ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Oral Supplementation with Taurine for Patients with Cirrhosis and Muscle Cramps

    Patients with cirrhosis frequently experience painful muscle cramps which can affect the hands, legs, feet, neck, back, sides and abdomen. They may last for several hours, often occur at night and may require opiates or presentation to accident and emergency to control the pain. The available therapies have limited efficacy. This study aims to determine the efficacy of oral taurine supplementation in reducing the frequency and intensity of painful muscle cramps in this group. It is a randomised control, crossover, blinded study where participants will receive either taurine supplements or placebo for a period of one month and then cross over to the other group. Participants will be asked to complete a questionnaire about muscle cramps prior to entering the study, at the cross over (1 month after entry) and at completion of the study. Participants will be asked to keep a diary of cramps prior to entry into the study and for the duration of the study. In addition to the usual blood taken when attending clinic, a small amount of blood will be taken for amino acid analysis, taurine in particular, and TNF and IL-6

  • Optimising Management of acute pain in Opioid Substitution Therapy patients: A pilot laboratory randomised study

    The aim of the current pilot study is to identify the efficacy of different pharmacological approaches for the management of experimentally induced nocioceptive pain in patients currently receiving opioid substitution treatment in the form of methadone or buprenorphine (+/- naltrexone) maintenance treatment (sublingual film or tablet). The pharmacological interventions to be assessed are (a) increasing maintenance opioid dose by 30%, (b) adding opioid agonist (oxycodone equivalent to 30% of the daily opioid maintenance dose, and (c) adding gabapentin to the usual maintenance dose. The primary outcome measure is change in pain response using a cold pressor model for acute pain. Measures of safety, including physiological and cognitive measures, will also be examined.

  • A 2-year, multi-centre double-blind, randomised, placebo-controlled trial to determine in men with total testosterone equal to or less than 14nmol/L the efficacy of testosterone treatment together with a lifestyle program in comparison to a lifestyle program alone, to normalise glucose tolerance in those with newly diagnosed type 2 diabetes (T2DM) or prevent progression to T2DM in those with pre-diabetes.

    The T4DM study will investigate whether treatment with testosterone in combination with a lifestyle program normalise glucose tolerance in men with either pre-diabetes or newly diagnosed type 2 diabetes, in comparison to placebo and a lifestyle program in men aged 50-74 years. See www.t4dm.org.au for details

  • VALDA: Volatile Associated Liver Disease Audit

    To assess whether anaesthetic gases in trauma patients may contribute to liver damage.

  • A prospective, randomised study Comparing cUrved versus straighT scissors to reduce episiotomy extension – The CUT Trial

    Third and 4th degree tears occur during childbirth when an episiotomy (a cut made to enlarge the birth canal) extends to the anal sphincter. At the research hospital, higher than average rates of 3rd and 4th degree tears have been observed among women having their first child. Episiotomies are generally cut on an angle, away from the anus but studies suggest that the angle is often less than the recommended 45 degrees. One strategy to ensure a 45 degree angle and to potentially decrease 3rd and 4th degree tears may be to use curved scissors that naturally take the incision away from the anus. The proposed study will test this assumption by comparing straight and curved scissors to cut an episiotomy.

  • A randomised controlled crossover pilot study of meropenem standard 30 minute infusion versus prolonged 3 hour infusion in intensive care patients

    Meropenem is an antibiotic used in the treatment of serious infections. This study aims to investigate whether giving meropenem a by a longer infusion (3 hours) but a lower dose, enables the antibiotic to be in the bloodstream for at least the same amount of time as a higher dose given over a short time (30 minutes).

  • Minocycline as a new treatment for depression

    This study aims to investigate minocycline as an adjunctive treatment for unipolar depression. Participants will receive 200 mg/day of minocycline or placebo for 12 weeks with improvements on the MADRS being the primary outcome. Secondary outcomes include potential improvements in functioning, quality of life and clincial impressions. Based on previous studies, minocycline should be well-tolerated for the duration of the study, however safety monitoring will also be reported as a secondary outcome.

  • Fetal cardiovascular response to maternal corticosteroid administration: a comparison of dexamethasone versus betamethasone

    The primary aims of the trial are (within the context of the RCT A*STEROID) 1) To evaluate the effects of betamethasone and dexamethasone on fetal cardiovascular status as assessed by the ultrasound parameters of umbilical artery Doppler, middle cerebral artery Doppler, ductus venosus Doppler, uterine artery Doppler, and myocardial performance index. 2) To evaluate the effects of betamethasone and dexamethasone on fetal cardiovascular status as assessed by computerized cardiotocograph (cCTG) using Dawes-Redman criteria. 3) To evaluate the effects of betamethasone and dexamethasone on placental weight, morphology and histological evidence of villous maturation postpartum, and correlate this with placental ultrasound and uterine artery Doppler findings.

  • Effects of Testosterone and Oestradiol Therapy on Clinical Indices and Biomarkers of Dry Eye in Post Menopausal Women

    This project will investigate the effect of restoration of transdermal Testosterone and Oestrogen on dry eye clinical indicators and biomarkers in post menopausal women. Association between these sex hormones levels and the measured parameters might be elucidated while suggesting for an option of dry eye treatment in this population.

  • Impact of Non-technical Skills Training on Performance and Effectiveness of a Medical Emergency Team

    The concept of non-technical skills training (NTST) arose in the aviation industry after observation that a number of avoidable incidents were caused by human error rather than mechanical failure. In medical training, clinical knowledge and skills are emphasised with little attention given to “human factors”. These encompass such aspects as leadership, team-working, communication and decision-making. Thus far, study in this area has been restricted to simulations. Our project aims to evaluate the impact of implementation of training in non-technical skills for our Medical Emergency Team (MET) service on team performance and patient outcomes. This will be a multi-partite quality improvement project run at the Lyell McEwin Hospital, a tertiary metropolitan hospital in Adelaide. We plan to perform a retrospective audit of existing MET service data to establish baseline data. Then a period of prospective study will occur before and after delivery of NTST to members of the MET service. Team attendances will be independently observed for demonstration of non-technical skills and patients will be tracked during their hospital admission. A pilot observation will also be conducted to validate the observational assessment tool and measure inter-rater reliability between the investigators. The primary outcomes will be 1) MET performance of non-technical skills as graded by a specifically developed qualitative assessment tool and 2) incidence of efferent limb failure as defined by a) requirement for a second MET attendance within 24 hours for the same calling criterion, b) unplanned admission to the Intensive Care Unit (ICU) within 24 hours of MET attendance, c) unexpected cardiac arrest and/or death within 24 hours of MET attendance. Secondary outcomes will include hospital and ICU length-of-stay, and vital status at hospital discharge. These will be used as a comparator between all periods of the project. NTST will be delivered to MET members by the investigators in collaboration with a group of active instructors from QANTAS and the Royal Australian Air Force Reserves. Oversight will be provided by the hospital Safety and Quality Unit. The baseline audit will include 2000 patients and the observational stage of the study is anticipated to enrol 600 patients, equally divided between the before- and after-NTST periods. We aim to demonstrate that training in non-technical skills improves MET service performance leading to a reduction in incidence of efferent limb failure. The anticipation is that this will then extrapolate to reductions in length-of-stay and mortality.

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