BioClinica Clinical Trial Studies

BioClinica Studies

2013

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.

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).

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).

Miller, V. A., V. Hirsh, et al. (2012). "Afatinib versus placebo for patients with advanced, metastatic non-small-cell lung cancer after failure of erlotinib, gefitinib, or both, and one or two lines of chemotherapy (LUX-Lung 1): a phase 2b/3 randomised trial." The Lancet Oncology.

Kavanaugh, A., D. van der Heijde, et al. (2012). "Golimumab, a human TNF-alpha antibody, administered every 4 weeks as a subcutaneous injection in psoriatic arthritis: Clinical efficacy, radiographic, and safety findings through 1year of the randomized, placebo-controlled, GO-REVEAL® study." Arthritis & Rheumatism.

Grube, E., B. Chevalier, et al. (2012). "The SPIRIT V Diabetic Study: A randomized clinical evaluation of the XIENCE V everolimus-eluting stent vs the TAXUS Liberte paclitaxel-eluting stent in diabetic patients with de novo coronary artery lesions." American heart journal 163(5): 867-875 e861.

Aberg, J. A., P. Tebas, et al. (2012). "Metabolic Effects of Darunavir/Ritonavir Versus Atazanavir/Ritonavir in Treatment-Naive, HIV Type 1-Infected Subjects over 48 Weeks." AIDS Res Hum Retroviruses.

DeJesus, E., J. K. Rockstroh, et al. (2012). "Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial." The Lancet 379(9835): 2429-2438.

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.

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.

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.

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]

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.

Yang, J. C. H., J. Y. Shih, et al. (2012). "Afatinib for patients with lung adenocarcinoma and epidermal growth factor receptor mutations (LUX-Lung 2): a phase 2 trial." The Lancet Oncology.

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

Weidemann, F., C. Rummey, et al. (2012). "The Heart in Friedreich Ataxia: Definition of Cardiomyopathy, Disease Severity, and Correlation with Neurological Symptoms." Circulation.

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

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.

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.

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

Tanaka, Y., M. Harigai, et al. (2011). "Golimumab in combination with methotrexate in Japanese patients with active rheumatoid arthritis: results of the GO-FORTH study." Ann Rheum Dis 71(6): 817-824.

2010

Hennerici MG, Bots ML, Ford I, Laurent S, Touboul PJ. Rationale, design and population baseline characteristics of the PERFORM vascular project: an ancillary study of the Prevention of cerebrovascular and cardiovascular Events of ischemic origin with terutroban in patients with a history of ischemic stroke or transient ischemic attack (PERFORM) trial. Cardiovasc Drugs Ther. 2010 Apr;24(2):175-80. PMID: 20490906

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

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

2007

Keaveny TM, Donley DW, Hoffmann PF, Mitlak BH, Glass EV, San Martin JA (Acknowledgement Bio-Imaging Technologies). Effects of Teriparstide and Alendronate on Vertebral Strength as Assessed by Finite Element Modeling of QCT Scans in Women With Osteoporosis. Journal of Bone and Mineral Research. 2007 Jan;22(1):149-57. PMID: 17042738

2006

Ripa RS, Jorgensen E, Wang Y, Thune JJ, Nilsson JC, Søndergaard L, Johnsen HE, Køber L, Grande P, Kastrup J, (Acknowledgement Bio-Imaging Technologies). Stem Cell Mobilization Induced by Subcutaneous Granulocyte-Colony Stimulating Factor to Improve Cardiac Regeneration After Acute ST-Elevation Myocardial Infarction. Circulation. 2006 Apr 25;113(16):1983-92. PMID: 16531621

Reid DM, Hosking D, Kendler D, Brandi ML, Wark JD, Weryha G, Marques-Neto JF, Gaines KA, Verbruggen N, Melton ME, (Acknowledgement Bio-Imaging Technologies). Alendronic Acid Produces Greater Effects than Risedronic Acid on Bone Density and Turnover in Postmenopausal Women with Osteoporosis. Clinical Drug Investigation. 2006;26(2):63-74. PMID: 17163237

McClung MR, Lewiecki EM, Cohen SB, Bolognese MA, Woodson GC, Moffett AH, Peacock M, Miller PD, Lederman SN, Chesnut CH, Lain D, Kivitz AJ, Holloway DL, Zhang C, Peterson MC, Bekker PJ; AMG 162 Bone Loss Study Group. Denosumab in Postmenopausal Women with Low Bone Mineral Density. The New England Journal of Medicine. 2006 Feb 23;354(8):821-31. PMID: 16495394

Bonnick S, Saag KG, Kiel DP, McClung M, Hochberg M, Burnett SM, Sebba A, Kagan R, Chen E, Thompson DE, de Papp AE, (Acknowledgement Bio-Imaging Technologies). Comparison of Weekly Treatment of Postmenopausal Osteoporosis with Alendronate Versus Risedronate Over Two Years. Journal of Clinical Endocrinology & Metabolism. 2006 Jul;91(7):2631-7. PMID: 16636120

Ripa RS, Wang Y, Jørgensen E, Johnsen HE, Hesse B, Kastrup J, (Acknowledgement Bio-Imaging Technologies). Intramyocardial injection of vascular endothelial growth factor-A165 plasmid followed by granulocyte-colony stimulating factor to induce angiogenesis in patients with severe chronic ischemic heart disease. European Heart Journal. 2006 Aug;27(15):1785-92. PMID: 16825290

2005

Chung KY, Shia J, Kemeny NE, Shah M, Schwartz GK, Tse A, Hamilton A, Pan D, Schrag D, Schwartz L, Klimstra DS, Fridman D, Kelsen DP, Saltz LB. Cetuximab Show Activity in Colorectal Cancer Patients with Tumors that do not Express the Epidermal Growth Factor Receptor by Immunohistochemistry. American Society of Clinical Oncology. 2005 Mar 20;23(9):1803-10. PMID: 15677699

Berthiaume MJ, Raynauld JP, Martel-Pelletier J, Labonté F, Beaudoin G, Bloch DA, Choquette D, Haraoui B, Altman RD, Hochberg M, Meyer JM, Cline GA, Pelletier JP. Meniscal Tear and Extrusion are Strongly Associated with the Progression of Knee Osteoarthritis as Assessed by Quantitative Magnetic Resonance Imaging. Annals of the Rheumatic Disease. 2005 Apr;64(4):556-63. PMID: 15374855

2004

Zhao B, Schwartz LH, Moskowitz CS, Wang L, Ginsberg MS, Cooper CA, Jiang L, Kalaigian JP. Pulmonary Metastases: Effect of CT Section Thickness on Measurement--Initial Experience. Radiology. 2005 Mar; 234(3);934-9. PubMed ID: 15681690

Sebba AI, Bonnick SL, Kagan R, Thompson DE, Skalky CS, Chen E, de Papp AE; Fosamax Actonel Comparison Trial investigators. Response to Therapy with Once-Weekly Alendronate 70 mg Compared to Once-Weekly Risedronate 35 mg in the Treatment of Postmenopausal Osteoporosis. Current Medical Research and Opinion. 2004 Dec;20(12):2031-41. PMID: 15706659

Raynauld JP, Martel-Pelletier J, Berthiaume MJ, Labonté F, Beaudoin G, de Guise JA, Bloch DA, Choquette D, Haraoui B, Altman RD, Hochberg MC, Meyer JM, Cline GA, Pelletier JP. Quantitative Magnetic Resonance Imaging Evaluation of Knee Osteoarthritis Progression Over Two Years and Correlation with Clinical Symptoms and Radiologic Changes. Arthritis and Rheumatism. 2004 Feb;50(2):476-87. PMID: 14872490

Kondagunta GV, Drucker B, Schwartz L, Bacik J, Marion S, Russo P, Mazumdar M, Motzer RJ. Phase II Trial of Bortezomib for Patients with Advanced Renal Cell Carcinoma. Journal of Clinical Oncology. 2004 Sept 15;22(18):3720-5. PMID: 15365068

Luckey M, Kagan R, Greenspan S, Bone H, Kiel RD, Simon J, Sackarowitz J, Palmisano J, Chen E, Petruschke RA, de Papp AE. Once-weekly alendronate 70 mg and raloxifene 60 mg daily in the treatment of postmenopausal osteoporosis. Menopause. 2004 Jul-Aug;11(4):405-15. PMID: 15243278

van der Heijde D, Landewé R, Klareskog L, Rodríguez-Valverde V, Settas L, Pedersen R, Fatenejad S, (Acknowledgement Bio-Imaging Technologies). Presentation and analysis of data on radiographic outcome in clinical trials: experience from the TEMPO study. Arthritis and Rheumatism. 2005 Jan;52(1):49-60. PMID: 15641062

Mayer SA, Brun NC, Begtrup K, Broderick J, Davis S, Diringer MN, Skolnick BE, Steiner T, (Acknowledgement Bio-Imaging Technologies). Recombinant activated factor VII for acute intracerebral hemorrhage. The New England Journal of Medicine 2005 Feb 25, 352(8):777-85. PMID: 15728810

2003

Raynauld JP, Kauffmann C, Beaudoin G, Berthiaume MJ, de Guise JA, Bloch DA, Camacho F, Godbout B, Altman RD, Hochberg M, Meyer JM, Cline G, Pelletier JP, Martel-Pelletier J. Reliability of a Quantification Imaging System Using Magnetic Resonance Images to Measure Cartilage Thickness and Volume in Human Normal and Osteoarthritic Knees. Osteoarthritis Cartilage. 2003 May;11(5):351-60. PMID: 12744941

Kauffmann C, Gravel P, Godbout B, Gravel A, Beaudoin G, Raynauld JP, Martel-Pelletier J, Pelletier JP, de Guise JA. Computer-aided Method for Quantification of Cartilage Thickness and Volume Changes Using MRI: Validation Study Using a Synthetic Model. IEEE Transactions on Biomedical Engineering. 2003 Aug;50(8):978-88. PMID: 12892325

2001

Drotman MB, Machnicki SC, Schwartz LH, Winston CB, Yoo HH, Panicek DM. Breast Cancer: Assessing the Use of Routine Pelvic CT in Patient Evaluation. American Journal of Roentgenology. 2001 Jun;176(6):1433-6. PMID: 11373208

2000

Schwartz LH, Ginsberg MS, DeCorato D, Rothenberg LN, Einstein S, Kijewski P, Panicek DM. Evaluation of Tumor Measurements in Oncology: Use of Film-Based and Electronic Techniques. Journal of Clinical Oncology. 2000 May;18(10):2179-84. PMD: 10811683