ANZCTR search results

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

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32103 results sorted by trial registration date.
  • REstrictive vs StandarD FlUid Management in Mechanically Ventilated ChildrEn Admitted to Paediatric Intensive Care Unit (PICU) - a Pilot Randomised Controlled Trial

    Hospitalised children regularly receive fluid that is infused through their veins (intravenous fluid therapy). The fluid is given to patients for resuscitation, as a routine daily requirement and to make up intravenous medicines. However, it can be harmful. When children are sick, they may hold on to fluid due to abnormal secretion of certain hormones. Additionally, their kidneys may not be working properly. These changes may lead to a child who inappropriately collects water in parts of the body, such as the lung. Unfortunately, this can cause difficulty with breathing and necessitate more support. Therefore, it may be beneficial to give less fluid and support their recovery. In this trial, we will directly compare a strategy of ‘less fluid’ to current standard care in critically ill children. With over 11,0000 children being admitted to intensive care units across Australia-New Zealand annually, knowledge from this project could potentially benefit many children.

  • The impact of endoscopy sedation information sheets on the level of concern regarding possible awareness in patients undergoing endoscopy sedation

    This study investigates the role of endoscopy sedation information sheets in reducing the level of concern regarding possible awareness during the procedure. We hypothesised that concern of awareness would be reduced with the introduction of the information sheet in the intervention group compared with control group receiving only the standard procedure consent form.

  • EVEREST: Evaluation of COVID-19 Vaccination Efficacy and Rare Events in Solid Tumours

    Who is it for? You may be eligible to join this study if you are planning to but yet to receive COVID-19 vaccination; or if you have received 1 dose of vaccine only, or if you are within 3 months of your second dose of COVID-19 vaccination. You may have received the Pfizer, AstraZeneca or Moderna COVID-19 vaccines. You can either be a cancer patient receiving systematic treatment including chemotherapy, immunotherapy or targeted therapy; or participate as a healthy control (if you have no history of cancer). Study details Participants in this study will undergo blood tests at up to five time-points: baseline (prior vaccination), 1 week prior to second vaccine dose, and 1, 3, and 6 months after the second dose of Covid-19 vaccine. All participants will have the 3 and 6 months post second vaccine dose sample taken. Earlier blood sample time-points will be taken where applicable (depending on when the participant enrolled in the study). Administration of the vaccine itself will not be part of part of this study. Patients will receive vaccination at their usual GP clinic, pharmacy or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice. It is hoped this research will increase knowledge of how cancer treatment affects the efficacy of vaccination, and thus contribute to the cancer immunology field and improve health outcomes for patients with cancer.

  • The effects of Mindfulness Meditation and Relaxation Training on Neural Correlates of Attention in Anxiety

    This study aims to examine the effects of a brief mindfulness meditation induction and a mindfulness meditation training intervention on neural correlates of attention (as measured by event-related potential components and EEG spectral activity) and measures of anxiety in young adults with high levels of anxiety and minimal meditation experience. A secondary aim is to identify individual characteristics related to attention changes, engagement/adherence to the intervention, and psychological outcomes (i.e., anxiety, other measures of wellbeing). Improvements in attention processes and reductions in anxiety are expected.

  • How the presentation of information about the prognosis of a health condition in different visual ways might affect people's comprehension?

    Comprehension of prognostic information might be affected by how the information is presented to patients or their caregivers. Subsequently, this might affect what health management decisions they make and further affect their health wellbeing. This is a four-parallel arm online randomised controlled trial. Two separate groups of adult Australians will be recruited using an online provider (Dynata) to participate in one of two trials. Trial A: Acute middle ear infection (Acute medical condition) and trial B: Tennis elbow (chronic medical condition). Participants of each trial will be randomly assigned to one of four groups: text only, bar graph, pictograph, and line graph. The four interventions in each trial will convey the same prognostic information but will be presented in four different visual formats. Comprehension of the presented information will be measured and its association to health literacy, numeracy, and educational level. As secondary outcomes, we will measure participants’ intentions towards which treatment option they would choose in each condition. Additionally, we will measure participants’ satisfaction with the presentation they were allocated to as well as their preferred presentation to be used in future communication.

  • Using a parenting program intervention (Tuning into teens (TINT)) to investigate parenting behaviour and adolescent brain development

    This project aims to understand how a parenting intervention influences emotional brain function in adolescent females at risk for depressive disorders. Participants will be randomly assigned to the intervention or the waitlist control group. Parents of adolescents in the intervention group will receive the TINT parenting program, which has shown to be effective in increasing parental emotional socialisation and decreasing adolescents' internalising symptoms. We hypothesise that adolescents whose parents are in the intervention group will show greater improvements in brain function and connectivity in the neural circuits underlying emotion regulation (i.e., greater reductions in amygdala activity and greater increases in prefrontal-amygdala connectivity) at 6-month follow-up compared to adolescents whose parents are in the waitlist control group.

  • NanaBis™ an Oro-Buccal Administered delta9-Tetrahydrocannabinol (d9-THC) and Cannabidiol (CBD) Medicine For The Management of Chronic Pain From Metastatic Bone Cancer

    The purpose of this study is to determine whether a nanoparticle cannabis-based medicine (NanaBis™) is effective in reducing metastatic bone pain in patients with cancer. Who is it for? You may be eligible for this study if you are aged between 18-75 years old, have been diagnosed with any cancer that has metastasised to bone, and are experiencing bone pain. Study details Participants will be randomised using a computer software program to receive either the NanaBis™ spray and placebo oxycodone tablets for breakthrough pain, a placebo spray and oxycodone tablets or a placebo spray and placebo tablets. Participants will self-administer the spray into their mouth up to 2-7 times every 4 hours unless asleep, and the tablet up to twice per day as needed. All participants will answer a number of questionnaires before the study starts and throughout the study. These questionnaires are answered weekly during the visits to the study site, except for the Numerical Pain Rating Scale which is completed twice daily as part of the participants medication diary. All questionnaires are also completed at the end of the 6-week period. Participants will also have the option to continue the treatment for a further 12 weeks after the study is complete. It is hoped that this study may demonstrate that NanaBis™ is safe, tolerable, and effective at reducing metastatic bone pain in patients with cancer.

  • Conventional vs custom made nasal Continuous Positive Airway Pressure (CPAP) mask for treatment of Obstructive Sleep Apnoea: Pilot study A

    The gold standard of OSA management is CPAP (Continuous Positive Airway Pressure). Adherence to CPAP remains the main barrier to effective therapy due to the cumbersome nature of the mask interfaces and their propensity to leak. We aim to assess whether custom made CPAP masks, which are not common or readily available, will improve patients’ adherence to treatment and therefore improve treatment outcomes.

  • A randomised controlled study In women undergoing an induction of labour to determine if the rate of intravenous fluid used impacts upon the duration of labour

    This is a randomised controlled study of women who require an induction of labour, to determine if excess, or inappropriate infusions of fluid given via a vein (intravenous route) is having an effect upon the duration of labour. For this study, women who require an induction of labour will be randomised to receive intravenous fluid at a rate of 40 ml/hr or 250 ml/hr. The duration of labour (in minutes), will be calculated from the commencement of an intravenous infusion of a medication to start labour (a hormone called oxytocin), until the birth of the baby.

  • Paediatric Facioscapulohumeral muscular dystrophy (FSHD) Longitudinal Outcome Study (iFSHD-LOS)

    The Paediatric Facioscapulohumeral muscular dystrophy (FSHD) Longitudinal Outcome Study (iFSHD-LOS) is designed to observe and record the natural disease progression of children and young adults aged 0-21 years diagnosed with FSHD (type 1 and type 2) through the collection of longitudinal data recording their medical, physical and psychological functioning. The study aims to: 1.Contribute to standards of care guidelines for children and young adults world-wide with FSHD. 2.Contribute to outcome measure and biomarker development to enhance clinical trial readiness. 3.Establish the cognitive and psychological profile of children and young adults with FSHD. 4.Develop a biobank of patient iPSCs to model disease and identify novel treatments in the future.

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