ANZCTR search results

Gay and other men who have sex with men (MSM) with HIV infection have the highest rates of anal cancer. The HPV vaccine is not beneficial for adult MSM with HIV who already have high risk HPV types. As treatment for the precursor to anal cancer (anal intraepithelial neoplasia, or AIN) is both invasive and inefficient, a method of clearing anal HPV before it progresses to AIN is needed for MSM with HIV. The aim of this pilot study is to determine the proportion of MSM with HIV and high risk types of HPV that can tolerate 5% imiquimod cream three times a week for 16 weeks followed by weekly imiquimod cream for 12 months. The secondary aim is to determine the proportion of individuals with HIV and high risk types of HPV who agree to be part of the trial. We will recruit MSM who have HIV from Melbourne Sexual Health Centre when they present to clinic for routine care. Consenting men will be tested for high risk types of HPV in the anus and only those with at least one high risk type will be eligible. Eligible men will receive the HPV vaccine and imiquimod treatment for 3x/week application for 4 months followed by 1 year of 1x/week application. We expect MSM with HIV and high risk HPV will tolerate this treatment and it will clear HPV.

To compare QoR-40 scores twenty-four hours post-operatively in patients who have undergone general anaesthesia using propofol infusion as maintenance to those in whom sevoflurane inhalation is used as maintenance. To compare rates of nausea and vomiting, pain scores and opioid consumption twenty-four hours post-operatively in patients who have undergone general anaesthesia using intravenous agents only as maintenance to those in whom sevoflurane inhalation is used as maintenance. To achieve this, participants will be asked to complete Visual Analogue Scale (VAS) questionnaires, one for pain and one for nausea, at baseline and at the twenty-four hour post-operative visit.

Femoroacetabular (hip) impingement (FAI) is a painful condition that commonly affects healthy active younger adults. It can limit their ability to continue playing sport and perform normal daily activities. It can be related to extra bone formation at the hip joint known as a cam deformity. Physiotherapy is one treatment people may use to reduce their symptoms and improve their function. This double-blind, randomised controlled trial (RCT) aims to compare the effects of two different physiotherapy treatment interventions to reduce pain and improve function in people with FAI.

Omega-3 fatty acids, in particular Docosahexaenoic acid (DHA) and Eicosapentaenoic acid (EPA) are known to play a critical role in both maternal health and infant development, and have a particularly important role in protection against preterm delivery and in ensuring the optimal development of the brain and visual system of the fetus and infant (Makrides & Gibson, Med J Aust, 2002; Demmelmair & Koletzko, World Rev Nutr Dietet, 2015). Achieving and maintaining an adequate supply of these fatty acids during pregnancy and breastfeeding is therefore of vital importance for both short and long term health outcomes of the infant. Recent studies have suggested that many women of childbearing age in many countries, including Australia and the US, fail to meet the recommended levels of intake of these fatty acids, and as a result have a low omega-3 status (Meyer, Nutrients, 2016). Therefore, there is a concern that a significant proportion of women have an insufficient omega-3 status during pregnancy and while breastfeeding in order to meet the needs of their infant. In addition, fish consumption in the majority of these countries also remains low, and therefore these women rely predominately on omega-3 supplements in order to increase their omega-3 status. It is also known, however, that the bioavailability of different supplements into human blood and breast milk can vary significantly according to the formulation and form in which the fatty acids are provided. This is particularly important in the case of women who are breastfeeding, since the uptake of supplements into breast milk depends on both the efficiency of uptake into the maternal circulation, and the transfer of these fatty acids to the breast milk. As such, it is vital to directly test the ability of supplements provided to lactating women to be taken up into the breast milk. The primary objective of this study is to assess the effect of supplementing breastfeeding women with the Pronovum formulation PRF-037 (150:500 Ethyl Ester in SMEDDS) on concentrations of DHA and EPA in breast milk after 4 weeks of supplementation.

Healthy subjects will be administered a single dose of febuxostat (80 mg) to examine the the pharmacokinetic and pharmacodynamic profiles of febuxostat following the administration of a single dose (80 mg). This study will also investigate the effect of a single dose of febuxostat (80 mg) on the renal handling of urate.

Early mobilisation post operatively is a key recommendation for people with fractured neck of femur (NOF). Exercise and early mobilisation may reduce complications post operatively, including delirium, and may lead to shorter length of stay and better outcomes. However, evidence indicates that as few as 50 % of people are able to be mobilised by day 2 post operatively. Barriers to mobilisation include confusion and drowsiness, low blood pressure or an unacceptable level of manual handling risk. Other methods of safely exercising people with fractured NOF who are unable to safely mobilise should be explored. Recumbent bike riding has been used for exercise in other bed bound populations including spinal cord injury and patients from an intensive care unit. Evidence has shown this treatment is feasible and safe in these populations. There is preliminary evidence that recumbent bike riding is associated with reduced incidence of delirium and reduced muscle wasting in people from Intensive Care Units (ICU). Recumbent bike riding has potential to allow early exercise in people with a fractured NOF, however to date this intervention has not been used in this population. Thus the purpose of this study is to demonstrate the feasibility of a trial of recumbent bike riding in people unable to mobilise post fracture NOF. A secondary aim is to obtain preliminary data on the impact of recumbent bike riding on mobility, delirium and length of stay. Fifty people who have received surgical management for a fractured NOF will be recruited within 48 hours of surgery. They will be randomly allocated to receive either usual care or usual care plus up to an hour active recumbent bike cycling. They will continue to receive the intervention until they can walk 15m with assistance of one person for two consecutive day. Primary outcomes include data demonstrating the feasibility of delivering the intervention and conducting the proposed RCT. The primary clinical outcome is mobility seven days post operatively, as measured using the Modified Iowa Level of Assistance Scale. (mILOA) Secondary clinical outcomes include mobility at discharge (measured using the mILOA and gait speed), discharge destination, length of stay and quality of life. Data from this study will inform the design of a larger RCT which will form the basis of applications to NHMRC and other funding bodies.

A TIA is a major warning sign for stroke. There is a 15% risk of stroke 90 days following initial event and the risk of cardiovascular events remains high 10-15 years post-TIA. It is best practice for TIA patients to receive secondary medical care to determine TIA cause and to commence preventative pharmacological therapy early post-event. Behaviour change programs which include education and group exercise (ie. advice and support to address modifiable CVD risk factors including hypertension, inactivity, poor diet etc) significantly reduce the odds of further cardiovascular events. These programs significantly increase the time TIA patients spend in moderately vigorous physical activity (ie. brisk walking). The latter is extremely important as increasing physical activity independently contributes to significant reductions in cardiovascular risk, with an inverse relationship between time spent in moderately vigorous physical activity and risk of cardiovascular events and all-cause mortality. Despite the evidence in support of the efficacy of behaviour change programs, TIA patients of Hunter New England Health Local Health District (HNE LHD) do not have access to an evidence based behaviour change program. It is clear that there is an unmet need in this patient population. S+SLAM-TIA, Service change and Supporting Lifestyle and Activity Modification after Transient Ischemic Attack (S+SLAM-TIA), will address this service gap. S+SLAM-TIA will bring together research active (i) stroke specialists and (ii) general practitioners (GPs), and the Community Stroke Team (CST) to embed a clinically feasible evidence based behaviour change program. This program will be delivered in a community gym and will be comprised of group education and exercise with the use of telehealth and telephone coaching. S+SLAM-TIA aims to: 1. Evaluate the development and implementation of a behaviour change program for people who have had a recent TIA or minor stroke 2. Increase the minutes/week people who have had a recent TIA or minor stroke spend in moderately vigorous physical activity 3. Improve the cardiovascular health, well-being and quality of life of people who have had a recent TIA or minor stroke 4. Determine the cost-effectiveness of this new service including the health service and community cost-savings that increasing physical activity levels in this population brings.

The study aims to explore the relationship between childhood behaviours and stuttering. This study will identify how many children who stutter have challenging behaviours, as well as determine if challenging behaviours affect stuttering therapy. In addition, one aspect of the study will implement an integrated stuttering intervention program that addresses child behaviour in addition to stuttering. The effect of addressing child behaviour in children who stutter, as a component of stuttering therapy, on stuttering outcomes, parenting and child behaviour will be examined. We anticipate that the project will provide invaluable information for future stuttering therapy, with the possibility of addressing child behaviour as a component of future therapy.

This study aims to investigate the efficacy and safety of tramadol/paracetamol combined dosing compared with paracetamol and oxycodone for pain management following major surgery in gynaecology oncology patients. Who is it for? You may be eligible to join this study if you are a female aged 18 years or more who is planned for major surgery for either benign or malignant tumours in gynaecological oncology. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will take oral Tramadol/paracetamol for post-operative pain management in the week following hospital discharge. Participants in the other group will take oral paracetamol and oxycodone in the week following discharge. All participants will be followed-up for 28 days in order to evaluate post-operative nausea, constipation, adverse events, hospital re-admission rates, and efficacy of pain relief. We hope to determine whether Tramadol / paracetamol is a safe, effective, and well-tolerated option for post-operative pain management.

Chronic obstructive pulmonary disease (COPD) affects approximately 20% of Indigenous Australian adults and an even greater proportion in remote regions. The prevalence of COPD is 2.5 times higher, death rate from COPD is three times higher and hospitalisation rates are five times higher in Aboriginal and Torres Strait Islander peoples than in non-Indigenous Australians. Best-practice care of COPD includes accurate diagnosis, smoking cessation, optimising medication and pulmonary rehabilitation to improve symptoms, activity levels and well-being. There is Level 1 evidence that pulmonary rehabilitation for people with COPD improves quality of life and reduces disability, reduces hospital admissions and length of stay, and is cost-effective. However, the implementation of this effective intervention into clinical practice in Indigenous communities is virtually non-existent, furthering the inequity of access to best-practice management of chronic lung disease. The research project will evaluate the implementation of an innovative program, the Breathe Easy Walk Easy Lungs for Life (BE WELL) program, in four distinct Aboriginal communities - metropolitan, regional, rural, remote- using the Knowledge to Action Framework. The BE WELL program aims to build the capacity of Aboriginal and Torres Strait Islander health workers to deliver best-practice management of COPD, Specifically, the project will evaluate the ability of the program to increase Aboriginal health workers’ knowledge and skills in managing COPD; improve exercise capacity and health-related quality of life of Indigenous people with COPD; and reduce hospital admissions and length of hospital stay for exacerbations of COPD. The resources for this program have been developed but the BE WELL program has not been implemented in Indigenous communities. We hypothesise that the BE WELL program will improve Aboriginal health worker knowledge and skills in the management of COPD and, for Indigenous people with COPD, BE WELL will improve exercise capacity and quality of life, and reduce hospital admissions and length of hospital stay. Knowledge gained from this project will be valuable for policy makers and health services in informing the future response to chronic lung disease management in Indigenous communities.