ANZCTR search results

The aim of the study is to explore the efficacy of the 4-week online IBD.Mindovergut.com resilience program for individuals living with Inflammatory Bowel Disease and low to moderate psychological distress. The IBD.mindovergut.com resilience program is based on 5 modules (1 module per week), with the 5th module being optional. Each module (consisting of videos, text, handouts, and audio files e.g. relaxation tracks) is designed to be completed once a week, taking approximately 30 minutes, with associated homework-based activities taking a further 20-40 minutes per day. It is hypothesised that participants will report reduced psychological distress and increased quality of life.

Dysregulated fear memory processing as well as disrupted sleep (particularly rapid eye movement sleep) are important factors in the development of posttraumatic stress disorder. 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 two insomnia drugs that alter REM sleep (suvorexant and temazepam) on processing of fear extinction learning and emotional memory consolidation compared to placebo in healthy individuals. Impairments in fear conditioning and extinction is the prevailing model of mechanisms involved in the development of PTSD. We hypothesize that suvorexant increases REM sleep and adaptive emotional memory processing compared to temazepam and placebo.

The purpose of the study is to evaluate whether a brief self-compassion based writing exercise, known as 'My Changed Body' (MyCB), can alleviate body image distress (BID) in women recently diagnosed with breast cancer, over and above and expressive writing alone. Who is it for? You may be eligible to join this study if you are aged 18 years or older and have been previously diagnosed with Stage I-III breast cancer and/or ductal carcinoma in-situ and undergone breast cancer-related surgery within the last 2 years Study details All participants will be randomly assigned (by chance) to one of three groups. One intervention group will focus on an online writing tool only, i.e 'MyCb', where participants will focus on self-compassion strategies over two writing sessions. The second intervention will also involve the MyCB writing tool plus a daily meditation component. The third group (control) will participate in an expressive writing activity. All participants will be asked to complete questionnaires about their body image. It is anticipated that MyCB plus meditation intervention can reduce body image distress and assist in maintaining a positive self image for longer. In addition, we hope to provide greater insight into psychological strategies that may help women with breast cancer.

Transfer of frail Residential Aged Care Facility (RACF) residents to Emergency Departments (ED) is common, risky and expensive. A nurse led ACE model together with telehealth video capability (PACE-IT) has the potential to optimise the benefits of both ACE and telehealth addressing avoidable RACF transfers. The project assesses whether the enhancement of ACE / ASET services through the addition of protocol guided interactive visual telehealth assessment and clinical decision-making, plus telephone follow-up, reduces RACF transfers to ED. No previous studies have reported the effectiveness of such an approach. The proposed intervention was piloted at JHH ED and 4 RACFs resulting in 40% of potential transfers being avoided.

Knee OA is a major contributor to the global burden of disease, associated with significant pain, physical dysfunction and reduced quality of life. Muscle weakness and decreased lower limb muscle mass are common in knee OA, and are associated with poor long term outcomes. Therapy that builds muscle mass and improves physical function offers a new avenue to improve patient outcomes. Testosterone is the classical anabolic steroid hormone, which increases muscle mass and strength in men. However, it has never been tested as an intervention in men with knee OA. This pilot RCT in men with knee OA, will test the hypothesis that testosterone therapy will increase physical function, reduce pain and increase leg strength. The study will be completed in a randomised, double-blind fashion. The investigators have expertise in rheumatology, endocrinology, neurology and physical sciences

This study aims to evaluate the safety and tolerability of an experimental new drug, ALMB-0166 being developed to help prevent patients who experience an acute spinal cord injury from developing secondary injuries.

Project Summary Anastomotic leakage (AL) is a serious complication of intestinal surgery, resulting in increased morbidity and mortality. Current approaches to early detection of AL are nonspecific and insensitive. As a consequence, AL are often diagnosed at a later stage with the presentation of clinical symptoms and often secondary complications. In our subsequent studies we propose utilising a commonly used radiological solution, Gastrografin, as a biomarker of early detection of AL. Gastrografin is a water soluble, contrast solution commonly used for abdominal CT (computer tomography). In clinical practice, when administered orally or as an enema Gastrografin acts as a radiological contrast for the detection anastomotic leaks. It is also employed in regular clinical practice in small bowel obstruction and ileus. Our feasibility study aims to assess safety and optimise the technique and conditions required to reliably detect Gastrografin in surgical samples by Dual Emission CT (DECT) The outcomes of this Phase 1 feasibility study and the separate validation study are important in the development of the standard operating protocols for our proposed main study “Drain fluid Gastrografin as a sensitive biomarker for early detection of anastomotic leaks after low anterior resection”.

The low utility of lung function testing in clinical practice, despite its importance, is not surprising as to date there are no randomised controlled trials (RCT) that have assessed the benefits in routine clinical practice. This RCT will assess the benefit of spirometry, in all paediatric respiratory conditions, which may lead to a change in routine clinical practice. If this study shows that spirometry has a positive impact on clinical decision making and quality of life, this evidence will encourage the use of spirometry as an important clinical assessment tool in both tertiary and primary care practice.

This study is a single-centre, two (2) groups (ischaemic and haemorrhagic stroke), observational study of participants with a diagnosed stroke whose data would be used to refine the algorithm of the software component of the EMVision brain scanner. No intervention or modification to the usual hospital based treatment of stroke is proposed as part of this trial. The study population will include patients of the Princess Alexandra Hospital, Brisbane, Australia, with stroke symptoms and radiological images of the type and location of the stroke. Patients who are confirmed/diagnosed to have stroke and have diagnostic CT or MRI images for comparison, would be considered for participation in the study. The microwave imaging will not change the standard clinical care, nor be used in clinical nor diagnostic evaluation in this study. A participant’s involvement may last up to approximately 28 days as an inpatient or until discharge (whichever is sooner). The total trial will be conducted over approximately 12 months (including enrolment of up to 30 participants).

Hyponatraemia is common in hospitalised patients. Our Australian data demonstrate that hyponatraemia leads to adverse outcomes and delays hospital discharge, due to unavailability of effective pathophysiology-based treatment. In Australia, fluid restriction is the mainstay of treatment for euvolaemic and hypervolaemic hypotonic hyponatraemia in hospital inpatients. Tolvaptan, a vasopressin V2-receptor antagonist, may be more effective.