training (PRT) program for depressed people aged 65 and over from the general practice setting will result in a reduced prevalence of depression at ten weeks and six months and a concomitant improvement in physical and psychological health, functional and quality of life status. The hypothesis to be tested is that the PRT program will produce a 60% reduction in depression rates amongst older people (akin to standard active therapies), compared to a 40% reduction in those receiving usual care. BACKGROUND: The prevalence of depression in older people ranges from 5 to 30%. Depressive illness results in reduced activity levels, functional disability and decreased quality of life, and can occur concurrently with other illnesses (e.g., cardiovascular disease) and impact adversely on these conditions. Depressed older people have much to gain from being physically active, with benefits reported in both physical and mental health. Physical activity offers an alternative to drug management for some older people, reducing iatrogenic and polypharmacy problems. PRT is one form of physical activity with a growing evidence base in depression management. It is both timely and critical that we test the effectiveness of PRT in improving mental and physical health of older people with depression when applied in the Australian primary health care context. RESEARCH PLAN: Older people will be recruited from primary and community care settings, via mailed invitations and referrals. Eligibility will be established via completion of the GDS-30 and medical clearance against proscribed criteria. Following baseline assessment, participants will be randomly allocated to a community-based, supervised PRT exercise program or usual care (comparison group). The PRT group will attend a local ‘Living Longer, Living Stronger’™ facility three times/week for 10 weeks. We will repeat baseline assessments at ten weeks and six months to determine whether the intervention’s impact is sustained. Sustainability is vital if the model is to be transferred into routine service delivery. Our approach will optimize the generalisability of study findings and the interventions’ subsequent adoption and implementation. Given the nature of the intervention, participants and exercise facilitators are not blinded to group allocation, but the data analyst is. OUTCOMES & SIGNIFICANCE: The primary endpoint is a clinically significant reduction in depressive symptoms. The secondary endpoint is a significant improvement in health and wellbeing status, measured using the Human Activities Profile, the Philadelphia Geriatric Morale Scale and the WHOQOL-Bref.

The goal of the trial was to determine whether Dose Administration Aids improve veteran outcomes and to characterise which veterans will benefit most from using a DAA. A randomised controlled trial with one year's follow-up was conducted involving Australian war veterans and war widow/ers from selected rural and urban areas of New South Wales, Victoria, Queensland, South Australia and Tasmania. Veterans were randomly allocated to have thier medication packed in a DAA by thier community pharmacy (intervention arm) or to recieve thier medication in the original packaging (control). Due to the nature of the intervention it was not possible to blind participants to the study conditions. The main outcomes were change in severity of illness and adherence.

Five to ten percent of primary school children fail to learn to read at the standard expected from their intelligence and educational and cultural background. This condition is known as dyslexia. In 2005-2006, a dyslexia project is being conducted in participating Southern Tasmanian schools. Past work has shown that some children with normal intelligence have reading problems because of problems with coordinating both eyes to read visual images. The project aims to screen for vision coordination problems among children with low literacy. It is not currently known what proportion of children who have difficulty reading have vision problems in relation to scanning text with both eyes working together. The main aim of the Literacy Pathways Project is: To assess how children may benefit from different programs to assist them with reading. Each program contains a mixture of activities that are based on past work indicating that they have benefited some children with reading problems. The relative importance of the different components within or between the programs is currently not known and is the subject of the educational trial. Participants are unaware of the intervention status and commercial names of the reading programs in the study. The programs are referred to as the orange, yellow or green program. Participants are not aware of the content of the other programs. The people conducting the assessments are blind to intervention status. Analysis - The true group allocation will be removed for the analysis and only added back in at the end. That is, the analyst will only analyse the data being aware of the orange, yellow or green categories but not the intervention status associated with each.

This study will investigate the effectiveness of Travelan, given alongside a patient's current medications, to reduce inflammation in ulcerative colitis. Travelan is a hyper-immune bovine colostrum extract from cows that have been vaccinated against the agents which commonly cause travellers diarrhoea. (ie a variety of E.Coli's). Travelan is currently sold as an over-the-counter medication in Australia to reduce the risk of traveller's diarrhoea. Medical Practitioners report that patients with a variety of chronic diarrhoea syndromes have a reduction in symptoms when taking Travelan to avoid traveller's diarrhoea. The 4 month pilot-study will review symptoms, blood and stool samples to evaluate if 2 months intervention with Travelan has an effect on bowel inflammation in ulcerative colitis.

The hypothesis is that fatty acids consumed in flaxseed oil are converted in the body to novel fatty acid oxidation products. The purpose of the study is to determine whether these fatty acid oxidation products can be measured in the blood and urine of men following supplementation with flaxseed oil for 4 weeks. The study subjects, the investigators and the statistical analyst are blinded to the treatment allocation.