ANZCTR search results

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

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31386 results sorted by trial registration date.
  • A pilot study to investigate warm and humidified carbon dioxide delivery to the surgical site in patients undergoing craniotomy.

    Open craniotomies, including procedures for tumour resection, aneurysm clippings or Arteriovenous Malformations (AVM), require an open wound including the removal of a section of skull to access to the brain. Standard practice is to leave the open wound exposed to the operating theatre environment for the duration of the surgery, which may be anywhere from two to eight hours. The air in the theatre is cold and dry (18-21 degrees celsius and 20-50 percent relative humidity) compared to the normal physiological conditions within the brain (37degrees celsius, 100 percent relative humidity). The wound is also subjected to the light from the surgical microscope which is used continuously for several hours for the microsurgical portion of the procedure. This light is very powerful and has the potential to produce high temperatures concentrated in and around the surgical site. This leads to continuous evaporation from the wound resulting in drying and desiccation of the neural tissue, intracranial blood vessels and dura mater. Current practice to manage tissue desiccation is to repeatedly irrigate the wound throughout the procedure. Each time irrigation is applied the surgeons view of the surgical site is obscured and excess irrigation must be removed via suction. The frequent irrigation - visual obstruction - suction cycle disrupts the surgeon’s workflow and cyclically interrupts the procedure. Warmed and humidified carbon dioxide insufflation is a therapy designed to deliver warm (37 degrees celsius) saturated (greater than 95 percent relative humidity) carbon dioxide to the surgical wound during the procedure, to prevent evaporation and desiccation. The intent of this study is to evaluate the safety of this insufflation to the surgical site during the craniotomy procedure.

  • Online personalised salt education: examining the effect on salt intake in adults with high blood pressure

    This project aims to investigate the effectiveness of an online, personalised intervention on salt reduction (called SaltED) in adults with high blood pressure. It hypothesises that SaltED is effective in reducing salt intake. Participants will be automatically randomised into two groups (active intervention or wait-listed control) by a computer algorithm to conceal allocation the first time they access the SaltED website. The intervention includes 6 modules of personalised salt intake advice delivered over 6 weeks. Module content will be personalised based on the participant's current salt intake (measured using a short questionnaire at week 1) and knowledge and use of food labels. Participants in the active intervention group will receive the intervention content from week 1. Participants in the control group will not receive the personalised intervention materials, until after their post-intervention measures, when they will be invited to access the intervention materials. Participants' sodium score and dietary sodium intake will be measured as primary outcomes at week 1 (baseline) and week 6 (post-intervention). Participants will also be invited (optional) to complete the 24-hour ambulatory blood pressure and urinary sodium measurements at baseline and post-intervention as secondary outcomes. Participants' acceptability and use of the platform will also be investigated using a survey post-intervention.

  • A Comparison of Goal-Oriented Guided Mental Imagery versus Goal Setting Interventions on Physical Activity Levels in Young, Inactive Adults with Overweight or Obesity Living in Australia

    The prevalence of overweight and obesity in young men is increasing as physical activity levels decline, suggesting strategies to promote and enhance physical activity levels should be improved. Goal-oriented guided mental imagery is a technique that we believe may enhance physical activity levels among overweight and obese young male adults. It has been shown to be an effective strategy to enhance physical activity among women with overweight and obesity, compared to observing set written goals. Therefore, the purpose of this study is to compare the efficacy of goal-oriented guided mental imagery and traditional goal-setting techniques for increasing physical activity levels among inactive overweight and obese young male adults. This study will compare the effects of these interventions on exercise compliance (prescribed cardiorespiratory exercise and strength training sessions), weekly physical activity levels, intrinsic motivation, enjoyment of exercise, and muscular endurance during a 6-week telehealth exercise program. Focus group data will be collected at the end of the program to obtain qualitative feedback on the feasibility and sustainability of the interventions and exercise program for future use. The research question for this study was derived using the acronym PICO (Population, Intervention, Comparison, Outcome). The research question is: Does goal-oriented guided mental imagery provided to young inactive overweight or obese male adults result in increased physical activity levels compared to setting goals alone? We hypothesize that compared to the goal-setting group, participants in the goal-oriented guided mental imagery group will: 1. Achieve greater adherence to cardiorespiratory activity based on logbook entries (e.g., at least 150 minutes of moderate-intensity physical activity each week over 6 weeks); 2. Achieve greater adherence to resistance training sessions based on logbook entries (e.g., complete at least two resistance exercise sessions per week over 6 weeks); 3. Have a greater magnitude of improvement in their muscular endurance results (i.e., muscular endurance pre- and post-assessment); 4. Have a greater magnitude of increase in physical activity levels (metabolic equivalents [MET] minutes) across the 6-week training intervention based on logbook entries. 5. Attain greater intrinsic motivation based on the ‘Exercise Motivation Scale’ and experience a greater level of physical activity enjoyment based on the ‘Physical Activity Enjoyment Scale'.

  • Investigating the effect of a co-designed consumer engagement intervention on medication safety in cancer services for ethnic minority consumer

    The purpose of this study is to test out an engagement strategy called Making it Meaningful (MiM). The MiM has been designed for people from culturally and linguistically diverse (CALD) backgrounds who use cancer services and may be undergoing a change in their medications. Who is it for? You may be eligible for this study if you are a cancer patient aged 18 or older, who is attending a cancer service at the Prince of Wales hospital and your primary language is Russian or Mandarin. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to either receive the MiM intervention tool, or to receive standard care provided by the cancer service. Participants who are allocated to the MiM group will attend an appointment with their health practitioner (nurse or medical practitioner) who will use the Make it Meaningful Tool (MiM) to facilitate communication at the individual appointment where medications are changed or at discharge from hospital. It is anticipated that this appointment will take no longer than your usual consultation. The health care practitioner will provide a paper copy of the MiM for the patient to take away from the appointment. The health care practitioner will also provide instructions to the patient about how the tool can be used to inform them of who to contact if they have any concerns or experience side effects, etc.. Participants who are allocated to the standard care group will not receive the MiM tool, they will instead discuss the new medications together with their health care practitioner using the existing medication management tool. All participants will be asked to complete a series of questionnaires over the phone when they first agree to participate in the study, 1 week and then 4 weeks after the medication discussion with their health care practitioner. It is expected that completion of these questionnaires will take 15 minutes. It is hoped this research will determine that use of the MiM tool is practical and acceptable to cancer patients who are from culturally and linguistically diverse backgrounds. If this small study shows that the MiM tool is helpful for cancer patients, it may be studied further in a larger trial that may lead to improvements in medication communication for cancer patients in the future

  • Sources of Exposure to Plastic-Associated Chemicals (PAC) in People living in the Perth Region.

    The fundamental premise underpinning the research is that exposure to PAC, combined with genetic and lifestyle factors, creates chronic and systemic inflammation that underpins cardiometabolic conditions. This antecedent cluster of risk factors contributes to a ‘pre-cardiometabolic syndrome’. In this trial, the first of a series of studies, we will measure the plastic-associated chemicals (PAC), phthalates and bisphenols (A, S, F), which leach from multiple plastic products in everyday use and enter the human body, as evidenced by urinary excretion of those chemicals. The challenge is to demonstrate that decreasing exposure to PAC will reduce inflammation, and there are methodological issues to overcome which we will address in this study. Including how to accurately identify sources of exposure and measure exposure levels, and how to identify the mechanisms by which PAC alter biomarkers at a cellular level triggering endocrine disruption. In addition, biostatistical methods will be applied to account for multiple and overlapping interactions, and exposures to chemical compounds. This protocol will establish methods to assess exposure using new tools, and measurement of PAC by urinalysis. The data gathered from the 200 participants in this 14-day study will provide baseline data for a pilot intervention testing the hypothesis that decreasing PAC exposure results in reduced excretion of PAC, and reference data for future research.

  • Evaluation of the effects of topical application of oral care agents on white spots in enamel in healthy adults

    To evaluate the effects of oral care agents on white spots, healthy human participants will wear appliances with tooth enamel slabs containing artificially-created early decay (white spots) attached. During one of the two treatment periods, a gel containing oral care agent will be applied to the surface of enamel slabs on the appliance. For each of the two treatment periods, participants will also be required to apply an oral care tooth crème on the enamel slabs on their appliances three times per day for 14 days. After completion of each treatment, the enamel slab surface colour change and mineral content in the white spots will be analysed. The study hypothesis will be that topical application of oral care agents on white spots will have no effects on colour changes and mineral content change in enamel in situ.

  • Effects of balance-enhancing footwear on postural sway when standing and walking in older women

    Footwear has the potential to influence balance in either a detrimental or beneficial manner, and is therefore an important consideration in relation to falls prevention. The objective of this study is to evaluate balance ability and gait patterns in older women while wearing prototype footwear and insoles designed to improve balance.

  • The ENJOY Seniors Exercise Park IMP-ACT project: IMProving older people’s health through physical ACTivity

    The ENJOY IMP-ACT project is an implementation research project designed to increase participation in physical activity to improve health outcomes for older people in Victoria. The project is built on an evidence-based physical and social activity program utilising specialised outdoor exercise equipment (the Seniors Exercise Park) for older people. By using an effectiveness–implementation hybrid II pre-post study design, we aim to evaluate (1) the effectiveness of the implementation framework on increasing uptake and usage of the Seniors Exercise Park across several local government areas (2) the impact of the ENJOY Seniors Exercise Park on older people’s physical activity and wellbeing and (3) the social return-on-investment (economic evaluation). Five local governments (6 public sites/parks) will undergo a 9-month implementation intervention incorporating key elements of Training, Engagement, Resources development, and Marketing and promotion. The program aims to enhance the physical and mental wellbeing and social connectedness of older people and build capacity and community engagement.

  • Assessing the effectiveness of using Poly Ether Ketone (PEK) framework to reinforce digital dental prostheses to prevent prostheses fracture for edentulous adult requiring dental rehabilitation

    The use of computer aided design and computer aided manufacturing dental prosthodontics have reduced the need for skilled manual work and removed the need for multiple fittings of the prostheses. The use of a framework made of milled material called polyetheretherketone (PEEK) is a common method of reinforcement to increase the strength of the dental bridge/prosthesis and reduce fracture incidence. Polyaryletherketone (PAEK) materials are semi-crystalline aromatic polyetherketones with excellent mechanical properties. Polyetherketone (PEK) and PEEK belong to the group of PAEK, and was developed for the use in 3D printing. Considerable scientific evidence currently exists to support the biocompatibility of PEEK and PEEK has been applied extensively in dental prostheses and a variety of surgical fields. In this study, we investigate the efficacy of using a novel 3D printed PEK substructure to reinforce the standard 3D printed resin bridge/dental prosthesis to minimise the risk of prosthetic fracture.

  • Exercise during breast cancer chemotherapy: A telehealth pilot feasibility study

    This study aims to assess the feasibility of an online group exercise and education program for women with breast cancer who are receiving chemotherapy treatment. Who is it for? You may be eligible for this study if you are a female aged 18 or older, you have been diagnosed with early stage breast cancer (stage I, II or IIIA), you are scheduled to undergo chemotherapy but you have not yet started, or you have started chemotherapy within the last 4 weeks, and you have a reliable internet connection together with devices to enable video-conferencing. Study details All participants who choose to enrol in this study will undergo a 12 week exercise and education program that is delivered entirely by telehealth. Participants will attend two weekly exercise classes which run for 45 minutes and one educational class each fortnight, which runs for 1 hour including a 15 minute Q&A component. Exercise classes will include a combination of aerobic and resistance training exercises, while the educational sessions will cover topics including how to exercise safely while you are receiving chemotherapy, how to look after your mental health and strategies that may assist you, guidance on maintaining a healthy diet while you are receiving chemotherapy and after treatment has finished. Once this 12 week exercise program is completed, you will receive 12 weeks of tapered phone calls from the research assistant involved in this study to encourage you to maintain exercise levels. It is hoped this research will demonstrate that it is possible and acceptable to deliver these therapies to breast cancer patients remotely via telehealth. If this study shows that delivery of this program by telehealth is successful, it may lead to a larger future study of telehealth delivery of these therapies to a greater number of breast cancer patients, and would particularly benefit those patients who are not able to travel to hospital on a weekly basis.

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