ANZCTR search results

Peripheral Arterial Disease (PAD) is characterised by blockages in the large arteries of the lower limbs. Chronic reductions in leg blood flow leads to microvascular impairment, including a reduction in muscle capillary density. These macro and microvascular impairments are independently associated with a severe reduction in functional (walking) ability. Patients are limited during daily activities by leg muscle pain and discomfort (claudication), and many develop signs of severe critical ischaemia, including rest-pain, tissue ulceration and gangrene. Lower limb revascularization procedures improve claudication symptoms by improving limb blood flow, but do not address the microvascular impairment, and do not fully restore functional capacity. However, when revascularisation procedures are combined with exercise therapy, greater gains are made in functional capacity without further change in large-artery blood flow. Based on evidence that supervised exercise therapy induces skeletal muscle capillary growth, and gains in functional capacity are related to increased muscle capillarisation, we hypothesise that the combination of revascularization plus post-operative supervised exercise therapy will lead to further improvements in outcomes (e.g. exercise tolerance and skeletal muscle microcirculation) compared to revascularisation alone. Therefore, this study aims to compare the efficacy of lower limb revascularisation plus supervised exercise therapy, with revascularisation alone, for improvement of walking capacity and skeletal muscle blood flow in PAD patients. This study will be conducted at the University of Sunshine Coast and the Department of Cardiology at Nambour General Hospital. Patients with PAD and symptoms of intermittent claudication, who are scheduled to undergo lower limb revascularisation, will be randomly assigned to one of two interventions at study entry: (1) standard post-operative care and monitoring (standard care) or (2) standard post-operative care plus an 8-week supervised exercise therapy program. Primary outcome measures will include walking capacity (6 minute walking distance) and calf muscle microvascular blood flow (using contrast-enhanced ultrasound [CEU]). Secondary outcomes will include i) leg muscle function (plantar-flexion strength and fatigue), ii) ankle brachial index, iii) arterial stiffness (augumentation index and carotid-femoral pulse wave velocity), iv) brachial and femoral artery function (flow mediated dilation) and v) leg blood flow (using venous occlusion plethysmography [VOP]). All parameters will be assessed in the limb undergoing revascularisation. Outcome measurements will be performed at baseline prior to revascularisation, then repeated following full recovery from revascularisation (2-6 weeks post-procedure), and then again at the completion of the 8 week post-operative intervention.

Proposed Research Design: We intend to pilot the app to establish its usability and possible effectiveness using an experimental design where 28 young adults are randomly assigned to one of two conditions. 1. Control: these participants use a restricted version of the app to self-monitor their drinking behaviour and related variables (e.g., mood, behaviour of others, etc.). 2. Intervention: in addition to self monitoring, these participants will receive harm minimisation strategies tailored to their goals and behaviours The intervention is delivered through participants’ mobile-phone devices. Kypri and colleagues (2003) found young adults as more receptive to engage with mobile phone interventions in comparison to web-based or one-on-one counselling sessions, as such, this design should minimise attrition rates.

Intense congestion, including shared accommodation and compromised hygiene, during mass events such as Hajj pilgrimage amplify the risk of invasive meningococcal disease. Intercontinental spread of serogroup A meningococcal disease in 1987 and serogroup W135 disease in 2000 and 2001 affected thousands of Hajj pilgrims globally. Quadrivalent meningococcal polysaccharide (serogroups A, C, W135 and Y) vaccine was able to bring these epidemics under control, but the vaccine is not effective at reducing pharyngeal carriage of meningococci. A conjugate vaccine can reduce long term meningococcal carriage; for example, the quadrivalent conjugate vaccine has been shown to reduce carriage over 12 months from vaccination in adults aged 18-24 years old. However, the impact of conjugate meningococcal vaccines on meningococcal carriage status among Hajj pilgrims, most of whom are older than 24 years, is not known. We, therefore, believe that a well-powered carriage study in Hajj pilgrims is an urgent need. During the Hajj 2017, we plan to conduct a single-blinded, randomised, controlled trial of quadrivalent meningococcal conjugate vaccine for head-to-head comparison with quadrivalent polysaccharide among pilgrims from Australia, Qatar and Saudi Arabia. Pilgrims from participating countries, planning to attend Hajj in Makkah in 2017 will be randomised to receive either a ‘conjugate vaccine’ or a ‘polysaccharide vaccine’. Following informed consent, pharyngeal swabs will be collected from pilgrims in both arms a few months before their travel to Hajj. The participants will then receive their respective vaccines (observers will remain blind to this selection), a second set of pharyngeal swabs will be collected within sixty days after completion Hajj, preferably within 7 days and a third set of pharyngeal swabs will be collected at 6 to 11 months. Pharyngeal swabs will be processed by standard culture methods to detect meningococcal carriage; isolates will be characterised by serogroup, subtype, serosubtype, and sequence type. The pharyngeal swabs will also be tested for any antimicrobial resistance elements present. Data will be anonymised and analysed for the following end points: a) comparison between the study arms with respect to pharyngeal carriage rates of meningococci after return from Hajj, b) change in pharyngeal carriage rates of meningococci from before to a few months after vaccination, and c) comparison of long term carriage rates at 6 to 11 months after vaccination between study arms, and d) comparison of adverse events related to vaccination between study arms. This research could inform renewed policy on meningococcal vaccination for Hajj pilgrims as well as for attendees of other large events.

The Magnific Study aims to determine if the use of magnetic acupuncture will reduce the stress and pain experienced by infants in newborn intensive care units in response to a very common painful stimulus, heel pricks for blood collection. Babies will be randomised to having 5 magnetic stickers or placebos placed on each ear for 3 days. During this time, the baby's response to a heel prick will be measured using a widely used pain scale, the PIPP score. After three days, the stickers (with and without magnets) will be removed and the PIPP scores will be examined.

The aim of this factorial randomised control trial is evaluate the efficacy of a lunchbox intervention, a physical activity intervention and a combined lunchbox/ physical activity intervention on child physical activity levels and the nutritional content of student lunchboxes.. Twelve primary schools in the Hunter region will be randomly allocated to one of 3 intervention arms or a control group. The final trial endpoint is 9 months.

Quetiapine is a commonly-prescribed drug with a good safety margin that is prescribed in psychotic illnesses, agitation and anxiety. Thyroid function is commonly checked in patients with psychotic disorders and signs of anxiety. We have observed that some patients taking quetiapine have low results on measure of free thyroid hormone level in blood, even though there is no other evidence that their thyroid function is impaired. We suspect this is because the quetiapine is interfering with the laboratory test, but it might actually be a biological effect of the quetiapine and potentially important to quetiapine’s adverse effects on metabolism. In this project, we will first ask 20 patients who are already taking quetiapine to provide us with one specimen of blood each to check thyroid function. In a subsequent part of the study (which has a different registration on the ANZ Clinical Trials Registry), we will also ask a further 20 patients in whom their treating psychiatrist has already made the clinical decision to commence quetiapine as part of their management plan, to provide us with a specimen of blood to check thyroid function on 4 occasions (prior to quetiapine commencement, 1 day following commencement of quetiapine, and at weeks 3 and 6 ). We will firstly check to see whether our impression, that free thyroid hormone tests are reading lower in patients on quetiapine by the current test, is correct. The current test is an immunoassay. Then we will use the same blood specimens to measure free thyroid hormone level by another newer, highly specific test (LCMSMS) that is not open to interference in the way immunoassays may be. A comparison of the results will tell us whether the problem is simply immunoassay interference from quetiapine.

This study aims to investigate if negative practice is more effective in assisting with motor learning of a voice motor skill compared with repetitive drill in the practice phase, among female adults with mildly hyperfunctional vocal patterns. This study will be a randomised controlled trial with three groups including a control group that does not receive any intervention, a repetitive drill group, and a negative practice group. All three groups will have the same number of participants. Negative practice refers to practising the voice task the wrong way, immediately followed by the correct way.

Central hypertension leading to early vascular remodelling is an independent predictor of major cardiovascular events. Aorta is not only a conduit artery but also act as a vascular buffer to each ventricle contraction. Overtime, this stretch leads to decrease aortic compliance resulting in aortic stiffness. Ageing and HTN are the predominant attributable risk factors leading to premature aortic stiffness. Central HTN can be computed by pulse wave morphology or velocity assessment. Central pressure indices including systolic, diastolic, pulse and augmented pressure along with augmentation index can be derived by central pulse wave morphology. Although evaluation of central haemodynamics can potentially flag the early phase of vascular remodelling but the precise component of central pressure indices predicting risk as per age is under considerable debate. Aortic stiffness is recognised as a surrogate for central arterial hypertension and its non-invasive estimation by pulse wave velocity (PWV) is considered “gold standard” by European Society of Cardiology (ESC) 2013 guidelines. Non-invasive central pulse wave morphology and velocity assessment is not being validated during atrial fibrillation (AF) . In addition, there is paucity of data revealing central pressure indices, including PWV appraisal as an independent predictor of outcome in AF. 1 Purpose of the study Raised central pressure is more closely associated with cardiovascular outcome as compare to peripheral HTN. There is evolving evidence that central HTN is underdiagnosed leading to inadequate treatment resulting in early vascular ageing. We propose a staged prospective investigation by designing two perspective studies to validate and incorporate central pressure indices (central systolic, diastolic and pulse pressure with augmentation index and PWV) respectively in AF risk stratification with a view to titrate treatment as per central pressure to study clinical outcome in AF. 2 Aims In this validation study we will compare invasive versus non-invasive central pressure indices appraisal including pulse wave morphology and velocity assessment in AF. Through this study we seek: I. To validate widely used non-invasive methods to assess local, regional and systemic central pressure indices while the subjects are in atrial fibrillation (AF). We will compare the non-invasive appraisal of central pressure with an invasive enumeration in our paroxysmal/persistent atrial fibrillation (PAF) cohort in atrial fibrillation and post restoration of sinus rhythm during elective pulmonary vein isolation (PVI). II. We will review the shift in central pressure profile with rhythm control in our PAF cohort to identify the early changes in central pulsatile load as well as conduit artery compliance with restoration of sinus rhythm. and will draw a comparison between invasive and non-invasive evaluation

Functional dyspepsia (FD) affects a considerable proportion of Australians and results in significant personal and economic cost. There is as yet no cure for this condition and current treatments are only satisfactory in a subset of patients. New insights into the pathophysiology of FD have found that activation of both mucosal and systemic immune responses are important and have been shown to be linked to symptoms in patients with FD. Specifically, increased mucosal permeability has been linked with mucosal inflammation and our pilot work has shown increased mucosal permeability occurs in FD. In this study we aim to define the effects of pharmacologically induced changes of intestinal permeability on immune activation, upper gut function (sensory & motor function) and symptoms in healthy controls and patients with FD. FD patients and controls will be randomised to receive a nonsteroidal antiinflammtory drug (aspirin) which is known to increase FD symptoms and mucosal permeability or a probiotic (Vivomixx), which is known to reduce the severity of dyspeptic symptoms, and intestinal permeability. In addition recent evidence suggests that that the intestinal microbiome plays a critical role in mucosal inflammation but to date this has not been properly investigated in FD. We aim to define the role of the intestinal microbiome in response to treatment with aspirin and the probiotic Vivomixx using a novel device we have developed and patented that allows targeted aseptic biopsies to be obtained from defined areas of the gastrointestinal mucosa utilising routine endoscopic tests. We will also compare the microbiome in intestinal biopsies from patients with FD and healthy controls to study the link between the diversity of the microbiome and mucosal inflammation. To do this study we will recruit 90 patients with functional dyspepsia and 90 age and sex matched controls without GI symptoms undergoing endoscopy for assessment of iron deficiency with a normal upper endoscopy. They will be randomised to receive either aspirin, Vivomaxx or placebo. They will undergo pre and post treatment testing including fill in questionnaires, donate a blood sample, donate a tissue sample (at baseline only), breath test and a standard nutrient drink challenge. This study will significantly advance the pathophysiology of FD and has the potential to pave the way for future cure of the disease.

Primary aim: To examine whether participation in the online parenting program significantly reduces father- and mother- reported dysfunctional parenting, parenting conflict and child behavioural problems from pre- to post-treatment, and whether these reductions are maintained at 3-month follow-up. Secondary aims: 1. To examine whether participation of fathers enhances the outcomes of the intervention for families in terms of reductions in child behaviour problems. 2. To examine the variables that predict father engagement in the online parenting program. 3. To examine moderators and mediators of program effectiveness (the factors that determine when and how the program works). Hypotheses: It is anticipated that participation in the program will lead to improvements in child emotional and behavioural adjustment, reductions in parental disagreements about parenting, reductions in dysfunctional parenting and improvements in positive parenting.