ANZCTR search results

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

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32712 results sorted by trial registration date.
  • Atmo Gas capsule localisation study in healthy volunteers

    The invention of an ingestible gas-sensing capsule promises a world of possibilities in research understanding of the activities of the gut bacteria in response to food. This technology, named the ATMO capsule, is capable of detecting changes in multiple gas concentrations (oxygen, carbon dioxide, hydrogen and methane) as a result of bacterial breakdown of food components (e.g. fibre) as it travels through different parts of the digestive tract. The completion of Phase 1 clinical studies in 23 healthy controls have proven its safety and functionality. Further studies are now needed to explore the utility of this technology in a clinical setting, such as in the assessment of regional transit times. If these studies are successful, this will mean the availability of a technology that is low cost, non-invasive and potentially usable as a point-of-care testing for individuals with gut conditions. A particularly attractive feature of the ATMO capsule is its ability to distinguish the small (aerobic region) vs large intestine (anaerobic region) via changes in oxygen concentrations. A step-wise decrease in oxygen levels have also been proposed as landmarks for distinguishing movement from the stomach to the small intestine. However, these anatomical landmarks remain theoretical and require further validation. A study utilising a similar ingestible capsule (the SmartPill capsule) is already underway to achieve this goal but preliminary results from this study require validation via an non-invasive imaging technique - gastrointestinal ultrasound. We have previously had good success in locating the ATMO capsule in one healthy volunteer but further data are needed to visualise the ATMO capsule within two key proposed anatomical positions (stomach to duodenum; ileum to caecum) in order to provide a way of validating gas profile landmarks. We hypothesised that changes in oxygen-equivalent and hydrogen concentrations as measured by the gas capsule provide identification of key anatomical landmarks within the gastrointestinal tract. The aim of the study was to develop and validate markers of anatomical landmarks of the ATMO gas capsule using gastrointestinal ultrasound in healthy controls.

  • Functional magnetic resonance Imaging GUided Radiation therapy dose Escalation in Head and Neck Cancer (FIGURE-rad HNC)

    The purpose of the study is to use a special type of imaging called diffusion weighted MRI, to target “high risk” areas within the tumour for radiation therapy treatment. The area defined by these images will be treated with a boost dose of radiation therapy in addition to the usual radiation treatment offered for your type of cancer. The aim of the study is to increase the dose of radiation therapy given to the tumour to improve the local control of the disease, without worsening the side effects of treatment. Who is it for? You may be eligible for this study if you are aged 18 years or older, have confirmed cancer of the head and neck region and are not suitable for have surgery or chemotherapy treatments. Study details: This study involves radiation therapy treatment. In addition to the normal procedures which will be required for standard radiation therapy, you will be required to have an extra MRI scan and may need to attend 1-2 extra clinic appointments at the hospital. You will also be asked to complete a questionnaire that will assess your quality of life before, during and after treatment. It is hoped this research will enable previously untreatable head and neck cancers to be more precisely targeted (and thus treated) with radiotherapy.

  • Being Your Best, a holistic approach to frailty through eating, connecting, moving and/or thinking.

    Frailty is a condition in which the individual is vulnerable and at increased risk of poor health outcomes or death when exposed to a stressor, such as illness or injury. As we age, frailty is common, affecting up to one in two people aged 65 years or more. The Being Your Best program, codesigned with health consumers, will address frailty in people aged 65 years and above. This proposal outlines two stages of work: Firstly, codesign of the Being Your Best program will be undertaken with health consumer representatives, including carers/nominated family members or persons (NFMPs), to understand their perspectives on how a set of frailty interventions may be best designed with their needs in mind. Secondly, we will undertake a feasibility and acceptability study of the Being Your Best program that will test the interventions developed in the codesign phase. This phase involves a needs-based assessment of people aged 65 years and above, and choice of existing community- or home-based interventions to prevent or overcome frailty. Interventions will address physical function through exercise (emphasising strength training), nutritional support, cognitive stimulation, and/or social support. Much of the detail around the design of this second phase will be determined by the outcomes of the initial codesign phase of work.

  • Prehospital code crimson activation - the initial experience from the Greater Sydney Area

    The purpose of this study is to join these two data sources (prehospital data from NSW State Wide Retrieval Database (SWRD) and Careflight’s retrieval database with in-hospital data from the NSW Trauma database). This will allow us to describe in better detail the patient population in whom a trauma ‘prehospital Code Crimson’ pathway was activated, the rate of requirement for continued in-hospital transfusion of blood products, the need for and timing of early interventions to control haemorrhage following hospital arrival, and the coagulation profile of these patients. It will also aim to review the accuracy of prehospital physicians in determining whether or not their haemodynamically unstable patients will require either ongoing transfusion or interventional haemorrhage control.

  • Effect of adding calcium salt of ethylene diamine tetra-acetate (CaEDTA) to nebulised tobramycin on bacterial clearance and lung function in patients with cystic fibrosis with chronic Pseudomonas aeruginosa lung infections: a randomised controlled trial..

    Airway iron level has been shown to be raised in patients with cystic fibrosis. Pseudomonas aeruginosa has been shown to have an absolute requirement for iron. We hypothesised that removing excess iron using chelating agents such as ethylene diamine tetra-acetate (EDTA) would improve the bacterial killing ability of antibiotics. We conducted a double-blind, randomised controlled trial to study the safety and efficacy of combining inhaled CaEDTA and tobramycin in cystic fibrosis patients with chronic Pseudomonas aeruginosa lung infection undergoing treatment for pulmonary exacerbation.

  • Does washing blood for transfusion make a difference to preterm babies?

    Standard red blood cell transfusion is almost unavoidable in very preterm newborns. This common therapy likely causes harm by inciting an inflammatory response in the recipient, a precursor to injury and end organ morbidity. This inflammatory signal can be ameliorated with use of washed red blood cells. Though currently available from Red Cross this washed product incurs additional manufacturing costs and has a shorter half-life. Our randomised controlled trial will determine if washed, allogeneic red cells reduces end organ morbidity in surviving, very preterm newborns resulting in life-long benefit and thereby defraying the additional costs of product manufacture.

  • MILQ: Mother Infant Lactation Questionnaire

    SAHMRI Women and Kids are conducting a new survey (MILQ), that will follow mother-infant pairs across the first 12 months of life to find out how South Australian babies are being fed. We would like to find out what is helpful in initiating and continuing breastfeeding, as well as anything that could make breastfeeding difficult. We are also interested in the timing of complementary foods (such as solids and semi-solids) and the types of foods given to babies in their first year of life. The aim of the MILQ study is to understand how families are feeding their full term infants over the first 12 months of life, and what challenges they experience. We hope to use this information to inform the support services at South Australian hospitals and postnatal care providers. The information collected will also help us understand the current practices for the introduction of complementary feeding.

  • Efficacy and safety of high frequency chest wall oscillation in paediatric patients with neuromuscular disorders

    Patients with neuromuscular disease can have impaired airway clearance which may lead to respiratory deterioration and death. Physiotherapy is vital in assisting with airway clearance for this patient population. Recent studies have suggested the use of high-frequency chest wall oscillation (HFCWO), however, there is little physiological evidence to support its efficacy. This study will use electrical impedance tomography and lung ultrasound to assess pre and post-treatment lung volume changes for patients receiving standard chest physiotherapy and HFCWO.

  • Neonatal CoVID-19 Study to evaluate the population health impacts of COVID-19 in mothers and their newborn infants cared for in tertiary and non-tertiary hospitals in Australia.

    In the midst of an unfolding global pandemic, there is a dearth of information about how COVID 19 infection affects neonates born to women with suspected or proven COVID 19. This study will contribute to an emerging and global body of information about COVID 19 in the perinatal period, enabling timely reporting and appropriate health service planning to ensure optimal outcomes for neonates, mothers and families. The aim of this project is to investigate the population health impacts of COVID -19 in mothers and their newborn infants cared for in tertiary and non-tertiary neonatal facilities. The research questions/hypothesis this study seeks to address include: 1. Incidence of COVID-19 in pregnant women and their newborn infants 2. Describe the outcomes for mothers and their newborn infants with COVID-19 3. Identify incidence of SARS-CoV-2 infection in the neonatal period and describe clinical course and outcomes for newborn infants with COVID-19 4. Collaborate with international COVID-19 registries to inform global variations and outcomes in care of newborn infants

  • Evaluating new, rapid point of care testing for hepatitis C in injecting drug users visiting a medically supervised injecting room.

    The aims of this study are to evalute the uptake and acceptability of point fo care testing for hepatitis C using the Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, as compared to standard of care HCV testing in persons who inject drugs presenting to the medically supervised injecting room in Richmond, Victoria. We also seek to evaluate if point of care testing increases the rates of initiation of HCV treatment. Participants will be those persons over the age of 18 years who inject drugs that visit the medically supervised injecting room in Richmond, Victoria. The study will be a time series design, with two arms, conducted over ten months. The recruitment phase will be a total of four months, with each arm (standard of care, point of care) recruiting for a consecutive period of two months. Participants recruited in the first two months (months 1-2) will undergo standard of care testing for HCV. Participants recruited in the subsequent two months (months 3-4) will undergo point of care testing with Xpert HCV VL Fingerstick. Participants who return a positive HCV RNA result, suggestive of chronic hepatitis C infection, will be offered treatment with direct acting antiviral therapy. Participants will be followed up throughout the treatment course at four-weekly intervals, at end of treatment and at 12 weeks post treatment completion to assess for sustained virological response (SVR12). Participants will also complete questionnaires at enrolment, following HCV testing and at each follow up visit to assess acceptability of point of care testing, as compared to standard of care testing.

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