ANZCTR search results

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

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31193 results sorted by trial registration date.
  • Assessment of Radiotherapy in the management of Dupuytren’s Disease

    This trial will assess patients with Dupuytren’s Disease in two settings: those who have early stages of the disease, and those who have progressive flexion contractures. It is the first trial of its kind and aims to assess safety and efficacy in the use of radiotherapy in both settings. We hypothesise that radiotherapy reduces the incidence of disease progression in people with Dupuytren’s Disease managed in the early stages with a policy of observation, or in the later stages following local treatment in the form of NA.

  • Telehealth Impact in caring for community palliative care patients in a rural setting

    The purpose of this study is to explore the clinical impart of providing telehealth for community based palliative care for patients in rural Victoria. You may be eligible for this study if you are an adult with a diagnosis of a life-limiting illness. If you participate in this research you will be randomly allocated either to the telehealth consultation group or the "usual" care group in which we will simply ask you to complete questionnaires which will greatly assist us to assess and compare telehealth to usual care. The random choice is done using a dedicated computer program to ensure it is completely random. If you are in the telehealth group then your GP/palliative care community nurse will make an appointment with the specialist palliative care doctor based at the Monash Medical Centre in Clayton for a video conference. Your palliative care nurse with assistance from our team will provide all the equipment needed for this to take place in your home as part of one of their usual nursing visits. Before you begin, the specialists will already have your information, from your GP and nurse. It is hoped that this research will provide the basis for more extensive research. The system used for the video conference is a special dedicated system is completely confidential and nothing from the consultation is stored.

  • High flow oxygen for children's airway surgery

    Infants and children with airway abnormality often require surgery of their upper airway to improve their breathing; a procedure called microlaryngoscopy. During this procedure the child is anaesthetised and the anaesthetist controls the child’s breathing. In these situations, known as ‘shared airway’ cases, both the surgeon and anaesthetist require simultaneous access to the child’s airway. The anaesthetist needs to maximise oxygen delivery and provide adequate depth of anaesthesia while the surgeon requires direct access to the airway and an unobstructed view to perform the procedure. In these circumstances it is often impractical for the anaesthetist to place an artificial breathing (endotracheal) tube to deliver oxygen and inhaled anaesthetic gases, therefore oxygen delivery must be achieved by other means. During this kind of surgery it is not uncommon for blood oxygen levels to fall (hypoxia). Surgery may need to be interrupted by the anaesthetist to correct this, potentially compromising patient safety, prolonging the procedure, increasing exposure to anaesthesia and reducing surgical efficiency. At Lady Cilento Children’s Hospital (LCCH), we recently conducted a clinical audit of the anaesthetic care of children undergoing airway surgery and found that 32% of children experienced one or more hypoxemic events (low oxygen levels). A further 23% of surgeries required interruption to apply rescue oxygenation. The method the anaesthetist chooses to oxygenate the child may help prevent this type of serious complication. Traditionally, anaesthesia technique has involved the delivery of low flow oxygen via a ‘Nasopharyngeal Low Flow Oxygen’ (NLFO) system, in which oxygen is delivered at flow rates of 2-6L/min, typically via an oxygen catheter tube placed in the nose. Our research team at LCCH has been investigating the use of a new mode of oxygenation for children undergoing anaesthesia called ‘High-Flow Nasal Oxygen Insufflation’ (HFNOI). In HFNOI, warm and humidified oxygen is delivered to the airway via nasal cannulae at weight-specific flow rates. For example, HFNOI can be delivered at rates of 2L/kg therefore a 10 kg infant the child would receive 20L/min. Matching flow to the patient’s breathing demand this allows the anaesthetist to deliver oxygen to the child at the required concentration. Recent studies conducted in anaesthetised children at LCCH, have demonstrated HFNOI is an effective alternative oxygen delivery technique that can be safely used in infants and children with abnormal airways. The choice of oxygenation method may have significant ramifications for the child, and for surgical efficiency. However, to date there have been no high-quality studies evaluating HFNOI in comparison to other oxygenation techniques during paediatric airway surgery. Therefore, we would like to test the two techniques to determine whether HFNOI is superior to traditional anaesthesia oxygenation methods during paediatric airway surgery. We will achieve this aim using a randomised controlled trial to compare HFNOI with NLFO as the mode of oxygen delivery, during microlaryngoscopy in infants and children. The investigators hypothesise that HFNOI will confer advantages over the alternative techniques when used as an airway management and oxygenation technique during anaesthesia of spontaneously breathing infants or children undergoing microlaryngoscopy surgery. It is important to determine which mode or modes of oxygenation confer the lowest incidence of hypoxia and rescue oxygenation during these surgeries. If we can demonstrate that HFNOI reduces the risk of hypoxia and surgical interruption, this has the potential to both improve both the safety and the operating efficiency of these surgeries for children.

  • A first in human study to evaluate the safety and immune response to a vaccine for the treatment of a respiratory virus, when administered into the arm in healthy adult participants.

    Advanced Vaccine Laboratories Pty Ltd is developing a recombinant Respiratory Syncytial Virus (rRSV) vaccine for the protection of children (6 months to 5 years old) and the elderly from RSV infection. Human RSV infects nearly all children by the age of two years, and it is a leading cause of severe lower respiratory tract (LRT) disease in both paediatric and elderly populations as well as in individuals was immune system is profoundly compromised. The investigational product BARS13 has not previously been administered to human subjects. The purpose of this study is to evaluate the safety of, and how the body reacts to, BARS13 investigational vaccine when administered in the arm to healthy adult participants aged 18 to 45 years according to a single (at Day 0) or repeat (at Day 0 and Day 30) vaccination schedule, with follow-up occurring for 60 days after the last vaccination.

  • Steroid Therapy and Outcome in Parapneumonic Pleural Effusion (STOPPE): A randomised double-blind placebo-controlled trial of intravenous steroid in the management of parapneumonic pleural effusion.

    The lung and the inside of the chest wall are both covered by a thin lining called the pleura, which produces a very small amount of fluid to lubricate the lung during normal breathing. Pneumonia can cause a build-up of fluid in between the pleural linings called a parapneumonic pleural effusion. In many cases, the effusion clears up with antibiotics; less commonly, a chest tube is required to drain the fluid. Steroids are anti-inflammatory medications that have been used for many years in the management of many medical conditions such as rheumatoid arthritis and asthma. In certain serious infections, inflammation is thought to be the cause of some of the symptoms, and steroids have been used to reduce these effects. Steroids have been used in people with pneumonia in the past with some success, and importantly, few side effects. There is some evidence to suggest that parapneumonic pleural effusions occur because of excessive inflammation, which may delay recovery. A recent study in children showed that patients with a parapneumonic effusion recovered faster if they were treated with steroids in addition to antibiotics. In this study, we aim to assess whether administering steroids to adults with a parapneumonic effusion will speed up their recovery from the illness. Study participants will receive 4 doses of steroid or a placebo over 48 hours. A placebo is a medication that looks the same as the steroid but doesn't contain any active drug. This study will be "double-blind" which means that neither the participant, nor the doctor, will know which treatment is administered until the end of the study. It is a randomised clinical trial which means that each participant will be put in one of the study groups (to receive the active drug or placebo) by chance and will not be able to choose their treatment. Two-thirds of participants will receive the study drug and one third will receive placebo. The 48 hour treatment course is considered to be short, which means that there is much less likelihood of any side effects. The main side effect of steroids is high glucose levels in the blood, which typically go back to normal once the treatment is stopped. Other possible side effects include inflammation/bleeding in the stomach, suppression of the immune system and worsening infection, oral thrush and mood disturbance. In studies that have been done so far, none of these were more common in the group treated with steroids compared to those who weren’t. The outcomes that we will assess to compare the two groups will include the time to recovery from the illness, changes in blood tests and chest x-rays over time, duration of antibiotic therapy and length of stay in hospital, need for a procedure to drain the fluid, quality of life over the 30 days post-treatment, adverse events (side effects of treatments) and overall survival. The data collected will be analysed by a statistician.

  • Group-based exercise physiology services for those aged over 50

    Our aim is to investigate the impact of short-term, group-based classes, specifically targeting multiple conditions associated with ageing (sarcopenia, osteoporosis and poor balance), on the health and wellbeing of participants. The common denominator in these classes will be the evidence-based design of the programs and delivery by accredited exercise physiologists. The hypothesis is that participants will improve in their physical capacity, exhibit less signs and symptoms of the target conditions and increase their ability to engage in activities of daily living. This increased functional capacity will be accompanied by improved measures of quality of life.

  • Women's action for Mums and Bubs (WOMB): a trial of participatory women's groups to improve Indigenous maternal and child health.

    Improving maternal and child health (MCH) care and outcomes has an impact throughout the lifespan. Most quality improvement interventions focus on service-level action, despite evidence that up to 2/3 of the variability in quality of care might be due to factors beyond health services. Good international evidence indicates participatory planning and implementation processes in partnership with community women can deliver real outcomes for improved MCH. Community participation is the collective involvement of local people in a geographic location, making decisions about their needs and priorities, implementing strategies, and monitoring progress in partnership with health services. Such community participation has not been tested in the Aboriginal and Torres Strait Islander primary health care (PHC) setting. This WOMB trial tests the effectiveness of community participation in improving Indigenous MCH. This stepped wedge intervention will see the formation of Participatory Women's Groups (PWGs, groups of women in a community interested in MCH improvement) at 10 sites across Australia. Community participation will involve training local facilitators of PWG groups, supportive engagement with local MCH data through workshops, PWGs identifying and prioritising issues and strengths and co-implementing solutions with health services. Outcomes will be measured with yearly MCH audits, cost-effectiveness and process evaluation. The PWG intervention will be structured on the Remote Services Futures community participation framework. If successful, the WOMB trial will provide rigorous evidence supporting community participation as a means for improving MCH in Indigenous communities, moving towards closing the gap in health outcomes across the lifespan.

  • Postural stability after deep brain stimulation in Parkinson disease patients

    This project aims to develop an improved understanding of how deep brain stimulation influences different motor symptoms of Parkinson’s disease. Specifically, it is anticipated that the outcomes of this research will clarify the effect of deep brain stimulation on symptoms relating to walking ability and balance, which will help to enhance the post-operative management of people with Parkinson’s disease following deep brain stimulation.

  • Assessing the safety and feasibility of depot buprenorphine in NSW custodial settings

    This four-month trial will compare long-acting depot buprenorphine (CAM2038) to standard of care (oral methadone) in adult males and females in custody with opioid use disorder to identify any unexpected safety and tolerability considerations specific to the adult custodial population in NSW. Analysis of routinely collected data will examine clinic-based diversion (or attempted diversion) among all inmates receiving opioid agonist therapy (depot buprenorphine, sublingual buprenorphine- naloxone film and oral methadone) as well as violent misconduct and involvement in assaults at each site and among trial participants. Further, a cost-consequence study will be undertaken to compare the costs and consequences of dosing activity recorded for all treatment types for both JH&FMHN clinical practice and CSNSW officer time. Finally, focus groups with CSNSW and JH&FMHN staff will be conducted to assess staff satisfaction and acceptability of OAT and related issues.

  • Safety, tolerability, and pharmacokinetics of single and multiple doses of a PLA2 inhibitor (c2) in men with prostate cancer: A Phase 0 and limited dose-escalation trial

    This is a first-in-human study of a new PLA2 inhibitor drug called c2. Who is it for? You may be eligible for this study if you are 18 or older and have prostate cancer confirmed by biopsy. Study details All participants in this study will receive the study drug (called c2), which is an oral pill. In the first part of the study, volunteers will be divided into 4 cohorts, each taking a different single dose of the medication. In the second part of the study, participants will take at a maximum of 10mg the study drug. Participants will be monitored for adverse events and medication efficacy, and provide blood and urine for analysis. It is hoped this research will provide evidence about this medication and lay the groundwork for future studies of this drug.

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