ANZCTR search results

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.

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.

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.

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.

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.

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.

In this prospective observational study, adult participants undergoing total or partial unilateral nephrectomy are assessed preoperatively and postoperatively (1 and 3 months after the surgery) by a kidney functional reserve (KFR) test .Preoperative KFR and postoperative loss of KFR will be assessed as predictors of long-term kidney function and damage as assessed by serum creatinine and albuminuria within 1 year after the surgery. The hypothesis is that a lower preoperative kidney functional reserve and/or a bigger loss of kidney reserve after the surgery will identify people at higher risk of developing worsening kidney function at long-term (i.e.: 1 after the surgery).

Falls in blood pressure after a meal (called postprandial hypotension) occurs commonly in people over the age of 65 years and currently has no suitable treatment. The study will determine the effects of 12 weeks treatment with the 'long-acting' glucagon-like peptide-1 (GLP-1) agonist, semaglutide once weekly (QW), also known as Ozempic, on the rate of stomach emptying, glycaemia, blood pressure (BP) and heart rate (HR) following ingestion of a glucose drink, in people over the age of 65 years who experience postprandial hypotension. This is a randomised parallel designed study. Subjects recruited into the study who pass screening criteria will be randomised to receive semaglutide QW or matching placebo. They will have a gastric emptying study performed using the gold standard technique (scintigraphy) at baseline and 12 weeks. Immediately following the first gastric emptying study they will commence treatment with semaglutide QW or Placebo, administered subcutaneously at weekly intervals. Blood pressure, heart rate, splanchnic blood flow, appetite sensations, blood glucose and gut hormones will be assessed during each of the gastric emptying measurements. Food intake for 30 min at a buffet meal will be assessed immediately following the gastric emptying study ie ~120-150 min after the gastric emptying studies. This study will help determine if semaglutide (Ozempic) can be useful in treating postprandial hypotension. We hypothesise that semaglutide (Ozempic) will slow the rate of gastric emptying and, hence, reduce the magnitude of the fall in BP after ingesting a glucose drink.

This research aims to measure the effects of a six-week weighted walking program on lower limb strength. It will also assess the effects on cardiorespiratory and other musculoskeletal fitness indicators and effects associated with exercising in nature. Findings from this research could inform exercise prescription for weighted walking with potential improvements to population health outcomes. It is hypothesized that the 6-week weighted walking program will lead to significant improvements in both musculoskeletal strength and cardiorespiratory fitness in physically active adults

When people contemplate suicide they can think using words (e.g., "I want to die") and/or mental imagery (e.g., visualising and mentally rehearsing suicide methods). Despite evidence that mental images of suicide are associated with greater risk of both having a detailed suicide plan and having previously enacted suicide behaviours, compared to verbal thoughts of suicide (Lawrence et al., 2022, 2023), no evidence-based treatment for suicide images has been published to date. We have developed a 3-4 session psychotherapy treatment for suicide imagery that is delivered as an addition to the usual-care that people experiencing suicidality receive in therapy. This project aims to evaluate feasibility, acceptability, and safety of this new treatment with a sample of people who receive the treatment. The project also aims to test the feasibility of evaluation procedures in preparation for a larger study of the efficacy of this intervention in future. We anticipate that the intervention will be safe and acceptable to participants, as well as feasible to deliver. We anticipate that the trial evaluation procedures will be suitable for use in a future larger evaluation of the efficacy of the intervention. We will recruit 40 people in therapy who experience mental imagery of suicide, and randomise half to receive the new treatment in addition to their regular care (the other half will continue their usual treatment without the new therapy). We will collect data about people’s experiences of the intervention, their suicidality and mood using online surveys and questionnaires. With participant consent, we will also ask for their regular therapists to complete surveys about their progress and what types of treatments they have received during the trial period.