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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.
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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.
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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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Preoperative kidney assessment to predict long-term renal function after kidney removal surgery
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).
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Effect of the diabetes medication, Ozempic, to reduce blood pressure falls after a meal in older people
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.
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Evaluating the musculoskeletal and cardiorespiratory effects of a 6-week weighted walking program in nature: a non-randomised, pre-post intervention study in physically active adults.
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
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Preliminary study of the SUicide IMagery REScripting (SUIMRES) treatment for adults experiencing mental images of suicide.
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.
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A randomised, double-blind, clinical crossover study to assess novel hydration formulations in healthy adults
The research project is looking at whether rehydration drinks can help improve hydration, sleep, and cognitive performance after exercise in hot conditions that cause dehydration. During the study, we will use a controlled method to reduce your body weight by 2% through dehydration. After that, you’ll be given one of four drinks: either a placebo (which contains no active ingredients) or one of three rehydration drinks. These drinks contain a mix of ingredients like electrolytes, vitamins, carbohydrates, proteins, amino acids, and sugar substitutes, all dissolved in water. Each participant will try all four drinks, with at least five days between each trial. We’ll assess how each drink affects your hydration that day, your sleep that night, and your cognitive performance both on the same day and the next day. Since dehydration can affect cognitive performance and sleep quality, we’re hoping these drinks may help with rehydration and recovery. By comparing the different drinks, we hope to discover which ones work best in supporting hydration, sleep, and cognitive performance after dehydration.
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RESIST-HF: A randomised controlled trial of a comprehensive nurse-coordinated home-based Resistance ExerciSe program to Improve frailty and phySical funcTion in adults with Heart Failure
This study aims to make people with heart failure feel stronger, improve their physical function, and keep them out of hospital. We hypothesise that a home-based nurse-coordinated program embedding resistance exercise and healthy eating advice will reduce hospital admission rates at 6 months and lead to improvements in frailty, physical functioning, and quality of life scores at 3 months in adults living with HF. Heart failure affects 1-2% of the Australian population, resulting in a significant number of hospital admissions and placing a huge burden on the NSW health system. Approximately half of those with heart failure will also develop frailty, a devastating syndrome of ‘accelerated ageing’, putting them at even greater risk of adverse events and hospitalisation. This project uses a randomised controlled trial study design to test whether a three-month comprehensive nurse-coordinated home-based exercise program can reduce hospital admissions for adults with heart failure and improve their frailty, physical function, and quality of life.
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Evaluating the Effect of a Patient Worksheet on Communication In The Surgical Clinic
Presenting to a surgical outpatient clinic can be a stressful experience for patients. Disparity in education levels, perceived power imbalances and other factors can result in the patient feeling unsatisfied or confused at the completion of the consultation. We propose a randomised controlled study; whereby, the participant is placed into either the intervention group and will receive a pre-designed form containing five prompts to ask their surgeon, or they are placed in the control group. The outpatient consultation will be audio-video recorded. Within 7 days of the consultation the participant will be contacted by telephone to discuss their experience. The purpose is to analyse the utility of a patient prompting document in improving patient understanding, increased patient empowerment and facilitating successful outpatient consultations.