ANZCTR search results

To determine if suprapubic cutaneous stimulation with cold fluid soaked gauze hastens CCU (within 5 minutes) in children aged 1 – 12 months in the paediatric emergency department, where a urine sample is required and the clinician has determined that CCU is an appropriate method of collection.

The aim of the Falls After Stroke Trial (FAST) is to test the effect of homebased, tailored intervention to reduce falls. A sample of communitydwelling stroke survivors who have finished formal rehabilitation, and therefore are at a high risk of falling again will assigned to an experimental group (habit-forming exercise and safety training) to test the feasibility of the intervention. The primary hypothesis is that the home-based, tailored intervention will be safe and reduce both the proportion of people falling and rate of falls over a one-year period in stroke survivors living in the community. The secondary hypotheses are: 2. That home-based, tailored intervention will also be associated with improvements in improving: balance, self-efficacy, mobility, physical activity, community participation, and health-related quality of life. This feasibility trial will test the experimental intervention over 6 months and evaluate feasibility of recruitment, intervention and assessment protocols as well as monitoring outcomes and adverse events.

Insomnia is a highly prevalent, complex and heterogeneous disorder. Diagnostically, insomnia is problematic due to a lack of objective markers and with the diagnosis based primarily on patient self-report. Patients with insomnia also have high rates of absenteeism, increased health risks and health-care utilisation, a higher risk of depression and neurocognitive impairments than good sleepers. The main nonpharmacological treatment for insomnia is Cognitive behavioral therapy for insomnia (CBT-I), which is an evidence-based psychological intervention, usually delivered by a psychologist individually, in small groups, or through automated web-based programs. CBT-I seeks to manage insomnia by targeting maladaptive thoughts, behaviors, and beliefs about sleep. CBT-I is a multicomponent approach and in the context of clinical trials improves sleep in 70% of insomnia patients and is considered the first-line treatment for insomnia by the American Academy of Sleep Medicine, National Institutes of Health, and British Association of Psychopharmacology. CBT-I is effective but it does not work for all patients with insomnia. As insomnia is a highly heterogeneous disorder it may be that certain phenotypes of insomnia respond differently to certain components of CBT-I. To date, insomnia phenotyping has focused on subjective clinical impressions by Sleep Physicians or Psychologists to label patients with a chief complaint of either: difficulty initiating sleep, difficulty maintaining sleep, early morning awakenings or mixed insomnia (a combination of at least two of the previously mentioned factors). Currently, there is a lack of objectivity in classifying insomnia phenotypes and evaluating phenotype treatment response to CBT-I. Our aim is to develop phenotyping toolkits to produce an objective diagnostic assessment of insomnia that will assist clinicians to determine the likelihood of an insomnia phenotype responding to treatment (CBT-I). We aim to phenotype all patients for the following three methods including: (A) Classic subjective insomnia phenotyping, diagnosed by a Sleep Physician / Sleep Psychologist interview (based on DSM-V criteria) will be used to identify four insomnia phenotypes characterised by a main complaint of either: (i) difficulty with sleep onset, (ii) difficulty with sleep maintenance, (iii) early morning awakenings, or (iv) mixed insomnia (a combination of at least two previously mentioned main sleep impairments). (B) One in-laboratory overnight polysomnographic assessment of sleep will also be used to quantify insomnia patients with either (i) short objective sleep with both sleep onset and maintenance impairments, (ii) short objective sleep with primarily sleep maintenance impairments, or (iii) long objective sleep. Based on previous results, participants will be assigned to either groups i, ii or iii through a pre-specified algorithm developed from insomnia clustering data (Miller et al., in preparation). (C) One in-laboratory dim light melatonin onset assessment (saliva) will be used to quantify insomnia patients with (i) late phase angle: the most severe 30% of the study sample with the greatest evening phase angle (i.e. melatonin rise after bedtime resulting in a mostly positive phase angle) and a melatonin rise time after 22:00 compared to (ii) normal phase angle: the remaining 70% of the sample. Phase angle onset is defined as the difference between 14 days (minimum of 5 days) of average actigraphy time for bed and the in-laboratory dim light melatonin onset rise time. We primarily aim to evaluate treatment response for these phenotypes of insomnia to standardised online CBT-I for measures of insomnia severity, sleep diary defined sleep onset latency and wake-time after sleep onset. Secondly, we aim to evaluate changes in neurocognition, mood, and actigraphy pre-to-post therapy for insomnia phenotypes. Third, we will compare phenotypes for differences in simulated driving (at 6pm and at one hour after habitual bedtime) and neurocognitive performance (at i. 6pm, ii. habitual bedtime, iii. in the morning after a full sleep opportunity with a patient preferred wake-time and iv. after a reduced sleep opportunity, by going to bed two hours later than average sleep-diary defined habitual bedtime). This study aims to provide evidence of tools to objectively phenotype insomnia by differentiating patients who may or may not respond well to CBT-I prior to the delivery of treatment. In turn, this will facilitate better treatment plans and lead to enhanced sleep, health and daytime performance.

Increased dietary calcium intake has been proposed as a population-based public health intervention to prevent osteoporotic fractures. We have examined whether calcium supplementation decreases clinical fracture risk in elderly women and its mechanism of action. This was a five-year, double-blind, placebo-controlled study of 1460 women recruited from the population and older than 70 years (mean age, 75 years) who were randomized to receive calcium carbonate, 600 mg twice per day, or identical placebo. The primary end points included clinical incident osteoporotic fractures, vertebral deformity, and adverse events ascertained in 5 years. Bone structure was also measured using dual x-ray absorptiometry of the hip and whole body, quantitative ultrasonography of the heel, and peripheral quantitative computed tomography of the distal radius.

This proposed investigation will build upon a previous feasibility study to explore acceptance, use, clinical utility (including effects of bidet use on asymptomatic bacteria in urine) and associated costs of the electronic toilet top wash-and-dry bidet by residents and staff of Australian residential aged care facilities, as a method of improving the toileting experience for older, frail and/or cognitively impaired residents of aged care facilities and staff.

After lung transplantation patients are prescribed drugs, called immunosuppression medication, to control the immune system to stop them from rejecting the new lung(s). Managing immunosuppression medication is lifelong post-transplant, and the Lung Transplant Physicians take many factors into consideration when dosing medications. The purpose of this project is to determine if the blood tests, QuantiFERON-Monitor (QFM), which measures immunity and QuantiFERON-CMV (QFN-CMV), which measures immunity to a virus, could provide extra information for the Lung Transplant Physicians to help in their decisions about immunosuppression medications. The aim of this study is to observe if there is any relationship between both the QFM and QFN-CMV Test results and immunosuppression drug levels and doses, and any occurrence of rejection and infection after transplantation. This study will be observational, immunosupression drug managment will be managed by the Lung Transplant Physicians as per standard practice. The QFN-Monitor and QFN-CMV tests will be collected for comparsion at the end of the study, but will not alter patient care.

To investigate the impact of a pre-discharge medication review by a hospital clinical pharmacist on 'at-risk' patients' health and quality of life.

The study is investigating the capacity of tDCS to alter ‘emotional processing bias’. Emotional processing bias refers to the interaction of cognitive and emotional processing that result in unconscious preferential processing of emotional stimuli of a certain valence (e.g. unconscious preference for positive or negative stimuli and information). We all have unconscious biases in our emotional processing. A positive emotional processing bias has been linked to aspects of mental health and maladaptive biases are a key component of many mental illnesses, such as depression. Very few studies have investigated whether tDCS can alter emotional processing bias, and due to methodological limitations the findings of those small number that have are inconclusive. Also, no studies to date have investigated the patterns of brain activity associated with tDCS and bias modification.

This study aims to describe the effect of limb compression on lymphoedema in terms of fluid distribution and soft tissue structure changes using MRI. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a clinically detectable unilateral secondary upper limb lymphoedema arising from treatment of breast cancer. This diagnosis must be made using accepted diagnostic thresholds for bioimpedance spectroscopy (BIS) or volume measurements. You must also currently use a compression garment for management of your lymphoedema. All participants enrolled in this study will have at least one MRI scan while wearing the upper limb compression garment. Depending on participant availability, a second MRI scan on a separate visit may also be performed where participants do not wear the compression garment for that day. It is hoped that this study will contribute to a better understanding of how different levels of compression can be used in control of the lymphoedema.

Cortisol is a steroid hormone produced by the adrenal gland that is critical for life. Cortisol controls many body functions including appetite, glucose metabolism, blood pressure and immune function. Cortisol secretion varies widely among healthy individuals. Recent studies have shown that higher cortisol secretion, even within the normal range, is associated with an increase in blood glucose and risk of heart disease. How variability in cortisol secretion contributes to increased risk of diabetes and heart disease is unclear. In this study, we will investigate whether variability in cortisol production causes insulin resistance and reduces blood vessel dilation. This could be a mechanism that explains a link between heart disease and diabetes.