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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.

Most options for HIV and hepatitis C testing currently involve people attending clinics or community testing sites. The purpose of the Dried Blood Spot (DBS) HIV/hep C testing pilot is to increase access to testing by providing people with ways to collect their own blood samples in the comfort of their own home. It offers significant advantages to conventional blood testing such as providing added convenience, privacy and confidentiality. This study also aims to assess whether DBS is an effective and manageable option for increasing access to HIV and hepatitis C testing among priority populations in NSW. It will also assess who is likely to use the program as well as ascertaining participants’ perspectives on the testing process. Addition of a sub-study for validation of hepatitis C testing Participants will be recruited from selected sites participating in the HIV and HCV Dried Blood Spot Testing Pilot with a focus on sites with high testing volumes. Clinic staff will identify participants and offer participation in the sub-study. After providing consent, participants complete a capillary blood finger-stick DBS sample and a venous blood sample. The paired identically labelled samples will be sent to the Serology & Virology Division, NSW Health Pathology, Randwick (SAViD NSWHP) for testing. Results delivery will be as per standard of care by NSW Health Pathology to the service ordering the tests. Participants will not receive HCV treatment as part of this study. Participants that are RNA positive will be linked to standard of care to assess for HCV treatment eligibility.

This study is assessing the efficacy of Theta Burst Stimulation (TBS), a form of Transcranial Magnetic Stimulation (TMS), in treating Obsessive Compulsive Disorder (OCD). It is a randomised control trial where participants will receive bilateral TBS to one of two different brain cortical regions. Each treatment course will involve TBS twice daily for 2 weeks (10 treatment days). Each treatment session will involve the application of 2 TBS trains, 15 minutes apart (a total of 4 trains per day and 40 trains per treatment course). Patients who do not respond to treatment will be crossed over and provided the alternate treatment. During treatment patients will be reclined in a comfortable chair and will be alert and awake. The sensation associated with treatment is usually well tolerated with most people describing it as a tapping sensation.

Our novel clinical approach could place innovative non-drug treatment solutions in the hands of children with Juvenile Idiopathic Arthritis (JIA). This multi centre randomised control-trial aims to integrate the Smart Watch to monitor pain levels, customised physical activity progression, and drug-therapy adherence in children with JIA.