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581 results on '"Berkowitz S"'

3. Evaluation of the benefit of rivaroxaban on VOYAGER PAD primary composite of limb, heart and brain outcomes using the global rank and win ratio methods

Author

Bonaca, M, primary, Debus, S, additional, Nehler, M, additional, Anand, S, additional, Patel, M, additional, Pap, A F, additional, Deng, H, additional, Hodge, S, additional, Szarek, M, additional, Haskell, L, additional, Muehlhofer, E, additional, Berkowitz, S, additional, and Bauersachs, R, additional

Published
2022
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7. Boundary convection during velocity sedimentation in the Optima analytical ultracentrifuge

Author

Thomas M. Laue and Berkowitz S

Subjects
Convection, Analytical Ultracentrifugation, Sedimentation coefficient, Work (thermodynamics), Temperature control, Materials science, Density gradient, Ultracentrifuge, Sedimentation, Biological system
Abstract

Analytical ultracentrifugation (AUC) provides the most widely applicable, precise and accurate means for characterizing solution hydrodynamic and thermodynamic properties. In recent times AUC has found broad application in the biopharmaceutical industry as a first-principle means for quantitatively characterizing biopharmaceuticals. Boundary sedimentation velocity AUC (SV-AUC) analysis is widely used to assess protein aggregation, fragmentation and conformational variants in the same solvents used during drug development and production. SV-AUC is especially useful for the analysis of drug substance, drug product and dosing solution, where other techniques may exhibit solvent matrix issues or concentration limitations. Recently, the only manufacturer of the analytical ultracentrifuge, released its newest (third generation) analytical ultracentrifuge, the Optima, in early 2017 to replace its aging 2nd generation XL series ultracentrifuges. However, SV-AUC data from four Optima units used in conducting characterization work on adeno-associated virus (AAV) has shown evidence of sample convection. Further investigation reveals that this problem arises from the temperature control system design, which is prone to producing destabilizing temperature induced density gradients that can lead to density inversions. The observed convection impacts both the qualitative and quantitative data generated by the Optima. The problem is intermittent and variable in severity within a given Optima unit and between Optima units. This convection appears to be mainly associated with low rotor speeds and dilute samples in dilute solvents, such as AAV samples in formulation buffers containing relatively low concentrations of salts, sugars, etc. Under these conditions it is found that a sufficiently robust stabilizing density gradient is not always present during sedimentation, making the sample susceptible to convection by localized density inversions. Because SV-AUC is used as an analytical tool in making critical decisions in the development and quality control of biotherapeutics, it is imperative to alert users about this potential problem. In general special attention to data quality needs to be made by those researchers working with very large biopharmaceutical particles (e.g. gene therapy products that involve viral vectors or nanoparticles), where the conditions leading to convection are most likely to occur. It is important to note that the XL series analytical ultracentrifuges do not suffer from this problem, indicating that this problem is unique to the Optima. Attributes that reveal the presence of this problem and strategies for its elimination or minimization are provided.

Published
2021

14. Joint Modeling of Chest Radiographs and Radiology Reports for Pulmonary Edema Assessment

Author

Massachusetts Institute of Technology. Department of Electrical Engineering and Computer Science, Chauhan, Geeticka, Liao, Ruizhi, Wells, William, Andreas, Jacob, Wang, X, Berkowitz, S, Horng, S, Szolovits, Peter, Golland, Polina, Massachusetts Institute of Technology. Department of Electrical Engineering and Computer Science, Chauhan, Geeticka, Liao, Ruizhi, Wells, William, Andreas, Jacob, Wang, X, Berkowitz, S, Horng, S, Szolovits, Peter, and Golland, Polina

Abstract

We propose and demonstrate a novel machine learning algorithm that assesses pulmonary edema severity from chest radiographs. While large publicly available datasets of chest radiographs and free-text radiology reports exist, only limited numerical edema severity labels can be extracted from radiology reports. This is a significant challenge in learning such models for image classification. To take advantage of the rich information present in the radiology reports, we develop a neural network model that is trained on both images and free-text to assess pulmonary edema severity from chest radiographs at inference time. Our experimental results suggest that the joint image-text representation learning improves the performance of pulmonary edema assessment compared to a supervised model trained on images only. We also show the use of the text for explaining the image classification by the joint model. To the best of our knowledge, our approach is the first to leverage free-text radiology reports for improving the image model performance in this application. Our code is available at: https://github.com/RayRuizhiLiao/joint_chestxray., NIH/NIBIB/NAC (Grant P41EB015902)

Published
2021

18. Rivaroxaban Compared with Standard Anticoagulants for the Treatment of Acute Venous Thromboembolism in Children: a Randomised, Controlled, Phase 3 Trial

Author

Male, C., Lensing, A. W. A., Palumbo, J. S., Kumar, R., Nurmeev, I., Hege, K., Bonnet, D., Connor, P., Hooimeijer, H. L., Torres, M., Chan, A. K. C., Kenet, G., Holzhauer, S., Santamaría, A., Amedro, P., Chalmers, E., Simioni, P., Bhat, R. V., Yee, D. L., Lvova, O., Beyer-Westendorf, J., Biss, T. T., Martinelli, I., Saracco, P., Peters, M., Kállay, K., Gauger, C. A., Massicotte, M. P., Young, G., Pap, A. F., Majumder, M., Smith, W. T., Heubach, J. F., Berkowitz, S. D., Thelen, K., Kubitza, D., Crowther, M., Prins, M. H., Monagle, P., Molinari, A. C., Nowak, Göttl, U., Chain, J., Robertson, J., Thom, K., Streif, W., Schwarz, R., Schmitt, K., Grangl, G., Van Damme, A., Maes, P., Labarque, V., Petrilli, A., Loggeto, S., Azeka, E., Brandao, L., Le, D., Sabapathy, C., Giordano, P., Wu, R., Ding, J., Huang, W., Mao, J., Lähteenmäki, P., Decramer, S., Bernig, T., Chada, M., Chan, G., Kally, K., Nolan, B., Revel-Vilk, S., Tamary, H., Levin, C., Tormene, D., Abbattista, M., Artoni, A., Ikeyama, T., Inuzuka, R., Yasukochi, S., Morales Soto, M., Solis Labastida, K. A., Suijker, M. H., Bartels, M., Tamminga, R. Y., Van Ommen, C. H., Te Loo, D. M., Anjos, R., Zubarovskaya, L., Popova, N., Samochatova, E., Belogurova, M., Svirin, P., Shutova, T., Lebedev, V., Barbarash, O., Koh, P. L., Mei, J. C., Podracka, L., Berrueco, R., Fernandez, M. F., Frisk, T., Grunt, S., Rischewski, J., Albisetti-Pedroni, M., Antmen, A., Tokgoz, H., Karakas, Z., Motwani, J., Williams, M., Grainger, J., Payne, J., Richards, M., Baird, S., Bhatnagar, N., Aramburo, A., Crary, S., Wynn, T., Carpenter, S., Ahuja, S., Goldenberg, N., Woods, G., Godder, K., Scott-Emuakpor, A., Roach, G., Raffini, L., Shah, N., Shah, S., Thornburg, C., Zia, A., Berkow, R., Male, C., Lensing, A. W. A., Palumbo, J. S., Kumar, R., Nurmeev, I., Hege, K., Bonnet, D., Connor, P., Hooimeijer, H. L., Torres, M., Chan, A. K. C., Kenet, G., Holzhauer, S., Santamaría, A., Amedro, P., Chalmers, E., Simioni, P., Bhat, R. V., Yee, D. L., Lvova, O., Beyer-Westendorf, J., Biss, T. T., Martinelli, I., Saracco, P., Peters, M., Kállay, K., Gauger, C. A., Massicotte, M. P., Young, G., Pap, A. F., Majumder, M., Smith, W. T., Heubach, J. F., Berkowitz, S. D., Thelen, K., Kubitza, D., Crowther, M., Prins, M. H., Monagle, P., Molinari, A. C., Nowak, Göttl, U., Chain, J., Robertson, J., Thom, K., Streif, W., Schwarz, R., Schmitt, K., Grangl, G., Van Damme, A., Maes, P., Labarque, V., Petrilli, A., Loggeto, S., Azeka, E., Brandao, L., Le, D., Sabapathy, C., Giordano, P., Wu, R., Ding, J., Huang, W., Mao, J., Lähteenmäki, P., Decramer, S., Bernig, T., Chada, M., Chan, G., Kally, K., Nolan, B., Revel-Vilk, S., Tamary, H., Levin, C., Tormene, D., Abbattista, M., Artoni, A., Ikeyama, T., Inuzuka, R., Yasukochi, S., Morales Soto, M., Solis Labastida, K. A., Suijker, M. H., Bartels, M., Tamminga, R. Y., Van Ommen, C. H., Te Loo, D. M., Anjos, R., Zubarovskaya, L., Popova, N., Samochatova, E., Belogurova, M., Svirin, P., Shutova, T., Lebedev, V., Barbarash, O., Koh, P. L., Mei, J. C., Podracka, L., Berrueco, R., Fernandez, M. F., Frisk, T., Grunt, S., Rischewski, J., Albisetti-Pedroni, M., Antmen, A., Tokgoz, H., Karakas, Z., Motwani, J., Williams, M., Grainger, J., Payne, J., Richards, M., Baird, S., Bhatnagar, N., Aramburo, A., Crary, S., Wynn, T., Carpenter, S., Ahuja, S., Goldenberg, N., Woods, G., Godder, K., Scott-Emuakpor, A., Roach, G., Raffini, L., Shah, N., Shah, S., Thornburg, C., Zia, A., and Berkow, R.

Abstract

Background: Treatment of venous thromboembolism in children is based on data obtained in adults with little direct documentation of its efficacy and safety in children. The aim of our study was to compare the efficacy and safety of rivaroxaban versus standard anticoagulants in children with venous thromboembolism. Methods: In a multicentre, parallel-group, open-label, randomised study, children (aged 0–17 years) attending 107 paediatric hospitals in 28 countries with documented acute venous thromboembolism who had started heparinisation were assigned (2:1) to bodyweight-adjusted rivaroxaban (tablets or suspension) in a 20-mg equivalent dose or standard anticoagulants (heparin or switched to vitamin K antagonist). Randomisation was stratified by age and venous thromboembolism site. The main treatment period was 3 months (1 month in children <2 years of age with catheter-related venous thromboembolism). The primary efficacy outcome, symptomatic recurrent venous thromboembolism (assessed by intention-to-treat), and the principal safety outcome, major or clinically relevant non-major bleeding (assessed in participants who received ≥1 dose), were centrally assessed by investigators who were unaware of treatment assignment. Repeat imaging was obtained at the end of the main treatment period and compared with baseline imaging tests. This trial is registered with ClinicalTrials.gov, number NCT02234843 and has been completed. Findings: From Nov 14, 2014, to Sept 28, 2018, 500 (96%) of the 520 children screened for eligibility were enrolled. After a median follow-up of 91 days (IQR 87–95) in children who had a study treatment period of 3 months (n=463) and 31 days (IQR 29–35) in children who had a study treatment period of 1 month (n=37), symptomatic recurrent venous thromboembolism occurred in four (1%) of 335 children receiving rivaroxaban and five (3%) of 165 receiving standard anticoagulants (hazard ratio [HR] 0·40, 95% CI 0·11–1·41). Repeat imaging showed an improved eff

Published
2020

19. Safety and efficacy of rivaroxaban in pediatric cerebral venous thrombosis (Einstein-Jr CVT)

Author

Connor, P., van Kammen, M. S., Lensing, A. W. A., Chalmers, E., Kállay, K., Hege, K., Simioni, P., Biss, T., Bajolle, F., Bonnet, D., Grunt, S., Kumar, R., Lvova, O., Bhat, R., van Damme, A., Palumbo, J., Santamaria, A., Saracco, P., Payne, J., Baird, S., Godder, K., Labarque, V., Male, C., Martinelli, I., Soto, M. M., Motwani, J., Shah, S., Hooimeijer, H. L., Prins, M. H., Kubitza, D., Smith, W. T., Berkowitz, S. D., Pap, A. F., Majumder, M., Monagle, P., Coutinho, J. M., EINSTEIN-Jr, Cerebral, Venous, Thrombosis, trial, investigators, Connor, P., van Kammen, M. S., Lensing, A. W. A., Chalmers, E., Kállay, K., Hege, K., Simioni, P., Biss, T., Bajolle, F., Bonnet, D., Grunt, S., Kumar, R., Lvova, O., Bhat, R., van Damme, A., Palumbo, J., Santamaria, A., Saracco, P., Payne, J., Baird, S., Godder, K., Labarque, V., Male, C., Martinelli, I., Soto, M. M., Motwani, J., Shah, S., Hooimeijer, H. L., Prins, M. H., Kubitza, D., Smith, W. T., Berkowitz, S. D., Pap, A. F., Majumder, M., Monagle, P., Coutinho, J. M., and EINSTEIN-Jr, Cerebral, Venous, Thrombosis, trial, investigators

Abstract

Anticoagulant treatment of pediatric cerebral venous thrombosis has not been evaluated in randomized trials. We evaluated the safety and efficacy of rivaroxaban and standard anticoagulants in the predefined subgroup of children with cerebral venous thrombosis (CVT) who participated in the EINSTEIN-Jr trial. Children with CVT were randomized (2:1), after initial heparinization, to treatment with rivaroxaban or standard anticoagulants (continued on heparin or switched to vitamin K antagonist). The main treatment period was 3 months. The primary efficacy outcome, symptomatic recurrent venous thromboembolism (VTE), and principal safety outcome, major or clinically relevant nonmajor bleeding,were centrally evaluated by blinded investigators. Sinus recanalization on repeat brain imaging was a secondary outcome. Statistical analyses were exploratory. In total, 114 children with confirmed CVT were randomized. All children completed the follow-up. None of the 73 rivaroxaban recipients and 1 (2.4%; CVT) of the 41 standard anticoagulant recipients had symptomatic, recurrent VTE after 3 months (absolute difference, 2.4%; 95% confidence interval [CI], 22.6% to 13.5%). Clinically relevant bleeding occurred in 5 (6.8%; all nonmajor and noncerebral) rivaroxaban recipients and in 1 (2.5%; major [subdural] bleeding) standard anticoagulant recipient (absolute difference, 4.4%; 95% CI, 26.7% to 13.4%). Complete or partial sinus recanalization occurred in 18 (25%) and 39 (53%) rivaroxaban recipients and in 6 (15%) and 24 (59%) standard anticoagulant recipients, respectively. In summary, in this substudy of a randomized trial with a limited sample size, children with CVT treated with rivaroxaban or standard anticoagulation had a low risk of recurrent VTE and clinically relevant bleeding. This trial was registered at clinicaltrials.gov as #NCT02234843. © 2020 by The American Society of Hematology

Published
2020

25. Abstract No. 451 Analysis of kinematic differences in hand motion between the dominant and nondominant hand of interventional radiology trainees performing simulated radial artery access

Author

Weinstein, J., primary, El-Gabalawy, F., additional, Sarwar, A., additional, Brook, O., additional, Faintuch, S., additional, Palmer, M., additional, DeBacker, S. Schroeppel, additional, Hsu, M., additional, Berkowitz, S., additional, and Ahmed, M., additional

Published
2020
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26. 023 Risk Stratification Using CHA2DS2-VASc and CHADS2 Scores in Patients With Chronic Atherosclerotic Cardiovascular Disease Receiving Aspirin With or Without Rivaroxaban: An Analysis of the COMPASS Trial

Author

Sen, J., primary, Tonkin, A., additional, Varigos, J., additional, Fonguh, S., additional, Berkowitz, S., additional, Yusuf, S., additional, Verhamme, P., additional, Vanassche, T., additional, Anand, S., additional, Fox, K., additional, Eikelboom, J., additional, and Amerena, J., additional

Published
2020
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27. 2180Estimating individual lifetime benefit and bleeding risk of adding rivaroxaban to aspirin for patients with stable cardiovascular disease: results from the COMPASS trial

Author

De Vries, T I, primary, Eikelboom, J W, additional, Bosch, J, additional, Westerink, J, additional, Dorresteijn, J A N, additional, Alings, M, additional, Dyal, L, additional, Berkowitz, S D, additional, Van Der Graaf, Y, additional, Fox, K A A, additional, and Visseren, F L J, additional

Published
2019
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29. Rivaroxaban or aspirin for patent foramen ovale and embolic stroke of undetermined source: a prespecified subgroup analysis from the NAVIGATE ESUS trial

Author

Kasner, S. E., Swaminathan, B., Lavados, P., Sharma, M., Muir, K., Veltkamp, R., Ameriso, S. F., Endres, M., Lutsep, H., Messe, S. R., Spence, J. D., Nedeltechev, K., Perera, K., Santo, G., Olavarria, V., Lindgren, A., Bangdiwala, S., Shoamanesh, A., Berkowitz, S. D., Mundl, H., Connolly, S. J., Hart, R. G., Abdelhamid, N., Abdul Rahman, D., Abdul-Saheb, M., Abreu, P., Abroskina, M., Abu Ahmad, F., Accassat, S., Acciaresi, M., Adami, A., Ahmad, N., Ahmed, F., Alberto Hawkes, M., Alemseged, F., Ali, A., Altavilla, R., Alwis, L., Amarenco, P., Amaro, S., Amaya Sanchez, L. E., Amelia Pinto, A., Amin, H., Amino, T., Amjad, A. K., Anagnostou, E., Andersen, G., Anderson, C., Anderson, D. C., Andrea Falco, M., Andres Mackinnon, F., Andreu, D., Androulakis, M., Angel Gamero, M., Angel Saredo, G., Angeles Diaz, R., Angels Font, M., Anticoli, S., Arauz, A., Arauz Gongora, A. A., Araya, P., Arenillas Lara, J. F., Arias Rivas, S., Arnold, M., Augustin, S., Avelar, W., Azevedo, E., Babikian, V., Bacellar, A., Badalyan, K., Bae, H. J., Baez Martinez, E. M., Bagelmann, H., Bailey, P., Bak, Z., Baker, M., Balazs, A., Baldaranov, D., Balogun, I., Balueva, T., Bankuti, Z., Bar, M., Baranowska, A., Bardutzky, J., Barker Trejo, S., Barlinn, J., Baronnet, F., Barroso, C., Barteys, M., Bartolottiova, T., Barulin, A., Bas, M., Bashir, S., Basile, V., Bathe-Peters, R., Bathula, R., Batista, C., Batur Caglayan, H., Baumgartner, P., Bazan, R., Bazhenova, O., Beaudry, M., Beer, J., Behnam, Y., Beilei, C., Beinlich, A., Bejot, Y., Belkin, A., Benavente, O. R., Benjamin, A., Berardi, V., Bereczki, D., Berlingieri, J., Berrios, W., Berrouschot, J., Bhandari, M., Bhargavah, M., Bicker, H., Bicsak, T., Bilik, M., Bindila, D., Birchenall, J., Birnbaum, L., Black, T., Blacker, D., Blacquiere, D., Blanc-Labarre, C., Blank, C., Blazejewska-Hyzorek, B., Bloch, S., Bodiguel, E., Bogdanov, E., Boos, L., Borcsik, L., Bornstein, N., Bouly, S., Braga, G., Bragado, I., Bravi, M. C., Brokalaki, C., Brola, W., Brouns, R., Bruce, D., Brzoska-Mizgalska, J., Buck, B., Buksinska-Lisik, M., Burke, J., Burn, M., Bustamante, G., Cabrejo, L., Cai, K., Cajaraville, S., Calejo, M., Calvet, D., Campillo, J., Campos Costa, E., Camps, P., Can Alaydin, H., Candeloro, E., Canepa, C., Cantu Brito, C. G., Cappellari, M., Carcel, C., Cardona Portela, P., Cardoso, F., Carek, M., Carletti, M., Carlos Portilla, J., Caruso, P., Casado-Naranjo, I., Castellini, P., Castro, D., Castro Meira, F., Cavallini, A., Cayuela Caudevilla, N., Cenciarelli, S., Cereda, C., Cerrone, P., Chakrabarti, A., Chaloulos-Iakovidis, P., Chamorro, A., Chandrasena, D., Chang, D. I., Che, C., Chembala, J., Chen, J., Chen, Z., Chen, T., Chen, H., Chen, X., Chen, G., Chen, L., Chen, S., Cheripelli, B., Chin, M., Chiquete Anaya, E., Chorazy, M., Christensen, H., Christensen, T., Christian, L., Chu, F., Chung, C. S., Clark, W., Clarke, R., Claverie, S., Clemente Agostoni, E., Clissold, B., Coelho, J., Cohen, D., Colakoglu, S., Collas, D., Condurso, R., Consoli, D., Constantin, C., Constantino Silva, A. B., Contardo, L., Corlobe, A., Correia, M., Correia, C., Cortijo Garcia, E., Coull, B., Coutts, S., Coveney, S., Cras, P., Crols, R., Crozier, S., Csanyi, A., Csiba, L., Csontos, K., Csuha, R., Cui, L., Cunha, L., Curtze, S., Czerska, M., Czlonkowska, A., Czurko, M., Czuryszkiewicz, M., Dagnino, M., Dai, C., Daineko, A., Dalek, G., Damgaard, D., Danese, A., Dani, K., Danku, V., Dario Toledo, W., Davalos, A., De Havenon, A., De Keyser, J., De Klippel, N., De La Torre, J., De Pauw, A., De Smedt, A., De Torres, R., De Vries Basson, M. M., Dearborn, J., Deganutto, R., Degeorgia, M., Deguchi, I., Del Giudice, A., Delcourt, C., Delgado-Mederos, R., Della Marca, Giacomo, Delpont, B., Deltour, S., Demets, D. L., Dennis, M., Desai, J., Devine, J., Dhollander, I., Di Mascio, M. T., Diaconu, M., Diaz Otero, F., Dietzel, J., Diez-Tejedor, E., Ding, N., Ding, J., Diomedi, M., Dioszeghy, P., Distefano, M., Domigo, V., Dorodnicov, E., Dossi, D., Doubal, F., Druzenko, I., Du, P., Du, J., Duman, T., Duodu, Y., Dutta, D., Dylewicz, L., Eckstein, J., Ehrensperger, E., Ehrlich, S., Einer Allende, G., Elena Halac, B., Elyas, S., Engelbrecht, J. M., Engelter, S., Epinat, M., Eren, F., Esbjornsson, M., Escribano, B., Escudero, I., Esisi, B., Essa, B., Esterbauer, M., Evans, N., Eveson, D., Fabio, S., Fang, L., Fanta, S., Fares, M., Fatar, M., Faust, K., Favate, A., Fazekas, F., Federica Denaro, M., Fedin, A., Felipe Amaya, P., Feng, J., Ferencova, K., Fernanda Gilli, M., Fernandez, M. D., Fernandez Pirrone, P. N., Fernandez Vera, J., Ferrari, J., Ferreira, A., Ferreira Junior, G., Fidler, M., Field, D., Field, T., Figueroa, C., Fiksa, J., Filipov, A., Firstenfeld, A., Fisch, L., Fischer, U., Fisselier, M., Fiszer, U., Fluri, F., Fortea, G., Fotherby, K., Fraczek, A., France, E., Freitas, G., Frey, S., Frick, M., Friedman, A., Friedrich, M., Frisullo, G., Fryze, W., Fuentes Gimeno, B., Fujigasaki, H., Fukuyama, K., Furlan, A., Furlanis, G., Furnace, J., Gabriel, M., Gabriel Reich, E., Gagliardi, R. J., Galati, F., Galli Giqueauk, E., Gallina, A., Gallinella, E., Gallo, J., Gangadharan, S., Gao, Y., Garcia Lopez, R., Garcia Pastor, A., Garcia Sanchez, S. M., Garnauf, M., Garnier, P., Gasecki, D., Gasic, K., Gasiorek, K., Gasser, S., Gaugg, M., Gebreyohanns, M., Gebura, K., Geng, J., Geniz Clavijo, M., Georg Haeusler, K., Geran, R., Geremek, M., Gerocs, Z., Ghia, D., Giannandrea, D., Giatsidis, F., Gien Lopez, J. A., Gil Nunez, A., Gimenez, L., Giralt, E., Glabinski, A., Gladstone, D., Gliem, M., Gluszkiewicz, M., Goddeau, R., Gogoleva, E., Gokce, M., Goldemund, D., Golikov, K., Gomes Neto, A., Gomez Schneider, M., Gomez-Choco, M., Gomis, M., Gongora-Rivera, J. F., Gonysheva, Y., Gonzalez, L., Gonzalez Toledo, M. E., Gottschal, M., Gozdzik, I., Grabowski, S., Graf, S., Green, D., Greer, D., Gregorio, T., Greisenegger, S., Greshnova, I., Griebe, M., Grzesik, M., Guan, J., Guarda, S., Gueguen, A., Guidoux, C., Guillermo Povedano, P., Guillon, B., Guiraudg, V., Gunathilagan, G., Guryanova, N., Gusev, V., Gustavo Persi, G., Gutierrez, R., Guyler, P., Gyuker, N., Hachinski, V., Hajas, A., Hallevi, H., Hankey, G., Hankey, G. J., Hanouskova, L., Hao, L., Haraguchi, K., Haralur Sreekantaiah, Y., Haratz, S., Hargroves, D., Harkness, K., Harmel, P., Harrasser, M., Harvey, M., Hasan, R., Hasegawa, Y., Hassan, A., Hattori, M., Hatzitolios, A., Hauk, M., Hayashi, T., Hayhoe, H., Hedna, V. S., Heine, M., Held, V., Hellwig, S., Henkner, J., Henninger, N., Hermans, S., Hernandez, J., Herrero, D., Hervieu-Begue, M., Herzig, R., Hicken, L., Hieber, M., Hill, M., Hirose, M., Hobeanu, M. C., Hobson, B., Hochstetter, M., Hoe Heo, J., Hoffmann, M., Holmstedt, C., Hon, P., Hong, K. S., Honma, Y., Horev, A., Horgan, G., Horvath, L., Horvath, M., Hoyer, C., Huang, D., Huang, H., Huber, B., Huhtakangas, J., Hussain, M., Igarashi, S., Iglesias Mohedano, A. M., Ignacio Tembl, J., Impellizzeri, M., Inanc, Y., Ioli, P., Irina Aniculaesei, A., Ishida, K., Itabashi, R., Iversen, H., Jagolino, A., Jakab, K., Jander, S., Janka, H., Jankovych, J., Jansen, J., Jasek, L., Javier Alet, M., Javor, L., Jin, X., Jing, P., Joachim, B., Joan Macleod, M., Johnson, M., Jose Martin, J., Joyner, C., Judit Szabo, K., Jun-Oconnell, A., Jura, R., Kaczorowska, B., Kadlcikova, J., Kahles, T., Kakaletsis, N., Kakuk, I., Kalinowska, K., Kaminska, K., Kaneko, C., Kanellos, I., Kapeller, P., Kapica-Topczewska, K., Karasz, O., Karlinski, M., Karlsson, J. 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A., Gil Nunez, A., Gimenez, L., Giralt, E., Glabinski, A., Gladstone, D., Gliem, M., Gluszkiewicz, M., Goddeau, R., Gogoleva, E., Gokce, M., Goldemund, D., Golikov, K., Gomes Neto, A., Gomez Schneider, M., Gomez-Choco, M., Gomis, M., Gongora-Rivera, J. F., Gonysheva, Y., Gonzalez, L., Gonzalez Toledo, M. E., Gottschal, M., Gozdzik, I., Grabowski, S., Graf, S., Green, D., Greer, D., Gregorio, T., Greisenegger, S., Greshnova, I., Griebe, M., Grzesik, M., Guan, J., Guarda, S., Gueguen, A., Guidoux, C., Guillermo Povedano, P., Guillon, B., Guiraudg, V., Gunathilagan, G., Guryanova, N., Gusev, V., Gustavo Persi, G., Gutierrez, R., Guyler, P., Gyuker, N., Hachinski, V., Hajas, A., Hallevi, H., Hankey, G., Hankey, G. J., Hanouskova, L., Hao, L., Haraguchi, K., Haralur Sreekantaiah, Y., Haratz, S., Hargroves, D., Harkness, K., Harmel, P., Harrasser, M., Harvey, M., Hasan, R., Hasegawa, Y., Hassan, A., Hattori, M., Hatzitolios, A., Hauk, M., Hayashi, T., Hayhoe, H., Hedna, V. S., Heine, M., Held, V., Hellwig, S., Henkner, J., Henninger, N., Hermans, S., Hernandez, J., Herrero, D., Hervieu-Begue, M., Herzig, R., Hicken, L., Hieber, M., Hill, M., Hirose, M., Hobeanu, M. C., Hobson, B., Hochstetter, M., Hoe Heo, J., Hoffmann, M., Holmstedt, C., Hon, P., Hong, K. S., Honma, Y., Horev, A., Horgan, G., Horvath, L., Horvath, M., Hoyer, C., Huang, D., Huang, H., Huber, B., Huhtakangas, J., Hussain, M., Igarashi, S., Iglesias Mohedano, A. M., Ignacio Tembl, J., Impellizzeri, M., Inanc, Y., Ioli, P., Irina Aniculaesei, A., Ishida, K., Itabashi, R., Iversen, H., Jagolino, A., Jakab, K., Jander, S., Janka, H., Jankovych, J., Jansen, J., Jasek, L., Javier Alet, M., Javor, L., Jin, X., Jing, P., Joachim, B., Joan Macleod, M., Johnson, M., Jose Martin, J., Joyner, C., Judit Szabo, K., Jun-Oconnell, A., Jura, R., Kaczorowska, B., Kadlcikova, J., Kahles, T., Kakaletsis, N., Kakuk, I., Kalinowska, K., Kaminska, K., Kaneko, C., Kanellos, I., Kapeller, P., Kapica-Topczewska, K., Karasz, O., Karlinski, M., Karlsson, J. E., Kasa, K., Kashaeva, E., Kaste, M., Kasza, J., Katalin Iljicsov, A., Katsurayama, M., Kaur, S., Kawanishi, M., Kaygorodtseva, S., Ke, K., Kei, A., Keilitz, J., Kellner, J., Kelly, P., Kelly, S., Kemlink, D., Kerekgyarto, M., Keskinarkaus, I., Khairutdinova, D., Khanna, A., Khaw, A., Kholopov, M., Khoumri, C., Kirpicheva, S., Kirshner, H., Kitagawa, K., Kittner, S., Kivioja, R., Klein, F., Kleindorfer, D., Kleinig, T., Klivenyi, P., Knecht, S., Kobayashi, Y., Kobayashi, A., Koch, M., Koehler, L., Koivu, M., Kolianov, V., Koltsov, I., Kondo, T., Konkov, I., Kopecky, S., Korompoki, E., Korpela, J., Kosarz-Lanczek, K., Koutroubi, A., Kovacs, K., Kovacs, T., Kovacs, H., Kowalczyk, K., Kowalska, M., Krajickova, D., Kral, M., Krarup Hansen, C., Kraska, J., Krebs, S., Krejci, V., Kremer, C., Kreuzpointer, R., Krzyzanowska, M., Kucken, D., Kulakowska, A., Kunzmann, J., Kurenkova, N., Kuris, A., Kurkowska-Jastrzebska, I., Kurtenkova, N., Kurushina, O., Kusnick, G., Kustova, M., Kuwashiro, T., Kwan Cha, J., Lago, A., Lagutenko, M., Lajos, B., Lambeck, J., Lamy, C., Landolfi, A., Lanfranconi, S., Lang, W., Lara Lezama, L. B., Lara Rodriguez, B., Largo, T., Lasek-Bal, A., Latte, L., Lauer, V., Le Bouc, R., Leal Cantu, R., Lechner, H., Lecouturier, K., Leder, S., Lee, J., Lee, B. C., Leger, A., Leira, E., Leisse, I., Leker, R., Lembo, G., Lenskaya, L., Leyden, J., Li, G., Li, M., Li, S., Li, J., Liamis, G., Liang, H., Liang, Z., Ligot, N., Lin, H., Lindert, R., Linna, M., Litwin, T., Liu, K., Liu, X., Llull, L., Lohninger, B., Longoni, M., Loomis, C., Lopes, D., Lopez Fernandez, M., Lopez Garza, N., Lord, A., Louw, S., Lovasz, R., Lowenkopf, T., Lu, Z., Lubke-Detring, S. C., Luder, R., Lujan, S., Luo, B., Lupinogina, L., Luschin, G., Lvova, A., Ly, J., Grosse, G. M., Ma, H., Ma, C., Machado, M., Machado, C., Macher, S., Machetanz, J., Macian-Montoro, F., Mackey, E., Mackey, A., Maclean, G., Maestre-Moreno, J., Magadan, A., Magyar, T., Mahagney, A., Majid, A., Majjhoo, A., Makaritsis, K., Mandzia, J., Mangas Guijarro, M., Mangion, D., Manios, E., Mann, S., Manning, L., Manno, C., Manuel Garcia, J., Maqueda, V., Mar Castellanos, M., Mar Freijo, M., Marando, C., Marcela Lepera, S., Marcos Couto, J., Maria Bruera, G., Maria Greco, L., Maria Lorenzo, A., Maria Obmann, S., Maria Roa, A., Marini, C., Marinkovic, I., Mario Sumay, G., Mario Torres, C., Marko, M., Markova, S., Markus, H., Marsh, R., Marsili, E., Marta Esnaola, M., Marta Moreno, J., Marti-Fabregas, J., Martina Angelocola, S., Martinez Sanchez, P., Martinez-Majander, N., Martins, S., Marzelik, O., Mastrocola, S., Matamala, G., Matoltsy, A., Matosevic, B., Matsumoto, S., Maud, A., Mauri Cabdevila, G., May, Z., Mayasi, Y., Mayr, A., Mazzoli, T., Mcarthur, K., Mccullough, L., Medina Pech, C. E., Medlin, F., Mehdiratta, M., Mehta, S., Mehta, D., Mehta, B., Melis, M., Melnikova, E., Mendez, B., Mendonca, T., Mengual Chirifie, J. J., Menon, N., Mensch, A., Meseguer, E., Messe, S., Metcalf, K., Meyer, N., Michas, F., Micheletti, N., Mikulik, R., Milionis, H., Miller, B., Milling, T., Minelli, C., Minhas, J., Minns, M., Mircea, D., Mishra, S., Mismas, A., Mistri, A., Mitrovic, N., Miyake, H., Modrau, B., Moey, A., Molina, C., Molina, J., Molis, A., Moller, J., Molnar, S., Moniche, F., Monosi, C., Monzani, V., Moonis, M., Morais, R., Morales, L., Morales, A., Morar-Precup, D., Moreton, F., Moro, C., Morozova, E., Morton, M., Morvan, T., Morvan, E., Motko, T., Mowla, A., Mozhejko, E., Muddegowda, G., Mudhar, O., Mueller, T., Muhl, C., Muir, K. W., Munoz, S., Murphy, C., Murphy, S., Murtuzova, A., Musuka, T., Mutzenbach, J., Myint, M., Mysliwy, W., Naccarato, M., Naeije, G., Nagakane, Y., Natarajan, I., Navaratnam, D., Nave, A., Nazliel, B., Nedeltchev, K., Nel, J., Nell, H., Nemeth, R., Nemeth, L., Neto, O., Ng, K., Ngeh, J., Nicolas Chialvo, L., Nieminen, T., Nikkanen, M., Nikl, J., Nikoforova, M., Nishino, S., Nishiyama, Y., Njovane, X., Nogawa, S., Nombela, F., Norrving, B., Nosek, K., Nowak, B., Nowakowska-Sledz, E., Ntaios, G., Numminen, H., Nunez, F., Obadia, M., Oberndorfer, S., Obrezan, A., Ochiai, J., Oczkowski, W., O'Donnell, M. J., Odyniec, A., Oh, K., Ohira, M., Okamoto, Y., Okpala, M., Okubo, S., Olah, L., Oleszek, J., Onat Demirci, N., Ondar, V., Ongun, G., Ooyama, K., Orosz, V., Ortiz, R., Osseby, G., Osterlund-Tauriala, E., Ovesen, C., Ozcekic Demirhan, S., Ozdoba-Rot, J., Ozturk, S., Ozyurt, E., Pablo Grecco, M., Pablo Povedano, G., Paciaroni, M., Padiglioni, C., Pagola, J., Palasik, W., Panczel, G., Panos, L., Papadopoulos, G., Papadopoulou, E., Papagiannis, A., Papavasileiou, V., Papina, M., Pardo De Donlebun, J. R., Parisi, V., Park, J. M., Pasten, J., Patel, N., Pavlik, O., Pawelczyk, M., Peacock, W. F., Pei, H., Peisker, T., Pena Sedna, L. F., Penn, A., Pentek, S., Pepper, E., Pereira, L., Perez, Y., Perez, S., Perez Leguizamon, P., Pernicka, M., Perry, R., Persico, A., Pesant, Y., Peska, S., Peters, D., Peters, G., Pettigrew, L., Phan, T., Philippi, S., Phinney, T., Pico, F., Pidal, A., Piechowski-Jozwiak, B., Pieroni, A., Pineiro, S., Piras, V., Pizova, N., Polanco, J., Polin, M., Polyakov, A., Polychronopoulou, E., Polymeris, A., Popov, D., Poppe, A., Postorino, P., Pozzerese, C., Pradhan, M., Prats, L., Prazdnichkova, E., Prendl, B., Pretorius, M., Profice, P., Prokopenko, S., Pudov, E., Pujol Lereis, V., Punzo Bravo, G., Purroy, F., Qiu, J., Qu, X., Quenardelle, V., Quesada Garcia, H., Radrizzani, L., Radtke, A., Raffelsberger, T., Ramirez Moreno, J. M., Ramos-Estebanez, C., Rani, A., Rapantova, P., Rashed, K., Rasheed Nihara, A., Rasmussen, J., Redondo Robles, L., Reif, M., Reiner, P., Rekova, P., Renu, A., Repetto, M., Reyes, P., Reyes Morales, S., Rha, J. H., Ribeiro, J., Ricci, S., Richard, C., Rigual, R., Rinaldi, C., Riveira Rodriguez, C., Rizzato, B., Robinson, T. G., Rocco, A., Rodrigues, M., Rodriguez, G., Rodriguez Campello, A., Rodriguez Lucci, F., Rodriguez Yanez, M., Roesler, C., Roffe, C., Roine, R., Roine, S., Roldan, A., Romana Pezzella, F., Romano, M., Roos, J. S., Rosso, C., Rostrup Kruuse, C., Roth, Y., Roukens, R., Roveri, L., Rozanski, D., Rozniecki, J., Rozsa, C., Rudilosso, S., Ruiz Ares, G., Ruiz Franco, A., Rum, G., Ruuskanen, J., Rybinnik, I., Ryota, K., Saarinen, J., Saavedra, V., Sabben, C., Sabet, A., Sagris, D., Sahlas, J., Sakai, N., Salamanca, P., Salgado, P., Salig, S., Salletmayr, T., Salnikov, M., Samoshkina, O., Samson, Y., Sanak, D., Sanchez Ceron, M., Santalucia, P., Santamaria Cadavid, M., Santiago, P., Sanz Cuesta, B., Sargento, J., Sarraj, A., Sas, K., Sas, A., Satoshi, O., Satsoglou, S., Sattar, N., Savitz, S., Savopoulos, C., Saw, J., Sawicka, M., Sawyer, R., Scandura, T., Schillinger, N., Schindler, J., Schlachetzki, F., Schneider, I., Schuppner, R., Schurig, J., Schwarzbach, C. J., Sebejova, M., Seidel, G., Sekaran, L., Selcuk, D., Selvarajah, J., Semerano, A., Semjen, J., Semushina, D., Sen, S., Seok Park, M., Serena, J., Serhat Tokgoz, O., Serles, W., Serrano, F., Sevin, M., Seynaeve, L., Shah, S., Shamalov, N., Shang, T., Sharrief, A., Shazam Hussain, M., Shchukin, I., Shen, W., Shepeleva, E., Shinsuke, I., Shmonin, A., Shuaib, A., Shulga, A., Sibolt, G., Sibon, I., Sicilia, I., Siebert, M., Sieczkowska, E., Sila, C., Silva, A. A., Silva, D., Silva, P., Silva, Y., Silvestrini, M., Simony, Z., Simpkins, A., Singh, B., Sinha, D., Sipos, I., Skoda, O., Skowron, P., Skowronska, M., Sliwinska, B., Slonkova, J., Smolkin, A., Smyth, A., Sobolewski, P., Sobota, A., Sohn, S. I., Soldatov, M., Solganov, I., Soloveva, L., Solovyeva, E., Sonntag, N., Soors, P., Sorgun, M., Soriano, C., Spence, D., Spengos, K., Sposato, L., Staaf, G., Stadler, K., Stakhovskaya, L., Stamatelopoulos, K., Steinert, S., Stetkarova, I., Stiehm, M., Stocker, R., Stoinski, J., Stoll, A., Stotts, G., Stumpp, A., Sucapane, P., Suenaga, T., Sun, X., Sundararajan, S., Sung Kim, J., Suzuki, H., Svaneborg, N., Szasz, G., Szczuchniak, W., Szczyrba, S., Szegedi, N., Szekely, A., Szewczyk, Z., Szilagyi, G., Szlufik, S., Szoboszlai, K., Szpisjak, L., Sztajzel, R., Sztriha, L., Ta Wil, S. E., Taggeselle, J., Takamatsu, K., Takao, M., Taki, W., Takizawa, S., Talahma, M., Tamayo, A., Tan, J., Tanne, D., Tapanainen, A., Tapiola, T., Tarasiuk, J., Tatlisumak, T., Tayal, A., Tcvetkova, S., Teal, P., Tejada Garcia, J., Tejada Meza, H., Tenora, D., Terceno, M., Terentiou, A., Tezcan, S., Thaler, D., Thomson, A., Thouvenot, E., Tiainen, M., Timberg, I., Timsit, S., Tinchon, A., Tirschwell, D., Togay Isikay, C., Tokunaga, K., Tolino, M., Toloza, C., Tomelleri, G., Tomoyuki, K., Tomppo, L. M., Tong, Z., Tong, L., Toni, D., Torres, J., Tossavainen, C., Toth, G., Tountopoulou, A., Touze, E., Tovar, M., Toyoda, K., Trillo, S., Trommer, A., Tropepi, D., Tryambake, D., Tu, H., Tuetuencue, S., Tumova, R., Tumpula, O., Turc, G., Tutaj, A., Tynkkynen, J., Uchiyama, S., Uchwat, U., Uhrinyakova, L., Ulku Acar, R., Uluduz Ugurlu, D., Urra, X., Urui, S., Usero Ruiz, M., Vaclavik, D., Vahedi, K., Valikovics, A., Valpas, J., Van Acker, P., Van Daele, W., Vanderschueren, G., Vanina Jure, L., Varela, R., Varga, Z., Varvat, J., Varvyanskaya, N., Vasco Salgado, A., Vasko, P., Vass, L., Vassilopoulou, S., Vastagh, I., Vazquez, P., Vecsei, L., Venti, M., Verdugo, M., Verocai, V., Veronica Marroquin, M., Veronica Simonsini, C., Veverka, T., Vigl, M., Vila, A., Vilar, C., Villanueva Osorio, J. A., Virta, J., Vitkova, E., Voglsperger, B., Volna, J., Von Weitzel-Mudersbach, P. A., Vora, N., Voznyuk, I., Wach-Klink, A., Wacongne, A., Walters, D., Wang, Y., Wang, J., Wang, L., Wang, X., Wang, W., Wang, N., Wang, D., Wang, H., Warnack, W., Wartenberg, K., Waters, R., Waters, M., Webb, T., Weber, J., Weiss, G., Weissenborn, K., Weitz, J. I., Weller, B., Wen, G., Weng, G., Werner, P., Werring, D., Wester, P., Whiteley, W., Whiting, R., Wijeratne, T., Willems, C., Wilson, L., Wilson, C., Winder, T., Windt, J., Winkler, A., Winska-Tereszkiewicz, A., Wisniewska, A., Wittayer, M., Wlodek, A., Wojnarowska-Arendt, A., Wolf, M., Wolff, V., Wolter, C., Wong, A., Wook Nah, H., Worthmann, H., Wu, W., Wu, S., Wunderlich, S., Wurzinger, H., Wyse, D. G., Xiao, B., Xiaopeng, W., Ximenez-Carrillo, A., Xiong, L., Xiong, Y., Xiong, W., Xu, Y., Xu, J., Xu, Z., Yalo, B., Yamada, T., Yamasaki, M., Yang, L., Yang, Y., Yang, X., Yang, Q., Yang, B., Yang, J., Yasuhiro, I., Yee Lam, M., Yegappan, C., Yip, S., Ylikallio, E., Ylikotila, P., Yongwon Jin, A., Yoon, B. W., Yoshida, Y., Yperzeele, L., Yuan, H., Yuasa, H., Zalewska, J., Zanferrari, C., Zapata, E., Zboznovits, D., Zelenka, I., Zhang, C., Zhang, B., Zhang, S., Zhang, M., Zhang, X., Zhang, J., Zhao, L., Zhirnova, O., Zhou, L., Zielinska-Turek, J., Zinchenko, I., Ziomek, M., Zitzmann, A., Zweifler, R., Zwiernik, J., and Della Marca G. (ORCID:0000-0001-6914-799X)

Abstract

Background: Patent foramen ovale (PFO) is a contributor to embolic stroke of undetermined source (ESUS). Subgroup analyses from previous studies suggest that anticoagulation could reduce recurrent stroke compared with antiplatelet therapy. We hypothesised that anticoagulant treatment with rivaroxaban, an oral factor Xa inhibitor, would reduce the risk of recurrent ischaemic stroke compared with aspirin among patients with PFO enrolled in the NAVIGATE ESUS trial. Methods: NAVIGATE ESUS was a double-blinded, randomised, phase 3 trial done at 459 centres in 31 countries that assessed the efficacy and safety of rivaroxaban versus aspirin for secondary stroke prevention in patients with ESUS. For this prespecified subgroup analysis, cohorts with and without PFO were defined on the basis of transthoracic echocardiography (TTE) and transoesophageal echocardiography (TOE). The primary efficacy outcome was time to recurrent ischaemic stroke between treatment groups. The primary safety outcome was major bleeding, according to the criteria of the International Society of Thrombosis and Haemostasis. The primary analyses were based on the intention-to-treat population. Additionally, we did a systematic review and random-effects meta-analysis of studies in which patients with cryptogenic stroke and PFO were randomly assigned to receive anticoagulant or antiplatelet therapy. Findings: Between Dec 23, 2014, and Sept 20, 2017, 7213 participants were enrolled and assigned to receive rivaroxaban (n=3609) or aspirin (n=3604). Patients were followed up for a mean of 11 months because of early trial termination. PFO was reported as present in 534 (7·4%) patients on the basis of either TTE or TOE. Patients with PFO assigned to receive aspirin had a recurrent ischaemic stroke rate of 4·8 events per 100 person-years compared with 2·6 events per 100 person-years in those treated with rivaroxaban. Among patients with known PFO, there was insufficient evidence to support a difference in risk o

Published
2018

30. Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial.

Author

Martinez‐Majander, N., Ntaios, G., Liu, Y. Y., Ylikotila, P., Joensuu, H., Saarinen, J., Perera, K. S., Marti‐Fabregas, J., Chamorro, A., Rudilosso, S., Prats‐Sanchez, L., Berkowitz, S. D., Mundl, H., Themeles, E., Tiainen, M., Demchuk, A., Kasner, S. E., Hart, R. G, and Tatlisumak, T.

Subjects
STROKE patients, ASPIRIN, CANCER patients, RIVAROXABAN, SUBGROUP analysis (Experimental design)
Abstract

Background and purpose: Cancer is a frequent finding in ischaemic stroke patients. The frequency of cancer amongst participants in the NAVIGATE ESUS randomized trial and the distribution of outcome events during treatment with aspirin and rivaroxaban were investigated. Methods: Trial participation required a recent embolic stroke of undetermined source. Patients' history of cancer was recorded at the time of study entry. During a mean follow‐up of 11 months, the effects of aspirin and rivaroxaban treatment on recurrent ischaemic stroke, major bleeding and all‐cause mortality were compared between patients with cancer and patients without cancer. Results: Amongst 7213 randomized patients, 543 (7.5%) had cancer. Of all patients, 3609 were randomized to rivaroxaban [254 (7.0%) with cancer] and 3604 patients to aspirin [289 (8.0%) with cancer]. The annual rate of recurrent ischaemic stroke was 4.5% in non‐cancer patients in the rivaroxaban arm and 4.6% in the aspirin arm [hazard ratio (HR) 0.98, 95% confidence interval (CI) 0.78–1.24]. In cancer patients, the rate of recurrent ischaemic stroke was 7.7% in the rivaroxaban arm and 5.4% in the aspirin arm (HR 1.43, 95% CI 0.71–2.87). Amongst cancer patients, the annual rate of major bleeds was non‐significantly higher for rivaroxaban than aspirin (2.9% vs. 1.1%; HR 2.57, 95% CI 0.67–9.96; P for interaction 0.95). All‐cause mortality was similar in both groups. Conclusions: Our exploratory analyses show that patients with embolic stroke of undetermined source and a history of cancer had similar rates of recurrent ischaemic strokes and all‐cause mortality during aspirin and rivaroxaban treatments and that aspirin appeared safer than rivaroxaban in cancer patients regarding major bleeds. www.clinicaltrials.gov (NCT02313909). [ABSTRACT FROM AUTHOR]

Published
2020
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31. Growing Crystals with a Computer.

Author

Berkowitz, S. J. and Haase, D. G.

Abstract

Describes an open-ended computer simulation project that can be used to illustrate the growth of solid crystals in different forms at any level from high school physics to graduate physics. Discusses a simple computer program in BASIC language on an IBM personal computer. Gives examples of simulations. (CW)

Published
1987

35. Embolic strokes of undetermined source: prevalence and patient features in the esus global registry

Author

Perera, K. S., Vanassche, T., Bosch, J., Giruparajah, M., Swaminathan, B., Mattina, K. R., Berkowitz, S. D., Arauz, A., O'Donnell, M. J., Ameriso, S. F., Hankey, G. J., Yoon, B. -W., Lavallee, P., Cunha, L., Shamalov, N., Brouns, R., Gagliardi, R. J., Kasner, S. E., Pieroni, A., Vermehren, P., Kitagawa, K., Wang, Y., Muir, K., Coutinho, J., Vastagh, I., Connolly, S. J., Hart, R. G., Czeto, K., Kahn, M., Gomez Schneider, M., Pujol Lereis, V., Hawkes, M., Pertierra, L., Perera, N., De Smedt, A., Van Dyck, R., Van Hooff, R. J., Yperzeele, L., Baptista Gagliardi, V. D., Cerqueir, L. G., Yang, X., Chen, W., Amarenco, P., Guidoux, C., Ringleb, P. A., Bereczki, D., Canavan, M., Toni, D., Anzini, A., Colosimo, C., De Michele, M., Di Mascio, M. T., Durastanti, L., Falcou, A., Fausti, S., Mancini, A., Mizumo, S., Uchiyama, S., Kim, C. K., Jung, S., Kim, Y., Kim, J. A., J. Y., Jo, Barboza, M., Quiroz-Compean, A., Colin, J., Nederkoorn, P. J., Roxas, A., Perez Marianito, V., Santo, G., Silva, F., Sargento-Freitas, J., Coelho, J., Kustova, M., Meshkova, K., Williams, G., Siegler, J., Zhang, C., Gallatti, N., Kruszewski, M., Clinical sciences, Neuroprotection & Neuromodulation, ANS - Neurovascular Disorders, Neurology, ACS - Amsterdam Cardiovascular Sciences, and ESUS Global Registry Investigators

Subjects
Male, medicine.medical_specialty, Internationality, Cross-sectional study, 030204 cardiovascular system & hematology, stroke-etiology, cerebral embolism, embolism, Atrial fibrillation, Cerebral embolism, Diagnostic evaluation, Embolism, Stroke, Stroke-etiology, Brain Ischemia, 03 medical and health sciences, ischemic-stroke, 0302 clinical medicine, Risk Factors, Internal medicine, medicine, Prevalence, Humans, atrial fibrillation, Registries, cardiovascular diseases, Aged, Retrospective Studies, Medicine(all), business.industry, International survey, Retrospective cohort study, Mean age, Middle Aged, diagnostic evaluation, medicine.disease, stroke, atrial-fibrillation, Cross-Sectional Studies, Neurology, stroke—etiology, Ischemic stroke, Cardiology, cryptogenic stroke, Female, Human medicine, business, 030217 neurology & neurosurgery
Abstract

Background Recent evidence supports that most non-lacunar cryptogenic strokes are embolic. Accordingly, these strokes have been designated as embolic strokes of undetermined source (ESUS). Aims We undertook an international survey to characterize the frequency and clinical features of ESUS patients across global regions. Methods Consecutive patients hospitalized for ischemic stroke were retrospectively surveyed from 19 stroke research centers in 19 different countries to collect patients meeting criteria for ESUS. Results Of 2144 patients with recent ischemic stroke, 351 (16%, 95% CI 15% to 18%) met ESUS criteria, similar across global regions (range 16% to 21%), and an additional 308 (14%) patients had incomplete evaluation required for ESUS diagnosis. The mean age of ESUS patients (62 years; SD = 15) was significantly lower than the 1793 non-ESUS ischemic stroke patients (68 years, p ≤ 0.001). Excluding patients with atrial fibrillation ( n = 590, mean age = 75 years), the mean age of the remaining 1203 non-ESUS ischemic stroke patients was 64 years ( p = 0.02 vs. ESUS patients). Among ESUS patients, hypertension, diabetes, and prior stroke were present in 64%, 25%, and 17%, respectively. Median NIHSS score was 4 (interquartile range 2–8). At discharge, 90% of ESUS patients received antiplatelet therapy and 7% received anticoagulation. Conclusions This cross-sectional global sample of patients with recent ischemic stroke shows that one-sixth met criteria for ESUS, with additional ESUS patients likely among those with incomplete diagnostic investigation. ESUS patients were relatively young with mild strokes. Antiplatelet therapy was the standard antithrombotic therapy for secondary stroke prevention in all global regions.

Published
2016

37. Neonatal maxillary orthopedics: past to present

Author

Kuijpers-Jagtman, A.M., Prahl, C., Berkowitz, S., Berkowitz, S., Orthodontie (ORM, ACTA), and Orthodontics

Subjects
Columella, Orthodontics, medicine.medical_specialty, Treatment protocol, SDG 16 - Peace, business.industry, Normal anatomy, Infant orthopedics, SDG 16 - Peace, Justice and Strong Institutions, Dentistry, Justice and Strong Institutions, law.invention, Randomized controlled trial, Lateral cartilage, law, Bilateral cleft lip, Orthopedic surgery, medicine, business
Abstract

Neonatal maxillary orthopedics was introduced in the treatment protocol for cleft lip and palate in the 1950s of the last century. A wide range of appliances has been designed with pin-retained active appliances at one end of the spectrum and passive appliances at the other. Although neonatal maxillary orthopedics originally was instituted to restore the normal anatomy and to guide growth and development of the maxillary segments, later on, many other unproven benefits were claimed. Based on the results of a randomized clinical trial into the effects of infant orthopedics performed by means of passive plates (DUTCHCLEFT), we conclude that neonatal maxillary orthopedics in unilateral cleft lip and palate patients as performed in this trial is not necessary for feeding, mothers’ satisfaction, or orthodontic and surgical reasons. Regarding speech, a positive but very limited effect was found until the age of 2–1/2 years, but the speech of the children with clefts remained far behind that of their non-cleft peers anyway. However, it is questionable whether this limited effect is important enough to justify neonatal orthopedics. The most recent type of neonatal maxillary orthopedics is nasoalveolar molding. In NAM, nasal stents are added to the alveolar molding plate. The appliance aims to improve nasal tip projection, and septal and lower lateral cartilage position, before cleft repair. In bilateral cleft lip and palate, the nasal stents can be used to gradually lengthen the deficient columella. However, so far, NAM suffers from lack of scientific evidence for its application.

Published
2013

38. Prevalence of complications associated with use of the Henderson equine castrating instrument.

Author

Hinton, S., Schroeder, O., Aceto, H. W., Berkowitz, S., and Levine, D.

Abstract

Summary: Background: Castration is one of the most common surgical procedures performed in the horse. Complication rate and types of complications associated with use of the Henderson equine castrating instrument have not been determined. Objective: To determine the complication rate and type of complications encountered when using the Henderson equine castrating instrument in equine ambulatory practice. Study design: Retrospective case series. Methods: Medical records of horses undergoing routine castration using the Henderson drill were identified and evaluated for the occurrence of complications. The relationship between potential risk factors and complications was examined using basic descriptive statistics and quantified by means of logistic regression. Results: Of 252 horses in the study population, 27 (10.7%) developed a complication after surgery; 25 of which were nonlife‐threatening and responded to medical management. Two complications, one each of wound botulism and evisceration, resulted in euthanasia. Age at the time of castration was significantly associated with the occurrence of (P = 0.005, Wilcoxon rank sum test) complications. Compared to younger horses, the odds of having a complication were significantly greater (OR 2.99, 95% CI 1.27–7.0; P = 0.01) for horses of 4 years of age or more. Main limitations: The retrospective nature of this study. There is also a lack of direct comparison between different castration methods. Conclusions: The Henderson equine castrating instrument is an acceptable alternative to traditional emasculators. Its use is associated with a low rate of complications (8.3%) in young horses (≤3 years of age) compared to older horses (21.3%) and a very low rate of serious complications (0.8%) in all ages of horses. [ABSTRACT FROM AUTHOR]

Published
2019
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39. Supercurrent distributions and flux penetration in YBa2Cu3O7-YBa2Co0.15Cu2.85O7-YBa2Cu3O7 edge...

Author

Gausepohl, S.C., Lee, Mark, Berkowitz, S. J., and Mallison, W. H.

Subjects
JOSEPHSON junctions
Abstract

Focuses on the measurement and analysis of critical current modulation and microwave response in magnetic field for a set of YBa2Cu3O7-YBa2Co0.15Cu2.85O7-YBa2Cu3O7 ramp-edge Josephson junctions. Contribution from edge supercurrents; Addition of a superconducting ground plane; Modeling of the current flow and field response.

Published
1997
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40. Theory of operation of high temperature Josephson fluxon-antifluxon transistor.

Author

Terzioglu, Esin, Beasley, M. R., Zhang, Y. M., and Berkowitz, S. J.

Subjects
JOSEPHSON junctions, TRANSISTORS, PENDULUMS
Abstract

Describes qualitative models for the operation of Josephson fluxon-antifluxon transistor based on the pendulum model and image currents induced in the junction. Background on the qualitative models; Numerical modeling of the models; Conclusion.

Published
1996
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41. Epitaxial growth and characterization of zinc-blende gallium nitride on (001) silicon.

Author

Lei, T., Moustakas, T. D., Graham, R. J., He, Y., and Berkowitz, S. J.

Subjects
EPITAXY, GALLIUM nitride, MOLECULAR beam epitaxy, CYCLOTRON resonance
Abstract

Presents information on a study which discussed the epitaxial growth of gallium nitride (GaN) films onto silicon by electron cyclotron resonance microwave-plasma-assisted molecular-beam epitaxy. Structure and microstructure of the films; Film growth; Surface morphology and cross-sectional view of a Β-GaN film on a p-type silicon substrate; Investigation of near-band-gap absorption by transmission measurement.

Published
1992
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42. An Introduction to Structural Analysis : The Network Approach to Social Research

Author

Berkowitz, S. D. and Berkowitz, S. D.

Subjects
Social sciences--Network analysis
Abstract

An Introduction to Structural Analysis: The Network Approach to Social Research discusses the fundamental concept of structural analysis. The book is comprised of five chapters that tackle the key concepts, central intellectual themes, and principal methodological techniques of structural analysis. Chapter 1 reviews structural analysis, while Chapter 2 discusses the structure of interpersonal communication. Chapter 3 deals with economic structure and elite integration. The book also covers structural models of large-scale processes. The future of structural analysis is also discussed. The text will be useful to scientists, such as sociologists, psychologists, and anthropologists who wish to utilize structural analysis in a research study.

Published
2013

43. Oral rivaroxaban for symptomatic venous thromboembolism

Author

Bauersachs, R, Berkowitz, SD, Brenner, B, Buller, HR, Decousus, H, Gallus, AS, Lensing, AW, Misselwitz, F, Prins, MH, Raskob, GE, Segers, A, Verhamme, P, Wells, P, Agnelli, G, Bounameaux, H, Cohen, A, Davidson, BL, Piovella, F, Schellong, S, Berkowitz, S, Büller, H, Gallus, A, Lensing, A, Peters, G, Prins, M, Raskob, G, et, al, DI MINNO, GIOVANNI, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Department of Epidemiology (MHP), Maastricht University [Maastricht], Service d'angiologie et d'hémostase (MR), Hôpital Universitaire de Genève, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM), Tewes, Mitra (Beitragende*r), Bauersachs, R, Berkowitz, Sd, Brenner, B, Buller, Hr, Decousus, H, Gallus, A, Lensing, Aw, Misselwitz, F, Prins, Mh, Raskob, Ge, Segers, A, Verhamme, P, Wells, P, Agnelli, G, Bounameaux, H, Cohen, A, Davidson, Bl, Piovella, F, Schellong, S, Berkowitz, S, Büller, H, Lensing, A, Peters, G, Prins, M, Raskob, G, DI MINNO, Giovanni, Et, Al, ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Epidemiologie, MUMC+: KIO Kemta (9), and RS: CAPHRI School for Public Health and Primary Care

Subjects
MESH: Pulmonary Embolism, MESH: Enoxaparin, medicine.drug_class, MESH: Factor Xa, Medizin, MESH: Morpholines, 030204 cardiovascular system & hematology, MESH: Anticoagulants, MESH: Intention to Treat Analysis, MESH: Venous Thromboembolism, 03 medical and health sciences, chemistry.chemical_compound, 0302 clinical medicine, Edoxaban, medicine, MESH: Double-Blind Method, 030212 general & internal medicine, MESH: Warfarin, MESH: Kaplan-Meier Estimate, MESH: Aged, Rivaroxaban, Acenocoumarol, MESH: Humans, MESH: Middle Aged, business.industry, Warfarin, MESH: Injections, Subcutaneous, MESH: Vitamin K, General Medicine, Vitamin K antagonist, MESH: Thiophenes, medicine.disease, MESH: Male, 3. Good health, Venous thrombosis, chemistry, Anesthesia, MESH: Administration, Oral, MESH: Venous Thrombosis, MESH: Acute Disease, Apixaban, MESH: Acenocoumarol, business, MESH: Female, MESH: Hemorrhage, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, medicine.drug, Andexanet alfa
Abstract

Background: Rivaroxaban, an oral factor Xa inhibitor, may provide a simple, fixed-dose regimen for treating acute deep-vein thrombosis (DVT) and for continued treatment, without the need for laboratory monitoring. Methods: We conducted an open-label, randomized, event-driven, noninferiority study that compared oral rivaroxaban alone (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with subcutaneous enoxaparin followed by a vitamin K antagonist (either warfarin or acenocoumarol) for 3, 6, or 12 months in patients with acute, symptomatic DVT. In parallel, we carried out a double-blind, randomized, event-driven superiority study that compared rivaroxaban alone (20 mg once daily) with placebo for an additional 6 or 12 months in patients who had completed 6 to 12 months of treatment for venous thromboembolism. The primary efficacy outcome for both studies was recurrent venous thromboembolism. The principal safety outcome was major bleeding or clinically relevant nonmajor bleeding in the initial-treatment study and major bleeding in the continued-treatment study. Results: The study of rivaroxaban for acute DVT included 3449 patients: 1731 given rivaroxaban and 1718 given enoxaparin plus a vitamin K antagonist. Rivaroxaban had noninferior efficacy with respect to the primary outcome (36 events [2.1%], vs. 51 events with enoxaparin-vitamin K antagonist [3.0%]; hazard ratio, 0.68; 95% confidence interval [CI], 0.44 to 1.04; P

Published
2010

46. Current land bird distribution and trends in population abundance between 1982 and 2012 on Rota, Mariana Islands

Author

Camp, Richard J., Brink, Kevin W., Gorreson, P. Marcos, Amidon, Fred A., Radley, Paul, Berkowitz, S. Paul, Banko, Paul C., Camp, Richard J., Brink, Kevin W., Gorreson, P. Marcos, Amidon, Fred A., Radley, Paul, Berkowitz, S. Paul, and Banko, Paul C.

Abstract

The western Pacific island of Rota is the fourth largest human-inhabited island in the Mariana archipelago and designated an Endemic Bird Area. Between 1982 and 2012, 12 point-transect distance-sampling surveys were conducted to assess bird population status. Surveys did not consistently sample the entire island; thus, we used a ratio estimator to estimate bird abundances in strata not sampled during every survey. Trends in population size were reliably estimated for 11 of 13 bird species, and 7 species declined over the 30-y time series, including the island collared-dove Streptopelia bitorquata, white-throated ground-dove Gallicolumba xanthonura, Mariana fruit-dove Ptilinopus roseicapilla, collared kingfisher Todiramphus chloris orii, Micronesian myzomela Myzomela rubratra, black drongo Dicrurus macrocercus, and Mariana crow Corvus kubaryi. The endangered Mariana crow (x̄ = 81 birds, 95% CI 30–202) declined sharply to fewer than 200 individuals in 2012, down from 1,491 birds in 1982 (95% CI = 815–3,115). Trends increased for white tern Gygis alba, rufous fantail Rhipidura rufifrons mariae, and Micronesian starling Aplonis opaca. Numbers of the endangered Rota white-eye Zosterops rotensis declined from 1982 to the late 1990s but returned to 1980s levels by 2012, resulting in an overall stable trend. Trends for the yellow bittern Ixobrychus sinensis were inconclusive. Eurasian tree sparrow Passer montanus trends were not assessed; however, their numbers in 1982 and 2012 were similar. Occupancy models of the 2012 survey data revealed general patterns of land cover use and detectability among 12 species that could be reliably modeled. Occupancy was not assessed for the Eurasian tree sparrow because of insufficient detections. Based on the 2012 survey, bird distribution and abundance across Rota revealed three general patterns: 1) range restriction, including Mariana crow, Rota white-eye, and Eurasian tree sparrow; 2) widespread distribution, low abundance, includi

Published
2015

47. Cause of death and predictors of all-cause mortality in anticoagulated patients with nonvalvular atrial fibrillation: Data from ROCKET AF

Author

Pokorney, S, Piccini, J, Stevens, S, Patel, M, Pieper, K, Halperin, J, Breithardt, G, Singer, D, Hankey, G, Hacke, W, Becker, R, Berkowitz, S, Nessel, C, Mahaffey, K, Fox, K, Califf, R, Parati, G, PARATI, GIANFRANCO, Pokorney, S, Piccini, J, Stevens, S, Patel, M, Pieper, K, Halperin, J, Breithardt, G, Singer, D, Hankey, G, Hacke, W, Becker, R, Berkowitz, S, Nessel, C, Mahaffey, K, Fox, K, Califf, R, Parati, G, and PARATI, GIANFRANCO

Abstract

Background-Atrial fibrillation is associated with higher mortality. Identification of causes of death and contemporary risk factors for all-cause mortality may guide interventions. Methods and Results-In the Rivaroxaban Once Daily Oral Direct Factor Xa Inhibition Compared with Vitamin K Antagonism for Prevention of Stroke and Embolism Trial in Atrial Fibrillation (ROCKET AF) study, patients with nonvalvular atrial fibrillation were randomized to rivaroxaban or dose-adjusted warfarin. Cox proportional hazards regression with backward elimination identified factors at randomization that were independently associated with all-cause mortality in the 14 171 participants in the intentionto- treat population. The median age was 73 years, and the mean CHADS2 score was 3.5. Over 1.9 years of median follow-up, 1214 (8.6%) patients died. Kaplan-Meier mortality rates were 4.2% at 1 year and 8.9% at 2 years. The majority of classified deaths (1081) were cardiovascular (72%), whereas only 6% were nonhemorrhagic stroke or systemic embolism. No significant difference in all-cause mortality was observed between the rivaroxaban and warfarin arms (P=0.15). Heart failure (hazard ratio 1.51, 95% CI 1.33-1.70, P<0.0001) and age ≥75 years (hazard ratio 1.69, 95% CI 1.51-1.90, P<0.0001) were associated with higher all-cause mortality. Multiple additional characteristics were independently associated with higher mortality, with decreasing creatinine clearance, chronic obstructive pulmonary disease, male sex, peripheral vascular disease, and diabetes being among the most strongly associated (model C-index 0.677). Conclusions-In a large population of patients anticoagulated for nonvalvular atrial fibrillation, ≈7 in 10 deaths were cardiovascular, whereas <1 in 10 deaths were caused by nonhemorrhagic stroke or systemic embolism. Optimal prevention and treatment of heart failure, renal impairment, chronic obstructive pulmonary disease, and diabetes may improve survival.

Published
2015

49. Oral Rivaroxaban for the Treatment of Symptomatic Pulmonary Embolism

Author

Agnelli, G, Berkowitz, S, Bounameaux, H, Büller, Hr, Cohen, A, Gallus, A, Lensing, Aw, Misselwitz, F, Haskell, L, Prins, Mh, Raskob, G, Schellong, S, Bauersachs, R, van Bellen, B, Boda, Z, Borris, L, Brenner, B, Brighton, T, Chlumsky, J, Davidson, B, Decousus, H, Eriksson, H, Jacobson, B, Kakkar, A, Kwong, Yl, Lee, Lh, Meijer, K, van der Meer, J, Minar, E, Monreal, M, Piovella, F, Sandset, Pm, Smith, M, Tomkowski, W, Verhamme, P, Wang, Y, Wells, P, Brandjes, D, Mac Gillavry, M, Otten, Hm, Carlsson, A, Laporte, S, Schulman, S, Gent, M, Turpie, A, Martinelli, I, Segers, A, Muhlhofer, E, Tewes, M, Trajanovic, M, Muller, K, Kim, C, Gebel, M, Benson, A, Pap, Af, Godrie, J, Horvat Broecker, A, Spadari, G, Peters Wulf, C, Roig, J, Baker, R, Bianchi, A, Blombery, P, Campbell, P, Carroll, P, Geraghty, R, Chong, B, Ramanathan, S, Archis, C, Coughlin, P, Salem, H, Crispin, P, Dean, M, Soni, R, Denaro, C, Kubler, P, Coghlan, D, Gan, Te, Tran, H, Coleman, C, Jackson, D, Khalafallah, A, Leahy, M, Leyden, M, Leyden, D, Sturtz, C, Mccann, A, Gibbs, H, Mcrae, S, Richards, B, Ward, C, Curnow, J, Baghestanian, M, Erdogmus, B, Samaha, E, Nikoupayan Mofrad, M, Hirschl, M, Sturm, W, Kirchmair, R, Marschang, P, Drexel, H, Mathies, R, Pilger, E, Brodmann, M, Weltermann, A, Buche, M, Demelenne, J, Gustin, M, Hainaut, P, Pothen, L, de Leersnyder, J, Motte, S, Schroë, H, Sprynger, M, Peerlinck, K, Delcroix, M, Vermassen, F, Verstraeten, P, Smet, V, Vossaert, R, Panico, M, Costa, C, Blondal, J, Kovacs, M, Rodger, M, Carrier, M, Wong, T, Bi, J, Chen, Z, Chen, R, Jing, Zc, He, J, Liu, C, Liu, S, Long, S, Ma, Y, Shao, Y, Wang, C, Yang, Yh, Xie, C, Xu, J, Ying, K, Zhihong, L, Hola, D, Jirat, S, Vitovec, M, Kovářová, K, Gilík, J, Dosál, J, Mandakova, E, Matoška, P, Podpera, I, Podperova, M, Spacek, R, Urbanova, R, Tuxen, C, Sukles, K, Pietila, K, Vesanen, M, Achkar, A, Agraou, B, Aquilanti, S, Rifaï, A, Berremili, T, Brisot, D, Brousse, C, Tarodo, P, Bura, A, Amid Lacombe, C, Malloizel, J, Boulon, C, Alavoine, L, Crestani, B, Mismetti, P, Buchmuller, A, Accassat, S, Elias, A, Elias, M, Emmerich, J, Ferrari, E, Guérin, T, Beaka, P, Lacroix, P, Szwebel, Ta, Benhamou, Y, de Maistre, E, Falvo, N, Mahe, I, Meneveau, N, Schiele, F, Meyer, G, Sanchez, O, Planquette, B, Mottier, D, Le Moigne, E, Couturaud, F, Parent, F, Pernod, G, Imbert, B, Elkouri, D, Dary, M, Queguiner, A, Quere, I, Galanaud, Jp, Roy, Pm, de Boisjolly Bonnefoi JM, Schmidt, J, Breuil, N, Heuser, S, Sevestre, Ma, Simoneau, G, Bergmann, Jf, Stephan, D, Trinh Duc, A, Gaillardou, A, Grange, C, Fassier, T, Wahl, D, Baron Von Bilderling, P, Kuhlencordt, P, Beyer Westendorf, J, Halbritter, K, Werth, S, Diehm, C, Lawall, H, Eifrig, B, Espinola Klein, C, Weisser, G, Giannitsis, E, Haering, Hu, Hasslacher, C, Herrmann, T, Hoffmann, U, Czihal, M, Horacek, T, Ibe, M, Bauer, A, Kieback, A, Landgraf, H, Lindhoff Last, E, Malyar, N, Petermann, W, Potratz, J, Ranft, J, Röcken, M, Pomper, L, Frommhold, R, Schwaiblmair, M, Berghaus, T, Taute, B, Lau, Yk, Tse, E, Olah, Z, Farkas, K, Kolossváry, E, Gurzó, M, Kis, E, Kovács, A, Landi, A, Lupkovics, G, Pecsvarady, Z, Riba, M, Sipos, G, Parakh, R, Sembiring, R, Barton, J, Goldstein, L, Gavish, D, Hoffman, R, Hussein, O, Inbal, A, Lishner, M, Elis, A, Lugassy, G, Varon, D, Zeltser, D, Rogowski, O, Steinvil, A, Zisman, D, Ageno, W, Ambrosio, G, Cattaneo, M, D'Angelo, A, Ghirarduzzi, A, Lotti, M, Pierfranceschi, Mg, Lodigiani, C, Palareti, G, Barone, M, Beltrametti, C, Porreca, E, Prandoni, Paolo, Spiezia, L, Quintavalla, R, Cho, Wh, Ha, Jw, Kim, Hs, Park, K, Sime, I, Miliauskas, S, Petrauskiene, R, Sathar, J, Beeker, A, Ten Cate, H, De Groot, M, Kamphuisen, P, Douma, R, Kooy, Mv, Coenen, J, Mäkelburg, A, Knol, M, Tichelaar, V, Harper, P, Knottenbelt, E, Ockelford, P, Young, L, Royle, G, Simpson, D, Chunilal, S, Ghanima, W, Foyn, S, Tveit, A, Abola, Mt, Adamiec, R, Gorski, P, Kloczko, J, Lewczuk, J, Nowak, M, Musial, J, Wronski, J, Ng, Hj, Adler, D, Becker, Jh, Ellis, G, Isaacs, R, Bloy, B, Allie, R, Eckstein, F, van Rensburg JH, Schmidt, S, Siebert, H, Zyl, L, Carrera, M, Del Campo, F, Diego, I, Garcia Bragado, F, Jiménez, D, Sánchez Álvarez, J, Redondo, M, Roman Sanchez, P, Villalta, J, Villegas Scivetti, M, Jonson, T, Tygesen, H, Lapidus, L, Ottosson, E, Själander, A, Asmis, L, Banyai, M, Heidemann, M, Baumgartner, I, Righini, M, Frank, U, Hayoz, D, Periard, D, Chang, Wt, Chiu, K, Wang, Ky, Weng, Zc, Angchaisuksiri, P, Pothirat, C, Rojnuckarin, P, Solis, J, Hunt, B, Luckit, J, Albrecht, C, Banish, D, Feinbloom, D, Botnick, W, Chen, D, Dexter, J, Ettinger, N, Gleeson, J, Jaffer, A, Joseph, S, Kennedy, M, Krell, K, Lavender, R, Lyons, R, Moll, S, Nadar, V, Darrow, K, Hardman, V, Rathbun, S, Rehm, J, Rodriguez Cintron, W, Stevens, K, Wright, P, Ramaswamy, M., ACS - Amsterdam Cardiovascular Sciences, Vascular Medicine, Other departments, Epidemiologie, MUMC+: KIO Kemta (9), RS: CAPHRI School for Public Health and Primary Care, Department of Vascular Medicine (DVM - AMC), Academic Medical Center - Academisch Medisch Centrum [Amsterdam] (AMC), University of Amsterdam [Amsterdam] (UvA)-University of Amsterdam [Amsterdam] (UvA), Department of Epidemiology (MHP), Maastricht University [Maastricht], Groupe de recherche sur la thrombose (GRT (EA 3065)), Université Jean Monnet [Saint-Étienne] (UJM), Service d'angiologie et d'hémostase (MR), Hôpital Universitaire de Genève, Groupe d'Etude de la Thrombose de Bretagne Occidentale (GETBO), Université de Brest (UBO)-Institut Brestois Santé Agro Matière (IBSAM), Université de Brest (UBO)-Université de Brest (UBO), Centre d'Investigation Clinique (CIC - Brest), and Université de Brest (UBO)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
MESH: Pulmonary Embolism, Male, Vitamin K, Administration, Oral, Pulmonary Embolism/drug therapy/mortality, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, chemistry.chemical_compound, 0302 clinical medicine, Rivaroxaban, Edoxaban, Recurrence, Hemorrhage/chemically induced, 030212 general & internal medicine, Vitamin K/antagonists & inhibitors, Enoxaparin/adverse effects/therapeutic use, MESH: Treatment Outcome, MESH: Aged, ddc:616, MESH: Middle Aged, Hazard ratio, General Medicine, MESH: Follow-Up Studies, Vitamin K antagonist, MESH: Thiophenes, Middle Aged, Thrombosis, Morpholines/adverse effects/therapeutic use, 3. Good health, Pulmonary embolism, MESH: International Normalized Ratio, Treatment Outcome, Anesthesia, MESH: Administration, Oral, Administration, Combination, Apixaban, Drug Therapy, Combination, Female, MESH: Hemorrhage, medicine.drug, Oral, MESH: Enoxaparin, medicine.drug_class, Morpholines, Anticoagulants/adverse effects/therapeutic use, MESH: Morpholines, Hemorrhage, Thiophenes, MESH: Anticoagulants, 03 medical and health sciences, Drug Therapy, medicine, Humans, International Normalized Ratio, Enoxaparin, MESH: Kaplan-Meier Estimate, Aged, MESH: Humans, business.industry, MESH: Vitamin K, Anticoagulants, medicine.disease, MESH: Male, MESH: Recurrence, Regimen, MESH: Drug Therapy, Combination, chemistry, Thiophenes/adverse effects/therapeutic use, business, Pulmonary Embolism, MESH: Female, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology, Follow-Up Studies
Abstract

International audience; BACKGROUND: A fixed-dose regimen of rivaroxaban, an oral factor Xa inhibitor, has been shown to be as effective as standard anticoagulant therapy for the treatment of deep-vein thrombosis, without the need for laboratory monitoring. This approach may also simplify the treatment of pulmonary embolism. METHODS: In a randomized, open-label, event-driven, noninferiority trial involving 4832 patients who had acute symptomatic pulmonary embolism with or without deep-vein thrombosis, we compared rivaroxaban (15 mg twice daily for 3 weeks, followed by 20 mg once daily) with standard therapy with enoxaparin followed by an adjusted-dose vitamin K antagonist for 3, 6, or 12 months. The primary efficacy outcome was symptomatic recurrent venous thromboembolism. The principal safety outcome was major or clinically relevant nonmajor bleeding. RESULTS: Rivaroxaban was noninferior to standard therapy (noninferiority margin, 2.0; P=0.003) for the primary efficacy outcome, with 50 events in the rivaroxaban group (2.1%) versus 44 events in the standard-therapy group (1.8%) (hazard ratio, 1.12; 95% confidence interval [CI], 0.75 to 1.68). The principal safety outcome occurred in 10.3% of patients in the rivaroxaban group and 11.4% of those in the standard-therapy group (hazard ratio, 0.90; 95% CI, 0.76 to 1.07; P=0.23). Major bleeding was observed in 26 patients (1.1%) in the rivaroxaban group and 52 patients (2.2%) in the standard-therapy group (hazard ratio, 0.49; 95% CI, 0.31 to 0.79; P=0.003). Rates of other adverse events were similar in the two groups. CONCLUSIONS: A fixed-dose regimen of rivaroxaban alone was noninferior to standard therapy for the initial and long-term treatment of pulmonary embolism and had a potentially improved benefit-risk profile. (Funded by Bayer HealthCare and Janssen Pharmaceuticals; EINSTEIN-PE ClinicalTrials.gov number, NCT00439777.).

Published
2012

50. The Monobloc Frontofacial Advancement

Author

Berkowitz S, Wolfe Sa, Morrison G, and Page Lk

Subjects
medicine.medical_specialty, Osteosynthesis, Monobloc, Frontofacial advancement, business.industry, Crouzon disease, Anterior cranial, Apert syndrome, medicine.disease, Surgery, Age groups, medicine, Airway, business
Abstract

The results of 32 patients who underwent transcranial monobloc frontofacial advancement by the senior author (Wolfe) are examined. Fifteen of the patients were Crouzon's, and 17 were Apert's, 14 of whom also underwent simultaneous facial bipartition. The ages ranged from 7 months to 14 years. Although a transcranial facial advancement carries with it substantial risks, with careful consideration of airway control, the anterior cranial base dura, and the retrofrontal dead space, the procedure is recommended for carefully selected patients. The indications and contraindications for the procedure in various age groups are given

Published
1993

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