ANZCTR search results

Understanding diurnal IOP variations over a 6 week period may provide clinically useful information to guide management decisions in patients with confirmed glaucoma who are commencing treatment or patients at risk of developing glaucoma. We hypothesize that extended IOP self-monitoring will provide refined insight of the patient’s response to treatment and diurnal IOP data that should enhance classification of the patients according to glaucoma progression risk. Such results may significantly alter glaucoma management and improve outcomes.

A proportion of individuals with schizophrenia (SZ) do not respond adequately to clozapine, with anything from 40-60% of individuals having residual symptoms at the completion of an adequate trial of clozapine. Agents that could work synergistically with clozapine to improve efficacy whilst not increasing the side effect burden are both desired and necessary to improve the lives of individuals with clozapine-resistant SZ, such as N-acetyl cysteine (NAC). Our group has extensive experience with NAC with pilot data support from a rigorous RCT exploring the efficacy of NAC in clozapine-resistant SZ. This project grant seeks funding to expand this work by conducting a multi-site randomised placebo-controlled trial of NAC in the treatment of clozapine-resistant schizophrenia, with 8, 24 and 52 week endpoints. We will target negative symptoms as our primary outcome measure, with quality of life and cognition as secondary outcomes. We will examine both peripheral and cortical glutathione concentrations. Additionally, we will measure a number of other biomarkers pertinent to the glutathione hypothesis. Such analyses will further our understanding the role of oxidative stress in SZ. The trial is a randomised controlled double-blinded superiority trial of two parallel patient groups. The study will be conducted across four Australian sites, namely Melbourne (St Vincent’s Mental Health Service), Sydney (Cumberland Hospital), Adelaide (Northern Adelaide Local Health Network), and Brisbane (Metro South Addiction and Mental Health Service). Forty-two patients will be recruited from each of the sites, with a total target of 168 patients aged 18 - 65 years meeting DSM-5 criteria for schizophrenia. Block randomisation will be used. This trial, if successful, will establish a cheap, safe and easy-to-use agent (NAC) as a ‘go to’ adjunct in patients only partly responsive to clozapine.

We have previously demonstrated that consuming a mixture of whey protein and guar gum (a dietary fibre) before a meal (as a “preload”) can slow stomach emptying and improve blood sugar control after the meal in people with type 2 diabetes. In the current study, we want to compare the effects of the whey protein and guar gum given either separately or in combination in people with type 2 diabetes. The current study is designed to evaluate the acute effects of whey protein and guar gum given in advance of the main meal either alone or in combination, on postprandial glycaemia (glucose levels after a meal), gastric emptying, glucose absorption, and the release of gut hormones and insulin in patients with type 2 diabetes.

Patients whom admitted to the intensive care unit commonly suffer from feeding intolerability. This can cause malnutrition and even increase their chances of dying. Erythromycin which is a kind of antibiotics has been shown that in low doses it can induce feeding tolerance, by acting on a specific targets in the stomach and gut. This study is intended to research whether a continuous infusion of lower dose of erythromycin is better than intermittent administration of the drug.

This is a pilot study to gain initial data for understanding how treatments of chronic pain in the lower back work. Subjects will be randomised to one of two treatment groups. One group will receive manual therapy (physiotherapists do this to reduce pain and muscle spasm) and muscle control treatment (training of the stomach and back muscles to activate when they should) at a physiotherapy centre (Advance Healthcare) over the course of 6 months. Another group will receive spine and general physical conditioning exercise (including muscle strengthening, improving endurance, improving posture control and balance) at Deakin University over the course of 6 months. To assess the response to the different treatment protocols, magnetic resonance imaging scanning, tests of muscle strength, performance and endurance, dual x-ray absorptiometry scan of the lumbar spine and whole body composition, a series of questionnaires, and the assessment of how muscle activation occurs in the brain will be performed. Each of these tests will be done three times: at the start of the study before randomisation, then after 3 months and then at the end of the study at 6 months. Subjects will also complete a short questionnaire every two weeks to monitor their progress.

Our primary aim is to compare the effectiveness of ultrasound-guided corticosteroid injections to foot orthoses (shoe insoles) for individuals with plantar heel pain, using an assessor-blinded randomised trial. Our hypothesis is that corticosteroid injections will be more effective in the short-term (0-4 weeks), while foot orthoses will be more effective in the longer term (5-12 weeks). Our secondary aims are to compare the effectiveness of corticosteroid injections to foot orthoses on: foot function; general health; plantar fascia thickness; work, sport and recreation; and fear-avoidance beliefs.

This study aims to determine whether a scan called Pentixafor-PET is a more accurate imaging test than the standard FDG-PET scan in patients with Non-Small Cell Lung Cancer (NSCLC). You may be eligible to join this study if you are aged 40 years or above and have a histological diagnosis of NSCLC and require an 18F-FDG PET/CT as part of routine work-up for diagnosis and staging. All participants in this study will have a standard FDG PET scan as part of their cancer staging, as well as a second PET scan using the experimental tracer agent Pentixafor. This will involve a second scan on a separate day within 2 weeks of the first scan. This will not delay or affect your treatment. If you participate in this trial a small dose of tracer will be administered via a cannula in the arm or hand. There will be a small additional radiation dose from the scan which is unlikely to result in any significant short or long term consequences. The test will usually take less than 2 hours. Results of the two tests will be compared by two specialist doctors in order to determine whether the new Pentixafor-PET scan is more accurate than the FDG-PET scan for local staging and identifying sites of metastatic disease. With your permission the results can be made available to your specialist.

Wollongong Hospital is a large regional hospital that performs approximately 13 000 episodes of operative care per year. The range of surgery performed covers all areas apart from cardio-thoracic, including neurosurgery, vascular, orthopaedics, urology, ENT general, colo-rectal, endoscopy, imaging, obstetrics and gynaecology, general paediatrics, and plastic surgery. The anaesthesia department at Wollongong Hospital has an audit and research focus particularly in the fields of education, obesity, and geriatric care. Australian Bureau of Statistics data report that 62.8% of adult Australians were overweight or obese in 2011-12. Of this number, approximately 12% had a body mass index (BMI) greater than or equal to 35, which, in the presence of comorbidities, has been defined as morbid obesity. Local data show that at least 13% of patients undergoing elective surgery at Wollongong Hospital each year are morbidly obese. Most of the literature suggests that morbidly obese patients have higher rates of clinical complications in the post-operative period than the non-obese although this finding has not been universally reported. Assessment of risk in obese patients cannot accurately be based on the presence of obesity alone. Measurement of functional capacity pre-operatively is considered essential for useful risk stratification and prediction of post-operative outcomes. Cardiopulmonary exercise testing (CPET) is the gold standard for assessing cardio-respiratory fitness. However, CPET is expensive, resource-intensive, and requires a dedicated specialist laboratory and trained technicians. In contrast, the six minute walk test (6MWT) is a simple and cheap test for evaluation of cardio-respiratory function that has compared well to CPEX in previous studies. It may be ideal for assessing functional capacity in morbidly obese patients as it can be performed by existing staff in a pre-operative assessment area and has been shown to be safe for morbidly obese patients in multiple papers. There are currently no published data on the use of the 6MWT as a screening tool to predict high risk in obese patients undergoing surgery. The aim of this study is to assess the ability of the 6MWT to predict postoperative functional recovery and medical complications in morbidly obese patients in Wollongong Hospital who attend a pre-admission assessment clinic (PAC). Identification of this subset of patients would allow peri-operative teams to target further investigations, optimise surgical planning, and stratify the intensity of intra-operative and post-operative care. With these strategies, it may be possible to decrease morbidity and mortality and the associated healthcare costs to the community.

The objective of the study is to determine whether consumption of sugar cane molasses extract (SCE) reduces dietary carbohydrate absorption from the small intestine

The aim of this study is to assess antibody persistence and cell-mediated immunity post administration of combined diphtheria-tetanus-acellular pertussis vaccine, Boostrix 'Trademark' (dTpa) in healthy adults who have received adult formulation diphtheria-tetanus-pertussis boosters 5-10 previously, compared to those that have not received a pertussis containing vaccine since childhood (<15 years of age). Health care workers (HCWs) in paediatric hospitals have been recommended to receive pertussis booster immunisations (Australian Immunisation Handbook 2013) as they are both at increased exposure to pertussis in the hospital and can cause nosocomial transmission to their patients. A booster dTpa immunisation (Boostrix™) is approved for use in Australia by the Therapeutic Goods Administration (TGA). It is now almost 10 years since Boostrix™ was introduced into Western Australia (2004) with high uptake by employees at Princess Margaret Hospital for Children in Perth and health care workers are being offered revaccination. Little is known about the duration of pertussis immunity in adults. No studies have yet provided an in-depth analysis of the immune responses induced by acellular pertussis vaccines and how fast these may wane over time. This study is a non-randomised cohort study. We propose to recruit a total of 150 healthy adults aged 23-64 years employed in the Child and Adolescent Health Service, University of WA School of Paediatrics and/or Telethon Kids Institute. Participants will be asked to attend 4 clinic visits over a 12 month period. These visits will take place at the Clinical Child Research Facility at Princess Margaret Hospital. Participants will be allocated to one of 2 groups depending upon whether or not they have previously received a booster for pertussis. During the first visit participants will be asked about their medical history, demographic data and previous reactions to vaccinations. Immunisation histories will be confirmed (if required) through hospital and GP records. In addition a brief medical directed medical examination may be conducted and vital signs will be taken. Females of child bearing potential will need to do a urine pregnancy test prior to vaccination. A blood sample of 25-30mls will be taken by trained staff before participants are vaccinated with Boostrix™. Following this, a 7 day diary documenting local reactions and adverse events will need to be completed. Further blood tests of 25-30mls will be taken 1 week, 4 weeks and 1 year post-vaccination. Safety data will be collected at each of these visits.