ANZCTR search results

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.

Osteopenia and osteoporosis is characterised by low bone mineral density (BMD) and associated with increased fracture risk in older adults. OsteoStrong® provides high-intensity progressive resistance training in a supervised setting, which may improve bone health in older adults with poor bone health. This pilot cohort study will primarily investigate the feasibility and safety of a 8-month exercise intervention undertaken by OsteoStrong® in 44 post-menopausal women with low BMD. The study will also determine if this intervention will result in significant improvements in BMD, bone quality, muscle composition and physical function.

The aim of the study is to evaluate whether an internationally recognised group program, Acceptance and Commitment Therapy (ACT) for Recovery from Psychosis, when delivered in routine practice by trained local clinicians, is effective in helping personal recovery for consumers living with psychotic disorders. The group program consists of 7 weekly sessions and one follow-up/booster session, each of 90 minutes duration. Participation in the evaluation is open to consumers who attend a group program as part of their routine clinical care at participating mental health services in Melbourne, Australia. We expect that participants’ personal recovery will stay the same while they wait for the group to start, then their personal recovery will improve from the start to the end of the group and then it will stay about the same after the group ends.