Found 165 results
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2019
J. M. Marrazzo, Dombrowski, J. C., Wierzbicki, M. R., Perlowski, C., Pontius, A., Dithmer, D., and Schwebke, J., Safety and Efficacy of a Novel Vaginal Anti-infective, TOL-463, in the Treatment of Bacterial Vaginosis and Vulvovaginal Candidiasis: A Randomized, Single-blind, Phase 2, Controlled Trial, Clin Infect Dis, vol. 68, no. 5, pp. 803-809, 2019.
T. A. Crowell, Colby, D. J., Pinyakorn, S., Sacdalan, C., Pagliuzza, A., Intasan, J., Benjapornpong, K., Tangnaree, K., Chomchey, N., Kroon, E., deSouza, M. S., Tovanabutra, S., Rolland, M., Eller, M. A., Paquin-Proulx, D., Bolton, D. L., Tokarev, A., Thomas, R., Takata, H., Trautmann, L., Krebs, S. J., Modjarrad, K., McDermott, A. B., Bailer, R. T., Doria-Rose, N., Patel, B., Gorelick, R. J., Fullmer, B. A., Schuetz, A., Grandin, P. V., OConnell, R. J., Ledgerwood, J. E., Graham, B. S., Tressler, R., ,, Chomont, N., Michael, N. L., Robb, M. L., Phanuphak, N., Ananworanich, J., and Dawson, P., Safety and efficacy of VRC01 broadly neutralising antibodies in adults with acutely treated HIV (RV397): a phase 2, randomised, double-blind, placebo-controlled trial, Lancet HIV, 2019.
H. M. El Sahly, Atmar, R. L., Patel, S. M., Bellamy, A., Liu, L., Hong, W., Zhu, H., Guan, Y., and Keitel, W. A., Safety and Immunogenicity of an 8 Year Interval Heterologous Prime-Boost Influenza A/H7N7-H7N9 Vaccination, Vaccine, vol. 37, no. 19, pp. 2561-2568, 2019.
F. M. Munoz, Anderson, E. J., Bernstein, D. I., Harrison, C. J., Pahud, B., Anderson, E., C Creech, B., Berry, A. A., Kotloff, K. L., Walter, E. B., Atmar, R. L., Bellamy, A. R., Chang, S., and Keitel, W. A., Safety and Immunogenicity of Unadjuvanted Subvirion Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Children and Adolescents, Vaccine, vol. 37, no. 36, pp. 5161-5170, 2019.
T. L. Schonfeld, Brown, J. S., N Amoura, J., and Gordon, B. G., Strength through Structure: Defending a Structured Approach to Contraceptive Mandates in Clinical Research., Ethics Hum Res, vol. 41, no. 3, pp. 33-35, 2019.
M. S. Natrajan, Rouphael, N., Lai, L., Kazmin, D., Jensen, T. L., Weiss, D. S., Ibegbu, C., Sztein, M. B., Hooper, W. F., Hill, H., Anderson, E. J., Johnson, R., Sanz, P., Pulendran, B., Goll, J. B., and Mulligan, M. J., Systems Vaccinology for a Live Attenuated Tularemia Vaccine Reveals Unique Transcriptional Signatures That Predict Humoral and Cellular Immune Responses., Vaccines (Basel), vol. 8, no. 1, 2019.
2018
F. M. Munoz, Jackson, L. A., Swamy, G. K., Edwards, K. M., Frey, S. E., Stephens, I., Ault, K., Winokur, P., Petrie, C. R., Wolff, M., Patel, S. M., and Keitel, W. A., Safety and immunogenicity of seasonal trivalent inactivated influenza vaccines in pregnant women., Vaccine, vol. 36, no. 52, pp. 8054-8061, 2018.
R. A. Annunziato, Bucuvalas, J. C., Yin, W., Arnand, R., Alonso, E. M., Mazariegos, G. V., Venick, R. S., Stuber, M. L., Shneider, B. L., and Shemesh, E., Self-management measurement and prediction of clinical outcomes in pediatric transplant., J Pediatr, vol. 193, pp. 128-133e.2, 2018.
H. Jim, Sutton, S., Majhail, N. S., Wood, W. A., Jacobsen, P. B., Wingard, J. R., Wu, J., Knight, J. M., Syrjala, K. L., and Lee, S. J., Severity, Course, and Predictors of Sleep Disruption Following Hematopoietic Cell Transplantation: A Secondary Data Analysis from the BMT CTN 0902 Trial, Bone Marrow Transplant, 2018.
M. Samai, Seward, J. F., Goldstein, S. T., Mahon, B. E., Lisk, D. Radcliffe, Widdowson, M. - A., Jalloh, M. I., Schrag, S. J., Idriss, A., Carter, R. J., Dawson, P., Kargbo, S. A. S., Leigh, B., Bawoh, M., Legardy-Williams, J., Deen, G., Carr, W., Callis, A., Lindblad, R., Russell, J. B. W., Petrie, C. R., Fombah, A. E., Kargbo, B., McDonald, W., Jarrett, O. D., Walker, R. E., Gargiullo, P., Bash-Taqi, D., Gibson, L., Fofanah, A. Bakarr, and Schuchat, A., The Sierra Leone Trial to Introduce a Vaccine Against Ebola: An Evaluation of rVSV∆G-ZEBOV-GP Vaccine Tolerability and Safety During the West Africa Ebola Outbreak., J Infect Dis, vol. 218, no. 3, p. 508, 2018.
D. Chiang, Chen, X., Jones, S. M., Wood, R. A., Sicherer, S. H., A Burks, W., Leung, D. Y. M., Agashe, C., Grishin, A., Dawson, P., Davidson, W. F., Newman, L., Sebra, R., Merad, M., Sampson, H. A., Losic, B., and M Berin, C., Single-cell profiling of peanut-responsive T cells in patients with peanut allergy reveals heterogeneous effector T2 subsets., J Allergy Clin Immunol, vol. 141, no. 6, pp. 2107-2120, 2018.
S. N. Taylor, Marrazzo, J., Batteiger, B. E., Hook, E. W., Seña, A. C., Long, J., Wierzbicki, M. R., Kwak, H., Johnson, S. M., Lawrence, K., and Mueller, J., Single-Dose Zoliflodacin (ETX0914) for Treatment of Urogenital Gonorrhea., N Engl J Med, vol. 379, no. 19, pp. 1835-1845, 2018.
J. M. Walker, Mulatya, C., Hebert, D., Wilson, S. H., Lindblad, A. S., and Weaver, L. K., Sleep assessment in a randomized trial of hyperbaric oxygen in U.S. service members with post concussive mild traumatic brain injury compared to normal controls., Sleep Med, vol. 51, pp. 66-79, 2018.
2017
L. A. Jackson, Frey, S. E., Sahly, H. M. El, Mulligan, M. J., Winokur, P. L., Kotloff, K. L., Campbell, J. D., Atmar, R. L., Graham, I., Anderson, E. J., Anderson, E. L., Patel, S. M., Fields, C., Keitel, W., Rouphael, N., Hill, H., and Goll, J. B., Safety and Immunogenicity of a Modified Vaccinia Ankara Vaccine Using Three Immunization Schedules and Two Modes of Delivery: A Randomized Clinical Non-Inferiority Trial, Vaccine, vol. 35, no. 13, pp. 1675-1682, 2017.
M. J. Groome, Koen, A., Fix, A., Page, N., Jose, L., Madhi, S. A., McNeal, M., Dally, L., Cho, I., Power, M., Flores, J., and Cryz, S., Safety and Immunogenicity of a Parenteral P2-VP8-P[8] Subunit Rotavirus Vaccine in Toddlers and Infants in South Africa: A Randomised, Double-Blind, Placebo-Controlled Trial, Lancet Infect Dis, vol. 17, no. 8, pp. 843-853, 2017.
P. Dumitrescu and Zhao, J., Safety of Off-label Use of Caffeine Citrate in Premature Infants, in The Pediatric Academic Societies (PAS) 2017 Meeting, San Francisco, CA, 2017.
V. Perla, SAS® Macros for Redacting Subject and Clinical Site Codes while Submitting Clinical Trial Data to FDA, in Philadelphia Area SAS Users Group (PhilaSUG) Winter 2017 Meeting, Blue Bell, PA, 2017.
I. U. Scott, Figueroa, M. J., Oden, N. L., Ip, M. S., Blodi, B. A., and VanVeldhuisen, P. C., SCORE2 Report 5: Vision-Related Function in Patients With Macular Edema Secondary to Central Retinal or Hemiretinal Vein Occlusion, Am J Ophthalmol, vol. 184, pp. 147-156, 2017.
V. Perla, Second Opening Plenary Session - Regulatory Presentation, in 2017 International Exchange, Austin, TX, 2017.
M. Eydelman, Hilmantel, G., Tarver, M. E., Hofmeister, E. M., May, J., Hammel, K., Hays, R. D., and Ferris, F. 3rd, Symptoms and Satisfaction of Patients in the Patient-Reported Outcomes With Laser In Situ Keratomileusis (PROWL) Studies, JAMA Ophthalmol, vol. 135, no. 1, pp. 13-22, 2017.