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 Randomized, Double-Blind, Placebo-Controlled study to determine the safety and tolerability of E5555, and its Effects on Markers of Inflammation in Subjects with Coronary Artery Disease

    E5555 is a small molecule that inhibits activation of PAR-1, the main thrombin receptor on platelets, preventing platelet aggregation (which is essential to clot formation); preventing platelet activation and release of inflammatory substances locally and into the bloodstream; reducing generation of more thrombin. These actions suggest that it may be a useful adjunct to current therapy for CAD and not a replacement for any currently established forms of treatment for CAD. This study will look at the safety and tolerability of E5555 in CAD patients for a period of 24 weeks. There will also be a further visit 4 weeks after the last intake of study drug. The entire study participation will be up to 31 weeks, to allow for a maximum 3 weeks screening period. The patient would be asked to attend clinic for a total of 11 visits over the course of the study, with visits being between 1 and 4 weeks apart. The type of assessments at each visit are what would be typically undergone by cardiac patients - physical examinations; blood pressure, pulse, temperature, ECGs (up to 11 in total); blood tests (up to 11 in total) and regular intake of study medication (three tablets taken once a day with breakfast). Any adverse events will be recorded, as will details of concurrent medication. There is a sub-study being undertaken by selected sites, and participation in this will be optional for the patients. This sub-study would entail 3 additional visits and several additional blood samples being taken for pharmacokinetic and pharmacodynamic purposes.

  • Comparison of fasting glucose and oral glucose tolerance testing to screen for diabetes mellitus in subjects on long-term glucocorticoid therapy

    The primary purpose of this study is to determine the prevalence of diabetes in subjects on long-term glucocorticoid (steroid) therapy and the best way to diagnose diabetes in this patient group.

  • Ambulatory Fetal Activity Monitoring predicts clinical outcome

    This study will measure the activity of the unborn baby during pregnancy, looking at the number of times s/he moves and how simple or complex the movements are. We expect that the unborn baby who is not getting enough nutrition during pregnancy will have fewer movements than other unborn babies. Once we have this information, we will be able to use it in the future to possibly prevent poor outcomes in those babies who do need help.

  • Effect of Gum-chewing on Postoperative Recovery of Gut Functions: A Randomised Controlled Clinical Trial

    Postoperative impairment of gut function following gastrointestinal surgery is a major cause of delay in resumption of normal oral intake and discharge from hospital. Gum-chewing as a form of sham-feeding (the act of chewing without swallowing) is thought to have a stimulatory effect on the normal reflexes associated with bowel movement. The purpose of this study is to examine whether this simple and cost-efficient treatment helps to improve recovery time following surgery to the gastrointestinal tract.

  • A randomised, controlled trial of exit site application of MedihoneyTM Antibacterial Wound Gel for the prevention of catheter-associated infections in peritoneal dialysis patients, The HONEYPOT Study

    The largest problem faced by peritoneal dialysis patients is infection of their dialysis catheter, which can occur at the point of entry of the catheter into the belly (exit site infection), along the catheter tunnel (tunnel infection) or inside the belly (peritonitis). Such infections are the commonest cause of death or failure of treatment in peritoneal dialysis patients at Princess Alexandra Hospital. Recent studies have suggested that honey may be a promising agent for preventing catheter-associated infections. Honey has natural antibacterial and antifungal actions and has been shown to be very effective in preventing infection when applied to a variety of wounds, including burns, ulcers and surgical wounds. A previous controlled trial by our group in haemodialysis patients showed that honey was as effective as, and less likely to select resistant germs than, standard antibiotic ointment (mupirocin). The purpose of the present proposed study is to determine if exit site application of standardised antibacterial honey (Medihoney Wound Gel) is more effective at preventing infection of peritoneal dialysis catheters than the standard antibiotic ointment, mupirocin, which is currently recommended by national guidelines.

  • Attention deficit hyperactivity disorder (ADHD) Controlled Trial Investigation Of a Non-stimulant (A.C.T.I.O.N).

    Attention Deficit Hyperactivity Disorder (ADHD) is defined by marked changes in both cognitive and emotional functions. The majority of medicated ADHD individuals are treated with stimulants (controlled substances). Up to 30% do not respond to stimulant treatment, and in others the potential for abuse remains. Atomoxetine is a recently approved non-stimulant (non-controlled) to treat ADHD, with evidence of clinical effectiveness. Yet, the impact of atomoxetine on objective measures of a range of cognitive and emotional function has not been studied. Several lines of evidence indicate it is effective for these functions. Atomoxetine has been shown to alleviate inhibitory capacity, while stimulants have not. Common disturbances may underlie abnormal inhibitory capacity and impaired emotional recognition in ADHD that is best treated with atomoxetine rather than stimulants. The primary aims of this project are to: (1) Examine the efficacy of a non-stimulant medication (atomoxetine) in ADHD using a randomised controlled design. (2) Demonstrate that atomoxetine has efficacy for both cognitive and emotional functions, assessed using objective tests, with indicators of clinical improvement. The outcomes from this project will be a significant step towards a 'personalised medicine' approach to ADHD, providing clinicians with increased options in the treatment of ADHD. Should atomoxetine prove to be efficacious for stimulant non-responders it would contribute to reducing the significant social and financial burden of this disorder.

  • A Prospective Study Investigating the Impact of Definitive Chemoradiation in Locally and/or Regionally Advanced Squamous Cell Carcinoma of the Skin

    Phase 2 This is a study of the effectiveness and toxicity of chemoradiation therapy for skin cancer (squamous cell carcinoma). Who is it for? You can join this study if you have squamous cell skin cancer that cannot be treated surgically. Trial details Participants will receive chemotherapy with the drugs cisplatin or carboplatin once per week for 6 weeks as well as daily radiotherapy. There is no control group in this study. Participants' response to treatment will be measured 8 weeks after treatment is completed. Side effects will be monitored during treatment, at 4, 8 and 12 weeks after treatment is completed, and then every 2 months for the first year, and every three months after that. Overall survival and disease free survival will be measured after 3 years. The study aims to document the effectiveness and toxicity of treatment with combined chemotherapy and radiotherapy.

  • Hydration following acute stroke

    This 7 week cross sectional study aims to get a 'snap shot' of the hydration status of stroke patients admitted to Flinders Medical Centre and the determine any significant differences in the hydration status and fluid intake between those receiving thickened fluids compared with stroke patients on thin fluids. This project also seeks to determine whether there are any associations between hydration status and rehabilitation outcomes post acute stroke. This will provide data to ascertain whether dehydration is a common phenomenon among acute stroke patients admitted to flinders medical centre and whether urine specific gravity is used in clinical practice to determine if stroke patients are dehydrated, and therefore, require additional fluid subcutaneously or intravenously to ensure adequate hydration.

  • Tai Chi and Qigong for metabolic syndrome and diabetes control

    To preliminarily evaluate the effects of the program on primary outcomes (indicators of metabolic syndrome and diabetes control), and to investigate the feasibility and acceptability of both the program and the methods to be used in the main study.

  • Chinese medical exercises for metabolic syndrome and diabetes control

    The primary purpose of the study was to determine the effects of a Tai Chi/Qigong intervention program on variables associated with metabolic syndrome and/or diabetes control, and on other psychological, general health, and physical activity variables.

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