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Is opportunistic screening appropriate for identifying arrhythmias and establishing effective clinical pathways for Aboriginal Australians?
Expand descriptionBackground: The leading cause of death for Aboriginal Australians is cardiovascular disease, including stroke and heart attack. Atrial Fibrillation is a precursor to stroke. There are no published studies about the prevalence of Atrial Fibrillation for Aboriginal people. The purpose of the study is twofold: to estimate prevalence of Atrial Fibrillation in Australian Aboriginal people and evaluate the effectiveness of opportunistic screening, and assessment and treatment pathways for Aboriginal people with Atrial Fibrillation or other arrhythmias. Methods: This is a mixed methods study which will screen 1500 Australian Aboriginal people living in New South Wales, Northern Territory or Western Australia to estimate prevalence of Atrial Fibrillation. This data will be analysed statistically to estimate prevalence. In addition, the study will conduct semi-structured interviews with Aboriginal workers who conduct the screens to evaluate qualitatively the effectiveness of opportunistic screening using an iECG to facilitate timely assessment and treatment for Aboriginal people over 45 years. Discussion: The study aims to determine the feasibility of the portable iECG device to diagnose abnormal heart rhythm in Aboriginal people and facilitate access to further assessment and treatment; estimate the prevalence of AF in Aboriginal people in Australia; improve health literacy in Aboriginal people and health workers; and help prevent the effects of untreated AF in Aboriginal people; including ischemic stroke and prevent early deaths or impairment.
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An Open-Label, Randomised Study of Ortho-ATI (Trademark) Versus Surgery for Treatment of Severe, Chronic, Resistant Lateral Epicondylitis
Expand descriptionLateral epicondylitis (LE) or "tennis elbow" is the most commonly diagnosed condition of the elbow and occurs mostly in patients whose activities require strong gripping or repetitive movements. 1 in 10 patients with LE who receive standard therapies like coricosteriod injections do not obtain relief from symptoms. In Australia, such patients with severe, chronic non responsive LE for over 6 months are referred for surgical treatment. OrthoATI (Trademark) is a class 3 biological autologous tenocyte implantation (ATI) product manufactured in Australia by Orthocell Ltd, that could potentially prevent or delay the need for surgery in LE patients who don't respond to standard therapies. OrthoATI (Trademark) is indicated for patients with symptoms of degenerative tendon injury who have failed conservative treatment methods. The current research project is a 1 year, single dose, single-centre, randomised, open label, parallel group, comparator controlled, non-inferiority study to assess the efficacy, safety and tolerability of OrthoATI (Trademark) in patients with severe, chronic, treatment resistant lateral epicondylitis compared to surgery.
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Morning versus evening exercise: Its effect on body composition and weight loss
Expand descriptionOverweight individuals use exercise primarily as a means to reduce body weight. Given the continued rise in the prevalence of overweight and obesity (Hill et al., 2012; Ziauddeen et al., 2015), optimising the benefits of exercise for weight loss is crucial. In recognition of this, evidence-based recommendations for exercise prescription including frequency, intensity, mode, duration, pattern, and volume have been developed (Donnelly et al., 2009; Garber et al., 2011). Similarly, some countries have established guidelines for minimum physical activity levels required for weight maintenance and weight loss (Donnelly et al., 2009; insert OZ ref). However, there is no such recommendation for the optimal time-of-day at which exercise should be performed to maximise its impact on weight loss. Circadian rhythms regulate several physiological processes that influence appetite, sleep/wake cycles and exercise performance (Almoosawi et al., 2013; Drust et al., 2005; Froy, 2007; Thun et al., 2015; Winget et al., 1985; Youngstedt et al., 2002), therefore, it is possible that individuals will respond differently when exercise is performed in the morning, compared to the evening. However, the majority of available exercise-based weight loss research either does not control, or does not report, the time-of-day at which exercise has been prescribed. Therefore, the implications of exercise time-of-day for weight loss are unknown. The aim of this chapter is to present an overview of the available literature including observational and experimental studies in the area of exercise timing and its potential effects on body weight and composition. Additionally, some discussion surrounding the physiological responses to exercise and circadian rhythm of hormones will be presented to provide additional insight to understand the mechanisms behind the time-of-day effect on body weight and composition
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Management of tooth decay in refugee children: a conservative approach
Expand descriptionDental caries (tooth decay) in the early childhood, known as Early Childhood Caries (ECC) can be debilitating, significantly impacting on a child’s growth, nutrition, sleep, learning, appearance and quality of life. Children from refugee backgrounds face significant barriers in accessing timely care and therefore continue to experience significant disparities in oral health. The persisting barriers to seek and provide dental care inevitably leads to emergency hospitalisations and dental extractions. Topical fluoride varnish application, specifically 5% sodium fluoride varnish (NaF), has been recommended in the prevention and control of dental caries in children. This forms part of current best practice in caries prevention along with provision of oral hygiene and dietary advice. Silver diamine fluoride (SDF) is another topical fluoride modality that has shown to have greater efficacy than NaF and is non-invasive, easy to apply, and effective treatment modality to arrest dental caries in high-risk children. The aims of this project are to evaluate the: (i) effectiveness of SDF in arresting carious lesions in refugee children (ii) quality of life (QoL) changes in refugee children before and after SDF application Refugee children under the age of 12 years will undergo a dental examination through the RHS, as per current protocols. The option of fluoride treatment will be offered to the parents of children presenting with at least one carious lesion. Eligible children will then undergo simple sequential randomisation and SDF or NaF will be applied to the carious lesions at initial visit, 6 months and 12 months at RHS and final review will be conducted at OHCWA at 18 months. Follow-up QoL surveys, dental charting and intra-oral photographs will be taken to assess changes in the carious lesions. The expected outcome of this study is to develop the use of SDF as an adjunctive treatment modality for refugee children, thereby improving their quality of life and reducing the need for emergency dental treatment.
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Gout Self-Management App: eHealth Tool for People with Gout
Expand descriptionBackground: Gout is increasing despite effective therapies to lower serum urate concentrations to 0.36 mmol/L or less, which, if sustained, significantly reduces acute attacks of gout. Adherence to urate lowering therapy (ULT) is poor, with rates of less than 50% one year after initiation of ULT. Attempts to increase adherence in gout patients have been disappointing. Aims: We aim to evaluate the effectiveness of use of a personal, self-management, ‘smartphone’ application (app) to achieve target serum urate concentrations in people with gout. We hypothesise that personalised feedback of serum urate concentrations will improve adherence to ULT. Method: A prospective, cluster randomised controlled trial is conducted in primary care setting. GP practices are randomised to either intervention or control clusters with their patients allocated to the same cluster. The intervention group has access to the Healthy.me app tailored for the self-management of gout. The control group patients have access to the same app modified to remove all functions except the Gout Attack Diary. Outcome measures: Primary outcome is the proportion of patients whose serum urate concentrations are less than or equal to 0.36 mmol/L after 6 months. Secondary outcomes are proportions of patients achieving target urate concentrations at 12 months, ULT adherence rates, serum urate concentrations at 6 and 12 months, rates of attacks of gout, quality of life estimations and process and economic evaluations. The study is designed to detect a =30% improvement in the intervention group above the expected 50% achievement of target serum urate at 6 months in the control group: power 0.80, significance level 0.05, assumed ‘drop-out’ rate 20%. Conclusion: The study is being conducted. Involvement of GPs is essential to the management of people with gout in the community and in the evaluation of usefulness of new technology in primary care.
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Neurocognitive function, sleep and well-being in patients with Cystic Fibrosis with mild lung disease
Expand descriptionThis will be an observational study in CF patients with mild lung disease, examining the relationship between neurocognitive function and sleep parameters. Additional factors to be studied include hypoxemia, inflammatory markers, circadian rhythm and mood. CF participants will be tested at baseline, during and after lung exacerbation. Age and education matched non-CF controls will be invited to participate as well. Summary of tests to be performed at each visit: 1. Sleep study with high density EEG 2. Blood tests 3. Activity and oxygen monitoring with watches 4. Neurocognitive tests and Questionnaires.
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Frailty and health outcomes in older people initiating an oral anticoagulant
Expand descriptionThe primary objective of the study is to investigate whether frailty increases the risk of major haemorrhage / clinically significant non-major bleed in older patients initiating an oral anticoagulant. The secondary objectives are to investigate whether frailty is a risk factor for cessation of oral anticoagulants, stroke / VTE and the association between pharmacological risk factors ability to predict the primary and secondary outcomes will be investigated in frail and non-frail participants.
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A Phase I, Randomized, Placebo-Controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of single oral dose of HMPL-689 in Healthy Adult Participants
Expand descriptionThis study aims to assess the safety, tolerability and pharmacokinetics of HMPL-689 in healthy adult volunteers. Who is it for? You may be eligible to join this study if you are a healthy adult aged between 18 and 45 years. Study details This study is evaluating safety of a new drug known as HMPL-689, that could be used for treatment of autoimmune diseases and B-cell mediated malignancies, in healthy adults. Participants will receive a single dose of HMPL-689 or matching placebo on Day 1 of their admission into the Phase 1 unit. The planned dose levels are: 1, 2.5, 5, 10, 20, 25 and 30 mg (about 7 cohorts of 8 subjects). In each dose cohort, 8 subjects will be randomized to receive HMPL-689 (6 subjects) or placebo (2 subjects) under fed conditions with a standard meal. For the first dose cohort (1 mg), a group of 2 subjects (1 HMPL-689 and 1 placebo) will be dosed 24 hours prior to the planned dosing of the remaining 6 subjects. Decisions regarding escalation to the next dose or termination of the study will be made jointly by the principal investigator and the sponsor based on the clinical data (safety, tolerability, available PK data and clinical laboratory values) of each dose cohort. Any dose level maybe repeated or reduced if deemed appropriate by the Principal Investigator and Sponsor’s medical expert. The estimated study participation for each participant is approximately 5 weeks. Follow up and assessments performed over these 5 weeks include: a) Collection of medical history b) Alcohol breath testing c) Regular physical exams d) ECG and vital signs measurements e) Urine sample assessments for general heath, safety and testing for drugs of addiction f) Blood sample analysis for routine measurements including clinical laboratory safety testing and screening for HIV (AIDS virus), hepatitis and tuberculosis (TB) g) Semen sample analysis h) Pharmacokinetic blood sample collections to measure the amount of study drug in your blood i) Adverse events monitored throughout the treatment period j) Use of concomitant medications reviewed throughout the study
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Natural history of naevi and the use of dermatoscope for skin self assessment of naevi in adults in Brisbane, Australia
Expand descriptionThis study is about identifying what genetic differences and dermatological characteristics (such as form and structure of moles and eye/hair colour), are associated with skin cancers and who is at greatest risk. The study is also looking at how people conduct their own skin self-examinations. Who is it for? We will be contact people via letter off the Brisbane Electoral Roll. The letter will include a Information sheet and contact details in which the letter recipient can use to make an initial appointment to participate in the study. Study details: Participants will be required to attend the Princess Alexandra Hospital, Clinical Research Facility for an appointment that will involve questionnaires, skin examination and mapping of skin naevi using 3D total body photography in their underwear. The participant will need to provide a saliva sample in order to sequence their genomic DNA. We will also ask participants to conduct a skin self-examination every 3 months for the duration of the study (3 years). Half of the participants will be randomised to receive a dermatoscope attachment for their mobile phone to use in the self examinations. We will also require participants to attend follow up visits every 6 months for the duration of the study. These visits will involve a repeat of 3D total body photography to monitor skin naevi changes. We will also ask participants to consider donating benign naevi for excision and any residual tissue from suspicious lesions recommended for excision. Tissue donated will be used for additional molecular analysis of gene products and proteins known to be involved in melanoma development and progression. This aspect of the study is optional, and will not affect eligibility for the trial.
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An observation of perioperative temperature changes in patients undergoing surgery for femur neck fracture
Expand descriptionUnintended perioperative hypothermia, defined as a core body temperature less than 36 degree celsius is not uncommon in elderly surgical patient. In the operating theatre, a combination of altered thermoregulatory mechanisms induced by anaesthesia and cooler ambient temperatures cause a decrease in core temperature.Unintended perioperative hypothermia can result in increased complications such increased surgical site infection, adverse cardiovascular events, delayed recovery from anaesthesia, increased surgical bleeding, impaired immune function, prolonged recovery room stay and hospitalization and increased costs. Different modalities of warming patients have been suggested such as forced air warmers or Bair Huggers, warming intravenous fluids, pre-warming patients from 30 minutes before surgery, warmed cotton blankets, but on many occasions, they have not been very effectively used resulting in unintended hypothermia. Elderly patients are more prone to hypothermia because of increase in frailty, comorbidities, impaired thermoregulation with age. In the current study, we aim to study the changes to the body temperature in patients undergoing hip fracture surgery through the perioperative course .