ANZCTR search results

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

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32469 results sorted by trial registration date.
  • Assessment of head and neck cancer margins with confocal laser endomicroscopy (CLE).

    The purpose of this study is to determine if an imaging method called laser confocal endomicroscopy can accurately identify the the presence of residual tumour in the margins of head and neck cancer during surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, under the care of the principal investigator with known head and neck cancer limited to the oral cavity, oropharynx or base of the tongue and requiring surgical intervention as standard therapy. Study details Participants in this study will undergo their usual surgical treatment for head and neck cancer. During this procedure the surgeon will image the tissue remaining after the tumour is removed and the researchers will also image the cancerous tissue which has been removed. The standard pathology tests will then be performed. If this study shows that laser confocal endomicroscopy can accurately determine margins in head and neck cancer then this will lead to larger clinical trials. Ultimately the aim is to give surgeons more precise tools for determining surgical margins to improve surgical outcomes for patients.

  • Feasibility and impact of SAIFR (Systematic Approach to the Implementation of Falls Recommendations) for older clients in community rehabilitation: a pilot cluster randomised trial

    In the context of ensuring that all clients of a health organisation receive care consistent with the best available evidence, this pilot trial aims to test the feasibility and potential impact of a new approach to integrate evidence into existing models of care, known as “SAIFR” (Systematic Approach to the Implementation of Falls Recommendations). SAIFR will be pilot tested within two sites of the community rehabilitation program at Eastern Health using a stepped-wedge design, with implementation guided by the COM-B Model for Behaviour Change. The feasibility of study methods (e.g. step timing, client recruitment, training feasibility, engagement, falls measurement, progression requirements, drop-out rates and contamination) will be evaluated. The potential impact of applying this systematic approach to implementing the World Guidelines for Falls Prevention and Management for Older Adults and the Australian Preventing Falls and Harm from Falls in Older People: Best Practice Guidelines to the Community Rehabilitation Program will also be evaluated, using the first four elements of the RE-AIM framework – reach, effectiveness, adoption and implementation. Findings related to potential impact and feasibility will determine whether pre-specified progression criteria are met to support progress to a fully powered stepped-wedge, randomised controlled trial of the Systematic Approach to the Implementation of Falls Recommendations (SAIFR).

  • Identification of critical thermal environments for aged adults

    The human body releases heat by sweating and increasing blood flow to the skin. However, when the temperature gets too hot, or the humidity too great, these processes become impaired. This causes heat to be stored in the body, and the body temperature to increase. Understanding the specific environmental conditions when this occurs is very important to prescribe advice regarding upper environmental limits for older adults engaging in physical activity in the heat. The objective of this study is to determine the ambient temperature and humidity at which age-related impairments can result in greater risk of heat illness. To determine these limits, participants will perform light intensity exercise in various environmental conditions and body temperature will be monitored while the humidity is increased throughout the trial. These data will be used to derive upper environmental limits for older men and women exercising in the heat.

  • Randomised controlled trial of an online ultra-brief treatment for depression or anxiety

    This study seeks to evaluate the efficacy of the Single Session Course, a brief intervention for depression and anxiety for adults, and to explore the impact of a pre-treatment diagnostic interview. The current study hypothesises that the Single Session Course will be more effective than a waitlist control and furthermore receiving a diagnostic interview prior to starting the Course will also be associated with reductions in depression and anxiety.

  • Colorectal Cancer: Helping patients Optimise their Opportunity for physical activity through Supported Exercise engagement (CHOOSE): A feasibility randomised controlled trial

    This research project aims to explore whether i) introducing regular exercise consultations from physiotherapists before and after colorectal cancer surgery and ii) allowing patients to choose when they want to participate in a formal exercise program is feasible and beneficial. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with stages I-III colorectal cancer and is within 6 weeks of planned primary tumour resection surgery for colorectal cancer at Eastern Health. Study details Participants will be randomly assigned to receive either three physiotherapist-led exercise consultations inclusive of an exercise assessment, delivered at key times of their cancer care pathway, or the usual care that people currently receive. Data on feasibility, acceptability, physical activity and health-related quality of life will be collected at key timepoints during the trial. It is hoped that findings from this study will help researchers understand how and when exercise support should be offered to people undergoing treatment for colorectal cancer in the future.

  • A study in healthy adults testing how eating nitrate-rich foods affects the formation of N-nitrosamines in the body.

    This project aims to measure biomarkers of nitrate metabolism in the body after vegetable and meat intake. To assess this, we will examine biomarkers (nitrate, nitrite and N-nitrosamines) in urine and faecal (stool) samples. The study hypothesis is that eating nitrate-rich vegetables with meats that do not contain added nitrate or nitrite will not increase potentially harmful N-nitrosamines in the body, whereas eating nitrate-rich vegetables with meats that do contain added nitrate or nitrite will increase these compounds, despite the natural protective substances found in vegetables.

  • Young adults’ experiences and recovery in Uspace’s transdiagnostic and OCD-specific inpatient programs: a mixed-methods study of outcomes for young people with complex mental health conditions.

    This study looks at how well the Uspace inpatient programs help young people aged 16–30 with complex mental health conditions in real-world hospital care. All participants receive usual multidisciplinary treatment, and some may also use newer tools such as virtual reality therapies, MRI-guided brain stimulation (TMS), and a digital mental health literacy platform, when clinically appropriate and with consent. The main hypothesis is that an admission of up to three weeks at Uspace will be associated with improvements in anxiety, depression and OCD symptoms, better day-to-day functioning and quality of life, and reduced overall distress. The study also hypothesises that programs co-designed with young people and families will be experienced as acceptable and helpful, and that higher engagement with groups and the new technologies will be linked to greater symptom improvement. Outcomes are assessed using standard questionnaires and service-use data, without any random assignment to treatments.

  • Comparison between the Camry and the Jamar Dynamometers in measuring hand grip strength in people with Inclusion Body Myositis

    A clinical performance comparison study which will assess the reliability and validity of different methods of handheld dynamometry for hand strength in IBM patients. The Camry dynamometer will be compared with the current gold standard dynamometer for measuring grip strength, the Jamar dynamometer. All participants will have grip strength measured using both dynamometry methods and compared. Order of testing will vary.

  • Assessment of Pain Biomarkers in Orthopedic Patients Undergoing Total Knee Arthroplasty

    Our study aims to address the gap in objectively measuring somatic pain, as opposed to subjectively measuring pain through widely used pain questionnaires, by examining the peripheral immune response in orthopedic total knee arthroplasty patients. We will use stimulated LPS (TLR-4) and PAM3 (TLR-2) responses to quantify IL-1ß from peripheral blood mononuclear cells (PBMCs) and synovial fluid mononuclear cells (SFMCs). Additionally, we will employ advanced spectral imaging to phenotype unstimulated cells. Our hypothesis is that patients with symptomatic OA exhibit elevated peripheral cytokine levels compared to asymptomatic controls. This approach aims to elucidate the role of peripheral inflammatory markers in OA pain and move towards objective, biomarker-based pain assessment. Our project builds on Prof. Mark Hutchinson's work on immune biomarkers. We aim to address the gap in objectively measuring somatic pain, by examining the peripheral immune response in orthopedic patients receiving total knee arthroplasty for symptomatic osteoarthritis (OA). We will use stimulated LPS (TLR-4) and PAM3 (TLR-2) responses to quantify IL-1ß from peripheral blood mononuclear cells (PBMCs) and synovial fluid mononuclear cells (SFMCs). Additionally, we will employ advanced spectral imaging to phenotype unstimulated cells. Our hypothesis is that patients with symptomatic OA exhibit elevated peripheral cytokine levels compared to asymptomatic controls. This approach aims to elucidate the role of peripheral inflammatory markers in OA pain and move towards objective, biomarker-based pain assessment.

  • Evaluating the Now & Next Program: A peer support program for caregivers of children with a disability and/or chronic illness

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