ANZCTR search results

Disturbances in cerebral blood flow and intracranial pressure may alter blood flow through collateral vessels connecting the intracranial and extracranial circulations. Some of these vessels are superficial and can be assessed non-invasively using Doppler ultrasound. This prospective observational study will investigate whether arterial and venous Doppler signals can be reliably obtained from superficial extracranial vessels in critically ill patients with suspected disturbed cerebral haemodynamics. Participants will undergo non-invasive Doppler ultrasound assessments of vessels including the superficial temporal and supraorbital/supratrochlear circulations. Up to three examinations may be performed during the first seven days following enrolment. Doppler waveform characteristics will be compared with clinical diagnosis, intracranial pressure where available, neurological findings and clinical outcomes. The primary aim is to determine the feasibility of obtaining adequate Doppler signals in this patient population. Secondary exploratory analyses will investigate whether extracranial Doppler waveform characteristics are associated with disturbances in cerebral haemodynamics and neurological outcomes.

People with spinal cord injury often sleep poorly. One reason is that spinal cord injury can disrupt the body’s ability to control temperature, and temperature control is one way the body prepares for sleep. This project will examine the efficacy of a home-based temperature-controlled mattress topper in 20 adults with chronic spinal cord injury using a randomised crossover design, with participants completing a 21-night usual-sleep condition and a 21-night mattress-topper condition separated by a three-night washout. Sleep will be estimated using a consumer smart ring, with morning questions, skin temperature measurements and questionnaires assessing sleep, insomnia, mood and wellbeing. We expect the mattress topper to improve sleep and overnight comfort, particularly for people with higher-level spinal injuries.

To pilot a brief intervention for family members of people with hoarding disorder to ensure the intervention is feasible and improve family member coping.

Vial Australia Pty Ltd is conducting a first-in-human study of VIAL-IL13xTSLP, an experimental bispecific antibody that targets two inflammatory proteins (IL-13 and TSLP) involved in asthma. The study will evaluate the safety, tolerability, and biological effects of the drug in patients with mild-to-moderate asthma.

This study is Part 3 of this Phase 1 study. Part 1 is ACTRN12626000320358 and Part 2 is ACTRN12626001173381. Part 3 evaluates the effect of fluvoxamine on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of fluvoxamine will not significantly change the systemic exposure of a single 50 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without fluvoxamine.

Light exposure influences a range of processes involved in the development of PTSD, including hormone release, stress, mood, cognition and sleep. The impact of light varies by wavelength (colour). This study will investigate whether regulating evening light exposure using coloured glasses can reduce symptom severity and the risk of developing PTSD after traumatic injury. Adults admitted to The Alfred Hospital Trauma Service will be asked to complete a two-step screening process that includes a light-sensitivity assessment. Eligible individuals will then complete a baseline assessment, including clinical interviews and questionnaires on mental health and sleep and may provide an optional saliva sample for genetic analysis. Participants will then be randomly assigned to wear one of two types of coloured glasses that selectively filter different wavelengths of light. Participants will wear the glasses for two weeks during the three hours before bedtime, complete brief daily sleep and mood assessments, and wear devices to track light exposure, sleep, activity, heart rate, and skin temperature. Follow-up assessments, including clinical interviews and self-report questionnaires, will be conducted at 6 and 12 weeks post-baseline. We hypothesise that individuals allocated to receive the intervention glasses will have reduced severity and risk of developing PTSD at 6 and 12 weeks post-baseline.

This study is testing whether a telehealth-delivered digital rehabilitation programme, called BIBO, is a practical and acceptable way to help people recover after knee replacement surgery. Thirty adults aged 55 and over who are having a knee replacement will take part in this single-group feasibility study, using the BIBO programme alongside their usual care instead of traditional face-to-face physiotherapy visits. The study team expects that most participants will be able to use the programme regularly and will find it acceptable, and that recovery outcomes will be broadly similar to those seen with standard rehabilitation care. Participants will complete short questionnaires and physical assessments at several points before and after their surgery to track their knee function, pain, range of motion and satisfaction with the programme. The findings will help determine whether a larger study of telehealth rehabilitation after knee replacement is worthwhile.

Around 3.6 million Australians live with chronic pain, which can have a major impact on health, wellbeing and daily life, particularly in rural and regional communities where access to evidence-based pain care may be limited. EQUiPP aims to find out whether a community-based approach involving local communities and primary healthcare services can improve understanding of chronic pain, reduce stigma and misconceptions, and support evidence-based pain care. The study will implement a co-designed public awareness campaign, education for healthcare professionals, and Community Champions working across seven rural and regional communities. We expect this approach will help people make more informed decisions about managing chronic pain, increase use of recommended evidence-based care, and reduce unnecessary use of opioid and pregabalin medicines. The findings will help determine whether this approach can improve chronic pain care and be successfully expanded to other rural and regional communities across Australia.

Competency in a range of movement skills (e.g. kicking, running, throwing) provides the foundation for an active lifestyle, however, very few children leave primary school having mastered foundational movement skills to support participation in a variety of physical activities. Our project will evaluate the effectiveness of a time-efficient foundational movement skill program in primary schools.

In this study, the safety and tolerability of the study treatment, CBT-248, will be evaluated in healthy volunteers when it is taken orally as single dose. CBT-248 is a potential new treatment for chronic pancreatitis which has not been given to humans before. This study aims to test how the body responds to the study drug, and whether it has any undesirable side effects.