ANZCTR search results

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

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31061 results sorted by trial registration date.
  • Maternal Anaemia and Postoperative Outcomes After Caesarean Section Surgery - The MAPOC Study (Feasibility Study)

    Anaemia is defined as having reduced haemoglobin (an oxygen carrying substance) concentrations in the blood. There are many causes but it is often due to iron deficiency which is common in women, especially during pregnancy. Currently in Australia about one in three pregnant women are anaemic and approximately one in four women undergo birth of their baby by caesarean section surgery – an abdominal surgical operation. This means that some women will undergo both caesarean section surgery and be anaemic. In non-pregnant adults pre-existing anaemia before surgery is associated with an increased risk of postoperative complications such as requiring a blood transfusion, increased risk of blood clots, infection and heart and lung complications. Anaemia is defined differently in men and non-pregnant women, and different again in pregnant people. However, investigators have recently questioned this and have challenged the dogma and traditional view that men, women and pregnant people should have different haemoglobin concentrations. They instead propose that the threshold value for defining anaemia should be the same in all adults and argue this strongly in the context of adults having major surgery. As caesarean section surgery is major surgery, then this would apply to pregnant women. There is only limited information about how anaemia, including the new thresholds proposed for pre-operative anaemia, affects the care of women having caesarean section surgery and the outcomes for their babies. In the future we aim to conduct a large multicentre study to examine the relationship between a pregnant woman’s haemoglobin concentration and her haemoglobin concentration on discharge from hospital to see if anaemia before surgery is associated with low haemoglobin concentrations after birth, and complications for the woman or her baby after caesarean section surgery. Before conducting a large study in this area we need to collect information about the feasibility of such a study including data that can inform sample size calculations regarding these associations. This is the purpose of this feasibility study.

  • A randomised control trial to evaluate the reactions of co-administration of influenza and COVID-19 vaccines

    This study will aim to evaluate, pragmatically and efficiently, the safety (reactogenicity) of seasonal influenza vaccines co-administered with licenced COVID-19 vaccines in Australia. Simultaneous administration of vaccines is common practice within vaccine programs for children and adults worldwide. Co-administration of COVID-19 vaccines with seasonal influenza vaccines could offer significant advantages for health systems planning (including cost, administrative practicalities and effective use of resources) and for increasing the uptake of both vaccines. These benefits may be substantial given the likely need for booster doses of COVID-19 vaccines. It is envisioned that this study will be extended to assess the safety and immunogenicity of other potentially co-administered vaccines.

  • Molecular networks underlying exercise-induced mitochondrial biogenesis in humans

    Mitochondria are compartments within our cells that facilitate various important processes, including that of energy generation. Mitochondria rapidly adapt to changing needs within the cell through a process called mitochondrial biogenesis, by which, new components are added to the network of mitochondria. Mitochondrial biogenesis is stimulated in skeletal muscle by exercise, however, the signalling that allows this to occur is poorly understood. This project aims to uncover the different signalling pathways activated by exercise in skeletal muscle using novel techniques combined with advanced statistical analysis. Analysis will be performed on quadriceps muscle biopsies collected from forty untrained men and women (equal numbers of each). Using samples both prior, in the middle, and at multiple time points after exercise, we will capture all changes in gene expression and protein localisation. This data will be combined with measurements of participants' fitness before and after training to generate a timeline and predictive model of mitochondrial biognesis signalling. Expanding the knowledge of mitochondrial biology will have many ramifications for both athletic and biomedical disciplines. Recently, links between the function of mitochondria and life expectancy have been discovered, with numerous diseases characterised by mitochondrial dysfunction, such as diabetes, cardiomyopathy and various neurological disorders on the rise globally. We hope by understanding how exercise triggers mitochondrial biogenesis, exercise can be used to a greater effect as therapy for these diseases. By applying this methodology to different exercise intensities and durations, better exercise prescription for athletes can also be determined. Additionally, the identification of novel mitochondrial biogenesis regulators may enable new targeted drugs that aid treatment of mitochondrial dysfunction or mimic exercise in those who cannot do exercise.

  • Evaluating typhoid vaccine responses in specific antibody deficiency patients receiving immunoglobulin replacement.

    Patients with specific antibody deficiency (SAD) have impaired immune function and suffer from recurrent infections. Some patients are treated with immunoglobulin replacement which involves receiving monthly infusions of pooled protective antibodies from healthy blood donors. This multi-centre study will be the first to investigate vaccine responses to a commonly used typhoid vaccine (Vi-polysaccharide; Vi-PS) in adult patients with SAD on immunoglobulin replacement. We hypothesise that Vi-PS vaccine responses will differ between SAD patients, in particular those who require long-term immunoglobulin replacement and those with less severe disease. This study will describe Vi-PS vaccine responses in SAD patients both on and off immunoglobulin replacement as well as healthy adults and patients with known antibody deficiency (common variable immunodeficiency). These groups will help us to understand normal and abnormal Vi-PS vaccine responses. Having more information on how to assess SAD patients on immunoglobulin replacement will help clinicians to better manage patients with SAD in the future.

  • Effect of Chitodex gel in ear drum repair (tympanoplasty) surgery

    The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty and mastoidectomy procedures to close tympanic membrane perforations (TMP). Packing of the middle ear has become a routine aspect of these procedures to provide structural support to graft material. Whilst no consensus exists regarding the best packing agents, Gelfoam has become the standard of care since its creation in 1945. Whilst it contains many desirable properties, it can be difficult to manipulate when wet and has been shown to illicit inflammatory responses and adhesions within the ME cavity. Chitodex is a chitin-based hydrogel that exhibits anti-inflammatory, anti-microbial and wound-healing properties. When set it remains in a semi-solid form and can provide similar structural support to Gelfoam. We aim to compare the success rates of tympanoplasty and mastoidectomy surgery between the two products. The ultimate goal is to identify the ME packing agent-of-choice to ensure TMP closure as well as minimal inflammation of the middle ear mucosa.

  • Feasibility and Participant acceptability of use of the UriSWAB™ collection system

    Biochemical validation is the gold standard of measuring smoking abstinence in smoking cessation clinical trials. It increases scientific rigor, however, feasibility of sample collection and stability of samples before testing can be a drawback in clinical trials. This study has the potential to establish acceptability of a novel urine collection method, and to test the feasibility of remote sample collection and stability of urine samples using the UriSWAB™ over time. If effective, this method will allow remote biochemical validation of smoking abstinence, which will be useful in larger scale smoking cessation clinical trials in the future.

  • The acceptance of digital mental mental health interventions for binge eating

    The present study will evaluate whether a brief acceptance-facilitated intervention can improve participants acceptance of digital mental health interventions for recurrent binge eating. We will also assess whether this AFI can boost motivation, positive attitudes, intervention uptake and engagement, study retention, and symptom improvement. While AFIs have been shown to lead to these outcomes in other clinical conditions (e.g., depression, chronic pain etc.), it is as yet unclear whether this pattern of results generalize to people with recurrent binge eating. If demonstrated, improvements in receptiveness to cheap and scalable mental health interventions may be realized. The following hypothesis was derived. Participants randomized to the AFI will experience significantly greater improvements in all primary and secondary outcomes than participants randomized to an assessment only condition.

  • Pharmacokinetics of Recombinant and Urinary Human Chorionic Gonadotrophin

    This research study will evaluate and update the efficiency of an old and new form of test to detect hCG in blood for an antidoping setting.

  • “Delirium in Trauma Patients in ICU: a prospective observational cohort study” (DELTA-ICU)

    Delirium is a temporary state of confusion and inattention that occurs in patients who are unwell or have undergone a major injury. Delirium is common and can worsen outcomes. This is an observational study of delirium and the factors associated with delirium in trauma patients admitted to the intensive care unit. We hypothesize that the rate of delirium and the severity in this group of patients will be higher than in other populations. There are certain factors that make the occurrence of delirium more likely and this study aims to quantify the occurrence of these factors . Among them is the quality of sleep, as poor quality sleep has been associated with delirium. To do this we will perform nightly assessments of duration of sleep, ask patients who have been discharged from ICU to answer a questionnaire about their sleep in ICU, and a small group of patients will undergo polysomnography, which is a specific sleep test that provides with in depth information about sleep.

  • Investigating the effect of the "Kalmer" relaxation intervention on emotional distress after stroke

    Anxiety and depression after stroke are associated with poor rehabilitation outcomes. High quality evidence on psychological treatments for these conditions in this population is lacking. Relaxation training is a proven treatment for anxiety in the non-stroke population and has shown promise in those with stroke. The aim of the proposed investigation is to investigate the effectiveness of this treatment for those with communication problems via a case series study. In this study 10 stroke survivors will complete relaxation training five times a week for five weeks and their depression and anxiety symptoms will be measured before and after treatment. Following this participants will be given the opportunity to provide feedback on the intervention. It is hypothesised that this relaxation video will reduce both anxiety and depressive symptoms in stroke survivors.

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