Publications

Education and training for medicines development, regulation, and clinical research in emerging countries

Author(s)
Kerpel-Fronius S, Rosenkranz B, Allen E, Bass R, Mainard JD, Dodoo A, Dubois DJ, Hela M, Kern S, Massud J, Silva H.
Publication date
Journal reference
Front Pharmacol. 2015 Apr 14;6:80. doi: 10.3389/fphar.2015.00080. eCollection 2015.

Cerebral near infrared spectroscopy oximetry in extremely preterm infants: phase II randomised clinical trial

Author(s)
Hyttel-Sorensen S, Pellicer A, Alderliesten T, Austin T, van Bel F, Benders M, Claris O, Dempsey E, Franz AR, Fumagalli M, Gluud C, Grevstad B, Hagmann C, Lemmers P, van Oeveren W, Pichler G, Plomgaard AM, Riera J, Sanchez L, Winkel P, Wolf M, Greisen G.
Publication date
Journal reference
BMJ. 2015 Jan 5;350:g7635. doi: 10.11 36/bmj.g7635.

Lower versus higher hemoglobin threshold for transfusion in septic shock

Author(s)
Holst LB, Haase N, Wetterslev J, Wernerman J, Guttormsen AB, Karlsson S, Johansson PI, Aneman A, Vang ML, Winding R, Nebrich L, Nibro HL, Rasmussen BS, Lauridsen JR, Nielsen JS, Oldner A, Pettilä V, Cronhjort MB, Andersen LH, Pedersen UG, Reiter N, Wiis J, White JO, Russell L, Thornberg KJ, Hjortrup PB, Müller RG, Møller MH, Steensen M, Tjäder I, Kilsand K, Odeberg-Wernerman S, Sjøbø B, Bundgaard H, Thyø MA, Lodahl D, Mærkedahl R, Albeck C, Illum D, Kruse M, Winkel P, Perner A; TRISS Trial Group; Scandinavian Critical Care Trials Group.
Publication date
Journal reference
N Engl J Med. 2014 Oct 9;371(15):1381-91. doi: 10.1056/NEJMoa1406617. Epub 2014 Oct 1.

Fostering EMA's transparency policy

Author(s)
Banzi R, Bertele V, Demotes-Mainard J, Garattini S, Gluud C, Kubiak C, Ohmann C.
Publication date
Journal reference
Eur J Intern Med. 2014 Sep 5. pii: S0953-6205(14)00212-X

EuroHYP-1: European multicenter, randomized, phase III clinical trial of therapeutic hypothermia plus best medical treatment vs. best medical treatment alone for acute ischemic stroke

Author(s)
van der Worp HB, Macleod MR, Bath PM, Demotes J, Durand-Zaleski I, Gebhardt B, Gluud C, Kollmar R, Krieger DW, Lees KR, Molina C, Montaner J, Roine RO, Petersson J, Staykov D, Szabo I, Wardlaw JM, Schwab S; EuroHYP-1 investigators.
Publication date
Journal reference
Int J Stroke. 2014 Jul;9(5):642-5.

Long-term outcomes in patients with severe sepsis randomised to resuscitation with hydroxyethyl starch 130/0.42 or Ringer's acetate

Author(s)
Perner A, Haase N, Winkel P, Guttormsen AB, Tenhunen J, Klemenzson G, Müller RG, Aneman A, Wetterslev J.
Publication date
Journal reference
Intensive Care Med. 2014 Jul;40(7):927-34. doi: 10.1007/s00134-014-3311-y. Epub 2014 May 8.

A phase I clinical study of a live attenuated Bordetella pertussis vaccine--BPZE1; a single centre, double-blind, placebo-controlled, dose-escalating study of BPZE1 given intranasally to healthy adult male volunteers

Author(s)
Thorstensson R, Trollfors B, Al-Tawil N, Jahnmatz M, Bergström J, Ljungman M, Törner A, Wehlin L, Van Broekhoven A, Bosman F, Debrie AS, Mielcarek N, Locht C.
Publication date
Journal reference
PLoS One. 2014 Jan 8;9(1):e83449. doi: 10.1371/journal.pone.0083449. eCollection 2014.

ROAMER: roadmap for mental health research in Europe

Author(s)
Haro JM1, Ayuso-Mateos JL, Bitter I, Demotes-Mainard J, Leboyer M, Lewis SW, Linszen D, Maj M, McDaid D, Meyer-Lindenberg A, Robbins TW, Schumann G, Thornicroft G, Van Der Feltz-Cornelis C, Van Os J, Wahlbeck K, Wittchen HU, Wykes T, Arango C, Bickenbach J, Brunn M, Cammarata P, Chevreul K, Evans-Lacko S, Finocchiaro C, Fiorillo A, Forsman AK, Hazo JB, Knappe S, Kuepper R, Luciano M, Miret M, Obradors-Tarragó C, Pagano G, Papp S, Walker-Tilley T.
Publication date
Journal reference
Int J Methods Psychiatr Res. 2014 Jan;23 Suppl 1:1-14. doi: 10.1002/mpr.1406.

Targeted Temperature Management at 33°C versus 36°C after Cardiac Arrest

Author(s)
Nielsen N, Wetterslev J, Cronberg T, Erlinge D, Gasche Y, Hassager C, Horn J, Hovdenes J, Kjaergaard J, Kuiper M, Pellis T, Stammet P, Wanscher M, Wise MP, Åneman A, Al-Subaie N, Boesgaard S, Bro-Jeppesen J, Brunetti I, Bugge JF, Hingston CD, Juffermans NP, Koopmans M, Køber L, Langørgen J, Lilja G, Møller JE, Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators.
Publication date
Journal reference
Rundgren M, Rylander C, Smid O, Werer C, Winkel P, Friberg H; TTM Trial Investigators. N Engl J Med. 2013 Dec 5;369(23):2197-206. doi: 10.1056/NEJMoa1310519. Epub 2013 Nov 17.

A European approach to clinical investigator training

Author(s)
Boeynaems JM1, Canivet C, Chan A, Clarke MJ, Cornu C, Daemen E, Demotes J, Nys KD, Hirst B, Hundt F, Kassai B, Kerpel-Fronius S, Kiessig L, Klech H, Kraehenbuhl JP, Lafolie P, Lucht M, Niese D, Pauli-Magnus C, Peters B, Schaltenbrand R, Stockis A, Stykova M, Verheus N, Klingmann I.
Publication date
Journal reference
Front Pharmacol. 2013 Sep 9;4:112. doi: 10.3389/fphar.2013.00112.