Articles: human.
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Multicenter Study
Phase IIa study of the CD19 antibody MOR208 in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.
This two-stage, phase IIa study investigated the antitumor activity and safety of MOR208, an Fc-engineered, humanized, CD19 antibody, in patients with relapsed or refractory (R-R) B-cell non-Hodgkin's lymphoma (NHL). CD19 is broadly expressed across the B-lymphocyte lineage, including in B-cell malignancies, but not by hematological stem cells. ⋯ NCT01685008.
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The lancet oncology · May 2018
Multicenter StudyTazemetostat, an EZH2 inhibitor, in relapsed or refractory B-cell non-Hodgkin lymphoma and advanced solid tumours: a first-in-human, open-label, phase 1 study.
Activating enhancer of zeste homolog 2 (EZH2) mutations or aberrations of the switch/sucrose non-fermentable (SWI/SNF) complex (eg, mutations or deletions of the subunits INI1 or SMARCA4) can lead to aberrant histone methylation, oncogenic transformation, and a proliferative dependency on EZH2 activity. In this first-in-human study, we aimed to investigate the safety, clinical activity, pharmacokinetics, and pharmacodynamics of tazemetostat, a first-in-class selective inhibitor of EZH2. ⋯ Epizyme and Eisai.
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Multicenter Study
Contextual Challenges to Safe Surgery in a Resource-limited Setting: A Multicenter, Multiprofessional Qualitative Study.
Safe surgery should be available to all patients, no matter the setting. The purpose of this study was to explore the contextual-specific challenges to safe surgical care encountered by surgeons and surgical teams in many in low- and middle-income countries (LMICs), and to understand the ways in which surgical teams overcome them. ⋯ Resource variability rather than lack of resources underlies many contextual challenges to safe surgical care in a LMIC setting. Understanding these challenges and resilient strategies to overcome them is critical for both LMIC surgical providers and surgeons from HICs working in similar settings.
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Randomized Controlled Trial Multicenter Study
Design of a 24-week trial of empagliflozin once daily in hypertensive black/African American patients with type 2 diabetes mellitus.
Black/African American individuals have a higher prevalence of type 2 diabetes mellitus (T2DM), diabetes-related complications and hypertension, but they are often underrepresented in clinical trials. The sodium-glucose co-transporter 2 inhibitor, empagliflozin, was associated with significant improvements in glucose control (via hemoglobin [Hb] A1c) and reductions in blood pressure (BP; via office and ambulatory BP monitoring) in a primarily white population with T2DM and hypertension. The aim of this ongoing study is to assess the safety and efficacy of empagliflozin in terms of glucose- and BP-lowering in a self-identified black/African American population with T2DM and hypertension. ⋯ Results of this study will add to our understanding of the efficacy and safety of empagliflozin in self-identified black/African American patients with T2DM and hypertension. (ClinicalTrials.gov identifier: NCT02182830.).
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Circ Cardiovasc Interv · Feb 2018
Multicenter StudyTreatment of Aortic Stenosis With a Self-Expanding, Resheathable Transcatheter Valve: One-Year Results of the International Multicenter Portico Transcatheter Aortic Valve Implantation System Study.
The aim of the Portico TAVI (transcatheter aortic valve implantation) system study was to evaluate outcomes ≤1 year after implantation of a novel resheathable, self-expanding TAVI system in a multicenter patient population with severe aortic stenosis (AS). ⋯ URL: https://www.clinicaltrials.gov. Unique identifier: NCT01493284.