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A comparison of Internet-based Cognitive Behavioural Therapy for Posttraumatic Stress Disorder with and without exposure: A randomized controlled trial
The purpose of this project is to explore the relative efficacy of three education programs in reducing PTSD symptoms in a population of adults (aged 18-75), when administered over the internet. A secondary purpose is to determine how acceptable people find each form of treatment. The study will inform how services can best improve future treatment programs for adults with PTSD.
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Muscle power training in Parkinson’s disease
Muscle power is reduced in people with Parkinson’s disease and is associated with reduced walking speed and falls. The aim of this randomised controlled trial is to determine whether the benefits of muscle power training on walking speed and balance demonstrated in the older general population can be gained by people with Parkinson’s disease. Muscle power training deliberately targets the fundamental problem of slowness of movement, making evaluation of the effect of this training an urgent research priority with potential to improve walking and balance in people with Parkinson's disease as well as provide insights into mechanisms underlying effects.
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Permissive HyperthErmia Through Avoidance of Paracetamol in Known or Suspected Infection in the Intensive Care Unit (ICU) - pilot study
Fever is an adaptive response to infections which occurs widely in the animal kingdom. The suppression of fever increases the risk of mortality in animals, although the effect of antipyretics in critically ill patients is unknown. The objective of this study is to determine whether paracetamol influences the risk of mortality in critically ill patients with fever and known or suspected infection. A phase 2b double blind randomised placebo controlled trial of paracetamol will be undertaken in 700 patients with fever and known or suspected infection in New Zealand and Australia under the auspices of the Australian and New Zealand Intensive Care Society Clinical Trials Group (ANZICS CTG). If either the aggressive or permissive antipyretic regimes influence outcomes including survival in patients with fever and infection, the findings will have a major impact on the burden of infectious disease in New Zealand and internationally.
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The effect of meals rich in carbohydrate and fat on metabolism and inflammation
Type 2 diabetes is an increasingly common disorder characterized by a poor response of the body’s tissues to insulin and impaired secretion of insulin from the insulin producing cells in the pancreas. The mechanisms causing these two defects are still poorly understood. Moreover, there are signs of chronic inflammation in the body, but its role in diabetes and the contribution of the immune system to this process is not known. We believe that studying the metabolic responses to glucose and insulin in subjects with or without a family history of diabetes will advance our understanding of early underlying impairments, possibly contributing to the development of diabetes.
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Validation of the Brain Anaesthesia Response (BAR) Monitoring System during Anaesthesia for Cardiac Surgery: a Double-Blinded, Randomised, Controlled Trial using Two Different Doses of Fentanyl.
The Brain Anaesthesia Response (BAR) monitor system is designed to non-invasively monitor brain function in response to anaesthetic and sedative agents. Electroencephalography (EEG) signals are collected using the sensor which is applied to the patients’ forehead. The signals are processed to calculate two BAR indices, Cortical State (CS) and Cortical Input (CI). The displayed indices are designed to assist the anaesthetist to estimate the levels of consciousness and analgesia of a patient during general anaesthesia. The study is designed to investigate whether the BAR indices recorded in the operating room environment can distinguish between two groups of patients anaesthetised with either a low or a moderate dose of fentanyl and show clinically meaningful correlations with levels of hypnosis.
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The Fit 4 Fun Program: Promoting physical fitness and health in primary school children (phase 2)
The aim of this research project (RCT) is to evaluate the impact of a school-based health-related fitness intervention (Fit 4 Fun) on the fitness and activity levels, and attitudes towards physical fitness, of Stage 3 primary school students. The study will assess changes over 10 weeks and 6-months. Phase 1 of the study evaluated the preliminary feasibility and efficacy of the program for use in primary schools. This phase of the study (Phase 2) will evaluate the feasibility and efficacy of the program using a larger sample group.
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Assessing Cognitive Function in the Elderly Through Telemedicine.
BACKGROUND: The suitability of video conferencing (VC) technology for clinical purposes relevant to geriatric medicine is still being established. OBJECTIVES: This project aimed to identify the validity of the diagnosis of dementia via VC. DESIGN: This was a multi-site, non-inferiority, prospective cohort study. All patients were assessed independently by two specialist physicians. They were allocated one FTF assessment (Standard Clinical Practice) and an additional assessment (either standard FTF assessment or a VC assessment) on the same day. The order of assessment, both doctor and format, was randomized. Each physician had access to the patient chart and the results of a battery of standardised cognitive assessments administered FTF by the clinic nurse. SETTING: Four Memory Disorders Clinics. PATIENTS: Patients, aged 50 years and over, referred by their GP for cognitive assessment. MEASUREMENTS: Percentage agreement (P0) and the weighted kappa statistic with linear weight (Kw) were used to assess interrater reliability across the two study arms on the diagnosis of dementia (cognition normal, impaired or demented). RESULTS: Of 270 eligible patients, 210 underwent randomisation, with a final sample of 205 available for analysis: Videoconference Group (n=100) or Control Group (n=105). 106 were male. The average age was 76 (SD9, 51-95) and the average Standardised Mini-Mental State Examination Score was 23.9 (SD4.7, 9-30). Agreement for the Videoconference Group (PO= 0.71; kw = 0.52; p<0.0001) and agreement for the Control Group (PO= 0.70; kW = 0.50; p<0.0001) were both statistically significant (p<0.05). The summary kappa statistic of 0.51 (p=0.84) indicated that VC was not inferior to FTF assessment. LIMITATIONS: This study included a range of experienced and relatively newly qualified specialist physicians for the paired assessments. CONCLUSIONS: The diagnosis of dementia was reliable when assessed by VC.
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The effects of Glucagon-Like Peptide 1 on gastric emptying in healthy volunteers with normal or low blood glucose levels
This study aims to determine the effects of Glucagon-Like Peptide-1 (a hormone) on gastric (stomach) emptying in heathly volunteers with normal and low blood sugar levels. In particular, the study aims to answer the question: does the slowing of stomach emptying caused by Glucagon-Like Peptide-1 persist even when a person has low blood sugar levels? The 'null hypothesis' is that the effects of Glucagon-Like Peptide-1 on gastric emptying will be unaffected by blood sugar levels. This study is important because important safety implications arise from the relationship between slowed gastric emptying caused by Glucagon-Like Peptide-1 and blood sugar levels. If a patient is receiving Glucagon-Like Peptide-1 as a therapy for Type II Diabetes Mellitus and also develops low blood sugar levels, then the rate his / her stomach empties is important for the correction of the low blood sugar levels.
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The Hunter Humira and Endothelial Function in Early Rheumatoid Arthritis Trial
Introduction Rheumatoid arthritis is a severe destructive inflammatory arthritis that affects 1.5% of the population. The anti-CCP antibody positive subgroup experience a 50% increased risk of cardiovascular events that is directly related to the disease process although the mechanisms of this remain unclear. There is mounting evidence that a “window of opportunity” exists during which time treatment is more likely to achieve remission. It therefore seems possible that a similar window of opportunity might exist for the treatment of vascular disease in rheumatoid arthritis. New effective treatments for rheumatoid arthritis called the "Biologics" have become widely available over the last decade. This has resulted in dramatic improvements in the treatment of the arthritis. However, it remains unclear whether these treatments influence the risk of cardiovascular events. Pooled analyses of the large trials have not had sufficient power and are of insufficient duration to answer this question. Meta-analysis of the combined registry data found dramatic differences in the TNF-inhibitor treated group but these effects may be explained by confounding. Studies using assessments of pre-clinical vascular disease using imaging and physiological assessments of arterial stiffness seem more likely to show treatment effects but have thus far been inconclusive. Based upon studies in hypertension it is likely that studies utilising assessments of arterial stiffness and carotid artery wall thickness would require randomised controlled trials of considerable size and duration to detect treatment effects. Earlier pathological processes in vascular disease such as endothelial dysfunction are more likely to change quickly and detectably in response to treatment. However, studies have been inconclusive possibly due to the small sample sizes, insufficient study duration and because the studies evaluated subject with established and possibly irreversible disease. The Australian PBS funds Biologic drugs for patients with rheumatoid arthritis only after they have failed to respond to 6 months conventional DMARD therapy. This 6 month period presents an opportunity to evaluate the effects of TNF-inhibition (with adalimumab) upon vascular function in a randomised controlled trial while at the same time enhancing patient care. This phase 2, single-centre, double-blind randomised, placebo-controlled study will evaluate the effects of adalimumab upon endothelial function in early and established anti-CCP positive rheumatoid arthritis. Methods Two groups will be studied in a randomised, controlled trial: 1. 30 subjects with Early Anti-CCP Positive Rheumatoid Arthritis (<12 months disease duration, age 18-50 years) and ; 2. 30 subjects with Established Anti-CCP Positive Rheumatoid Arthritis (>12 mths disease duration, age>18 years) Subjects within each group will be randomised 1:1 to receive adalimumab / placebo for 24 weeks in addition to "usual care”.
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Research study into the McKenzie method and motor control exercises on low back pain
The purpose of this study is to investigate the effect that the McKenzie method or lower abdominal exercises have on the thickness of the lower abdominal muscles in patients who have chronic low back pain when measured from images taken from real time ultrasound scans. We believe that patients who receive specific lower abdominal exercises will show an increase in thickness of these muscles while those who receive the McKenzie method will not show any thickening of these muscles, while pain and disability will improve similarly in both groups.