ANZCTR search results

The primary purpose of this study is to identify biological markers in tumour and blood samples which may predict clinical outcomes and response to treatment in prostate cancer patients. Who is it for?: You may be eligible to participate in this study if you are aged 18 or over, with a diagnosis of prostate cancer of which a tumour specimen has already been taken and is available for further testing. Study details: All participants in this study will have a small sample of their tissue (primary and metastatic) that was taken at diagnosis used for research. Researchers will look at the DNA inside the tissue and see if they can find any 'markers' that may make patients respond better to certain types of treatments. A blood sample will also be taken at the start and at the end end of any treatment you may have. Researchers will also use medical records to correlate any biological markers with disease outcomes. It is hoped that the findings of this study will lead to the identification and validation of biological markers which may allow more personalised treatment for future prostate cancer patients.

Aquatic Physiotherapy has been shown to improve the ability of people to move and function following total hip and knee replacement surgery. The primary aim of this study is to examine if early commencement of aquatic physiotherapy (6 days after surgery) improves function, as compared to standard commencement of aquatic physiotherapy (typically 14 days after surgery- once the wound has healed). Patients attending undergoing total hip replacement or total knee replacement surgery at Dandenong or Moorabbin Hospital who require in-hospital rehabilitation at Dandenong Hospital or the Kingston Centre will be recruited to participate in a randomised controlled trial. One group of participants will receive aquatic physiotherapy 6 days following surgery (intervention), whilst the other group will wait 14 days to commence aquatic physiotherapy as per standard practice (control). A total of 60 people will be randomly assigned to one of these groups. The main measure used to evaluate the intervention will be the de Morton Mobility Index, a measure of walking and balance. A range of other measures will also be administered to evaluate the effect of early aquatic physiotherapy on the ability to function, length of hospital stay, pain, walking speed, quality of life, cost of wound dressings and presence of wound infections. These outcome measures will be assessed at baseline, on discharge from rehabilitation. Function, pain, quality of life, function and presence of wound infections will also be assessed at 6 weeks following surgery.

Youth have an increased likelihood of experiencing fatigue, which is associated with increased workplace mortality and morbidity. Not surprisingly, young workers (<24y) account for 20% of all work related injuries; a rate 18% higher than for workers aged >25y. The South Australian Work Health and Safety Youth Strategy 2014-2018 highlights areas for action to improve workplace health and safety outcomes for young workers. Fatigue is identified as one of the key risks that urgently needs to be addressed. There is currently no approach to fatigue management for youth in South Australia. We have developed an innovative web- and app-based fatigue intervention – YAWN (Young Adults Working Nights). The YAWN program will now be evaluated in a sample of young workers (n=300; 16-25y), recruited via Facebook and the Passport to Safety program, using a two-group randomized controlled trial design. yaOutcome variables (including sleep duration, subjective fatigue, sleep hygiene, quality and knowledge) will be measured at baseline, and one and four months post-baseline in both groups. Web and app usage statistics will be tracked and program satisfaction will be assessed after one month. Anticipated outcomes of the YAWN program will be improvements in sleep duration, quality and hygiene, and decreased fatigue levels. Better fatigue management for young workers will improve health and safety outcomes and mitigate against health problems associated with fatigue and sleep loss including cardiovascular disease, gastrointestinal disease, type 2 diabetes and poor mental health.

A beta blocker is a type of medication that is commonly given to cardiac patients. This medication has been shown to reduce the risk of death in patients who have suffered a heart attack, or in those who experience heart failure. Beta blockers are associated with some side effects that may affect individual patients differently and may prevent their use in certain patients. In this project, the researchers will study the genetic differences between patients who can take this medicine and those who are unable to tolerate the side effects. At the end of the study, we hope to have improved our understanding of how genetic differences may affect the use of this important medication.

Venous leg ulcers (VLU) account for 80% of all leg ulcers. They adversely affect quality of life and exact a financial burden on individuals and the health care sector. The use of graduated compression is considered ‘gold standard’ for the treatment of venous leg ulceration. Negative pressure wound therapy (NPWT), used in the management of wounds, has been found to reduce time to healing. However, no robust studies exist which compare the healing rates of VLU treated with compression bandaging and NPWT as compared to those treated with compression bandaging alone. Aim: To investigate the effectiveness of NPWT and four layer compression bandaging (4LCB) as compared to 4LCB and usual treatment, for healing venous leg ulcers. Objectives: 1. To investigate the efficacy of NPWT dressings and 4LCB as compared to usual treatment and 4LCB for healing VLUs. 2. To determine the impact of a VLU and its treatment on quality of life (QoL). 3. To conduct a prospective economic analysis to determine the costs associated with healing VLUs and the effect on quality adjusted life years (QALYs). Method: A single site two arm RCT with 150 patients, randomised to two groups of 75 will be undertaken. Patients will receive NPWT dressings and 4 LCB or usual treatment (tulle gras wound contact layer and absorbent pad) and 4 LCB for 12 weeks, or less if healed prior to 12 weeks. Ulcerated legs will be graded according to the CEAP classification. The Silhouette (Trademark) (ARANZ) device will be used to collect measurements. The EQ-5D-5L Tool and the Charing Cross Venous Leg Ulcer Tool (CXVLU) will be used to determine the impact of the VLU and treatments on quality of life and quality adjusted life years. Statistical analysis of healing times and QoL will be performed using t-test and regression analysis. A prospective economic analysis will be performed to determine the costs associated with healing VLUs and QALY.

The aim of the study is to investigate the effect of brain stimulation on memory in those with Parkinson’s disease. The investigation will use a type of transcranial current stimulation (TCS) called transcranial direct current stimulation (tDCS) to examine the effect of stimulation on memory. Some of the difficulties that individuals with Parkinson’s disease often experience are problems with their memory. Research has found marked impairment in the accuracy of memory tasks when compared to those without the disease. Transcranial direct current stimulation is a technique that non-invasively stimulates the brain by applying electrical currents to a small region of the scalp, which transmit into the brain. The currents are usually in the order of a few milliamps and stimulation lasts for several minutes. For the current project, the strength will be 2 milliamperes (mA) and delivered for 20 minutes to test the impact this has on memory performance.

A post-exertional exacerbation of fatigue and other symptoms is a characteristic feature of chronic fatigue syndrome (CFS) following a relatively small amount of physical or cognitive activity. Although it is well established that graded exercise therapy (GET) is beneficial for the management of CFS, this intervention, which uses cautious, symptom-limited increases in gentle aerobic exercise, has only modest effectiveness. The key limiting factor is the delayed exacerbation of symptoms that follows exercise. This post-exertional exacerbation has been well characterized in exercise challenge studies. Modafinil, a psycho-stimulant drug, has been licensed in Australia and internationally and used clinically for some time. Additionally, it has demonstrated some benefit in reducing fatigue in multiple sclerosis, and daytime sleepiness in Parkinson’s disease. In healthy subjects, the effect of a single dose of modafinil on exercise time has been examined and showed a prolonged time to exhaustion of 22% for high intensity exercise (Jacobs and Bell, 2004). Interestingly, the rate of perceived exertion (RPE) reported by participants was statistically significantly lower in the modafinil exercise trial compared to the placebo exercise trial. Since the symptom of fatigue is the limiting factor in the progression of GET, it is appealing to test the possibility that modafinil may attenuate the exacerbation of fatigue following exercise for patients with CFS. This opens up the possibility of greater progression in GET and, therefore, potentially further increases in physical function. However, before a training study is undertaken a systematic evaluation of the acute response of the post-exertional exacerbation of fatigue and symptoms following modafinil is warranted. It is hypothesized that for modafinil compared to placebo, patients will report a lower RPE during exercise and less post-exertional exacerbation of fatigue. The protocol will involve two sessions of a six-day assessment period, each including a 48 hour pre-exercise baseline assessment and 96 hour post-exercise assessment. Each participant (n=20) will be asked to complete two exercise sessions (one with modafinil and one with placebo) separated by at least two weeks. The order of the treatment trial (placebo or modafinil) will be randomised and counter-balanced as well as double-blinded. The exercise bout will consist of moderate-intensity cycling for generally 20 minutes.

We are trying to establish the mechanism by which remote ischaemic preconditioning confers protection to the heart

In the womb, blood flows to and from the baby through blood vessels in the umbilical cord which connects the placenta (lining of the womb) to the developing baby (fetus). After the birth of a baby blood continues to flow back and forth whilst the umbilical cord remains unclamped allowing some remaining blood from the placenta to flow to the baby. It is routine to clamp and cut the cord after birth. At present, we do not know the ideal time for the umbilical cord to be left unclamped and uncut. The aim of our study is to find out how cord clamping affects the normal adaptation a newly born baby has to make in adjusting circulation of their blood and their breathing patterns and effort. We intend to do this by measuring newly born babies oxygen saturation levels and their heart rate using a monitor (pulse oximeter) we use routinely in the nursery. We know that it takes a few minutes after birth for babies to adapt to life outside the womb and would like to document the changes in oxygen levels and heart rate in the first 10 minutes after birth and to investigate if the timing of cord clamping affects these values. This information will help us to determine the best time to cut the umbilical cord. What the study involves: We place a pulse oximeter sensor on a baby’s right hand, and for some infants place 3 sensors on their chest to measure heart rate) In a small subgroup of infants we will place sensors on the babies head to measure cerebral oxygenation. As soon as possible after a baby is born and while she/he is on their mother’s chest we dry baby’s hand and place the sensor on their right hand. We can do this without disturbing parents from cuddling their new baby. It does not interfere with the midwife caring for the women whilst waiting for the placenta to be delivered. The sensor on a baby’s hand stays in place for the first 10 minutes after baby’s birth. The researchers do not interfere with the normal care given to a newly born baby. Our aim is to combine measurements from many babies to get a picture of what happens to oxygen levels and heart rate in normal healthy babies in the first minutes after their birth.

This randomised, double-blind, placebo-controlled trial aims to investigate the effects of 12 weeks of supplementation with a bioavailability enhanced curcumin supplement, Longvida (registered trademark) Optimized Curcumin, on cognition and mood and wellbeing, in healthy individuals aged 50 to 85 years. To better understand how cognitive and mood benefits might be achieved the study will also investigate the effects of curcumin on cardiovascular function and a range of blood markers of health. In a subset of participants an MRI component of the study will explore the effects of curcumin on brain function. Finally the study will investigate whether difference in genetic make-up influence the effects of curcumin. Participants will attend 4 study visits; a practice and screening visit at which consent will be taken, eligibility will be ensured and participants will be familiarised with study measures and procedures, and assessment visits as baseline, 4 weeks and 12 weeks. Participants taking part in the fMRI part of the trial will complete 2 additional assessment which, where possible, will be performed on the same day as their baseline and 12 week study visits.