Results 1 to 10 of about 2,415,358 (183)

Expanded Access Programme for the use of tecovirimat for the treatment of monkeypox infection: A study protocol for an Expanded Access Programme [PDF]

PLoS ONE
BackgroundMonkeypox is a viral zoonotic disease commonly reported in humans in parts of Central and West Africa. This protocol is for an Expanded Access Programme (EAP) to be implemented in the Central African Republic, where Clade I monkeypox virus ...
Josephine Bourner, Festus Devincy Redji Mbrenga, Christian Noël Malaka, Jake Dunning, Amanda Rojek, Emmanuel Fandema, Peter Horby, Yap Boum, Emmanuel Nakouné, Piero Olliaro   +9 more
doaj   +4 more sources

Ruxolitinib for Emergency Treatment of COVID‐19–Associated Cytokine Storm: Findings From an Expanded Access Study [PDF]

The Clinical Respiratory Journal
Introduction This expanded access program (EAP) provided ruxolitinib (oral, selective Janus kinase [JAK]1/JAK2 inhibitor) for emergency treatment of COVID‐19–associated cytokine storm in patients eligible for hospitalization (NCT04355793).
Jeffrey Weinstein, Nikhil Jagan, Shawnta Lorthridge‐Jackson, J. E. Hamer‐Maansson, Peg Squier   +4 more
doaj   +2 more sources

Neighborhood characteristics of expanded access patients at an academic referral center [PDF]

Journal of Clinical and Translational Science
Expanded access (EA) is a United States regulatory approach for the use of investigational drugs/devices that do not yet have conventional approval, in clinical care contexts. We conducted a retrospective study to analyze the neighborhood characteristics
Misty Gravelin, Jeanne Wright, Adrian Weyhing, Vikas Kotagal   +3 more
doaj   +2 more sources

Taking AIM at serious illness: implementing an access to investigational medicines expanded access program [PDF]

Frontiers in Medicine, 2023
When seriously ill patients have exhausted all treatment options available as part of usual care, the use of investigational agents may be warranted. Food and Drug Administration’s (FDA) Expanded Access (EA) pathway provides a mechanism for these patient’
Meghan Morrison Joly, Terri L. Edwards, Rebecca N. Jerome, Alex Mainor, Gordon R. Bernard, Jill M. Pulley   +5 more
doaj   +2 more sources

512 Understanding Expanded Access: Who are the Patients? [PDF]

Journal of Clinical and Translational Science
OBJECTIVES/GOALS: The FDA allows physicians to request clinical use of investigational drugs, biologics, and devices for patients with no satisfactory treatment options through a pathway called Expanded Access (EA).
Misty Gravelin, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax, Laurie Rigan   +11 more
doaj   +2 more sources

Impact analysis of expanded access to ketamine for treatment-resistant depression [PDF]

Journal of Comparative Effectiveness Research
Aim: This study aimed to estimate the economic impacts of expanded access to ketamine relative to electroconvulsive therapy (ECT) by offering intravenous ketamine to US patients with nonpsychotic treatment-resistant depression (TRD) and moderate-to ...
Thanh Lu, Sophia D’Angelo, Zohra Tayebali, Matthew Dempsey, Kristen Giombi, Olga Khavjou   +5 more
doaj   +2 more sources

508 A Multi-Institutional Look at Single-Patient Expanded Access Submissions [PDF]

Journal of Clinical and Translational Science
OBJECTIVES/GOALS: Physicians can request the clinical use of investigational products for their patients through an FDA pathway called Expanded Access (EA). Most evaluations of EA focus on the FDA submission only.
Misty Gravelin, Laurie Rigan, Joan E Adamo, Sharon Ellison, Erika Segear, Amanda Parrish, Christine Deeter, Jennifer Hamill, Erik Soliz, Ahamed Idris, George A Mashour, Kevin J Weatherwax   +11 more
doaj   +2 more sources

Factors Associated with Zero-Dose Childhood Vaccination Status in a Remote Fishing Community in Cameroon: A Cross-Sectional Analytical Study

Vaccines, 2022
Background: Cameroon’s suboptimal access to childhood vaccinations poses a significant challenge to achieving the Immunization Agenda 2030 goal—ranking among the top 15 countries with a high proportion of zero-dose (unvaccinated) children worldwide ...
Sangwe Clovis Nchinjoh, Yauba Saidu, Valirie Ndip Agbor, Clarence Mvalo Mbanga, Nkwain Jude Muteh, Andreas Ateke Njoh, Shalom Tchofke Ndoula, Bernard Nsah, Nnang Nadege Edwige, Sveta Roberman, Chen Stein Zamir   +10 more
doaj   +1 more source

Expanded access to psychedelic treatments: comparing American and Canadian policies [PDF]

General Psychiatry
Jeremie Richard, JACK E HENNINGFIELD, Albert Garcia-Romeu   +2 more
doaj   +2 more sources

The effect of the ongoing civil strife on key immunisation outcomes in the North West and South West regions of Cameroon

Conflict and Health, 2021
Background Civil strife has long been recognized as a significant barrier in the fight against vaccine preventable diseases in several parts of the world. However, little is known about the impact of the ongoing civil strife on the immunisation system in
Yauba Saidu, Marius Vouking, Andreas Ateke Njoh, Hassan Ben Bachire, Calvin Tonga, Roberts Mofor, Christain Bayiha, Leonard Ewane, Chebo Cornelius, Ndi Daniel Daddy Mbida, Messang Blandine Abizou, Victor Mbome Njie, Divine Nzuobontane   +12 more
doaj   +1 more source