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.
Moderate-risk surgical patients have a very high incidence of early serious postoperative complications (approximately 50% at Royal Adelaide Hospital, RAH). This affects patients' wellbeing and produces a high rate of unplanned postoperative hospital re-admissions. This is also costly, and patients unnecessarily fill approximately 4000 RAH bed days annually. A trial of a new model of enhanced care after surgery (Advanced Recovery Room Care, 'ARRC') demonstrated that complications were quickly identified and expertly addressed. Re-admission days appeared to decrease by 80%. Business and economic analysis showed (i) patients can expect 3 extra days at home, (ii) 4000 bed days can be freed annually, and (iii) better care at lesser cost (technically, ICER = -$600/day at home). Freeing hospital beds, and rapid cost savings, are critical in this Covid era. This trial re-introduces ARRC for Orthopaedic, Colorectal, Gynae-Oncology and Neurosurgery, and other specialties, and formally examines patient outcomes and costs compared to eligible patient who do not receive ARRC. Data from patient progress and vital signs are to be used to improve patient risk stratification and triage at defined timepoints before, during, and after surgery. This may allow better and earlier identification of patients (not) needing ongoing ARRC, potentially reducing costs of care further without affecting safety. A Markov cost-effectiveness model provides the platform for cost effectiveness outcomes (Days at Home V Cost).
ASN51-101 is a randomized, double-blind, placebo-controlled, phase 1 first in human (FIH) safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) study of oral ASN51 in healthy young adult and elderly subjects and elderly subjects with AD. The study is comprised of three parts (Part 1, Part 2, and Part 3).
The overall goal of this real-world data collection is to assess demographic, clinical characteristics and real-world effectiveness of pediatric neuroblastoma patients treated with lorlatinib through the expanded access program.
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and to determine the maximum tolerable dose (MTD) and/or recommended phase 2 dose (RP2D) of HH30134 administered orally on a continuous once daily (QD) schedule in adults patients with advanced solid tumors.
This is a Phase 3 study of the PI3Kδ inhibitor Zandelisib (ME-401) in combination with rituximab, in comparison to standard immunochemotherapy (Rituximab-Bendamustine or Rituximab-CHOP) in subjects with relapsed or refractory FL and MZL.
This is a phase I, open-label, dose escalation study to evaluate the safety, tolerability, PK, and preliminary efficacy of LM-061 in subjects with advanced tumors.
This is an interventional study to assess the safety, PK, and efficacy of HST5040 in 12 subjects - 6 with Methylmalonic Acidemia (MMA) and 6 with Propionic Acidemia (PA). The study consists of 3 parts: - Part A: Open-label, within-subject, dose escalation study in PA and MMA subjects ≥ 2 years old to identify a safe and pharmacologically active (optimal) dose of HST5040 for use in Part B. Subjects will continue in a Part A open-label extension until all subjects complete Part A and the optimal dose of HST5040 is identified for use in Part B. - Part B: 6-month, randomized, double-blind, placebo-controlled, 2-period crossover in the same subjects from Part A to evaluate safety and efficacy of the optimal dose of HST5040 in addition to standard of care (SoC). - Part C: open-label long-term extension study in PA and MMA subjects ≥ 2 years old (N = approximately 12, 6 each) to evaluate the long-term safety and efficacy of the optimal dose of HST5040. This study will determine whether HST5040 can improve levels of disease-associated toxins that accumulate in patients with PA and MMA.
This study is designed as an open-label, single arm, proof of concept study in order to determine the appropriate emapalumab dosing regimen neutralizing IFNγ in patients at risk of GF. Patients presenting CXCL9 levels above a defined threshold and other clinical criteria will be eligible to receive emapalumab. Both children and adults, with malignant and non-malignant underlying diseases, receiving allo-HSCT who are at high risk of GF as defined in the inclusion criteria will be included in the study. The main objective of the study is to determine the appropriate emapalumab dose regimen neutralizing interferon gamma (IFNγ) activity to pre-empt graft failure post allo-HSCT in a population with various underlying diseases and at high risk of graft failure (GF). Maximum 3 cohorts are foreseen to determine the appropriate dose regimen to pre-emptively treat patients at risk of primary GF. Emapalumab will be administered by IV infusion and treatment will last up to 56 days (15 infusions) or until evidence of engraftment. The study is expected to last approximately 3 years from screening to the last follow-up phone call for each patient.
The purpose of this study is to first, in Part A, assess the safety, tolerability and drug levels of Bempegaldesleukin (BEMPEG) in combination with nivolumab and then, in Part B, to estimate the preliminary efficacy in children, adolescents and young adults with recurrent or treatment-resistant cancer.
Primary Objective: -To determine the effect of early versus delayed treatment with venglustat on the total kidney volume (TKV) in participants at risk of rapidly progressive autosomal dominant polycystic kidney disease (ADPKD). Secondary Objective: - To determine the effect of early versus delayed treatment with venglustat on the renal function (estimated glomerular filtration rate [eGFR] [Chronic Kidney Disease Epidemiology Collaboration {CKD-EPI} equation]). - To characterize the safety profile of venglustat. - To evaluate the effect of venglustat on the lens by ophthalmological examination. - To evaluate the effect of venglustat on mood using Beck Depression Inventory-II (BDI-II).