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57. Effect of hepatic and renal impairment on the pharmacokinetics of olanzapine and samidorphan given in combination as a bilayer tablet

Author

Sun L, Yagoda S, Du Y, and von Moltke L

Subjects
olanzapine, samidorphan, renal impairment, hepatic impairment, pharmacokinetics, Therapeutics. Pharmacology, RM1-950
Abstract

Lei Sun,1 Sergey Yagoda,2 Yangchun Du,3 Lisa von Moltke21Department of Clinical Pharmacology and Translational Medicine, Alkermes, Inc., Waltham, MA, USA; 2Department of Clinical Research, Alkermes, Inc., Waltham, MA, USA; 3Department of Biostatistics, Alkermes, Inc., Waltham, MA, USACorrespondence: Lei SunClinical Pharmacology and Translational Medicine, Alkermes, Inc., 852 Winter Street, Waltham, MA 02451, USATel +1 781 609 6151Fax +1 781 609 5851Email lei.sun@alkermes.comBackground: A combination of olanzapine and samidorphan (OLZ/SAM) is in development to provide the established antipsychotic efficacy of olanzapine while mitigating olanzapine-induced weight gain.Methods: Two multicenter, open-label, parallel-cohort studies were performed to evaluate the effect of moderate hepatic impairment (Child-Pugh score 7–9 [class B]; study 1) and severe renal impairment (estimated glomerular filtration rate: 15–29 mL/min/1.73 m2,; study 2) on the pharmacokinetics, safety, and tolerability of a single dose of OLZ/SAM 5/10 mg.Results: There was a 1.67-fold increase in area under the plasma concentration-time curve from time 0 to infinity (AUC0-∞) and a 2.17-fold increase in maximum plasma concentration (Cmax) of olanzapine, and a 1.52-fold increase in AUC0-∞ and a 1.63-fold increase in Cmax of samidorphan, in subjects with moderate hepatic impairment compared with healthy control subjects. Compared with healthy control subjects, subjects with severe renal impairment had a 33% and 56% reduction in clearance, a 1.51- and 2.31-fold increase in AUC0-∞, and a 1.32- and 1.37-fold increase in Cmax of olanzapine and samidorphan, respectively.Conclusion: OLZ/SAM 5/10 mg was generally well tolerated under the conditions of the studies, with a safety profile consistent with that observed in other clinical studies of OLZ/SAM.Keywords: olanzapine, samidorphan, renal impairment, hepatic impairment, pharmacokinetics

Published
2019

58. Mechanism-Based Approach to New Antibiotic Producers Screening among Actinomycetes in the Course of the Citizen Science Project

Author

Inna A. Volynkina, Yuliya V. Zakalyukina, Vera A. Alferova, Albina R. Belik, Daria K. Yagoda, Arina A. Nikandrova, Yuliya A. Buyuklyan, Andrei V. Udalov, Evgenii V. Golovin, Maxim A. Kryakvin, Dmitrii A. Lukianov, Mikhail V. Biryukov, Petr V. Sergiev, Olga A. Dontsova, and Ilya A. Osterman

Subjects
citizen science, crowdsourcing, antibiotic producers screening, actinomycetes, reporter systems, chartreusin, Therapeutics. Pharmacology, RM1-950
Abstract

Since the discovery of streptomycin, actinomycetes have been a useful source for new antibiotics, but there have been diminishing rates of new finds since the 1960s. The decreasing probability of identifying new active agents led to reduced interest in soil bacteria as a source for new antibiotics. At the same time, actinomycetes remain a promising reservoir for new active molecules. In this work, we present several reporter plasmids encoding visible fluorescent protein genes. These plasmids provide primary information about the action mechanism of antimicrobial agents at an early stage of screening. The reporters and the pipeline described have been optimized and designed to employ citizen scientists without specialized skills or equipment with the aim of essentially crowdsourcing the search for new antibiotic producers in the vast natural reservoir of soil bacteria. The combination of mechanism-based approaches and citizen science has proved its effectiveness in practice, revealing a significant increase in the screening rate. As a proof of concept, two new strains, Streptomyces sp. KB-1 and BV113, were found to produce the antibiotics pikromycin and chartreusin, respectively, demonstrating the efficiency of the pipeline.

Published
2022
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59. Souvenirs: A Case Study for the 90s.

Author

American Society for Microbiology, Washington, DC., Shagam, Janet Yagoda, Decker, Janet, and Stanley, Ethel

Abstract

The case-based study, which presents students with a dilemma that encourages exploration, is becoming a popular method for teaching biology. This Web-based report offers one such case study that asks readers to solve problems and make decisions based on information gathered as they engage with characters or situations in the story. The basis for the study narrative is antavirus, a topic of interest in the global scientific community. The story is broken into five sections: (1) It All Started Here: Old College Friends Return from a Dig; (2) Home Sick: Travelers Show Signs of Illness at Home; (3) What Hit Us? One is Dead and Another is Fighting for Her Life; (4) Of Mice and Men: Identifying the Source of the Infection Continues; and (5) Loose Ends and Law Suits: What are the Real Costs of a Disease? The study can be used as a single unit or it may be broken up and presented, as appropriate, throughout the semester. Included are extensive resources for both instructors and students who wish to try case-based investigations in their courses. (AS)

Published
1999

60. Plasma Vascular Endothelial Growth Factor Concentrations after Intravitreous Anti–Vascular Endothelial Growth Factor Therapy for Diabetic Macular Edema

Author

Browning, David, Antoszyk, Andrew N., Price, Angela K., Fredenberg, Sherry L., Herby, Jenna T., Fleming, Christina J., McClain, Ashley A., Ennis, Sarah A., Gallagher, Kelly R., Karow, Angella S., Grupp, Autumn C., Puskas, Danielle, Watson, Lynn, Bojaj, Swann J., Balasubramaniam, Uma M., McClain, Donna, Styles, Donna R., Kuopus, Jeff A., Kimrey, Kathryn, Clark, Loraine M., Jackson, Lisa A., McOwen, Michael D., Dunlap, Matt, Held, Susannah J., Pieramici, Dante J., Nasir, Ma'an A., Castellarin, Alessandro A., Dhoot, Dilsher, Fishbein, Sarah, Giust, Jack, Wan, Lisha, Hanna, Michelle S., Rabena, Melvin D., Smith, Jerry, Bone, Layne J., Avery, Kelly, Giust, Matthew, Walker, Aimee, Shook, Aimee H., Esau, Sara, Ruvalcaba, Nitce L., Wells, John A., Clark, W. Lloyd, Johnson, David L., Payne, John F., Swinford, Tiffany R., Taylor, Mallie M., Garrison, Cassandra L., Miller, Peggy D., Houlahan, Amber R., O'Neill, Charlotte A., Floyd, Ashley, Parker, Crystal C., Sease, Courtney, Graham, Tara, Spencer, Robin, Ogbuewu, Tiffany N., Studebaker, Ashley, Huggins, Tyler, Spivey, Robbin, Jones, Brian, Williams, Ashley, Petty, Ron, Poston, Erin L., Ward, G. Michael, Baker, Carl W., Tilford, Ron H., Caldwell, Tracey M., Lambert, Lynnette F., Palmer, Mary J., Martin, Tracey R., Williams, Tana R., Kettler, Samantha, Camp, Alecia B., Silva, Paolo S., Arrigg, Paul G., Sharuk, George S., Shah, Sabera T., Sun, Jennifer K., Westerfeld, Corey, Andreoli, Christopher Michael, Aiello, Lloyd Paul, Schlossman, Deborah, Murtha, Timothy, Kwak, Hanna, Flores, Flor M., Stockman, Margaret E., Kieser, Troy, Krigman, Michael N., Bestourous, Leila, Weimann, Elizabeth S., Cavallerano, Jerry D., Hock, Kristen M., Robertson, Mary Ann, Kirby, Rita K., Papaconstantinou, Steve L., Madigan, Kylie M., Cavicchi, Robert W., Palitsch, Kate A., Yilmaz, Taygan, Berger, Brian B., Jhaveri, Chirag D., Moore, Tori, Manhart, Ginger J., Walsh, Rachel A., Gunderson, Ivana, Riepen, Dietrich, Bravenec, Chelsey A., Reid, Ryan M., Ren, Yong, Ostrander, Ben, Stovall, Christopher C., Elman, Michael J., Liss, Robert A., Leder, Henry A., Starr, JoAnn, Belz, Jennifer L., Putzulo, Charlene K., Sandler, Dallas R., Simmons, Jennifer L., Singletary, Pamela V., Davis, Ashley, Simpson, Perel M., Coffey, Teresa, Ketner, Daniel J., Cain, Terri, Metzger, Ashley M., Sotirakos, Peter, Marcus, Dennis M., Singh, Harinderjit, Roberts, Courtney N., Floyd, Geri L., Ortiz, Siobhan O., Mims, Virginia, Foster, L. Allison, Coursey, Christy, Gardner, Jared C., Ivey, Ken, O'Keefe, John Stewart, Astruc, Juan A., Schwent, Bryan J., Tabassian, Ali R., Rosen, Suzette A., Vaughan, David C., Michaels, Jeffrey, Arndt, Natalie J., Maziarz, John J., Friedman, Scott M., Moinfar, Nader, Williamson, Kimberly A., Fagan, Damanda F., Dawson, Katrina L., Walters, Paige N., McKinney, Allen, Carlton, Steve, Kwun, Robert C., Knudsen, Victoria L., Winward, Kirk E., Swartz, Mano, Howard, James G., Riley, Michelle, Taylor, Gena, Holt, Michelle, Winward, Jason G., Walsh, Adam, Taylor, Teresa, Walsh, Daniel, Hampton, G. Robert, Brown, Jamin S., Seth, Rajeev K., Sienkiewycz, Laurie J., Appleton, Deborah A., Grinnell, Cindy J., Cowley, Charity A., Kwasniewski, Lynn M., Manley, Michelle L., Robarge, Nicole E., DeSantis, Stefanie R., Hay, Peter B., DeForge, Teresa M., Wykoff, Charles C., Wong, Tien P., Chen, Eric, Brown, David M., Kim, Rosa Y., Major, James C., Schefler, Amy C., Fish, Richard H., Benz, Matthew S., Lipman, Meredith, Hutson, Amy, Landaverde, Nubia, Chancey, Ashley E., Cone, Cassie, Royse, Tressa, Sneed, Veronica A., Almanza, Belinda A., Dives, Brenda, Richter, Beau A., Kegley, Eric N., Lauer, Andreas K., Flaxel, Christina J., Bailey, Steven T., Schain, Mitchell, Lundquist, Ann D., Hanel, Shelley A., Ira, Shirley D., Nolte, Susan K., Steinkamp, Peter N., Ryan, Dawn M., Pickell, Scott R., Hui, Jocelyn T., Brix, Michelle, Barth, Jordan, Howell, Chris S., Fox, Gregory M., Cooper, Blake A., Batlle, Ivan R., Manning, Lexie R., Batlle, Karla A., Wyrick, Holly, Pippin, Katherine, Perkins, Samantha, Yeager, Frank T., Rush, Ryan B., Gardner, Glenn R., Rush, Christi, Hawkins, Johnathan R., Dumas, Brenda, Ysasaga, Ben, Shah, Chirag P., Morley, Michael G., Wiegand, Torsten W., Cleary, Tina S., Topping, Trexler M., Colegrove, Lindsey, Bechtel, Katharine, Johnson, Britta, Lebedew, Lisa, Lorius, Natacha, Chong, Sandy G., Stone, Jennifer L., Jones, Michael Cullen, Donovan, Dennis, Malone, Sherry, Graham, Margie, Santos, Audrey, Bennett, Steve A., Blinder, Kevin J., Smith, Bradley T., Nobel, Ginny S., Weeks, Rhonda F., Hoehn, Erika A., Stuart, Maria A., Pepple, Kelly E., Boyd, Lynda K., Pulliam, Brook G., Schremp, Steve A., Guevara, Stephanie L., Wehmeier, Jarrod, Wright, Timothy L., Gabel, Dana L., Miller, David G., Schartman, Jerome P., Singerman, Lawrence J., Coney, Joseph M., Novak, Michael A., Rao, Llewelyn J., Rath, Susan C., McNamara, Elizabeth, Stone, Larraine, Smith, Veronica A., Rykena, Cecelia, DuBois, Kimberly A., Ilc, Mary A., Tanner, Vivian, Drury, Kim, Nitzsche, Trina M., Greanoff, Gregg A., DuBois, John C., Burgess, Stuart K., Lara, Tirso M., Pereda, Noel H., Fernandez, Cindy V., Davis, Deborah, Quinchia, Evelyn, Workman, Karen, Nielsen, Jared S., Sohn, Jeong-Hyeon, Alliman, Kyle J., Saggau, David D., Parker, Marianne, George, Bethany, Eastvold, Carrie L., Sells, Kristin, Woehl, Tami Jo, Johnson, Marilyn A., Keenan, Holly, Coleman, Jennifer L., Spillman, Jamie, Freeman, Shannon, Schmidt, Leigh S., Boender, Lisa M., Partin, Jill L., Bennett, Bailey R., Rostvold, Jay, McLure Stone, Cameron, Raymer, Lea R., Menzel, Andrea K., Rickman, Leslie D., Campbell, Barbara, Sherlin, Lorraine P., Hawkins, Lisa H., Buckner, Melissa L., Matsipura, Olesya N., Price, Paula A., Ghuman, A. Thomas, Raskauskas, Paul A., Sharma, Ashish G., Wing, Glenn, Walker, Joseph P., Knips, Eileen, Kiesel, Cheryl, Peters, Crystal Y., Ryan, Cheryl, Greenhoe, Laura, Torres, Natalie N., Youngblood, Rebecca J., Turnbo, Danielle, Leslie, Anita H., Schoeman, Etienne C., Kiesel, Raymond K., Kingsley, Ronald M., Shah, Vinay A., Leonard, Robert E., Miller, Heather R., Icks, Sonny, Bergman, Vanessa A., Drummond, Vanessa K., Ross, Brittany L., Ellis, Reshial D., Whittington, Tina R., Almeida, Shannon R., Butt, Amanda M., Burris, Russ, Peters, Mark A., Lee, Michael S., Tlucek, Paul S., Ma, Colin, Hobbs, Stephen, Milliron, Amanda C., Ho, Stephanie L., Kopfer, Marcia, Logan, Joe, Hoerner, Christine, Khawly, Joseph A., Rahman, Hassan T., Abdelgani, Diana, Miller, Pam S., Fredrickson, Debbie, Pineda, Erica, Lopez, Desiree, Lowd, Donald K., Blank, Colin, Martinez, Lorena R., Muniz, Jason E., Gottlieb, Justin, Ip, Michael S., Blodi, Barbara A., Dietzman, Kristine A., Burke, Kathryn F., Smith, Christopher M., Olson, Shelly R., Wealti, Angela M., Reed, Sandie L., Krolnik, Denise A., Peterson, John C., Gonzalez, Victor Hugo, Diaz-Rohena, Roberto, Santiago, Juan G., Adyanthaya, Rohit, Patel, Nehal R., Anaya, Deyla, Garcia, Dina, Cruz, Edna E., Alvarez, Crystal A., Iracheta, Ruth, Rodriguez, Jessica, Cantu, Monica R., Flores, Rebecca R., Jasso, Hector, Rodriguez, Rachel, Miranda, Karina, Lozano, Krystle R., Garza, Maricela, Aguero, Lazaro, Sandoval, Amanda L., Montemayor, Monique, Alonso, Samuel, Garza, Santos, DiLoreto, David Allen, Ramchandran, Rajeev S., Kleinman, David M., O'Gara, George W., Czubinski, Andrea M., MacDowell, Peter, Steinmetz, Kari M., Castillo, Dan A., Yu, Yvonne F., Tongue, Salina M., Keim, Melissa S., Hollar, Rachel, Deats, Brandi N., Richardson, Brittany S., Singer, Lynn, Pannell, Taylor A., Daniels, Stewart A., Ranchod, Tushar M., Leong, Craig J., Touson, Stacey, Earl, Shannon R., Bartlett, Melissa C., Fernando, Christine, Factor, Djorella, Garcia, Jessica, Nguyen, Anna K., Hom, Betty, Walker, Cathy, Marudo, Grace M., Suazo, Jose Carlos, McNeil, Leah M., Hanamoto, Fred, Hughes, Matthew D., Ross, Robin D., Sanford, Susan M., Markiewicz, Nicole Martini, Utley, Tracy M., Henderson, Shannon, Lippincott, Joanie H., Streasick, Patricia, Glazer, Louis C., Garber, Frank W., Zheutlin, Jeffrey D., Listerman, Angela D., Feehan, Christine E., Cruz, Heather L., Kuitula, Donald E., Rainey, Olivia P., Weatherbee, Sue, Googe, Joseph M., Shuler, R. Keith, Anderson, Nicholas G., Perkins, Stephen L., Oliver, Kristina, Grindall, Nicole, Arnold, Ann, Beerbower, Jennifer, Hunt, Cecile, Schulz, Kathy L., Oelrich, Sarah M., Whetstone, Jerry K., Walsh, Justin, Morris, Chris, Wong, Robert W., Nixon, Peter A., Leon, Jeni L., Montesclaros, Chris A., Leung, Carrie E., Le, Phill, Harborth, Codey L., Rodriguez, Margaret A., Mangham, Cory, Aaberg, Thomas M., Westhouse, Scott J., Vincent, Holly L., Malone, Rebecca, Karsten, Kathy L., Maturi, Raj K., Harless, Ashley M., Novak, Carolee K., Bleau, Laura A., Steele, Thomas, Harris, Charlotte, Bildner, Alisha, Maple, Abby, Stone, Thomas W., Isernhagen, Rick D., Kitchens, John W., Holcomb, Diana M., Van Arsdall, Jeanne, Buck, Michelle, Slade, Edward A., Chiu, Mark T., Reddy, Ashok K., Wyant, Frank W., Montano-Niles, Mary M., Carter, Lorraine J., Maerki, Shirley, Tartaglia, Laura, Gomez, Paul P., Maestas, Stephen A., Shanta, Camille, Jimenez, Lisbrenda M., Stoltz, Robert A., Vanderveldt, Stephanie L., Lampert, Scott I., Marcus, Leslie G., Fulbright, Shelly, Martin, James P., Novack, Roger L., Liao, David S., Lo, Tammy Eileen, Kurokouchi, Janet, Ngo, Richard, Hoang, Connie V., Sierra, Julio, Zamboni, Adam, Protacio, Eric G., Kessinger, Jeff, Garg, Seema, Houghton, Odette M., Ulrich, Jan Niklas, Chavala, Sai H., DuBose, Elizabeth L., Barnhart, Cassandra J., Karmalkar, Megha, Jani, Pooja D., Goble, Justin, Cantrell, Debra, Esquejo, Rona Lyn, Shah, Sandeep N., Harmon, Natasha, Dhalla, Mandeep S., del Cid, Mario R., Halperin, Lawrence S., Brady, Jaclyn A., Hamlin, Monica, Lopez, Monica L., Mariano, Jamie, Neale, Candace M., Veksler, Rita R., Mannarelli, Angelica, Coffee, Robert E., Carvounis, Petros Euthymiou, Hemati, Pejman, Dorenbach, Cindy J., Joshi, Annika S., Leger, April, Barnett, Dana B., Morales, Joseph F., Mansour, Sam E., Choyce, Cathy, Dirawatun, Aissa L., Nagy, Emma A., Kerkstra, Jamie C., Fan, Joseph T., Suthar, Mukesh Bhogilal, Rauser, Michael E., Santiago, Gisela, Marvyn Cerdenio, Liel, Perez, Brandi J., Halsey, Kara E., Kiernan, William H., Knabb, Jesse, Catren, Rachel, Shami, Michel, Arrington, Brenda K., Neuling, Keri S., Meeks, Ashaki, Garcia, Natalie R., Blair, Kayla, Rhymes, Ginger K., Medrano, Janet, Kim, Judy E., Weinberg, David V., Stepien, Kimberly E., Connor, Thomas B., Williams, Vesper V., Kaczanowski, Tracy L., Packard, Krissa L., Flanders, Judy, Barwick, Vicki, Winter, Pat A., Beringer, Joseph R., Selchert, Kathy J., Lehr, John T., Rodriguez-Roman, Elaine, Jones, Teri, Haddox, Martha Eileen, Pena, Mark, Hernandez, Brenda, Chan, Clement K., Lalezary, Maziar, Lin, Steven G., Walther, Kimberly S., Gonzales, Tiana, Myers, Lenise E., Huff, Kenneth M., Chace, Richard, Kallay, Sunny, Stevens, Kirsten, Dolbec, Nicole, Baker-Hill, Ronda, Surette, Janea, Rose, Steven J., Connolly, Brian P., Guillet, Ernest G., Hall, Edward F., Yagoda, Margaret M., Doran, Mary Jo, Burgess, Mindy, Reynard, Ann, Powers, Margaret, Territo, Joe, Mein, Calvin E., Chica, Moises A., Lane, R. Gary, Holy, Sarah Elizabeth, Kirschbaum, Lita, Martinez, Vanessa D., Baker, Jaynee, Kincaid, Christa G., Castillo, Elaine, Wienecke, Christopher Sean, Schlichting, Sara L., Nakoski, Brenda, Diddie, Kenneth R., Cadwell, Deborah M., Van Arsdale, Louise, Boisvert, Taryn F., Galonsky, Joyce, O'Hayer, Susie, Johnson, Melissa L., McCabe, Frank J., Baker, Brad J., Defrin, Melvyn H., Lampson, Marie V., Pratte, Heather, Baron, Selena A., Borelli, Aundrea S., Davidorf, Frederick H., Wells, Michael B., Chang, Susie, Christoforidis, John Byron, Letson, Alan D., Salerno, Jill A., Perry, Jerilyn G., Shelley, Stephen E., Fish, Patrick J., Scott, Michael H., Dixon, James A., Walsh, Shannon R., Ozpirincci, Philomina M., Tebon, Brenda L., Moyle, Marcia J., Pavlica, Michael R., Matta, Noelle S., Brubaker, Cristina M., Backer, Alyson B., Bhagat, Neelakshi, Fay, Catherine, Mikheyeva, Tatiana, Lazar, Michael, Ellenberger, Janie D., Malpica, Beth, Brucker, Alexander J., Kim, Benjamin J., VanderBeek, Brian L., Drossner, Sheri, DuPont, Joan C., Salvo, Rebecca, Engelhard, Stephanie B., Berger, Jim M., Morales, Sara, Serpentine, Beth, Kaufman, Paul L., McCluskey, Jessica D., Wynne, Kathy T., Jordan, Julian, Watson, Brandun, Wirthlin, Robert S., Guglielmo, Eric S., Dittman, Eileen A., Waidelich, Dylan C., Garza, Cristofer J., Stone, Adeline M., Oakes, Ashley Nicole, Suner, Ivan J., Hammer, Mark E., Peden, Marc C., Traynom, Janet R., DenBoer, Rochelle, Vargo, Heidi, Ramsey, Susan, Malzahn, Anita Kim, Jeffres, Debra, Chaudhry, Nauman A., Shah, Sumit P., Haffner, Gregory M., German, Emiliya, Moreau, Shannan, Fox, Laura A., Matteson, Jennifer M., Pelletier, JoAnna L., Fontecchio, Alison, Morse, Emily, McNamara, Greg, Laglivia, Marie Grace, Scherf, Marissa L., LaPre, Angela, Cocilo, Justin A., Das, Arup, Friesen, Linda, Franco, Michele, Lucero, Johnny, Frazier, Melissa, Laviolette, Robert, Mian, Umar Khalil, Riemer, Rebecca L., Koestenblatt, Evelyn, Wolf, Louise V., Kim, Christine, Katkovskaya, Irina, Otoo, Erica, Ellerbe, Kevin A., Boyd, Kenneth, Costa, Caroline, Edwards, Paul Andrew, Gao, Hua, Hessburg, Thomas, Desai, Uday, Murphy, Janet, Monk, Mary K., Hall, Julianne, Mazurek, Melina, Ventimiglia, Katie M., Rusinek, Brian A., Stern, Bradley A., Brouhard, Kris, Weier, Katie M., Allis, Megan, Shaken, Jenny, Massu, Nicole M., Troszak, Tracy A., Burley, David, Bhavsar, Abdhish R., Emerson, Geoffrey G., Jones, Jacob M., Anderson, Tracy A., Gilchrist, Andrea, Peloquin, Matt D., Gaid, Gaid, Vang, Yang, Ryan, Samantha, Vang, Denise, Evans, Alanna C., Scherer, Tonja, Lazarus, Howard S., Bunch, Debra Paige, Davis, Liana C., Booth, Kelly, Trimble, Margaret, Bledsaw, Mary A., Moore, Jay, Rosberger, Daniel F., Groeschel, Sandra, Madry, Miriam A., DiGirolamo, Nikoletta, Pressley, Dustin, Santora, Robert, Gomez, Yenelda M., Olsen, Karl R., Bergren, Robert L., Conrad, P. William, Rath, Pamela P., Vyas, Avni Patel, Liu, Judy C., Merlotti, Lori A., Chamberlin, Jennifer L., Mechling, Holly M., Kelly, Mary E., Marfisi, Kellianne, Yeckel, Kimberly A., Bennett, Veronica L., Schultz, Christina M., Rigoni, Grace A., Walter, Julie, Forish, Missy A., Fec, Amanda, Foreman, Courtney L., Steinberg, David, McBroom, Keith D., Chen, Melvin C., Levy, Marc H., Torres, Waldemar, Jelemensky, Peggy, Raphael, Tara L., Rich, Joann, Sneath, Mark, Kinyoun, James L., Vemulakonda, Gurunadh Atmaram, Rath, Susan A., Ernst, Patricia K., Pettingill, Juli A., Jones, Ronald C., Clifton, Brad C., Leslie, James D., Solomon, Sharon D., Bressler, Neil M., Levin, Lisa K., Donohue, Deborah, Frey, Mary, Larez, Lorena, Murray, Keisha, Denbow, Rita L., Graul, Janis, Emmert, David, Herring, Charles, Rhoton, Nick, Belz, Joe, Lyon, Alice T., Mirza, Rukhsana G., Krug, Amanda M., Ramirez, Carmen, Kaminski, Lori, Castro-Malek, Anna Liza M., Mills, Amber N., Rozenbajgier, Zuzanna, Skelly, Marriner L., Simjanoski, Evica, Degillio, Andrea R., Lim, Jennifer I., Chau, Felix Y., Niec, Marcia, Johnson, Tametha, Ovando, Yesenia, Janowicz, Mark, Carroll, Catherine, Gross, Jeffrey G., Fishburne, Barron C., Flowers, Amy M., Stroman, Riley, Ochieng, Christen, McDowell, Angelique S.A., Paul, Ally M., Price, Randall L., Drouilhet, John H., Lacaden, Erica N., Nobler, Deborah J., Cummings, Howard L., Long, Deanna Jo, McCord, Ben, Robinson, Jason, Swift, Jamie, Maynard, Julie P., Pahk, Patricia J., Palmer-Dwore, Hannah, Dave, Dipali H., Pacheco, Mariebelle, Galati, Barbara A., Simpson, Eneil, Barkmeier, Andrew J., Vogen, Diane L., Berg, Karin A., Howard, Shannon L., Burrington, Jean M., Morgan, Jessica Ann, Overend, Joan T., Goddard, Shannon, Lewison, Denise M., Tesmer, Jaime L., Greven, Craig Michael, Fish, Joan, Everhart, Cara, Clark, Mark D., Miller, David T., Hubbard, George Baker, Yan, Jiong, Cribbs, Blaine E., Curtis, Linda T., Brower, Judy L., Dobbs, Jannah L., Jordan, Debora J., Ahmad, Baseer U., Huang, Suber S., Sedlacek, Hillary M., Hornsby, Cherie L., Ferguson, Lisa P., Carlton, Kathy, Sholtis, Kelly A., Allchin, Peggy, Clow, Claudia, Harrod, Mark A., Pankhurst, Geoffrey, Baum-Rawraway, Irit, Hrvatin, Stacie A., Gentile, Ronald C., Yang, Alex, Carrasquillo-Boyd, Wanda, Masini, Robert, Samy, Chander N., Kraut, Robert J., Shirley, Kathy, Corso, Linsey, Ely, Karen, Scala, Elizabeth, Gross, Stewart, Alava, Vanessa, Margalit, Eyal, Neely, Donna G., Blaiotta, Maria, Hagensen, Lori, Harris, April E., Lennon, Rita L., Cota, Denice R., Wilson, Larry, Wells, John A., III, Aiello, Lloyd P., Beck, Roy W., Bressler, Susan B., Chalam, Kakarla V., Danis, Ronald P., Arnold-Bush, Bambi J., Ferris, Frederick, Glassman, Adam R., Almukhtar, Talat, Dale, Brian B., Baptista, Alyssa, Connor, Crystal, Conner, Jasmine, Constantine, Sharon R., Dowling, Kimberly, Dupre, Simone S., Ayala, Allison R., Huggins, Meagan L., Inusah, Seidu, Johnson, Paula A., Loggins, Brenda L., McClellan, Shannon L., Melia, Michele, Battle, Eureca, Stockdale, Cynthia R., Stanley, Danielle, Jaffe, Glenn, Balsley, Brannon, Barbas, Michael, Burns, Russell, Busian, Dee, Ebersohl, Ryan, Heydary, Cynthia, McEwan, Sasha, Myers, Justin, Robertson, Amanda, Shields, Kelly, Thompson, Garrett, Winter, Katrina, Young, Ellen, Davis, Matthew D., Huang, Yijun, Blodi, Barbara, Domalpally, Amitha, Reimers, James, Vargo, Pamela, Wabers, Hugh, Myers, Dawn, Lawrence, Daniel, Allan, James, Jampol, Lee M., Antoszyk, Andrew, Friedman, Scott, Scott, Ingrid U., Schron, Eleanor, Everett, Donald F., Miskala, Päivi H., Connett, John, Abrams, Gary, Barnbaum, Deborah R., Flynn, Harry, Weinstock, Ruth S., Wilkinson, Charles P., Wisniewski, Stephen, Genuth, Saul, Frank, Robert, Ferris, Frederick L., III, Jaffe, Glenn J., Bhavsar, Abdhish, Googe, Joseph, Jr., Lauer, Andreas, McClain, Ashley, Liu, Danni, Duh, Elia J., and Quaggin, Susan

Published
2018
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61. Developing a Community Based Pre-College Medical Science Collaborative.

Author

Albuquerque Technical Vocational Inst., NM. and Shagam, Janet Yagoda

Abstract

Designed to assist secondary and post-secondary educators develop community interactive science programs, this manual describes steps undertaken at New Mexico's Albuquerque Technical Vocational Institute to develop pre-college medical science programs that encourage local high school students to consider the college's medical technology program. First, an introduction provides a general description of the pre-college programs and sample comments from program participants. The second part summarizes program objectives from 1994-95 and 1995-96 and indicates that 6 students were served in 1994-95 and 13 in 1995-96. The third part focuses on beginning the process of developing a program, discussing issues related to funding, preparing the proposal, costing out the proposal, hiring support staff, budgeting for contracted services and teachers' salaries, and buying supplies. The fourth part discusses specific considerations in project development related to establishing academic requirements, administrative needs, scheduling and school calendars, student attendance, student activities, ancillary services, developing syllabi, and ordering and storing materials and perishable supplies. The final sections review drawbacks to relying on donations, ideas for organizing guest speakers and field trips, and methods for handling public relations and outreach. Appendixes provide sample course syllabi, examples of program pre- and post-tests, and a sample program abstract used to publicize the project. (HAA)

Published
1996

62. Pegilated interferon alpha 2b «Pegaltevir» chronic hepatitis C treatment (randomized clinical trial)

Author

Marina V. Mayevskaya, Ye. N. Bessonova, P. O. Bogomolov, N. I. Geyvandova, K. V. Zhdanov, V. G. Morozov, V. D. Pasechnikov, I. Yu. Khomenko, A. V. Yagoda, and V. T. Ivashkin

Subjects
хронический гепатит с, лечение, исследуемый препарат пегальтевир®, препарат сравнения пегинтрон®, эффективность, безопасность, Diseases of the digestive system. Gastroenterology, RC799-869
Abstract

Aim of investigation. Nowadays the question, whether pegylated interferon should be completely abandoned in the treatment of chronic hepatitis C (CHC) is still open. Beneficial interferon properties include: absence of mutagenic capacity for hepatitis C virus and drug interaction, stimulation of host immune response. These qualities formed the basis for development of the Russian pegilated interferon-alpha 2b (Pegaltevir®, LLC «FARMAPARK», Russia) and carrying out doublestaged randomized open clinical trial: study of safety, tolerability and pharmacokinetics of Pegaltevir® at single injection of increasing doses in various groups of healthy volunteers - the I stage; studying of efficacy and safety of Pegaltevir® in comparison to PegIntron® (Schering-Plough, USA) at CHC as a part of double antiviral therapy with ribavirin (Rebetol®, Schering-Plough, USA) - the II stage. This article presents results of the II phase of investigation. Material and methods. Original study included 140 adult antiviral treatment-naive patients with CHC and compensated liver function. Patients (aged 18 to 70 years) were distributed into four groups. Group 1 (main group, Pegaltevir®/Rebetol® treatment) - 55 patients, HCV genotype 1; group 2 (comparison group, PegIntron®/Rebetol® treatment) - 20 patients, HCV genotype 1; group 3 (main group, Pegaltevir®/Rebetol® treatment) - 47 patients, non-genotype 1 (2 and 3); group 4 (comparison group, PegIntron®/ Rebetol ® treatment) with non-genotype 1 (2 and 3). Assessment of Pegaltevir® efficacy was carried out in 4 weeks (rapid virologic response, RVR) and 12 weeks of treatment (early virologic response, EVR) in groups 1 and 3 in comparison to corresponding scores in groups 2 and 4 (primary criteria of efficacy were estimated in all 140 patients enrolled in original study. The response rate at the moment of secession of antiviral therapy, the sustained virologic response (SVR), histologic response (comparison of paired liver biopsies) served as secondary efficacy criteria and were estimated in 129 patients who completed treatment. The safety analysis was carried out for each patients included in the protocol who received at least one Pegaltevir® dose in comparison to patients who received at least one dose of PegIntron®, - respectively 102 and 38 patients. Results. RVR was comparable in the Pegaltevir® and PegIntron® groups: 65,6 and 82,4% respectively (p>0,05). RVR frequency genotype one patients was 45,3% in Pegaltevir® treatment group and 66,7% in PegIntron® treatment group (p>0,1). At patients with non-genotype 1 (2 and 3): 92,5 and 100% respectively (p>0,05). RVO did not significantly differ in the studied groups: 91,6 and 97,1% for all genotypes respectively (р>0,1). RVO rate for genotype 1 patients in Pegaltevir® group was 86,8%, in PegIntron® treatment group - 94,4% (р>0,1), in non-genotype 1 patients (2 and 3) it reached 97,6 and 100% in the specified patient groups (р>0,1). Response rate at the moment of treatment secession for Pegaltevir® and PegIntron® was 87,4 and 97,1% respectively for all genotypes (р>0,05). In patients with HCV genotype 1 this score Pegaltevir® treatment group reached 79,3%, in PegIntron® group - 94,4% (р> 0,05), in non-genotype 1 patients (2 and 3) - 97,6 and 100% respectively (р>0,1). SVR rate at Pegaltevir® treatment was 82,1% (for all genotypes), PegIntron® - 82,4% (for all genotypes, p>0,1). In HCV genotype 1 patients in Pegaltevir® treatment group SVR made 73,6%, in PegIntron® treatment group - 83,3%, p>0,1, for non-genotype 1 (2 and 3) - 92,9 and 81,3%, p>0,1. No significant differences between basic and control groups at analysis of paired liver biopsies for fibrosis stage reduction rate, absence of negative changes for fibrosis severity and proportion of patients with fibrosis progression were found. Pegaltevir® and PegIntron® treatment groups were comparable safety profile, adverse events were expected, mainly of mild and moderate severity. Conclusion. The hypothesis of identical efficacy of the Russian drug Pegaltevir® tested in the protocol in comparison to PegIntron® was correct and proved. Safety of Pegaltevir® was comparable to safety of PegIntron® as well.

Published
2018
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65. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study

Author

Christoph U, Correll, Evan, Stein, Christine, Graham, Lauren, DiPetrillo, Sarah, Akerman, Arielle D, Stanford, Ying, Jiang, Sergey, Yagoda, David, McDonnell, and Craig, Hopkinson

Subjects
Psychiatry and Mental health
Abstract

Background and Hypotheses Weight gain and adverse cardiometabolic effects often limit the clinical utility of olanzapine. In ENLIGHTEN-2, combining olanzapine with the opioid receptor antagonist samidorphan (OLZ/SAM) mitigated olanzapine-associated weight gain. These analyses tested the hypothesis that OLZ/SAM would be associated with reduced adverse cardiometabolic effects compared with olanzapine. Study Design This phase 3 double-blind study randomized adults with schizophrenia to OLZ/SAM or olanzapine for 24 weeks. Post hoc analyses assessed changes from baseline to week 24 in cardiometabolic risk parameters, including body mass index (BMI), risk of developing obesity (BMI ≥30 kg/m2) or metabolic syndrome, waist circumference, along with mean and potentially clinically significant changes in blood pressure, glucose, and lipids. Results After 24 weeks’ treatment, compared with olanzapine, OLZ/SAM was associated with smaller least-squares mean (LSM) changes from baseline in systolic blood pressure (LSM difference, −2.63 mm Hg; 95% CI: −4.78, −0.47), diastolic blood pressure (LSM difference, −0.75 mm Hg; 95% CI: −2.31, 0.80), and BMI (LSM difference, −0.65 kg/m2; 95% CI: −1.01, −0.28). OLZ/SAM treatment was also associated with reduced risk of shifting from normal blood pressure to stage 1/2 hypertension (odds ratio [OR], 0.48; 95% CI: 0.24, 0.96), becoming obese (OR, 0.52; 95% CI: 0.32, 0.82), and developing metabolic syndrome (OR, 0.55; 95% CI: 0.31, 0.99) compared with olanzapine. No treatment group differences were noted for risk of hyperglycemia or hyperlipidemia. Conclusions OLZ/SAM treatment was associated with lower risk of worsening cardiometabolic risk factors related to obesity, hypertension, and metabolic syndrome relative to olanzapine. NCT02694328, https://clinicaltrials.gov/ct2/show/NCT02694328.

Published
2022
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66. Olanzapine/samidorphan combination consistently mitigates weight gain across various subgroups of patients

Author

Jonathan M. Meyer, Adam Simmons, Ying Jiang, Christine Graham, Sergey Yagoda, and David McDonnell

Subjects
Psychiatry and Mental health, Neurology (clinical)
Abstract

Objective A combination of olanzapine and the opioid receptor antagonist samidorphan (OLZ/SAM) has been approved in the United States for the treatment of adults with schizophrenia or adults with bipolar I disorder. In a phase 3 study in adults with schizophrenia (ENLIGHTEN-2), OLZ/SAM treatment was associated with significantly less weight gain compared with olanzapine. Prespecified subgroup analyses explored the consistency of the weight mitigation effect of OLZ/SAM vs olanzapine across demographic subgroups in ENLIGHTEN-2. Methods The multicenter, randomized, double-blind ENLIGHTEN-2 study (NCT02694328) included outpatients aged 18–55 years with a diagnosis of schizophrenia based on DSM-5 criteria, a body mass index (BMI) of 18 to 30 kg/m2, and stable body weight (self-reported change ≤5% for ≥3 months before study entry). Patients were randomized 1:1 to receive OLZ/SAM or olanzapine for 24 weeks. Co-primary endpoints (previously reported) were percent change in body weight and proportion of patients with at least 10% weight gain from baseline at week 24. Prespecified exploratory subgroup analyses by sex, age, self-reported race, and baseline BMI were conducted. Results At week 24, treatment with OLZ/SAM resulted in numerically less percent weight gain than with olanzapine across all subgroups evaluated. The proportion of patients with at least 10% weight gain was smaller in each subgroup treated with OLZ/SAM vs olanzapine. Conclusion In these exploratory subgroup analyses from the ENLIGHTEN-2 study, weight-mitigating effects of OLZ/SAM vs olanzapine were observed consistently across patient subgroups and were in line with results from the overall study population.

Published
2022
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67. The possibilities of soluble selectins in the prediction of severe fi brosis in nonalcoholic fatty liver disease

Author

P. V. Koroy, Yu. A. Kravchenko, and A. V. Yagoda

Subjects
Hepatology, Gastroenterology
Abstract

The aim of the work was to study the relationship of selectins with hepatic fi brosis in nonalcoholic fatty liver disease (NAFLD).Material and methods. In 40 patients with histologically confi rmed NAFLD (42.5% of women, 57.5% of men) aged 19 to 65 years (mean age — 40.93±1.95 years), the levels of E-, P- and L-selectins in the blood was studied. Severe liver steatosis was present in 47.5% of patients, nonalcoholic steatohepatitis was observed in 57.5% of cases, and severe liver fi brosis was detected in 22.5% of patients. The control group consisted of 60 practically healthy people.Results. The increase of plasma levels of all selectins was observed in NAFLD. The blood levels of E-selectin elevated with increasing of histological signs of hepatic steatosis. The concentration of E- and P-selectins in the blood was higher in patients with nonalcoholic steatohepatitis than in cases of its absence. The maximum values of E- and P-selectins in the blood were present in severe liver fi brosis. Correlation of soluble E- and P-selectins with fi brosis index was determined. The risk of severe fi brosis in NAFLD increased 27-fold with E-selectin values above 89 ng/ml and 33-fold in cases of P-selectin values greater than 166 ng/ml. The accuracy of the above levels of E- and P-selectins in predicting severe fi brosis in NAFLD was 80.0 and 82.5%, respectively. The probability of severe liver fi brosis in NAFLD was related with the presence of insulin resistance and increased levels of P-selectin in the blood.Conclusion. Determination of the profi le of soluble selectins in NAFLD allows us to state the severity of liver fi brosis and stratify patients into groups with its diff erent severity.

Published
2022
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68. Functioning and Cognition in Patients with Schizophrenia After Initiating Treatment with Aripiprazole Lauroxil: Secondary Outcomes and Post Hoc Analysis.

Author

OPLER, MARK G. A., CLAXTON, AMY, MCGRORY, JAMES, GASPER, SABINA, MEIHUA WANG, and YAGODA, SERGEY

Subjects
DRUG therapy for schizophrenia, MEDICAL protocols, COGNITIVE testing, THERAPEUTICS, DATA analysis, RESEARCH funding, FUNCTIONAL status, TREATMENT effectiveness, DESCRIPTIVE statistics, ATTITUDE (Psychology), ATTITUDES of medical personnel, STATISTICS, ARIPIPRAZOLE, PATIENTS' attitudes, CAREGIVER attitudes, ACTIVITIES of daily living, EVALUATION
Abstract

Background: Clinical practice guidelines support efforts to improve functioning in patients with schizophrenia. Discrepancies in the perception of cognitive status between clinicians, patients with schizophrenia, and their caregivers have been associated with impaired functional abilities in patients; medication side effects might worsen both cognition and daily functioning. We assessed daily/social functioning and cognition in stable patients with schizophrenia who switched to the long-acting injectable (LAI) antipsychotic aripiprazole lauroxil (AL). Methods: Clinically stable adults with residual symptoms of schizophrenia or intolerance following three or more doses of paliperidone palmitate or risperidone LAI were switched to flexibly dosed open-label AL treatment (441mg, 662mg, or 882mg every 4 weeks or 882mg every 6 weeks) for six months (ClinicalTrials.gov identifier: NCT02634320). Daily/social functioning was assessed using the Personal and Social Performance Scale (PSP); total and subscale scores were summarized using descriptive statistics. The cognitive status of patients was assessed using the New York Assessment of Adverse Cognitive Effects of Neuropsychiatric Treatment (NY-AACENT) at baseline and Month 6 or early termination, providing patient, caregiver, and clinician perspectives. A post hoc analysis assessed level of agreement in ratings of cognitive status among respondents, evaluated at baseline and last assessment, using weighted kappa coefficients (0.01-0.20, slight agreement; 0.21-0.40, fair agreement; 0.41-0.60, moderate agreement; 0.61-0.80, substantial agreement.). Results: All 51 enrolled patients received one or more AL doses; 35 completed the study, and 45 contributed data at last assessment. Mean age was 40.6 years; 72.5 percent of patients were male. Based on PSP total score, functioning was maintained from baseline (mean [standard deviation (SD)]: 55.1 [10.5]) through six months of AL treatment (mean [SD]: 57.7 [13.2]). Proportions of patients rating personal and social functioning issues as "not present" or "mild" remained stable between baseline and Month 6 for each PSP subscale. At baseline (n=50), cognitive difficulties were most commonly rated "not present" or "mild" in all NY-AACENT domains by patients (58-86% across domains), clinicians (62-94%), and caregivers (50-92%), and these rates were maintained or increased at last assessment for all reporters. Weighted kappa coefficients indicated fair-to-substantial agreement between patients and clinicians across domains at last assessment (0.32-0.64; baseline: 0.14-0.55); patient--caregiver agreement ranged from 0.07 to 0.50 at last assessment (baseline: 0.25-0.60). Conclusion: In clinically stable patients with schizophrenia who initiated AL, self-reported functioning was maintained over six months of treatment. Clinician-, caregiver-, and patient-reported cognitive function was stable at baseline and maintained in all NY-AACENT domains; patient--clinician agreement on level of cognitive impairment increased over six months of treatment with AL. [ABSTRACT FROM AUTHOR]

Published
2024

69. DIAGNOSTIC SIGNIFICANCE OF VASCULAR ENDOTHELIAL GROWTH FACTOR IN PATIENTS WITH PRIMARY MITRAL VALVE PROLAPSE

Author

A. V. Yagoda, N. N. Gladkikh, and Т. E. Zangelova

Subjects
mitral valve prolapse, vascular endothelial growth factor type a, receptors to vascular endothelial growth factor, risk stratification, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Aim. To evaluate diagnostic significance of the type A vascular endothelial growth factor (VEGF-A) and its receptors type 1 and 2 (VEGF-R1 and VEGF-R2) in primary mitral valve prolapse (MVP) patients.Material and methods. Totally, 83 MVP patients studied: 61 males, 22 females; mean age 21,93±4,22 y. o. The signs of systemic inflammation were assessed, as the grade of connective tissue involvement. Immune enzyme analysis was done for serum levels of VEGF-А, VEGF-R1 and VEGF-R2 (“Bender MedSystems GmbH”,Austria). Controls included 20 healthy volunteers — 14 males, 6 females, mean age 21,10±0,55 y. o. with no MVP and any other dysplastic features.Results. In the MVP group, the decreased levels of circulating VEGF-R1 were found, as the increase of cases number of high (42,17%) and low (32,53%) concentration of VEGF-А. In low levels of VEGF-A and VEGF-A/ VEGF-R1 prevalence of grade II mitral regurgitation increases 5,1 times comparing to the group of retained balance of VEGF-A and VEGF-R1 — 95% confidence interval (CI) 1,25-20,88, and the prevalence of clinically significant cardiac rhythm and conduction disorders increases 5,25 times in comparison to the cases with elevated VEGF-A and VEGF-R1 — 95% CI 1,33-20,76 and 4,09 times — comparing MVP patients with retained balance of VEGF-A and VEGF-R1 — 95% CI 1,18-14,17.Conclusion. In primary MVP patients, regardless clinical phenotype of monogenic hereditary syndromes, the heterogeneity of deviation and regulation of VEGF has been established. Highest number of II grade mitral regurgitation, significant rhythm disorders was found in the group with low VEGF-A and VEGF-A/VEGF-R1, that might be implemented as optimized risk stratification in heterogenic MVP patients population.

Published
2017
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71. Family of selectins in non-alcoholic fatty liver disease

Author

Yagoda A.V. Yagoda, Koroy P.V. Koroy, Kravchenko Yu.A. Kravchenko, and Stavropol Municipal Polyclinic No

Subjects
medicine.medical_specialty, business.industry, Internal medicine, Fatty liver, Medicine, Non alcoholic, Disease, business, medicine.disease, Gastroenterology, Selectin
Published
2021
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73. Addressing Health Disparities Through Voter Engagement

Author

Yagoda, Nicholas

Subjects
Voting -- Influence, Health services administration -- Public participation, Health care disparities -- Management, Company business management, Health, Science and technology
Abstract

Although the public's essential capacity for self-rule in the United States lies in the power of the ballot, there exist many barriers to voting, particularly for marginalized communities. These barriers cultivate less representative government and less inclusive public policy. Nonprofit and private health organizations, and in particular community health centers and safety-net hospitals, can help marginalized voting-eligible individuals overcome barriers to the ballot. With augmented, unbiased voter participation, elections would yield government that is more representative and public policy that is more equitable, while reducing costly and preventable health disparities. Health organizations can promote comprehensive, nonpartisan voter engagement through registration, mobilization, education, and protection of all voters. Key words: health; disparities; integrated; equity; voter engagement; voter registration; mobilization; education; voter education; protection, INTRODUCTION In 2016, more than 90 million Americans, nearly 40% of our voting-eligible population, did not vote. (1) Significant gaps in voter participation occurred along racial, educational, and income-level divides, [...]

Published
2019
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82. Experience of therapy of chronic viral hepatitis c patients with unfavourable response predictors

Author

N. I. Geyvandova, A. V. Lipov, P. V. Koroy, A. V. Yagoda, and S. S. Rogova

Subjects
chronic viral hepatitis c, anti-viral therapy, forecasting, interferon-free drugs, Medicine
Abstract

Introduction in practice of therapeutic establishments in the RF of antiviral therapy of chronic viral hepatitis in the form of interferon-free schemes led to considerable increase of the frequency of the stable virologic response. Study objective: determination of virologic response predictors in CVHC patients when various therapeutic schemes are used. Materials and methods: Group 1 of CVHC 52 patients with genotype 1 of HCV received standard anti-viral therapy, Group 2 (21 subject) – interferon-free scheme (Viekira Pak+ Ribavirin). Genetic polymorphisms IL-28В rs12979860 (С>Т) and rs8099917 (Т>G) and blood interferon-γ induced protein – IP-10 were determined. Results: standard anti-viral therapy in Group 1 resulted in SVR (sustained viral response) in 29 patients (55.7%). In Group 2 that received Viekira Pak 100% SVR was achieved in spite of more frequent F3 and 4 stage of fibrosis, unsuccessful anti-viral therapy (9 persons), contraindications to IFN-α drugs (6 persons). Unfavorable genotypes IL-28B ТТ (rs12979860) and GG (rs8099917) were associated in Group 1 with lack of SVR, level of IP-10 in patients with SVR was lower than the one in non-respondents. The therapy by Viekira Pak was well tolerated and resulted in SVR despite presence of grave hepatic fibrosis/ cirrhosis, concomitant pathology, unfavourable options of IL-28B, high IP-10 protein levels. Conclusion: choice of optimal anti-viral therapy schemes for each patient with CVHC must be done taken into account all possible predictors, which allows optimizing the therapy and preventing the necessity of repeated therapy.

Published
2016
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83. The specifics of adhesion function of endothelium in various clinical variants of primary mitral valve prolapse

Author

A. V. Yagoda, N. N. Gladkikh, and L. N. Gladkikh

Subjects
mitral valve prolapse, adhesion molecules, endothelium, Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Aim. To assess the condition of adhesion function of endothelium in various clinical variants of primary mitral valve prolapse (MVP). Material and methods. Totally, 91 patient studied with primary MVP at the age 21 (19-24) y. First grade mitral regurgitation was found in 45,1% and II — in 54,9% patients. MVP was solitary variant (6,6%) and comorbid with 1-3 minor anomalies of the heart (93,4%). Doppler-echocardiography was done on Vivid07 equipment (Israel). The grade of systemic involvement of connective tissue was 2 (1,5-4,0) points. Controls were 10 healthy persons, matched by age, sex, smoking, body mass index. By the immune enzyme method we checked plasmatic concentrations of L-, E-, Р-selectins, ICAM-1, VCAM-1, PECAM-1 (Bender MedSystems GmbH, Austria). Findings are presented as mediana (25-75 percentiles). Results. In MVP patients the levels of Е-selectin — 43,0 (33,7-54,8) ng/ mL, ICAM-1 — 669,9 (546,4-883,3) ng/mL and VCAM-1 — 925,0 (707,5- 1215,0) ng/mL, were significantly higher, and the level of РЕСАМ-1 — 49,8 (40,4-63,2) ng/mL, in opposite, lower than in control group. L- and P-selectins levels in MVP group were measured as relevant to controls values (p>0,05). In regurgitation cases of II degree, the level of E-selectin and ICAM-1 were maximal (p

Published
2016
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85. 'Environmental Agenda' in the latest political history of Republic of North Macedonia (1990s – 2020s)

Author

Yagoda Mitrevska and Dmitrii G. Seltser

Abstract

The place of the environmental agenda in the general logic of the political process of the Republic of North Macedonia is analyzed. The genesis of the environmental agenda in Macedonian politics, its development in the public rhetoric of the establishment and the activities of political parties are revealed. The influence of political conjuncture, disposition and arrangement of po-litical subjects on the relevance of the environmental factor in Macedonian politics and socio-political processes is shown. The algorithm of the impact of the environmental agenda on the change of power in the country is demonstrated. The procedures for the pressure of opposition forces on the state at different stages of the country’s recent political history are detailed. Specific scenarios of transformation of the environmental agenda into a political one are described. A detailed description of the emergence and activity of environmental movements and parties, as well as electoral declarations of leading political parties on environmental issues are given. An explanatory model of the influence of the environmental agenda on the pendulum nature of the change of power in the country is created. A forecast is made for the prospect of preserving the environmental agenda in political and social discourse. The factor of international influence on the activation of the environmental factor in Macedonian political life is established. It is understood which political forces of Northern Macedonia and beyond benefit from maintaining the presence of the environmental theme in the political space.

Published
2022
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88. Truaa Earthquake Early Warning System for Israel –Operational Stage and the Public’s Perspective

Author

Nof, Ran Novitsky, Yagoda-Biran, Gony, and Zwebner, Yonat

Abstract

Truaa - Israel’s Earthquake Early Warning System (EEWS), is in operational mode since January 27th, 2022. Israel is amongst the few countries in the world to run a national, government- operated EEWS. Building and operating such a system involves not only many technical challenges, but also considering the social aspects of alert strategy and public’s perceptions.In the determination of an alert magnitude threshold, there is an inherent tradeoff between urgency and necessity. In this presentation we combine three independent data sets to inspect Israel’s alerting strategy: (1) We analyze the performance of the EEWS in the past two years to derive uncertainties of earthquake early warning alerts in Israel; (2) We re-project these uncertainties to the historic earthquake catalog of 2010-2020 and (3) We analyze a dataset of unnecessary injuries following missile alerts, to estimate the potential toll of unnecessary earthquake alerts.We then present the social point of view of alerts in Israel, as obtained by a first-of-its-kind questionnaire in Israel, focusing on people’s perceptions and perspective on earthquake alerts.Taken together, we find that the expected injury toll from unnecessary alerts is an order of magnitude lower than the potential damage of shorter reaction time (the time period between the alert and s-wave arrival) and that the public’s preferences may allow the alerting strategy to be less conservative, and to accommodate the EEWS uncertainties and limitation by allowing potentially faster alerts., The 28th IUGG General Assembly (IUGG2023) (Berlin 2023)

Published
2023

90. PSYCHOANALYZING THE PRESIDENT: WHAT DROVE SIGMUND FREUD AND HIS AMERICAN CO-AUTHOR TO WRITE A SCANDALOUS BIOGRAPHY OF WOODROW WILSON?

Author

Yagoda, Ben

Subjects
Thomas Woodrow Wilson: A Psychological Study (Biography) -- Authorship, Ambassadors -- Works -- Beliefs, opinions and attitudes, Writers -- Works -- Beliefs, opinions and attitudes, Ex-presidents -- Portrayals, History
Abstract

SIGMUND FREUD WAITED TOO LONG. Throughout the 1930s, as the Nazis rose to power in Germany and took ever more aggressive action against the country's Jews, the father of psychoanalysis [...]

Published
2018

91. YOUR LYING MIND

Author

Yagoda, Ben

Subjects
Cognitive biases -- Analysis, Brain research, General interest, News, opinion and commentary
Abstract

ARE WE HARDWIRED TO DELUDE OURSELVES? THOSE WHO STUDY COGNITIVE BIAS SEEM TO THINK SO. THEY DISAGREE ON WHETHER WE CAN DO MUCH ABOUT IT. I am staring at a [...]

Published
2018

92. Variations in Levels of Intercellular Adhesion Molecule-1 with Disease Course in Rheumatoid Arthritis Patients

Author

Vijaya Jawahar Sarithala, Pavel Koroy, and Alexander Yagoda

Subjects
cardiovascular risk, functional class, osteocalcin, systemic effects, Medicine
Abstract

Introduction: Adhesion molecules play an important role in the migration of leukocytes, process of inflammation and in remodeling of tissue. Intercellular Adhesion Molecule-1 (ICAM-1) is expressed along the luminal, intercellular, and subluminal surface of endothelial cells and their expression increases after stimulation by cytokines and TNF-α in Rheumatoid Arthritis (RA). Aim: To study the serum concentration of ICAM-1 in patients with rheumatoid arthritis. Materials and Methods: Levels of ICAM-1 in 134 patients with rheumatoid arthritis (30 male, 104 female) aged 20 to 66 years were studied. Control group constituted of 70 healthy individuals of age 22 to 55 years. Concentration of ICAM-1 was determined by ELISA. Statistical analysis of the data was performed using two sample Student’s t-criterion, criteria of Newman-Keuls and correlation n analysis with application of Pearson (r) and Spearman (rs) criteria. Results: Index DAS28 scored up to 5.49 (4.88-6.01) in the patients. Most of the patients were diagnosed with III x-ray stage, II and III functional class of the disease. In patients with rheumatoid arthritis significantly increased (p

Published
2018
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93. Case of intravital diagnosis of endocardium separation in patient with post-infarction cardio­sclerosis with formation of subendocardial aneurysm

Author

Gladkikh N.N. Gladkikh, Dolzhenko T.A. Dolzhenko, Ushakova O.V. Ushakova, Mikhaylenko E.M. Mikhaylenko, Yagoda A.V. Yagoda, Bataeva A.S. Bataeva, and Belotserkovskaya M.I. Belotserkovskaya

Subjects
medicine.medical_specialty, Aneurysm, Post infarction, business.industry, Internal medicine, medicine, Cardiology, In patient, medicine.disease, business, Endocardium
Published
2021
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95. Engineering-Oriented Ground-Motion Model for Israel

Author

Ronnie Kamai and Gony Yagoda-Biran

Subjects
Geophysics, Building and Construction, Geotechnical Engineering and Engineering Geology, Civil and Structural Engineering
Abstract

This study presents a response-spectral Ground Motion Model (GMM) for Israel, called KYB22 herein and derived with practical applications in mind. This model is based on the former work by Maiti et al. (2021), which derived a suite of nine Fourier amplitude spectra GMMs, based on both empirical data and calibrated point-source simulations. In this study, a weighted average of the Maiti et al. (2021) FAS models is computed and a synthetic database is created. Next, this database is converted to the Response spectral domain using the random vibration theory and a new GMM is regressed, constraining the magnitude and distance scaling on the synthetic response-spectral data. Site scaling is represented by VS30 and is a combination of empirical scaling with other considerations which are discussed in the text. Nonlinear site response is constrained from a global model, as are finite-fault effects, such as hanging-wall, mechanism and top of rupture – which cannot be constrained from the data because it does not contain enough large magnitude data. State-wide hazard is then computed using KYB22, comparing results with other GMM combinations. It is found that the hazard results obtained by using KYB22 as a backbone model are comparable to results obtained using other popular combinations of GMMs in the logic tree. Therefore, we recommend using the new GMM as one of the branches within the ground-motion logic tree when conducting seismic hazard calculations for Israel.

Published
2022
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97. Reduction in Multiple Cardiometabolic Risk Factors With Combined Olanzapine/Samidorphan Compared With Olanzapine: Post Hoc Analyses From a 24-Week Phase 3 Study

Author

Correll, Christoph U, primary, Stein, Evan, additional, Graham, Christine, additional, DiPetrillo, Lauren, additional, Akerman, Sarah, additional, Stanford, Arielle D, additional, Jiang, Ying, additional, Yagoda, Sergey, additional, McDonnell, David, additional, and Hopkinson, Craig, additional

Published
2022
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