ANZCTR search results

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

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30455 results sorted by trial registration date.
  • 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.

  • Safety and Efficacy of the Estriol Eluting (E-Leviate) Vaginal Pessary to Treat Pelvic Organ Prolapse in Postmenopausal Women with Symptomatic Pelvic Organ Prolapse.

    This research project is testing a new treatment. The new treatment is a vaginal ring pessary that delivers estriol to treat both pelvic organ prolapse (POP) and genitourinary syndrome of menopause (GSM) at the same time. We hypothesise that, compared to the existing vaginal pessary and estrogen therapy in the market, the estriol integrated vaginal pessary is an effective treatment for symptomatic pelvic organ prolapse and genitourinary syndrome of menopause (GSM) without additional treatment side effects.

  • The Prevalence of Resilience, Psychological Well-being, and Mental Illness in Emergency Responders

    This study aims to quantitatively assess the prevalence of mental health conditions and positive psychological factors among emergency responders in Australian Paramedics. The findings will inform the development of targeted interventions to improve mental health support and outcomes within these critical workforce sectors.

  • An Open-Label, Crossover, Relative Bioavailability Study Comparing Tablet and Capsule Formulations of SKY-0515 in Healthy Volunteers

    Study Hypothesis This study aims to compare how the body absorbs two different forms of the drug SKY-0515 tablet and capsule in healthy volunteers. Based on preclinical data, we expect the exposures of these two formulations in healthy volunteers to be similar. Skyhawk will eventually use the tablet formulation to treat Huntington's patient. Who is it for? You may be eligible for this study if you are a healthy male or female volunteer aged 18 to 70 years of age who has met all inclusion criteria and do not meet any exclusion criteria will be eligible to be enrolled. Study details The study is designed to compare the relative bioavailability of single dose oral administration of 2 formulations of SKY-0515, tablet solid dosage form to capsule formulation, in healthy volunteers. All healthy volunteer participants who choose to enroll in this study will receive 8 mg of SKY-0515 which will be administered orally as either a capsule (Treatment A) or a tablet (Treatment B). On Day 1 (Period 1), participants in treatment sequence AB will receive SKY-0515 as a capsule formulation while participants in treatment sequence BA will receive SKY-0515 as a tablet formulation. On Day 9 (Period 2), participants in treatment sequence AB will receive SKY-0515 as a tablet formulation while participants in treatment sequence BA will receive SKY-0515 as a capsule dose. Dose administration between periods will be separated by washout period of 8 days. All participants will have their vital signs (heart rate, blood pressure, temperature and respiratory rate) and ECGs checked, and will provide blood and urine samples for testing to ensure SKY-0515 is safe and well tolerated.

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