ANZCTR search results

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

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30792 results sorted by trial registration date.
  • A registry-based before and after retrospective observational study of change in the renal management of cardiac surgical patients admitted to Australian Intensive Care Units

    Approximately 15,000 cardiac operations requiring cardiopulmonary bypass are undertaken in Australia each year. Major cardiac surgery necessitates the admission to the Intensive Care Unit for immediate and early post-operative care. Acute kidney injury (AKI) is a common and serious postoperative complication of cardiac surgery with an incidence rate of 5-42%. Cardiac surgery-associated AKI (CSA-AKI) has significant impacts on patients' morbidity, mortality, and healthcare costs. The PROTECTION trial which involved the administration of intravenous amino acids to patients undergoing cardiac surgery, and published in the New England Journal of Medicine (PMID 38865168) should improved renal outcomes for those who received the amino acid therapy compared to those who received the placebo. Crucially, with the publication of the PROTECTION trial, practice change locally, nationally, and international is occurring or likely to occur. In response, evaluating such practice change is a key component of recognising and responding to trends in care and outcomes that are otherwise invisible. We aim to perform a registry-based before and after observational study to evaluate change in the management of cardiac surgical patients admitted to Australian Intensive Care Units. Specifically, we wish to evaluate the change in key practice areas concerning renal injury identification and management. The total evaluable period of time for this before-and-after study is 6 years: 1st January 2022 until 20 – 31st December 2027. Data will be obtained from the Australian & New Zealand Society of Cardiac & Thoracic Surgeons (ANZSCTS) registry.

  • Plasmapheresis for Treatment Refractory Postural Orthostatic Tachycardia Syndrome

    The primary purpose of this study is to determine if plasmapheresis, a medical intervention undertaken in hospital and used for treatment of some autoimmune conditions, may reduce symptoms in people who are living with Postural Orthostatic Tachycardia Syndrome (POTS), that has not improved with standard lifestyle and pharmacological measures. Plasmapheresis involves separating out plasma from other parts of the blood and replacing this with a different fluid. The hypothesis of this study is that plasmapheresis will be superior to intravenous fluids in reducing autonomic symptom burden.

  • A pilot randomised controlled trial investigating feasibility and acceptability of the prototype Daily Growth parenting program in parents/carers and their children aged 2-4 years

    The research project conducted a randomised controlled trial in March-April 2023 to assess the feasibility and acceptability of EMI survey delivery and a small prototype of the Daily Growth program. This pilot evaluated ten prototype parenting resources (5 x Emotion Coaching; 5 x Active Play) offered to parents over two weeks delivered via a web platform. Specifically, the project aimed to test: 1. The feasibility of the prototype version of Daily Growth in terms of parent recruitment rates, retention, and flow through the stages of the study, as well as parent engagement via completion rates of the baseline survey, post-study survey, and daily prompts. 2. The acceptability of the ten prototype video resources and the program delivery method via twice-daily pre- and post-EMI prompts. 3. The feasibility of the prototype version of the Daily Growth program and the evaluation process in improving parent/child emotion regulation, mental health, and emotion coaching parenting behaviours in-the-moment and post-intervention compared to the control condition.

  • A Randomised Controlled Trial for Pharmacist Review to Optimise Medicines in Residential Aged Care (PROMPT-RC)

    The PROMPT-RC study will assess whether the use of the AusTAPER App/Pathway by pharmacists improves medication management for residents in aged care facilities compared to usual care. This intervention helps pharmacists identify and reduce potentially inappropriate medicines (PIMs) to optimise medication regimens. The study hypothesises that the AusTAPER tool will lead to safer and simpler medication use, resulting in optimised medications and improved quality of life over 12 months.

  • Food is medicine: Testing 'produce prescription' for pregnant women with food insecurity and at high risk of gestational diabetes mellitus in Australia

    Healthy eating advice is recommended by guidelines as a mainstay therapy for women at high risk or those who have developed gestational diabetes mellitus (GDM), prior to pharmacotherapy. GDM is a condition characterised by higher-than-normal blood sugar levels during pregnancy with immediate and long-term health consequences. 'Food is Medicine' programs aim to integrate nutrition interventions into the health care system to help improve the clinical population's diets and complement pharmacologic treatment of diseases. 'Produce prescription' is one such approach whereby clinicians and other health professionals prescribe free or subsidised healthy foods to people who experience food insecurity as part of their treatment. We will assess the effect of produce prescription on gestational weight gain for women with food insecurity and at high risk of GDM compared to usual care. We will conduct a randomised control trial of a produce prescription intervention in pregnancy women at high risk of GDM, who have difficulty buying or eating nutritious food. Intervention participants will be prescribed produce boxes from 14-18 weeks gestation to 34-38 weeks gestation. In addition, intervention participants will also receive three consultations with a dietitian. Predefined, composite secondary maternal (GDM, pregnancy related hypertension, excess gestational weight gain, caesarean section) and neonatal (large for gestational age, preterm birth, mortality) outcomes will be assessed. Diet quality, cardiometabolic outcomes, food and nutrition security, patient-reported outcome measures, and the feasibility and acceptability of the produce prescription program will also be assessed. Finally, a sub-sample of participants will be interviewed to explore how the program worked (or did not work) for them, and ways the program can be improved and scaled up. We hypothesise that the intervention group will have improved diet quality and reduced gestational weight gain during pregnancy which will prevent a range of pregnancy complications. We anticipate that the program will be highly acceptable to pregnant women and suitable for scale up as part of healthcare.

  • Combined Hyperinflation and Expiratory Strength Training in People Living With Motor Neurone Disease (CHEST-MND: PRO)

    Breathing and coughing difficulties are extremely distressing for people living with MND and therapies that improve breathing capacity and related symptoms are needed. Our research team has previously shown that breathing exercises using a hand-held device to help people take a bigger breath (lung volume recruitment) can produce important changes in lung capacity. Separately, our collaborators in the United States have found that exercises using a different hand-held device (expiratory muscle strength training) can improve expiratory muscle strength in people with MND. This research project will evaluate whether combining these two therapies together has added benefit. We will test whether five weeks of combined respiratory training is feasible and acceptable to people living with MND and their carers, and whether it improves breathing and cough strength, symptoms and quality of life in people affected by MND.

  • Rapid eye movement sleep & extinction trial in post-traumatic stress disorder

    Dysregulated fear memory processing as well as disrupted sleep (particularly rapid eye movement [REM] sleep) are important factors in the development of posttraumatic stress disorder (PTSD). Sleep is one of the few modifiable variables in the aftermath of a traumatic event, which might be utilized to prevent PTSD onset. Therefore, the aim of this project is to examine the effect of the insomnia drug lemborexant, that increases rapid eye movement (REM) sleep in primary insomnia, on fear extinction learning and extinction recall, as well as emotional memory consolidation compared to placebo in individuals with PTSD. We recently completed a similar pilot study in healthy controls using suvorexant (same mechanism of action like lemborexant but lower clinical effect, and safe in PTSD) and found increased REM sleep was associated with better extinction recall (ACTRN12619001694101). This study will provide evidence for the potential of enhancing REM sleep as a therapeutic target for improving PTSD onset.

  • Endo Gut Study - Understanding the prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis.

    The purpose of this study is to understand the prevalence, type and frequency of gastrointestinal symptoms in women with and without endometriosis, and to understand the role of psychological distress and stool and vaginal microbiota in influencing these symptoms. It is hypothesised that gastrointestinal symptoms will be more severe in women with endometriosis than those without.

  • A smartphone and wearable tool to manage anger after trauma (Shift): A micro-randomized trial

    Problem anger after experiencing trauma is a common mental health issue. Shift is a new cognitive-behavioral based just-in-time-adaptive intervention (JITAI), co-designed with users and experts, that works by prompting users to report their current anger state, and delivering personalised support to manage anger accordingly. A micro-randomised trial will be implemented with 65 adults with problem anger and a history of trauma exposure. For 30 days, four times a day, each participant will be prompted to self-report their current anger state, and will be randomised to be shown intervention components tailored to their anger state, or not. Post intervention surveys, and app use and engagement indices will be analysed to evaluate the acceptability of the intervention. The aim of the study is to test whether the intervention components designed within Shift actually reduce anger intensity. To test this, we are using a novel type of method, called a micro-randomised trial, where every participant will recieve both the intervention and the control at different times. This will be the first digital trial using micro-randomisation to optimise a JITAI for problem anger in a population who have experienced trauma, and one of the few micro-randomised trials to optimise digital mental health tools to manage dysregulated mood.

  • Community Implementation of the ‘Recapture Life’ Online Program for Adolescent and Young Adult Cancer Survivors

    The aim of this study is to determine the impact of a online intervention (Recapture Life) to teach adaptive cognitive-behavioural coping skills to promote resilience in early survivorship. Who is it for? You may be eligible for this study if you are a young cancer survivor who have finished treatment, male or female, aged between 13 -39 years old. Also, fluent in English, able to provide consent and have access to internet and a suitable computer. Study details Participants who choose to participate in Recapture Life received six weekly 90 minute sessions delivered online. Each group consisted of a facilitator plus 3-6 AYAs with mixed childhood cancer diagnoses and genders. Sessions were delivered through a secure, password-protected video conferencing software. Each 90-minute module included both psychological skills and cancer related content, applying CBT techniques to the key domains of concern identified by previous studies, including fear of cancer recurrence and changes to activity levels The study design involves simple pre- and post-intervention measures. AYA participants completed questionnaires at intake (T1), and six-months later, after the completion of the intervention and the booster session (T2). These were completed online through a secure questionnaire portal. Questionnaires obtained participant demographic data, assessed Quality of Life (the primary outcome variable), psychological distress, and peer support. It is hoped that findings from this study will provide skills-based support for adolescents and young adult cancer survivors.

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