ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31330 results sorted by trial registration date.
  • Goal-directed Therap for Patients Undergoing Major Liver Resection

    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.

  • The effect of meal timing on postprandial glucose in healthy volunteers

    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.

  • Evaluation of a bespoke e-health platform on general health and wellbeing in young Australians: a pilot study

    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).

  • JOURNEY TO SOCIAL INCLUSION MARK II: A randomised control trial to assess a modified homelessness intervention (J2SI Mark II) for chronically homeless adults in Melbourne

    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.

  • A retrospective review of the pre-testing and vaccination using the Q VAX vaccine in Australian meat processor and livestock workers from 2002.

    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.

  • The effects of feeding on blood flow to the gut in preterm infants receiving red blood cell transfusion

    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.

  • Anterior Pelvic Organ Prolapse Surgery: A randomised controlled trial of Xenform anterior repair versus anterior colporrhaphy.

    Female anterior pelvic organ prolapse (POP) is common. In POP, the vaginal tissues become weak, causing descent of vaginal walls. In moderate to severe anterior POP, conservative treatments may be unsuccessful. In these cases surgical treatments can include: *Surgical repair with a patient’s own tissue (anterior colporrhaphy) *Surgical repair with reinforcement using a tissue graft to provide additional support. The aim of this study is to compare two established surgical techniques for anterior POP to determine which has the best result. The primary outcome will be measured using the following criteria. All three must be met qualify as success: 1) objective measures (anatomical), 2) subjective measures (validated quality of life questionnaire), 3) participant not having repeat procedure for anterior POP recurrence. The primary outcome will be assessed at one year after surgery. This is a multicentre blinded prospective randomised trial. Participants will be randomised to: 1. Anterior colporrhaphy 2. Xenform anterior vaginal repair Both procedures are routinely performed by urogynaecologists in the private and public sectors. Xenform Matrix (Boston Scientific, Marlborough, MA, USA) is used in Australia and by the urogynaecologists in Perth in the private and public sectors for surgical repair of POP. Xenform has been approved since 2010 for POP repair by the Australian Therapeutic Goods Administration. For the participants at Hollywood Private Hospital, they will be recruited from the surgeon’s private rooms. Participants will be eligible if they have symptomatic anterior POP to the level of the hymen and desire surgical treatment. At recruitment, participants will have a pelvic examination to assess pelvic organ prolapse quantification (POP-Q as per International Continence Society). A validated quality of life questionnaire (QoL) (Pelvic Floor Distress Inventory Short Form 20) will also be administered. POP-Q and PFDI-20 will be repeated one year after the operation.

  • Making active choices more attractive: Do physical activity incentives improve heart health?

    This project aims to test the feasibility and effectiveness of incentives for promoting increased physical activity, decreased sedentary behaviour, and improvements in heart health risk factors among adults. We hypothesised that an intervention involving relatively small, intermittent incentives in the form of points exchangeable for gift vouchers, offered over a 4-month period, and supplemented by an initial motivational interview and regular motivational text (mobile-phone SMS) messages, will lead to significant increases in time spent in physical activity; decreases in time spent in sedentary behaviours; and decreases in BMI and blood pressure, among middle-aged (40-65 year old) adults. Participants receive one point per minute, capped at 30 minutes per day, for engaging in physical activity; and one point per minute, also capped at 30 minutes per day, for reducing their sedentary time. Physical activity and sedentary time are monitored using a Fitbit One device provided to participants and linked to a purpose-designed study website that records points.

  • The feasibility and utility of using an accessible controller to improve motor and sensory function in people recovering from stroke through computer gaming: A randomised controlled pilot study.

    Rehabilitation can be a long process for people after stroke, and needs to be intensive to drive functional recovery. Computer gaming is proposed as a way for people to increase their therapeutic time while engaged in enjoyable activities during their rehabilitation stay. This project will investigate if computing gaming, through the use of the OrbIT Gaming System, has benefits for people during their stroke rehabilitation. Particularly, we are interested in finding out if participation in computer gaming will improve movement and sensation in the affected upper limb following a stroke. The study will also ask participants and staff about their experiences using this system. This study is being conducted as part of a Physiotherapy student honours project. Participants are allocated (by chance) to one of two groups. Both groups will participate in the computer gaming activity using a novel controller and laptop, which will be readily available over a three-week period. The controller requires bimanual use – thus “forcing” the affected hand and arm to participate in directing motion of the unit. Further it is capable of delivering a haptic stimulation (vibration) to the affected hand only to theortically increase awareness of the affected hand. This will be used as an additional rehabilitation tool during each participant's stay at Hampstead Rehabilitation Centre, allowing as much use as possible. The games have been designed to be of broad appeal and easy to play (no experience required). Participants will also receive the usual rehabilitation ('standard care'). All participants (regardless of group) will be asked to undergo assessment at the beginning of the study and after the three-week period (1 hour for each assessment). All participants will be asked specific questions after the three-week intervention through a written questionnaire. This will enable us to compare the effects of computer gaming.

  • The AUSMED Heart Trial: The Australian Mediterranean diet trial for secondary prevention of heart disease

    This study is a multicentre, parallel design, randomised controlled trial, at La Trobe University using cardiology patients from two major Hospitals in Melbourne. The intervention will be 6 months in length with a follow up at 12 months. There will be two groups, the Mediterranean diet intervention arm versus the standard care diet (low fat, National Heart Foundation guidelines) control arm. The aim of this study is to determine whether the Mediterranean diet compared to standard diet intervention can prevent secondary cardiac events and improve cardiometabolic risk factors (lipid profile, inflammatory markers, metabolic parameters, anthropometry, body composition) in a multi-ethnic Australian population.

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