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Aims: Bronchiolitis is an extremely common cause of respiratory illness in infants caused by viral infection. The primary aim of this study is to determine whether treatment with nitazoxanide (NTZ) reduces the duration and severity of respiratory symptoms caused by bronchiolitis. Justification: Bronchiolitis affects over a third of infants in their first two years of life, and in Australia approximately 5,000 infants are hospitalised every year with the condition (Garcia et al. 2010). This is estimated to cost the healthcare system between 32 and 62 million dollars per year (Deshpande & Northern 2003). Infants who are born prematurely, or who have lung disease or heart disease are at the highest risk of developing bronchiolitis and also have the most severe disease. Bronchiolitis increases the risk of subsequently developing recurrent wheezing and asthma in childhood (Shay et al. 1999). An effective treatment would be of enormous benefit, not only by reducing infant suffering, but also by reducing the impact on parents and the healthcare system and the long-term consequences of infection. Participant Groups: This study will involve 124 infants between the ages of 1 and 12 months with a clinical diagnosis of bronchiolitis (62 in each study arm). Project Design: This study is a phase II double-blind randomised, placebo-controlled clinical trial of oral nitazoxanide for the treatment of bronchiolitis. Methods: Parents of infants presenting to Princess Margaret Hospital and diagnosed with bronchiolitis will be invited to participate. Following a full explanation of the study, informed consent will be taken from interested parents. A brief clinical history of the illness will be taken, and the infant assessed for respiratory distress using a validated scoring system (the Respiratory Distress Assessment Instrument). A painless swab will be taken from the front of the infant’s nose to try and detect the virus that has triggered the illness. Infants will then be allocated at random (similar to tossing a coin) to receive either treatment with NTZ or placebo for five days. Infants will be reviewed after three days of treatment, and their respiratory distress score repeated. The change in the score, combined with a change in respiratory rate will be used to calculate the Respiratory Assessment Change Score (RACS). In order to assess if NTZ is a useful treatment for bronchiolitis the RACS will be compared between the placebo and the NTZ groups. Symptoms over the first week of illness and oxygen requirement will also be compared using a parental completed diary card. To see if NTZ reduces the amount of virus present, a nasal swabs at day 3 and day 5 will be collected and the viral load compared with that at baseline. For infants that need to be admitted to hospital, the amount of medical support need ed will be recorded (for example, the need for oxygen therapy) as well as the duration of hospitalisation. The number of times that the infant has to come back to hospital for either bronchiolitis or wheeze will be recorded over the six months after treatment using electronic hospital records. Expected Outcomes: This study will determine whether NTZ is an effective empirical treatment for bronchiolitis. It will also help us to understand what effect NTZ has on the amount of virus present and how viral load changes over the course of the disease. If this study shows that NTZ is a useful treatment, then a larger study will be conducted enrolling infants that present to primary care facilities.

Critically ill tracheostomised mechanically ventilated patients are often left voiceless due to air bypassing their vocal folds. There are speaking valves that can be used in this population to restore verbal communication, however they are not widely used with ICU patients due to concerns about the required cuff deflation causing a leak in the ventilation circuit and potentially leading to derecruitment of the patients' lungs. This in turn would be deleterious towards patients weaning off mechanical ventilation. This study is looking at assessing patients' lung mechanics before, during and after the speaking valve use to guide us on respiratory physiology and advise us on future best practice.

Peripheral intravenous cannula (PIVC) insertion is the one of the most common clinical interventions performed in the Emergency Department (ED) worldwide. Improving the first time insertion success rate and dwell time of PIVCs inserted in EDs can prevent repeat needle insertions. A number of factors have been identified as predictor’s of insertion failure and premature device failure. However, none have focused on the patient's journey with PIVC from ED to hospital admission. Purpose: This study proposes to determine the predictors of first time PIVC insertion success in ED and risk factors for PIVC failure for ED patients admitted to the hospital wards. Methods: A prospective observational cohort study of PIVC insertions in a patient population presenting to ED, with follow-up of subsequent admissions to hospital wards. Data in relation to clinician and patient risk factors will be collected from medical records and observations, as well as device information. Multivariable regression analyses will be sued to identify factors associated with insertions success and PIVC failure Results: The projected sample size n=1000 PIVC insertions will provide sufficient power to determine the association between risk factors and first-time insertion success and premature device failure. Conclusion: This study will provide new evidence to improve insertion success rates in ED and identify strategies to reduce premature device failure for patients admitted to hospital wards with PIVC.

The ROC study aims to compare the effectiveness of a new model of eye care (Residential Ocular Care) with the Usual care received in aged care homes on presenting and best corrected near and distance vision. It will also assess the effectiveness off ROC on various aspects of quality of life, depression, rate of falls and eye care utilisation.

A quasi-experimental study will investigate whether provision of pork, a rich source of dietary thiamin, as the main protein source in meals four times a week for 12 weeks will result in improved muscle mass, body strength and cognitive function in healthy community-living older adults.

This is a first in human study to evaluate the safety, tolerability and performance of a new vaccine delivery device. The sponsor is developing a novel approach for the administration of vaccines that does not require the use of needles. Small nanopatches patches designed to carry the vaccine are applied to the skin and kept in place for 2 minutes. This study will assess how safe and acceptable these nanopatches are.

Surgery provides the most efficient method of weight loss in severely obese patients, but also leads to malabsorption of micronutrients. Sleeve gastrectomy is a purely restrictive procedure and removes the greater curvature of the stomach leaving a small gastric sleeve. Advantages include rapid weight loss, comorbidity reduction, and avoidance of the complications seen in bypass procedures. Nutrient deficiency in this patient group is common, with Vitamin D deficiency reported in 21-80% of patients one year post-surgery. This may predispose these patients to poorer health outcomes, as inadequate Vitamin D levels have been associated with disruptions to calcium homeostasis, impaired bone metabolism and osteoporosis, cancer, insulin resistance, diabetes, cognitive dysfunction, depression and cardiovascular disease. However, there is also current debate around whether Vitamin D levels are a marker for, rather than a cause of chronic illness. It would be expected that stored Vitamin D in the extensive adipose tissue of these patients would help correct deficient levels as weight is lost, although there is no evidence to support this in the literature. It is possible that these patients have: (i) excess storage and potential dysfunctional metabolism and release of Vitamin D from adipose tissue; (ii) lower sun exposure and dietary intake due to lifestyle factors, or (iii) impaired synthesis and release from the skin. These mechanisms are unclear, and there are few published studies about treating Vitamin D deficiency post-surgery in this patient group and no consensus on recommendations for supplementation dosage and duration for gastric sleeve, or indeed any of the bariatric surgeries. This emphasises a significant gap in patient care recommendations. There is currently insufficient evidence to support the development of uniform supplementation guidelines post-surgery for patients undergoing bariatric surgery, and data for sleeve gastrectomy patients is most lacking, therefore protocols for supplementation are only consensus-driven. Further understanding the effect of supplementation in gastric sleeve patients is critical, as two recent studies have suggested Vitamin D supplementation may cause net harm in other groups and a recent systematic review confirmed little to no association between 25(OH)D levels and the course of a range of diseases/conditions shown to be associated with low 25(OH)D levels in epidemiological studies (e.g. cancer, insulin resistance, diabetes, cognitive dysfunction, cardiovascular disease). Current reasoning behind this null effect includes variations in baseline levels, body mass index and genetic variations in response to supplementation. There is significant individual variation in 25(OH)D levels pre-bariatric surgery, with most patients being deficient (<25nmol/L) or insufficient (<50nmol/L). There is also evidence for varied responses to set doses of Vitamin D3 post surgery however there is no data on this for patients undergoing sleeve gastrectomy. Genetic variation in the Vitamin D binding protein and the Vitamin D receptor in target tissues has been implicated in such variation in obese individuals. The current test for Vitamin D – serum 25(OH)D levels – does not account for this potential genetic variation, or for individual variation in Vitamin D metabolism (i.e. production of active metabolites) in tissues. Measuring the variation in genes for the Vitamin D binding protein and Vitamin D receptor alongside the response to Vitamin D supplementation would add clarity to the variations in responses to Vitamin D supplementation in order to determine evidence-based supplementation guidelines. The mechanistic work completed as part of this study will form the basis of future clinical trials to optimise supplementation strategies for these patients. In addition to the lack of understanding of the basis of 25(OH)D levels and supplementation response in sleeve gastrectomy patients, there is no evidence of the contribution of UV exposure and diet on Vitamin D status in these patients. As UV exposure plays an important part in endogenous production of Vitamin D, this is vital. In a group with already restricted intake and a higher risk of nutrient deficiencies, understanding the influences on Vitamin D intake and production are critical to optimising sun exposure, dietary intake and supplementation practices. Aims *To optimise patient outcomes post gastric sleeve surgery by achieving adequate and sustained 25(OH)D levels through individualised supplementation (usual care) *To establish the variation in 25(OH)D levels in patients undergoing gastric sleeve surgery before and 6, and 12-months after surgery to monitor the effect of usual care supplementation practices *To examine differences in 25(OH)D levels in patients before and 6 and 12-months after gastric sleeve surgery according to direct and indirect measures of sun exposure, detailed dietary intake data, genetic variation in the circulating Vitamin D binding protein and Vitamin D receptor, to provide pilot data on the variation of individualisation required in future supplementation practice

Traumatic Brain Injury (TBI) can lead to fundamental changes in a person’s ability to function day-to-day. The development of cognitive impairment is a particularly common and disabling consequence. As such, rehabilitation of cognition is an important part of post head injury treatment but current standard cognitive rehabilitation (consisting of either re-training / remediating impaired abilities) has generally resulted in only modest improvements in functioning. Our study will explore an innovative approach to repairing cognitive functioning following TBI that combines biological modulation of neural systems with behavioural remediation. We will combine transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, with cognitive training and examine the effectiveness of this combination using a Randomised Controlled Trial design. The ultimate aim of this research is the development of an effective targeted treatment for cognitive impairment following TBI to allow for a more complete recovery following injury.

The aim of this study is to recruit and educate participants with obsessive-compulsive disorder using a 5-lesson education program administered via the Internet. Participants in the Internet self-guided group begin the program immediately, and their results will be compared with a waitlist control condition. To understand who responds best to a self-guided education, participants will complete various measures assessing variables such as self-efficacy, reason for compulsion, type of obsession, level of disgust, readiness to change and emotion regulation deficits. Participants in Group 2 will receive access to the education program when Group 1 completes post-education assessments (Week 9). Both groups will be followed up at 3-,12-, and 24-months post-education.

This study aims to identify changes in the genes and proteins within the ovarian cancer tissues. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above presenting at Royal Women's Hospital or the Peter MacCallum Cancer Centre with recurrent epithelial ovarian cancer (including peritoneal and fallopian tube cancers), regardless of histological subtype. Study details: All participants in this study will be required to undergo a biopsy procedure on a single occasion to obtain a tumour tissue sample, or have archived formalin-fixed, paraffin-embedded tumour tissue retrieved from pathology laboratory archives. A blood sample will also be drawn. The samples will then be analysed using a next generation sequencing panel targeted to ovarian cancer. Initially, our work will focus on getting a better understanding of the specific types of changes in ovarian cancer. Over time we hope to use that information to design and implement better treatments for women with ovarian cancer. No treatments will be administered as part of this study. This study was designed to enable women with advanced ovarian cancer to be rapidly selected for clinical trials of targeted therapies.