ANZCTR search results

The principal aim of this clinical study was to determine the short-term blood-glucose control and tolerability of Partially-hydrolysed guar gum (PHGG) and Gum Arabic in mild-to-moderate symptom gastroparesis patients. There were four interventions in total, the test fibres PHGG and Gum Arabic, the positive control Psyllium Husk and the negative control Water. The study hypothesizes that the 'low-viscosity' test fibres PHGG and Gum Arabic provide blood glucose regulation / control comparable to the positive control, Psyllium Husk, while causing fewer severe symptoms comparable to the negative control, Water.

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 in the absence of exercise, a novel Fucoidan blend increased muscle mass. While the animal study evidence does exist for Fucoidan influencing 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 muscle health and lean body mass in healthy human subjects not participating in any form of exercise. We hypothesize that fucoidan could be a supplement that increases muscle strength without a need for exercise. Here we propose a study designed to establish whether a novel fucoidan blend can improve muscle and body health in sedentary participants.

The aim of this study is to investigate if patients can safely continue their blood thinner medication for small polypectomies without any procedure related complications.

With 1 in 9 Australians of childbearing age living with endometriosis, this chronic condition is characterised by debilitating physical symptoms which negatively impact on their psychological wellbeing and quality of life. This pilot study will assess the feasibility of a co-designed supportive text message program (EndoSMS) to enhance the psychological wellbeing and quality of life of those with endometriosis. Co-designed text message interventions have been demonstrated to improve health-promoting behaviours and medication adherence in individuals with chronic conditions and are a cost-efficient means of providing health education and support. Text messaging is particularly suited for young to middle-aged people (the majority of those impacted by endometriosis) because mobile phone ownership is high, little effort is required to receive the intervention, and texts can be read/re-read at times that suit users. Informed by psychological and communication theory, this study aims to develop a co-designed bank of text messages focused on providing evidence-based information about endometriosis management, psychological support and tips for self-care and a healthy lifestyle. Following co-designed development of the text message bank, piloting of the EndoSMS intervention will be undertaken with a minimum sample of 120 individuals living with endometriosis.

This within-patient, split-mouth randomised controlled trial aims to determine whether orthodontic bracket bonding with resin-modified glass ionomer cement (RMGIC) to sodium hypochlorite (NaOCl) conditioned enamel will affect the development of white spot lesions (WLSs) compared to brackets bonded with resin composite cement (RC). It is hypothesised that bonding with RMGIC after pre-treatment with NaOCl will reduce the prevalence of WSLs around orthodontic brackets compared to RC.

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.

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.

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.

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: 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.