ANZCTR search results

We will undertake an individually randomised controlled trial: effectiveness implementation hybrid type 1 (n=200) to test the impact of a telehealth physiotherapy PA advisory service on physical activity of clients in the target groups. Implementation outcomes will be assessed alongside effectiveness outcomes and will include dose and implementation determinants. The PA advisory service will be staffed by a physiotherapist who will provide support to both health professionals and clients in the target groups to promote PA. The PA advisory service will provide a range of services including motivational interviewing, assistance in locating suitable community activities (in-person and on-line), advice on transport and subsidised/low- cost programs, liaison with community providers and where necessary supporting the person to attend these activities. Assistance for health professionals seeking information on these issues will also be available. Clients in the intervention group will receive services provided by the telehealth physiotherapy PA service. The control group will receive usual care which consists of an information brochure about the NSW Active and Healthy website and the Get Healthy coaching service. Clients in both groups will complete a baseline survey and after 3 months, a follow up survey. The intervention group will also complete an additional survey about their impressions of the intervention at 3 months. Clients will complete actigraph data collection at baseline and 3 month follow up to collect data on PA levels (specifically number of steps/day).

The purpose of this project is to evaluate the movement of immune cells that occur naturally in the clear window at the front of the eye (the cornea). This movement will be evaluated before and after the application of commercially available eye drops used to treat sign and symptoms of mild to severe dry eye. Immune cells with and without dendrites give the immune system the ability to sequester, tightly regulate, and increase the efficiency of defense against internal and external pathogens. Understanding the cell dynamics in healthy individuals will contribute to normative data to future studies on ocular and systemic diseases. In addition to assessing the corneal nerves, corneal confocal microscopy is also capable of detecting dendritic cells. These cells have a distinctive hyper-reflective shape and are located at the same depth of the corneal nerves, at approximately a 50 µm depth from corneal epithelium. Hence, the assessment of these two important ocular structures in a single image offers useful insight into the association and interaction between both; the nervous and immune systems of the ocular surface. The ability to observe and quantify migration rates of dendritic cells in vivo is likely to reveal previously unknown insights into corneal and general pathophysiology and may serve as an effective biomarker to intervention therapies. The dynamics of corneal resident dendritic cells located at the corneal sub-basal nerve plexus may provide a powerful approach to understanding the spectrum of immune and neurological diseases with applications in observational and analytic epidemiology, randomised clinical trials, screening and diagnosis and prognosis. DC dynamics have the potential to also reflect the entire spectrum of autoimmune diseases from the earliest manifestations to the terminal stages. The behaviour of these cells could potentially offer the means for homogeneous classification of autoimmune and systemic disease and risk factors, and also extend our base information about the underlying pathogenesis of immune diseases.

This randomised controlled trial will compare the effect of liberal vs. conservative oxygen therapy on survival and neurological function at six months in adults who are comatose following resuscitation from a cardiac arrest. The study hypothesis is that conservative use of oxygen (giving the smallest amount of oxygen possible to achieve safe oxygen levels in the blood) will increase the number of patients who survive with good neurological function.

Patients with persistent pelvic pain (PPP), including those with endometriosis associated pelvic pain, often have pelvic floor muscle tenderness and tension. These problems may be related to their pelvic pain continuing, despite medical or surgical treatments for endometriosis. Prior to a patient’s first laparoscopy for the investigation of PPP, we will investigate if they experience tenderness and tension in their pelvic floor muscles and whether this is associated with their pelvic pain. We will also investigate whether the pelvic floor muscle tenderness and tension, and pelvic pain, change following the laparoscopy, in the short term (3 months) and the medium term (1 year). This study will also test how well gynaecologists and physiotherapists are able to detect pelvic floor muscle tenderness and tension to ensure patients with pelvic floor muscle problems receive appropriate treatment.

This study aims to evaluate the impact of an online low health literacy fertility-related decision aid (DA) for young women with early breast cancer among women of all health literacy levels. The primary hypothesis is that the Intervention (DA website) is superior to the control (DA booklet), as measured by a greater reduction in decisional conflict at 12 months via the Decisional Conflict Scale. Who is it for? You may be eligible to take part in this study if you are a pre-menopausal woman aged between 18-40 years, have recently been diagnosed with early stage breast cancer, have not had an advanced cancer, have not undergone adjuvant therapy for breast cancer, want to find out more about fertility and/or fertility preservation at the time of diagnosis, and have easy access to the internet. Study details Participants will be randomly allocated (by chance) to receive either the new decision aid website or the existing decision aid booklet. The decision aid website contains easy-to-understand information about the side effects of cancer treatments on women's fertility, and options for preserving fertility to increase the chances of having a baby in the future. Participants will be asked to complete surveys at 4 timepoints: baseline (before viewing the DA), 1-month, 6-months, and 12-months after recruitment. We will then assess how effective the new DA is in supporting women to make decisions about breast cancer treatment and fertility. It is hoped that the DA will lead to better understanding of fertility-related issues and educated involvement in decision-making among women with diverse levels of health literacy.

This study is a FIH, open label, SAD and MAD study to determine the safety and PK characteristics of mEphA4-Fc in HVs and patients with ALS. Measurements of clinical endpoints associated with ALS will also be assessed. All potential subjects will be required to provide written informed consent prior to any study specific Screening procedures being performed. Subjects eligible to participate in the study will be assigned to receive their first IMP administration no later than 28 days after Screening. Part 1 (SAD): Total of 20 healthy volunteers (HVs) in five cohorts Part 2 (MAD): Total of 8 ALS patients in two cohorts Part 3 (Extended Access Study): Total of 8 ALS patients in two cohorts. The study patients will receive 5 cycles of 4 weekly infusions.

Does four weeks of malt extract supplementation in individuals with IBS reduce IBS symptoms, improve gut health and improve quality of life?

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This study follows the mothers and infants that have participated in the SUMMIT randomized controlled trial, and aims to compare the impact of two doses of domperidone on long-term breastfeeding, child growth and neurodevelopment up to 24-36 months infant corrected age. Eligibility participants will be mothers of preterm infants (< 34 weeks' gestation at birth), with insufficient breast milk (<300 mL/day or < 500 mL/day depending on postnatal age), who are expressing an average of six times a day or more, between 7 to 28 days postpartum, and who participated in the SUMMIT trial. Eligible women were randomised to receive high dose (60 mg/day) or low dose (30 mg/day) domperidone for 21 days.

The aim of this two-arm cluster-randomised controlled trial is to determine whether the less resource- and cost-intensive version of the PACE program (i.e., ePACE) is non-inferior with regards to increasing teachers’ implementation of classroom physical activity via Energisers, relative to the original PACE program. Eighty primary schools will be recruited to examine this. In each of the two arms, teachers will receive support to increase the amount of physical activity time, in particular Energisers, they deliver across the school week. Schools in the ePACE program will receive executive support, access to an online portal, equipment pack vouchers and ongoing project officer support. The comparator (i.e., PACE) condition will include the original face-to-face in-school champion training, an educational session delivered to teachers by in-school champions as well as executive support, and information and resources to support implementation. Eighty primary schools will be randomly allocated to one of two intervention groups. The final trial endpoint is defined as 12 months after baseline.

This project aims to extend research conducted by Alt and colleagues in the United States in 2014 and 2020 which found preliminary efficacy of a speech pathology treatment for children who are late to talk (late language emergence). This treatment was based on theories of statistical word learning where a speech pathologist spoke to the child in language containing target words spoken a large number of times (high dose), within different types of sentences (linguistic variability) and referencing a number of different physical objects (physical variability). This treatment was found to result in children speaking more target words and in a quicker timeframe than established treatments. This treatment was administered by speech pathologists however, which is not traditional for this young population (commonly parent-administered) or cost effective. This project aims to examine if this treatment can be trained to a group of parents, to be administered at home. The specific research questions are: 1 - Can parents be successfully trained in administering an intervention to their children which presents target words with high dosage and variability? 2 - Will the parent group training program be acceptable to parents, children and study personnel? 3 - Will children with late language emergence (LLE) receiving the parent intervention learn a significantly higher number of treated words relative to control words? 4 - Will children with LLE receiving the intervention protocol acquire untreated words at a rate exceeding that of typical language acquisition in late talking toddlers?