ANZCTR search results

This pilot study will investigate the feasibility of implementing a multidisciplinary pre-operative very low calorie (VLCD) weight loss program in adult obese patients awaiting general elective surgery. This study will initially enrol a pilot sample of 50 patients who have a Body mass Index (BMI) equal to or over 30kg/m2 who attend the Pre-admission clinic for elective general surgery at The Prince Charles Hospital. Participants will be randomised into a control group or an intervention group. Participants in the intervention group will follow an 8 week very low calorie diet that incorporates Optifast meal replacement shakes. Participants randomised to the control group will receive standard care that includes a generic weight loss information pack provided by the clinic nurse. Measures to assess health related quality of life, body composition and adherence to the program will be collected. Unfavourable surgical outcomes will be measured until 30 days post elective surgery.

Major depression affects one in 16 young Australians. The first line of pharmacological treatment for severe depressive disorders in young people is selective serotonin reuptake inhibitors (SSRI). However, beneficial clinical effects are rarely observed before 4-8 weeks, whilst negative side effects (e.g., increased activity leading to increased suicide risk) are present. Consequently, a major question is whether there is a treatment strategy that could alleviate depressive symptoms in the initial 4-8 weeks? Recent data showed that a single dose of nitrous oxide (N2O) in adults with severe depression had significant antidepressant effects, and maximum effects were observed 24 hours after administration. However, no studies using N2O in minors have been conducted. The proposed research aims to investigate whether N2O has the same antidepressant effects in minors by using a between-group single-blind design. Participants will be randomly allocated to treatment (N2O) or placebo, and monitored weekly up to 12 weeks after treatment initiation. We expect that an average improvement in mood will be observed for the group allocated to the nitrous oxide condition.

The aim of this study is to determine if tailored, theory informed Knowledge Translation (KT) interventions can increase the uptake of an Australasian bronchiolitis guideline in reducing the use of therapies/management known to be of no benefit in the management of infants with bronchiolitis. This will be done by conducting a cluster randomised controlled trial - randomising hospitals to either intervention or control groups with focus on Emergency Department and General Paediatrics units. Results from this study will influence the implementation of other guidelines and evidence based practise in paediatric settings.

The overall aim of this research is to explore the effects of a program of sensory motor integration activities, The Learning Connections Schools Program, on young children’s behaviour, development and early academic skills. In order to achieve this aim, the objectives are to: *Conduct a cluster, pragmatic, unblinded, controlled trial to investigate the effect of a program of sensory motor integration activities on behaviour, development and academic skills in children in Prep Year and Year 1 of school. *Implement the sensory motor integration program with a group of children (the experiment / intervention group) in Prep Year and Year 1, across a variety of schools *Determine the effects of this program on behaviour, development and academic skills in that group of children by examining before and after measures *Compare the results from these children to the results for a control group of children in the same years of schooling, from similar schools, who have not participated in the sensory motor integration program. Sample All Brisbane Catholic Education primary schools have been invited to participate. Of those that volunteered, 12 will be randomly selected to participate using a computer-based random number generator selection process (randomisation). School Principals will then be required to consent to their school participating in the research. As well teachers will be asked to consent to participation in the research, and parents will be asked to consent for their children to undertake the sensory motor program in class and undertake the assessments as part of usual classroom activities. The final sample will consist of six (6) control schools (3 urban; 3 rural/semirural/regional) and six (6) experimental schools (3 urban; 3 rural/semirural/regional). Based on the average school with an intake PREP year of 50-60 pupils (with an average class size of n = 25-30), this will result in an expected sample size of between 600 to 720 pupils across 12 schools. Inclusion criteria *All Brisbane Catholic primary schools with PREP year and Year 1 classes. Exclusion criteria *Schools with existing sensory motor integration programs (for the control group)

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.