ANZCTR search results

Approximately 30% of patients referred to the outpatient Mental Health service at The Royal Children’s Hospital present with significant and impairing irritability, aggression and mood dysregulation. Irritability and mood dysregulation are defined as a proneness to anger that is out of proportion to the situation and which often leads to verbally or physically aggressive outbursts. Children who are highly irritable have been found to have poorer quality of life, daily functioning, and social functioning, and are at very high risk of developing multiple psychiatric disorders. Currently however, there are no evidence based treatments for irritability. As such this study aims to assess the feasibility and acceptability of a behavioural treatment program in children (aged 6-15 years) referred to the RCH outpatient mental health service with severe irritability, and to explore the impact on child and family outcomes. Participants will be randomised into usual care (n=15) or a 6 session intervention (n=15). The intervention consists of six hour-long weekly sessions. All participants will be assessed three months post-randomisation to assess preliminary outcomes.

Groups of healthy male subjects will be administered escalating single doses of PXS-5338K to examine the safety, pharmacokinetic and pharmacodynamic profiles of PXS-5338K. This study will also investigate the safety, pharmacokinetic and pharmacodynamic profiles after repeated doses of PXS-5338K over a 14 day period.

Depression is a common, severe and often difficult to treat illness. Repetitive transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, is an effective and well tolerated treatment for depression. TMS uses magnetic pulses to stimulate and change the activity in areas of the brain related to depression, using a specialised coil placed on the head while the patient is awake and alert. Although TMS is effective, it takes a long time to induce clinical response, often 4-6 weeks. This limits its applicability in clinical practice and is associated with considerable treatment costs. Response to rTMS can be accelerated with intensive treatment schedules involving a number of treatments a day, but these are also time consuming. Theta burst stimulation (TBS), a type of TMS, appears to produce similar effects to standard TMS when applied on a daily basis but with markedly less time demands (3 minutes compared to 40 minutes per session). TBS would appear to be an ideal intervention to use in an intensive / accelerated format where multiple daily sessions could be applied but still in a limited amount of time. However, the optimal TBS treatment parameters, such as treatment intensity, are still unknown and require investigation. This study is therefore a randomised controlled trial to compare an accelerated TBS intervention to standard once daily TMS to evaluate its relative effectiveness and rapidity of antidepressant effect. We will also compare the relative efficacy of two different strengths of TBS to investigate the most effective TBS treatment parameters. Participants will receive 20 sessions of lower intensity TBS, higher intensity TBS or standard TMS over a 2 - 4 week period. Participants will take part in interviews at baseline, week 1, 2, 4 and 8-10. Participants responding to the treatment will be followed up for six months

The aim of this study is to compare self-collected versus practitioner collected samples for HPV-based cervical cancer screening. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above, and are attending an appointment for a colposcopic procedure. Study details All participants in this study will attend a single clinical appointment, during which time they will self-collect a vaginal sample using a dry flocked swab. Following this, a healthcare practitioner will collect a cervical sample using a cervical collection device (brush/broom). Both samples will be tested for Human Papillomavirus (HPV) nucleic acid, and the results compared. The study will also examine the rate of invalid HPV results for both the self-collected and practitioner-collected samples. This study will contribute information on the sensitivity of a self collected sample for HPV-based cervical screening and may contribute to this method being adopted as part of the new HPV-based national cervical screening program due to begin in late 2017.

This project is the implementation and evaluation of a newly proposed model of service in the emergency department. The service comprises consultation with older patients (80 years and over) suffering from advanced frailty or chronic illness to make choices about their preferences and values so these can be incorporated in the treatment decisions. The evaluation will use a randomised trial design to compare the effectiveness of the new Goals of Care service with 'usual care' provided at Liverpool hospital before/during the intervention and with a control group in another teaching hospital (Westmead) where another model of service has been in place for several years. Mixed methods will include a qualitative investigation of the patient's and the implementers' satisfaction with the service. The aim of the study is to examine the feasibility, acceptability and effectiveness of the Goals of Care initiative in terms of type of care choices and place of death (institutional vs. community-based), as well as establishing concordance of wishes with actual care provided. It is hoped that the identification of the older people at high risk can be embedded in routine practice and the Goals of Care service will improve the uptake of advance care planning and reduce unnecessary hospitalisations.

Mild cognitive impairment (MCI) affects at least 10% of older adults globally, and in this cohort the risk of incident dementia is greatly increased from 1-2% per annum to 10-15%. Exercise has been shown to be beneficial for some cognitive outcomes in MCI, although results are heterogeneous, and the optimum exercise dose and modality for preservation or improvement of cognition is not fully defined. Progressive resistance training (PRT) has been shown to have larger effects on cognition than aerobic training in meta-analyses. The limited benefit of some aerobic training studies may be due to insufficient intensities of the intervention, which have produced suboptimal changes in aerobic capacity or other physiological adaptations potentially mechanistic for improved brain function. High intensity interval training (HIIT) results in more beneficial cardiovascular adaptations compared to standard moderate intensity aerobic training. The wealth of data linking aerobic fitness to cognition suggests that HIIT, which approximately doubles the average improvement in aerobic fitness compared to standard training, is of potentially great interest in MCI therefore. However, HIIT has never been tested alone or directly compared to PRT for cognitive benefits in any cohort. We hypothesize that PRT and HIIT will be robust, alternative exercise interventions to improve cognition in MCI. We will conduct a multi-national, randomised controlled trial over 4 years in which we randomise 210 older adults with MCI in Australia and Canada to PRT, HIIT or a sham exercise control group for 12 months. Executive function is the primary cognitive outcome. Secondary outcomes include other cognitive domains, biomarkers for cognitive decline and distinct mediators of benefit for PRT (e.g., anabolic hormones, lean mass) vs. HIIT (e.g., arterial stiffness, aerobic fitness), functional status, brain structure and connectivity, and psychological wellbeing. The study is powered for our primary hypothesis that both PRT and HIIT will improve Executive Function Domain relative to the control. We will recruit 70 participants per group for a total sample size of 210 across the three sites. This sample size will allow to demonstrate a relative ES of 0.48 (PRT vs. Control or HIIT vs. Control) assuming alpha less than 0.05 and beta of 0.2. Sample size has not been inflated for loss to follow-up, as we will utilise linear repeated measures mixed models and/or General Linear Models in intention-to-treat analyses including all randomised participants irrespective of dropout or adherence. We do not intend to compare PRT to HIIT as we hypothesise both to be effective, therefore the comparisons are for intervention vs. control only. BRAIN will be the first trial of HIIT for cognition in any cohort, and the largest and only multi-national study of exercise for Mild Cognitive Impairment ever conducted.

This study is looking at whether the use of robotic technology can assist youth with acquired brain injury function better in their lives. This is important because we know from previous studies that functional improvements in brain injury, such as better walking, can come from more intensity of therapy (doing lots of therapy). Robotic technology may be a fun way to provide this therapy to young people. Based on studies in people with neurological conditions it is felt that the technology could assist, but further studies are needed to determine whether this is true. This study is being conducted to assist in answering that question. This study will involve two robotic machines - the Lokomat and the Armeo. The Lokomat is a robotic device to assist with walking and endurance. You/your child will be fitted to the device and while using it have the opportunity to engage with the interactive software used for fun and motivation. The Armeo is an upper limb robotic device that allows for practice of upper limb (arm and hand) skills, movement and strengthening. This device is connected to computer graphics with games and activities to motivate you/your child to complete activities. They allow for repetitive functional movements with instant feedback and the user practices these movement skills in virtual reality games. They are both located in the Little Heroes Foundation Centre for Robotics and Innovation at the Women's and Children's Hospital. Initially you/your child will be randomly allocated to one of two treatment groups: robotic therapy or conventional physiotherapy (usual land-based physiotherapy). Then, after a 6 week break, will be crossed over into the other group for the second treatment block. All participants therefore get to experience both robotic and conventional physiotherapy. In each treatment group you/your child will receive 15 training (therapy) sessions in total over a 5 week period. Each training session should take approximately 1 hour to complete. There is a series of assessments (muscle length, walking speed, walking endurance etc) that will be conducted by an assessment physiotherapist before and after treatment blocks and at a 3 month follow up. We expect these to take about 1 hour each time.

The purpose of this study is to describe the safety and tolerability of the study drug compared to the vehicle solution with twice daily dosing in subjects with Atopic Dermatitis. Patients with Atopic Dermatitis aged between 18 and 65 years, inclusive, will participate. BTX 1204 4% Solution or Vehicle Solution will be applied twice daily for 28 days. The study consists of a screening visit (up to 14 days before receiving study treatment) and an enrolment visit initially. There is a visit on Day 8 and Day 15 during the 28 day dosing period. Participants will return to the clinic on Day 29 for safety assessments. The maximum study duration for any participant will be a total of up to 43 days; screening period (up to 14 days), 28 days of treatment and a visit on Day 29.

A private hospital in Western Australia introduced a pilot Enhanced Recovery Program (ERP) for THR in 2012 based on an orthopaedic recovery program established in United Kingdom (Wainwright & Middleton, 2010). The ERP for THR included a range of strategies to support the pre-admission, peri-operative, post-operative and post-discharge patient care. After an extensive evaluation of the pilot program the ERP was introduced as part of standard care in 2013 and has continued as standard care. The education components of the ERP include information book, hospital based pre-operative education session and post-operative phone follow-up. Patient feedback of the ERP was positive but for patients living in rural locations it was difficult to attend the pre-operative education session. The private hospital recognised a virtual platform as a solution to provide information for all patients undergoing a THR and also provide a patient clinician interface in the post-discharge period. The private hospital commissioned the development of a virtual program for THR and plan to implement a pilot study to compare the effects of the virtual program versus the standard program for patients undergoing primary THR replacement on patient outcomes. The aim of this study is to compare a virtual program versus standard program as part of care for primary total hip replacement (THR) on patient outcomes.

Retinoblastoma is the most commonly occurring paediatric eye cancer. The earliest signs of disease include leukocoria (white pupil) and strabismus (crossed eye). Untreated, retinoblastoma results in loss of sight, eye or life. Common strabismus occurs in up to 2-4% of children resulting in poor vision when diagnosed and treated late. Unfortunately, white pupil or strabismus are often ignored as there is a lack of information and misinformation regarding the importance of these signs. Currently, no systematic information is provided to parents in Victoria regarding leukocoria or strabismus. Raising parental awareness of these signs could reduce delays in diagnosis and result in earlier treatment with the potential for improved outcomes. This randomized controlled trial aims to evaluate an evidence-based, theory-informed information pamphlet that has been developed for parents. It is hypothesized that parents who receive the pamphlet would be more alert to these early signs and have heightened help-seeking intentions.