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.
  • A Phase II Randomised, Double-Blind, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Oral NP202 in Reducing the Incidence of Atrial Fibrillation in Adults who have undergone Cardiac Surgery.

    Atrial fibrillation (AF) remains a frequent complication after coronary artery bypass graft surgery (CABG) with a rate of occurrence from 10 to 40%.. This study will assess the ability of a novel treatment (NP202) to prevent post operative atrial fibrillation in comparison to a placebo. NP202 is a small molecule that inhibits a protein that is central to atrial fibrillation. Subjects will be treated with NP202 or placebo for 3 days prior to their surgery and through the duration of their hospital stay. After surgery, the amount of atrial fibrillation will be assessed during the in hospital recovery period.

  • Using image enhancement in colonoscopy to increase detection of colonic polyps

    Our overall objective is to demonstrate whether LCI increases the detection rate compared with high-definition white light (current standard of care). The purpose of this study is to compare the rates of polyp detection with Linked Colour Imaging (LCI) and high-definition white light in patients undergoing elective colonoscopy. Who is it for? You may be eligible for this study if you are aged over 18 and are undergoing elective colonoscopy at the Gold Coast University Hospital. Study details All participants in this study will undergo a single colonoscopy as planned. The type of light used will be randomised by chance. We will record where polyps were found and their size. Any cancerous or pre-cancerous appearing lesions detected will be treated as per standard procedure. Resected polyps will be pathology tested as part of your routine care. No tissue samples will be obtained or stored purely for research purposes alone. The results of your tissue analysis will be de-identified and used only to confirm that lesions seen during your colonoscopy were really polyps. It is hoped this research will demonstrate whether LCI increases the detection rate compared with the current standard of high-definition white light.

  • Dementia prevention and risk Management Program for Aboriginal Australians - DAMPAA Project

    This study aims to produce an Aboriginal Health Practitioner coordinated risk factor management program to reduce cognitive decline and functional impairment in Aboriginal Australians aged 45 years and over. The Dementia prevention and risk management program for Aboriginal Australians (DAMPAA) program will include AHP coordination and care planning of a) an exercise program including falls prevention strategies; b) cardiovascular risk management. This will be achieved through a 5 year research project in partnership with three ACCHS’s by: 1) Refining and piloting an intervention program (DAMPAA) that targets key dementia risk factors for Aboriginal people, and is based on existing best practice guidelines and cultural and service provider recommendations. 2) Completing a randomized controlled trial (RCT) comparing the DAMPAA program with usual care; 3) Evaluating the efficacy and cost-effectiveness of the DAMPAA. Significance: Given the rapid ageing of the Aboriginal population, the impact that dementia has on Aboriginal communities, and the resulting financial cost to society, there is a pressing need to develop and translate programs capable of reducing dementia in Aboriginal Australians. This project will produce a prevention program designed to meet the needs of Aboriginal Australians at risk of dementia.

  • Does The Explanation of Tendon Sensitivity Affect Pain and Function in people with Achilles Tendinopathy?

    Contemporary thinking suggest that pain may be enhanced by the messages that health practitioners convey to patients in their initial meeting as they have been shown to have a strong influence upon their prior beliefs . Despite there being a very weak relationship between observable tissue pathology and symptoms research suggests that clinicians commonly use tissue based structural descriptions to explain clinical status in people with persistent musculoskeletal pain problems . The aim of this study therefore is to examine the instantaneous effect of diagnostic messaging on pain and function in people with AT. To achieve this, we will assess pain and leg stiffness with hopping in people with AT before and after a standard diagnostic discussion that includes discussion of tendon pathology and compare these results with participants who receive a diagnostic explanation that does not reference tendon pathology.

  • The effect of an immediate pre-operative haemoglobin blood test on hip fracture patient outcomes: A before and after cohort study

    In patients with hip fracture, low haemoglobin (Hb) levels are associated with post-operative complications, mortality, and increased hospital Length of Stay (LOS). A pre-operative Hb is taken on admission to the Emergency Department at Sir Charles Gairdner Hospital (SCGH). At the time of surgery, admission Hb levels may not be reliable indicators of current patient Hb status due to continual acute fracture-related blood loss, haemo-concentration and delays to surgery. This cohort study will investigate if an intervention of an Hb test immediately before surgery will improve patient outcomes. We will compare outcomes between 300 prospective patients and 300 retrospective patients. The outcome measures include hospital LOS, use of blood transfusions, Post-Anaesthetic Care Unit LOS, post-operative complications, admission to critical care areas, and survival to discharge. We foresee the results of this study may improve patient outcomes.

  • A wellbeing and performance enhancement program for Professional Dancers

    There continues to be a culturally embedded perspective that performing artists may need to “suffer for their art” and often wellness and artistry are treated as if they are unrelated. This randomised controlled trial will compare the effect of a 7week wellbeing and performance enhancement program with mindfulness, to a waitlist control group who receive the education only (without the mindfulness component), for Professional Ballet Dancers employed at The Australian Ballet. Dancers will be asked to complete electronic questionnaires and semistructured interviews in addition to completing the wellbeing program.

  • Lignocaine versus Opioids in Coronary Intervention: Assessing Antiplatelet Activity and Ticagrelor Levels (LOCAL) study

    This randomised study will evaluate the efficacy of intravenous lignocaine as an alternative analgesic in patients undergoing percutaneous coronary intervention to fentanyl which is standard of care. The rationale behind this study relates to multiple biochemical studies demonstrating delayed absorption of antiplatelet agents when opioid analgesia is administered. Furthermore, these studies demonstrate that by delaying gastric absorption, the antiplatelet effects of ticagrelor based on platelet function are also delayed. Retrospective analysis of large clinical studies suggest poorer clinical outcomes in patients treated wtih opioid analgesia. Patients admitted and consented for coronary angiography will be recruited from The Alfred Hospital, Victoria. Patients presenting with STEMI, cardiogenic shock, out of hospital cardiac arrest, previous opioid or P2Y12 administration, coagulopathy or allergy to opioids or lignocaine will be excluded. Patients undergoing percutaneous coronary intervention will be randomised to receive either lignocaine or fentanyl as follows: For patients allocated to lignocaine: - Lignocaine 1mg/kg (maximum dose 100mg) will be given as a bolus at the start of the case - During the case, if analgesia is required a further bolus of 0.5mg/kg will be given. - If satisfactory analgesia is not achieved then patient will crossover to fentanyl arm - Total lignocaine dose will be recorded For patients allocated to fentanyl: - If under 70 years of age 0.75mcg/kg of Fentanyl IV will be given at the start of the case. If >70 years of age 0.5mcg/kg will be given at the start of the case. - Further IV fentanyl boluses can be given at the discretion of the interventional cardiologist if further analgesia is required during the case - Fentanyl IV 0.5mcg/kg mcg will be given at the end of the case at the time of administration of ticagrelor. Study endpoints will evaluate the efficacy of intravenous lignocaine in terms of analgesic efficacy and assess the interaction in terms of platelet function studies and pharmacokinetic analysis. This will determine if lignocaine is a safe, effective alternative analgesic which does not interact with antiplatelet agents.

  • A randomised controlled trial comparing video-assisted informed medical consent to traditional doctor patient consent for Mohs micrographic surgery.

  • An investigation of new methods to improve body image among people with eating disorders

    This study is to investigate the effectiveness of Imagery Rescripting (IR) in treatment eating disorders. It is common for people with eating disorders to report that memories of early negative experiences related to their body or eating (e.g., being teased about weight), or even unrelated to their body or eating (e.g., being rejected by a friend), are still relevant to how they feel emotionally about their body and eating today. With the use of IR, we go back in our imagination to experience the past event from a new perspective. We hypothesized that eating disorders treatment is more effective in decreasing disordered eating behaviours and improving body image among people with an eating disorder than with IR is used as a treatment adjunct.

  • Rotational Thromboelastometry (ROTEM)-guided blood product in patients with cirrhosis undergoing invasive procedures

    The aim of this project is to examine the role of a ‘global’ coagulation assay called Rotational Thromboelastometry (ROTEM) in the guidance of prophylactic blood product in patients with liver cirrhosis undergoing invasive procedures. Currently available laboratory tests (such as platelet count, International Normalised Ratio (INR) and activated partial thromboplastin time (aPTT)) are suboptimal for the assessment of bleeding risk in patients with chronic liver disease. These tests may overestimate the risk of bleeding, and their use may result in unnecessary transfusion of blood and coagulation products, exposing the patients to risk of serious adverse events and potentially overuse of scarce blood products. During the past few years, ‘global’ coagulation tests such as ROTEM have been developed to provide an overall measurement of the clotting system. These point of care tests provide quick results and have been used to assess coagulation and better guide blood product transfusion in a number of surgical and trauma multi-transfusion settings. However, the value of these global tests in predicting bleeding outcomes and guiding blood component transfusion in liver disease has not been well studied. We plan a multi-centre randomised-controlled trial (RCT) examining ROTEM-based decisions to guide FFP and platelet use in patients with cirrhosis undergoing invasive procedures. We hypothesise that using ROTEM to guide blood product delivery in this setting, will lead to reduced usage of blood products whilst maintaining optimal clinical outcomes.

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