ANZCTR search results

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

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32704 results sorted by trial registration date.
  • Lactate values as a risk stratifying tool in the Adult Emergency department for the unwell and undifferentiated patient

    Research Question Can measurements of lactate clearance with a point of care lactate measuring device (StatStripAccutrend) assist in the management and early identification of patients at higher risk of deterioration in the emergency department? Rationale for Current Study In the emergency department, the undifferentiated patient presents a diagnostic and time management challenge. Lactate is used as a surrogate marker for global hypoperfusion in sepsis, trauma and patients with surgical abdomens, but there are also other areas of developing interest where lactate measurements could be used to assist in fast tracking decisions and risk stratifying patients to decide their disposition. Primary Objective 1. To measure serial lactate measurements in the ED within the first hour of presentation and at 3 hours of stay to monitor and predict deterioration in the department or the hospital in the first 72 hours? STUDY DESIGN This study is a prospective longitudinal study where data will be collected over a year. The data will be collected with written or and verbal consent, and fact sheet given to the participant about the study. Verbal and written consent will be obtained at the first reading and second readings taken to make sure that participants are happy to continue with the study. Patients can withdraw at any time in the study. Exclusion criteria of patients will include those that are <18 years old, severe hepatic failure, presentation of known seizure disorders and those triaged to other areas apart from the adult acute area or self discharged from the department before completion of treatment, if they don’t have a serial measurement of their lactate at 3 hours. The lactate measurements will be recorded at a time within one hour of presentation and the second reading at 3 hours of presentation electronically on their medical records. The data will then be extracted and de-identified for this research project and determined if the participant is to be excluded or included in the study. . This study to reach the sample size of 1000 participants would approximately go over the course of 6 months to a year.

  • Standard versus mIninal Monitoring : Pragmatic triaL in hepatItis C Treatment

    In March 2016, several new, all oral treatments became available in Australia for chronic hepatitis C virus (HCV) infection, bringing the “interferon era” to a close. These new treatments are much easier to take and more effective than the previous standard treatment, which was based on an injected medicine called interferon. Although we know these new treatments are very safe with side effect rates in clinical trials similar to placebo (sugar pills), we don’t know exactly how much monitoring is needed during a course of treatment. A “standard” monitoring plan has recently been developed by Australian experts, but this is based on what we know of the new treatments, and it has never been directly compared with less intensive monitoring. For the old interferon-based treatments, patients had some blood tests and a clinic appointment every 2 to 4 weeks for at least 24 weeks. For the new all-oral treatments, we know that much less intense monitoring is needed, but different monitoring strategies have not been tested in clinical trials. The purpose of SIMPLICITY is to compare “standard monitoring” with “minimal monitoring”, to determine if minimal monitoring results in similar cure rates but with lower cost and better patient satisfaction. The SIMPLICITY trial is being co-ordinated by Associate Professor Joshua Davis, who is based at John Hunter Hospital in Newcastle, and at the Menzies School of Health Research in Darwin. It aims to enrol a total of 100 participants at two sites in Australia (Darwin and Newcastle). There are no medications being given specifically as part of this study. You will receive the same medications whether or not you choose to take part in this study. The only difference between the two study arms is the number of blood tests and clinic visits during your course of treatment.

  • Transcranial Magnetic Stimulation in the diagnosis of Atypical Parkinsonism

    Transcranial Magnetic Stimulation is capable of inducing action potentials in cortical neurones, and provides the capacity to measure cortical neuronal excitability and interneuronal function. Preliminary data in previous studies shows this may be a method for measuring neuronal function in Progressive Supranuclear Palsy, which may enable its use as a biomarker. The intention of this study is to determine if these measurements are able to distinguish PSP from other parkinsonian syndromes with similar clinical features, ie. Multiple System Atrophy and Parkinson's Disease, and if these measurements correlate with markers of disease activity including cognitive changes. Results will also be compared with a group of healthy control participants to determine the reliability of these measurements.

  • 18FGE-180-Positron Emission Tomography in Graft Versus Host Disease

    The primary purpose of this trial is to evaluate whether 18FGE-180-Positron Emission Tomography (PET) scans can predict response to steroid treatment for acute gastrointestinal graft versus host disease (GI-GVHD) following haematopoietic progenitor cell transplantation (HPCT) for a haematological cancer. Who is it for? You may be eligible to enrol in this trial if you are aged 18 or over and have been referred for diagnostic endoscopy within the previous 7 days for suspected GI-GVHD following HPCT in the previous 100 days for a haematological cancer. Study details All participants enrolled in this trial will receive standard treatment for their condition. In addition, they will all receive two 18FGE-180-PET scans at enrolment (within 7 days of referral for endoscopy) and another scan 7-14 days after the first. The scans will last approximately 30 minutes and will involve receiving an intravenous injection of 18FGE-180 waiting 60 minutes and then proceeding to have a PET/MRI of 30 minutes duration. Researchers will compare the results of these scans to results of the endoscopy procedure by reviewing each patient's medical records. It is hoped that the findings from this trial will provide information on whether 18FGE-180-PET may be useful for predicting response to steroid treatment in these patients

  • The PIPA Project: examining the effectiveness of integrated psychosocial assessment during pregnancy

    Studies examining psychosocial and depression assessment programs in maternity settings have not adequately considered the context in which psychosocial assessment occurs or how broader components of integrated care, including clinician decision-making aids, may optimise program delivery and its cost-effectiveness. There is also limited evidence relating to the diagnostic accuracy of symptom-based screening measures used in this context. The Perinatal Integrated Psychosocial Assessment (PIPA) Project was developed to address these knowledge gaps. The PIPA Project will provide evidence relating to the clinical- and cost- effectiveness of psychosocial assessment integrated with electronic clinician decision making prompts, and referral options that are tailored to the woman’s psychosocial risk, in the maternity care setting. It will also address research recommendations from the Australian (2011) and NICE (2015) Clinical Practice Guidelines.

  • Improving vitamin D status and related health in young women (part-A)–cross-section study

  • Implementation of a service to improve quality use of medicines and outcomes in older hospital patients

    Australia has an ageing population with an associated increase in people living with multiple chronic diseases. There has been a major increase in polypharmacy (multiple medicines use) in Australia over the past decade and the prevalence continues to rise, especially in older adults. Polypharmacy can lead to medication errors, adverse drug reactions, falls, confusion, frailty, loss of independence, hospitalisation and mortality. Evidence is emerging that supervised withdrawal of harmful or unnecessary medicines (deprescribing) is safe and may improve quality of life in older people. Over 90% of older adults surveyed in a range of settings, including Royal North Shore Hospital inpatients stated they would like to stop one of their medicines if their doctor said it was possible. An acute hospital stay represents a missed opportunity to review a patient’s medicines and reduce polypharmacy. In the Royal North Shore Hospital (RNSH) inpatient aged care service, the prevalence of hyperpolypharmacy increases from 45.8% on admission to 60.4% on discharge. Involvement of clinical pharmacists has been shown to improve care of hospitalised patients. The main barriers to optimising medicines during admission are a focus on the acute presenting problem; inadequate information on the patient’s comorbidities and medications prior to admission; difficulties reaching consensus between the patient, multiple specialists and general practitioner; inadequate time with short length of stay; and lack of expertise by junior medical officers, who do most of the prescribing. Failure to address polypharmacy in hospital results in longer lengths of stay due to adverse drug events, and a higher likelihood of readmission. We propose testing a new service at RNSH to improve Quality Use of Medicines by older patients across the continuum of care. Quality Use of Medicines, which is a pillar of Australia’s National Medicines Policy, is best achieved through partnership between consumers, clinicians, academics and policy makers. Such partnership is central to the Multidisciplinary Multiple Medicines Management Service (4MS) that will be tested in this proposal.

  • Comparison of the oral microorganisms between patients being treated with orthodontic brackets or aligners.

    This research will compare the individual bacterial taxa between 2 orthodontic appliances, the fixed self-ligating bracket system and Invisalign clear aligners. The association of individual taxa and the presence or absence of white spot lesions and gingivitis for both orthodontic techniques will be analysed.

  • Novel processed carrot-based products to supplement vegetable intake in healthy adults

    People all over the world do not meet the recommended intake for fruit and vegetables. New strategies and options are needed to help people to boost their vegetable consumption. Carrots are an exceptional source of carotenoids, as well as fibre. Carotenoids are a precursor for vitamin A, one of the most common deficiencies worldwide, essential for eye health and may have various other health benefits through their antioxidant activity. The primary hypothesis of the study is that daily consumption of processed carrot powder added to foods is an effective, convenient and consumer accepted strategy to supplement vegetable intake, as shown by greater increases in carotenoid status after 4 weeks compared to daily consumption of carotenoid-rich vegetables.

  • The impact of different proline and glycine containing test foods and supplements on serum amino acid availability, and engineered ligaments

    Specific amino acids (i.e. proline and glycine) and/or sequences of these amino acids (i.e. peptides) play a supportive role in the synthesis of collagen, the predominant protein found within connective tissues. Recent work by our team has shown a dose response relationship between amino acid availability and collagen content, and tissue mechanics in engineered ligaments following the ingestion of gelatin (a food form of collagen). However, it is not currently known whether other foods/supplements containing relevant amino acids/ peptides have the potential to support collagen synthesis. Furthermore, the bioavailability (i.e. timing and peaks of appearance within the blood) of varying collagen and non-collagen containing food sources is currently unknown. Therefore the goal of this study is twofold; Part a) Determination of the plasma amino acid response to dietary and supplemental sources of non- collagen and collagen containing foods while measuring potential biomarkers of collagen intake urinary HYP. Part b) Investigation of the effect of dietary and supplemental sources of non-collagen and collagen containing proteins on in-vitro collagen synthesis in engineered ligaments and cultured fibroblast cell lines.

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