ANZCTR search results

Exercise therapy, in particular aerobic exercise, in the CKD population has been shown to decrease cardiovascular risk factors and subsequent CVD, however there has been little work comparing the effectiveness of different exercise prescriptions. Furthermore, patients with CKD endure significant muscle wasting which greatly impacts on their ability to complete day to day activities and their quality of life. The primary measure will be cardiorespiratory fitness, measured as maximal oxygen uptake using expired air gas analysis during an exercise stress test. Additionally, although previous studies in chronic disease populations have demonstrated exercise therapy to be effective in reducing muscle wastage, the intensity of the training required for maximum benefits is still equivocal. The effects of training intensity on muscle wasting will be assessed through whole body composition dual x-ray absorptiometry. As the mechanisms of the persistent loss of muscle mass observed in patients with CKD is poorly understood, this study also aims to investigate the effects of exercise training on pathways of muscle breakdown. To investigate the mechanisms, plasma samples will be collected and muscle biopsies will be performed before and after the training.

Implantation of the embryo remains a key rate limiting step for successful outcome in an IVF/ICSI cycle in women with subfertility. Several small and heterogeneous studies have suggested that injury to the endometrium (lining of the uterus) prior to an IVF/ICSI cycle improves the clinical pregnancy rate or live birth rate. The aim of this study is to determine whether a single endometrial biopsy prior to an IVF/ICSI cycle influences the live birth rate in women under 40 years of age who have failed to conceive a pregnancy despite having undergone at least 2 embryo transfers of reasonable quality embryos. The study will be a large, single blind, randomised controlled trial with the above aim, whilst trying to control for many of the confounders present in previous small studies.

A randomised controlled trial comparing Internet based cognitive behavioural therapy for major depressive disorder plus a cognitive bias modification intervention (OxIGen) vs. Internet based cognitive behavioural therapy for major depressive disorder vs. a waitlist control on symptoms of depression and negative interpretation bias.

This study will randomly allocate participants to either (a) Healing Program, or (b) Healing Program + Cognitive Behaviour Therapy.

Fever is common in critically ill patients. Maintaining a normal temperature (“normothermia”) in the acute phase after brain injury is considered to be the default clinical practice. This is based on theoretical rationale, data from animal studies, and, observational clinical studies. In the context of neurological injury, the febrile response may be a marker of illness severity, may potentially represent a modifiable risk factor for morbidity and mortality, or, may be linked to a protective host response to illness. We intend to test the hypothesis that early fever would have an independent association with worse outcome in the presence of neurological injury except for neurological infection. Specifically, we hypothesize that peak temperature during the first 24 hours after ICU admission would be associated with increased mortality in patients admitted with an admission diagnostic codes for stroke and TBI, but, reduced mortality, in those with neurological infections.

Pregnancy and birth directly affect almost 300,000 families in Australia each year. A key concern is that the caesarean section rate in Australia is higher than similar countries with a lack of support for women to have a vaginal birth after caesarean section. We plan to undertake a trial to determine whether midwifery continuity of care increases the rate of vaginal birth in women who have had a previous caesarean section. This trial could significantly alter the way maternity care is provided.

The project '10 Small Steps' encompasses the development and evaluation of a general practice based RCT designed to improve ten lifestyle behaviours known to be associated with chronic diseases. The low-intensity intervention involved providing computer-tailored feedback, based on a health behaviour summary score, to more than 4500 adult patients recruited through 21 general practitioners in Brisbane, Australia. Participants were followed-up at 3 and 12 months. The intervention was effective in improving the health behaviour score. These findings demonstrate the potential for a low-intensity intervention to improve the adoption and maintenance of health behaviours in a primary care population and for general practice as a conduit for the primary prevention of non-communicable diseases. Although the individual behaviour changes resulting from the intervention were relatively small the health score, 'Prudence Score', which is easy to calculate and interpret, appears to be a useful tool for promoting a population-wide primary prevention strategy.

Diabetic macular oedema (DMO) is thought to result from a series of biochemical and cellular changes, causing progressive leakage and exudation. Focal and grid photocoagulation remains the standard care for diabetic maculopathy. However, the availability of new agents raises the possibility of improvements in outcomes. Vascular endothelial growth factor (VEGF) levels have been found to be elevated in the aqueous and vitreous humour of patients with DMO.The study is designed to confirm the efficacy and safety of ranibizumab (0.3 mg), an anti-VEGF agent, as therapy in patients with visual impairment due to DMO, in whom current treatments of intravitreal injections of triamcinolone (IVTA) is no longer effective. The primary objective of this study is to determine whether ranibizumab 0.3 mg given as monthly intravitreal injections is effective in patients who meet the criteria for steroid (IVTA) resistence, defined as: - An improvement in VA of less than 5 letters - A reduction in central retinal thickness in OCT of less than 100 microns (or less than 20%, whichever is greater) 6 weeks after treatment with IVTA for at least 2 consecutive injections RESEARCH DESIGN AND METHODS We will, after investigations to exclude any other cause of visual loss, conduct an open label study to administer intravitreal injections of 0.3 mg of ranibizumab at four weekly intervals to all enrolled patients, with a minimum 4 injections planned with additional doses at the same interval if clinically indicated at the discretion of the Investigator for up to 12 months. All patients will be followed for at least 12 months.

The JMoF program aims to improve individuals’ confidence to cook, cooking skills, and potentially improve their healthy eating behaviours. This evaluation will help to understand if the JMoF program makes a difference for people who participate. What we learn from this evaluation will help to support the extension of Jamie’s Ministry of Food Program and guide any future improvements in Australia and internationally. The evaluation will add to the promising but limited evidence base regarding the effectiveness of cooking skills programs The study aims to answer two research questions about the JMoF Program: 1. Does the program increase participants’ knowledge, skills, attitudes and confidence to cook healthy meals? 2. Does the program result in broader positive outcomes for participants in terms of a healthier diet, more affordable healthy meals, improved self-esteem and social connectedness?

With the rise in overweight and obesity, the number of women developing diabetes in pregnancy increases as well. Diabetes in pregnancy is associated with complications for mother and baby during the pregnancy but also later in life with higher rates of obesity in babies whose mothers had diabetes in pregnancy and higher risks for the mother to develop type 2 diabetes. Prevention of diabetes in pregnancy is ideal. This study will investigate if probiotics are an effective method to reduce rates of diabetes in pregnancy in overweight and obese women.