ANZCTR search results

The purpose of this trial is to assess whether a high CBD/low THC medicinal cannabis oil product [CannEpil. 20:1 cannabidiol (CBD) to (-) -trans-9-tetrahydrocannabinol (THC)] causes driving impairment using a high fidelity driving simulator. In particular the study will assess whether this medicinal cannabis product causes changes in the standard deviation of the lateral position (SDLP) variable obtained from the driving simulator compared to placebo. Additionally, the project aims will explore the subjective mood and sedative effects of this medicinal cannabis product compared to placebo. 31 participants will undergo a screening and practice visit followed by two testing visits spaced at least one week apart. At each testing visit they will receive either CBD/THC treatment or placebo in a crossover design. Participants will be instructed to consume a standardised breakfast prior to each testing session. During each testing visit participants will complete a driving simulation, cognitive tasks and questionnaires as well as having blood and saliva samples taken.

Obese people comprise 33% of Western Sydney and are 6x and 10x more likely to develop diabetes and non-alcoholic fatty liver disease (NAFLD), respectively, compared to normal weight individuals. This trend will lead to alarming rates of cardiovascular death, liver cirrhosis (scarring) and liver cancer. Weight loss can lead to diabetes remission and can be achieved successfully using very low calorie diets (VLCD), with rates close to 86% in adults. Additionally, a widely available and effective diabetes therapy – glucagon-like peptide-1 receptor analogues (GLP1-RA) – also assist with weight loss. Both treatments lead to significant weight loss, improve diabetes, and can reverse liver damage caused by NAFLD, yet the combination of these treatments has never been studied. This is a pragmatic pilot study of patients attending the Metabolic and Weight Loss Program at Blacktown hospital to investigate the efficacy of VLCD +/- GLP1-RA in achieving diabetes control and reversal of liver injury. This will lead directly to practice change by senior clinicians involved in the study and improve patient care in the clinics at Blacktown hospital, and potentially further afield.

Consuming fruits and vegetables, which naturally contain antioxidants, reduces the risk of developing chronic diseases potentially through reducing oxidative stress and low-grade inflammation in the body. Oxidative stress and inflammation (OSI) are common and are associated with meal digestion, however this only lasts for a short period of time in healthy bodies. We hypothesise that by matching the time when antioxidants are taken and are present in the blood with the onset of post-meal OSI we can optimise the benefits of the antioxidants. This study will provide data on the time course and appearance of markers of oxidative stress and inflammation following a meal.

Background Management of dyspepsia in Australian Emergency Departments (ED) typically includes lidocaine viscous and an antacid (pink lady or pink mix). We will investigate whether the addition of either lidocaine viscous or lidocaine solution improves analgesic efficacy, compared to an antacid monotherapy. Methods A double-blind randomised controlled trial will be undertaken in the ED of the Royal Melbourne Hospital, 7 days a week from 0800 to 2300. Patients prescribed a pink lady by the treating clinician and meeting inclusion criteria will be invited to participate. Patients will be randomly allocated one of three solutions. Option 1: 10mL oral lidocaine 2% viscous plus 10mL Gastrogel, option 2: 10mL lidocaine solution 2% plus 10mL Gastrogel, option 3: 20mL Gastrogel. Patient and investigator will be blinded to the medication given, and a pain score taken at t = 0, 30 and 60 minutes. The primary outcome will be the change in pain on a visual analogue scale at 60 minutes. Secondary outcomes include the change in pain scores at 30 minutes and an evaluation of taste, bitterness, texture and overall acceptability score using visual analogue scores. Proportions will be tested for significance using the chi-square test. Continuous variables are assumed to be non-parametric and will be tested using the Kruskal-Wallis test for difference in populations.

The overall aim of this research is to compare the effects of using special contoured insoles compared to flat insoles in people who suffer painful osteoarthritis (OA) in their big toe joint. To test this, participants who have big toe OA and are eligible to take part in the study, will be allocated into two different insole groups via a random process. All participants will see a podiatrist who will provide one pair of insoles (either flat or contoured depending on which group they are in), which they will be instructed to wear at all times when wearing shoes for the following 12 weeks.

Recent studies have described the change in blood magnesium levels following its administration to children, pregnant women and patients who have had cardiac surgery. We wish to study the effects of IV magnesium supplementation in the general adult ICU population, specifically those who are receiving both ventilatory and blood pressure support. We also wish to study the effect of kidney function on IV magnesium supplementation in these patients. We aim to assess the blood and urine levels of magnesium immediately prior to and during magnesium replacement, administered as a 1-hour bolus followed by a 24-hour infusion, in 30 critically ill patients admitted to the Austin Hospital ICU. Blood and urine samples are already routinely collected in ICU patients for monitoring purposes; it is not anticipated that the additional tests would cause any harm. Retrospectively, we will also record basic demographic and admission details about the patients so that we can appropriately describe the study cohort. It is hoped that the information gathered from this study would fill a fundamental gap in our knowledge of IV magnesium supplementation in the critically unwell patient, helping clinicians to standardise their practice regarding the usage of magnesium.

The Entourage project is funded by the Movember Foundation's 2018 Social Innovators Challenge and seeks to address symptoms of social anxiety in young people. The primary aim of the project is to improve social connectedness, reduce loneliness and isolation and restore social functioning in young people with social anxiety. The Entourage project will achieve these goals by piloting a dynamic, integrating e-mentoring and social networking platform based on the moderated online social therapy (MOST) model. Overarching goals of the project include determining the acceptability, feasibility and long-term sustainability of the intervention platform.

Summary Aim: To investigate the effect of intraoperative acupuncture on postoperative pain in children following tonsillectomy. Background: Tonsillectomy in children is usually accompanied by significant morbidity, including postoperative bleeding, pain, nausea, vomiting, poor oral intake and dehydration. Recent evidences in literature indicate that acupuncture may have a role in reducing postoperative pain in these children. Methods: This prospective randomized controlled trial is to evaluate the effectiveness of intraoperative acupuncture in reducing pain following tonsillectomy in 251 children. All patients received a standardised anaesthesia and surgery including intraoperative Morphine, Dexamethasone, Granisetron and Clonidine. In the acupuncture group, acupuncture was applied at 10 specified points immediately after induction of anaesthesia. Postoperative pain relief consisted of regular Paracetamol and Oxycodone as required. All patients, nursing staffs and parents are blinded. All assessors evaluated postoperative pain using the Face, Legs, Activity, Cry, Consolability (FLACC) pain scale. Pain scores were recorded at regular intervals during the first 24 hours in hospital and on day 1,2 and 5 following discharge at home.

Postprandial (post-meal consumption) blood triglyceride level has emerged as a clinically relevant risk factor for the development of cardiovascular disease. It is normal for postprandial triglycerides to rise after a fat-rich meal, however, elevated and excessive postprandial plasma triglyceride levels are associated with several cardio-metabolic events such as the formation of atherosclerosis. Long chain omega 3 fatty acids (eicosapentanoic acid and docosahexaenoic acid) are established triglyceride lowering agents which are primarily obtained from marine sources or fish oil. Medium chain fatty acids (MCFA, 6-12 carbon atoms) derived from coconut oil have been shown to lower triglyceride levels and raise HDL-cholesterol compared to long-chain saturated fatty acids in preclinical studies. The purpose of this trial is to investigate the combination of a single dose of dietary MCFA (coconut oil) and LCn-3PUFA (fish oil) on the post-meal rise in blood triglyceride levels in healthy individuals.

Non-healing soft tissue and malignant wounds can be very challenging to treat in the palliative care setting. Instead of complete healing, the goals of care in this setting are to reduce symptoms such as malodour, exudate and pain, to maintain patients’ dignity and to improve quality of life. This study aims to investigate the use of sterile larvae therapy in treating non-healing soft tissue and malignant wounds in the palliative care setting.