ANZCTR search results

Severe aplastic anaemia is a rare disease where current standard upfront treatment is immunosuppressive therapy (IST) in those ineligible for haematopoietic stem cell transplant (HSCT). Approximately 20% of patients with severe AA are refractory to IST and another third of patients will relapse within two years. Partial or no response to IST leaves patients at ongoing risk of life-threatening complications of AA such as, infections, haemorrhage and patients will require ongoing supportive treatments such as antibiotics, red blood cell and platelet transfusions, to combat these complications. Eltrombopag is a thrombopoietin (TPO) mimetic and has shown promising efficacy for severe AA in phase II trials. Avatrombopag is a second generation TPO mimetic which has been studied in immune thrombocytopenia and thrombocytopenia due to chronic liver disease. It has several potential advantages over eltrombopag, including dosing, lack of toxicities, pharmacokinetics and potential increased potency. Avatrombopag has not been tested in AA to date. In this study, avatrombopag will be given to severe AA patients relapsed or refractory to IST to determine if the rate of production of platelets, red blood cells and white blood cells is increased.

Severe aplastic anaemia is a rare disease where current standard upfront treatment for patients ineligible for haematopoietic stem cell transplant (HSCT) is immunosuppressive therapy (IST). Although patients with severe AA treated with IST (horse antithymocyte globulin [ATG] and CyA) have overall responses reported in 50-75%, the minority achieve complete responses, approximately 20% are refractory to IST and approximately 30% will relapse by 2 years. Partial or no response to IST leaves patients at ongoing risk of life-threatening complications of AA such as infections, haemorrhage and patients will require ongoing supportive treatments such as antibiotics, red blood cell and platelet transfusions, to combat these complications. Eltrombopag is a thrombopoietin (TPO) mimetic and has shown promising efficacy for severe AA in phase II trials. Avatrombopag is a second generation TPO mimetic which has been studied in immune thrombocytopenia and thrombocytopenia due to chronic liver disease. It has several potential advantages over eltrombopag, including dosing, lack of toxicities, pharmacokinetics and potential increased potency. Avatrombopag has not been tested in AA to date. In this study, avatrombopag will be given in addition to standard IST to treatment naive severe AA patients to determine if the rate of production of platelets, red blood cells and white blood cells is increased.

This study aims to evaluation of The Chinese Herbal Medicine (T50) as Add-on Treatment to Metformin Monotherapy in Participants with Type 2 Diabetes Mellitus: A 12-week randomised, double-blind, placebo-controlled pilot clinical trialParticipants will be male or female, aged greater than or equal to 18 years, with type 2 diabetes treated with metformin as monotherapy and with suboptimal glycaemic control as evidenced by a glycosylated haemoglobin (HbA1c) level between 7% and 9%. Participants will be recruited from a large GP centre in Sydney. Awareness of the study will be via the University of Technology Sydney website, and by advertising in the Medical Centre. Study Drugs: T50 (a sachet formulation of Chinese herbal extracts)

Research Aims: To determine the clinical effectiveness of the Epley manoeuvre versus the somersault manoeuvre using a multi-axial repositioning device (Epley Omniax Machine) for the treatment of posterior canal Benign Paroxysmal Positional Vertigo (BPPV). This will be a randomised controlled trial. Participants: ~100 participants with Posterior canal Benign Paroxysmal Positional Vertigo Methods: Participants will be recruited from The Royal Victorian Eye and Ear Hospital Balance Disorders and Ataxia Clinic from those referred to the Epley Omniax for repositioning treatment of BPPV. For those determined to have posterior canal BPPV, they will be randomly assigned to one of two treatment groups being either the Epley manoeuvre, or the Somersault manoeuvre. A maximum of four treatments will be performed before removing from the trial. Patients will receive the alternative treatment if the experimental treatment is not successful. Treatment success is determined by resolution of nystagmus and symptoms on re-assessment. Expected outcomes: It is anticipated the somersault manoeuvre could be more clinically effective than the Epley manoeuvre for the treatment of BPPV, particularly in the case of refractory presentations.

Study Synopsis Background: Post-Traumatic Stress Disorder (PTSD) is a mental illness that develops in some individuals following a traumatic event. PTSD can cause significant distress, poor function and detrimental health outcomes for patients as well as their primary relative/friend or carer and has been estimated to be prevalent in more than a third of both patients and relatives, though reported prevalence is highly variable. Objective: Quantify the burden of PTSD in survivors of out-of-hospital cardiac arrest (OHCA) and in their primary caregiver at 6 and 24-months and determine changes over time in PTSD rates. Method: This is a sub-study of the TTM2 Trial. All participants that have been included in the TTM2 trial who attend the 6-months follow-up for the main study are eligible for inclusion in the PTSD study. The primary carer of the participant is also eligible if they meet the following criteria: Witnessed the cardiac arrest OR visited the participant at least once in the ICU AND lives with the participant OR whom has weekly or more frequent contact (in person or over the telephone) with the participant AND attends the 6-months visit with the participant. The participant and their primary caregiver will be asked to complete a self-administered 20-item questionnaire (Post-traumatic stress CheckList-5 (PCL-5)). Outcome: Proportion of participants and primary caregivers meeting the mild, moderate, severe and extreme Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) categories for PTSD symptoms. Changes over time of PTSD rates at 6-months vs 24-months will also be reported.

This project evaluates the effectiveness of cognitive-behavioural therapy (CBT) for improving depressive symptoms for older adults living in residential aged care facilities. The therapy involves three components: Face to face CBT for residents, training and support for family or friends of residents (“family/friends”) and training and consultation with facility staff. Hence, the treatment involves a systemic approach involving residents, family/friends and facility staff. Using a cluster-randomised controlled trial, this project compares the effectiveness of the intervention over and above usual practice, for improving depressive symptoms in residents of aged care facilities.

The number of people needing a colonoscopy is going to increase in the future following the national rollout of the National Bowel Cancer Screening Program (NBCSP). The NBCSP was extended to include Australians 60 and 70 years in 2013 and 2015 respectively and biennial screening from 2017-18, meaning that the future demand for screening and surveillance endoscopy procedures is set to escalate, and the current service model will not meet demand. This has prompted reconsideration of current models of service delivery. It is important to gauge how well a novel service model will be received before the development of a role can occur. This study aims to hypothetically test a general service model that has not been wholly defined. The level of agreement or disagreement with the statements will indicate, in general terms, the level of support such a role would garner from the Department of Anaesthesia. Participants will have the opportunity to discuss their support or concerns for the program. Themes identified in these discussions will be used to influence future decision making. The survey and face to face interviews have been designed to be completed quickly and pose no risk of harm to the participants.

For shift workers there is an increased risk of 23% of developing obesity and 44% of developing type 2 diabetes. There are currently 1.5 million Australians (~16% of workforce population) who are at risk. The risk of obesity and type 2 diabetes in this population group do not appear to be related solely to overall energy intake. Previous research has shown that meal timing i.e. eating late into the night, as is common among shift worker, is associated with metabolic complications such as impaired glucose tolerance and insulin resistance, potentially contributing to weight gain. However, there is currently a lack of evidence to identify effective weight loss strategies in shift workers with obesity. We aim to compare three weight loss regimens in a population of shift workers to identify weight loss strategies that will a) result in successful weight loss and b) be flexible to the demanding lifestyles of the shift working population. This six month dietary intervention study will compare continuous energy restriction (diet 1) with intermittent fasting (5:2). The two fast days will either be days that participants work a day shift (diet 2) or days that participants work night shift (diet 3). The study hypothesises that each of the dietary interventions will be effective at inducing weight loss but there will be a differential effect of the diets across time on HOMA-IR (a measure of insulin resistance).

In patients in whom intubation of the airway is predicted to be difficult, a C-MAC D-blade videolaryngoscope™ (Karl Storz Endoscopy, Tuttlingen, Germany) is commonly used to improve visualisation of the Glottis. Due to the high angulation of the D-Blade it is not uncommon to encounter a "can see, cannot intubate" situation, This study will compare the intubation times of two airway adjuncts used with the CMAC D-blade - the Construct Medical Flexible Tip Bougie, and the GlideRite rigid stylet, We hypothesise that the flexible tip bougie will offer improved speed of intubation owing to its ability to adjust the direction of the bougie tip during the intubation.

The purpose of this study is to evaluate how a drug moves around the body. The drug is called C595 Mab and will be combined with some existing radioactive chemicals routinely used in cancer imaging, called 99mTc and 111In. Who is it for? You may be eligible for this study if you are aged 18 or older with locally advanced or metastasised pancreatic cancer. Study details All participants in this study will have their scheduled biopsy. After laboratory testing confirms eligibility, participants will receive an injection of C595 Mab with 99mTc through a needle in the arm. Participants will then have a one CT scan. Depending on the results, after two weeks new participants will have an injection of C595 Mab with 111In through a needle in the arm, and three CT scans. Participants that will receive either 99mTc or 111In injections will have their vital signs (like temperature, blood pressure, heart rate and pulse) monitored for a few hours after their injection. It is hoped this research will help provide further information on the safety and usefulness of C595 as part of a potential future therapy for pancreatic cancer.