ANZCTR search results

This 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.

The 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.

The 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.

Up 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.

The 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.

This 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.

The primary purpose is to evaluate how long a single hand disinfection lasts.

This 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.

A randomized, placebo-controlled Phase 2a study to test the efficacy and safety of cilnidipine alone and in combination with tadalafil in participants at least 18 years of age diagnosed with severe secondary Raynaud’s disease (Raynaud’s Condition Score [RCS] greater than o r equal 40 and at least a 2-phase colour change in fingers of pallor, cyanosis, and/or reactive hypermedia in response to cold exposure or emotion) mostly resulting from SSc and exhibiting regular and frequent RP attacks (averaging at least one attack per day) during the Screening period. Double-blind, Placebo-controlled, Parallel-group, Dose Selection to assess the safety and efficacy of two doses of cilnidipine (10 mg and 20 mg), alone and in combination with tadalafil. Participants will be randomized to one of six prespecified treatment arms. During the study 36 participants will receive treatments in a blinded fashion. Placebo tablets (matching cilnidipine) and placebo capsules (matching tadalafil), for oral administration, will be provided to the site as well as the investigational treatments (cilnidipine and tadalafil). Medications will be dispensed during the preceding in-clinic study visit for self-administration by the participant. Each Dosing Period will last for 12 days (allowing for a variance window of -2 days [d10] or +2 days [d14] ) in which participants will take daily doses of assigned treatment in the morning. For each day of dosing, participants will take one capsule and one tablet to blind the active therapy being received. Dropouts will not be replaced. Primary Efficacy Endpoint: Percentage change from baseline in frequency of weekly RP attacks. Safety Endpoints: Incidence of adverse events (AEs) and serious adverse events (SAEs), including clinically significant vital signs from the time of randomization until 7 days following the last protocol dose.

It is currently estimated that approximately 35% of all dementias can be attributed to risk factors that are highly modifiable, including low mood, poor sleep, poor heart health and low cognitive/social engagement. The BetterBrains trial will test whether remotely delivered (via online, telephone and smartphone application) person-centred education and lifestyle behaviour change strategies, targeted at modifying these four risk factor clusters, can prevent cognitive decline in middle-aged adults aged between 40 – 70 years. The trial will recruit 1510 people living in the community throughout Australia. Of these people, 755 participants will be randomised to the intervention group and will receive the personalised BetterBrains program, while the other 755 participants will receive health education materials about dementia risk reduction. We hypothesise that a higher proportion of participants randomised to the BetterBrains program will show a favourable cognitive outcome at 24-months than those randomised to the control group.