ANZCTR search results

Stroke is a leading cause of disability amongst Australians. After stroke, activity levels are low, with few people able to exercise at an intensity which will reduce the risk of future cardiovascular events. This project examines the effectiveness of implementing a combined high intensity treadmill training program embedded in a self-management approach to improve activity levels, mobility, cardiovascular risk profile in stroke survivors, increasing their independence and reducing the burden of care.

Vitamin D in your body comes from exposure to the sun or from your diet. Having enough vitamin D in your blood stream is important for maintaining healthy bones, but we don’t really know how much our bones need. Having higher vitamin D levels might also reduce risks of diseases such as diabetes, heart disease, multiple sclerosis and some cancers, but this is uncertain. To fully understand the health effects of vitamin D we need to do studies with very large numbers of people. We are aiming to recruit about 25,000 Australians aged 60-79. The aims are to see if taking a vitamin D tablet changes the risk of a person being diagnosed with health conditions such as cancer, heart disease or infections (like flu). D-Health will give us much-needed information so that we can advise people correctly in the future.

Mindfulness interventions are emerging as a potentially promising intervention to reduce mental health problems in the perinatal period, however there is a need for more robust evidence supporting their efficacy. The current proposal outlines a pilot study with the primary aim of exploring feasibility issues to inform the development of a randomised-controlled trial of a mindfulness-based intervention in pregnancy. We propose to test and evaluate a range of recruitment strategies designed to maximise uptake of a program offered to women booked in to give birth at the Royal Women's Hospital. We aim to recruit around 45 women to this pilot study. Participants in the project will complete study questionnaires at three time-points: pre-intervention, post-intervention, and at a three months postpartum follow-up. Questionnaires will include standardised measures of depression, anxiety, stress, and mindfulness. The postnatal follow-up questionnaire will include items on maternal postnatal quality of life and child outcomes (cry-fuss-sleep behaviour). Analysis will focus on uptake via different recruitment methods and assess rates of ongoing participation, engagement, and acceptability of study instruments. The data collected in this study will be used to inform the development of a large scale randomised controlled trial evaluating a mindfulness-based group intervention in pregnancy for reducing perinatal anxiety and depression. In addition, the pilot study will support and develop collaborative links between staff at The Royal Women's Hospital and researchers in the Healthy Mothers, Healthy Families group at the Murdoch Childrens Research Institute.

This project is to assess the feasibility of comparing the current standard care of a patient referred to the Sunshine Coast Hospital and Health Service-renal services, with a novel approach where the referred patient has a telephone consultation with the specialist while with his/her GP.

This pilot study will assess the feasibility of undertaking a larger study to determine if telephone-delivered cognitive behaviour therapy followed by communication with on-going specialist and primary care providers is a successful and sustainable treatment option for adult heart transplant recipients with anxiety or depression. Additionally, this study will also help determine the accuracy of simple, self-adminsitered questionnaires to screen for anxiety and depression.

This study is exploring whether a blood test might be a feasible additional or alternative diagnostic test to a biopsy in patients with lung cancer. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have stage IIIB or IV adenocarcinoma of the lung. You should have had a lung tissue biopsy that is archived and available for testing, or be a candidate for a new biopsy. Trial details All participants in this study will provide 2 blood samples (one before drug therapy and another taken between 14 to 21 days after drug therapy has commenced) to be tested for the epidermal growth factor receptor (EGFR) mutation using a new test kit. The results of this test will be compared to the EGFR mutation status reported via tissue testing for those patients where this information is available. Knowledge of EGFR gene status (positive or negative) can help guide treatment decisions. Based on these results we aim to determine whether the blood test is a feasible alternative or additional approach to a 'traditional' biopsy in evaluating EGFR mutation status.

Hypothesis and Outcomes: This study will test the primary hypothesis that nebulised heparin improves lung function, assessed by the change in the partial pressure of arterial oxygen to the fraction of inspired oxygen (PaO2/FiO2) over the operative period. Secondary outcomes include the extent of post-operative organ supports and duration of intensive care and hospital stays. Significance: Nebulised heparin offers the possibility of a cost-effective strategy to prevent respiratory failure developing in patients following heart surgery. Health benefits and healthcare cost savings could be substantial. An effective strategy could save the Australian healthcare system at least $8.5 million per year in intensive care costs alone.

This study is evaluating the effect of the drugs dabrafenib and trametinib given prior to surgery and after for the treatment of melanoma. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with AJCC (American Joint Committee on Cancer) Stage IIIB or IIIC BRAF V600 mutation positive melanoma. Trial details: All participants in this study will take dabrafenib 150 mg tablets twice daily and trametinib 2 mg tablets once daily for 3 months. They will then undergo complete lymph node dissection surgery, followed by treatment with twice daily dabrafenib 150 mg and once daily trametinib 2 mg for a further 9 months. Participants will be assessed at 12 weeks post treatment in order to evaluate treatment response and surgical outcomes.

The current study aims to evaluate the effectiveness of a cognitive behavioural therapy in reducing depression in adolescents with autism spectrum disorders. We hypothesise that there will be a significant reduction in mean depression scores post-intervention relative to baseline depression, and relative to the wait-list control.

Infants born prematurely often require gastric tube feeding. The transition from gastric tube feeds to sucking feeds (breast and/ or bottle) usually starts around 32-34 weeks’ post menstrual age when infants begin to demonstrate the ability to coordinate sucking, swallowing and breathing. However, during sucking feeds immature infants may experience physiological instability, including lower oxygen saturations (SpO2) and heart rates (HR), and periods of apnoea or cyanosis. However, preterm infants may have sucking feeds by bottle for a number of reasons, for example infants whose mothers are no longer expressing, or who are unable to be present for a breastfeed. During bottle feeds infants typically feed cradled in a flexed, semi-reclining “en face” position. In contrast, during breastfeeding infants’ are generaly placed so that they lie across the mother’s abdomen in an unflexed position with the infant’s head in a straight line with their body. In a pilot study, comparing a side-lying position against a semi-upright position for bottle feeding preterm infants, Clark reported an improvement in SpO2 measurements in the side-lying position In our previous study at RWH with 25 preterm infants we showed there was little difference in mean (SD) SpO2 during feeds between the cradle-hold and side-lying position 94(6)% versus 95(6)% respectively (p=0.55, CI -1.4, 5.4). During feeds 17/ 25 (68%) experienced a period of SpO2 <80% in the cradle-hold position compared with 14/25(56)% in the side-lying position (p=0.26, CI 0.68, 4.10). However, in post hoc analysis we saw that in 8 infants receiving respiratory support during feeds 7/8 (87%) versus 5/8 (62%) in cradle versus side lying feeding positions experienced a SpO2 < 80% (p=0.25). There are several reports showing that there is a reduction in oxygen saturation in preterm infants with bronchopulmonary dysplasia (BPD) during bottle feeds in the cradle-hold position. Residual lung disease is probably the most prevalent sequela of prematurity that affects feeding. There are no reports measuring the effect of alternate bottle feeding positions for infants receiving respiratory support during bottle feeding. We hypothesise that for infants who are receiving respiratory support there might be increased physiological stability during bottle-feeding in the side-lying versus the cradle-hold position. The aim of this study is to determine the physiological stability and efficiency of bottle feeding in the side lying position (SLP) in preterm infants receiving respiratory support who are transitioning to suck feeds.