ANZCTR search results

The primary purpose of this exercise study (in collaboration with JCU) is to investigate if regular physical activity in a group or individually improves the psychological effects whilst on hormone and radiation treatment. We aim to recruit 117 patients. The exercise program will be conducted by the exercise physiologists at the JCU clinic. Who is it for? You may be eligible to participate in this study if you have been recently diagnosed with localised prostate cancer, for which you have been scheduled to begin a combination of radiotherapy and Eligard hormone treatment. You must not have commenced Eligard hormone treatment more than one month previously. Study details: Participants enrolled in this study will be randomly allocated (by chance) to one of three groups. *The first group involves completing a group exercise program. *Participants allocated to the second group will complete an individual exercise program. *Participants allocated to the third group will not complete any exercise program, but will simply continue with their cancer treatment as normal. Participants allocated to either of the first two groups, i.e. the exercise program groups, will complete a 60 minute training session either as part of a group or on their own, three times per week for the duration of their hormone and radiotherapy treatment, or for a maximum of eight months. Exercise sessions involve aerobic/light impact activity and resistance/light impact activity. The program will alternate each week. Week 1: *2 sessions of aerobic/light impact activity *1 session of resistance/light impact activity Week 2: *1 session of aerobic/light impact activity *2 sessions of resistance/light impact activity Researchers will assess the efficacy of the exercise programs using questionnaires, s fitness test before starting the program and after finishing the program, and through a brief 15 minute interview with participants at the end of their radiation treatment. It is hoped that the findings from this trial will provide further information on the benefits of exercise during treatment for prostate cancer, and on which format of exercise is preferable and most beneficial for patients.

This study aims to determine whether using wearable technology activity monitors coupled with brief behavioural counselling and goal setting can increase physical activity and decrease sitting time amongst breast cancer survivors. Who is it for? You may be eligible to join this study if you are a post-menopausal breast cancer survivor who was diagnosed with stage I-III breast cancer, and who has completed primary treatment (ongoing hormone therapy is acceptable). Eligible participants will also engage in less than 75 minutes of moderate-vigorous physical activity per week, more than six hours of sitting each day. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group receive a novel 12 week intervention which involves: 1) Attending an initial information and training session; 2) wearing a technology activity monitor daily to enable real-time monitoring of physical activity and sitting time; and 3) receiving five behavioural counselling and goal setting sessions via telephone. The intervention will be followed by a 12 week maintenance period. Participants in the other group will receive no intervention for the first 12 weeks. After this time they will attend an information and training session and wear the activity monitor for 12 weeks. They will not receive the behavioural counselling and goal setting sessions. All participants will complete assessments by wearing an accelerometer and inclinometer at baseline, after 12 weeks, and after 24 weeks in order to evaluate physical activity and sitting time. The proposed intervention has the potential to be an inexpensive and sustainable addition to usual care provided by clinicians, allied health professionals or via telephone-delivered cancer information and support services (such as those delivered by Cancer Councils across Australia).

This is a single-centre study using naturally acquired Plasmodium vivax (P. vivax) HMPBS02-Pv challenge inoculum to infect healthy participants in order to characterize the infectivity of the parasite isolate P. vivax HMPBS02-Pv in vivo. The goal is to determine the safety of the P. vivax blood stage malaria model following inoculation of healthy participants with P. vivax HMPBS02-Pv and the registered Chloroquine anti-malarial drug treatment. This study will be conducted in consenting and eligible male or female participants. Each participant will be inoculated on Day 0 with around 1,100 viable P. vivax-infected human erythrocytes administered intravenously. On an outpatient basis, the participants will be monitored for presence of parasites by qPCR following the challenge and then during and after the treatment, until free of parasites. During this time, participants will also be monitored for the unexpected early onset of malaria symptoms, signs or parasitological evidence of malaria. On the day designated for commencement of treatment, as determined by PCR results and/or onset of clinical symptoms of malaria infection, participants will be admitted to the study unit and confined for safety monitoring and registered Chloroquine anti-malarial treatment. Based on previous studies, it is anticipated that treatment will occur on approximately Day 8 to Day 10. Following treatment, the participants will be followed up as in-patients for 72 hours to ensure tolerance of therapy and clinical response. Once clinically well, the participants will be followed up on an out-patient basis for continued assessment of anti-malarial drug levels, and monitoring of safety, in particular liver function tests, and clearance of malaria parasites via qPCR. Follow up visits for safety assessments will be performed at specific time points until Day 28 after the malaria infection and the participants are required to be contactable and available up to 2 weeks following this end of study visit. The overall period of participation will therefore be around 4 weeks from the time malaria infection.

Iron deficiency is a common nutritional deficiency among women of childbearing age. Iron deficiency during the third-trimester of pregnancy is associated with premature birth, foetal growth restriction, stillbirth and infection. Women with iron deficiency are at risk of needing red blood cell transfusion, and having cardiovascular problems like enlarged heart or high blood pressure, reduced immune function, tiredness and depressive episodes. Iron infusion increases iron levels in the body and reduces the risk of the problems described above, but it remains unclear how the blood vessels and the heart respond to the increased iron levels. The aim of this study is to find out whether pregnant women with iron-deficiency or iron-deficiency anaemia display impaired heart and blood vessel function, and, whether this improves after iron infusion of ferric carboxymaltose. We will compare results with a group of age– and gestation-matched healthy pregnant women. We will make 2 or 3 one-hour appointments for participants to come into the Lyell McEwin Hospital: First : on the day or week before the iron infusion Second : two - four days post infusion (Third : two weeks from the first visit depending on the stage of pregnancy) 4 non-invasive tests will be performed: Laser Doppler studies — Small probes sit on the skin and measure blood flow through the very small blood vessels. We measure the way the blood vessels dilate when a drug or mild heat is applied to a small area of the skin. Arteriograph — This is a special blood pressure cuff that also measures how stiff blood vessels are. USCOM — A small ultrasonic probe rests on the skin surface of the neck and measures heart function using sound waves. Retinal photograph — We will take a photo of the blood vessels at the back of the eyes.

This study aims to evaluate if patients undergoing major liver resection managed by intraoperative goal directed therapy with the Flotrac/Vigileo deviceTM will have a shorter length of hospital stay with fewer post-operative complications compared to patients managed by standard care. Who is it for? You may be eligible to join this study if you are aged 18 years or more and are scheduled to undergo major liver resection. Study details: Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will have their haemodynamic variables (fluid dynamic and blood flow) be managed by intraoperative goal directed therapy (GDT) using the Flotrac/Vigileo deviceTM (FloTrac/Vigileo Version 3.02, Edwards Lifesciences, Irvine, CA, USA). This minimally invasive device automatically calculates key flow parameters every 20 seconds and recognizes and allows for adjustments in haemodynamic variables in patients undergoing major surgery. Importantly, it enables the anaesthetist to make a differential diagnosis leading to either a volume or cardiovascular intervention (preload, afterload and contractility), by providing continuous information on the patients cardiac output, stroke volume, and systemic vascular resistance. Participants allocated to the control group will have fluid management and inotropic use guided by the routine cardiovascular monitoring in place i.e. arterial line, and central venous catheter, which will be at the discretion of the anaesthetist, who will be blinded to Flotrac data. The Control group anaesthetist will be allowed to have the Flotrac haemodynamic data unblinded if needed for clinical decision making but patients will be removed from analysis if this occurs. There is now compelling evidence that fluid optimization and GDT in patients undergoing colorectal surgery leads to better outcomes, particularly in high risk patients. This study will contribute to understanding if similar benefit of GDT is also observed in patients undergoing major liver resection.

There is some evidence to suggest that the timing of a meal intake directly impacts postprandial insulin and glucose responses with meals consumed later during the day being more metabolically detrimental that the same meals consumed during the day. This information is particularly pertinent to the 16% of people employed in shift-work professions in Australia who have little choice but to eat during the late evening and overnight. The purpose of this study, therefore, is twofold. We propose to compare postprandial glucose and insulin responses following 1) an oral glucose tolerance test (OGTT) in the morning and in the evening followed by 2) a meal low in GI (glycaemic index) in the morning and the evening in healthy adults. These studies will enable us to confirm differences in metabolic functioning after eating at different times during the day using a standard test (OGTT) and then whether provision of a meal (low GI), thought to reduce postprandial insulin and glucose , will improve the unavoidable consequences of of eating at night on postprandial insulin and glucose.

The NSW Synergy Online Ecosystem is a new and innovative web-based resource of integrated apps and etools designed to help young people (aged 16 to 25 years) manage their general health and wellbeing (including mental health). If needed, the NSW Synergy Online Ecosystem also provides a seamless transition into web-based (or face-to-face) primary care. The study will employ a naturalistic research design wherein potential participants (young people aged 16 to 25 years; living in the NSW target communities on the Central Coast, Western Sydney or the Far West; with regular access to a smartphone [iPhone or Android] and the Internet) will be given access to the NSW Synergy Online Ecosystem. Participants will be given access to the NSW Synergy Online Ecosystem for a period of 90 days only. Participants are then able to navigate the website (or online system) at their own accord, naturally engaging with the recommended apps and etools. At five time points (Day 1, Day 15, Day 30, Day 60 and Day 90), participants will be asked to complete a short questionnaire via LimeSurvey. This questionnaire will include items regarding engagement with, efficacy and effectiveness of the website (or online system).

HYPOTHESIS The J2SI Mark II enhanced service model will lead to improved housing, employment, social, and mental health and well-being outcomes for homeless participants when compared to those receiving a standard service. AIMS To break the cycle of chronic long-term homelessness and improve housing outcomes and the health of those experiencing homelessness. The J2SI Mark II research project aims are to: - Evaluate the impact of a new enhanced homelessness intervention compared with existing service provision with regards to outcomes in: Education, Employment and Income; Social Inclusion; Mental Health; Physical health; Housing and; Service Usage. - Examine the cost of the new homelessness program compared with existing service provision and assess the cost-effectiveness of the J2SI service Model – Mark II; and, - Provide a framework for scaling up the intervention pending positive evaluation findings. OBJECTIVES - Investigate the impact of an integrated homelessness prevention intervention on positive mental wellbeing, mental ill health, quality of life and behavioural risk factors at baseline, during and after the study - Identify changes in protective and risk factors for mental health (e.g., social support networks, loneliness) and behavioural risk factors (smoking, alcohol, drug use) at baseline, during and after the intervention - Model the relative and combined contribution of housing support, educational and employment opportunities, access to services and support to the health and wellbeing of participants at baseline, during and after the intervention - Evaluate changes in health outcomes and service usage at baseline, during and after study and - Model the cost effectiveness of the program in relation to service usage, emergency admissions, and contact with justice services.

The aim of the study is to perform a retrospective analysis of the Q Fever Register’s data to determine the profile of individuals included in the Register, and determine the rate of vaccination and whether results from serology testing contribute additional information to support the decision to vaccinate.

Background: Development of anaemia in preterm infants is a common occurrence during hospitalisation as a result of iatrogenic blood loss and poor erythropoiesis. A significant proportion of extremely preterm infants are exposed to one or more RBC transfusions during their neonatal intensive care unit (NICU) stay. The association between red blood cell (RBC) transfusions and the development of necrotizing enterocolitis (NEC) in preterm infants was first recognized in the late 1980’s and has since been increasingly recognized. This association between RBC transfusion and NEC may coincide as a result of the timing of their occurrence, as most preterm infants will receive transfusions within the first 4 weeks of life, which is the same time frame for the development of NEC. Mechanisms related to the development of TANEC are unknown. Several hypotheses have been proposed including the prolonged storage of blood, increased viscosity of blood, perfusion-reperfusion injury and enteral feeding. The effect of enteral feeding during RBC transfusion on the mesenteric perfusion and oxygenation has not been fully elucidated. Due to the association between NEC and feeding practices in the preterm infants, there have been concerns about the effects of feeding during RBC transfusion. As a result, there is a wide variety of feeding practices during RBC transfusion of preterm infants including withholding of feeds to reduce the risk of NEC. Technological advances in near-infrared spectroscopy (NIRS) have allowed for the measurement of oxygenated and deoxygenated haemoglobin within tissue in real time. NIRS is able to measure changes in signals received via the skin sensors and calculate the proportion of haemoglobin in oxygenated and deoxygenated states from a mixed capillary, venous and arterial sample in the tissues approximately 2cm below the sensor placement. This allows for the non-invasive real-time measurement of the balance between oxygen supply and tissue demand. This technology has allowed for the continuous measurement of tissue oxygenation of the cerebral and splanchnic beds and for demonstration of differential tissue perfusion during periods of haemodynamic instability, anaemia and RBC transfusions. Autoregulation of brain perfusion allows for the oxygenation of the brain to be preserved except in the most severe situations. Thus, a ratio of cerebral splanchnic oxygenation has been proposed to be able to measure changes in gut perfusion. Aim: To assess the effect of feeding and withholding of feeding on gut oxygenation and perfusion in preterm infants receiving RBC transfusions. Hypothesis: We hypothesize that mean CSOR and mean mesenteric FOE during RBC transfusion will not be different between preterm infants in the withheld group and the full volume group.