ANZCTR search results

This trial seeks to determine if one of 2 currently used treatment regimens for chronic antibody mediated rejection of the renal allograft is superior to the other in terms of preventing chronic damage. The 2 arms include conversion to tacrolimus, mycophenolate and oral prednisolone with pulse methylprednisolone. Arm one has the addition of 3x monthly doses of IVIg. A second round of therapy will be offered if at 3 months a renal biopsy shows ongoing rejection. Chronic damage will be assessed by chronic allograft damage index scores at 12 months.

We aim to investigate the efficacy and cost-efficacy of dietary improvement in the treatment of Major Depressive Episodes (MDE) using a randomised controlled trial.

This study is a 6 months intervention using a mobile devices to collect food intake data, provide dietary feedback and ongoing tailored nutrition messages to promote dietary change in young adults aged 18 to 30 years.

This study aims to investigate the efficacy of naturally occurring edible compounds, that effect (block or activate) ion channels on nerves and some cells involved in inflammation, used topically to reduce the symptoms of chronic eczema. The eczema study will investigate patients with Dermatologist or Allergist diagnosed eczema who have significantly impaired quality of life and frequent need for moisturising creams and topical steroids. A randomized, controlled, crossover clinical trial will be undertaken with 2 sequential arms of treatment, 13 weeks duration each, and a 2 week washout period between each arm. One of the treatment arms will be active and one will be placebo. Patients will have a SCORAD completed at weeks 0 and 13 of each treatment arm with weekly PO-SCORAD measurements for self completion in between. Use of steroid cream, number of infected eczema episodes and quality of life measures will also be recorded. Patients will be recruited through specialist allergist and dermatology rooms.

Eye Movement Desensitization and Reprocessing (EMDR) is a well-established first line psychological treatment for post-traumatic stress disorder. In the addictions field, it has been suggested that clients presenting with addictions have a concomitant history of trauma, and comorbidity rates of up to 75%. However, few studies to date have documented the use of EMDR in this area, and its efficacy as a treatment for addictions remains unclear and less well established in the literature. In the utility of EMDR for the treatment of alcohol dependency, the limited research available has suggested promising results in reducing craving for alcohol. The experience of craving for substances has been suggested by researchers to be one of the factors maintaining alcohol/drug use, as well as a precipitating factor for relapse. Implications for establishing the efficacy of EMDR in addiction treatment therefore includes the potential to improve existing relapse prevention programs, and consequently to reduce relapse rates. The current study aims to examine and evaluate the application of EMDR in the treatment of individuals with substance dependence. Specifically, the efficacy of an EMDR treatment that targets the experience of craving for substances will be investigated. Research questions for the study are as follows: 1. Is the application of EMDR in targeting craving effective as an adjunct to treatment for substance dependent individuals? 2. How does adding EMDR to a standardized treatment program for substance dependence compare to the: (a) addition of an active relapse prevention program (Mindfulness-based relapse prevention, MBRP)? and (b) addition of a program unassociated with craving and relapse prevention (cognitive rehabilitation)?

Obstructive Sleep Apnoea (OSA) affects approximately 4% (3% to 8%) of men and 2% of women in the general population, although among the obese population the prevalence is significantly higher. It is now fairly well accepted that OSA is independently associated with hypertension, and cardiovascular disease. More recently a number of studies have demonstrated an association between OSA and type 2 diabetes mellitus (T2D), insulin resistance, glucose intolerance and dyslipidemia. Indeed there is a growing body of research that suggests OSA is independently associated with insulin resistance and T2D. Furthermore, increasing insulin resistance has been correlated with increasing severity of OSA. A number of studies have examined the prevalence of OSA among people with T2D. These studies have demonstrated the prevalence of OSA could be as high as 30%, which is well above the estimated prevalence of 2–8 % in the general population. The GLYCOSA study is currently determining the direct effects of 6 months treatment with Constant Positive Airway Pressure (CPAP) on glycaemic control and other cardiometabolic factors in patients with T2D and OSA. In this study, participants with T2D were randomised into either a treatment (CPAP and lifestyle advice) group or a control (lifestyle advice only) group. Microchip downloadable S8 Autoset Spirit CPAP machines (ResMed) were used. This machine allows recording of CPAP use for at least 3 consecutive months based on time the mask is actually applied to a subject’s face (not machine run time). Data collection by the machine is not influenced by the type of mask used by the subject, provided leakage in the system is not excessively high. All subjects were counselled regarding adopting a healthy lifestyle and advised on the Heart Foundation nutrition and exercise recommendations. At the end of the 6 months, participants in the no treatment arm were offered CPAP treatment and this was done as per usual care clinical scenario. Longer term follow-up of the participants would be valuable for several reasons. First, a number of trials in diabetes in recent years have shown that the benefits of the intervention only become fully manifest with further follow-up after the trial end, despite discontinuation of the randomised allocations. Thus, benefits not apparent at trial end may be present at a later follow-up. Second, since many of the GLYCOSA participants were asymptomatic, compliance with CPAP was difficult during the randomised phase; longer term follow-up will provide an opportunity to assess compliance outside the rigours of an on-going trial. It will also allow a determination of whether any benefits seen at the 6-month trial end are sustained over a longer period. Third, CPAP was offered to participants in the control (lifestyle) arm at the end of the 6-month trial. This was done in a non-trial setting, and a comparison of compliance with, and effects of, CPAP between the two groups will provide insights into the benefits of the more intensive CPAP support provided during the trial for the CPAP group compared to the less intensive non-trial CPAP support given to the control group. The GLYCOSA has just completed all study visits and it is timely to conduct a follow-up of participants to determine the long-term impact of CPAP treatment on glycaemic control, cardiovascular outcomes and improvement in quality of life.

The purpose of the study is to assist surgeons in aligning the acetabular cup in the acetabulum. By having a better alignment there is a potential for a reduction in post operative complications such as hip dislocation, and loosening of the prosthesis. The study hopes to show that by using the navigation device, surgeons are able to align the device with more accuracy than by using standard operative techniques.

Chronic heart failure (CHF) is a major health burden in Australia, with an estimated 300,000 patients affected. Our goal is to optimise approaches aimed at enhancing exercise capacity in these patients, which will directly translate to improved prognosis and morbidity in advanced CHF. Our aims will be achieved by bringing together novel biomechanical and physiological approaches that have not previously been applied in the context of CHF in testing the following hypotheses: 1) The mechanical work capacity of skeletal muscle will be significantly lower in CHF patients, compared to age-matched controls. This will be linked to sub-optimal in vivo mechanical properties of the muscle. 2) Eccentric exercise training (EET) will significantly increase a) the mechanical work capacity of the skeletal muscle and b) exercise capacity in CHF, relative to the impact of conventional exercise training approaches. Significance: Exercise intolerance is a cardinal symptom of CHF and is associated with poor prognosis.The locus of physical limitations in CHF is typically in the periphery (skeletal muscle). However, traditional approaches to exercise rehabilitation in CHF have borrowed from ideas that work in healthy populations, in whom the limitations to performance differ from those relevant to CHF. Surprisingly, no studies have investigated the relevance of in vivo skeletal muscle mechanical characteristics in these patients. Consequently, no exercise interventions have been applied which are specifically designed to ameliorate skeletal muscle biomechanical limitations in CHF. We propose that eccentric training will significantly improve skeletal muscle mechanics and exercise capacity, compared to conventional exercise approaches. The findings from this study will help to optimise exercise prescription in CHF, directly benefiting CHF life expectancy and quality, and will encourage the widespread prescription of evidence-based exercise approaches for patients with CHF.

This study will evaluate the effect of a drug called regorafenib for treatment of advanced oesophago-gastric cancer. 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 advanced (metastatic or locally recurrent) oesophago-gastric cancer which has not responded to treatment. Trial Details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take regorafenib (Group 1) or a placebo (sham) (Group 2) tablet oncer per day on days 1-21 of each 28 day cycle. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo until after the trial is completed. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.

The purpose of the study is to help reduce the incidence of contrast induced nephropathy in patients who have impaired kidney function and required a purcutaneous coronary intervention procedure (e.g. stent) due to cardiovascular disease.