ANZCTR search results

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

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31170 results sorted by trial registration date.
  • Effectiveness of A Fast Track Giant Cell Arteritis Clinic in Western Australia

    Giant Cell Arteritis (GCA) is a condition of inflammation of blood vessels which commonly affects the blood supply to the eyes. Left undetected, GCA can rapidly cause irreversible blindness. Other potential complications include stroke, aortic dissection and death. Therefore, early diagnosis and intervention is imperative. Traditionally, diagnosis has relied on early suspicion of the disease, urgent review by a physician and an ophthalmologist, along with a surgical procedure (temporal artery biopsy). Following diagnosis of the disease, prompt treatment with potent immune suppressant medication is required. Biopsies are a relatively expensive procedure with a low positive yield. Additionally, biopsies can often take weeks to organise, but treatment needs to be given relatively urgently, so delay in obtaining biopsy means that diagnosis can be obscured by the treatment. Better ways of screening and managing patients are needed. Recently, international models of care have recommended an alternative approach to deliver assessment and care for GCA through “Fast Track” GCA Clinics, which have demonstrated improved outcomes for patients. These are collaborative clinics between rheumatologists and ophthalmologists that provide clinical review followed by assessment using ultrasound imaging of the arteries instead of biopsy. This approach avoids hospital admission but produces quick, accessible and reliable diagnostic yield and only a subgroup will require progression to biopsy. Fast Track GCA Clinics have not yet been implemented in the Australian health care setting. We aim to establish a collaborative Fast Track GCA Clinic in Western Australia and demonstrate direct health care savings, validity of ultrasound at the primary diagnostic tool over temporal artery biopsy, improved clinical outcomes for patients, and further the research agenda in this relatively common, potentially devastating, but treatable condition.

  • Renal protection during open heart surgery

    Open heart surgery saves thousands of lives each year in Australia, but often injures the kidney. Kidney oxygen deficiency is a major cause of kidney injury. We propose a new way to prevent acute kidney injury by increasing kidney oxygen levels during heart surgery. The aim of this trial is to determine whether this new approach to prevention of kidney injury is safe, feasible and effective.

  • Safety and tolerability of increasing doses of ZY-19489 compared to placebo in healthy volunteers.

    This study represents a first-in-human clinical trial for ZY-19489 and aims to determine the safety, tolerability and pharmacokinetics activity of the drug when administered to healthy human subjects. The study will be conducted in three parts. This registration is for Part 1. Part 1 will be a single ascending dose) study which will provide information on the safety, tolerability and pharmacokinetic profile of different single oral doses of ZY-19489 administered to fasted subjects. It will be conducted in up to 7 cohorts of 8 subjects each. Each cohort will be enrolled within a 28 day screening period to ensure subjects meet all the inclusion criteria and none of the exclusion criteria. Subjects will be randomised within each cohort to receive a single oral dose of ZY-19489 or placebo on Day 0 after an overnight fast of at least 10 hours in a ratio of 6:2. A sentinel dosing strategy will be employed for each dose cohort. Two sentinel subjects (one subject randomised to ZY-19489 and the other subject randomised to placebo) will be dosed and a review of the blinded safety data obtained up to 48 hours post-dosing will be conducted by the Investigator. If no safety concerns are identified, the remaining 6 subjects of the cohort will be dosed (5 subjects randomised to ZY-19489 and 1 subject randomised to placebo). Adverse events and concomitant medications will be followed throughout the study. The study will be over-sighted by Principal Investigator, Dr James McCarthy, an Infectious Diseases physician experienced in the conduct of malaria challenge studies.

  • Ridge preservation in prevention of sinus augmentation

    Ridge preservation has been utilised to reduce alveolar bone resorption following tooth extraction. Currently, there is no randomised controlled trial that has simultaneously investigated the effect of ridge preservation on sinus pneumatisation and vertical ridge resorption in the posterior maxilla. If effective, ridge preservation could decrease the need for sinus augmentation by maintaining the bone height available for implant placement. The aim of this pilot clinical study was to compare the changes in vertical ridge dimensions and sinus volume and to evaluate the potential need for sinus augmentation following tooth extraction with or without ridge preservation in the posterior maxilla.

  • Common ground impedance as a biomarker for post operative hearing loss and dizziness in cochlear implant recipients

    Spikes in common ground impedances have been associated with loss of residual hearing and the development of post-operative dizziness in cochlear implant recipients. The aim of this trial is to test the use of monitoring common ground impedances to detect these events

  • Online eTherapy Program for Individuals with Bulimia Nervosa

    The study will evaluate the effectiveness of a new interactive online Cognitive Behavioural Therapy program for individuals who experience difficulty with binge eating, named Binge Eating eTherapy or BEeT. BEeT consists of ten, one-hour interactive, multi-media sessions with all core components of CBT demonstrated effective in eating disorders, including establishing regular eating according to the “three-hour rule” and self-monitoring, thought challenging and feared food exposure. The study will examine whether engaging with BEeT results in a significant decrease in individuals' binge eating and compensatory behaviours and if there are any added benefits for patients who receive low intensity, face-to-face support from a healthcare professional whilst using BEeT. It is expected that individuals who receive support and guidance whilst engaging with BEeT will show a better treatment response than those who independently use BEeT.

  • Long-term implantable continuous glucose monitor in type 1 diabetes

    Achieving optimal glucose control in type 1 diabetes requires frequent monitoring of glucose which can be burdensome for many patients. The most common methods for self-monitoring glucose involve frequent "finger-pricking" or continuous glucose monitors inserted under the skin which last up to 1-2 weeks and require at least daily calibration with finger-pricks. This investigational device is an implantable long-term glucose sensor that measures an individual's glucose levels continuously and sends data to a receiver outside the body. Following implantation, the sensor requires no user interaction, and the receiver only needs to be kept close by. The only maintenance required of the receiver is battery changes and data downloading. This study aims to collect glucose information from the implanted sensor to optimise sensor signal processing and improve sensor performance.

  • Vitamin B1 (thiamine) administration in enterally-fed critically ill patients with hypophosphatemia: A prospective, randomised clinical trial

    Adequate thiamine is an essential co-factor to utilise glucose. There is biological plausibility that phosphate deficiency may identify a cohort at greater risk of thiamine deficiency, and that these deficiencies are synergistic. However, currently, critically ill enterally-fed patients with hypophosphatemia do not receive pharmacological administration of thiamine. Data from the use of thiamine in a wide range of settings suggest that the dose regimen to be evaluated in this trial is tolerable and safe, and this is consistent with the Australian Register of Therapeutic Goods listing of thiamine. However, to the best of our knowledge, there are no studies in the ICU population to evaluate whether pharmacological administration of thiamine to this cohort of patients provides biological, physiological, or even clinical advantages. This multi-site randomised, controlled trial will test whether the intervention (thiamine) administered to patients with hypophosphatemia significantly reduces the primary outcome, blood lactate, which is a robust marker of clinical outcome.

  • Randomised Placebo controlled trial on Systemic Steroids to protect the Inner ear during Cochlear Implant Surgery

    This study aims to determine whether steroid (medication) delivered directly through an intravenous cannula before cochlear implant operation will better protect ear function during and after the operation.

  • A Clinical Study of Pre and Post Vaccination Serology in Children Receiving the Seasonal Southern Hemisphere Formulation of Inactivated Influenza Vaccine

    A total of 40 children (aged between 6 months and 9 years of age) will be enrolled into this research study. After written and informed parental consent, a 3ml blood sample will be collected to determine the baseline anti-haemagglutination antibody titre. The participant will then be administered the Southern Hemisphere Licensed Quadrivalent Seasonal Influenza vaccine according to the Australian Immunisation Handbook (AIH) guidlines. At the last visit, a second 3ml blood sample will be collected for the determination of post-vaccination antibody titres.

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