ANZCTR search results

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.

This is a retrospective study of the influence of intra-operative blood pressure management and depth of anaesthesia on mortality after fractured neck of femur (NOF) surgery. Hospital admission and surgery for hip fractures is very common, and is associated with a high mortality rate. To date, finding anaesthesia interventions which could influence mortality has been unsuccessful. This study will review the medical, surgical, and anaesthesia records of patients admitted for NOF surgery in a 4 year period (2012 – 2016) in Liverpool Hospital. Relevant anaesthesia data, such as blood pressure pre- and intra-operatively, as well as depth of anaesthesia levels, will be collected. NOF patients will be identified through the Department of Orthopaedics database of surgical operations records for the same period. This also records 30- and 120-day mortality. This will allow researchers to analyse the impact of anaesthesia management on post-operative mortality.

Congenital myopathies refers to a group of muscle disorders that appears in infancy. It results in muscle weakness due to abnormalities within the muscle cell. Congenital myopathies as a group are one of the most common neuromuscular disorders. There are no effective medicines or exercise regimes that currently exist to improve the muscle weakness for these children. Their muscle weakness leads to difficulty in doing normal physical activities, like getting dressed, walking, climbing stairs or opening jars. We think that a home exercise program could increase their muscle size and strength, to help them perform physical activities better. We think the home exercise programme could also improve the strength of their bones, reducing the chance of a fracture, and improve their quality of life. The home exercise programme will use Whole body vibration training (WBVT). To use WBVT, children stand on a specialised vibration platform that moves like a see-saw, a few millimetres at a time, exercising the muscles, for a few minutes a day. WBVT is an emerging, simple and safe training method, which has been shown to improve muscle function and fitness in adults and children, and we think could help children with congenital myopathies also. Children in the study will undergo comprehensive clinical assessments at baseline and after the 3 month WBVT treatment period. This will then be compared with an observation period of 3 months. Children will then repeat the WBVT treatment for another 3 months, followed by a further observation period of 3 months with assessments after each stage. This novel therapy is non-invasive, simple, and potentially could help affected children maintain their ability to walk, perform physical activities, and improve their quality of life.