ANZCTR search results

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.

The primary purpose of this study is to assess the feasibility of conducting a placebo controlled trial in the Corrective Services setting and also to generate pilot data for use in the application of funding for a multi-centre trial in due course. It is expected that the fish oil plus micronutrients supplemented group will have reduced aggressive behaviour comapred to the placebo group.

The study is evaluating the impact of a telehealth-based intervention on service provision for palliative care patients as well as assessing its potential in replacing current usual care through increased video link contact opportunities and remote monitoring of patients and their carers at home. Who is it for? You may be eligible to join this study if you are aged over 18 years, require palliative care in Seaford, Aldinga, McLaren Vale and Willunga in South Australia, and have access to a National Broadband Network (NBN) connection. Trial details: Participants in this study will be provided with regular and responsive online access to health professionals, and access to quality information and resources to support palliative care patients and their carers. Participants will be monitored on a regular and ongoing basis to determine the feasibility, acceptability and utility of the telehealth-based intervention.

Vitamin D deficiency is a public health issue in developed countries. Many countries recommend supplementing infants with 400 IU/day of vitamin D. These recommendations have been introduced based on the evidence that supplementation reduces the risk of rickets, which occurs generally among those with moderate to severe vitamin D deficiency. There is debate whether a similar policy should be introduced in Australia where rickets only occurs in high risk groups which can be easily identified. While vitamin D has potential benefits for bone health beyond the prevention of rickets by improving bone acquisition, the current evidence in infants is sparse, inconsistent and cannot even rule out a detrimental effect on bone. An expansion from supplementation of at-risk to supplementing all infants should only occur if there are health benefits beyond rickets. However, practice is starting to run ahead of the evidence, and infants are now increasingly being supplemented in the absence of this evidence. High quality and well-powered randomised controlled trial (RCT) evidence is required to show that supplementation of mildly deficient infants is beneficial and does not cause harm. Aim – To determine whether vitamin D supplementation of 400 IU/day of cholecalciferol from birth to age 2 yrs improves bone health outcomes Hypothesis – Compared to placebo, vitamin D supplementation from birth to age 2 years improves whole body bone mineral content at age 2 and 4 years. Significance – Irrespective of its outcome, this study is critical to our ability to make evidence-based decisions around vitamin D supplementation programs in infancy. If our hypothesis is supported, it has the potential to reduce childhood fracture risk by ~50% with a 5% increase in bone mineral density and to delay the onset of osteoporosis in later life by as much as 13 years with a 10% increase in peak bone mass.