ANZCTR search results

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

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32871 results sorted by trial registration date.
  • Randomised controlled trial of donor site dressings in paediatric split skin grafts

    Paediatric split skin grafts leave a donor site, requiring a dressing. The optimum dressing for this site is the subject of much discussion and debate amongst burns clinicians. In our unit there are currently three dressings in regular use. We therefore have equipoise to undertake a randomised controlled trial in an effort to determine which is the best of the three. Outcome measures we will be examining relate to both patients and staff. These outcomes include pain and itch while the dressing is on ease of application, care, and removal time to reepithelialisation cost cosmetic appearance of the donor site There are a number of such trials in the literature. None of them have directly compared our three dressings (algisite, cuticerin, sorbact). Few of the trials in the literature have looked at children, so the answer is not already in the literature. By using real world controls we hope to find the optimum dressing in our environment. This will become our new preferred dressing, and will naturally then become the new control against which we will measure the performance of newer products that will inevitably come onto the market in subsequent years. Patients will be randomised to one or more of the three arms of the study, without them or the assessing staff being aware of the contact dressing. We will then measure outcomes with the above aims in mind; using previously validated scoring systems examining the responses of parents, patients and staff members. We will use both qualitative and quantitative assessment methods.

  • An Australasian, phase II, multicentre, randomised, study investigating efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL).

    The study is evaluating the efficacy and safety for dose reduced fludarabine, cyclophosphamide and intravenous obinutuzumab (G-FC3) versus oral chlorambucil and intravenous obinutuzumab (G-Clb) in previously untreated, comorbid, elderly patients with chronic lymphocytic leukaemia (CLL). Who is it for? You may be eligible to join this study if you are aged 65 years and older, have documented CD20+ B-cell CLL according to NCI/IWCLL criteria, previously untreated CLL requiring treatment according to NCI/IWCLL criteria, CIRS score >= 6, an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 at screening, able to comply with study protocol procedures and a minimum of 14 months of follow-up, and a life expectancy of at least 6 months. Trial details Participants in this study will be randomly (by chance) divided into one of two groups. Participants in one group will receive obinutuzumab (GA101) combined with fludarabine and cyclophosphamide (G-FC3). GA101 will be administered intravenously, 100 mg day 1 cycle 1, 900 mg day 2 cycle 1, 1000 mg day 8 and 15 cycle 1, 1000 mg day 1 cycles 2-6. Fludarabine will be administered orally, 24mg/m2 day 1-3 cycles 1-6. Cyclophosphamide will be administered orally, 150mg/m2 days 1-3 cycle 1-6. Participants in the second study group will receive GA101 with chlorambucil (G-Clb). GA101 will be administered intravenously, 100 mg day 1 cycle 1, 900 mg day 2 cycle 1, 1000 mg day 8 and 15 cycle 1, 1000 mg day 1 cycles 2-6. Chlorambucil will be administered orally, 150mg/m2 days 1-3 cycle 1-6. A treatment cycle is 28 days in length. A maximum of 6 cycles of therapy will be administered to each patient.

  • The Avastin in Trabeculectomy Study

    Glaucoma is a progressive disease of the optic nerve, which if undiagnosed, can lead to blindness. Surgery is often reserved for very severe cases and as such, surgical success is imperative. Our project will address this by performing a randomised double blinded assessment of the adjunctive use of intraoperative intravitreal bevacizumab (Avastin), a currently available and widely used anti-VEGF drug, on post-operative glaucoma surgery success. If this intervention is successful, the outcomes could undoubtedly influence future surgical management.

  • 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

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