ANZCTR search results

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

You can narrow down the results using the filters

31097 results sorted by trial registration date.
  • Effect of the Autonomous Sensory Meridian Response on pre-operative anxiety and vital signs : A prospective randomised placebo controlled research study

    The primary objective of this study is to investigate whether an ASMR intervention produces a measurable difference on pre-operative anxiety and primary vital signs using a randomised placebo controlled research study. Validated tools, the Amsterdam Preoperative Anxiety and Information Scale (APAIS), State-Trait Anxiety Inventory (STAI) questionnaire and Visual Analogue Scale (VAS) will be used to assess the pre-operative anxiety. Measuring the blood pressure and respiratory rate will assess the pre-operative primary vital signs. We hypothesise that for responders to ASMR, the intervention will improve anxiety scores and improve vital signs.

  • To assess the effects of two cosmetic skin creams containing stem cell-derived growth factors developed by CK Cell Technologies Pty Ltd.

    This is a pilot study to test the skin care effects of growth factors derived from stem cells isolated from either fast tissue – CKC-E1 or from dental pulp tissue – CKC-E2. Both of these are incorporated into two CKC creams for topical human application. Benefits include reduction/removal of fine lines and wrinkles – crows’ feet and improvement in overall skin elasticity and skin hydration. CKC topical creams in the dosages under study are likely to be well tolerated; therefore, the risk/benefit appears satisfactory based on anecdotal evidence.

  • Tracking surgical site infection post caesarean section through HealthTracker

    Caesarean section (CS) is one of the most common surgeries in Australia. Women who undergo a CS are at risk of surgical site infections (SSI), and post-CS SSI is associated with substantial maternal morbidity and healthcare costs, and can lead to significant physical and emotional burden for mothers. Despite this burden, no standardised CS SSI surveillance mechanism or mandatory reporting system exists, and CS SSI may therefore be undetected. This project will address the gap in surveillance through trialling an electronic wound healing questionnaire via an app called, HealthTracker. Acceptability of the survey will be evaluated through the response rate of the women, and a feedback questionnaire. Data from HealthTracker will enable post-CS SSI rates to be monitored post discharge from hospital in order to identify true infection rates and to inform decision making related to preventative strategies.

  • Increasing Attainment of Patient-Identified Goals through Comprehensive Geriatric Assessment: A Controlled Trial for Frail Older People with Lung Cancer

    This study will determine whether conducting a comprehensive health assessment in older people with non-small cell lung cancer can assist in setting health-related goals and personalised treatment plans to achieve these goals. Who is it for? You may be eligible for this study if you are aged 65 years and older, you have been diagnosed with metastatic (spread to other body systems) non-small cell lung cancer, and you meet certain objective 'frailty' criteria. Study details Participants who are enrolled in the first 6 months of this study will receive standard care from their Oncologist. Participants who are enrolled in the second 6 months of this study will undergo a Comprehensive Geriatric Assessment, which involves seeing a Geriatrician for a 1-hour face-to-face assessment. The Geriatrician will ask participants a number of questions relating to their physical, mental and social health, identify any issues, and subsequently write a report with their recommendations and refer the patient to specialists who can help them further. All participants will be asked to complete a goal setting exercise after they have agreed to participate in the study, and will be asked to complete two questionnaires about their health as well. Participants in both phases of the study will be asked to attend two follow-up visits at 3 and 6 months after study enrolment. It is hoped this research may be used to improve health outcomes for older patients with non-small cell lung cancer by identifying health outcomes that are important to them and designing their treatment in a personalised manner to achieve these outcomes.

  • TiNT: Trametinib in Neurofibromatosis type 1 associated tumours

    The purpose of this study is to determine if a targeted therapy (a drug called trametinib) has an effect on tumour response in children, teenagers and young adults with neurofibromatosis type 1 (NF1) associated Plexiform Neurofibromas and Optic Pathway Gliomas. Who is it for? You may be eligible for the treatment arm of this study if you are between 3 months and 25 years old and have NF1 associated plexiform neurofibromas or progressive optic pathway gliomas. You may be eligible for the control arm of the substudy if you are between 3 months and 25 years old with NF1. Study details All participants in the main part of this study will receive the targeted therapy (trametinib) and are expected to take this drug daily for two years. The medication will be provided as either an oral tablet or an oral solution. Participants taking trametinib will be expected to complete some assessments at enrolment and attend monthly hospital visits for general health reviews. Additionally, every three months for two years, assessments will include MRI scans, and cardiac and vision testing. These assessments will measure whether trametinib is effectively treating the tumour and will also monitor any side effects. There is also a sub-study occurring within this study to find out if trametinib can improve learning, behaviour and well-being for those with NF1. For this part of the study, an untreated control group will be enrolled to compare to the trametinib-treated group described above. The untreated control group will be children, teenagers and young adults with NF1 who do not have a tumour that requires trametinib treatment. All participants in the trametinib-treated and the control groups will attend four Neuropsychology Clinic Visits over a two-year period. During these visits they will complete a number of questionnaires and tests to measure their cognitive function (thinking skills), behaviour and quality of life. It is hoped this research will help determine if trametinib has an effect on tumours and if there are any additional impacts to cognitive function, behaviour and quality of life.

  • Proof of concept: can pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (PIPAC-O) be added to standard treatment for resectable high-risk gastric cancer patients?

    The purpose of this study is to determine the possibility of adding a one-time PIPAC procedure (spraying chemotherapy drug into the abdomen) to the standard treatment of gastric cancer Who is it for? You may be eligible for this study if you are aged 18 years or older, with diagnosis of gastric adenocarcinoma and undergoing or being recommended for the standard treatment. Study details Participants in this study will undergo a procedure with a camera is inserted into the abdomen to check for metastatic disease. During this procedure, chemotherapy drug will be sprayed into the abdominal cavity. The patient will spend one night in hospital for observation and be discharged home in the morning. Participants will be expected to complete some assessments. Assessments will include clinic visits and quality of life questionnaires. It is hoped that this research will help to determine whether patients will be able to tolerate the additional the standard of care regime without increased toxicity or a need to spend more than one extra day of time in hospital.

  • Sirolimus in Inclusion Body Myositis (IBM)

    Currently an estimated 1,250 Australians are living with Inclusion Body Myositis (IBM), a rare, chronic and incurable neuromuscular disease. IBM causes progressive muscle weakness and disability, compelling major life changes for patients and their families. There are no current disease-modifying treatments available for IBM. We are planning a clinical trial of a re-purposed drug (Sirolimus), to stabilise or slow progression of IBM, allowing patients to retain mobility, independence and quality of life for longer, as well as reducing healthcare costs. Sirolimus (Rapamycin) has been identified in pre-clinical studies as a strong treatment candidate based on its known mechanisms of action and our understanding of the pathogenesis of IBM. A small monocentric pilot study in France of Sirolimus in IBM demonstrated disease stabilisation in a cohort of 44 patients. This is an international, investigator-led Phase III trial of Sirolimus in 140 IBM patients. The trial will be led from Australia, and conducted as a double-blind, randomised, controlled Phase III trial (dbRCT). The study team includes leading IBM specialists across the globe, facilitating rapid translation into clinical care worldwide.

  • Wellbeing Track & Change: Usability and evaluation of Workplace Wellbeing Assist, a digital tool for the mental wellbeing of residential aged care workers

    The aim of this project is to develop and evaluate whether a digital monitoring and support tool, called Workplace Wellbeing Assist (WWA), is effective in promoting a workplace culture that enhances the mental wellbeing of RAC staff working at a facility located in the Barwon South West region of Victoria, Australia. Direct care staff, managers and the general public will first be invited to participate in a 2-week unmoderated usability trial of WWA to test the digital tool and determine whether there are any problems. Direct care workers and managers will then be invited to participate in a 24-week in-situ evaluation of WWA. Specifically, this project seeks to: (1) Determine whether WWA increases perceptions of psychosocial safety in the RAC workplace from pre- (week 0), to mid- (week 12), to post-evaluation (week 24). (2) Determine whether WWA can successfully promote RAC direct care workers’ mental wellbeing and quality of life, and reduce psychological distress and workplace risk factors from pre- (week 0), to mid- (week 12), to post-evaluation (week 24). (3) Use quantitative and qualitative evaluation data to further explore the acceptability, usability, and usefulness of WWA, and to allow for future optimisation of WWA in the RAC sector. The results of this research will be used to determine whether a digital intervention can effectively promote a mentally healthy workplace that enhances staff mental wellbeing within RAC facilities and how it could potentially be optimised for other workplaces.

  • Kick the Smokes: Augmented Reality resources to provide smoking cessation information for Aboriginal South Australian tobacco users, and to provide culturally-tailored smoking cessation advice to health professionals.

    The 'Kick the smokes' research project is seeking to increase quit smoking rates. To achieve this, our project will develop a workbook and resources for South Australian Aboriginal and health professional participants, respectively. These educational resources are enhanced through the use of Augmented reality (AR) that is made accessible through the use of our bespoke smartphone App. Participant groups will be given the opportunity to access, use and review their respective resources; their feedback will be used to refine and improve these resources. This project will result in the completion of an AR enhanced workbook as designed by users that can safely support their quit smoking attempts; and, a series of AR enhanced resources for professionals that provides them with a concise and accurate quit smoking educational program.

  • A feasibility trial of EMU (Education, Movement and Understanding): A primary school-based Indigenous games program targeting health, well-being and academic achievement in children.

    The EMU (meaning “be happy”) program is designed to enhance the health and well-being of children, and their numeracy and literacy levels, through participation in an enjoyable and engaging PA program in the community/at school. The EMU program will specifically target the development of a positive learning environment through positive teaching practices i.e., through Aboriginal/Indigenous games. The overall aim of this study is to evaluate the impact of the EMU program on PA levels, well-being outcomes, and literacy and numeracy attainment in a sample of primary school-aged children. We hypothesise that students may receive various benefits to a variety of health outcomes i.e., resulting from participation in EMU.

Tags:
  • Finding clinical trials