There are about 10460 clinical studies being (or have been) conducted in Australia. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
This is a Phase 1b, open-label, multicenter study designed to evaluate the safety and pharmacokinetics of venetoclax as a single-agent and in combination with azacitidine in participants with relapsed/refractory Myelodysplastic Syndromes (MDS).
The purpose of this study is to try to find out how critically ill patients receiving the antibiotic, ceftolozane-tazobactam, process it in their body. Investigators would like to study if the antibiotic concentrations during a dose of this antibiotic reaches the right concentrations necessary to kill the bacteria that is causing the infection. The process by which a drug travels through the body in blood, how it is broken down and removed by the body is called pharmacokinetics (PK). We can measure the PK by taking blood samples at specific times after the antibiotic is given. Investigators would like to do the study in patients receiving dialysis and patients who are not receiving dialysis. This information about how the antibiotic is processed in the critically ill patient is unknown and it is important to know whether the doses doctors give patients to fight infection are adequate. If antibiotic concentrations are low in the blood, it gives the bacteria an opportunity to become resistant to the antibiotic which can lead to the antibiotic being less effective against bacteria potentially exposing future patients with infections to a limited range of effective antibiotics. Patients will be consented, and given the antibiotic as prescribed. Blood samples will be taken from the drip that is already in the patients arm just as the antibiotic starts, at 15 and 45 minutes, at 1,2,3,4,5,6,7 and 8 hours. Patients who are on dialysis will have the blood samples taken from the dialysis machine before the blood reaches the dialysis filter (same blood samples as the non dialysis patients) and also bloods samples taken after the filter at 45 minutes, 2 and 6 hours. Dialysis patients will also have 5 separate samples of ultrafiltrate taken (approximately 10mls) - ultrafiltrate is the waste product of the dialysis process. The total amount of blood will be 40mls which is equal to about 2 tablespoons. The dialysis patient will have 50mls of blood taken.Information about the patients ICU stay will also be recorded.
Primary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: - To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations - To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously - To determine the incidence of anti-blinatumomab antibody formation following SC administration - To evaluate efficacy response following treatment with SC blinatumomab administration Exploratory Objective: - To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration - To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation
The use of echocardiography in intensive care is a developing field. In expert hands echocardiography has proven its utility in diagnosing cardiac pathology, differentiating shock states and in haemodynamic monitoring. However, whether the results obtained by experts can be generalized to trainees or specialists with limited training remains unclear. Further, concerns around training time and cost for intensive care staff have been a factor in limiting the uptake of echocardiography in intensive care. The investigators aim to assess the diagnostic accuracy of Australian ICU doctors in training after completion of the current minimum training. After completing a structured teaching program and 30 mentored training scans trainees will be assessed on their accuracy with echocardiography. In the research phase trainees will complete a further 40 scans with each one matched with an expect scan. The results from the expert and trainee scans will be compared to determine the trainee's accuracy.
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe cGVHD.
To prospectively validate the SERT (Sydney EMR Recurrence Tool) scoring system for adenoma recurrence rates around the endoscopic mucosal resection (EMR) scar after wide field-EMR with thermal treatment applied to the defect margin. The primary aim of the study will be to ensure the safety of this approach and there will be constant monitoring to ensure that this is the case.
This is an open-label, Phase I, dose-escalation study to determine the recommended Phase 2 dose (RPTD), maximum tolerated dose (MTD), and evaluate the safety and pharmacokinetic (PK) profile of ABBV-428 when administered as monotherapy or in combination with nivolumab in participants with advanced solid tumors.
This study aimed to investigate the efficacy and safety of PDR001 in patients with advanced or metastatic, well-differentiated, non-functional neuroendocrine tumors of pancreatic, gastrointestinal (GI), or thoracic origin or poorly-differentiated gastroenteropancreatic neuroendocrine carcinoma (GEP-NEC) that progressed on prior treatment.
The purpose of this Post Market Study (PMS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.
The purposes of the study are: - To evaluate the effectiveness of a perceptual-based training program in enhancing cognitive and everyday functioning of older adults with mild cognitive impairment and mild dementia - To evaluate the effectiveness of a semantic-based training program in enhancing cognitive and everyday functioning of older adults with mild cognitive impairment and mild dementia