ANZCTR search results

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

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31378 results sorted by trial registration date.
  • Glycaemic impact of a glucose telemetry system amongst hospitalised adults

    This study aims to answer the question: Does use of a glucose telemetry system amongst hospitalised patients with diabetes mellitus treated with multiple daily injections of insulin improve glycaemic outcomes? Eligible participants will be randomised to the glucose telemetry system or to usual care. The glucose telemetry system will provide nursing staff with real-time glucose alerts to facilitate inpatient diabetes care. We will assess whether use of a glucose telemetry system improves inpatient glycaemia. We hypothesise that use of a glucose telemetry system in hospital will improve CGM-based glycaemic outcomes.

  • Optimizing patient selection for physiotherapy pathways after knee joint replacement: a randomised controlled trial.

    Within Gold Coast Health all patients who have their knee joint replaced (total knee arthroplasty) are referred for supervised outpatient physiotherapy after their surgery. This is in contrast to growing evidence that indicates that some patients who are having their knee joint replaced can achieve good post-surgery outcomes without the need for supervised outpatient physiotherapy, offering convenience and potential savings. The KAPPA criteria, previously established in a private sector cohort trial, demonstrated that simple and reproducible outcome measures assessed by a physiotherapist at two weeks post-surgery could determine which individuals could successfully continue with unsupervised rehabilitation versus those who would benefit from supervised outpatient physiotherapy. This project will validate these findings in a public health setting in patients who are undergoing knee joint replacement with the primary aim to compare the effectiveness and cost-efficiency of stratified physiotherapy using the KAPPA criteria with existing care through randomised methodology.

  • Quiet Minds for Cardio Kids - Exploring the Effect of Physical Activity on Brain and Psychological Development in Children with and without ADHD

    Physical activity (PA) is a promising intervention for children with ADHD that is safe, accessible, and effective in improving symptoms and mental skills. To maximise the effectiveness of PA programs for children with ADHD, researchers and clinicians need a better understanding of the brain mechanisms through which PA benefits children with ADHD. This information is essential for optimising treatment and will provide researchers with specific neurobiological targets for objectively evaluating PA interventions. The principal aim of this study is to examine the benefits of a tennis-based PA program on brain development, ADHD symptoms and mental skills in children with and without ADHD. It is hypothesized that PA will be associated with changes in brain development, ADHD symptoms and mental skills (executive functions). It is further hypothesised that PA induced brain changes will be associated with reduced ADHD symptoms and/or improved mental skills (executive functions) in children with and without ADHD.

  • Investigating Safety and Effectiveness of a Peripheral Stimulation Device

    A number of neurological disorders such as Parkinson’s disease (PD) are characterised by abnormal brain activity (e.g. unusually large numbers of neurons simultaneously active). Application of stimulation– in the form of mild electrical pulses or vibration – has been used as a therapeutic approach to reset the abnormal synchronous brain activity. ‘Peripheral stimulation’ involves the administration of non-invasive stimulation (mild electrical pulses or vibration) to patches of skin on the hands or feet. Early studies have shown that the use of a specific pattern of peripheral stimulation – called ‘coordinated reset stimulation’ – applied to the fingers, improved hand movements in patients with Parkinson’s disease, with benefits lasting several weeks. In this project, we aim to record the brain's response to ‘coordinated rest stimulation’ applied to the hands and feet in a group of healthy participants. This will assist in developing a future protocol for use with individuals with Parkinson’s Disease if indicated.

  • Low dose Multi-nut Oral immunotherapy (L-MO)

    This study will investigate the safety and efficacy of low dose OIT (60mg of each nut protein) compared to standard dose multi-nut OIT (300mg of each nut protein) in children under 6 years old with one or more nut allergies. This study is a head-to-head, open label, randomised non-inferiority trial. A total of 208 children will be randomised 1:1 to low or standard dose multi-nut OIT, stratified by age and number of nut allergies. The primary outcome of this trial is sustained unresponsiveness to all nuts, defined as passing an oral food challenge to all nuts to which a participant was allergic at baseline, after completing 18 months of OIT followed by 4 weeks of nut avoidance. Secondary outcomes are desensitisation after 18 months of OIT (defined as passing an oral food challenge while still on uninterrupted OIT), safety, tolerability, feasibility, immune changes and patient-reported experience and outcomes of multi-nut OIT.

  • Beliefs and Expectations as Predictors of Response to the Low FODMAP Diet

    The low FODMAP diet is an effective symptom management approach for 50-75% of individuals with irritable bowel syndrome (IBS), leaving 25-50% as non-responders. Determining predictors of treatment response at the individual level during all three-phases of the low FODMAP diet are lacking. The aim was to investigate predictors of symptom response to the low FODMAP diet in patients with IBS. Adult IBS participants undertook the low FODMAP diet via one-on-one dietetic education including elimination, reintroduction and personalisation phases. Predictor variables included levels of depressive, anxiety, and extraintestinal somatic symptoms, stress, treatment beliefs and expectations, behavioural avoidance, and illness perceptions. Symptom severity and quality of life were the outcome variables. Questionnaires assessing psychological predictors, symptoms and QoL were completed at five timepoints: pre-dietitian (week 0), immediately post-dietitian, at the end of the elimination (week 5), reintroduction (week 13) and personalisation (week 25) phases. Statistical analyses will assess the predictive relationships between psychological predictors and symptom severity.

  • My Emotions Community Trial: A waitlist randomized controlled trial of a brief clinic-based parent-child emotions intervention program for children aged 5-13 years

    We aim to determine whether the My Emotions intervention, delivered by provisional psychologists in their usual work setting, is feasible, acceptable, and effective. Therefore, in this waitlist controlled randomised controlled trial, we aim to determine whether a brief emotions intervention delivered by provisionally registered psychologists: 1. Is feasible and acceptable when delivered in real life clinical settings (primary outcome) 2. Decreases emotions problems as measured by the Strengths and Difficulty Questionnaire (SDQ) at 3-months post randomisation follow-up (secondary outcome).

  • Optimising a group exercise service for people with cancer

    This study is seeking to understand the relationship between exercise health service utilisation and other patient factors including diagnosis, cancer-related medical treatments and geographical location. Furthermore, the study will also look at patient’s current experiences around referral to exercise services and barriers related to this. Who is it for? If you are an adult with a diagnosis of cancer, any type and stage, living in NSW and able to give informed consent. Study details Participants will be participating in a semi structured group interview and be asked about their experience with advice about exercise and referral to exercise services after a cancer diagnosis. Participants will also complete a questionnaire detailing their demographic information. This research hopes to improve access to exercise services for people with cancer.

  • A randomised control trial evaluating the Study Without Stress plus Social Connectedness (SWoS-Social) Program among Australian high school students

    The current research project aims to test the efficacy of an enhanced version of the Study Without Stress program (i.e., SWoS-social) among high school students completing their final high school exams i.e., Higher School Certificate (HSC). To test its efficacy, we will implement a counterbalanced design and include measures of academic stress and social connectedness. We hypothesise that there will be an association between social connectedness and academic stress pre-treatment, and that students will experience a reduction in stress and increase in social connections pre- to post- SWoS-social program. Further, students who experience an increase in social connectedness throughout the SWOS-social program will experience lower academic stress post treatment. The outcomes of this study will further our understanding of the importance of social connectedness among high school students, as well as test the efficacy of an enhanced social version of the SWoS program for reducing stress.

  • Understanding Role of Nicotine Vaping Products in Smoking Cessation: A Qualitative Study

    Participants from a previous quit smoking clinical trial who have experience using NVPs for smoking cessation and have reached different points in their quit journey will be asked to participate in this qualitative project. The study will use in-depth interviews to explore the barriers and facilitators of quitting smoking using NVPs and gain insight into how ex-smokers switch away from NVP use. These insights will be further explored and built upon in focus group sessions, which will allow participants to share their ideas for a text message program that helps smokers quit both tobacco smoking and vaping. This can include changes to the existing types of messages, message style, how specific or tailored they are and other features.

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