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Bioclinica Clinical Trial Studies

Bioclinica Studies

2017

Edwin DeJesus, Moti Ramgopal, Gordon Crofoot, Peter Ruane, Anthony LaMarca, Anthony Mills, Claudia T Martorell, Joseph de Wet, Hans-Jürgen Stellbrink, Jean-Michel Molina, Frank A Post, Ignacio Pérez Valero, Danielle Porter, YaPei Liu, Andrew Cheng, Erin Quirk, Devi SenGupta, Huyen Cao. Switching from efavirenz, emtricitabine, and tenofovir disoproxil fumarate to tenofovir alafenamide coformulated with rilpivirine and emtricitabine in virally suppressed adults with HIV-1 infection: a randomised, double-blind, multicentre, phase 3b, non-inferiority study.  The Lancet HIV. Volume 4, Issue 5, 2017, Pages e205-e213. ISSN 2352-3018.

Makoto TanakaEmail author, Yoshitaka Hashimoto, Chihiro Hasegawa, Steve Deacon and Richard Eastell.  Antiresorptive effect of a cathepsin K inhibitor ONO-5334 and its relationship to BMD increase in a phase II trial for postmenopausal osteoporosis.  BMC Musculoskeletal Disorders, 2017 18:267.  DOI: 10.1186/s12891-017-1625-y

Michael Weller, Nicholas Butowski, David D Tran, Lawrence D Recht, Michael Lim, Hal Hirte, Lynn Ashby, Laszlo Mechtler, Samuel A Goldlust, Fabio Iwamoto, Jan Drappatz, Donald M O'Rourke, Mark Wong, Mark G Hamilton, Gaetano Finocchiaro, James Perry, Wolfgang Wick, Jennifer Green, Yi He, Christopher D Turner, Michael J Yellin, Tibor Keler, Thomas A Davis, Roger Stupp, John H Sampson, Nicholas Butowski, Jian Campian, Lawrence Recht, Michael Lim, Lynn Ashby, Jan Drappatz, Hal Hirte, Fabio Iwamoto, Laszlo Mechtler, Samuel Goldlust, Kevin Becker, Gene Barnett, Garth Nicholas, Annick Desjardins, Tara Benkers, Naveed Wagle, Morris Groves, Santosh Kesari, Zsolt Horvath, Ryan Merrell, Richard Curry, James O'Rourke, David Schuster, Mark Wong, Maciej Mrugala, Randy Jensen, John Trusheim, Glenn Lesser, Karl Belanger, Andrew Sloan, Benjamin Purow, Karen Fink, Jeffrey Raizer, Michael Schulder, Suresh Nair, Scott Peak, James Perry, Alba Brandes, Michael Weller, Nimish Mohile, Joseph Landolfi, Jon Olson, Gaetano Finocchiaro, Ross Jennens, Paul DeSouza, Bridget Robinson, Marka Crittenden, Kent Shih, Alexandra Flowers, Shirley Ong, Jennifer Connelly, Costas Hadjipanayis, Pierre Giglio, Frank Mott, David Mathieu, Nathalie Lessard, Sanchez Juan Sepulveda, József Lövey, Helen Wheeler, Po-Ling Inglis, Claire Hardie, Daniela Bota, Maciej Lesniak, Jana Portnow, Bruce Frankel, Larry Junck, Reid Thompson, Lawrence Berk, John McGhie, David Macdonald, Frank Saran, Riccardo Soffietti, Deborah Blumenthal, Sá Barreto Costa Marcos André de, Anna Nowak, Nimit Singhal, Andreas Hottinger, Andrea Schmid, Gordan Srkalovic, David Baskin, Camilo Fadul, Louis Nabors, Renato LaRocca, John Villano, Nina Paleologos, Petr Kavan, Marshall Pitz, Brian Thiessen, Ahmed Idbaih, Jean Sébastien Frenel, Julien Domont, Oliver Grauer, Peter Hau, Christine Marosi, Jan Sroubek, Elizabeth Hovey, P.S. Sridhar, Lawrence Cher, Erin Dunbar, Thomas Coyle, Jane Raymond, Kevin Barton, Michael Guarino, Sumul Raval, Baldassarre Stea, Jorge Dietrich, Kirsten Hopkins, Sara Erridge, Joachim-Peter Steinbach, Losada Estela Pineda, Quintero Carmen Balana, Barco Berron Sonia del, Miklós Wenczl, Katalin Molnár, Katalin Hideghéty, Alexander Lossos, Linde Myra van, Ana Levy, Rosemary Harrup, William Patterson, Zarnie Lwin, Sith Sathornsumetee, E-Jian Lee, Jih-Tsun Ho, Steven Emmons, J. Paul Duic, Spencer Shao, Hani Ashamalla, Michael Weaver, Jose Lutzky, Nicholas Avgeropoulos, Wahid Hanna, Mukund Nadipuram, Gary Cecchi, Robert O'Donnell, Susan Pannullo, Jennifer Carney, Mark Hamilton, Mary MacNeil, Ronald Beaney, Michel Fabbro, Oliver Schnell, Rainer Fietkau, Guenther Stockhammer, Bela Malinova, Karel Odrazka, Martin Sames, Gil Miguel Gil, Evangelia Razis, Konstantin Lavrenkov, Guillermo Castro, Francisco Ramirez, Clarissa Baldotto, Fabiana Viola, Suzana Malheiros, Jason Lickliter, Stanislaw Gauden, Arunee Dechaphunkul, Iyavut Thaipisuttikul, Ziad Thotathil, Hsin-I Ma, Wen-Yu Cheng, Chin-Hong Chang, Fernando Salas, Pierre-Yves Dietrich, Christoph Mamot, Lakshmi Nayak, Shona Nag. Rindopepimut with temozolomide for patients with newly diagnosed, EGFRvIII-expressing glioblastoma (ACT IV): a randomised, double-blind, international phase 3 trial. The Lancet Oncology.  23 August 2017. ISSN 1470-2045.

Fiona C Moreton, Marco Düring, Thanh Phan, Velandai Srikanth, Richard Beare, Xuya Huang, Eric Jouvent, Hugues Chabriat, Martin Dichgans, Keith W Muir.  Arterial branching and basal ganglia lacunes: A study in pure small vessel disease.  European Stroke Journal, July-07-2017.

McClung, M.R., Lippuner, K., Brandi, M.L. et al. Osteoporos Int (2017).  Effect of denosumab on trabecular bone score in postmenopausal women with osteoporosis.  Springer London, Print ISSN 0937-941X, Online ISSN 1433-2965.

Katie L. Stone Ph.D., Li-Yung Lui M.A., M.S., William G. Christen Sc.D., Aron M. Troen Atkinson D. Phil, Douglas C. Bauer M.D., Deborah Kado M.D., M.S., Christopher Schambach M.F.A., Steven R. Cummings M.D., JoAnn E. Manson M.D., Dr.P.H.  Effect of Combination Folic Acid, Vitamin B6, and Vitamin B12 Supplementation on Fracture Risk in Women:A Randomized, Controlled Trial.  JBMR, 29 July 2017.  DOI: 10.1002/jbmr.3229.

Lee S. Schwartzberg, Francis P. Arena, Bryan J. Bienvenu, Edward H. Kaplan, Luis H. Camacho, Luis T. Campos, J. Paul Waymack, Mary A. Tagliaferri, Michael M. Chen, Dapeng Li.  A Randomized, Open-Label, Safety and Exploratory Efficacy Study of Kanglaite Injection (KLTi) plus Gemcitabine versus Gemcitabine in Patients with Advanced Pancreatic Cancer.  Journal of Cancer 2017; 8(10): 1872-1883. doi: 10.7150/jca.15407.

S. Petersenn, L. R. Salgado, J. Schopohl, L. Portocarrero-Ortiz, G. Arnaldi, A. Lacroix, C. Scaroni, S. Ravichandran, A. Kandra, B. M. K. Biller.  Long-term treatment of Cushing's disease with pasireotide: 5-year results from an open-label extension study of a Phase III trial.  Endocrine (2017) 57:156–165. DOI 10.1007/s12020-017-1316-3.

Hideaki Ishibashi, Daria B. Crittenden, Akimitsu Miyauchi, Cesar Libanati, Judy Maddox, Michelle Fan, Li Chen, Andreas Grauer. Romosozumab increases bone mineral density in postmenopausal Japanese women with osteoporosis: A phase 2 study. Bone, Volume 103, 2017, Pages 209-215, ISSN 8756-3282.

Michael A Davies, Philippe Saiag, Caroline Robert, Jean-Jacques Grob, Keith T Flaherty, Ana Arance, Vanna Chiarion-Sileni, Luc Thomas, Thierry Lesimple, Laurent Mortier, Stergios J Moschos, David Hogg, Iván Márquez-Rodas, Michele Del Vecchio, Céleste Lebbé, Nicolas Meyer, Ying Zhang, Yingjie Huang, Bijoyesh Mookerjee, Georgina V Long.  Dabrafenib plus trametinib in patients with -mutant melanoma brain metastases (COMBI-MB): a multicentre, multicohort, open-label, phase 2 trial.  The Lancet Oncology, Volume 18, Issue 7, 2017, Pages 863-873. ISSN 1470-2045.

K.R. Maravilla, D. San-Juan, S.J. Kim, G. Elizondo-Riojas, J.R. Fink, W. Escobar, A. Bag, D.R. Roberts, J. Hao, C. Pitrou, A.J. Tsiouris, E. Herskovits, and J.B. Fiebach.  Comparison of Gadoterate Meglumine and Gadobutrol in the MRI Diagnosis of Primary Brain Tumors: A Double-Blind Randomized Controlled Intraindividual Crossover Study (the REMIND Study).  AJNR, June 29, 2017.

2016

Felicia Cosman, M.D., Daria B. Crittenden, M.D., Jonathan D. Adachi, M.D., Neil Binkley, M.D., Edward Czerwinski, M.D., Serge Ferrari, M.D., Lorenz C. Hofbauer, M.D., Edith Lau, M.D., E. Michael Lewiecki, M.D., Akimitsu Miyauchi, M.D., Cristiano A.F. Zerbini, M.D., Cassandra E. Milmont, Ph.D., Li Chen, Ph.D., Sc.D., Judy Maddox, D.O., Paul D. Meisner, Pharm.D., Cesar Libanati, M.D., and Andreas Grauer, M.D. Romosozumab Treatment in Postmenopausal Women with Osteoporosis.  September 18, 2016.  DOI: 10.1056/NEJMoa1607948

Anita BoyapatiEmail author, Jérôme Msihid, Stefano Fiore, Janet van Adelsberg, Neil M. H. Graham and Jennifer D. Hamilton.  Sarilumab plus methotrexate suppresses circulating biomarkers of bone resorption and synovial damage in patients with rheumatoid arthritis and inadequate response to methotrexate: a biomarker study of MOBILITY.  Arthritis Research & Therapy, 201618:225.  DOI: 10.1186/s13075-016-1132-9.

Panés J, MD, García-Olmo D, MD, Van Assche G, MD, Frederic Colombel J, MD, Reinisch W, MD, C Baumgart D, MD, Dignass A, MD, Nachury M, MD, Ferrante M, MD, Kazemi-Shirazi L, MD, C Grimaud J, MD, de la Portilla F, MD, Goldin E, MD, Paule Richard M, MD, Leselbaum A, MD, Danese S, MD, for the ADMIRE CD Study Group Collaborators.  Expanded allogeneic adipose-derived mesenchymal stem cells (Cx601) for complex perianal fistulas in Crohn's disease: a phase 3 randomised, double-blind controlled trial.  The Lancet, 29 July 2016.

Malouf-Sierra, Jorge, Tarantino, Umberto, García-Hernández, Pedro A., Corradini, Costantino, Overgaard, Søren, Stepan, Jan J., Borris, Lars, Lespessailles, Eric, Frihagen, Frede, Papavasiliou, Kyriakos, Petto, Helmut, Aspenberg, Per, Caeiro, José Ramón, Marin, Fernando. Effect of Teriparatide or Risedronate in Elderly Patients with a Recent Pertrochanteric Hip Fracture: Final Results of a 78-Week Randomized Clinical Trial. JBMR, 26 December 2016. DOI: 10.1002/jbmr.3067.

Humphrey S, MD, Sykes J, MD, Kantor J, MD, MSCE, MA, Bertucci V, MD, Walker P, MD, PhD, R. Lee D, MS, F. Lizzul P, MD, PhD, MPH, MBA, M. Gross T, PhD, C. Beddingfield F, MD, PhD.  ATX-101 for reduction of submental fat: A phase III randomized controlled trial.  Journal of the American Academy of Dermatology, 16 July 2016.

Greendale GA, Wilhalme H, Huang M-H, Cauley JA, Karlamangla AS (2016).  Prevalent and Incident Vertebral Deformities in Midlife Women: Results from the Study of Women's Health Across the Nation (SWAN). PLoS ONE 11(9): e0162664. doi:10.1371/journal.pone.0162664

Ferrero J, Williams L, Stella H, Leitermann K, Mikulskis A, O'Gorman J, Sevigny J.  First-in-human, double-blind, placebo-controlled, single-dose escalation study of aducanumab (BIIB037) in mild-to-moderate Alzheimer's disease. Translational Research & Clinical Interventions, 20 June, 2016.

Paul D. Miller, MD; Gary Hattersley, PhD; Bente Juel Riis, MD; et al Gregory C. Williams, PhD; Edith Lau, MD; Luis Augusto Russo, MD, PhD; Peter Alexandersen, MD; Cristiano A. F. Zerbini, MD; Ming-yi Hu, PhD; Alan G. Harris, MD; Lorraine A. Fitzpatrick, MD; Felicia Cosman, MD; Claus Christiansen, MD; for the ACTIVE Study Investigators.  Effect of Abaloparatide vs Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis.  JAMA. 2016;316(7):722-733. doi:10.1001/jama.2016.11136

2015

F. Labrie, M. Montesino, D. F. Archer, L. Lavoie, A. Beauregard, I. Côté, C. Martel, M. Vaillancourt, J. Balser, E. Moyneur & other participating Members of the Prasterone Clinical Research Group.  Influence of treatment of vulvovaginal atrophy with intravaginal prasterone on the male partner.  30 October 2015.

Philip M. Grant, Douglas Kitch, Grace A. McComsey, Camlin Tierney, Belinda Ha, Todd T. Brown. Differential skeletal impact of tenofovir disoproxil fumarate in young versus old HIV-infected adults. February 2015.

Dr Alice T Shaw, MD, Leena Gandhi, MD, Prof Shirish Gadgeel, MD, Gregory J Riely, MD, Jeremy Cetnar, MD, Howard West, MD, D Ross Camidge, MD, Prof Mark A Socinski, MD, Alberto Chiappori, MD, Tarek Mekhail, MD, Bo H Chao, MD, Hossein Borghaei, DO, Kathryn A Gold, MD, Ali Zeaiter, MD, Walter Bordogna, PhD, Bogdana Balas, MD, Oscar Puig, PhD, Volkmar Henschel, PhD, Prof Sai-Hong Ignatius Ou, MD on behalf of the study investigators.  Alectinib in ALK-positive, crizotinib-resistant, non-small-cell lung cancer: a single-group, multicentre, phase 2 trial.  18 December 2015.

Anthony Mills, MD, Jose R Arribas, MD, Prof Jaime Andrade-Villanueva, MD, Giovanni DiPerri, MD, Prof Jan Van Lunzen, MD, Ellen Koenig, MD, Richard Elion, MD, Matthias Cavassini, MD, Jose Valdez Madruga, MD, Jason Brunetta, MD, David Shamblaw, MD, Edwin DeJesus, MD, Chloe Orkin, MBBch, David A Wohl, MD, Indira Brar, MD, Jeffrey L Stephens, MD, Prof Pierre-Marie Girard, MD, Gregory Huhn, MD, Andrew Plummer, BS, Ya-Pei Liu, PhD, Andrew K Cheng, MD, Dr Scott McCallister, MD for the GS-US-292-0109 team.  Switching from tenofovir disoproxil fumarate to tenofovir alafenamide in antiretroviral regimens for virologically suppressed adults with HIV-1 infection: a randomised, active-controlled, multicentre, open-label, phase 3, non-inferiority study.  1 November 2015.

Paul E Sax, David Wohl, Michael T Yin, Frank Post, Edwin DeJesus, Michael Saag, Anton Pozniak, Melanie Thompson, Daniel Podzamczer, Jean Michel Molina, Shinichi Oka, Ellen Koenig, Benoit Trottier, Jaime Andrade-Villanueva, Gordon Crofoot, Joseph M Custodio, Andrew Plummer, Lijie Zhong, Huyen Cao, Hal Martin, Christian Callebaut, Andrew K Cheng, Marshall W Fordyce, Scott McCallister, for the GS-US-292-0104/0111 Study Team. Tenofovir alafenamide versus tenofovir disoproxil fumarate, coformulated with elvitegravir, cobicistat, and emtricitabine, for initial treatment of HIV-1 infection: two randomised, double-blind, phase 3, non-inferiority trials. 15 April 2015.

Hugues Chabriat, MD; Dominique Hervé, MD; Marco Duering, MD; Ophelia Godin, PhD; Eric Jouvent, MD; Christian Opherk, MD; Nassira Alili, MD; Sonia Reyes, MSc; Aude Jabouley, MSc; Nikola Zieren, PhD; Jean-Pierre Guichard, MD; Chahin Pachai, PhD; Eric Vicaut, MD; Martin Dichgans, MD. Predictors of Clinical Worsening in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy Prospective Cohort Study.  17 November 2015.

Douglas L. Mann, Randall J. Lee, Andrew J.S. Coats, Gheorghe Neagoe, Dinu Dragomir, Enrico Pusineri, Massimo Piredda, Luca Bettari, Bridget-Anne Kirwan, Robert Dowling, Maurizio Volterrani, Scott D. Solomon, Hani N. Sabbah, Andy Hinson and Stefan D. Anker.  One-year follow-up results from AUGMENT-HF: a multicentre randomized controlled clinical trial of the efficacy of left ventricular augmentation with Algisyl in the treatment of heart failure.  11 November 2015.

Pitale S, Thomas M, Rathi G, Deshmukh V, Kumar P, Reddy S, Shetty N, Kakar A, Babhulkar S, Mody B, Chacko J, Acharya S, Joglekar S, Halbe V, Kravitz BG, Waterhouse B, Nino AJ, Fitzpatrick LA.  A randomized placebo-controlled trial of the efficacy of denosumab in Indian postmenopausal women with osteoporosis.  Indian Journal of Endocrinology and Metabolism.  Jan-Feb 2015.

S. Papapoulos, K. Lippuner, C. Roux, C. J. F. Lin, D. L. Kendler, E. M. Lewiecki, M. L. Brandi, E. Czerwiński, E. Franek, P. Lakatos, C. Mautalen, S. Minisola, J. Y. Reginster, S. Jensen, N. S. Daizadeh, A. Wang, M. Gavin, C. Libanati, R. B. Wagman, H. G. Bone.  The effect of 8 or 5 years of denosumab treatment in postmenopausal women with osteoporosis: results from the FREEDOM Extension study. 23 July 2015.

John P. Bilezikian, Nelson B. Watts, Keith Usiskin, David Polidori, Albert Fung, Daniel Sullivan, and Norm Rosenthal.  Evaluation of Bone Mineral Density and Bone Biomarkers in Patients With Type 2 Diabetes Treated With Canagliflozin.  18 November 2015.

Chapman KR, Burdon JGW, Piitulainen E, Sandhaus RA, Seersholm N, Stocks JM, Stoel BC, Huang L, Yao Z, Edelman JM, McElvaney NG on behalf of the RAPID Trial Study Group.  Intravenous augmentation treatment and lung density in severe α1 antitrypsin deficiency (RAPID): a randomised, double-blind, placebo-controlled trial.  The Lancet, 27 May, 2015.

Fernand Labrie MD, PhD, Leonard Derogatis PhD, David F. Archer MD, William Koltun MD, Andrée Vachon MD, Douglas Young MD, Louise Frenette MD, David Portman MD, Marlene Montesino MD, Isabelle Côté BSc, Julie Parent PhD, Lyne Lavoie MSc, Adam Beauregard BSc, MBA, Céline Martel PhD, Mario Vaillancourt BSc, MBA, John Balser PhD, Érick Moyneur BSc, MA and Members of the VVA Prasterone Research Group.  Effect of Intravaginal Prasterone on Sexual Dysfunction in Postmenopausal Women with Vulvovaginal Atrophy.  23 November 2015.

Timothy M Cox, Guillermo Drelichman, Renata Cravo, Manisha Balwani, Thomas Andrew Burrow, Ana Maria Martins, Elena Lukina, Barry Rosenbloom, Leorah Ross, Jennifer Angell, Ana Cristina Puga. Eliglustat compared with imiglucerase in patients with Gaucher's disease type 1 stabilised on enzyme replacement therapy: a phase 3, randomised, open-label, non-inferiority trial. 26 March 2015.

Dr Samir K Gupta, MD, Prof Grace A McComsey, MD, John Lombaard, MD, Prof Juan Echevarría, MD, Catherine Orrell, MD, Anchalee Avihingsanon, MD, Olayemi Osiyemi, MD, Mario Santoscoy, MD, Neelanjana Ray, PhD, David A Stock, PhD, Samit R Joshi, DO, George J Hanna, MD, Max Lataillade, DO.  Efficacy, safety, bone and metabolic effects of HIV nucleoside reverse transcriptase inhibitor BMS-986001 (AI467003): a phase 2b randomised, controlled, partly blinded trial.  11 December 2015.

2014

Zimran A, Gonzalez-Rodriguez DE, Abrahamov A, Elstein D, Paz A, Brill-Almon E, Chertkoff R.  Safety and efficacy of two dose levels of taliglucerase alfa in pediatric patients with Gaucher disease.  Blood Cells, Molecules, and Diseases.  Volume 54, Issue 1, January 2015, Pages 9–16.

Flinn IW, Richard van der Jagt R, Kahl BS, Wood P, Hawkins TE, MacDonald D, Hertzberg M, Kwan Y, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM. Open-label, randomized, noninferiority study of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of advanced indolent NHL or MCL: the BRIGHT study. Blood March 3, 2014. Published online before print March 3, 2014, doi: 10.1182/blood-2013-11-531327.

Carolan BJ, Hughes G, Morrow J, Hersh CP, O’Neal WK, Rennard S, Pillai SG, Belloni P, Cockayne D, Comellas AP, Han M, Zemans RL, Kechris K and Bowler RP.  The association of plasma biomarkers with computed tomography-assessed emphysema phenotypes.  Respiratory Research 2014, 15:127.

Behrens F, Tak PP, Østergaard M, Stoilov R, Wiland P, Huizinga TW, Berenfus VY, Vladeva S, Rech J, Rubbert-Roth A, Korkosz M, Rekalov D, Zupanets IA, Ejbjerg BJ, Geiseler J, Fresenius J, Korolkiewicz RP, Schottelius AJ, Burkhardt H. MOR103, a human monoclonal antibody to granulocyte–macrophage colony-stimulating factor, in the treatment of patients with moderate rheumatoid arthritis: results of a phase Ib/IIa randomised, double-blind, placebo-controlled, dose-escalation trial. Ann Rheum Dis annrheumdis-2013-204816Published Online First: 17 February 2014 doi:10.1136/annrheumdis-2013-204816.

Poole KES, Treece GM, Gee AH, Brown JP, McClung MR, Wang A, Libanati C. Denosumab Rapidly Increases Cortical Bone in Key Locations of the Femur: A 3D Bone Mapping Study in Women with Osteoporosis. JBMR 2014. DOI: 10.1002/jbmr.2325

M. Dohm, C.M. Black, A. Dacre, J.B. Tillman, G. Fueredi, on behalf of the KAVIAR investigators.  A Randomized Trial Comparing Balloon Kyphoplasty and Vertebroplasty for Vertebral Compression Fractures due to Osteoporosis.  AJNR Am J Neuroradiol, October 2014.

Flinn IW, van der Jagt R, Kahl BS, Wood P, Hawkins TE, MacDonald D, Hertzberg M, Kwan YL, Simpson D, Craig M, Kolibaba K, Issa S, Clementi R, Hallman DM, Munteanu M, Chen L, Burke JM.  Randomized trial of bendamustine-rituximab or R-CHOP/R-CVP in first-line treatment of indolent NHL or MCL: the BRIGHT study. May 8, 2014; Blood: 123 (19).

Eastell R, Boonen S, Cosman F, Reid IR, Palermo L, Cummings SR, Black DM.  Relationship Between Pre-treatment Rate of Bone Loss and Bone Density Response to Once-Yearly ZOL: HORIZON-PFT Extension Study. J Bone Miner Res.  2014.

Sugimoto T, Matsumoto T, Hosoi T, Miki T, Gorai I, Yoshikawa H, Tanaka Y, Tanaka S, Fukunaga M, Sone T, Nakano T, Ito M, Matsui S, Yoneda T, Takami H, Watanabe K, Osakabe T, Okubo N, Shiraki M, Nakamura T.  Three-year denosumab treatment in postmenopausal Japanese women and men with osteoporosis: results from a 1-year open-label extension of the Denosumab Fracture Intervention Randomized Placebo Controlled Trial (DIRECT).  Osteoporosis International.  18 Nov 2014.

Fitzpatrick LA, Wooddell M, Dabrowski CE, Cicconetti G, Gordon DN.  Bone mineral density changes following discontinuation of ronacaleret treatment: Off-treatment extension of a randomized, dose-finding phase II trial.  Bone, Published Online: May 01, 2014.

Gadgeel SM, Gandhi L, Riely GJ, Chiappori AA, West HL, Azada MC, Morcos PN, Lee R, Garcia L, Yu L, Boisserie F, Di Laurenzio L, Golding S, Sato J, Yokoyama S, Tanaka T, Ignatius S.  Safety and activity of alectinib against systemic disease and brain metastases in patients with crizotinib-resistant ALK-rearranged non-small-cell lung cancer (AF-002JG): results from the dose-finding portion of a phase 1/2 study. The Lancet Oncology 19, Aug 2014.

Bone HG, Dempster DW, Eisman JA, Greenspan SL, McClung MR, Nakamura T, Papapoulos S, Shih WJ, Rybak-Feiglin A, Santora AC, Verbruggen N, Leung AT, Lombardi A.  Odanacatib for the treatment of postmenopausal osteoporosis: development history and design and participant characteristics of LOFT, the Long-Term Odanacatib Fracture Trial.  Osteoporosis International. 29 Nov 2014.

Quittner AL, Marciel KK, Salathe MA, O’Donnell AE, Gotfried MH, Ilowite JS, Metersky ML, Flume PA, Lewis SA, McKevitt M, Montgomery AB, O’Riordan TG, Barker AF. A preliminary Quality of Life Questionnaire-Bronchiectasis: A patient-reported outcome measure for bronchiectasis. Chest. 2014. doi:10.1378/chest.13-1891.

Solomon DH, Diem SJ, Ruppert K, Lian Y, Liu C, Wohlfart A, Greendale GA, Finkelstein JS. Bone Mineral Density Changes Among Women Initiating Proton Pump Inhibitors or H2 Receptor Antagonists: A SWAN Cohort Study. JBMR 17, AUG 2014.

2013

Graffagnino C, Bergese S, Love J, Schneider D, Lazaridis C, LaPointe M, Lee K, Lynch G, Hu M, Williams GC. Clevidipine Rapidly and Safely Reduces Blood Pressure in Acute Intracerebral Hemorrhage: The ACCELERATE Trial.  Cerebrovasc Dis 2013;36:173-180 (DOI:10.1159/000351149)

Ringelstein EB, Thijs V, Norrving B, Chamorro A, Aichner F, Grond M, Saver J, Laage R, Schneider A, Rathgeb F, Vogt G, Charissé G, Fiebach JB, Schwab S, Schäbitz WR, Kollmar R, Fisher M, Brozman M, Skoloudik D, Gruber F, Leal JS, Veltkamp R, Köhrmann M, Berrouschot J; for the AXIS 2 Investigators. Granulocyte Colony-Stimulating Factor in Patients With Acute Ischemic Stroke: Results of the AX200 for Ischemic Stroke Trial. Stroke. 2013 Aug 20. [Epub ahead of print] PMID: 23963331

Chawla S, Henshaw R, Seeger L, Choy E, Blay JY, Ferrari S, Kroep J, Grimer R, Reichardt P, Rutkowski P, Schuetze S, Skubitz K, Staddon A, Thomas D, Qian Y, Jacobs I. Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study. Lancet Oncol. 2013 Aug;14(9):901-8. doi: 10.1016/S1470-2045(13)70277-8. Epub 2013 Jul 16. PMID: 23867211.

Barras CD, Tress BM, Christensen S, Collins M, Desmond PM, Skolnick BE, Mayer SA, Davis SM; for the Recombinant Activated Factor VII Intracerebral Hemorrhage Trial Investigators.  Quantitative CT Densitometry for Predicting Intracerebral Hemorrhage Growth.  AJNR Am J Neuroradiol. 2013 Jan 10. [Epub ahead of print].  PubMed PMID: 23306009.

Wintermark M, Albers GW, Broderick JP, Demchuk AM, Fiebach JB, Fiehler J, Grotta JC, Houser G, Jovin TG, Lees KR, Lev MH, Liebeskind DS, Luby M, Muir KW, Parsons MW, Kummer RV, Wardlaw JM, Wu O, Yoo AJ, Alexandrov AV, Alger JR, Aviv RI, Bammer R, Baron JC, Calamante F, Campbell BCV, Carpenter TC, Christensen S, Copen WA, Derdeyn CP, Haley EC, Khatri P, Kudo K, Lansberg MG, Latour LL, Lee TY, Leigh R, Lin W, Lyden P, Mair G, Menon BK, Michel P, Mikulik R, Nogueira RG, Østergaard L, Pedraza S, Riedel CH, Rowley HA, Sanelli PC, Sasaki M, Saver JL, Schaefer PW, Schellinger PD, Tsivgoulis G, Wechsler LR, White PM, Zaharchuk G, Zaidat OO, Davis SM, Donnan GA, Furlan AJ, Hacke W, Kang DW, Kidwell C, Thijs VN, Thomalla G, Warach SJ. Acute Stroke Imaging Research Roadmap II. 2013, 16 July. Print ISSN: 0039-2499. Online ISSN: 1524-4628.

Meirhaeghe JV, Bastian L, Boonen S, Ranstam J, Tillman JB, Wardlaw D. A Randomized Trial of Balloon Kyphoplasty and Nonsurgical Management for Treating Acute Vertebral Compression Fractures. SPINE Volume 38, Number 12, pp 971–983. 2013, Lippincott Williams & Wilkins.

Righart R, Duering M, Gonik M, Jouvent E, Reyes S, Hervé D, Chabriat H, Dichgans M. Impact of regional cortical and subcortical changes on processing speed in cerebral small vessel disease. NeuroImage: Clinical 2 (2013) 854–861.

Rini BI, Bellmunt J, Clancy J, Wang K, Niethammer AG, Hariharan S, Escudier B. Randomized Phase III Trial of Temsirolimus and Bevacizumab Versus Interferon Alfa and Bevacizumab in Metastatic Renal Cell Carcinoma: INTORACT Trial.  J Clin Oncol. 2013 Dec 2. [Epub ahead of print]. PubMed PMID: 24297945.

Mease PJ, Gladman DD, Papp KA, Khraishi MM, Thaçi D, Behrens F, Northington R, Fuiman J, Bananis E, Boggs R, Alvarez D. Prevalence of rheumatologist-diagnosed psoriatic arthritis in patients with psoriasis in European/North American dermatology clinics. J Am Acad Dermatol. 2013 Aug 24. pii: S0190-9622(13)00777-9. doi: 10.1016/j.jaad.2013.07.023. [Epub ahead of print] PMID: 23981683

Sugiyama A, Hashimoto H, Nakamura Y, Fujita T, Kumagai Y. (2013), QT/QTc Study Conducted in Japanese Adult Healthy Subjects: A Novel Xanthine Oxidase Inhibitor Topiroxostat Was Not Associated With QT Prolongation. Journal of Clinical Pharma. doi: 10.1002/jcph.226

Hoy, J., Grund, B., Roediger, M., Ensrud, K. E., Brar, I., Colebunders, R., Castro, N. D., Johnson, M., Sharma, A., Carr, A. and for the INSIGHT SMART Body Composition Substudy Group (2013), Interruption or deferral of antiretroviral therapy reduces markers of bone turnover compared with continuous therapy: The SMART body composition substudy. J Bone Miner Res, 28: 1264–1274. doi: 10.1002/jbmr.1861

Selmaj K, Li DK, Hartung HP, Hemmer B, Kappos L, Freedman MS, Stüve O, Rieckmann P, Montalban X, Ziemssen T, Auberson LZ, Pohlmann H, Mercier F, Dahlke F, Wallström E. Siponimod for patients with relapsing-remitting multiple sclerosis (BOLD): an adaptive, dose-ranging, randomised, phase 2 study. Lancet Neurol. 2013 Jun 11.

Cefalu WT, Leiter LA, Yoon KH, Arias P, Niskanen L, Xie J, Balis DA, Canovatchel W, Meininger G. Efficacy and safety of canagliflozin versus glimepiride in patients with type 2 diabetes inadequately controlled with metformin (CANTATA-SU): 52 week results from a randomised, double-blind, phase 3 non-inferiority trial. Lancet. 2013 Sep 14;382(9896):941-50. doi: 10.1016/S0140-6736(13)60683-2. Epub 2013 Jul 12. PMID: 23850055

2012

Freymann, J. B., J. S. Kirby, J. H. Perry, D. A. Clunie and C. C. Jaffe (2012). "Image data sharing for biomedical research—meeting HIPAA requirements for de-identification." Journal of Digital Imaging 25(1): 14–24.

Samaille T, Fillon L, Cuingnet R, Jouvent E, Chabriat H, Dormont D, Colliot O, Chupin M. Contrast-based fully automatic segmentation of white matter hyperintensities: method and validation. PLoS One. 2012;7(11):e48953. doi: 10.1371/journal.pone.0048953. Epub 2012 Nov 12. PubMed PMID: 23152828.

Stolk, J., R. A. Stockley, et al. (2012). "Randomized controlled trial for emphysema with a selective agonist of the gamma type retinoic acid receptor." Eur Respir J. 2012 Jan 26. [Epub ahead of print]

Weidemann, F., Rummey, C., Bijnens, B., Störk, S., Jasaityte, R., Dhooge, J., Baltabaeva, A., Sutherland, G., Schulz, J., Meier, T. (2012) "The Heart in Friedreich Ataxia".

Douglas, P. S., J. J. Carr, M. D. Cerqueira, J. E. Cummings, T. C. Gerber, D. Mukherjee and A. J. Taylor (2012). "Developing an Action Plan for Patient Radiation Safety in Adult Cardiovascular Medicine Proceedings from the Duke University Clinical Research Institute/American College of Cardiology Foundation/American Heart Association Think Tank Held on February 28, 2011." Journal of the American College of Cardiology 59(20): 1833–1847.

Sims E, Garnett S, Guzman F, Paris F, Sultan C, Eugster E. Fulvestrant treatment of precocious puberty in girls with McCune-Albright syndrome. International Journal of Pediatric Endocrinology 2012, 2012:26.

Sharma, A. M., G. Bakris, J. M. Neutel, T. W. Littlejohn, M. Kobe, N. Ting and L. Ley (2012). "Single-pill combination of telmisartan/amlodipine versus amlodipine monotherapy in diabetic hypertensive patients: an 8-week randomized, parallel-group, double-blind trial." Clinical Therapeutics 34(3): 537–551.

Carrié D, Berland J, Verheye S, Hauptmann KE, Vrolix M, Violini R, Dibie A, Berti S, Maupas E, Antoniucci D, Schofer J. A Multicenter Randomized Trial Comparing Amphilimus- With Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions. J Am Coll Cardiol.

Cheriyan, J., S. Kim, L. J. Wolansky, S. D. Cook and D. Cadavid (2012). "Impact of inflammation on brain volume in multiple sclerosis." Archives of neurology 69(1): 82

Düsing, Rainera; Brunel, Patrickb; Baek, InYoungb; Baschiera, Fabiob. Sustained Decrease in Blood Pressure Following Missed Doses of Aliskiren or Telmisarten: the Assertive Double-Blind Randomized Study. Journal of Hypertension, May 2012 - Volume 30 - Issue 5.

Takeuchi T, Harigai M, Tanaka Y, Yamanaka H, Ishiguro N, Yamamoto K, Miyasaka N, Koike T, Kanazawa M, Oba T, Yoshinari T, Baker D. Golimumab monotherapy in Japanese patients with active rheumatoid arthritis despite prior treatment with disease-modifying antirheumatic drugs: results of the phase 2/3, multicentre, randomised, double-blind, placebo-controlled GO-MONO study through 24 weeks. Ann Rheum Dis annrheumdis-2012-201796: 14 September 2012.

Pro, B., R. Advani, P. Brice, N. L. Bartlett, J. D. Rosenblatt, T. Illidge, J. Matous, R. Ramchandren, M. Fanale and J. M. Connors (2012). "Brentuximab vedotin (SGN-35) in patients with relapsed or refractory systemic anaplastic large-cell lymphoma: results of a phase II study." Journal of Clinical Oncology 30(18): 2190–2196.

Annamaria Colao, M.D., Ph.D., Stephan Petersenn, M.D., John Newell-Price, M.D., Ph.D., James W. Findling, M.D., Feng Gu, M.D., Mario Maldonado, M.D., Ulrike Schoenherr, Dipl.-Biol., David Mills, M.Sc., Luiz Roberto Salgado, M.D., and Beverly M.K. Biller, M.D., for the Pasireotide B2305 Study Group. A 12-Month Phase 3 Study of Pasireotide in Cushing’s Disease. The New England Journal of Medicine, (ISSN 0028-4793) Vol. 366:914-924 (March 8, 2012).

Drier A, Tourdias T, Attal Y, Sibon I, Mutlu G, Lehéricy S, Samson Y, Chiras J, Dormont D, Orgogozo JM, Dousset V, Rosso C. Prediction of Subacute Infarct Size in Acute Middle Cerebral Artery Stroke: Comparison of Perfusion-weighted Imaging and Apparent Diffusion Coefficient Maps. Radiology. 2012 Aug 24.

Pérez-Cano, R., J. J. Vranckx, et al. (2012). "Prospective trial of Adipose-Derived Regenerative Cell (ADRC)-enriched fat grafting for partial mastectomy defects: The RESTORE-2 trial." European Journal of Surgical Oncology (EJSO).

Carr, J. J., F. M. D. Cerqueira, F. J. E. Cummings, T. C. Gerber and F. D. Mukherjee (2012). "Developing an Action Plan for Patient Radiation Safety in Adult Cardiovascular Medicine."

Harrington K, Berrier A, Robinson M, Remenar E, Housset M, de Mendoza FH, Fayette J, Mehanna H, El-Hariry I, Compton N, Franklin N, Biswas-Baldwin N, Lau M, Legenne P, Kumar R. Randomised Phase II study of oral lapatinib combined with chemoradiotherapy in patients with advanced squamous cell carcinoma of the head and neck: Rationale for future randomised trials in human papilloma virus-negative disease. Eur J Cancer. 2012 Dec 19. doi:pii: S0959-8049(12)00919-7. 10.1016/j.ejca.2012.11.023. [Epub ahead of print] PMID: 23265705

Heilbraun, J. "Blood Pressure as a Cardiac Safety Endpoint: Practical Considerations for Blood Pressure Evaluation in Oncology Research."

Zaidat OO, Castonguay AC, Fitzsimmons BF, Woodward BK, Wang Z, Killer-Oberpfalzer M, Wakhloo A, Gupta R, Kirshner H, Eliasziw M, Thomas Megerian J, Shetty S, Yoklavich Guilhermier M, Barnwell S, Smith WS, Gress DR; VISSIT Trial Investigators. Design of the Vitesse Intracranial Stent Study for Ischemic Therapy (VISSIT) Trial in Symptomatic Intracranial Stenosis. J Stroke Cerebrovasc Dis. 2012 Dec 21. doi:pii: S1052-3057(12)00365-5. 10.1016/j.jstrokecerebrovasdis.2012.10.021. [Epub ahead of print] PMID: 23261207

2011

Ari Zimran, Einat Brill-Almon, Raul Chertkoff, Milan Petakov, Francisco Blanco-Favela, Eduardo Terreros Muñoz, Sergio E. Solorio-Meza, Dominick Amato, Gloria Duran, Fiorina Giona, Rene Heitner, Hanna Rosenbaum, Pilar Giraldo, Atul Mehta, Glen Park, Mici Phillips, Deborah Elstein, Gheona Altarescu, Mali Szleifer, Sharon Hashmueli, and David Aviezer. Pivotal trial with plant cell–expressed recombinant glucocerebrosidase, taliglucerase alfa, a novel enzyme replacement therapy for Gaucher disease. Blood. 2011;118(22):5767-5773.

Perlman, E. S. (2011). "Imaging CRO Perspective on Quantitative Imaging Measurements" Imaging.

D. Pearson, B. Horton, D. J. Green, Cross calibration of Hologic QDR2000 and GE lunar prodigy for whole body bone mineral density and body composition measurements. J Clin Densitom. 2011 Jul-Sep;14(3):294-301. Epub 2011 May 19. PMID:21600823

Berenson, J, Pflugmacher R, Jarzem P, Zonder J, Schechtman K, Tillman JB, Bastian L, Ashraf T, Vrionis F. "Balloon kyphoplasty versus non-surgical fracture management for treatment of painful vertebral body compression fractures in patients with cancer: a multicentre, randomised controlled trial." The lancet oncology. 2011. 12(3): 225-235.

2010

Ward LM, Rauch F, Whyte MP, D'Astous J, Gates PE, Grogan D, Lester EL, McCall RE, Pressly TA, Sanders JO, Smith PA, Steiner RD, Sullivan E, Tyerman G, Smith-Wright DL, Verbruggen N, Heyden N, Lombardi A, Glorieux FH. Alendronate for the Treatment of Pediatric Osteogenesis Imperfecta: A Randomized Placebo-Controlled Study. J Clin Endocrinol Metab. 2010 Nov 24. PMID: 21106710

Borradaile, K., R. Ford, M. O'Neal and K. Byrne (2010). "Discordance between BICR readers".

2009

Grund B, Peng G, Gibert CL, Hoy JF, Isaksson RL, Shlay JC, Martinez E, Reiss P, Visnegarwala F, Carr AD; INSIGHT SMART Body Composition Substudy Group. Continuous antiretroviral therapy decreases bone mineral density. AIDS. 2009 Jul 31;23(12):1519-29. PMID:19531929

2008

de Borst GJ, Meijer R, Lo RH, Vosmeer H W G, Ackerstaff R G A, Moll F L. Effect of Carotid Angioplasty and Stenting on Duplex Velocity Measurements in Porcine Model. Journal of Endovascular Therapy. 2008 Dec;15(6):672-9. PMID: 19090631

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