ANZCTR search results

This study is exploring the possible benefits of adding clinical grade digital sleep assessment and clinician advice to the standard first line treatment for insomnia (Cognitive Behavioural Therapy-Insomnia, CBT-I). Specifically, we are evaluating the Somfit (https://www.compumedics.com.au/somfit) sleep monitoring device and Somfit program when added to standard Cognitive Behavioral Therapy for Insomnia (CBT-I). We will assess the feasibility, acceptability, and treatment outcomes compared to standalone CBT-I.

INNA051 is being developed as a prophylactic against respiratory viruses, for example influenza (the flu), SARS-CoV-2 (coronavirus), and respiratory syncitial virus (RSV). This study will test increasing doses of a dry powder formulation of study drug for safety and tolerability, and to measure how the immune system responds in older adults.

We aim to test the feasibility and acceptability of "Modif-i", an app that delivers personalised "approach bias modification" training, in tobacco smokers who are trying to cease smoking. We also aim to obtain preliminarily evidence on the app’s effectiveness as a smoking cessation aid. Specifically, we will assess whether Modif-i is effective, relative to a control version that does not include approach bias modification, at (a) increasing likelihood of abstinence from tobacco; (b) reducing tobacco craving and severity of tobacco dependence; and (c) improving quality of life. We also aim to test whether Modif-i significantly reduces impulsive responses to tobacco imagery.

Eloxx Pharmaceuticals has developed a new product which works on mutated gene and allows for production of the correct protein instead of the defective protein typical to a number of hereditary diseases. The product is called ZKN-0013 and it is taken orally. The purpose of this research is to determine whether ZKN-0013 is safe and well tolerated in humans. In addition, the study purpose is to learn about the study drug properties. The participants will take one or multiple doses of ZKN-0013 during their participation based on the group they will be assigned to.

Sleep problems in children aged 3-12 years are highly prevalent, chronic and are a transdiagnostic risk factor for numerous deleterious mental health, physical health, academic and cognitive outcomes in both the short- and long-term. We have developed a group-based, parent-focused, program for preschool (3-5 years) sleep problems and demonstrated that it not only improves child sleep, but that it also leads to significant improvements in anxiety and behaviour problems, and prevents the later emergence of anxiety. The transdiagnostic impact of our sleep program has the potential to significantly improve the lives of young Australian children and their families. The next step is to make it accessible to as many families as possible by a) extending the program to include children up to 12 years of age with sleep problems and b) digitising the program in order to circumvent barriers to help-seeking. The aim of the proposed randomized controlled trial is to determine the relative short- and long-term treatment efficacy of an online, parent-focused treatment program (TX) for children with behavioural sleep problems (aged 3-12 years), compared to a Waitlist Control (WLC) condition. The TX condition will be assessed at baseline, post-assessment (6-wks post-baseline), 12-week, and 6-month follow-up. The WLC condition will be assessed at time points corresponding to baseline, post-assessment, and 12-week follow-up, after which they will receive the TX program. Our end goal, if this program is found to be efficacious, is to disseminate the program nationally to all Australian families through our Momentum online digital mental health assessment and treatment platform.

The study is an Australian multicentre prospective imaging study performing multiparametric MRIs after acute reperfusion treatment for anterior circulation large vessel occlusion with cerebral perfusion, microstructural, metabolic and functional assessment at multiple follow-up time points. The project has received ethical approval from the Melbourne Health Human Research Ethics Committee (HREC). The HREC confirms that your proposal meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). This HREC is organised and operates in accordance with the National Health and Medical Research Council’s (NHRMC) National Statement on Ethical Conduct in Human Research (2007), and all subsequent updates, and in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), the Health Privacy Principles described in the Health Records Act 2001 (Vic) and Section 95A of the Privacy Act 1988 (and subsequent Guidelines).

The study is an Australian multicentre prospective imaging study performing multiparametric MRIs after acute reperfusion treatment for anterior circulation large vessel occlusion with cerebral perfusion, microstructural, metabolic and functional assessment at multiple follow-up time points. The project has received ethical approval from the Melbourne Health Human Research Ethics Committee (HREC). The HREC confirms that your proposal meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). This HREC is organised and operates in accordance with the National Health and Medical Research Council’s (NHRMC) National Statement on Ethical Conduct in Human Research (2007), and all subsequent updates, and in accordance with the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95), the Health Privacy Principles described in the Health Records Act 2001 (Vic) and Section 95A of the Privacy Act 1988 (and subsequent Guidelines).

This study will explore potential sex differences in skeletal muscle microvascular blood flow and other cardiovascular responses to acute maximal exercise in 34 healthy young adults (17 premenopausal females and 17 age-matched males). Microvascular blood flow will be assessed via contrast-enhanced ultrasound at rest, immediately after, and 30 minutes after completing a maximal graded exercise test. Additional assessments include heart and large artery function, body composition, physical activity levels, and blood sampling for biomarkers associated with cardiometabolic health. We hypothesise that healthy premenopausal females will have larger skeletal muscle microvascular blood flow responses to acute maximal exercise than age-matched males, reflecting their known greater vasodilatory responses in large arteries. Findings will inform sex-specific cardiovascular risk factors, and aid in the development of early detection strategies and more targeted prevention and management approaches.

This study aims to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. You may be eligible for this study if you are an adult male or female referred for investigation of reflux symptoms or other suspected gastrointestinal disease, as well as patients with established Barrett’s oesophagus and/or suspected or established oesophageal adenocarcinoma. Any patient with one of the Barrett's related conditions or random healthy patients who may undergo an endoscopy for another indication, maybe approached to consider participation in this study. Participants will be asked to contribute samples of saliva, blood and gastric fluid before undergoing an endoscopic procedure. This study aims to determine if a panel of salivary biomarkers could assist in the diagnosis of Barrett's oesophagus and its pathological variants, dysplasia and oesophageal adenocarcinoma. You may be eligible for this study if you are an adult male or female referred for investigation of reflux symptoms or other suspected gastrointestinal disease, as well as patients with established Barrett’s oesophagus and/or suspected or established oesophageal adenocarcinoma. Any patient with one of the Barrett's related conditions or random healthy patients who may undergo an endoscopy for another indication, maybe approached to consider participation in this study. Participants will be asked to contribute samples of saliva, blood and gastric fluid before undergoing their usual endoscopic procedure. It is hoped that findings from this study will help to develop a simple non-invasive saliva test to screen for oesophageal cancer.

This prospective cross sectional observational study aims to explore the protein and energy expenditure of patients with ulcerative colitis. Patients will undergo indirect calorimetry and nitrogen balance studies to determine their metabolic demand. The primary endpoint is nitrogen balance measured in nitrogen(g)/kg participant body weight/day. The secondary endpoint is resting metabolic rate in kcal/kg/day. Patient metabolic outputs will be compared to that of healthy controls. It is hypothesized that patients with ulcerative colitis do not have increased metabolic demands compared with healthy controls.