ANZCTR search results

A mixed method, waitlist-randomised controlled trial with 200 older adults in rural and remote areas in Australia will be conducted. The aim of the program is to implement an intervention to improve dementia risk, dementia awareness and cognition. Participants will be assigned to either the multidomain behaviour change group or a waiting-list control group and assessed when they initially register for the program, 3 and 9 months after the intervention. The waiting-list control group will receive the intervention after 12 weeks. The primary outcome is dementia risk score, measured by the LIBRA index. Secondary outcomes include dementia awareness and cognitive performance. An impact/outcome evaluation, which will involve semi-structured interviews, will be conducted at the end of the trial including participants from both multidomain behaviour change group and control groups to examine the feasibility and acceptability of the intervention. The aim of this intervention is to increase awareness of dementia, decrease risk of dementia through reducing lifestyle factors and improve brain health in the long-term.

Vocal cord dysfunction/inducible laryngeal obstruction (VCD/ILO) is common but seldom recognised at first since patients experience intermittent breathlessness leading in most cases to a diagnosis of asthma and treatment with inhaled corticosteroids (CS). Diagnosis of VCD/ILO is further complicated by coexistence of asthma and VCD/ILO in 20-40% of asthmatics and VCD/ILO can make asthma seem more severe leading to over-treatment with high-dose inhaled or oral CS. To date a swift diagnosis is seldom achieved. The current gold-standard for diagnosis of VCD/ILO is laryngoscopy and the quintessential abnormality is inspiratory closure of the vocal cords and formation of a diamond-shaped small opening or ‘chink’ posteriorly. Laryngoscopy requires expertise that may not be available within a reasonable time-frame and the procedure can be technically challenging or fail if a patient is breathless and distressed. Consequently, laryngoscopy may be delayed or not performed. Laryngoscopy in expert hands remains the definitive diagnostic modality but innovations in diagnostic imaging have created alternative options. Present-day imaging technologies with superior spatial and temporal resolution have made it possible to visualise not only anatomical features, but also movement and function of a particular organ. We have developed dynamic CT larynx to detect and quantify laryngeal movement, a technology that can be applied wherever cardiac CT is performed. We hypothesised that dynamic CT larynx would have comparable diagnostic accuracy to laryngoscopy in VCD/ILO, when performed contemporaneously and when utilised in a real-world clinical context.

This project is testing the safety, tolerability and brain delivery of INB-01, an intranasal formulation of a currently marketed MRI contrast agent. You may be eligible for this study if you are a healthy adult man or woman aged between 18 and 55 years old. Participants will be randomised (assigned randomly, like flipping a coin) to one of two stages. In Stage 1 you will receive a single intranasal dose of placebo. In Stage 2 you will receive a single intranasal dose of INB-01, the active experimental contrast agent. It is hoped that this research will help determine the safety of INB-01 when given to healthy men or women and to see if it gets to the brain tissues

The objective of this Phase 1B, multicentre, longitudinal, prospective, PK, open label study is to assess any changes in LCM plasma concentrations that may result from physiological changes that occur during pregnancy in women with epilepsy. A change of PK during pregnancy will be assessed relative to postpartum LCM concentrations. In addition, if subjects give additional consent, this study will also measure LCM concentrations in mature breast-milk to estimate newborn LCM exposure. This collaborative study will be conducted as a sub-study of The Raoul Wallenberg Australian Pregnancy Register (RWAPR), which is an observational, prospective, longitudinal study of pregnancies in women taking ASMs, and also women with epilepsy not taking ASMs. The study is interventional due to the additional collection of blood samples and breast milk from women which are exceeding medical practice. However, all other study assessments are part of routine clinical practice, and any decision to continue/discontinue or change LCM therapy during pregnancy and breastfeeding will be made between the participant and her treating physician, taking into account potential risks and benefits, and according to the local label.

This study aims to assess whether the technique of snare tip soft coagulation (STSC) during polypectomy (removal of colon polyps) improves safety and reduces polyp recurrence. Who is it for? You may be eligible for this study if you are aged 18 years or above, and will undergo elective colonoscopy. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. One group will be treated with STSC therapy following removal of their colonic polyp. The other group will be treated with standard of care during their removal of colonic polyps removed, without any additional procedures. After treatment, there will be 30-day monitoring of adverse events via a questionnaire. Polyp recurrence will be assessed at 6 months with a follow up colonoscopy. It is hoped that this research will reveal if the STSC technique is safe and effective in reducing polyp rates, thus improving patient outcomes and reducing risk of colon cancer.

There is an acknowledged lack of available specialist vocational rehabilitation services for adults with stroke. This trial-within-a-cohort will investigate the effectiveness of two models shown to be effective outside of Australia: (1) a resource facilitation approach which will support existing clinical rehabilitation teams to address return-to-work goals, and (2) a more intensive specialist rehabilitation model where a central team of expert clinicians will provide the rehabilitation. The aim is to determine whether a model of vocational rehabilitation will support returning to work after stroke more than clinical rehabilitation.

Rates of cross-reactivity to rocuronium and vecuronium can be used to estimate population exposure and therefore correct individual rates to exposure to give a risk per dose.

Half of mental health condition present before the age of 14, making schools an important platform for supporting student mental health. However most of the research has focused on secondary schools with little attention on the effectiveness of mental health support in primary schools. Therefore, the current study will train a qualified teacher in a new role of Mental Health and Wellbeing Coordinator (MHWC) in primary schools across Victoria, Australia to build the capacity of schools to support student mental health. Our hypothesis is that the MHWC role and associated training (ie. the 'MHWC model') is effective in improving teacher and student outcomes using objective and self-reported measures, when compared to business as usual schools. The primary objective of this study is to assess whether the MHWC model leads to changes in classroom teachers’ self-reported confidence to support student mental health and wellbeing. This study will also assess changes to teachers’ mental health literacy, perceived levels of support to manage child mental health and wellbeing among staff, the prioritisation of child mental health and wellbeing within schools and student mental health and wellbeing. Our hypothesis is that teacher's self-reported confidence to support student mental health and wellbeing will increase following the implementation of the MHWC model.

The purpose of this research is to further the knowledge on the benefits of aerobic exercise to persons with advanced multiple sclerosis (MS). As MS worsens, the ability to perform aerobic exercise at moderate to high intensities becomes difficult due to leg and or arm paresis, access to equipment and the possible effects of MS related fatigue. Low physical fitness and inactivity is associated with a higher risk of cardiovascular and metabolic disease and poor body composition in persons with advanced MS. The main purpose of the study will be to assess exercise capacity, cardiorespiratory and power outcomes on two modes of exercise during three different exercise protocols. The results will allow us to understand how to elicit higher intensities of exercise in people with advanced MS.

This online mental health check aims to identify and detect symptoms of anxiety and depression in children, while triaging aims to increase children’s access to evidence-based care to support children’s mental health. The primary purpose of this study is to evaluate whether the mental health check alone significantly impacts stigma in children aged 6 to 12 years by conducting a school-based cluster randomised controlled trial. Specifically, this study aims to answer the following question: Does the mental health check significantly impact stigma for children aged 6 to 12 years and their parents, compared to children who do not complete regular mental health checks and their parents?