ANZCTR search results

This is a randomised, double-blind, placebo-controlled, First-in-Human Study to assess the safety ofXG2002 and how this drug acts in the body in healthy volunteers. XG2002 may be indicated for use in patients with acute and chronic pain, but a trial of the drug in healthy volunteers is needed before trials in patients suffering from acute and chronic pain can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of XG2002 or placebo. All participants will have their vital signs checked (heart rate, blood pressure with Core Body Temperature (CBT) being measured by an ingested real-time monitoring device), and will provide blood and urine samples for testing. If the drug appears safe, additional participants will be assigned by chance to receive a larger single dose of XG2002 or placebo, followed by blood and urine testing. This will continue until a maximum safe dose is determined. It is hoped this research will determine the maximum dose of XG2002 that can be administered safely without causing severe reactions. Once the dose of XG2002 has been determined in healthy volunteers, a trial investigating the efficacy of XG2002 as a treatment for patients with acute and chronic pain may proceed.

Polyphenol-rich sugarcane extract (PRSE) is derived from sugarcane molasses. Polyphenols are naturally occurring substances in plants, known to reduce blood glucose levels. The aim of this study is to investigate the ability of PRSE to reduce blood glucose levels after eating a sandwich. We will investigate two doses of PRSE to find out the best concentration to reduce blood glucose levels of healthy people

The study is a randomised control trial (RCT) testing a self-directed online childbirth education course aimed at improving a mother’s childbirth self-efficacy and reducing the onset and/or severity of birth related PTSD symptoms, and in turn improving mother-infant bonding. The experiment was conducted as a primary prevention study by recruiting women during pregnancy. It was hypothesised that the intervention group would report greater prenatal childbirth self-efficacy, less postnatal birth related PTSD symptoms and greater mother-infant bonding than in control groups.

A tri-generational survey study of 500 rural families exploring preparation for hospital care, preparation for hospital discharge, parenting skills, access to information, chronic disease management in rural communities and attitudes to changes in healthcare. New mothers will be invited to participate along with their partner (if applicable) and a grandparent (if applicable).

This is a first in human Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic of TP-317 (oral tablets) under fasted conditions in Adult Healthy Volunteers. TP-317 is being developed to address the high unmet medical need for a safe, oral therapy for chronic treatment of mild to moderate inflammatory bowel disease (IBD) This study consists of 3 planned dose cohorts. Each cohort will enroll a total of 8 participants with 6 randomized to TP-317 treatment arm and 2 randomized to the placebo treatment arm. Safety Review Committee will review the participant safety data as needed and determine dose escalation to the next cohort. Participants in the study will be administered oral tablet(s) under fasted conditions, defined as no food or water 10 hours prior to oral dosing.

The main aim of the study is to evaluate the safety and tolerability of single doses of APG808 in healthy participants, and multiple doses of APG808 in patients with mild-to-moderate asthma.

Anxiety disorders are one of the most common mental health conditions in young people, affecting around 7% of adolescents in Australia. Yet, the rate of inadequate treatment response and corresponding functional impairment in anxiety is high. Cannabidiol (CBD), a main component of Cannabis, can effectively reduce anxiety in adults with social anxiety disorder and has found to be safe and well tolerated in children and adolescents with epilepsy. The current study team have previously tested CBD (up to 800 mg/day for 12 weeks) in a pilot study involving in 31 individuals (mean 21 yrs) with treatment resistant anxiety disorders (ACTRN12617000825358). Two-thirds of participants had a >33% reduction in anxiety severity and 40% of participants had >50% reduction at 12 weeks. CBD was well tolerated with no severe, or unexpected adverse events; 94% of participants completed the intervention, indicating high acceptability. Thus, CBD may be a suitable candidate intervention for youth with inadequate response to anxiety treatments. This is a two-armed randomised control trial in 180 young people with a treatment-resistant anxiety disorder aged 12-25 years, randomised to receive CBD (600mg -800mg/d) or placebo equivalent at a 1:1 ratio, for 12 weeks. Ethics approval was received on 24/10/2023.

This project will test the impact of a nurse-led care co-ordination intervention for people living with dementia and their carers. People with dementia and their carers will be randomly allocated as a pair to either the intervention or usual care condition. For those in the intervention condition, will receive a nurse-delivered care co-ordination intervention over 7 months. It is expected that people with dementia who receive the intervention will have more days in the community at 12 months' post enrollment, reflecting fewer unplanned hospital transitions.

To test the efficacy of a second version of a new virtual reality intervention that was designed to support the social and cognitive recovery of young people with psychosis. This second version was designed alongside young people with lived experience of psychosis and social challenges, and the purpose of this study is to compare version 1 to version 2 of this intervention, to determine the differences in efficacy. The study team hypothesize that version 2 of the intervention will be more effective at improving social functioning compared to the first version at a follow up interview six months after the delivery of the intervention.

This is a non interventional extension study to assess immunogenicity of Tdap-1018 3000 mcg and Boostrix approximately 2.5 to 3 years after study injection in Study DV2-TDAP-01. Adult individuals who participated in Dynavax-sponsored study DV2-TDAP-01 and received either Tdap-1018 3000 mcg or Boostrix will be invited to return 2.5 to 3 years (± 60 days) after the DV2-TDAP-01 study injection for a follow-up blood draw. This is an extension study to ACTRN12620001177943.