ANZCTR search results

This 16-week, phase II, randomised, placebo-controlled study aims to evaluate the effects of oraglutide QW — an oral formulation of an injectable medicine commonly used to treat type 2 diabetes, that mimics a naturally occurring hormone in the body (GLP-1) to help regulate blood sugar and support weight management — on body weight in overweight or obese individuals without T2D, and on glycaemic control (fasting and postprandial glucose, HbA1c) in those with T2D. Secondary aims are to assess the pharmacokinetic effects of oraglutide QW, as well as changes in gastric emptying, lipid profile (cholesterol and triglycerides), safety, tolerability, and treatment satisfaction in overweight or obese individuals with or without T2D.

To assess the feasibility of implementing a structured postpartum follow up program for women with a pregnancy complicated by HDP. We hypothesize that a structured postpartum program is feasible, acceptable to consumers and cost effective.

The primary objective of this study is to evaluate the implementation of a digitally supported self-management and pulmonary rehabilitation platform, known as Perx-R, in people with chronic respiratory diseases in real-world clinical settings. This study will be a multi-site, mixed-methods, hybrid type III implementation-effectiveness study. Phase 1 (pre-implementation) will involve clinician engagement in education and completion of surveys and focus groups or interviews to inform development of an implementation support toolkit. Phase 2 (implementation) will involve training of clinicians in how to use the Perx-R program and recruitment of people with chronic respiratory disease to use the digital platform to support their self management (recruited from inpatient settings and outpatient respiratory clinics) or pulmonary rehabilitation program programs (recruited following pulmonary rehabilitation assessment)

This research is looking at a new way to help older adults improve their balance and reduce their risk of falling. Falls are a common problem for older people and can lead to serious injuries. One way to prevent falls is through "reactive balance training" that helps people react quickly when they lose their balance—like when they slip or trip. Many current reactive balance training methods use expensive equipment and are hard to use in everyday settings. To make this kind of training more practical and accessible, we’ve developed a simple LEAP training program that uses basic items like a foam block and a plastic sheet. These exercises are designed to mimic real-life situations and help people learn how to recover their balance safely from trips and slips. We will test this program with older adults who live in the community. Participants will come to our lab once a week for six weeks. Each session will include warm-up activities and reactive balance exercises supervised by trained staff. The exercises will include both standing and walking tasks to improve balance reactions from trips and slips. To see how well the program works, we will compare two groups: one that does the LEAP training right away, and another that waits and does the same training later. We will measure how well participants can recover their balance in the lab, as well as how confident they feel about their balance and how anxious they are about falling. We’ll also look at how they move—like how fast they walk and how steady they are when standing. The results of this study will help us understand whether this simple and low-cost training method can be used more widely, especially in places that don’t have access to expensive equipment. It may also help guide future research for people with neurological conditions who are at risk of falling.

This study evaluates the safety and tolerability of a new investigational drug, AP003, in healthy adult volunteers. Participants receive a single dose of AP003 or a placebo, and researchers monitor for side effects, vital signs, and laboratory results. The study also investigates how AP003 is processed in the body.

This study will evaluate the safety and effectiveness of Relfydess (RelabotulinumtoxinA) for treating forehead lines using a randomised, single-blind, placebo-controlled design. This also seeks to inform best practices by comparing contraction-pattern driven versus standardised injection approaches and evaluating treatment durability following repeated administration. In Part A, participants will be randomised in a 4:1 ratio to receive either active or placebo and will be treated according to their forehead muscle contraction pattern. In Part B, those who first received active treatment will cross-over to receive a standardised injection approach, while those who first received placebo will receive active treatment, administered according to their forehead muscle contraction pattern.

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.