ANZCTR search results

Obesity is a major health issue that is currently affecting millions of people worldwide. Differences in the taste system due to genetic and dietary factors might explain why some individuals are more prone to become obese than others. There is increasing evidence that humans, apart from being sensitive for the five primary taste qualities, can also taste fat in form of free fatty acids when additional sensory cues are masked. However, in the common diet, the concentration of free fatty acids is relatively low and fat is mainly consumed in the form of triglycerides. The present study aims to determine detection thresholds for canola oil as a triglyceride-rich source of fat and to investigate the associations between individual differences in fat taste sensitivity with detection thresholds of additional sensory stimuli, diet, body mass index, and saliva composition. In this study, detection thresholds of fat (canola oil, paraffin oil, canola oil + oleic acid) and fatty acids (oleic acid) will be determined in a repeated measure design in 30 subjects between 18-55 years. Each of the four stimuli will be tested on 3 separate days with 1 testing sessions per day. Hence, in total there will be 12 testing sessions of approximately 1 hour on 12 measuring days for each subject. All sessions will be held in the Deakin University Centre for Advanced Sensory Science laboratories. At the initial study appointment, body weight and height will be measured to calculate the subjects’ body mass index. Saliva samples will also be collected during the first session to determine the level of the saliva enzyme lingual lipase which is responsible for hydrolyzing triglycerides into free fatty acids. Additionally, eating behavior-related questionnaires and food diaries of each testing day will be collected. Each testing day, detection thresholds of one of the four stimuli will be determined using the ascending 3-alternative forced choice method. In this method, subjects receive a set of 3 samples (one test sample containg the stimulus at a specific concentration and two control samples) and the instruction to taste each sample and to identify the odd one out.

This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children. Enrolled patients will be randomised and an allocation ratio of 1:1 will be made via weighted minimisation, where half of the patients will receive non-operative management with intravenous Piperacillin with Tazobactam, while the other half will have an appendicectomy.

The primary purpose of this trial is to examine the safety and tolerability of a newly developed antibody, MIL-38/Gallium67 (MILGa) for imaging metastases in adults with prostate, bladder or pancreatic cancer. Who is it for? You may be eligible to participate in this trial if you are aged 18 years or older, have been diagnosed with prostate, pancreatic or urothelial (bladder, ureter, urethra, renal pelvis) metastatic cancer, with between 2 and 15 metastases, with the cancer determined to be stable or progressing slowly. Study details: Patients 4-12 will be given a single dose of unlabelled chMIL38-DOTA one hour prior to MILGa drug infusion. All participants in this study will be given a single dose of MILGa, followed by various scans and blood tests for the following 4 weeks. Scans will include a range of CT scans, and patients will also be monitored for adverse events. It is hoped that the findings from this trial will provide information on the safety and tolerability of MILGa administration, and on the efficacy of the antibody for imaging metastases. Cohort 2 (Patients 4, 5 and 6) Patients in this cohort will be infused with 3.5 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga. Each patient in this cohort will be dosed 2 weeks apart. Cohort 3 (Patients 7, 8 and 9) Patients in this cohort will be infused with an incrementally higher dose within the range of 3.5 mg and 24 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga and. Each patient in this cohort will be dosed 2 weeks apart. Cohort 4 (Patients 10, 11 and 12) Patients in this cohort will be infused with an incrementally higher dose within the range of 3.5 mg and 24 mg of unlabelled chMIL-38-DOTA prior to receiving 1 mg chMIL-38-DOTA labelled with 250 MBq 67Ga. Each patient in this cohort will be dosed 2 weeks apart. At end of each cohort: Safety assessment by DSMC and preliminary assessment of chMIL-38-DOTA-67Ga scan utility will be determined. Furthermore, the effect of the dose of un-labelled chMIL-38-DOTA used per cohort on tumour targeting will be reviewed at the end of each cohort to determine the cold antibody dose for the subsequent cohort.

This phase II study will determine whether the combination of Paclitaxel and Epirubicin can be used safely in the neoadjuvant setting in women with locally advanced breast cancer. The study will determine whether, in a multi-centre setting, the activity of this combination is maintained with acceptable toxicity. The study will also determine the disease free survival and overall survival in patients with locally advanced breast cancer, treated with neoadjuvant Paclitaxel and Epirubicin followed by definitive local surgery and radiotherapy and adjuvant Cyclophosphamide Methotrexate Fluorouracil.

Objectives: The primary objective is to evaluate the efficacy of a psychological intervention for treating co-occurring anxiety and depression in patients with Parkinson’s disease in comparison to treatment as usual. The secondary objectives are to evaluate the impact of the psychological intervention on carer’s levels of distress and burden. Study design : Blinded RCT with two conditions: CBT and Treatment as Usual. Planned sample size: N = 40 (n = 20 for each condition). Selection criteria: Inclusion criteria are participants aged 50 years and over with a diagnosis of Parkinson’s disease and patient reported clinically significant anxiety symptoms (Geriatric Anxiety Inventory >6) and depressive symptoms (Geriatric Depression Scale -15 scores > 5). The patient’s spouse or carer will be invited to participate. The exclusion criteria are the presence of active suicide ideation, psychos is, substance abuse, uncontrolled bipolar disorder limited English literacy or significant cognitive impairment (2 or more errors on the Six Item Screener for Cognitive Impairment). Use of psychiatric medication will be required to be stabilised one month prior to study entry. Study procedure: Written and informed consent will first be gained for both the participants and carers. Participants and caregivers will complete the self-report measures. Suitable participants will be randomly allocated (via a computer generated randomisation list allocated to sealed envelopes) to receive the intervention face to face or treatment as usual. At the end of 10 weeks, participants and caregivers will recomplete psychometric measures, as well as again I month after treatment has finished (1 month follow up). Participants and carers in both treatment groups will complete all psychometric measures pre-, post- and 1 month post intervention. Patients who received CBT will complete the consumer feedback interview at the end of CBT. Analysis plan: Analyses will be conducted using intention-to-treat. Categorical data will be analysed via chi-squared tests, and continuous data with parametric or equivalent non-parametric tests including mixed linear models. Duration of the Study June 2016 – June 2017 (including follow-ups)

The purpose of this study is to promote widespread uptake of evidence based, best practice falls prevention in Australian residential aged care facilities. It is hypothesised that by employing implementation strategies such as education, conducting audits and facilitating system change to improve the timely identification of residents, we will see an increase in the use of vitamin D supplements by residents. It is anticipated that this will then assist with a reduction in falls over the long term in Australian residential aged care facilities.

Stress cardiomyopathy (Tako-Tsubo Cardiomyopathy; TTC) was once thought to be a relatively rare form of transient regional cardiac dysfunction, occurring largely in ageing women. Given the apparently benign course of this condition, little attention has been directed until recently to its cause, or to appropriate treatment. However, it is now apparent that TTC is neither rare nor benign and accounts for about 10% of “heart attacks” in women. Our studies have led to expedited diagnosis, and have delineated a number of aspects of the natural history of TTC. Specifically, attacks, presenting usually as episodes of chest pain and/or breathlessness, TTC actually represents a form of catecholamine-triggered myocardial(heart muscle) inflammation of varying severity, which may engender lethal arrhythmias (abnormal heart rhythms), However the main cause of death post hospital admission is the development of severe hypotension (low blood pressure), which causes death in 2 – 3% of cases. The recovery is slow, due to persistent inflammation and energetic impairment within myocardium (heart muscle), and is associated with prolonged impairment of quality of life. There is also a substantial risk of recurrence. Furthermore, we have data from post-mortem studies and from a rat model of TTC developed in our laboratory that the myocardial inflammation is associated with increased nitrosative stress. Currently, there has not been an established treatment for TTC. We wish to test the hypotheses that agents that limit nitrosative stress (such as NAC and ramipril) might:- (i) Reduce the severity of inflammation and associated myocardial energetic impairment in TTC, and (ii) Accelerate recovery from TTC

The overall objective of the study is to investigate if a personalised education and medication management intervention reduces medication related problems for patients with decompensated cirrhosis. The morbidity and healthcare costs associated with complications of decompensated liver cirrhosis are substantial, as patients require complex medical care and have very high use of hospital services. People with cirrhosis are often prescribed multiple medications for therapeutic or prophylactic use, and the number of medications prescribed on hospital discharge is a risk factor for early readmission. Medication-related problems (MRPs) contribute to patient morbidity, hospitalisation and mortality in many chronic health conditions in the Australian community. The prevalence of MRPs has not been formally investigated in patients with cirrhosis, although a recent pilot study identified the prevalence of discrepancies between patient-reported and medical-record documented medications, and a lack of patient knowledge about their liver disease, medications and self-care tasks. The study identified only 44.5% of all medication entries to be concordant between patients and their medical records. Discrepancies of clinical significance were identified in 27 of 50 patients (54%) with a mean of 3.12 discrepancies per patient (range 1 to 8 discrepancies). Medication discrepancies were associated with older age (p=0.04), polypharmacy (p<0.01) and poorer levels of adherence (p<0.01). Gaps in patients’ disease-specific knowledge, medication-management skills, and lower levels of engagement in treatment may be a barrier to effective clinician-patient interaction and impair disease management. Limitations within the current outpatient model of care for cirrhosis patients include: * No designated clinician role for medication reconciliation or regular disease education * Lack of patient assistance to develop skills in the day-to-day management of their health condition * Lack of adequate information about opportunities for self-management or the need for medication adherence * Time constrained hepatologists and limited contact with patients Pharmacist-driven education and medication-management interventions have been shown to reduce hospital admissions, increase adherence to therapy and improve patient outcomes in other studies of collaborative outpatient practice. It is hypothesised that patient-centred education and medication-management intervention may address the complex relationship between patient knowledge, adherence and medication-management to improve outcomes for people with cirrhosis and reduce the burden on hospital resources.

Return to sports and physical activity is increasingly being evaluated as a factor in judging orthopaedic surgical outcomes, in particular, joint arthroplasty. Furthermore, patient satisfaction is closely correlated with the resumption of regular activities, and in the case of RSA, it has been shown that those who return to their pre-surgery physical activity and recreational sports after RSA, report greater levels of satisfaction post-surgery. There currently exists a clinically unmet need to evaluate the best and “optimal” course of management before and after reverse shoulder arthroplasty (RSA), and whether this translates to a more successful return to activities of daily living (ADL) and recreational sports. Furthermore, the use of activity monitors in the upper extremity as an alternative method for evaluating patient function post-surgery may allow for a more accurate and objective measurement of the frequency, duration, and intensity of shoulder function in patients after RSA, compared to self-reported questionnaires. Therefore, this research aims to investigate the benefit of a structured, postoperative exercise program in patients following RSA, compared with control subjects who receive the usual conservative course of management. Furthermore, this study will also investigate the effectiveness of using upper limb activity monitors to objectively capture upper extremity function in patients following RSA. Patients being offered RSA that meet the inclusion criteria for this study will be invited to participate in the trial, and upon acceptance and enrollment, will be randomised into one of the two rehabilitation arms of the study: usual management (UM) group or the exercise management (EM) group. Patients assigned to the exercise group will be required to participate in an 18-week postoperative rehabilitation, whereas those assigned to UM group will follow conservative care. All patients will be assessed clinically using validated subjective and functional assessment measures at specific time-points throughout the postoperative timeline, including body-worn activity monitors. Data obtained from these activity monitors, using previously described algorithms, will be compared between the operated and non-operated upper limbs of patients in both rehabilitation pathways, as well as a matched, healthy control group.

Depression is common in people with Alzheimer’s disease (AD) and their carers and is a frequent cause of distress and reduced quality of life (QoL). Pharmacological treatment is modestly effective in treating major depression, although this is largely ineffective in those with milder depression (subsyndromal depression - SSD) and in people with dementia ,and is frequently associated with unacceptable side effects. It is therefore essential that we are able to identify safe and easily accessible therapies for these debilitating symptoms. Cognitive bias modification (CBM) is a simple, novel and safe intervention that targets attentional and interpretative biases associated with anxiety and depression. CBM has been shown to be effective in reducing depressive symptoms in younger adults but studies in people with cognitive impairment and their carers are lacking. Our preliminary research has indicated that CBM is well tolerated by people with AD and could be easily accessed at home, making it a potentially invaluable intervention for depression in this population. The aims of this study are to determine; The effect of CBM in reducing the severity of depressive symptoms in AD, the effect of CBM in improving mood in carers of people with AD, and the effect of CBM on QOL of people with AD and their carers. People with AD and their carers (dyads) will be randomly assigned to an active or control CBM intervention in a 2 x 2 double-blind, parallel design. The intervention will be conducted over 6 months. For AD participants and carers, change in severity of depressive symptoms, and change in QoL, after 12 weeks, will be outcomes of primary interest. For AD participants and carers, change in severity of depressive symptoms after completion of treatment at 26 weeks, and incidence of major depression at 6 months, will be secondary outcomes of interest. Burden of care as reported by carers at 12 and 26 weeks will also be a secondary outcome of interest. Dementia is a common condition and is frequently associated with a diverse range of neuropsychiatric symptoms, including depression and anxiety. Our current understanding of the cause and management of these symptoms is far from optimal. The proposed study trials a simple and safe treatment that could be easily implemented into everyday clinical practice. This study will provide high quality evidence for the efficacy of CBM in improving the quality of lives of people with AD.