ANZCTR search results

In this study, we will be looking at the education process as a part of informed consent prior to an elective caesarean section. In particular, we will be comparing a 25-minute multimedia module that we have developed, with the current RANZCOG published written pamphlets on caesarean section and vaginal birth after caesarean section. We hypothesise that the multimedia module will compare favourably in terms of improved knowledge and satisfaction scores, and reduced anxiety scores in comparison to the written pamphlets that patients currently receive.

We hypothesise that strengthening the respiratory muscles will improve exercise capacity and improve quality of life in people with pulmonary hypertension. This work plans to generate important information to help clinical specialists treat people suffering from pulmonary arterial hypertension. Currently, the best drug therapies available improve the distance a person can walk in 6 minutes by a mere 50m. Traditional types of exercise have been shown to have similar beneficial effects on exercise capacity, symptoms and quality of life but training needs to be carefully supervised because of safety issues making it impractical for many people. Respiratory muscle training places minimal stress on the cardiovascular system and thus could be safely performed in the home setting and may have important benefits in the setting of PAH.

This study aims to investigate the safety of new formulation of bevacizumab called CBT124 and bioequivalence when compared to two already marketed formulations, one approved in US and other in EU. Who is it for? You may be eligible to join this study if you are an adult healthy male aged 18 to 50 years (inclusive). Study details Participants will be randomised (allocated by chance) to either a test formulation or one of the two marketed formulations of bevacizumab. Drugs will be administered intravenously once only. The study will compare the safety, tolerability, pharmacokinetics (PK) (the levels of drug in the blood), pharmacodynamics (PD) (what the drug does to the body) and immunogenicity (body’s immune response) of the three drugs. In order to measure this, blood samples will be collected at various points after treatment has been given.

While impaired functioning has been shown to substantially influence quality of life for survivors of ICU in numerous studies, these studies are always limited as it has not been possible to objectively quantify patient’s pre-morbid function. This information is crucial as currently we cannot precisely quantify activity levels prior to their critical illness and, therefore, we cannot quantify the change in function for an individual patient. The ability to quantify change in functional ability would be a monumental advancement for researchers in other areas of medicine, but of pivotal importance in our field of critical care as researchers could then quantify the impact of intervention as a change in activity levels for an individual patient. Functional capacity after critical illness is an important outcome measure. Previously to determine functional capacity, researchers have focused on the six-minute walk test and questionnaires to quantify quality of life (QOL) and physical function. Such measures rely upon surrogates being used to subjectively assess pre-morbid functional capacity. There has never been a pre-morbid objective measurement and pedometers have never been used to assess physical activity following critical illness. The primary objective of this study is to establish feasibility of retrospectively obtaining pre-morbid pedometer/accelerometer and GPS data from the smart-phones of survivors of critical illness. The secondary objectives of this study are to validate accelerometer data extracted from a patient’s smart phone when they are recovering from critical illness. This will be achieved by comparison with pedometer data, which we will consider as the ‘gold standard’. In addition we will compare these data with data from a mobile phone app (MOVES) data, six-minute walk test, grip strength and functional assessment scores. These measurements of activity will be compared against measurements of function, i.e. the Functional independence measure (FIM), independent activities of daily living (iADLs), Activities of Daily Living (ADLs), extended Glasgow outcome scale (GOSE), Rivermead mobility index, (RMI) and EuroQoL05D-5L-35. Comparisons will be made at 3 and 6 months The tertiary objective of the study is to explore whether we can use GPS data extracted from the patient’s phone to construct activity or life space polygons to describe the recovery from critical illness at 3 and 6 months.

Aim The aim of this trial is to assess the impact of a smartphone-based secondary prevention program, initiated on discharge in patients with acute coronary syndromes, on exercise capacity, cardiovascular risk factors, quality of life and mood. Hypothesis The primary hypothesis is that a smartphone-based secondary prevention program would improve exercise capacity, as measure by a 6-minute walk test, compared to standard care. Secondary hypotheses are: A smartphone-based secondary prevention program will result in earlier return to work and improvement in cardiac depression and quality of life scores. It is also hypothesized that there will an improvements in cardiovascular risk factors (lipid profile, blood pressure, HbA1C, anthropometry) and secondary prevention pharmacotherapy use between the groups.

This project is a randomised controlled trial exploring the effectiveness of electronic methods of information dissemination and prompting for encouraging completion of advance directives (ADs) by South Australian Baby Boomers (b. 1946-1965). Advance Directives are legal instruments created to address future health, welfare and financial decision-making (Office of the Public Advocate South Australia 2003). Engagement with these instruments is typically at a time of terminal illness or frail age but they actually serve a broader purpose and were designed for a broader audience including the healthy and well (Wilkinson, Wenger et al. 2007). However the generally healthy and well public in South Australia remain relatively unaware of these instruments, their specificity and purpose (South Australian Government 2008). To advance the use of these instruments, the SA Government Department of Health has recently created a new bill (The Advance Care Directives Bill, 2012) to provide the public with a consolidated information base on the application and use of these instruments. It is anticipated that this will also include an online form that can be completed and uploaded to appropriate parties and locations. The Boomer population is targeted in this research study because there is worldwide concern of the effects this cohort will have on healthcare resource provisions (World Health Organisation, 2011). Understanding Boomer use of ADs to protect their autonomy and decision-making on future healthcare may provide critical information for healthcare policy planning when considering future healthcare resource allocation. The design of this current research study has been based on suggestions by participants in a previous study that if ADs were made more flexible and convenient, such as in an online environment, people would be more likely to engage with these instruments. Targeting Boomers with electronic means of AD information is supported by an Australian Bureau of Statistics report (Australian Bureau of Statistics, 2011) indicating that Boomers in Australia and South Australia are proficient and regular users of electronic computer technologies. Researchers in the US, UK and Canada have identified that the online environment is one which may be effective in disseminating information on and assisting completion of ADs for the more technologically literate (Mueller, Reid et al. 2010; Berg 2012). The theoretical proposition or hypothesis of this research project, therefore, is that when AD information and electronic prompting about ADs are made available online to SA Boomers, completion rates and discussion of ADs will increase. Results of this research will provide empirical evidence of the effectiveness of electronic means of communication on ADs to improve completion rates by this cohort.

Looking into the potential utility and generalizability of the ‘Secret Agent Society’ (SAS) computer game in schools that have pupils with ASD. The SAS will be implemented in grade 5 classrooms and we will follow students and the program effect as they progress to highschool. The aim is to investigate whether the SAS program in a whole classroom setting improves social and emotional skills for pupils with ASD, as well as decrease bullying behaviour experienced in the classroom as the education system works to support an inclusive classroom. Data will be collected from parents and teachers at several time points in the form of questionnaire batteries. For example, a questionnaire battery will be administered to the grade 5 teachers of each class. The teachers are to assess and report back on each student within their class on a variety of measures. The assessment battery contains questionnaires designed to assess social and emotional functioning of the child. In the following Primary and Secondary outcome boxes, any measure labelled (teacher form) is referring to this assessment battery. A second battery will also be given to the children within each class comprising of four measures designed to ascertain their current level of social and emotional function. They will be given at the same time points as the teacher questionnaires. In the following Primary and Secondary outcome boxes, any measure labelled (child form) is referring to this assessment battery.

Caffeine is readily available and widely consumed by adults of all ages. We are interested in whether temporarily manipulating caffeine levels (from complete washout to a controlled dose of caffeine) has an effect on visual perception in healthy adults. Specifically, we are testing its effect on a contrast judgment task (is one stripey pattern higher in contrast than another?) that our laboratory frequently uses to indirectly measure changes in brain function that occur with normal ageing or in conditions such as migraine. If caffeine indeed influences our test results, then future studies may need to control caffeine consumption.

This is a novel study to determine if patients lying in the prone position for spinal surgery develop evidence of mild cardiac bruising as evidenced by a serial serum Troponin rise and ECG abnormalities We suspect that, after prolonged positioning in the prone position, some patients develop evidence of mild cardiac bruising. If so, we intend to study factors that may be predictive of such cases. If confirmed, our study would indicate that all patients undergoing prone position spinal surgery should be consented for the possibility of developing cardiac bruising. If certain risk factors could be identified and if supine position surgery was also simultaneously indicated, then the risk of cardiac bruising would have to be evaluated in conjunction with other pros and cons of each approach, so that the individual could decide upon the best approach for their spinal surgery: i.e. anterior or posterior approach.

The purpose of this Phase III study is to determine whether regorafenib is effective in prolonging survival in patients with Advanced Gastro-oesophageal Carcinoma Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with advanced (metastatic or locally recurrent) Gastro-oesophageal Carcinoma which has not responded to a minimum of 2 lines of prior anti-cancer therapy. Trial Details: Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants will either take regorafenib (Group 1) or a placebo (Group 2) tablet oncer per day on days 1-21 of each 28 day cycle. Treatment will continue until disease progression or prohibitive adverse events. Participants will not know whether they are taking regorafenib or the placebo until after the trial is completed. Participants will be followed up every 2-4 weeks in order to evaluate how they are responding to treatment.