ANZCTR search results

The proposed research broadly aims to examine social cognitive changes and neuropeptide mechanisms in healthy older (vs. young) adults. This involves testing the effects of a small dose of acute intranasal OT (relative to placebo) on core social cognitive functions (e.g., emotion recognition, theory of mind), and to test if normal adult ageing is associated with changes in baseline levels of oxytocin and related hormones. We also explore whether individuals' level of functioning influence any of relationships between social cognition and oxytocin.

A First-In-Human, Randomised, Double-Blind, Controlled, Dose-Ranging, Phase 1 Study in Healthy Volunteers aged 18-45 years. A total of up to 56 healthy male and female participants will receive one oral dose of LHF-535-SDD or placebo which consists of the inert polymer HPMCAS. The primary objective of this study is to determine the safety and tolerability of LFH-535 (LHF-535-SDD) compared to placebo controls when administered to healthy adults. LFH-535-SDD the study drug being researched in this project is an experimental drug being developed by Kineta. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. LFH-535-SDD is a small molecule designed to stop the virus that causes Lassa Hemorrhagic Fever from entering the hosts cells and replicating. A maximum of 7 Cohorts will be recruited, as follow: Cohort 1: 6 participants will receive 0.3 milligrams per kilogram of body weight of LHF-535 and 2 participants will receive placebo Cohort 2: 6 participants will receive 1 milligram per kilogram of body weight of LHF-535 and 2 participants will receive placebo Cohort 3: 6 participants will receive 3 milligrams per kilogram of body weight of LHF-535 and 2 participants will receive placebo Cohort 4: 6 participants will receive 10 milligrams per kilogram of body weight of LHF-535 and 2 participants will receive placebo Cohort 5: 6 participants will receive 30 milligrams per kilogram of body weight of LHF-535 and 2 participants will receive placebo Cohort 6: optional cohort, dose to be determined by the safety committee Cohort 7: optional cohort, dose to be determined by the safety committee

This is a 15-day, single-blind, placebo-controlled study intended to assess the safety and tolerability as well as pharmacokinetics of the food product, AXA3359 administered over 8 days in adult participants with mild traumatic brain injury (mTBI). Up to 30 participants will be enrolled and randomised to receive either AXA3359 or matched placebo at a 2:1 ratio respectively. Participants will receive their first administration of study product within 24 hours of a mTBI and will receive a total of 3 study product administrations on the first study day regardless of food. On Days 2-7 participants will received study product twice daily 30 minutes before breakfast and dinner respectively. On Day 8, participants will have blood samples collected before and after administration to assess the pharmacokinetic properties of AXA3359. Safety follow up will extend to 15 days post first dose.

The primary objective of this study is to examine the tolerability and antiviral activity of switching to Biktarvy from a current antiretroviral regimen (CAR) consisting of a Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI) and /or a Protease Inhibitor (PI) in HIV-1 infected antiretroviral therapy (ART) experienced subjects aged 55 years and older who are virologically suppressed as determined by the proportion of subjects with HIV-1 RNA greater than or equal to 50copies/mL at Week 48. The primary outcome of interest change in viral load from baseline to Week 48 will be formally tested under the assumption that “higher is bad”. Similarly change in CD4 t cell count from baseline to week 48 will also be formally tested under the assumption that “higher is good”. The secondary objective is to evaluate quality of life and safety of the treatment group through Week 48. The secondary outcome of interest change in distress index assessments from baseline to Week 48 will be formally tested under the assumption that” no difference between the two time points”

This is a double-blind, randomised, clinical trial with a 2-month treatment duration with 2 arms (1 active ingredient arm and 1 placebo arm). Participants will be recruited from databases and public media outlets. Following preliminary screening via telephone, potential participants will attend the clinic for an information session and will be required to provide their consent for inclusion in the trial. Consenting participants will undergo a health assessment including lifestyle, current medications and medical history; this data will be used for the comprehensive screening and to provide contextual data for the study. Once enrolled in the trial, participants will be randomly allocated to either the placebo group or the active intervention groups. Briefly, participants will have baseline measurements performed and receive a 2-month supply of the study product. Baseline testing includes: several questionnaires (Pittsburgh sleep quality survey, Epworth sleepiness scale, PROMIS sleep disturbance, self-assessment of sleep quality, Consensus sleep diary, SF-36, GI tolerance), anthropometry measures (weight, height, BMI, waist/hip circumference), 20 mL blood sample (TNF-a, IL-6, IL-8, IL-10, hs-CRP, PEA concentration, ELF/T) and wrist actigraphy (3 days wearing a Polar A370). Participants will be asked to consume the allocated product according to the dose prescribed (350 mg/day PEA or placebo). An opaque bottle containing opaque vegetable capsules will be provided to each participant according to their group allocation. Participants will then return at timepoint: 8 weeks for subsequent testing. At the 8-week time points, the testing will be a repeat of baseline measurements. At 5 days, 2 and 4 weeks the participants will complete the same testing except for any blood markers and anthropometry measurements. Two weeks after treatment cessation participants will be asked to complete questionnaires again online.

Motor imagery (MI) refers to the mental simulation of movement in the absence of overt movement. A strong body of evidence suggests that MI activates the human motor system in similar ways to actual movement. For example, the time taken to mentally simulate movement correlates with actual movement time, while there is considerable overlap in the neural systems activated during real and imagined movement. Interestingly, MI based interventions have shown moderate effect at improving motor ability in healthy adults (e.g. athletes) and patient groups (e.g. stroke). In some cases MI appears to be an effective adjunct to actual movement therapies for improving action efficiency. However, evidence as to the efficacy of MI therapies nonetheless remains mixed. Research, in large part, has attributed this to a poor understanding of the neural basis of MI. To this end, the putative role of important ‘motor’ structures such as the primary motor cortex (PMC) and the Supplementary motor cortices (SMA) remain debated. Clarifying the role of the PMC and SMA in MI is critical to developing a unified account of motor control, and the development of effective interventions for those with motor difficulties. Aim: The proposed study will aim to clarify the role of the PMC and SMA in MI in samples of young adults (18 to 35 years) with and without movement problems.

Childhood eczema places an enormous burden on children and families. While good evidence for therapeutic interventions exists, ongoing non-compliance with treatment is common and presents a serious problem, increasing morbidity and impacting quality of life for children and families. Existing approaches have a record of failure in improving adherence. This study will improve clinical outcomes for children with eczema by integrating evidence-based support for parents who rely on existing eczema care services, to improve treatment adherence, reduce disease severity, and improve the quality of life for affected children. A randomised controlled trial will evaluate a brief parenting skills-training program for parents of children with eczema, comparing the intervention with usual care. We expect that this approach, which aims to enhance parental self-efficacy via application of practical parenting skills, will lead to improvements in adherence with medical treatment regimens and better disease control.

PURPOSE: To compare the efficacy of Bystander Intervention Model-informed suicide prevention material with standard existing material in promoting appropriate suicide risk assessment and protective action in the general community according to best-practice to suicide prevention. HYPOTHESES: 1. The experimental condition will have a significantly higher suicide risk assessment ability score than the standard condition. 2. The experimental condition will have a significantly higher suicide protective action ability score than the standard condition.

PURPOSE: The aim of the study is to evaluate whether a BIM-guided factsheet about suicide prevention can improve participants’ knowledge, confidence and intent to intervene more than a standard condition when presented with a peer at risk of suicide. HYPOTHESIS: A public suicide prevention strategy which addresses the BIM will be more effective at increasing knowledge, confidence and intent to intervene when presented with someone at risk of suicide than a standard condition which does not address the BIM.

Several factors link OSA and atherosclerosis, including metabolic abnormalities, activation of inflammatory and oxidative pathways, autonomic dysfunction and mechanical factors linked to snoring. However, the relationship between OSA and its treatment with the burden and progression of atherosclerotic plaque has not been systematically investigated. Advances in computed tomography (CT) imaging permit noninvasive high-resolution plaque imaging, enabling characterisation of the factors driving disease progression. This study is an observational study of 75 adults to determine the relationship between OSA and its treatment with plaque burden, composition and progression. Imaging of the coronary arteries will be performed on a CT scanner at a baseline and 12 month follow-up visit. The baseline phase permits evaluation of the relationship between OSA and its severity with the extent, distribution and composition of plaque. The serial phase permits a real-world assessment of the impact of changes in OSA severity on plaque progression.