ANZCTR search results

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

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32856 results sorted by trial registration date.
  • Low dose versus standard dose oxytocin in pregnant women undergoing elective caesarean delivery

    This study sought to determine whether 3IU oxytocin was comparable to standard 5IU regarding postpartum blood loss in pregnant women undergoing elective caesarean delivery under spinal anaesthetic, but could reduce blood pressure elevating medication (vasopressor) requirements and adverse events. We hypothesized that patients receiving 3IU oxytocin would be non-inferior to 5IU regarding postpartum blood loss and superior regarding uterine tone, incidence of low blood pressure (hypotension), blood pressure elevating medication (vasopressor) requirements and adverse events.

  • Can a primary health care intervention prevent diabetes in people with depression?

    Approval # H11321 Approved by the Human Research Ethics Committee at Western Sydney University Type 2 diabetes (T2D) is an increasing health and economic burden in Australia that is frequently associated with depression and psychological distress. The annual incidence of T2D in Australia could be higher than 10% for adults with depression who have impaired glucose regulation (‘pre-diabetes’). Lifestyle programs aimed at achieving and maintaining a healthy weight are recommended for the primary prevention of T2D, especially for people with pre-diabetes. Lifestyle guidelines, based on findings of several large-scale clinical trials that excluded people with prevalent psychopathology, cannot be generalised to people with depression, who are least likely to engage in or adhere to healthy lifestyle recommendations and may be taking diabetogenic medications (e.g. some anti-depressants). Depression presents a major barrier to effective and sustained healthy lifestyle changes (especially exercise) that needs to be addressed to prevent T2D in this high-risk population group. While both collaborative, multidisciplinary care (‘team-based care’) and lifestyle programs are known to be effective interventions for depression treatment and diabetes prevention, respectively, there is a lack of information on how to effectively prevent T2D in community-based patients with co-morbid depression and pre-diabetes in the Australian primary health care system. Specific aims 1.To provide preliminary evidence on the effectiveness of collaborative, multidisciplinary health services covered by the Medicare Benefits Schedule (MBS) for preventing T2D in community-based patients with co-morbid depression and pre-diabetes (DPD care) compared with usual general practitioner (GP) care 2.To assess the feasibility of conducting a large, full-scale study

  • Volunteer Family Connect: Can a volunteer home visiting program improve the wellbeing and social connectedness of vulnerable families, and improve health and wellbeing outcomes for the volunteers who deliver the service?

    Volunteer home visiting is a place-based strategy for strengthening vulnerable families, facilitating civic participation, and establishing inclusive community networks among individuals and service organisations. A research trial across four Australian states in partnership with three leading non-Government organisations, will provide a robust assessment of its effectiveness and opportunities to mobilise communities in this way to support improved well-being and social connectedness outcomes for families as well as volunteers. This innovative trial will directly inform national strategic research priorities relating to population well-being and participation. It will also establish social return on public investment in this strategy.

  • Assessing the Olympus 190 series narrow band imaging for colonic polyp detection rates: A prospective randomised multicentre study

    The primary purpose of this trial is to evaluate the efficacy of the Olympus 190 series colonoscope narrow band imaging (NBI) technology for the detection of polyps and adenomas, in comparison to the current standard white light technology used during colonoscopies. Research to date has found no difference between the two technologies of illumination, but with improved technology we believe that NBI may now improve our detection rate of polyps and adenomas- thereby decreasing the overall cancer risk per patient. Who is it for? You may be eligible to participate in this study if you are aged 18 or over, and have been scheduled to undergo a colonoscopy for diagnostic/investigational purposes. Study details All participants in this study will be randomly allocated (by chance) to receive either the NBI or standard white light colonoscopy. All other aspects of the procedure, other than the type of light used during the colonoscope withdrawal will remain the same between each group, as per standard care. NBI is simply a type of light available by pushing a button on the colonoscope, which uses filters to illuminate tissue at a selected wavelength. This may be beneficial for the detection of polyps and adenomas, despite providing less illumination overall than the standard white light. Researchers will then review the colonoscopy procedure and histological notes to assess the detection rates for polyps and adenomas between each type of light. Subsequently, statistical analysis will determine which technology is better for polyp and adenoma detection. It is hoped that the findings of this trial will provide information on which type of light may be the most effective for the detection of polyps and adenomas in patients undergoing colonoscopy.

  • A single injection dose study of DUR-928 in patients with impaired kidney function and healthy volunteers

    This research project is being conducted to look at how safe and well tolerated a new drug called DUR-928 is when given as an intramuscular injection to subjects with chronic kidney disease when compared with healthy control subjects. The study will look at the study drugs effect when given as a single-dose injection at 2 different dose levels. The pharmacokinetics of DUR-928 will also be studied; this is done by measuring the amount of DUR-928 in the blood at different times throughout the dosing periods, allowing us to evaluate how DUR-928 is handled by the body (for example how quickly it gets into the blood stream). The pharmacodynamics will also be studied; this is done by measuring the amount of selected biomarkers in the blood and/or urine at different times throughout the dosing periods, allowing us to evaluate the effect of DUR-928 on the body.

  • Anti-anginal Efficacy of Ticagrelor in Coronary Slow Flow.

    The Ticagrelor in Coronary microvascular dysfunction (TIC) program is an extensive research program investigating the potential therapeutic benefits of ticagrelor in patients with a condition referred as slow flow phenomenon, speculating that its benefits extend beyond its anti-platelet effects and suggesting that it may have an important role in the management of these patients. Ticagrelor has been developed as an anti- platelet agent and is currently utilised in the management of heart attack and unstable angina. Slow flow means heart muscle does not receive blood quickly enough and as a consequence patient may experience chest pain. Medical treatment is directed towards controlling the angina pain. Taking Ticagrelor orally twice a day, which has the ability to relax the small microscopic blood vessels in the heart, may lead to better blood flow to the heart muscle and reduce the associated symptoms of chest pain. However, at present, there is no scientific evidence available demonstrating how effective ticagrelor is in patients with slow flow. The aim of this study is to investigate whether taking ticagrelor (90mg twice daily for 4 weeks) can reduce frequency of chest pain in these slow flow patients.

  • Central Venous Access Device (CVAD) Registry - an electronic database to monitor the outcomes of patients with CVADs

    Treatment today is unthinkable without vascular access devices for the management of patients. CVADs are essential for the administration of intravenous medications and blood sampling. This registry will collect information about the patients requiring CVADs, the type of CVADs being inserted, any complications experienced and the reasons for removal. The registry will provide clinicians and researchers with first-hand information about CVADs for patients receiving treatment and over time will increase our understanding of the complications associated with CVADs. The CVAD Registry will provide clinicians and researchers with an increased understanding of device failure, therefore improving clinical outcomes for patients with CVADs. The CVAD Registry will prospectively collect clinical data on device characteristics, adverse outcomes and risk factors. The Registry will: 1. Store existing clinical data pertaining to patients with CVADs in one database. 2. Facilitate quality improvement and research projects about patients with CVADs.

  • Group metacognitive therapy for repetitive negative thinking: Evaluation in a transdiagnostic adolescent sample

    There is evidence to suggest that it may be of benefit to look at the common (transdiagnostic) processes that appear to exist across psychological disorders, rather than the typical approach of splitting into discrete disorders. Suggested processes include metacognition (beliefs about our thinking, which can be both positive and negative) and repetitive negative thinking (RNT), which includes worry and rumination. Metacognitive therapy has been used as a treatment approach across a range of mental disorders to target these proposed common underlying processes of metacognition and repetitive negative thinking and has shown promising results in studies with adult participants. There is evidence to suggest that similarities may also outweigh differences between psychological disorders in youth, particularly adolescents. Support is growing for an extension of models related to transdiagnostic processes of metacognition and repetitive negative thinking from adults to adolescents, although studies of the benefits of metacognitive therapy in adolescents have been limited. New research coming from the adult literature has shown that group metacognitive therapy is as beneficial as individual treatment protocols, but is delivered in a much briefer time frame and is found to be benefit individuals with a range of mental health diagnoses. The aim of the proposed study is to provide a preliminary evaluation of the acceptability and efficacy of brief group metacognitive therapy (MCT) targeting repetitive negative thinking for adolescents with a diagnosed emotional disorder.

  • The SHAKE IT pilot study: Shakes and meal replacements to Help children and Adolescents Kick-start healthy Eating In Type 2 diabetes

    The aim of this pilot study is to investigate the effectiveness of a very low energy diet (VLED), consisting primarily of meal replacements, to resolve the metabolic abnormalities underlying type 2 diabetes in children and adolescents. We hypothesise that children and adolescents who achieve rapid weight loss through short-term use of a VLED will reverse the metabolic abnormalities underlying their type 2 diabetes. Our approach to cure type 2 diabetes is innovative and is in contrast to current practice which is aimed at managing type 2 diabetes. To our knowledge this study will be a world's first with the aim of curing diabetes in youth.

  • Topical estradiol add-back in hypogonadal men: dose-finding study

    The primary purpose of this trial is to determine the ideal dose of estradiol to give to men receiving androgen deprivation therapy (ADT) for prostate cancer, in order to replace the normal estradiol levels that they would have if they were not taking ADT. Who is it for? You may be eligible to participate in this trial if you are aged 55 to 80 years of age, and have been diagnosed with non-metastatic Prostate Cancer (T1-3NxM0) for which you are receiving treatment with GnRH agonists to suppress androgen production with a planned duration of further treatment of greater than 4 weeks. Study details All participants enrolled in this trial will be randomly allocated (by chance) to one of three groups. The first group will receive 0.9mg per day of estradiol, the second group will receive 1.8mg per day of estradiol, and the third group will receive a placebo (sham) treatment which contains no active ingredient. All three treatments are given as a gel which is rubbed into the skin once per day for 4 weeks. Researchers will take weekly blood samples from baseline to the end of the 4 week treatment period to determine the impact of each treatment on the level of estradiol in the blood as well as some indicators of bone health and diabetes, and a diary of hot flushes will be completed by all participants. It is hoped that this trial will provide information on the optimal dose of estradiol to give to men with prostate cancer on ADT, to replace the normal blood (serum) level of estradiol that they would have had were they not taking ADT. A subsequent study will investigate whether this treatment is effective in reducing some of the side effects of ADT.

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