ANZCTR search results

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

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33073 results sorted by trial registration date.
  • A comparison of the new laryngeal mask airway (LMA), LMA-Protector with the LMA-Supreme in surgical patients requiring airway management with an LMA.

    In this study we are comparing two laryngeal mask airways (LMAs), a current model which is commonly used with the latest model of the device for flexibility, traumatic effect and ease of optimal positioning. We are performing a randomised controlled study to find out which device performs better in clinical practice. We are randomly selecting people to the groups and giving each a different device. The results will be compared to see if one is better. There is a 50:50 chance of being in one group or the other.

  • A randomised, double blind, placebo controlled comparative trial of Ceramide Cream and Ceramide Cleanser in the management of moderate eczema in adults

    The purpose of this study is to determine if two cosmetic products, a cleanser and a moisturiser, containing ceramides can be of benefit for those with moderate eczema. It is hypothesised that daily use of such products will be of benefit as part of the maintenance regimen for those with moderate eczema.

  • Efficacy of a sound wave vibration intervention on heart rate and blood pressure.

    The hypothesis of this study is that transmitted acoustic energy delivered via the collar bones to the pressure receptors in the neck will modulate the nervous system to reduce blood pressure and heart rate in normal individuals. The main aim is to investigate the effect of mechanical vibration delivered non-invasively via the collar bones to affect the heart rate and blood pressure. Primary Objective: To determine if acute use of the Sympara Therapeutic System (STS) device reduces sympathetic activity in three distinct subject populations. A. Healthy controls B. Healthy individuals with elevated sympathetic activity (e.g. anxiety) C. Individuals with early to mild hypertension Study Design: Acute, prospective, study to evaluate the potential mechanism of action for the STS.Participants will be randomized in a 1:4 ratio to either a sham or active STS device.

  • Study on survival from prolonged cardiac arrest treated with an artificial blood pump (ECMO)

    Only a few patients (less than 10%) survive cardiac arrest that lasts for more than 30 minutes, even if the cause is potentially reversible. ECMO is a blood pump that can be placed in large blood vessels in the groin and takes over the functions of the heart and lungs. This study will look at how many people survive persisting cardiac arrest when ECMO is used to support the heart until the cause of the cardiac arrest has been treated and the heart has had time to recover.

  • Investigating the effects of metformin on growth factors involved in prostate cancer progression in prostate cancer patients

    The primary purpose of this study is to determine the effect of metformin on certain growth factors that drive progression of prostate cancer. Who is it for? You may be eligible to join this study if you are aged 50 to 80 years, with histologically confirmed prostate cancer of early or locally advanced stage, or metastatic prostate cancer with bone involvement only and have been on stable treatment with androgen deprivation therapy (ADT) in the form of a GnRH agonist for more than 6 months. Study details: Metformin is a commonly used medication for the treatment of type 2 diabetes. We have early evidence that the use of metformin may slow down the growth of prostate cancer cells. However, the exact mechanism remains unknown. In this study participants will be randomly allocated (by chance) to start with either metformin or placebo treatment. Metformin or placebo tablets will be given twice daily over 6 weeks each. You will not know which tablet you are taking until after the trial. Blood samples will be taken at baseline and 6 and 12 weeks in order to assess how metfromin affects levels and activity of growth factors involved in prostate cancer progression.

  • Prospective Longitudinal Evaluation of Coagulation with Novel Thromboelastography Technology in Patients after Subarachnoid Hemorrhage - A Pilot Study

    When patients suffer from bleeding into the subarachnoid space surrounding the brain it is known as a “Subarachnoid Haemorrhage” (SAH). When a SAH is suffered the patient is exposed to very high risk of death and long-term illness and disability. This is due to development of multiple complications following the start of the bleeding. The cause of these complications can be attributed directly to the cause of the bleeding in the first place. Examples include thinning of the blood, trauma or aneurysms (a weakness in the wall of the brain arteries that become enlarged and rupture). However, one of the most serious complications of subarachnoid bleeding occurring 3 to 7 days after bleeding is a phenomenon called vasospasm. This phenomenon in which the blood vessels narrow and decrease the blood flow, reducing the blood supply and oxygen delivery to the brain tissue, potentially causing permanent brain damage ( stroke) . It can be fatal if severe. The causes of vasospasm and subsequent brain damage are not fully understood. Understanding the causes of vasospasm and the way it causes brain damage could help in starting new treatment lines that eventually might lead to a better outcome. We believe that increased blood clotting could be a contributing factor in reducing blood flow to the brain causing permanent blockage of brain blood vessels and brain damage. Therefore, our study seeks to determine whether patients who develop symptoms of delayed brain damage have an increased blood clotting tendency. The study involves a simple, point of care test of blood clotting - thromboelastogram (TEG) that measures increased clotting susceptibility far better than other conventional blood tests. These blood test results will be correlated against longer term progress of patients neurological recovery. The outcome test will use standard CT scan, serial Doppler Ultrasound for brain blood vessels and neurological information obtained during routine followup by neurosurgeons and neurologists. The blood for the TEG will be taken together with other routine blood tests and should not usually require separate blood samples. The neurological assessments will be part of routine care. Some blood plasma may be stored for additional coagulation tests depending on the primary result of the study. All information gathered will be aggregated and no individual patient would be identified in any publication. This study is prospective cross sectional cohort study and use thromboelastogram in patients with subarachnoid bleeding excluding trauma related causes. We suspect that there will be association between brain damage symptoms and increasing coagulation of the blood. That will facilitate, in future studies, introducing medical intervention earlier to assist in treating such morbid complication.

  • Effects of oxytocin on body perception in healthy volunteers

    This study will test whether a single dose of oxytocin influences body perception. Body perception will be examined using a multi-sensory illusion, in which individuals experience a sense of ownership for a prosthetic limb, involving integration of visual, tactile and proprioceptive sensory information. Perceptual and kinematic effects of this illusion will be assessed. Oxytocin will be delivered via nasal spray, and compared to a placebo spray in a repeated measures design. Participants will be healthy adult males. The effects of oxytocin on body perception will be examined with respect to autism spectrum traits (in the sample of healthy volunteers). It is hypothesised that oxytocin will facilitate the effects of the illusion.

  • OPAL: The first placebo-controlled trial of opioid analgesia for acute spinal pain

    Low back pain and neck pain are extremely prevalent and are responsible for an enormous burden of disease both in Australia and globally. Strong analgesics, such as opioid analgesics, are recommended by clinical practice guidelines for people with acute low back pain or neck pain who are slow to recover and require more pain relief. The latest Australian data suggest that opioid analgesics are now the most widely prescribed medicine for low back pain and neck pain in general practice. Despite the widespread use, there are no randomised, placebo-controlled trials evaluating opioid analgesics for acute low back pain or neck pain. Concerns regarding opioid use are further heightened due to the risks of adverse events, some of which can be serious such as opioid misuse, poisoning, and deaths. Given the lack of evidence on efficacy and concerns regarding safety, there is an urgent need to understand whether opioid analgesics are beneficial for patients with acute low back pain and/or neck pain. OPAL is a randomised, placebo-controlled, triple-blinded trial that will investigate the judicious use of an opioid analgesic in 346 participants with acute low back pain and/or neck pain who are slow to recover. Participants will be recruited from general practice and randomised to receive the opioid analgesic (modified-release oxycodone up to 20 mg per day) or placebo in addition to guideline care for up to 6 weeks. The primary outcome will be pain severity measured up to 12 months with treatment efficacy over the 6-week treatment period being the primary time point for analysis. Medication-related adverse events will be assessed and a cost-effectiveness analysis will be conducted. We will additionally assess long-term use and risk of misuse of opioid analgesics for up to 12 months. The results of this study will be critical in providing robust evidence to inform the quality use of opioid analgesia in acute low back pain and neck pain. The results will also influence international clinical practice guidelines and most importantly, improve care for patients suffering acute spinal pain.

  • Mobile sequential pneumatic calf compression for leg swelling study.

    The purpose of the research is to investigate the effects of a sequential calf compressor device, which is somewhat similar to a blood pressure cuff, on lower leg swelling when it is a result of poor vein function. The study also wishes to evaluate if there are any safety concerns with this device. It is hypothesized that there will be improvement on lower leg swelling, as well as being a safe intervention.

  • Adaptive Radiotherapy for Head and Neck Cancer: Feasibility and Clinical Implications

    This project aims to evaluate whether a protocol of adaptive radiotherapy (ART) for Head and Neck cancer patients can provide significant reduction in radiotherapy dose to critical structures, particularly the parotid salivary glands, aiming to potentially reduce the long term side effects of radiotherapy (particularly dry mouth). Who is it for? You may be eligible to join this study if you are aged 18 years or above and have been diagnosed with locally advanced head and neck cancer for which you plan to undergo curative-intent definitive radiotherapy. Study details All participants in this study will receive standard radiotherapy treatment (5 days a week for 7 weeks) as prescribed by the treating Radiation Oncologist. At 3 weeks and 5 weeks participants will have a repeat non-contrast planning CT scan plus repeat PET scan. We then overlay the initial radiotherapy plan on to the new CT dataset to determine if there are significant shape changes, whether the critical structures are receiving too much dose, or if the target volume (the tumour) is receiving too little dose. The participant’s radiotherapy plan will only be altered if there are unacceptable areas of radiotherapy over or under-dosage according to the discretion of the treating radiation oncologist. All participants will have a new radiotherapy plan created using their repeat scans. These plans will be run through our treatment planning computers to model the dose distribution on the new CT datasets. We will then compare the dose received by the normal structures and the tumour using this "adaptive approach" with the expected doses if no changes are made to the initial plan. This will give us a measure of the benefit of ART. We will also record how much time each re-planning takes to evaluate whether an adaptive approach is feasible in a real world clinical setting.

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