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Voluntary exploratory data submissions to the US FDA and the EMA: experience and impact.
Published in:
2010
By:
- Goodsaid, Federico M.;
- Amur, Shashi;
- Aubrecht, Jiri;
- Burczynski, Michael E.;
- Carl, Kevin;
- Catalano, Jennifer;
- Charlab, Rosane;
- Close, Sandra;
- Cornu-Artis, Catherine;
- Essioux, Laurent;
- Fornace, Albert J.;
- Hinman, Lois;
- Huixiao Hong;
- Hunt, Ian;
- Jacobson-Kram, David;
- Jawaid, Ansar;
- Laurie, David;
- Lesko, Lawrence;
- Heng-Hong Li;
- Lindpaintner, Klaus
Publication type:
review
A methodological framework for drug development in rare diseases.
Published in:
Orphanet Journal of Rare Diseases, 2014, v. 9, n. 1, p. 164, doi. 10.1186/s13023-014-0164-y
By:
- Nony, Patrice;
- Kurbatova, Polina;
- Bajard, Agathe;
- Malik, Salma;
- Castellan, Charlotte;
- Chabaud, Sylvie;
- Volpert, Vitaly;
- Eymard, Nathalie;
- Kassai, Behrouz;
- Cornu, Catherine
Publication type:
Article
Experimental designs for small randomised clinical trials: an algorithm for choice.
Published in:
Orphanet Journal of Rare Diseases, 2013, v. 8, n. 1, p. 1, doi. 10.1186/1750-1172-8-48
By:
- Cornu, Catherine;
- Kassai, Behrouz;
- Fisch, Roland;
- Chiron, Catherine;
- Alberti, Corinne;
- Guerrini, Renzo;
- Rosati, Anna;
- Pons, Gerard;
- Tiddens, Harm;
- Chabaud, Sylvie;
- Caudri, Daan;
- Ballot, Clément;
- Kurbatova, Polina;
- Castellan, Anne-Charlotte;
- Bajard, Agathe;
- Nony, Patrice
Publication type:
Article
Experimental designs for small randomised clinical trials: an algorithm for choice.
Published in:
2013
By:
- Cornu, Catherine;
- Kassai, Behrouz;
- Fisch, Roland;
- Chiron, Catherine;
- Alberti, Corinne;
- Guerrini, Renzo;
- Rosati, Anna;
- Pons, Gerard;
- Tiddens, Harm;
- Chabaud, Sylvie;
- Caudri, Daan;
- Ballot, Clément;
- Kurbatova, Polina;
- Castellan, Anne-Charlotte;
- Bajard, Agathe;
- Nony, Patrice;
- CRESim & Epi-CRESim Project Groups;
- Aarons, Leon;
- Bertrand, Yves;
- Bretz, Frank
Publication type:
journal article
Effect of Non-Steroidal Anti-Inflammatory Drugs on Sport Performance Indices in Healthy People: a Meta-Analysis of Randomized Controlled Trials.
Published in:
Sports Medicine - Open, 2020, v. 6, n. 1, p. 1, doi. 10.1186/s40798-020-00247-w
By:
- Cornu, Catherine;
- Grange, Clémence;
- Regalin, Amanda;
- Munier, Justine;
- Ounissi, Sonia;
- Reynaud, Natane;
- Kassai-Koupai, Behrouz;
- Sallet, Pierre;
- Nony, Patrice
Publication type:
Article
Assessing the reach, effectiveness, adoption, implementation, and maintenance of the ProACTIVE SCI physical activity counseling intervention among physiotherapists and SCI peer coaches during the transition from rehabilitation to community.
Published in:
Frontiers in Neurology, 2023, p. 1, doi. 10.3389/fneur.2023.1286129
By:
- Olsen, Kenedy;
- Ginis, Kathleen A. Martin;
- Lawrason, Sarah;
- McBride, Christopher B.;
- Walden, Kristen;
- Le Cornu Levett, Catherine;
- Colistro, Regina;
- Plashkes, Tova;
- Bass, Andrea;
- Thorson, Teri;
- Clarkson, Ryan;
- Bitz, Rod;
- Ma, Jasmin K.
Publication type:
Article
Thyroglobulin measurement in fine-needle aspirates of lymph nodes in patients with differentiated thyroid cancer: a simple definition of the threshold value, with emphasis on potential pitfalls of the method.
Published in:
Clinical Chemistry & Laboratory Medicine, 2010, v. 48, n. 8, p. 1171, doi. 10.1515/CCLM.2010.220
By:
- Bournaud, Claire;
- Charrié, Anne;
- Nozières, Cécile;
- Chikh, Karim;
- Lapras, Véronique;
- Denier, Marie-Laure;
- Paulin, Christian;
- Decaussin-Petrucci, Myriam;
- Peix, Jean-Louis;
- Lifante, Jean-Christophe;
- Cornu, Catherine;
- Giraud, Céline;
- Orgiazzi, Jacques;
- Borson-Chazot, Françoise
Publication type:
Article
SGLT2 inhibitors in type 2 diabetes: a systematic review and meta-analysis of cardiovascular outcome trials balancing their risks and benefits.
Published in:
Diabetologia, 2022, v. 65, n. 12, p. 2000, doi. 10.1007/s00125-022-05773-8
By:
- Marilly, Elisa;
- Cottin, Judith;
- Cabrera, Natalia;
- Cornu, Catherine;
- Boussageon, Remy;
- Moulin, Philippe;
- Lega, Jean-Christophe;
- Gueyffier, François;
- Cucherat, Michel;
- Grenet, Guillaume
Publication type:
Article
A double-blind placebo-controlled randomised trial of omega-3 supplementation in children with moderate ADHD symptoms.
Published in:
European Child & Adolescent Psychiatry, 2018, v. 27, n. 3, p. 377, doi. 10.1007/s00787-017-1058-z
By:
- Cornu, Catherine;
- Mercier, Catherine;
- Ginhoux, Tiphanie;
- Masson, Sandrine;
- Mouchet, Julie;
- Nony, Patrice;
- Kassai, Behrouz;
- Laudy, Valérie;
- Berquin, Patrick;
- Franc, Nathalie;
- Le Heuzey, Marie-France;
- Desombre, Hugues;
- Revol, Olivier
Publication type:
Article
Oral nomegestrol acetate and transdermal 17-beta-estradiol for preventing post-partum relapses in multiple sclerosis: The POPARTMUS study.
Published in:
Multiple Sclerosis Journal, 2021, v. 27, n. 9, p. 1458, doi. 10.1177/1352458520978218
By:
- Vukusic, Sandra;
- Ionescu, Iuliana;
- Cornu, Catherine;
- Bossard, Nadine;
- Durand-Dubief, Françoise;
- Cotton, François;
- Durelli, Luca;
- Marignier, Romain;
- Gignoux, Laurence;
- Laplaud, David-Axel;
- Moreau, Thibault;
- Clavelou, Pierre;
- De Seze, Jérôme;
- Debouverie, Marc;
- Brassat, David;
- Pelletier, Jean;
- Lebrun-Frenay, Christine;
- Le Page, Emmanuelle;
- Castelnovo, Giovanni;
- Berger, Eric
Publication type:
Article
Improved informed consent documents for biomedical research do not increase patients' understanding but reduce enrolment: a study in real settings.
Published in:
British Journal of Clinical Pharmacology, 2015, v. 80, n. 5, p. 1010, doi. 10.1111/bcp.12716
By:
- Paris, Adeline;
- Deygas, Béatrice;
- Cornu, Catherine;
- Thalamas, Claire;
- Maison, Patrick;
- Duale, Christian;
- Kane, Maty;
- Hodaj, Enkelejda;
- Cracowski, Jean‐Luc
Publication type:
Article
Impact of the reduction of calcineurin inhibitors on renal function in heart transplant patients: a systematic review and meta-analysis.
Published in:
British Journal of Clinical Pharmacology, 2014, v. 78, n. 1, p. 24, doi. 10.1111/bcp.12289
By:
- Cornu, Catherine;
- Dufays, Christophe;
- Gaillard, Ségolène;
- Gueyffier, François;
- Redonnet, Michel;
- Sebbag, Laurent;
- Roussoulières, Ana;
- Gleissner, Christian A.;
- Groetzner, Jan;
- Lehmkuhl, Hans B.;
- Potena, Luciano;
- Gullestad, Lars;
- Cantarovich, Marcelo;
- Boissonnat, Pascale
Publication type:
Article
Informed consent document improvement does not increase patients' comprehension in biomedical research.
Published in:
British Journal of Clinical Pharmacology, 2010, v. 69, n. 3, p. 231, doi. 10.1111/j.1365-2125.2009.03565.x
By:
- Paris, Adeline;
- Brandt, Christian;
- Cornu, Catherine;
- Maison, Patrick;
- Thalamas, Claire;
- Cracowski, Jean-Luc
Publication type:
Article
No effect of a homoeopathic combination of Arnica montana and Bryonia alba on bleeding, inflammation, and ischaemia after aortic valve surgery.
Published in:
British Journal of Clinical Pharmacology, 2010, v. 69, n. 2, p. 136, doi. 10.1111/j.1365-2125.2009.03574.x
By:
- Cornu, Catherine;
- Joseph, Pierre;
- Gaillard, Ségolène;
- Bauer, Christian;
- Vedrinne, Catherine;
- Bissery, Alvine;
- Melot, Ghislaine;
- Bossard, Nadine;
- Belon, Philippe;
- Lehot, Jean-Jacques
Publication type:
Article
Growth curves for congenital adrenal hyperplasia from a national retrospective cohort.
Published in:
Journal of Pediatric Endocrinology & Metabolism, 2016, v. 29, n. 12, p. 1379, doi. 10.1515/jpem-2016-0156
By:
- Bretones, Patricia;
- Riche, Benjamin;
- Pichot, Emmanuel;
- David†, Michel;
- Roy, Pascal;
- Tardy, Véronique;
- Kassai, Behrouz;
- Gaillard, Ségolène;
- Bernoux, Delphine;
- Morel, Yves;
- Chatelain, Pierre;
- Nicolino, Marc;
- Cornu, Catherine
Publication type:
Article
A dietary supplement to improve the quality ofsleep: a randomized placebo controlled trial.
Published in:
BMC Complementary & Alternative Medicine, 2010, v. 10, p. 29, doi. 10.1186/1472-6882-10-29
By:
- Cornu, Catherine;
- Remontet, Laurent;
- Noel-Baron, Florence;
- Nicolas, Alain;
- Feugier-Favier, Nathalie;
- Roy, Pascal;
- Claustrat, Bruno;
- Saadatian-Elahi, Mitra;
- Kassaï, Behrouz
Publication type:
Article
Primary endpoint adjudication: comparison between the expert committee and the regulatory MedDRA® coding in the MITRA‐FR study.
Published in:
European Journal of Heart Failure, 2022, v. 24, n. 2, p. 396, doi. 10.1002/ejhf.2401
By:
- Facile, Anthony;
- Mewton, Nathan;
- Nguon, Marina;
- Durand de Gevigney, Guy;
- Grinberg, Daniel;
- Bodenan, Eurielle;
- Samson, Geraldine;
- Plattner, Valérie;
- Trochu, Jean Noel;
- Cornu, Catherine
Publication type:
Article
Effect of desipramine on patients with breathing disorders in RETT syndrome.
Published in:
Annals of Clinical & Translational Neurology, 2018, v. 5, n. 2, p. 118, doi. 10.1002/acn3.468
By:
- Mancini, Josette;
- Dubus, Jean‐Christophe;
- Jouve, Elisabeth;
- Roux, Jean‐Christophe;
- Franco, Patricia;
- Lagrue, Emmanuelle;
- Castelnau, Pierre;
- Cances, Claude;
- Chaix, Yves;
- Rougeot‐Jung, Christelle;
- Cornu, Catherine;
- Desportes, Vincent;
- Vallée, Louis;
- Bahi‐Buisson, Nadia;
- Truillet, Romain;
- Attolini, Laurence;
- Villard, Laurent;
- Blin, Olivier;
- Micallef, Joëlle
Publication type:
Article
Are concomitant treatments confounding factors in randomized controlled trials on intensive blood-glucose control in type 2 diabetes? a systematic review.
Published in:
BMC Medical Research Methodology, 2013, v. 13, n. 1, p. 1, doi. 10.1186/1471-2288-13-107
By:
- Boussageon, Rémy;
- Supper, Irène;
- Erpeldinger, Sylvie;
- Cucherat, Michel;
- Bejan-Angoulvant, Theodora;
- Kassai, Behrouz;
- Cornu, Catherine;
- Gueyffier, François
Publication type:
Article
Are concomitant treatments confounding factors in randomized controlled trials on intensive blood-glucose control in type 2 diabetes? a systematic review.
Published in:
2013
By:
- Boussageon, Rémy;
- Supper, Irène;
- Erpeldinger, Sylvie;
- Cucherat, Michel;
- Bejan-Angoulvant, Theodora;
- Kassai, Behrouz;
- Cornu, Catherine;
- Gueyffier, François
Publication type:
journal article
French academic's views on financial compensation of participants.
Published in:
European Journal of Clinical Investigation, 2016, v. 46, n. 7, p. 619, doi. 10.1111/eci.12638
By:
- Dualé, Christian;
- Breysse, Gaétan;
- Bories‐Azeau, Béatrice;
- Cornu, Catherine
Publication type:
Article
Revising the ECRIN standard requirements for information technology and data management in clinical trials.
Published in:
Trials, 2013, v. 14, n. 1, p. 1, doi. 10.1186/1745-6215-14-97
By:
- Ohmann, Christian;
- Canham, Steve;
- Cornu, Catherine;
- Dreß, Jochen;
- Gueyffier, François;
- Kuchinke, Wolfgang;
- Nicolis, Enrico B.;
- Wittenberg, Michael
Publication type:
Article
Impact of the early reduction of cyclosporine on renal function in heart transplant patients: a French randomised controlled trial.
Published in:
Trials, 2012, v. 13, n. 1, p. 231, doi. 10.1186/1745-6215-13-231
By:
- Boissonnat, Pascale;
- Gaillard, S‚golŠne;
- Mercier, Catherine;
- Redonnet, Michel;
- Lelong, Bernard;
- Mattei, Marie-Fran‡oise;
- Mouly-Bandini, Annick;
- Pattier, Sabine;
- Sirinelli, AgnŠs;
- Epailly, Eric;
- Varnous, Shaida;
- Billes, Marc-Alain;
- Sebbag, Laurent;
- Ecochard, Ren‚;
- Cornu, Catherine;
- Gueyffier, Fran‡ois
Publication type:
Article
Low doses of recombinant human erythropoietin does not affect C‐terminal FGF23 in healthy men.
Published in:
Drug Testing & Analysis, 2020, v. 12, n. 7, p. 975, doi. 10.1002/dta.2795
By:
- Bejder, Jacob;
- Robach, Paul;
- Lundby, Anne‐Kristine;
- Cornu, Catherine;
- Sallet, Pierre;
- Cairo, Gaetano;
- Lundby, Carsten
Publication type:
Article
Trends in the number and the quality of trial protocols involving children submitted to a French Institutional Review Board.
Published in:
2017
By:
- Gautier, Isabelle;
- Janiaud, Perrine;
- Rollet, Nelly;
- André, Nicolas;
- Tsimaratos, Michel;
- Cornu, Catherine;
- Malik, Salma;
- Gentile, Stéphanie;
- Kassaï, Behrouz
Publication type:
journal article
Efficacy and safety of insulin in type 2 diabetes: meta-analysis of randomised controlled trials.
Published in:
BMC Endocrine Disorders, 2016, v. 16, p. 1, doi. 10.1186/s12902-016-0120-z
By:
- Erpeldinger, Sylvie;
- Rehman, Michaela B.;
- Berkhout, Christophe;
- Pigache, Christophe;
- Zerbib, Yves;
- Regnault, Francis;
- Guérin, Emilie;
- Supper, Irène;
- Cornu, Catherine;
- Kassaï, Behrouz;
- Gueyffier, François;
- Boussageon, Rémy
Publication type:
Article
A randomized controlled phase III study comparing hadrontherapy with carbon ions versus conventional radiotherapy - including photon and proton therapy - for the treatment of radioresistant tumors: the ETOILE trial.
Published in:
2022
By:
- Balosso, Jacques;
- Febvey-Combes, Olivia;
- Iung, Annie;
- Lozano, Hélène;
- Alloh, Abdoulkader Soumai;
- Cornu, Catherine;
- Hervé, Magali;
- Akkal, Zohra;
- Lièvre, Michel;
- Plattner, Valérie;
- Valvo, Francesca;
- Bono, Cristina;
- Fiore, Maria Rosaria;
- Vitolo, Viviana;
- Vischioni, Barbara;
- Patin, Stéphanie;
- Allemand, Hubert;
- Gueyffier, François;
- Margier, Jennifer;
- Guerre, Pascale
Publication type:
journal article
Influence of measles vaccination on the progression of atopic dermatitis in infants.
Published in:
Pediatric Allergy & Immunology, 2007, v. 18, n. 5, p. 385, doi. 10.1111/j.1399-3038.2007.00537.x
By:
- Hennino, Anà;
- Cornu, Catherine;
- Rozieres, Aurore;
- Augey, Frédéric;
- Villard-Truc, Florence;
- Payot, François;
- Lachaux, Alain;
- Nicolas, Jean-François;
- Horvat, Branka
Publication type:
Article
Association of clinical events with everolimus exposure in kidney transplant patients receiving reduced cyclosporine.
Published in:
Clinical Transplantation, 2013, v. 27, n. 2, p. 217, doi. 10.1111/ctr.12045
By:
- Shihab, Fuad S.;
- Cibrik, Diane;
- Chan, Laurence;
- Kim, Yu Seun;
- Carmellini, Mario;
- Walker, Rowan;
- Zibari, Gazi;
- Pattison, James;
- Cornu‐Artis, Catherine;
- Wang, Zailong;
- Tedesco‐Silva Jr, Helio
Publication type:
Article
Protocol of GLUcose COntrol Safety and Efficacy in type 2 DIabetes, a NETwork meta-analysis: GLUCOSE DINET protocol-Rational and design.
Published in:
Fundamental & Clinical Pharmacology, 2017, v. 31, n. 3, p. 258, doi. 10.1111/fcp.12263
By:
- Grenet, Guillaume;
- Lajoinie, Audrey;
- Ribault, Shams;
- Nguyen, Gia Bao;
- Linet, Thomas;
- Metge, Augustin;
- Cornu, Catherine;
- Cucherat, Michel;
- Moulin, Philippe;
- Gueyffier, François
Publication type:
Article
Improvement of the comprehension of written information given to healthy volunteers in biomedical research: a single-blind randomized controlled study.
Published in:
Fundamental & Clinical Pharmacology, 2007, v. 21, n. 2, p. 207, doi. 10.1111/j.1472-8206.2007.00472.x
By:
- Paris, Adeline;
- Nogueira da Gama Chaves, Daniel;
- Cornu, Catherine;
- Maison, Patrick;
- Salvat-Mélis, Muriel;
- Ribuot, Christophe;
- Brandt, Christian;
- Bosson, Jean-Luc;
- Hommel, Marc;
- Cracowski, Jean-Luc
Publication type:
Article
French adaptation and preliminary validation of a questionnaire to evaluate understanding of informed consent documents in phase I biomedical research.
Published in:
Fundamental & Clinical Pharmacology, 2006, v. 20, n. 1, p. 97, doi. 10.1111/j.1472-8206.2005.00391.x
By:
- Paris, Adeline;
- Cornu, Catherine;
- Auquier, Pascal;
- Maison, Patrick;
- Radauceanu, Anca;
- Brandt, Christian;
- Salvat-Melis, Muriel;
- Hommel, Marc;
- Cracowski, Jean-Luc
Publication type:
Article
Impact of French‘Comités de Protection des Personnes’ on the readability of informed consent documents (ICD) in biomedical research: more information, but not better information.
Published in:
Fundamental & Clinical Pharmacology, 2005, v. 19, n. 3, p. 395, doi. 10.1111/j.1472-8206.2005.00327.x
By:
- Paris, Adeline;
- Cracowski, Jean-Luc;
- Maison, Patrick;
- Radauceanu, Anca;
- Cornu, Catherine;
- Hommel, Marc
Publication type:
Article
GLUcose COntrol Safety & Efficacy in type 2 DIabetes, a systematic review and NETwork meta-analysis.
Published in:
PLoS ONE, 2019, v. 14, n. 6, p. 1, doi. 10.1371/journal.pone.0217701
By:
- Grenet, Guillaume;
- Ribault, Shams;
- Nguyen, Giao Bao;
- Glais, Faustine;
- Metge, Augustin;
- Linet, Thomas;
- Kassai-Koupai, Behrouz;
- Cornu, Catherine;
- Bejan-Angoulvant, Théodora;
- Erpeldinger, Sylvie;
- Boussageon, Rémy;
- Gouraud, Aurore;
- Bonnet, Fabrice;
- Cucherat, Michel;
- Moulin, Philippe;
- Gueyffier, François
Publication type:
Article
DPP-4 Inhibitors and Respiratory Infection: A Systematic Review and Meta-analysis of the Cardiovascular Outcomes Trials.
Published in:
2021
By:
- Grenet, Guillaume;
- Mekhaldi, Samia;
- Mainbourg, Sabine;
- Auffret, Marine;
- Cornu, Catherine;
- Cracowski, Jean-Luc;
- Gueyffier, François;
- Lega, Jean-Christophe;
- Cucherat, Michel
Publication type:
Letter
Reappraisal of Metformin Efficacy in the Treatment of Type 2 Diabetes: A Meta-Analysis of Randomised Controlled Trials.
Published in:
PLoS Medicine, 2012, v. 9, n. 4, p. 1, doi. 10.1371/journal.pmed.1001204
By:
- Boussageon, Rémy;
- Supper, Irène;
- Bejan-Angoulvant, Theodora;
- Kellou, Nadir;
- Cucherat, Michel;
- Boissel, Jean-Pierre;
- Kassai, Behrouz;
- Moreau, Alain;
- Gueyffier, François;
- Cornu, Catherine
Publication type:
Article
Primary endpoint adjudication: comparison between the expert committee and the regulatory MedDRA® coding in the MITRA-FR study.
Published in:
European Journal of Heart Failure. Supplements, 2022, v. 24, n. 2, p. 396, doi. 10.1002/ejhf.2401
By:
- Facile, Anthony;
- Mewton, Nathan;
- Nguon, Marina;
- de Gevigney, Guy Durand;
- Grinberg, Daniel;
- Bodenan, Eurielle;
- Samson, Geraldine;
- Plattner, Valérie;
- Trochu, Jean Noel;
- Cornu, Catherine
Publication type:
Article
Is basal ultrasensitive measurement of calcitonin capable of substituting for the pentagastrin-stimulation test?
Published in:
Clinical Endocrinology, 2013, v. 78, n. 3, p. 358, doi. 10.1111/cen.12001
By:
- Pina, Géraldine;
- Dubois, Séverine;
- Murat, Arnaud;
- Berger, Nicole;
- Niccoli, Patricia;
- Peix, Jean‐Louis;
- Cohen, Régis;
- Guillausseau, Claudine;
- Charrie, Anne;
- Chabre, Olivier;
- Cornu, Catherine;
- Borson‐Chazot, Françoise;
- Rohmer, Vincent
Publication type:
Article
Energy Expenditure in Older People Hospitalized for an Acute Episode.
Published in:
Nutrients, 2019, v. 11, n. 12, p. 2946, doi. 10.3390/nu11122946
By:
- Bonnefoy, Marc;
- Gilbert, Thomas;
- Normand, Sylvie;
- Jauffret, Marc;
- Roy, Pascal;
- Morio, Béatrice;
- Cornu, Catherine;
- Roche, Sylvain;
- Laville, Martine
Publication type:
Article
A positioning pillow to improve lumbar puncture success rate in paediatric haematology-oncology patients: a randomized controlled trial.
Published in:
BMC Cancer, 2009, v. 9, p. 1, doi. 10.1186/1471-2407-9-21
By:
- Marec-Bérard, Perrine;
- Bissery, Alvine;
- Kebaïli, Kamila;
- Schell, Matthias;
- Aubert, Françoise;
- Gaillard, Ségolène;
- Rabilloud, Muriel;
- Kassaï, Behrouz;
- Cornu, Catherine
Publication type:
Article

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