ANZCTR search results

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

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31373 results sorted by trial registration date.
  • Investigating whether drinking purple and red fruit juices can improve memory, reduce inflammation, and support metabolic health in people with obesity

    This pilot study will investigate whether consuming purple and red-rich fruits can improve inflammation, oxidative stress, adiponectin levels, and memory in adults living with obesity. Over six weeks, participants will be randomly assigned to consume red dragon fruit juice (rich in betalains), Queen Garnet plum extract (rich in anthocyanins), or a placebo drink. Blood samples will be analysed for markers of inflammation (e.g. TNF-a, IL-6), oxidative stress, and adiponectin. Cognitive function, mood, and clinical health indicators will also be assessed. The results may help clarify the potential benefits of natural fruit compounds for metabolic and brain health.

  • My Personal Rehab: A digital home-based program to improve physical function in older people undergoing rehabilitation

    This study aims to evaluate the effectiveness, cost-effectiveness and implementation of a digital rehabilitation intervention to improve physical function in adults aged >50 years requiring hospital or community rehabilitation for lower body function. Participants will enrol in a 6-month randomised controlled trial of either usual care control, or usual care plus digital rehabilitation program - consisting of the StandingTall application and a personalised walking program (via a smartphone app and smartwatch). Both groups will receive health education. The intervention group will also receive behavioural change strategies to promote rehabilitation adherence. We hypothesise that our intervention will lead to improved physical function at 6-months. We will also evaluate key implementation outcomes for healthcare professionals. Intervention and implementation components were co-designed with older adults and healthcare professionals to optimise usability and ensure integration into existing rehabilitation workflows

  • Developing Protocol for Strengthening the Inspiratory Muscles of Cancer Patients After a Procedure to Prevent Fluid Re-Accumulating in the Chest

    This project aims to determine whether a 6 week respiratory muscle training (RMT) program is a well-tolerated, feasible and acceptable intervention in patients with malignant pleural effusion (MPE) after undergoing respiratory procedures. Who is it for? You may be eligible for this study if you are an adult with an MPE requiring definitive intervention (talc pleurodesis or indwelling pleural catheter). Study details Participants will be given a Power Breathe Plus RMT device and receive training from physiotherapists so they know how to use this. They then commence a 6-week training program involving 30 rapid inspired deep breaths through the Power Breathe Plus RMT device, repeated twice daily. The pressure that they are breathing against will be gradually increased by the physiotherapist during regular telehealth follow-up, in an individualised manner. It is hoped that findings from this study help develop this RMT program for use in patients with MPE.

  • Hepatitis D: Epidemiology, screening practices and linkage to care using universal HDV screening in South Australia (HIDE-SA study).

    HIDE-SA is a state-wide multi-centre interventional prospective study with a historical control arm. Clinicians will be prompted and reminded during clinics to adopt universal HDV screening of all chronic hepatitis B (CHB) patients. This will be combined with the concurrent introduction of an electronic prompt within the centralised laboratory testing system to remind clinicians to perform reflexive HDV RNA testing on all HDV seropositive patients.. This intervention will run for a 12-month period aiming to increase HDV testing and linkage to care in South Australia. Testing results will be compared to a historical control arm, that will audit HDV testing data during the the preceding 12 month period of standard of care.

  • Outcome after surgery for lung cancer

    Lung cancer is the leading cause of cancer-related mortality globally, and non-small cell lung cancer (NSCLC) accounts for approximately 85% of these cases. There has been recent interest in understanding the textbook outcomes after non small cell lung cancer patients undergo lung resection. The aim of this study is to provide a detailed overview of the number of patients who have a textbook outcome after a lung resection for NSCLC. The ‘textbook outcome' is a patient-centred quality measure, which integrates multiple clinical and perioperative outcomes into a single, readily interpretable indicator capturing the ideal postoperative scenario. Who is it for? You may be eligible for this study if you are an adult with NSCLC who underwent any type of lung resection. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent lung resection surgery at the Austin Hospital between 1 January 2011 and 31st December 2023. It is hoped that this research will help to provide a better understanding of the outcomes associated with any type of lung resection surgery.

  • TAPentadol vs OxycodoNe on the incidence of persistent opioid use after hip or knee arthroplasty (TAP-ON Study)

    Many people are given opioid medications such as oxycodone after hip or knee replacement surgery to help manage pain. While these medications can be effective for short-term relief, they come with serious risks, particularly when use continues beyond the recovery period. Ongoing opioid use after surgery has been linked to falls, fractures, constipation, higher infection rates, and even the need for revision surgery. Yet, inappropriate persistent use of opioids after hip or knee arthroplasty remains common in Australia and around the world. Tapentadol is a newer opioid that may offer similar pain relief to oxycodone but with fewer side effects. Early research suggests that patients taking tapentadol may be less likely to continue using opioids long-term. However, these findings come from observational studies, and more rigorous evidence is needed to confirm whether this alternative truly reduces the risk of persistent opioid use. This pilot study will compare tapentadol and oxycodone in patients recovering from hip or knee replacement surgery. Participants will be randomly assigned to receive either tapentadol or oxycodone as needed for pain, while all other aspects of post-operative care including non-opioid medications and anaesthetic techniques will remain the same between groups. The study will take place across multiple hospitals in Australia and include both metropolitan and regional sites. The main goal of the study is to see whether it is feasible to run a larger trial by looking at how many eligible patients can be recruited, how many stay in the study, and how closely they follow their assigned treatment. The study will also explore whether patients taking tapentadol are less likely to continue using opioids 90 days after surgery, and whether they report less pain, and improved function. Safety outcomes, including opioid-related side effects during the hospital stay and after discharge, will also be closely monitored. By testing whether an alternative opioid can reduce the risk of long-term harms, this study has the potential to improve surgical recovery and reshape how post-operative pain is managed in Australia.

  • The Heart Health Literacy Toolkit: Targeted Cardiovascular Disease (CVD) risk screening with health literacy support by Short Message Service (SMS) in general practice

    This project aims to test the impact of providing online health literacy support within an established Heart Foundation model of targeted CVD risk screening invitations, delivered by SMS in general practice. We will recruit participants in the standard Heart Health Check invitation SMS, via a link to information about the study. Those who consent will be randomised to usual care or access to a health literacy support website (www.checkyourheart.com.au). Those who don't click on the study link in the invitation SMS, or do not consent after the click on the link, can attend a Heart Health Check as usual with no study data collected. Participants who consent will take part in two online surveys delivered by SMS, one at baseline and a second survey after 3 months. We will compare the control and intervention group on health literacy and CVD related knowledge outcomes, as well as determining the acceptability of and engagement with the SMS and website support model. No data will be extracted from from medical records for this study.

  • Implementation and evaluation of a dashboard of predictive analytics and decision support to drive care quality and person-centred outcomes in aged care

    We will implement an intervention to improve the quality of care for residents in aged care facilities. The intervention consists of an electronic dashboard on falls and quality of life. It is intended for use by aged care staff and predicts the risk of falls and poor wellbeing and presents information, action areas and clinical evidence-based recommendations that can be inputted by staff minimize resident risk of poor health outcomes. To evaluate the dashboard we will be conducting a cluster randomised controlled trail where we will randomise 20 facilities into intervention and control groups (i.e. 10 in each group). The intervention will be introduced across all intervention sites at the same time in early 2023. A 1-month intervention wash-in period will be allowed to allow the integration of the dashboard into routine practice. Since the intervention is an add-on to an existing system, 1 month will be sufficient to allow users to familiarise themselves with the dashboard. The impacts of the dashboard will then be compared between the intervention and the control sites after 12 months (excluding the wash-in period data). We will include two additional sites for the pilot testing. The primary outcome we will look at is rate of all falls (i.e., any falls regardless of whether an injury was involved, or hospitalisation was required). We hypothesise that the intervention will reduce the rate of falls in the intervention group in comparison to the facilities in the control group. The secondary outcomes include: injurious falls, falls requiring hospitalisation, client wellbeing, social service use (attendance at leisure and lifestyle activities), hospital service use, use of the Peninsula Health Falls Risk Assessment Tool and change in use of Falls-Risk Increasing Drug use.

  • The impact of time-restricted eating in adults with obstructive sleep apnoea

    This study will utilise a Time Restricted Eating (TRE) dietary regime as adjunctive weight loss therapy alongside CPAP treatment of OSA. TRE is an eating pattern which reduces or eliminates night-time eating and prolongs nightly fasting intervals to >12 hr prompting energy intake to earlier in the biological day without any complex dietary prescription. With high adherence, tolerance, and safety, TRE is a promising and novel dietary strategy to investigate for OSA management. Aim: To investigate the effect of a TRE dietary regime as adjunctive weight loss therapy, on sleep and cardio-metabolic health in OSA patients using CPAP.

  • Impact of premenopausal risk-reducing bilateral salpingo-oophorectomy on non-cancer outcomes in BRCA1/2: 10-year follow up of a multicentre prospective controlled study.

    This is a follow up study evaluating the impact of risk-reducing bilateral salpingo-oophorectomy (RRBSO) on sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function in high-risk, pre-menopausal women who participated in the WHAM study 10 years ago. Who is it for? You may be eligible if you participated in the WHAM study 10 years ago. Study details Participants will be assessed for non-cancer outcomes including sexual function, menopause symptoms and quality of life issues, bone health, cardiovascular health, sleep quality, depression/anxiety symptoms and cognitive function will be assessed at the 10 year follow up using the following: Blood tests, Bone mineral density scanning, Completion of questionnaires, cognitive function (online and face-to-face) testing Total time commitment no greater than 6hours. It is hoped that the result from this study will contribute to understanding the long-term effects of RRBSO to better inform future management.

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