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Actigraphy Study Endpoints to Reduce Sample Size and Facilitate Drug Development for Pediatric Pulmonary Arterial Hypertension.

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Title: Actigraphy Study Endpoints to Reduce Sample Size and Facilitate Drug Development for Pediatric Pulmonary Arterial Hypertension.
Authors: Sun H; Office of the Commissioner, U.S. Food and Drug Administration (FDA), Silver Spring, MD. Electronic address: haihao.sun@fda.hhs.gov., Stockbridge N; Office of the Commissioner, U.S. Food and Drug Administration (FDA), Silver Spring, MD., Ivy DD; Section of Cardiology, Department of Pediatrics, University of Colorado School of Medicine, Denver, CO., Clark J; Office of the Commissioner, U.S. Food and Drug Administration (FDA), Silver Spring, MD., Bates A; Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada., Handler SS; Division of Cardiology, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI., Krishnan US; New York Presbyterian Hospital and Columbia University Irving Medical Center, New York City, NY., Mullen MP; Boston Children's Hospital, Boston, MA; Harvard Medical School, Boston, MA., Yung D; University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA., Hopper RK; Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA., Varghese NP; Baylor College of Medicine and Texas Children's Hospital, Houston, TX., Avitabile CM; Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA., Fineman J; UCSF Benioff Children's Hospital, San Francisco, CA., Austin ED; Vanderbilt University, Nashville, TN., Freire G; Johns Hopkins All Children's Hospital in St Petersburg, St. Petersburg, FL.
Source: The Journal of pediatrics [J Pediatr] 2025 Feb; Vol. 277, pp. 114383. Date of Electronic Publication: 2024 Nov 01.
Publication Type: Journal Article; Multicenter Study; Research Support, U.S. Gov't, P.H.S.
Journal Info: Publisher: Mosby Country of Publication: United States NLM ID: 0375410 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1097-6833 (Electronic) Linking ISSN: 00223476 NLM ISO Abbreviation: J Pediatr Subsets: MEDLINE
Database: MEDLINE Ultimate
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  Data: Actigraphy Study Endpoints to Reduce Sample Size and Facilitate Drug Development for Pediatric Pulmonary Arterial Hypertension.
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  Data: <searchLink fieldCode="AU" term="%22Sun+H%22">Sun H</searchLink>; Office of the Commissioner, U.S. Food and Drug Administration (FDA), Silver Spring, MD. Electronic address: haihao.sun@fda.hhs.gov.<br /><searchLink fieldCode="AU" term="%22Stockbridge+N%22">Stockbridge N</searchLink>; Office of the Commissioner, U.S. Food and Drug Administration (FDA), Silver Spring, MD.<br /><searchLink fieldCode="AU" term="%22Ivy+DD%22">Ivy DD</searchLink>; Section of Cardiology, Department of Pediatrics, University of Colorado School of Medicine, Denver, CO.<br /><searchLink fieldCode="AU" term="%22Clark+J%22">Clark J</searchLink>; Office of the Commissioner, U.S. Food and Drug Administration (FDA), Silver Spring, MD.<br /><searchLink fieldCode="AU" term="%22Bates+A%22">Bates A</searchLink>; Department of Pediatrics, Stollery Children's Hospital, University of Alberta, Edmonton, Alberta, Canada.<br /><searchLink fieldCode="AU" term="%22Handler+SS%22">Handler SS</searchLink>; Division of Cardiology, Department of Pediatrics, Medical College of Wisconsin, Milwaukee, WI.<br /><searchLink fieldCode="AU" term="%22Krishnan+US%22">Krishnan US</searchLink>; New York Presbyterian Hospital and Columbia University Irving Medical Center, New York City, NY.<br /><searchLink fieldCode="AU" term="%22Mullen+MP%22">Mullen MP</searchLink>; Boston Children's Hospital, Boston, MA; Harvard Medical School, Boston, MA.<br /><searchLink fieldCode="AU" term="%22Yung+D%22">Yung D</searchLink>; University of Washington School of Medicine and Seattle Children's Hospital, Seattle, WA.<br /><searchLink fieldCode="AU" term="%22Hopper+RK%22">Hopper RK</searchLink>; Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA.<br /><searchLink fieldCode="AU" term="%22Varghese+NP%22">Varghese NP</searchLink>; Baylor College of Medicine and Texas Children's Hospital, Houston, TX.<br /><searchLink fieldCode="AU" term="%22Avitabile+CM%22">Avitabile CM</searchLink>; Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA.<br /><searchLink fieldCode="AU" term="%22Fineman+J%22">Fineman J</searchLink>; UCSF Benioff Children's Hospital, San Francisco, CA.<br /><searchLink fieldCode="AU" term="%22Austin+ED%22">Austin ED</searchLink>; Vanderbilt University, Nashville, TN.<br /><searchLink fieldCode="AU" term="%22Freire+G%22">Freire G</searchLink>; Johns Hopkins All Children's Hospital in St Petersburg, St. Petersburg, FL.
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  Data: <searchLink fieldCode="JN" term="%220375410%22">The Journal of pediatrics</searchLink> [J Pediatr] 2025 Feb; Vol. 277, pp. 114383. <i>Date of Electronic Publication: </i>2024 Nov 01.
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  Data: <i>Publisher: </i><searchLink fieldCode="PB" term="%22Mosby%22">Mosby </searchLink><i>Country of Publication: </i>United States <i>NLM ID: </i>0375410 <i>Publication Model: </i>Print-Electronic <i>Cited Medium: </i>Internet <i>ISSN: </i>1097-6833 (Electronic) <i>Linking ISSN: </i><searchLink fieldCode="IS" term="%2200223476%22">00223476 </searchLink><i>NLM ISO Abbreviation: </i>J Pediatr <i>Subsets: </i>MEDLINE
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        Value: 10.1016/j.jpeds.2024.114383
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              Text: 2025 Feb
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