ANZCTR search results

We will recruit 200 patients with T2DM between the ages of 25 and 65 with no history of coronary artery disease (CAD) or cardiovascular complications. We anticipate numbers of men and women to be roughly equal. All testing will take place at Princess Alexandra Hospital in the cardiovascular clinical measurements department and intensive exercise sessions will also be held at the Princess Alexandra hospital in the cardiovascular imaging research centre gym. The primary outcome variable of this study will be: 1. Increased capillary recruitment and glycaemic control Secondary outcomes measures will be: 1. Improvement in left ventricular systolic and diastolic function 2. Improvement in functional capacity.

Thirty four patients undergoing elective ophthalmic operations under regional anaesthesia were enrolled in this study after informed consent. Standard, waterproof ophthalmic drapes were used to cover the patients during the procedure and oxygen was administered via a modified plastic canister at a flow rate of 6L/min. In this study we characterise this elderly population and show patients are exposed to an increased inspired oxygen (FiO2), inspired carbon dioxide (FiCO2) and end-tidal carbon dioxide (EtCO2) level. The operation progressed without adverse events.

This study aims to test an educational program to improve sun protective behaviour of Queensland teenagers. Who is it for? You may be eligible to join this study if you are a male or female student aged 12 to 17 years who attends a public or private secondary school in metropolitan or regional Queensland, Australia. Trial details Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants in one group will receive the intervention straight away. Participants in the other group will receive the intervention on completion of the study. The intervention involves 3 x 1 hour sessions over a 3 week period. The sessions are delivered during school hours by a trained facilitator, and will focus on encouraging supportive sun protective attitudes and beliefs, fostering perceptions of normative support for sun protection behaviour, and increasing perceptions of control/self-efficacy over using sun protection. Participants will be asked to complete questionnaires before and after the program. The study will provide valuable information about the effectiveness of the program in improving the sun protective behaviour of adolescents, which is important to prevent future skin cancers.

This study aims to determine the efficacy of surgery without radiotherapy as treatment for low risk cutaneous head and neck squamous cell carcinoma. Who is it for? You may be eligible to join this study if you are aged 18 years or more and have low-risk cutaneous head and neck squamous cell carcinoma for which you have previously received no treatment. Trial details All participants in this trial will undergo surgical treatment without additional radiotherapy. Surgical treatment includes removal of all relevant lymph nodes of the neck. You will be assessed for a period of up to 5 years to determine disease specific survival, the incidence of recurrence and associated consequences [assessment will be done by regular clinical examinations plus/minus ultrasound].

This study aims to determine the safety and efficacy of a tailored exercise program in prostate cancer patients with bone metastases. Who is it for? You may be eligible to join this study if you are a man with prostate cancer with diagnosed bone metastases. Trial details. Participants in this trial will be randomly (by chance) allocated to one of two groups. One group will undergo supervised exercise training. This involves resistance, aerobic (stationary cycling) and flexibility exercises, three times per week over a period of 3 months and then will be monitored (without training) for a further 3 months. The other group will be assigned to no treatment for the first 3 months. After this time participants in this group will commence the exercise program for the next 3 months. Participants will complete some tests of physical function and questionnaires about fatigue, pain and physical activity levels, and have their body composition measured at these time points. It is thought that the exercise program will be safe and will improve physical function when compared to no training.

The aim of the study is to develop a simple diary than can accompany antenatal care to help pregnant women attain weight gains in pregnancy consistent with IOM recommednations and to reduce rates of gestational diabetes.

Background Spinal ultrasound has great potential as a teaching tool for epidural insertion; however it is currently underutilized. Purpose The purpose of the study was to test the efficacy of a standardized training programme of spinal ultrasound and to determine the optimal teaching method. Methods The study was conducted as a prospective, assessor-blinded randomized controlled trial as part of 2 standardized workshops 1 week apart at a single centre in Australia during December 2010. For each workshop the anaesthesiologists (novices in performing the spinal ultrasound technique) were randomized according to a computer-generated random table, into 2 teaching groups to receive standardized training via either an explicit (didactic) 10-step or an implicit (interactive) learning method. Allocation concealment achieved with opaque sequentially numbered sealed envelopes. This was followed by a practice session and assessment of specific ultrasound tasks on pregnant volunteers. They were individually videorecorded for assessment, and subsequently rated by two experienced international blinded assessors from a using a global rating scale (GRS) and checklist. Saved lumbar intervertebral images were also rated. Main outcome measure: GRS score. Secondary outcome measures: Task specific checklist and image quality scores. ICC’s were calculated to assess agreement between reviewers.

Idiopathic pulmonary fibrosis (IPF) is a progressive and disabling lung disease characterized by significant dyspnoea and fatigue, reduced exercise tolerance and has a poor prognosis. Oxidative stress is a prominent feature of IPF, which is increased during exercise. This increased oxidant burden during exercise is accompanied by hypoxemia and an impaired metabolic response which may contribute to skeletal muscle dysfunction and limit exercise endurance in patients with IPF. Currently there is no evidence regarding the effect of supplemental oxygen on exercise induced oxidative stress in patients with IPF, despite several studies showing promising outcomes in patients with COPD . The primary aim of this study is to identify whether supplemental oxygen is successful in reducing exercise induced oxidative stress in IPF and whether it plays a role in attenuating impaired skeletal muscle metabolism leading to an improvement in exercise tolerance.

This project aims to compare a complex care model, the Victorian Comprehensive Parkinson’s Disease Program (VCPP) with usual care (conventional care), to determine which caters best for the complexity and cumulative morbidity over time of people with Parkinson’s disease (PD) and at what cost. A quasi-experimental trial will be conducted in the Melbourne metropolitan region incorporating an economic analysis alongside the clinical trial. 180 people with PD will be recruited from referrals to the VCPP (intervention group), or to the Monash Medical Centre Neurology Department (control group). Participants will be seen at four times (baseline, 1 year, 2 years and 3 years) following recruitment into the study. The long term follow-up is required to encompass the effects of natural deterioration with PD and ageing. In addition, participants will be contacted by telephone at 6 months, 18 months and 30 months to encourage completion of the health service utilization and falls questionnaire. The primary outcome is quality of life, which will be measured using the PDQ39 form. We will also measure other aspects of impairment, functioning and participation. The cost analysis will include information on participants’ primary health care visits, medication type and usage, hospitalizations and length of stay, episodes of inpatient rehabilitation care and aged care institutional care. This data will be collected using the health service utilization questionnaire and Medicare Australia data. Optimal management of the complexity of the condition is important to the person with PD and their family, and the detainment of costs is important for health systems (private and public), governing authorities and support organizations. The findings of this report have the potential to determine if the comprehensive care model is more cost effective for management of PD from a health system perspective. The implications would then have the capacity to revolutionize care for people with PD.

Female stress urinary incontinence, which is exertional or activity related urinary incontinence commonly brought on by coughing and sneezing, is both common and have a high burden of suffering. The traditional operation to treat stress urinary incontinence has been open colposuspension, which involve an abdominal skin incision and a hospital stay of at least 5 days. Modern advances involve development of minimally invasive procedures which saw the introduction of tension free vaginal tapes (TVT) and transobturator tape (e.g. Monarc, TVT Obturator) which provides good success rates when compared to the traditional operation, although with the advantage of a quicker recovery. These procedures involve inserting slings made of synthetic material underneath the water pipe (urethra) to provide support. They exit through the abdomen, in the case of TVT or through the groin in the case of Monarc. Although these operations work very well, they do come with known complications such as bleeding and bladder injury, voiding difficulty or thigh pain. Whilst similar to the Monarc procedure, MiniArc it is placed using a very small incision and has no exit site. TVT Abbrevo is similar to the established TVT Obturator, except it comes with a shorter sling that do not come into potential contact with the thigh muscles thereby reducing risk of groin pain. The purpose of this project is to evaluate the success of these two types of surgical procedures (MiniArc and TVT Abbrevo) in the treatment of women with stress urinary incontinence.