ANZCTR search results

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.

The primary purpose of this study is to determine whether omega-3 fatty acid dietary supplementation will reduce blood biomarkers of inflammation and improve blood vessel function in patients with a small abdominal aortic aneurysm. We hypothesize that 12 week dietary supplementation with omega-3 fatty acids will reduce the concentration of inflammatory biomarkers in the blood, and improve indices of arterial stiffness. We will recruit 50 patients who have small abdominal aortic aneurysm (maximal diameter of 3.0-4.9 cm, determined by non-invasive imaging techniques). Participants will visit the laboratory for testing on 4 separate occasions (Day 0 and Weeks 3, 8, and 12). Blood and urine collections, and testing of vascular function will carried out during the Day 0, Week 3 and Week 12 visits. Participants will be randomized to receive fatty acid capsules (active or placebo), and will take 3/day for 12 weeks. Participants and investigators will be blinded to the treatment groups. Unused capsules will be returned by the participant at their next visit. The research team include vascular surgeons and fundamental scientists.

This study aims to examine the safety and effect of 12 months of BGP-15 treatment on heart function in people with non-ischemic dilated cardiomyopathy. This is a phase 2, randomised, double-blind, placebo-controlled, adaptive design study of orally administered BGP-15 in patients with evidence of increased cardiac fibrosis as suggested by cardiac MR imaging. Safety monitoring will be conducted at 3, 6 and 12 months of drug therapy. Efficacy will be assessed by cardiac MR, echocardiography and exercise capacity tests at baseline, 6 months and 12 months. The adaptive design study has 2 parts. Part A involves treatment of 30 participants with placebo and 2 doses of BGP-15. Safety analysis by an independent DMC will recommend an on-going dose for Part B (or termination if required). Part B involves 60 patients treated with placebo and one dose of BGP-15.

Patients who require treatment in the Intensive Care Unit (ICU) can develop stomach ulcers or duodenal (small intestine) ulcers. This occurs most commonly when life support (a breathing machine) is required or when the patient develops a bleeding tendency as a result of their illness. These kinds of ulcers are known as ‘stress ulcers’ and may cause life-threatening bleeding. Patients who require life support in the ICU are typically given one of two types of medicine to try and prevent the development of stress ulcers. The two types of medicines are called ‘proton pump inhibitors’ (PPIs) and ‘histamine-2 receptor blockers’ (H2RBs). While the prevention of stress ulcers is very important, the medicines used to prevent ulcers may have important side effects including an increased risk of developing certain kinds of infections. The risk of side effects may depend on the medication used. This study will establish which of the two types of medicines that are commonly used for stress ulcer prophylaxis in ICU patients who require life support leads to the lowest risk of upper gastrointestinal bleeding, prolonged mechanical ventilation, and Clostridium difficile infection. The study will use a design known as a ‘cluster crossover registry design’. In this type of study, data are collected primarily from existing data sources rather than the medical records of individual patients. There will be two study treatment periods. During the first treatment period, half of the participating ICUs will be randomly (like the toss of a coin) instructed to use PPIs for stress ulcer prophylaxis in patients who require life-support while the other half will use H2RBs. During the second treatment period each ICU will swap to using the opposite treatment. This means that, in situations where PPIs and H2RBs are regarded as being equivalent by the treating clinician, the treatment administered to the patients will be determined based on the treatment assigned to the patient’s ICU. However, if there is a specific indication for either PPI treatment or H2RB treatment (for example, an allergy), the treatment indicated for the particular patient concerned will be administered irrespective of the treatment assigned to the ICU.

This study is the first large-scale trial of Functional Imagery Training (FIT). FIT aims to enhance the effectiveness of existing best treatment for alcohol use, Motivational lnterviewing (MI), by harnessing the motivational power of mental imagery. Alcohol misuse is a high prevalence problem with substantial health and social impacts. This study examines the additive effect of embedding FIT techniques within MI when treating Alcohol Use Disorder. A total of 480 participants who are drinking >4 standard drinks per day on average and who meet criteria for DSM-5 Alcohol Use Disorder will be recruited and randomly allocated to one of the following three treatment groups: 1. Motivational Interviewing (MI) – delivered by phone in 2 calls over 1 week. Treatment contact time totals 2 hours. Participants discuss the advantages and feasibility of reducing drinking, and therapists elicit emotional reactions and dissonance between core values and current behaviour. 2. Motivational Interviewing plus Support (MI+S) – delivered by phone in 8 calls over 25 weeks. Treatment contact time totals 3.5 hours. MI+S has the same initial sessions as MI. Later calls offer non-specific support and social reinforcement for progress and encourage brief relaxation practice, but do not shape new coping strategies unless a lapse occurs. A smartphone app assists practice of progressive muscular relaxation, including an audio file to guide practice and photos of peaceful nature scenes. 3. Functional Imagery Training (FIT) – delivered by phone in 8 calls over 25 weeks. Treatment contact time totals 3.5 hours. Is based on MI+S but uses imagery throughout the sessions. During sessions, participants generate multisensory images about positive outcomes from controlling drinking, past success with self-control, and strategies to control drinking. Later sessions elicit achievements, outcomes and effective strategies, rehearsing imagery and making it routine by linking it to daily tasks. Mindfulness is practised instead of relaxation. A smartphone app assists practice of imagery, including an audio file to guide practice and the ability to take photos to facilitate practice. Participants complete assessments at Baseline and at 3, 6, and 12 months post-Baseline. Follow-up assessors are blind to treatment condition.