ANZCTR search results

This research project, called the OPAL-3 Study will help us determine the best dose of omega-3 supplements to give pregnant women, who have a moderate level of omega-3. Omega-3 fatty acids (DHA and EPA) are found in fish and fish oils and thought to have several health benefits including maintaining a pregnancy to full term (>37 weeks). Previous studies have shown that women who are low in omega-3 fatty acids are at increased risk of having a premature baby. This risk can be reduced by taking an omega-3 supplement containing DHA and EPA. Studies have also shown that women who have sufficient levels of omega-3 fatty acids have a lower risk of giving birth to a premature baby and do not need to take supplements. What is not clear from the research is the best advice to provide women with moderate omega-3 levels. The aim of this study is to work out the dose of omega-3 fatty acids (DHA and EPA) needed to best match the fatty acid levels of women who are sufficient in omega-3 fatty acids. This study will compare women who have moderate levels of omega-3 and taking different doses of study supplements to women who have sufficient levels of omega-3. We will also compare with women who have low levels of omega-3 and are taking the recommended dose to correct their low levels. This will be done by looking at the omega-3 levels in blood spot samples throughout pregnancy.

This research will examine the impact of implementing a point of care (PoC) lactate machine on the administration of antibiotics in paediatric patients presenting with potential sepsis in the Emergency Department (ED). Elevated lactate levels are proven to be an accurate prognostic factor in predicting morbidity among patients with sepsis. Current practice requires that serum lactate samples are collected via intravenous cannulation or venepuncture, a distressing procedure for children and parents and challenging and time-consuming for staff . The PoC lactate machine is a portable, single-operator handheld device requiring finger prick blood sampling to obtain accurate lactate results. This negates the need for intravenous cannulation or venepuncture to obtain objective data to aid clinical decision-making. This may result in the earlier recognition of sepsis, administration of antibiotics and transfer to definitive care.

This double blind, placebo controlled, first-in-human study will assess the safety, tolerability of single and multiple oral doses of MRX-5 tablets in healthy men or women of non -child bearing potential and also to assess the pharmacokinetic (PK) profile of MRX-5 and its metabolite MRX-6038, and to compare the PK of a single dose of MRX-5 administered fed vs. fasted conditions. Who is it for? You may be eligible for this study if you are a healthy adult aged between 18 and 55 years old. Approximately 84 healthy participants will be enrolled in this study. (60 subjects in Part 1 and 24 subjects in Part 2) The total participation in the study will last around 5 weeks which consists of Screening visit, Admission and treatment period and Follow up visit.

This study will look at the effects of wearing surgical and N95 masks have in patients with respiratory failure currently using non-invasive ventilation. The aim of the study is to see whether this affects your oxygen or carbon dioxide levels as well as measures of comfort. The hypothesis of this study is there will not be a clinically important change in oxygen saturation and Transcutaneous carbon dioxide when wearing a surgical mask and N95 mask compared to no mask. There may be some changes in subjective comfort and breathlessness.

The prevalence of ocular allergies is increasing worldwide, affecting individuals’ quality of life and causing a significant socioeconomic burden. Allergic conjunctivitis can be managed using a range of treatment options. Ocular inflammatory cell (e.g., dendritic cell) play a substantial role in initiating the immune response in the setting of ocular allergies. The proposed study will be single centre, double-blinded, randomised, placebo-controlled, parallel group clinical trial. All participants will go through a washout period for 1 week using topical 0.25% polyethylene glycol 400 eyedrops (lubricant eyedrops) before starting the trial interventions. This study consists of three arms; arm 1 will be given topical ketotifen 0.025% eyedrops; arm 2 will be given prednisolone sodium phosphate 0.5% eyedrops; the placebo group will be given topical 0.4% polyethylene glycol 400, 0.3% propylene glycol eyedrops. All participants will remain on the trial interventions for 14 days. Assessment of the trial outcomes will take place pre-treatment, 24 hours, 7 days and 14 days after starting the treatment, 7 days and 14 days post-treatment. Both investigators and participants will be double-blinded to the group and treatment allocation until the results have been analysed.

Individuals living with a severe mental illness experience a significantly reduced life expectancy when compared to the general population, attributable in part to increased rates of cardiovascular diseases and metabolic syndromes that are associated with psychotropic medication use and poor health behaviours (e.g., low physical activity levels, poor diet quality and high sedentary time). There is a concerted effort to preserve (and improve) the physical health of individuals living with mental illness, with exercise increasingly advocated as part of mental health care due to the positive effect exercise has on physical and psychological health. One of the challenges for exercise services is to provide best practice exercise therapy, and support consumers to establish and maintain positive health behaviours in a client-centred and efficient manner. This trial will implement an effectiveness-implementation hybrid design to determine the feasibility and effectiveness of supported exercise therapy within transdiagnostic tertiary mental health care services. The aims are: • To determine the feasibility of implementation of low and high-support exercise therapy in a transdiagnostic tertiary mental health service. • To assess the preliminary effectiveness of low and high-support exercise therapy on consumer health outcomes including physical health outcomes, health behaviours, and quality of life.

Multiple system atrophy (MSA) is a rare, severe and life-threatening adult-onset neurodegenerative disease, characterized by a combination of parkinsonism, cerebellar ataxia, and autonomic dysfunction. At present, only symptomatic therapy is available for the treatment of MSA, and most of the prescribed medications are being used in an off-label manner. YA-101 is being developed for the treatment of subjects with MSA, a serious and life-threatening condition with a high, unmet clinical need. The safety, tolerability, PK, and food effect of YA-101 will be evaluated in HV in Parts 1 and 2 of this study. The study will be conducted in healthy volunters aged between 18-65 years . Besides the one food effect (FE) cohort, each cohort in Part 1~Part 2 is randomized, placebo-controlled, double-blinded to establish safety and tolerability in healthy volunteers (HV) following single ascending dose (SAD) and multiple ascending dose (MAD). A total of 60 participants will be enrolled in Australia. Duration of the study Part 1 HV SAD: Total duration of study is up to 8 days with 1-day treatment Part 2 HV MAD: Total duration of study is up to 21 days, 14-day treatment Part 2 HV FE: Total duration of study is up to 11 days with 1-day treatment

This is a characterisation research study investigating the different features of the Nutromics Sensor Device platform.Characterisation studies to help guide development of the Nutromics Sensor Device platform will provide invaluable information to Research and Development (R&D) teams. Since this is a minimally invasive patch based platform, with minimally invasive needle, characterisation of adhesive, ergonomics and human factors will be crucial.

Traditionally, many dancers and instructors use light aerobic activity combined with static stretching as a warm-up. There is limited research investigating how a warm-up affects dance performance, particularly for range of motion, jump height, force production and muscle activation for unilateral jumps and dance specific skills. The aim of this research is to compare a dynamic warm-up to a traditional dance warm-up and determine how this affects dance performance. Participants will each complete 3 separate days of testing, each one beginning with warm-up that includes either static stretching, dynamic stretching and no stretching (control). It is hypothesised that dancers will demonstrate superior performance when a dynamic warm-up is used compared to a traditional dance warm-up. The outcomes will be valuable as it will allows dancer and dance instructors to implement more evidence-based training to produce optimal results.

The study aims to investigate whether the use of mindfulness applications that incorporate peer support improves perinatal mental health outcomes. An exploratory sequential mixed method design consisting of two phases will be used in the study. The first phase involves qualitative study conducted through a focus group to explore women's knowledge and experiences of support groups and mindfulness. Phase one findings will inform the design and structure of the intervention in phase two. In the second phase, a pilot study using a quasi-experimental one-group pre-post test design will be used to assess peer support combined with a mindfulness app on anxiety, depression, mindfulness practices, perceived social support, and salivary cortisol levels. Peer support groups intervention aim to bring women together for mutual support and use of the mindfulness-based app (Headspace) activity together.