Woollongabba, Australia

Sedation, Temperature and Pressure After Cardiac Arrest and Resuscitation

3500 patients who are comatose after cardiac arrest will be included in a trial studying three separate targets. All patients will be randomised to a control or an intervention arm for sedation, temperature and blood pressure targets. These are. 1. Continuous deep sedation for 36 hours or minimal sedation (SEDCARE) 2. Fever management with or without a feedback-controlled device (TEMPCARE) 3. A mean arterial pressure target of >85mmHg or >65mmHg. (MAPCARE) Participants will be followed up at 30 days and 6 months. The primary outcome will be survival at 6 months.

Trial of Venovenous ECMO to De-Sedate, Extubate and Mobilise in Hypoxic Respiratory Failure

Mechanically ventilated patients with moderate to severe acute hypoxic respiratory failure are at increased risk of dying, short and long-term health problems and are often very costly to treat. The mechanical ventilator, whilst often lifesaving, may harm patients in two ways i) directly via damage to the lungs (termed ventilator induced lung injury), and ii) indirectly via paralysis and sedation that patients require to tolerate mechanical ventilation. Paralysis and sedation can increase the risk of secondary infections, weakness, prolonged duration of intensive care, as well as long-term physical disability. There is a need to develop new treatments that support patients and at the same time reduce these complications. Extracorporeal membrane oxygenation (ECMO) is a device that supports the lungs by adding oxygen and removing carbon dioxide from the blood. By providing non pulmonary gas exchange, veno-venous (VV) ECMO can reduce the need for the mechanical ventilator. This in turn can reduce the risk of lung damage, and also removes the need for sedating medications so that activities like physiotherapy can begin earlier. The REDEEM trial is a phase 2, investigator initiated, multicentre randomised controlled trial that will recruit 140 patients with moderate to severe acute hypoxic respiratory failure. It is designed to test whether adding ECMO to the mechanical ventilator, as compared to using the mechanical ventilator on its own, leads to an increase in the number of patients who survive and are discharged earlier from the intensive care unit. If the REDEEM trial confirms adding ECMO is more effective than mechanical ventilation alone, it has the potential to change the current paradigm of intensive care treatment of hypoxic respiratory failure, and could lead to changes in practice globally.

A Clinical Study to Investigate the Efficacy of Tigilanol Tiglate Directly in Head and Neck Cancer

Primary Objective 1. To evaluate tumour ablation following treatment(s) with intratumoural injections of tigilanol tiglate. Secondary Objectives 1. To assess the safety and tolerability of intratumoural injections with tigilanol tiglate. 2. To evaluate disease control by assessing time to local disease recurrence from last treatment. 3. To evaluate the tumour recurrence rate at injected tumour sites. 4. To evaluate survival by assessing Progression Free Survival (PFS). Exploratory Objectives 1. To assess the impact on Quality of Life (QoL). 2. To assess the degree of wound healing after each treatment. 3. To assess the tumour response in injected and non-injected tumours, based on Response Evaluation Criteria in Solid Tumours (RECIST) v1.1. 4. To assess the tumour response according to intratumoural Response Evaluation Criteria in Solid Tumours (itRECIST). 5. To assess changes in tumour biomarkers. 6. To assess the tumour microenvironment.

A Trial to Evaluate EP-104IAR in Adults With Eosinophilic Esophagitis (EoE).

The SHIELD Study-silicosis

Background: Silicosis is a fatal lung disease caused by inhaling silica particles. Australia is currently facing an epidemic with hundreds of young workers having contracted silicosis from machining engineered stone. AIMS: To establish the SHIELD COHORT and associated SHIELD BIOBANK to drive further discovery including assessing the efficacy of whole lung lavage for accelerated silicosis, uncovering disease biomarkers, and druggable targets. PARTICIPANTS: 75 participants who are respirable crystalline silica exposed workers, (this includes n=30 with silicosis, n=15 with progressive massive fibrosis and n=30 with no pneumoconiosis). METHODS: Advanced microscopy, 'omic platforms and single cell RNA sequencing. OUTCOME: The SHIELD study builds on the knowledge gap to accurately diagnose silicosis, as well as predict disease progression, assess response to treatment, and hasten therapeutic discovery

A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.