ANZCTR search results

Already, there are five clinical trials registered at Monash Health to assess the safety and efficacy of allogeneic amniotic epithelial cells for (i) bronchopulmonary dysplasia; (ii) acute ischaemic stroke; (iii) compensated liver cirrhosis; and (iv) Crohn’s related perianal fistulas. To date, 27 individuals (17 neonates, 10 adults) have received allogeneic amniotic epithelial cells intravenously. No serious adverse events associated with cell administration or tumorigenesis have been reported. Preclinical biodistribution studies indicate that the AECs do not engraft and are not detected in any tissues after 5 days. Intravenous infusions of up to 8 million cells per kilogram have been well tolerated in extremely premature babies. Based on our extensive preclinical and clinical expertise with AEC, we propose a Phase 1b/2a trial to assess the safety and efficacy of allogeneic AECs for the treatment of COVID-19 related respiratory illness and multi-organ complications.

This single-center, two-part, Phase 1 clinical trial will assess the safety, tolerability, pharmacokinetics (PK) and PD of multiple-ascending doses of PRAX-944 in healthy male and female participants aged 18 to 55 years, inclusive.

This study is being conducted to look at the safety and immune response (how the immune system of the human body reacts) to a vaccine for SARS-CoV-2 (the virus responsible for COVID-19 infection) when administered as an intramuscular injection (an injection directly into the muscle) to the upper arm of healthy participants, on two occasions at least 28 days apart.

It is well-established that persons with serious mental illness (SMI) do not receive the comprehensive treatment and support that they need. Therefore, greater efforts and resources have been directed towards integrating mental health services in the community. MyCare is a step-down, community-based mental health program developed in Australia that provides assertive outreach support to individuals aged 18-64 years old with SMI. A controlled trial is necessary to determine the impact of MyCare on hospital readmissions and psychosocial functioning in comparison to control participants who will be on a treatment order receiving standard Mental Health Services from the Tasmanian Department of Health. Hospital readmissions, psychosocial functioning, and fidelity data will be collected by MyCare Care Coordinators at multiple time points throughout the study. It is expected that those who engage with MyCare for the duration of the program will have lower readmission rates and improved psychosocial functioning in comparison to participants in the control group.

This project aims to pilot a protocol for a randomized controlled trial which will compare the effectiveness of two experimental conditions (online mindfulness training and online compassion and loving-kindness training) with an active control (online progressive muscle relaxation training) for improving maternal mental health (scores on the mental health continuum short form), symptoms of maternal distress (symptoms of stress, anxiety, and depression) during pregnancy. All intervention conditions will be delivered over 8 weeks and will be minimal-contact, meaning that participants will use an online program at home to practice mindfulness, loving-kindness/compassion, or the relaxation condition. Participants will also receive a weekly text message to ask them about their engagement with the program and ask them to complete a short weekly online measure battery (measures of affect, stress, and emotion regulation). The aim of the pilot study is to assess the feasibility of the RCT protocol which compares the three conditions delivered online as a series of instructional material and brief daily practices. Feasibility will be assessed based on recruitment, randomization, retention, acceptability and adherence. Adverse events for all conditions will be monitored and compared. We also aim to explore the experiences of women in the trial by conducting interviews with randomly selected participants in each condition.. Finally, we will use data gathered to estimate standard deviation values for each outcome measure. This will be used to inform sample-size calculates for a full-scale RCT. We aim to recruit 25 participants per treatment arm (75 participants in total). Participants will be eligible if they are over 18 years old, and are participants in The ORIGINS Project longitudinal birth cohort. Participants will be recruited from Joondalup Health Campus at their earliest antenatal visit.

This is a single-site phase 2 open-label study to assess the effects of CNSA-001 in patients with Parkinson’s Disease who need adjunctive treatment in combination with levodopa. The study will enroll approximately 6 patients. The total study duration is up to 65 days, which includes a 21-day screening window, 14 days of treatment with CNSA-001 and a 30-day follow up period.

This trial is part of the real-world implementation of INFANT. INFANT is an established, efficacious group-based program offered to parents and caregivers of infants, generally through Maternal and Child Health (MCH), community health, and other existing service structures. INFANT aims to improve parents’ and caregivers’ knowledge and skills around promoting healthy eating, active play, and limiting screen time and, in turn, healthy growth from the start of life. A trained health professional runs four face-to-face sessions from child age 3-12 months focusing on healthy infant feeding, active play and sedentary time. This is complemented by the My Baby Now app/website resource for parents/caregivers . From 2020, regions across Victoria will have the opportunity to deliver INFANT as part of their usual service. Regions will receive implementation guidance to support them in embedding INFANT into routine service delivery. The research component of this project will investigate the effectiveness of the program at-scale and to do this we will collect data from caregivers receiving usual care and data from caregivers receiving usual case plus INFANT (this trial). We will also be investigating what helps organisations within LGAs to adopt and deliver the program, how they embed this in their service and whether the program is cost-effective. This project is internationally unique and will give significant insight into how best to take a controlled research trial and translate it into the real world, into existing state-wide services.

The purpose of this study is to develop new and simple ways to screen which patients with bowel symptoms, inflammation, or anaemia will need a colonoscopy using a novel biomarker test. These results can help reduce the need for colonoscopy, and prioritising it for those that need it most. Who is it for? You may be eligible for this study if you are an adult who is booked for a colonoscopy at participating hospitals for any indication. Study details: After completing a consent form, participants may be provided a faecal immunochemical test (FIT) kit and questionnaire for completion. Participants may also be met before their colonoscopy to have a short medical history interview & blood sample taken. Optionally, tissue samples may also be requested from the colonoscopy, Samples will be analysed for biomarkers which might indicate that there is inflammation, cancer, or polyp in the bowel. Biomarker results will be compared to colonoscopy findings. Sometimes there are long waiting lists for colonoscopies. The development of novel biomarker tests will help guide doctors in determining which patients need colonoscopy.

The purpose of this study is to examine the safety of completing a stem cell transplant of your own cells in the outpatient setting. Who is it for? You may be eligible for this study if you are aged 18 -75 and are undergoing a stem cell transplant with your own cells at Nepean Hospital. Study Details Participants will choose between two locations for their transplant, inpatient or outpatient. Inpatient participants will receive all pre-transplant, transplant and post transplant care in hospital. Inpatient participants will be discharged when they are well enough. Outpatient participants will come to the centre for their pre-transplant chemotherapy, transplant and post transplant care but be able to stay at home between visits until they become unwell or require extra care unable to be provided at home. The outpatient participants will also take oral antibiotics after the transplant. As part of this study, participants and their carers will complete questionnaires and consent to study staff reviewing their medical records. It is hoped this research will show that stem cell transplant can be performed in an outpatient setting, which may improve quality of life.

Australian data on the management of chemical thromboprophylaxis (CTP) and mobilization in splenic trauma patients is limited. The authors review the outcomes of early CTP and mobilization practices in splenic trauma from a single institution. Retrospective review on the outcomes of splenic trauma patients based on timing of CTP and mobilization was conducted from April 2013 to April 2018. Data was collected on demographics, AAST injury grade, ISS, co-existing injuries precluding early CTP or mobilization, blood product requirement, bleeding events, and thromboembolic events.