ANZCTR search results

The aim of this clinical trial is to test the effectiveness of a topical treatment on facial cold sores (herpes simplex labialis): whether it reduces the duration of healing and the amount of pain and other symptoms. A minimum of 292 male and female participants in Australia and New Zealand, aged from 18 to 65 years, will be randomly assigned to receive either a placebo or a medically approved topical treatment. Participants will complete an initial study 'visit' with an investigator either at a pharmacy or by phone. The first visit will be cover an initial assessment and treatment. Participants will report symptoms and healing progression in an on-line daily diary which researchers will monitor for reports of adverse side effects. A second visit will be conducted by phone for comparative assessment once the participant has healed or 14 days have passed.. We expect the primary outcome to be a reduction in the duration of the cold sore compared to the placebo controlled group.

This project aims to explore: 1- The type and amount of exercise or physical activity that people with MND participate in. 2- Explore the factors that influences level of exercise/physical activity participation in people with MND 3- Investigate the changes to exercise/physical activity participation as the disease progresses. We will use the physical activity scale for the elderly (PASE) which is a short questionnaire to collect data regarding physical activity over the last 7 days.

The purpose of this study is determine the feasibility of an inpatient and subsequent home based exercise and education program for patients undergoing allogeneic bone marrow transplant for haematological cancer at the Royal Melbourne Hospital. Who is it for? You may be eligible for this study if you are an adult aged 18 years or above, planned to undergo an allogeneic bone marrow transplant for haematological cancer at the Royal Melbourne Hospital. Study details All participants will receive a protocolised exercise and education program for the duration of their inpatient admission for their allogeneic bone marrow transplant (alloBMT). The program will include aerobic and resistance training at an individualised level, provided by a physiotherapist in a supervised group setting. The sessions will operate for up to 1-hour up to 5-days per week. Measurement of physical function, physical activity levels, health-related quality of life and body composition will be completed at four time-points: (1) recruitment to the study (approximately 1 month pre-alloBMT); (2) hospital admission; (3) hospital discharge (usually one month after admission); and, (4) 60 days post-alloBMT. We will also obtain consumer feedback through questionnaires and interviews, and look at health care resource usage. This study will provide important information to generate evidence to target our resources in an attempt to minimise physical burden associated with haematological (blood) cancer.

The primary aim of this study is to examine the feasibility of investigating whether Australian children aged 8-13 years will consume 30g almonds on 5 days per week for 8 weeks. The secondary aim is to compare the effects of consuming almonds on cognitive function compared to a nut-free control phase. Additionally, this study aims to examine the effect of sleep quality and quantity on cognitive performance in primary school aged children. This study is an 18-week randomized, controlled cross-over feasibility study. Forty free-living healthy children aged 8-13 years (without known nut allergies) will be randomized (using a random number generator) to start in either the almond or the control phase for 8 weeks. Following a washout period for 2 weeks, children will then cross-over to the alternate condition for another 8 weeks. Children will undergo cognitive performance testing using computerized tasks five times - screening (for familiarization), and then before and after each phase. The study will be conducted by the Alliance for Research in Exercise, Nutrition and Activity (ARENA), University of South Australia. Participants will consume 30g of raw, unsalted almonds for 5 days a week. In the control phase participants will be given 250ml bottled water as an attention control. Participants will be provided with individual packets of almonds (5 days x 8 weeks = 40 packets). During the control phase participants will be asked not to consume nuts or nut products. In the almond phase participants will be asked not to consume nuts or nut products other than the almonds provided.

The primary aim of this project is to increase resilience among adolescents who participate in sport by delivering a face-to-face workshop supported by online/app-based resources. The secondary aims of this project are to (i) increase wellbeing, (ii) reduce psychological distress, (iii) reduce maladaptive implicit beliefs, (iv) reduce burnout, and (v) increase athlete engagement.

This study will investigate the influence of a selective serotonin reuptake inhibitor (SSRI; citalopram) on the brains response to light stimuli, using fMRI scans. Participants will be healthy young men and women. Participants will complete two seperate fMRI scans, with ~1 week between scans. At each scan, participants will take either a single dose of citalopram 30mg, or placebo (in a randomised order) prior to undergoing a scan during which they are exposed to alternating periods of light and dark. We hypothesise an increase in the brain's response to light after citalopram administration, relative to placebo.

The Anterior Cervical Discectomy and Fusion (ACDF) is one of the most common operations utilised in treating cervical degenerative disc disease. This involves removal of an intervertebral disc and cartilage with surrounding bone removal to release compressed spinal nerves. Once the disc has been removed, an implant known as an ‘inter-body cage’ is introduced into the disc space to restore disc height with restoration of physiological alignment and create an environment to achieve bony fusion. Overall, this procedure aims to improve neck pain and nerve pain via neural decompression and improved stabilisation. One of the inherent problems with introducing an implant that is more resistant to compressive forces (i.e. an increased bulk modulus) when compared to vertebral bodies is subsidence. Subsidence involves the ‘sinking’ of an implant postoperatively into vertebral bodies over time. Radiologically, this is the distance measured between two vertebral bodies at the segment of interest. This can result in narrowing if the neural exit foramen and development of pathological alignment leading to recurrence of symptoms. Furthermore, adjacent levels are subjected to abnormal biomechanical stresses, ultimately leading to development of further issues. Early subsidence can also lead to increased mobility in the segment and lead to failure in fusion. Currently, there lacks consensus on the definition of subsidence, with reported parameters of radiological subsidence varying amongst publications, thus making comparison between studies difficult. Generally, it is accepted that subsidence has occurred when there is an absolute loss of 2-4mm in interbody height, or a 10% reduction in interbody height, when compared to cervical x-rays performed immediately postoperatively. Subsequent to the introduction of the ACDF utilising a standalone cage, the operation has been augmented by the addition of a metal, anterior cervical plate. By bridging the anterior aspect of a fused segment, this was shown to supplement the cage leading to increased fusion rates and better stability. However, some of the disadvantages associated with use of a plate included post-operative dislodgement, soft-tissue injury and dysphagia. Currently, there is no consensus over whether anterior cervical plating offers any added benefit, hence the need for this trial.

In older adults, insufficient protein intake facilitates muscle loss by limiting muscle anabolism. Furthermore, older people may experience ‘anabolic resistance’, increasing the threshold of protein required to stimulate postprandial protein anabolism (>25-30g). Importantly, providing that sufficient protein is ingested, ageing does not impair the capacity for muscle protein synthesis. Therefore, protein-rich supplements are commonly used to manage undernutrition in older people. In younger adults, protein is known to be the most satiating macronutrient - high-protein diets are often advocated to promote weight loss. Therefore, the satiating effects of increased protein ingestion could counteract the positive effects of increased protein ingestion on lean mass in older people. Interestingly, our studies have previously shown that suppression of energy intake after intraduodenal and oral whey protein loads is less in older compared to young people, despite slower gastric emptying and increased plasma CCK and GIP concentrations in the older subjects, factors which are associated with suppression of energy intake in young people. Timing of protein supplements (i.e. 3, 2, 1 hour(s) or just before a meal) did not affect energy intake at a subsequent meal. These studies suggest that older people have impaired appetite and energy intake regulation. The lack of suppression caused an increase in overall energy and protein intake, which supports the use of ‘pure’ protein supplements in undernourished older people. The aim of the study is to characterise in healthy younger and older individuals, the effect of oral protein ingestion 30 min before breakfast, lunch and dinner on energy intake, appetite, blood glucose and plasma gut hormone concentrations (e.g. insulin, glucagon, ghrelin, CCK, GIP, GLP-1 and PYY). We hypothesise that the acute suppression of appetite and energy intake by oral whey protein is less in healthy older than younger people. To investigate this, a total of 15 healthy older men aged 65-85 years with a body mass index (BMI) of 20-30 kg/m2 and 15 healthy younger men aged 18-35 years with a BMI of 20-30 kg/m2 will be recruited. Each subject will be studied on 3 occasions. On each occasion, they will receive, in randomized fashion, a drink of flavoured water (control; ~2 kcal) or a drinks of 30 g whey protein (120 kcal) 30 min before a breakfast (~9am, t = 30). Energy intake will be assessed at breakfast (t=30), lunch (t=270) and dinner (t=510). Blood samples will be taken, antral area will be measured and visual analog scales will completed at regular time intervals. Subjects will be allowed 30 min for all meals to freely consume food until they are comfortably full.

This project will be a 10 week strength training intervention in trained distance runners. The aim of this study is to investigate the effect a strength and conditioning program has on the mediators of running performance, in particular, running mechanics and muscle-tendon properties in distance runners. Methods will include collecting strength and stiffness measures using dynamometry and ultrasonography, an incremental treadmill running test to determine running economy and maximal aerobic capacity, and 3-dimensional motion analyses and musculoskeletal modeling of running and strength exercises. We anticipate this project will improve exercise prescription practices in distance runners. In addition, we expect this project to provide a greater understanding of the mechanisms underpinning improvements in run performance following a strength and conditioning intervention.

Premature infants usually need extra oxygen after birth because their lungs are not fully developed. However, their bodies do not yet have the ability to balance the stress that receiving that oxygen can cause. Oxygen is necessary for life, but both too much or too little can damage eyes, lungs, brain and other important organs of newborn babies. This study will compare outcomes of 1470 preterm infants up to 28/6 weeks gestation who have had respiratory care in the delivery room with (A) Initial FiO2 0.6 versus (B) Initial FiO2 0.3, followed by common SpO2 targeting until admission to NICU. FiO2, SpO2, and heart rate are recorded each minute from delivery of the child’s body for 10 minutes, then every 5 minutes until admission to NICU. Routine assessments are collected at baseline, 36 weeks, discharge and at 2 years corrected for gestation. Additionally a parent-completed developmental questionnaire is also collected at 2 years corrected for gestation.