ANZCTR search results

Research over the last decade has shown that less sitting throughout the day is associated with a decreased risk of many chronic conditions such as type 2 diabetes, heart disease, and some cancers. While at work, office workers report high levels of sitting time, mostly due to the nature of their computer and desk based jobs. Height-adjustable workstations may provide a means of reducing sitting time at work. However, the most effective way to introduce such workstations to organisations is yet to be established. That is, whether the installation of height-adjustable workstations alone is sufficient to reduce sitting time in office workers, or whether additional aspects of the workplace (including indiviudual staff and managers, organisational social norms etc) need to be targeted as well. The objective of the Stand Up UQ study was thus to evaluate (in a three-arm study) whether a multifaceted intervention involving height-adjustable desks and organisational and individual behavioral change elements leads to greater reductions in objectively measured workplace sitting when compared to the use of height-adjustable workstations alone (and in comparison to a control group).

This study looks at: 1. The safety of two different dose levels of Veliparib when it is given together with WBRT 2. To determine if participants benefit more with veliparib and WBRT compared to placebo (a substance that looks like the real medication but has no active ingredients) and WBRT. Who is it for: Patients with brain metastases from non-small cell lung cancer. Trial details: Participants will take Veliparib/Placebo orally twice per day, every day while receiving WBRT. Participants will also dose the day following the last day of WBRT. Participants will then have monthly visits for 9 months, followed by visits every 3 months for up to 2 years.

The aim of this study is to evaluate the benefits of a new parasternal technique for continuous infusion of ropivacaine after coronary artery graft surgery (CAGS) in an Australian cardiac surgery population for adjunctive pain management. A randomised, double blind, pilot study using this technique is designed to be the pilot for a larger, multicenter trial. This pilot study will determine feasibility of, and provide evidence and a framework for a large, blinded, randmoised controlled, extension trial powered to show improved pain management. Reduction of pain can improve the treatment of cardiac surgical participants by enabling earlier extubation, allowing fast tracking of participants to a High Dependency Unit (HDU) bed on the ward, thereby reducing the need for intensive care beds. This would have potential important impact on cost, waiting times and through-put of cardiac surgery cases.

This is a prospective single arm study. Hypothesis Primary hypothesis is that patients are able to comply with the use of vaginal dilators after radical chemoradiation for anal cancer. Secondary hypotheses include that the use of vaginal dilators reduces grade 3-4 vaginal toxicity (stenosis), and therefore improves vaginal health, sexual function and quality of life. Inclusion Criteria Inclusion criteria are age greater than 18 years, female, histologically-proven non distant metastatic anal cancer (squamous cell carcinoma or adenocarcinoma), suitable for treatment with radical pelvic radiotherapy to greater than 45 Gray with or without concurrent chemotherapy (Mitomycin C (MMC) and/or 5-Fluorouracil (5FU). Exclusion Criteria Participants with pre-existing psychiatric illness or who had abdominoperineal resection are excluded. Radiation Therapy Treatment The standard regimen consist of external beam radiotherapy to a total dose of 50.4 to 54Gy using a three-phase technique. From 2011, some participants are treated with a two-phase Intensity Modulated Radiotherapy Technique (IMRT). Chemotherapy Treatment Standard concurrent chemotherapy consists of infusional 5FU 1g/m2 for 4 days in week 1 and 5, with MMC 10mg/m2 on day 1. Some participants will receive protracted infusional 5FU (PVI 5FU) 300mg/m2 for 96 hours each week. Device Vaginal dilators are smooth rigid cylinder-shaped pieces of plastic. There are four standard sizes of varying diameters. They are used with a lubricant or oestrogen cream. Standard recommendation for their use: initiate insertion within 6 weeks of completing chemoradiation; insert 3 times per week for 5 minutes duration. Follow-up Schedule At the completion of chemoradiation, participants will be reviewed at 4 weeks; and 3, 6, 9, 12, 18, 24 and 36 months. Sample Size and Duration A pragmatic sample size of forty participants will be accrued for this trial. The anticipated duration to complete accrual is 30 months. Participants will undergo 6 weeks of chemoradiation and then 3 years follow up. The total study duration is therefore expected to be 68 months. A planned interim analysis will take place after 15 participants have completed 12 months follow up.

This project will investigate the efficacy of intermittent or interval exercise training compared to graded exercise (steady state or constant load) for individuals with Chronic Fatigue Syndrome. Current evidence suggests that the graded exercise combined is beneficial for CFS, but there has been no research investigating intermittent exercise effects with CFS. Intermittent exercise has been shown to improve functional capacity with reduced perceived exertion and symptoms in individuals with cardiovascular and pulmonary disease, and it may be a more effective exercise strategy than graded exercise, as the exercise intervals are alternated with short periods of rest or very low intensity exercise. The project is a 12 week randomised controlled study, comparing intermittent, graded and control (usual care) groups. Efficacy of each type of delivery of exercise will be measured by outcomes such as aerobic capacity, exercise duration and tolerance, symptoms (pain and fatigue), perceived exertion, quality of life, immune cell counts and function, inflammatory cytokine responses, physiological adaptations and functional capacity for activities for daily living (ADL). Participants will exercise on a cycle ergometer in a supervised health clinic for three sessions per week. Outcome measures will be assessed pre- and post-training; resting and recovery heart rates, blood pressures and exercise Rate of Perceived Exertion (RPE) will be recorded at each exercise session. Participants will also keep an exercise and symptom diary to record muscle and general fatigue, weakness and pain (if any) on exercise and rest days. Data will be statistically analysed using ANOVA and Cohen’s Effect size (SPSS). The results will be applicable to CFS and other chronic disease-related fatigue sufferers (e.g. cancer and cardiac patients), and will contribute to further larger grant applications to NHMRC and ARC.

To study the clinical pharmacology of a number of drugs in overdose. Many medications behave differently in overdose than in clinical situations. There is limited data on the pharmacokinetics and dynamics of many new drugs in overdose. This study aims to model drug concentration and clinical effects from data collected from overdose patients

Research Question: Does splinting and early mobilization in the dart-throwers plane of motion improve functional outcomes and reduce postoperative complications in people after scapho-lunate ligament repairs? Hypothesis: A dynamic splint configured to allow motion only in the dart thrower’s plane applied after plaster cast removal (this is determined by the surgeon according to operative technique, and is usually 6 weeks post surgery, but can be 4-10 weeks post surgery)will result in faster return to usual activities (including self-care, work and recreation) better patient ratings of function, less pain, and less post-operative complications than a static splint. Aim/s: To compare outcomes between two groups of patients – one of whom received the dynamic splint, the other the static splint at 12 weeks post scapho-lunate ligament repair - to determine whether patients recover more quickly, and rate their function and pain differently; and To see if a larger multi-centre study is feasible. Both groups will be advised that splints are to be removed only for hygiene and 2 hourly exercise program for 4 weeks, after which time it is phased out over the following 2 weeks. This means it is taken off for light activity at first, then ceased altogether.

The study aims to demonstrate that the implementation of a Minimal Intervention Dentistry approach to a group of community public dental patients (adolescents aged 11-14 years) is likely to be ‘cost-effective’ compared to ‘current practice’ in achieving positive oral health outcomes for this population group. The study targets adolescents who are assessed as being at high risk to dental caries and are currently accessing community dental clinics in Metropolitan Melbourne. Equal numbers of community dental clinics will be recruited from local government areas with low and high SEIFA indexes to join the study. The design of the Study is that of a cluster randomised control trial. Minimal Intervention Dentistry (MID) is a multi-pronged approach which comprises of a range of strategies including prevention, early intervention, non-surgical and surgical management of the condition. Minimal Intervention Dentistry is based on the premise that early carious lesions can be reversed through remineralisation and changes to diet and oral hygiene habits to arrest the progression of the disease. The primary outcomes of the study are to: Demonstrate a reduction in the number of new and progressing carious lesions amongst the participants who have undertaken this approach Demonstrate a cost effectiveness of the MID approach in this study population The study is scheduled for completion June 2015.

This cross-sectional study is the first to assess the use of rapid HIV tests in a clinical setting in New South Wales (NSW). The study will assess acceptability of the process of rapid HIV testing for gay, bisexual and other men who have sex with men (MSM) among patients and staff in public sexual health clinics in Sydney. The study will also assess barriers to HIV testing; patient flow in clinics during the study; and the performance of the rapid test compared to conventional laboratory HIV serology. The patient and staff surveys used in this study were piloted with patients and staff during development. The study aims to recruit at least 1000 MSM subjects across four sites: Sydney Sexual Health Centre, Albion Street Centre, Clinic 16 Royal North Shore Hospital and Parramatta Sexual Health Clinic. The rapid test used in the study is the Alere Determine HIV 1&2 Antigen/Antibody Combo assay which produces a result 20 minutes after the patient specimen is applied. MSM attending for screening will be identified through triage and provided with information regarding the study. Eligible MSM who consent will receive pre-test discussion and have specimens taken for sexually transmitted infection screening, rapid HIV testing and conventional HIV serology. Rapid test results are provided to subjects during their visit with counsellor support for reactive results when required. The recruitment period will be at least 12 months from October 2011.

To investigate whether splinting and activity modification can make a clinically significant change to pain levels and day-to-day function in people with this condition. As this is a pilot study, all subjects will receive the same treatment. Comparison will be pre- and post- treatment measures