Found 157 results
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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, 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.
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.
W. H. Chen, Pasetti, M. F., Adhikari, R. P., Baughman, H., Douglas, R., El-Khorazaty, J., Greenberg, N., Holtsberg, F. W., Liao, G. C., Reymann, M. K., Wang, X., Warfield, K. L., and Aman, M. J., Safety and Immunogenicity of a Parenterally Administered, Structure-Based Rationally Modified Recombinant Staphylococcal Enterotoxin B Protein Vaccine, STEBVax, Clin Vaccine Immunol, vol. 23, no. 12, pp. 918-925, 2016.
R. Libster, McNeal, M., Walter, E. B., Shane, A. L., Winokur, P., Cress, G., Berry, A. A., Kotloff, K. L., Sarpong, K., Turley, C. B., Harrison, C. J., Pahud, B. A., Marbin, J., Dunn, J., El-Khorazaty, J., Barrett, J., and Edwards, K. M., Safety and Immunogenicity of Sequential Rotavirus Vaccine Schedules., Pediatrics, vol. 137, no. 2, pp. 1-10, 2016.
G. Mutua, Hanke, T., Fast, P., Hannaman, D., Chinyenze, K., Oino, G., Sajabi, R., Verlinde, C., Barin, B., Reilly, M., and Jaoko, W., Safety and Tolerability of pSG2.HIVconsv DNA MVA.HIVconsv and Ad35-GRIN Prime-Boost Combinations Administered to Healthy HIV-Uninfected Kenyan Adults, in HIV R4P 2016, Chicago, IL, 2016.
R. Lindblad, Saxon, A., Van Veldhuisen, P., Lu, L., Hu, L., Hasson, A., Thomas, C., Sparenborg, S., Mooney, L., and Ling, W., Safety of Combination Buprenorphine/Naloxone and Extended Release Naltrexone, in 2016 CPDD Scientific Meeting, Palm Springs, CA, 2016.
S. Churchill, R Miller, S., Deru, K., Wilson, S. H., and Weaver, L. K., Simple and Procedural Reaction Time for Mild Traumatic Brain Injury in a Hyperbaric Oxygen Clinical Trial, Mil Med, vol. 181, no. 5 Suppl, pp. 40-44, 2016.
R. Hess, Shmueli-Blumberg, D., Sincam, M., and Huser, V., Standardizing Research Common Data Elements: Initiatives, Exchange Formats and Current Use by Patient-Level Trial Results Databases, in The 40th Annual Conference of the American Medical Informatics Association (AMIA), Chicago, IL, 2016.
D. Knepper, Lindblad, A., Sharma, G., Gensler, G., Manukyan, Z., Matthews, A., and Seifu, Y., Statistical Monitoring in Clinical Trials: Best Practices for Detecting Anomalies Suggestive of Fabrication or Misconduct, Therapeutic Innovation and Regulatory Science, no. TransCelerate Special Issue, pp. 1-11, 2016.
S. P. Lerner, Bajorin, D. F., Dinney, C. P., Efstathiou, J. A., Groshen, S., Hahn, N. M., Hansel, D., Kwiatkowski, D., O'Donnell, M., Rosenberg, J., Svatek, R., Abrams, J. S., Al-Ahmadie, H., Apolo, A. B., Bellmunt, J., Callahan, M., Cha, E. K., Drake, C., Jarow, J., Kamat, A., Kim, W., Knowles, M., Mann, B., Marchionni, L., McConkey, D., McShane, L., Ramirez, N., Sharabi, A., Sharpe, A. H., Solit, D., Tangen, C. M., Amiri, A. T., Van Allen, E., West, P. J., Witjes, J. A., and Quale, D. Z., Summary and Recommendations from the National Cancer Institute's Clinical Trials Planning Meeting on Novel Therapeutics for Non-Muscle Invasive Bladder Cancer, Bladder Cancer, vol. 2, no. 2, pp. 165-202, 2016.
M. E. Roland, Barin, B., Huprikar, S., Murphy, B., Hanto, D. W., Blumberg, E., Olthoff, K., Simon, D., Hardy, W. D., Beatty, G., and Stock, P. G., Survival in HIV-positive Transplant Recipients Compared with Transplant Candidates and with HIV-negative Controls, AIDS, vol. 30, no. 3, pp. 435-444, 2016.