ANZCTR search results

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

You can narrow down the results using the filters

32856 results sorted by trial registration date.
  • Developmental differences in circadian rhythm establishment in preterm and term infants

    A circadian rhythm is any endogenous biological process exhibiting an entrainable daily oscillation. Circadian rhythms are essential for normal physiological and behavioural functioning and alignment with the 24 h light/dark cycle. Circadian rhythms are coordinated by a set of rhythmically expressed clock genes. A ‘master clock’ in the hypothalamic suprachiasmatic nucleus (SCN) synchronises peripheral cellular clocks and hormonal rhythmicity (e.g., plasma melatonin and cortisol concentrations). Light is the dominant environmental cue setting the rhythm of the SCN master clock. The developing fetus is not exposed to light. The development of the fetal circadian system is driven by maternal variation in circadian hormones transmitted to the fetus via the placenta. The fetus cannot synthesise its own hormones until near term. Premature delivery deprives the fetus of these materno-placental circadian cues. Hospitalisation of preterm infants in the neonatal intensive care unit (NICU) further disrupts circadian input and rhythm development due to constant lighting and noise, and invasive procedures/therapies. This prospective study is observational and investigates the circadian rhythm development across infants of different gestational ages; gestation specific patterns will be identified from physiological, hormonal and molecular outcome variables. This study will inform a second prospective study; a randomised-controlled trial of two interventions to normalise circadian rhythm development in preterm infants: modification of environmental light/dark information; and environmental modification with additional time-specific supplementation of endogenous circadian hormones (melatonin and cortisol). The clinical trial will identify if a circadian intervention improves short-term clinical outcomes.

  • Propofol on Trial for Headaches in the Emergency Department Setting

    Headache is a common reason why patients present to the hospital emergency department. Often patients are presenting to hospital for the simple reason that they are experiencing a headache that is not responding to commonly available medications used to get rid of headaches. Unfortunately there is not good evidence to support which available hospital medications consistently offer effective pain relief to individuals with these types of refractory headache. Understandably this is a challenging scenario in the emergency department setting for both the patient and physician that often leads to inadequate or unsatisfactory symptom relief. However a few small trials to date have shown promising evidence that the medication propofol is potentially an effective, safe and quick treatment alternative for stubborn headaches. It is important to note that propofol is not a new medication and is routinely used on a daily basis throughout hospitals for both general anaesthesia and procedural sedation. It is the intention of this research project to demonstrate that infusing a low dose of this medication over a relatively short period of time is an effective new use for a familiar and already commonly utilised medication. This has the potential to introduce a new safe and effective treatment option for stubborn headaches that can significantly reduce treatment times by rapidly restoring patients to baseline levels of function and comfort. Furthermore it reduces overall lengths of stay in the emergency department and contributes to overall improved emergency department patient flow.

  • Enhancing Language Learning in Ageing with Exercise.

    There is now compelling evidence demonstrating the importance of exercise in maintaining and improving cognition in late adulthood (Hillman et al. 2008), but little is known about the effect of acute exercise on age-related problems in language function and memory consolidation. In order to tackle this issue, we will examine the influence of acute exercise on how older adults learn and consolidate new word representations. New word learning is impacted by ageing (Service & Craik, 1993; Whiting et al. 2011) and involves the hippocampus and the striatum; regions that are both implicated in exercise effects on cognition and vulnerable in ageing (Erickson et al., 2011) suggesting candidate mechanisms for exercise-induced enhancement of word learning. The proposed research will examine how exercise affects new word learning when different intensities of exercise and types of learning are involved. This project will employ an innovative combination of behavioural and biomarker measurement to achieve the following overall aims: 1) Determine the effects of acute exercise on new word learning and brain function in older adults; 2) Identify the relationship between word learning and exercise-induced changes in neurotrophins and neurotransmitters; 3) Examine the influence of acute exercise on initial acquisition versus consolidation of new words.

  • Investigating two different refeeding formulations to improve safety and efficiency of hospital management of adolescent and young adults admitted with anorexia nervosa

    Patients admitted to hospital with anorexia nervosa (AN) require nutritional rehabilitation to reverse malnutrition and its complications. However, conservative guidelines advocate reintroducing nutrition at a very slow rate to avoid refeeding complications. At the Children’s Hospital Westmead and the Adolescent ward of Westmead Hospital, adolescents with AN have been successfully treated with more aggressive nutrition intervention without adverse side effects, and with a more rapid improvement of weight status. Evidence in higher caloric feeding is not as robust in the adult AN population as compared with adolescent patients. Of particular concern is the reintroduction of carbohydrate in a starved patient, which can lead to electrolyte derangement and increase the risk of developing refeeding complications. The standard enteral feed provided to patients provides 54% carbohydrate, while the literature suggests the use of continuous feeding strategies with less than 40% of energy from carbohydrate. The aim of this study is to test if a lower carbohydrate (CHO) content enteral feed will provide better health outcomes to adolescent and young adult patients with AN. This study will be multi-centred, including Westmead Hospital and RPAH. Patients admitted with AN and requiring enteral tube feeding (TF) during an 18 month data collection period, will be randomly assigned to receive either: 1. Standard treatment regime of nasogastric feeding (using an enteral feed with a carbohydrate content similar to standard care) commencing at 35mL/hr for 12 hours, providing 630kcal, 26g protein, 86g carbohydrate, 21g fat in 420mL feed, using a standard polymeric formula (Ensure Plus 54% CHO, 26% fat), and progressing to a rate up to 70mL/hr as tolerated; 2. Trial treatment regime of nasogastric feeding commencing at 35mL/hr for 12 hours, providing 630kcal, 26g protein, 45g carbohydrate, 39g fat in 420mL feed, using a lower carbohydrate, higher fat formula (Pulmocare 28% CHO, 56% fat), and progressing to a rate up to 70mL/hr as tolerated. Expected total number of patients, n = 48, with 24 in each arm. Inclusion and exclusion criteria will apply to participants. Primary outcome measure: Hypophosphataemia. Secondary outcome measures: Change in weight, Length of hospital stay (LOS), hypoglycaemia (nocturnal and postprandial), oedema, thiamine, electrolyte replacement, admission to ICU, days required to reach medical stability. This study has the potential to change practice in the nutritional management of young adults admitted with AN across the state, with the goal to inform future policy in this field. It will include the 2 hospitals in NSW with specialised inpatient treatment programs for adult patients with AN.

  • A new e-health model of care for management of chronic disease: determining safety, efficacy and satisfaction to patients and health care providers

    The primary purpose of this trial is to assess the feasibility of using an innovative web-based platform to unite patients, Specialist Nurses, General Practitioners (GPs) and Specialists and to improve multidisciplinary care for patients with chronic hepatitis C infection. Who is it for? You may be eligible for this study if you are aged between 18 and 85 years, have chronic hepatitis C (CHC) and have recently commenced therapy or are currently receiving ongoing monitoring and/or therapy. You will also need to have access to internet to take part in this study. Study details All participants involved in this study will be enrolled into our electronic platform called HealthELink. Enrolment on to this platform will be in addition to your standard of care treatment for your condition. At the time of recruitment you will be trained by a qualified investigator to use HealthELink. Through this portal, you will be able to engage with your care team electronically. You will be able to send and receive messages about your health to and from your care team in real time. This includes your Specialist Nurse, Specialist and GP. This will enable you to be up to date with your necessary tests and appointments, as well as your medical information, including diagnoses and medications. Your usual care will continue, however, should you need to talk to a doctor, or a problem arises between appointments, you will be able to communicate with your Specialist care team and GP directly. Likewise, should you be well (including a lack of symptoms and normal blood results), you may forgo a scheduled face-to-face appointment provided you and your care team agree. Hopefully, through effective electronic communication we can avoid unnecessary hospital appointments. You will also be asked to provide feedback on HealthELink and how it has impacted on your care. We hope that the HealthElink platform will be able to improve the management of your care by enabling you to have electronic access to your health care team between appointments. Without compromising your care or Specialist supervision, we hope this will enable fewer unnecessary Outpatient Department appointments, hospital admissions and emergency presentations. Every element of your care will be recorded, thus providing quality control for the care delivered.

  • End-tidal oxygen achieved with preoxygenation via non-rebreather mask at different flow rates in healthy volunteers

    Preoxygenation is critical to safe emergency airway management. Outside of the operating theatre and in prehospital environments, ‘Over flow’ from a standard wall/cylinder outlet has been proposed to greatly enhance preoxygenation via a Non-rebreather mask (NRB). Methods We performed a randomised crossover trial using two preoxygenation conditions; a NRB at 15lpm and the other a NRB with the 15lpm flowmeter with the dial turned all the way open (over-flow). End-tidal oxygen (ETO2) as a measure of preoxygenation/denitrogenating efficacy, was measured by single exhaled vital capacity breath.

  • Using eye movements to measure vision in children

    If eye problems occur in early childhood, they can affect the development of the brain areas that are responsible for sight and cause lifelong visual impairment. In addition, vision problems can affect the development of fine control over arm and hand movements and, in older children, impact on education. Many of the eye problems that affect young children can be treated effectively, however detecting these problems is challenging. Young children find it difficult to complete standard tests of vision because these tests require high levels of attention. Many tests also involve recognising shapes and letters and are therefore not suitable for young children. To address this problem we are developing a new computer-based vision test suitable for use with children as young as 2-years old. The test is simple and easy to use; carefully designed moving patterns are shown to the child that causes a reflexive, involuntary movement of the eyes if the child is able to see the pattern (which thereby yields a measure of visual performance). At the same time we record the movement of the eyes with a video camera attached to a computer and the software we are developing will identify whether the child is able to see the pattern or not. Finally, the visibility of the pattern will be varied to measure how well the child can see. In this project, we will develop and perform clinical validation tests in ophthalmology and optometry clinics in New Zealand and the USA. The overall aim of this research is to validate a device that we envisage could be used to rapidly and accurately test visual acuity in young children to allow for the early detection and treatment of vision problems. We propose here to conduct data collection of OKN eye movement using our prototype system developed from our own research to date. This study will involve three clinical sites: (1) the University of Auckland Optometry research clinic, (2) a private ophthalmology clinic (Eye Doctors, Ascot Hospital) led by co-investigator and ophthalmologist Dr Shuan Dai and his research assistant (orthoptist, Nia Stonex), and (3) the Retina Foundation of the Southwest (a non-profit eye research institute in Texas, USA) led by co-investigator Prof. Eileen Birch and her research team.

  • Addition of nasal cannula can either impair or enhance preoxygenation with a bag valve mask: a randomised crossover trial comparing oxygen flow rates

    Objectives A critical safety component of emergency anaesthesia is the avoidance of hypoxaemia during the apnoeic phase of a rapid sequence intubation. Preoxygenation with a bag valve mask (BVM) or anaesthetic circuit may be improved with supplemental oxygen by nasal cannulae (NC) if there is a mask leak. In addition, NC are recommended for apnoeic oxygenation after induction and may be placed prior to preoxygenation . However, the optimum NC flow rate for preoxygenation or whether presence of NC itself creates a mask leak remains unclear. Methods We performed a randomized crossover study on healthy volunteers comparing BVM alone and BVM with NC flow rates of 0 (NC-0), 5 (NC-5), 10 (NC-10) and 15 (NC-15) litres per minute . Our primary outcome was end tidal oxygen (ETO2) after 3-minutes preoxygenation.

  • The effects of continuous positive airway pressure (CPAP) treatment on brain activity during sleep in obstructive sleep apnea (OSA).

    This research study which will investigate the effect of continuous positive airway pressure (CPAP) treatment on brain wave activity recorded using high density electroencephalography (EEG) in patients diagnosed with moderate to severe obstructive sleep apnea. The study will examine changes in sleep and wake brain activity profiles and how these may relate to neurobehavioural function including memory following CPAP treatment.

  • A randomised stepped wedge control interventional trial assessing the impact of a novel disease management software module on disease risk factor detection, disease diagnosis rates and disease key management items in the primary care setting.

    Chronic diseases can be burdensome and are often interrelated. Chronic Kidney Disease (CKD), Cardiovascular Disease (CVD) and Type 2 Diabetes Mellitus (T2DM) are a cluster of interrelated chronic diseases sharing cardio-metabolic risk factors including obesity, hypertension and dyslipidaemia. Each are burdensome with around 10% of Australians (1.7 million) showing measured biomedical signs of CKD, an estimated 4.9% (just over 1 million) with diabetes and 22% of adult Australians (3.7 million) reporting that they had 1 or more CVD, including hypertensive disease, stroke, heart failure or heart disease. As many as 1 in 300 of the population have Familial Hypercholesterolemia (FH), the commonest autosomal dominant disorder in the community. Untreated FH can lead to death from coronary heart disease before age 60 while treated patients have a normal life expectancy. CKD, CVD and T2DM are in the top 10 for leading causes of death in Australia. They can have complex causal relationships between them leading to more severe illness and poorer prognosis. For example, CKD and T2DM are strong risk factors for future coronary events and all-cause mortality. With CKD, CVD and T2DM requiring intensive management often over a long period of time the costs to the Australian community and health-care system is immense. They can lead to disability, loss of quality of life and premature death. In 2009, CKD accounted for approximately 2% of total health care expenditure, equivalent to ~ $900 million. In 2008-09 health care costs attributable to heart disease was $2.03 Billion. Diabetes directly costs the health care system approximately $1.7 billion per year, and indirectly, $14 billion per year. It is known that 85% of Australians visit a general practitioner (GP) each year. As such, efforts to increase awareness of chronic diseases and their risk factors amongst GPs as well as providing opportunities for improved screening and management in the general practice setting is essential in combating this growing public health concern. Chronic Disease IMPACT (Chronic Disease early detection and Improved Management in PrimAry Care ProjecT) is an extension of the CKD-EMAP project and an initiative of Western Health, Victoria University the University of Melbourne. It is supported by a legacy grant from the former Macedon Ranges and North Western Melbourne Medicare Local. The Chronic Disease IMPACT project aims to further enhance primary care software to aid detection and management of chronic diseases focussing on CKD, CVD, Heart Failure, T2DM and risk factors such as Familial Hypercholesterolemia

Tags:
  • Finding clinical trials