Results 11 to 20 of about 65,249 (309)
Viruses, 2021 Presently, the use of convalescent plasma and hyperimmunoglobulin obtained from individuals who have recovered from coronavirus disease 2019 (COVID-19) has proved to potentially provide passive antibody-based immunity, thereby leading to several clinical
Sunha Choi, Soyoon Hwang, Kitae Kwon
doaj +1 more source
Research and Practice in Thrombosis and Haemostasis, 2021 Background Coagadex is a high‐purity plasma‐derived factor X concentrate (pdFX) developed to treat hereditary factor X deficiency (FXD). Objective Evaluate the efficacy and safety of pdFX administered to patients with hereditary FXD.
James N. Huang +4 more
doaj +1 more source
Compassionate open-label use of rituximab following a randomised clinical trial against neuromyelitis optica (RIN-2 study): B cell monitoring-based administration [PDF]
Multiple Sclerosis and Related Disorders, 2022 The aim of the RIN-2 study was a compassionate use of rituximab (RTX) for patients who completed the RIN-1 study, a multicentre, randomised, double-blind, placebo-controlled trial of RTX. We also investigated the long-term safety and efficacy of RTX.A study design was a prospective open-label extension study following the RIN-1 study.
Masayuki Tahara +12 more
openaire +2 more sources
The High “Cost” of Experimental Drugs Obtained Through Health Litigation in Brazil
Frontiers in Pharmacology, 2020 BackgroundBrazilian patients have legal right to access unlicensed medicines undergoing clinical research, if there is evidence of efficacy and safety. This study investigated the occurrence of serious adverse events related to very high-cost medicines ...
Ricardo Eccard da Silva +4 more
doaj +1 more source
Frontiers in Pharmacology, 2022 Patients with rare diseases often have limited or no options for approved treatments or participation in clinical trials. In such cases, expanded access (or “compassionate use”) provides a potential means of accessing unapproved investigational medicines.
Tobias B. Polak +10 more
doaj +1 more source
An analysis of common ethical justifications for compassionate use programs for experimental drugs [PDF]
, 2016 BACKGROUND: When a new intervention or drug is developed, this has to pass through various phases of clinical testing before it achieves market approval, which can take many years.
Raus, Kasper
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Ethics review in compassionate use
BMC Medicine, 2017 Background Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use ...
Jan Borysowski +2 more
doaj +1 more source
Characteristics of ADHD symptom response/remission in a clinical trial of methylphenidate extended release [PDF]
, 2019 Clinical trials in attention-deficit/hyperactivity disorder (ADHD) have typically measured outcome using clinician ratings on the Attention-Deficit/Hyperactivity Disorder Rating Scale, Fourth Edition (ADHD-RS-IV) and the Clinical Global Impression ...
Adjei, Akwete L +5 more
core +2 more sources
Clinical Pharmacology & Therapeutics, 2022 Compassionate use is a system that provides patients with exceptional access to investigational new drugs to treat life‐threatening diseases that have no effective conventional treatments. The purpose of this study was to characterize and assess the current status of the compassionate use program’s application in Japan by evaluating expanded access ...
Hideki Maeda +4 more
openaire +2 more sources
Facial expressions depicting compassionate and critical emotions: the development and validation of a new emotional face stimulus set [PDF]
, 2013 Attachment with altruistic others requires the ability to appropriately process affiliative and kind facial cues. Yet there is no stimulus set available to investigate such processes. Here, we developed a stimulus set depicting compassionate and critical
A Lutz +70 more
core +3 more sources