ANZCTR search results

OPTIMISM is a 4-week double-blind placebo-controlled feeding trial. All meals and snacks will be provided to participants for the duration of the study. In total, 22 healthy volunteers will be recruited along with 44 adults with a major depressive disorder (see linked record). Study visits will be conducted at baseline and week 4 at either the Health Education and Research Building (HERB), Barwon Health, Geelong, or at the Alfred Centre, Monash University, Melbourne.

This study is investigating the ability of the SeedTracker monitoring system to improve the accuracy of radiotherapy treatment delivered to the prostate, and any resultant changes in patient quality of life during and after radiotherapy. Who is it for? You may be eligible for this study if you are a prostate cancer patient receiving definitive radiotherapy to the prostate with current treatment protocol used within Liverpool and Macarthur cancer therapy centres. Study details The SeedTracker system will detect the position of radiopaque markers implanted in patients during pre-treatment position verification via monoscopic x-ray images acquired in real-time during treatment delivery. Radiation oncologists, Radiation Therapists and Physicists will use this data to monitor treatment margins accordingly throughout treatment, whilst monitoring the actual dose of radiation delivered. Participants will also be asked to complete quality of life questionnaires monitoring their bowel, urinary and sexual function during treatment and up to 5 years after completion of treatment. The researchers hope this trial will result in better outcomes for prostate cancer patients and lower side effects.

The aim of this study is to assess the effects and feasibility of the intervention for bedtime device use in new career starters. Using a three-arm randomised design, we will investigate the effects of intentions and habit-based approaches to reduce bedtime device use. The primary outcomes will be sleep duration, sleep quality, and bedtime device use. The secondary outcomes will be bedtime procrastination and excessive device use. We will further measure habit strength and motivation as mechanisms of change. Feasibility items to be assessed include daily survey completion rate, intervention attrition rate, as well as the effect of the intervention on outcome variables. The intervention will take place online, over a two-week period with a information video and coaching session on Zoom, as our needs assessment indicated this was the most commonly requested duration, format, and delivery method for an intervention program. It is hypothesised that: 1. Substitute and Prevent conditions will have a decrease in bedtime device use in week 2 compared to Control. 2. Substitute and Prevent conditions will have improved sleep outcomes in week 2 compared to week 1. 3. Substitute and Prevent conditions will have decreased bedtime procrastination scores, excessive device use and improved sleep quality at follow-up compared with baseline.

Prematurity remains common, and infants born prematurely have an increased risk of brain injury. “Encephalopathy of prematurity” refers to brain dysfunction and injury in preterm infants due to a variety of processes. It is known to be an important risk factor for adverse neurodevelopmental outcomes, however a thorough understanding of the causes, clinical presentation, evolution, and outcomes has not been fully established. The aim of this study is to better identify, understand and predict encephalopathy in preterm infants. This is an observational prospective cohort study that investigates babies born at less than 29 weeks’ gestation. Data will be collected on antenatal history, birth and resuscitation details, progress, clinical examinations and investigations in the Neonatal Intensive Care Unit (NICU). For the study, participants will undergo additional periods of brain monitoring and brain imaging. Video recordings will also be taken of routine neurological examinations at certain timepoints. Data will then be collected from routine developmental progress. Data will then be collected from the routine neurodevelopmental follow-up appointments at 12-14 weeks and 24-30 months corrected age. Outcomes of the study have the potential to improve the identification and care of infants at risk of encephalopathy, and better understand their prognosis. A better understanding of the condition may pave the way for future studies on targeted therapies to improve neonatal neurological and developmental outcomes.

This is a open-label, randomized, 3-period, 6-sequence crossover study to determine the relative bioavailability of two formulations (10% and 30%) of radiprodil under fasted and fed conditions in healthy adult participants. Radiprodil may be indicated for use in patients with GRIN related disorders, but a trial of the drug in healthy volunteers is needed before trials in patients with GRIN related disorders can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 55 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will receive a single dose of radiprodil over 3 separate periods under fasted and fed conditions. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with GRIN related disorders.

The aim of this pilot study (n=20) is to better understand the impact of wood heaters on residential air quality as well as the effectiveness of portable air cleaners in improving indoor air quality and asthma and health symptoms. Indoor and outdoor air quality monitors will be placed in homes to measure fine particles in air (particulate matter (PM2.5) - this is a component of woodsmoke that results in poor air quality. We will also place small metal sampling tubes inside and outside your home to measure concentrations of volatile chemicals (volatile organic compounds (VOCs), which also contribute to poor air quality. Monitoring will be conducted for two months during winter. The air quality monitors transmit their data every 10 minutes to a secure cloud-based data repository.

The objective of this study is to demonstrate the safety and functionality of the Edwards 12F Sheath Introducer Set in conjunction with the Edwards SAPIEN X4 THV in subjects with symptomatic, severe, calcific AS. This is a prospective, single arm, multicentre, feasibility study that will include up to 30 subjects who have the 12F Sheath inserted at up to 5 sites in Australia and New Zealand. Subjects will be assessed at screening, procedure, post-procedure, discharge, and 30 days. Expected enrolment duration is approximately 6 months, resulting in a total study duration of approximately 9 months.

This research will conduct a randomized controlled trial (RCT) of the Growing Minds Check-In (GMCI-P) for parents, a universal online child mental health check-in and referral tool, that involves parents answering a set of questions about their child’s social, emotional and behavioural wellbeing (wellbeing), receiving automated feedback based on their responses to the questions and recommendations for evidence-based programs and information matched to their child’s needs.

‘GLY-200' is an orally-administered, pH-dependent, gut-restricted therapeutic polymer developed by Glyscend Therapeutics. GLY-200 interacts with the mucus on the surface of the duodenum (the first part of the small intestine) to form a temporary barrier that lasts several hours. This mimics the effects of gastric bypass surgery – a very effective surgical procedure for type 2 diabetes and obesity – where the duodenum is removed from contact with meal contents. We don’t fully understand how excluding the duodenum from contact with nutrients results in lowering of blood glucose or body weight, but possible mechanisms include slowing of stomach emptying or passage of contents through the small intestine, reduction in glucose absorption from the duodenum, or changes in the levels of hormones secreted by the small intestine. This study is designed to investigate these possible mechanisms, in both healthy volunteers and people with type 2 diabetes treated only with diet or metformin.

This research project is based at Eating Disorders Victoria (EDV) and embeds a master of clinical psychology placement program for postgraduate psychology students within a research program examining evidence-based eating disorder assessment and treatment. (Master Research Agreement attached) This is a pilot and feasibility RCT with two primary aims: (i) to explore the viability of running a full RCT to compare treatment efficacy and cost effectiveness of a stepped-care model of eating disorder treatment, specifically comparing two interventions; Cognitive Behaviour Therapy (CBT-E) and Guided Self Help (GSH); and (ii) to explore the feasibility of providing specialised training in eating disorder treatment and access to treatment via a community-university partnership that embeds professional psychology training in an ongoing research and treatment program. It is expected that eating disorder symptoms will be significantly reduced from pre- to post-treatment in both CBT-E and GSH. It is also expected that those allocated to the CBT-E group will have significantly lower eating disorder symptoms post-treatment compared to those allocated to GSH.