ANZCTR search results

This study will investigate a new drug, sodium selenate, for the treatment of behavioural variant frontotemporal dementia (bvFTD). Up to 120 patients with bvFTD will be recruited in to the study. Half of the patients will receive 52 weeks of treatment with sodium selenate (15 mg three times a day), and the other half a placebo (a sugar pill). The main outcome of the study will be the change in brain volume over 52 weeks, comparing the treatment group to the placebo group. Additional outcomes will look at the overall safety and tolerability of the treatment, the levels of tau (a protein involved in the development of bvFTD) in the cerebrospinal fluid, the rate of cognitive decline and changes in behavioural symptoms observed in patients over the 52 weeks of treatment.

The purpose of this study is to see if the medication ixekizumab might be used to treat underlying inflammation associated with chronic venous ulcers. The study is for anyone with a chronic venous ulcer that has failed to respond to standard therapy (compression bandaging for four consecutive weeks). 28 patients are required for this trial. 14 patients will receive the treatment medication and 14 will receive the placebo medication. Neither the patients nor the staff will know who is receiving which medication. You will receive injections fortnightly for 12 weeks including continuing with the dressings and compression bandaging that you were being treated with prior to the trial. After the 12 weeks it is hoped that this medication Ixekizumab will have added in a significant reduction in the wound size.

The study is investigating the safety, tolerability and pharmacokinetics of multiple ascending doses of the already approved drug Zolmitriptan in 48 adult healthy volunteer subjects, for the potential treatment of people with Austism spectrum disorders.

Atrial fibrillation (AF) is a heart-beat irregularity that is often asymptomatic to patients and increases the risk of stroke. This project will develop and test an automated ECG self-screening station that will be put in GP waiting rooms to detect AF among patients 65 years of age and older. Patient self-screening will be integrated within the workflow and software of GP practices. We propose that this intervention could become the mechanism for widespread implementation of the new Australian and international AF screening and management guidelines, and thereby contribute to the greater prevention of avoidable strokes in Australia.

The underlying principle of trials evaluating the effectiveness of pharmacological treatments is to compare a drug against a placebo. The difference in effectiveness is then attributed to the active ingredient of the drug. Typically, placebos are designed to resemble the drug as much as possible, but conventional placebos that only contain lactose fibres (or other inert substances) do not elicit side effects and therefore do not fully resemble all features of the drug. We therefore developed and evaluated an active placebo that elicits side effects but has no other effects on sleep. Prior research has shown that perceived treatment allocation and beliefs about side effects can influence an intervention’s effectiveness. We therefore want to further understand the role of participants beliefs about side effects. The main aim of this study is therefore to test whether framing participants beliefs about side effects influences the efficacy and tolerability of an active placebo. We hypothesise that participants receiving positive framing will demonstrate a larger placebo effect for sleep than a no-framing condition, and that a negative framing condition will show the smallest placebo effect.

Health information is easily accessible through the media and internet, and therefore people are more actively involved in the management of their own health. However, much of the available health information is of variable quality, and basing health decisions on unreliable information can be harmful to the person and a waste of healthcare services. In this cluster randomised controlled trial, we aim to recruit approximately 12 schools. We will assess a brief educational intervention (approximately 4 hours in duration), specifically designed for this study, to teach Australian high school students in grades 7-9 (ages approximately 12-15 years) to be able to identify and evaluate claims about health interventions. This intervention aims to enhance students “critical thinking” skills about health information, which requires specific education. The effect of this intervention on knowledge/understanding and skills will be assessed in a randomised comparison against no exposure to the intervention. It is anticipated that the intervention group students' ability to identify and analyse health claims will improve.

Purpose: The most recent national antibiotic recommendations for moderate DFI is to treat with IV Amoxicillin/Clavulanate (AUG). Previous guidelines recommended Piperacillin/tazobactam (PTZ) but was changed to the current recommendation based on largely expert opinion and anecdotal evidence. Study hypothesis: AUG is non-inferior to PTZ in adults in empiric treatment of moderate DFI and can therefore be safely used as first line empiric therapy Intervention: Participants will be randomised to receive either intravenous PTZ or intravenous AUG for at least 48hrs and ending at the direction of the treating clinician.

The primary aim of this pilot study is to determine the feasibility of an anti-inflammatory diet on clinical features of knee osteoarthritis. All participants will be enrolled into the intervention group and receive specific dietary advice on an anti-inflammatory diet. . Over the course of the 9 week study period, participants will undertake: 3-day food diaries at regular time intervals, as well as completing surveys regarding their knee pain, function and quality of life. Our hypothesis states that post 9-week dietary intervention, participants will have a clinically meaningful difference in clinical features of osteoarthritis compared to the control arm.

Abnormal donor site colour causes much distress to children and their families and remains a difficult problem for clinicians to treat. In children receiving a skin graft to treat a burn injury, the donor site is a source of pain, itch and at risk of scarring. The current the donor site dressings mainly enable faster wound healing. None of the dressings address the colour restoration in donor sites. The Regenerative Epithelial Suspension (RES™) prepared using the RECELL® Autologous Cell Harvesting (ACH) device has been in clinical use for over a decade. Once prepared a mixture of epithelial cells is applied to the wound. There are few studies that evaluate donor site wound management in children with RES™. Recently, in a study comparing RES™ with skin grafts (control group), wounds treated with RES™ had comparable healing, with significantly smaller donor site, less pain and better appearance relative to the control group. The RECELL® ACH device is easy to use, requires smaller donor skin sample, fewer dressing changes, lower pain scores and as such, may incur less cost in the overall burn wound treatment. Delayed wound healing is associated with higher scarring risk in children. Graft loss results in delayed healing. Current standard practice at the study site includes the topical application of ARTISS® (biological product that acts as an adhesive agent) onto the recipient site before skin graft. The fibrin facilitates adhesion of the sheet graft to the recipient site. The combination of RES™ with skin graft was reported as both effective and safe in adult studies. However, the effect of RES™ on the skin graft, recipient site graft takes and colour in children has not been assessed in the published literature. This study aims to evaluate the efficacy of a RES™ on donor site colour at 12 months after skin graft and recipient site graft take in children.

The RBI represents a new concept in dental implant design. The specific needs addressed by this novel dental implant are: (i) maximal utilisation of the remaining bone volume; (ii) minimisation of risk to the Inferior Alveolar Nerve (IAN) or other vital structures in or near the oral cavity; and (iii) maximisation of force distribution. It is aimed at providing a specialized dental implant fixture for complex clinical cases with minimal chairside time and surgery.