ANZCTR search results

The study aims to evaluate the performance of the Lubdub AECG device compared with a clinically accepted AECG device used in routine clinical care. Participants who are already referred for AECG monitoring will wear both devices at the same time for 24 to 48 hours. The study will assess the technological performance of the Lubdub AECG device during normal daily activities compared to the comparator AECG device. We expect to evaluate if the Lubdub AECG device will provide ECG recordings, signal quality and technological performance comparable to the clinically accepted AECG device, while maintaining high levels of participant usability and comfort.

Opioid overdose is a major public health issue, causing significant morbidity and mortality. Naloxone is a drug for reversal of opioid overdose and is typically administered through intravenous or intramuscular injection. Intranasal administration of naloxone has several advantages over injection, particularly ease of use and removal of the risk of needle stick injury. This study is a randomised controlled trial to test the hypothesis that naloxone administered intranasally will be non-inferior to naloxone administered intramuscularly in achieving an adequate response (no requirement for a rescue dose of intramuscular naloxone). There is limited quality evidence about intranasal naloxone efficacy. Previous trials used volumes greater than the now-recommended optimal delivery volume for intranasal drug administration, of equal to 0.2ml per nostril, or smaller doses than those typically used in the Australian context. Our trial will evaluate the efficacy of a concentrated naloxone spray (2mg/0.1ml) compared to the 800mcg intramuscular standard in reversing the effects of opioid overdose and the production of any naloxone-associated side-effects.

Prostate cancer recurrences have limited treatment options with current whole gland surgery or systemic therapy associated with significant morbidity. Focal therapy with the Profocal laser may offer men with recurrent prostate cancer post-radiotherapy a safe and efficacious treatment option. This study will assess the safety of the laser focal therapy device in 40 men.

Dizziness is one of the most common and disabling symptoms after an acquired brain injury (ABI), such as concussion or traumatic brain injury. Many people begin to avoid movements, places and activities that bring on their dizziness, which can slow recovery, increase the risk of falls, and affect mood, work and quality of life. Standard vestibular (balance) rehabilitation gradually exposes people to movements and environments that provoke symptoms, but is usually delivered using simple 2D videos that lack real-world realism. This study will recruit participants to take part in a virtual reality (VR) program delivered by trained clinicians during their usual outpatient rehabilitation sessions at the Brain Injury Rehabilitation Service (BIRS) Day Hospital or Concussion Clinic at the Princess Alexandra Hospital. Participants will wear a VR headset and be gradually exposed to virtual environments that vary in visual busyness and movement, chosen and progressed by their treating clinician based on their individual symptoms and goals. The sessions will last for about 30 minutes. Questionnaires and balance assessments will be completed before and after the program, and some participants and clinicians will be invited to a short interview about their experience. It is hoped this study will show that VR-based graded exposure is practical, safe and acceptable in outpatient brain injury rehabilitation. The study will also be used to provide early evidence about its effects on dizziness, avoidance of activity, anxiety and everyday function. The findings will inform a future larger controlled trial.

This research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the ABEL microsampler device. The primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (COPD), hayfever, chronic sinusitis, asthma and rhinitis.

Our proposed study will address this gap by comparing postprandial muscle protein synthesis in response to iso-nitrogenous beef meals varying in fat content and structure: lean steak, higher-fat steak, and lean steak with added rendered tallow. We will assess this in the rested state, which better reflects typical feeding patterns and avoids confounding from exercise-enhanced responses.

University teaching staff are at increased risk of vocal fatigue and voice disorders due to high occupational voice demands. This pilot randomised controlled trial will evaluate the feasibility, acceptability, and preliminary effectiveness of supplementing a standard Voice Care Programme with a mindfulness-based intervention. Sixty University of Melbourne teaching staff with vocal fatigue will be randomly allocated to either a Voice Care Programme alone or a Voice Care Programme plus mindfulness intervention. Feasibility outcomes will include recruitment, retention, adherence, and participant acceptability. Preliminary effectiveness outcomes will include vocal fatigue, voice quality, phonation threshold pressure, psychological distress, interoceptive awareness, and burnout.

This study uses a double-blind, placebo-controlled, randomized, parallel group study design. This study involves the testing for eight weeks of a TGA-listed off-shelf supplement (Swisse Nutra Cellular Skin Hydration product), The research study aims to compare the effect of the product against a placebo on objective measures of skin hydration, wrinkle reduction, water loss and skin elasticity, as well as change of the measures from first visit. It also aims to compare the end user experience of the product against a placebo in an eight-week real-life product testing.

Older Australians make up the largest proportion (6 in 10) of people diagnosed with cancer and the majority living with and surviving cancer. This study aims to evaluate a geriatric oncology model of care compared to geriatric screening alone (to identify older people at risk). Who is it for? You may be eligible for this study if you are aged 65 years or older (or 50 years of older if you are of Indigenous background), you have been recently diagnosed with cancer and you have been referred to a cancer specialist and are being considered for chemotherapy, targeted therapy, or immunotherapy (including as part of a clinical trial). Study details Cancer services who take part in this study will be randomly assigned to commence using the new geriatric oncology model of care. This model of care will involve geriatric screening to identify older people at risk of frailty, followed by a comprehensive geriatric assessment for those identified at risk to inform tailored cancer treatment, interdisciplinary clinic care and support, shared decision-making an ongoing monitoring of patients. Participants who receive access to the model of care may have increased travel time or appointments due to assessment findings. All patients will receive the best care available, regardless of the cancer clinic/hospital that they attend. It is hoped this research will determine factors that enable the best approach to support uptake of specific care practices for older cancer patients into current practice, and that this may lead to improved quality of life for older cancer patients.

Alzheimer's disease is associated with inflammation in the brain, but inflammation elsewhere in the body may also contribute to the disease. This study aims to determine whether inflammation in the thoracic aorta is associated with changes in brain glucose metabolism in people undergoing clinically indicated FDG PET/CT for suspected Alzheimer's disease. Participants will undergo analysis of their clinically acquired brain and thoracic PET/CT images, together with cognitive assessments and clinical information. The study will investigate whether greater aortic inflammation is associated with more severe brain changes and cognitive impairment. The findings may improve understanding of the relationship between vascular inflammation and Alzheimer's disease and help identify new imaging biomarkers.