ANZCTR search results

To establish the feasibility, patient acceptability, effect on blood pressure and thereby overall potential of a simplified treatment strategy with 'hypertension polypill', which includes four common blood pressure lowering medications each at 1/4 strength dose. This pilot study will be double blind randomised placebo- controlled crossover trial of 50 patients with established hypertension not on any medical therapy. Subjects will be randomised into two arms - intervention (Quadpill) and control (placebo)- for a period of four weeks. They will undergo office blood pressure as well as 24 hour ambulatory BP assessment at baseline and in 4th week in addition to safety monitoring blood tests. Thereafter there will be a 2 week washout phase prior to crossing over to opposite arm of the study. The patients will undergo another baseline blood and 24 hour ambulatory BP assessment. The study will conclude at 10 week with repeat measurements. The outcomes assessed will be change in the mean blood pressure, safety, tolerability and acceptability.

This study will investigate the impact of chemotherapy on vascular and metabolic parameters that may predispose to cardio-metabolic illness after cancer. Who is it for? You may be eligible to join this study if you are a female aged at least 18 years who has been diagnosed with early stage breast cancer, for which you are due to commence chemotherapy. Healthy age and gender matched control patients will also be recruited to provide a benchmark for comparison. Study details All participants in this study will undergo interviews, questionniares, cardiovascular investigations, and metabolic investigations. This will involve insertion of intravenous cannulas (i.e. into the vein), so that blood samples can be taken. Breast cancer patients will be assessed at 3 timepoints over 9 months, i.e. at baseline (just prior to first chemotherapy) 3 months and then 9 months later. Healthy volunteers will be assessed on a single occasion only. The following assessments will take place at each visit; Study procedures: Participant presents after overnight fast. The visit will take about 5-6 hours. General Assessment: Measuring weight, height, waist and hip circumference, heart rate, blood pressure and temperature will be recorded. Assessment of cardiovascular risk: Measurement of arterial stiffness: assessed by measuring the pressure wave the heart produces in arteries with a small blunt probe. Assessment is not painful and usually takes about 30 minutes to complete. Measurement of autonomic nervous system activity: measured non-invasively: small changes in heart rate and blood pressure will be measured. Urine test: the specimen will then be sent to the lab to be tested for the amount of some chemicals which help measure the activity of the sympathetic nervous system. Measurement of endothelial function: measured by placing a probe on one finger of each hand to record pulsation of the arteries in the finger. By measuring the change in blood vessels after a blood pressure cuff on the arm is inflated and then deflated. Blood tests: A needle will be inserted into a vein in one arm, with a small plastic tube (drip) left in from which we will take blood samples. A baseline blood sample will be taken from you. You will then be asked to eat a meal over 15 minutes; then a series of blood samples will be collected from intravenous catheter over the two hours following the meal. In all, about 75mL of blood (less than one sixth of a blood donation) will be collected as part of this test. The results from these blood tests will tell us how much insulin the body makes in response to the meal. Additional blood samples: When we take the first blood sample before the meal we will also take an additional sample. This could be used to measure the cholesterol and other markers of cardiovascular risk that show up in your blood. Assessment of energy intake and expenditure: Estimating Energy intake: through an interview by on the doctors or nurses involved in the study, and asking to tell us what you have eaten over the last 24 hours. (10 to 15 minutes.) Physical activity: We will ask you to complete a questionnaire to tell us of your physical activity levels over the last 7 days. (10 to 15 minutes) Indirect calorimetry: measures the rate of energy expenditure before and after the meal. A clear plastic hood will be placed over the head for 20 minutes. You can breathe normally while under the hood and it does not restrict the amount of oxygen you inhale. The hood is connected to a machine that measures the energy expenditure Measurement of brown fat activity: by taking a picture with a special infrared camera before and after the meal that measures the temperature in the supraclavicular fossa (lower neck) very accurately. Measurement of body composition using a DEXA machine (the same machine that is used to measure bone density). You will be asked to lie on a bed while a scanner takes a picture of you. The scan is painless and takes about 10 minutes.

This study will investigate the effects of combining metformin with androgen deprivation therapy (ADT) in men with metastatic prostate cancer. You may be eligible to join this study if you are male, aged 18 years or above and have been diagnosed with metastatic prostate adenocarcinoma, for which you have not received any ADT. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will take 3 x 500mg oral tablets of metformin hydrochloride daily for 30 weeks, whilst participants in the other group will take 3 oral tablets of placebo (inactive treatment) daily for 30 weeks. Participants will be followed-up every 6 weeks for 54 weeks, in order to determine metabolic and tumour responses and tumour progression.

Preliminary scientific evidence suggests that Saffron (Crocus sativus) may have beneficial effects on the central nervous system (CNS), and have therapeutic applications for mood, anxiety, depression, insomnia, memory and as an anticonvulsant. The aim of this study is to conduct a preliminary study of a Affron, a standardised extract of Crocus sativus (Saffron) for potential efficacy for mood and cognitive function in healthy adults.

Amnestic mild cognitive impairment (a-MCI) is believed to represent a transition period between normal aging and Alzheimer's disease. People with a-MCI experience problems with their memory without it impacting on their daily functioning. As a-MCI represents a stage prior to irreversible neurodegeneration, it is important from a therapeutic perspective that neural changes occurring in a-MCI are determined in order to see if there remains potential for response to treatment. Neuroplasticity refers to the brains ability to re-organize its function in response to the environment. One aspect of this is known as long-term potentiation (LTP), which is imperative in learning and memory. LTP-like plasticity can be induced through brain stimulation techniques including transcranial direct current stimulation (tDCS). Application of tDCS through a gentle electrical current can increase brain activity as measured through electroencephalography (EEG) and behavioural outcomes. When transcranial magnetic stimulation (TMS) is applied in combination with EEG, the cortical excitability of the stimulated and surrounding brain regions can be determined. This provides information about the LTP-like plasticity that is present. Together with cognitive performance, this information can help to determine the changes occurring in a-MCI compared to younger and older adults, and the relationships between plasticity and cognition. The aim of our study is to investigate whether LTP can be induced in a-MCI and if there are differences in LTP-like plasticity compared to younger and older healthy adults, and the relationship of plasticity to cognitive performance.

Consumption of foods rich in saturated fats have been associated with elevated blood lipid levels and adverse health effects. However studies using animal models have demonstrated that dietary saturated fats raise blood lipid (cholesterol and triglyceride) levels only when the diet is deficient in omega-3 fatty acids (n-3PUFA). If the same is true for humans, this research will have important implications for the prevention of cardiovascular disease and other chronic diseases. Therefore we hypothesize that saturated fat consumption does not raise blood lipid levels if the diet is sufficient in n-3PUFA. We also hypothesize that the benefits of n-3PUFA can be optimized when consumed in combination with saturated fats. This is a randomized controlled, dietary intervention trial, in parallel design with healthy adults. Subjects will be asked to consume 4x1g fish oil capsules (2.4g EPA:DHA 100:500) daily for 4 weeks, then they will be randomly assigned to one of two diets, a high saturated fat (SFA) diet or a high omega-6 fatty acid (n-6PUFA) diet both combined with n-3PUFA (fish oil), which they will consume for 10 days. Subjects on the SFA diet will consume daily 24g butter (which can be spread on bread, muffins or crackers), 40g white chocolate and 4x1g fish oil capsules, they will also be advised on how to use more foods containing saturated fat for cooking and reduce n-6PUFA containing oils. Subjects on the n-6PUFA diet will consume 20g margarine (which can be spread on bread, muffins or crackers), 42g sunflower seeds and 4x1g fish oil capsules, they will also be advised on how to use more foods and oils containing n-6PUFA for cooking, and reduce saturated fat. Participants will donate blood, give information on medical and supplement usage and physical activity and they will have their anthropometric measurements taken, at baseline, at 4 weeks and after 10 day of consuming either the SFA diet or the n-6PUFA diet. Subjects will also complete a 3 day food record.

This is a randomised controlled trial analysing two rehabilitation techniques for non-union scaphoid fractures. This study aims to investigate whether the use of an anatomically contoured scaphoid specific locking plate with non-vascularised bone graft in scaphoid non-union allows for early mobilisation and union. This study will be conducted as a randomised controlled trial with the control arm receiving the gold standard rehabilitation (1) and the experimental arm receiving no plaster and early mobilisation. Our hypothesis is there will be no difference in union rates between the gold standard and experimental cohorts. We are hoping this will result in a change in standard practice for this group of patients.

Toshiba medical systems have developed a new rapid diagnostic test device kit for influenza using new technology from current rapid tests available. The device is able to detect influenza virus in a much smaller sample and provide a result in around ten minutes. It will be compared with the Denka Seiken QuickNavi POCT device already marketed for use overseas for accuracy of results however neither device will be used to make a diagnosis. The diagnosis will be made from the accepted RT-PCR (separation culture) test. Participants will have 3 samples taken from either the nose or throat. 1sample for the culture and 1 sample for each device.

There is an expanding evidence-base demonstrating benefits of exercise for improving balance and mobility in people with Parkinson’s disease. Yet the role of exercise in improving arm and hand function has been neglected to date. The primary aim of this randomised controlled trial is to determine the impact of a home-based, interactive videogame system designed for people with Parkinson’s disease on upper limb function. The secondary aims are to determine the effect on finger and upper limb dexterity, performance of upper limb tasks, quality of life, and cognition. In addition, the participants’ perception of the effect of the intervention and acceptability of the intervention will be evaluated. Since difficulty performing upper limb activities is associated with poor quality of life, the development of effective, sustainable and engaging exercise programs to improve upper limb function in people with Parkinson’s disease is an urgent research priority.

Vaccines used in Australian clinical practice have been tested for safety in clinical trials and are then registered for use by the Therapeutic Goods Administration. Safety monitoring of vaccines (as for all licensed medicines) is an ongoing process. This is usually done in Australia by “passive” or voluntary reporting of any reactions known as ‘adverse events’ that may occur after a drug or vaccine is used. The purpose of the Stimulated Telephone Assisted Rapid Safety Surveillance (STARSS) study is to evaluate a new way of monitoring the safety of vaccines. This system is a way of involving the consumer in reporting immunisation adverse events and will give “real time” information about vaccine safety. This will be achieved by sending a short message service (SMS) mobile phone text similar to what one often gets to remind you to attend a doctor’s appointment. The potential benefit of such a study is that vaccine and drug safety could be evaluated in a large number of consumers and any potential issues (these would be unlikely) can be identified very soon.