ANZCTR search results

This pilot study will assess the feasibility of a larger multicenter study to evaluate the association between a pregnant patient’s fibrinogen level on admission to hospital for labour and their risk of major bleeding (postpartum hemorrhage). Participants will be enrolled and consented in the antenatal clinic by trained research assistants. When the participant presents to hospital in labour, and routine intravenous access is inserted, a baseline fibrinogen level will be taken. This result will be blinded to both patient and treating clinician for three days after it is taken unless it produces a grossly abnormal result (fibrinogen <1.5g/L). All participants will be followed up to determine if they have a postpartum haemorrhage, the extent of haemorrhage, its clinical management and impact on the participant. If the pilot study is successful, the purpose of the multicenter study is to evaluate if fibrinogen levels can be used as a novel predictor of postpartum haemorrhage. Furthermore data from this pilot study can be used to inform our current practice regarding postpartum haemorrhage, and to improve our current management, if required.

A recent trial with 89 participants (ACTRN12622000113752) demonstrated the efficacy and safety of an accessible online therapy for people with chronic pain (Pain and Emotion Therapy) which focused on improving emotion regulation through guided group sessions and home practice using an app and handbook. Results showed significant improvements in emotion dysregulation and provided preliminary evidence to improve the trials secondary outcomes of pain severity, depression, anxiety, sleep and quality of life. The primary aim of the current randomised controlled trial is to evaluate the efficacy of an individualised (one-on-one) version of Pain and Emotion Therapy to reduce pain severity. Secondary aims include evaluating the effects on depression, anxiety, sleep problems, pain disability, emotion dysregulation, and quality of life.

This is a single-centre safety and feasibility study of a new device designed for the ablation of uterine tissue. Subjects with a specific condition will be enrolled where the new device will be used to deliver energy to abnormal uterine tissue; these subjects will be followed up to 1-year post-procedure. This is not a powered study, so there is no formal hypothesis. This research is an early feasibility study and will determine whether use of this new system is safe and feasible.

This is a single-centre safety and feasibility study of a new device designed for the visualization of the upper digestive tract and facilitation of tool delivery for diagnostic or therapeutic interventions. Subjects will undergo a procedure with a new device designed to assist qualified physicians to navigate a GI endoscope and endoscopic tools in the upper GI tract using endoscopic visualization for observation, diagnostic procedures, and/or endoscopic treatment. These subjects will be followed up to 30 days post-procedure as per standard of care. This is not a powered study, so there is no formal hypothesis. This research is an early feasibility study and will determine whether use of this new system is safe and feasible.

Approximately 511,000 Australians live with heart failure. with more than 73,000 people being diagnosed each year. Following a first hospital admission for heart failure, 75% of people are readmitted within one year, and 33% die during that period. A simple admission for heart failure costs $3,440, whereas more complex admissions cost around $7,260, resulting in $3.1 billion in health costs per year. These data highlight the need to keep people living well in the community and out of hospital. There is an urgent need for new models of person-centred care to support self-care of heart failure at home and in the community. Digital health can transform the quality and sustainability of health and care. Our multidisciplinary team has co-designed and developed an innovative digital program, . It uses sensing technology, combined with artificial intelligence (AI) for early detection of heart failure deterioration. It prompts action by end-users, thereby improving opportunity for early intervention, and reducing further deterioration and re-hospitalisation

SUN-001 is a drug being developed as a potential treatment for idiopathic pulmonary fibrosis (IPF). IPF is a chronic progressive Interstitial Lung Disease, the cause of which is unknown. IPF is associated with declining lung function and progressive respiratory failure. SUN-001 is expected to slow fibrosis progression and improve clinical outcomes in patients with IPF. In this study, we will look at the safety and tolerability of SUN-001. This study will also determine the levels of SUN-001 in the bloodstream when SUN-001 is given by nebuliser.

The aim of this study is to assess the efficacy of blood flow restriction exercise training during a 6-week community-based cardiac rehabilitation exercise program. Specifically, in individuals with coronary artery disease who are eligible for cardiac rehabilitation, this study will assess whether adding blood flow restriction (via inflating pneumatic cuffs on the proximal portion of the legs) during aerobic exercise portions of the rehabilitation program leads to greater improvements in exercise capacity, 6 minute walking distance and markers of vascular health, when compared with the routine aerobic exercise undertaken by cardiac rehabilitation participants (no cuffs). Participants will be randomised to either the blood flow restriction exercise group or the routine rehabilitation exercise group for the duration of the 6-week (12 session) program. Participants will also attend a total of 4 assessment visits; 2 baseline (week 0) measurement visits (the first of which includes screening to assess eligibility) and 2 visits post-program (week 7 post-baseline) to compare changes between groups and over time.

AXA-042 furnctions through a multi-cellular mechanism to re-engage the innate immune response. This first in human study is planned to evaluate the safety, tolerability, pharmacokinetics (PK), preliminary efficacy, and pharmacodynamics (PD) of AXA-042 in combination with cemiplimab, an anti-PD-1 monoclonal antibody, in subjects with advanced solid tumours. Who is it for ? You may be eligible for this study if you are aged 18 years or over, have a diagnosis of a locally advanced or metastatic solid tumor, and are refractory or intolerant to standard of care therapies. Study details – Participants will receive AXA-042 followed by cemiplimab, both administered as intravenous infusions on Day 1 of a 21-day treatment cycle. AXA-042 will be given first; if no significant infusion-related reaction occurs within one hour, cemiplimab will follow. Treatment will continue until disease progression, withdrawal of consent, or toxicity that in the opinion of the investigator or Sponsor requires study treatment discontinuation, or up to study completion, whichever occurs first. Dose escalation will follow a 3+3 design, where 3 to 6 participants will be enrolled per cohort to evaluate safety and determine the maximum tolerated dose. The starting dose level of AXA-042 is 0.00001 mg/kg, and all doses of cemiplimab are fixed at 350 mg IV every 3 weeks. The dose of AXA-042 will be increased by up to 3-fold in each subsequent cohort, after review of safety data, to determine the maximum tolerated dose. Participants will be monitored for adverse events throughout treatment and for at least 30 days after their last dose. of study drug. Participants will also have blood samples taken throughout day 1 (and in subsequent cycles on certain days) of treatment after receiving AXA-042 to study the time course of drug absorption, distribution, metabolism and excretion. Preliminary efficacy and pharmacodynamics will be determined through objective response rate, progression-free survival, time to response and overall survival and pharmacodynamics data on cytokines and other immune response biomarkers in response to AXA-042 treatment (in combination with cemiplimab). It is hoped that this study may show that AXA-042, in combination with cemiplimab, is safe and effective for the treatment of advanced solid tumours, which may lead the way for larger efficacy trials in future.

INDUCE is a multicentre prospective randomised controlled trial to compare the efficacy and safety (using standardised clinical outcomes plus non-invasive monitoring of mucosal healing using gastrointestinal ultrasound of Upadacitinib vs Corticosteroid in patients with Ulcerative Colitis and Crohn's Disease flares. We hypothesize that upadacitinib is non-inferior in terms of efficacy to prednisolone for disease flares, with no difference in rate of adverse event.

This study aims to test whether inserting a ureteric stent — a small tube used to relieve kidney blockage caused by kidney stones — can be done safely and effectively using local anaesthesia in the emergency department, instead of general anaesthesia in the operating theatre. We are inviting adults who come to hospital with kidney stone pain requiring stent placement to take part. The procedure will be done using numbing gel and other local pain relief, with additional medications like Penthrox (green whistle) available if needed. We will assess whether the procedure can be successfully completed under local anaesthesia, how well patients tolerate it, and how satisfied both patients and doctors are with the experience. The study will also look at the impact on hospital workflow, resource use, and cost. We hope this approach could offer a quicker, simpler, and more efficient alternative to standard care, especially in busy emergency settings.