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Indigenous Australians comprise a major proportion of the Central Australia population and there are a number of issues relating to those requiring critical care for sepsis, including higher rates of bacteraemia and poorer socio-economic status compared with non-indigenous populations in Australia. Despite high sunlight exposure in this region, it is thought that a combination of factors is likely to contribute to lower vitamin D levels among this population. The study will aim to establish baseline vitamin D levels in critically ill patients with sepsis in a Central Australian population. Our hypothesis is that there will be a significant degree of vitamin D deficiency in the critically ill, particularly among the septic cohort, and that it may be so prevalent as to justify routine supplementation in all critically ill patients without prior screening, further down the track

Background: Physical activity is reduced during the post-partum period. Facebook is frequently used by Australian mothers, and offers flexibility, high levels of engagement and the ability to disseminate information and advice via social contacts. The Mums Step it Up Program is a newly developed 50 day team-based physical activity intervention delivered via a Facebook app. The program involves post-partum women working in teams of 4-8 friends aiming to achieve 10,000 steps per day measured by a pedometer. Women are encouraged to use the app to log their daily steps and undertake social and supportive interactions with their friends and other participants. This study aims to determine the effectiveness of the Mums Step it Up Program. Method/Design: A sample of 126 women up to 12 months post-partum will be recruited through community-based health and family services. Participants will be randomly allocated into one of three groups: control, pedometer only and the Mums Step it Up Program. Assessments will be completed at baseline, 6 weeks and 6 months. The primary outcome (objective physical activity) and the secondary outcomes (sleep quality and quantity, depressive symptoms, weight and quality of life) will be used to determine the effectiveness of the Mums Step it Up Program compared with the control and pedometer only groups. Analyses will be undertaken on an intention to treat basis using random effects mixed modeling. The effect of theorized mediators (physical activity attitudes, subjective norms and perceived behavioral control) will also be examined. Discussion: This study will provide information about the potential of a Facebook app for the delivery of health behavior interventions. If this intervention proves to be effective it will be released on a mass scale and promoted to the general public.

Although intramuscular injections of androgen's are known to be effective, they result in varying degrees of pain at the injection site that may last for a day or two. These injections need to be given into a precise location of the buttocks and require staff with expert training. Unlike many other injections these cannot be self-injected due to the difficulty of safely injecting into the buttocks. A SC injection, if effective, may be given by yourself in your own home, which would be more convenient to avoid extra medical visits as well as saving GP and hospital resources. Many men who require androgen replacement therapy may have bleeding disorders or are on medications that may intentionally slow the ability of their blood to clot. These men have a theoretical risk of bleeding and a very large bruise deep in an important muscle may later become infected and cause significant disability. As a result men using these anti-clotting drugs are usually prescribed other forms of androgen replacement therapy that are not always optimal. A SC injection, if effective, may be used in these men. Nandrolone decanoate (ND) Subcutaneous (SC) will be trialed in healthy volunteers,with a historical, intramuscular (IM) control data set. This is the first stage of a 2 stage research study

It is well established that parents of primary school aged children substantially influence the food and physical activity home environment through behaviours, attitudes, feeding styles and role modelling. However, the contribution of fathers’ influence on children’s physical activity and eating behaviour is often overlooked.The Healthy Dads Healthy Kids (HDHK) project is based on research that shows the eating habits and exercise routine of fathers and father figures influence the ways in which the whole family approaches their health. The program was developed and successfully trialled at the University of Newcastle, with trial results showing that the major aims of HDHK were achieved. These were (i) to help overweight/obese fathers achieve a healthy weight, and (ii) to improve the activity and eating behaviours of their children (using fathers as the key agents of behaviour change). Phase 1 of the HDHK community effectiveness trial (http://www.anzctr.org.au/trial_view.aspx?ID=335368 ) was to evaluate the impact of the program in a community setting with trained local facilitators, employing a RCT design. The intention of this current project (Phase 2) is to research the effectivenss of the HDHK program on a larger scale community roll-out using a non-randomized, prospective design.

Normal cognitive ageing is characterised by slowing of information processing and a decline in a range of cognitive abilities that involve problem solving, attention, working memory, episodic memory and executive function. Cognitive ageing only interferes with daily activities when there are complex cognitive demands occurring jointly with sensory and physical demands. In order to improve everyday function in older adults, we aim to develop an intervention targeting both complex cognitive demands and physical demands. As a pilot study, we aim to compare executive function training with a physical activity intervention (Jazzercise), compared with a comparison group receiving no intervention, on everyday function outcomes including a driving simulator task.

The hypothesis to be tested is that diffuse fibrosis in patients with hypertrophic cardiomyopathy is reduced following eplerenone therapy in a randomised, double-blind placebo controlled study

Stroke is a disease with severe consequences for the survivor and the unexpected carer. Carers experience tremendous changes and challenges from role reversal to financial struggle and subsequent increased burden, low mood, and poor overall health. In Australia, there are approximately 60,000 new strokes per year; a decrease in stroke mortality as a result of improvements in medical and surgical management mean people are living longer with the residues of stroke, and that carers increasingly face long-term burden. Eighty percent of individuals who experience stroke return home with varying degrees of neurological, behavioural and psychological symptoms. At home, they often rely on informal carers for their physical and emotional support. Previous psychosocial interventions to support informal carers of stroke survivors have shown promising results; however none have sought to integrate carer interventions with care coordination. To address this, the Australian Care Coordination program (ACCORD) has combined a 12-week individualised Collaborative Therapy with 3-month, 6-month and 12-month follow-up and care coordination in a 4-year study. This research will assess the feasibility and cost-effectiveness of improving the mental and physical health, social connectedness and health service utilisation of the carers of stroke as well as stroke survivors. This model will be designed with the intention of being readily adapted and applied in the context of other physical and also mental diseases. The findings of this randomised control trial will investigate the impact of ACCORD on reducing carer depression, burden and emotional stress.

Bionomics has discovered and is developing BNC105P as a Vascular Disrupting Agent (VDA). VDAs are a novel class of agents that target endothelial cells and pericytes of the already established tumor vasculature, leading to an occlusion (blockage) of tumor blood vessels, thus starving tumors of oxygen and other required nutrients. The disruption of blood vessels that feed tumors represents a promising therapeutic strategy for treating cancer. In addition, BNC105P has a direct anti-proliferative effect on cancer cells. BNC105P is the phosphate ester of BNC105, a small molecule Tubulin Polymerization Inhibitor (TPI), and which has displayed a strong efficacy in renal, breast and colon tumor models and other tumor types. Clinical studies undertaken to date have shown BNC105P, administered as a 10 minute IV infusion on Days 1 and 8 of a repeating 21-day cycle, is tolerated at 16 mg/m2. Upon exposure to hypoxia (a low oxygen environment induced by disruption of tumor blood flow), renal tumors have been shown to upregulate an intracellular signaling pathway termed the ‘mTOR’ pathway, as a survival response. The combined blockade of tumor blood flow (via the use of BNC105P) and the blockade of the mTOR pathway (via the targeted mTOR inhibitor Everolimus) is the underlying rationale behind this trial. This dual blockade may result in improved clinical outcomes for RCC patients who have progressed on other available agents. The randomized phase II component of this trial will compare everolimus alone (a current standard of care) with everolimus plus BNC105P. Progression Free Survival (PFS) at 6 months is the primary endpoint. The study has been powered to detect an improvement in 6-month PFS from 36% for everolimus to 60% with the combination group. Additionally, patients progressing on everolimus alone will be offered BNC105P (a sequential approach), which will provide an opportunity to evaluate the activity of monotherapy with BNC105P alone.

Background: The armamentarium for cutaneous warts is vast, the majority of which are not supported by high quality, randomised, controlled trials. We hypothesised that needling of a pedal wart would create local inflammation and a subsequent cell-mediated immune response against human papillomavirus. The primary objective of this study was to investigate if needling to induce cell-mediated immunity against human papillomavirus is an effective treatment of pedal warts in comparison to liquid nitrogen cryotherapy. A secondary objective of this study was to investigate if the cell-mediated immune response induced by needling is effective against satellite pedal warts. Methods: Eligible participants presenting to the University of Western Australia Podiatry Clinic with pedal wart/s were randomly allocated to treatment — either needling or nitrogen cryotherapy. Only the primary pedal wart was treated during the study. The participants were followed over a twelve-week period with outcome assessments made independently under blinded circumstances. Results: Thirty-seven participants were enrolled in the study with 18 allocated to needling and 19 to liquid nitrogen cryotherapy. Regression of the primary pedal wart occurred in 64.7% (11/17) of the needling group and 6.2% (1/16) of the liquid nitrogen cryotherapy group (p=0.001). There was no significant evidence to suggest needling of the primary pedal wart will result in regression of one or more satellite pedal warts (p=0.615) or complete pedal wart regression (p=0.175). There was no significant difference in pain, satisfaction or cosmesis between the two groups. Conclusions: The regression rate or the primary pedal wart is significantly higher in the needling group compared to the liquid nitrogen cryotherapy group. There is no significant evidence that needling of the primary pedal wart to induce a cell-mediated immune response is effective against satellite pedal warts.

This study aims to investigate radiation-related changes in the lungs using a novel, high-resolution imaging modality, in patients with non-small cell lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above, and are receiving curative intent radiotherapy for non-small cell lung cancer with or without chemotherapy. You should also have had a FDG-PET scan performed for staging of your cancer. Study details: All participants in this study will undergo a Gallium PET scan before radiotherapy treatment, midway through treatment, 3 months after treatment and 12 months after treatment. They will also receive a standard PET scan (similar to the one initially used to diagnose the extent of the cancer) after 3 months after radiotherapy treatment. In addition, lung function tests and 6 minute walk tests will be performed before treatment, mid-way throughout treatment and every 3 months after treatment for up to 12 months. These assessments will enable us to evaluate changes in lung function. By documenting these changes, we aim to better understand the fundamental effects of radiation on pulmonary (lung) physiology, better predict for radiation toxicity, and in the future reduce radiation toxicity by avoiding irradiation of functionally critical segments of lung. In an additional sub-study we will collect blood samples at 5 different timepoints from before treatment to 3 months after radiation treatment, in order to assess radiation induced DNA damage outside of radiation fields.