ANZCTR search results

Rates of obesity and chronic disease amongst women in Australia are growing, as is the percentage of women not meeting the Physical Activity guidelines. Consequently, the Australian Government's National Women's health strategy 2020-2030 has highlighted the need for commitment to improving women's health particularly through the development of interventions designed to target physical, emotional and psychological health. Currently professional sport clubs are receiving considerable attention regarding their potential to engage men in health promoting programs, and given this success in men’s health, this could be an innovative and appropriate way to engage women in health promotion programs. Therefore the purpose of this study is to explore the preliminary feasibility and acceptability of a 12-week gender tailored intervention for middle-aged women in South Western Sydney (SWS).

The ENJOY MAP for HEALTH aims to evaluate the impact of the Seniors Exercise Park (specialized outdoor exercise equipment for older people) and associated capacity building activities on park visitation, park-based physical activity by older people and community physical activity programs delivery. The effects of age-friendly outdoor spaces on physical activity and wellbeing will take place in 6 participating Victorian municipalities. Each Council will undergo 4 stages (Site construction and development, Promotion and marketing, Capacity building and training, Evaluation and sustainability). Several activities and methods will be employed from Stage 1 through Stage 4 to evaluate the potential impact of the age-friendly outdoor spaces on physical activity and wellbeing and will comprise the following elements: Site observation and equipment utilisation, development of an online access monitor and community building activities. The project is expected to result in a significant change in the physical outdoor environment for the participating councils and communities whereby older people and other community members will be able to engage in safe physical and social activity programs, socialise more and hence improve the overall wellbeing of older people.

This is a single-blind, placebo controlled, single-dose study to evaluate the safety, tolerability, and PK profile of SPT-2101 following a single IT administration. In all study subjects, SPT-2101 or saline will be delivered unilaterally (one ear will remain untreated). Subjects will enter a 4-week (+/- 2 weeks) lead in period. During this time, subjects will complete a daily patient diary to document baseline vertigo episodes and complete additional laboratory testing. Subjects will then be further screened based on laboratory results and vertigo diary entries. Eligible subjects will return for additional baseline assessments and treatment on Day 1. Cohort 1: A first cohort of subjects (up to 10) will receive SPT-2101 administration in an open-label manner. Cohort 2: A second cohort of subjects (up to 30) will be randomized 1:1 to either: • Arm 1: Subjects receive IT administration of SPT-2101 or • Arm 2: Subjects receive a placebo involving IT administration of saline using a sham procedure. Following study drug administration or sham procedure, subjects will be discharged from the clinic and will return 24 hours post-administration for safety assessments (Day 2). Subjects will have additional follow up visits at Day 8, Day 15, Day 29, Day 57, Day 85, and Day 169. At Day 85, subjects in the placebo arm who meet prespecified criteria will be eligible to receive SPT-2101 in an open label manner. Placebo subjects who cross over to SPT-2101 treatment will restart the study follow-up schedule at Day 2 following the study schedule for Cohort 1.

Spinal cord injury is devastating injury with significant functional and financial cost. Long term outcomes vary and depend on early injury factors and prevention of secondary neurological injury. This is a retrospective cohort study. The aim of this study is to identify current practice with reference to factors that influence prognostication and prevention of secondary neurological injury. These are early documentation of neurological status, and defence of blood pressure targets in keeping with international guidelines. Identifying current practice will facilitate design of future studies that aim to investigate long term outcomes. The primary objective of this study to describe current practice in the acute assessment and intensive care (ICU) management of spinal cord injury, with respect to timing and documentation of neurological status after injury, and acute blood pressure management in ICU.

The objective of this study is to measure the effectiveness of a Mindfulness Based Stress Reduction (MBSR) program delivered via telehealth in developing mindfulness knowledge and practice, and in turn reducing anxiety, depression, stress and pain, and improving emotion regulation, in adults with cerebral palsy (CP). Participants (n=48) will be randomly allocated to either an online MBSR Group Program (treatment) or a waitlist control group. For feasibility of group interaction by telehealth, the MBSR treatment group will be divided into 3 groups (8 participants in each group). The MBSR Program led by a social worker includes content focused on developing mindfulness skills. The MBSR program consists of 9 x 90-minute sessions, run over 9 weeks provided by telehealth practice. Participants will be assessed at baseline (T1), at the conclusion of the course (T2), and then re-assed 8 weeks after the program has finished (T3).

Australian nurses have experienced higher levels of anxiety during the COVID-19 pandemic compared with the pre-pandemic. This may have affected their long-term mental health and intention to stay in the profession resulting in a workforce shortage and its associated impact on the health of the public. This protocol details a trial to examine the feasibility of light acupuncture and five-element music therapy intervention to involve nurses’ mental wellbeing in Western Australian (WA) hospitals.

We aim to investigate whether anticoagulation with apixaban 2.5mg BD is as safe as warfarin in patients implanted with a Ventricular Assist Device (VAD). Our hypothesis is that when used in combination with an antiplatelet agent (such as aspirin 100mg daily), apixaban is not inferior to warfarin for the prevention of thrombosis formation in patients who have had a VAD implanted for a minimum of 2 months and without any bleeding or thrombotic complications during the period between 2 months post VAD implantation

The aim of this study is to investigate whether addition of a new therapy using the NanoKnife system improves survival in patients with unresectable stage 3 pancreatic cancer. The Nanoknife system is a type of irreversible electroporation (IRE) device. “Electroporation” is a cellular destruction technology that can be used to treat cancer. It uses electrical pulses to make small holes in cells that cause cell death. This destroys the targeted tissue in the body and the treated tissue is then removed by the body’s natural processes in a matter of weeks, mimicking natural cell death. Who is it for? You may be eligible for this study if you are aged 18 years or older, have a diagnosis of unresectable stage 3 pancreatic ductal adenocarcinoma, and have received (or will receive) at least 3 months of a single line of chemotherapy prior to enrolment. Study details Within 1 to 3 weeks after completing their 3 months of chemotherapy, all participants will undergo the IRE procedure. The IRE procedure will only be performed by a surgeon qualified in the use of the NanoKnife System. The procedure will require a general anaesthetic and will take approximately 2-3 hours to complete. As part of the procedure, a diagnostic laparoscopy (a procedure where a camera is inserted into the abdomen through small incisions) will be used to rule out the presence of metastases. Following this, the abdomen will be opened to perform IRE. A tissue biopsy will be taken during the procedure if safe to do so. After recovery from anaesthesia, participants will stay in hospital for up to 7 days before being discharged home when they are well. Participants will be asked to complete a number of questionnaires at 3, 6, 12, 18, and 24 months following the procedure, and will also be asked to report any side-effects that they experience for the duration of follow-up. Following treatment with the NanoKnife, you may continue to receive other standard of care treatment such as further chemotherapy or radiotherapy. This will be decided by your treating oncologist. It is hoped that this study may demonstrate that use of the NanoKnife system in patients with unresectable stage 3 pancreatic cancer who have already received chemotherapy is safe to use, improves survival, reduces pain, and increases quality of life compared to patients receiving chemotherapy alone.

We aim to examine the clinical effectiveness and economic benefit of a whole of class self-regulation program in mainstream schools. We aim to: 1) improve the self-regulation skills of school-aged children experiencing social disadvantage and 2) determine the cost of an occupational therapy service delivering the intervention. Participants: Eligible Stage 2 students from two separate schools, one as the control group and the other an intervention group. Participants will be children aged 8-10 years, and their classroom teacher. Methods: a control group and treatment group will be utilised to establish a cause and effect relationship between a whole class occupational therapy led self-regulation program, and the selfregulation skills of participants. Hypotheses: we expect that the self-regulation skills of children in the treatment group will show more improvement over time than the control group. A reduction in behavioural incidents, suspensions and absenteeism is also expected.

This study aims to investigate the impact of a body appreciation-based writing intervention on a female cancer survivor population. Who is it for? You may be eligible for this study if you are a female aged 18+ years who has completed active anticancer treatments (i.e. not currently receiving chemotherapy, radiotherapy, surgery), for any cancer type. Study details Participants will be randomly allocated by chance (similar to flipping a coin) to a single-session 15-minute writing intervention which will either be writing about your day, or writing about appreciating your body. Measures will be taken directly before the writing session, after the writing session, and one week later. It is hoped that information from this study will help develop a program aimed at improving wellbeing for female cancer survivors.