ANZCTR search results

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

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31346 results sorted by trial registration date.
  • Optimising Protection for Pregnant Women with Influenza Vaccination

    Pregnant women are at greater risk of complications from influenza infection and vaccination provides the best protection against influenza to pregnant women and their infants. Since 2010, the Australian Government has provided free seasonal influenza vaccine to all pregnant women (in any trimester). Whilst there are numerous data suggesting that influenza vaccination during pregnancy is beneficial to the mother and infant, there is limited data on factors that could potentially reduce the effectiveness of the influenza vaccine response in pregnant women. It is possible factors such as body mass index (BMI), may influence the immune response to influenza vaccine. Studies have shown that obese adults are at increased risk of severe disease from influenza and the immune response to some inactivated vaccines is reduced. The main objective of this study is to determine whether there is any relationship between BMI and the effectiveness of influenza vaccination in pregnant women. Approximately 300 pregnant women will be enrolled in this study at Women’s and Children’s Hospital over two influenza seasons (2014 and 2015). Approximately 150 obese and 150 non-obese participants will be enrolled. Licensed 2014 or 2015 seasonal influenza vaccines will be provided to all participants, with the vaccine administered during ultrasound imaging for a subset of pregnant women (n=70) to determine exact location of vaccine deposition. Two blood samples will be collected from all participants during the study (at baseline and at approximately 28 days post vaccination) in order to assess antibody responses to the vaccine. We will also measure cytokines (IL6 + TNFa) to determine associations with obesity and immunogenicity. In addition, for influenza vaccines we don’t know whether the immune response is different for people who receive the influenza vaccine subcutaneously vs intramuscularly. We will investigate whether obesity is associated with a lower likelihood of intramuscular vaccination and the implication of this for immune response. As it is likely that many pregnant women do not receive the influenza vaccine (standard fixed 16mm needle) intramuscularly. This study will inform vaccine policy and guidelines by providing evidence on the impact of BMI on influenza vaccine response for pregnant women.

  • Joint pain without a joint? An investigation into the nature of postsurgical pain following joint replacement

    One of the most common treatments for severe osteoarthritis is to undergo surgery and receive a total joint replacement (the painful joint is removed and a plastic or metal joint is put in its place). Many people have a good response to this treatment and their pain is reduced. However, there is a group of people who have a poor response to this treatment and continue to have pain in the joint, despite the joint being replaced. We do not know what causes this pain. This study aims to see how common it is in people with osteoarthritis to have pain in the knee following surgery to replace the knee joint. We are also interested in determining what type of pain this might be. One theory is that it may be a type of pain called neuropathic pain, or in other words, pain due to problems with the nerves supplying the leg. Another theory is that the pain might occur because of specific changes in brain function. Finding out how common it is to have persistent pain after joint replacement and what type of pain it is, is important because it will allow us to better predict who will do well and who will not, and to prevent and treat the problem.

  • Assessment of a tight posterior capsule using a 4-Dimensional Computed Tomography scanner

    Shoulder pain is common in the community, especially in overhead sports. Around every shoulder joint are ligaments which hold the socket of the shoulder in place. These ligaments can become particularly tight in the back of the shoulder. This is known as a tight posterior capsule and is a cause of shoulder pain. Repetitive movements of the shoulder can lead to a tight posterior capsule. Patients with a tight posterior capsule are at risk of developing secondary shoulder pathology, such as instability of the joint. Better understanding of problems like a tight posterior capsule whilst the shoulder is in motion is important to improve early diagnosis, help prevent pathology developing and for treatment. A 4D CT scanner is a machine which has been available at Monash Medical Centre for a number of years and is used in the standard care of patients. It creates a 3D reconstruction of the shoulder while a joint is moving. This allows the relevant structures to be shown moving in relationship to one another in real time. This is useful in determining the underlying pathology affecting the shoulder joint. The project plans to study the relationship of a tight posterior capsule and shoulder joint movement. It was thought that the 4D CT scan would be the most effective tool to measure this. It is hoped that the results of these 4D CT scans will provide greater information about shoulder joint pathology and allow more effective early intervention in the future, especially in the management of a tight posterior capsule and secondary shoulder problems.

  • The effect of zopiclone on the respiratory arousal threshold in obstructive sleep apnoea

    The purpose of this physiology study is to determine the effects of zopiclone (sedative) on the awakening (arousal) response to respiratory stimuli during sleep and on upper airway muscle activity and breathing during sleep.

  • Promoting healthy eating, active play and sustainability consciousness in early childhood curricula: Addressing the Ben10 (Trademark) problem.

    This paper details the research protocol for a study funded by the Australian Research Council. An integrated approach towards helping young children respond to the significant pressures of ‘360 degree marketing’ on their food choices, levels of active play, and sustainability consciousness via the early childhood curriculum is lacking. The overall goal of this study is to evaluate the efficacy of curriculum interventions that educators design when using a pedagogical communication strategy on children’s knowledge about healthy eating, active play and the sustainability consequences of their toy food and toy selections.

  • Assessment of a non-invasive system to detect changes in physiological tremor in type 1 diabetes mellitus

    The objective of this study is to verify the effectiveness of a non invasive warning system in detecting hypoglycaemic (low blood sugar levels) episodes in type 1 diabetics.

  • Cabrini Scribe Trial 2014 - a study to investigate the relationship between emergency department scribes and emergency physician productivity - to compare physician productivity, billing and staff satisfaction with and without the assistance of a scribe during emergency medicine consultations

    There is a rising medical cost base in emergency medicine. There is a rising seniority of medical staff required to safely perform the role of physician in an emergency department. The currently accepted productivity of a FACEM is one patient per hour. Much of this time is spent writing and printing notes, faxing documents and contacting physicians. None of this work requires the skill set of an emergency physician and could be performed by a well-trained medical scribe or secretary. To date scribes have not been used in Australian Emergency Departments and offer a novel way of addressing emergency physician productivity without compromising the quality of emergency physician work. The degree that a medical scribe increases emergency physician productivity in emergency medicine in Australia has been investigated by this team in a pilot that lends itself to further investigation. This is a second trial to investigate whether a medical scribe would increase emergency physician efficiency

  • A Phase 1 Randomised, Double-Blind, Placebo-Controlled, Ascending Dose Study of the Safety, Tolerability and Pharmacokinetics of Orally Administered PRN1008

    Placebo-controlled, First-In-Human study assessing the safety and tolerability of PRN1008 in healthy volunteers. Participants will be randomised to receive a single oral dose of PRN1008 or a single oral dose of placebo. Up to four cohorts of eligible participants will be studied.

  • The effect of ivacaftor (VX-770, registered in Australia as Kalydeco) on exocrine pancreatic function in patients 6 years and older with cystic fibrosis and at least one copy of the G551D CFTR mutation and who are naive for ivacaftor

    Examine the effect of twice daily administration of 150mg ivacaftor on exocrine pancreatic function of patients with cystic fibrosis and at least one copy of the G551D CFTR mutation

  • Investigating the effect of Rasagiline on freezing of gait in Parkinson’s disease using accelerometry and functional MRI.

    We will evaluate whether Rasagiline is an effective treatment to alleviate symptoms of freezing of gait (FOG) in Parkinson’s disease. 40 patients with FOG will be randomised to either Rasagiline or placebo arms. Treatment response will be assessed by video recordings and accelerometry of specific walking tasks (Timed up and Go test), taken before and after the intervention. In addition, functional brain imaging whilst patients perform a validated virtual reality gait paradigm will be used to determine the brain activation patterns associated with improvements in FOG. The use of brain imaging will also allow us to see why patients might have differential responses to therapy. Identifying the nature of these relationships will hopefully advance our understanding of freezing.

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