ANZCTR search results

This study aims to determine if hands-on pressure applied by paramedics to patches during defibrillation of patients in cardiac arrest will help to improve survival.

LU-TEMP is a single-site pilot clinical trial of combination therapy with lutate and temozolomide for participants who have inherited from their parents a gene change called succinate dehydrogenase (SDH) and who have a tumor called pheochromocytoma or paraganglioma. The trial asks the question of whether combination therapy with lutate and temozolomide can reduce disease progression and improve survival. Who is it for? You may be eligible to be involved in this trial if you have pheochromocytoma or paraganglioma associated with a gene change called succinate dehydrogenase and are 18 years or older. Study details Participants will be enrolled in the study, attend standard of care treatment and follow up visits at 3 months after the completion of treatment. The intervention is an intravenous infusion once every 6 weeks and an oral capsule on days 10-14 of every 6 week cycle. Participants are asked to complete additional quality of life surveys. The total duration of follow up is 24 months as participants will receive a brief phone call at 24 months. The data will be used to improve treatment of participants living with pheochromocytoma or paraganglioma. It is anticipated that if the objectives of this pilot study are met successfully, a larger Phase 2 study will follow.

Anxiety is common in autistic adults and can be more disabling than the core features of autism. Medications for anxiety are often prescribed for autistic adults but their effectiveness or side effects in this population are not well known. Research findings in non-autistic populations may not apply to autistic adults. This study aims to find out whether the drug sertraline is an effective treatment for anxiety in adults with a diagnosis of autism. We will compare the use of sertraline in autistic adults with placebo, a non-active identical capsule. We are interested to see whether the treatment improves symptoms of anxiety, enhances quality of life, and is effective in the longer term. We are also interested in understanding side effects of the treatment. We will run this trial in five geographical regions in England and Western Australia. We aim to include 75 people in Australia (total study population will be 306 internationally) who will be allocated at random to receive either encapsulated sertraline or identical inactive placebo, which they will be asked to take for up to 12 months. They will be asked to complete questionnaires about themselves, their anxiety and mental health, use of services, and any adverse effects they may experience at several time points. The results will help understand whether sertraline is an acceptable treatment and whether it is better or not than placebo in the treatment of anxiety in autistic adults.

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.