ANZCTR search results

Background: Asthma is a common chronic lung disease and symptoms vary from mild to severe. Within the general population with asthma, approximately 5-10% suffer with severe asthma. People with severe asthma run the highest risk for acute and/or severe exacerbations and mortality, yet there is not much empirical data on how this affects the patients lived experience. Aim: Using the Database of Personal Experiences of Health and Illness (DIPEx) methodology we aim to explore the personal experiences of people living with severe asthma. Methods: Participants will be included if they are over 18 years old and must be diagnosed with severe asthma. A maximum variation sample of approximately 30-50 participants will be recruited from different settings across Australia. DIPEx methodology involves audio and/or video recording potential participants and encourages them to talk without interruption about all aspects of their experiences that mattered to them. The collected data will be transcribed and coded into ‘categories’ and ‘themes’. These categories and themes will be based on areas that are identified as important to the participants. Significance: These stories will be used as a reliable source of information to educate students and health care professionals, and as an evidence base to inform person-centered care and future policy improvements to understand the concerns, meaning and priorities of a diverse range of people with severe asthma. The topic summaries, and selected video clips, will also be published on the website http://healthtalkaustralia.org

One in 16 young Australians is currently experiencing depressive symptoms, which underlines the significant prevalence of depressive disorders in minors. When it comes to treating such symptoms using a pharmacological approach so-called selective serotonin reuptake inhibitors (SSRIs) are frequently used for treatment of depressive disorders, but there is a clear scarcity of evidence-based predictors for treatment response. However, there is no understanding as to why antidepressant effects are often observed after a period of 4-7 weeks into treatment. The aim of this project is to investigate how well Acute Tryptophan Depletion (ATD) can predict treatment response. ATD is a dietary method that diminishes brain serotonin (5-HT) synthesis for a short period of 5 to 7 hours. We expect that ATD will have dysfunctional effects on mood.

Benzodiazepines are a commonly prescribed for anxiety and sleep problems despite their high risk for dependence. Benzodiazepine withdrawal syndrome involves anxiety, tremor, sweating, nausea, headaches, cognitive difficulty, poor memory, muscle pain and potentially seizures and hallucinations. The current first-line treatment for benzodiazepine dependence involves gradual dose reduction so as to avoid sudden onset of withdrawal symptoms however this therapy can take a very long time and the success rate is quite low. Flumazenil, conventionally viewed as a benzodiazepine antagonist with agonist actions having been observed at low doses, has demonstrated potential for treating benzodiazepine withdrawal syndrome. This study aims to assess the efficacy and safety of low-dose flumazenil infusion administered subcutaneously as an option for detoxification from benzodiazepines. It will also explore the role of flumazenil-assisted benzodiazepine withdrawal in maintaining abstinence post-withdrawal.

This study examines the reliability, validity and feasibility of using Archie, a foot biofeedback device to determine if mid arch movement and foot exercise practice can be measured and monitored in those with a range of foot types or foot problems associated with weak feet. Various physical measures, questionnaires and surveys will be collected from participants over the course of one day. The results of this study will be used to prepare for future randomised controlled trials on foot exercise for the treatment of a range of foot problems associated with weak feet.

The purpose of this study is to further explore the effect of colloidal silver sinonasal rinses in recalcitrant chronic rhinosinusitis. Colloidal silver has already shown to be effective as an anti-biofilm agent in Staphylococcus aureus chronic rhinosinusitis (CRS) in a sheep model (Rajiv et al, 2015). We aim to further evaluate the effects of colloidal silver in patients affected by recalcitrant CRS. The specific aim of this study is to investigate the effect of colloidal silver on persistent infection in patients who have already undergone surgical management for chronic rhinosinusitis (CRS).

This will be a single-center, open-label, 4-period study to investigate the relative bioavailability of a single dose of PRN1008 when administered as a new tablet formulation compared to the current tablet formulation under fasted and fed conditions. Period 1 is intended to investigate the pharmacokinetics of the 100mg new formulation tablet at a 200mg dose, and to determine an appropriate dose for the new tablet formulation to be used in Periods 2 to 4, the relative bioavailability crossover portion of the study. Participants will be screened for this study within 28 days before dosing. Total length of participation in the study for participants is 76 days from screening through study completion.

The prevalence of type 2 diabetes and obesity are rising at alarming rates. Across Australia, these chronic diseases account for billions in health care costs and lost productivity. Rates of type 2 diabetes and obesity are high among shift workers, even after controlling for lifestyle and socioeconomic status. Shift workers experience poor timing of their body clocks to the daily light/dark cycle, and they show abnormal metabolic responses, including insulin resistance and glucose intolerance. Simulated shift work studies in rodents provide a link between timing of meals and metabolic processes: withholding feeding during 'night-shift' prevents the adverse metabolic effects of simulated shift work. Whether this strategy is effective in humans remains to be demonstrated. Our preliminary data from humans in several laboratory studies indicate that meal timing does play an important role in metabolic disturbance. Indeed eating at night, when the body is primed for sleep, seems to underlie an increase in metabolic disturbance that could predispose them to chronic disease. To test this, we will measure metabolic markers in healthy men and women studied under simulated shift work conditions, where we will keep daily energy intake constant but vary meal times. We propose that by simply altering the timing of meals we will be able to mitigate the negative metabolic consequences of shift work. These results could be readily translated to existing dietary guidelines, industry recommendations and workplace policy reducing the significant and increasing burden of metabolic disease in shift workers and the wider community.

Physical inactivity is responsible for the second largest chronic disease burden in Australia (6.6%) and costs the health care system $1.6 billion every year. Over 85% of Australians have access to the Internet, and while most users have embraced the advantages of fast broadband connections, little research has investigated how this can be used for health promotion. More recently, there has been a large uptake of advanced activity trackers (e.g. Fitbit) that provide accurate information about personal activity levels. The vast reach and low cost of innovative web-based interventions can contribute significantly to promote physical activity and prevent chronic disease on a population level. Current web-based interventions often fail to engage participants long enough to achieve long-term behaviour change and health benefits. As such, innovative approaches, in tune with how people use the Internet today, are needed. Based on our previous research we aim to demonstrate that highly personalised (e.g. tailored to age, gender, activity levels and self-efficacy) physical activity advice that is based on feedback from an advanced activity tracker is more credible, engaging and effective to increase physical activity when compared to personalised physical activity advice that is based on a self-report measure (e.g., the Active Australia Survey). Study aims are: To study the effectiveness of the computer-tailored physical activity intervention supported with Fitbit activity monitors relative to a computer-tailored physical activity intervention without Fitbit support (4 group, 3 month randomised trial) on: a. The primary outcome measure of change in physical activity. b. The secondary outcome measures: credibility and acceptability of the personalised advice, the engagement with the intervention (assessed through website usage statistics) and intervention feasibility.

The aim of this project is to assess the effectiveness of ProKera (registered trademark) in the treatment of corneal ulcers. The current treatment for non-healing corneal ulcers include lubricating eye drops/ointments, extended wear contact lenses, tarsorrhaphy and botulinum-induced ptosis. Amniotic membrane has also been shown to promote the healing of the corneal surface. However, it is not commercially available in Australia. This project will assess ProKera (registered trademark), which is a commercially available amniotic membrane. It is currently approved by the US Food and Drug Administration but not the Australian Therapeutic Goods Administration. Patients above the age of 18 who are attending the cornea clinic with severe chemical injuries or poorly healing corneal ulcers will be invited to participate. Information to be collected include ulcer size and time to healing, and any complications from using ProKera (registered trademark).

Dialysis is the artificial replacement of a patient’s non-functioning kidney which has been damaged due to medical disease. There are two main techniques, peritoneal dialysis (PD) and haemodialysis (HD). PD requires the insertion of a catheter into the patient’s abdomen prior to use. Historically this has been done surgically, however a new technique is for it to be inserted radiologically, which appears to have several benefits including decreased waiting times, inpatient admissions and hospital expenses. The main purpose of this trial is to determine the optimal time to use these catheters post radiological insertion which no study has previously investigated. The most appropriate time to initiate dialysis after radiological insertion of Tenckhoff catheters is not clear in the literature. There is the possibility of peritoneal dialysis (PD) complications such as leakage and infection if dialysis is started too soon after insertion. However, much morbidity and expense could be saved by reducing dependency on haemodialysis (HD) by earlier initiation of PD post catheter insertion. Previous studies are observational and mostly compare surgically inserted catheters and their immediate or delayed use. The primary objective is to determine the safest and shortest time interval between radiological placement of a Tenckhoff catheter and starting PD. The goal is to compare initiation of PD at one and two weeks post radiological Tenckhoff catheter insertion. This will be done by measuring the incidence of PD complications in a period post PD commencement as well as the HD associated problems during the same period if bridging HD is performed. This is a randomised controlled trial of patients who will start PD after radiological insertion of a Tenckhoff catheter at Royal Brisbane and Women’s Hospital (RBWH) and who meet the inclusion criteria. The patients will be randomised to one of two treatment groups. Group 1 will start PD 7 +/-2 days after Tenckhoff catheter insertion and group 2 at 14 +/-2 days. Nurses and physicians will be blinded to the randomised allocation. The primary end point is the complication rate (leaks and infection) after initiation of PD.