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.
  • The Medical Management of Miscarriage Study

    The optimal dose of Misoprostol to be used in the medical management of miscarriage before 13 weeks has not been resolved. This study was undertaken to evaluate the effectiveness and side effect profile of two different dosages of Misoprostol. Methods A randomized controlled, equivalence study comparing 400mcg vs 800mcg Misoprostol per vaginum (PV) on an outpatient basis. The allocated dose was repeated the next day if clinically the products of conception had not been passed. Complete miscarriage was evaluated using two methods: ultrasound criteria on Day 7; and the need for surgical management (clinical criteria). Equivalence was demonstrated if the 95% confidence interval [CI] of the observed risk difference between the two doses for complete miscarriage lay between -15.0% and 15.0%. Differences in side effects and patient satisfaction were evaluated using patient-completed questionnaires.

  • An open label clinical trial of an orally-dosed herbal formulation Zinova (Registered Trademark) for the prevention of dysmenorrhoea (menstrual pain).

    This is a single-site, open-label short-term clinical trial with baseline data collection. Approximately 20 female participants aged between 18 and 45 years will be recruited from the CRO’s participant database and public media. Following initial screening via telephone, potential participants will attend the clinic for an information session and will be requested to provide their consent for inclusion in the trial. Consenting potential participants will undergo a medical assessment including lifestyle, current medications, physical examination, medical history, and menstrual history; this data will be used for the comprehensive screening and to provide contextual data for the study. The primary outcome measure is the pain VAS rating scales. The secondary outcome measure is analgesic use. The expected duration of the trial is five consecutive menses (approximately five months) for each participant. Baseline data will be collected during the first 2 menstrual cycles prior to intervention and for 3 months while on treatment.

  • The Body, Brain, Life Program –a prevention trial to reduce risk of Alzheimer's Disease

    This project is a randomised control trial of an online program that aims to reduce risk for Alzheimer’s disease (AD) by intervening in modifiable risk factors. The sample will be healthy but have several modifiable risk factors for AD. Hence this is classified as an indicated prevention trial. The intervention will educate individuals about AD and risks for AD. The intervention itself is tailored to individuals based on their readiness for change and level of risk in particular domains. There will be three groups; a control group who receives a pre and post assessment, an online only intervention group and an online plus small face-to-face intervention group. The trial involves 7 modules (one per week). Level of risk for AD will be assessed at baseline, 13 weeks and 26 weeks.

  • The effect of withdrawal of oral iron supplementation on airway microbiology and outcomes in people with Cystic Fibrosis

    The study is an open study examining the effects of withdrawal of oral iron supplements in patients with the genetic condition Cystic Fibrosis (CF). In CF it is believed that unusually high levels of iron can be found in respiratory tract, and that the presence of iron within the airways may promote bacterial infection. In this study we explore how withdrawal of iron supplements may effect airway iron content and microbiology. As well as assessing the effect on systemic iron stores, lung function, and disease related symptoms. This study will be conducted by the staff of the Adult Cystic Fibrosis Centre located at The Prince Charles Hospital, Brisbane, Australia. All patients who meet the inclusion criteria will be invited to participate. Subjects will provide written informed consent prior to participation. If patients decide to withdraw from the study at any point this will not have any impact on their ongoing care.

  • A comparison of two commercially-available eye drops on corneal epithelial cell shedding when eye drops are used in one eye for two weeks in healthy participants

    this trial will investigate the effect of preservatives in comfort eye-drops on corneal epithelial cells

  • The effect of the Accu-chek Mobile blood glucose monitoring system of testing frequency in type one diabetes.

    This project aims to test whether a new blood glucose monitoring system increases the number of tests that patients with type 1 diabetes do as compared with an existing blood glucose monitoring system. The project also aims to test whether the new blood glucose testing system improves diabetic control and improves how you feel about your diabetes. The project also aims to test whether the new blood glucose testing system is preferred by users over the existing system Many studies have demonstrated that regular self monitoring of blood glucose improved overall control in type 1 diabetes and that better control results in better long-term outcomes and fewer complications. There are many reasons why people with type 1 diabetes do not monitor optimally. These include forgetfulness, difficulties with handling and disposing of test strips, lifestyle alignment (embarrassment of monitoring in public and lack of time and difficulty monitoring away from home), as well as inability to make decisions based on results. The new blood glucose testing system addresses some of these issues and previous surveys have shown that compliance with a testing regime is improved. There has, however, not been a formal study of the system to date and this study hopes to fill that gap in medical knowledge. Fifty people with type 1 diabetes will be recruited from Eastern Health and Royal Prince Alfred diabetes clinics to participate in the study. Subjects will be randomized to receive either the existing or the new system to begin with and to use that system for 3 months. After that period subjects will swap to the alternate system for a further 3 months. At the end of 6 months subject will be able to chose which system they prefer to use for the remaining 3 months of the study which therefore has a total duration of 9 months. Subjects will be required to attend every 3 months during the study (total of 4 visits) at which time the content of the meters memory will be down loaded for analysis. Subject will also be asked to complete questionnaires relating to their mood, level of distress, attitude and satisfaction.

  • Under-Recognition of Allergic conjunctivitis in Patients with Allergic Rhinitis

    Aim: To determine the most effective way of detecting the incidence of allergic conjunctivitis (AC). Method: The first step includes asking patients in an allergy specialist's outpatient clinic about their Total Ocular Symptom Score (tearing, itching and eye redness), then asking them about indirect symptoms of AC (squinting, blinking, frontal headaches or eyelid dermatitis), and finally using an olopatadine challenge to determine if any chronic, undetected symptoms of AC are relieved and thus suffered. A control group will be used to determine if the lubricating effects of the olopatadine eye drops is acting as the relieving factor in the intervention group.

  • Clobetasol Propionate ointment application to grafted burn wound

    Burn injuries result in pain, inflammation and destruction of skin cells. Skin grafting will be required when the depth of the injury destroys the deeper skin layers. Despite grafting, the burn injury continues to produce inflammatory chemicals or mediators. These mediators result in a thickened and raised scar with increased sensitivity and itching. The purpose of this research is to see if Clobetasol propionate can reduce the inflammatory mediators thereby reducing active scar tissue formation.

  • A pilot investigation of an online, parent-only Cognitive Behaviour Therapy (CBT) intervention for preschool children with anxiety.

    A significant amount of research demonstrates that CBT is effective in reducing anxiety in youngsters aged 7 to 17 years using both face-to-face and online formats. Surprisingly, however, little research has investigated the efficacy of early intervention for anxiety disorders in the preschool years. Over the last several years, our research team has been systematically developing an internet-based CBT program for the treatment of childhood anxiety disorders. This pilot study intends to investigate the potential efficacy of an online CBT intervention delivered to the parents of anxious 3-5 year old children.

  • A phase IIb randomised controlled trial of continuous beta-lactam infusion compared with intermittent beta-lactam dosing in critically ill patients BLING II

    The primary aim of this study is to compare the effects of two approaches to the administration of beta-lactam antibiotics (continuous infusion and intermittent bolus dosing) on ICU-free days up to Day 28, with dosing at clinician discretion and independent of randomisation group. The null hypothesis is that there is no difference in ICU-free days up to Day 28 between patients assigned to continuous infusion and those assigned to standard bolus dosing.

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