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Failure of Unicompartmental knee replacement bearings
This trial reports the unforeseen consequence of a novel design of a unicompartmental knee arthroplasty (UKA) that resulted in a specific mechanical and tribiological mode of failure. Convex polyethylene bearings were developed to decrease bearing dislocation and used in 32 patients with disabling medial compartment osteoarthritis of the knee. This study reports the clinical outcomes (PROMS) and revisions for failed implants,
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Process evaluation of the Healthy Youngsters, Healthy Dads Community program: a healthy lifestyle program for fathers and their preschool-aged children delivered by trained facilitators in community settings
HYHD is an evidenced-based 8-week program aiming to improve the healthy lifestyle behaviours of fathers and their pre-school aged children. HYHD provides fathers with the knowledge, motivation and parenting strategies to engage with their children and become role models to improve physical activity levels, dietary behaviours and weight status of both themselves and their children. This program has been successfully tested in a feasibility trial and RCT at the University of Newcastle. The aim of this community trial is to test the effectiveness of the HYHD program in a community setting.
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The Dream On Study: A randomised controlled trial of efficacy and acceptability of a smart phone application in improving sleep in young people.
This project aims to evaluate the effectiveness of the “Sleep Ninja” mobile phone app in reducing sleep disturbance in adolescents, and secondary depressive symptoms. The Sleep Ninja mobile app uses CBT principles to directly monitor and address poor sleep. It is predicted that 6-weeks of access to the Sleep Ninja app will reduce symptoms of insomnia and depression compared to an active control group that do not access the app.
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Does asymptomatic Atrial Fibrillation lead to Cognitive Decline? An observational (non intervention) study of participants with Subclinical Atrial Fibrillation and possible decline in memory function.
The study explores the idea whether subclinical AF (SCAF) is associated with risk of dementia and is a longitudinal prospective study conducted over 3 years in patients with Cardiac Implantable Electronic Devices (CIED's) inserted. The study group will consist of 200 patients with SCAF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. The control group will consist of 200 patients with documented absence of AF and CHA2DS2-Vasc score (non-gender) of greater than or equal to 2. All participants will undergo neurocognitive testing and quality of life questionnaires and optional brain Magnetic Resonance Imaging to assess for cerebral changes at study completion.
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How Intraoperative pain indices Predict Post-operative Outcomes in children younger than 2 years: HIPPO study
This study will explore whether intraoperative NIPE values correlate to the level of post-operative pain and the amount of analgesia required after elective surgery in children. This has not yet been explored, and could ultimately result in less pain and distress to children and their carers.
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Does supplemental brexpiprazole affect sleep-wake and circadian parameters in youth with depressive syndromes?
The proposed study aims to evaluate the relationships between changes in sleep-wake and circadian parameters and changes in depressive symptoms following adjunctive brexpiprazole treatment in young adults with Major Depressive Disorder and sleep-wake disturbance, who have failed to respond to at least 1 antidepressant treatment for the current episode. More specifically, this study wants to investigate whether a reduction in depressive symptoms following adjunctive brexpiprazole treatment is associated with sleep-wake and circadian rhythm (i.e. body clock) changes. The study will be conducted at Brain and Mind Centre, University of Sydney, and Woolcock Centre for Medical Research. Investigators expect to enroll 50 subjects in the trial.
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Efficacy of Tendon Strip Injections compared to sham following failure of conservative therapy for Achilles tendinopathy
The primary aim of the study is to examine the efficacy of TSI with steroid and TSI without steroid versus sham injection among individuals with Achilles tendinopathy at 12 months. The primary outcome measure will be the Victorian Institute of Sport Assessment – Achilles (VISA-A) at 12 months. Study hypothesis: TSI with steroid and TSI without steroid will lead to superior VISA-A outcome compared to sham at 12 months.
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NAG: the Non-Adherence Gadget to motivate and remind children to follow their medical treatments
To use a child-friendly smartphone application (App), called NAG, the Non-Adherence Gadget which incorporates tailored reminders, rewards and cognitive behaviour therapy (CBT) to overcome psychosocial barriers to following treatment advice for patients with chronic health conditions (specifically kidney or bladder conditions). The research is a pilot study to determine whether the App is useful in improving treatment adherence and is acceptable to children, parents and doctors.
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The Use of an Advanced Hybrid Closed Loop System in the Management of Individuals with Type 1 Diabetes and Sub-optimal Glycaemic Control Aged 12-25
This is a 6 month multi-centre randomized controlled trial assessing the effect of advanced hybrid closed loop (AHCL) in adolescents with poor glycaemic control and comparing this technology with their standard care. The purpose of this project is to utilize an automated insulin delivery system to improve glycaemic control which has been shown during in-home use by adolescents and adults with increased time in target, and reductions in HbA1c, hyperglycaemia and hypoglycaemia, compared to baseline. Hence, it would be valuable to test the effectiveness of AHCL in patients with poor glycaemic control. We hypothesize that AHCL system will circumvent the significant glycaemic excursion associated with conventional therapy in patients with poor glycaemic control. Reduced adherence to diabetes self-management tasks is often associated with poor glycaemic control and this trial will address, in effect, whether the challenge of managing AHCL is less than the challenge of routine treatment and will generate data that will inform approaches to enhance adherence.
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Intensive Follow-up via Remote Monitoring of Implantable Cardioverter Defibrillators in people with severe left ventricular dysfunction.
Implantable cardioverter-defibrillators (ICDs) are common for prevention of sudden cardiac death in patients with heart muscle dysfunction. Traditionally, ICDs have been followed up via clinic visits every 3 to 6 months. Remote monitoring of ICDs has become more common, allowing for early detection and intervention following clinical or device related events. However, in practice many patients do not receive remote monitoring, and those that do have sub-optimal compliance, suggesting more intensive management of remote monitoring may be better. This project aims to evaluate the efficacy of an intensive remote monitory strategy to help improve treatment and outcomes for ICD patients.