ANZCTR search results

The aim of the study is to explore the efficacy of the 4-week online IBS.Mindovergut.com resilience program for individuals living with irritable bowel syndrome and low to moderate psychological distress. The IBS.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 IBS symptoms and increased quality of life.

Motor neurone disease involves the destruction of the nerve cells that control your body’s movements. It is a progressive disease involving cells from the immune system attacking the nerve cells in the brain and spinal cord, which eventually causes death. The research project is testing the safety of a new drug called PMX205, which has been designed to interfere with how the body’s immune system attacks the brain. The purpose of this research is to determine if PMX205 is safe, if it affects the body as expected, and how much is in the blood after dosing. PMX205 will be injected under the skin in the top part of the abdomen. Alsonex Pty Ltd has shown that PMX205 can slow down the disease in animals and is safe to use. Medications, drugs and devices must be approved for use by the Australian Federal Government; the Therapeutic Goods Administration (TGA). PMX205 has not been approved for marketing by the TGA in Australia and is not yet approved anywhere else in the world. Therefore, the use of PMX205 in this study is experimental.

Preterm brain injury continues to be an important complication of preterm birth, especially in extremely premature and extremely low birth weight infants. Umbilical cord blood derived stem cells (UCBCs) are being increasingly evaluated for their neuroprotective and neuroreparative properties. There remains a paucity of information on the feasibility and safety of autologous UCBC transplantation in extremely premature infants. Methods: A single centre safety and feasibility study in preterm babies born before 28 weeks gestation. Cord blood will be collected after birth and, if sufficient blood is obtained, UCBC will be harvested from the cord blood, characterised and stored. After excluding infants who have already suffered severe preterm brain injury, preterm infants will be infused with autologous UCBC via the intravenous route at a dose of between 25-50 million UCBCs/kg body weight. A minimum of 20 infants will be administered autologous UCBCs. Primary outcomes will include feasibility and safety. Feasibility will be determined by access to sufficient cord blood at collection and UCBCs following processing. Safety will be determined by lack of adverse events directly related to autologous UCBC administration in the first few days after administration. Secondary outcomes studied will include neonatal, and neurodevelopmental morbidities till 2 years of life.

The diagnosis of insomnia is made based on an individual’s self-reported sleep complaints. Research has found varying degrees of discrepancy between self-reported and objectively measured sleep. Individuals with insomnia tend to overestimate the time they spent awake during the night and how long it took them to fall asleep compared to normal sleepers. They also tend to underestimate their total sleep time compared to normal sleepers. Further, greater discrepancy has been associated with higher insomnia severity, and Cognitive Behavioural Therapy for Insomnia (CBT-I), an effective non-pharmacological intervention for insomnia, has been shown to reduce this discrepancy. Sleep-measuring wearables are increasingly used by consumers. However, the existing devices rarely provide feedback with guidance to support helpful interpretation of objectively recorded sleep. This is especially important for individuals with insomnia, where appropriate guidance on interpreting objective-perceived sleep discrepancy may be large. Conversely, CBT-I was developed before the rise of consumer wearables and does not typically incorporate data from these devices despite them being available from many patients. Therefore, the aims of this study are threefold (1) to examine whether providing monitoring and feedback on objective sleep with support for helpful interpretation of discrepancy improves insomnia and (2) to explore potential mechanisms of change.

The Total Knee Replacement (TKR) procedure is a standard of care intervention to treat severe degenerative knee joint disease conditions (such as osteoarthritis). All patients being considered for enrollment in this trial will be undergoing TKR as per usual treatment management plans. The NEXT-AR Navigation system comprises of infrared cameras that are able to track the movement of the knee joint throughout surgery and can provide the surgeon with data about the state of the collateral ligaments of that patient. This ligament data can inform the surgeon about the optimal positioning of the knee prosthesis to potentially improve the patient satisfaction and knee kinematics post-operatively. The hypothesis for this investigation is that NEXT-AR Navigation system data is able to reproduce soft tissue balance patterns and native knee function following prosthesis implantation and thereby improve patient outcomes and satisfaction post-surgery.

The COAST Study will assess the feasibility and efficacy of lifestyle intervention programs to reduce modifiable risk factors for dementia through behaviour-change in people with Mild Cognitive Impairment (MCI). The study will use three different interventions of varying intensity level - 1) delivery of risk information to change behaviour; 2) delivery of risk information plus weekly text message support to change behaviour; 3) delivery of risk information plus weekly face-to-face intervention delivered by a psychologist designed to change behaviour. Acceptability of the interventions will be assessed along with cognitive and affective outcomes. It is hypothesised that the text message support group will display greater behaviour-change than the information only group, and that the face-to-face group will show the greatest change of all three groups.

Young people experiencing severe mental health disorders, also have poorer physical health compared to their healthy peers. Orygen Youth Health (OYH) offers a range of physical health interventions to tackle this need. One novel intervention recently set up by a senior clinician within OYH is a boxing group which utilises non-contact boxing training techniques to improve fitness and strength. This research study is being conducted to determine whether a boxing group is a feasible and acceptable way of supporting young people with mental health disorders to improve their physical and mental well-being. It will allow us to establish data that could be used to support future grant applications as well as data to support the ongoing inclusion of boxing groups in the OYH group program.

Prior research strongly suggests that the drug epoetin alfa improves the outcome of critically ill trauma patients. If proven correct, this has important implications for the management of trauma patients throughout the world.. We will conduct an international multi-centre trial in critically ill trauma patients that will determine the effect epoetin alfa on the rate of death and severe disability.

This study aims to identify if women with a diagnosis of endometriosis are using social media to gain health information, share stories and both provide and receive online support regarding endometriosis. It involves completion of a once-off questionnaire with questions relating to basic demographics, health information and social media use both in general and specifically related to endometriosis. We are recruiting women from the Royal Women's Hospital general gynaecology teams and aiming to have 100 participants. We hypothesise that a large proportion of our patients use social media as a self-management strategy for endometriosis.

Older adults admitted for acute care are extremely sedentary, more so for post-hip fracture patients. With the relationship between sedentary behaviour (SB) and poor outcomes, various interventions to reduce SB and increase physical activity (PA) is critical if older adults are to achieve some level of pre-fracture status post-hip fracture across all continuum of care. However, so far, it is not clear if providing coaching and real-time feedback to patients on their level of SB and PA will encourage them to take more action to reduce SB and increase PA during acute care and afterwards. Therefore, an individualised goal-setting intervention to break SB and increase PA while on admission in acute care post-hip fracture is important. This study will utilise health coaching and ActiGraph-based real-time feedback to break SB and increase PA while on admission and follow-up at 3, 6 and 12 weeks respectively to determine the effect of an intervention on SB, PA and other geriatric-specific outcomes in the long-term. Study Hypothesis: There will be no significant difference between intervention and control groups on sedentary behaviour and physical activity measures