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

31170 results sorted by trial registration date.
  • A weekend intervention for families with screen disordered children

    Approval was granted to run trials of a 3 day weekend intervention for children and parents in families where one child is screen disordered. This application was carefully scrutinised by the HREC, a separate meeting was organised to discuss more sensitive issues, and all ethical aspects were carefully addressed to HREC satisfaction before final approval was given. The trial will be run through Macquarie University, and the first trial will be filmed and paid for by Channel 7 for their Spotlight program. Prospective participants are given two information and consent forms - one from Macquarie and one from Channel 7 - and will speak to Channel 7 at length before making a decision to apply to participate, as we believe it is crucial participants are fully informed about the implications of the trial being televised before agreeing to participate. Final vetting of applications are by Prof Warburton and Mr Marshall, with the key criterion being no reasonably identifiable indication of potential harm to participants and an assessed likelihood that the child will benefit from the program.. Participants are fully informed and not coerced in any way to participate. Prof Warburton and Mr Marshall are not paid to create or run the program and have no conflicts of interest. It is hypothesised that child participants in the intervention will show reduced screen disorder symptoms and greater insight into their screen use immediately after the intervention, with continued benefits at 3 months after the program. It is also hypothesised that parents will report feeling more able to manage screen use issues in the home post intervention and will report improvements in their child's screen habits and symptoms 3 months after the program.

  • Investigating the effect of HypnoBirthing on epidural use during labour and birth

    This study will adopt a multi methods approach to assess the effect of the HypnoBirthing program (Mongan Method) on analgesia use during labour and the birth experience. Data sources will consist of routinely collected clinical data from perinatal datasets, validated psychometric surveys, questionnaires and individual participant interviews. Clinical outcomes will be compared to a control population of birthing women using propensity matching of demographic, clinical and potentially confounding variables.

  • Noninvasive vagal nerve stimulation for abdominal symptoms in people with spinal cord injury

    This pilot study will examine the efficacy of transcutaneous (non-invasive) vagal nerve stimulation in people with spinal cord injury. Many people with spinal cord injury suffer from abdominal pain and gastrointestinal symptoms that do not respond to treatment target usual pain receptors. It has been postulated that these symptoms are mediated by the vagus nerve. Modulating the vagus nerve by transcutaneous stimulation may provide relief from these symptoms. Efficacy will be examined by patient-reported pain scores, pain maps, as gastrointestinal motility study.

  • Effects of Exclusive Enteral Nutrition (EEN) with fibre in healthy participants

    Exclusive Enteral Nutrition (EEN) reduces inflammation and allows complete gut healing in up to 80% of people with Crohn’s Disease (CD). EEN involves removing all food and replacing it with a liquid containing all essential nutrients for 6-8 weeks. This treatment is superior to steroids in treating inflammation and is being increasingly used across Australasia as first-line therapy, particularly in children. Despite EEN having been shown to be effective in numerous studies, the ways in which it works to reduce inflammation is still unknown and this study seeks to address the hypotheses by assessing how EEN works. The best way to assess how a therapy works to treat disease is to examine its impact in a 'normal' gut with limited confounders.

  • Comparison of demographics, clinical symptoms, and urodynamic findings between detrusor overactivity with detrusor underactivity patients under the age of 70 and those aged 70 or older

    Detrusor overactivity with detrusor underactivity (DO-DU) is classically described in frail institutionalized elderly patients, but we have also observed this diagnosis in younger populations. This research attempts to retrospectively compare demographic characteristics, clinical presentations, and urodynamic findings between two age groups of DO-DU patients: those younger than 70 years and those aged 70 years or older. Our hypothesis predicts that the younger group would exhibit a higher prevalence of risk factors in their demographic data, while the elderly group will demonstrate a greater incidence of urgency and urge incontinence, likely attributed to limited mobility. Additionally, the urodynamic findings are expected to reveal less bladder contraction in the elderly group, which can be attributed to the effects of advanced age.

  • A longitudinal pilot study assessing the medical and surgical treatment of babies with congenital upper airway conditions.

    Laryngomalacia is the most common congenital airway abnormality in young children. In the most severe cases, surgical intervention is necessary to prevent serious complications from arising and to allow for the normal development of breathing and feeding. Supraglottoplasty is the most common surgical procedure employed to address severe laryngomalacia. The procedure reduces or stabilises the problematic laryngeal tissue preventing further obstruction from occurring. Existing literature on the efficacy of this surgery has demonstrated that this procedure is not always effective at resolving symptoms. The factors that contribute to the success or failure of supraglottoplasty have been difficult to elucidate but are likely closely related to the patient’s pre-operative clinical condition. We propose a prospective study investigating the use of continuous pre-operative pulse oximetry as a tool to better understand the nature of the laryngomalacia present and identify patients most likely to benefit from supraglottoplasty surgery.

  • AMLM26/T3 INTERCEPT: A multi-arm trial for patients with acute myeloid leukaemia investigating new treatments which target early relapse and changes in disease characteristics - Low-dose cytarabine (LDAC) + Venetoclax

    This is a combination drug treatment arm within the ALLG AMLM26 INTERCEPT trial platform, which is registered on ANZCTR with ID ACTRN12621000439842. The combination of Low dose cytarabine (LDAC) and venetoclax will be evaluated for its activity in a population of participants with progressive acute myeloid leukemia (AML). Who is it for? You may be eligible for to receive this treatment if you are a part of the AMLM26 Intercept trial which is registered on ANZCTR with ID ACTRN12621000439842 (ie if you are aged 18 or older, you have been diagnosed with progressive acute myeloid leukemia, and are currently in your first or second morphologic remission with a known and trackable minimal residual disease (MRD) marker.). If you are on the AMLM26 Intercept trial you may be eligible for this treatment option if your disease is worsening. The trial management committee will review your disease characteristics and determine your best treatment option(s) available on the trial. Study details: Venetoclax will be administered orally once daily (QD) Days 1–28, of a 28-day cycle, with a designated dose of 600 mg daily. Please note that Venetoclax dose ramp-up is required only for patients commencing therapy with bone marrow blasts of greater than or equal to 5%: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4 onwards. LDAC (20 mg/m2) is administered subcutaneously (SC) QD following administration of Venetoclax on Days 1-10 of every cycle Participants will undergo a disease assessment at screening after cycle 1, cycle 2, cycle 3, cycle 6 and then 2 monthly until progression. This will require blood tests and bone marrow biopsies. Safety and tolerability of treatment will be assessed throughout the trial whilst you are receiving treatment. Health related quality of life during treatment will be assessed on the first treatment day of 3 consecutive cycles. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that Low dose cytarabine and Venetoclax will be well tolerated and may improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

  • 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.

Tags:
  • Finding clinical trials