ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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30792 results sorted by trial registration date.
  • Investigating the impact of external factors on diurnal changes to corneal immune cells

    This study is investigating whether ‘time of day’ factors and sleep patterns affect immune cells (cells that protect the eye) in the cornea (transparent front part of the eye). This study will also examine whether different light filtering lenses (that block different wavelengths of light) influence the behaviour of corneal immune cells. The study will aim to enrol 24 participants, with a target of 18 completed participants, aged 18 to 45 years, who have healthy eyes and do not regularly wear contact lenses or spectacles for daily activities. Participants will attend for 8 study visits in total, comprising 3 visits in the morning (08:00 AM-10:00 AM) and 5 visits in the late afternoon (16:00 PM-18:00 PM). Over the course of the study, participants will be asked to wear various forms of eye wear, consisting of an eyepatch and safety glasses with a filtered lens over one eye, overnight and/or throughout the day, as directed by the study team, as well as have some tear and blood samples collected.

  • GRIP (Group Run Virtual Physiotherapy): A pilot study examining the feasibility of providing a physiotherapy-led falls prevention group exercise class via telehealth

    The study will look at the acceptability and suitability of older adults participating in an online group exercise class aimed at reducing the risk of falls. It will explore barriers and faciliators to a virtual falls prevention program. Participants included in the study will be recruited from RPA Virtual Hospital who meet a specific eligibility criteria. They will partake in a 12-week virtual falls prevention service that includes assessment and delivery of exercise. We are hoping that older adults will find the 12 week virtual falls prevention service acceptable and suitable for their needs.

  • TRI-ME: Trimetazidine to treat Myalgic Encephalomyelitis/Chronic Fatigue Syndrome: A double-blind, randomised, placebo-controlled efficacy trial

    Existing treatments for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) are inadequate and ME/CFS therapy represents an unmet need of healthcare. Our aim is to assess the efficacy of trimetazidine, a metabolic agent, in treating ME/CFS in a double-blind, randomised, placebo-controlled clinical trial. Mitochondrial dysfunction has long been associated with inflammation and oxidative stress of ME/CFS and may be the potential final common pathway in the pathophysiology of ME/CFS. Trimetazidine increases metabolic efficiency in the mitochondria by promoting glucose oxidation rather than fatty acid oxidation (i.e. increased energy generation) and has anti-inflammatory and antioxidant properties. Importantly, in preclinical rodent studies confirmed trimetazidine increases mitochondrial function in the brain and facilitates longer swimming in the forced swim test without causing hyperactivity in the large open field. Trimetazidine was also identified using an atheoretical drug screening approach that showed trimetazidine to redress mitochondrial dysfunction. The therapeutic potential of trimetazidine is clear, Trimetazidine is highly accessible, affordable, and has regulatory approval to treat angina in Asia and Europe, making it particularly suitable to repurpose for ME/CFS.

  • Optimization of indocyanine green use in gall bladder removal surgeries

    Indocyanine green has been used in laparoscopic cholecystectomies for several years now to improve the visualization of patients’ extrahepatic biliary anatomy. Various doses and timings of indocyanine green have been used to improve visualization while reducing liver hyper fluorescence, with no optimization of either. The purpose of this study is to find an optimal dose and time to administer indocyanine green in laparoscopic cholecystectomies which are currently mostly conducted as day cases at St. Vincent’s Hospital in Melbourne, Australia. The primary hypothesis is that a lower dose of ICG administered within an hour of surgery provides better visualization of the extrahepatic biliary anatomy compared to the commonly-used higher dose.

  • The impact of emergency medicine pharmacists on medication safety for critically ill patients in the resuscitation area of an emergency department

    Medication errors are an important cause of harm in Emergency Departments (EDs). The resuscitation area of Emergency Departments are busy, high risk environments in which patients who are in a critical condition are treated. Pharmacists have demonstrated an ability to improve medication safety in EDs and improve medicine use. However, the resuscitation area does not usually have a dedicated pharmacist. The aim of this study is to determine if the presence of an ED pharmacist in the resuscitation area to assist with the treatment of very unwell patients has a benefit to these patients. The hypothesis for this study is that an emergency medicine Pharmacist in the ED resuscitation team setting will reduce medication errors, help doctors and nurses give critical medicines more quickly, improve documentation of medications on medication charts, and optimise patient outcomes.

  • Understanding the impacts of nutritional education to help in the treatment of age-related muscle loss

  • Bone-Health Nutrition Training for Food Service Staff in Aged Care: A Food-Based Approach to Manage Fracture Risk

    Older adults living in aged care homes have the highest fracture risk, accounting for 30% of hip fractures in Australia. We increased provision of high-protein, high-calcium foods from 2 to 3.5 servings/day for 2 years in over 3300 aged-care residents and reduced fractures by 33%, hip fractures by 46% and falls by 11% compared to the 3800 residents that consumed from their regular menus. This was done by supporting food service staff to incorporate these foods into their menus. To upscale this program we have developed a Bone Health Nutrition Training Program via an on-line community of practice that aged-care food service staff can access. A community of practice enables staff within a given organisation or age care provider group to converse and share thoughts, recipes, and ideas amongst the group within a secure invitation-only platform. This is an important aspect of the training and on-going support of staff as they can securely converse within their network and share strategies and ideas within their own network as changes implemented within an organisation may have copyright or other restrictions attached to it. This project will assess the efficacy of this Training Program by measuring improved protein content of menus, and improved protein intake of residents. The project involves 16 aged care homes; half of which will be randomised to intervention (education program) with the remaining half to continue with food provision from their usual menus. Food service staff from the intervention aged care homes will undertake the Bone Health Nutrition Training Program. Food service staff at control sites will continue with their usual food provision. Menus will be assessed for nutritional quality before and after training completion. Food service staff will report on the barriers and enablers for implementing the menu changes via focus groups or interviews. A sample of at least 8 residents per aged care home will have their dietary intake recorded across two days by measuring plate waste, have their nutritional status determined using the mini nutrition assessment tool, and quality of life determined by questionnaire at baseline and after training completion and implementation of menu changes based on learnings from the Training Program (~ 2-3 months). The education will be conducted virtually. There is minimal disruption to residents’ activities with nutritional status and quality of life determined at a time that is convenient for them. Food service (e.g., timing of meal delivery) will remain unchanged. Research staff involved in data collection in aged care homes are all qualified and will be fully vaccinated and trained on infection control and processes and procedures for each aged care home.

  • Safety and Feasibility Study of the Ligo In situ Bioprinting System

    This study is being done to evaluate the safety and performance of the Ligo system, an investigational treatment to print skin by combining a patient's own skin cells with a biomaterial directly in the wound site. The study hypothesis is that the use of the Ligo Bioprinting System is safe for use in participants with burn injuries involving less than ten percent Total Body Surface Area that requires skin grafting.. The Ligo System is new and considered to be experimental.

  • Does intra-operative humidification with warmed CO2 reduce the time to return of bowel function? A multi-centre randomized control trial in patients undergoing elective and emergency open colorectal resection

    Research Aims To assess the efficacy of warm humidified carbon dioxide (CO2) insufflation in reducing the time to return of bowel function in patients undergoing open colorectal surgery. Participants Adult participants undergoing open colorectal surgery at Dandenong Hospital who meet the inclusion and exclusion criteria. Methods Eligible participants will be randomised to receive standard of care or standard of care plus warm humidified carbon dioxide insufflation of the open wound during their scheduled open colorectal procedure. Insufflation will be provided with the HumiGard Surgical Humidification system, up to 10L of carbon dioxide gas will be slowly insufflated into the surgical cavity for the duration of the operation. Participants will be blinded to their allocation. Expected outcomes Completing this project will allow us to determine whether warmed and humidified carbon dioxide gas can assist with accelerating the recovery of bowel function postoperatively, potentially leading to shorter hospital stays and improved patient outcomes.

  • The investigation of effectiveness of mindfulness meditation on sleep quality in patients with myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS)

    Unrefreshing sleep is the hallmark of myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), affecting up to 95% of patients. Sleep is defined by coordinated cortical and cardiac oscillations reflecting communication between the central (CNS) and autonomic nervous systems (ANS), which can be modulated by mindfulness meditation. There is a growing interest in the effectiveness of mindfulness meditation for sleep disturbed populations. Mindfulness meditation may help improve sleep quality in ME/CFS patients. This study is designed to evaluate the effect of an 8-week mindfulness meditation on sleep quality in patients with ME/CFS and understand the underlying neurobiological process of meditation in patients with ME/CFS using self-report questionnaires and neuroimaging measures.

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