ANZCTR search results

It is hypothesised that consideration of glycaemic index (GI) knowledge and the deliberate use of GI foods to modify low/high GI meals will improve post-prandial glycaemia in patients on insulin pump therapy. Aims: To investigate the effectiveness of clinical dietary advice regarding use of GI knowledge to improve PPG in pediatric patients with T1DM on insulin pump therapy; 1. To assess the clinical effectiveness of the dietary advice regarding the addition of a low GI food to a high GI meal to determine what proportion of the meal needs to contain low GI carbohydrates to improve postprandial glycaemic outcome.

This study is a multi-center, prospective, open label, feasibility study enrolling up to 30 patients. Safety and feasibility are the primary objectives based on completion of surgical implantation and analysis of reported and observed adverse events. A series of validated subject-completed questionnaires, a visual analogue scale for pain and formal orthopaedic examination, will be performed over the course of the 60 months at the following intervals: baseline, 24-48 hours post-op, 2 weeks, 6 weeks, 3 months, 6, 12, 24, 36, 48 and 60 months. X-ray and/or MRI data will be collected pre-operatively and the following post operative intervals, 2 weeks, 6 months, 12 months, 24 months and 60 months.

Fat and inflammation in the liver caused by insulin resistance and oxidative stress is termed nonalcoholic steatohepatitis (NASH). NASH is the commonest cause of hepatitis in Australia and may lead to cirrhosis, liver cancer and death. Current therapies are largely ineffective. Iron in the body has been linked to promoting insulin resistance and oxidative stress and thus represents a suitable treatment target. This proposal examines the effect of removing iron by venesection in patients with NASH compared to controls. The effect on insulin resistance, oxidative stress and liver fat, inflammation and scarring will be assessed during the trial.

Polycystic kidney disease is a common cause of kidney failure Statins may slow kidney disease progression. This study aimed to assess whether pravastatin 20mg could slow the progression of kidney disease

Study rationale: Thrombophilias are disorders that result in a predisposition to develop Venous Thromboembolic Events (VTEs). Thrombophilias are common in the general population. Recent evidence indicates that women with thrombophilia not only have an increased risk of VTEs during pregnancy, but also increased risk of pre-eclampsia, intrauterine growth restriction (IUGR), abruptio placentae and foetal loss. The management of thrombophilic women in pregnancy is controversial and antithrombotic prophylaxis may reduce the rate of complications in pregnancy and the rate of VTEs. Phase II studies with low molecular weight heparin (LMWH) in pregnant women, for a variety of indications, suggest that there may be a benefit to their use in this high-risk group. However, to date there have been no controlled clinical trials using LMWH to prevent pre-eclampsia, IUGR or foetal loss. The purpose of this study is to determine the safety and efficacy of LMWH in preventing VTE, pre-eclampsia, IUGR and foetal loss in pregnant thrombophilic women. Study design: This study is a multi-centre, open-label, randomised controlled clinical trial based in a maximum of 30 centres. Three hundred and eighty-five(385) pregnant women with confirmed thrombophilia and at high risk for pregnancy complications will be randomised to prophylactic dose dalteparin or control (identical follow-up and care, but no drug intervention). The study will consist of five periods: a screening period, randomisation, antenatal follow-up, labour and delivery, and postpartum follow-up. Maximum time on study will vary between 26 and 46 weeks. The primary objective of this study is to identify if LMWH prophylaxis in thrombophilic pregnant women results in a greater than 33% relative risk reduction in the composite outcome measure (VTE, pre-eclampsia, IUGR and foetal loss) compared to control. Secondary objectives will be to: 1. Identify if prophylactic LMWH will reduce rates of PIH, pre-term labour and abruptio placentae in pregnant thrombophilic women compared to control. 2. Determine safety of LMWH use in pregnancy (specifically rates of bleeding, thrombocytopenia and fractures). 3. Identify whether prolonged LMWH use in pregnancy results in decreased BMD compared to control

In Australia each year ten million IV drips are inserted in patients’ arms or in the backs of their hands to give fluid and medications. Many drips are routinely replaced every few days in the hope that this reduces infection, however preliminary research suggests it would be better and more cost effective to leave them alone. That would save patients the pain of another needle as well as interruption to treatment. It would save doctors and nurses time, and reduce waste from plastic disposables. The research will provide the evidence to know one way or the other whether IV drips should be routinely changed or left alone.

This three-phase interdisciplinary and collaborative project funded by the Australian Research Council. It draws together researchers from the fields of music composition and performance, sound art, emergency medicine and clinical psychology to determine the effect of sound and music on the anxiety of patients located in the Emergency department at St Vincent’s Hospital - Melbourne. Phase one of the project will involve the development of sample soundtracks and musical compositions by a PhD Candidate from the School of Art, RMIT. A total of 20 soundtracks of 60 seconds duration will be created; 10 that are electronic/acoustic and 10 that are environmentally based (e.g., rain sounds). In Phase two, 250 ED patients that consent to participate will be provided with the specially created soundwork samples to listen to using headphones. Patient impressions of and responses to the specially created soundtracks will be evaluated through a purpose designed questionnaire. This information will be considered in the development of two longer soundtracks for use in Phase 3. The soundtracks will be of 30 minutes duration. One will be electronic/acoustic and one will be environmentally based. Phase three (clinical trial) will investigate whether specific soundtracks and musical compositions decrease the anxiety of ED patients. Patients that are triaged as having a condition that is of moderate acuity (Australasian Triage Category 3) will be approached by a researcher during their ED visit for participation in the study. Consenting patients will be given two validated scales: one that rates their self-reported level of anxiety and one that assesses their level of satisfaction with emergency care received. They will then be randomly allocated to one of five groups based, one for each types of sound work to be tested. Patients in group 1 will be given no soundwork intervention. Group 2 will receive a 30 minute soundtrack of re-constructed ambient sound simulating the emergency department to listen to via headphones. Those allocated to group 3 will be given a 30 minute soundtrack of electronic/acoustic sound. Those in Group 4 will be given a 30 minute soundtrack of environmentally based sound, and those in group 5 will be given a 30 minute soundtrack that uses binaural beat (alternating frequency) which is known to induce a mild meditative state. At the conclusion of the 30 minute period, patients allocated to each of the four groups will be given the anxiety and satisfaction surveys to complete again.

Central retinal artery occlusion (CRAO) is an eye Stroke, usually caused by the blood vessel supplying the eye being blocked, resulting in the eye not working. Usually, once the eye stroke occurs, the vision in the eye is severely affected and recovery is minimal. Unfortunately, most standard treatments at the moment do not improve vision. On average, most patient are not able to see the biggest letter on the eye chart out of the affected eye after the eye stroke. Some centres overseas have looked at using the medication used in heart attack (tPA) in eye stroke using a procedure to deliver the medication to the blocked blood vessel. The results are preliminary but promising. Most of the studies delivers the drug through an invasive procedure to deliver the medication close to where the blood vessel blockage is near the eye. Another way to deliver the medication is through a drip. This is the method for treatment in acute stroke of the brain when people present within a certain time window. This study aims to see if admininstration of the medication through a drip may improve the vision in acute eye stroke yet reducing the side effects of bleeing.

Patients with ANCA (Anti-neutrophil cytoplasmic antibodies) vasculitis and healthy individuals were recruited to assess their response to influenza vaccination. It was anticipated that the the response to the vaccine by the patients would be less than the healthy control group, but still sufficient to provide protection against the influenza virus. The response of healthy individuals and those with ANCA vasculitis will be compared. Patients with ANCA vasculitis were monitored throughout the study to determine whether the influenza vaccination caused any change in their disease activity.

The VentrAssist left ventricular assist device will provide circulatory support for patients with end-satge heart failure with results comparable to other left ventricular assist devices