ANZCTR search results

The primary aim of the current study is to determine the effect of a moderate protein, high carbohydrate predominantly plant-based diet on appetite control and short-term health outcomes in individuals 65-75 years of age using a meal delivery based dietary intervention. 220 subjects, comprising equal numbers of men and women will be recruited. Participants will attend the RPA-CPC Clinic on 3 occasions. The first will be to attend a screening interview where they will be asked to complete questionnaires on their medical history, medications, cognitive health and eating behaviour. Eligible participants will then be invited to attend a baseline testing morning at the RPA-CPC Clinic. At the baseline testing, participants will arrive after an overnight fast with un-brushed teeth, bringing with them a 7d food diary, completed questionnaires about their lifestyle and general health, a stool sample and a 24hr urine collection. A blood sample will be collected and then an oral health examination will be performed and saliva and bacterial samples from tooth-surfaces will be collected. Body weight, waist and hip circumference, blood pressure, body composition and physical performance will also be measured. Participants will be randomly assigned to one of four dietary interventions. On the week after baseline testing study diets will be provided via a meal delivery company. Participants will be asked to consume the foods ad libitum. Participants will be requested to consume only from study foods and to keep a weighed food diary. During the 4 wk intervention, a study co-ordinator will contact each participant by phone on 5 different occasions. The first will be to ensure food has been delivered on the day before the study is to start, and the remaining 4 calls will be for a 48hr food recall. At the end of the final week of the dietary intervention participants will attend the RPA-CPC Clinic for final testing. At final testing, participants will arrive after an overnight fast with un-brushed teeth and will bring with them their study diary and a 24hr urine collection. A blood sample will be collected and an oral health examination will be performed and saliva and bacterial samples from tooth-surfaces will be collected. Measurements of body weight, waist and hip circumference, blood pressure, body composition and physical performance will be repeated.

The goal of the proposed research is testing the hypothesis that the non-invasive electrical stimulation of the tongue muscle cortical neurons may reduce the desire for nicotine addiction. This hypothesis has been suggested according to a recent evidence (Vicario et al., 2014, The Journal of Psychiatry and Neuroscience) documenting altered electrical activity of this neurons in chronic smokers during tobacco abstinence. Thus, we propose to test the impact of a single session non-invasive electrical stimulation of the tongue muscle cortical representation in one group of chronic smokers (CS) under nicotine withdrawal. This research goal will be pursued by using medical device named transcranial direct current stimulation (Tdcs).

The overall aim is to improve health professional’s management of smoking in Aboriginal and/or Torres Strait Islander pregnant woman in a culturally tailored approach. The study will include 6 Aboriginal Medical Services in 3 states (NSW, SA, and QLD). Each service will receive webinar training to all the staff, audit and feedback, an educational resources package and free oral Nicotine Replacement Therapy for participating pregnant women. This study is a pilot study aimed to assess how the intervention is likely to be feasible in a full clinical study and foresee any implementation challenges we will need to overcome.

This study aims to determine the effect of exercise training on heart function in breast cancer patients undergoing Anthracycline based chemotherapy and to evaluate the use of exercise Cardiac Magnetic Resonance, a novel imaging technique. Who is it for? You may be eligible to join this study if you are between the ages 18 and 70 years old, have been diagnosed with breast cancer and are scheduled for Anthracycline-based chemotherapy. Study details Participants can chose which group they wish to join. Participants can select the intervention group where they will follow a personalised exercise program 2 times per week for 60minutes at the Baker IDI Heart and Diabetes institute and one home based (unsupervised) session for 100min for the duration of their Anthracycline chemotherapy. Whilst participants who elect to be in the control group will not follow an exercise program but are encouraged to exercise at their discretion. All participants will undergo an echocardiogram, VO2 max test and exercise Cardiac Magnetic Resonance (CMR) at baseline and 3 weeks after the last anthracycline treatment cycle. The exercise CMR is a novel technique hypothesized to aid in earlier diagnosis of heart failure. Participants will pedal a specially adapted cycle while lying in the narrow tube of the MRI machine.

The primary purpose of this study is to evaluate the safety of a new cancer drug, APG-1252 which has not yet been tested in humans. The study will also look at the amount of drug in the blood to evaluate the way the body processes the drug and the way the drug acts on the growth of tumours in cancer patients. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been diagnosed with Small cell lung cancer or other solid tumor types with no standard treatment options. Before the study starts, they are asked to sign a consent form. Each participant then goes through a series of tests to see whether the study is suitable for them. These tests include reviewing the participants medical and medication history, a physical examination, an electrocardiogram (ECG), CT and bone scans (to locate and measure tumours), taking urine and blood samples for testing and asking about how able they are to do their usual daily activities. If a participant's test results are satisfactory, they are enrolled into the study. Study details: All participants in this study will receive a specified dose of APG-1252 in 28-day cycles, which is administered intravenously (i.e. directly into the vein), at a starting dose of 10mg. The first set of participants will start on the lowest dose level, with the next highest dose only commencing in the next set of participants once the safety of the first dose has been confirmed. Researchers will take a number of blood samples on days 1, 3, 8, 15, 22 of dosing in each participant to examine the rate that the body processes the drug. Further blood samples, as well as CT, MRI scans other medical imaging/assessments will be taken before treatment and at the end of treatment to look for changes in tumour growth. Participants will also be assessed for side effects throughout the study period. It is hoped that the findings of this trial will show whether APG-1252 can be safely given to cancer patients, and provide information on the rate of processing of the drug in the body. Using this information, researchers hope to find the best dose to use for further testing of APG-1252 in cancer patients.

Many heart conditions impair the heart's ability to pump blood. This is known as heart failure. Exercise training is an important component in the management of heart failure, but in severe cases, symptoms such as breathlessness and fatigue limit patients' ability to undertake and benefit from exercise. Left ventricular assist devices (LVADs) are small pumps implanted into the heart of patients with severe heart failure to assist the heart in pumping blood around the body. LVADs reduce symptoms of heart failure, enabling patients to undertake exercise that wasn't previously possible. However, little is known about the most effective form of exercise training in patients with LVADs. This research project will involve an international multicentre randomised controlled trial investigating the effects of a new approach of exercise training in patients with LVADs, involving alternating bouts of moderate and high-intensity exercise. Six weeks after being implanted with a LVAD, participants will be randomised to either 12 weeks of high-intensity interval exercise or 12 weeks of moderate intensity exercise. Before and after the exercise programs, participants will undergo tests to compare the effects of the two exercise programs on fitness, heart and blood vessel function and quality of life. We anticipate the findings of this project will help optimise exercise rehabilitation for people with LVADs and provide information that will help inform exercise prescription in people with cardiovascular disease more generally.

Obesity has reached epidemic proportions globally and is associated with serious co-morbidities, including type 2 diabetes. Once adipose tissue has been accumulated, and food intake is limited by low calorie diets, counter-regulatory mechanisms induce an increase in appetite and a decrease in energy expenditure, which makes weight loss very difficult to maintain. To combat the global burden of obesity and its co-morbidities, a major challenge lies in the development of effective therapies that increase fullness and satiety, and result in good blood glucose control, while lacking adverse effects that are often associated with current therapies. There is increasing evidence that nutrient stimuli in the gastrointestinal tract play a central role in the control of energy intake and blood glucose. Proteins, and their building blocks, amino acids, are of interest, since high-protein diets are very effective for weight loss, particularly loss of fat, rather than muscle mass, and for improving postprandial glycaemic control, in obese individuals with and without type 2 diabetes. There is some evidence that a number of amino acids (including L-phenylalanine) may also have effects on energy intake, blood glucose and gut function in humans. Thus, they are of special interest in terms of potential therapeutic approaches for obesity and type 2 diabetes. This is an exploratory study and will investigate the dose-related effects of intragastric administration of L-phenylalanine on gastric emptying, gut hormone release, glycaemic control, appetite perceptions and energy intake in healthy, normal weight subjects.

Current cardiac arrest algorithms require assessment of the return of spontaneous circulation (ROSC) following rhythm checks. Current recommendations for assessment of ROSC include observation for patient movement or spontaneous respiration, both of which may be absent in sedated and paralysed patients. Healthcare professionals are advised to check the pulse in the presence of an organized rhythm, however previous studies have shown poor ability to correctly detect the presence or absence of a pulse in a simulated pulseless electrical activity (PEA) arrest. In one study, 45% of participants incorrectly diagnosed pulselessness in cardiac surgery patients no longer on bypass, despite systolic pressures greater than 80mmHg. In coronary artery bypass graft (CABG) surgery, when coming off bypass, blood flow changes from continuous to pulsatile. This may offer a model by which to simulate the return of pulsatile flow, and allow a comparison of radial arterial pressures when pulsatile flow becomes first apparent on 2D US and colour flow Doppler US of the carotid artery. This pilot study proposes to investigate whether pulsatile flow can be reliably assessed by the use of carotid artery ultrasound, and whether CABG patients can be used as a model to evaluate this.

Wrist fractures in patients are commonly managed using internal fixation. At the Royal Adelaide Hospital last year, 175 distal radius plating procedures were performed. Austofix have designed a new plate, the “VRP 2.0”, with the following proposed advantages over the current commonly available volar radial plate systems : 1. The plate is universal and not “sided” – this has beneficial effects in simplifying implant choice in theatre, as well as minimising hospital stock / inventory 2. The Locking mechanism is unique, and patented 3. The plate is lower profile than many on the market 4. The available angle for the variable angle screws has a range of 40 degrees, compared to 30 degrees for other systems. This may allow more accurate fragment specific fixation, and thus improve maintenance of fracture reduction, and hence eventual functional outcome. 5. The system offers improved instrumentation over currently used systems To confirm the clinical benefits of the Austofix VRP 2.0 plate system a combined prospective randomised controlled trial is proposed. This trial will compare outcomes of patients managed with the Austofix VRP 2.0 vs those managed with a conventional alternative. The VRP 2.0 plate is TGA registered, and on the approved list of implants with SA Health. Study Hypothesis: Adults with closed distal radius fractures who are managed operatively using the VRP 2.0 plate will perform at least 10 points better on the Patient-rated Wrist Evaluation (PRWE) score than those managed operatively using a conventional distal radius locking plate. Null hypothesis: There is no difference in clinical outcome up to one year post injury between patients managed with these 2 different plating systems. Aim: This study aims to provide high quality evidence for the effectiveness of surgical treatment of distal radius fractures using 2 different plating systems. It is proposed that the study will be conducted using a randomised controlled trial. Results will support and influence the future treatment of this common injury for optimal patient outcome.

Total knee arthroplasty (TKA) is a very common procedure. In the USA it is the commonest surgical procedure performed in the private system over the age of 45yrs. One in five Americans over the age of 54 have had a knee replacement. Other countries are also performing increased number of TKAs. In Australia there are approximately 48,000 TKAs performed each year. Studies have shown that up to 20% of patients are unhappy with the outcome after TKA. These patients are characterised by measures of depression and distress. Considering the expense and complication associated with TKA these figures are concerning, especially as they could be avoidable. STUDY HYPOTHESIS; In patients undergoing a TKA, improved outcomes are associated with a combination of pre-surgical preparation (pre-habilitation) and post-operative rehabilitation using treatments that address unhelpful psychosocial factors and provide training in active pain management strategies. The delivery of these treatments can be successful achieved by an internet-based protocol incorporating electronic peripheral functional monitors and provider- and user-interfaces on a hand-held “tablet” device. Success of this pilot study is assessed by a review of patient satisfaction with the protocol, as well the identification of any problems which can be rectified prior to the commencement of the pivotal trial. In addition, a successful study will be shown by an improvement in function and quality of life and reduced analgesic requirements in patients treated with the Personalised Rehabilitation Program.