ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31058 results sorted by trial registration date.
  • An open FEAsibility study of a ShorT duration peanut oral immunotherapy (OIT) for inducing sustained unresponsiveness / remission of peanut allergy (FEAST).

    Peanut allergy is a common allergy in Australia. As many as one in 200 children and 3 percent of infants have a peanut allergy. Reactions may occur after eating very small amounts of peanut. Reactions to peanut may be severe and life threatening. Peanut allergy is the commonest cause of severe life-threatening reactions (anaphylaxis) and death due to food allergy. Peanut allergy usually persists throughout life. Peanut oral immunotherapy (OIT) is a treatment where a person who is allergic to peanut is asked to eat peanut, starting at very low doses then increasing to a higher maintenance dose that they will then continue to take daily dose for a specified amount of time. This research is looking to recruit up to 40 participants in an open label trial where ALL participants will receive the active peanut OIT treatment over a 12month treatment period. In our previous peanut oral immunotherapy trials, children were given peanut OIT treatment over a course of 18 months. At the completion of the study we found that 80% of the participants who received the active peanut OIT were able to tolerate peanut in their diets. This new study will aim to investigate whether a 12-month treatment plan can achieve the same levels of remission in children. In this study, we want to find out if peanut oral immunotherapy treatment over the course of 12 months is: • Effective in producing tolerance in children with peanut allergies • Able to produce a long-term tolerance of up to 8 weeks

  • Sustainability of evidence-based practices in the care for infants with bronchiolitis in hospitals involved in the Knowledge Translation (KT) in Australasian Paediatric Acute Care Settings Study

    The Paediatric Research in Emergency Departments International Collaborative (PREDICT) network developed an Australasian Bronchiolitis Guideline in 2016 that provided high quality evidence that widely used interventions were ineffective. The PREDICT ‘Knowledge Translation in Australasian Paediatric Acute Care Settings: a multi-centred, cluster-randomised controlled trial comparing a tailored, theory informed Knowledge Translation intervention versus passive dissemination of a bronchiolitis guideline’ (PREDICT Bronchiolitis KT study) (ACTRN12616001567415), multicentred, cluster, randomised controlled trial found that targeted, theory-informed bronchiolitis interventions were effective in reducing the use of five inappropriate therapies (chest X-ray, salbutamol, glucocorticoids, antibiotics, and adrenaline) compared to passive dissemination of a guideline. The aim of this study is to assess sustainability of these improvements at the 26 sites which participated in the PREDICT Bronchiolitis KT study, one (2018) and two years (2019) post implementation of intervention. A retrospective medical audit will be conducted at the 26 Australian and New Zealand hospitals which participated in the PREDICT Bronchiolitis KT study. Our results will help determine the sustainability of this intervention over time, determine any improvements in control group hospitals, examine the learning and decay effects of the intervention, determine fidelity and adaptation of the intervention and explore factors which may have contributed to sustained improvements in either intervention or control group sites.

  • Whole genome sequencing in high risk breast cancer patients

    The aim of this study is to use whole genome sequencing technology to define the genetic variations present within a breast cancer patient’s tumour, prior to treatment. This information will be used to determine whether we could predict whether different therapies could elicit an improved response should the tumour not respond to the first round of drugs or if it recurs or spreads some time after initial treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned for treatment via a neo-adjuvant pathway. Study details Prior to starting neoadjuvant therapy, all participants will have a core biopsy taken by a qualified radiologist and give a blood sample. After neoadjuvant treatment is complete, participants will undergo their planned surgery, where a sample of the resected tumour will may be taken (if the treatment has not been completely effective). Samples will be analysed via whole genome sequencing. We will also be analysing patient blood for circulating tumour DNA and circulating tumour cells in order to predict treatment response and recurrence. A detailed health economics analysis will also take place to determine if whole genome sequencing offers a cost effective benefit to patients and the health system. It is hoped that this study will demonstrate that whole genome sequencing technology can be used to identify genetic variations in breast cancer patients that could be targetable by drug therapies. This could help to justify personalising breast cancer therapy based on whole genome sequencing analysis in future.

  • Self-management and recovery training (SMARTStart) to help young people make healthy choices: Pilot trial of feasibility and acceptability

    This pilot study will assess the feasibility and acceptability of the SMARTStart program, a group program designed to help young people make healthy choices. We will deliver weekly group programs facilitated by a psychologist and a peer worker who are trained to deliver the Self-Management and Recovery Training (SMART) program. SMART is based on cognitive-behavioural therapy and motivational interviewing and is guided by mutual aid principles. The program is designed to bring small groups of young people together (in person or online) to share their experiences and offer suggestions and support other young people with similar experiences. The aim of the program is to help young people make healthier choices, especially in areas of addiction (e.g., drugs, alcohol, tobacco, gambling, internet use, shopping, screen time, etc.). We will assess the feasibility and acceptability of the program once the program is completed (post-intervention) as the primary study outcome. Through assessment of the feasibility and acceptability of this program, we hope to collect information that will inform the delivery of a larger study designed to assess efficacy and that can be used to best adapt the current SMART program to suit the needs and desires of young people. We will also collect information about mental and physical health, and health behaviours at baseline and post-intervention.

  • Augmented reality technology to deliver cognitive and behavioural therapies for the treatment of symptoms of anxiety among teenagers with asthma

    A range of challenges faced by children and adolescents with asthma contribute to their increased experience of psychological distress and lower quality of life than peers without asthma. Psychological interventions such as cognitive and behavioural therapies (CBT) may provide young people with techniques and strategies to manage symptoms of psychological distress and therefore symptoms of asthma, to avoid exacerbations. However, reports indicate low uptake of psychological intervention in this age group, with youth preferring to seek help themselves via internet sources. To improve access to and uptake of evidence-based treatments for elevated psychological distress in adolescents (aged 13-17 years) with asthma, this project will evaluate augmented reality technology (AR) as a delivery mechanism for a component of CBT. Development of AR tools have been guided by a comprehensive protocol for health program development, with direction from experts in Design, Information Technology, Respiratory Medicine, and Psychology. The practicality and feasibility of these tools for use by youth, their parents/guardians, and health professionals will be explored through this feasibility pilot study with 1-month follow-up. This study will provide essential pilot data to guide development of a fully powered randomised controlled trial.

  • The impact of dementia training on interpreters' communication during cognitive assessments

    This project aims to develop online dementia assessment training for interpreters. We will co-design with interpreters, clinicians, people with dementia and their carers online training modules for interpreters. These training modules will: describe dementia and its impact on cognitive and linguistic ability; explain the tools used to assess and diagnose dementia; and engage interpreters with effective interpreting strategies for cognitive assessments. The impact of the training on interpreter’s quality of communication will be evaluated using a randomised controlled trial. Key objectives of this project are to: a) improve the quality of interpreter communication in cognitive assessment for dementia, and b) implement the training in Victoria to plan for national scale-up. The training modules will ultimately be maintained on our industry partner, the National Accreditation Authority for Translators & Interpreters (NAATI) website and will be integrated in the mandatory Continuing Professional Development (CPD) for interpreters. Interpreters will be able to complete the training at any time once it is on the NAATI website.

  • A phase 3 clinical trial examining the effects of SingINg For breathing in chronic obstructive pulmonary disease (COPD) aNd interstitial lung disease (ILD) pAtients

    This study is being conducted to determine the feasibility, acceptability, and effectiveness of online singing groups as an intervention for wellbeing and symptom management in participants with COPD and interstitial lung disease (ILD) in Australia. Online delivery is important to determine feasibility and acceptability of alternative delivery models to improve accessibility and equity. Previous studies have shown some benefits to singing groups for COPD patients, but no randomized, controlled trials have been conducted in Australia or in participants with ILD. Singing is not anticipated to present risks or adverse effects based on previous cilnical trials and widespread implementation in the UK.

  • I-TREAT: Intensive Follow-up via Remote Monitoring for Implantable Cardiac Devices

    Remote monitoring (RM) has been established as advantageous in the follow-up of patients with implantable cardiac devices as a safe alternative to standard clinic follow-up. While RM is associated with various benefits, compliance is often sub optimal suggesting a more intensive model of RM is required. The aim of the current trial is to determine the clinical utility, feasibility and workflow of implementing an intensive RM program compared to standard RM in patients with implantable cardiac devices. We hypothesize that time from event to action will be shorter for patients in the intensive remote monitoring program compared to participants in the standard remote monitoring program.

  • A phase 2 clinical trial examining the feasibility of SingINg For breathing in chronic obstructive pulmonary disease (COPD) aNd interstitial lung disease (ILD) pAtients

    This study is being conducted to determine the feasibility, acceptability, and effectiveness of online singing groups as an intervention for wellbeing and symptom management in participants with COPD and interstitial lung disease (ILD) in Australia. Online delivery is important to determine feasibility and acceptability of alternative delivery models to improve accessibility and equity. Previous studies have shown some benefits to singing groups for COPD patients, but no randomized, controlled trials have been conducted in Australia or in participants with ILD. Singing is not anticipated to present risks or adverse effects based on previous cilnical trials and widespread implementation in the UK.

  • Evaluating the impact of educator training on educators and children attending early childhood education centres in Western Sydney

    This project will investigate the impact of a professional development training program, (herein called the Training) for early childhood educators that has a focus on improving the communication interactions with children in their care. The Training is a modified version of Learning Language and Loving It [Trademark] Online program developed by the Hanen Centre [Registered Trademark] and modified by the current research team to suit the needs of the local community. The modification has been approved by the Hanen Centre [Registered Trademark]. Previous research by the current team established that educators reported increased confidence using trained interaction strategies following the Training. The current study will evaluate the direct change in child and educator language use during communication interactions before and after the Training. We hypothesise that participation in the Training leads to positive child and educator communication outcomes including an increase in the number of interaction skills used by educators following Training, and the number and complexity of words used by children during these interactions. Eligible educators and children will be paired by centre of attendance and language background. Children will be aged 24-42 months and have typically-developing communication skills. Twenty-four educator-child pairs will be recruited in two groups: Group A and Group B. Each group of educators will receive the 8-week Training in two separate stages; Group A in Stage 1 and Group B in Stage 2. This will allow for control and follow-up comparisons to be completed. Demographic information will be collected from educator and child participants before any training commences. In addition, 15-minute educator-child interactions will be video recorded at four time-points within their early childhood education centre. Measures will examine the extent to which educators use target interaction strategies and the way children use language in these interactions. This project will help to address a critical gap in knowledge about whether this modification of the Learning Language and Loving it [Trademark] Program has a direct impact on children’s communication outcomes.

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