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Embolization of the Middel Meningeal Artery (MMA) with NVS-1 System for treatment of chronic Subdural Hematomas (cSDHs)
Expand descriptionChronic subdural hematoma (cSDH) is a common condition, especially in older adults, where blood slowly collects on the surface of the brain. This can cause headaches, confusion, weakness, or other neurological symptoms. Current treatments often involve surgery, such as drilling small holes in the skull to drain the blood. However, surgery carries risks and the hematoma can sometimes come back. This study will test a new minimally invasive treatment called the NVS-1 System. In this procedure, doctors use a very thin tube (NVS-Catheter1) inserted through an artery in the groin or wrist to reach a small vessel called the middle meningeal artery (MMA), which supplies blood to the membranes around the hematoma. A liquid material called NVS-Gel1 is injected through the NVS-Catheter1 and then solidified using a special light (NVS-Laser1) delivered inside the artery. This is designed to safely block the blood flow to the membranes that cause the hematoma, with the goal of reducing or eliminating the hematoma without the need for open surgery. This is the first time the NVS-1 System will be used in people. The study will include up to ten patients at Gold Coast University Hospital. The main goal is to evaluate safety and effectiveness of the NVS-1 System. Patients will be followed for 90 days with CT scans and clinical assessments to check for hematoma resolution and improvement in symptoms.
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An Integrated Phase 1a/1b, First-in-human, Randomized, Double-blinded, Placebo-controlled Split-scar Study in a Cohort of Adult Participants with Hypertrophic Sternotomy Scars to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
Expand descriptionThis is a Double-blinded, Placebo-controlled Split-scar Study in a Cohort of Adult Participants with Hypertrophic Sternotomy Scars to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics. Who is it for? You may be eligible for this study if you are aged 18 to 60 years with a hypertrophic scar. Study details: This is a split-scar study where participants apply SNT9465 to one treatment segment of their scar (either superior or inferior) and the other will be treated with placebo daily for 90 days. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with Hypertrophic Scars.
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Exploring the effectiveness of multidisciplinary primary care for the management of chronic conditions in older patients
Expand descriptionThe project will examine the effectiveness of co-located multidisciplinary primary care for the management of chronic conditions. The project aims to (1) explore, compared to stand-alone practices, whether GP practices with co-located primary care disciplines are more effective at reducing potentially preventable hospitalisations (PPH) and/or emergency presentations among patients with selected chronic conditions; (2) compare quality of life, patient experiences of care and health care use between a subset of patients with chronic conditions from multidisciplinary practices and stand-alone practices; (3) describe each practice’s approach to integrated multidisciplinary care and explore how this affects PPH, quality of life, healthcare use, and patient experiences of care. The study will recruit 12 GP clinics, with patients completing surveys at 4 time points, and a small subset of patients completing interviews at 2 time points. Clinicians will complete a survey and interview. Primary care data will be linked with admitted patient data to gauge health service outcomes. This study will provide information to inform policy decisions about which multidisciplinary models have the greatest potential for impact.
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Music Attuned Technology for Care via eHealth (MATCH) in Professional Care
Expand descriptionTo create scalable solutions for the growing number of people living with dementia, we developed MATCH. MATCH is an eHealth solution – Music Attuned Technology for Care via eHealth – developed to support care staff to use music intentionally to support care with people with dementia. The MATCH App has been developed for home and professional care (RAC/hospital) settings, and preliminary trials have been conducted in Victoria, South Australia, and Western Australia. MATCHplus integrates the MATCH App with a bespoke agitation detection system via wearable sensors and an AI-based music recommender system. In this study we will recruit across different professional care settings to: a) Assess the feasibility of implementing MATCH in dementia care in different professional aged care settings; b) Understand the impact of using MATCH Strategies during care on their job satisfaction and care outcomes using self-reported data from care staff; c) Collect data via clinical assessment tools to understand the impact of using MATCH Strategies during personal care and in moments of agitation on neuropsychiatric symptoms of dementia; d) Explore the feasibility, acceptability and utility of the MATCH agitation detection and prediction system; e) Explore the feasibility, acceptability and utility of the MATCH music recommender system for suggesting appropriate individualised music; f) Understand care staff experiences of using MATCH Strategies during care using post-trial interviews; and g) Understand nursing (registered nurse/nurse-in-charge) and management perspectives on the acceptability and utility of implementing MATCH in their professional care setting using post-trial interviews.
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Investigating the effect of synoptic procedural reporting on quality indicators in systematic Staging Endobronchial Ultrasound (EBUS) in Non-small cell lung cancer (NSCLC)
Expand descriptionThis prospective, multi-centre quality improvement study will assess whether introducing synoptic procedural reporting improves the quality and consistency of endobronchial ultrasound (EBUS) procedures that are used to determine cancer stages in patients with suspected or confirmed non-small cell lung cancer (NSCLC). This study will include both historical (pre-intervention) and prospective (post-intervention) phases and involves 25 international sites. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older, you have known or suspected non-small cell lung cancer (NSCLC) and you are planned to undergo an endobronchial ultrasound (EBUS) assessment at a participating hospital. Study details Participants who choose to enrol in the prospective part of this study will undergo their EBUS procedure per the standard protocols. The procedure itself won't change for cancer patients, the intervention will be ensuring that the doctors conducting the EBUS procedure use a structured reporting document (called a synoptic reporting template) to capture specific characteristics during the procedure. Characteristics collected using the synoptic reporting template will then be compared to historical data that were collected without the structured guidelines. Doctors completing the new structured reporting template will also be asked to provide feedback on the template and reporting procedure. It is hoped this research will demonstrate that using a synoptic reporting template is easy and acceptable for doctors who are conducting EBUS for cancer staging in patients with NSCLC. It is also hoped that using the synoptic reporting template will enable doctors to consistently collect relevant details regarding a person's cancer that can then be used to choose the best treatment option for each person.
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A study of the effect of relabotulinumtoxinA on enlarged jaw muscles (masseter hypertrophy) and facial shape in adults aged 18 to 40 years.
Expand descriptionBotulinum toxin type A (BoNTA) is commonly used to temporarily reduce muscle size and activity without surgery. One area of interest is the masseter muscle in the lower face, which can become enlarged and cause a broader jawline. Previous studies using other BoNTA products have shown that the greatest effect occurs about three months after treatment and can last between six and twelve months. Early research with relabotulinumtoxinA (Relfydess) in facial lines suggests it may act more quickly and last longer, but it has not yet been evaluated for jaw muscle enlargement. This study will group participants based on their degree of muscle enlargement and apply treatment according to recent evidence on dosing and injection patterns. The findings may help determine the safety, effectiveness, and duration of action of Relfydess for non-surgical facial contouring.
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Understanding the small vessels in the lungs and their function with a novel method of lung microvascular assessment in healthy patients and those with pulmonary hypertension.
Expand descriptionPulmonary hypertension affects many people worldwide and can severely reduce quality of life and shorten lifespan. The disease begins in the lung’s tiny blood vessels (the microcirculation), which are invisible on routine tests. The current gold-standard test, right heart catheterisation, cannot measure microcirculatory function and often detects disease only after damage is established. This study will (1) determine whether a new, invasive method to assess lung microcirculation is feasible to use in practice, and (2) establish normal values in healthy adults. By identifying microcirculatory problems in the lungs earlier, we aim to enable earlier, more effective treatment.
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Cardiovascular risk calculators in people with diabetes
Expand descriptionWe will collect patient data for cardiovascular risk calculator comparisons and CV outcomes, to test whether different risk calculators are roughly equal. Our hypothesis is that cardiovascular risk calculators will give different estimates within the same patients.
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Atrial Fibrillation and Frailty management through Individually Tailored exercise and lifestyle interventions (AF-FIT)
Expand descriptionPatients with atrial fibrillation may have their treatment path altered due to frailty, yet we do not have guidelines in place to manage frailty if it is diagnosed. The project aims to recruit patients with atrial fibrillation >60 years old who also have some level of frailty and can still participate in exercise. These patients will undergo a multidomain assessment battery establishing multiple aspects of their biopsychosocial health with the primary focus being on physical frailty. Patients will then be randomised to either continuing their medical care as usual or adding an exercise intervention to their treatment for 6-months. At the end of the intervention and 6-montss following (12-months from baseline) patients will undergo the same assessment battery as baseline to determine if exercise is effective in managing frailty in patients with atrial fibrillation.
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Feasibility of a digital self-management App, StudyU, for testing the individual effectiveness of different non-drug treatments in management of chronic non-cancer pain
Expand descriptionOur project aims to evaluate the feasibility of a digital self-management App, StudyU, for testing the individual effectiveness of different non-drug treatments in reducing the pain disability associated with chronic non-cancer pain, including but not limited to, pain persisting after Road Traffic Crashes. StudyU is a new, free, mobile phone App, which allows patients to rigorously compare different interventions using gold-standard Single Case Experimental Designs (SCEDs) (personalised single patient behavioural experiments). SCEDs provide a very high level of evidence to evaluate treatment effectiveness in individual patients, empowering them to adopt treatments that help their pain, and discontinue ineffective treatments (even if these are generally recommended). The StudyU App sends patients daily reminders to record pain levels, functional impact and any additional pain medication use. After each trial, it visually displays results (eg pain ratings) for patients. Additionally, sophisticated statistical analyses compare baseline and treatment conditions so doctors can discuss treatment effectiveness with their patient. Testing the effectiveness of different self-management treatment options, such as lifestyle/behavioural interventions, empowers patients to self-manage persistent pain, in partnership with their treating practitioner.