ANZCTR search results

The Queensland Children’s Hospital and Perth Children’s Hospital have identified a need to determine if SASS is superior to SSD for PICC and tunnelled CVC securement for; a) patients requiring PICC that have compromised skin integrity and b) all patients requiring insertion of tunnelled CVC. The results of this study will inform paediatric healthcare practice, provide reliable estimates of the comparative effect of SASS, and inform the feasibility of conducting a larger, definitive trial. We have completed an inbuilt feasibility study (n=60) and are continuing on to a powered RCT.

This is a Phase 1b, randomised, double-blind, placebo-controlled, parallel study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of multiple SC doses of OLP-1002 in patients who have pain due to moderate to severe osteoarthritis (OA) in a hip and/or knee joint. The study consists of: • Screening period: up to 14 days (defined as Day -23 to -9) • Washout period: 5 days (± 1 day) (defined as Day -8 to -4) • Baseline period: 3 days (± 1 day) (defined as Day -3 to -1, where Day -1 is the day before dosing) • Treatment period: 15 days (± 1 day) (defined as Day 1 to 15, where Day 1 is the day of first dosing) • Follow-up period: 30 days (± 5 days) (defined as Day 16 to 45, assuming Day 15 is the day of the last dose) Up to 30 patients will be enrolled in the study and will be randomised in the ratio 1:1:1 to the following arms: • Arm A: 10 patients will receive 5 µg twice-weekly (BIW) OLP-1002 • Arm B: 10 patients will receive 10 µg BIW OLP-1002 • Arm C: 10 patients will receive Placebo BIW

This study will examine the impact of the National Bowel Cancer Screening Program (NBCSP) on colorectal cancer outcomes for people over the age of 50 with severe mental illness. Who is it for? This retrospective study will be looking at data on people aged 50-74 and who have participated in the NBCSP, with or without severe mental illness. We will also be consulting with people with severe mental illness and their carers on barriers to screening and optimal care. Study details This is a data linkage study of multiple Commonwealth datasets: NBCSP, Medicare Benefits Schedule, Pharmaceutical Benefits Scheme, Australian Cancer Database and the National Death Index. Data linkage with NSW Cancer registry and hospital data will also be used. This research project is directly focused on identifying where access and/or treatment disparities exist along the colorectal cancer care pathway for people with severe mental illness in order to improve access and service utilisation, and ultimately to improve cancer survival for this very disadvantaged group.

The National Hand Hygiene Initiative (NHHI) was implemented in Australia aiming to improve healthcare worker hand hygiene and thus reduce the risk of healthcare-associated infections. However, health care associated infections are still ongoing issues in hospitals nationally. It is therefore important to monitor healthcare worker hand hygiene compliance and also its effectiveness. The use of remote video auditing has been described in the operating theatre to improve patient quality care because it influences healthcare worker’s behaviour, encourages best practice and also helps objectively analyse any adverse events. At the Royal Melbourne Hospital, we are installing remote video cameras in the operating theatre complex. The aim of this study is to assess healthcare worker hand hygiene compliance after contacting post-surgical patients in recovery rooms. We will compare the compliance rate before and after feedback with the use of remote video auditing. Methods This study will be conducted over an 8-week period – 4 weeks without feedback of results to healthcare workers (HCW), followed by 4 weeks of weekly feedback of performance reports to HCW. We hypothesise that the compliance rate will improve after weekly feedback.

In these unprecedented times of global concern associated with the effects of COVID-19, the aim of the study is to produce and disseminate a low-intensity, self-help CBT guide to coping with anxiety and depression during the COVID-19 pandemic. This will include information for use with regards to children (use of parts relating to children will be facilitated by adult participants only), adolescents (use of parts relating to adolescents will be facilitated by adult participants only), and adults (including older adults) and include simplified CBT coping strategies as well as a comprehensive resource list of the many internet-based CBT programs, websites, and self-help books available as e-books to help people recognize and address different types of unhelpful thought patterns and behaviours which may contribute to heightened anxiety and depression during the pandemic. The recommendations for coping strategies and resources will be compiled by an international panel of experts in CBT. The guide will be disseminated through GP practices, WA hospitals, public mental health services, private mental health services and WA government websites, and the research will involve feedback from consumers on the relevance and usefulness of the information in relation to their stress, worry and low mood related to the pandemic. The information will be evaluated for the effectiveness of the treatment on symptoms of anxiety and depression. Research Questions and Hypotheses: 1. Do adult consumers find the CBT strategies to improving mental health guide for COVID-19 useful as indicated by their qualitative feedback in interviews? Due to the exploratory nature of this question no specific hypotheses are outlined. 2. Is there evidence through a pilot investigation of the efficacy of the guide in decreasing anxiety and depression in adults? It is hypothesised that participants randomised to the intervention will show significantly lower symptoms of anxiety on the GAD-7 and depression on the PHQ-9 after 1 week compared to control participants. 3. Can a CBT guide to improving mental health during COVID-19 be produced which covers strategies for both and adults and children (including those with specific needs, for example children with special needs such as Autism; use of parts relating to children will be facilitated by adult participants only)?

COVID-19 is associated with a high rate of lung infection (pneumonia), and it is uncertain for how long the inflammatory changes of pneumonia remain in the lungs once people have recovered from their symptoms and whether this is associated with adverse long-term outcomes. This study aims to determine if there are persistent areas of inflammation in the lungs in people who have recovered clinically from COVID-19 pneumonia, and also to assess whether there is evidence of increased blood vessel inflammatory activity in these people. As inflammation has an important role in the development and progression of cardiovascular disease, the persistence of inflammation may be a predictor of increased risk for future heart disease. 18FDG-PET/CT is an imaging test which is very sensitive to detection of inflammation.

The purpose of this study is to determine what dose of ReoCure, a virus that targets and kills cancer cells, is safe to use in humans. Who is it for? You may be eligible for this study if you are an adult who has a confirmed advanced/late stage solid tumour. Study details: Dose Escalation: Part A will test ReoCure at 3 different dose levels, Participants will receive 1 injection every 3 weeks in 3 Cohorts. Part B will test 2 dose levels of ReoCure in combination with a fixed dose of Pembrolizumab (200mg every 3 weeks) in 2 cohorts. Dose Expansion: ReoCure in combination with a fixed dose of pembrolizumab (200 mg once in every 3 weeks) treated with the recommended dose selected from Dose Escalation part. Blood, sputum, urine and faeces samples will be obtained for PK assessment before and after administration of study drug. Blood and urine will also be collected for clinical laboratory tests (haematology, clinical chemistry, blood coagulation and urinalysis), tumour marker evaluation and immunological response evaluation. It is hoped that this study will determine the safest and most effective dose of ReoCure for those with advanced or late stage cancer, and help provide more insight in the effect of ReoCure.

Critically ill patients receive inadequate nutrition, potentially contributing to muscle wasting and reduced physical function in the long term. Increased protein delivery is recommended during critical illness with the intent of maintaining muscle mass, but there is little understanding on how the body handles protein during critical illness. This study is aimed at understanding whether the ability of critically ill patients to use dietary protein to build muscle is dependent on the amount of amino acids provided. Critically ill patients will be recruited from the Intensive Care Unit at the Royal Adelaide Hospital and randomised to receive either 20g or 40g of protein. The amount of muscle protein synthesis that occurs following these protein doses will be measured.

BACKGROUND / RATIONALE: After recent disaster Incidents such as the Bourke & Flinders Street events, The Alfred Emergency & Trauma Centre staff have reported feeling under prepared and having a lack of awareness, confidence & knowledge to respond to such situations. OBJECTIVES: This study aims to evaluate that a practical face to face disaster response training program, in comparison to the standard annual on-line emergency preparedness training, will improve Emergency Department staff’s confidence and knowledge regarding disaster response preparedness. METHODOLOGY: A prospective approach will be adopted for this study. The intervention group will be exposed to the enhanced practical face-to-face training program; the comparator group will undergo the standard electronic hospital training program. The evaluation of post-training knowledge and confidence will be compared across the two groups. STUDY PERIOD: 3-month study period. EXPECTED OUTCOMES: At the conclusion of this study it is anticipated that staff involved in the study group will report a greater degree of confidence & demonstrate a greater degree of knowledge in responding to disaster situations, in comparison to the control group who only participated in the mandatory on -line training.

This research study investigates an online healthy lifestyle behavioural modification intervention and the associated changes in cardiometabolic risk parameters and mental health symptoms in young people seeking treatment for mental health related issues. All participants will engage in an online 12-week self-paced healthy lifestyle behavioural modification intervention program. This will involve structured nutrition, physical activity, sleep-wake and healthy lifestyle advice delivered fortnightly over 6 online workshops (week 1, 3, 5, 7, 9, and 11). During this time, participants will be asked to wear an actigraphy watch to detect body movement on the non-dominant wrist intermittently throughout the study. Two-week actigraphy recordings will be collected during weeks 1-2, 6-7 and 10-12. Blood tests, anthropometric assessments (blood pressure, height, weight and waist circumference), self-report questionnaires and clinician administered assessments will be conducted in weeks 1 and 12.