ANZCTR search results

Fatigue is the most common and persistent complaint following a traumatic brain injury (Sinclair, 2012). It has been reported in patients who have experienced TBI across the spectrum of injury severity (Mathias & Alvaro, 2012) and is present in both the early and later stages of recovery (Baumann, Werth, Stocker, Ludwig, & Bassetti, 2007; Cantor, Bushnik, & Cicerone, 2012; Kempf, Werth, & Kaiser, 2010). Despite this, there are currently no effective treatments for post­traumatic brain injury fatigue (PTBIF). However, findings from a recent pilot trial suggest that light therapy may reduce PTBIF, as well as daytime sleepiness (Sinclair et al., 2014). The study found reductions in fatigue and daytime sleepiness following blue light treatment, in addition to a nonsignificant trend towards reduced depression, which suggest that light therapy may be an effective treatment for fatigue and sleepiness following TBI. However this therapy required the person with TBI to sit in front of a light box for 45 minutes in the morning. As such it places considerable demand on the user. As a consequence for many individuals it does not represent a long­term solution to the problem. This project aims to develop, implement and evaluate the efficacy of an in-­home light therapy treatment for individuals experiencing post-­traumatic brain injury fatigue (PTBIF). The study will be a pilot randomized controlled trial evaluating the impact of in­-home lighting on subjective fatigue, as well as daytime sleepiness, sleep quality, psychomotor vigilance, mood, activity levels and quality of life. The study will employ a cross­over design and thus all participants will be exposed to both lighting conditions (the active light condition, consisting of bright predominantly short wavelength light) and a second lighting condition that constitutes a placebo condition. Primary and secondary outcome variables will be measured at four weekly intervals: baseline, mid­way and end of each intervention and one month­ follow up, resulting in a protocol of approximately 5.5 months, with six assessment points. Multiple measures will be taken at each of the assessment points. The study will recruit participants from the Epworth hospital who have sustained a mild, moderate or severe TBI and who are self-­reporting significant fatigue. A sample size of 34 is proposed. Participants order of exposure to the light conditions will be randomised. The placebo condition will constitute a sham condition, and all participants will be blinded to the treatment conditions. The study will also entail a health economics analysis to assess the cost ­effectiveness of the intervention, as well as an examination of factors associated with response to the intervention.

This study aims to compare the Quality of life and Quality adjusted life years of surgical versus non-surgical Recurrent Rectal Cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and have an isolated locally recurrent adenocarcinoma of the rectum or recto-sigmoid being considered for radical resection with or without perioperative chemoradiation. Study details If you choose to take part in this research, you will be asked to allow the investigators to access your disease related health information and will also be asked to complete questionnaires numerous times over five years. You will be asked about your demographics and quality of life at baseline; you will be asked about your quality of life at 3 months, 6 months, 12 months, 18 months, 24 months, 30 months, 36 months, 48 months, and 60 months. Conversely, if you choose not to take part in the study, the care provided to you will not be changed or prejudiced due to this decision; this is a purely voluntary study. There is no reimbursement for time or expenses. This study will provide important information about both the quality and quantity of the lifespan after diagnosis of Recurrent Rectal Cancer band thus could potentially assist in future treatment decisions.

The proposed registry is necessary to monitor the natural history of shoulder pathologies occurring in the general population and to monitor short-term and long-term patient outcomes associated with the condition and contemporary treatment options. The aim of the registry is to objectively assess patient-centred outcomes of definitive management for shoulder and elbow pathologies. Patients will be enrolled in an opt-out clinical registry (longitudinal observational design) hosted by the clinic providing diagnosis and treatment of their condition. Patient outcomes, clinical imaging, joint function, as well as treatment and clinical information will be collected as part of standard of care and collated into an electronic registry maintained at the clinic. Patients will be monitored for up to 5years after definitive treatment.

The primary aim of this study is to investigate if providing three short 15 minute sessions of physiotherapy each therapy day for patients admitted to inpatient rehabilitation after hip fracture is more effective than providing the usual one long 45 minute session each therapy day in improving mobility. The secondary aims of this study are to: * Determine if this model of care reduces length of stay in this patient group * Determine whether more walking is achieved in 3 shorter sessions 5 days/week versus 1 longer session 5 days/week both within and outside of therapy sessions * Determine whether there is an increased chance of returning home with this model of care * Determine if Functional Independence Measure Scores for mobility improve faster in the distributed model * Compare the 30 day readmission rate after discharge in both groups * Determine if the new model of care is acceptable to patients and physiotherapists by means of a brief survey about the project.

Obesity is one of the most prevalent and challenging diseases affecting our community. According to the latest census figures, 63.4% of Australians aged 18 years and over were overweight or obese, namely, 35.0% overweight and 28.3% obese. Significant weight loss (>20% body weight) delivers impressive health and economic benefits, but even modest weight loss (>5% body weight) leads to significant health benefits and cost savings. Weight loss, therefore, has the potential to be one of the most important heath care interventions in our community. Yet despite the recognised benefits for both the obese individual and society as a whole from weight loss, obesity remains a disease that is largely under-diagnosed and under-treated. The reasons for this paradox are complex and include the difficulty treating obesity, along with a lack of effective treatment options. The situation is then complicated by societal stigmatisation of the obese individual. It is well recognized that healthcare professionals also stigmatize the obese, and often feel uncomfortable raising the issue of weight control with their patients. In this study, we aim to pilot a programme designed to increase awareness of the importance of diagnosing obesity in the tertiary hospital setting. We hypothesise that if a tertiary hospital provides a diagnosis of obesity to a patient, this will motivate the patient to make an attempt at weight loss and by providing the patient's GP the opportunity to raise obesity as a health issue, will help to reduce the stigma associated with obesity. Building on Alfred Health’s success with a brief intervention for smokers, we have worked with the Nutrition and Dietetics Department to design a brief intervention tool to be provided to patients. This tool provides simple information on healthy eating, exercise and community resources to support weight loss. Given that The Alfred protocol requires weight, height and BMI calculation on admission to the Alfred, we plan to provide a diagnosis of obesity to all patients with a BMI >30 and then provide them with this tool as well as inform the General Practitioner (GP) of the diagnosis and recommend weight management in the discharge summary. Prior to broadly implementing this programme we wish to test feasibility and acceptability of this approach. We plan to trial the programme by randomizing patients to either standard care or the new programme. Three months post discharge we will ascertain if the GP did discuss weight management with their patient, if there has been any attempt at weight loss as well as GP and patient satisfaction. Feedback from the hospital staff will also be collected.

Ultrasound-guided regional anaesthesia (UGRA) is a complex procedural skill to learn. A diverse and extensive mix of knowledge, motor skills, cognitive planning, and mental reconstruction of anatomical structures is necessary. Successful performance of UGRA thus requires hand-eye coordination and interpreting 3-dimensional anatomy using 2-dimensional ultrasound images. Currently, an UGRA teaching curriculum is taught to all novices at an institution. However, novices learn at different rates and are receptive to different styles of teaching. Learning curves in UGRA consistently demonstrate a large inter-individual variation in proficiency and error rates, despite all novices receiving instruction from the same expert faculty. One possible reason for this wide variability is the innate psychometric ability of novices. Psychometric ability is a subset of human intelligence, further divided into visuospatial and psychomotor abilities. Visuospatial ability is the capacity to generate, retrieve, and process visual information. Psychomotor ability influences the accuracy, reaction speed, and coordination required to control objects through hand-eye coordination. In complex tasks, innate differences in psychometric ability could contribute as much as 40% of differences in inter-individual learning speed and performance. Previous studies suggest that a) visuospatial abilities are a better predictor of UGRA performance than psychomotor abilities, and b) certain visuospatial factors are more predictive of UGRA performance than others, specifically spatial visualisation (e.g., the ability to visualize and rotate 3-dimensional objects based on 2-dimensional images). There is evidence in other complex medical procedures that visuospatial ability influences performance, with shorter times taken to complete procedures and reduction in errors. 10-12 These procedures include laparoscopic surgery, plastic reconstructive surgery, 15 basic surgical knot tying, colonoscopy and gastroscopy. Of these numerous psychometric tests, the MRTA remained consistently useful in discriminating low and high ability novices, and has the advantage of extensive population data. An unexplored avenue in UGRA education research is thus being able to identify novices for which the UGRA task will be difficult to learn. Early identification may allow training to be individualised, allowing educators to target and allocate scarce training resources to novices who will benefit greatly from extra attention. In this study, we will be recruiting medical students without prior exposure to UGRA. We will use the MRTA to assess participants’ visuospatial ability. Participants will then be randomised into a control group (no training) and a deliberate practice group.

A multicentre clinical observational study to determine whether dysbiosis of the neonatal gut microbiome, driven by antibiotic exposure in the perinatal period, leads to impairment of subsequent antigen-specific responses to routine infant immunisations. This study will enrol vaginally born, term infants, with and without perinatal antibiotic exposure (maternal intrapartum antibiotics administered within 28 days of delivery or direct infant antibiotic exposure in the first 28 days of life. Infants will be vaccinated according to the National Immunisation Program and will have stool and blood samples collected to assess gut microbiome, gene expression responses and antigen specific vaccine responses. Proportions achieving seroprotective antibody titres at approximately 7 months and 18 months of age will be compared between exposed and unexposed groups to assess impact of early antibiotic exposure on subsequent vaccine responses.

This study is testing olaparib, in Homologous recombination (HR) deficient metastatic breast and relapsed ovarian cancer in patients who do not have hereditary mutations in BReast CAncer susceptibility gene 1 and gene 2 (BRCA1 and BRCA2). Who is it for? You may be eligible to join this study if you are aged 18 years or above and are either: a) men or women with confirmed evidence of metastatic triple negative breast cancer OR b) women with confirmed evidence of relapsed high grade serous ovarian cancer or high grade endometrioid ovarian cancer Study details All study participants will take olaparib 300 mg orally twice daily until disease progression or unacceptable toxicity. Assessments for safety and efficacy will be followed up for a minimum of 6 months Olaparib, has been approved overseas and in Australia in women shown to have inherited changes in their BRCA1 or 2 genes. There is strong evidence to show that olaparib will also work in people who do not have any changes in their genes. The purpose of this study is to assess whether the olaparib is effective in treating these tumours.

Idiopathic Pulmonary Fibrosis (IPF) is a debilitating, progressive lung disease with poor prognosis and limited current treatment. It is characterised by distorted lung architecture, loss of respiratory function, poor quality of life and unresolved pathogenesis. In 2014, the FDA and TGA approved the first two oral drugs for the treatment of IPF, however they only slow the progression of IPF. As such, there continues to be a need for a more effective treatment method for this fatal disease. To address this need, Samumed has developed a small molecule inhibitor of the Wnt pathway, SM04646. Studies have suggested that dysregulation of the Wnt/b-catenin pathway is associated with the pathophysiology of IPF. A number of preclinical pharmacology efficacy studies have been carried out which indicate that SM04646 blocks the progression of lung fibrosis in animal models of IPF. A Phase I study has also been conducted recently in Australia using single ascending doses (SAD) of SM04646 in healthy volunteers. No dose limiting toxicities or serious adverse events were reported. The current study is a Phase I open label, multiple ascending-dose (MAD) safety study of SM04646 inhalation solution in subjects with mild to moderate IPF. SM04646 will be administered as a single use nebulised inhalation. Dose levels will be 2.0mg, 7.0mg, and 20.0mg. Subjects will be treated for 28 consecutive daily doses and will be followed for approximately 30 days after last treatment. Samumed is conducting this trial to evaluate the safety, tolerability and systemic exposure of SM04646 Inhalation solution in IPF patients. Safety monitoring throughout the study will allow for the estimation of the maximum recommended dose to be used for future studies conducted with individuals with IPF

Knee osteoarthritis is a common condition that affects the cartilage lining of the knee joint and causes pain and stiffness. It is therefore important to find effective treatments that improve people’s symptoms and quality of life, and also slow down the loss of joint cartilage that happens in osteoarthritis. One such therapy that may be effective is platelet-rich plasma (PRP) injections. This treatment involves an injection of the person’s own PRP, which is made from blood taken from their arm and injected into their knee. Blood contains plasma, red blood cells, white blood cells and platelets that release chemicals which can stimulate the healing process. This may give rise to improvements in symptoms and slowing of the disease process. This study aims to find out whether a series of three PRP injections (one per week for three weeks) into the knee joint is effective in reducing pain and slowing loss of cartilage in the knee joint. To do this, we will compare outcomes over 12 months in a group of patients with knee osteoarthritis who receive three PRP injections and a group who receive three injections of inactive sterile salt injections (saline). We will recruit 288 people with mild to moderately severe knee osteoarthritis from the community. Measurements will be taken at baseline, 2 months and 12 months and will comprise questionnaires and magnetic resonance imaging. Participants will be randomly allocated to either the PRP or saline injection group and neither the participant, nor the injecting doctor or the assessor will know which injection the participant will receive.