ANZCTR search results

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

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31615 results sorted by trial registration date.
  • A Phase I, Randomized, Double-Blind, Placebo-Controlled Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EMA401 Following Single Ascending Oral Dosing of EMA401.Na in Healthy Volunteers Administered Orally in the Fasted and Fed State.

    This study is to evaluate the pharmacokinetics (the way the body absorbs the drug) and to determine what the safest that can be used.

  • The Role Of Community Pharmacy in Post Hospital Management of Patients Initiated on Warfarin

    Warfarin is a difficult drug to manage safely especially when commenced. The Australian population is ageing and the use of warfarin particularly in the elderly as a treatment for stroke prevention is increasing. Furthermore changing treatment trends have resulted in shorter hospital stays which has increased the risk for warfarin patients who are being discharged before achieving a stable and effective warfarin level. This study will compare a control group following the usual care post discharge pathway with an intervention group receiving the proposed best practice discharge pathway. This will include a home medication review from an accredited pharmacist and follow-up checking of the INR of patients using a portable monitor within their home. Result will be referred to the patient's GP for evaluation. Outcomes such as bleeding and clotting events as well as unplanned hospital re-admission will be compared between the two groups. A small group of thirty of the intervention patients will, if consenting and able, be trained to perform self monitoring of the INR in their homes. The results obtained will be forwarded to their GP on a weekly basis for evaluation and possible warfarin dosage adjustment.

  • The Relevent trial: Rate of Lower Limb Deep Venous Thrombosis in patients with Traumatic Brain Injury (TBI): a pilot observational study

    Patients who are admitted to the intensive care unit with traumatic brain injuries (TBI) are at a significant risk of developing blood clots in their legs because (1) they are immobile, (2) their blood clots more quickly (part of the stress response to TBI) and (3) they tend not to be prescribed anti-clotting medication as they are at risk of further bleeding into their brain. About 30% of blood clots in the lower leg extend into the thigh and if untreated half of these will travel to the lung. Of those clots that travel to the lung 25% cause death. There is no current Australian or international data concerning the rate of blood clots in the legs in TBI. We plan to assess all patients with TBI on admission to the intensive care unit for blood clots by performing an ultrasound of their legs and repeating this twice weekly until discharge. We also plan to determine each participant’s propensity to develop clots: this shall be done by performing a blood test (1 teaspoon) called a thromboelastogram and these tests shall be done whenever a patient has an ultrasound. The results of the study will provide currently unknown data regarding the rate of lower limb blood clots in this at risk population. This in turn will help in the design of a future clinical trial comparing different clot prevention strategies in these patients.

  • Prospective, open label, multi-block study of currently marketed 'contact lenses' and 'lens care solutions' to evaluate product performance in both experienced & new contact lens wearers.

    To evaluate the on-eye performance of marketed contact lenses and contact lens solutions so as to evaluate which combinations perform best with each other

  • Molecular Profile of Melanoma Chemosensitivity and Resistance

  • Doxycycline in Lymphanioleiomyomatosis (LAM): a randomised double blind placebo controlled crossover trial

  • Effect of breakfast on children's cogntion and satiety.

    The aim of the study is to examine the effect of dairy consumption on satiety and certain aspects of cognition in a sample of primary school children aged 10-12 years. It is hypothesized that beverages with a lower glycaemic load and higher dairy composition will be associated with improvements in measures of cognitive function and satiety compared to beverages high in gylcaemic load and containing no dairy food.

  • Managing Fatigue and Sleep Disturbance Following Traumatic Brain Injury

    The objective of the proposed research is to establish a clinical program to test novel therapeutic interventions for TBI patients with fatigue and/or sleep disturbance. Specifically, the proposed four-year study aims to evaluate, in a randomized controlled trial, the effectiveness of light therapy, administered for 4 weeks in alleviating fatigue, sleep complaints, and cognitive performance following TBI. Our primary hypotheses are that participants receiving blue light therapy daily (active condition) will show reduced self-reported fatigue, reduced daytime sleepiness, improved sleep (assessed subjectively and objectively) and improved cognitive performance 4 weeks after commencement of therapy compared to those receiving the yellow light condition (placebo) and treatment as usual condition.

  • Can Chiropractic care improve reading ability in children with learning delay?

    This study is being undertaken as a masters degree thesis. There is alot of anecdotal evidence of chiropractic care helping children with learning disabilities. The purpose of this research is to use a scientific method to measure if children having difficulty reading can benefit from chiropactic care.

  • A one-year, open label, extension study of flupirtine for the treatment of painful Human Immunodeficiency Virus (HIV)-sensory neuropathy (SN) in patients who have pain inadequately controlled by opioids

    Painful HIV-SN is a neurological complication of HIV infection that can result from either the HIV disease process itself and/or from the use of some of the anti-retroviral medications that are used to treat HIV. There has been considerable research into the treatment of painful HIV-SN neuropathy. However, treatment with currently available pain killing medications rarely renders the patient pain free and the use of medications may be limited by side effects. This current research project is only being offered to the participants who have taken part in the previous research project entitled “A placebo controlled multiple dose research project of Flupirtine for the treatment of painful HIV-SN”. The previous study has the protocol number CNSBio 01/07. “CNSBio 01/07” is investigating the short-term (one week) effectiveness and safety of the pain killing medication Flupirtine when taken in combination with opioids for the treatment of painful HIV-SN. CNSBio 01/07 is not yet completed and the results of this clinical trial are not yet available. The purpose of this research project is to investigate further if the drug Flupirtine is a safe and effective treatment for HIV-SN when taken in combination with opioids for longer than a week (up to one year). Flupirtine is an experimental treatment. This means that currently the drug is not an approved treatment for painful HIV-SN in the United States by the Food and Drug Administration (FDA) or in Australia by the Therapeutic Goods Administration (TGA). It is however approved for the treatment of back pain, muscle stiffness and pain associated with surgery and arthritis in Germany, Russia, Portugal, China and Brazil. CNSBio Pty Ltd is sponsoring the current research project with the aim of developing Flupirtine for the treatment of painful HIV-SN in Australia and America if flupirtine proves to be safe and effective in this context.

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