ANZCTR search results

The purpose of this study is to determine if nutrients that have been shown to improve blood flow and increase circulating insulin-like growth factor 1 concentrations in the blood can improve both blood flow in the ovary and elevate the concentration of insulin-like growth factor 1 in the follicular fluid surrounding the eggs. The ability to increase the concentration of IGF-1 in follicular fluid surrounding the eggs in the ovary in this way may provide an inexpensive and simple alternative to growth hormone treatment for improving egg quality in patients undergoing IVF treatment.

To determine whether a brief period of topical glucose application to the eye can transiently elevate the vitreous glucose concentration. This is a pilot study designed to provide motivation (or not) to proceed to further research. It would be inappropriate to proceed without a pilot study of this nature We aim to proceed to a human trial using topical glucose as a neurorecovery agent in glaucoma patients. However, before proceeding to this trial we need to establish that topical glucose can elevate the vitreous glucose concentration. This is a Phase I type study in the sense that glucose eye drops have not been previously used therapeutically and we are not assessing efficacy. But it differs from a classic Phase I study in the sense that we are not seeking to assess the dose at which the glucose becomes unacceptably toxic; however, we believe that a modified dose escalation strategy would provide the optimal safety and still provide the necessary vitreous concentration data for statistical analysis.

The introduction of induction transplant medications (i.e. given before transplantation) such as Thymoglobulin and Basiliximab has led to a major reduction in acute kidney rejection and enhanced early kidney transplant survival. Despite improvement in short-term outcomes, there has been minimal improvement in longer-term kidney transplant survival due to progressive scarring and damage of transplanted kidneys, partly attributed to the use of other transplant medications such as tacrolimus (a form of calcienurin-inhibitor). In addition, renal transplant recipients receiving marginal donor kidneys (poorer quality kidneys) have more damage/scarring and have reduced graft survival compared to standard donor kidneys. A population of circulating rare cells known as regulatory T cells, have been shown to be beneficial in kidney transplantation, possibly by reducing patients’ immune responses (therefore may reduce rejection risk) and prevent inflammation and scarring (which may improve long-term outcome of kidney transplants). Thymoglobulin and sirolimus (another type of transplant medication) have been shown independently to promote the development of regulatory T cells and may possibly prevent scarring in the transplanted kidney. However, the combination of thymoglobulin with sirolimus on transplant outcomes have not been evaluated. The aims of this study will be to compare recipients of donation after cardiac death donor kidneys receiving Thymoglobulin compared to basiliximab induction with low-dose tacrolimus, mycophenolic acid and steroids (other transplant medications) for at least months, changing to sirolimus in appropriate recipients up to 12 months post-transplant. The following outcomes will be assessed: proportion of circulating regulatory T cells, transplant kidney injury and scarring, metabolic and inflammatory outcomes as well as efficacy and tolerability between the two treatment groups.

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.