ANZCTR search results

This project will recruit pregnant women to receive either a prebiotic supplement or a placebo supplement. They will be asked to take the supplement from 18-20 weeks gestation until their baby is 6 months of age. We will then examine whether supplementing the mother’s diet during pregnancy and breastfeeding with the prebiotic powder will reduce the development of allergies in her child. Both study groups will include children deemed to be at high risk of allergic disease (based on family allergy history).

This study aims to invesitgate the neuroprotective effects of ketamine in elderly patients undergoing cardiac and major vascular surgery. Delirium and depression are common effects of cardiac and major vascular surgery. Ketamine is believed to have a protective effect against delirium and depression. Participants will undergo neuropsychological testing prior to surgery and again at day 7 and 3 months postoperatively. Deliriuma and depression will be measured during patient hospital stay. Additionally, inflammatory bloods will be taken to assess the role inflammation plays in the role of postoperative cognitive dysfunction.

UBWELL is a smart-phone app-based continuous, real-time data tracker which can link to current available wearable technology (i.e. Fitbit) and other smart software systems (i.e. HealthKit, Google Fit and Project Synergy) to collect physiological and experiential measures and then monitor, analyse and report these results. Currently, UBWELL can measure physical activity, sleep, mood, anxiety, energy, substance use (alcohol, tobacco), functional engagement (relationships, work, study), healthy eating and weight. This data can be used by an individual to help maintain good health and wellbeing; as well as by health professionals to more effectively plan, implement and monitor treatment to patients, thus providing enhanced, personalised healthcare. The use of this innovative technology has the potential to empower young people to actively engage in their general health and wellbeing (including mental health) by reliably tracking the metrics that are important to them. Unfortunately, the majority of apps for mental health that are currently available lack scientific evidence about their efficacy, and few (if any) have the capacity for the continuous comprehensive integrated assessment that UBWELL offers. This project aims to evaluate the engagement, efficacy and effectiveness of UBWELL (as compared to Recharge and OzHealth) among the Australian general population to improve general health and wellbeing outcomes.

This study investigates whether addition of the drug acetazolamide to a dexamethasone treatment for controlling raised intracranial pressure symptoms, related to high grade glioma brain tumour (such as headache, nausea and vomiting), will allow the dexamethasone dosage to be reduced, and whether this leads to less dexamethasone-related side-effects. Who is it for? You can join this study if you are required to restart or increase a dexamethasone treatment to control recurrent or increased symptoms of intracranial pressure, that may be related to your brain tumour, high grade glioma. Study details: If you like to join this study you will first be screened by your specialist to see if you meet the eligibility criteria to participate in this study. If you are deemed eligible to participate you will be randomly (by chance) assigned to one of two possible treatment groups: Group 1 will receive 1 tablet of 250mg acetazolamide twice per day for 8 weeks, in addition to the dexamethasone treatment. Group 2 will receive 1 tablet of placebo twice per day for 8 weeks, in addition to the dexamethasone treatment. Your chance to receive the group 1 treatment is equally high as to receive the group 2 treatment. You cannot choose to which group you are assigned and both you and your doctor will not know which treatment you received until the study is finished. Participants will be asked to attend clinic visits every 2 weeks during the treatment period and then 1 more time (about 1 month after having received the last treatment). During these visits the specialist will assess your physical and mental health, and ask you about your well-being. Participants will also be asked to undergo tests and procedures, such as blood testing, scans, and questionnaire completion.

Stabilizing the circulation of critically ill patients presenting with severe sepsis or septic can be complicated by a phenomenon called catecholamine hyposensitivity, which leads to a decreased effect of vasoactive drugs. Massive release of endogenous catecholamines like adrenaline and noradrenaline in the setting of sepsis can cause down-regulation and de-sensitization of alpha-1 receptors making the vasculature less responsive to catecholamines. Interestingly, animal studies found that high doses of central alpha2-agonists like clonidine and dexmedetomidine increase vasopressor responsiveness in a septic shock model. In view of the potentially deleterious effects of adrenergic overstimulation and receptor desensitization more research about the effect and use of alpha-2-agonists in clinical doses and critically ill patients is warranted. In the critical care setting, the alpha-2-agonist clonidine has become an established drug for the management of conditions with a high sympathetic activity and it is also commonly used as a supplementary sedative agent. Dexmedetomidine has anaesthetic and analgesic properties and has much higher a2-receptor selectivity than clonidine. Like clonidine, dexmedetomidine is used for sedation in adult critically ill patients. In view of the potential benefits of dexmedetomidine in septic patients, we aim to conduct a retrospective cohort study of the haemodynamic effect of dexmedetomidine compared to standard care sedation in septic patients admitted to the intensive care unit of the Austin Hospital.

This study aims to investigate if, following anaesthesia related healthcare inteventions, individuals with higher levels of inflammation at baseline, have a higher rate of postoperative cognitive dysfunction at 3 months after surgery. Participants will be having surgery with an expected stay of 3 or more days and consent to neuropsychological testing and having bloods taken during their hospital stay. Cognitive and memory testing will take place prior to surgery and at 3 months after surgery. Tests for delirium will also be conducted during the participants time in hospital.

Delivery of air flow by high flow nasal cannula (HFNC) has become increasingly popular in neonatal and paediatric intensive care units throughout Australia and the world. Despite this, there is limited knowledge on how to determine the most appropriate flow rate for the infant. This study will measure the electrical activity of the diaphragm to determine when the work of breathing is optimal and then examine what other physiological measures correlate with this. The aim of this study is to demonstrate the physiological effect of randomly applied levels of high flow on the work of breathing (WOB) indirectly measured with electric diaphragmatic activity. Methods: This is a prospective interventional study of premature infants with respiratory distress admitted to the Neonatal Critical Care Unit (NCCU), Mater Mothers Hospital, South Brisbane and infants with bronchiolitis admitted to Lady Cilento Childrens Hospital (LCCH). Work of breathing (WOB) will be measured with diaphragmatic electrical activity - measured transoesophageal (Edi)and transdermal (Tdi), and respiratory inductance plethysmography (RIP). Using the Edi signals we will measure the WOB during HFNC treatment and assess its impact on patients with respiratory distress. Edi requires inserting a specially designed sensing nasogastric tube into the infants’ nose, Tdi involves placing five regular skin elecrodes on the chest, and RIP consists of two stretch bands placed around the chest and abdomen. Both Edi and RIP signal can be recorded continuously during the entire study period and recorded on a dedicated computer and further analysed. Physiological variables of respiratory rate (RR), heart rate (HR), and oxygen saturations (SpO2) will also be monitored throughout the study. From the collected data the SpO2/FiO2 ratio will be calculated. Study Procedure: Infants recruited into the trial will be on HFNC oxygen therapy using the Fisher & Paykel 850 humidifier. The in situ nasogastric tube will be replaced by the Edi probe. The first measurement will be done when the infant is settled but within the first 24 hours of HFNC administration. Thereafter, flow rates between 2 and 8 L /min will be randomly applied for the preterm infant and between 0.5 L/kg/min and 2 L/kg/min for the infants with bronchiolitis. At the conclusion, initial HFNC settings will be reinstituted.

The primary purpose of this study is to determine the feasibility and efficacy of an exercise program to ameliorate the primary physical and mental health problems faced by men on prostate cancer active surveillance and to explore potential mechanisms underlying the influence of phsical exercise on markers of disease progression. Who is it for? You may be eligible to join this study if you are aged 18 years or over and have been diagnosed with prostate cancer in the previous year, currently undergoing active surveillance. Study details Participants will be randomly allocated (by chance) to receive either the exercise program or usual care. Participants in the exercise program group will receive supervised resistance and aerobic exercise sessions, each lasting approximately one hour, three times per week for six months. These participants will also be encouraged to complete additional aerobic exercise at home to create a total of 150 minutes of moderate aerobic exercise per week. Participants allocated to receive usual care will be encouraged to complete a walking program and will be given an information booklet detailing the current national aerobic exercise recommendations for cancer survivors along with a log-book to record their physical activity. The aim will be to complete a total of 150 minutes of aerobic exercise per week by month 6. Patient outcomes will then be assessed through blood samples, fitness tests and questionnaires at 3 months and 6 months. It is hoped that the findings of this trial will provide information regarding the feasibility of implementing an exercise intervention for prostate cancer patients on active surveillance, as well as the efficacy of such a program on mental and physical health outcomes, as well as on disease progression.

People with cystic fibrosis (CF) often have thick mucus in the airways of the lungs that is hard to cough up. The mucus builds up and eventually leads to chronic cough and lung infections. Research has shown that even young children with CF may have thickened mucus in the lungs. Inhaling a concentrated salt solution, called hypertonic saline (HS), may help thin the mucus in the lungs. Thinning the mucus can make it easier to cough up. This helps to clear the lungs and improve lung health. Research studies about the safety and effectiveness of inhaled HS have been done in adults and children with CF 6 years of age and older. Patients in these studies took HS for up to a year. HS appears to be a safe treatment in these age groups. The main side effects were cough, throat irritation, and wheezing. The use of HS in older children and adults decreased the need for antibiotics for acute respiratory infections. It also improved lung function and quality of life. HS is now routinely used by many CF patients over 6 years of age. Because HS treats a very early step in the chain of events that leads to chronic lung problems in people with CF, it may be particularly helpful when started early in life. Based on several studies, HS appears to be safe in children less than 6 years of age, but its effectiveness has been difficult to measure. In a previous study, children less than 6 year-old receiving HS had the same number of lung infections as children receiving normal saline. However, we think that children this young need a more sensitive test to see if HS works in preventing lung damage. In this study Computed Tomography (CT) scans will be used to get an image of the lung. In addition a new type of breathing test, called Multiple Breath Washout (MBW), will be used. This is relatively easy for preschool children to perform, and may allow us to measure the effectiveness of HS in preschool children with CF. The MBW tests measures lung function. This study will be conducted in parallel with the North American SHIP001 clinical study, registered on Clinicaltrials.gov NCT02378467.

The objectives of treatment of symptomatic rotator cuff disease are to relieve pain and restore movement and function of the shoulder. Surgery is usually reserved for patients who fail to respond to conservative treatment. Greater understanding of the cellular and molecular pathology of tendon injury led to the development of biological scaffolds to augment tendon repair. The scaffold promotes cellular migration, adhesion and proliferation. This results in rapid ingrowth of host tissue and assists with transition of remodelled tissue into mature tendon in the bioactive chamber created by the membrane-tendon interface. Scaffolds are not intended to replace normal body structure or provide full mechanical support for tendon repair. Commercially available scaffolds for tendon repair are manufactured from animal or human connective tissues such as dermis, small intestine mucosa and pericardium. The tissues are processed to extract lipids, DNA and other non-collagen components, and may be cross-linked to increase mechanical strength before sterilisation. Removal of non-collagenous components is critical to avoid foreign-body reaction or rejection by the host. The final product is a membrane composed predominantly of type I and III collagen fibres. CelGro(tm) is an acellular type I/III collagen membrane of porcine origin manufactured in Australia by Orthocell Ltd and is intended for use as a resorbable bioscaffold in surgical applications. It is a Class III Medical Device. The product consists of natural collagen bundles without cross-linking or chemical additives. It is free from animal-derived DNA and pathogens of porcine origin. CelGro(tm) presents as a white to off-white sheet of collagen fibres with both a smooth and slightly rougher surface. Due to the natural origin of this product, small variations in thickness and surface texture may be noted. The CelGro(tm) bilayer structure has a rough, porous side that allows for the ingrowth of cells and a smooth side which prevents invasion of connective tissue. The rough side has a random and loose distribution of collagen bundles of varying size and length. The smooth side is composed of parallel arrangements of densely packed collagen bundles with abundant knitted collagen holes which enable cells and fluids to pass through to the rough side. CelGro(tm) is manufactured in Australia, using collagen originating from Australian Government veterinarian-certified animals bred and raised in Australia, eliminating disease transmission concerns associated with foreign products. Additionally, the collagen bundle structure of CelGro(tm) is mechanically stronger and more elastic than other collagen membrane products of this type. This trial is a pilot study to explore the use of CelGro(tm) collagen membrane to augment surgical repair of rotator cuff tendinopathy and tear.