ANZCTR search results

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.

The overall aim of this project is to trial a conversation therapy program to improve the quality of conversations between people with Parkinson's and their communication partners. This therapy program was co-designed with people with Parkinson's and their communication partners in the previous phase of this PhD project. Aim1: To evaluate the feasibility and effectiveness of the treatment program through a clinical trial. Aim 2: To evaluate the acceptability, clinical, and social validity of the treatment program, from the perspectives of the people with Parkinson’s and their partners who received the intervention.

Invisalign has released a new 3D-printed product (Invisalign Palatal Expander System – IPES) to replace traditional jackscrew-based expander plates in children 6-11 years of age. Instead of relying on a jackscrew-type system to open the jaws, it involves sequential wear through a series of 3D-printed removable plates of progressively greater width. It has recently (early 2024) been launched in global markets, with relevant approval granted from regulatory bodies (TGA & FDA). It has been marketed as equally effective but more comfortable and stress-free to use compared to traditional metal jackscrew-based expansion plates. No external studies have validated these claims.

This study aims to investigate the local (bladder wall) and systemic (liver, kidney, lung, bone marrow) distribution of durvalumab with a radioactive isotope when injected in the sub-urothelium for Bladder Cancer (SUBDUE-3) Who is it for? You may be eligible to join this study if you are aged 18 years or above with a diagnosis of muscle invasive bladder cancer or high-risk non-muscle invasive (T1, high grade Ta, carcinoma in-situ) bladder tumours and scheduled for a cystectomy. Study details All participants will receive a single dose of 89Zr-Durvalumab injected to their bladder. Participants will have positron emission tomography (PET) imaging at pre-determined timepoints to visualise the distribution of the drug over time up to 7 days post injection. Blood samples will be taken and any adverse events will be recorded for up to 2 weeks post-cystectomy. It is hoped that SUBDUE-3 will contribute to the further understanding and development of immunotherapy treatments being delivered directly into the wall of the bladder with the aim of achieving bladder preservation in localised bladder cancer. This trial will contribute to the understanding and further development of sub-urothelial immunotherapy as a potential treatment for patients with bladder cancer.

For parents of children with disabilities, including cerebral palsy (CP), navigating the complex National Disability Insurance Scheme (NDIS) system to develop an evidence-based package of therapies for their child is challenging. Parents tell us that they need to develop advocacy skills and have a greater understanding of what constitutes evidence-based therapies in order to successfully navigate the NDIS system and choose from 182 available therapies and over 1000 service providers. Currently, there are no capacity building programs for parents of children with disabilities that are peer-driven and peer-led. We will iteratively co-develop and test a novel web-based multi-component knowledge platform on EDX called CP-KASP (Cerebral Palsy Knowledge, Advocacy Skills and Support Program) comprising (a) webinars and interactive consumer-led virtual groups for families of newly diagnosed children with CP entering the NDIS systemCP-KASP (Cerebral Palsy Knowledge, Advocacy Skills, and Support Program) will reduce parental stress, increase parental empowerment, self efficacy and family quality of life for parents of young children with cerebral palsy. CP-KASP will be acceptable, feasible and adoptable with high levels of fidelity.