ANZCTR search results

This is a first in human testing of novel HIV-1 protein nanoparticles vaccine candidates, UVAX-1107 and UVAX-1197 mixed with Aluminum Hydroxide (AH) and CpG 1018 adjuvants. After meeting all eligibility criteria, approximately 34 participants will receive a 4 dose vaccination regimen of either 2 priming vaccinations of UVAX-1107 followed by 2 boosting vaccinations of UVAX-1197, or 4 doses of UVAX-1107, or placebo. Subject participation is expected to last up to 374 days, including up to a 30-day screening period and a 337-day study period during which subjects will be followed for safety and immunogenicity outcomes.

Hand osteoarthritis (OA) is a disabling condition impeding activity of daily living leading to pain, functional impairment, and reduced quality of life. The age-standardised prevalence of hand OA in the general population is 44·2% in women and 37·7% in men. Despite the high prevalence and significant disease burden, there is no effective therapy for hand OA. Hand OA is a heterogeneous condition. The inflammatory phenotype is a commonly encountered clinical phenotype, characterized by joint swelling (synovitis). The presence of synovitis being associated with joint pain and structural progression. Therefore, synovitis has the potential to be a target for treatment in hand OA. Methotrexate is a well-established, low-cost, and effective treatment for inflammatory arthritis with a well-described safety profile. In our previous METHODS study (a randomized, double-blind, placebo-controlled trial to determine the effect of 20 mg methotrexate once weekly on reducing pain and improving function in patients with symptomatic hand OA and synovitis over 6 months, ACTRN12617000877381), we showed that methotrexate would reduce pain and stiffness over 6 months compared to placebo in patients with hand OA and synovitis. But there are still a number of unknown questions regarding the use of methotrexate, including how long we need to treat those with hand OA with methotrexate; is there a group that are more likely to respond; and does response to treatment predict less joint damage. Thus, we conducted this METHODS-Extend open label study to address those queries.

Therapeutic devices are essential to support the clinical care of critically ill patients, yet such devices are recognised as a potential source of harm to the skin and mucous membranes in the form of therapeutic device-related pressure injuries. The neonatal, paediatric and adult populations have distinctive anatomical, physiological and developmental factors that influence their risk for device-related pressure injury development. The project aim is to co-develop implementation strategies, and then test, evaluate and disseminate a bundle of evidence-based, cost-effective scalable practices to prevent medical device-related pressure injury in critically ill patients of all ages. Phase 1 will recruit clinical staff for surveys and workshops to develop the site-specific SAFET bundle. Phase 2 will evaluate the effectiveness of the bundle using a multi-centre, stepped-wedge, cluster randomised trial design comparing device-related pressure injury incidence in patients (proportion) in the control period with the intervention period. The cost-effectiveness of the SAFET bundle will be analysed. The hypothesis of this project will be to detect a significant reduction in device-related pressure injury across the lifespan in ICU leading to the elimination of DRPI among babies, children and adults after using the SAFET care bundle.

The purpose of this research study is to investigate the impact of carbohydrate loading with high and low FODMAP diets on markers of gastrointestinal integrity, function, symptoms and performance implications in response to endurance exercise. FODMAPs are short chain fermentable carbohydrates (e.g., lactose, fructose, fructans, galactans and polyalcohols), which are transported slowly in the small intestine and are rapidly fermentable by the colonic microbiota. This fermentation can lead to bloating, visceral hypersensitivity and/or a change in gut motility. To determine any gastrointestinal changes, this will be achieved through the consumption of a high carbohydrate diet with high or low FODMAPs 48-hours before two hours of continuous running, following by a one-hour performance test.

To study the if cleaning the surgical wound immediately after wound closure causes increase in bacterial growth on the skin. This study includes patients undergoing elective total hip and total knee arthroplasty. Cleaning surgical site after wound closure is a common practice seen in operating theatres. In an attempt to remove dried body fluids from the skin, vigorous rubbing using surgical sponges is often required. Such a technique can introduce skin flora into the wash fluid and may risk a wound infection.

The failing heart has been found to shift to ketone bodies as a significant fuel source with resultant improvements in cardiac function. There is a strong theoretical rationale for ketosis in improving heart failure, yet clinical research of this therapeutic strategy in heart failure with reduced ejection fraction (HFrEF) is lacking. In fact, there are very few dietary trials in patients with heart failure, despite diet being a cornerstone of cardiovascular disease prevention and treatment. This is an investigator-initiated, open-label, prospective randomised controlled pilot study, with two groups: control (no dietary intervention, n=30) and intervention: a normocaloric KD (N=30). This study has the pre-specified goal of exploring the cardiovascular effects of a KD in patients with heart failure to guide a larger clinical trial.

This study aims to establish the feasibility, acceptability and fidelity of a high- and low-intensity self-efficacy-based dietary intervention for adults with CKD for a future large-scale clinical trial.

The current study will investigate the feasibility and effectiveness of a combined treatment approach for primary school aged children who are suffering from traumatic stress and sleep disturbance after experiencing a traumatic event. The 10-session treatment utilises both Cognitive Behaviour Therapy for Insomnia (CBT-i) and Trauma-Focused Cognitive Behaviour Therapy (TF-CBT) that are recommended evidence-based treatments for sleep and posttraumatic stress, respectively. Outcome measures will be assessed at pre-, during- and post-treatment, and at a 3-month follow-up. Primary outcomes are posttraumatic stress (diagnosis, good end-state achievement, severity reduction) and sleep (onset, duration, awakenings, efficiency). Important secondary outcomes include behavioural sleep problems, quality of life, and feasibility (i.e., ease of delivery). It is hypothesised that this approach will be feasible, and we predict that most clients will achieve good end state functioning in terms of posttraumatic stress symptoms and sleep disturbance.

PRSE’s naturally occur in plant derived foods and beverages and holds great potential for enhancing human health. However, further research is required to understand the broad-spectrum of effects of PRSE’s by assessing its potential short and long-term benefits to general well-being. This study is a 6 month double-blinded randomised controlled cross over trial. Participants will receive either the control sample (placebo) or the PRSE sample for a duration of 3 months, followed by the reversal of conditions for the subsequent 3 months. The nutritional intervention is to be completed in the participants own setting (i.e. home/work). This study aims to investigate the prebiotic effects of PRSE, as well as the effects on inflammation and key blood biomarkers, including HbA1c, C-reactive protein, and triglycerides/omega-3 status. The study will also explore the influence of PRSE on general mood and well-being.

The purpose of this study is to determine whether it is feasible for Early Career Pharmacists (ECPs) in Australia to take part in an online peer support program. The program is inspired by Hand-N-Hand Peer Support, an initiative originally created for medical personnel in 2020. In the future, it is hoped that more in-depth studies will be conducted to trial the efficacy of such a program as well. If deemed feasible and effective, an aim is for the pharmacy profession to adapt a similar model to boost morale and maintain employee retention.