Results 51 to 60 of about 83,381 (315)

Evolving Real‐World Data and Evidence Use for New Drugs and Regenerative Medical Products Approvals in Japan—An Analysis of the 6‐Year Trend

Clinical Pharmacology &Therapeutics, EarlyView.
Several regulatory initiatives have been made to clarify the acceptability and requirements of real‐world data and real‐world evidence (RWD/E) for the benefit/risk assessment of new medical products in Japan. The objectives of this review were to characterize the use of RWD/E in regulatory applications of new medical products and to describe the ...
Suguru Okami, Kako Shimotsumagari, Yasunari Sadatsuki   +2 more
wiley   +1 more source

Molecular Study of Occult Hepatitis C Infection among Iranian Hemophilia Patients Treated with Direct-acting Antiviral Agents

Journal of Medical Microbiology and Infectious Diseases, 2020
Introduction: A new pathological form of HCV named as occult HCV infection (OCI) has been recently characterized by the presence of HCV RNA in liver biopsy and/or peripheral blood mononuclear cell specimens (PBMCs) and the absence of detectable ...
Elnaz Agi, Saber Asghari, Ali Namvar, Niloofar Khairkhah, Niloofar Naderi, Ali Anvar, Alireza Azizi Saraji, Azam Bolhassani   +7 more
doaj  

Sustained high-level expression of human factor IX (hFIX) after liver-targeted delivery of recombinant adeno-associated virus encoding the hFIX gene in rhesus macaques [PDF]

, 2002
The feasibility, safety, and efficacy of liver-directed gene transfer was evaluated in 5 male macaques (aged 2.5 to 6.5 years) by using a recombinant adeno-associated viral (rAAV) vector (rAAV-2 CAGG-hFIX) that had previously mediated persistent ...
Davidoff, AM, Hanawa, H, Hoffer, FA, Hu, Y, Lozier, JN, Mandrell, TD, Nathwani, AC, Ng, CYC, Nienhuis, AW, Nikanorov, A, Slaughter, C, Vanin, EF, Zhou, J   +12 more
core   +1 more source

Large Language Models for Clinical Trial Protocol Assessments

Clinical Pharmacology &Therapeutics, EarlyView.
The purpose was to evaluate the utility of large language models (LLMs) for reviewing the statistical analysis plan (SAP) and pharmacokinetics–pharmacodynamics (PK–PD) components of clinical trial protocols. Clinical trial protocols and SAPs were obtained from clinicaltrials.gov for a testbed of 15 small‐molecule drugs, biologics, and global antibiotic
Euibeom Shin, Amruta Gajanan Bhat, Murali Ramanathan   +2 more
wiley   +1 more source

Pharmacokinetics Guided Personalized Management of Hemophilia Rehabilitation: A Chinese Consensus Based on Modified Delphi

罕见病研究
Hemophilia is a collection of hereditary bleeding disorders that are X-linked recessive. Patients often experience recurrent bleeding in joints, leading to a cascade of complications including chronic synovitis, hemophilic arthropathy, muscle atrophy ...
Hemophilia Treatment Center Collaborative Network of China
doaj   +1 more source

Strategies for Hemophilia Treatment, a literature review of current evidence

مجله دانشگاه علوم پزشکی بیرجند, 2023
Hemophilia is an inherited bleeding disorder caused by malfunctioning or lacking blood coagulation factor VIII (hemophilia A) or IX (hemophilia B). Currently, the main treatments for these X-linked diseases are replacement therapy using periodic and ...
Fahimeh Ghasemi, Nafiseh Erfanian, Samira Karbasi, Alireza Zomorodipour   +3 more
doaj  

Evaluation of coagulation disorders and iron deficiency in women with heavy menstrual bleeding

International Journal of Gynecology &Obstetrics, EarlyView.
Abstract Objective To explore the incidence of congenital bleeding disorders (CBD), which may result in anemia, in a large cohort of women referred for heavy menstrual bleeding (HMB) in a specialized gynecologic unit. Methods Between January 2022 and January 2024, all women referred for HMB were screened.
Lucia Rugeri, Yelena Fruchou, Caroline Brodbeck, Marianne Bastien, Amandine Lioux, Giulia Gouy, Marion Cortet, Gil Dubernard, Yesim Dargaud   +8 more
wiley   +1 more source

Hemophilia treatment and transfusion medicine

Zhongguo shuxue zazhi
The improvement of hemophilia treatment is attributed to the development of transfusion medicine, and the discovery of cryoprecipitate has opened up a new era of hemophilia treatment, laying the foundation for the development of modern hemophilia ...
FANG Yunhai, CHENG Yan, ZHANG Xinsheng
doaj   +1 more source

Perioperative blood loss during joint replacement: comparison between patients with and without hemophilia

Journal of Orthopaedic Surgery and Research, 2022
Background Although arthroplasty provides satisfactory pain relief, functional improvement, and reduced flexion contracture in patients with hemophilia arthropathy, bleeding remains the primary problem associated with hemophilic arthropathy joint ...
Shanyou Yuan, Lixia Song, Haoli Jiang, Jinghua Wang, Xianjia Ning, Wenxue Jiang   +5 more
doaj   +1 more source

FIGO good practice recommendations: Assisted vaginal birth and the second stage of labor

International Journal of Gynecology &Obstetrics, EarlyView.
Abstract Cesarean birth (CB) rates are increasing globally, with a current prevalence of 21.1% and a projected prevalence of 28.5% by 2030. Conversely, assisted vaginal birth (AVB) rates are declining, with reported rates of less than 10% in low‐ and middle‐income countries (LMICs) and 10%–15% in high‐income countries (HICs). In some African countries,
Akaninyene E. Ubom, Eytan R. Barnea, Nicoletta DiSimone, Martin Mueller, Jolly Beyeza‐Kashesya, Ines Nunes, Albaro J. Nieto‐Calvache, Elif G. Topcu, Zechariah J. Malel, Bo Jacobsson, Alison Wright, the FIGO Childbirth and Postpartum Hemorrhage Committee   +11 more
wiley   +1 more source