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A randomized pretest-posttest waitlist-controlled trial to examine the effects of an online mindfulness-based intervention.
Mindfulness-based interventions are interventions that aim to address the causes of psychological stress and the pathways to relieving it (Crane et al., 2016). Furthermore, mindfulness-based intervention we will be evaluating is endorsed as a stress reduction program specifically for student populations (Monash University, 2020). For these reasons, the primary aim of the current study is to evaluate the effect of Mindfulness for Wellbeing and Peak Performance on psychological stress in a non-clinical (i.e., healthy) sample of tertiary education students. The chosen research design will be a pragmatic randomized pretest-posttest waitlist-controlled study, which will yield an unbiased estimate of the effect of this intervention on this dependent measure. A second exploratory aim of this study will be to evaluate the effect of this intervention on secondary outcomes, including mental health outcomes associated with stress (e.g., wellbeing, depressive symptoms, anxiety symptoms), physical health factors (e.g., sleep quality), interpersonal factors (e.g., loneliness), and factors that have been associated with improvements in mental health (e.g., mindfulness, emotion regulation strategies, self-compassion, and self-esteem). This study will be critical to determine whether participation in Mindfulness for Wellbeing and Peak Performance in a manner that is generalizable to typical usage in the target population is associated with the type of salutary mental health outcomes that are typically reported in more established mindfulness-based interventions, and which are claimed of this intervention in the course outline.
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The effects of an Ocimum tenuiflorum (Holy Basil) extract on perceived stress, mood, sleep, and the stress response in healthy adults experiencing high stress
In this randomised, double-blind, placebo-controlled study, 100 adults experiencing high stress and sleep difficulties will be randomly assigned to receive capsules containing either an Ocimum tenuiflorum (Holy Basil) extract (125 mg twice daily) or a placebo for 8 weeks. We will assess change in stress levels, general mood, sleep quality, and quality of life via several validated self-report measures. We will also examine change in sleep quality and resting heart rate using a wrist-word device (Fitbit) that will be worn for 8 weeks. Group differences in hair cortisol concentrations collected at week 8 will also be examined. At week 8, participants will be exposed to an experimental stress procedure known as the Maastricht Acute Stress Test (MAST). We will assess group differences in salivary cortisol, a-amylase, blood pressure, pulse rate, and mood ratings during and after this procedure.
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INNA-051 intranasal safety and tolerability study
INNA051 is being developed as a prophylactic against SARS-CoV-2 (coronavirus). This is the first in human trial of INNA051 and will test increasing doses of study drug for safety and tolerability, and to measure how the immune system responds.
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PharmacoKinetic modelling for Antibiotics and Antifungals in Paediatric Patients on Life-saving therapies (Extracorporeal Therapies) - Phase 1 and 2
The aims are to characterise key antimicrobials (cefotaxime, vancomycin, meropenem, ampicillin, gentamicin, piperacillin-tazobactam, flucloxacillin voriconazole, fluconazole, micafungin, ceftazidime, anidulafungin & teicoplanin) pharmacokinetics (PK) in critically ill children on extracorporeal membrane oxygenation (heart and/or lung support) & continuous renal replacement therapy (kidney support). We aim to design dosing regimens that will be optimised, to achieve maximal effective antimicrobial exposure. Participants will be critically ill children in the Paeditric Intensive Care Unit at Queensland Children's Hospital & University Children's Hospital, Zurich. Method: A prospective observational antimicrobial PK study of critically ill children on extracorporeal therapies. The PK analysis will be performed using a population PK modelling approach P-Metrics 3.5.1 using the concentrations from the patient plasma samples. Building PK models will include an assessment and correlations between the extracorporeal therapy settings, developmental factors and/or clinical factors for each child. Expected outcomes: Improved, optimised antimicrobial dosing treatment regimens for children on extracorporeal therapies.
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Can robotic technology assist children with cerebral palsy after botulinum toxin injection?
Botulinum toxin to treat lower limb hypertonia has been shown to benefit children with cerebral palsy when coupled with therapy. There is little consensus on the details of the therapy regimes. There is concern about the potential effects for the Botulinum toxin to produce significant atrophy in the muscle, felt to be related to repeated injections. Efforts to limit the number of injection episodes by prolonging the effects of the toxin should be explored. This study aims to investigate if the duration of effect of Botulinum toxin injection in the legs of children with cerebral palsy differ with robotic-enhanced therapy compared to conventional therapy. The study will also investigate whether robotic-enhanced therapy is judged to be more or less engaging and fun for participants, and if it is cost effective.
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Confirmatory Phase III study of Nasodine Nasal Spray (povidone-iodine 0.5%) as a symptomatic treatment for early stage common cold in the natural setting.
This research project is being conducted to determine whether treatment with Nasodine Nasal Spray reduces the severity of the common cold when given within 36 hours of symptom onset and over 5 consecutive days, multiple times a day.
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Development and Evaluation of A Digital Version of the REsilience Activities for every DaY (READY) Program for Adults with Multiple Sclerosis
The purpose of this project is to evaluate a digital version of an empirically supported group resilience-training program for adults living with multiple sclerosis (MS) called REsilience Activities every DaY (READY) for MS. The program was developed by researchers at University of Queensland (UQ) and is designed to teach resilience skills for managing life challenges. It is based on acceptance and commitment therapy (ACT), which is a recent variant of the well-established cognitive and behaviour therapy. The project involves a collaboration between UQ and two industry partners: a patient support organisation (Partizan Worldwide Pty Ltd) and a pharmaceutical company, Biogen Australia Pty Ltd. It is predicted that compared to people with MS on a waitlist, those who participate in the READY program will report significantly greater improvements in resilience, quality of life and distress.
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Agomelatine in Depression: An Open-Label Study of Agomelatine in Adults with Major Depressive Disorder
This is an open-label study of adjunctive treatment with agomelatine in adults with major depressive disorder. This study aims to understand the biological correlates and consequences of agomelatine treatment.
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Sleep parameter validation of a consumer home sleep monitoring device, EMFIT Quantified Sleep (QS), against Polysomnography
Current research provides strong support that there is a relationship between sleep disturbances and developing many diseases, such as cardiovascular diseases and dementia. This highlights the key role of sleep monitoring in identifying important changes in individual’s sleep at a very early stage. The EMFIT QS (Quantified Sleep), an unobtrusive, contact-free sleep monitoring device, is used for tracking the changes in individual’s sleep. This device provides heart and respiration rate measurements, a sleep stage estimation, sleep quality analysis, and heart rate variability. This study is an open label pilot trial to determine sensor validation.
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Adelaide Stroke Incidence Study - 2
The last Adelaide Stroke Incidence Study (ASCEND) was carried out for 12 months between 2009 and 2010, sampling the western suburbs of Adelaide. We are 10 years on, and significant changes to the delivery model of stroke care in South Australia has occurred. Newer acute therapies and primary prevention methods, with shifting demographics make a repeat study necessary. A repeat population based study in South Australia (SA) will allow: 1. Identification of current Stroke incidence, outcome, recurrence rates and aetiology in SA. 2. Comparison to other Australian and International incidence studies – Are we still providing good quality care? 3. Comparison to initial ASCEND population – Are our primary prevention strategies well targeted? Is stroke incidence and aetiology evolving? Are risk profiles changing and are we managing risk better? 4. Evaluating future burden of stroke in SA for better directed resource allocation. 5. Identifying gaps in our current model of hyperacute stroke care provision. Are we missing out on revascularisation opportunities of Large Vessel occlusion strokes? 6. Understanding of how evolving demographics is modifying stroke incidence and risk profiles. 7. Comparison of Coded stroke aetiology to Trial of ORG 10172 in Acute Stroke Treatment (TOAST); Atherosclerosis, Small vessel disease, Cardioembolism, Other, Dissection (ASCOD) criteria and causative classification system (CCS) criteria. 8. Investigating the embolic stroke of undetermined source population for rates of symptomatic non-stenotic carotid disease (SyNC) to see if this may be a potential under-reported aetiology that warrants a different treatment paradigm. Expressed in the null, our main hypothesis is that in South Australia (SA), the age adjusted incidence of stroke will be similar to that reported 10 years ago in a similar population. In summary, a repeat Adelaide stroke incidence study, will allow an accurate contemporary classification of stroke incidence, risk profiles, subtypes and outcomes assisting in judicious delivery of primary prevention, hyperacute, subacute and rehabilitation stroke services in SA and nationally