ANZCTR search results

The primary purpose of this study on healthy volunteers is to determine the safety and tolerability of multiple doses of oral AD-6626 in normal healthy volunteers

This will be a 12 week, 2x2 factorial randomised controlled trial of the effect of testosterone treatment, with and without exercise training, on cardiorespiratory fitness, physical activity levels and vascular health and physiology (validated markers of cardiovascular risk) in men aged 50-70 years who have waist circumference 95 cm or more. The hypothesis is that 12 weeks of testosterone plus exercise training will produce additive beneficial effects on fitness, physical activity and measures of vascular physiology, compared to either intervention alone, or placebo. These results would inform the debate over the risks and benefits of testosterone therapy in men.

Cystic fibrosis (CF) is the most common Caucasian genetic disease and has a reduced life expectancy of approximately 40 years of age. The decline in lung function in CF is accelerated by exacerbations. Severe exacerbations require treatment with intravenous antibiotics (IVABs), but of concern many do not regain the lung function they have lost following treatment. One of the major factors in this failure to regain lung function is the delay in time it takes for the individual with CF to present to the CF centre to report symptoms and commence treatment. In collaboration with Curtin University and the Burke Rehabilitation and Research Institute in New York, USA, we have developed a smartphone application that can be used by participants to report their symptoms to the CF team at Sir Charles Gairdner Hospital on a weekly basis or sooner if they feel they need to. We will now aim to complete a 12 month randomised controlled trial in 60 participants, investigating the impact of using this smartphone application on the number of exacerbations requiring IVABs per participant, as well as other health outcomes and measures of healthcare utilisation.

Background Postoperative delayed wound healing impacts on patient wellbeing and return to normal life and can result in intrinsic and extrinsic complications. Unilateral mastectomy impacts on patient healing as well as body image perspective and is further complicated by the diagnosis of cancer. Aim of the study The purpose of the study is to determine the effectiveness of negative pressure wound therapy on seroma formation following unilateral mastectomy. Who is it for? The study is for females about to undergo an elective unilateral mastectomy that consent to be in the study. Study participants are randomly allocated (by chance) to one of two groups. Participants in one group will receive a negative pressure dressing applied to their wound for 7 days, whilst participants in the other group will receive a standard surgical dressing. Patients will be followed-up for up to 30 days postoperatively to determine seroma formation during the post operative period.

Attention modification training refers to training participants to attend away from emotionally relevant information. In the pain literature, ABM has been shown to improve pain outcomes. However, all research has used the dot-probe paradigm, the reliability of which has been questioned. This project aims to trial a novel ABM procedure using painful faces.

This study will investigate the effect of modifying interpretations of ambiguous faces on performance of a painful task. Specifically, we will compare how effective training participants to interpret an ambiguous facial expression as happy compared to painful. We are interested to know whether this training is more effective when instructions are explicit versus implicit.

With the tight work schedules of the dental workers, we propose that small daily doses of neck/shoulder specific exercise is an optimal approach to minimise the risk of neck/shoulder pain for these workers. This project will test the feasibility and benefits of a 10-week workplace-based exercise intervention in a population of dental health students in their clinical environment.

A primary objective of orthodontic treatment is to achieve a functional and aesthetic outcome efficiently and with minimum root resorption. Preliminary research has shown promising results with micro-osteoperforations and accelerated orthodontic tooth movement. Being a relatively recent adjunct to orthodontic treatment, further research is required to gain insight into the effects of micro-osteoperforation on tooth movement as well as on root resorption. The aim of the proposed investigation is twofold. The first part consists of applying buccally directed orthodontic forces to the upper 1st premolars to compare the amount of root resorption that occurs with normal orthodontic tooth movement, with that which occurs with orthodontic tooth movement in areas treated with micro-osteoperforations. The micro-osteoperforations will be applied using a disposable appliance designed for this purpose by Propel Orthodontics. The Propel device is a TGA approved, FDA registered medical device specifically designed to create micro-osteoperforations. The second part consists of quantitatively measuring the rate of bodily canine retraction with normal orthodontic tooth movement, and orthodontic tooth movement associated with micro-osteoperforations. The hypothesis of this research project is that micro-osteoperforations will minimise orthodontic root resorption while allowing accelerated rates of orthodontic tooth movement. The proposed investigation will be a Prospective Cohort study involving 12-14 subjects. The first part of the project involves placing orthodontic braces only on the upper posterior teeth. Using a split-mouth design, one side will be randomly made control, while the other will be the experimental side in which micro-osteoperforations will be placed. Three perforations in a vertical alignment will be placed on both the mesial and distal aspects of the upper first premolar. Orthodontic force will be applied to the first premolars bilaterally for 4 weeks, after which the teeth will be extracted as part of the patient’s ongoing orthodontic treatment. These extracted teeth will then be scanned with a MicroCT scanner and the extent of resorption measured. Patients will also be asked to record their level of discomfort on the experimental and control side following the placement of braces and micro-osteoperforations. The second part of the study involves placing full braces on the subjects with 24 weeks of aligning and levelling teeth. After this period, another three perforations in a vertical alignment will be placed distal to the upper canine on the experimental side and the rate of canine retraction will be compared to the control side. Patients will be assessed and tooth movement measured off study models every 2-4 weeks, over an 8-week period. Conclusion: Root resorption is a significant consequence of orthodontic treatment. As micro-osteoperforations is a new adjunctive treatment to orthodontics, further research is needed to assess its effect on root resorption and to confirm its association with accelerated orthodontic tooth movement.

Tourette Syndrome (TS) is a neurodevelopmental disorder with childhood onset, characterised by the presence of both motor and vocal tics (American Psychiatric Association, 2013). Once thought to be a rare disorder, the prevalence of TS is now understood to be approximately 1% in the general population (Robertson, Eapen & Cavanna, 2009). A growing body of evidence suggests that noninvasive brain stimulation techniques, including transcranial Magnetic Stimulation (TMS) and transcranial Direct Current Stimulation (tDCS), may have a promising role in the diagnosis, monitoring and treatment of a variety of neurological and psychiatric conditions, including TS. For example, TMS has been found to be safe and effective in the treatment of TS among children and adolescents (Le, Liu, Sun, Hu & Xiao, 2013; Wu, Shahana, Huddleston, Lewis & Gilbert, 2012). With the exception of a report on two adult cases (Mrakic-Sposta et al., 2008), no study to date, however, has investigated tDCS as a therapeutic intervention for TS, despite previous research demonstrating its safety and tolerability for children and adolescents with other neurological and psychiatric disorders (for a review, see Krishnan, Santos, Peterson & Ehinger, 2015). This clinical pilot study will examine the feasibility and safety of tDCS for treatment of TS in individuals aged over 12 years.

The infant born very preterm (23-31 weeks gestation) is at high risk of an adverse neurodevelopmental outcome (10% cerebral palsy, 50% learning and behavioural difficulties at school age) which, if present, results in costs of billions of dollars annually in Australia. Currently there is no accurate way to either predict the motor, cognitive and neurobehavioural outcomes in these high-risk infants or to adequately monitor structural and functional brain development. Cerebral palsy is often not diagnosed until the second year of life and cognitive and educational disability even later. As a result, early intervention to target those at most risk is not possible. However, in the several months after very preterm birth, the brain is at its maximal capacity for neuroplasticity and repair, which offers a window of opportunity for effective and safe interventions to be implemented to improve outcomes. The purpose of this research is to learn which tests (clinical, MRI and EEG) can be used at 30 weeks and 40 weeks, to accurately identify which babies may have problems later in life, so that those babies and their families can be provided with the help they need as early as possible. We aim to predict adverse neurodevelopment earlier and more accurately than currently possible in a cohort of 237 babies using: (i) advanced brain MRI to determine the structural wiring diagram of the brain ('brain connectome'), (ii) dense array EEG to establish the functional activity or electrical 'traffic' being carried on the main branches of the connectome and (iii) structured clinical neurodevelopmental assessments to provide a cutting edge view of the state of brain development. We aim to achieve this in a prospective longitudinal cohort study of 200 preterm infants born <31 weeks GA, and a reference group of 37 healthy term-born infants. Infants will undergo a brain MRI at 30 and 40 weeks GA to develop our understanding of the brain structure and maturation that occurs between these time points. A combination of neurological, neuromotor and neurobehavioural assessments will be performed at 30 and 40 weeks GA to understand the relationship between brain structure and function. These data will be compared to clinical neurodevelopmental assessments at 3 months, 12 months and 24 months corrected age. We will merge two research teams using Australia's only two MRI compatible incubators (RBWH and Monash Medical Centre) to establish the role of cutting edge approaches in clinical assessment, MRI and EEg methods to improve neurodevelopmental outcomes for preterm infants.