ANZCTR search results

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

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30806 results sorted by trial registration date.
  • 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.

  • Minimum 2-year follow up of a reverse total shoulder arthroplasty using a wedged baseplate in patients aged 90 or less

    Surgical insertion of a reversed total shoulder replacement in patients with arthritis and torn muscles and tendons. The use of a wedged base plate in reverse shoulder replacement allows easier positioning of the socket part of the shoulder joint and less removal of bone .

  • Mental images of suicide imagery rescripting study

    Suicide is the leading cause of death among Australians aged 15-24 . Increasing our understanding of risk factors and developing novel indicated interventions to reduce deaths by suicide is urgently needed. In this project, we aim to develop and test the acceptability, feasibility and safety of a novel psychological intervention for young people with suicidal thoughts, that specifically targets a distressing form of suicidal thoughts that has been underrecognized in both clinical practice and research to date: mental images of suicide. One promising psychological intervention for treating intrusive and distressing mental images is imagery rescripting. Imagery rescripting involves individuals focusing on the content of their intrusive and distressing mental images and then vividly imagining an alternative outcome. This image is generated and rehearsed with a therapist. No previous studies have used imagery rescripting to directly target suicide-related mental images and to assess the effectiveness of this intervention in young people, for whom suicide is the leading cause of death. In this pilot study we aim to examine whether this intervention is acceptable, feasible, and safe in a small pilot study.

  • Validation of finger prick testing for 5-fluorouracil drug level monitoring in cancer patients.

    This study aims to validate a finger prick test against a peripheral blood test to measure 5-fluorouracil blood levels, so that finger prick testing could be done at home in future. Who is it for? You may be eligible for this study if you are an adult male or female receiving a 46-hour infusion of 5FU as part of your treatment for cancer. Study details Participants will return to hospital on Day 2 of their infusion to have a consecutive finger prick test and a peripheral blood test. Patients can participate in the finger prick and peripheral blood testing for more than 1 cycle of treatment. The correlation between 5-fluorouracil plasma drug level in a finger prick test compared to a peripheral blood test will be measured, and participants will be asked to complete an evaluation of the finger prick instructions. It is hoped that findings from this study will validate finger prick testing to replace peripheral blood testing so that testing can occur at home.

  • Can Cognitive Behavioral Therapy (CBT)-Insomnia be enhanced with clinical-grade, at-home sleep monitoring?: A Pilot study

    This study is exploring the possible benefits of adding clinical grade digital sleep assessment and clinician advice to the standard first line treatment for insomnia (Cognitive Behavioural Therapy-Insomnia, CBT-I). Specifically, we are evaluating the Somfit (https://www.compumedics.com.au/somfit) sleep monitoring device and Somfit program when added to standard Cognitive Behavioral Therapy for Insomnia (CBT-I). We will assess the feasibility, acceptability, and treatment outcomes compared to standalone CBT-I.

  • INNA-051 dry powder safety and tolerability study

    INNA051 is being developed as a prophylactic against respiratory viruses, for example influenza (the flu), SARS-CoV-2 (coronavirus), and respiratory syncitial virus (RSV). This study will test increasing doses of a dry powder formulation of study drug for safety and tolerability, and to measure how the immune system responds in older adults.

  • Modif-i Tobacco Trial: A clinical trial of the efficacy of a “brain-training” smartphone app to assist tobacco cessation

    We aim to test the feasibility and acceptability of "Modif-i", an app that delivers personalised "approach bias modification" training, in tobacco smokers who are trying to cease smoking. We also aim to obtain preliminarily evidence on the app’s effectiveness as a smoking cessation aid. Specifically, we will assess whether Modif-i is effective, relative to a control version that does not include approach bias modification, at (a) increasing likelihood of abstinence from tobacco; (b) reducing tobacco craving and severity of tobacco dependence; and (c) improving quality of life. We also aim to test whether Modif-i significantly reduces impulsive responses to tobacco imagery.

  • Single and multiple ascending dose study of oral ZKN-0013 or placebo given randomly to healthy volunteers to evaluate the safety, tolerability and the amount of drug in the body after drug administration.

    Eloxx Pharmaceuticals has developed a new product which works on mutated gene and allows for production of the correct protein instead of the defective protein typical to a number of hereditary diseases. The product is called ZKN-0013 and it is taken orally. The purpose of this research is to determine whether ZKN-0013 is safe and well tolerated in humans. In addition, the study purpose is to learn about the study drug properties. The participants will take one or multiple doses of ZKN-0013 during their participation based on the group they will be assigned to.

  • Setting kids up for life: Evaluating the effectiveness of a digital program for improving the sleep and mental health of children aged 3-12 years

    Sleep problems in children aged 3-12 years are highly prevalent, chronic and are a transdiagnostic risk factor for numerous deleterious mental health, physical health, academic and cognitive outcomes in both the short- and long-term. We have developed a group-based, parent-focused, program for preschool (3-5 years) sleep problems and demonstrated that it not only improves child sleep, but that it also leads to significant improvements in anxiety and behaviour problems, and prevents the later emergence of anxiety. The transdiagnostic impact of our sleep program has the potential to significantly improve the lives of young Australian children and their families. The next step is to make it accessible to as many families as possible by a) extending the program to include children up to 12 years of age with sleep problems and b) digitising the program in order to circumvent barriers to help-seeking. The aim of the proposed randomized controlled trial is to determine the relative short- and long-term treatment efficacy of an online, parent-focused treatment program (TX) for children with behavioural sleep problems (aged 3-12 years), compared to a Waitlist Control (WLC) condition. The TX condition will be assessed at baseline, post-assessment (6-wks post-baseline), 12-week, and 6-month follow-up. The WLC condition will be assessed at time points corresponding to baseline, post-assessment, and 12-week follow-up, after which they will receive the TX program. Our end goal, if this program is found to be efficacious, is to disseminate the program nationally to all Australian families through our Momentum online digital mental health assessment and treatment platform.

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