ANZCTR search results

Brief summary Background Australia drivers are required to stop driving for at least six weeks if they experience a severe hypoglycaemic event (requiring the assistance of another person for recovery). Australian fitness to drive guidelines indicate that specialist support should be available during this time to assist in the individual’s assessment and their potential return to driving. However, at present there are no structured education programs in place to assist these drivers when they return to driving, or pre-emptively, to minimize the risk of a hypoglycaemia-related driving incident. Objectives This project will develop an Australian version of the DiabetesDriving.com intervention, a low-cost educational program specifically aimed towards at-risk drivers with type 1 diabetes. Study Plan This is a pilot randomized controlled trial (RCT) conducted in Australia. The number of blood glucose related driving mishaps is the primary outcome. Secondary outcomes include self-assessed risky driving behaviour and the frequency of pre-driving blood glucose checks. The latter is relevant as current guidelines require drivers to check their blood glucose level before driving. As a pilot, no power calculations have been undertaken. Data will inform a larger RCT. Estimating a 20% dropout/incomplete data, we will recruit a minimum of 60 participants to achieve a sample of 50.

The aim of this study is to assess whether medium chain triglycerides (MCT) can protect the brains of adolescents with type1 diabetes mellitus (T1D) during hypoglycaemia. Glucose is the dominant metabolic substrate for brain function. Hypoglycaemia is an inevitable consequence of insulin therapy in type 1 diabetes mellitus (T1D). Even with good control, children and adolescents with T1D spend up to one hour per day with blood glucose levels in the hypoglycaemic range. If untreated, hypoglycaemia can lead to impaired cognition, loss of consciousness and potentially death. Fear of the neurologic consequences of hypoglycaemia is one of the main impediments to optimal metabolic control in children with T1D. Thus there is an imperative for neuroprotective therapies that mitigate or prevent the effects of hypoglycaemia. Using hyperinsulinaemic glucose clamp techniques and simultaneous neuroimaging we have previously investigated the effects of hypo- and hyperglycaemia on brain metabolism, neural networks and cognition in adolescents with T1D. Our studies found clinically important, novel, consistent and robust changes in regional brain perfusion, activation and metabolism during passage from euglycaemia to hypoglycaemia. These abnormalities in neuronal activity persist over hours despite return to euglycaemia. We now plan to exploit these novel findings and to study whether the observed changes can be mitigated or prevented by the prophylactic administration of MCT prior to hypoglycaemic challenge. We will test the efficacy of MCT during clamp-induced hypoglycaemia in a randomised, cross-over placebo-controlled trial. The study population will be 10 adolescents aged 12-18years with Type 1 diabetes, recruited from the Diabetes Clinic at the Royal Children’s Hospital, Melbourne. Our primary outcome will be difference in cerebral perfusion as measured by arterial spin labelling – ASL) during hypoglycaemia induced following MCT as compared with placebo.. Our secondary outcomes will be differences between groups in, functional connectivity /activation in the default mode network (measured using blood oxygen level dependent [BOLD] signalling), brain metabolism (measured using BOLD signalling), frontal lobe biochemistry (measured spectroscopically) and cognitive function (measured on a working memory task). We hypothesize that the changes in all of these outcome measures during hypoglycaemia will be mitigated or prevented by prior oral MCT administration. Our ultimate aim is to devise a simple oral therapy that can be taken by all children with T1D to protect the brain from hypoglycaemia. This will lead to improved neurologic outcomes and facilitate better overall metabolic control of their diabetes.

Our research focuses on nutritional strategies for bone health to prevent osteoporosis and reduce the risk of fractures in overweight post-menopausal women. Osteoporosis and obesity both impose major cost burdens for their associated care. There is increasing evidence of a high prevalence of fractures in overweight and obese people. There are approximately 400 fractures per day in Australia as a result of osteoporosis. Breaking a bone is very painful but there are longer term effects such as difficulty in walking and it has now been shown that fracture contribute to premature death. Osteoporosis arises when bones lose calcium more quickly than it can be replaced, reducing their strength. Although only a small amount of calcium is present in blood; this calcium is essential for the functioning of the heart, muscles and nerves. So far, studies have mainly investigated impact of calcium supplementation in reducing bone loss in normal weight women. However there are increasing numbers of overweight women in our community and therefore it could be that dietary calcium does not have the same benefits for bone health in overweight women as it does in thin women. Our research aims to answer two important questions:- 1) Can dietary calcium protect the bones of overweight and obese post-menopausal women? 2) Which form of calcium intake, calcium from food or calcium as supplement, is better for overweight/obese post-menopausal women.

The REVIAN study is designed as a prospective, randomized, controlled, double-blind, parallel study to evaluate the efficacy and safety of the REVIAN System in male participants with androgenic alopecia. An Active modulated light therapy REVIAN System will be compared to a Placebo Comparator non-active REVIAN System in participants using the device for a daily 10-minute treatment over the course of 26-weeks. At each follow-up visit, participants will be interviewed to determine if any adverse events (AEs) were experienced since the previous follow-up visit. All participants will be required to complete self-administering scalp hair growth and life quality questionnaires at each follow-up visit. Investigators will be required to complete global assessments of scalp hair growth for each enrolled participant at each follow-up visit. Macrophotography evaluations will be performed at baseline, 8-, 16-, and 26 weeks for all participants using standard Canfield blinded reviewer. Global photographs of superior and vertex scalp will be taken by participants and by PI to be assessed by a blinded reviewer once all photos have been captured for each participant per visit.

Project Summary This is a pilot study of a new, non-invasive, cuffless blood pressure measuring device, worn on the chest. This is a world first for Monash University engineers. Blood pressure (BP) measurement is an essential vital sign, and provides a cornerstone for diagnostic and treatment decisions in healthcare. Existing technology requires either uncomfortable arm cuff inflation, or invasive catheters placed into patient’s arteries. Monash University engineers have developed a device consisting of sensing pads (4 ecg dots) and a radar to be placed on the patient’s chest. Initial lab testing suggests that the device functions well in fit young volunteers. Further testing is now required on volunteers with a range of resting blood pressures and body shapes to determine how the device performs on a broader section of the adult population. We are evaluating this device at Cabrini on a reasonably healthy adult volunteer population aged 18 years and over. Some of the subjects need to have uncomplicated hypertension. The study requires most participants (N=29) to attend for an hour, wear the new device on their chest, and a normal ‘gold-standard’ BP cuff on their arm. The volunteer will then go through a range of tasks whilst having their BP measured both ways. The tasks involve resting on a bed, sitting up, clenching their hands and riding an exercise bike for a few minutes. A smaller sub-group of the healthiest participants (N=16) would be required to take a small dose of glyceryl trinitrate (GTN) to lower their blood pressure by a small amount, whilst resting on a trolley in a treatment room in the Emergency Department at Cabrini. We aim to establish the precision of the device by correlating what the new device against an established ‘gold standard’ method of BP measurement measures (arm cuff). The dataset of BP readings from the chest device allows the engineers to apply mathematical algorithms to convert the data into accurate blood pressure readings. The aim of the research is to develop a method whereby BP can be measured accurately, continuously, and without patient awareness or discomfort, thus in the future eliminating the need for a sphygmomanometer or arterial line catheter for patients.

Lower limb pathology is the most common form of disability among sporting populations, accounting for over 50% of all sporting injuries. Taping is routinely recommended with the expectation it restricts joint range of motion, and therefore reduces the risk of injury. While the effects of taping have been well investigated in the literature, gaps still exist around the effect of ankle strapping on knee function, and whether ankle movement increases as strapping tape fatigues. Gaining a better understanding of the relationship ankle strapping has with knee function, and whether fatigued strapping tape has the ability to limit ankle range of motion. As the current research has many limitations and inconsistencies, the findings may enable better decision making by practitioners looking to prevent lower limb injuries. This study has been developed with two aims: 1) To inform athletes, and those working with athletes, about the impact of tape fatigue on tapes role as an injury prevention method, and 2) To inform athletes, and those working with athletes, about the impact of ankle tape on knee mechanics.

The purpose of this project is to test the addition of a new treatment called denosumab to standard immunotherapies for patients with metastatic melanoma. Denosumab has been used for many years to help treat cancers such as prostate cancer and breast cancer, but it is not currently used in melanoma. We hope the addition of denosumab to current melanoma therapies will make these treatments work better without adding to the side effects. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with metastatic melanoma (melanoma that has spread). Study details Nivolumab and ipilimumab are approved treatments for advanced melanoma in Australia and overseas. Patients with metastatic melanoma, who are not enrolled in a study, are commonly prescribed nivolumab alone or the combination of nivolumab and ipilimumab as standard care. However, there is limited information on the effectiveness and safety of these treatments in combination with denosumab. Recent melanoma research in animal models has shown that denosumab can make immunotherapies such as ipilimumab and nivolumab work better. Because denosumab has been used in patients with breast and prostate cancer for a long time and is safe, we now want to test the benefits and safety of adding denosumab to immunotherapies in this study. Patients in Arm A will receive nivolumab 3 mg/kg IV (intravenous) every 2 weeks for 4 doses and denosumab 120 mg SC (subcutaneous) D1, D8, D15, D29. Thereafter, nivolumab 480 mg IV and denosumab 120 mg SC every 4 weeks for a total of 24 months Patients in Arm B will recieve ipilimumab at 3 mg/kg combined with nivolumab at 1 mg/kg IV every 3 weeks for 4 doses with denosumab 120 mg SC given D1, D8, D15, D29, D57. This will be followed by nivolumab 480 mg IV and denosumab 120 mg SC ever 4 weeks for a total of 24 months. Responses to treatment and progression will be regularly monitored until the last patient has been in survival follow-up for 5 years. Tumour and blood samples will also be taken to determine possible predictive biomarkers.

Atrial fibrillation (AF) is a fast irregular heart rate that can cause abnormalities in the structure and electrical function of the heart and can cause strokes through formation of blood clots in the heart which move to the brain. A stroke is when blood flow to the brain is interrupted. Although AF is known to increase the risk of stroke, there is new evidence that suggests that other factors may be independently present that cause formation of blood clots in the heart leading to a stroke. The primary purpose of this study is to identify changes in structure of the heart, the electrical properties within the heart and in the blood chemistry that might increase a person’s risk for having a stroke.

Background: Increasing referrals and competing demands for limited resources are challenges faced by many government and non-government early intervention (EI) services. and the metropolitan Child Development Service (CDS) of Perth, Western Australia is no exception. CDS is a publically funded agency that forms part of Child and Adolescent Community Health and provides services for approximately 20,000 children with developmental delay and/or disability across the metropolitan region. In recent years referrals have increased significantly, and are expected to rise further due to migration and increased birth rates which can impact negatively on waiting lists. Operating with waiting lists is a problem many EI organisations face which has resulted in pressure to consider alternative models of delivering services to enable vulnerable children and families to access critical services in a timely way. Playgroups are used throughout the community to increase community engagement and parenting capacity whilst promoting children’s development through developmentally appropriate play. Therapeutic playgroups target families and children with specific risk factors or identified developmental delays/disabilities and aim to provide support and information specific to the child’s needs. They have been shown to have positive impacts on both caregiver and child outcomes. Objective: To evaluate a therapeutic playgroup protocol for children and families when first referred to CDS. Project Plan: This project will aim to develop, test and evaluate the playgroup protocol. This will include; focus groups and collection of demographic and descriptive data a playgroup working group, a pilot trial to assess feasibility and acceptability of the playgroup intervention and a randomised controlled trial to evaluate playgroup effectiveness compared to usual care. Prior to this a scoping review was conducted to identify key elements of playgroups from the literature.

To reduce breastfeeding complications in mothers of preterm infants by initiating expressing and massage within the first hour of birth as compared to one to six hours of birth or later. A pilot RCT will be used to inform the study methods to design a larger RCT.