ANZCTR search results

This is a pharmacokinetic study of Lumacaftor/Ivacaftor (Orkambi) in children between 2 years and 18 years of age who are homozygous for Phe508del-CFTR with severe cystic fibrosis related liver disease, in comparison to those without severe liver disease.

Respiratory complications are reportedly very low (<2%) following open incision lower abdominal surgery and simple laparoscopic upper gastrointestinal surgery (e.g. lap choles). Due to a high cost to benefit ratio, prophylactic physiotherapy directed respiratory exercises and assisted early ambulation is not provided to these patients over and above standard ward care in a majority of hospitals in Australia or Europe. However as more complex procedures, such as bowel resections are increasingly being performed, the corresponding operation times are extending well past 3 hours. This may independently increase the risk of a respiratory complication. However, reports on respiratory complications in prolonged (>3r) laparoscopic and open lower abdominal is lacking. This trial aims to measure rates of respiratory complications in this population in the context of standard hospital ward care. Risk prediction modelling of those patients at highest risk will ensure that future prophylactic delivery of respiratory exercises and Physiotherapy is targeted to those patients that most require them.

Patients with AF frequently reports dyspnea upon exertion and exercise intolerance. However, the factors that contribute to these symptoms are not clear. In this study, we will objectively quantify exercise capacity, with the aim of assessing the impact of preselected clinical features on peak oxygen uptake and ventilatory efficiency.

This project investigates the effectiveness of a rhythm and movement intervention, delivered by early childhood teachers, to improve self-regulation for preschool-aged children living in disadvantaged communities. Coordinated rhythmic movement activities are proposed as an effective means to support the neurological bases of self-regulation and enhance motor, auditory, and self-regulatory functioning. Project outcomes will include resources designed for teachers on how to use rhythmic movement activities to improve young children’s skills to regulate attention and behavior. This will have significant benefits for positive school transition, and may help to address disparities in early learning and childhood wellbeing.

Pain and mental health conditions, especially posttraumatic stress disorder (PTSD), are common and disabling after injury. This study is evaluating an adaptation of the Trauma Survivor Outcome Support (TSOS) model that was developed in Seattle, USA. The intervention that we are evaluating will provide tailored psychological support and coordinated care through a case manager, and aims to reduce the prevalence and impact of persistent pain and symptoms of mental health conditions after major trauma. The control group receives enhanced usual care in which the participant's primary care provider receives a letter summarising the participants potential ongoing treatment needs when they enter the study. The study hypothesis is that the TSOS model of care will be acceptable to patients after major trauma, and that it will reduce the severity of pain and mental health symptoms compared with enhanced usual care.

An advanced hybrid closed-loop (A-HCL) insulin delivery system has shown safety and high time-in-range in a previous study. The use of a faster acting insulin aspart (FiASP) with a more rapid onset and shorter duration of insulin action compared to standard insulin aspart could improve the responsiveness of a HCL system. Limited data is available regarding the use of FiASP in HCL systems. The aim is to compare meal-time glucose control using A-HCL delivering FiASP vs. insulin aspart. All participants will undertake the study over a 22 week period, completing 2 study stages, each of 11 week duration 1) A-HCL with insulin aspart, 2) A-HCL with FiASP. Each stage will be identical with respect to meal challenges (2 per week of differing meal compositions). Outcome measures include CGM time-in-range and time in hyperglycaemic and hypoglycaemic ranges and system performance outcomes.

In this study, we are interested in the effects of mental health nursing on patient outcomes. A mental health nurse has had special training in how to care for people who are mentally unwell. Our study aim is to find out if it is possible to use routine health data to test if there is a link between the amount of mental health nurse care patients get and the chance of them have a relapse after they leave the hospital.

The purpose of this study is to evaluate a diagnostic blood test (C-reactive protein) to detect infection and inflammation in the first 3-5 days following bowel surgery. Who is it for? You may eligible for this study if you are 18 years or older and undergoing elective colonic or rectal resection with a primary anastomosis at Lyell McEwin Hospital. Study details Patients enrolled in the study will be allocated into two groups, the control and intervention group. Participants in the control group will be monitored via standard care protocols at the hospital. The intervention group will have a blood test with a small needle in the arm on days 3, 4 and 5 after surgery. If the CRP value is above certain thresholds on these days, a 'septic screen' will be performed to look for a source of infection. The assessments that you may be involved in include, a CT scan, chest x ray, wound swab and urine/blood tests. It is hoped this research will help determine if using a clinical protocol based on the CRP to perform an infection screen will allow earlier detection of infectious complications following major colorectal surgery. It is hoped this will also allow for earlier intervention and treatment.

Older patients undergoing surgery are at an increased risk of post-operative complications including geriatric syndromes such as delirium, functional decline and falls.. The Aged Care Department at Concord Hospital will introduce a novel co-management model of care for older adults admitted under the vascular surgery service. As part of the new service proactive comprehensive geriatric assessment and management will be undertaken by the geriatrician who will work collaboratively with the vascular surgery nursing staff and team. Using a prospective before and after study design, this research will evaluate the impact of this innovative, interdisciplinary and patient-centred model of care on important health outcomes.

Currently the gold-standard treatment for PTSD is prolonged exposure therapy (PE), however, despite robust evidence of the efficacy of PE, approximately 40% of those completing the treatment show only partial or no treatment response, therefore, it is critical to advance the field to identify new ways to facilitate treatment response to PE. Research suggests that a neuropeptide, Brain derived Neurotrophic Factor (BDNF), can improve the main mechanism underlying the PE treatment in PTSD and a well-validated way to increase BDNF levels is through acute moderate intensity (aerobic) exercise. This project aims to investigate whether combining a 20-minute aerobic exercise intervention with PE treatment to increase BDNF levels during therapy would increase the effectiveness of PE treatment in PTSD. We hypothesise that the treatment response will be greater in PTSD patients receiving aerobic exercise intervention with PE treatment compared to control group of PTSD patients receiving a 20-minute gentle stretching with PE treatment and this effect will be mediated by the exercise induced changes in BDNF levels.