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1948. Characteristics of Clinical Studies Conducted Over the Total Product Life Cycle of High-Risk Therapeutic Medical Devices Receiving FDA Premarket Approval in 2010 and 2011.
作者: Vinay K Rathi.;Harlan M Krumholz.;Frederick A Masoudi.;Joseph S Ross.
来源: JAMA. 2015年314卷6期604-12页
The US Food and Drug Administration (FDA) approves high-risk medical devices, those that support or sustain human life or present potential unreasonable risk to patients, via the Premarket Approval (PMA) pathway. The generation of clinical evidence to understand device safety and effectiveness is shifting from predominantly premarket to continual study throughout the total product life cycle.
1949. Association Between Intermittent Hypoxemia or Bradycardia and Late Death or Disability in Extremely Preterm Infants.
作者: Christian F Poets.;Robin S Roberts.;Barbara Schmidt.;Robin K Whyte.;Elizabeth V Asztalos.;David Bader.;Aida Bairam.;Diane Moddemann.;Abraham Peliowski.;Yacov Rabi.;Alfonso Solimano.;Harvey Nelson.; .
来源: JAMA. 2015年314卷6期595-603页
Extremely preterm infants may experience intermittent hypoxemia or bradycardia for many weeks after birth. The prognosis of these events is uncertain.
1950. Variation in Dialysis Facility Referral for Kidney Transplantation Among Patients With End-Stage Renal Disease in Georgia.
作者: Rachel E Patzer.;Laura C Plantinga.;Sudeshna Paul.;Jennifer Gander.;Jenna Krisher.;Leighann Sauls.;Eric M Gibney.;Laura Mulloy.;Stephen O Pastan.
来源: JAMA. 2015年314卷6期582-94页
Dialysis facilities in the United States are required to educate patients with end-stage renal disease about all treatment options, including kidney transplantation. Patients receiving dialysis typically require a referral for kidney transplant evaluation at a transplant center from a dialysis facility to start the transplantation process, but the proportion of patients referred for transplantation is unknown.
1951. Effects of Testosterone Administration for 3 Years on Subclinical Atherosclerosis Progression in Older Men With Low or Low-Normal Testosterone Levels: A Randomized Clinical Trial.
作者: Shehzad Basaria.;S Mitchell Harman.;Thomas G Travison.;Howard Hodis.;Panayiotis Tsitouras.;Matthew Budoff.;Karol M Pencina.;Joseph Vita.;Connie Dzekov.;Norman A Mazer.;Andrea D Coviello.;Philip E Knapp.;Kathleen Hally.;Emma Pinjic.;Mingzhu Yan.;Thomas W Storer.;Shalender Bhasin.
来源: JAMA. 2015年314卷6期570-81页
Testosterone use in older men is increasing, but its long-term effects on progression of atherosclerosis are unknown.
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