ANZCTR search results

The Queensland Ambulance Service (QAS) is changing its drug management of acute behavioural disturbance (ABD) from midazolam to droperidol based on the research undertaken by the chief investigator (Page) and one of the principle investigators (Isbister) in the emergency department setting. New South Wales ambulance service has undertaken this change in 2015. Auditing to date of the QAS ambulance report form (ARF) use of midazolam demonstrates poor use of sedation scores, missing information & adverse effects from midazolam. It is therefore planed to audit this change over in drug management with an audit form in addition to standard reporting (ARF). This will be a prospective observational study, as part of a quality assurance monitoring process of this changeover looking at effectiveness and safety of both agents. Possible outcomes will hopefully be a more effective and safer management of this condition.

The Predict-CP cohort provides further follow-up at 8-12 years of two overlapping preschool-age cohorts examined from 2-5 years (NHMRC465128 motor and brain development; NHMRC569605 growth, nutrition and physical activity). This population based cohort study undertakes state-wide surveillance of 245 children with CP born in Queensland (birth years 2006-2009). Children will be classified for Gross Motor Function Classification System (GMFCS); Manual Ability Classification System (MACS), Communication (CSFS) and OPD (EDACS). Outcomes include gross motor function, musculoskeletal development (hip displacement, spasticity, muscle contracture), upper limb function, communication difficulties, participation, parent and child reported quality of life and medical and allied health resource use. These detailed phenotypical data will be compared to brain macro and micro structure using 3T MRI. Relationships between brain lesion severity and outcomes will be analysed using multilevel mixed-effects models.

The clinical utility of ketamine as demonstrated efficacy as a novel antidepressant and anti-anxiolytic, as well as a low-risk, effective tool to manage chronic pain among treatment resistant patients. Perhaps paradoxically, however, the associated cognitive, behavioural and attention impairments pose significant implications for driving ability and road safety. Despite this, no studies are currently available which explicitly assess the effect of sub-anaesthetic doses of ketamine on several facets of neurocognitive functioning related to driving performance, as well as explicit assessments of driving impairment. This study aims to assess the effect of three doses of intravenously (IV) administered ketamine infusions delivered in an increasing step-dose manner on measures of higher-order cognitive processes and driving simulator performance. We will also assess the relatedness between the level of ketamine in the blood samples and over the 8 hour testing session in order to assess the relationship between ketamine blood concentration, cognitive function and driving ability. We also want to monitor the relationship between the treatment (ketamine infusion low, medium or high dose) and levels of subjective alertness over time, and how this relates to performance outcomes on the cognitive and driving tasks.

The research project proposed is to develop cardiac magnetic resonance imaging (CMRI) techniques currently used at standard magnetic field strengths (1.5 or 3 Tesla) for significantly higher field strengths at 7 Tesla (7T). The aims are as follows: 1. To valuate the performance of 7T CMRI compared with standard clinical CMRI at 1.5T. 2. To determine whether 7T CMRI can provide adequate images to measure heart function and cardiac scar imaging. Methods: Participants will be recruited from patients with cardiac scar tissue undergoing routine clinical CMRI with gadolinium contrast agent at 1.5T. All recruited subjects will have an additional 7T CMRI with gadolinium contrast agent. CMRI is a painless, non-invasive test that involves lying in a scanner for a duration of approximately 1 hr. The results of the clinical 1.5T CMRI scan and the experimental 7T CMRI scan will be compared.

The prevalence of type 2 diabetes (T2D) and its associated complications represents a major global health hazard. According to the Diabetes Australia, the number of individuals with T2D reached 1.7 million with 1.2 million diagnosed and registered cases. Individuals with T2D are associated with two-four fold increased the risk of cardiovascular diseases (CVD) such as stroke, peripheral vascular disease, myocardial infarction and angina pectoris. CVD accounts for more than 70% of deaths in patients with T2D. Epidemiological studies documented T2D as an independent risk factor for CVD in both men and women. Despite effective glucose control measures and advances in the management of CVD in T2D, several other chronic risk factors like high blood pressure, abnormal triglycerides, small dense LDL particles, low HDL-C and insulin resistance increase the risk of developing CVD in individuals with type 2 diabetes. T2D related changes in the plasma lipid levels are key factors among the other factors that are manageable by interventions to control the CVD risk. It is well documented that combination of high plasma triglyceride levels and low HDL-C (HDL-C2) is well associated with cardiovascular risk. The previous meta-analysis has reported that every 1mmol/L increase in triglyceride increase cardiovascular disease risk by 32% in men and 76% increase in women. Along with the triglycerides, the glycosylation and oxidation of LDL particles differ in type 2 diabetes when compared with non-diabetic individuals. Several randomized controlled trials have supported the association of the reduction of LDL-C (up to 1mmol/L) with reduced cardiovascular disease. Targeting blood lipids and inflammation in type 2 diabetes individuals who are at a high risk of developing CVD will help to resolute these modifiable risk factors and presumably reduce the overall risk of developing CVD. In the present study, we propose to evaluate the complementary and/or synergistic effects of curcumin and n-3PUFA in modulating lipid profiles (decrease in triglycerides and small dense LDL-C particles) in individuals with type 2 diabetes through a 6 weeks factorial randomised controlled trial . We also evaluate the effects of curcumin and LCn-3PUFA on secondary outcomes such as inflammation, blood glucose, and blood pressure.

An observational, non-randomised pilot study in children and adolescents, 5 -18 years of age, with Type 1 Diabetes of a non-invasive device for monitoring signs of hypoglycaemia. The Firefly Monitoring Device, is a non-invasive wrist-band device which is worn overnight for 6 nights at home to monitor signs of hypoglycaemia such as physiological tremor using mutiple sensors. The Firefly Monitoring device is worn along with a continous glucose monitor (CGM) to assist in measuring glucose levels. The aim of this study is to refine the hypoglycaemia detection system of the Firefly Monitoring Devce in children and adolescents.

Objectives: To examine the efficacy of compound topical Gabapentin, Amitriptyline, and Lignocaine ointment for the treatment of acute and intermediate pain post-haemorrhoidectomy surgery, when compared with placebo. Design, setting, and participants: Prospective, double blinded, randomised, controlled, two-arm superiority trial conducted at a single Victorian site. Patient recruitment will be conducted between November 2016 and December 2017 of patients with grade III or IV haemorrhoids. The study will require 166 adult patients randomly allocated to have formal haemorrhoidectomy followed with either post-operative compound topical Gabapentin, Amitriptyline, and Lignocaine ointment (Group A), or placebo ointment (Group B). Patients, and treating team are blinded to group allocations. Interventions: Both groups will be receiving formal haemorrhoidectomy under general anaesthesia, with the conventional intra­operative pudendal nerve block, and post­operative oral opioid pro re nata. Post-operatively patients will be randomised to either receive the compound topical Gabapentin, Amitriptyline, and Lignocaine ointment (Group A) or placebo ointment (Group B). Main outcome measure: The quality of post-haemorrhoidectomy pain control by measuring Visual Analogue Score (VAS) recorded in an individualised pain diary, and also measuring the amount of additional pro re nata opioid consumption required for analgesia. Monitoring for the presence of urinary retention, or any faecal impaction will also be made, as a secondary measure of pain post-haemorrhoidectomy surgery. Conclusion: Compound topical Gabapentin, Amitriptyline, and Lignocaine ointment is expected to produce better quality post-haemorrhoidectomy pain control, when compared with placebo ointment.

Cognitive impairment is a significant cause of psychosocial disability in people with schizophrenia and schizoaffective disorder, and persists even when psychiatric symptoms are well managed. Cognitive remediation has demonstrated much promise as a method of alleviating cognitive symptoms and supporting improvements in real-world functioning. Nevertheless, well-controlled research trials remain a minority in the research literature, particularly those focusing on self-reported psychosocial outcomes that form key components of recovery from mental illness. There is also little consideration of patient related factors that may impact treatment adherence or success. At Monash University, in affiliation with the Monash Alfred Psychiatry research centre, we are running a randomized controlled trial to explore the unique benefits of CR on cognitive and self-reported psychosocial outcomes when compared to an active control in a population with schizophrenia or schizoaffective disorder. We will also examine the role of patient-related factors in predicting treatment-related outcomes and qualitatively explore the lived experience of participation in a social group based intervention.

An Healthy Volunteer, Open-Label, Cross-Over Phase I Study to Determine the Safety, Tolerability and Pharmacokinetics of a Single Oral Dose of AWP-09VDB-S under Fed and Fasted Conditions. AWP-09VDB-S is a novel formulation of zanamivir, neuraminidase inhibitor used for the treatment and prophylaxis of influenza, and the permeability enhancers glycerol and Capmul MCM C8 presented in a gastric resistant capsule.

Geriatric Evaluation and Management (GEM), sometimes called slow stream rehabilitation, manages patients with complex conditions associated with ageing, cognitive dysfunction, chronic illness and disability. A multidisciplinary team provides care that helps the person to return home with optimal levels of health. There is strong evidence that Geriatric Evaluation and Management works but hospital length of stay is long and the service is typically only provided from Monday to Friday. Providing Saturday allied health services in other areas of rehabilitation reduces length of stay. Using routinely collected patient data, this project will find out if the introduction by the health service of a Saturday multidisciplinary allied health service in Geriatric Evaluation and Management is a cost effective way of reducing length of stay and improving health outcomes.