ANZCTR search results

The study will determine if AndroForte (R) 5 (testosterone cream) is bioequivalent to Testogel (R) 1% (testosterone gel) for the treatment of men with low testosterone levels. Participants will apply the cream or gel to their torso for 30 days during each treatment period and at the start and finish of each of the treatment periods, participants will provide blood samples at pre-determined time points for the measurement of blood testosterone levels. This study aims to establish that AndroForte (R) 5 is equally effective as Testogel (R) 1% (considered to be the standard comparator for transdermal testosterone worldwide), in increasing the testosterone levels in men with low testosterone to within the normal circulating range.

Swinburne's eTherapy Unit will run a research trial to investigate the efficacy of a fully automated self-help online mindfulness intervention, Mindfulness Online, in the promotion of wellbeing amongst 18 to 25 year old TAFE and Further Education students. Swinburne University of Technology's eTherapy Unit and National eTherapy Centre (NeTC) have developed numerous internet-based prevention and treatment programs that are available to the general public for the treatment of clinical conditions and the promotion of well being. To continue the development of effective online programs information relating to the appropriateness and efficacy of specific programs for specific user groups is required. The current project seeks to examine the efficacy of the Mindfulness Online program (developed by Dr Jo Mitchell) in its application to a group of 18 - 25 year old Australian Tertiary education students. The results of this research will inform future development and recommendation of internet based interventions for specific user groups.

The aim of this project is to see whether continuous local anaesthetic wound infiltration for 48 hours post-operatively is useful in hepatobiliary surgical procedures in terms of: 1. Better pain relief 2. Reduced opiate consumption via patient-controlled analgesia (PCA) regime 3. Reduced opiate side effects (eg. nausea and vomiting, sedation, itch) All patients enrolled would have a continuous wound infiltration catheter with a local anaesthetic pump device attached, as well as an opioid-continaing PCA machine. The contents of this pump device would be randomised to contain either local anaesthetic agent or normal saline (placebo). The wound infiltration catheter and infusion pump would remain for 48 hours post-operatively, and the PCA would remain available to each patient as long as clinically required. Each patient would be reviewed post-operatively as per our normal Acute Pain Service (APS) practice, and each patient would have regular observations performed and recorded as per normal protocol. The data collected from each patient would include total opioid requirement via PCA, visual analogue scale (VAS) pain scores both at rest and with movement, and any side effects possibly related to local anaesthetic agents or infusion pump catheters.

Hepatitis C is one of the major global causes of chronic hepatic infections, particularly in third world countries, and is associated with a significant rate of cirrhosis and hepatoma. In Australia and the United States of America, the burden of disease is significant. Unfortunately, the incidence and associated sequelae have been predicted to increase in the coming decades. Consequently, a large and growing number of patients will undergo treatment for hepatitis C. Of those receiving combination treatment with interferon (IFN)-a and ribavirin (RBV), approximately 5-10% will develop thyroid-related complications. Whilst there are a number of favourable factors in the prediction of favourable hepatic outcome such as genotype, ethnicity, and early viral load reduction, there are few published reports that assess the development of thyroid disease (TD) in relation to sustained virological response (SVR). Our previous meta-analysis did not find any difference, although this may be due to inherent differences in the published reports. The aim of this report is to investigate the hypothesis that the development of thyroid disease in patients treated for HCV is associated with a significantly increased likelihood of attaining SVR.

The nul hypothesis for the study is that there will be no significant difference in the clinical outcomes of cognitive and behavioural therapy approaches to the treatment of pathological gambling (gambling addiction). Some cost or time efficienciies may emerge from this detailed study fo the outcomes of these two approaches to therapy.

This study aims to identify the effect of physical activity on health indicators including circulating cortisol levels, anthropometric measures and psychological distress.

Patients with low back pain who fulfil the diagnostic criteria for deficient load transfer through the sacro-iliac joint (SIJ) (Hungerford et al, 2004; Mens et al, 2001) (sacro-iliac joint dysfunction) and who do not respond to exercise therapy have deficient ligamentous function. 1. The primary hypothesis of this study is that the injection of 20% Glucose solution into the posterior ligaments of the SIJ will stimulate the formation of new collagen and increase ligament strength. Tis will be measured by improvement in the following tests: a) Stork test (Hungerford et al Spine 2004), b) Active straight leg raise (ASLR) (Mens et al, 2001 and 2002) , c) Posterior pelvic pain provocation test (PPPP) (Ostgaard et al, 1994, Vleeming et al, 2002) d) Palpation of the long dorsal sacro-iliac ligament (Vleeming at al, 1996) 2. The secondary hypothesis is that the improvement in the ligament function will lead to a decrease in symptoms and an improvement in quality of life measured by a) Quebec Back Pain Disability Scale (Kopek et al, 1995) and b) Patient Generated Index Questionnaire (PGI) Ruta at al, 1994 Both have been used previously in back pain studies. The aim of the study is to compare by randomised trial wether CT guided injection of 20% glucose solution into the ligaments of the sacroiliac joint as compared to a sham injection control results in a) A negative Stork test b) A negative ASLR test c) A negative PPPP test d) A lower Quebec score e) Improvement in the PGI, as measured three months after the intervention

One of the most visible signs of ageing is the loss of muscle mass. This loss of muscle mass has subtle, yet significant, impacts on the health of an individual. Muscle provides the necessary tissue for physical activity, therefore a loss of muscle reduces physical capacity. With time, the loss of muscle mass, strength and coordination increases the risks of falls. NatraGuard consists of proteins isolated from cow’s milk. Studies have been performed on muscle cells in the laboratory and in mouse models that demonstrate NatraGuard stimulates muscle cell growth and therefore may contribute to muscle strength. The aim of this project is to determine, in participants undertaking aerobic and resistance training, the dose(s) of a dairy protein extract (NatraGuard) that produce improvement in muscle strength. This new knowledge will be used to design future research studies.

Malnutrition, especially unintentional weight loss, is a known issue in Parkinson's disease. Malnutrition is associated with a number of adverse outcomes including decreased physical function, higher mortality, impaired immunity, longer hospital stays and decreased quality of life. People with Parkinson's disease are at a higher risk of malnutrition due to the motor and non-motor symptoms associated with the disease as well as the side effects of anti-parkinsonian medication. To date, an intervention to address malnutrition in this population has not been conducted.

The relationship between periodontal disease and cardiovascular surrogate endpoints, both of which are high among the Indigenous Australian population, is established. This study seeks to explore the prevalence of cardiovascular surrogate endpoints among this population with periodontal disease, and to determine if implementation of a periodontal intervention leads to improved cardiovascular risk outcomes. There may be benefit in applying this model to other areas of Indigenous health research.