ANZCTR search results

To assess visual performance of prototype soft contact lens designs compared to commercially available contact lenses.

The proposed study is a single-blind, randomised controlled trial (RCT) comparing two forms of early intervention for psychosis. The proposed interventions are the current model of early intervention for psychosis (i.e., 18 months to 2 years of specialised treatment followed by discharge to standard treatment; FU-ST), and FU-ST in conjunction with a world-first online psychosocial intervention (Horyzons). Patients with first episode psychosis (FEP) will be randomised from between 3 months prior to discharge and discharge from specialised treatment to receive either i) FU-ST, or ii) FU-ST+ Horyzons, for 18 months. The primary hypothesis is that FU-ST+Horyzons participants will show better outcomes than FU-ST participants on social functioning at 18 months follow-up. The secondary hypotheses are that FU-ST+Horyzons participants will show improved outcomes compared with FU-ST on the secondary outcomes of: i) relapse rates; ii) depression; iii) psychological wellbeing, iii) anxiety, iv) social support and social isolation; v) quality of life; vi) satisfaction with life; vii) self-esteem; viii) empowerment; ix) physical health; xi) vocational status; and xii) substance use, over 18 months follow-up. Finally, FU-ST+Horyzons will be more cost-effective than FU-ST at 18 months follow-up. This will be the first study to examine whether an innovative online intervention is an effective strategy for maintaining the clinical benefits beyond discharge of early intervention in first episode psychosis.

This is a single-site, double-blind, randomised, clinical trial of 16 weeks duration and utilising active and placebo arms with baseline data collection. The study aims to: Assess the effectiveness of orally dosed supplement Skin Accumax on treatment of persistent acne grade II and lll in men and women aged 16 to 35, over 16 weeks. Assess quality of life and self-esteem before and after treatment. Evaluate dietary influences on acne through dietary survey. Evaluate safety and tolerability over 16 weeks. Provide information that will be required by Therapeutic Goods Administration (TGA) and international regulatory bodies to support product tolerability and therapeutic claims.

Narrowing or occlusion of the arteries of the lower limb, caused by atherosclerotic lesions, can lead to leg pain, ulceration and ultimately amputation. Endovascular revascularisation is a procedure in which the artery opened through the use of balloons or stents inserted under the guidance of a special x-ray technique called angiography. These procedures have a high rate of failure with about half developing a >/=50% narrowing (or restenosis) within a year. Much of this failure rate is attributed to technical factors such as incorrect size of catheter or incorrect positioning and in part may relate to the limited view provided by angiography. Intravascular ultrasound (IVUS) is an alternative imaging method that provides a more complete view of the artery. It has been shown that IVUS adds more information when combined with angiography but it is unclear whether this results in changes to treatment and whether this then results in better outcomes for patients. This aim of this study is to investigate whether the addition of IVUS improves the outcomes for endovascular revascularisation. This is a randomised control trial comparing endovascular revascularisation procedures guided by angiography with procedures guided by both angiography and IVUS. The study sample of 150 patients will be recruited from patients requiring treatment of lesions in the superficial femoral or popliteal arteries. Patients will be randomised into two groups of equal size; a control group having angiography guidance only and a second group having both angiography and IVUS guidance. All patients will have non-invasive tests of endothelial function (tests of the functioning the inner surface of the artery – an essential component in maintaining vascular wellbeing) before their and after the procedure as well as the standard blood tests and regular surveillance imaging that is normally scheduled for patients after these procedures. The primary outcome measure will be >/=50% restenosis of the treated artery. This degree of restenosis requires re-intervention to reopen the artery. At this point the original procedure will be deemed to have failed for the purposes of analysis. The restenosis rate will be compared for each group.

The aim of this study is to determine the effectiveness of Smartphone application technology as a brief primary care intervention to increase sustained physical activity levels and decrease the risk of developing type 2 diabetes. 30 participants over the age of 35 who are at high risk of developing diabetes will be selected. Participants diabetes risk will be calculated using the AusDrisk tool. The participants will be divided into two randomised groups. The active intervention group will be introduced to the Smartphone application while the Control intervention group will not. The participants weight, height, waist circumference, blood pressure and AusDrisk score will be measured in both groups at weeks 12, 26, 38 and 50. The anticipated outcome for the project is a measurable increase in the physical activity and decease in AusDrisk score in the active intervention group compared to the control intervention group.

Warming up is considered an integral part of pre-performance preparation in sport and music, and yet little information exists on how to best prepare to play. As such, this study will investigate the effects of core muscle, general cardiovascular, and on-instrument warm-ups on upper extremity and core muscle activity during violin performance. Additionally, the effects of the three warm-ups on participant audible performance quality will be analysed. It is predicted that both the use of warm-up and the mode undertaken will have a variable positive effect on muscle activity and sound quality.

The major mechanism of action of GLP-1 agonists in lowering post-prandial glycaemia is their ability to slow gastric emptying. Acute hyperglycaemia itself is known to slow gastric emptying substantially and it is likely that many patients will be hyperglycaemic at the time of GLP-1 administration. If GLP-1 does not further slow gastric emptying during marked hyperglycaemia then it is likely the agonists will have only a minimal effect to attenuate postprandial glycaemia. The latter observation would support a rationale to reserve GLP-1 agonists until fasting glycaemia is reduced, eg. by initial insulin therapy, whereas if the hypothesis is rejected then GLP-1 agonists would be a rational choice as single agents even in patients with marked fasting hyperglycaemia. Accordingly, it is important to determine whether hyperglycaemia per se affects the capacity for GLP-1 to slow gastric emptying.

The purpose of this study is to determine the optimum dose of exogenous glucagon-like peptide-1 (GLP-1) with stepped administration; and evaluate the effects of GLP-1 on gastric emptying, mesenteric blood flow and glucose metabolism when compared to exogenous insulin.

Few patients admitted to the intensive care unit (ICU) have a previous record of directly measured BP during nighttime or resting (hereto referred as basal) state. Therefore, the usual hemodynamic targets in ICU are broadly based on values relevant to the general population. Individualising these targets could vastly improve management of critically ill patients. A validated protocol to estimate a patient’s baseline BP would enable this tailored therapy for the patients. The main purpose of this study is to assess the agreement (or the difference) between a protocol-estimated value and a directly measured value for the resting BP in a cohort of patients who recently underwent direct measurements of their resting arterial BP. In this study, we hypothesise that the directly measured and protocol-estimated BP values will correlate well with minimal bias.

Few studies have investigated how to improve parents' understanding of clinical trials they are asked to join or how to reduce any possible distress. The INPUT study proposed will explore the effect of positive, negative or neutral language on parents' understanding, stress and willingness to participate in clinical trials.