ANZCTR search results

Balance impairment is an important fall risk factor and increases in range in postural sway in the medio-lateral direction in older adults are associated with increased fall risk and rates. Multivariate analysis reveals serum vitamin D levels as an independent variable associated with postural sway. In individuals with suboptimal levels of vitamin D, postural sway improves after supplementation, independently of changes to fall rate or number of people falling. Both epidemiological and longitudinal studies have shown that vitamin D levels show seasonal variation. Lowest levels of serum vitamin D are recorded towards the end of winter, approximately four weeks after the shortest day of the year. Fall rates have been shown to decrease post supplementation with vitamin D in older adults with insufficient levels (between 22 and 49nmol/L) (RaR 0.72, 95% CI 0.55 to 0.95). As vitamin D varies seasonally, and is related to postural sway, this study investigates whether postural sway varies seasonally and is related to seasonal changes in vitamin D or fall rate.

Chronic obstructive pulmonary disease (COPD) is a debilitating condition that results from inflammation of the airways. This inflammation impairs lung function and thus reduces an individuals’ ability to undertake physical activities, including activities of daily living. Long-chain omega-3 polyunsaturated fatty acids (LCn-3PUFA) have been shown in a number of studies to elicit anti-inflammatory effects. People with COPD will be supplemented with either LCn-3PUFA or placebo; effects on inflammation, lung and physical function will be assessed at four months. It is anticipated that supplementation with LCn-3PUFA will reduce inflammation, and improve physical function (exercise capacity), which will collectively improve health related quality of life

Difficulty in maintaining the upright posture is called Orthostatic Intolerance. Orthostatic Intolerance may result in fainting or symptoms such as light-headedness, blurred vision, nausea and palpitations. These symptoms come on when standing or sitting, particularly for prolonged periods or time or in warm weather, and are relieved by lying down. They are often associated with an abnormal blood pressure or heart rate response to sitting or standing. Our research to date has looked in detail at two clinical groups with these symptoms. Both of these groups have overall normal nervous system function, but with intermittent difficulty in maintaining the upright posture. One group always has very low blood pressure (Low Supine Blood Pressure Orthostatic Intolerance) and the other normal blood pressure (Normal Supine Blood Pressure Orthostatic Intolerance). Our studies have particularly looked for differences in the way a part of the nervous system called the sympathetic nervous system responds to the upright posture in these two groups when compared to healthy control participants. The sympathetic nervous system, the stimulant arm of the nervous system is responsible for our “flight and fight” response to a threatening situation. The sympathetic nervous system is also crucial in the control of blood pressure and allows us to stand upright and supply blood to our vital organs, including the brain, in the face of gravity that pulls blood towards our legs. We have found that people with these two forms of Orthostatic Intolerance do not release as much of the main chemical messenger of the sympathetic nervous system – called noradrenaline - into their circulation in response to upright posture when compared with healthy control participants. We have found distinct differences between these two groups and between each group and healthy control participants in the processing pathways for noradrenaline. Current medical treatments for these forms of Orthostatic Intolerance have focused on increasing blood volume by increasing dietary salt or by the use of a medication (Fludrocortisone) that make the body retain salt and fluid. In addition medications that act to tighten blood vessels with standing (Midodrine or Dihydroergotamine) may also be used. These medications can be very helpful for some patients but are often not tolerated due to side effects and many patients continue to experience symptoms even with these medications. None of these medications has been proven to be of benefit in randomised trials to date. This trial will be comparing a new treatment – L-DOPS (Droxidopa) – with placebo (a tablet that appears the same as the L-DOPS tablets but contains no active ingredients) in patients with the two forms of Orthostatic Intolerance described above. L-DOPS is a nerve transmitter precursor that is converted by the body to noradrenaline, the main nerve messenger of the sympathetic nervous system. L-DOPS is an experimental treatment. This means it is not approved for patients with Low- or Normal- supine blood pressure Orthostatic Intolerance in Australia or other parts of the world. L-DOPS has been marketed in Japan since 1989 for use in patients with Parkinson Disease and Orthostatic Intolerance. L-DOPS remains an investigational drug in the United States and Australia. Current trials in the United States and Canada are studying its benefit in blood pressure regulation disorders in Parkinson disease and in symptoms in patients with Chronic Fatigue syndrome and Fibromyalgia (a condition associated with painful muscles). This study will include: 20 Healthy control Participants 28 Participants with Low supine Blood Pressure Orthostatic Intolerance 28 Participants with Normal Supine Blood Pressure Orthostatic Intolerance All participants will be studied through the Alfred Baker Medical Unit at the Alfred Hospital The purpose of this research is twofold: 1. The baseline assessment will compare the way the sympathetic nervous system responds to the ‘stress’ of the upright posture in healthy control participants and participants with the two different clinical presentations of Orthostatic Intolerance described above. These responses will be correlated with the individual pattern of nerve proteins and nerve transmitter levels - obtained from a forearm vein biopsy- in the participants. This part of the study is to being performed to confirm our previous findings in a larger group of participants and to provide baseline measurements for the participants with Orthostatic Intolerance who will participate in the second phase of the study. 2. The second phase of the study is to assess whether the nerve transmitter replacement L-DOPS(Droxidopa) is able to improve symptoms and normalise the sympathetic nervous system response to upright posture in participants with the low- and normal- supine blood pressure variants of Orthostatic Intolerance.

In Queensland, facilities for seriously ill children are centralised in Brisbane. The Paediatric Intensive Care Unit (PICU) at the Royal Children's Hospital provides advice and retrieval services for children who have presented at rural and regional hospitals throughout Queensland. When advice is needed, it is provided by telephone and this relies on the ability of the remote clinician to provide a good verbal description of the patient and an accurate interpretation of paediatric x-rays. Clinicians at the remote hospital may be relatively inexperienced at caring for critically ill children. Support from the PICU is essential. Telemedicine allows clinicians to hold a consultation at a distance by video. In addition to face-to-face communication, telemedicine may be used to view the patient, the monitors and x-rays - as if present in the same room. The addition of visual information offers the potential for a much richer dialogue than is possible by telephone alone. Alongside high-quality local care and a well co-ordinated retrieval service, telemedicine may be a potentially useful tool. This is a new area of research and very little has been reported in the literature. A limited number of studies in the USA have shown that telemedicine assists in the management of seriously ill children at a distance. Over a three year period, this study will formally evaluate the use of telemedicine to provide critical care support from the RCH PICU to four regional hospital emergency departments. The study will provide evidence on the feasibility, clinical usefulness and economics of the approach within the Queensland context. The following hypotheses will be tested: Efficacy Paediatric critical care consultation by telemedicine will: (i) improve patient condition between initial call and retrieval team arrival; (ii) reduce the time needed by the retrieval team to stablise the patient before transport; (iii) reduce diagnostic discordance; (iv) reduce the number of retrieved patients admitted to general wards; (v) improve 30 day mortality. Economics Paediatric critical care telemedicine is economically beneficial from the health service perspective reducing the number and therefore cost of retrieval and unnecessary tertiary admission.

This study aims to evaluate the efficacy of a new treatment for disruptive children with callous-unemotional traits. The treatment is called 'Emotional Engagement' Treatment, and focuses on the affective dimension of parent-child relations. It has been created specifically to boost warmth in parent-child relationships, and remediate deficits in eye contact by enhancing the salience of the eyes for high CU children. The aims of the treatment are twofold – to increase parental warmth and to increase the child’s attention to parental warmth. It is believed that improvements in these areas will translate to reductions in disruptive and antisocial behavior. It is hypothesised that following treatment: 1. Children will show lower levels of disruptive behaviour 2. Children will show higher levels of eye contact 3. There will be higher levels of parental warmth

The results from this study will allow for further understanding of the ocular surface response and subjective comfort responses of the emmetropic population. The insight into the subjective comfort responses of this population can further enhance knowledge in the subjective comfort responses of the spectacle and contact lens wearing populations. The hypothesis of this study is that there will be no difference in ocular health and comfort in emmetropes over the course of three months.

The results from this study will allow for further understanding of the ocular surface response and subjective comfort responses of the spectacle wearing population. By understanding spectacle wearer responses, it may contribute to the knowledge of the causes of discomfort in the contact lens wearing population. The hypothesis of the study is that there will be no difference in the ocular health and subjective comfort of spectacle wearers over the course of three months.

The optimal dose of Misoprostol to be used in the medical management of miscarriage before 13 weeks has not been resolved. This study was undertaken to evaluate the effectiveness and side effect profile of two different dosages of Misoprostol. Methods A randomized controlled, equivalence study comparing 400mcg vs 800mcg Misoprostol per vaginum (PV) on an outpatient basis. The allocated dose was repeated the next day if clinically the products of conception had not been passed. Complete miscarriage was evaluated using two methods: ultrasound criteria on Day 7; and the need for surgical management (clinical criteria). Equivalence was demonstrated if the 95% confidence interval [CI] of the observed risk difference between the two doses for complete miscarriage lay between -15.0% and 15.0%. Differences in side effects and patient satisfaction were evaluated using patient-completed questionnaires.

This is a single-site, open-label short-term clinical trial with baseline data collection. Approximately 20 female participants aged between 18 and 45 years will be recruited from the CRO’s participant database and public media. Following initial screening via telephone, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a medical assessment including lifestyle, current medications, physical examination, medical history, and menstrual history; this data will be used for the comprehensive screening and to provide contextual data for the study. The primary outcome measure is the pain VAS rating scales. The secondary outcome measure is analgesic use. The expected duration of the trial is five consecutive menses (approximately five months) for each participant. Baseline data will be collected during the first 2 menstrual cycles prior to intervention and for 3 months while on treatment.

This project is a randomised control trial of an online program that aims to reduce risk for Alzheimer’s disease (AD) by intervening in modifiable risk factors. The sample will be healthy but have several modifiable risk factors for AD. Hence this is classified as an indicated prevention trial. The intervention will educate individuals about AD and risks for AD. The intervention itself is tailored to individuals based on their readiness for change and level of risk in particular domains. There will be three groups; a control group who receives a pre and post assessment, an online only intervention group and an online plus small face-to-face intervention group. The trial involves 7 modules (one per week). Level of risk for AD will be assessed at baseline, 13 weeks and 26 weeks.