ANZCTR search results

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

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32707 results sorted by trial registration date.
  • A phase II open label study to determine the ocular pharmacokinetics of oral OCX063.

    This is a multi-centre, open label, 2 cohort study to determine the ocular exposure levels of oral OCX063 in participants requiring retinal repair surgery. Following an OCX063 loading dose on the day of surgery, samples of aqueous and vitreous humour will be collected during the surgical procedure. Post-surgery, patients will take a once daily dose for the following 7 days. On Day 8, an aqueous humour sample will be collected via an aqueous tap.

  • Extubation Of preterm infants: The Diagnostic utility of UltraSound (EXODUS)

    Babies who are born early (premature babies) often require help with their breathing. Some premature babies will require a breathing tube (intubation) and help from a breathing machine (ventilator). A ventilator helps babies to stay alive but may damage their lungs. To minimise this damage, we try to take the breathing tube out (extubate) as soon as possible. Unfortunately, some babies will not succeed and require the breathing tube to be put back in (reintubation). These babies are likely to be sicker in the long term than those who are successfully extubated. There are few tools available to help predict which babies will fail extubation. Ultrasound is a form of imaging that uses reflected sound to create an image of different parts of the body. It is safe, painless and does not use radiation. Ultrasound can be used to image the lungs of babies. We are exploring whether a lung ultrasound performed before a baby is extubated will help us predict extubation failure. We are also exploring if repeated lung ultrasound will give us more information on how a baby’s lungs behave after being extubated. Additionally, we are exploring two new types of ultrasound, one of a baby’s diaphragm (the main muscle of breathing) and one of their vocal cords. In this study, we will perform and ultrasound of a baby’s lungs and diaphragm before and after extubation and then daily for the next three days. We will also perform one vocal cord ultrasound 24 hours after extubation. We will use this information to see if we can predict which babies will require reintubation.

  • The effect of soccer heading on the brain.

    This study is a randomised, controlled, crossover, non-pharmacological, unblinded pilot trial. Participants will complete two experimental trials during which they will perform either a soccer heading or control kicking task. Brain structure, function and chemistry will be assessed ~30-minutes later using advanced neuroimaging techniques. Individuals will also provide blood samples and complete cognitive function tests at regular intervals post-intervention. Trials will be conducted at Neuroscience Research Australia (NeuRA), Randwick, NSW. We hypothesise that reduced efficiency of brain function and neural viability will be detected relative to the control condition.

  • An open-label study of the safety and efficacy of 12 weeks treatment with BIT225 and Combination Antiretroviral Therapy (cART) in patients with Human Immunodeficiency Virus-1 (HIV-1) with only partial immune reconstitution.

    The proposed study aims to expand previous observations of immune activation and inflammation marker changes noted in the BIT225-009 study (ACTRN12617000025336) amongst treatment naïve individuals, to include a population of HIV-1 infected individuals maintained on a fully suppressive, chronic cART regimen, but not achieving full immune reconstitution. This population has not realised the same benefits of cART as those achieving more complete immune reconstitution, and as such has clear, unmet medical need. This study will investigate whether treatment with BIT225 over twelve (12) weeks can restore elements of immune reconstitution when compared to baseline by examining changes in inflammatory, immune, immune activation and viral markers.

  • I-HEART: Implementation of HEArt failure guidelines for patients with acute heart failure in Regional AusTralia

    Heart failure (HF) is a common disease of the heart with a high rehospitalisation and mortality rate. Regional HF patients rarely receive the full benefits of evidence-based care simply due to inaccessibility to a HF specialist team. The aim of this project is to determine the effectiveness of improving the translation of HF guidelines into clinical practice through implementing key recommendations from the guidelines and improving access to specialist services in regional health services. I-HEART involves post-discharge optimisation of medications, and rapid access to HF specialists and community-based services within 30-days of discharge.

  • Very Low Calorie Diet in Patients Receiving Haemodialysis

    The aim of this study is to determine if the use of a very low calorie diet (VLCD) with three meal replacement products per day is a safe and effective method for weight loss for patients with end stage renal failure undergoing haemodialysis (HD) therapy.

  • A phase I trial to study the effect of food on orally dosed IMG-7289 (Bomedemstat) in healthy adult volunteers

    This is a study of safety and tolerability of a drug called IMG-7289; also known as bomedemstat. The study will compare the amount of IMG-7289 that is in the blood after taking a single dose of 2 different formulations of IMG-7289, both with food and without food. IMG-7289 is being developed to inhibit an enzyme (LSD1) known to contribute to tumour growth, and may be used as a future treatment for cancers including myeloid leukemia and myelofibrosis. Who is it for? You may be eligible for this study if you are a healthy adult aged 18 to 65 years, have a non-smoker status and have no prior history of relevant drug hypersensitivity. People who have been diagnosed with cancer will not be eligible for this study. Study details In this study participants will test two formulations of IMG-7289 with and without food. In each study period, participants will spend 4 nights in clinic followed by 4 follow-up visits. There will be 4 study periods, with one End of Study outpatient visit. There will be a 14-day washout period between doses to ensure there is no IMG-7289 in their body before the next dose. All participants will be asked to undergo blood tests and answer questions regarding their health. It is hoped that information from this study informs researchers of how the body metabolises IMG-7289 and thus how it may be used to treat bone marrow malignancies, such as myeloid leukemia and myelofibrosis.

  • Clinical study assessing the anti-cancer activity of sulfasalazine in patients with advanced or metastatic pancreatic ductal adenocarcinoma whose cancer has worsened following therapy with current standard of care.

    This study will assess the anti-cancer activity of sulfasalazine in patients with advanced or metastatic pancreatic ductal adenocarcinoma. Who is it for? You may be eligible for this study if you are participating in the Cancer Molecular Screening and Therapeutics (MoST) Program (ACTRN12616000908437) and have SLC7A11-positive pancreatic ductal adenocarcinoma that has progressed following therapy with current standard of care. Study details All participants will be treated with oral sulfasalazine. It is usual to start taking sulfasalazine at a lower dose and gradually increase. Participants will start treatment by taking one 500mg tablet, three times a day. If the sulfasalazine is tolerated, the dose will be increased during the first cycle of treatment up to a maximum dose of four 500mg tablets, three times a day. To prevent low levels of folic acid that can occur with sulfasalazine treatment, participants will also take 1mg of oral folic acid tablets daily. Participants will be regularly assessed throughout the study in order to monitor safety and tumour response. Participants will have weekly clinic visits during Cycle 1 dose escalation. The frequency of visits declines to monthly later in the study. It is hoped that this study will help increase treatment options for patients with advanced pancreatic cancer.

  • REthinking the Model of Outpatient Diabetes Care utilising eHeaLth in Regional, Rural and Remote Populations

    For better educating patients and sustaining their self-management, we have developed, based on digital health principles, an innovative Mobile-based Diabetes Management System (MDMS). The MDMS consists of a clinician portal, as well as a consumer-facing smartphone application. The proof-of-concept, feasibility and pilot trials of the Mobile Diabetes Management System (MDMS) that we have completed have demonstrated a significant improvement in blood glucose levels, a high degree of consumer satisfaction and a good proportion of conventional in-person visits being substituted in a tertiary diabetes service at the Princess Alexandra Hospital, Brisbane. In this project we have added an insulin titration feature to the MDMS, which will be trialled with people living in regional, rural and remote Queensland. Participants will be recruited from the PA’s telehealth service. The aim of the project is to trial the updated MDMS for efficacy and safety. We anticipate that this project will lead to improved glycaemic outcomes.

  • The effect of low-level laser acupuncture for frozen shoulder in adults

    Frozen shoulder is a type of shoulder disorder that affects an individual's physical and mental health in daily life. It could cause economic burden to individuals, families, health system, and the society. It is essential to find the best treatment plan to promote frozen shoulder patients' wellness and fasten the recovery time. Laser acupuncture has been used in a few health conditions with positive outcomes. However, the evidence in use laser acupuncture for frozen shoulder is still limited and inconclusive. This study will investigate the feasibility and therapeutic effect of using low-level laser acupuncture to manage frozen shoulder, and provide preliminary evidence in this field.

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