ANZCTR search results

It is known that survivors of burn injury often experience impairments in strength and functional ability for the rest of their life. This is a result of losses in skeletal muscle mass and strength. This study aims to investigate the effect of resistance training on the muscle mass, strength and quality of life of a burns patient. It is expected that patients who undertake a structured resistance exercise training program will exhibit increased muscle mass, increased strength and an improved quality of life compared to the control group.

RADICALS is an interdisciplinary model of care that brings together the expertise of different health professional groups to provide a solution for a major public health problem, chronic obstructive pulmonary disease (COPD). This community-based model mainly surrounds interdisciplinary collaboration to deliver intensive smoking cessation support, COPD management according to COPD-X guidelines, home medication review and a home-based exercise/self-management program. This study aims to evaluate the effectiveness and cost-effectiveness of the RADICALS program in reducing the burden of smoking and COPD through: (a) increasing the detection of COPD among long-term smokers, (b) improving the effectiveness of smoking cessation care provided in general practices; and (c) improving health-related quality of life (HRQoL) of people with COPD. It is hypothesised that: (a) A general practice-based screening program among smokers will result in early identification of COPD (b) Interdisciplinary care will result in higher abstinence rates at 6 months than ‘Quitline referral’ among smokers; and (c) Among people with COPD, interdisciplinary care will maintain HRQoL better than usual care at 6 months

A randomised, placebo-controlled study looking at the effectiveness of an intravulvo-vaginal cream Lyrica (registered trademark) for treatment of chronic pain in the vulvo-vagina. A research project is being conducted by Professor Chris Benness, Dr Elizabeth Willsteed and Dr Jane Manning to investigate a treatment for chronic vulvo-vaginal pain. Why is the research being done? The purpose of this project is to establish whether a prescription drug, Pregabalin (Lyrica - registered trademark) when applied topically as a vulvo-vaginal cream is a safe and effective means of treating vulvo-vaginal pain. Previous research has suggested that it may be effective. We hope it causes fewer side effects than Pregabalin when taken orally which is a standard treatment for the condition. This drug is not experimental or new, and is approved to treat chronic neuropathic pain. Method: Two creams, A and B will be prepared. One of which will contain pregabalin . Treatment allocation will be double blind and randomized. Participants who satisfy inclusion criteria will apply the cream for 6 weeks with dose adjustment allowed. They will then have the option to receive the active pregabalin cream (open label) for a further 6 weeks if they wish. They will complete questionnaires designed to detect relevant demograohic factors and factors that may potentially confound results. They will complete questionnaires on line or by mail at 0, 2 4 ,6 and 12 weeks. Participants: Those with vulvo-vaginal pain that has stopped tampon use or intercourse or regular internal examination for 6 months or more. Those over 17 Those not pregnant and are not planning to become pregnant (that is, you must be currently using effective contraception) Those with no known allergy to Pregabalin. Those whose pain is not due to cancer or past radiation treatment or to lichen planus or lichen sclerosis, or other treatable causes. Those who have time to participate over 6 weeks and who live within 200 km of Sydney NSW Australia Area Those who don’t have significant kidney disease. What would participants be asked to do? They will need to be available for a minimum of 2 visits over a minimum 6 weeks to assess response to a blinded treatment cream. The first visit will take approximately 1 hour. Participating in the study will involve: A vulvo-vaginal examination at the first visit Attending for a first visit and a possible visit at 2 weeks Completing five (5) Questionnaires which will be provided at visit 1, and again at weeks 2, 4, 6 and also week 12 if they wish to continue. These questions will ask about general health and the nature of the vulvo-vaginal pain. Some of these are sensitive questions asking about sexual function and possible abuse history. They will complete a 24 hour voiding diary (how often you go to the toilet) prior to the first visit. After the initial visit, online questionnaires or postal questionnaires will be possible to complete for all subsequent review, or if they wish they can attend in person. They will collect a study drug package, labelled either A or B at the 1st visit. All participants will apply cream throughout the 6 week study, but the contents of the cream will be either Lyrica (registered trademark) pregabalin or a placebo (not active medication). Participants will not be told which cream they receive. What are the risks and benefits of participating? Benefits Participating in this study may benefit your condition (vulvo-vaginal pain). Risks Although the cream base is neutral - local irritation may still occur Irritation with use of this vulvo-vaginal cream may occur for 14% of women. Sedation may still occur even though it has not been reported using this cream. Tiredness, dizziness, confusion is common with many oral medications used to treat vulvo-vaginal pain. How will privacy be protected? All information gained will be treated confidentially. It will be accessed, used, managed and stored in accordance with the NSW Health Records and Health Information Privacy Act 2002

The purpose of this study is to determine the pharmacokinetics (how the body absorbs the drug), safety, and tolerability of oxycodone and axelopran when given together and separately.

The adoption of healthy school canteen policies has been recommended as a strategy to prevent excessive weight gain. A number of jurisdictions in Australia and internationally have policies requiring school adoption of healthy canteen strategies. Despite this, internationally, schools have failed to adopt healthy canteen practices consistent with such policies. If the benefits of obesity prevention initiatives are to be realised, policies recommended to prevent overweight must be implemented. However, research measuring the effectiveness of interventions to facilitate widespread implementation of health promoting policies and practices in schools is limited. The aim of the research is to assess the effectiveness of a multi-component intervention intervention in increasing canteen practices consistent with the mandatory NSW government healthy canteen policy (‘Fresh Tastes @ School’). The study will employ a randomised trial design. Sixty-three primary schools will be randomised to receive a 9 month intervention, or a no intervention comparison group. The intervention will facilitate implementation of the policy through encouraging executive support and endorsement, training, resources, monitoring and feedback, communication strategies and ongoing telephone support. The effectiveness of the intervention will be determined by comparing post intervention differences between canteen menus audited by Dietitians in: i) the proportion of schools with a canteen menu containing foods or beverages restricted (‘red’ items) under the policy and; ii) the proportion of schools where healthy canteen items (‘green’) represent the majority (>50%) of products listed on the menu as recommended by the policy.

Smoke-Free Recovery from trauma surgery is a trial taking place at the John Hunter and Liverpool Hospital, NSW. The study will investigate the uptake and usage of an online smoking cessation programme following an orthopaedic trauma. Smoke-Free Recovery will be developed to provide help for patients’ recovery from orthopaedic trauma surgery while successfully quitting smoking. The program will be specifically tailored to the individual’s smoking profile and will provide information about the effects of smoking on their specific wound recovery. This study aims to determine if it is feasible to provide patients with an online smoking cessation programme to promote smoking cessation during and following hospitalisation.

Postpartum depression (PPD) is characterised by low mood, irritability, fatigue, insomnia, change in appetite, anxiety, guilt, feelings relating to an inability to cope and worthlessness and thoughts of suicide. Postpartum depression (PPD) is estimated to affect 8-25% of women in the first 36 months after giving birth. Currently, psychosocial assessments (interview) and depression screening (self report questionnaire) during the perinatal period is routine clinical practice in New South Wales. Assessments aim to identify psychosocial risk factors for poor postnatal mental health (e.g. lack of support or recent stressors). There is little information regarding the genetic or biological indicators of PPD. Postpartum depression can have serious and prolonged effects on the mental and physical health of both the mother and child. Current studies support the positive influence of physical activity for treating PPD. This project aims to investigate the antenatal predictors of PPD and physical activity in adult women residing in the New England region. The aims of this research project are threefold: 1) To determine if there is an association with genetic variation and the incidence of PPD; 2) To evaluate the relationship between genetic variation and physical activity participation and; 3) To determine the relationship between theory driven predictors of physical activity and postpartum physical activity participation in women who live in rural areas. Variables including demographic information, medical information relating to pregnancy and labour, symptoms of postnatal depression, health related quality of life, emotional resilience, maternal social support, objectively measured physical activity, physical activity self-efficacy, social support for physical activity participation, ratio of perceived advantages and disadvantages of physical activity (decisional balance), biological markers of stress (including salivary cortisol and aAmylase) and potential genetic markers of vulnerability to depression (serotonin transporter gene polymorphisms and reelin gene (RELN) polymorphisms) will be assessed at two time points; participants second antenatal clinic visit (approximately 20 weeks gestation) and three months postnatal. Relationships between measured variables at each time point will be assessed using standard statistical techniques (e.g. Pearson correlation, Fishers Z score). Multiple regression analyses will be used to determine psychosocial and biological antenatal predictors (absolute and relative changes from pre to postnatal) of postnatal physical activity and symptoms of depression. The project outcomes aim to provide a mechanism for improved screening, contribute to the research relating to the prevention of PPD, and evaluate the predictors of physical activity.

The proposed PADDAG trial is a prospective, stratified-randomised controlled trial to determine whether the use of intraoperative dexamethasone, a widely used antiemetic in adult surgical patients, is associated with an increased blood glucose concentration, and whether this increase is greater in patients with diabetes than in those without. Secondary outcomes will include the risk of infection, and the interaction between dexamethasone administration, diabetic status, glycaemic control and infective complications.

Currently, opinion amongst obstetric anaesthetists is divided as to whether an intravenous (IV) route is superior to the per rectum (PR) route for perioperative mangagement of post caesarean section pain. An audit of the mean total 48 hour opioid requirements post caesaren section was undertaken at The Northern Hospital during March 2014. This did not reveal a difference in the mean opioid requirement between the two different routes of analgesia administration. Despite this, there is a significant increased cost associated with the use of IV analgesia. It has been estimated that for every 4,000 deliveries, by not using IV analgesia, a cost saving of $20,000.00 will result. Therefore, we wish to conduct a randomised controlled trial, using current Australian TGA approved medications and formulations, in line with current obstetric anaesthesia practice to determine if the IV route provides superior analgesia. As such, we would expect to find a 20% decrease in total 48 hour opioid consumption when the IV route is compared to the PR route. Statistical anlaysis of the prior audit has determined that we will need to recruit 50 women into each arm of this trial.

Treatment effectiveness: This study will determine whether there is a difference between the number and type of circulating tumour cells in cancer patients before and after treatment. Who is it for? You may be eligible to join this study if you are aged 18-80 years, diagnosed with any cancer and have received treatment at least 3 weeks ago or will receive treatment within one week. Study details The study aims to establish the Circulating Tumour Cell (CTC) detection method using the ISET (Isolation by Size of Epithelial/Trophoblastic Tumour Cells) device (Rarecells, France) in conjunction with cancer therapies offered at National Institute of Integrative Medicine. There will be no changes to the participants’ cancer treatment plans. Participants will be required to provide a blood sample at the beginning of their treatment and 3 months after commencement of treatment. The blood will be processed using the ISET technology to determine the number and types of circulating tumour cells. Early detection screening: This component of the study aims to determine whether the ISET-ED screening blood test can be used for early detection of cancer. Who is it for? You may be eligible to join this part of the study if you are aged between 18-80 years and have a family history of cancer, or have been diagnosed with chronic disease, or are attending a health check. Study details: Participants in this part of the study will undergo a blood test at baseline and at 3 months. The ISET-ED (early detection screening) test has the potential to detect potentially malignant cells, and other illness causing rare cells.