ANZCTR search results

The study aims to demonstrate that the implementation of a Minimal Intervention Dentistry approach to a group of community public dental patients (adolescents aged 11-14 years) is likely to be ‘cost-effective’ compared to ‘current practice’ in achieving positive oral health outcomes for this population group. The study targets adolescents who are assessed as being at high risk to dental caries and are currently accessing community dental clinics in Metropolitan Melbourne. Equal numbers of community dental clinics will be recruited from local government areas with low and high SEIFA indexes to join the study. The design of the Study is that of a cluster randomised control trial. Minimal Intervention Dentistry (MID) is a multi-pronged approach which comprises of a range of strategies including prevention, early intervention, non-surgical and surgical management of the condition. Minimal Intervention Dentistry is based on the premise that early carious lesions can be reversed through remineralisation and changes to diet and oral hygiene habits to arrest the progression of the disease. The primary outcomes of the study are to: Demonstrate a reduction in the number of new and progressing carious lesions amongst the participants who have undertaken this approach Demonstrate a cost effectiveness of the MID approach in this study population The study is scheduled for completion June 2015.

This cross-sectional study is the first to assess the use of rapid HIV tests in a clinical setting in New South Wales (NSW). The study will assess acceptability of the process of rapid HIV testing for gay, bisexual and other men who have sex with men (MSM) among patients and staff in public sexual health clinics in Sydney. The study will also assess barriers to HIV testing; patient flow in clinics during the study; and the performance of the rapid test compared to conventional laboratory HIV serology. The patient and staff surveys used in this study were piloted with patients and staff during development. The study aims to recruit at least 1000 MSM subjects across four sites: Sydney Sexual Health Centre, Albion Street Centre, Clinic 16 Royal North Shore Hospital and Parramatta Sexual Health Clinic. The rapid test used in the study is the Alere Determine HIV 1&2 Antigen/Antibody Combo assay which produces a result 20 minutes after the patient specimen is applied. MSM attending for screening will be identified through triage and provided with information regarding the study. Eligible MSM who consent will receive pre-test discussion and have specimens taken for sexually transmitted infection screening, rapid HIV testing and conventional HIV serology. Rapid test results are provided to subjects during their visit with counsellor support for reactive results when required. The recruitment period will be at least 12 months from October 2011.

To investigate whether splinting and activity modification can make a clinically significant change to pain levels and day-to-day function in people with this condition. As this is a pilot study, all subjects will receive the same treatment. Comparison will be pre- and post- treatment measures

Participants will be recruited from Metropolitan Melbourne, and the following regional areas of Victoria: Geelong, Bendigo, and Ballarat. This project aims to inform policy development and implementation in regards to novice driver safety, by: 1. Quantifying the effectiveness of the Driving Safety Behaviour Change Program versus Usual Practice in terms of improved outcomes, both primary and secondary (self-reported and police crashes, and reported traffic offences), within 18-months post licensing; and 2. Identifying factors (self-reported road safety behaviours) which predict optimal response to the intervention and quantifying the relationship between these factors and the treatment response.

The project will be an intervention aimed at supporting adults with a mental illness who are at risk of developing or have developed chronic physical health conditions and who are living in the community to self-manage their physical health conditions. The project will be a controlled trial consisting of two groups of 40 participants each. The intervention group will receive the Flinders Program of Chronic Condition Management (CCM). This will be achieved through the training of non-clinical support workers, including peer support workers in community organisations in Western Australia in the Flinders Program of CCM which is an evidence-based, client driven, motivational and collaborative process for planning and delivering self-management support. The control group will receive health promotional materials. The project will run for 3 years.

The aim of this project is to identify key differences in cellular pathways involved in energy metabolism at rest and following an acute bout of exercise between healthy overweight and obese and lean individuals. Forty age-matched and fitness-matched (20 lean, 20 overweight and/or obese) healthy males and females between the ages of 20 and 50 years will be recruited. Participants will perform a buccal swab and donate a venous blood sample to obtain a genetic and metabolic signature profile at rest. Participants will perform a low (40% VO2peak-LO) and high-intensity (80% VO2peak-HI) exercise bout for approximately 70 and 38 minutes, respectively, separated by 2 weeks. A DEXA scan will be performed prior to the first exercise test. Venous blood will be sampled prior to, immediately after, 15 minutes, and 3 hours following completion of the exercise. Muscle biopsies will be sampled prior to, 15 minutes and 3 hours following completion of the exercise. Urine samples will be collected prior to, 90 minutes and 3 hours following the completion of the exercise. This proposed project will allow parallel measurement of metabolism in response to exercise intensity and to be mapped against variations in genetic disposition. This will help identify and contextualize biomarkers of metabolic flexibility or inflexibility in healthy overweight and obese individuals. These biomarkers can then be used as targets for exercise, nutrition and pharmacological interventions.

Severe sepsis accounts for significant morbidity and mortality in the community and is a large contributor to healthcare costs. The hallmark of severe sepsis is organ failure or shock. Patients with community acquired sepsis are initially assessed in the Emergency Department (ED). The signs of early organ dysfunction or shock may not be present when the patient is seen in in the ED, leading to delayed treatment and increased costs. This study will investigate a new technique to measure tissue oxygenation (StO2) non-invasively called near-infrared spectroscopy (NIRS) using a commercially available device. StO2 is a measure of impaired circulation and may be an early indicator of developing shock. We will measure StO2 in the ED in patients who are being admitted to hospital with sepsis. The study hypothesis is that StO2 is associated with organ failure and so can be used to identify patients at risk in this setting. We aim to recruit 300 patients presenting to two metropolitan Emergency departments in Western Australia during this study. This study is investigator initiated and has been designed and funded independently from the manufacturer of the NIRS device or any other industry sponsor.

In a pre-clinical study we examined the effect of oral fenofibrate added to drinking water (approximate dose based on average drinking rates 100mg/kg/d) over a 4 week period on aortic dilatation induced by angiotensin II infusion in apolipoprotein e deficient mice [1]. This model is currently the most commonly used animal model of AAA and has a number of pathological similarities to the human condition but like all animal models of complex diseases cannot be considered to be completely comparable [2]. These studies demonstrated that: a) Fenofibrate inhibited aortic dilatation: mean suprarenal aortic diameters were 1.51+/-0.13 and 2.10+/-0.14mm in fenofibrate treated and control mice, respectively, n=27, P=0.001; b) Fenofibrate reduced aortic concentration of osteopontin (OPN): median suprarenal aortic OPN concentrations were 126 and 3198 pg/mg protein in fenofibrate treated and control mice, respectively, n=15, P=0.006; c) Fenofibrate reduced aortic infiltration by macrophages: median suprarenal aortic CD68 staining areas were 4% (interquartile range 2.5-3.9) and 13% (interquartile range 8.4-20.0) in fenofibrate treated and control mice, respectively, n=10, P<0.01. We have previously shown that OPN is upregulated in human AAA [3] and marked macrophage infiltration is a consistent feature of human AAA [4]. OPN is a known macrophage chemokine and thus aortic OPN would be expected to promote macrophage influx to the aorta. The ability of fenofibrate to downregulate OPN may be critical in reducing macrophage infiltration (and associated release of proteolytic enzymes) and limiting AAA expansion. Within the mice model the downregulation of OPN and inflammation appeared to occur rapidly. Fenofibrate also raises HDL in some human subjects and high HDL has been associated with protection from AAA [5]. The effect of fenofibrate in the mouse model cannot be explained by HDL mechanisms however since this medication does not increase HDL in apolipoprotein e deficient mice [6]. In humans therefore it is postulated that a short cause of fenofibrate will inhibit AAA OPN expression, associated macrophage based inflammation and possibly also induce other beneficial effects by raising HDL. FAME is a multi-centre, randomised, double-blind, placebo-controlled clinical trial. Participants will be randomised to receive fenofibrate (145mg once a day for 4+/-2 weeks) or placebo (once a day for 4+/-2 weeks), in a parallel group, double blind design. Randomisation lists will be generated by a statistician and provided to the study centres ensuring both Investigators and participants are blinded to drug assignment. REFERENCES 1.Moran CS, McCann M, Karan M, Norman P, Ketheesan N, Golledge J. Association of osteoprotegerin with human abdominal aortic aneurysm progression.Circulation. 2005;111:3119-25. 2. Golledge J, Clancy P, Jamrozik K, Norman PE. Obesity, adipokines, and abdominal aortic aneurysm: Health in Men study. Circulation. 2007;116:2275-9. 3. Golledge J, Muller R, Clancy P, McCann M, Norman PE. Evaluation of the diagnostic and prognostic value of plasma D-dimer for abdominal aortic aneurysm. Eur Heart J. 2010 Jun 8. 4. Golledge J, van Bockxmeer F, Jamrozik K, McCann M, Norman PE. Association between serum lipoproteins and abdominal aortic aneurysm. Am J Cardiol. 2010;105:1480-4. 5. Golledge J, Muller J, Daugherty A, Norman P. Abdominal aortic aneurysm: pathogenesis and implications for management. Arterioscler Thromb Vasc Biol. 2006;26:2605-13. 6. Golledge J, Cullen B, Rush C, Moran CS, Secomb E, Wood F, Daugherty A, Campbell JH, Norman PE. Peroxisome proliferator-activated receptor ligands reduce aortic dilatation in a mouse model of aortic aneurysm. Atherosclerosis. 2010;210:51-6.

Oocyte activation is characterised by a dramatic increase in intracellular calcium concentration followed by short high frequency calcium oscillations. This is triggered when the spermatozoa penetrates the egg. Without this calcium influx the oocyte will fail to fertilise. Many studies have shown that the fertilsation rate can be improved as well as embryo development and consequent implantation rates, by mimicking the physiological cell-signalling mechanism using an activation agent such as a calcium ionophore. We wish to use a commercially avaliable calcium ionophore, GM508 Cult-Active, supplied by Gynemed Germany to study this effect on our patients who have undergone a complete failed fertilization cycle or a reduced fertilzation cycle (< 50% of oocytes injected) or where severe male factor infertility is evident.

Atrial fibrillation (AF) is a disorganised abnormal heart rhythm which causes the heart to beat in an irregular fashion. Current curative ablation methods are based on targeted circles of burns around the openings of the pulmonary veins which are connected to the left atrium (or “top chamber”) of the heart. We call this part of the procedure pulmonary vein isolation. In some patients, pulmonary vein isolation alone is not enough to cure their AF. In this case, the conventional strategy is to apply additional burns in special sites in the atrium with irregular local electrical signals. These areas are called complex fractionated atrial electrogram sites (or CFAE, pronounced like ‘café’). We believe, however, that other areas that may be selected with novel computational algorithms may be important to sustaining AF in many patients. The aim of this project is to examine whether burns targeting these sites in the atrium will improve control of AF, and improve cure rates for ablation.