ANZCTR search results

This project aims to determine if a major flavonoid component found in apple skin can improve blood vessel function and blood pressure in human volunteers. The apple variety Cripps Pink, marketed as ‘Pink Lady’ is particularly rich in the flavonoid quercetin. Our previous short term studies with pure quercetin and apples show improved blood vessel function. We now wish to determine if long term consumption (4 weeks) of apples will improve vessel function and lower blood pressure and try to understand the biochemical mechanism of this beneficial effect.

The aim of this study is to evaluate the revised versions of the ATLAS and NEAT school-based health-related fitness (HRF) programs for adolescents using a cluster randomised controlled trial in 16 secondary schools located in the Hunter, Central Coast and Sydney regions of New South Wales (NSW), Australia. The revised ATLAS and NEAT programs will be delivered over 10-weeks to male and female students in grade 9 at the study schools. The ATLAS and NEAT programs include a range of strategies aimed at improving HRF and social and emotional well-being among adolescents. Assessments will occur at baseline, 6-months, and 12-months. The primary outcome is muscular fitness (push-ups and standing long jump). Secondary outcomes for students include perceived and actual HRF, physical activity, resistance training skill competency, social and emotional well-being, self-esteem, screen-time, consumption of discretionary foods, motivation for resistance training and physical activity, sleep time and sleep quality. Hypothesised mediators of physical activity and HRF will also be explored. Secondary outcomes for teachers include confidence to teach HRF activities, perceived barriers to teaching HRF activities, and perceived fitness.

A double blind single-dose study to evaluate pharmacokinetics, safety and tolerability of Stelis Teriparatide [rh-PTH (1-34)] with innovator product Forsteo Registered Trademark (European Innovator) in healthy volunteers via subcutaneous administration of a single dose of 20 mcg .

This pilot study aims to determine whether knowledge of personal genetic risk of melanoma, compared to standard prevention advice, can motivate behaviour change among the general population. Who is it for? People aged 18-69 years from the general population, who have never had melanoma and have registered with 'Join a Research Study' database. Study details All participants in this study will be required to provide a saliva sample and have their DNA tested to determine their risk of melanoma. Participants are then randomly allocated (by chance) to one of two groups. Participants in one group will receive personal information about their melanoma genetic risk, with access to telephone-based genetic counselling as well as written educational materials on melanoma preventive behaviours including sun exposure, sun protection and skin examinations. Participants in the other group will receive only written educational materials on melanoma preventive behaviours during the intervention period. This group will then be offered genetic risk information at the end of the study (about 8 months after the saliva sample). The aim of this study is to pilot methods for an intervention that provides information on personal genetic risk of melanoma to participants from the general population, and to gather pilot and feasibility data regarding its short-term effectiveness on sun protection, sun exposure and skin examination behaviours, as well as the broader impact on ethical, social, psychological and economic outcomes.

The rationale of the study is to evaluate the roles of memory reactivation and cognitive therapy as a means of preventing PTSD shortly after trauma exposure. This study compares the relative effectiveness of (a) Cognitive Therapy Combined with Memory Reactivation, (b) Cognitive Therapy Alone, and (c) Wait-list in reducing posttraumatic stress disorder symptoms. It is hypothesised that Cognitive Therapy combined with Memory Reactivation will lead to greater symptom reduction than Cognitive Therapy, which will lead to greater symptom reduction than Wait-List.

This project involves evaluating the effectiveness of a new parenting resource, Confident Body, Confident Child (CBCC). Parents who receive CBCC will be compared with parents who do not receive CBCC on attitudes, behaviours, and knowledge about body image and healthy eating patterns at pre-intervention, and at three post-intervention time points.

There is a growing body of evidence of altered sensory processing in people with shoulder pain however it is not known which pain modulation pathway is affected in this population. It has also been reported that manual therapy techniques for the shoulder complex improve outcomes in patients with shoulder impingement compared to standard physiotherapy, sham or control interventions; however some findings suggest that a subgroup of individuals with shoulder pain may exist who will respond dramatically to these interventions. The aims of this study are to determine 1) the dominant pain modulation process in shoulder impingement individuals and 2) prognostic factors from the history, physical examination and pain modulation process in individuals with shoulder impingement who are likely to experience improvements following physiotherapy associated with manual therapy techniques. In this instance the population will be individuals with shoulder impingement symptoms and healthy controls. For the first aim of the study, all the subjects will be assessed twice at the baseline, with an interval of 48 hours between the measurements. For the second aim of the study, subjects with shoulder impingement will be treated during 4 weeks with manual therapy, physiotherapy and, when necessary, shoulder taping, and then reassessed after the 4-weeks rehabilitation program. The primary outcome measures will be heat pain threshold, cold pain threshold, cold pressor threshold, conditioned pain modulation and temporal summation of pain. The results of this study will contribute to our understanding of the dominant pain modulation process as mechanism for success in this technique and to guide physical therapists in selecting which patients with shoulder pain may experience improved outcomes following physiotherapy and manual therapy treatment. To date no scientific study has been conducted to investigate the pain modulation pathways in this population neither the predictive factors for successful outcomes concerning pain modulation in people with shoulder pain.

Debilitating Fatigue is a common complaint in survivors of stroke and transient ischaemic attack (TIA) and can persist for years after the acute event, causing lack of physical activity and participation in rehabilitation and socialisation. Currently there are no pharmaceutical agents approved for the treatment of this fatigue. Modafinil has been shown to reduce fatigue in patients suffering other neurological conditions such as MS and Parkinson's disease, and to improve cognition and memory. This study will aim to measure the efficacy of modafinil in survivors of stroke and TIA experiencing self-reported fatigue.

Administration fluids directly into a vein is commonly used to treat low blood pressure in critically ill patients, termed fluid resuscitation. The aim of fluid resuscitation is to restore and maintain organ function. Two commonly administered intravenous fluids are 20% albumin and 4% albumin. Intensive care doctors do not known if either of these two fluids should be used in preference to the other for fluid resucitation. In response, the aim of this study is to establish the feasibility, safety, biochemical and physiologicy efficacy of intravenous 20% albumin solution compared with intravenous 4% albumin soluation for fluid bolus therapy in critically ill patients. For a period of 48 hours from enrolment, patients that are enrolled in this study will receive either of the study fluids when their treating intensive care doctors deems it necessary. This study will enrol 400 patients for two intensive care units of hospitals located in Melbourne and Adelailde, Australia. If our findings support one intravnous fluid over the other then we would aim to conduct larger studies to assess its benefits in terms of patient-centred outcomes.

Disability, mortality and healthcare burden from fractures in older people is a growing problem worldwide. During 2007, there were an average 262 fracture-related hospitalisations per day in Australia with the financial burden associated with direct treatment cost for fractures in Australia estimated at $1.9billion per year. A small number of low-quality observational studies examining the effect of aspirin on fracture risk in older people have demonstrated conflicting results. A large-scale controlled trial is required to provide more accurate information on this effect. The ASPREE-Fracture sub-study aims to investigate whether daily low-dose aspirin (100mg) is associated with decreased incidence of vertebral, hip and non-vert-non-hip fractures in healthy men and women aged 70 years and over; and whether the reduced fracture risk is explained, in part, by reducing risk of fall-related hospital presentations. The ASPREE-Fracture sub-study has the potential to change current fracture prevention practice and policies for older people by offering a population intervention. Even if small impacts are observed on fracture incidence, the net benefits of aspirin in terms of reduced fracture risk at a population level may be substantial.