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Assessment of Adjunctive Acetazolamide for Furosemide Treated Critically Ill Patients
Expand descriptionFurosemide (a loop diuretic) and Acetazolamide (a carbonic anhydrase inhibitor) are two commonly used diuretic drugs in the intensive care unit. Evidence suggests that giving Acetazolamide together with Furosemide has beneficial physiological effects. This multi-centre, cluster, crossover trial will assess a two-dose Acetazolamide regimen over 48 hours and focus on its physiological effects and evaluate patient outcomes, such as time spent in ICU and hospital. The trial will enrol approximately 144 patients from approximately 3 intensive care units in Australia and Japan. Each hospital will be randomly allocated to ‘Adjunctive acetazolamide’ arm or ‘Furosemide only’ arm. Each hospital will follow each Arm for a period of 6 months before swapping to the alternative regimen for 6 months. This is a crossover design. The trial will be complete in 12-months. Findings from this study will be used to improve diuretic management in the ICU and inform the design of future trials.
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A randomised controlled trial evaluating a mental health training refresher module for managers in the ambulance service
Expand descriptionThis randomised controlled trial is embedded into a parent controlled trial aimed at investigating the effectiveness of MindWise Leadership, an evidence-based mental health training program for people-leaders in the ambulance service. The parent controlled trial will be used to measure whether the MindWise Leadership training program, compared to a control group, will improve managers' and leaders' responsive behaviours, preventative behaviours, confidence, knowledge and stigma regarding employee mental health. It also aims to investigate whether any changes are sustained over a 12-month period. The current embedded randomised controlled trial will investigate the effectiveness of providing a short 15-minute online refresher training module at 6-months post-intervention for half of the intervention group. This refresher training will be delivered immediately following the 6-month data collection for the parent controlled trial to a random selection of the intervention of the parent-controlled study. This forms the intervention group for the embedded RCT described here. The other half randomly assigned to not receive the refresher module will form the control group for this embedded RCT. Outcomes measured 6-months after the refresher module (captured in the 12-month data of the parent-controlled trial) will be compared to evaluate whether this top-up training module will promote participants outcomes at 12-months post-intervention. The research questions that this research seeks to address are: 1. Does this refresher training module at 6-months post-intervention improve leaders’ responsive and preventative behaviours at 12-months post-intervention? 2. Does this refresher training module at 6-months post-intervention improve leaders’ confidence addressing mental health matters in the workplace at 12-months post-intervention? 3. Does this refresher training module at 6-months post-intervention reduce mental health stigma among leaders in the ambulance service at 12-months post-intervention? 4. Does this refresher training module at 6-months post-intervention improve workplace mental health knowledge among leaders at 12-months post-intervention?
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COMparative Pharmacotherapy And peRsonalised stratEgy in the management of Coronary Microvascular Dysfunction double blind randomised controlled Trial - Part 1
Expand descriptionCoronary artery disease(CAD) is the leading cause of death in Australia, with 10 - 15% of the patients suffering from debilitating angina(chest pain), a prominent CAD symptom. While obstructive CAD is well understood, coronary microvascular dysfunction(CMD), a disorder of the small coronary vessels is under recognised, but now acknowledged as a major contributor to patient’s symptoms. It disproportionately affects women & is linked to impaired quality of life, high healthcare utilisation($1.5 billion/year) & worse outcomes. Despite its significant burden, CMD remains undertreated, with international guidelines highlighting major evidence gaps, with no consensus on 1st & 2nd-line therapies. With no established treatment framework & limited clinician guidance, many patients receive sub optimal management - often empirical with a one-size-fits-all approach leading to debilitating symptoms, polypharmacy, financial strain & rehospitalisations. This represents a critical failure in equitable cardiovascular care. Part 1 will compare the acute effects of commonly prescribed cardiovascular drugs on microvascular function using invasive, gold-standard physiological indices to identify optimal therapies, thereby identifying 1st/2nd line therapies.
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COMparative Pharmacotherapy And peRsonalised stratEgy in the management of Coronary Microvascular Dysfunction double blind randomised controlled Trial - Part II
Expand descriptionCoronary artery disease(CAD) is the leading cause of death in Australia, with 10 - 15% of the patients suffering from debilitating angina(chest pain), a prominent CAD symptom. While obstructive CAD is well understood, coronary microvascular dysfunction(CMD), a disorder of the small coronary vessels is under recognised, but now acknowledged as a major contributor to patient’s symptoms. It disproportionately affects women & is linked to impaired quality of life, high healthcare utilisation($1.5 billion/year) & worse outcomes. Despite its significant burden, CMD remains undertreated, with international guidelines highlighting major evidence gaps, with no consensus on 1st & 2nd-line therapies. With no established treatment framework & limited clinician guidance, many patients receive sub optimal management - often empirical with a one-size-fits-all approach leading to debilitating symptoms, polypharmacy, financial strain & rehospitalisations. This represents a critical failure in equitable cardiovascular care. PART II will assess if personalised treatment based on coronary function testing will improve patient symptoms compared to physician directed care.
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A pilot study evaluating whether the Growing Minds Check-In for Young People (GMCI-Y) is acceptable and improves help-seeking behaviour, intentions & efficacy in adolescents
Expand descriptionThis research will conduct a pilot randomized controlled trial (RCT) of the Growing Minds Check-In for Young People (GMCI-Y), a universal online mental health check-in and referral tool that involves young people answering questions about their mental health and wellbeing, receiving automated feedback based on their responses and recommendations for evidence-based programs, services, and information matched to their need. It is expected that the pilot RCT will show that the GMCI-Y is acceptable as an intervention, based on responses to satisfaction and usefulness questions, and that at one-month follow-up the intervention group, relative to the waitlist control group, will be more likely to show an increase in mental health help-seeking intentions, have actively sought help for their mental health (i.e., help-seeking behaviour), and show an increase in mental health help-seeking efficacy (i.e., knowledge and ability to seek help).
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The FAME 2 Kidney trial is a study of whether fenofibrate is able to slow kidney disease progression in adults with type 2 diabetes with moderate kidney damage
Expand descriptionThe FAME 2 Kidney study is a large international clinical trial testing whether a low-cost, once-daily medication called fenofibrate can slow kidney damage in people with type 2 diabetes and moderate chronic kidney disease. Researchers believe fenofibrate may help protect kidney function and reduce other diabetes-related complications, compared to a placebo.
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HILINER: Randomised Control Trial to determine the optimal dosing of radioactive iodine dosing in Intermediate/High risk papillary thyroid cancer
Expand descriptionThis study aims to evaluate whether treatment with 1 GBq of radioactive iodine (RAI) is as effective as 4 GBq of RAI in patients with intermediate-risk or high-risk papillary thyroid cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with non-metastatic papillary thyroid cancer, and your cancer has been determined to be BRAF-positive (a specific genetic sub-type of this cancer). Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two treatment groups. Participants allocated to the first group will be asked to take a 1 GBq dose of radioactive iodine. Participants allocated to the second group will be asked to take 4 GBq dose of radioactive iodine. Participants in both groups will then be asked to complete blood tests and imaging of their thyroid every 3 months after their first dose for a 12 months. It is hoped this research will determine whether a 1 GBq dose of RAI is as effective or at least not any less effective than 4 GBq of RAI. If this study shows that a low dose of RAI is as effective as a high dose of RAI, this may be expanded to a larger study involving more patients with papillary thyroid cancer.
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While We Wait: Finding hope and support for adolescents waiting for mental health treatment
Expand descriptionThis pilot study is testing a new support service called "While We Wait", designed specifically for adolescents aged 14 to 17 years who are waiting for mental health treatment as referred by their General Practitioner (GP). The study will explore whether this new service is practical to deliver, whether young people, their families, and GPs find it helpful and easy to use, and whether it provides any early psychological benefits or causes any problems. The research team will focus on the feasibility and acceptability, preliminary benefits to mental health, as well as the safety of the intervention.
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A randomised trial of an intervention to sustain Physical Activity for Everyone (PA4E1) program delivery in secondary schools
Expand descriptionThis study will evaluate whether low-intensity support helps schools sustain delivery of the Physical Activity 4 Everyone (PA4E1) program—a proven initiative supporting schools to implement seven practices that boost student physical activity. We will compare schools receiving light touch sustainment support to those receiving usual support, assessing how many physical activity practices are maintained at the end of active implementation (baseline), and at 12- and 24-month follow-ups.
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Randomised controlled trial on GLP-1 agonists in acute pulmonary embolism with insulin resistance and obesity: a proof-of-concept study.
Expand descriptionPulmonary embolism (blood clots in the lungs) is a common, potentially life-threatening condition affecting 50 to 75 per 100,000 people each year in Australia. The current long-term treatment of blood clots is limited to blood thinners alone, and there are no other studies investigating different treatment approaches. Mechanisms that determine persistence of blood clots in the lung blood vessels despite adequate blood thinning treatment remain unknown. Inflammation within the blood vessel walls following a blood clot seems to be an important driver of impaired clot resolution, but treatments targeting inflammation within the blood vessels are limited. Glucagon-like peptide-1 (GLP-1) agonists, which are commonly used in diabetes treatment, have prominent anti-inflammatory and blood vessel relaxation properties supporting their use in patients with lung blood clots at higher risk of worse outcomes. The purpose of this study is to test a novel treatment approach with a once-a-day medication (Liraglutide), in hospitalised patients with acute lung blood clots.