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A Phase 1, Double-Blind, Randomized, Placebo-controlled, Single Ascending Dose Study of Flecainide Acetate Inhalation Solution to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers
Expand descriptionPart A: A single inhaled dose of flecainide acetate inhalation solution or placebo inhalation solution will be administered per participant in the dose escalation part of the study. Single ascending doses will be administered in a sequential ascending manner from Cohorts 1 through to 4. Part B: The open label crossover part of the study consists of two Periods, Period 1 and Period 2. In Period 1 the administration of flecainide will be via inhalation, whereas in Period 2 the administration of flecainide will be intravenous. The two Periods will be separated by a 10 day washout period. In Part C, six participants will be enrolled, in a cross-over arrangement where two different sources of compressed medical air will be compared using the AeroEclipse XL device to deliver an inhaled flecainide acetate dose of up to 60 mg. Update 2: Part C was not completed.
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Connecting Rural Children to Therapy Supports: A Trial of Telepractice for Allied Health Service Provision
Expand descriptionChildren with disability living in rural and remote communities often do not receive the allied health therapy services they need to live the best life possible. Telepractice, or the delivery of therapy services via videoconferencing, has much potential for spreading therapists’ reach into rural Australia. However, little is known about how telepractice can be used to work effectively with children with disabilities. In this study, we aim to investigate the feasibility, acceptability, and outcomes of telepractice provision of allied health therapy services to children with disability living in rural and remote communities in Australia. Fifteen children and their parents/legal guardians will receive assessment and therapy services from an occupational therapist and/or speech pathologist via videoconferencing, connecting to therapists via web-cam equipped device in their home or other setting. Telepractice models will vary across children as negotiated with parents. e.g., location, number, duration, and frequency of sessions will be tailored to children’s needs. Case study methodology utilizing mixed methods will be used to gain insights into the unique settings and circumstances of each individual child, their family, and community, and how these impact on telepractice. We will collect data about (a) effectiveness of telepractice by examining children’s attainment of therapy goals after completing a telepractice therapy episode; (b) acceptability of telepractice delivery of therapy services to parents/legal guardians, allied health professionals, and other stakeholders, via interviews; (c) feasibility of telepractice by examining assessment and treatment process data routinely collected by allied health professionals throughout the duration of a telepractice therapy episode. This research will reveal the essential components of telepractice models needed to achieve outcomes for children and their families, and will demonstrate the potential of technology for addressing inequalities experienced by rural children in accessing quality allied health therapy services.
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Women's Wellness Program: An e-Health lifestyle intervention for mid-life women living with type2 diabetes
Expand descriptionPrimary purpose of the study is to deliver an e-Health 12 week lifestyle intervention to Women with type 2 diabetes. Primary aim is to improve health related quality of life. secondary aims are to reduce BMI, increase physical activity, and improve diabetes management self efficacy. Hypothesis is that women undertaking this intervention will improve in these aspects of their life through coaching with the registered nurse and access to evidence based information provided in the I-Book and through the interactive website they have access to.
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A randomised clinical trial to evaluate the effects of continuous positive airway pressure (CPAP) on nocturnal beat to beat blood pressure and vascular function
Expand descriptionIn order to better assess the role of CPAP in mitigating cardiovascular risk factors of participants with obstructive sleep apnoea (OSA), this study aims to assess the effect of a night of active and a night of sham CPAP on beat to beat blood pressure and vascular function. To measure vascular function, non-invasive and benign ultrasound based techniques will be used to assess peripheral artery vascular function in the brachial artery, along with intracranial arterial function utilising transcranial Doppler assessments. Finally, we will measure urinary catecholamines from urine collections pre and post sleep. Blood pressure will be monitored continuously throughout the night using a finapress device while participants are simultaneously having their sleep monitored by polysomnography. The results of this study have the ability to further understand the physiological effects of missing one night of CPAP treatment in patients with OSA.
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A Prospective observational trial to assess if thromboelastography (TEG) can be used to predict blood culture results in clinically septic patients.
Expand descriptionThis study will examine if there are changes in coagulation which can be detected by TEG that occur in patients with a bacteraemia before it has been detected in blood cultures. The benefits of being aware of these potential changes may include earlier consideration of non-infective causes of SIRS and altered antibiotic prescribing practices. In contrast, early identification of a potentially life-threatening infective process that is responsible for the SIRS presentation is essential to ensure ‘ideal outcomes’ for patients (1). It is a common and important clinical challenge to distinguish between those patients who have sepsis and those who have SIRS. A hypocoagulable state in sepsis is thought to be associated with increased mortality. Specifically, impaired fibrinolysis may be associated with a diagnosis of sepsis versus SIRS (2). On admission to ICU, patients generally have a set of routine admission bloods sampled; these may include full blood count, electrolytes, renal and hepatic function and a coagulation profile. Routine blood tests may also include blood cultures if the patient is thought to be septic. However, the routine coagulation profile sent to pathology is thought to provide limited clinical information when assessing in vivo hypocoaguable changes (2). Research has demonstrated that TEG parameter changes throughout an episode of sepsis may provide some predictive value for mortality and risk of bleeding (3). Recent research has aimed to identify early TEG parameters that may predict a positive blood culture result (4). The aim of our study is to identify blood changes detected by TEG that may indicate whether a patient has sepsis or a non-infective cause for SIRS. References; 1. Simpson S. New Sepsis Criteria; A change we should not make. Chest. 2016; 149(5). 2. Muller MC, Meijers JCM, Vroom MB, Juffermans NP. Utility of thromboelastography and/or thromboelastometry in adults with sepsis: a systematic review. Critical care (London, England). 2014; 18(1):R30-R. 3. Haase N, Ostrowski SR, Wetterslev J, Lange T, Moller MH, Tousi H, et al. Thromboelastography in patients with severe sepsis: a prospective cohort study. Intensive Care Medicine. 2015; 41(1):77-85. 4. Grant HW, Hadley GP. Prediction of neonatal sepsis by thromboelastography. Pediatric Surgery International. 1997; 12(4):289-92.
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Improving independence in driving for people with Autism Spectrum Disorder
Expand descriptionIndividuals with autism spectrum disorders (ASD) face social and cognitive difficulties that affect their ability to establish relationships, maintain employment and participate in community activities. Difficulties in community mobility act as barriers to their social inclusion. Driving is often difficult for people with ASD, as it requires the individual to make quick decisions and solve problems in response to road conditions and unpredictable traffic. There is currently a lack of understanding on how learner drivers with ASD read and respond to traffic and hazards on the road. The problem is further confounded as there are currently no established standards in Australia for assessing driving behaviours. The aim of the proposed research is to address community mobility challenges experienced by young adults with ASD by designing, pilot testing and evaluating the feasibility, appropriateness and effectiveness of an ASD-specific driver training package in supporting learner drivers with ASD to obtain a driver’s license and maintain on-road safety. The driving project will involve four studies. The Randomised-Controlled Trial study is the last study of this project with the aim to test the effectiveness and appropriateness of the ASD-specific driver training package: - Reducing the number of attempts learner drivers with ASD take to successfully obtain a provisional licence. - Reducing the number of face-to-face practice training sessions learner drivers with ASD require before obtaining a driver’s licence. - Improving driving behaviour, hazard perception skills and attitude to risk taking of learner drivers with ASD. - Improving learner drivers’ reflection on their driving.
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The impact of studying a new language and health-related lifestyle recommendations on thinking abilities and biomarkers in older individuals with memory complaints.
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Optimizing hyperglycaemia management in the Acute Medical Unit: investigation of barriers to achieving adequate glucose control in patients with diabetes in the acute medical setting; introduction and evaluation of tools to assist clinicians in prescribing insulin
Expand descriptionIt is very common for people with diabetes to require admission to hospital, sometimes for reasons that are unrelated to diabetes. In the Acute Medical Unit at the Launceston General Hospital, over 50% of the patients admitted have diabetes. There is evidence that people with diabetes admitted to hospital for most illnesses are more prone to develop complications and take significantly longer to recover. This is thought to be related to their blood glucose levels being higher than normal: being unwell, eating different foods, changes to medications, stress, pain and having reduced physical activity can all result in high blood glucose levels. Managing diabetes in these circumstances can be difficult, and many doctors, especially junior medical staff, do not have enough experience in prescribing insulin to be able to keep the patient’s blood glucose levels under good control. We plan to introduce tools into the Acute Medical Unit that will improve the way patients with diabetes are currently managed: these tools consist of a specialized chart for prescribing insulin and specific education on how to control glucose levels in acutely ill patients. We will measure the effect of this intervention by collecting information on blood glucose levels in patients in the Acute Medical Unit before and after the new tools are introduced, as well as surveying patients for their opinions on their diabetes care at both time points. We will also determine if our intervention has changed the attitudes of doctors to managing diabetes in their acutely ill patients. Our objective in carrying out this project is to improve outcomes for patients with diabetes who are admitted to the Acute Medical Unit: we anticipate that our intervention can achieve this, with significant benefits to the patients themselves and also potentially to hospital healthcare costs.
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Investigating the psychological and speech effects of adding Internet anxiety treatment to speech restructuring treatment with adults who stutter.
Expand descriptionAnxiety-related mental health disorders, particularly social anxiety disorder, are common comorbid conditions among adults who stutter. Our research has discovered that social anxiety disorder and other DSM-V disorders involving anxiety prevent effective speech treatment for adults who stutter. We have developed and trialled an innovative Internet cognitive behaviour therapy (CBT) program specifically designed to target the social anxiety experienced by people who stutter. This CBT program has been shown to reduce the social anxiety experienced by adults who stutter and even eliminate social anxiety disorder diagnoses. The proposed study aims to investigate whether access to an Internet cognitive behaviour therapy (CBT) program immediately after completing treatment designed to reduce stuttering behaviours, improves speech and/or psychological outcomes. The research will be a randomised clinical trial of speech restructuring treatment alone or speech restructuring treatment plus Internet-based CBT treatment for adults who stutter. The outcomes of this research will generate new knowledge about the benefits of concurrently controlling the speech problems and the anxiety related mental health disorders of adults who stutter.
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Effect of High Flow Tracheostomy Device for weaning from Mechanical Ventilation
Expand descriptionThe weaning of long term tracheostomised ICU patients from prolonged mechanical ventilation can be difficult, challenging and at a great financial cost to the health care institution. Humidified oxygen can be delivered via a humidified t-piece at up to 15 litres a minute but this is unlikely to offer any benefit in terms of generating positive airway pressure and increasing end expiratory lung volume.The High flow tracheostomy device (HFT) allows the delivery of warmed, humidified oxygen at a prescribed fraction of inspired oxygen (FiO2) at flow rates much higher than previously allowable with other delivery systems. The use of this method of oxygen and flow delivery in weaning off mechanical ventilation is becoming more common in our ICU and there is a real need to determine if this therapy generates positive airway pressure and increases end expiratory lung volume; to quantify these changes; and also to determine if this treatment has any clinically relevant benefit which will lead to improved outcomes for these patients. Electrical Impedance Topography (EIT) is a relatively new non-invasive radiation-free imaging technique which can be used easily and safely at the bedside to provide real-time dynamic images of regional lung ventilation. Changes in end-expiratory lung impedance (EELI) as measured by EIT have been shown to have a strong linear correlation with changes in end-expiratory lung volume (EELV). Therefore, it will be possible to assess both pressure and volume simultaneously within the lung. This study aims to determine if HFT has any clinically relevant benefit in weaning patients from mechanical ventilation by assessing whether this treatment provides positive airway pressure and an increase in EELV, in addition to assessing their effects on oxygenation, respiratory rate and subjective scoring of dyspnoea