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A double-blind placebo-controlled randomised clinical trial assessing the efficacy and safety of a novel herbal formulation for weight loss in an Australian population of healthy adults who are overweight.
Expand descriptionThis trial is based on findings from a studies conducted overseas which investigated the same product that will be used in this study to reduce weight. It was found to be very beneficial in these populations to reduce weight in people who are overweight, but we need to find out if it also assists people in Australia. Overweight is considered to be anyone who has a body mass index (BMI) between 25 to 29.9. This trial involves participation in a randomized controlled clinical trial which means being randomized to either a placebo or an active product group. There will be three trial sites, Lismore, Gold Coast or Brisbane. It will be conducted for 16 weeks (4 months) per person.
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Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) effects on perception of illusions, schizotypy and cognition in healthy volunteers
Expand descriptionThe hypothesis is that there are certain types of what are called schizotypy (schizophrenic-like) states or traits that can predict how a person may respond to THC and/or CBD: in a pro- or anti-psychotic manner, to guide potential medicinal use of cannabis in psychiatry. The aim s to compare THC (the psychoactive component in cannabis) with CBD ("non-psychoactive" component in cannabis) on its effects on the multi-sensory perceptions in the healthy volunteers. We have previously shown that certain drugs can produce effects on the perception of illusions that are similar to differences in the perceptions of those illusions by people suffering from schizophrenia. Determining the effect of the cannabinoids on these differences in perceptions in healthy people, and the relationship of those effects with the effect on mild schizophrenic similar states and traits may allow us to determine which people will find THC or CBD to be medicinally helpful, and those that should avoid these drugs.
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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of of PRTX007 in Healthy Adults
Expand descriptionThis project is testing the safety and pharmacokinetics and pharmacodynamics of single and multiple oral doses of a new drug called PRTX007. PRTX007 is being developed for the treatment of patients with COVID-19 and the prevention of viral infection in adults and children exposed to SARS-CoV-2 You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 65 years old. In Cohorts 1 through 8, participants will be randomised (assigned randomly, like flipping a coin) to receive single oral dose(s) of either the active study drug or placebo. In Cohorts 9 through 12, participants will be randomised (assigned randomly, like flipping a coin) to receive multiple oral dose(s) of either the active study drug or placebo. For subjects in Cohorts 1, 3, 4, 5, 6, 7 and 8, study participation will require 29 calendar days which will include 4 days (3 nights) in the CRU. For subjects in Cohort 2, study participation will require 56 calendar days which will include two stays of 4 days (3 nights) each in the CRU. For subjects in Cohorts 9, 10, 11 and 12, study participation will require 42 calendar days which will include 15 days (14 nights) in the CRU. It is hoped that this research will help determine the safety of PRTX007 when given to healthy men or women so that it can be tested in patients with COVID-19.
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Evaluating the 'First Step' in treatment for individuals seeking substance use interventions
Expand descriptionThe aim is to conduct a feasibility trial of First Step, a substance-use brief intervention of 2 sessions, which is based upon the Quikfix Intervention, and has been adapted through a co-designed collaboration between UQ and LLW staff. We will recruit 400 participants (200, 18-35 years, 200 over 35 years). It is expected that First Step will result in significant reductions in substance use (as measured by the WHO ASSIST and ATOP), when comparing baseline to 1 and 3 month follow-up evaluations.
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The Acceptability and Efficacy of a Parent-Mediated Video Conferencing Intervention for Treatment of Sleep Problems in Preschool Aged Children: A Randomised Controlled Trial
Expand descriptionThe aim of this study is to a trial a parent-focussed treatment program for sleep problems in young children delivered by videoconference. We will determine whether the sleep program is more effective than waitlist, in reducing sleep, fear and anxiety problems in children, and improving parenting and family outcomes. Furthermore, the program including the delivery mode (video conference) will be evaluated by parent satisfaction ratings as well as a 15-minute telephone interview.
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Does increasing the amount of swallowing therapy improve outcomes for adults with swallowing problems after stroke?
Expand descriptionUp to two thirds of patients after stroke have swallowing problems. Patients with swallowing problems typically have worse health outcomes, reduced nutrition and hydration and poorer quality of life. Swallowing rehabilitation includes swallowing exercises which can improve swallowing ability. However, there is limited evidence about what dosage, or amount of swallowing intervention is most beneficial for patients. This project will investigate the effect of increasing the dosage of swallowing intervention for patients with swallowing problems after stroke. The project will recruit 15-20 adults with swallowing difficulties after stroke from an inpatient rehabilitation hospital. Participants will receive daily swallowing intervention (five days per week) with a high dosage of swallowing exercise repetitions per session during their inpatient stay. Intervention will involve typically used rehabilitative swallowing exercises as identified by a medical record audit. Change in oral intake, functional and instrumental swallowing assessments, muscle strength and quality of life outcome measures will be taken. Results will be compared before and after intervention. Results will also be compared with a historical control group of adults with post-stroke swallowing difficulties who received the same swallowing intervention at a lower dosage (i.e. mean of two-three days per week). We will also investigate patient experiences of high-dosage swallowing intervention and perceived barriers and facilitators to achieving high-dosage swallowing intervention through semi-structured interviews.
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Endoscopic ultrasound guided portal pressure measurement to predict the outcome of liver resection
Expand descriptionThe study is looking for participants that are required to have abdominal surgery, liver resection, or liver transplantation. Portal hypertension is an increase in blood pressure in the portal vein; the blood vessel that carries blood within the gastrointestinal tract to the liver. Portal hypertension is a condition that is present in individuals with cirrhosis of the liver and other liver diseases, and assessing the degree of this condition is important for prognosis, risk evaluating, and to guide appropriate treatment. This is done by calculating a portal pressure measurement. The current gold standard for measuring portal hypertension is the ‘Transvenous technique’; however, this is a technically limiting procedure with potential complications, and may only provide indirect measurements of portal pressure. We aim to assess the safety and efficacy of measuring portal pressure via an ‘endoscopic ultrasound technique’ (EUS). Compared to the Transvenous approach, this method is new but is deemed relatively safer and more accurate. We are particularly interested in comparing the clinical outcomes of the two techniques, and to determine that the EUS approach for measuring portal hypertension is much more useful in predicting surgical and survival outcomes for liver disease patients. The study will not only determine the usefulness and safety profile of the EUS portal pressure measurement, but could also open up a whole new diagnostic approach for the majority of patients with liver diseases. We hypothesise that: (i) EUS technique for portal pressure measurement can predict clinical outcomes and survival in cirrhotic patients who undergo abdominal surgery, liver resection or liver transplant; and (ii) EUS technique for portal pressure measurement is safe and feasible.
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Flutext 4 U - The effect of provider and parent strategies on influenza vaccination rates in children and adolescents with special risk medical conditions.
Expand descriptionThis project aims to see how well a multi-component intervention can increase influenza vaccination for children and adolescents who are medically at-risk from severe influenza disease. The Flutext-4U intervention components at the tertiary, primary care and parent levels e.g. SMS reminders for parents; reminders for WCH specialists to discuss and/or deliver vaccines; and communication from the tertiary provider to the child's GP about influenza vaccination. Study participants are WCH specialists, GPs and parents. This single-site trial will provide the tertiary-level intervention components to a group of parents (trial arm#1), while another group will additionally receive primary care level and parent level intervention components (trial arm #2). Parents (of children identified as medically at risk of serious influenza disease) will be randomly allocated to either group. The study will test the intervention by comparing both groups and will use immunisation records to assess vaccine uptake. At the end of the intervention period, the study will also use an SMS survey to assess vaccine uptake; acceptability of the SMS reminders to get their child vaccinated; whether they would want to receive SMS reminders in the future; their most convenient place to receive the vaccine and what prompted vaccine receipt.
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Effect of different hand sanitizers on the microbes on fingers
Expand descriptionThe primary purpose is to evaluate how long a single hand disinfection lasts.
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A prospective, open label study to evaluate the safety and pharmacokinetics of ML-004-ER under fed and fasted conditions in healthy adult volunteers
Expand descriptionThis is a Phase 1 Open Label Crossover study of ML-004-ER, an extended release drug product (intended for use in the management of patients with autism spectrum disorder), in adult healthy volunteers that characterise the bioavailability and pharmacokinetic profile of single dose under fasted and fed conditions. Each participants will receive a single oral dose of ML-004-ER prior to or following a designated meal, and the pharmacokinetic profile will be assessed for up to 24 hours to assess the impact food has on the rate and extent of absorption.