ANZCTR search results

The purpose of the study is to compare two Hepatitis B vaccination (HBV) schedules of 40 µg at 0, 1, 2 and 6 months with schedule of 20 µg at 0, 1, 2 and 6 months in patients with stage 4 or 5 Chronic Kidney Disease (CKD), and the response to routine vaccination against influenza. The study will also examine responses to booster HBV in CKD patients who are receiving haemodialysis. This will enable us to determine the best way to vaccinate people with CKD against hepatitis B, and will provide us with information about changes that occur in the immune system in people with CKD.

Amphetamine-type substances, especially d-methamphetamine, are second only to alcohol for incurred personal, economic and societal burden. Both alcohol and methamphetamine produce impairments in many areas of cognitive/neurobehavioural functioning which are also observed under complex driving conditions, and these two drugs are detected in as many as one-third of drivers injured and killed in road traffic accidents. No controlled experimental research is available which assesses performance on these tasks when alcohol and methamphetamine are used in combination, and importantly, how these deficits may translate into increased crash risk. This trial aims to assess the direct effect of combined usage of low (legal) doses of alcohol combined with d-methamphetamine in measures of higher-order cognitive and neurobehavioural functioning, driving performance and ocular activity. This will be achieved through a within-subjects, double-blind, placebo-controlled design comprising four experimental sessions [alcohol (placebo: 0.00% BAC; active: 0.04% BAC) and d-methamphetamine (0.42mg/kg, placebo; active). This project will provide vital information of how several behavioural, cognitive, neurobehavioural and physiological indices are affected following combined alcohol and methamphetamine use, and will show the effect of these combined drugs on driving performance and accident risk.

Sleep disordered breathing is common with obstructive sleep apnoea (OSA) being the predominant type. OSA is the repetitive complete obstruction (apnoea) or partial obstruction (hypopnoea) of the collapsible part of the upper airway during sleep. Symptoms include excessive daytime sleepiness, unrefreshing sleep and fatigue. Numerous studies have shown that OSA is associated with depression, hypertension, stroke, motor vehicle accidents, and other cardiovascular disorders. Obstructive sleep apnoea (OSA) is diagnosed with polysomnography. Respiratory events, either apnoeas or hypopnoeas, frequently worsen when lying in the supine position. Previous data have shown that 60% of patients with OSA have supine predominant OSA (OSA that occurs at least twice as frequently in the supine position) and 25% of patients have OSA that is solely present when lying supine (Joosten et al, 2012). In this context, knowledge of OSA severity in different body positions is crucial to informing patient management. Polysomnography involves sleeping while attached to a significant number of sensors and electrodes to measure sleep quality and breathing and cardiac parameters. Because of the inconvenience of the test, patients commonly report that the position they sleep in during polysomnography does not represent what they usually do at home, with patients most commonly reporting that they sleep more in the supine position that they would normally do. However, patient reports of habitual body position during sleep may not necessarily be accurate and whether body position in polysomnography reflects habitual body position at home has never been systematically addressed in a research study. Therefore, our project aims to look at the body position of patients during polysomnography in comparison with the habitual body position of patients at home. We intend to enrol patients having sleep studies in our tertiary academic sleep unit, and provide them with a small, unobtrusive body position sensor to detect their habitual body position in their home over the subsequent week. We hypothesise that there will be a discordance between polysomnography determined body position and habitual sleeping body position, with less time spent supine when at home that during polysomnography, given multiple factors. These could include less restriction due to leads, changes in bedroom environment and bed size.

The National Dermatology Radiation Oncology Registry (NDROR) is a human research Registry that collects and collates information from patients referred for radiotherapy for the management of non-melanoma and melanoma skin cancer and difficult to manage inflammatory skin diseases. Who is it for? Patients aged 18 years or above will be recruited based on referral from their current treating dermatologist to a Genesis Cancer Care (GCC) Radiation Oncologist once diagnosed with a lesion or condition deemed treatable with radiotherapy. Study details Data may be collected from eligible patients retrospectively regarding their previous relevant medical history, and prospectively, including treatment schedule and treatment outcomes of their radiotherapy treatment. Upon agreeing to participate in the NDROR, the referring dermatologist (RD) will send information to the Treating Radiation Oncologist (TRO). Previous relevant medical history as well as current treatment plans will be imported by both RD and TROs into the data Registry called the Skin and Radiotherapy Online Secure Platform (OSP). The intended outcome of this Registry is to ultimately assess the safety, tolerability and outcomes of treatment. Although treatment of skin cancer and inflammatory skin conditions with radiotherapy is currently used, limited practical evidence into the safety, tolerability and outcomes based evidence has been established in Australia. This Registry will be the first of its kind in Australia and will provide a basis for a number of research publications assessing these outcomes.

Each year in Australia 300-400 new cases of Spinal Cord Injury (SCI) are reported with prevalence predicted to continue to increase with population growth and improved medical care. The most obvious consequence of SCI is paralysis however it also has an impact on many other body functions as well, including social, financial and psychological implications. Most long-term wheelchair users adopt a sedentary lifestyle with prolonged sitting and limited opportunities to engage in physical activities. As a result, many people with SCI experience progressive physical deconditioning and its associated multifactorial health consequences such as diabetes and hyperlipidaemia. This contributes to loss of functional ability and the increased risk of cardiovascular morbidity and mortality. Physiotherapy during rehabilitation focuses on goals related to improving functional ability such as walking, transferring, propelling a wheelchair, balance and upper limb usage. This involves the management of weakness, reduced range of movement, decreased fitness, pain, and respiratory compromise. For those patients with paralysis there is often great difficulty in assisting them to stand and support their body weight. It places a substantial burden on therapists who must assist the patient into standing whilst trying to facilitate exercise and prevent falls. Therefore, these patients are often denied opportunity for the intense, functional therapy this is required to produce positive outcomes. The development of robotic exoskeletons has the potential to overcome the current limitations to therapy. These overground exoskeletons provide motorised assistance at the hips, knees and ankles via motors and coordinate movements at these joints to produce or assist with standing, upright exercises, and walking. They can be used to make gait training, transfer training, and balance training, easier and provide a safe opportunity for intensive practice related to standing and strenuous exercise. There are many different types of robotic exoskeletons currently available but there is no published evidence investigating the patient benefits of using the REX Bionics exoskeleton (HELLEN) as a rehabilitation tool. We aim to examine the potential benefits of using this device as an adjunct tool for rehabilitation in people with SCI. This data will be compared to data being collected in adjacent trials in Stroke and Multiple Sclerosis, currently being conducted by this research team.

Obesity is a major contributing factor in chronic disease burden within our community. While there are already established intervention management strategies for obesity, results on conventional primary care, non-invasive and/or drug-free approaches appear to be inconclusive. The planned study focuses on evaluating the efficacy of an already existing, peer-supported, behavioural change obesity intervention program, the “My Health for Life” (MH4L) program. The MH4L program is based around scheduled peer support sessions facilitated by a trained health or allied health professional. Participants in the intervention group also receive a MH4L workbook and printed material to assist with the behaviour change process. This is all in addition to their usual general practice care for weight management. This group will be compared with an active control where participants receive regular GP led management for obesity (6 month management plan designed by the participant’s regular GP which includes 5 visits to appropriate allied health services and 5 visits to chronic disease nurses as well as regular GP consultations as appropriate). All participants are tracked for 2 years after randomisation with measurements significant to obesity taken every 6 months. The study is a single blinded, randomised controlled trial. This means that there are two different treatment groups. One group is called the control group and they will receive currently established management for obesity. Another group is called the treatment group who will receive the new management program for obesity. Participants are not told what group they are assigned to (single blind) and group assignment is random. There is a 2 in 1 chance of being placed in the new treatment group. It is hoped that all participants in this study will, at a minimum, receive the best and most current medical management for obesity. However, the study will reveal the efficacy of a peer-supported obesity management program.

While Lisdexamfetamine dimesylate (LDX) is indicated for moderate to severe binge-eating disorder (BED) in Australia, the exact mode of its therapeutic action in BED remains unknown. This study aims to provide a comprehensive understanding of the neural mechanisms by which LDX improves symptoms of BED. We hypothesise that: 1. LDX will act by altering connectivity within and between brain circuits responsible for reward and inhibition. 2. A reduction in binge-eating behaviours will correlate with increased activity and connectivity of brain regions within reward and inhibition circuits.

The purpose of this study is to compare the ease of use and accuracy of 3 different protocols currently used at the Royal Dental Hospital of Melbourne to place dental implants. Specifically, the study will measure exactness of the placed implant in comparison to the planned implant position. In addition, it will evaluate if the type of implant restoration has an effect on the clinical outcome.

Participants: In infants greater than or equal to 32 weeks gestational age at birth who require resuscitation at delivery, Intervention: Does establishing effective ventilation, either via PPV or effective spontaneous breathing, prior to umbilical cord clamping* versus Comparator: Standard care- immediate cord clamping followed by resuscitation Outcome: Result in a higher average heart rate between 60-120 after birth. *In the intervention arm (Baby-DUCC), infants that receive PPV will have umbilical cord clamping at least 1 minute after pedicap/neostat colour change, or at least 2 minutes after delivery, which ever time occurs last. Pedicap/neostat colour change indicates exhaled carbon dioxide levels are greater than or equal to 15mmHg, therefore, the lungs are aerated and pulmonary gas exchange has begun. If the infant is still receiving PPV at 5 minutes, the umbilical cord will be cut and the infant will be moved to the warming bed. If the infant requires respiratory support after birth, the infant will be randomised to Baby-DUCC (resuscitation prior to umbilical cord clamping) or the control arm (immediate cord clamping and the infant will be moved to the warming bed for resuscitation measures). If the infant is vigorous and does not need resuscitation, the infant will not be randomised and umbilical cord clamping will occur at least 2 minutes after birth, oxytocin administration will occur after umbilical cord clamping. In these vigorous infants, we aim to collect heart rate and SpO2 data in the first 10 minutes after birth.

Given the scarcity of literature and no clinical practice guidelines written for speech pathologists (SPs) currently working in paediatric palliative care, a need was identified to explore the scope of clinical practice and strategies used by SPs. This study therefore aims to undertake an international investigation of clinical practice by gathering data from comprehensive literature searches, demographic surveys, in­-depth interviews and an online Delphi study, to identify current speech pathology (SP) practices, experiences and opinions with the purpose of developing current consensus-­driven 'Recommendations for Speech­Language Pathologists in Paediatric Palliative Care Teams' (ReSP3CT).