ANZCTR search results

This is a Post-market, multi-centre, non-comparative, open label study . The study aims to measure the performance and the safety of Trinity™ Dual Mobility System in patients who will receive Trinity™ Dual Mobility System during Total Hip Arthroplasty (THA). A subset of these patients will also provide blood sample for measuring whole blood metal ions (Co, Cr and Ti) levels in patients receiving the TrinityTM Dual Mobility System. In the prospective component, patients who are eligible for the THA that will receive the TrinityTM Dual Mobility System in combination with a Corin Femoral Stem. These patients will complete follow up visits over a span of 5 years where the safety and performance of the Trinity DM cup will be measured by quality of life questionnaires. Those patients that are deemed suitable will be invited to provide a blood sample for the measurement of Cobalt, Chromium and Titanium levels. The metal ion levels in the blood of the participants will be monitored over time to determine any presence of metal ions (Co, Cr and Ti) above the local laboratory normal range in whole blood.

Study Aim is to identify the mean quantities and ranges of fat, protein and carbohydrate consumed in meals and snacks times in a small sample of children aged 6-18 years with type 1 diabetes attending John Hunter Children's Hospital and to then explore any possible associations between macro nutrient variability and HbA1c or BMI.

In Australia, one in 6 couples will have difficulty conceiving a baby. Diminished ovarian reserve (DOR) lowers the chance of pregnancy even more. The best way to assist women with DOR is unclear as there are few helpful treatments available. Many women in Australia use naturopathy to improve their chances of getting pregnant and having a healthy baby. However, there is no rigorous evidence that can tell us if naturopathy is effective or safe for women with DOR. We are also interested in the possible role of naturopathy as an additional treatment to increase pregnancy rates in women with DOR. To answer this question, we will need to first check that rigorous clinical trial methodology is acceptable to women with DOR and, if it is, to follow up with a larger clinical trial. Prior to embarking on such a large and expensive study, we propose to do a small, preliminary study to see if women with DOR are interested in participating in clinical research of naturopathy, and gather preliminary safety data. We have completed a survey with women with DOR which has informed the design of this study; and a survey and focus group to ensure the naturopathic management being evaluated is close to that which is provided by naturopaths when they support women with DOR.

This research will investigate the effects of exercise for people with rotator cuff tendinopathy. Rotator cuff tendinopathy is the most common reason for pain among people experiencing shoulder pain. It is characterised by pain at the front or side of the shoulder and may radiate into the upper arm. Pain is typically worse when lifting the arm, completing overhead activities or generally with increased shoulder activity. Current guidelines recommend exercise, activity modification and anti-inflammatory medication as first line treatment for rotator cuff tendinopathy. However, we do not yet know which exercise is most effective. The proposed study is a two arm parallel group randomised control trial. The primary aim of this research is to compare the feasibility of two different exercise interventions for rotator cuff tendinopathy.

Cognition is required so that individuals can make decisions, communicate, think, analyse and move on a daily basis. Patients with chronic obstructive pulmonary disease (COPD) have impaired cognition compared to age matched healthy controls and this is associated with increased mortality and disability (Wen et al. 2018). However, the mechanisms for this cognitive dysfunction remain poorly understood. Several studies have also reported that a reduced brain (cerebral) blood flow can lead to cognitive dysfunction and patients with COPD also have a reduced brain blood flow compared to age matched healthy controls (Beaudin et al. 2017). This finding suggests that the impaired cognition observed in patients with COPD may be due to a reduction in brain blood flow. However, this hypothesis has not been tested. Patients with COPD experience airway obstruction which loads the respiratory muscles and increases the work of breathing. Inspiratory loaded breathing required healthy individuals to breathe through a narrow tube and increases the work of breathing and replicates an exacerbation of COPD. This model of airway obstruction can be used to replicate COPD in healthy young individuals and investigate the effects of loaded breathing on cognition and brain blood flow. The aim of the study is to investigate the effects of inspiratory loaded breathing on cerebrovascular blood flow and cognition in healthy young adults. We will test the hypothesis that inspiratory loaded breathing reduces cerebrovascular blood flow and cognition.

Aphasia is a communication disorder often caused by stroke and may affect a person's ability to talk, read, write and understand language. Aphasia does not affect a person's intelligence. Speech Pathologists provide intervention and therapy for people with aphasia to support their language recovery. Research has shown that people with aphasia benefit when more therapy is provided over a longer period, however the amount of therapy that people with aphasia receive in Australia is typically less than what is recommended. The University of Queensland has developed the Comprehensive, High-dose Aphasia Treatment (CHAT) program to address this issue. The overall aim of this research project is to evaluate the real-world implementation of the CHAT program. Specifically, this research aims to: 1) Evaluate the process of implementing the CHAT program within rehabilitation settings 2) Determine how effective the CHAT program is compared to current therapy options (usual care) 3) Examine the potential cost-effectiveness of CHAT compared to current therapy options (usual care) 4) Investigate whether speech pathologists report and demonstrate increased knowledge and skills in providing high-quality aphasia treatment We hypothesise that compared to current therapy options (usual care), the CHAT program will result in: 1) A greater proportion of high-quality aphasia therapy being delivered to people with aphasia 2) Improved recovery for language, communication and quality of life of people with aphasia 3) Increased speech pathologist knowledge and skills in providing high-quality aphasia treatment

A small number of patients presenting to emergency departments need intubation, a process to place a tube in their windpipe to protect their airway, and allow breathing support with a ventilator. Drugs are used to ensure that they are unconscious and to relax their muscles to make placement of the tracheal tube possible, but these drugs can cause changes to vital signs such as pulse and blood pressure, which could worsen their condition. Ketamine is often used as a sedative agent for intubation, and an opioid (morphine-like) drug is sometimes used to try and normalise the blood pressure during the procedure. Fentanyl is the most commonly used opioid for this purpose, but another drug called alfentanil is theoretically a better choice. In this clinical trial, we intend to randomise patients to receive equivalent doses of either fentanyl or alfentanil, in a blinded fashion, as part of a drug regimen with ketamine and a muscle relaxant called rocuronium. The study aims to test the null hypothesis that there is no difference in the outcomes measured between fentanyl and alfentanil.

This study aims to test if the online Better Health Program helps to build healthy and long-term lifestyle behaviour changes in children aged 7-13 years who are above a healthy weight in Victoria. The program currently runs in Western Australia. When delivered face-to-face, the program has improved health outcomes for children who are above a healthy weight.

The intervention will be a support group conducted on TEAMs and will be a patient led group moderated by senior nursing staff. Allied health will be invited to contribute to the sessions as required and the content included in the sessions will be ascertained by engaging with patients to keep the initiative very patient focused. The sessions will be run weekly for approximately 1 hour over the course of 4 weeks. It will be an opportunity for patients to engage with and support each other as well as a chance to engage with relevant healthcare professionals who will provide relevant support and education. Two validated tools will used pre intervention to assess the participants anxiety and depression and quality of life. The same tools will then be used again after the 4-week intervention to reassess and provide quantitative data for the study. The online support group will be a patient centred approach to providing self-management support. This study will look at quality of life and anxiety and depression outcomes associated with the online education and support group intervention.

Background: People with unhealthy lifestyles are known to be more at risk of type 2 diabetes, heart disease, and hypertension; these conditions in turn lead to a higher risk of certain forms of dementia, especially Alzheimer’s disease. A recent clinical trial in Finland (the FINGER study: Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability) showed that a combination of lifestyle changes, aimed at reducing the incidence of the above conditions, can help to preserve brain function in people aged 60-77 years who were considered at higher risk of dementia. Hypothesis: Using the FINGER study as a model, the AU-ARROW 2-year study will help establish, in an Australian cultural setting, whether the combination of lifestyle changes including regular physical exercises, a healthier diet, regular brain training exercises, and regular health monitoring, will preserve brain function in people considered at higher risk of dementia. Study details: Australia’s AU-ARROW study will be run in Sydney (NSW) and Perth (WA), and will recruit 600 people aged 60-79 considered at high risk of developing dementia, who will be allocated randomly and evenly into 2 groups: the health education & coaching group (HC), or the multidomain lifestyle intervention group (ML). HC participants will attend information sessions about exercise, diet, and activities to keep mentally and socially active at five group meetings over the 2 years of the trial, and will also receive yearly medical counselling. The ML group will receive similar information more frequently (group meetings at least monthly), free gym memberships and personalised exercise regimes, monthly dietary counselling, 6-monthly medical counselling, and will carry out online brain training exercises 3-4 times per week, for 2 years. All AU-ARROW study participants will undergo six-monthly memory tests, blood tests and physical assessments, as well as complete several questionnaires, to help determine whether this combination of lifestyle changes can reduce the risk of dementia.