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A Phase 3, open-label, 96-week trial to study the safety, tolerability, and efficacy of tezacaftor/ivacaftor in children ≥ 6 years of age homozygous for F508del or heterozygous for F508del and a residual function CFTR variant.
Sawicki GS, Chilvers M, McNamara J, Naehrlich L, Saunders C, Sermet-Gaudelus I, Wainwright CE, Ahluwalia N, Campbell D, Harris RS, Paz-Diaz H, Shih JL, Davies JC. Sawicki GS, et al. Among authors: naehrlich l. J Cyst Fibros. 2022 Jul;21(4):675-683. doi: 10.1016/j.jcf.2022.02.003. Epub 2022 Feb 18. J Cyst Fibros. 2022. PMID: 35190292 Free article. Clinical Trial.
New clinical diagnostic procedures for cystic fibrosis in Europe.
De Boeck K, Derichs N, Fajac I, de Jonge HR, Bronsveld I, Sermet I, Vermeulen F, Sheppard DN, Cuppens H, Hug M, Melotti P, Middleton PG, Wilschanski M; ECFS Diagnostic Network Working Group; EuroCareCF WP3 Group on CF diagnosis. De Boeck K, et al. J Cyst Fibros. 2011 Jun;10 Suppl 2:S53-66. doi: 10.1016/S1569-1993(11)60009-X. J Cyst Fibros. 2011. PMID: 21658643 Free article. Review.
Misdiagnosis of cystic fibrosis: experience from Germany.
Naehrlich L, Bagheri-Behrouzi A; German CF quality assurance group. Naehrlich L, et al. J Cyst Fibros. 2013 Jan;12(1):68-73. doi: 10.1016/j.jcf.2012.06.008. Epub 2012 Jul 24. J Cyst Fibros. 2013. PMID: 22835809 Free article.
Nasal potential difference measurements in diagnosis of cystic fibrosis: an international survey.
Naehrlich L, Ballmann M, Davies J, Derichs N, Gonska T, Hjelte L, van Konigsbruggen-Rietschel S, Leal T, Melotti P, Middleton P, Tümmler B, Vermeulen F, Wilschanski M; ECFS Diagnostic Network Working Group. Naehrlich L, et al. J Cyst Fibros. 2014 Jan;13(1):24-8. doi: 10.1016/j.jcf.2013.08.006. Epub 2013 Sep 7. J Cyst Fibros. 2014. PMID: 24022019 Free article.
Is there evidence for correct diagnosis in cystic fibrosis registries?
Thomas M, Lemonnier L, Gulmans V, Naehrlich L, Vermeulen F, Cuppens H, Castellani C, Norek A, De Boeck K. Thomas M, et al. Among authors: naehrlich l. J Cyst Fibros. 2014 May;13(3):275-80. doi: 10.1016/j.jcf.2013.10.010. Epub 2013 Nov 22. J Cyst Fibros. 2014. PMID: 24274930 Free article.
Lumacaftor-Ivacaftor in Patients with Cystic Fibrosis Homozygous for Phe508del CFTR.
Wainwright CE, Elborn JS, Ramsey BW, Marigowda G, Huang X, Cipolli M, Colombo C, Davies JC, De Boeck K, Flume PA, Konstan MW, McColley SA, McCoy K, McKone EF, Munck A, Ratjen F, Rowe SM, Waltz D, Boyle MP; TRAFFIC Study Group; TRANSPORT Study Group. Wainwright CE, et al. N Engl J Med. 2015 Jul 16;373(3):220-31. doi: 10.1056/NEJMoa1409547. Epub 2015 May 17. N Engl J Med. 2015. PMID: 25981758 Free PMC article. Clinical Trial.
Efficacy and safety of lumacaftor and ivacaftor in patients aged 6-11 years with cystic fibrosis homozygous for F508del-CFTR: a randomised, placebo-controlled phase 3 trial.
Ratjen F, Hug C, Marigowda G, Tian S, Huang X, Stanojevic S, Milla CE, Robinson PD, Waltz D, Davies JC; VX14-809-109 investigator group. Ratjen F, et al. Lancet Respir Med. 2017 Jul;5(7):557-567. doi: 10.1016/S2213-2600(17)30215-1. Epub 2017 Jun 9. Lancet Respir Med. 2017. PMID: 28606620 Free article. Clinical Trial.
Effects of Lumacaftor-Ivacaftor Therapy on Cystic Fibrosis Transmembrane Conductance Regulator Function in Phe508del Homozygous Patients with Cystic Fibrosis.
Graeber SY, Dopfer C, Naehrlich L, Gyulumyan L, Scheuermann H, Hirtz S, Wege S, Mairbäurl H, Dorda M, Hyde R, Bagheri-Hanson A, Rueckes-Nilges C, Fischer S, Mall MA, Tümmler B. Graeber SY, et al. Among authors: naehrlich l. Am J Respir Crit Care Med. 2018 Jun 1;197(11):1433-1442. doi: 10.1164/rccm.201710-1983OC. Am J Respir Crit Care Med. 2018. PMID: 29327948
74 results