ANZCTR search results

CodaVax-H1N1, the study drug being researched in this project, is an experimental vaccine being developed by Codagenix, Inc. This means that it is not an approved treatment in Australia, and is not yet approved anywhere else in the world. CodaVax-H1N1 is a vaccine that is intended to prevent influenza. The primary objective of this study is to determine the safety and tolerability of CodaVax-H1N1 influenza vaccine compared to placebo control when administered to healthy adults.

Current recommendations by the Australian and New Zealand College of Anaesthetists professional standards are that quantitative neuromuscular transmission (NMT) monitoring be used in every case of neuromuscular blockade to ensure that the reversal of muscle relaxants is adequate. However, international surveys have demonstrated that as few as 18% of anaesthetists use quantitative neuromuscular transmission (NMT) monitoring routinely. Common (38-64%) and potentially serious complication of general anaesthesia, including respiratory failure, airway collapse, aspiration of gastric contents. Electromyography (EMG) has emerged as the clinical gold standard for NMT monitoring. In particular, Tetragraph is a novel EMG-based monitor that has advantages over older monitors including availability as a stand-alone unit without the need for expensive and specially designed monitors. However, the differences in its electrode design and in-built method for waveform analysis can affect its relative performance to older monitors. Given its recent development, data regarding its relative precision and bias in different muscles of the hand are also lacking. Therefore the hypotheses is that the first dorsal interosseous (FDI) will be more precise and accurate in comparison to the other muscles of the hand and foot and that the Tetragraph, using the train of four ratio (TOF) stimulation of the ulnar nerve under general anaesthesia, will be more precise and accurate compared to the NMT Electrosensor, during spontaneous recovery from non-depolarizing neuromuscular blockade.

This is a randomised, doubleblind, placebo controlled, multicenter study to be conducted across Australia, with an expected study duration of 8 weeks to determine the safety and efficacy of metronidazole ointment. Primary Objective • To determine whether treatment with metronidazole ointment increases healing in subjects presenting with non healing pilonidal disease. Method Patients with non healing pilonoidal sinus wounds will be randomised to one of two treatments or placebo. The wound healing will be measured using percentage improvement in wound size(rate of healing), "PUSH" score and time to healing recorded. Hypothesis Metronidazole ointment increases healing in subjects presenting with non healing pilonidal disease when compared to placebo. The research is a medical / clinical research project which studies the efficacy and safety metronidazole ointment in facilitating resolution of non healing pilonidal sinus.The study design is double blind placebo controlled, randomised control trial.

The aim of this study is to understand the impact of classroom-based active breaks on sitting time, cognitive functioning, brain activity and on-task behaviour in children with neurodevelopmental disorder.

The aim of this study is to understand the impact of cognitively challenging classroom-based active breaks on sitting time, cognitive functioning, brain activity and on-task behaviour in children with typical development.

We plan to determine if, a topical wound gel (Plurogel®), commonly used in chronic wounds and burn wounds, is effective in reducing the amount of bacteria in chronic non-healing diabetic foot wounds, and what effect it may have on the rate of wound healing . By analysing the microbial wound burden prior to treatment start, we will be able to determine what effect the Plurogel has on planktonic (free floating bacteria) and wound biofilm. We will do this using real-time qPCR and 16S rRNA, to identify and quantify the bacterial to human DNA ratio. Scanning electron microscopy will be used to observe the mean amout of biofilm as a reflective marker of intervention efficacy. The most common method to assess infection in a wound is to take a swab of the wound and see what, if any, bacteria grows. The available evidence suggests that taking a tissue sample from a suspected infected wound provides better information about what bacteria is present than taking a wound swab alone. The tissue sample is then provided to a laboratory for them to grow the bacteria. This is currently the standard way that all health care facilities operate. In addition, we also plan to send a piece of the tissue for testing with a new advanced molecular technique, as it has recently been found that trying to grow bacteria in a laboratory may not find all the bacteria that maybe present in a wound. This could explain why some people with high levels of bacteria in their chronic wound do not respond to the standard treatments we provide such as antibiotics and/ or wound care products. Using these new advanced methods will allow us to find all the bacteria in a wound and/or identify certain types of bacteria that don’t grow in laboratories. This may help change the way we treat infections as we can more successfully target particular bacteria, and in turn, this could potentially reduce some of the risks associated with foot infection, like amputation.

This research project will investigate new markers of altered brain structure in various forms of neurodegenerative diseases using 3 Tesla (3T) Magnetic Resonance Imaging (MRI) as well as more highly sensitive 7 Tesla MRI. Each of the neurodegenerative diseases has a characteristic profile (pathology) when the brain is examined under a microscope. Obviously, it is not an option though to remove the brain of a living person for a microscopic examination so we are trying to use MRI brain scans to capture information that could act as indicators for the types of brain pathology that cause these diseases. This is why this project aims to study a range of different degenerative diseases: we predict that the different diseases will be associated with different patterns of change detected with the MRI scans. Standard MRI scans such as those used presently in medical practice cannot make precise diagnoses of specific degenerative brain diseases. In fact, one of the main uses of standard clinical MRI is to rule out non-degenerative diseases such as strokes or tumours. Among the different degenerative diseases themselves, however, standard MRI only provides limited information. In this study, we will utilise a more powerful scanning technology, such as 7T MRI, to provide ultra-high resolution images. This means that we may be able to detect very small tissue changes in the brains that may have not been revealed previously. On the day of MRI scan, participants will be asked to perform some pen and paper tests of their mental abilities (such as memory, thinking, and language) in order to related the scan to their illness stage. MRI scan will take place once these neuropsychological tests are completed. We aim, with this research, to develop new types of MRI scans that may give more information about the precise diagnosis of degenerative brain diseases. As well as improving diagnostic accuracy, we also hope this project may identify new information about how these diseases affect the brain.

This research study examines new approaches to help people regulate their emotions after brain injury. The objective is to determine whether a technique of biofeedback is useful to assist in emotion regulation. The study is being conducted at the University of New South Wales by Professor Skye McDonald, UNSW, and researchers in her team who work under her supervision. In order to better understand how we can improve emotion regulation difficulties experienced by people with brain injuries, we need to include individuals who have had brain injury in our research. Participants will be asked to attend up to 9 sessions over 2-3 weeks, each of which will take approximately 1-2 hours. Most sessions will take place at the University of New South Wales’ Kensington campus. The first and the last session will assess naturally-occurring changes to heart rate while breathing at different rates. To do this, a flexible belt will be fitted around the waist (to measure respiration) and small electrodes will be placed on the undersides of the wrists and fingers (to measure heart rate and skin conductance). During recording, participants will be asked to perform some computer tasks (such as counting numbers) and watch some short video clips. After the first session, participants will be told whether they have been allocated to immediate treatment or deferred treatment. Immediate biofeedback treatment: Participants will attend six sessions which will also involve monitoring heart rate and breathing. In these sessions participants will be asked to follow instructions on a screen concerning this. Deferred treatment: Participants will be asked to wait two weeks before treatment commences. They will attend a second “assessment” session before commencing. We will ask participants to complete some questionnaires and we may ask a close relative also. We will access information from hospital files to complete our records. The protocol has been approved by the Research Ethics and Governance Office at Royal Prince Alfred Hospital: PROTOCOL X16-0279 & HREC/08/RPAH141 – "Emotion disorders following traumatic brain injury: An experimental approach to remediation"

The aim of this study is to identify an insulin dosing strategy for people with T1D using MDI that will effectively control their blood glucose levels after eating meals high in fat and protein. Participation will involve consuming the same test meal for breakfast, a protein shake and a muesli bar on 4 mornings. Each morning participants will be allocated a different insulin dosing strategy. We hypothesise that increasing the insulin dose by 25% and extending the duration of insulin action by using regular human insulin will optimise blood glucose levels.

The purpose of the TIPS study is to compare the effectiveness of two different interventions given before surgery to see if they improve the time needed to recover after surgery. The two interventions being tested are a ‘carboloading’ drink and pain medication called pregabalin (Lyrica ®). The study aim is to reduce the time needed to recover after surgery. Who is it for? You may be eligible for this study if you are an adult woman who will undergo an operation for ovarian cancer. Study details The study involves randomly allocating participants to two different interventions. Firstly, participants are randomised to receive a carbohydrate drink (Nutricia PreOp Drink), water or no drink before surgery. The drink is to be taken 2 hours before the operation. Secondly, participants are randomised to receive pain medication capsule (pregabalin) or a placebo capsule. The capsule is given by mouth 1 hour before the operation and 12 hours after the first dose. Following routine surgery participants will have to complete some questionnaires and answer some questions about how they're feeling, once discharged from hospital the study team will call them 30 days after discharge to ask some questions about their recovery. It is hoped that the findings from this study may improve women having surgery for ovarian cancers comfort prior to an operation and reducing pain after the operation.