ANZCTR search results

The SPinal Emergency Evaluation of Deficits (SPEED) has been developed to determine whether a brief and simple neurological assessment tool can rapidly determine the severity and level of cervical spinal cord injury. The primary purpose of this study is to prospectively validate this assessment tool in cohort of patients with suspected cervical spinal cord injury. SPEED will be undertaken within 2 hours of injury and will be correlated with neurological assessments performed during the acute hospital admission and at 6 months post-injury. The hypothesis of this study is that an acute neurological assessment (SPEED) performed by paramedics within 2 hours of injury can accurately determine the severity and level of spinal cord injury prior to surgery or within 24 hrs post-injury.

dentifying and addressing cognitive impairments post-stroke is a significant component of stroke rehabilitation. However, few cognitive assessments measure real-world performance. One assessment that addresses cognition in the ‘here and now’ is Perceive Recall Plan Perform (PRPP). PRPP is an assessment and intervention system used by Occupational Therapists (OTs) to identify errors of cognitive strategy application and structure individualised intervention. PRPP is a unique tool: it measures cognitive strategy application in any task, in any setting, and can be used with any client, regardless of diagnosis or age. PRPP is standardised, reliable, valid and criterion-referenced assessment (Chapparo & Ranka, 2012), meaning that it can be used to measure how much of a task that an individual needs to do in their own situation, rather than using generic criteria to measure success. It consists of a two stage assessment framework: stage one uses task analysis to record motor steps and errors. Stage two is used to attribute errors in applying cognitive strategies which occurred during the task. PRPP is widely used for assessment and intervention in brain injury (Nott, Chapparo, & Heard, 2009), however there is little documented evidence of PRPP in stroke rehabilitation. This study will be conducted with stroke survivors in an Early Supported Discharge (ESD) setting, titled Rehabilitation in the Home (RITH). Three different assessments will be conducted by OTs: PRPP on two different tasks, the Functional Independence Measure (FIM) to measure burden of care and Lawton’s Instrumental Activities of Daily Living (LIADL) to measure domestic task independence. PRPP stage one and stage two scores will be related with these measures and examined for any trends. All data will be collected within the first five OT home visits as a component of standard care and full data sets from ten patients are required for analysis. This exploratory study aims to examine the use of PRPP in stroke as a tool to identify errors in using cognitive strategy application, measure task mastery and detail trends in the assessment results. The objectives are to: Determine if it is feasible to use PRPP with stroke patients receiving ESD, examine the usefulness of each aspect of PRPP in stroke rehabilitation; and explore the association between PRPP and FIM and LIADL. It is anticipated that this study will examine the feasibility of using PRPP in stroke ESD, provide evidence for the use of PRPP in stroke to assess cognitive strategy application and explore PRPP as a real-world measure of information processing in stroke rehabilitation.

Root resorption defects as a sideffect of orthodontic treatment. The aim of this study is to compare whether a lower level laser operated in a stimulatory mode has an effect on the rate of healing of root resorption defects associate with routine orthodontic tooth movement. The first part consists of applying buccally directed (towards the cheek) orthodontic forces to the upper 1st premolars to simulate orthodontic tooth movement. After 1 month, all force will be removed and the teeth retained passively to allow the natural process of root resorption repair following orthodontic tooth movement to occur. During this period, laser will be applied to one side of the mouth whilst a sham laser (no laser energy) will be used on the control side. After another month, premolars on both sides of the mouth (laser treated and controls) will be extracted and analysed with a micro-ct to determine if laser has any effect on the rate of healing of orthodontic induced root resorption. Root resorption is a significant consequence of orthodontic treatment. LLLT has been used in a biostimulatory manner in the healing of soft tissue wounds, implant related infections and in oral mucositis. Findings may provide clinical evidence in relation to use of LLLT in the aid of repair of root resorption.

This project will compare two "next generation" methods of measurement of physical function to the accepted gold standard assessment of physical function: in-person testing using validated physical function outcome measures. We will measure physical activity using (1) wearable devices and smartphone applications and (2) a telephone assessment of global function; we will compare these convenient at home assessments to the gold standard in-person assessments in order to quantify the validity and feasibility of these new approaches to inform future clinical trial design. The results will be used both within Australia and New Zealand, and internationally, to design future RCTs aiming to measure post discharge and long term physical function outcomes. Moreover, our results will also inform the design of new in-home monitoring strategies for post-ICU clinics and interventions.

Many women fail to achieve the current exercise guidelines for pregnancy which recommend that pregnant women without contraindications engage in 20-30 minutes or more of moderate intensity exercise on most days of the week. As exercise enjoyment is an important factor which affects exercise adherence, it is important to determine the optimal format of exercise which promotes enjoyment. Interval type exercise has been reported to be more enjoyable in the non-pregnant population but no study had investigated this format of exercise in pregnancy. Thus, this trial investigated the effects of adding brief higher intensity intervals to moderate intensity continuous cycling on the overall energy expenditure and intensity of exercise and the enjoyment of exercise. It was hypothesised that the addition of brief higher intensity intervals to moderate intensity continuous cycling will increase the overall energy expenditure and intensity of exercise, at the same time as enhancing enjoyment. The trial of interval cycling was found to increased energy expenditure by 28% when compared to the continuous cycling trial. At the same time, the interval cycling trial significantly enhanced the enjoyment of exercise in late pregnancy. Importantly, the findings was specific to recreationally active women only, but this study provides a rationale for future studies to examine the physiological and psychological responses to regular interval training during pregnancy to optimise exercise prescription.

The decline in estrogen production at menopause heightens a woman’s risk of osteoporosis, heart disease, hypertension, stroke and dementia. We have now identified postmenopausal women as another vulnerable population at risk of dementia who may also benefit from resveratrol supplementation – a strategy that can be easily incorporated into the daily diet. We aim to gather evidence for the efficacy of vasoactive nutrients in maintaining optimal circulatory function to reduce the risk of developing dementia. Given that resveratrol supplements are available over-the-counter to consumers in Australia, the anticipated outcomes will offer a non-pharmaceutical approach for managing menopause-related symptoms and counteracting accelerated cognitive and physical decline and loss of bone mineral density in women post-menopausally, which can be readily implemented by clinicians and the public. We will recruit 170 post-menopausal women aged between 45 and 85 years old. A 24 month randomised, double-blind, placebo-controlled, crossover dietary intervention trial will be conducted at the University of Newcastle. A crossover intervention means that all participants will receive the resveratrol treatment. The primary objective of the study is to determine in postmenopausal women the ability of resveratrol supplementation for 12 months to improve cognitive function. The secondary objectives are: To determine whether improvements in cognition, mood, overall well-being (sleep quality, menopausal symptoms and pain) and physical function are accompanied by improvements in cerebrovascular responsiveness to cognitive demands, photic stimulation and/or to hypercapnia. To determine whether resveratrol supplementation can attenuate global cognitive decline. To determine whether resveratrol supplementation can change body bone mineral density and body composition. To determine the effects of resveratrol supplementation on clinic blood pressure and arterial compliance. To determine whether the improvements in the outcomes are related to changes in biomarkers of cardiovascular and bone health, hormone levels and plasma resveratrol concentration.

This study will examine the links between melanoma risk and the genetics controlling skin, hair and eye colour and mole type and distribution. Who is it for? You may be eligible to join this study if you are a patient of the Victorian Melanoma Service who is able to attend an appointment at the Alfred Hospital and who has had a previous or current melanoma diagnosed. People aged 18 or older are eligible. Study details All participants in this study will attend a one-off appointment where they will fill out a questionnaire about their sun exposure and medical history and give a saliva sample for DNA testing. A research assistant will record the participant's skin, hair and eye colour, weight and height and take full body images of the participant in their underwearas well as dermoscopic (close-up) images of moles larger than 5mm in diameter. This usually takes between 1 and 2 hours. We hope that this research will contribute to better melanoma screening procedures and identify people who would benefit from more frequent skin checks. Data will be combined with a similar, previously registered and ongoing study (trial ID - ACTRN12615000244505).

This is a randomised, double blind, placebo-controlled study in healthy subjects. As a phase 1 study, it is designed to evaluate the safety and tolerability of intranasal pentosan polysulfate sodium (Rhinosul 'Trademark') in healthy subjects, following single and repeat dose administration.

Type 2 diabetes is a leading cause of end-stage kidney disease (ESKD). The risk of cardiovascular complications is high in diabetic dialysed patients. Metformin has been shown to reduce these complications. However, it is not used in these patients due to the risk (very low) of acidosis. To address this urgent health problem, we aim to investigate the safety of low dose metformin in these patients. This study will consist of 3 arms, the pharmacokinetics arm, the extended pharmacokinetics arm and the safety arm. In the first arm patients (n=5) will receive 500 mg of metformin after dialysis for 12 weeks. In the second (n=10) and thrid arm (n=50) patients will receive 250 mg of metformin after dialysis (3 dialysis session per week) for 24 weeks. We hypothesis that low dose metformin can be safely given to dialysis patients.

What is this study about The purpose of this study is to investigate how safe and tolerable repeat doses (applied twice daily for 13 days and once on the 14th day) of ZYN002 transdermal gel is in healthy volunteers. The study will look at how the body absorbs the study drug. This will be done by analysing the levels of ZYN002 in your blood at various times following drug administration. Your skin at the application sites and your hands will be checked to see if there is any irritation or reactions present after ZYN002 application. In the study you will be provided with moisturizer to apply to assist with potential dryness of the skin caused by the study treatment. Who is if for? You may be eligible to join this study if you are aged between 18 and 55 years and are in general good health. Study details: This study will investigate various doses of ZYN002 compared to a placebo gel (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means you and your study doctor, together with the study staff administering the study treatment will not know whether you are receiving ZYN002 or placebo gel. What does study participation involve? Your participation in the study includes A screening visit, which could be up to 28 days before your study treatment..Throughout the study you will have various medical tests (physical examinations, vital signs measured, ECG measured, C-SSRS assessment and will have several blood and urine samples collected for laboratory analysis. You will report to the clinic your first day of treatment (Day 1). The study treatment will be applied twice daily for 13 days with one treatment on day 14. Days 1-13, each morning while at the research facility, you will apply your AM treatment of ZYN002 or placebo gel. You will apply the study treatment to the treatment site assigned to you (either your left and right shoulder and/or upper arms, or your left and right upper thighs). You will apply your AM dose of all the study drug to clean, dry, intact skin, thoroughly massaging it into the application sites assigned. You will continue to massage study drug into the application site until the application site feels dry to the touch. This will take approximately 2-4 minutes but everyone’s skin is different so it could take less or more time for you. You will repeat this procedure at your home for the afternoon application on Days 1 to 13. You will return to the research facility every morning on Days 1-13 for the AM dose. On Day 14 you will stay at the research facility until the evening of Day 15, 36 hours after the last study treatment. You will return to the research facility on Days 17, 19, 21, 23, 27, 31 and Day 35 for study assessments.