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The safety and performance of the Apex Total Knee Replacement system manufactured by Omni Life Science and Global Orthopaedic Technology will be evaluated following primary total knee arthroplasty.

Social isolation is a major cause of depression onset and relapse in young people. Yet this is not directly targeted in current treatments for depression. To address this disconnect, our project will conduct a randomised controlled trial to assess the efficacy of a novel intervention that targets social isolation in young people with depression (called Groups 4 Health). Our trial will compare the effectiveness of Groups 4 Health to another effective treatment, group Cognitive Behaviour Therapy (CBT), at program completion and one-year follow up. Participants will be 200 young people aged 15-25, recruited from public and private mental health services in the Southeast Queensland region. We expect that both interventions will be effective in reducing depression symptoms, but that Groups 4 Health will be superior in reducing the social isolation that causes depression. This trial will test the capacity for Groups 4 Health to function not only as a treatment, but also as relapse prevention for young people at risk of depression recurrence. Therefore, the benefits of Groups 4 Health are expected to be particularly apparent by the one-year follow-up. This program offers a new approach to treatment and relapse prevention of the leading cause of disability among young people in Australia.

Thinking Maths has been developed by the South Australian Department of Education and Child Development (SA DECD), based on its Teaching for Effective Learning Framework. The program aims to address a significant drop in mathematics performance in NAPLAN from Year 7 to Year 9. The program supports Year 7 and Year 8 teachers in the deep learning of mathematical content as outlined in the Australian Curriculum Mathematics. The project focuses on the following three areas for better teaching and learning of mathematics: • Quality task design; • Sequencing of conceptual development and; • Research-informed effective pedagogies Five professional learning days are run over two terms by facilitators who model rigorous teaching and learning processes, undertaking tasks with multiple entry and exit points to differentiate the curriculum to cater for students with a wide range of mathematical experience and dispositions. After each session teachers make a commitment to implement high gain strategies to improve student achievement and engagement. Between sessions, telephone, email and online platforms support teachers’ improvement efforts in a professional learning community. At each session after the first, there are three to four presentations from participants to share their experiences, successes and challenges. The SA DECD has identified the drop in mathematics performance between Year 7 and Year 9 as a critical state-wide issue and has designed this program in response to it. In order to inform the Department’s understanding of the effect and cost-effectiveness of the program, a rigorous and independently-funded trial is useful. As a decline in mathematics performance is also evident in Australian students’ results more widely, the findings from this trial may be of interest to other Australian practitioners and policy makers, as well. To date, there has been no rigorous evaluation of the impact this program has on student achievement in mathematics. The program however uses approaches which have a basis in research evidence, Teachers in the program receive explicit feedback from peers on their instruction and feedback, on average, yields 8 months’ learning progress for students. Further, the professional learning has been designed with key findings from Timperly et al’s Teacher Professional Learning Best Evidence Synthesis (2007) in mind. The program evaluator, the Australian Council for Educational Research (ACER), is the leading independent Australian organisation in educational research. The trial is structured as a clustered randomised control trial (RCT), with pairs of Year 7 and Year 8 Maths teachers recruited from 167 South Australian government schools. 120 recruited teachers (57 pairs and 6 individuals in 63 schools) will receive the intervention and the other 198 teachers (94 pairs and 10 individuals in the remaining 104 schools) will as act as a business-as-usual control.

Smiling Mind is a not for profit organisation that develops app-based mindfulness programs to support the wellbeing of children, young people and adults. Smiling Mind has previously developed mindfulness-based programs for primary and secondary school age children. In partnership with Early Childhood Australia (ECA) they have developed a mindfulness program for pre-school age children, called the Early Minds program. The program has been designed to be implemented by trained early childhood educators within Early Learning Centres (ELCs). Educators will be trained by two online learning modules prior to implementing the program, which consists of 8-weeks of mindfulness–based meditations and activities. The aim of this pilot study, led by the Murdoch Children’s Research Institute, is to evaluate the feasibility and acceptability of conducting the Early Minds program within selected Victorian ELCs. Educator’s experience of the program, use of the program, and barriers to use will be examined. Secondary aims will explore preliminary impacts of the program on educator and caregiver reported child wellbeing and behaviour. Educators will be randomised into the program group or the usual care group. Children will be placed in the group their educator is in. Participants will complete surveys at three months post-randomisation to assess primary outcomes.

Traditionally, the only treatment options for patients diagnosed with severe aortic stenosis were relatively invasive interventions such as surgical aortic heart value replacement (SAVR) or balloon aortic valvuloplasty (BAV), or non-invasive treatment such as medical therapy. The preferred treatment option for patients with severe aortic stenosis has long-been surgical aortic value replacement (SAVR) due to the superior outcomes over medical therapy, however, a number of patients, such as those in advanced age with additional diseases, have not been suitable for surgery, often due to the considerable risks associated with surgical procedures in these patients. More recently, there has been the development of a procedure known as transcatheter aortic heart value implantation (TAVI) which is a less invasive surgical procedure than the standard surgical aortic valve replacement (SAVR) and has allowed doctors to treat patients with severe aortic stenosis who have previously not been suitable for the surgical intervention. This TAVI procedure could therefore be beneficial to many patients with severe aortic stenosis who have been considered too high-risk to undergo the standard surgical procedure and have had to rely on medical therapy alone. What we therefore aim to do in this study is to find out the value of the TAVI procedure in comparison to other treatment options, both surgical and non-surgical, by looking at patient outcomes, patient quality of life and cost effectiveness of those undergoing each of the treatment options.

Adhesive capsulitis (AC), rotator cuff tears (RCT) and osteoarthritis (OA) is a disabling and poorly understood pathological conditions of the shoulder joint. The current study aims to increase our understanding of the pathogenesis, diagnosis and clinical outcomes of people with AC, RCT and OA by investigating: 1) transcriptome-wide alterations in gene expression of the glenohumeral joint capsule compared to people with non-inflammatory shoulder instability (controls); 2) serum and urine biomarkers to better understand diagnosis and staging of AC, RCT and OA; and 3) clinical outcomes in people with AC, RCT and OA compared to controls 12-months following arthroscopic capsular release or labral repair respectively. The study is a multi-centre, non-randomised study investigating people undergoing surgery for AC, RCT and OA compared to people undergoing arthroscopic stabilization for shoulder instability. Tissue samples collected from the anterior glenohumeral joint capsule during surgery will undergo RNA-seq to determine differences in gene expression between the study groups. Gene Set Enrichment Analysis will be used to further understand the pathogenesis of AC as well as guide serum and urine biomarker analysis. Clinical outcomes regarding pain, function and quality of life will be assessed using the Oxford Shoulder Score, Oxford Shoulder Instability Score, Quick DASH, American Shoulder and Elbow Society Score, EQ-5D-5L and active shoulder range of movement. Clinical outcomes will be collected pre-operatively and 12-months post-operatively and study groups will be compared for statistically significant differences (p<0.05).

Hereditary Angiodema (HAE) is a rare disease caused by low levels of C1 serine protease inhibitor in the body. Deficiencies in this protein leads to increased activation of inflammatory pathways which can cause swelling, severe abdominal pain and airway obstruction that can be life threatening. ATN-249 is a potential once a day oral treatment for HAE. The purpose of this research study is to test the safety and tolerability of ATN-249 as well as the pharmacokinetics and pharmacodynamics of the study drug. The study is open to healthy male volunteers and the research goals are: - Does the drug have any side-effects and is it well tolerated when given as a single dose? - How much of the drug gets into the blood stream, and how long does the body take to get rid of it? - What effect does food have on the PK profile of the study drug? This study will look at how the human body uses ATN-249 at different dose levels with and without food. The effects of the drug will be studied. This is a double-blind, randomised and placebo-controlled and consists of two parts. Part A will look at the effects of a single dose of the study drug given as 1 dose and Part B will look at the effects of a single dose of the study drug given as 2 doses 12 hours apart.

This trial protocol has been endorsed by the ANZCA Clinical Trials Network. We aim to conduct a multicentre, randomised controlled trial of the efficacy and safety of peppermint- flavoured chewing gum to treat postoperative nausea and vomiting (PONV) in the post-anaesthesia care unit (PACU). We will test the primary hypothesis that chewing gum is non-inferior to ondansetron in achieving complete cessation of nausea, retching and vomiting within 2 h of administration, with no recurrence between cessation and 2 h after administration, and no rescue medication between administration and 2 h after administration (i.e. complete response) in female patients aged 12 years and older with nausea, retching and/or vomiting in the PACU after volatile anaesthetic-based general anaesthesia for breast or laparoscopic surgery. Chewing gum is a simple and inexpensive drug-free treatment for the common, costly and distressing problem of PONV. This study has the potential to significantly improve clinical and economic outcomes for millions of patients and health services in high-, middle- and low-income nations worldwide.

This is an open label study of patients with macular oedema, secondary to diabetic retinopathy who are naïve or have minimal exposure to intravitreal anti- vascular endothelial growth factor (VEGF) therapy. The study will assess the effectiveness of a treat and extend regimen of intravitreal Aflibercept (Eylea) in a clinical setting,

This research project is designed to test the safety, tolerability, the effect on movement and pharmacokinetics (how the body processes the study drug) of INP103. INP103 is a drug-device combination product; the drug is L-dopa (levo-dopamine); the device is the I231 Precision Olfactory Delivery (POD) device, which is a novel nasal (nose) spray. This study will measure the results of administration of L-dopa given by the intra-nasal POD device, against the effect of placebo, also given by the intra-nasal POD device. Participants will be given either L-dopa or placebo to determine how effective the new POD device is at delivering the drug to the body.