ANZCTR search results

Peripheral quantitative computed tomography (pQCT) is a novel tool that has the ability to assess trabecular bone independently of cortical bone, and to evaluate various measures of macroscopic bone geometry, which can be combined into indices of bone strength. A randomised, placebo control trial of vitamin D treatment versus placebo will be performed. Muscle strength and cross sectional muscle area will also be assessed at each follow up time point for all eligible patients.

Oxidative stress (OS) is a key mechanism by which liver injury occurs in chronic hepatitis C (CHC) virus infection. For this Study, it was hypothesised the use of antioxidant compounds would reduce OS, hepatic necroinflammation and hepatic fibrosis in CHC patients. To test this hypothesis, a randomised, double-blind, placebo-controlled clinical trial (termed the Hep573 Study) was conducted in three Australian teaching hospitals in New South Wales. One hundred and eighteen participants were recruited through the liver outpatient clinics at the hospitals from July, 2003 to March, 2006. They were randomised to treatment in blocks of six to one of three groups: placebo; silymarin (720 mg silybin/day); and silymarin with antioxidants (720 mg silybin plus 12 other ingredients). Study duration was 48 weeks: 24 weeks on active treatment or placebo, and 24 weeks follow-up post treatment. The primary outcome measure was the proportion of patients with alanine aminotransferase (ALT) normalisation at Week 24 (Fisher's exact test). Secondary outcome measures were the percentage change from baseline to Week 24 in F2-isoprostanes, and to Week 24 and Week 48 in ALT, HCV viral load (HCV RNA), FibroTest and Hepascore (Linear Mixed Effects). Results were analysed on an intention-to-treat basis. In patients with compensated CHC, the use of silymarin and antioxidant compounds achieved a higher rate of ALT normalisation than placebo (P=0.02) or silymarin (P=0.003) at Week 24. This result could not be attributed to alcohol, diet or caffeine, as intake across the groups did not change throughout the Study. In addition, there was a significant improvement in the overall mental-health score (Mental Component Summary), QualityMetric Hepatitis Quality of Life Questionnaire Trademark (HQLQ) in the silymarin and antioxidant (SOX) group (P=0.002). This novel randomised, double-blind, placebo-controlled trial of oral silymarin and oral antioxidants has shown a reduction in hepatic necroinflammation and an improvement in overall mental-health status in a specific CHC population.

This project will address a significant problem in healthcare which is to provide safe, effective and reliable vascular access when commencing a patient on Total Parenteral Nutrition (TPN). TPN is used in patients where the gastro-intestinal tract cannot be used for the ingestion, digestion and absorption of essential nutrition. Two types of central venous access devices (CVADs) are central venous catheters (CVCs) which are inserted centrally into the veins on the neck and peripherally inserted central catheters (PICCs) which are inserted via veins in the arms. PICCs can be associated with central line associated blood stream infection (CLABSI), thrombotic complications (thrombosis) and mechanical complications (catheter occlusion, phlebitis). These complications impact on the cost of care, and have the potential to be a life-threatening adverse event. To help combat this problem PICC lines have been developed that are coated with antiseptics or antibiotics, referred to as anti-infective lines. There are few comparison studies that have analysed the safety and costs of the lines by comparing anti-infective PICCs and standard PICCs in patients that receive TPN. Despite this gap in research, there is an increased use of the PICC line based on perceived time benefit, lower cost and fewer mechanical complications, where there is a lack of scientific evidence to support this choice. The main aim of this study is to determine if there is a difference in the failure rates and costs between the patients who receive TPN via an anti-infective PICC line and a standard PICC line. This feasibility pilot study will be a carried out a single centre. Participants will be patients requiring the insertion of a CVAD for delivery of TPN during the study period that meet the inclusion criteria and sign consent. They will be randomised into one of two groups, we aim to recruit 30 patients per group: * group 1 (Anti-infective PICC) * group 2 (Standard PICC) It is envisaged that findings from this study will provide a foundation for a larger study to explore the failure rates of PICC and anti-infective PICC lines used for delivery of parenteral nutrition, and to develop recommendations for the choice of PICC in patients receiving TPN.

A large scale randomised controlled trial conducted using a smartphone application to evaluate the comparative effects of four different forms of front-of-pack nutrition labelling against the current back-of-pack nutrition information panel on the healthiness of foods purchased. The four front-of-pack nutrition labelling formats tested will be: 1. Colour-coded multiple traffic-light labels; 2. Monochrome daily intake guide labels; 3. The "energy stars" based front-of-pack nutrition labels; and 4. Advisory labels. The findings will feed directly into the ongoing policy debate about the format of front-of-pack nutrition labelling to be introduced in Australia.

Venous thromboembolism (VTE) is a significant health problem especially in hospitalized patients, with a high associated morbidity and mortality. For most patients, the standard of care is to use prophylactic anticoagulation (heparin) and intermittent pneumatic compression to both lower limbs. There is a group of patients who are at very high risk of VTE but these VTE prophylactic measures cannot be used or considered adequate, either for physical reasons (lower limb fractures / open wounds ) or risk of bleeding from anticoagulants (such as severe brain injury). In these patients, the options are to use no intervention or to insert an Inferior Vena Cava filter (IVCF). Although IVCFs are widely used as a mechanical VTE prophylaxis in patients who have contraindications to conventional VTE prophylactic measures, their effectiveness in this regard has not been established. This phase II / III randomized controlled trial aims to assess the clinical effectiveness, benefits and harms, and also the cost- effectiveness of the early use of IVCFs (<72 hrs of admission after severe injury) for trauma patients who have contraindications to conventional VTE prophylactic measures (pharmacological thromboprophylaxis). This trial has the capacity to influence the management of trauma patients worldwide, and to establish the place of IVCFs in modern medical practice.

ANDROFEME (Registered trademark) cream is currently the only available testosterone product in Australia with widespread use in clinical practice. The available pharmacokinetics indicate the most appropriate dose for women is 0.5ml (5mg)/day. However the absorption of transdermal preparations is known to vary according to the area of application. This was not controlled for in prior studies. Furthermore, the investigators believe the upper arm is not an appropriate site for the drug application as 1) there is a greater risk of transfer of the applied drug to others; 2) contamination when blood is drawn for measuring testosterone levels is common (resulting in falsely elevated levels) and 3) the possibility of increased blood levels of testosterone in the ipsilateral breast. In this study we will evaluate the pharmacokinetics of two application sites of 0.5ml (5mg) of this testosterone 1% cream in postmenopausal women: an area on the upper outer thigh/ lower buttock approximately the size of the palm (approximately 80cm2) and a broad area on the outer thigh/ lower buttock (approximately 300cm2).

Research suggests that there are an insufficient number of services available to help the large number of Australians who experience mental illness. Therefore the focus should be on prevention. The internet has been shown to be an effective way of delivering mental health education and prevention in schools. One such internet delivered intervention is the Managing Stress program (from ‘THIS WAY UP Schools’ a sector of CRUfAD), which has previously been evaluated in a large RCT with an adolescent population (van Vliet and Andrews, 2009). The current research aims to address the need for early intervention by replicating van Vliet and Andrews (2009) study in evaluating the effects of the Managing Stress online program for children in year 5 of primary school.

This pilot study is to define the acceptability of short vs. long course of antibiotics for the treatment of young children hospitalized with pneumonia

PULSAR stands for ‘Principles Unite Local Services Assisting Recovery’. The overall aim of the PULSAR project is to imbed recovery-oriented practice in primary care and specialist mental health services throughout the Monash Health catchment. Recovery-oriented practice involves supporting a process of change through which individuals improve their health and wellness, live a self-directed life, and strive to reach their full potential. A package of training interventions has been developed in the United Kingdom that promotes recovery-oriented practice in teams. We adapt these materials for the Australian setting so that the content and processes of training and development are sensitive to needs of the Victorian mental health care system, the local cultural and legal contexts. The PULSAR intervention involves training staff in recovery-oriented practice using these adapted materials. This trial pertains to the evaluation of the PULSAR intervention within specialist community-based mental health services; the evaluation of PULSAR in primary care services is being evaluated in separate trial, which is separately registered with ANZCTR. In the specialist care trial, we are delivering the PULSAR intervention to staff at 14 specialist community mental health care settings (clusters) and evaluating the effect on adult consumers of these services. Half of the clusters are randomised to receive the PULSAR intervention in year 1, and the other half receive the PULSAR intervention in year 2. Our key hypotheses are that consumers in the PULSAR intervention clusters will experience significantly greater gains in personal recovery and in health and wellbeing compared to consumers receiving care in control groups. Data will be collected cross-sectionally from a minimum of 252 volunteer service users at three time points: baseline, end of year 1 and again at the end of year two. The total number of participants will be at least 756 consumers (i.e. minimum of 18 consumers per cluster per time point). Consumers are recruited into the study if they respond to an invitation letter by completing and returning a short recovery-focused survey. A subset of participants who also return a signed "consent to future contact form" are invited to attend a face-to-face interview where more detailed data will be collected assessing recovery, health and well-being, service satisfaction, perceived coercion in accessing services and health economic impact. Longitudinal data are collected from a further subset of participants invited to attend two face-to-face interviews at time points corresponding to the pre and post intervention periods for their particular cluster. The significance of the work will be to develop, evaluate, and make readily available a set of training materials and organisational change tools that would facilitate participating mental health services working together to successfully deliver recovery-oriented practice.

This study aims to investigate the interactions and effects of salt and fat consumption on palatability. The objective is to quantify the contributions of different concentrations of salt and fat in food on subjective liking and wanting in humans classified according to fatty acid taste sensitivity. Fifty participants, aged 18-45 will participate in the study and will taste food samples with varying salt and fat contents. Subjective liking and wanting will be assessed in addition to assessing individuals oral fatty acid sensitivity.