ANZCTR search results

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

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32707 results sorted by trial registration date.
  • Effect of Content Specificity in Interpretation Training for Adults with Social Anxiety Symptoms

    The study aims to evaluate the factors that contribute to the success of a Cognitive Bias Modification of Interpretations (CBM-I) program. Specifically, the study will look at whether the content (or topic) of the training scenarios in the program needs to match participants’ anxiety concerns (e.g., social concerns) to be effective in modifying the ways that individuals interpret information. Adults with elevated symptoms of social anxiety will be randomly allocated to CBM-I training that matches their anxiety type (using social scenarios), or CBM-I training that does not match their anxiety type (using fear of heights scenarios). All participants will complete a single session of CBM-I, with 60 training scenarios. Interpretation bias, social anxiety symptoms, and state anxiety will be assessed immediately before and after the CBM-I training. We expect that that the group that receives training scenarios that matches their anxiety type (social) will demonstrated greater reductions in negative interpretation bias, social anxiety, and state anxiety from pre-training to post-training, compared to the group that is assigned scenarios that do not match their anxiety type (heights).

  • CogScreen: Validating cognitive screening in young people with first-episode psychosis

    To validate a brief cognitive screening tool for young people with FEP using established classification accuracy methodology and to explore the acceptability, feasibility and implementation barriers and facilitators of screening as part of an implementation evaluation.

  • Part 1 and Part 3: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of AC-101

    This is a single center, randomized, double-blind, placebo-controlled, dose-escalation study to evaluatethe safety, tolerability, pharmacokinetics (PK) f AC-101 following oral single/multiple ascending doseadministration in healthy male and female participants. The study will consist of 3 parts: a SAD phase (Part1) enrolling a total of 5 cohorts of healthy participants; and a MAD phase (Part 3) enrolling 3 cohorts ofhealthy participants. All doses of study drug will be administered orally with approximately 240mL of room temperature water. In Part 1 to Part 3, all doses will be administered after an overnight fast of at least 10 hours,

  • Examining the role of gut taste receptors in food preferences, weight loss, and metabolic improvements after bariatric surgery.

    An unintended but common outcome of bariatric surgeries is reduced preference for sweet and fatty foods. It is not known why this occurs. This study will examine whether changes in food preferences after bariatric surgery are related to changes in taste receptors in the gut. In volunteers undergoing sleeve gastrectomy or gastric bypass, food preferences and gut taste receptors will be examined and compared before and 12 months after surgery. Relationships between food preferences, gut taste receptors, weight loss, blood glucose and lipid profile will be examined. This will indicate whether changes in gut taste receptors are related to the effects of bariatric surgery.

  • Pain in Open and Laparoscopic Hernia Operation: POLHO Study

    This study will explore whether intraoperative pain measured with the NIPE monitor correlates to the level of postoperative pain and the amount of analgesia required after elective laparoscopic and open inguinal hernia repair. This could clarify if laparoscopic inguinal hernia repair is associated with reduced intraoperative and postoperative pain leading to a reduction of postoperative analgesia and length of hospital stay. This has not yet been explored and this may ultimately result in less pain and distress to children and their carers, and also reduce healthcare costs.

  • 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.

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