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.
  • The role of a low emulsifier diet in treating Crohn’s disease - Study 2

    It is hypothesised that removal of dietary emulsifiers, which can help mix oil and water together, will treat gut inflammation seen in Crohn's disease. This proposal aims to address the main research question: Are dietary emulsifiers associated with breakdown of the intestinal barrier and inflammation? We have designed a low and high emulsifier diet and we plan to conduct a human dietary trial to examine the effects of a low emulsifier diet in patients with Crohn's disease. Crohn's disease patients will receive either a low emulsifier or controlled diet for 4 weeks. At the end of diet period, subjects will give blood, urine and faecal samples, which will be analysed for markers of inflammation.

  • Vaginal Laser therapy for Treatment of Vaginal Looseness

    This is a study to determine if vaginal laxity (looseness of the vagina) can be successfully treated using vaginal laser therapy. Currently there is no known effective treatment for this condition. For participants enrolled in the study, they will be assigned with equal likliehood to an active treatment with vaginal laser or sham (fake treatment) arm. Participants will receive 3 treatments, 4 weeks apart. We want to know how many women still have vaginal laxity 3,6 and 12 months after their final treatment.

  • RECOVERY APP- The use of a smartphone based application to improve and personalize preparation for and rehabilitation of patients undergoing knee replacement surgery; a feasibility and usability study.

    Hypothesis: The use of prehabilitation and rehabilitation coordination and support using the Internet of things (via a smart phone App) will allow personalisation of therapy and improve recovery from knee replacement in these patients. This study will provide important information in these areas 1. Can the delivery of significant components of care be by the Internet of things (IoT). The PRIMO protocol would standardise components of care at RNSH. In NSLHD, up to 60% of patients are “out of area” This study will not include these patients but it is envisaged that the RECOVERY APP will be associated with improved outcomes in this group and they will be studied as part of a separate HREC application at an appropriate time. 2. Does the RECOVERY Platform result in improved adherence to rehabilitation prescriptions and improved outcomes in a range of domains that inform a new standard of care. This study is not sufficiently powered to show statistically significant changes nor does it have a comparative arm.

  • Insights in body esteem: Exploring people's experience of body image

    The Insights in Body Esteem survey is an exploratory project, seeking to investigate the experience of Australians, 18 years and over, in relation to their body esteem, and the impact these feelings have on their day to day lives. The project will contribute to an understanding of body image in Australia, and also guide the development of effective engagement practices in the prevention of eating disorders.

  • Impact of virtual reality training on allied health professional’s knowledge and perception of dementia

    This study will evaluate the effectiveness and acceptability of the Virtual Reality (VR) workshop Enabling EDIE as a teaching resource for Allied Health Professionals (AHPs), Allied Health Assistants (AHAs) and physiotherapy students working with people with dementia. A short series of surveys will be used to assess the knowledge, perception, and impact on clinical practice of AHPs, AHAs and physiotherapy students that provide care for people with dementia. It is hypothesised that specific dementia-related virtual reality training will improve understanding, perception and clinical practice in dementia care. it is also anticipated that less experienced clinicians and students will benefit most from this type of training and are more likely to implement changes in routine practice following the Enabling EDIE workshop.

  • Can Pre-operative High Intensity Interval Exercise Improve Surgical Outcomes After Major Abdominal Surgery?

    This study aims to compare high intensity exercise to standard pre-operative preparation on cardiovascular fitness and incidence of post-operative complications in major upper gastrointestinal cancer patients. Who is it for? You may be eligible to join this study if you are aged 18 years or above and are scheduled to undergo major upper gastrointestinal cancer surgery at John Hunter Hospital. Study details Participants in this study will be randomly allocated (by chance) to one of two groups. Participants in one group will receive standard pre-operative care, which consists of advice to improve fitness but no supervised or structured program. Participants in the other group will undertake prescribed, structured and supervised high intensity interval exercise over three sessions per week whilst on the wait list for major cancer surgery (approximately 30 days). This exercise will be primarily on a stationary bicycle and can bo done at home or in a hospital gym. All participants will undergo cardiovascular exercise testing upon enrolment and the week prior to surgery in order to assess any changes in fitness. A blood test will also be taken at the start and completion of the program, and a CT Scan used at the point of diagnosis and then 3 months following completion of the study. Participants will be followed for 90 days post-operatively in order to review any surgical complications, length of time in hospital, and other clinical outcomes. If the pre-operative fitness intervention is successful in this cancer population, and improved fitness relates to better outcomes, then borderline operative candidates may be able to undergo a similar program with a view to extending the option of curative surgery to a larger patient population.

  • Hookworm Therapy for young people at high risk for colorectal cancer

    This study aims to evaluate low-dose hookworm therapy in adults who are at a high risk of developing colorectal cancer (CRC). The study will assess how useful the hookworms are in improving the richness and diversity of bacterial species within the gut, which may be a preventive measure against the development of CRC. Who is it for? You may be eligible to join this study if you are aged 18- 55 and have a cumulative history of 2 or more conventional colorectal polyps. Study details All participants will have 10 hookworms applied to their skin and then again 4 weeks later, this will provide a mild infection to the gut. The study will involve taking a variety of biological samples before the infection (including, blood, stool and rectal tissue specimens) and again after approximately 6 and 12 months. These specimens will be subjected to laboratory analysis to determine if the hookworm infection changed the types of bacteria within the gut and how this relates to gut inflammation. If any pre-cancerous tissue is identified during the surveillance period, it will be removed and similarly inspected for bacteria and inflammation. All participants will be required to undertake quality of life questionnaires and blood samples will be carefully analysed by commercial pathology providers to monitor safety of the hookworm infections.

  • Controlling device Occlusion by needleless ConnectOr design. A pilot randomised control trial (COCOA Trial)

    Peripheral intravenous catheters (PIVCs) are the most frequently used vascular access device to provide intravenous treatment to hospitalised patients. A needleless connector (NC) allows a PVC to be connected to an administration set or syringe without the use of needles. Many hospitals (including the Royal Brisbane and Women’s Hospital) use a negative pressure NC. This device, on the completion of access or flushing, creates a negative displacement allowing a small amount of blood to move back into the catheter. Manufacturers have recently created complex NCs comprised of mechanical valves with neutral pressure (no fluid displacement). This randomised controlled trial will test the efficacy, cost effectiveness and acceptability to patients of a neutral pressure NC. Sample: 200 adult patients in the cancer care, general medical and surgical wards of the RBWH. Primary outcomes: (1) feasibility (2) device failure.

  • Perioperative use of steroids in knee arthroplasty trial

    This study will consist of a prospective randomised control trial comparing standard perioperative care for primary total knee replacement with and without the addition of a perioperative dose of methylprednisolone. We aim to determine the best peri-operative pain control for patients undergoing this painful procedure whilst limiting the risks. This is hypothesised to allow early gains in range of movement, hospital discharge and reduction in post operative nausea and vomiting, postural hypotension, post operative analgesia requirements and an improvement in knee scores. Patients will be assessed daily during their inpatient stay and then at 2 and 6 weeks for pain control, satisfaction, signs of infection and range of movement. The study will be conducted over a three month time frame. This information will be used to enhance pain control for future patients whilst reducing risks. It is also expected to enhance the patient journey for those undergoing TKA at SJOG Murdoch.

  • Feasibility and acceptability of a personalised healthy diet versus a medical nutrition therapy ketogenic diet in reducing migraine frequency and severity

    Our aim is to determine which of two dietary approaches is more effective in reducing migraine frequency, severity and duration in individuals within the community who identify as migraine sufferers. In a randomised cross-over trial, we will evaluate the feasibility, acceptability and efficacy of a ketogenic diet (high in fat, low in total carbohydrate) compared to an ‘anti-headache diet’ we have developed based on common triggers identified by our review of the research evidence. The value of this study will be the potential to improve quality of life, reduce functional impairment and reduce the need for or dose of medications in individuals who experience frequent or severe migraine. Clinicians will also benefit from an increased knowledge of food triggers and dietary strategies that can aid in the management of migraine.

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