ANZCTR search results

The aim of this study is to validate the PICNICC clinical decision rule and explore potential biomarkers that will assist in prediction of microbiologically documented infection in children undergoing treatment for cancer or leukaemia presenting with febrile neutropenia (FN). Who is it for? You may be eligible to join this study if you are aged less than 18 years and have are undergoing active treatment for cancer or leukaemia with a diagnosis of fever and with absolute neutrophil count less than 1.0 cells/ microlitre. Study details The study involves obtaining routinely documented information from medical records related to the FN episode. In addition requesting permission to access Medicare data over a 12 month period, to analyse costs that may have occurred due to the FN episode for the participant and their family. Participants (aged 3 to 18 years) and their parent/guardian will be asked to complete an electronic survey at presentation to hospital, seven days thereafter and a follow up survey at 30 days. At one site participants will be asked to provide two small blood samples at routine blood sampling times to assist in analysing markers in the blood that may be able to diagnose and predict the severity of an infection. FN is the most frequent complication of the treatment of childhood cancer. Throughout Australia and the rest of the world, management usually involves hospital admission for intravenous antibiotics until resolution of fever and recovery of neutrophil count. International and local data indicate these unplanned FN admissions negatively impact quality of life (QOL), increase the risk of hospital-acquired infection and pose a significant economic burden on the healthcare system. In collaboration with the European-based PICNICC group, this project will test an established clinical decision rule (CDR) that predicts severe infection in children with cancer presenting with FN. This rule will enable emergency department, oncology and other paediatric doctors to reliably identify patients at low-risk of severe infection who will benefit from reduced intensity antibiotic treatment and early hospital discharge. This study will also identify novel biomarkers in blood that may be used in the future to improve our prediction of exactly which children with FN have a severe infection. Finally, we will also explore the cost of treatment of FN in Australia as well as the impact of this common condition on patient and family quality of life. This information will be used to inform future research and identify areas for cost savings and improvements in quality of life.

Antihistamines and intranasal steroid sprays are considered first line pharmacological treatment options for alleviating symptoms of allergic rhinitis. The aim of this research is to examine any link between corticosteroid vs antihistamine vs combined corticosteroid and antihistamine administration and local gene expression patterns which may reveal biological pathways involved in each treatment type .

This is a single centre, randomised, double-blind phase 1 study to assess the safety, tolerability and pharmacokinetics (PK) of single ascending doses of intravenous (IV) or subcutaneous (SC) administrations of CSL312 in healthy subjects. A maximum of 48 subjects will be randomised into this study. Eligible subjects will be enrolled and randomised to receive either CSL312 or placebo. Dosing and initial dose escalation will begin within the IV groups, and upon reaching the third IV cohort, the study will also progress to an SC group. Dose escalation within the IV and SC groups will then progress in parallel with the SC cohorts staggered to start after sentinel dosing in their respective IV cohorts. Blood samples will be collected at various time points for safety, PK and pharmacodynamics (PD) evaluation, and immunogenicity (anti-CSL312 antibodies). Clinical evaluations will include electrocardiograms, vital signs, and physical examinations. Safety follow-up will occur until approximately 84 days after dosing.

In this trial, the safety and tolerability of a EU-C-001 is being evaluated. Additionally the amount of study drug and its metabolites is being measured in blood and urine after it is administered by different routes and at different dose levels. This is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion.

What is known? PVAI for AF is the standard of care in people with symptomatic paroxysmal AF (class I indication) but the next step in ablation for people with persistent AF is unknown. A major international landmark trial has yielded neutral results with some forms of additional ablation but the effect of PWI + PVAI has not been formally assessed in a multicentre randomised trial. What this study adds? Multicentre randomised trial assessing the effect of adding PWI to PVAI in persistent AF on 12-month arrhythmia free survival. Primary Endpoints Recurrence of atrial tachyarrhythmia (AT/AF/AFL) for >30 seconds. Single procedure success rate off antiarrhythmic drugs at 12 months. Secondary Endpoints Procedural duration Fluoroscopy time Requirement for antiarrhythmic medication beyond 3 months Success after multiple procedures at 12 months off AADs Success after multiple procedures at 12 months on AADs Complication rates at 12 months (including pulmonary vein stenosis, perforation, tamponade, stroke) AFEQT quality of life score AF6 score Canadian Cardiovascular Society Severity in AF (CCS-SAF) score New York Heart Association (NYHA) score Echocardiographic dimensions (LA dimensions and volume, left ventricular end-systolic and end-diastlic dimensions)

This is a phase 2 study to assess the efficacy and safety of CMX-020 in treating adults with active osteoarthritis of the knee.

This study aims to investigate the effectiveness and safety of a single intraarticular injection of Articul One in comparison with Synvisc-One Registered Trademark or placebo for the treatment of symptomatic primary knee osteoarthritis. 30 subjects will be randomized to receive either Articul one , the experimental arm (20 subjects), Synvisc-One Registered Trademark, the active comparator arm (5 subjects), or Placebo (5 subjects). This will be done by analysing questionnaires to understand the severity of the disease status, pain and rescue medication diary, and side effects. Safety will be monitored during the treatment visits using standard measures, including physical exams, vital signs (including oral temperature), and side effect monitoring. Subjects may be eligible to join this study if they are aged over 40 years, have knee pain due to osteoarthritis of the knee and are in otherwise general good health. This study will investigate a single dose of Articul One in comparison with Synvisc-One Registered Trademark or placebo (a treatment with no active ingredients which looks like the real thing but it is not). This study is ‘double-blind’ which means the subject and the assessing doctor, together with the study staff will not know whether the subject is receiving Articul One, Synvisc-One Registered Trademark or placebo. The person who administers the injection will be unblinded (they will know what treatment the subject will receive) however, they will not allow the subject or the assessing team know which treatment is being received. The study includes a screening visit (visit 1) to check eligibility and to explain the study.. There will be 1 treatment visit (visit 2) which will occur within 21 days of visit 1. There will also be 4 further visits to assess the safety and effectiveness of the treatment. These visits will occur at weeks 4, 12, 20 and 26. During the follow up period, four clinic visits are required for: review of diary, medications, AEs;. Participants will record rescue pain medication in a daily diary.

The aim of this study is to evaluate the effect of two separate interventions via a randomised controlled trial on the dextrous performance of novice podiatry students in order to identify an evidence-based strategy to help target students struggling with manual clinical skills. One of the interventions will target afferent input (sensory system) via sensory awareness training whilst the other will target efferent output (motor system) via additional motor practice.

This study will be an open-label, 12 week, clinical trial in males aged 18 to 45 with the aim: To compare genetic expression patterns after 12 weeks treatment of temulawak extract in male adults. To evaluate safety parameters of the active compound. A total of 32 participants will be enrolled into the study in order to allow for 24 participants to complete the study. Participants will be asked to attend the clinic at Screening, Day 1 (Visit 1), Day 7 (Visit 2), Day 40 (visit 3) and Day 81 (visit 4) the end of study visit. The study will last approximately 4 months in total for each participant from screening to last visit. Participants will need to attend the clinical unit 5 times for around three hours at each visit.

Alfred Health has implemented a partnered pharmacist medication charting (PPMC) model which has been in place since November 2012. A randomised trial conducted in 2015 demonstrated that PPMC significantly reduced medication errors on admission compared to a standard medical model. As part of a Department of Health Workforce Innovation Grant, the PPMC model is being extended as a standard of care to patients on admission to residential aged care following discharge from an inpatient admission. The specific aim of this project is to evaluate whether a pharmacist generated interim medication chart facilitates the transfer of medication information when patients are transferred from an inpatient hospital admission to a residential care facility. Aiming to reduce the proportion of missed medication doses and the number of locum medical officer visits in the first 7 days postadmission to the residential care facility. And improving the communication and continuation of hospital medication plans onto long term residential care medication charts. A pre and post methodology will involve visiting the 10 most utilised residential care facilities (RCF) in the Alfred Health catchment to collect data.