ANZCTR search results

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

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33573 results sorted by trial registration date.
  • Evaluating the effectiveness of a fluoroquinolone-based treatment of isoniazid-resistant tuberculosis: The FLIRT Trial

    Tuberculosis (TB) kills over 1.4 million people each year and has been the top infectious cause of death worldwide since 2015. Drug resistance is a major driver of prolonged morbidity and mortality, contributing to poor outcomes and allowing ongoing transmission of this airborne infection. Drug-resistant TB is caused by Mycobacterium tuberculosis that is resistant to at least one of the four first-line antibiotics used in combination to treat TB (isoniazid [INH], rifampicin [RIF], pyrazinamide [PZA] or ethambutol [EMB]). No trials of INH-resistant (INH-R) TB have been performed since the availability of later-generation fluoroquinolones (FQs), one of the best-tolerated and most effective group of antibiotics against TB. Safer and more effective regimens are needed. WHO called for treatment trials for INH-R TB, yet none are planned based upon our review of trial registries. The study hypothesis is that six months of an antibiotic treatment that includes a fluoroquinolone antibiotic will improve treatment outcomes for patients with isoniazid-resitsant tuberculosis. The research question to be addressed by this trial is: “What is the effectiveness and safety of a 6-month fluoroquinolone-containing intervention regimen, with 2 months of pyrazinamide, in comparison to that of a control regimen not containing a fluoroquinolone for treatment of isoniazid-resistant fluoroquinolone resistant tuberculosis?”

  • Comparing NursE recording Accuracy and Time taken for blood glucose checks with different glucose meters (NEAT) - Pilot Study

    Audit comparing amount of nursing time taken and accuracy of blood glucose levels recorded in the electronic medical record for the standard Nova Biomedical glucose meter currently used for clinical care compared with the AMSL wi-fi connectivity Statstrip glucose meter. Nova Biomedical manufactures a wi-fi connectivity glucose meter which can upload its glucose data directly to the patient electronic medical record (eMR). We anticipate that using the wi-fi connectivity glucose meters will substantially save nursing time and also contribute to an increase in the accuracy of glucose recording in the eMR. We plan to compare the time taken to check and record in the eMR a finger prick glucose level using each glucose meter type and to determine the proportion of glucose levels recorded accurately in the eMR by each technique (correct patient, correct time, correct glucose level and delay to glucose being documented in the eMR).

  • Comparing outcomes between the use of autologous fascia lata graft versus synthetic polypropylene mesh for sacrocolpopexy in the treatment of apical vaginal prolapse

    A study to investigate the differences in subjective, objective and quality of life outcomes between sacral colpopexy with mesh (Type 1 polypropylene) versus alternative graft (autologous fascia lata) at 6, 12, 24 month and 5 years

  • A 3-part study consisting of a randomised, double-blind, placebo-controlled, single ascending dose study in healthy participants, followed by an open-labelled single dose LPS-challenge study in healthy participants and an open-labelled multiple dose study in COPD patients to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EMP-012 for Injection Administered Subcutaneously.

    This is a 3-part study consisting of a randomised, double-blind, placebo-controlled, single ascending dose study in healthy participants, followed by an open-labelled single dose LPS-challenge study in healthy participants and an open-labelled multiple dose study in COPD patients to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of EMP-012 for Injection Administered Subcutaneously Registration is for Part A only. Part B and Part C are registered separately in ISRCTN. Who is it for? You may be eligible for this study if you are aged 18 to 65 years and are in good general health without a clinically significant medical history. Study details All healthy volunteer participants who choose to enrol in this study will be assigned by chance to receive either a single dose of EMP-012 or placebo. All participants will have their vital signs checked (heart rate, blood pressure, temperature, etc), and will provide blood and urine samples for testing. It is hoped this research will determine the maximum dose of EMP-012 that can be administered safely without causing severe reactions.

  • Integrating physical and psychological care for persistent musculoskeletal pain

    We propose to test a promising model of care for individuals with persistent MSK pain that provides immediate access to a psychologically based and internet-delivered pain management intervention in addition to usual care from physiotherapists and chiropractors. While the current study is dedicated to determining feasibility and acceptability of this model of care, we do hypothesise that this approach will broadly be sustainable, scalable, enhance clinical outcomes, economically efficient, improve access to healthcare resources, and increase the capacity of the health system to deliver multi-disciplinary care.

  • Development and pilot of a rapid-response, virtual, fall-risk assessment and management service for community-dwelling aged care clients.

    This project aims to develop and then pilot the following: (i) An evidence-based risk stratification algorithm for use by home care staff to identify deteriorating aged care clients who are at high fall-risk, drawing on recently available guidelines, followed by; (ii) A structured mobility and falls assessment, using evidence-based tools, able to be delivered rapidly by a virtual (i.e., telehealth / videoconference enabled) consultation with an AHP aided by a member of the clients’ usual care team being present in the client’s home.

  • Recollection of Event Memory following Drugs, Alcohol, and Stress

    Understanding the effect of intoxication on witnesses is important to the legal system, but there are key gaps in our knowledge in this area. While the research on alcohol and memory is advancing (e.g., see Jores et al., 2019), there is still little known on other substance effects in an eyewitness context. Specifically, there is minimal research on amphetamines and event memory, and no known research on any type of amphetamines and their impact on face recognition in a line-up context. This leaves many remaining questions and gaps which this study aims to fill as itpertains to dosage, timing, expectancy effects (i.e., anticipating potential substance effects that influence performance). Furthermore, many crimes are distressing in nature, however minimal research has explored intoxication and memory in the context of a distressing event. The role of stress must also be addressed because stress hormones are released during amphetamine use. This requires research about whether stress and amphetamine intoxication combine to impact memory. Additionally, it is unclear whether alcohol use will reduce the stress response, or whether stress will lead to a pause in alcohol metabolism, and how either of these may interact with memory. Study hypotheses: it is anticipated that alcohol may impair memory completeness but not accuracy, whereas it is possible that dexamfetamine may improve memory. An exploratory aim is to investigate whether stress impacts drug response (e.g., makes drug effects more or less pronounced and subsequently impacts memory accordingly).

  • A randomised controlled trial comparing animation-based with written patient information for educating patients about robotic-assisted radical prostatectomy

    This study aims to explore whether an audiovisual medium is more effective than written information for patients seeking information necessary for informed consent for robotic-assisted radical prostatectomy (RARP). Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with prostate cancer and you have been scheduled to undergo a robotic-assisted radical prostatectomy. Study details All participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two groups. Participants allocated to the first group will be asked to watch a 10 minute animated video about the robotic-assisted prostatectomy procedure prior to answering questions about the procedure and the consent process. Participants allocated to the second group will be asked to read an information pamphlet about the robotic-assisted radical prostatectomy via a website prior to answering questions about the procedure and the consent process. It is hoped this research will determine whether presenting prostate cancer patients with audio-visual information about a complex surgical procedure allows patients to develop a greater understanding of the procedure compared to traditional written pamphlets.

  • The Impact of Dietary Histamine in Chronic Pain – Pilot Study

    Chronic pain is one of the most common, distressing, and burdensome forms of disability in Australia, with around 20% of Australians experiencing chronic pain (>3 months) at any one time. Chronic pain is associated with markedly reduced quality of life, high levels of distress and often co-occurs with depression, anxiety, fatigue, sleep disturbance and relationship strain. Some studies have found an association between a low histamine diet and reduced migraine and other symptoms. This study aims to assess to assess the impact of an exogenous histamine-reducing dietary intervention on pain as measured by the Brief Pain Inventory (BPI) 1 month after commencing the low histamine diet, and the cost effectiveness of the intervention.

  • Evaluating educational interventions to support safe use of ChatGPT for health: a randomised-controlled trial of ChatGPT users

    ChatGPT is a publicly available AI chatbot that is free, easy to use and gives quick, human-like responses to user questions and requests. However, sometimes the information it gives is incorrect, missing key information, or unsafe. In this online study we want to test two social media interventions to see if they help people use ChatGPT more safely when asking health questions. Participants will be allocated to one of three groups: image carousel (instagram tiles), animation (short video) or control (health eating infographic). After viewing the intervention we will ask participants which kinds of questions they would try asking or avoiding asking ChatGPT.

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