ANZCTR search results

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

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31027 results sorted by trial registration date.
  • Effect of patient information cards on surgical patient comprehension and communication support

    he purpose of this study is to find out if patient experience can be improved by patient information cards. Who is it for? You may be eligible for this study if you are aged 18 or older, and are admitted under the Urology team at John Hunter Hospital. Study details Participants who consent to this study will be randomly allocated to either the group that receives the patient information card, or the group that undergoes routine clinical care (without the card). Participants who are given the card can write questions on the card regarding their hospital stay or surgery, and the questions will be answered daily. Relevant medical record information will also be automatically collected, and all participants will be surveyed at the end of the study. It is hoped that this research will demonstrate that patient information cards can improve communication and patient understanding about their health, and thus benefit patient experience.

  • A randomised controlled trial to compare drug dose reduction strategies in adults with rheumatoid arthritis and psoriatic arthritis for safer and more efficient drug use

    Overview: This trial aims to determine whether the high-cost, highly specialised biologic, biosimilar and targeted synthetic disease modifying anti-rheumatic drugs (b/tsDMARDs), used to treat Australians living with severe rheumatoid arthritis (RA) and psoriatic arthritis (PsA), can be safely reduced without compromising efficacy. The trial will concurrently address patient and clinician concerns regarding drug safety, efficacy and health system sustainability, with potential to lead to less harms and substantial individual and societal savings. The project will generate new knowledge on RA and PsA low disease activity state and/ or remission in the short to medium term while optimising long-term return on investment by following participants longitudinally as a clinical registry/biobank cohort. Clinical and biomarker predictors of successful (or failure) of down-titration strategies will be evaluated. Design: A multi-centre, open-label, non-inferiority, parallel-group randomised controlled trial of disease-modifying antirheumatic drug (DMARD) +/- conventional synthetic (cs)DMARD dose continuation (USUAL CARE) vs discontinuation after tapering (STOP) in adults with rheumatoid arthritis and psoriatic arthritis in sustained low disease activity at baseline. Comprehensive clinical, self-reported and administrative data and biospecimens will be collected throughout the study.

  • Bright Light Therapy for Adolescent Depression

    The current study aims to evaluate to what extent inclusion of bright light therapy as an adjunct to the treatment for depression, improves sleep and mental health outcomes for young people with depression.

  • Can an online parenting intervention improve outcomes for children with eczema? A pilot study

    Childhood eczema is one of the most common chronic health conditions among children. There is no cure, and it places an enormous burden on affected children and their families. Interventions to help parents develop the skills to handle challenging child behaviour, manage their own stress, and implement treatment consistently can improve children’s health outcomes. Brief parenting intervention is effective in targeting the child behaviour and parenting challenges that can make condition management more difficult for parents; however, face-to-face intervention delivery poses a barrier to many families and limits accessibility and reach. This research will examine whether a self-directed online parenting intervention can deliver the same outcomes as a face-to-face group program, leading to improvements in parenting practices, parents' self-efficacy with eczema management, child emotional and behavioural adjustment, health-related quality of life, symptom severity, and treatment adherence, with better accessibility and at lower cost. Given the current pandemic, it is essential that we harness online and telehealth approaches to ensure that evidence-based programs are able to be accessed by the families who need them. This research will examine a novel and unique application of an online parenting intervention that will complement existing health care services and make a significant difference to Australian children.

  • Cancer Molecular Screening and Therapeutics (MoST) Program Addendum 19 substudies 41-42: Sotorasib

    This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This study will assess the clinical activity of Sotorasib in adult patients with advanced cancers (excluding non small cell lung cancer and colorectal cancers) harbouring KRAS G12C mutations. Who is it for? You may be eligible for this study if you are an adult aged 18 years or over with and advanced and/or metastatic solid cancer. Study details: Participants will receive 960 mg of oral Sotorasib to be taken daily. The duration of the study is until disease progression. Participants will complete imaging, clinical and safety assessments throughout the study. Participants will undergo imaging assessments at screening, cycle 2 day 1, cycle 3 day 1 then 8 weekly intervals for 12 months and then 12 weekly, or as clinically indicated in order to evaluate tumour response. Safety and tolerability of treatment and health related quality of life during treatment will be assessed at 4 weekly intervals. Each cycle is 28 days. We cannot guarantee that patients will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Sotorasib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study

  • UPLIFT: Progressive Resistance Training (PRT) as Adjunctive Treatment for Alcohol Use Disorder (AUD)

    The primary aims of this project are to determine the effects of high intensity progressive resistance training (PRT) on the number of alcoholic drinks consumed per week, measured using a 7-day recall in adults who have undergone rehabilitation for alcohol use disorder with mental health comorbidities. Participants will be randomised to receive either PRT, 3 days per week for 12 weeks after discharge into the outpatient program in addition to usual care provided in the outpatient program at St John of God (Burwood) Hospital, or usual care in the outpatient program only at St John of God (Burwood) Hospital. Participants randomised to the control intervention will receive usual care in the 12-week Alcohol, Drugs and Addictive Behaviours outpatient program at St John of God (Burwood) Hospital. We will not advise on treatment. Blinded assessments will occur pre-, and post intervention. Unequal randomisation will be used to minimise drop-out rates, in a ratio of 2 participants randomised to the intervention group and 1 to the control group. For this trial we have conservatively estimated an effect size of 1.1. With a beta 0.8 and alpha of 0.05, a total of 32 participants will need to be recruited, 11 participants in the control group and 21 in the intervention group, to show significant effects for the number of drinks consumed per week.

  • Understanding tissue mechanics, architecture and function using a gravitational magnetic resonance elastography transducer.

    This study aims to measure the architecture and mechanical properties of soft tissues of the human body as they are stretch or compressed using the magnetic resonance (MR) imaging technique of MR elastography. MR elastography uses an MRI scanner to capture the propagation of vibration through the soft tissues. In this study the vibration will be generated by a new ‘gravitational’ transducer. We hypothesise that there will be differences in the mechanical properties of these soft tissues during these loading conditions, from which we can quantify the large deformation tissue mechanical properties.

  • Clinical trial comparing the efficacy of interdental oral irrigation devices with interdental brushes in adults with gingivitis

    This clinical trial is designed to compare the efficiency in the removal of interdental plaque and interdental gum.. Participants are instructed on how to use each device correctly and safely. We use plaque and bleeding scores to determine which healthbrushes and an oral irrigation device (water flosser) to clean in between your teeth.

  • StandingTall with our Mob Project (STOMP!): A holistic approach towards active and healthy ageing of Aboriginal and Torres Strait Islander peoples

    StandingTall-with our Mob is culturally-safe and tailored to Aboriginal Australians, and has shown excellent indicative success in pilot research studies. It considers underlying social determinants of Indigenous health and well-being whilst meeting evidence-based guidelines to safely and sustainably advance healthy ageing through exercise, cognitive training and stress reduction. The program combines home-based and group-based sessions with traditional and technology-driven methodologies across three key components: (i) a home-based exercise program offering balance exercises through mobile technology; (ii) a home-based cognitive-motor program focusing on training executive function, attention and working memory using a dual-task paradigm through mobile technology, and (iii) a group mindfulness-based stress-reduction program, to improve social and emotional well-being and reduce the impact of stress through cultural connection. This project comprises a cross-over style trial to determine adherence and effectiveness of our holistic healthy ageing program in 100 older Aboriginal people (aged 45+ years) over 6-months. We hypothesise that our holistic, multifaceted program will lead to improved mobility, cognitive function, and quality of life in Aboriginal Australians. Principles of inclusiveness and attendance flexibility, and acknowledgment of Aboriginal culture are incorporated in all activities.

  • Correlating invasive and non-invasive measures of coronary flow in patients with angina

    The aim of this study is to compare invasive (meaning it is done from inside the body) assessment of blood flow through the large and small arteries of the heart to the heart muscle (via angiography) and a single proton emission computed tomography with low dose CT (SPECT/CT) scan assessing the same thing. This is because SPECT/CT assessment of blood flow to the heart through small arteries is a relatively new technology that we would like use more if the results of this study deem it to be accurate. Presently it is difficult to assess whether there are abnormalities of the small arteries of the heart, which is a common cause of chest pain in people who are diagnosed as having “normal coronary arteries”. The only way to do this currently is with an invasive test, using special pressure wires to measure blood flow in the small arteries. This would mean that patients with chest pain could have a SPECT/CT scan alone rather than an angiogram (requiring a procedure with inherent risks) to investigate their symptoms. Involvement in this study involves addition of a pressure wire test to the normal heart angiogram procedure, along with a SPECT/CT scan. Additionally, participants will be checked in on at 1 and 12 months following their tests to assess their progress, whether they have had any heart problems, how their symptoms are, and whether they have had any further tests or diagnoses. This will all help to assess how useful the SPECT/CT scan will be in the future.

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