ANZCTR search results

The purpose of the Stepathlon study is to determine the impact of Stepathlon on lifestyle and health outcomes including step count, sitting duration, exercise duration and weight.

The aims of this study are to identify the electrophysiological biomarkers that may guide and optimise future management of OCD by DBS. This research project will utilise a new device, the Activa PC+S (Medtronic Minneapolis USA) which is identical to the implantable DBS system utilised over the past 10 years for movement disorder with the addition that the Activa PC+S can be used over many months as a passive recording device of brain electrical activity. The recording of these signals can be stored or "played" in real-time. These electrical signals from the brain offer the strong long term prospect of more accurately guiding the surgeon in the placement of the stimulating electrodes in the targeted region of interest. As such, the hypothesis of the research are: 1. That the brain electrical activity changes in response to stimulation and that the changes in brain electrical activity account for clinical changes in the symptoms associated with obsessive compulsive disorder. 2. That brain electrical activity can be used as a marker to guide electrode placement. 3. That the recorded electrical signals will provide useful information about the electrophysiological basis of Obsessive Compulsive Disorder and the effect of DBS treatment on the biological markers of this condition. In order the evaluate these hypothesis, the proposed research will implant the new Activa PC+S device in a series of ten participants who suffer from treatment resistant obsessive compulsive disorder. The recording functionality of the Activa PC+S does not detract in any way from the likely positive outcomes of DBS for OCD but adds to the prospect of improved outcomes in the future with more accurate placement of electrodes and more informed programming post operatively. This is highly significant in that this work in OCD has not been done anywhere else in the world and as such will not only inform the current treatment of participants in this study, but will inform treatment of other participants world wide. The patients will be rigorously screened with well defined inclusion and exclusion criteria for the procedure and will have thorough medical, psychiatric and neurocognitive testing before implantation and post-procedure and during a very structured two-year follow up.

This is a randomised controlled trial comparing a programme of monitoring unborn babies during labour using ST analysis (STan) of fetal ECG to intrapartum cardiotography. We aim to reduce our emergency caesarean section rate from 18% to 12% with improvement or clinical equivalence of neonatal outcomes, whilst maintaining maternal wellbeing and both maternal and caregiver satisfaction. The WCH is the first Australian centre to introduce STan fetal monitoring, as a part of a comprehensive educational package on fetal monitoring.

Recent research has shown Kyolic aged garlic extract to improve cardiovascular function, including peripheral and central blood pressure and arterial stiffness. Arterial stiffness is inversely correlated to aerobic capacity. Additionally, animal and clinical data have linked aged garlic extract to ameliorate physical fatigue, increase exercise tolerance and increased oxygen uptake. This study aims to investigate the effect of 3-month supplementation of aged garlic extract compared to placebo on arterial stiffness and aerobic fitness measured by oxygen uptake, lactate levels and muscle fatigue (as 'lactate to rated perceived exertion (RPE) ratio), in a group of sedentary adults during moderate intensity exercise.

Cardiovascular disease (CVD) is the leading cause of death globally. However, many individuals are unaware of their CVD risk factors. We systematically review the medical literature to determine the efficacy of existing intervention strategies to increase the uptake of cardiovascular risk factor screening. A systematic search was conducted through Pubmed, CINAHL, EMBASE and Cochrane Central Register of Controlled Trials. Additional articles were located through backward and forward citation search. The quality of studies was evaluated using Cochrane risk of bias assessment tool. Data were pooled using random-effects model..

This study aims to develop a multi-centre trial and to assess which infants and children with acute respiratory failure benefit using High Flow Nasal Cannula Therapy (HFNC). For this purpose we will perform a randomised controlled trial comparing current best practice (standard oxygen delivery via subnasal prongs, facemask, venturi mask) versus HFNC therapy. With the introduction of this simple to use respiratory system in regional and tertiary centres we aim to investigate if HFNC therapy has a lower treatment failure rate in comparison to standard oxygen delivery, and to investigate if there is a reduction in the need for transfer of these patients to a tertiary hospital or admit to an intensive care unit.

Intravenous sedatives and analgesics are commonly administered to mechanically ventilated children post cardiac surgery, however there is substantial variability in sedation practices in different intensive care units and in different countries around the world. The Cardiac BabySPICE pilot study will evaluate the hypothesis that early light sedation with dexmedetomidine reduces length of mechanical ventilation and length of stay in PICU compared to standard practice (midazolam). In addition we will follow up the neurodevelopment (at 6 and 12 months) of the included subjects; infants undergoing cardiac surgery on bypass <6 months of age. The purpose of the Cardiac BabySPICE Pilot RCT is to obtain preliminary data on the feasibility and safety of conducting a study that tests this hypothesis. This is a pilot prospective randomised controlled trial that will be conducted in the Lady Cilento Children's Hospital paediatric intensive care unit in Australia and will recruit 60 patients. The study will recruit patients undergoing repair of congenital heart disease who require a breathing tube at least 24 hours after enrolment AND need immediate and ongoing sedation. Patients will be recruited into one of 2 study groups. The study drug will commence whilst the child is in surgery. The intervention arm will receive dexmedetomidine as the primary agent, with the addition of secondline sedatives as required by infusion, boluses or both. The use of benzodiazepines in this arm will be minimized and clonidine will not be used concurrently with dexmedetomidine. The control arm will have midazolam according to usual practice.In both groups, the default sedation level in PICU is light sedation, as defined by a target State Behaviour Scale (SBS) of 1 to +1, unless otherwise specified by the treating clinician. The primary outcome measure for the pilot study is to demonstrate separation between the intervention group (Dex) and the control group (Mid) with respect to the proportion of patients achieving light sedation (SBS 1 to +1) in the first 48 hours of sedation in intensive care.WE will also examine length of veniltation, PICU length of stay and long term outcomes. Information from the Pilot RCT will be used to design a subsequent phase III trial.

Shoulder impingement is a common diagnosis referred for physiotherapy treatment. Patients complain of pain when lifting their arm and difficulty with functions such as washing their hair or when reaching for objects. (Michener, McClure et al. 2003) suggest “it is the most common disorder of the shoulder, accounting for 44-65% of all complaints of shoulder pain during a physician’s office visit.” In addition, approximately one-fifth of all disability payments for musculoskeletal disorders are for shoulder disorders (Michener, Walsworth et al. 2004) These statistics indicate that a large portion of the general community may be affected by a shoulder disorder and that it causes significant discomfort and limitation to their function. Physiotherapists use past clinical experience in addition to a thorough examination to identify physical characteristics causing signs of impingement and which are able to be modified (Sorohan and Mc Creesh 2009). A study has been completed (JCU ethics approval number H3945) which took an homogeneous group, aged 40 to 60 years, presenting with positive shoulder impingement signs and symptoms of gradual onset and without trauma, and compared these physical characteristics to a matched asymptomatic group in age and physical activity level. Significant differences between groups were found in upper back (thoracic) posture, range of upper back (thoracic) movement and tightness in the back of the shoulder. No significant differences were found in shoulder muscle strength or shoulder blade positioning. This prospective, randomized double blinded,control trial will compare the clinical efficacy of two evidence based physiotherapy treatment approaches (one directed at the thoracic spine and one directed at the posterior shoulder) as compared to ultrasound treatment. The results of this project will result in the development of an evidence based program to manage shoulder impingement.

The primary aim of this trial is to develop and evaluate a risk model to aid doctors to identify head and neck cancer patients who are most at risk of developing hearing loss as a result of treatment. Who is it for? You may be eligible to participate in this trial if you are aged 18 or older and have been diagnosed with a head or neck squamous cell carcinoma for which you have been scheduled to receive radiotherapy at the Princess Alexandra Hospital. Study details All participants in this study will first be allocated to one of the two study groups based on their risk of developing hearing loss during treatment. Those identified as minimal risk will receive standard radiotherapy care. Those identified as high risk will receive a new protocol of radiotherapy care following the guidelines developed by these researchers. This care includes tighter radiation dose tolerances for your ear structures and the use of a validated, audiology contouring atlas to ensure more accurate definition of your ear structures on your radiotherapy planning scan. These recommendations are expected to be followed unless it is not in the best interest of treatment of the cancer. All patients will have hearing test visits before treatment, at week 5 of treatment, at 3 months and at 1 year after finish of treatment. Outcomes will be assessed using results of these hearing tests and by questionnaires completed by participants. It is hoped that the findings of this study will provide more information on the radiotherapy dose required to induce hearing loss, any links to specific chemotherapy drugs which may increase risk of hearing loss and the efficacy of the risk profiling tool to identify patients at greatest risk of developing hearing loss.

Delayed cord clamping (DCC) is slowly becoming common practice in the management of uncomplicated births in Australia, however it is unclear how the administration of maternal uterotonics such as oxytocin as part of the active management of the third stage of labour have on the newborn DCC. Oxytocin is administered prophylactically as it has been shown to significantly decrease the risk or post partum haemorrhage (PPH). PPH occurs in more than 5% of births and is most commonly caused by uterine atony, the failure of the uterus to adequately contract after birth. Oxytocin causes contractions of the uterus, which helps to reduce this risk. In Australia and New Zealand, an intramuscular (IM) or intravenous (IV) injection of Syntocinon ('Registered Trademark'), a synthetic form of the hormone, oxytocin, is administered as the anterior shoulder of the fetus is delivered. There are currently no guidelines indicating how to prophylactically treat PPH during delayed cord clamping. Current standard practice of care allows for the provision of early or delayed cord clamping. however, if cord clamping is delayed a maternal IM injection of 10IU oxytocin is routinely administered with delivery of the anterior shoulder of the fetus. Therefore DCC is currently being performed under the influence of oxytocin without an understanding of the potential effects of uterotonic administration prior to cord clamping on the newborn. This clinical trial aims to determine the effect of maternal IM Syntocinon ('Registered Trademark') administration during delayed umbilical cord clamping on neonatal arterial oxygen saturation (SpO2) and heart rate (HR) at vaginal birth.