Results 51 to 60 of about 21,353 (254)

Reshaping study design for faster extrapolation‐based drug approval in pediatric inflammatory bowel diseases: An ESPGHAN–NASPGHAN position paper

Journal of Pediatric Gastroenterology and Nutrition, EarlyView.
Abstract Children with inflammatory bowel diseases (IBD) have limited access to the available advanced therapies, given the lengthy gap between adult and pediatric approval. We aimed to review key hurdles for pediatric trials and recommend practical solutions.
Dan Turner, Amit Assa, Mikkel Malham, Shira Yuval Bar‐Asher, Carla Rayan, Jeffrey S. Hyams, Holm H. Uhlig, Brad Pasternak, David C. Wilson, Hilary K. Michel, Lissy de Ridder, Eric Zuckerman, Marina Aloi, Peter Szitanyi, Marla C. Dubinsky, Anne M. Griffiths, Roberto Saldana, Javier Martín‐de‐Carpi, Eytan Wine, Richard K. Russell, Jeremy Adler, Joseph Picoraro   +21 more
wiley   +1 more source

Safety of opioid patch initiation in Australian residential aged care [PDF]

, 2015
Explores opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Abstract Objective: To explore opioid use by aged care facility residents before and after initiation of transdermal opioid patches. Design:
Elizabeth Roughead, Lisa Pont, Svetla Gadzhanova   +2 more
core   +1 more source

Phase 3b Extension Study MT‐1186‐A04 to Evaluate the Continued Efficacy and Safety of Edaravone Oral Suspension for Up to an Additional 48 Weeks in Patients With Amyotrophic Lateral Sclerosis

Muscle &Nerve, EarlyView.
ABSTRACT Introduction/Aims An On/Off dosing regimen of intravenous (IV) edaravone and edaravone oral suspension is currently approved in the US for treatment of amyotrophic lateral sclerosis (ALS). Placebo‐controlled clinical trials showed that IV edaravone slows physical functional decline.
Angela Genge, Jeffrey Rothstein, Shari De Silva, Lorne Zinman, Marvin Chum, Adriano Chiò, Gen Sobue, Masashi Aoki, Hiide Yoshino, Manabu Doyu, Daniel Selness, Vesna Todorovic, Manabu Hirai, Nissim Sasson, Fumihiro Takahashi, Michelle Cecić, Art Wamil, Stephen Apple   +17 more
wiley   +1 more source

Post-Market Surveillance Study of a Skull Flap Fixation Device: Cranfixer

Iranian Journal of Neurosurgery, 2019
Background and Aim: Cranfixer was approved in 2017 by the Food and Drug Administration of Iran as a skull flap fixation and also a burr hole cover.
Seyed Roholah Ghodsi, Hosein Esmaili Dezaki, Morteza Alizadeh, Zahra Namazi   +3 more
doaj  

Long-term safety and effectiveness of abatacept in Japanese patients with rheumatoid arthritis: 3-year follow-up of a postmarketing surveillance [PDF]

, 2021
Masayoshi Harigai, Katsuki Tsuritani, Yuri Yoshizawa, Tatsuya Atsumi, Yoshiya Tanaka   +4 more
openalex   +1 more source

A case report on the long‐term use of teduglutide in a pediatric patient with short bowel syndrome

Nutrition in Clinical Practice, EarlyView.
Abstract Short bowel syndrome (SBS) is the leading cause of intestinal failure, frequently necessitating long‐term parenteral nutrition (PN). Teduglutide (TED), a glucagon‐like peptide‐2 analog, has demonstrated efficacy in reducing PN dependence in both adults and children. However, long‐term data in pediatric populations remain limited.
Tsuyoshi Sakurai, Hironori Kudo, Nakamura Megumi, Ryo Ando, Takuro Kazama, Ryuji Okubo, Masatoshi Hashimoto, Ko Minoshima, Motoshi Wada   +8 more
wiley   +1 more source

Population scale data reveals the antidepressant effects of ketamine and other therapeutics approved for non-psychiatric indications. [PDF]

, 2017
Current therapeutic approaches to depression fail for millions of patients due to lag in clinical response and non-adherence. Here we provide new support for the antidepressant effect of an anesthetic drug, ketamine, by Inverse-Frequency Analysis of ...
Abagyan, Ruben, Atayee, Rabia, Cohen, Isaac V, Makunts, Tigran   +3 more
core   +2 more sources

Striking balance between expedited review and expecting efficacious anticancer drug and biologics: An ongoing challenge

Perspectives in Clinical Research, 2017
Objective: The objective of this study is to assess the postmarketing status: Efficacy and safety drugs and biologics related with cancer approved under expedited review.
Krishnan Vengadaragava Chary, Anita Ramesh   +1 more
doaj   +1 more source

Effectiveness and Safety of Radium‐223 for Bone‐Metastatic Castration‐Resistant Prostate Cancer: The KYUCOG‐1901 Study

Cancer Science, EarlyView.
The KYUCOG‐1901 prospective multicenter study evaluated radium‐223 in 93 Japanese patients with bone‐metastatic castration‐resistant prostate cancer. Ra‐223 was well tolerated, produced meaningful declines in ALP, and yielded a median overall survival of 23.0 months. Early initiation in patients with lower disease burden and integration with subsequent
Masaki Shiota, Shuichi Tatarano, Tomomi Kamba, Toshiyuki Kamoto, Tsukasa Igawa, Naoya Masumori, Hirotsugu Uemura, Kensuke Mitsunari, Takayuki Sumiyoshi, Hiroji Uemura, Katsuyoshi Higashijima, Shoji Tokunaga, Masatoshi Eto   +12 more
wiley   +1 more source

Rituximab induced pulmonary edema managed with extracorporeal life support [PDF]

, 2018
Though rare, rituximab has been reported to induce severe pulmonary edema. We describe the first report of ECLS utilization for this indication. A 31-year-old female with severe thrombotic thrombocytopenic purpura developed florid pulmonary edema after ...
Aguilar, Patrick, Balsara, Keki R, Isakow, Warren, Itoh, Akinobu, Masood, Muhammad F, Miller, Jacob R, Sanfilippo, Kristen M   +6 more
core   +3 more sources