ANZCTR search results

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

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31027 results sorted by trial registration date.
  • Vaccine choices, regret and patient characteristics in covid-19 positive patients admitted as an inpatient: a prospective multicentre trial

    Patient presents/referred to hospital, unvaccinated/vaccinated status is flagged SARS covid-19 infection is confirmed using standardised testing Patient is admitted as an inpatient in the RAH/FMC Approached for inclusion and participation by Dr Lin, on day 3 or whenever well enough. Inclusion and survey are completed either electronically or via a telephone system built into isolation bay. No face-to-face contact, no prolongation of in-person contact. No use of PPE or risk of additional exposure to staff. Microsoft Forms platform survey allowing for electronic signature for written informed consent, or if no electronic device available/other technical difficulty- patient gives verbal consent for the study investigator to electronically sign on their behalf. Survey is completed in same manner; electronic or via handset system built into isolation bay. Survey is conducted during inpatient admission on day 2 or whenever the patient can communicate adequately and is medically stable enough to complete a research survey. Study investigators will review patient for suitability from Day 2 of admission, on a daily basis. No long term follow-up. One time point for data collection.

  • The sensitivity and specificity of Gram stain on formalin fixed tissue sections in the diagnosis of bacterial skin infection - a study of diagnostic test accuracy

    This study aims to determine the test performance and diagnostic accuracy of Gram stain on FFPE tissue sections in diagnosing bacterial skin infection. Measures of test performance and diagnostic accuracy include sensitivity (the “true positive rate” or the ability of a test to identify positive cases correctly), specificity (the “true negative rate” or the ability of a test to identify negative cases correctly), positive predictive value (the probability of having a particular disease given a positive test result), negative predictive value (the probability of not have a particular disease given a negative test result), positive likelihood ratio (LR(+)) (the degree to which a person’s probability of having a particular disease is increased by having a positive test result), and negative likelihood ratio (LR(-)) (the degree to which a person’s probability of having a particular disease is decreased by having a negative test result). Although each of these parameters will be reported, our hypothesis focuses on test performance in terms of likelihood ratios, because likelihood ratios a more patient specific and therefore clinically appropriate measure of test performance. Our hypothesis is that Gram stain on FFPE tissue sections has poor test performance in diagnosing bacterial skin infection, as defined by LR(+) of less than 2 and LR(-) of more than 0.5. These thresholds for acceptable test performance are consistent with those reported by Schecter and Sheps (1985). If our hypothesis is confirmed, the findings of this study may encourage a more informed approach to test selection, improvements in healthcare resource utilisation, and enhance the interpretation of histopathology reports.

  • Flexible Bronchoscopy Insufflated and High-Flow Nasal Oxygen Pilot Trial in Children

    Infants and children with an abnormality in their airway and lungs often require procedures to further investigate their lungs and improve their breathing. During the anaesthesia for this procedure, the anaesthetist delivers oxygen and monitors the adequacy of the child’s breathing. In this situation both the proceduralist and the anaesthetist share the child’s airway for delivery of oxygen and for placement of a small telescope to directly view the anatomy within the airway and lungs. It is impractical for the anaesthetist to place a breathing tube into the airway for delivery of oxygen as this obstructs the view. It is not uncommon for the oxygen levels in the blood to fall (hypoxaemia) during these procedures. The procedure may need to be interrupted to correct this which can potentially compromise the safety of the child, prolong the procedure, increase exposure to anaesthetic agents and affect the success of the procedure. At Queensland Children’s Hospital, we reviewed the anaesthetic care of children undergoing flexible bronchoscopy procedures and found that 28% of children experienced low oxygen levels one or more times during the procedure. The method which the anaesthetist chooses to give the oxygen to the child may help to prevent the occurrence of low oxygen levels. Traditionally anaesthetists have delivered oxygen via face mask or airway device which is placed inside the mouth above the voice box part of the airway at flow rates of up to 6 litres per minute. Our research team have recently investigated a new mode of oxygen delivery called Nasal High. Flow. In Nasal High Flow, warm and humidified oxygen is delivered to the airway via nasal cannulae, at a rate determined by the child’s weight. For example, Nasal High Flow can be delivered at rates of 2L/kg/min. Therefore, a 10kg infant would receive 20 litres per minute. Matching the flow delivered to the patient’s breathing allows the anaesthetist to deliver oxygen to the child at the required concentration. Our recent studies have demonstrated Nasal High Flow is an effective alternative technique for oxygen delivery that can be safely used in infants and children with abnormal airways. To date there have been no large-scale studies evaluating Nasal High Flow in comparison to other oxygenation techniques during flexible bronchoscopy in children. Therefore, we aim to compare the two techniques using a randomised controlled trial in infants and children during flexible bronchoscopy. If we can determine that Nasal High Flow reduces the risk of low oxygen levels, this has the potential to both improve both the safety and the success of these procedures for children.

  • Evaluation of Swelling following Radiation Therapy for Non-Melanoma Skin Cancer of the Legs.

    With recent advances in radiation therapy, non-melanoma skin cancer of the legs may be treated using volumetric modulated arc therapy (VMAT). The purpose of this study is to monitor swelling during and following VMAT treatment. Who is it for? You may be eligible for this study if you are aged 50 years or above, have symptomatic extensive skin field cancerisation, and are undergoing VMAT radiation therapy. Study details All participants in this study will continue to receive VMAT radiation therapy as per routine clinical care. Participants will undergo two indocyanine green lymphography scans which will be used to map the lymphatics. These scans will be done prior to commencing radiation therapy and six months after completing radiation therapy. Additionally participants will have their legs measured (using a tape measure), bioimpedance spectroscopy (BIS) measurements using the SOZO® ImpediMed, Australia) device, and fill in questionnaire/s weekly during their radiation therapy then at 1,2 and 6 weeks, and 3- and 6-months post completion of radiation therapy. BIS a non-invasive, pain free method of measuring fluid levels and body composition. All additional study assessments except for the ICG lymphography scans will be completed when the participant attends for clinical review. It is hoped that this research will reveal factors that influence swelling during VMAT treatment and improve understanding of radiation therapy for treating non-melanoma skin cancer.

  • DeCaf-Me: Can delirium be prevented with caffeine and melatonin? A randomised, placebo-controlled trial

    DeCaf-Me: Prevent Delirium with Caffeine or Melatonin is a open label cross over factorial randomised controlled trial that is aiming to recruit 57 spinal or vascular participants over the age of 65 at Royal Prince Alfred Hospital. Participants will be recruited via the Department of Anaesthetics in the pre-admission clinic. They will be assessed for eligibility and risk at this time, informed consent will be done pre-operatively. Participants will be randomised to one of four arms - 1)100 mg caffeine at 7am and 2pm, 4 mg melatonin at 8pm, 2)100mg caffeine at 7am and 2pm, 3)4mg melatonin at 8pm or 4)no intervention. Primary outcomes are incidence of post-operative delirium on day 1 and secondary outcomes are Richmond Agitation and Sedation Score, differences in EEG power from 0.5-0.6Hz, changes in incidence of delirium, post-operative pain and opioid use. Patients will be monitored intraoperatively via BIS monitoring/EEG and on post operative days 1-3 receive delirium assessments on the ward/ICU. Additionally an EEG will be preformed on post-operative day 1 and a 10mL blood sample will be collected for biomarker analysis during standard blood collection intra-operatively and on post-operative day 1. Participants will be finished on post-operative day 7 after completing a cognitive assessment in person or over the phone. The rationale of this study is that the use of post-operative caffeine could have an effect on inflammation that could effect post-operative delirium severity and the consequential slowing of electroencephalogram readings. Additionally the use of caffeine and melatonin to help maintain circadian rhythms could help promote more restful sleep and reinforce normal sleep patterns which can reduce instances of post-operative delirium.

  • Seaweed extract, Fucoidan, as a supplement to support the development of muscle strength and function

    Nutritional supplements are routinely ingested throughout a training period to maximise exercise-based adaptations. Edible seaweeds (macroalgae) have the potential to provide a rich and sustainable source of macronutrients and micronutrients to the human diet. The recent surge of interest in seaweed is fueled by attention on the bioactive components of seaweed, which have potential applications in the food and nutraceutical industries, with impetus toward the reducing cholesterol and improving blood sugar levels. One candidate bioactive compound of interest is the polysaccharide, Fucoidan. Fucoidans are found in brown seaweeds and the health benefits of Fucoidans have been demonstrated in both human and animal studies where the multiple effects include anti-inflammatory, anti-oxidant, anti-tumour, and immune-modulating properties. Our research group in collaboration with industry leading Fucoidan producers (Marinova Pty Ltd) have shown in a pre-clinical study in mice that a novel Fucoidan blend increased muscle mass. While the animal study evidence does exist for Fucoidan imfluencing muscle health, more human evidence (including mechanistic evidence) is needed to evaluate both the nutritional benefit conferred and the efficacy of Fucoidan on muscle health. Therefore, the aim of this pilot clinical trial is to evaluate the effect of oral supplementation of a Fucoidan blend on exercise endurance, muscle strength, anabolic parameters and lean body mass in healthy human subjects. We hypothesize that fucoidan could be a supplement that increases muscle strength with greater adaptations when consumed in addition to resistance training. Here we propose a study designed to establish whether a novel fucoidan blend can potentiate the adaptation of muscle to a resistance training protocol.

  • Western Australia Asbestos Review Program

    This is a longitudinal observational study that will monitor the health of Western Australians who have been exposed to asbestos through an annual clinical review. Who is it for? You may be eligible for this study if you are a resident of Western Australia aged 16 years or older, you are an asbestos exposed ex-worker and/or ex-resident of Wittenoom (the asbestos mine), or if you are an individual with more than 3 months cumulative asbestos exposure and/or radiological evidence of asbestos related disease. Study details All participants who choose to enrol in this study will be asked to undergo a general and lung health assessment, lung function tests and an ultra-low dose CT scan of the chest to look for lung disease from asbestos. The Western Australian Asbestos Review Program (ARP) also performs blood tests to see if we can find markers of lung disease to help diagnose problems earlier. Each of these investigations will be completed annually, the appointment usually takes about two hours. The ARP has no limit on age or how long it is since first exposure to asbestos – the study aims to follow as many people exposed to asbestos for as long as possible. It is hoped this research will provide important information that will allow clinicians to further characterise, diagnose and understand asbestos-related diseases. This information may then be used to improve health outcomes of future patients who have been affected by asbestos exposure.

  • A Phase II, prospective, open-label, dual-centre, single-arm feasibility study of Pregabalin for the management of uraemic pruritus in patients with End Stage Kidney Disease (ESKD) who are conservatively managed.

    Itch is a common and disabling symptom for people living with advanced kidney disease (termed Uraemic Pruritus (UP)). It causes skin irritation and bleeding, disrupts sleep, is associated with mood changes (depression) and often indicates a shortened survival. As many as 75% of patients, who are not receiving dialysis, suffer from UP. The cause of UP currently remains poorly understood. Pregabalin is a medication which acts by desensitizing peripheral nerve fibers, which leads to a reduction of the itch sensation. It is an emerging drug that is becoming more commonly used in clinical practice to treat UP. However, current evidence is weak, and further research is required to definitely confirm the benefit of this medication. This proposed Phase 2 Feasibility Study is an open-label, single arm, dose up-titration study that is looking at Pregabalin efficacy and tolerability in treating patients with moderate to severe UP who are being conservatively treated for End Stage Renal Failure (ESRF) (eGFR<30, CKD 4 and 5). The primary outcome measure is to recruit at least 24 patients over a 12 month period at both Liverpool and St George Hospitals. It is a 12 week study with the primary outcome measure at Week 4 which specifically looks at a Retention rate of >60. It is important to note that both hospitals contain large culturally and linguistically diverse (CALD) populations. The results of this Phase 2 study will be used to design a subsequent Phase 3 study that will specifically look at the effectiveness of Pregabalin for the treatment of UP and may facilitate access to the medication through subsidised means, if found to be effective.

  • The Dose and Timing Relationship Between Caffeine and Subsequent Sleep Quantity and Quality

    This research project is investigating if the amount of caffeine and the time that it is consumed during the day changes the quantity and quality of night-time sleep. The project will involve a low (100mg) and high (400mg) dose of caffeine administered in the morning, afternoon and evening to find out if the effect on sleep changes. Given caffeine is a stimulant, it is expected that sleep will be influenced when more caffeine is consumed closer to bedtime. By investigating different dose and timing combinations, we are aiming to determine if there is a cut-off time for consuming caffeine to avoid poor sleep. This is important as poor sleep is associated with an increased risk of illness, accidents and injuries.

  • Paediatric Intensive Care Unit (PICU): Every Child, Every Day, Back to Play: the PICUstars protocol

    PICU related complications can affect up to 66% of critically ill children. They not only impact duration of hospital length of stay and cost of care (short-term impacts), but can also cause morbidity with significant ongoing negative consequences on the child’s quality of life, including psychological, behavioural and neurocognitive problems (long-term impacts). There is a lack of paediatric specific bundles to help in the recognition and prevention of PICU-related complications. It is essential to have more studies shifting from a mortality focus to quality of survivorship. The focus of the PICU Liberation study is improvement in quality of care through interdisciplinary team collaboration and best methods for sustainable quality inititative implementation. There is strong clinical evidence in the adult ICU context that the ICU Liberation program leads to significant, and dose-related, improvements in patient outcomes. This study is a single-centre prospective cohort trial evaluating the PICU Liberation program that adapts the A2F bundle in adult ICU to the PICU of a large children’s hospital in Queensland (Australia). The study aims to establish the feasibility of adapting the A2F bundle from the adult to the child context, assess the implementation success of the PICU Liberation trial through measuring the capacity to achieve A2F bundle objectives, improve patient quality of care, and optimise children’s recovery as well as reducing PICU length of stay.

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