ANZCTR search results

The purpose of this project is to provide evidence for an alternative administration method for short term continuous intravenous (IV) antibiotic infusion in patient with only peripherally inserted venous cannula (PIVC) access. The evidence may allow our Hospital In The Home (HITH) to broaden service provision locally but will ultimately provide evidence for those HITH services considering to expand infusion modality, or to those previously relying on anecdotal and observational evidence. It is hypothesised that a Baxter LV10 elastomeric infusor paired with a PIVC when compared to a CADD-solis 2120 programmable pump will deliver at least 90% of the intravenous antibiotic volume after at least 22 of the 24 hours of continuous infusion.

The purpose of this study is to determine if new imaging technologies are a valid and accurate method of detecting lymph node metastases. Who is it for? You may be eligible for this study if you are an adult who has been diagnosed with prostate cancer. Study details All participants will have 2 specialised imaging scans (68Ga-PSMA PET and nano-MRL) prior to a prostatectomy and lymph node dissection. It is hoped that this research will help determine if these two imaging tests are useful in providing accurate but non-invasive methods of diagnosing metastatic prostate cancer. Thus guiding better targeted treatment.

The primary purpose of this study is to investigate the effects a brief, one-off writing exercise can have on the psychological outcomes of individuals living with a stoma. The study design is a mixed analysis of variances (MANOVA) comparing 2 groups (intervention and control condition) across 3 time points (baseline, one week and one month following the writing exercise). It is hypothesised that those in the intervention condition will see statistically significant improvements in a range of psychological outcomes, and more so in comparison to those in the control condition.

This is a nationwide study funded by the National Health and Medical Research Council that will determine the clinical efficacy, cost -effectiveness and patient acceptability of a new treatment for children who have anxiety disorders. For many children and their parents, anxiety can be highly disruptive and prevent children from doing things that other children their age can do. Participants will be 380 anxious children aged 7 - 12 years. This project will examine two computer-delivered treatment conditions and determine if they are as effective as each other in alleviating children’s anxiety disorders. Children will be randomly assigned into one of two treatment conditions that are delivered via computer at home. One treatment condition is called positive search training (PST), this will take 30 minutes to complete, 4 times a week over 3 weeks on a computer, laptop or tablet. Children view a wide variety of pictures and learn to focus their attention on the positive and calm pictures among them. PST also includes verbalisations, catch phrases and interactive games. The second treatment program is called cognitive behavioural training (CBT). Children complete 10 sessions (one per week) over 10 weeks and parents complete 6 sessions over 10 weeks, on a computer, laptop or tablet. The sessions are 20 - 60 minutes in duration, and include a variety of interactive games, quizzes and animations. Both treatment conditions are accompanied with instructions and phone calls to assist with setting up the treatment at home and children's progress will be monitored by therapists and project staff throughout the duration of treatment. The following hypotheses will be examined: (a) Primary clinical outcome: PST will produce significantly greater reductions on the primary outcome measure of clinician rated diagnostic anxiety severity by the post-PST end-point compared to computer-delivered CBT. By the primary 6-month end-point, PST will be non-inferior to CBT. Between the post-PST and 6-month end-points, diagnostic severity will remain low in children who received PST and decline in children who received CBT, such that any differences between PST and CBT will be clinically unimportant at the 6-month end-point and the 12-month follow-up. Also examined will be cost effectiveness and patient acceptability. PST will be associated with lower treatment costs and greater child and parent acceptability

Caregivers’ own attachment experiences are integral in predicting their child’s formation of secure attachment relationships, which are fundamental to healthy psychological development. As such, parents’ disrupted early attachment experiences may lead to parallel disruption in their child’s attachment experiences, increasing vulnerability to emotional and behavioural problems during development and later in life. Thus, the current study aims to reduce emotional and behavoural problems in children by targeting underlying processes relating to caregivers’ own attachment experiences and resulting behaviours. As such, a randomised, parallel-groups, controlled trial will be conducted to evaluate the efficacy of a newly-developed, six-week attachment-based family intervention compared to treatment as usual. Participants will include the families of children aged 6-12 experiencing either emotional or behavioural difficulties. Other outcome variables that will be explored include parents’ reflective functioning, parental mental health and helplessness, and overall family functioning.

To determine the association between patient serum vitamin d status and clinical IVF outcomes such as clinical pregnancy and live births arising from fresh embryos transferred. Our hypothesis is that those with a sufficient vitamin d status (> 50 nmol/L) will have more favourable outcomes in comparison to those with insufficient levels (< 50 nmol/L). We will examine vitamin d status as a continuous and as categorical variables while adjusting for various other infertility parameters including patient age and ovarian reserve.

The aim of this study is to define what is a normal blood glucose level post meal in people without diabetes. This study involves consuming five standardised test meals of varying macronutrient composition over five days. To assess the effect of each meal on post-meal blood glucose participant glucose levels will be measured continuously for 4 hours post- meal.

This study aims to assess changes in body composition following TIPS procedures in decompensated cirrhosis. Patients already referred for TIPS will be recruited from inpatient and outpatient clinics to participate in an observational study with 6 months of follow up. This aims to comprehensively analyse the changes body composition including lean muscle mass, adipose tissue, muscle strength and performance measures and correlate these with biomarkers of immune function, portal hypertension and muscle regulation.

Aortic stenosis (AS) is the most common heart valve disease in the Western World. Transcatheter aortic valve implantation (TAVI) has substantially expanded the therapeutic options available to patients suffering from severe AS. However, despite the rapidly expanding clinical use of TAVI, patients remain at high risk for both thrombotic/clotting (e.g., stroke and valve thrombosis) and bleeding complications. Optimal preventative therapy is essential to minimise thrombosis without incurring excessive bleeding risk. Current recommendations for clot prevention in TAVI are extrapolated from heart vessel stunting (also known as percutaneous coronary intervention or PCI) data despite significant patient and procedural differences that likely result in different risk profiles. Until this is addressed, clinicians are left to advise and treat their patients without essential information. This observational study will recruit 40 patients undergoing TAVI, PCI and AVR to compare the clotting / bleeding changes that occur during the procedure. Blood will be sampled from each patient at 5 time points depending on the procedure. These blood samples will be assessed for the bleeding / clotting potential of the blood at that time using the latest blood clotting tests including ROTEMSigma, TEG6s, MultiPlate and various other specialised laboratory tests.

The aim of this project is to evaluate the Safety of Immune Cells for Patients with Relapsed Leukaemia or Lymphoma after chemotherapy. Who is it for? You may be eligible to join this study if you have persistent or relapsed B-cell malignancy after standard chemotherapy. Study details Patient derived CAR19 T-cells will be administered intravenously after lymphodepleting cyclophosphamide and fludarabine. This T-cell therapy may be administered alone or in addition to salvage chemotherapy. Three CAR19 T-cell dose levels will be assessed within each patient: 1x10^7cells/m^2, 5x10^7cells/m^2 and 1x10^8/m^2. Dose escalation will be determined 4 weeks after the last dose dependent on persistence of disease, no severe toxicity and falling CAR19 T-cell numbers. Patients will be monitored for early and long term toxicity, persistence of CAR T-cells and disease response. If successful, this treatment will enable the widespread application of CAR19 T-cells to patients with few other effective treatment options.