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Atezolizumab Trial in Endometrial cancer.
Expand descriptionThis study is testing a new cancer treatment, atezolizumab, given in combination with standard chemotherapy (paclitaxel and carboplatin) for endometrial cancer. Who is it for? You may be eligible to join this study if you are a woman aged 18 years or above, with advanced endometrial cancer or endometrial cancer recurrence. Study details Patients will be randomly allocated to one of two groups, Group 1 or Group 2. Group 1 One third of participants will receive paclitaxel and carboplatin administered intravenously (through a fine needle directly into a vein in your arm or through an infusion port if you have one) every 3 weeks for 6-8 cycles or until treatment no longer seems to be controlling your cancer, whichever comes first. In addition, a placebo will be given via a vein every 3 weeks, until the treatment no longer controls the participants cancer. A placebo is a medication with no active ingredients that is identical in appearance to the real medication. Group 2 Two thirds of participants will receive of paclitaxel and carboplatin administered intravenously (through a fine needle directly into a vein in your arm or through an infusion port if you have one) every 3 weeks for 6-8 cycles or until treatment no longer seems to be controlling your cancer, whichever comes first. In addition, atezolizumab will be given via a vein every 3 weeks, until the treatment no longer controls the participants cancer. The purpose of this study is to measure the effect of atezolizumab given in combination with paclitaxel and carboplatin and placebo given in combination with paclitaxel and carboplatin. This study will also investigate the activity of this treatment on the control of cancer growth.
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Evaluation of peripheral intravenous volume analysis in patients receiving haemodynamic monitoring
Expand descriptionThe monitoring of blood volume status in patients requiring advanced monitoring in the operating theatres or the intensive care unit is fundamental to patient protection and treatment. However, it is currently difficult and only partly addressed by the use invasive monitoring devices. The development of new technique called peripheral intravenous volume analysis (PIVA) has recently been shown in animal experiments and dialysis patients to provide a continuous, reliable, reproducible, safe, and non-invasive assessment of blood volume state. The monitor then does mathematical modifications of the pressure waves to calculate a blood volume signal. Then it displays such information about the pressure generated by the volume of blood in the veins to the treating doctor. Finally, the monitor allows the collection of such pressure information every minute, which can then be used for detailed analysis. In this study, we simply want to connect this device to the existing drip line in a group of patients having major surgery or admitted to ICU for advanced haemodynamic monitoring. The aim of this study is to see if the PIVA monitoring delivers similar information to that which we currently obtain with more invasive, more expensive, and more complex technology. Moreover, we aim to ask clinicians whether easy to use; and achieves the reliable delivery of good quality data. Finally, we wish to see if all these aspects of PIVA prove correct, as we will then seek approval to conduct further and more advances studies of PIVA.
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Follow-on study of a multicentre randomised, controlled trial (PPOIT-003) evaluating the long-term safety and efficacy of Probiotic and Peanut Oral Immunotherapy (PPOIT) compared with Oral Immunotherapy (OIT) alone and with placebo in peanut allergic individuals
Expand descriptionThe aims of the PPOIT-003 randomised trial was to evaluate if Probiotic and Peanut Oral Immunotherapy (PPOIT) is more effective than placebo in inducing sustained unresponsiveness (SU) in children with peanut allergy, and more effective than peanut OIT alone, in inducing SU in children with peanut allergy. This is a follow-on study for all participants who complete the PPOIT-003 randomised trial in order to evaluate whether the beneficial effects of PPOIT (at inducing sustained unresponsiveness or desensitization) are maintained out to 72 months post treatment.
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Is early introduction of tree nuts in infants at high risk of food allergy feasible? The TreEAT Pilot Study: a randomised controlled trial
Expand descriptionEarly and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. Little is known about tree nut allergy. Current allergy testing methods are indicative of IgE sensitisation only and are not diagnostic of food allergy. Current practice at RCH allergy clinic in children who are egg and/or peanut allergic is to advise families to introduce each individual tree nut into their child’s diet via a cautious home introduction protocol without prior allergy testing (screening). The safety and effectiveness of this strategy has not been formally evaluated. This pilot study is a 2-armed, open-label, randomised, controlled trial (RCT) to assess the safety and feasibility of a supervised hospital based multi-tree nut oral food challenge (OFC) versus standard care (home introduction of individual tree nuts) in infants with egg and/or peanut allergy to reduce the risk of developing tree nut allergy.
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The effect of red meat consumption on human metabolic and gut health in free living adults.
Expand descriptionThis study will investigate the effects of regular and premium grade beef mince consumption on indicators of metabolic and gut health in healthy human participants. The specific aims of this study will determine the effects of two, 1-week intervention periods on either regular or premium grade beef mince consumed at in low (65g /day) and high (130g/day) amounts. The specific aims of the study will seek to determine the metabolic and gut response to red meat as part of the habitual diet in free living healthy adults; and how the quantity (serving size) and quality (fat content) of red meat mediates these responses. By answering these questions the study will aim to generate clinically relevant results and knowledge.
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Evaluation of the Implementation of a Delirium Education Intervention using Clinical Simulation in a Private Healthcare Setting
Expand descriptionThis study will be a clustered randomised control trial comparing a multi-modal delirium education intervention to traditional didactic education on translating delirium knowledge into clinical practice. The study will be conducted across three private hospital sites, with inpatient medical and surgical wards randomised into the intervention or control group. All participants will be invited to complete a survey at two time points, (i) immediately prior to the intervention and (ii) 6 weeks post intervention. The surveys consist of four questions asking the participants to rate their self- perceived confidence and competence on delirium assessment and knowledge using a 5-point Likert scale. The surveys also consist of a 20 questions delirium knowledge quiz. Six weeks post intervention participants will be observed in clinical practice undertaking a delirium assessment.
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Shared Medical Appointments for Type 2 Diabetes
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The impact of continuous terlipressin infusion on complications of end-stage liver disease
Expand descriptionEnd-stage liver disease, known as cirrhosis, is a common condition in Western society, and is associated with poor prognosis. Cirrhosis can lead to many complications, including fluid retention, kidney impairment and increased risk of infection. Many patients with cirrhosis are malnourished and also develop muscle wasting. Terlipressin is a medication used in the management of severe bleeding and some forms of kidney impairment associated with liver disease, but little is known about its impact on other complications of liver disease such as muscle wasting, fluid retention or infection. Early data from our centre suggests that terlipressin can also improve nutrition in this population. This study will attempt to confirm that long-term terlipressin can improve nutrition and muscle mass in patients with end-stage liver disease as well as understanding the mechanisms by which this occurs. It will also look at whether it improves other complications such as ascites (fluid retention in the abdominal cavity), infection, hospital admissions and healthcare costs. Participants will undertake 2 study periods: an observation period and a treatment period, where they will receive a continuous infusion of terlipressin for 12 weeks which will be administered via the Hospital-in-the-Home program. They will undergo assessment of muscle strength and function using radiology scans and bedside tests, as well as monthly blood tests during both study periods. Hospital records will be accessed to identify causes of hospital admission and estimates of infection rates and to calculate direct healthcare costs. Quality of life will be assessed using validated questionnaires. In total, the participants will be involved in the study for a period of 6 months.
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Accelerating ventilator weaning in spinal cord injury with non-invasive Abdominal Stimulation
Expand descriptionA spinal cord injury is a devastating event, with approximately 350 new cases in Australia every year. Each injury has a lifetime cost of >$5m. More than half of these injuries will be caused by an injury to the cervical (neck) area of the spinal cord, termed tetraplegia. While tetraplegia is commonly associated with paralysis of all four limbs, paralysis also affects the major respiratory muscles, namely the diaphragm, abdominal and intercostal muscles. This reduces respiratory function, with associated complications a leading cause of illness and death for people with tetraplegia. Poor respiratory function leads to approximately 40% of people with tetraplegia requiring mechanical ventilation in the early stage of injury. This increases the likelihood of illness and death, delays rehabilitation and hospital discharge and costs an additional $2,000 per patient per day. The application of electrical pulses to the abdominal muscles, called Abdominal Functional Electrical Stimulation (Abdominal FES) improves respiratory function in tetraplegia. We have shown that Abdominal FES is a feasible technique to assist ventilator weaning for this group. Despite these positive results, a lack of data from large trials has prevented Abdominal FES being adopted as a standard treatment. We propose an international randomised controlled trial to assess whether Abdominal FES reduces mechanical ventilation duration in people with tetraplegia. Such a reduction has the potential to improve the health and rehabilitation prospects of people with tetraplegia globally, and result in a significant cost saving for health care providers. The final outcome of this project will be the development of an Abdominal FES treatment program, facilitating the successful translation of this research into worldwide clinical practice.
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Does a single dose of steroid improve the time to resolution of cellulitis (skin infection) in adults when given with standard antibiotic treatment
Expand descriptionThe use of steroids in combination with antibiotics for cellulitis may reduce symptoms, such as swelling, warmth, pain and redness for patients and time to resolution of the infection. For the Emergency Department (ED) this may mean a reduction in admissions into hospital/observation unit, the use of secondary antibiotics, and re-presentation to the ED. The study is designed as a double-blind placebo-controlled study with the use of a single dose of 50mg prednisolone or a single dose of placebo alongside standard care of antibiotics on first presentation of cellulitis to the ED. Measurement of time to resolution of symptoms will be obtained by telephone follow up at day 3 and 7, also at day 14 if infection has not resolved. Electronic medical records will be checked at day 28 to see if the participant re-presented to ED. There is a suggestion from limited previous research that courses of steroids in cellulitis alongside standard care (antibiotics) have reduced hospital stays. This study will focus on patients discharged from ED with oral antibiotics. Primarily, comparisons will be made between the two groups (steroid vs placebo) to determine if there is a statistically significant difference in time to resolution and patient’s perceived symptoms. The secondary objective will be to compare rates of re-presentation to the ED