ANZCTR search results

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

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30856 results sorted by trial registration date.
  • Good Way Yarning for Better Health: Implementing Clinical Yarning in Western Australia's Midwest - Phase 1

    The overall project is a mixed-method implementation study conducted over four phases. This record focusses on phase one, a context analysis that includes understanding Aboriginal patients experience of communication (objective 1 – mixed method design using a patient survey and qualitative data collection), developing a system to collate existing health care information known to be associated with patient-practitioner communication (objective 2 – system development and retrospective audit of data from patient health care databases), and investigating barriers and enablers to implementing Clinical Yarning in Western Australia Midwest (objective 3 – qualitative interviews with health care staff). Study hypotheses are that: • taking an evidence-informed, systematic approach will result in effective implementation of Clinical Yarning in WA Country Health Service (WACHS) - Midwest region • implementation of Clinical Yarning will result in improved patient-practitioner communication and health service outcomes Objectives: Context • to ascertain barriers and enablers to implementing Clinical Yarning training across the Midwest region at the individual, health service, and system-level • using this information, to develop a systematic, evidence-informed implementation strategy, including a system for ongoing evaluation and monitoring of communication outcomes • to implement Clinical Yarning training across the Midwest • to investigate changes in communication, patient, and health service outcomes following Clinical Yarning implementation strategies • to embed findings in a subsequent Clinical Yarning implementation strategy for sustainable use in other regions

  • Real-time microwearable sensor for monitoring human hydration status

    WearOptimo is developing the MicrowearableTM Hydration Sensor (the Microwearable) that utilizes localized impedance measurements to monitor, in real-time, changes in hydration. The Microwearable has been designed on the hypothesis that mild, systemic dehydration can be detected through changes in the impedance characteristics of the skin. By passing a small alternating current between microneedles that have been painlessly inserted into the uppermost layers of the skin, detection and notification of dehydration status can be provided to the Microwearable user. This study will be the first in-human study of the WearOptimo Microwearable Hydration Sensor. A key question for the feasibility of the Microwearable is whether dehydration at the systemic level will produce a corresponding pattern of changes in skin impedance that is consistent enough to support dehydration detection and diagnosis, against the background of natural confounding processes (sweat, motion, heart rate, blood pressure and local skin temperature changes). To monitor contrasting levels of hydration, each participant will attend two trials with intervals of light exercise: • Exercise in a hot and dry environment with continuous fluid replacement; • Restriction of fluids for 24-hours followed by exercising in a hot and dry environment. The primary endpoint will be the diagnostic performance of the Microwearable for detection of the dehydrated state. Diagnostic performance will be evaluated with sensitivity and specificity of detection of the dehydrated state determined by receiver operating characteristic (ROC) analysis of a binary classification distinguishing euhydrated and dehydrated states.

  • CONNECT 50+ Healthy ageing for midlife and beyond using community health programs: a feasibility trial

    We propose to use a preventive approach to health problems by providing a holistic program that allows older adults to independently improve their own health. Adults aged 50 years and over need accessible and easy opportunities to reduce their reliance on the health system and to actively engage in their own healthy ageing. This can improve their ability to prevent functional decline normally associated with ageing and chronic disease. Community hubs are neighbourhood organisations that could be a means of hosting preventive holistic health programs, while concurrently improving social connections. They could be used as a means of delivering programs that improve older adults’ ability to manage after hospitalisation, however community hubs at present are not utilised for these types of programs. Our team recently designed a community-hub based wellness program that consisted of an exercise program and wellness activities to address healthy ageing during the COVID-19 pandemic. There was overwhelming support for the program from participating community-hub members, with promising changes in health and wellness. We are now ready to upscale to a pilot randomised trial to determine the feasibility of this type of program for delivery for people aged 50 years and over experiencing chronic disease recently discharged from hospital. This is a pilot randomised controlled trial to identify if the wellness program (CONNECT 50+) is helpful to people who have ongoing health problems, and who have recently come home from hospital. Some people will belong to the group that completes CONNECT 50+ and monitors their daily physical activity using a smartwatch (intervention group), while another group will only monitor their physical activity using a smartwatch (control group). We will collect information about both group’s physical ability and their satisfaction with their life at the beginning and at the end of the 12-week program. The research officer will be blinded during data collection at baseline and 12-week follow-up. The research will help us understand what the benefits of the wellness program are, what worked well and how this could be helpful for a future larger study.

  • The SAD-AF trial: a study of escitalopram (a selective serotonin reuptake inhibitor, SSRI) antidepressant vs placebo in patients with atrial fibrillation (AF) and depression, on AF-related quality of life

  • Dynamic liquid molecular profiling in anaplastic lymphoma kinase (ALK) Non-Small Cell Lung Cancer

    This study aims to use specialised blood tests to assess any changes in of the tumour DNA circulating in the blood of patients with advanced ALK-positive (ALK+) non-small cell lung cancer (NSCLC) throughout their diagnosis and treatment to help improve outcomes. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older and you have been diagnosed with advanced ALK+ non-small cell lung cancer. Patients commencing but who have not started treatment with a new ALK-targeted tablet therapy may be eligible to participate in this study. This study is being conducted through the Australian Registry and Biobank of Thoracic Cancers (AURORA). Existing and new AURORA participants will be screened for eligibility and offered participation. Non-AURORA patients can be enrolled into AURORA through a referral by their treating clinician to an AURORA site specifically to participate in this study. Patients receiving treatment at a site not registered with AURORA will still receive their treatment at their local Center, whilst undergoing DYNAMALK activities through the AURORA site which may occur in person or virtually as appropriate. Study details All who choose to participate in this study will be asked to provide blood samples at three occasions over a 2 year period, once after they have enrolled, once at 6-12 weeks after enrolment and once again at 2 years after enrolment, or at any earlier time if they have evidence that their cancer has progressed and the current treatment is recommended to stop to consider a new approach. Tissue samples will be collected where biopsies are performed as part of standard care. Collection of these samples will be organised to coincide with participants' scheduled appointments with their oncologist to minimise the need for additional travel requirements. Participants who choose to enrol in this study will also be asked to allow the research team to review their previous medical history relevant to their NSCLC diagnosis and treatment. Results from the blood assessments will be provided to participants by their treating clinician within a few weeks after collection and may help their treating clinician to decide on the best treatment strategy. It is hoped this research will identify how markers from DNA in the blood could be used to understand more confidently how well a treatment will work for patients with ALK+ NSCLC and identify markers that could be used to guide new therapies that will treat these cancers more precisely.

  • The effects of Solid Lipid Curcumin Particle Preparation (Longvida) on memory and cognition in adults with mild cognitive impairment

    In this randomised, double-blind, placebo-controlled study, 80 adults aged 50 to 85 years with mild cognitive impairment will be randomly assigned to receive capsules containing either a curcumin extract (Longvida, 400 mg daily) or a placebo for 12 weeks. Changes in cognitive performance will be assessed at baseline and week 12 by administering the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) and the Montreal Cognitive Assessment (MoCA). Moreover, to help understand how curcumin works to improve cognitive function, changes in blood concentrations of Brain-derived neurotrophic factor (BDNF) and Amyloid beta (Aß) will be measured over time.

  • The Readability Study: A randomised trial to examine the effect of health information written at different grade reading levels.

    The aim of this study is to investigate the impact of health information written at different grade reading levels on knowledge, perceived reading ease and acceptability. We will also explore whether there are differences in scores across health literacy and education. We hypothesize that information written at higher grade reading levels will result in lower knowledge scores, perceived reading ease and acceptability.

  • A safety and early efficacy study of LSTA1 in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment in locally advanced pancreatic ductal adenocarcinoma (PDAC)

    This study aims to assess the safety and tolerability of a new cancer treatment drug, LSTA1, in combination with durvalumab, gemcitabine and nab-paclitaxel, as first-line treatment for patients with locally advanced pancreatic ductal adenocarcinoma (PDAC). Who is it for? You may be eligible for this study if you are aged 18 years or older (or aged 20 or older if Japanese), you have been diagnosed with locally advanced pancreatic ductal adenocarcinoma and you have not yet started treatment for your cancer. You will also need to meet certain health criteria prior to being eligible for this study. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of 3 treatment groups. Participants allocated to the first treatment group will receive gemcitabine, nab-paclitaxel and two placebo treatments. Participants allocated to the second treatment group will receive gemcitabine, nab-paclitaxel, LSTA1 and one placebo treatment. Participants allocated to the third treatment group will receive gemcitabine, nab-paclitaxel, LSTA1 and durvalumab treatments. All treatments will be administered on set days of a 28-day treatment cycle. Participants will continue to receive their allocated treatments every 28 days unless they experience any serious side effects, they have disease progression or such a time that their health deteriorates to the point where the treatment is no longer practicable . During treatment, participants will be asked to undergo blood tests, imaging and a biopsy to determine how the treatment is affecting their cancer. It is hoped this research will determine whether adding the new cancer treatment drug, LSTA1 and immunotherapy to currently used cancer treatment drugs is safe and whether it has any effect on cancer cells. If this study finds that LSTA1 is safe to use in combination with the current cancer treatment drugs, it may be expanded to a larger study to further assess the effect of LSTA1 on cancer cells for patients with locally advanced pancreatic ductal adenocarcinoma. Thus far, we have not been able to get immunotherapy to engage with pancreatic cancer cells. Early studies, however, indicate that LSTA1 changes the tumour environment to make the immune cells work more effectively. This mechanism decreases immunosuppressive Tregs (Regulatory T cells (Tregs) which are a specialised subpopulation of T cells that act to suppress immune response against the tumour) and increases the percentage of cancer-fighting CD8+ T cells within the tumour. (CD8+T cells can mount a response against pathogens by secreting cytokines and can defend against tumours by directly killing transformed cells.)

  • Analysis of features of eye gaze useful in the diagnosis of Glaucoma for people living in rural and remote communities. A comparative study between people with early to mid-stage Glaucoma and age-matched healthy volunteers.

    Glaucoma results in irreversible visual field loss so early detection and diagnosis of this disease is needed to avoid sight loss. Pupillary light responses and analysis of saccadic movements are new techniques for the detection of glaucoma. The purpose of this study is to identify robust features of pupillary light responses and saccades as demonstrated using a commercial eye tracking device that may be used to identify and assess for abnormalities of eye gaze. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of abnormalities for people living in rural and remote communities. Patients will be able to record eye gaze under specified conditions. The recordings will be analysed and eye gaze recordings and their analysis sent to a specialist physician. The aim of this study is to ascertain features of eye gaze that are most useful in identifying differences between glaucoma patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Glaucoma patients will exhibit significantly different eye gaze responses compared with healthy age-matched controls.

  • Analysis of features of eye gaze useful in the diagnosis of Parkinson's disease for people living in rural and remote communities. A comparative study between people with early to mid-stage Parkinson's disease and age-matched healthy volunteers.

    Eye movement abnormalities including the pupillary light reflex (PLR) and saccades occur in movement disorders including Parkinson’s disease. The purpose of this study is to identify robust features of eye gaze as demonstrated using a commercial eye tracking device that may be used to identify and assess eye movement abnormalities in Parkinson’s disease patients and those at risk of developing Parkinson’s disease. The ultimate aim of this work is to develop an automated diagnostic tool for the diagnosis and assessment of eye gaze abnormalities for people living in rural and remote communities. Patients will be able to record their eye gaze under specified conditions. The recordings will be analysed and eye gaze and analysis sent to a specialist physician. The aim of this study is to ascertain features of the PLR and saccades that are most useful in identifying differences between Parkinson’s disease patients and healthy age-matched controls using a commercially available eye tracker. The hypothesis is that Parkinson’s disease patients will exhibit significantly different eye gaze features compared with healthy age-matched controls.

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