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A protocol to standardise intravenous fluid therapy after cardiac surgery
Expand descriptionThe purpose of this study is to identify if introducing a protocol to standardise post-cardiac surgery fluid resuscitation can reduce the amount of intravenous fluid administered and potential patient harm. By using a protocol and the calculated mean systemic filling pressure analogue, the amount of intravenous fluid received post-cardiac surgery can be restricted.
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The Efficacy, Safety and Tolerability of Oral NP202 in Adults who have Paroxysmal Atrial Fibrillation and a Cardiac Device
Expand descriptionNP202 has been shown to reduce rhythm disturbances in heart muscle in the ventricles, and it is compelling to discover if it similarly reduces rhythm disturbances in heart muscle in the atria. As AF is the most common rhythm disturbance in the atria, it is the most suitable target to investigate a benefit. This is a single-centre, randomised, double blind, placebo controlled study to assess the efficacy, safety and tolerability of NP202. Subjects will be screened during routine interrogation of their cardiac device. Eligible subjects will have a high burden of paroxysmal atrial fibrillation. They will be randomised and administered their first dose of investigational product (IP) on Study Day 1. Subjects will take their IP dose once a day for 1 month (30 days). During this treatment period they will return to the site for study visits at Week 2, and Months 1, 2, and 3. Month 3 is the end of the Treatment Period. Subject will return for follow up and the final study visit at Month 4. A Data Monitoring Committee (DMC) will review safety data at agreed recruitment and progression milestones to provide independent oversight of subject safety. Armaron Bio Pty Ltd has provided the study drug at no cost. They have not have provided any funding and the study investigators have full intellectual property and rights over the study data.
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Breath-Hold in Abdominal & Lung Cancer Radiotherapy - Tumour Reproducibility, Tumour Stability & Patient Experience
Expand descriptionThis aim of this study is to compare three breath hold techniques for radiotherapy in patients with liver, kidney, adrenal, pancreatic or lung tumours. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are eligible for radiotherapy treatment to the liver, kidney, adrenal gland, pancreas or lung. Study details Non-lung cancer participants will undergo three breath hold techniques in a random order: exhale breath-hold (EBH); inhale breath-hold (IBH) and deep-inhale breath-hold (DIBH). Participants with lung cancer will undertake the DIBH technique only. The patient breathes through an Active Breathing Coordinator machine, which automatically stops air flow when the correct volume of air is measured. Exhale Breath Hold requires the patient to breathe out and hold their breath. Inhale Breath Hold requires the patient to breathe in and hold their breath. Deep Inhale Breath Hold requires the patient to take a deep breath in and hold their breath. X-Ray images will be taken while the patient holds their breath, to measure the stability and reproducibility of their tumour. Patients will also be asked to complete a questionnaire to assess their experience of the breath-hold technique(s). It is hoped that we can determine the best techniques to enable delivery of high dose radiation to the tumour, while minimising the radiation dose to healthy organs.
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Improving quality of life and mental health using a music engagement program people for aged-care residents with Alzheimers disease and dementia
Expand descriptionThis single group trial aims to evaluate the effectiveness of a music engagement program in improving quality of life and depression in aged-care residents with Alzheimers disease and dementia. We hypothesise that residents' indicators of quality of life (including feelings of social connectedness to others and emotional mood) will improve from pre to post session. We also hypothesise that residents' symptoms of depression will improve from pre- to post-intervention (8 weeks).
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HI-LO Trial in Lymphoedema – What is the optimal pressure for compression garments prescribed to women with upper limb lymphoedema
Expand descriptionThe purpose of this study is to provide some preliminary data on the impact of different levels of compression on lymphoedema. Who is it for? You may be eligible for this study if you are over 18, have completed breast cancer therapy (except hormone treatments) at least 6 months ago and have been diagnosed with secondary arm lymphoedema. Study details Participants in this study will be randomised (by chance) into two groups. All participants will wear a compression garment for 12 hours a day for 6 months and will be a sleeve and gauntlet. You will be measured for these by a certified lymphoedema therapist. One group will wear a high compression garment, and the other will wear a low compression garment. Participants will have the garments checked after one week, two months and 4 months of wear; as well as have some scans, undergo some measurements and complete a questionnaire before and after the 6 month trial. It is hoped this research will provide important preliminary information as to what the optimal level of compression is for people with secondary arm lymphoedema.
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Evaluating the effectiveness of a video-based online intervention in reducing depression and anxiety in adults
Expand descriptionThis trial will test the effectiveness of a brief, video-based online program for reducing depression and anxiety in Australian adults (FitMindKit). Those with elevated psychological distress will be invited to participate and randomised to use either FitMindKit or a comparable general health online program (HealthWatch) for a period of 4 weeks. FitMindKit is an online program that uses brief therapeutic modules to reduce symptoms of common mental disorders (major depression, anxiety disorders, substance use disorders). The intervention consists of 12 modules adapted and abridged to encapsulate CBT-based therapeutic techniques, such as behavioural activation, cognitive reframing, problem solving, and mindfulness. Participants will complete brief pre- and post-program questionnaires, and will receive weekly e-mail reminders to use FitMindKit or HealthWatch. Outcome measures include depression and anxiety symptoms. It is hypothesised that those who receive the FitMindKit program will show significant reductions in depression and anxiety symptoms relative to those in the control condition post-intervention. It is also hypothesised that greater adherence to the intervention (number of modules completed) will be observed in the intervention group relative to the control group, and that greater adherence will be associated with greater reductions in depression and anxiety symptoms post-intervention among those who receive the FitMindKit program.
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A Dismantling Study of Dialectical Behaviour Therapy (DBT) Skills: Investigating the Effectiveness of Distress Tolerance, Emotion Regulation, and Interpersonal Effectiveness Skills Groups
Expand descriptionThis dismantling study will examine the effectiveness of the three DBT skills modules - distress tolerance, emotion regulation and interpersonal effectiveness - on distress tolerance skills, emotion regulation skills, and interpersonal skills, in a sample of patients with Borderline Personality Disorder (BPD) in three adult mental health services in Queensland, Australia. It will further analyse the differential and combined effects of these modules on symptoms of BPD. We hypothesise that patients who participate in the skills modules will show specific improvements in the domains that the skills are designed to address.
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Positive End-Expiratory Pressure (PEEP) Levels during Resuscitation of Preterm Infants at Birth (The POLAR Trial).
Expand descriptionThis multicentre randomised controlled trial will determine how best to apply Positive End-Expiratory Pressure (PEEP) to support the preterm lung during stabilisation (‘resuscitation’) at birth. PEEP is a proven therapy that helps preterm babies breath but what PEEP levels to use is unknown. Currently PEEP levels of 5-6 cmH2O are usually used, but increasing evidence suggests that higher PEEP levels than this are initially needed immediately after birth. We hypothesise that in preterm infants born between 23 and 28 weeks post menstrual age, a high, dynamic PEEP strategy (PEEP 8-10 cmH2O individualised to clinical need) as compared to a standard, static PEEP of 5-6 cmH2O during stabilisation at birth, will 1) increase survival without bronchopulmonary dysplasia, 2) reduce the failure of non-invasive respiratory support in the first 72 hours of life (co-primary outcomes), and 3) reduce rates of common neonatal morbidities (secondary outcomes).
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Pilot testing the usability and acceptability of an online decision aid for women considering egg freezing for non-medical reasons.
Expand descriptionConceiving before natural fertility declines is impossible or unsuitable for some women, which may lead to missed opportunity due to age-related infertility. Egg freezing can extend a woman's reproductive lifespan, however the decision to freeze is complex and requires consideration of a number of different factors. A decision aid (DA) may assist women to make an informed decision about egg freezing, as it aims to provide unbiased and balanced information about the positive and negative aspects of egg freezing and its alternatives. This study aims to evaluate whether an online DA is acceptable and useful for women considering egg freezing. To be eligible to participate in this study: - You are female and aged between 18-45 years; - Interested in receiving egg freezing information (even if you have already frozen your eggs or made a decision about egg freezing); - Live in Australia, and; - Able to read English well. Participants will be given access to the online DA by the Research team, and asked to read through the website over a two week period. Participants will also be asked to complete two surveys (one before, and one after being provided with access to the DA). Each survey will take about 10-15 minutes to complete.
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Functional Outcomes following a Road Traffic Crash
Expand descriptionThe disability associated with a minor to moderate injury sustained in a road traffic crash (RTC) can have a significant impact on a range of life domains, one of which is returning to paid employment. This inception cohort study will follow people injured in a road traffic crash (RTC) from within 28 days of injury over 12 months. It is intended that multiple hospital health services will be recruited across Queensland. Participants will also be recruited through print and social media. The specific aims of the study are as follows: • Aim 1: To plot the trajectory of recovery of vocational and functional outcomes following RTC • Aim 2: To explore associations between key sociodemographic, injury, quality of life, physical activity, symptomatic, and psychosocial wellbeing factors with vocational and functional outcomes at 6 and 12 months • Aim 3: To determine the factors that predict vocational and functional outcomes at 6 and 12 months, for people who had been working prior to RTC • Aim 4: To determine the factors that predict functional outcomes at 6 and 12 months, for people who had not been working prior to RTC • Aim 5: To explore the pattern of objectively measured physical activity changes in a subgroup of participants at baseline, 6 and 12 months