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The effect of a social robot on pain and behavioural and psychological symptoms in people with dementia: A pilot randomised controlled study
Expand descriptionAs pain is a disturbing problem for people living with dementia, pharmacological approaches are necessary for pain management, but medications may bring undesirable side effects; however, non-pharmacological interventions have been recommended to manage pain without obvious side effects. Among them, social robot intervention such as PARO is promising to reduce pain and it is convenient for both health care providers and patients, especially for people with dementia. Findings from this study may provide an evidence-based intervention to improve pain management thus improving the quality of life for people with dementia and decreasing the care burden for nursing staff as well as family carers.
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Westmead Feelings Program pilot study for adolescents with autism and mild intellectual disability
Expand descriptionOne in 100 children is diagnosed with Autism Spectrum Disorder (ASD). Up to 70% of children and adolescents with Autism also experience mental illnesses including anxiety and depression. In addition to the impact of Autism on individuals, the mental illnesses they suffer from are of at least the same severity as that of their disability. However, unlike Autism, mental health problems are reversible and preventable. While approximately 40-50% of adolescents with Autism also have an Intellectual Disability (ID), there is very little research or evidence based programs aimed at this vulnerable population that aim to promote mental health, emotional development and social skills. For adolescents with Autism and an intellectual disability there is no intervention promoting mental well-being. The Westmead Feelings Program (WFP) is an innovative autism specific program developed and researched by psychologists at the Children’s Hospital at Westmead. It is a group based program consisting of 3 modules and a booster session (16 sessions in total). Previous implementation research on the WFP has established the effectiveness of emotion-based learning for primary school-aged children on the autism spectrum, with and without an intellectual disability, and adolescents without an intellectual disability, both in school and clinical settings, in improving emotions competence and reducing symptoms of mental disorder. The aim of this study is to address a current gap in intervention, by developing an adaptation of the Westmead Feelings Program for adolescents with autism and mild intellectual disability, to be piloted in a clinic and school based setting. This study is divided into three parts: Part A: Literature review and development of WFP adapted for adolescents with autism and mild intellectual disability. Part B: Explore and co-design the content in the adapted WFP in focus groups with target population participants (adolescents, parents, educations and other professionals) and explore the adapted WFP feasibility. Part C: Adapted intervention pilot across two settings (clinic setting and a school based setting) – to assess the participant experience, feasibility, barriers to successful implementation and explore whether there are improvements in adolescent well-being, social skills and emotions competence over time, concurrent with using adapted WFP. It is expected that the study will confirm adequate positive experience, feasibility and improvements over time concurrent with using the WFP adapted for adolescents, which may warrant further feasibility and acceptability testing of the adapted WFP in a larger study.
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A randomised trial of Curcuma longa for treating symptoms and effusion-synovitis of knee osteoarthritis.
Expand descriptionOsteoarthritis is a common joint disorder for which there is no cure. Curcuma longa (commonly known as Turmeric) has anti-inflammatory, cartilage and bone protective properties, and can potentially be used to treat osteoarthritis patients with an inflammatory form of osteoarthritis. Previous studies of Curcuma longa have been of dubious quality and did not select patients with knee swelling, which is a clinical indication of inflammation. The aim of this clinical trial is to determine the efficacy of Curcuma longa extract for treating knee osteoarthritis symptoms and effusion-synovitis (assessment of excess joint fluid using MRI). If successful, treatment with Curcuma longa can be easily implemented as it is inexpensive, safe and available over-the-counter.
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The Influence of Serum and Aqueous Cytokine Concentrations on the Efficacy of Intravitreal Ranibizumab for the Treatment of Diabetic Macular Oedema
Expand descriptionDiabetic retinopathy is one of the most debilitating complications of diabetes. Diabetic Macular Oedema (a retinopathy) may be related to a combination of inflammatory and angiogenic cytokines that exist in the blood and aqueous fluid in the eye. The main objective of the study is to assess if aqueous and plasma cytokine concentrations of angiogenic/ inflammatory cytokines correlate with the change in mean best-corrected visual acuity from baseline to 12 months
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A trial to evaluate an oral medicinal cannabis extract compared with placebo for the treatment of insomnia.
Expand descriptionInsomnia is the most common sleep disorder. Australian surveys have shown that 13-33% of the adult population have regular difficulty getting to sleep or staying asleep. Previous studies have shown the benefit of synthetic delta-t-tetrahydrocannabinol (THC) and medical cannabis for a range of sleep disorders, however these trials were mainly targeted to investigate outcomes in other conditions such as pain and multiple sclerosis. The aim of this study is to provide preliminary evidence for orally delivered medical cannabis for the treatment of sleep disorders due to insomnia. This trial will enrol 24 participants aged (25-70) inclusive who have insomnia defined as self-reported difficulty initiating and/or maintaining sleep for 3 or more nights per week for at least 3 months. Participants will also be screened with a clinically validated questionnaire for insomnia by an Investigator team member before being recruited into the trial. Participants involvement in the trial will be for approximately 8-11 weeks (depending on their availability to take the assessments). After completing a series of health asessments and questionnaires relating to their sleep, participants will commence the trial with a 2 week period of baseline measures (without investigational product or placebo) where they will need to wear a wrist-worn device to measure their quantity and quality of their sleep, as well as complete a sleep diary. On the final night of the 2 week period (night 14) they will have an overnight sleep study at the sleep centre site using a non-invasive measuring device to measure sleep patterns and assessments with questionnaires about their sleep by the Investigator team. Following a 1 week break, participants will be randomly allocated (by chance) to receive investigational product or placebo. Each of the treatment phases of both investigational product and placebo will be for 2 week periods including a 1 week break in between the treatments. The same requirements including measurements and assessments as per the baseline will be requried for each of the 2 week periods of investigational product and placebo. This trial will provide information on the efficacy of medical cannabis for the treatment of sleep disorders due to insomnia.
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Phase I non-randomised safety study of prophylactic topical dexamethasone/hyaluronic acid formulation on facial nerves during parotidectomy and neck dissection surgery
Expand descriptionThis study seeks to determine the safety of applying the potent corticosteroid dexamethasone in a slow release hyaluronic acid gel formulation directly to exposed nerve branches of the facial nerve during standard parotidectomy and neck dissection surgery. Who is it for? You may be eligible to join this study if you are aged 18 years or over and are undergoing parotidectomy (malignant or benign) or neck dissection surgery. Study details Consenting patients will receive the dexamethasone in a slow release gel formulation directly to the exposed nerve during surgery, in which the surgeon will coat exposed branches of the facial nerve with the formulation once. Consenting participants will undergo their standard clinical treatment involving parotidectomy or neck dissection surgery which includes an initial consult involving facial nerve function assessments, parotidectomy or neck dissection surgery and follow-up visits assessing wound healing/infection and facial nerve function over 2 months.
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Trial of Amnion Cell Therapy for Ischaemic Stroke (I-ACT)
Expand descriptionThis trial is a dose escalation study to determine the maximal tolerable dose of human amnion stem cell for the treatment of acute ischaemic stroke (focal brain ischaemia from blood clot obstructing the vessel lumen).
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Exploring the impact of chronic obstructive pulmonary disease (COPD) patient characteristics on inhaler device capability and inhaler device characteristics on treatment efficacy.
Expand descriptionIn COPD, inhaler capability may be impaired due to advanced age, comorbid illness and airway mechanics. Observational study - looks at COPD patient characteristics and how they relate to inhaler capability in acute COPD exacerbation and recovery phase. Interventional study - published pharmaceutical trials predominantly compare drug effects on lung function without accounting for differing inhaler devices or exploring outcomes reflecting chronic disease morbidity. This trial specifically compares two devices in terms of clinical outcomes.
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Impact of central high blood pressure treatment on atrial fibrillation outcomes.
Expand descriptionAmongst the attributable factors, hypertension is the predominant risk leading to atrial fibrillation (AF) and premature cardiovascular events. As compare to brachial blood pressure, central blood pressure and aortic stiffness assessment even in “normotensives”, has shown improve predictability of cardiovascular outcomes including atrial fibrillation. Cardiovascular risk stratification based on central blood pressure indices can be more relevant as it demonstrates the central pulsatile load an organ is exposed to and reveals early vascular remodelling of central arterial tree resulting in aortic stiffness. Non-invasively derived central hemodynamic indices have been demonstrated to predict cardiovascular outcomes in a variety of settings. We propose a single blinded, randomised prospective trial to risk profile our AF patients according to their non-invasive assessment of peripheral or central blood pressure including aortic stiffness estimate. The impact of central or peripheral blood pressure treatment , on AF outcomes will be analysed. In addition, the relationship between central or peripheral high blood pressure and non-invasive indicators of end organ (cardiac, vascular, renal and retinal) injury will be explored.
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Comparing two antibiotic regimens for the treatment of late onset sepsis in neonates
Expand descriptionAbout 25% of very preterm infants in the neonatal intensive care unit will develop a suspected infection, or late onset sepsis. Current empirical late onset sepsis treatment regimens usually include vancomycin, however this antibiotic is associated with the development of drug resistance. Antimicrobial resistance threatens the effective prevention and treatment of infections and is a serious threat to public health. Patients with infections caused by drug-resistant bacteria are at increased risk of worse clinical outcomes and consume more health resources. The aim of this study is to lead to the development of a safe and effective antibiotic regime for late onset sepsis in preterm infants using a randomised controlled trial design. Preterm infants <29 weeks with suspected late onset sepsis will be randomised to receive either a vancomycin or cephazolin containing antibiotic regimen, both of which should appropriately treat common bacterial causes of late onset sepsis. The trial results will potentially lead to reduced vancomycin use in Australasia and subsequently reduce the development of multi drug resistant organisms, and an overall reduction in health care costs.