ANZCTR search results

A proof of concept, open-label, placement of a novel sternal band and plate fixation device with similar mechanics of stabilisation to the current routinely used band and plate system at Royal Melbourne. Evidence of adequate bone healing (proof of concept) will be assessed in the same way as the previous prospective randomised trial was conducted, with early assessment using high-frequency ultrasound imaging of the bone edges, and a CT scan at three months post operative to allow assessment of new bone formation.

This is an observational research study, meaning no investigational drug will be administered and the study involves only gathering data through standard clinical assessments for Geographic Atrophy condition. This study consists of 2 parts. Part 1 is intended to identify potential participants for a separate study and will evaluate changes in Geographic Atrophy characteristics based on optical coherence tomography (OCT) and fundus autofluorescence (FAF) imaging. Part 2 will study the natural disease progression in participants diagnosed with Geographic Atrophy over an up to 18-month period.

This is an exploratory study collecting Cerebrospinal Fluid (fluid in the spinal column) via spinal tap to study the biomarkers of a new product being developed by Evecxia Therapeutics that could help patients with depression. The study is to determine what quantity of EVX-301 (through looking at the biomarkers) after 24 hours of iv infusion can pass through the blood/brain barrier for treatment of depression in patients.

This study aims to determine if specific changes to the National Bowel Cancer Screening Program (NBCSP) increases participation in ‘persistent never screeners’. ‘Persistent never screeners’ are defined as people who have been eligible for at least 3 consecutive screening invitations (sent kits), but never completed an NBCSP screening test. Who is it for? You may be eligible for this study if you are an adult in Australia over the age of 50 who has never returned a bowel screening kit from the NBSCP. Study details The trial will have three arms, with a sample size of 60,000 people (20,000 people in each arm). People in Arm 1 will not be sent a NBCSP kit but will be sent a pre-invitation letter with details about how to order a kit. People in Arm 2 will be sent a revised letter with additional health promotion messages on the outside envelope and in the letter including a QR code link to tips to help overcome known barriers to participation. People in the control arm (Arm 3) will be sent the standard material – letters, the NBCSP kit and reminders. Eligible people who are due for their pre-invitation letter will be randomly assigned into one of the three arms and followed up for six months from the time the last kit has been sent out. We will compare the percentage of people who return the kit between the three arms, to determine the impact of each intervention on kit return. It is hoped that this study will help determine if changes to the way people are invited to take part in the NBSCP kit will have an impact on the number of kits returned for testing.

The MANTRA Study aims to test, via a randomised non-inferiority trial, trauma-sensitive yoga (TSY) for people who have experienced non-consensual sexual experiences to improve their mental health and wellbeing. The project aim to recruit 370 people who have experienced non-consensual sexual experiences and are currently experiencing Complex Post Traumatic Stress Disorder and randomly assign them to participate in either TSY or the comparator, group Cognitive Processing Therapy. We hypothesise that TSY will not be inferior to the control group for reducing Complex PTSD symptoms, mood disturbance and negative feelings while also improving feelings of self-compassion. Further, we hypothesise that TSY will be more cost-effective compared to the control intervention.

The overall aim of the study is to determine the efficacy of a co-designed prehabilitation model of care to optimise outcomes for patients undergoing abdominal surgery at West Moreton Health. Research has demonstrated that engaging in prehabilitation cardiovascular exercise, inspiratory muscle training and receiving preoperative physiotherapy and dietitian led education can improve outcomes following surgery. This study aims to test an Allied Health led model of care conglomerating these interventions by examining the feasibility of its' implementation, as well as its efficacy for the West Moreton Health cohort.

This pilot study will assess the feasibility of a larger multicenter study to evaluate the association between a pregnant patient’s fibrinogen level on admission to hospital for labour and their risk of major bleeding (postpartum hemorrhage). Participants will be enrolled and consented in the antenatal clinic by trained research assistants. When the participant presents to hospital in labour, and routine intravenous access is inserted, a baseline fibrinogen level will be taken. This result will be blinded to both patient and treating clinician for three days after it is taken unless it produces a grossly abnormal result (fibrinogen <1.5g/L). All participants will be followed up to determine if they have a postpartum haemorrhage, the extent of haemorrhage, its clinical management and impact on the participant. If the pilot study is successful, the purpose of the multicenter study is to evaluate if fibrinogen levels can be used as a novel predictor of postpartum haemorrhage. Furthermore data from this pilot study can be used to inform our current practice regarding postpartum haemorrhage, and to improve our current management, if required.

A recent trial with 89 participants (ACTRN12622000113752) demonstrated the efficacy and safety of an accessible online therapy for people with chronic pain (Pain and Emotion Therapy) which focused on improving emotion regulation through guided group sessions and home practice using an app and handbook. Results showed significant improvements in emotion dysregulation and provided preliminary evidence to improve the trials secondary outcomes of pain severity, depression, anxiety, sleep and quality of life. The primary aim of the current randomised controlled trial is to evaluate the efficacy of an individualised (one-on-one) version of Pain and Emotion Therapy to reduce pain severity. Secondary aims include evaluating the effects on depression, anxiety, sleep problems, pain disability, emotion dysregulation, and quality of life.

This is a single-centre safety and feasibility study of a new device designed for the ablation of uterine tissue. Subjects with a specific condition will be enrolled where the new device will be used to deliver energy to abnormal uterine tissue; these subjects will be followed up to 1-year post-procedure. This is not a powered study, so there is no formal hypothesis. This research is an early feasibility study and will determine whether use of this new system is safe and feasible.

This is a single-centre safety and feasibility study of a new device designed for the visualization of the upper digestive tract and facilitation of tool delivery for diagnostic or therapeutic interventions. Subjects will undergo a procedure with a new device designed to assist qualified physicians to navigate a GI endoscope and endoscopic tools in the upper GI tract using endoscopic visualization for observation, diagnostic procedures, and/or endoscopic treatment. These subjects will be followed up to 30 days post-procedure as per standard of care. This is not a powered study, so there is no formal hypothesis. This research is an early feasibility study and will determine whether use of this new system is safe and feasible.