ANZCTR search results

Spinal cord injury results in a devastating change in a person’s life quality due to a loss in function to not only voluntary motor control but also to regulatory systems that control bodily processes. Over 200,000 new cases of spinal cord injuries occur each year, with more than half of these injuries occur at the level of the cervical spine and upper thoracic spine (C1-T5). Injuries to these levels result in alteration to the sympathetic nervous system which causes dysregulation to blood pressure control. A treatment that may increase blood pressure is electrical muscle stimulation. Stimulation is applied to the muscles through surface electrodes and transfer a current that activates muscles fibres and nerves. This study will investigate whether electrical stimulation of the abdominal muscles can improve blood pressure control for people with a spinal cord injury.

Women aged 50 years of age or older and men aged 70 years of age or older who require admission to an Intensive Care Unit (ICU) lose bone at a significantly higher rate compared to adults who do not become critically ill. Zoledronic acid and denosumab are medications that prevent bone breakdown but are not commonly used in the ICU population. This trial aims to study the effects of these medications, compared to placebo, on bone density in 450 critically ill women aged 50 years of age or older and men aged 70 years or older. Participants will be allocated to receive one of the medications listed or a placebo. Participants will have a bone density scan after trial drug is administered and again at 12 months and have information such as falls, fractures hospital readmissions and quality of life collected at 6 and 12 months. A smaller group of participants, with prior consent will be enrolled to have some additional blood tests to measure markers of bone breakdown in the blood.

The aim of this research is to evaluate the impact of a preoperative dietitian-led VLCD intervention to determine whether the intervention reduces incidence of unfavourable surgical outcomes arising from elective, non-bariatric surgery in adults with obesity. It is hypothesised that obese adult patients who receive preoperative dietitian-led VLCD-based treatment will have shorter operating time and fewer unfavourable surgical outcomes than controls. This study will be a parallel group, two-arm, superiority randomised controlled trial with 1:1 allocation ratio. The study population will be obese adult patients on elective surgery waiting lists at Logan Hospital for a range of general, colorectal, gynaecological, and orthopaedic procedures. In absence of appropriate literature, this intervention is not being widely adopted despite likely improved surgical outcomes and cost-benefits. This research will significantly contribute to the small body of literature and likely highlight the need and allow for more widely accepted implementation of this intervention across a variety of surgery types.

The typical way of presenting information on labels of dispensed medicines can confuse some people. The project aims to evaluate the effectiveness of dispensing labels designed to be easier to read, these labels are called "patient-centred labels". It is expected that patient-centred labels will improve comprehension of medication dosing instructions.

Patients requiring cardiac surgery during COVID-19 are at greater risk of death and adverse events. Smartphone based support could help to improve outcomes during this pandemic. Health services have been drastically reduced; preadmission clinics are limited or closed, telehealth services are inadequate, elective cardiac surgery is restricted, hospitals are limiting visitors and almost 50% of cardiac rehabilitation services have ceased. Evidence for strategies that optimise post cardiac surgery recovery is sparse. In this study the effect of a GoShare mHealth (smartphone) intervention on recovery after adult cardiac surgery during COVID-19 will be evaluated. Interventions using smartphone technology have proven effectiveness for a range of cardiovascular conditions under normal conditions. COVID-19 has created extraordinary circumstances that will persist for some time. We hypothesise that the GoShare mHealth intervention will improve (intermediate and ongoing) patient recoveryafter cardiac surgery, reducing representation and readmission rates when compared to usual care during COVID-19. This study provides an opportunity to improve patient outcome and experience for adults undergoing cardiac surgery throughout and beyond the COVID-19 pandemic in Australia. This study aims to reduce representation and readmission, by empowering patients as end-users with strategies for self-help.

Do you have type 1 diabetes and want to know how the glycemic index affects your blood glucose levels? The ‘iBolus: GI’ Study is exploring at how the glycemic index in meals high in protein and fat influences blood glucose levels in adults with type 1 diabetes and using insulin pump or multiple daily injections. You will be asked to have a blood test and do the test sessions at home with remote training and support by researchers to eat two different type of toast (high and low GI) served with peanut butter, take an insulin bolus and monitor your BGL by CGM system for 5.5 hr.

This trial is designed to evaluate safety, tolerability, PK and PD of BI 456906 in male and female patients with non-alcoholic steatohepatitis (NASH) and liver fibrosis using multiple escalation schemes and doses, and will support dose selection for phase 3 clinical development of BI 456906 . Currently, no approved pharmacotherapy for NASH, the progressive form of NAFLD, is available, relying on treatment of the comorbidities of the metabolic syndrome. Obesity is associated with a variety of medical conditions, including all components of the metabolic syndrome, cardiovascular, pulmonary, gastrointestinal, endocrine, joint and psychosocial disorders. Currently, the available weight loss medications lack sufficient efficacy, safety, tolerability and convenience to reduce body weight and improve its associated co-morbidities/ conditions. This trial is a randomised, double-blind, placebo-controlled trial in which three dose regiments of BI 456906 will be compared to placebo over 48-week treatment period. Only approximately 60 patients out of total 240 patients will be randomised to receive placebo treatment. A placebo-control design is required for evaluation of evaluation of BI 456906 tolerability and safety. In addition, a placebo arm is needed in order to avoid potential confounding factors, such as placebo effect, potential investigator bias in safety and efficacy assessment or regression to the mean in endpoint scoring.

This project aims to provide a scientific evaluation of a mental health program delivered in a "real world" clinical setting. The Tern Program was developed in response to a gap in local mental health services in regional Queensland, and was designed to provide a modern psychological treatment based on the latest knowledge in the field of trauma research. This program is being operated at two community youth mental health services in Townsville and Mackay, and is offered to young people aged 12-25 with a history of childhood trauma. The Tern Program is a multi-component intervention designed to address the broad needs of young people with a history of trauma. This program includes one-to-one counselling, a psychoeducational group program, Limited Case Management, and components designed specifically to support the therapists providing the intervention. Young people may access support through this program for for up to 24 months, or less as needed. As the Tern program is a new intervention model, it is necessary to conduct a formal evaluation to determine the tolerance and effectiveness of the program for the young people receiving it. This project will gather data on the participants in the program, on a number of clinical and functional outcomes, over an 18 month timeframe between 2021 and 2022. It is hypothesised that young people receiving the program will experience a reduction in their posttraumatic stress symptoms, and improvements in their overall quality of life and degree of occupational activity.

This study is a randomised controlled open labelled pilot trial. The research study aims to explore the effect of fibre and antioxidant supplementation on values of inflammation found in blood and the microbiome on older adults living in the community aged 60-70 years old. This pilot trial is significant because the researchers hope the results of this trial will provide initial evidence of the effect of nutritional supplements on the health status of older Australians especially in relation to nutrition, inflammation and frailty.

In this project, we will use a new therapeutic lighting technology developed by our team at Queensland University of Technology, that can provide preferentially directed light spectrums to increase melanopsin activity thus may improve non-motor circadian/sleep behavior and motor symptoms in people with PD. Participants will be exposed to the light therapy at home every day for 30 minutes over 4 weeks and sleep and motor function will be assessed before, after 4 and 6 weeks of light intervention. We hypothesize that using light to preferentially activate melanopsin cells in the eye will help people with Parkinson’s disease sleep better. A better sleep will also positively impact on their movements such as balance, gait and tremor during the day.