ANZCTR search results

All patients booked for elective TKR surgery under the care of the investigating surgeon who meet the inclusion criteria will be invited to participate and informed consent will be obtained. Prior to surgery, all patients will complete standradr pre-operative testing and questionniares as is usual practice. A pre-operative pain score (average over 7 days prior to surgery) and pre-operative opioid use will be recorded in the patients electronic file. TKR surgery will be carried out according to standard protocol. Prior to wound closure, additional treatment will be given with the Avanos Coolief Cooled Radiofrequency System. This involves the use of a radiofrequency generator that transmits a small current of radiofrequency energy through an insulated electrode that is placed within the tissues. Due to the friction of charged molecules, heating occurs and thermally deactivates the nerves responsible for sending pain signals to the brain. Radiofrequency energy is delivered through water-cooled electrodes, enabling more energy to be safely delivered to the target areas. This lower intensity technique makes the risk of permanent or irreversible damage to the tissues very unlikely. The application of the Coolief Cooled Radiofrequency System will add 5-10 minutes to the surgery time. Wounds will be closed in the standard fashion and standard post-operative care will be given. Standard post-operative care involves initially daily (and subsequently weekly) follow-up about pain levels and opioid intake until the 6 week post-operative mark.

Cerebral palsy (CP) is the most common childhood physical disability, and among the most costly health conditions in Australia. Consistent with the prevailing trend for poorer health outcomes for Indigenous Australians, significantly more children from Indigenous communities have CP, usually with poorer functional skills. The current state of evidence allows reliable prediction of infants at risk of CP from 13 weeks, however children in remote Indigenous communities typically don’t seek diagnosis until far later, and also face significant barriers to accessing support and intervention. This means we are missing a significant window of opportunity for treatment when infants’ neuroplasticity is optimal. This study aims to determine the effectiveness of an early intervention program for Indigenous infants at high risk of CP. This is a randomised single blind controlled trial of 86 high risk infants (inclusion criteria: absent fidgety General Movements at 12-18 weeks, or abnormal score on the Hammersmith Infant Neurological Evaluation at 18 weeks-2 years). Infants are randomised into a community-based parent-delivered 'best practice' intervention (30 weeks of enriched environment (based on the Learning Games curriculum, demonstrated effective in over 16 RCTs); goal-directed training; and parent education, including nutrition, parenting and health) versus standard care (based on the Integrated Management of Childhood Illness). The intervention will be conducted through an Indigenous Allied Health Worker model, based on the highly effective lay health worker model, to ensure long-term sustainability. Primary infant outcomes will be measured post intervention and at 2 years corrected age using the Peabody Developmental Motor Scales and Bailey Scales of Infant Development; and primary caregiver outcomes on the Depression Anxiety and Stress Scale. It is hypothesised that children receiving the intervention will have improved motor and cognitive outcomes, and caregivers to have improved mental health. This program presents a feasible, transposable and scalable model which, if shown to be effective, has the potential to reduce the burden of disability in remote Indigenous communities of Australia.

Prolonged mechanical ventilation has been associated with significant respiratory muscle weakness that remains detectable 7 days post successful weaning. This weakness has been associated with difficulty weaning from mechanical ventilation. Inspiratory Muscle Training (IMT) is a novel physiotherapy technique that addresses respiratory muscle weakness. IMT uses progressive resistance to achieve a strengthening effect for respiratory muscles. Several high quality RCTs and a recent systematic review demonstrate IMT increases Maximal Inspiratory Pressure (MIP) in patients following prolonged mechanical ventilation. Furthermore a case series utilising threshold-based IMT have demonstrated safety and feasibility in ventilator dependent ICU patient. The resistance of this device is limited to 9 - 41cmH20, creating a ceiling and floor effect. Electronic inspiratory muscle training devices offer a greater magnitude of inspiratory resistance and may be more effective in providing precise assessments and training loads. However electronic inspiratory muscle training has received less attention in the literature, with only one pilot study indicating it could be feasible in ICU patients (Tonella et al 2017). While some European centres are already using electronic IMT and planning randomised trials using this technology (Hoffman et al 2018), the feasibility of this approach in ICU patients is yet to be established. Before establishing efficacy of the electronic inspiratory muscle training device for mechanically ventilated patients, safety/feasibility of the intervention must be established. Therefore we are aiming to conduct a dual centre feasibility study with an aim to recruit 20 patients at both Princess Alexandra Hospital (Brisbane, Queensland) and Canberra Hospital. Eligible participants will be mechanically ventilated for greater than 5 days or have failed a spontaneous breathing trial. Furthermore participants will be required to have sufficient alertness to follow commands in order to participate with training whilst ventilated. Outcomes will evaluate both feasibility and safety of the intervention. We expect the electronic inspiratory muscle training device will be feasible to use in clinical practice.

Children with disruptive behaviour problems represent a heterogeneous group whose difficulties arise from multiple developmental pathways, leading to differential treatment response to traditional evidence-based behavioural interventions. The challenge of treatment non-response is also often compounded by limited accessibility of traditional evidence-based interventions in community settings. The current trial aims to evaluate the acceptability and efficacy of an evidence-based behavioural intervention called Parent-Child Interaction Therapy (PCIT) that is matched to the individual needs of young children with disruptive behaviour problems, delivered in a public school setting. It is hypothesised that families receiving matched intervention will show greater improvement in outcomes of interest at post-intervention and 3-month follow-up than those assigned to non-matched intervention, as well as better engagement with treatment. Our secondary aim is to evaluate whether teaching staff and classroom peers of target students who receive school-based PCIT show a reduction in stress levels and improved wellbeing between pre- and post-intervention, assessed via a stress and wellbeing screening occurring at the beginning and end of the academic year.

This study aims to evaluate the feasibility of point-of-care (POC) C-reactive protein (CRP) testing to support pharmacists’ management of respiratory tract infections (RTIs) in community pharmacies in Western Australia. POC CRP testing provides a result in less than five minutes, using a capillary blood sample from a finger prick and is a biomarker of inflammation used to assist differentiation between bacterial from viral infections in some circumstances. The study hypothesis is that CRP testing in community pharmacies, in addition to pharmacists' routine assessment, following a validated clinical guideline and protocol, is feasible in the community pharmacy setting and acceptable by consumers and pharmacists.

Injecting medicine into the eye is an effective treatment for swelling of the macular in diabetes. Aflibercept is one of two medicines approved to treat this swelling. While effective, treatment can be prolonged. After three initial monthly injections, the duration between subsequent injections varies. It can be fixed, given when the condition worsens or timed according to response. The effectiveness of injections when timed according to a person’s response is being investigated. This is known as a ‘treat and extend’ protocol. This protocol reflects real world treatment in Australia. This study will help look at the effectiveness of this approach. It will also allow us to identify the best interval between injections.

This study is being conducted to evaluate the pharmacokinetics of single oral doses of XW10172 and Xyrem in healthy volunteers under fast and fed conditions.

The purpose of this study is to test the safety and tolerability of two types of a potential breast cancer treatment called endoxifen. Who is it for? You may be eligible for this study if you are a healthy female aged 18-65. [***Please note participants who have cancer are not eligible for this study.***] Study details Participants in this study will be organised into two groups. One group will receive capsules to be taken by mouth, and the other group will receive tablets, to be taken by mouth. Within the capsule and tablet groups, participants will be randomised (by chance) to either the active drug or a placebo. Neither the participant nor investigators will know who gets the active or placebo drug. Initially, only a single capsule or tablet will be taken. After checking the results of this first day, participants may take their assigned tablet/capsule once a day for another 14 days. As part of this study, all participants will need to provide blood samples, urine samples, answer questionnaires and have a physical exam.

A prototype bio-impedance recording device called Cardia [TIP2] has been developed by Melbourne based medical device company Grey Innovation. An earlier prototype of this device [TIP1] has already undergone a clinical study (CTN-03513-1) in dialysis patients where 16 patients wore the device over 19 sessions lasting 4-6 hours each. It was found that changes in bio-impedance were reliably measured with the Cardia [TIP2] prototype - correlating with fluid removed from the participant during dialysis. This study will enable the prototype to be tested in heart failure patients, the end user population over a longer period of time. This study will provide information that will enable us to move towards an optimised device that is to be tested in a large-scale home-based trial. The home-based trial will compare those who do have the real-time volume status information to act upon against those who do not and will assess whether relevant clinical outcomes can be improved, i.e. prevention of heart failure re-hospitalisation or minimisation of time in hospital for acute decompensation. Thus, this specific project is critical in advancing the commercial and therapeutic/diagnostic potential of the device, before such a study can be considered. Our goal is that this will ultimately lead to the development of a commercially viable, low-cost (potentially disposable), non-invasive approach to assessment of fluid status to allow early intervention and increase health outcomes in heart failure patients.

One-quarter of adolescents live with regular, debilitating kneecap pain. This causes substantial pain and disability, and reduces quality of life. Kneecap pain in adolescents is not a self-limiting condition – up to 95% continue to have pain after two to eight years. This can set the scene for a lifetime of knee pain and associated health implications, with many adolescents reducing or withdrawing from sport and physical activity. The problem is the lack of evidence and clinical guidelines for effective treatments for adolescents with kneecap pain. Best-evidence treatments for adults with kneecap pain, such as exercise, are not as effective for adolescents. This may be because adolescents simply do not do their prescribed exercises. 'Off-the-shelf' shoe inserts may be the solution. These are simple, accessible, low-cost devices that are easy for adolescents to wear in their regular footwear, such as school and sports shoes. The HAPPi Kneecaps! Trial will determine the feasibility of conducting a full-scale randomised clinical trial investigating shoe inserts for adolescents with kneecap pain. Secondary outcomes will explore whether shoe inserts can improve pain, function and quality of life in this population. Findings will inform future large-scale clinical trials, with the potential to advise clinical practice guidelines providing adolescents with effective, evidence-based options for managing their kneecap pain. This study is an essential first step in identifying effective interventions for adolescents with kneecap pain, with the potential to change the persistent, chronic nature of kneecap pain at its earliest onset.