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Efficacy, Safety and Tolerability Study of Long-acting Cabotegravir Plus Long-acting Rilpivirine (CAB LA + RPV LA) in Human-immunodeficiency Virus-1 (HIV-1) Infected Adults
Expand descriptionThis Antiretroviral Therapy as Long Acting Suppression every 2 Months (ATLAS-2M) study is designed to demonstrate the non-inferior antiviral activity and safety of CAB LA + RPV LA administered every 8 weeks (Q8W) compared to CAB LA + RPV LA administered every 4 weeks (Q4W) over a 48-week treatment period in approximately 1020 adult HIV-1 infected subjects. Subjects will be divided in 2 groups; Group 1 will include subjects receiving current anti-retroviral (ART) standard of care (SOC) therapy whereas group 2 will include subjects currently receiving CAB LA + RPV LA Q4W in ATLAS study. Subjects in both groups will be randomized to receive CAB LA + RPV LA Q4W or Q8W. The study will be carried out in 3 phases including screening phase, maintenance phase and extension phase. Subjects choosing not to enter the Extension phase can complete their study participation at the Week 100 visit and enter into the 52-week Long-Term Follow-Up (LTFU) Phase as required. A sub-study in the ATLAS-2M study will evaluate the pharmacokinetics, tolerability and efficacy of CAB and RPV long acting injections following intramuscular administration in the Vastus Lateralis Muscle (thigh) in HIV-infected Adult Participants who have received at least three years of Gluteal Injections in this ATLAS-2M Study.
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Effect of Blinatumomab on Minimal Residual Disease (MRD) in Diffuse Large B-Cell Lymphoma (DLBCL) Subjects Post Autologous Hematopoietic Stem Cell Transplantation (aHSCT)
Expand descriptionThe study will estimate the MRD-negative response rate after treatment with blinatumomab in subjects with high-risk DLBCL who are MRD-positive following aHSCT. The clinical hypothesis is that the MRD-negative response rate will be greater than 10%. Achieving an MRD-negative response rate of 30% would be of scientific and clinical interest.
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Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Expand descriptionThis study will generate new information on how to optimise brain targets with ECT stimulation.
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Safety and Efficacy of EMA401 in Patients With Painful Diabetic Neuropathy (PDN)
Expand descriptionThe purpose of this study is to evaluate safety and efficacy of EMA401 compared to placebo in patients with painful diabetic neuropathy (PDN).
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Study of AMG 596 in Patients With EGFRvIII Positive Glioblastoma
Expand descriptionThis is a Phase 1/1b Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AMG 596 monotherapy or in combination with AMG 404 in Subjects with Glioblastoma or Malignant Glioma Expressing Mutant Epidermal Growth Factor Receptor Variant III (EGFRvIII). This is a first in human (FIH), open-label, sequential-dose-escalation study in subjects with EGFRvIII-positive glioblastoma or malignant glioma. This study will enroll 2 groups of subjects according to disease stage, recurrent disease (Group 1) and maintenance treatment after SoC in newly diagnosed disease (Group 2).
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Composition of Functional Tooth Units and Nutrient Intake in Older Men
Expand descriptionVarious definitions of poor dentition in older adults has been linked with inadequate intake of nutrients and poor diet quality. This study aims to look at the associations between poor dentition as defined by the composition of functional tooth units, and dietary intake of nutrients in community dwelling older men.
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Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
Expand descriptionThe aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
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KONTAKT Australia a Social Skills Group Training for Adolescents on the Autism Spectrum
Expand descriptionThis study evaluates the KONTAKT social skills group training in Australian adolescents on the autism spectrum compared to an active control group which is a group cooking class
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Clinical Trial Evaluation of the Percutaneous 4Tech TriCinch Coil Tricuspid Valve Repair System
Expand descriptionThe objective of the study is to generate safety and performance data for the 4Tech TriCinch Coil System in symptomatic patients suffering from significant functional tricuspid regurgitation with annular dilatation. The TriCinch Coil System is a percutaneous catheter-based medical device for tricuspid valve repair.
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A Study of Recombinant Vaccinia Virus in Combination With Cemiplimab for Renal Cell Carcinoma
Expand descriptionThis is a Phase 1b/2a, open-label, multi-center, dose-escalation and safety/efficacy evaluation trial of Pexa-Vec plus Cemiplimab in patients with metastatic or unresectable renal cell carcinoma (RCC). The trial consists of a dose-escalation stage, where the maximum feasible dose of Pexa-Vec in combination with Cemiplimab will be determined, followed by an expansion stage. During the expansion patients will receive Cemiplimab alone or in combination with Pexa-Vec, which will be administered either through intravenous (IV) or intratumoral (IT) injection.