ANZCTR search results

This is a Phase 1a single ascending dose (SAD) escalation and multiple ascending dose (MAD) escalation study, single centre, placebo controlled, randomized, study to assess safety and tolerability of oral GLY-200 in healthy volunteers. The study consists of two parts: Part 1. single ascending dose (SAD) escalation (3-4 cohorts), and; Part 2 multiple ascending dose (MAD) escalation (3-4 cohorts).

Currently, Queensland does not provide any follow-up services to children following a severe illness or injury, despite research showing the significance of emerging, persisting impairments. The aim of this research is to pilot a collaborative, online screening platform and General Practitioner shared-care follow-up model following PICU admission. We will explore the acceptability of this model with parents and GPs to ensure the best methods for follow-up. We will also determine those children most at risk and the best times to provide early interventions. We will screen 233 children. Children will be followed up at baseline, 3-and-6-months via phone and email, using validated parent completed neurodevelopmental questionnaires. This research will lead to a clinical care model of follow-up for PICU survivors that can be applied across Australia and New Zealand.

The clinical study is testing a new treatment for pectus excavatum called "custom-made 3D printed scaffold-based soft tissue reconstruction". The new method uses a combination of the patients own adipocytes (fat cells) with a 3D printed scaffold (PCL Pectus Scaffold) to support soft tissue regeneration in the patient's chest using the body's natural healing processes. The implanted scaffold acts as a resorbable frame to support the growth of cells. The substance used for the scaffold is resorbable, it's similar to the substance used for sutures and stitches, and it's already TGA approved for bone reconstruction of the skull. The implanted scaffold degrades over time, leaving the tissue in its place.

The overall aim of this research is to test whether brain training can be used as an adjunct to CBT in treating Social Anxiety Disorder (SAD) symptoms. In this study, two forms of brain training will be compared, and both will be administered before a course of iCBT. An initial pilot study testing the methodology of this experimental study with a mixed non-clinical and clinical sample has already been completed. The experimental study will also contain individuals diagnosed with SAD and elevated levels of social anxiety.

Background: Diagnosis of chronic disease in a child can result in unresolved grief (UG) in parents. Aims: to evaluate efficacy of psychological insight-oriented therapy (IOT) as a treatment for UG compared to disease related education in parents of children with cystic fibrosis (CF). Sequence of delivery, first IOT then disease related education (or vice versa) also examined, to let all participants experience both interventions. Methods: Parents screened for UG. Parents with UG randomised to either five one-hour sessions of IOT or five one-hour sessions of education. Measures assessed pre-intervention, after the first intervention period (primary efficacy assessment), and after the second intervention period (swapping intervention). Primary outcome measure: resolution of grief as measured by the Reaction to Diagnosis Interview. Secondary outcome measures: Anxiety, Stress, Depression as measured by the Depression, Anxiety, Stress Scale (DASS), and the Parent Stress Index (PSI).

This study will investigate the feasibility and potential efficacy of a text message intervention in addition to usual care, to improve prescription opioid tapering self-efficacy. Participants will be patients with chronic non-cancer pain who are commencing prescription opioid medication tapering. 40 participants who meet the selection criteria will be randomized to receive either an educational video contextualising the intervention, followed by text messages for four weeks in addition to their usual care, or usual care alone. The message library consists of text messages that are intended to increase the recipient’s self-efficacy to taper prescription opioids. This includes pain management and opioid tapering information, as well as supportive content. The study will evaluate the feasibility of the intervention and a future trial methodology as the primary objective and compare the changes in opioid medication tapering self-efficacy between groups across a 4-week intervention period as the secondary objective to evaluate potential efficacy.

This study is aiming to determine the feasibility of delivering pelvic floor muscle training using telehealth to treat urinary incontinence in women with breast cancer in Australia. Who is it for? You may be eligible for this study if you are aged 18-80, you have been diagnosed with breast cancer (stages I-IV) and you are currently experiencing stress urinary incontinence (urinary leakage when you cough or sneeze). Study details All participants who choose to enrol in this study will receive a femfit® device that provides live data on the person's ability to correctly contract their pelvic floor muscles. All participants will be offered 8 instructional sessions with the research physiotherapist via videoconference (e.g. Zoom platform) over a 12 week period. Each session will be 30 mins in duration. Using the femfit® device, the research physiotherapist will then teach the pelvic floor muscle training program. As a home exercise program, the participant will complete the pelvic floor muscle training program using the femfit® app and record their progress on an exercise diary. Participants will be asked to complete an online questionnaire to assess the frequency, severity and impact of their urinary incontinence at the start and end of the 12 week intervention. They will also complete a questionnaire measuring their satisfaction of the program and perceived change in urinary incontinence at the end of the 12 weeks.

Endometriosis is a chronic gynaecological disease affecting 11.4% of women by age 40-44. Endometriosis occurs when endometrial-like tissue, similar to the tissue lining the womb, starts to grow in other parts of the body outside of the womb. The most troublesome symptom associated with endometriosis is pelvic pain (period pain, persistent pelvic pain [PPP], pain during or after sexual intercourse, or pain associated with going to the toilet). This can have significant effects on normal day-to-day activities and overall quality of life. Following surgery to diagnose and treat endometriosis, patients have a 6-67% chance of requiring re-operation for recurrence. The aim of the work described in this application is: To establish a clinical prediction model for recurrent disease. Hypothesis - We can predict risk of endometriosis recurrence using readily available clinical variables.

Primary sclerosing cholangitis (PSC) is a progressive, chronic liver disease leading to end stage liver-failure with limited treatment options. Case series and a recent systematic review and meta-analysis found that antibiotic therapy and in particular treatment with the non-absorbable antibiotic vancomycin was associated with substantial clinical improvement or even remission of PSC and the concomitant inflammation of the bowel. Against this background we aim in a placebo-controlled trial in PSC patients with and without  concomitant IBD to define the effects of antibiotic therapy on disease activity. It is hypothesised that targeted modulation of the microbiota with vancomycin will improve clinical outcomes for these patients.

VA-ECMO is a life-saving therapy in patients with cardiovascular or respiratory failure. The use of VA-ECMO is increasing and has doubled globally in the last 5 years. Percutaneous cannulation can be achieved using ultrasound guidance, even in unfavourable clinical and/or environmental conditions. If the patient recovers and can be weaned from VA-ECMO, or if ongoing VA-ECMO support is futile and no longer meets its intended goals, withdrawal of the VA-ECMO is required. Removal of the large (15-21F) femoral arterial cannulas is typically performed in an open surgical procedure. However, surgical decannulation is associated with several complications such as bleeding, delayed wound healing and infections. In addition, there is an increased strain on healthcare resources: patients need a vascular or cardiac surgeon, general anaesthesia, theatre time with support of a perfusionist, and transport to and from the theatre. To circumvent this, manual compression and suture-based vascular closure devices have been used in VA-ECMO decannulation, but both were associated with an increased risk of bleeding (5-10%) or requiring additional steps during initial VA-ECMO cannulation. The MANTA vascular closure device is a collagen plug based device, that is increasingly used in large bore interventional therapies such as transcatheter aortic valve implantation, endovascular aneurysm repair or periprocedural of left ventricular assist devices. This is a non-randomised open-label feasibility study. We aim to include 20 patients on VA-ECMO in which decannulation of ECMO support is pursued by the treating team, to investigate the safety and feasibility of percutaneous decannulation of femoral VA-ECMO using the MANTA VCD.