ANZCTR search results

With the increasing incidence of type 2 diabetes and heart disease, people are routinely advised to reduce the intake of sugars (high glycemic index foods) and increase the intake of whole grains and fibre rich (low glycemic index) foods. It has been suggested that consumption of whole grains and fibre rich foods leads to an improved blood glucose and triglyceride (blood fat or lipid) status, which may reduce the risk of diabetes and heart disease. On the other hand, some research suggests that increased intake of protein may be a better option than carbohydrate and fibre rich whole grains. The study aims to investigate and compare the effects of three different meals, providing different amounts of GI content or protein, on post-meal glucose, insulin, triglycerides, brachial and central blood pressure and platelet aggregation.

The primary purpose of the study is to observe the effect of anti-immunoglobulin E antibody in the treatment of a small number of people with symptomatic mastocytosis.

The broad aim of this study is to deliver a personalised smoking cessation intervention within a community pharmacy setting. The specific aims are to test the efficacy of an intervention based on personalised, vivid illustrations of 'smoker's face' on quitting, quit attempts or 'state of change' progression attitudes among young smokers (18-30 years old). The study hypothesis: If quit attempts or ‘state of change’ progression attitudes are related to personalised smoking photo-ageing pictures, then exposing young smokers (18-30 years old) to their smoking photo aged picture in community pharmacies will result in higher rates of quit attempts or ‘state of change’ progression attitudes.

Subjects will be examined for the presence of head louse eggs. Those subjects who have at least 20 live eggs will be randomised into one of 3 treatment groups. Pre-treatment: 10 eggs will be removed from the head by cutting the single hair with the live egg attached, before the treatment. Treatment: The subject will then receive a single treatment application according to manufacturers instructions. Then the treatment will be washed from the hair as per the manufacturer’s instructions. Post-treatment: At least 10 treated (live) eggs will be removed from the head by cutting the single hair with the egg attached, after the treatment. All of the eggs will be held in an incubator for 14 days. The proportion of eggs which hatch after 14 days will be compared for the pre-treatment and post-treatment eggs. Demographic data will be collected for each subject (hair type, hair colour, hair length, subject age, subject sex) to investigate the affect of hair type on ovicidal efficacy.

CLARIFY is an international, observational, longitudianl registry in stable coronary artery disease outpatients with 5 year follow up. The registry will improve knowledge surrounding the care of outpatients with coronary artery disease.

Aim of Study: To determine the therapeutic efficacy and effects on arterial function of oral L-citrulline and of the combination of L-citrulline and BH4 in patients with peripheral arterial disease Background to study: Loss of the protective actions of L-arginine derived nitric oxide is a cardinal feature of endothelial dysfunction, which contributes to the pathogenesis and progression of cardiovascular disease. Supplementation with L-arginine has been shown to improve vascular function in some but not all clinical studies. Importantly L-arginine bioavailability is low. In contrast L-citrulline, a natural precursor of L-arginine, raises plasma L-arginine levels more effectively. In addition there is a naturally occurring substance called tetrahydrobipterin (BH4) which is a key co-factor in the production of nitric oxide. We believe that there may be additional benefit using the combination (L-citrulline plus BH4). Therefore this study will investigate the clinical effects of oral L-citrulline and combined BH4 supplementation in patients with peripheral arterial disease.

Research Hypothesis: In HIV-infected subjects who have virologically failed first-line antiretroviral therapy comprising 2NRTI + NNRTI a regimen of second-line therapy incorporating ritonavir-boosted lopinavir and raltegravir provides comparable (i.e. non-inferior) antiretroviral efficacy over 48 weeks to a regimen containing ritonavir-boosted lopinavir and 2-3NRTIs. Study Design: This is a Phase IIIb/IV, international, randomised, open label study comparing two regimens of combination antiretroviral therapy in people living with HIV with confirmed virological failure of first-line NNRTI/2 NRTI regimens. The study will run for 96-weeks but the primary analysis will take place at the week 48 time point. Eligible participants will be randomised in equal proportions to one of two regimens of combination ART as follows: I. ritonavir boosted lopinavir (LPV/r) + 2-3NRTIs II. ritonavir boosted lopinavir (LPV/r) + raltegravir Number of Subjects per Group: Approximately 275 eligible subjects will be randomly allocated to each of the two treatment arms giving a study total of 550 participants.

The aim for the current trial is to understand how polyphenols affect cognition, brain functioning and blood flow for both acute and chronic doses. We wish to explore the acute (single dose) and four-week (28 doses) neuro-cognitive effects of polyphenols in 72 healthy middle aged volunteers. The cognitive effects will be assessed using the CDR computerised cognitive assessment system and the neurophysiological effects will be measured using high spatial resolution electrical brain recordings measures by the Steady State Topography technique (SST) which has been pioneered at the Brain Sciences Institute and used in over 50 published studies. The cardiovascular effects will be measured using Transcranail Doppler Ultrasound to measure blood flow and the sphygmocor system to measure arterial stiffness

Eligible patients - brain tumour Aim - to develop new, more sensitive Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) measures for detecting early treatment response Treated as per standard practice with the addition of 3 3,4-dihydroxy-6-fluoro-phenylalanine (FDOPA) PET scans.

Confirmation of correct nasogastric tube (NGT) placement is essential to ensure the safe delivery of nutrition without the risk of morbidity and mortality associated with misplacement in the lung resulting in aspiration, pneumonia, pneumothorax or death. Previous studies indicate a pH < 4 is indicative of gastric aspirate and hence a reliable indicator of correct NGT placement. At the Royal Children’s Hospital (RCH) in Melbourne, the current practice is to use this pH cut-off < 4 based on Metheny’s work, but this is not always clinically practical. The use of antacid medication and/or the presence of enteral feeds due to delayed gastric emptying may be contributing factors in a higher pH result, casting doubt on NGT position. A number of different clinical methods have been reported to determine NGT position including auscultation (listening for air passed down the tube), aspirate colour, administering oral fluids or flushing NGT with oral rehydration solution (ORS), but none are evidence-based methods. Radiography confirmation is the gold standard but has limited application secondary to availability, cost and radiation exposure. This study was undertaken to directly compare pH results of gastric aspirate samples with endotracheal aspirate samples, and particularly to examine potential overlap of pH results between the aspirate samples. This data can then be used to establish a reliable and clinically practical pH cut-off value for gastric aspirate without risking the safety of the patient by not identifying a misplaced NGT in the lung. Whilst undertaking this study, an adverse nasogastric-feeding incident occurred in the UK which led to the formation of a working party to challenge the assumptions and rituals of NGT placement. An NGT algorithm was developed using a risk assessment approach to improve the safety of NGT fed children and increase the awareness of the risks to health care providers. Subsequently, the National Patient Safety Agency (NPSA) published an alert that accepted a pH cut-off <5.5 as being an acceptable risk. This was decided by expert opinion and consensus rather than the result of new clinical research. This current study will provide further evidence for this consensus statement and ensure that our recommendations are based on evidence-based practice and lead to reduced patient risk. We compare the range of pH results between gastric and endotrachael aspirate samples, with particular interest in the area of overlap between the two samples. This data will help to determine a reliable and practical pH value to confirm NGT placement, without increasing the risk of not identifying a misplaced NGT.