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1. Fundamental limitations on photoisomerization from thermodynamic resource theories

Author

Yunger Halpern, N and Limmer, DT

Subjects
Quantum Physics, Physical Sciences, Chemical sciences, Mathematical sciences, Physical sciences
Abstract

© 2020 American Physical Society. Small, out-of-equilibrium, and quantum systems defy simple thermodynamic expressions. Such systems are exemplified by molecular switches, which exchange heat with a bath. These molecules can photoisomerize, or change conformation, or switch, on absorbing light. The photoisomerization probability depends on kinetic details that couple the molecule’s energetics to its dissipation. Therefore, a simple, general, thermodynamic-style bound on the photoisomerization probability seems out of reach. We derive such a bound using a resource theory. The resource-theory framework is a set of mathematical tools, developed in quantum information theory, used to generalize thermodynamics to small and quantum settings. From this toolkit has been derived a generalization of the second law, the thermomajorization preorder. We use thermomajorization to upper-bound the photoisomerization probability. Then, we compare the bound with an equilibrium prediction and with a Lindbladian model. We identify a realistic parameter regime in which the Lindbladian evolution saturates the thermomajorization bound. We also quantify the energy coherence in the electronic degree of freedom, and we argue that this coherence cannot promote photoisomerization. This work illustrates how quantum-information-theoretic thermodynamics can elucidate complex quantum processes in nature, experiments, and synthetics.

Published
2020

2. Mathematics and the ESL Student.

Author

Halpern, N., Patkowski, M., and Brooks, E.

Abstract

This paper describes a pilot program at the City University of New York Brooklyn College which pairs an English as a Second Language (ESL) reading and writing class with a Calculus I class. The class focuses on students' language development but makes use of themes, readings, and vocabulary from calculus. This model requires coordination before and during the term between the language and calculus teachers. Students are provided with enriched, intensive instructional teams who meet their curricular requirements. The school uses block scheduling for students in their first two semesters of college to help ensure success. Students are placed in a block of classes and travel with the same people from class to class in the enriched environment. The ESL/mathematics class meets 6 hours per week, and students who register for it must have both the appropriate ESL placement and math prerequisites. A glossary of English words commonly used in math is available for students enrolled in the integrated classes. (Contains 17 references.) (SM)

Published
1996

5. Clinical Characteristics and Prognosis of Gastric Cancer Patients with BRCA 1/2 Germline Mutations: Report of Ten Cases and a Literature Review

Author

Halpern N, Grinshpun A, Boursi B, Golan T, Margalit O, Aderka D, Friedman E, Laitman Y, Hubert A, Kadouri L, Hamburger T, Barnes-Kedar I, Levi Z, Ben-Aharon I, Brenner B, Goldberg Y, Peretz T, and Shacham-Shmueli E

Subjects
brca1, brca2, gastric cancer, parp inhibitors, dna damaging agents, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282
Abstract

Naama Halpern,1,2 Albert Grinshpun,3 Ben Boursi,1,2 Talia Golan,1,2 Ofer Margalit,1,2 Dan Aderka,1,2 Eitan Friedman,2,4 Yael Laitman,2,3 Ayala Hubert,3 Luna Kadouri,3 Tamar Hamburger,3 Inbal Barnes-Kedar,2,5 Zohar Levi,2,6 Irit Ben-Aharon,2,7 Baruch Brenner,2,7 Yael Goldberg,2,5 Tamar Peretz,3 Einat Shacham-Shmueli1,2 1Department of Oncology, Sheba Medical Center, Tel-Hashomer, Israel; 2Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel; 3Sharett Institute of Oncology, Hadassah-Hebrew University Medical Center, Jerusalem, Israel; 4The Susanne Levy Gertner Oncogenetics Unit, The Danek Gertner Institute of Human Genetics, Chaim Sheba Medical Center, Tel-Hashomer, Israel; 5Recanati Genetics Institute, Rabin Medical Center, Beilinson Hospital, Petach Tikva, Israel; 6Division of Gastroenterology, Rabin Medical Center, Early Detection and High Risk Unit, Petach Tikva, Israel; 7Institute of Oncology, Davidoff Center, Rabin Medical Center, Petach Tikva, IsraelCorrespondence: Naama HalpernDepartment of Oncology, Sheba Medical Center, Tel-Hashomer, Rmat Gan, IsraelTel +972-3-530-2668Fax +972-3-5304958Email naama.halpern@sheba.gov.ilBackground: The prognosis of gastric cancer (GC) is poor with a median overall survival (OS) of less than 12 months in advanced-stage disease. The search for distinct genetic subgroups of GC patients and predictive biomarkers is ongoing. While BRCA1 or BRCA2 germline mutations (gBRCAm) have potential therapeutic implications in ovarian, breast and pancreatic cancers, their significance in GC patients has not been established.Patients and Methods: A retrospective multi-center data analysis of GC patients with gBRCAm was conducted, detailing the clinical characteristics and disease course in this unique subset of patients.Results: Ten GC patients with gBRCAm were identified, six of them with metastatic disease. The median OS of all ten GC patients was 47.5 (13– 192) months. Median OS for patients diagnosed with operable disease was 55.5 (13– 192) months and of the patients with metastatic disease (calculated from metastatic disease diagnosis) 32 (15– 52) months with an exceptional 1-, 2- and 3-year survival rate of 100%, 83.3% and 50%, respectively.Conclusion: These preliminary data suggest that gBRCAm in GC patients are associated with a favorable prognosis. Furthermore, gBRCAm might be a predictive biomarker to DNA-damaging agents response in GC patients, similarly to its established role in other malignancies. Further research is needed to confirm our findings.Keywords: gastric cancer, BRCA1, BRCA2, DNA-damaging agents, PARP inhibitors

Published
2020

8. Conceptualising airport digital maturity and dimensions of technological and organisational transformation

Author

Halpern, N., Budd, T., Pere Suau-Sanchez, Bråthen, S., and Mwesiumo, D.

Subjects
digital transformation, ComputerApplications_COMPUTERSINOTHERSYSTEMS, airports, maturity models
Abstract

As airports undergo digital transformation, ie a paradigmatic shift in the way digital technologies are adopted and used, there is a need for actionable insights to ensure that airport digital maturity is achieved. Using an integrative review of literature, this paper develops an airport digital maturity model, focusing mainly on a passenger experience perspective. The paper then delineates two dimensions of digital transformation — technological and organisational. Subsequently, an airport digital transformation model is conceptualised to identify key factors that airports need to consider when transforming their business and interesting lines of enquiry for future research. Insights offered by the model are relevant to both practitioners and researchers interested in conducting future studies in this area.

Published
2021

10. Impact of “critical lesions” on outcomes following cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy

Author

Ben-Yaacov, A., primary, Laks, S., additional, Goldenshluger, M., additional, Nevo, Y., additional, Mor, E., additional, Schtrechman, G., additional, Margalit, O., additional, Boursi, B., additional, Shacham-Shmueli, E., additional, Halpern, N., additional, Purim, O., additional, Hazzan, D., additional, Segev, L., additional, Zippel, D., additional, Adileh, M., additional, and Nissan, A., additional

Published
2021
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11. Abstracts of papers presented at the 15th conference of the weed science society of Israel

Author

Eizenberg, H., Tanaami, Z., Jacobsohn, R., Lalazar, A., Hayut, M., Sibony, M., Tal, A., Rubin, B., Sibony, M., Yossef, T., Plakhine, D., Kleifeld, Y., Weinberg, T., Lior, E., Eizenberg, H., Tanaami, Z., Avdat, N., Jacobsohn, R., Portnoy, V. H., Katzir, N., Joel, D. M., Buxbaum, H., Goldwasser, Y., Hershenhorn, J., Zamski, E., Kleifeld, Y., Goldwasser, Y., Plakhine, D., Hershenhorn, Y., Golan, S., Herzlinger, G., Chilf, T., Losner-Goshen, Dalia, Portnoy, V. H., Joel, D. M., Aly, R., Hershenhorn, Y., Halpern, N., Kleifeld, Y., Blumenfeld, T., Herzlinger, G., Chilf, T., Shomer-Ilan, Adiva, Mayer, A. M., Bar-Nun, Nurit, Ben-Hod, G., Amsellem, Ziva, Gressel, J., Kernyi, Z., Hornok, L., Cohen, B., Amsellem, Ziva, Gressel, J., Sharon, A., Kitahin, S., Bosak, A., Bar-Peled, Y., Barnea, N., Sibony, M., Yasour, H., Hayut, M., Tal, A., Bosak, A., Alon, Y., El-Nahhal, Y. Z., Nir, S., Polubesova, T., Margulies, L., Siti, E., Kaplan, Ch., Levanon, I., Gokkes, M., Hadar, A., Chachlon, Y., Yovel, H., Colodney, G., Glidai, S., Tal, Shuli, Nir, A., Yasur, E., Kigel, J., Yaacoby, T., Nir, A., Ye, Bin, Gressel, J., Kimel, U., Manulis, Shulamit, Kleitman, Frida, Dror, Orit, Chalupowicz, Laura, Khayat, E., Tsror (Lahkim), Leah, Erlich, Orly, Menashe, A., Wysoki, M., Gerson, U., Slabezki, Y., Dag, A., Efrat, H., Yacobson, B., Palevsky, E., Reuveny, H., Oppenheim, D., Okonis, O., Raccah, B., Kritzman, Anat, Yunis, H., Raccah, B., Gera, A., Tanne, Edna, Cohen, J., Tanne, Edna, Sandu, Z., Alexandrov, Svetlana, Geral, A., Cohen, Y., Farkash, Sonja, Baider, A., Zahavi, Tirza, Reuveni, M., Scheglov, D., Lavee, S., speltoides, Aegilops, Manisterski, J., Ben-Yehuda, Pnina, Shimony, Ayelet, Eilam, Tamar, Anikster, Y., Freeman, S., Lahav, C., Sztejnberg, A., Nitzani, Y., Maimon, M., Katan, Talma, Shtienberg, D., Kritzman, G., Herzog, Z., Openheim, D., Zilberstaine, Miriam, Blatchinsky, Daphna, Elad, Y., Mesika, Y., Elad, Y., Nitzani, Y., Kirshner, B., Shmulevitz, Y., David, Dalia Rav, Sztjenberg, A., Yehezkel, Hanna, Shmuel, D., Taari, E., Posalski, Y., Cohen, Y., Fuchs, M., Mesika, Y., Elad, Y., Nitzani, Y., Kirshner, B., Shmulevitz, Y., David, Dalia Rav, Sztjenberg, A., Yehezkel, Hanna, Shmuel, D., Taari, E., Posalski, Y., Katan, J., Pivonia, S., Cohen, R., Kigel, J., Katan, J., Levite, Rachel, Gamliel, A., Grinstein, A., Zilberg, V., Benihes, Marina, Ucko, Orna, Klein, L., Uriely, E., Stangheilini, M. E., Katan, J., Korolev, Nadia, Katan, J., Katan, Talma, Tsror, Leah, Hazanovsky, Marina, Leviush-Mordechai, Sara, Sivan, Sara, Rekah, Yael, Shtienberg, D., Katan, J., Tsror, Leah, Hazanovsky, Marina, Aharon, M., Peretz-Alon, I., Prusky, D., Beno-Moualem, Delilah, Prusky, D., Yakoby, N., Kobiler, Ilana, Dinoor, A., Prusky, D., Dudai, N., Reuveni, R., Chaimovitch, D., Sa’adi, Daya, Larkov, Olga, Dor, Evgenia, Lewinsohn, E., Putievsky, E., Afek, U., Orenstein, Janeta, Nuriel, E., Carmeli, S., Rodov, V., Bar-Joseph, M., Eshel, D., Ben-Arie, Ruth, Dinoor, A., Prusky, D., Reuven, Michal, Zviebil, Aida, Szmulewich, Y., Kleitman, Frida, Manulis, Shulamit, Ben-Yephet, Y., Ben-Yephet, Y., Reuven, Michal, Zviebil, Aida, Szmulewich, Y., Lavkovits, Airit, Markovits, T., Mor, I., Bar-Yosef, B., Iraki, N. M., Ahmad, M. N., Abu-Sa’id, J. N., Manulis, Shulamit, Barash, I., Assaraf, M., Ginzburg, C., Yarden, O., Katan, J., Gamliel, A., Gamliel, A., Grinstein, A., Ucko, Orna, Mduel, A., Klein, L., Shtienberg, D., Katan, J., Oren, Y., Solel, Z., Kimchi, Miriam, Sadovski, A., Oren, Y., Yogev, E., Yaniv, A., Omari, A., Ofer, I., Sarid, P., Avisar, E., Naot, O., Bing, B., Ovadia, S., Yunis, H., Sachs, Y., Sandu, Z., Mor, Neta, Gotlieb, Y, Zahavi, Tirza, Reuveni, M., Naot, O., Ofer, I., Sarid, P., Yaniv, A., Omari, A., Benishti, Ronit, Bing, B., Ovadia, S., HaMeiri, Y., Blatchinsky, Daphna, Sarig, P., Zahavi, Tirza, Reuveni, M., Yogev, Anat, Barzilai, Y., Balaom, B., Tsror, Leah, Hazanovsky, Marina, Erlich-Holtzer, Orly, Peretz-Alon, I., Ben-David, Tselila, Lang, M., Lubovsky, U., Engel-Kirshner, R., Ofer, I., Omari, A., Benishti, Ronit, Sarid, P., Yaniv, A., Avisar, E., Naot, O., Bing, B., Ben-Arie, Ruth, Yunis, H., Zachs, Y., Dubitzky, A., Mor, Neta, Genaim, N., HaMeiri, Y., Gotlieb, Y., Zahavi, Tirza, Cohen, Y., Reuveni, M., Zahavi, Tirza, Cohen, Y., Porat, R., Vinocur, V., Weisseah, Batya, Cohen, Leah, Droby, S., Dor, Evgenia, Dudai, N., Chaimovitch, D., Larkov, Olga, Putievsky, E., Hershenhorn, J., Sharon, Edna, Bar-Eyal, Meira, Mor, M., Kleifeld, O., Chet, I., Spiegel, Y., Yechye, U., Sztejnberg, A., Nof, E., Rubin, B., Dinoor, A., Dinoor, A., Guske, Susanne, Nof, Esther, Lichter, A., Dvir, Orit, Zutkhi, Y., Kapulonov, Tania, Sonego, Lillian, Sarig, P., Ben-Arie, Ruth, Gamliel, A., Gokkes, M., Israel, S., Skutelski, Yael, Lahav, Tamar, Gamliel, A., Kritzman, G., Peretz-Alon, Y., Becker, E., Zilberg, V., Heiman, O., Shlevin, E., Mahrer, Y., Katan, J., Fluhr, R., Pan, Q., Sela, Marianne, Pisanti, Odelia, Hadrian, Ofra, Fainzilber, Ada, Sivaldi, Sigal, Zamir, D., Silverman, D., Kritzman, G., Katan, J., Ausher, R., Melamed, Y., Gal-On, A., Slutsky, G., Wang, Y., Galiakparov, Nurbol, Aziz, Orly, Tanne, Edna, Sela, I., Gafny, R., Teverovsky, Emma, Akad, F., Gidoni, D., Czosnek, H., Loebenstein, G., Bakshi, S., Yarden, Oded, Sztejnberg, Abraham, Yassur, Inbal, Wolf, S., Dickman, M. B., Mitra, A., Yarden, O., Sharon, A., Robinson, M., Maor, R., Ezra, D., Manulis, Shulamit, Barash, I., Pardes, Einat, Manisterski, J., Ben-Yehuda, Pnina, Kosman, I., Anikster, Y., and Sharon, A.

Published
1999
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12. Clinical course and outcome of patients with high-level microsatellite instability cancers in a real-life setting: a retrospective analysis

Author

Halpern N, Goldberg Y, Kadouri L, Duvdevani M, Hamburger T, Peretz T, and Hubert A

Subjects
Treatment, Outcome, Microsatellite instability, Malignancy, lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282, digestive system diseases
Abstract

Naama Halpern,1 Yael Goldberg,2 Luna Kadouri,2 Morasha Duvdevani,2 Tamar Hamburger,2 Tamar Peretz,2 Ayala Hubert2 1Institute of Oncology, The Chaim Sheba Medical Center, Tel Hashomer, Israel; 2Sharett Institute of Oncology, Hadassah Medical Center, Hebrew University, Jerusalem, Israel Background: The prognostic and predictive significance of the high-level microsatellite instability (MSI-H) phenotype in various malignancies is unclear. We describe the characteristics, clinical course, and outcomes of patients with MSI-H malignancies treated in a real-life hospital setting.Patients and methods: A retrospective analysis of MSI-H cancer patient files was conducted. We analyzed the genetic data, clinical characteristics, and oncological treatments, including chemotherapy and surgical interventions.Results: Clinical data of 73 MSI-H cancer patients were available. Mean age at diagnosis of first malignancy was 52.3years. Eight patients (11%) had more than four malignancies each. Most patients (76%) had colorectal cancer (CRC). Seventeen patients (23%) had only extracolonic malignancies. Eighteen women (36%) had gynecological malignancy. Nine women (18%) had breast cancer. Mean follow-up was 8.5years. Five-year overall survival and disease-free survival of all MSI-H cancer patients from first malignancy were 86% and 74.6%, respectively. Five-year overall survival rates of stage 2, 3, and 4 MSI-H CRC patients were 89.5%, 58.4%, and 22.9%, respectively.Conclusion: Although the overall prognosis of MSI-H cancer patients is favorable, this advantage may not be maintained in advanced MSI-H CRC patients. Keywords: microsatellite instability, malignancy, treatment, outcome

Published
2017

16. Nuclear Export Inhibition for Radiosensitization; a Proof-of-Concept Phase I Clinical Trial of Neoadjuvant KPT-330 Plus Chemoradiation in Locally Advanced Rectal Cancer

Author

Lawrence, Y., primary, Shmueli, E., additional, Yarom, N., additional, Khaikin, M., additional, Venturero, M., additional, Apter, S., additional, Inbar, Y., additional, Aderka, D., additional, Halpern, N., additional, Berger, R., additional, Shani, A., additional, Schvimer, M., additional, Raskin, S., additional, Ackerstein, A., additional, Rashal, T., additional, Symon, Z., additional, and Golan, T., additional

Published
2018
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17. Prolonged overall survival of metastatic gastric cancer patients with BRCA germline mutations

Author

Halpern, N., primary, Grinshpun, A., additional, Boursi, B., additional, Golan, T., additional, Margalit, O., additional, Aderka, D., additional, Laitman, Y., additional, Friedman, E., additional, Hubert, A., additional, Peretz, T., additional, Hamburger, T., additional, Kedar-Barnes, I., additional, Levi, Z., additional, Ben-Aharon, I., additional, Goldberg, Y., additional, and Shacham-Shmueli, E., additional

Published
2018
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18. Systemic Immunization for the Induction of IgA Responses

Author

Tarkowski, A., Lue, C., Moldoveanu, Z., Kiyono, H., McGhee, J. R., Prchal, J. T., Halpern, N. B., Mestecky, J., Compans, R. W., editor, Cooper, M., editor, Koprowski, H., editor, McConell, I., editor, Melchers, F., editor, Oldstone, M., editor, Olsnes, S., editor, Saedler, H., editor, Vogt, P. K., editor, Wagner, H., editor, Wilson, I., editor, Mestecky, Jiri, editor, and McGhee, Jerry R., editor

Published
1989
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19. Performance and prospects of smaller UK regional airports

Author

Halpern, N. and Graham, A.

Subjects
regional airports, traffic developments, financial performance, United Kingdom (UK), airport ownership, airline strategies, low cost carriers, airport capacity
Abstract

This paper investigates the traffic and financial performance of smaller UK regional airports between 2001 and 2014. Fourteen airports that typically serve less than 5 million passengers per annum were selected for the analysis. A period of strong growth in passenger demand was experienced from 2001 to 2007, driven largely by low cost carriers. The period from 2007 to 2014 was characterised by declining demand, resulting in significant losses for many of the airports. Airline strategies, such as the use of an increased unit fleet size and average sector length, may further limit future prospects for smaller UK regional airports in favour of larger ones with greater local demand. The relationship between traffic throughput and the generation of aeronautical revenues seems to vary at airports. There is generally a strong and significant relationship between traffic throughput and the generation of commercial revenues and total operating costs at airports serving 3–5 million passengers, but the situation for airports serving fewer than 3 million is less certain.

Published
2017

20. Entropic equality for worst-case work at any protocol speed

Author

Dahlsten, O, Choi, M, Braun, D, Garner, A, Halpern, N, and Vedral, V

Subjects
Quantum Physics, 02 Physical Sciences, Statistical Mechanics (cond-mat.stat-mech), Fluids & Plasmas, FOS: Physical sciences, Quantum Physics (quant-ph), Condensed Matter - Statistical Mechanics
Abstract

We derive an equality for non-equilibrium statistical mechanics in finite-dimensional quantum systems. The equality concerns the worst-case work output of a time-dependent Hamiltonian protocol in the presence of a Markovian heat bath. It has has the form "worst-case work = penalty - optimum". The equality holds for all rates of changing the Hamiltonian and can be used to derive the optimum by setting the penalty to 0. The optimum term contains the max entropy of the initial state, rather than the von Neumann entropy, thus recovering recent results from single-shot statistical mechanics. Energy coherences can arise during the protocol but are assumed not to be present initially. We apply the equality to an electron box., Comment: 4 page + 14 page appendix; 8 figures; AAM

Published
2015
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23. Genetic features of Lynch syndrome in the Israeli population

Author

Goldberg, Y., primary, Barnes-Kedar, I., additional, Lerer, I., additional, Halpern, N., additional, Plesser, M., additional, Hubert, A., additional, Kadouri, L., additional, Goldshmidt, H., additional, Solar, I., additional, Strul, H., additional, Rosner, G., additional, Baris, H.N., additional, Peretz, T., additional, Levi, Z., additional, and Kariv, R., additional

Published
2014
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31. Postoperative Hypertension

Author

HALPERN, N. A., primary, GOLDBERG, M., additional, NEELY, C., additional, SLADEN, R. N., additional, GOLDBERG, J. S., additional, FLOYD, J., additional, GABRIELSON, G., additional, and GREENSTEIN, R. J., additional

Published
1993
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35. Septic shock and multiple organ failure after hematopoietic stem cell transplantation: treatment with recombinant human activated protein C.

Author

Pastores, S. M., Papadopoulus, E., van den Brink, M., Alicea, M., and Halpern, N. A.

Subjects
SEPSIS, STEM cell transplantation
Abstract

Presents a study that examined the safety and efficacy of drotrecogin alfa in patients with severe sepsis after hematopoietic stem cell transplantation (HSCT). Causes of morbidity after HSCT; Factors that contibute to sepsis syndrome; Role of protein C in coagulation during sepsis.

Published
2002
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39. Musculoskeletal Demands on Flamenco Dancers: A Clinical and Biomechanical Study

Author

Bejjani, F., Halpern, N., Pio, A., Dominguez, R., Voloshin, A., and Frankel, V.

Abstract

The flamenco dancer acts on the floor like a drummer. The percussive footwork and vibration patterns created during dancing impose unusual demands on the musculoskeletal system. This study investigated the clinical and biomechanical aspects of this task.Using the electrodynogram and skin-mounted accelerometers, foot pressures as well as hip and knee vibrations were recorded in 10 female dancers after a thorough clinical evaluation. A health questionnaire was also distributed to 29 dancers.Foot pressures and acceleration data reveal the percussive nature of the dance. Some clinical findings, like calluses, are related to pressure distribution. Urogenital disorders, as well as back and neck pain, may be related to the vibrations generated by the flamenco dance form. The hip joint seems to absorb most of the impacts.“Vibration-pressure” diagrams are suggested as a useful tool for evaluating a dancer's biomechanical behavior, as well as the effect of floors and footwear on this behavior.

Published
1988
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45. RECOMBINANT HUMAN INTERLEUKIN-1 RECEPTOR ANTAGONIST IN THE TREATMENT OF PATIENTS WITH SEPSIS SYNDROME - RESULTS FROM A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL

Author

Fisher, Cj, Dhainaut, Jfa, Opal, Sm, Pribble, Jp, Balk, Ra, Slotman, Gj, Iberti, Tj, Rackow, Ec, Shapiro, Mj, Greenman, Rl, Reines, Hd, Shelly, Mp, Thompson, Bw, Labrecque, Jf, Catalano, Ma, Knaus, Wa, Sadoff, Jc, Astiz, M., Carpati, C., Bone, Rc, Freidman, B., Mure, Aj, Brathwaite, C., Shapiro, E., Melhorn, L., Taylor, R., Keegan, M., Obrien, J., Schein, R., Pena, M., Wasserlouf, M., Oropello, J., Benjamin, E., Delguidice, R., Emmanuel, G., Lie, T., Anderson, L., Marshall, J., Demajo, W., Rotstein, O., Foster, D., Abraham, E., Middleton, H., Perry, C., Levy, H., FRY, DE, Simpson, Sq, Crowell, Re, Neidhart, M., Stevens, D., Coffman, T., Narasimham, N., Merrick, Dk, Bergquist, W., Matzel, Ke, Huebler, M., Foulke, Ge, Albertson, Te, Walby, Wf, Allen, Rp, Baughman, R., Hasselgren, Po, Fink, Mp, Favorito, F., Thompson, Bt, Corbin, R., Shellhorse, Gy, Frazier, A., White, S., Garrard, C., Acourt, C., Storer, S., Gervich, Dh, Foshe, D., Brase, R., Bagdahn, A., Cooney, R., Smith, Js, Martin, Lf, Vincent, Jl, Friedman, G., Berlot, G., Fletcher, Jr, Williams, Md, Wright, Tf, Johnson, S., Feild, C., Wolf, K., Macintyre, N., Dubin, Hg, DURKIN, MR, Dubin, Pk, Staubach, Kh, Fein, Am, Schulman, Db, Niederman, Ms, Chalfin, Db, Vanleeuwen, Pam, Boermeester, Ma, Schneider, Aj, Bander, J., Imm, A., Bernard, G., Nelson, L., Stroud, M., Safcsak, K., Cerra, F., Rindal, J., Mann, H., Halpern, N., Silverstein, J., Alicea, M., Sibbald, Wj, Martin, Cm, Rutledge, Fs, Petti, K., Russell, Ja, Kruger, R., Drummond, A., Lange, P., Seifert, T., Durocher, A., Tenaillon, A., Boiteau, R., Lherm, T., Lowry, Sf, Coyle, Sm, Barie, Ps, Demaria, E., Snydman, Dr, Schwaitzberg, Sd, Nasraway, Sa, Grindlinger, J., Summer, W., Deboisblanc, B., Wahl, M., Alestig, K., Grossman, J., Maki, D., Paz, Hl, Weiner, M., Bihari, D., Campbell, D., Bleichner, G., Dahn, Ms, Lange, Mpa, Hall, J., Pohlman, A., Wenzel, Rp, Grosserode, M., Costigan, M., Mileski, W., Weigelt, J., Yeston, N., Irizarry, C., Ross, J., Robbins, J., Nightingale, P., Owen, K., Sandstedt, S., Berg, S., Simon, Gl, Seneff, Mg, Conry, Km, Zimmerman, Jl, Dellinger, Rp, Johnston, R., Allee, P., Grande, Po, Myhre, E., Dhainaut, Jf, Hamy, I., Mira, Jp, Harmon, J., White, J., Mckie, L., Silverman, H., Tuma, P., Bennett, D., Joanna Porter, Laurell, Mh, Jacobs, S., Ash, S., Stiles, Dm, Prior, Mj, Knatterud, G., Terrin, M., Kufera, J., Wilkens, P., Ra, K., Monroe, L., Sprung, C., Hamilton, Cm, Matthay, R., Mccabe, W., Tonascia, J., Wiedeman, H., Wittes, J., Campion, Gv, Croft, Cr, Lustick, R., Lookabaugh, J., Gordon, Gs, Noe, L., Bloedow, D., Smith, Cg, Brannon, D., Kush, R., Ng, D., Moore, E., Bazemore, K., Galvan, M., Wagner, D., Harrell, F., Stablein, D., and Other departments

Abstract

Objective.-To further define the safety and efficacy of recombinant human interleukin 1 receptor antagonist (rhlL-1ra) in the treatment of sepsis syndrome. Study Design.-Randomized, double-blind, placebo-controlled, multicenter, multinational clinical trial. Population.-A total of 893 patients with sepsis syndrome received an intravenous loading dose of rhIL-1ra, 100 mg, or placebo followed by a continuous 72-hour intravenous infusion of rhIL-1ra (1.0 or 2.0 mg/kg per hour) or placebo. Outcome Measure.-Twenty-eight-day all-cause mortality. Results.-There was not a significant increase in survival time for rhIL-1ra treatment compared with placebo among all patients who received the study medication (n=893; generalized Wilcoxon statistic, P=.22) or among patients with shock at study entry (n=713; generalized Wilcoxon statistic, P=.23), the two primary efficacy analyses specified a priori for this trial. Results from secondary analyses suggest an increase in survival time with rhIL-1ra treatment among patients with dysfunction of one or more organs (n=563; linear dose-response, P=.009). Retrospective analysis demonstrated an increase In survival time with rhIL-1ra treatment among patients with a predicted risk of mortality of 24% or greater (n=580; linear dose-response, P=.005) as well as among patients with both dysfunction of one or more organs and a predicted risk of mortality of 24% or greater (n=411; linear dose-response, P=.002). Conclusions.-There was not a statistically significant increase in survival time for rhIL-1ra treatment compared with placebo among all patients who received the study medication or among patients with shock at study entry. Secondary and retrospective analyses of efficacy suggest that treatment with rhIL-1ra results in a dose-related increase in survival time among patients with sepsis who have organ dysfunction and/or a predicted risk of mortality of 24% or greater

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