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Effectiveness of exercise in Systemic Lupus Erythematosus.
The aim of this project is to compare the effectiveness and individual experience of supervised and structured aerobic exercise to resistance exercise on key clinical outcomes in people with Systemic Lupus Erythematosus.
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PROM implementation for elective surgery patients in Australia: national implementation of the “AusPROM Recommendations” (Phase III)
Incorporating patient reported outcome measures (PROMs) into usual care in hospitals can improve safety, quality and patient satisfaction. The aims of this clinical trial are to: (i) test the feasibility of national implementation of the QoR-15 PROM for elective surgery; (ii) test the patient acceptability of the QoR-15 PROM for elective surgery day and overnight patients, (iii) establish if the QoR-15 PROM has concurrent validity with the EQ-5D-5L, and (iv) report the percentage of patients who return to pre-surgery status (as measured on the QoR-15) in the week following surgery and at four weeks following surgery. The trial protocol has adopted the Guidelines for Inclusion of Patient Reported Outcomes in Clinical Trials Protocols (SPIRIT-PRO). The findings will highlight value of patient (acceptability domains) feedback to inform the AusPROM recommendations for the implementation of patient focused outcome measures. The trial will also illuminate the feasibility and value of using the QoR-15 to understand patient views about elective surgery outcomes.
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Pragmatic Adaptive Trial for Respiratory Infections in Children (PATRIC) : Amoxicillin Duration
Acute respiratory infection (ARI) is a common cause of childhood morbidity and the most common reason for paediatric emergency department presentation and hospitalisation. Despite numerous professional bodies describing the limited trial data available to inform management guidelines, there has been little progress towards evidence-based ARI care in developed nations in the past decade. Antimicrobial use (or misuse) is a major driver for antimicrobial resistance (AMR) and identified by the WHO as an urgent threat to the prevention and treatment of an ever-increasing range of infections. AMR is a serious threat to global public health, requiring urgent action across all government sectors and society. Most antibiotics in children are prescribed for common paediatric conditions, particularly ARI. Our group has demonstrated that >50% of ARI-episodes are confirmed to be secondary to viral infections, yet >50% of children with fever and cough are prescribed antibiotics. Therefore, most antibiotics prescribed to children with ARI are likely to be unhelpful and given the impact on AMR, potentially harmful. The primary objective of this trial is to generate the evidence for optimal duration of antibiotic treatment for pneumonia and ARIs in children. This trial will compare different treatment arms of amoxicillin for 2, 3, 4 or 5 days for physician-diagnosed pneumonia in children aged greater than or equal to 6 months to 15 years.
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Investigating the effect of a Rugby League Community program on Women's Health
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).
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ENJOY MAP for HEALTH: outdoor exercise for older people
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.
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Phase 1 Study of SPT-2101 Given as a Single Intratympanic Injection in Subjects with Unilateral Meniere's Disease
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.
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Acute Management of Spinal Cord Injury
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.
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A Mindfulness Based Intervention for Adults with Cerebral Palsy with Anxiety and/or Emotion Regulation Difficulties
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).
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The effect of light acupuncture and five-element music therapy for nurses’ mental health and wellbeing during and post COVID-19
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.
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Comparing two anticoagulant treatment, Warfarin (Standard treatment) and Apixaban (A new treatment) in patients with a Mechanical Heart for bleeding and thrombosis complications.
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