ANZCTR search results

Primary Sclerosing Cholangitis (PSC) is a rare and chronic liver disease with no proven effective medical therapies to prevent disease progression. Most patients with PSC have ulcerative colitis (UC), with potential overlapping pathophysiological mechanisms including an abnormal gut microbiota. Diet is a key fertiliser of the gut microbiota and limited evidence suggests diet may have a role is disease pathogenesis. However, there is very limited international data on the habitual diet and diet quality of adults and adolescents with PSC to inform dietary treatment targets. Therefore, this cross-sectional study will comprehensively evaluate the dietary patterns of people with PSC and understand how people who live with PSC perceive diet in disease development and progression as a first step toward informing further dietary interventions.

The aim of this study is to establish a comprehensive registry to capture the lived experiences of patients with brain tumours. Who is it for? You may be eligible for this study if you are a male or female age 18 or older, have a brain tumour diagnosis, including but not limited to glioma, meningioma, brain metastases and rare tumours including medulloblastoma and ependymoma. Study details Participants will be asked to self register to the BEACON portal and complete questionnaires every 3 months regarding 1) Diagnosis and treatment, 2) Home supports (3) Quality of life. All data entered will be available to the participant to download after each survey is completed. It is anticipated that the surveys will take between 20 to 30 minutes to complete each time. It is hoped that BEACON will assist in determining the impact of being diagnosed with a brain tumour, from the time of diagnosis through treatment, and recurrence or progression events, and survivorship.

A phase III randomised, double-blind, placebo-controlled, multicentre study to evaluate the efficacy and safety of treatment with corticoSTeroids at onset, And Rituximab during a relapse, of Myelin Oligodendrocyte Glycoprotein antibody-associated disease. Ultimately, the STAR-MOG trial will identify if two cost-effective and globally available immunotherapies can reduce relapse rates and improve outcomes of people with MOGAD, with national and global implications for clinical care.

Impaired swallowing can result in food/fluids entering the lungs (aspiration), causing significant damage to developing lungs in children. Current management for aspiration in children includes change to food/fluid texture and/or enteral feeding with no specific treatments available. Respiratory muscle strength training (RMST) is effective in improving swallow function in adults with neurological diseases; however no data exists in children. The aim is to improve the management and respiratory outcomes of children who aspirate. We will conduct a study in which children will either complete respiratory muscle strength training with the RMST device or plain mask (control arm). We will see if this improves aspiration and quality of life.

Australia’s population is rapidly ageing and advances in public and clinical healthcare have contributed to a near doubling in the past two decades of Australians aged over 90 years The aim of this study is to assess the characteristics and outcomes of nonagenarians admitted to an Australian Intensive Care Unit (ICU). Who is it for? You may be eligible for this study if you were aged > 90 years who has been admitted to ICU for for any indication. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of nonagenarians who were admitted to ICU between 1 Jan 2010 and 31 December 2020. It is hoped that this research will help to provide a better understanding of predicting risk in nonagenarians being admitted to ICU.

The primary aim is to assess the effect of metformin versus metformin and semaglutide on absolute change in body weight over 6 months with women with a recent history of Gestational Diabetes Mellitus with persisting dysglycaemia who are overweight or obese. We also assess the efficacy of a physical activity intervention of wearable activity monitors on increasing activity levels (minutes per week) in these women. Secondary aims include assessing the acceptability, tolerability and safety of metformin with/without semaglutide. In addition, we will examine changes in outcomes at 12 months. Hypothesis Among women with persistent dysglycaemia and Body Mass Index (BMI) is greater than or equal to 25kg/m2 within 5 years of a Gestational Diabetes Mellitus (GDM)-affected pregnancy: 1. 6 months treatment with metformin and semaglutide will result in greater persistent weight loss compared to treatment with metformin alone. 2. A monitor-based physical activity intervention will result in higher mean activity levels at 6 months, compared to no physical activity intervention.

Dysphagia (i.e., swallowing difficulties) is common among people with Parkinson’s Disease (PwPD). Parkinson’s Disease results in movements that are smaller and slower than desired. There is limited research evidence on intervention options that improve tongue movement patterns in PwPD. This study aims to develop and test an intervention program that works on improving tongue movement patterns when eating and drinking with the use of ultrasound visual feedback and principles of motor learning. The study will use a single case experimental design to determine the effectiveness of the developed intervention in reducing the time taken to eat and drink as well as its impact on quality of life in PwPD. The hypothesis is that PwPD with dysphagia who participate in a four-week intervention using ultrasound visual feedback and principles of motor learning will show improvements in their swallowing efficiency.

Falls are common following a hospital admission and many people are unable to get up despite being uninjured, leading to complications from remaining on the ground for a long time, ambulance callouts to assist the person up off the floor but without transport to hospital, or a fear of falling and loss of independence. The LIFT study aims to co-design a training program (LIFT program) that teaches people how to get up off the floor and evaluate its feasibility in adults recently discharged from hospital who are at risk of falls. The LIFT program will be embedded during usual-care physiotherapy home visits as part of a community rehabilitation program. Participants will be assessed on their ability to independently get up off the floor before and after the six-week intervention. Semi-structured interviews and focus groups will be used to explore participants and therapists’ satisfaction and the practicality of delivering the program. It is hypothesised that floor transfer training is practical and acceptable to deliver within a home-based community rehabilitation program, and after 6-weeks of training the majority of participants will be able to independently get up off the floor, with or without using a chair.

This trial is a treatment specific appendix in a modular component of the Precision Therapies in Monogenic Epilepsies (PRIME) master protocol, for a series of N-of-1 studies of precision therapies in monogic epilepsies. It uses a within-participant, controlled, multi-crossover design to test the hypothesis that 4-AP, a potassium channel blocker, improves seizure control and/or ataxia associated with epilepsies due to gain-of-function (GoF) variants in the voltage-gated potassium channel genes KCNA1 (Kv1.1) and KCNA2 (Kv1.2).

A national, multi-centre observational study is proposed to evaluate the prevalence of coronary artery vasospasm in patients with unexplained cardiac arrest. Patients over the age of 18 years who have suffered an unexplained cardiac arrest (n=60) will undergo invasive functional angiography with acetylcholine challenge to assess for coronary artery vasospasm as a potential cause for their cardiac arrest. A small control group of patients with explained cardiac arrest (n=10) will also undergo functional coronary angiography as a comparator. The primary end point is the percentage of patients with a diagnosis of coronary artery vasospasm as defined by the Coronary Vasomotor Disorders International Study Group (COVADIS) criteria. The secondary end point is the association of risk factors leading to a diagnosis of coronary artery vasospasm. We expect this study will show a significant percentage of patients with a diagnosis of coronary artery vasospasm as a potential cause for their cardiac arrest, which will allow for targeted treatment in the prevention of further cardiac arrest, leading to improved patient outcomes.