ANZCTR search results

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

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30819 results sorted by trial registration date.
  • Neoadjuvant chemotherapy in resectable pancreatic cancer

    This project is investigating the use of chemotherapy drugs called mFOLFIRINOX in individuals with pancreatic cancer before surgery, rather than the usual process of using these drugs after surgery. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years, you have been diagnosed with pancreatic cancer that is suitable to be treated by surgery and you meet other health requirements. Study details Participants who choose to enrol in this study will be randomly allocated by chance (similar to flipping a coin) to one of two treatment arms. Participants who are allocated to treatment arm A will undergo surgery first, followed by 12 cycles of mFOLFIRINOX chemotherapy. Participants who are allocated to treatment arm B will undergo 6 cycles of mFOLFIRINOX chemotherapy, followed by surgery and will then complete the last 6 cycles of mFOLFIRINOX. It is hoped this research will determine whether administering these chemotherapy drugs before surgery has a positive impact including possibly shrinking tumours prior to surgery. If this study finds that pre-surgical chemotherapy is beneficial, this information could be used to improve outcomes for future pancreatic cancer patients.

  • A pilot study for smart dental hygiene (the Smart toothbrush) in aged care facilities

    The oral health of residents in aged care facilities (ACF) is poor, contributing to infections, hospital admissions, and decreased quality of life. Furthermore, evidence associates poor oral health with a range of medical conditions, including aspiration pneumonia, bacteraemia, and stroke. A leading cause of mortality in ACFs is pneumonia where one in ten cases could be prevented by improving oral hygiene (Sjögren et al., 2008). Oral hygiene among ACF residents has been identified in Australia’s National Oral Health Plan 2015-2024 as being in a state of crisis (COAG, 2015). Less than 20% of aged care residents maintain oral hygiene without assistance and ACF staff are often under time pressure to do so thoroughly (Tynan et al, 2018). Smartbrushes that record and transmit information about brushing patterns are not routinely deployed in ACFs. Yet, their use in ACFs promise better oral healthcare. This study aims to investigate the appropriateness, suitability, and acceptability of smartbrushes for ACF residents and to design a program that analyses brushing practices of residents. Research question: Are electronic toothbrushes (eBrush) and new IT applications (SmartBrush) acceptable tools for use by the elderly and their carers to support teeth cleaning? • Objective 1: Assess the acceptability and usability of an eBrush and SmartBrush for oral hygiene amongst the older adults. • Objective 2: Assess the acceptability and useability of an eBrush and SmartBrush by carers when providing assistance for oral hygiene to older adults. References Sjögren P, Nilsson E, Forsell M, Johansson O, Hoogstraate J. A Systematic Review of the Preventive Effect of Oral Hygiene on Pneumonia and Respiratory Tract Infection in Elderly People in Hospitals and Nursing Homes: Effect Estimates and Methodological Quality of Randomized Controlled Trials. JAGS 2008; 56: 2124–2130. Council of Australian Governments. Oral Health Monitoring Group. Healthy Mouths, Healthy Lives: Australia’s National Oral Health Plan 2015–2024. Canberra:COAG, 2015. URL: http://www.coaghealthcouncil.gov.au/Publications/Reports/ArtMID/514/ArticleID/81/Australias-National-Oral-Health-Plan-2015-2024. Accessed Nov 2022. Tynan A, Deeth L, McKenzie D. An integrated oral health program for rural residential aged care facilities: a mixed methods comparative study. BMC Health Serv Res. 2018;18:515.

  • Comparing Surgical Approaches for Displaced Hand Fractures: A Clinical Study of Intramedullary Screws versus Dorsal Plates

    Extra-articular metacarpal fractures are a common injury that often require surgical intervention. There are two commonly used surgical methods for fixing these fractures: intramedullary screw fixation and dorsal plating. The optimal surgical method is currently unclear, with limited evidence available to guide clinical decision-making. This study aims to compare these two surgical methods to determine which produces better patient outcomes. This is a multicenter randomized controlled trial conducted in two hospitals in New South Wales and one hospital in Queensland, Australia. Patients with extra-articular metacarpal fractures will be recruited and randomly assigned to receive either intramedullary screw fixation or dorsal plating. The primary outcome measure is total active motion (TAM) of the involved digit at six weeks post-surgery. Secondary outcome measures include TAM of the involved digits at three, six, and 12 months, grip strength, hand function (as measured by the DASH and MHQ scores), pain, complication rates, and operative time. The study is designed to provide high-quality evidence to guide clinical decision-making regarding the optimal surgical method for fixing extra-articular metacarpal fractures. By comparing the two most commonly used surgical methods in a randomized controlled trial, this study will provide valuable information to help clinicians make informed decisions about the best way to treat these common injuries. The inclusion of three hospitals in two different states of Australia will help to ensure the generalizability of the results and increase the external validity of the study. Overall, this study has the potential to significantly improve patient outcomes and optimize the delivery of surgical care for patients with extra-articular metacarpal fractures.

  • Early Discharge to Clinic-Based Therapy of Patients Presenting with Heart Failure (EDICT-HF Trial)

    Acute heart failure is an important condition involving a high rate of death and complications. Currently, patients with this condition are admitted to hospital and follow a common management strategy. This study aims to determine whether it is safe and effective to discharge patients presenting to the hospital with acute heart failure to an out-of-hospital clinic-based management strategy instead of having to be admitted to hospital. Evidence suggests that with each admission, patients often lose part of their function and are at a high risk for the negative effects associated with being in hospital. This study therefore may support the use of similar discharge management strategies for future patients and improve their quality of life, risk of hospital-acquired complications, hospital costs and help to preserve their physical function. Study participants will either discharge to this out-of-hospital pathway or be admitted under usual care, and results between the two groups will be compared. Participants will be medically managed under these two pathways until they are fit enough to be discharged home as if they were admitted to hospital. Both groups will have daily reviews by clinical staff to ensure their safety.

  • Effect of posture change and/or hand gripping on venous cannulation induced vasovagal response

    This study is a randomized controlled trial, testing preventative/treatment strategies for managing vasovagal responses induced by intravenous cannulation in patients requiring cardiac CT with contrast. The strategies involve the employment of counter pressure maneuvers (hand gripping and/or adopting a lying down position) during intravenous cannulation. The researcher hypothesizes that the employment of counter pressure maneuvers (hand gripping and/or adopting a lying down position) will decrease the incidence of vasovagal response induced by intravenous cannulation.

  • Does small-group sleep therapy improve sleep, pain and quality of life for people with chronic pain?

    The aim of this study is to determine the feasibility and effectiveness of a small-group 'Cognitive Behaviour Therapy for Insomnia' intervention for people with chronic pain who also have trouble sleeping. Participants from the Flinders Medical Centre Pain Management Unit will attend the small-group sessions with around 8 other people, once a week for six weeks, with four separate groups running. In this program, they will learn different ways to improve their sleep using sleep hygiene, stimulus control, sleep restriction, relaxation, and cognitive therapy. To determine how well the program works, researchers will measure participants' sleep, pain and quality of life prior to and immediately after the therapy, as well as 3 months later. If the program helps our participants, it could lead to more research to help others with similar problems.

  • Employee Burnout: Resilience and Recovery as Employee Retention Strategy in Residential Aged Care

    This project delivers a training initiative to managers and staff in the residential aged care workforce to support staff in learning to recover from work-related burnout. Pre-, post-, and follow up surveys will be used to assess the effectiveness of the workshops and five weeks of self-reflection exercises after the workshops. We aim to establish the efficacy of the workshops and the workbook activities to improve aged care employees' resilience to work-related burnout.

  • The impact of online media on the awareness and uptake of pre-exposure prophylaxis among Asian-born men who have sex with men in Australia

    Aim and participants: To evaluate the acceptability and the impact of an audio drama on the awareness and uptake of PrEP, compared to written information on a website, among Asian-born MSM in NSW, VIC and QLD. Methods: This trial will be conducted online. After participants consent to participate in the trial, and Qualtrics confirms that they are eligible, they will enter the trial. In the first part of the trial, participants will answer questions regarding their demographic characteristics, contact information, questionnaires related to HIV- and PrEP knowledge, attitudes toward PrEP and intention-to-use PrEP. Subsequently, they will be randomized to receive either the audio drama or written information page (Pan.org.au). The survey platform (Qualtrics) will assign participants to either arm randomly. After completing the intervention, they will complete post-intervention questionnaire. At one- and two months after the intervention, they will answer questions regarding the uptake of PrEP. Expected outcomes: The audio drama significantly increases the knowledge, intention-to-use, attitudes towards and uptake of PrEP and is more acceptable and engaging than PAN.org.au.

  • An examination into the effects of a saffron extract (affron) on mood and general wellbeing in adults experiencing low mood: a randomised, double-blind, placebo-controlled trial

    In this randomised, double-blind, placebo-controlled study, 200 adults aged 18 to 70 years with self-reported low mood will be randomly assigned to receive 14mg twice daily of a saffron extract (affron) or a placebo for 12 weeks. Changes in mood, sleep, and quality of life through the administration of validated self-report questionnaires will be assessed over time.

  • The effect of virtual reality on quality of life in palliative care.

    Palliative care patients’ capacity to participate in meaningful activities may be limited and this can negatively impact their quality of life. A personalised Virtual Reality (VR) intervention was trialled in an inpatient palliative care setting to establish the effects of multiple VR sessions on quality of life and symptom burden in patients. The intervention encouraged participants to visit their choice of memorable and desired places. Participants completed three 20-minute VR sessions and the effects of the intervention on symptom burden and quality of life were measured.

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