ANZCTR search results

Participants are asked to fill in 4 online questionnaires of memory, mindfulness, attention, mood and mind-wandering, and complete two online tasks of working memory and reasoning ability prior to training. Participants are asked to complete similar tests after the training is completed. After completing baseline measures, participants are then randomly assigned to either of the training groups (mindfulness training or computerised working memory training). Working memory training group is our intervention group and participants in this group will complete their training from the DREAM website by playing CrushStations game. The game is based on the principles of n-back task, a measure of working memory capacity popularly used in working memory training research. Different types and colors of ocean animals will be displayed on participant's screen, and at a later recall test, participants will be asked to recall and remember types and colors of ocean animals. Group 2 is our active control group where participants will complete mindfulness training via the Mindfulness Coach Explorer app. Participants will practice open monitoring and focused attention types of meditation during their training. Both groups will train for 21 minutes in each sitting, for 4 days a week and for 6 weeks altogether. It is hypothesised that working memory training group will show improved performance at post-test on the measures of working memory and reasoning ability, whereas mindfulness training group will show improved performance on the measures of mood, mind-wandering, and mindfulness trait.

This study aims to establish and evaluate Australia’s ‘Birthing on Country’ rural demonstration site at Waminda South Coast Women’s Health and Wellbeing Aboriginal Corporation in Nowra, New South Wales (Waminda), Yuin Lands. A redesign of the health service will increase continuity and quality of maternity care, and positively impact the health and wellbeing of Aboriginal and Torres Strait Islander (referred to hereafter as Aboriginal in accordance with Waminda’s wishes) women and babies who are accessing care at Waminda. The clinical safety and cost effectiveness of the new service will be systematically evaluated. This project has strong Aboriginal governance, agency and leadership.

There are disproportionately higher rates of lifetime trauma and Post-traumatic Stress Disorder (PTSD) among people with substance use disorders (SUDs), which can both precede, and occur as a consequence of substance use. Cognitive Processing Therapy (CPT) is a ‘gold-standard’ PTSD treatment, with a strong emphasis on processing and restructuring maladaptive beliefs around a traumatic event without employing exposure-based strategies. However, the effectiveness of CPT for individuals with co-occurring PTSD and SUD has not been extensively studied. The current project will be a randomized controlled parallel-group trial, which will determine the outcomes of CPT for young people with SUD/PTSD in the residential treatment setting for substance use. Participants will be randomised to receive either TAU or CPT alongside their usual residential treatment (CPT+TAU). Client outcomes on measures of substance use and PTSD, depression, anxiety symptoms will be evaluated at baseline, 1-, 3-, 6-, and 12-months follow-up.

This study is investigating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single ascending dose of BW-20829 in subjects with elevated lipoprotein(a) in 5 dose level cohorts (up to 3 optional cohorts with 24 subjects may be added). Approximately 40 men and women aged (more than equal to) 18 to (less than equal to) 65 years who fulfill the inclusion and exclusion criteria will be enrolled at sites in Australia. Eligible subjects will be admitted to the clinical research unit on Day -1, dosed on Day 1, discharged on Day 2 (24 hours post-dose), and return for outpatient visits through Day365. Within each cohort, 8 subjects will be randomized in a 3:1 ratio to receive a single dose of BW-20829 (n=6) or placebo (n=2) on Day 1 in a double-blind fashion.

This is a first-in-human, single-centre, randomised, double blind, two-part single and multiple ascending dose study to assess the safety of FB102-101, and how this drug acts in the body in healthy volunteers. FB102-101 may be indicated for use in patients with autoimmune and inflammatory diseases, but a trial of the drug in healthy volunteers is needed before trials in patients with autoimmune and inflammatory diseases can proceed. Who is it for? You may be eligible for this study if you are aged 18 to 60 years and are in good general health without a clinically significant medical history. Study details: All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single or multiple doses of FB102 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. The data generated in this study will inform the design of future clinical studies and to select the dose(s) for future studies in patients with autoimmune and inflammatory diseases.

The aim of this study is to evaluate the feasibility of measuring cerebral autoregulation as an individualised metric of hypotension in non-cardiac surgery patients. Specifically, we will translate our novel signal processing techniques to identify the lower limit of cerebral autoregulation. Crucially, translation of this metric will both predict individualised optimal blood pressure targets and act as a target for goal-directed, autoregulation-oriented blood pressure therapy during surgery.

Preterm babies are born with a patent ductus arteriosus (PDA), a blood vessel which connects major blood vessels of heart (aorta) and lung (pulmonary artery). PDA can be associated with complications in preterm babies. Therefore, we try to close it with medications, like paracetamol. However, we still don’t succeed in closing a PDA in 30-35% babies. It is possible, that the dose, which we currently provide, may not be enough for some babies. It is still unknown how much paracetamol concentration (level) is needed to achieve a PDA closure. The aim of this study is to measure the concentration and develop a pharmacokinetic-pharmacodynamic (PK-PD) model of paracetamol in preterm babies. This study will enable us to find the appropriate target concentration necessary for PDA closure. We will be able to use this information to vary the dose of paracetamol to achieve higher success rate in preterm babies in future.

Occupational therapists use a range of rehabilitative approaches to work towards their patients’ goals, one of which is implementing occupation-based interventions. Occupation-based interventions, involve the therapeutic use of engagement in occupation (or an intended daily activity) to achieve change. Delivering occupation-based interventions in the inpatient rehabilitation setting is often time and resource intensive, and the demand for increasing intensity of rehabilitation services poses additional challenges to both clinicians and the health system. Occupational therapists commonly use group-based interventions alongside individual therapy. There are several potential benefits identified by both clinicians and patients for group-based interventions including building connections with co-participants through shared experiences, peer-based learning, and improving motivation for therapy; there are also clear economic benefits as groups can improve time and cost-effectiveness through being able to see more patients at once, as well as offering the potential for a higher intensity of task practice. This study aims to compare the effectiveness of occupation-based groups to occupation-based interventions delivered individually. Occupation-based interventions should be client-cenetred, individualised, and flexible in nature, with the content, intensity and duration of therapy tailored to each patient and their specific occupational performance goals. Thus, further research is warranted to determine whether occupation-based interventions delivered in a group setting using semi-supervised practice can uphold the client-centred nature of this intervention effectively, compared with individual-based delivery. This research will aim to determine the effectiveness of occupation-based groups in adult inpatient rehabilitation and explore the factors impacting on implementation and outcomes of such interventions. It is hypothesized that an occupation-based group intervention will be more effective in improving occupational performance outcomes in adult inpatient rehabilitation compared to usual care.

Synthetic haemostatic agent at laparoscopic ovarian cystectomy on ovarian reserve in women aged 25 to 40 years: STASIS study Ovarian cysts are a common gynaecological issue facing reproductive age women and the good standard surgical management is laparoscopic (key hole) ovarian cystectomy (removal of cyst). This procedure can associated with bleeding. Traditional methods to stop bleeding can damage the normal ovary (ovarian reserve) and potentially impact future fertility. Hameostatic (blood clotting) agents are commonly used surgical products applied to the ovary after the cyst has been removed to treat bleeding in a way that minimises damage to the normal ovary. Current available products are human or animal derived. Purastat is a similar product but completely synthetic (does not contain human or animal products), used in Gastrointestinal procedures (colonoscopy and gastroscopy) and is effective in reducing complications related to blood loss. We would like to study if applying this product to the ovary after the time of laparoscopy ovarian cystectomy is protective for ovarian reserve and future fertility.

Each year 160,000 critically ill Australians are admitted to an Intensive Care Unit (ICU) to receive life-saving treatments and around-the-clock care. There is concern that sleep disturbances may result in worse outcomes, including confusion, memory impairment, and depression, some of which may persist for months after leaving the ICU. There are numerous barriers to monitoring the quality and quantity of sleep in ICU patients, with the gold-standard technique of polysomnography (PSG) posing substantial technical and logistical challenges. A new, wearable device, the Somfit (Compumedics) that uses a smartphone app and computer analysis to measure sleep may provide a simpler alternative. This study will compare this novel device and automated scoring algorithm to polysomnography (PSG) interpreted by a trained sleep technologist in adult patients in the ICU.