ANZCTR search results

BIO-STRIP is an exploratory study aiming to identify potential protein biomarkers in the skin of patients with Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) using tape strips. Currently, no laboratory tests exist to accurately diagnose or monitor DRESS. Blood tests and a skin biopsy can help guide the diagnosis of DRESS. However, skin biopsies are moderately invasive (with risk of infection and scarring) and is not practical to obtain multiple samples from the same patient. Tape stripping is a simple and minimally invasive technique alternative to skin biopsy, permitting the collection of the outermost skin layers and the proteins contained within them. The investigators propose that combining tape stripping with proteomics, which allows detailed analysis of proteins, offers a new approach to finding biomarkers in DRESS. The project will investigate the safety of using skin tape strips and characterise differences in protein expression between affected (lesional) and unaffected (non-lesional) skin in patients with DRESS, compared to patients with Drug Reaction with Eosinophilia without systemic symptoms (DRE) and ‘healthy’ individuals with no history of severe drug allergy, to identify markers specific to DRESS for disease diagnosis and monitoring.

Most heart attacks are caused by blocked coronary arteries; however, some people, particularly women, experience a heart attack despite having no significant arterial blockages. This condition is known as MINOCA, or myocardial infarction with non-obstructive coronary arteries. Many individuals with MINOCA do not receive a clear explanation for their symptoms, and a substantial proportion continue to experience chest pain long after the initial event. We hypothesise that dysfunction of the heart’s small blood vessels, termed coronary microvascular dysfunction, may underlie these symptoms. Current methods to assess this condition are invasive and not routinely available. In this study, we will use a novel, non-invasive magnetic resonance imaging technique to assess how these small vessels respond to controlled changes in breathing. Findings from patients with MINOCA will be compared with those from individuals with myocardial infarction due to obstructive coronary artery disease, patients with hypertension, and healthy volunteers. This research aims to improve understanding and diagnosis of MINOCA by identifying a mechanism that is frequently overlooked.

Menstrual health conditions impact many facets of young people’s lives. Early intervention at adolescence is critical to reducing the lifelong personal and societal impacts of menstrual symptoms and conditions. However, problematically, young people do not know how to adequately manage menstrual health conditions. Movement and exercise have been found to be beneficial for managing menstrual health conditions. However young people often don’t recognize its benefits or believe it will aggravate symptoms further. This study is designed to test whether an online education intervention (Movement Matters) is acceptable for young people with menstrual health conditions.

This study will establish innovative magnetic resonance imaging (MRI) techniques, develop standard protocols, establish normal ranges and apply the techniques in different disease populations. Its aims are to: • Establish state-of-the-art innovative MRI techniques for the investigation of biomarkers relevant to the diagnosis of heart disease and related conditions; • Develop standard protocols for such MRI techniques; • Establish the normal ranges acquired through scan protocols using such techniques; • Apply the techniques in different disease populations to obtain information on effect size for future research projects.

This is a Phase 2, Randomised, Open-Label, Dose-Ranging Study of Minoxidil Sublingual (SL) Tablets in the Treatment of Male Androgenetic Alopecia (AGA) in Adults The study will evaluate the safety and efficacy of three doses of minoxidil (5 mg, 7.5 mg, 10 mg) SL tablets in participants who have completed all study visits in the preceding SAM-002 study (placebo and active). Participants will be randomised 1:1:1 to two 2.5 mg minoxidil SL tablets, three 2.5 mg minoxidil SL tablets, and four 2.5 minoxidil SL tablets daily. The study duration is up to 48 weeks. Approximately 120 participants are expected to take part in this open label extension study. The efficacy objective is to evaluate the effect of varying doses of SL minoxidil tablets over 48 weeks on Target Area Hair Count (TAHC) in men with AGA. The study evaluates efficacy from Baseline to Week 48 using a Primary Endpoint of mean change in vertex scalp TAHC via macro-photography, and Secondary Endpoints including global and macro photographic hair assessments, PROs (PGA and CMPHL-PRO), and investigator-blinded evaluations. Safety will be evaluated over 48 weeks by assessing the tolerability of minoxidil SL tablets across dose levels through comparison of the incidence of treatment-emergent adverse events (TEAEs), treatment-related TEAEs, serious adverse events (SAEs), and clinically significant changes in vital signs and electrocardiograms (ECGs) from Baseline to Week 48.

This study aims to improve treatment access for people receiving medication assisted treatment for opioid dependence by introducing a collaborative model of care. In the EPIC-MATOD model, prescribers can delegate routine clinical review and clinical tasks to pharmacists, who complete structured assessments with patients. Pharmacies in several Australian regions will be randomly allocated to receive either a basic support package or an enhanced support package designed to help them implement this model. We hypothesise that pharmacies receiving enhanced support will adopt the model more effectively.

The study hypothesis is that removing overhead announcements in hospital will improve patient's sleep. To investigate the effect of removing overhead announcements on a cardiorespiratory ward in an Australian tertiary hospital. Observational study before and after removal of overhead announcements being implemented as part of hospital policy. 1. Baseline (Phase I): Data collection hospital ward- noise levels overnight, patient sleep duration and quality. 2. Phase II: Data collection hospital ward after removal overhead announcements- noise levels overnight, patient sleep duration and quality.

The goal of this study is to test a new digital program designed to help parents support their children in overcoming nighttime fears and related anxiety. The program delivers primarily exposure with optional sleep treatment at the end of the program, all delivered through an app that families can use at home. Parents are supported with sessions with a therapist. We aim to find out whether this parent-led approach is acceptable and feasible for families and whether it helps reduce children’s nighttime fears, anxiety symptoms, and sleep difficulties. We hypothesise that the digital intervention will be acceptable and feasible for families and will lead to improvements in children’s nighttime fears, anxiety, and sleep outcomes.

Coeliac disease is a serious illness in which the immune system reacts badly to gluten, a protein found in wheat, rye, and barley. This reaction damages the lining of the small intestine and causes a range of unpleasant symptoms. The only treatment is a strict gluten-free diet, which usually helps to settle symptoms and allow the intestine to heal. However, this treatment is challenging and for some people even small amounts of gluten intake is associated with persistent symptoms and/or small intestinal damage. Currently, there are limited treatment options in this situation and there is a need to address this unmet need. The aim of this study is to test if HCQ can reduce immune responses to gluten in people with coeliac disease.

We hypothesise that a multidisciplinary program model of care (MoC) will be effective, safe, feasible, sustainable, and have high fidelity in young people with CHD. The study will also look to identify the barriers, facilitators, and resources required to implement an exercise and lifestyle program for people with CHD. It will also look to investigate the effectiveness, fidelity, safety, feasibility, adoption, sustainability, and patient satisfaction of a exercise and lifestyle program.