ANZCTR search results

A phase 1, single centre, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered BT-409 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BT-409 in Healthy Volunteers. Study Population: Part A and B: Healthy male and female volunteers aged 18 to 50 years of age (inclusive) at the time of screening. Study Design: This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of BT-409. The study will be conducted in 3 parts, with 2 parts conducted on healthy volunteers: • Part A: a single ascending dose (SAD) with up to 5 dose levels in heathy volunteers • Part B: a multiple ascending dose (MAD) with up to 3 dose levels in healthy volunteers

This study looks at how nutrition care is currently provided to people having pelvic exenteration surgery across hospitals in Australia and New Zealand. Pelvic exenteration is a very large cancer operation, and many patients struggle to eat enough during recovery, which may affect healing and complications. The study will observe usual care to see how hospitals assess nutrition, what types of nutrition support are used (such as eating normally, tube feeding or intravenous nutrition), and what makes it harder for patients to meet their nutrition needs. The study hypothesis is that nutrition practices vary widely between hospitals, even though patients face similar challenges after surgery. Understanding these differences will help identify opportunities to improve nutrition care and guide the development of future best-practice nutrition guidelines for this high-risk group.

This study will test whether a nutritional supplement approach can help reduce migraines in adults who experience frequent episodic migraines. Participants will take either L-arginine alone or L-arginine combined with a garlic extract, with neither the participants nor researchers knowing which treatment is given until the study ends. The garlic extract contains a standardised compound thought to improve blood flow and reduce inflammation, and the study will compare migraine frequency, pain severity, and quality of life between the two groups. We hypothesise that the combination of L-arginine and garlic extract will be more effective at preventing migraines than L-arginine alone.The trial will be conducted in two phases over 16 weeks. In the initial 8-week open-label phase, all participants will receive L-arginine. In the subsequent 8-week double-blind phase, participants will have been randomised in a 1:1 ratio to receive either L-arginine with placebo, or L-arginine with GE. Both participants and investigators will remain blinded to group allocation during this second phase. The primary outcome measures will be: 1) a short-form McGill pain questionnaire administered every 2 weeks, which assesses the occurrence and characteristics of migraine episodes, along with a visual analogue scale of average pain intensity; and 2) a migraine-specific quality-of-life questionnaire administered every 4 weeks, which evaluates the extent to which migraines interfere with aspects of daily living. The secondary outcomes will be: 1) blood levels of nitrite as a vasodilation biomarker; and 2) blood levels of asymmetric dimethylarginine (ADMA) and endothelin 1 (ET-1) as biomarkers of vasoconstriction; also, 3) an unexpected-effects questionnaire every 4 weeks, to assess positive, negative and/or neutral unexpected affects the participant would attribute to this treatment.

Project aims: The aim of this project is to increase prevention and early identification of mental health issues in the early years. We aim to empower families with strengths-based, timely and accessible solutions and interventions, including children with special needs (e.g. neurodivergent, chronic conditions), and from disadvantaged families. Study aims: This study aims to [1] evaluate the acceptability and feasibility of The Flourishing Intervention, and [2] collect and analyse data on post-intervention changes in parent and child outcomes including (i) perceived self-efficacy in recognising and supporting flourishing (ii) perceived knowledge of how and when to seek support, (iii) engagement with and participation in supports relevant to flourishing (iv) parent wellbeing and (v) pediatric quality of life. We hypothesize that the Flourishing Intervention (Flourishing Check and Pathway Tool) will be acceptable and feasible to parents of children aged 0-5 years, as indicated by questionnaire responses, qualitative feedback, and website engagement metrics (primary aim). Given the brief duration of the intervention and follow-up period, and the relative stability of many parenting and wellbeing characteristics over short timeframes, we anticipate detecting only small changes in most of the secondary outcome variables. We do not anticipate that we will detect significant improvements to parental wellbeing or pediatric quality of life within the timeframe of this study. However, this will be measured to assess the feasibility and sensitivity of these measures, and to inform effect size estimates and outcome selection for a future trial evaluating the intervention's effectiveness.

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.