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Intravitreal Dexamethasone vs Bevacizumab in Aboriginal People With DMO
Expand descriptionDMO is the most common cause of visual loss in people with diabetes. Regular injections of bevacizumab (Avastin) given as frequently as every month remain the current standard of care for centre-involving DMO; however, this regimen is impractical for many Aboriginal patients. Using Ozurdex implants every 3-6 months could be as effective as the currently used Avastin injections. In order to address this real-world problem, this study seeks to investigate whether it is possible to safely use a long-acting steroid preparation such as the dexamethasone IVT implant (Ozurdex) to manage DMO in Aboriginal patients living in Western Australia.
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Invasive Fungal Infections in Patients Following Stem Cell Transplant
Expand descriptionThis study will be a descriptive, retrospective evaluation and analysis of invasive fungal infections (IFI) conducted in patients who underwent allogeneic haematopoiectic stem cell transplant (aHSCT) in a single tertiary transplant centre, the Bone Marrow Transplant Clinical Service across Peter MacCallum Cancer Centre (PMCC) and Royal Melbourne Hospital (RMH), Victoria, Australia.
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HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer
Expand descriptionThis study is designed to evaluate the antitumor activity of patritumab deruxtecan in participants with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R) who have received and progressed on or after at least 1 EGFR TKI and 1 platinum-based chemotherapy-containing regimen.
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A Study of EMB-02 in Participants With Advanced Solid Tumors
Expand descriptionThe primary purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule assessed to be safe for EMB-02 and to characterize the safety and tolerability of EMB-02 at the RP2Ds. Pharmacokinetics (PK), immunogenicity, and the anti-tumor activity of EMB-02 will also be assessed.
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Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120102 in Patients With Huntington's Disease
Expand descriptionWVE-HDSNP2-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120102 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362331 (SNP2). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP2-001.
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Open-label Extension Study to Evaluate the Safety and Tolerability of WVE-120101 in Patients With Huntington's Disease
Expand descriptionWVE-HDSNP1-002 is an open-label extension (OLE) study to evaluate the safety, tolerability, PK, PD, and clinical effects of WVE-120101 in adult patients with early manifest HD who carry a targeted single nucleotide polymorphism, rs362307 (SNP1). To participate in the study, patients must have completed the Phase 1b/2a clinical study WVE-HDSNP1-001.
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A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
Expand descriptionA 38-week dosing trial of lonapegsomatropin, a long-acting growth hormone product, administered once-a-week versus placebo-control. A daily somatropin product arm is also included to assist clinical judgement on the trial results. A total of 264 adults (males and females) with growth hormone deficiency were included. Randomization occurred in a 1:1:1 ratio (lonapegsomatropin: placebo: daily somatropin product). This is a global trial conducted in, but not limited to, the United States, Europe, and Asia.
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Improving Outcomes in Patients With Cardiovascular Seasonality
Expand descriptionDespite a range of evidence-based programs to identify high-risk patients and apply strategies to keep them out of hospital, a growing number of cases are "resistant" to such programs. These "seasonal frequent flyers" routinely overwhelm hospital services. The investigators have identified vulnerability to provocation of seasonal and acute weather changes ("seasonality") as a major driver of preventable/costly hospitalisations in typically older patients with heart disease and multimorbidity subject to gold-standard care. From this research the investigators developed the RESILIENCE Program which is tailored to each person and designed to assist the participants to become more "resilient" to changes in the weather. The overall aim of the RESILIENCE Trial is to demonstrate the cost-effectiveness of an individually tailored, interventional health care program designed to address the debilitating, costly and deadly phenomenon of seasonal vulnerability in a growing number of individuals admitted to hospital with chronic heart disease and multimorbidity.
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Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
Expand descriptionThis is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects likely to respond to therapy with LUM-201.
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Autologous LN-145 in Patients With Metastatic Non-Small-Cell Lung Cancer
Expand descriptionThis is a prospective, open-label, multi-cohort, non-randomized, multicenter phase 2 study evaluating LN-145 in patients with metastatic non-small-cell lung cancer