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1. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Peh, C. Au, Chakera, A., Cooper, B., Kurtkoti, J., Langguth, D., Levidiotis, V., Luxton, G., Mount, P., Mudge, D., Noble, E., Phoon, R., Ranganathan, D., Ritchie, A., Ryan, J., Suranyi, M., Rosenkranz, A., Lhotta, K., Kronbichler, A., Demoulin, N., Bovy, C., Hellemans, R., Hougardy, J., Sprangers, B., Wissing, K., Pagnoux, C., Barbour, S., Brachemi, S., Cournoyer, S., Girard, L., Laurin, L., Liang, P., Philibert, D., Walsh, M., Tesar, V., Becvar, R., Horak, P., Rychlik, I., Szpirt, W., Dieperink, H., Gregersen, J., Ivarsen, P., Krarup, E., Lyngsoe, C., Rigothier, C., Augusto, J., Belot, A., Chauveau, D., Cornec, D., Jourde-Chiche, N., Ficheux, M., Karras, A., Klein, A., Maurier, F., Mesbah, R., Moranne, O., Neel, A., Quemeneur, T., Saadoun, D., Terrier, B., Zaoui, P., Schaier, M., Benck, U., Bergner, R., Busch, M., Floege, J., Grundmann, F., Haller, H., Haubitz, M., Hellmich, B., Henes, J., Hohenstein, B., Hugo, C., Iking-Konert, C., Arndt, F., Kubacki, T., Kotter, I., Lamprecht, P., Lindner, T., Halbritter, J., Mehling, H., Schönermarck, U., Venhoff, N., Vielhauer, V., Witzke, O., Szombati, I., Szucs, G., Garibotto, G., Alberici, F., Brunetta, E., Dagna, L., De Vita, S., Emmi, G., Gabrielli, A., Manenti, L., Pieruzzi, F., Roccatello, D., Salvarani, C., Dobashi, H., Atsumi, T., Fujimoto, S., Hagino, N., Ihata, A., Kaname, S., Kaneko, Y., Katagiri, A., Katayama, M., Kirino, Y., Kitagawa, K., Komatsuda, A., Kono, H., Kurasawa, T., Matsumura, R., Mimura, T., Morinobu, A., Murakawa, Y., Naniwa, T., Nanki, T., Ogawa, N., Oshima, H., Sada, K., Sugiyama, E., Takeuchi, T., Taki, H., Tamura, N., Tsukamoto, T., Yamagata, K., Yamamura, M., van Daele, P., Rutgers, A., Teng, Y., Walker, R., Chua, I., Collins, M., Rabindranath, K., de Zoysa, J., Svensson, M., Grevbo, B., Kalstad, S., Little, M., Clarkson, M., Molloy, E., Pamplona, I. Agraz, Anton, J., Lucia, V. Barrio, Ciggaran, S., Cid, M. Cinta, Encarnacion, M. Diaz, Oliveras, X. Fulladosa, Soler, M. Jose, Rusinol, H. Marco, Praga, M., Porras, L. Quintana, Segarra, A., Bruchfeld, A., Segelmark, M., Soveri, I., Thomaidi, E., Westman, K., Neumann, T., Burnier, M., Daikeler, T., Dudler, J., Hauser, T., Seeger, H., Vogt, B., Jayne, D., Burton, J., Al Jayyousi, R., Amin, T., Andrews, J., Baines, L., Brogan, P., Dasgupta, B., Doulton, T., Flossmann, O., Griffin, S., Harper, J., Harper, L., Kidder, D., Klocke, R., Lanyon, P., Luqmani, R., McLaren, J., Makanjuola, D., McCann, L., Nandagudi, A., Selvan, S., O'Riordan, E., Patel, M., Patel, R., Pusey, C., Rajakariar, R., Robson, J., Robson, M., Salama, A., Smyth, L., Sznajd, J., Taylor, J., Merkel, P., Sreih, A., Belilos, E., Bomback, A., Carlin, J., Chen Lin, Y. Chang, Derebail, V., Dragoi, S., Dua, A., Forbess, L., Geetha, D., Gipson, P., Gohh, R., Greenwood, G.T., Hugenberg, S., Jimenez, R., Kaskas, M., Kermani, T., Kivitz, A., Koening, C., Langford, C., Marder, G., Mohamed, A., Monach, P., Neyra, N., Niemer, G., Niles, J., Obi, R., Owens, C., Parks, D., Podoll, A., Rovin, B., Sam, R., Shergy, W., Silva, A., Specks, U., Spiera, R., Springer, J., Striebich, C., Swarup, A., Thakar, S., Tiliakos, A., Tsai, Y., Waguespack, D., Wasko, M. Chester, Cortazar, Frank B., Niles, John L., Jayne, David R.W., Merkel, Peter A., Bruchfeld, Annette, Yue, Huibin, Schall, Thomas J., and Bekker, Pirow

Published
2023
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2. The role of regional organisations in international copyright law

Author

Correa Carranza, Laurin L.-L.

Subjects
340
Abstract

This research will examine the role which regional organizations play for the implementation of the international copyright protection framework in their member states. This is done in order to gain an increased understanding of the impact that international and regional agreements have on national copyright legislation and its enforcement through national and regional courts. The issue of how copyright balance is reflected and implemented in these legal structures is of central importance to this research, since regional or national preferences can influence in which manner the creator’s or the user’s interests are represented in law. The theoretic concepts of constitutionalization (particularly in terms of institutionalization), embedded liberalism (as providing a theoretical link between social concerns and trade liberalization) as well as proportionality (in representation of the rights balancing done by courts) will be utilised in this research. The interconnected legal relationship of copyright will be examined utilizing the case studies of the European Union and the UK as well as the example of the Andean Community and Ecuador. In order to have an increased understanding of the difference in terms of implementation between being part of a regional union and not being a member state of such, the situation in Chile will also be part of this research and the comparative analysis. Chile is a case study which, through comparison with the legal and institutional framework of regional organizations, illustrates the situation of a country which is not part of a regional organization and entered into independent bilateral treaty obligations instead. These countries provide also a basis for considering the differences in preferences between developed and developing countries in the context of international and regional copyright protection. This can bridge the current gap in understanding of the particular effect that international and regional copyright legislation has on such countries. The conclusions and research findings of this research provide an insight into the importance that regional organizations have in shaping the legal framework of their members in accordance with a set of preferences in regards to copyright interests.

Published
2015
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3. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, Wasko, M, Cortazar F. B., Niles J. L., Jayne D. R. W., Merkel P. A., Bruchfeld A., Yue H., Schall T. J., Bekker P., Peh C. A., Chakera A., Cooper B., Kurtkoti J., Langguth D., Levidiotis V., Luxton G., Mount P., Mudge D., Noble E., Phoon R., Ranganathan D., Ritchie A., Ryan J., Suranyi M., Rosenkranz A., Lhotta K., Kronbichler A., Demoulin N., Bovy C., Hellemans R., Hougardy J., Sprangers B., Wissing K., Pagnoux C., Barbour S., Brachemi S., Cournoyer S., Girard L., Laurin L., Liang P., Philibert D., Walsh M., Tesar V., Becvar R., Horak P., Rychlik I., Szpirt W., Dieperink H., Gregersen J., Ivarsen P., Krarup E., Lyngsoe C., Rigothier C., Augusto J., Belot A., Chauveau D., Cornec D., Jourde-Chiche N., Ficheux M., Karras A., Klein A., Maurier F., Mesbah R., Moranne O., Neel A., Quemeneur T., Saadoun D., Terrier B., Zaoui P., Schaier M., Benck U., Bergner R., Busch M., Floege J., Grundmann F., Haller H., Haubitz M., Hellmich B., Henes J., Hohenstein B., Hugo C., Iking-Konert C., Arndt F., Kubacki T., Kotter I., Lamprecht P., Lindner T., Halbritter J., Mehling H., Schonermarck U., Venhoff N., Vielhauer V., Witzke O., Szombati I., Szucs G., Garibotto G., Alberici F., Brunetta E., Dagna L., De Vita S., Emmi G., Gabrielli A., Manenti L., Pieruzzi F., Roccatello D., Salvarani C., Dobashi H., Atsumi T., Fujimoto S., Hagino N., Ihata A., Kaname S., Kaneko Y., Katagiri A., Katayama M., Kirino Y., Kitagawa K., Komatsuda A., Kono H., Kurasawa T., Matsumura R., Mimura T., Morinobu A., Murakawa Y., Naniwa T., Nanki T., Ogawa N., Oshima H., Sada K., Sugiyama E., Takeuchi T., Taki H., Tamura N., Tsukamoto T., Yamagata K., Yamamura M., van Daele P., Rutgers A., Teng Y., Walker R., Chua I., Collins M., Rabindranath K., de Zoysa J., Svensson M., Grevbo B., Kalstad S., Little M., Clarkson M., Molloy E., Pamplona I. A., Anton J., Lucia V. B., Ciggaran S., Cid M. C., Encarnacion M. D., Oliveras X. F., Soler M. J., Rusinol H. M., Praga M., Porras L. Q., Segarra A., Segelmark M., Soveri I., Thomaidi E., Westman K., Neumann T., Burnier M., Daikeler T., Dudler J., Hauser T., Seeger H., Vogt B., Jayne D., Burton J., Al Jayyousi R., Amin T., Andrews J., Baines L., Brogan P., Dasgupta B., Doulton T., Flossmann O., Griffin S., Harper J., Harper L., Kidder D., Klocke R., Lanyon P., Luqmani R., McLaren J., Makanjuola D., McCann L., Nandagudi A., Selvan S., O'Riordan E., Patel M., Patel R., Pusey C., Rajakariar R., Robson J., Robson M., Salama A., Smyth L., Sznajd J., Taylor J., Merkel P., Sreih A., Belilos E., Bomback A., Carlin J., Chen Lin Y. C., Derebail V., Dragoi S., Dua A., Forbess L., Geetha D., Gipson P., Gohh R., Greenwood G. T., Hugenberg S., Jimenez R., Kaskas M., Kermani T., Kivitz A., Koening C., Langford C., Marder G., Mohamed A., Monach P., Neyra N., Niemer G., Niles J., Obi R., Owens C., Parks D., Podoll A., Rovin B., Sam R., Shergy W., Silva A., Specks U., Spiera R., Springer J., Striebich C., Swarup A., Thakar S., Tiliakos A., Tsai Y., Waguespack D., Wasko M. C., Cortazar, F, Niles, J, Jayne, D, Merkel, P, Bruchfeld, A, Yue, H, Schall, T, Bekker, P, Peh, C, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schonermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, De Vita, S, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, van Daele, P, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, de Zoysa, J, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, Pamplona, I, Anton, J, Lucia, V, Ciggaran, S, Cid, M, Encarnacion, M, Oliveras, X, Soler, M, Rusinol, H, Praga, M, Porras, L, Segarra, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Burton, J, Al Jayyousi, R, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Chen Lin, Y, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, Wasko, M, Cortazar F. B., Niles J. L., Jayne D. R. W., Merkel P. A., Bruchfeld A., Yue H., Schall T. J., Bekker P., Peh C. A., Chakera A., Cooper B., Kurtkoti J., Langguth D., Levidiotis V., Luxton G., Mount P., Mudge D., Noble E., Phoon R., Ranganathan D., Ritchie A., Ryan J., Suranyi M., Rosenkranz A., Lhotta K., Kronbichler A., Demoulin N., Bovy C., Hellemans R., Hougardy J., Sprangers B., Wissing K., Pagnoux C., Barbour S., Brachemi S., Cournoyer S., Girard L., Laurin L., Liang P., Philibert D., Walsh M., Tesar V., Becvar R., Horak P., Rychlik I., Szpirt W., Dieperink H., Gregersen J., Ivarsen P., Krarup E., Lyngsoe C., Rigothier C., Augusto J., Belot A., Chauveau D., Cornec D., Jourde-Chiche N., Ficheux M., Karras A., Klein A., Maurier F., Mesbah R., Moranne O., Neel A., Quemeneur T., Saadoun D., Terrier B., Zaoui P., Schaier M., Benck U., Bergner R., Busch M., Floege J., Grundmann F., Haller H., Haubitz M., Hellmich B., Henes J., Hohenstein B., Hugo C., Iking-Konert C., Arndt F., Kubacki T., Kotter I., Lamprecht P., Lindner T., Halbritter J., Mehling H., Schonermarck U., Venhoff N., Vielhauer V., Witzke O., Szombati I., Szucs G., Garibotto G., Alberici F., Brunetta E., Dagna L., De Vita S., Emmi G., Gabrielli A., Manenti L., Pieruzzi F., Roccatello D., Salvarani C., Dobashi H., Atsumi T., Fujimoto S., Hagino N., Ihata A., Kaname S., Kaneko Y., Katagiri A., Katayama M., Kirino Y., Kitagawa K., Komatsuda A., Kono H., Kurasawa T., Matsumura R., Mimura T., Morinobu A., Murakawa Y., Naniwa T., Nanki T., Ogawa N., Oshima H., Sada K., Sugiyama E., Takeuchi T., Taki H., Tamura N., Tsukamoto T., Yamagata K., Yamamura M., van Daele P., Rutgers A., Teng Y., Walker R., Chua I., Collins M., Rabindranath K., de Zoysa J., Svensson M., Grevbo B., Kalstad S., Little M., Clarkson M., Molloy E., Pamplona I. A., Anton J., Lucia V. B., Ciggaran S., Cid M. C., Encarnacion M. D., Oliveras X. F., Soler M. J., Rusinol H. M., Praga M., Porras L. Q., Segarra A., Segelmark M., Soveri I., Thomaidi E., Westman K., Neumann T., Burnier M., Daikeler T., Dudler J., Hauser T., Seeger H., Vogt B., Jayne D., Burton J., Al Jayyousi R., Amin T., Andrews J., Baines L., Brogan P., Dasgupta B., Doulton T., Flossmann O., Griffin S., Harper J., Harper L., Kidder D., Klocke R., Lanyon P., Luqmani R., McLaren J., Makanjuola D., McCann L., Nandagudi A., Selvan S., O'Riordan E., Patel M., Patel R., Pusey C., Rajakariar R., Robson J., Robson M., Salama A., Smyth L., Sznajd J., Taylor J., Merkel P., Sreih A., Belilos E., Bomback A., Carlin J., Chen Lin Y. C., Derebail V., Dragoi S., Dua A., Forbess L., Geetha D., Gipson P., Gohh R., Greenwood G. T., Hugenberg S., Jimenez R., Kaskas M., Kermani T., Kivitz A., Koening C., Langford C., Marder G., Mohamed A., Monach P., Neyra N., Niemer G., Niles J., Obi R., Owens C., Parks D., Podoll A., Rovin B., Sam R., Shergy W., Silva A., Specks U., Spiera R., Springer J., Striebich C., Swarup A., Thakar S., Tiliakos A., Tsai Y., Waguespack D., and Wasko M. C.

Abstract

Introduction: In the 330-patient ADVOCATE trial of avacopan for the treatment of antineutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, in which 81% of patients had renal involvement, estimated glomerular filtration rate (eGFR) increased on average 7.3 ml/min per 1.73 m2 in the avacopan group and 4.1 ml/min per 1.73 m2 in the prednisone group (P = 0.029) at week 52. This new analysis examines the results in the patient subgroup with severe renal insufficiency at enrollment into the trial, i.e., eGFR ≤20 ml/min per 1.73 m2. Methods: eGFR was determined at baseline and over the course of the trial. Changes in eGFR were compared between the 2 treatment groups. Results: In ADVOCATE, 27 of 166 patients (16%) in the avacopan group and 23 of 164 patients (14%) in the prednisone group had a baseline eGFR ≤20 ml/min per 1.73 m2. At week 52, eGFR increased on average 16.1 and 7.7 ml/min per 1.73 m2 in the avacopan and prednisone groups, respectively (P = 0.003). The last eGFR value measured during the 52-week treatment period was ≥2-fold higher than baseline in 41% of patients in the avacopan group compared to 13% in the prednisone group (P = 0.030). More patients in the avacopan group versus prednisone group had increases in eGFR above 20, 30, and 45 ml/min per 1.73 m2, respectively. Serious adverse events occurred in 13 of 27 patients (48%) in the avacopan group and 16 of 23 patients (70%) in the prednisone group. Conclusion: Among patients with baseline eGFR ≤20 ml/min per 1.73 m2 in the ADVOCATE trial, eGFR improved more in the avacopan group than in the prednisone group.

Published
2023

4. Renal Recovery for Patients with ANCA-Associated Vasculitis and Low eGFR in the ADVOCATE Trial of Avacopan

Author

Cortazar, Frank B., primary, Niles, John L., additional, Jayne, David R.W., additional, Merkel, Peter A., additional, Bruchfeld, Annette, additional, Yue, Huibin, additional, Schall, Thomas J., additional, Bekker, Pirow, additional, Peh, C. Au, additional, Chakera, A., additional, Cooper, B., additional, Kurtkoti, J., additional, Langguth, D., additional, Levidiotis, V., additional, Luxton, G., additional, Mount, P., additional, Mudge, D., additional, Noble, E., additional, Phoon, R., additional, Ranganathan, D., additional, Ritchie, A., additional, Ryan, J., additional, Suranyi, M., additional, Rosenkranz, A., additional, Lhotta, K., additional, Kronbichler, A., additional, Demoulin, N., additional, Bovy, C., additional, Hellemans, R., additional, Hougardy, J., additional, Sprangers, B., additional, Wissing, K., additional, Pagnoux, C., additional, Barbour, S., additional, Brachemi, S., additional, Cournoyer, S., additional, Girard, L., additional, Laurin, L., additional, Liang, P., additional, Philibert, D., additional, Walsh, M., additional, Tesar, V., additional, Becvar, R., additional, Horak, P., additional, Rychlik, I., additional, Szpirt, W., additional, Dieperink, H., additional, Gregersen, J., additional, Ivarsen, P., additional, Krarup, E., additional, Lyngsoe, C., additional, Rigothier, C., additional, Augusto, J., additional, Belot, A., additional, Chauveau, D., additional, Cornec, D., additional, Jourde-Chiche, N., additional, Ficheux, M., additional, Karras, A., additional, Klein, A., additional, Maurier, F., additional, Mesbah, R., additional, Moranne, O., additional, Neel, A., additional, Quemeneur, T., additional, Saadoun, D., additional, Terrier, B., additional, Zaoui, P., additional, Schaier, M., additional, Benck, U., additional, Bergner, R., additional, Busch, M., additional, Floege, J., additional, Grundmann, F., additional, Haller, H., additional, Haubitz, M., additional, Hellmich, B., additional, Henes, J., additional, Hohenstein, B., additional, Hugo, C., additional, Iking-Konert, C., additional, Arndt, F., additional, Kubacki, T., additional, Kotter, I., additional, Lamprecht, P., additional, Lindner, T., additional, Halbritter, J., additional, Mehling, H., additional, Schönermarck, U., additional, Venhoff, N., additional, Vielhauer, V., additional, Witzke, O., additional, Szombati, I., additional, Szucs, G., additional, Garibotto, G., additional, Alberici, F., additional, Brunetta, E., additional, Dagna, L., additional, De Vita, S., additional, Emmi, G., additional, Gabrielli, A., additional, Manenti, L., additional, Pieruzzi, F., additional, Roccatello, D., additional, Salvarani, C., additional, Dobashi, H., additional, Atsumi, T., additional, Fujimoto, S., additional, Hagino, N., additional, Ihata, A., additional, Kaname, S., additional, Kaneko, Y., additional, Katagiri, A., additional, Katayama, M., additional, Kirino, Y., additional, Kitagawa, K., additional, Komatsuda, A., additional, Kono, H., additional, Kurasawa, T., additional, Matsumura, R., additional, Mimura, T., additional, Morinobu, A., additional, Murakawa, Y., additional, Naniwa, T., additional, Nanki, T., additional, Ogawa, N., additional, Oshima, H., additional, Sada, K., additional, Sugiyama, E., additional, Takeuchi, T., additional, Taki, H., additional, Tamura, N., additional, Tsukamoto, T., additional, Yamagata, K., additional, Yamamura, M., additional, van Daele, P., additional, Rutgers, A., additional, Teng, Y., additional, Walker, R., additional, Chua, I., additional, Collins, M., additional, Rabindranath, K., additional, de Zoysa, J., additional, Svensson, M., additional, Grevbo, B., additional, Kalstad, S., additional, Little, M., additional, Clarkson, M., additional, Molloy, E., additional, Pamplona, I. Agraz, additional, Anton, J., additional, Lucia, V. Barrio, additional, Ciggaran, S., additional, Cid, M. Cinta, additional, Encarnacion, M. Diaz, additional, Oliveras, X. Fulladosa, additional, Soler, M. Jose, additional, Rusinol, H. Marco, additional, Praga, M., additional, Porras, L. Quintana, additional, Segarra, A., additional, Bruchfeld, A., additional, Segelmark, M., additional, Soveri, I., additional, Thomaidi, E., additional, Westman, K., additional, Neumann, T., additional, Burnier, M., additional, Daikeler, T., additional, Dudler, J., additional, Hauser, T., additional, Seeger, H., additional, Vogt, B., additional, Jayne, D., additional, Burton, J., additional, Al Jayyousi, R., additional, Amin, T., additional, Andrews, J., additional, Baines, L., additional, Brogan, P., additional, Dasgupta, B., additional, Doulton, T., additional, Flossmann, O., additional, Griffin, S., additional, Harper, J., additional, Harper, L., additional, Kidder, D., additional, Klocke, R., additional, Lanyon, P., additional, Luqmani, R., additional, McLaren, J., additional, Makanjuola, D., additional, McCann, L., additional, Nandagudi, A., additional, Selvan, S., additional, O'Riordan, E., additional, Patel, M., additional, Patel, R., additional, Pusey, C., additional, Rajakariar, R., additional, Robson, J., additional, Robson, M., additional, Salama, A., additional, Smyth, L., additional, Sznajd, J., additional, Taylor, J., additional, Merkel, P., additional, Sreih, A., additional, Belilos, E., additional, Bomback, A., additional, Carlin, J., additional, Chen Lin, Y. Chang, additional, Derebail, V., additional, Dragoi, S., additional, Dua, A., additional, Forbess, L., additional, Geetha, D., additional, Gipson, P., additional, Gohh, R., additional, Greenwood, G.T., additional, Hugenberg, S., additional, Jimenez, R., additional, Kaskas, M., additional, Kermani, T., additional, Kivitz, A., additional, Koening, C., additional, Langford, C., additional, Marder, G., additional, Mohamed, A., additional, Monach, P., additional, Neyra, N., additional, Niemer, G., additional, Niles, J., additional, Obi, R., additional, Owens, C., additional, Parks, D., additional, Podoll, A., additional, Rovin, B., additional, Sam, R., additional, Shergy, W., additional, Silva, A., additional, Specks, U., additional, Spiera, R., additional, Springer, J., additional, Striebich, C., additional, Swarup, A., additional, Thakar, S., additional, Tiliakos, A., additional, Tsai, Y., additional, Waguespack, D., additional, and Wasko, M. Chester, additional

Published
2023
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7. Unveiling Retention Physical Mechanism of Ge-rich GST ePCM Technology

Author

Laurin, L., primary, Baldo, M., additional, Petroni, E., additional, Samanni, G., additional, Turconi, L., additional, Motta, A., additional, Borghi, M., additional, Serafini, A., additional, Codegoni, D., additional, Scuderi, M., additional, Ran, S., additional, Claverie, A., additional, Ielmini, D., additional, Annunziata, R., additional, and Redaelli, A., additional

Published
2023
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10. Chemobrain: A Pilot Study Exploring the Severity and Onset of Chemotherapy-Related Cognitive Impairment

Author

DaiWai M. Olson, Sonja E. Stutzman, C. Kelly Moore, and Laurin L. Priddy

Subjects
Male, medicine.medical_specialty, medicine.medical_treatment, Trail Making Test, Antineoplastic Agents, Pilot Projects, General Practitioner Assessment of Cognition, Severity of Illness Index, 03 medical and health sciences, 0302 clinical medicine, Humans, Medicine, In patient, Prospective Studies, Cognitive impairment, Aged, General Environmental Science, Chemotherapy, 030504 nursing, business.industry, Symptom management, Significant difference, Middle Aged, 030220 oncology & carcinogenesis, Physical therapy, General Earth and Planetary Sciences, Female, Observational study, Cognition Disorders, 0305 other medical science, business
Abstract

BACKGROUND Chemotherapy-related cognitive impairment refers to a cluster of symptoms commonly referred to as "chemobrain". To date, nursing literature on the progression of and tools used to evaluate chemobrain is limited. OBJECTIVES The purpose of this pilot study was to explore the onset of chemobrain in patients who recently began chemotherapy treatment, as well as those who have been receiving chemotherapy for an extended period of time. METHODS This prospective, nonrandomized, observational pilot feasibility study used the General Practitioner Assessment of Cognition and the Trail Making Test Parts A and B to examine chemotherapy-related cognitive impairment symptoms in patients undergoing chemotherapy treatment. FINDINGS Paired t tests showed a significant difference in scores on the Trail Making Test Part A from baseline to eight months (p < 0.05) and in scores on the Trail Making Test Part B from four to eight months (p < 0.05). The mixed results suggest that the Trail Making Test Parts A and B may not be effective for testing chemotherapy-related cognitive impairment in patients.

Published
2019
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14. Avacopan for the Treatment of ANCA-Associated Vasculitis

Author

Jayne, David R W, Merkel, Peter A, Schall, Thomas J, Bekker, Pirow, ADVOCATE Study Group:, C Au Peh, Chakera, A, Cooper, B, Kurtkoti, J, Langguth, D, Levidiotis, V, Luxton, G, Mount, P, Mudge, D, Noble, E, Phoon, R, Ranganathan, D, Ritchie, A, Ryan, J, Suranyi, M, Rosenkranz, A, Lhotta, K, Kronbichler, A, Demoulin, N, Bovy, C, Hellemans, R, Hougardy, J, Sprangers, B, Wissing, K, Pagnoux, C, Barbour, S, Brachemi, S, Cournoyer, S, Girard, L, Laurin, L, Liang, P, Philibert, D, Walsh, M, Tesar, V, Becvar, R, Horak, P, Rychlik, I, Szpirt, W, Dieperink, H, Gregersen, J, Ivarsen, P, Krarup, E, Lyngsoe, C, Rigothier, C, Augusto, J, Belot, A, Chauveau, D, Cornec, D, Jourde-Chiche, N, Ficheux, M, Karras, A, Klein, A, Maurier, F, Mesbah, R, Moranne, O, Neel, A, Quemeneur, T, Saadoun, D, Terrier, B, Zaoui, P, Schaier, M, Benck, U, Bergner, R, Busch, M, Floege, J, Grundmann, F, Haller, H, Haubitz, M, Hellmich, B, Henes, J, Hohenstein, B, Hugo, C, Iking-Konert, C, Arndt, F, Kubacki, T, Kotter, I, Lamprecht, P, Lindner, T, Halbritter, J, Mehling, H, Schönermarck, U, Venhoff, N, Vielhauer, V, Witzke, O, Szombati, I, Szucs, G, Garibotto, G, Alberici, F, Brunetta, E, Dagna, L, S De Vita, Emmi, G, Gabrielli, A, Manenti, L, Pieruzzi, F, Roccatello, D, Salvarani, C, Dobashi, H, Atsumi, T, Fujimoto, S, Hagino, N, Ihata, A, Kaname, S, Kaneko, Y, Katagiri, A, Katayama, M, Kirino, Y, Kitagawa, K, Komatsuda, A, Kono, H, Kurasawa, T, Matsumura, R, Mimura, T, Morinobu, A, Murakawa, Y, Naniwa, T, Nanki, T, Ogawa, N, Oshima, H, Sada, K, Sugiyama, E, Takeuchi, T, Taki, H, Tamura, N, Tsukamoto, T, Yamagata, K, Yamamura, M, P van Daele, Rutgers, A, Teng, Y, Walker, R, Chua, I, Collins, M, Rabindranath, K, J de Zoysa, Svensson, M, Grevbo, B, Kalstad, S, Little, M, Clarkson, M, Molloy, E, I Agraz Pamplona, Anton, J, V Barrio Lucia, Ciggaran, S, M Cinta Cid, M Diaz Encarnacion, X Fulladosa Oliveras, M Soler, J, H Rusinol, M, Praga, M, L Quintana Porras, Segarra, A, Bruchfeld, A, Segelmark, M, Soveri, I, Thomaidi, E, Westman, K, Neumann, T, Burnier, M, Daikeler, T, Dudler, J, Hauser, T, Seeger, H, Vogt, B, Jayne, D, Burton, J, R Al Jayyousi, Amin, T, Andrews, J, Baines, L, Brogan, P, Dasgupta, B, Doulton, T, Flossmann, O, Griffin, S, Harper, J, Harper, L, Kidder, D, Klocke, R, Lanyon, P, Luqmani, R, Mclaren, J, Makanjuola, D, Mccann, L, Nandagudi, A, Selvan, S, O'Riordan, E, Patel, M, Patel, R, Pusey, C, Rajakariar, R, Robson, J, Robson, M, Salama, A, Smyth, L, Sznajd, J, Taylor, J, Merkel, P, Sreih, A, Belilos, E, Bomback, A, Carlin, J, Y Chang Chen Lin, Derebail, V, Dragoi, S, Dua, A, Forbess, L, Geetha, D, Gipson, P, Gohh, R, T Greenwood, G, Hugenberg, S, Jimenez, R, Kaskas, M, Kermani, T, Kivitz, A, Koening, C, Langford, C, Marder, G, Mohamed, A, Monach, P, Neyra, N, Niemer, G, Niles, J, Obi, R, Owens, C, Parks, D, Podoll, A, Rovin, B, Sam, R, Shergy, W, Silva, A, Specks, U, Spiera, R, Springer, J, Striebich, C, Swarup, A, Thakar, S, Tiliakos, A, Tsai, Y, Waguespack, D, M Chester Wasko, Internal Medicine, Immunology, Jayne, D, Merkel, P, Schall, T, Bekker, P, Pieruzzi, F, Jayne, David RW [0000-0002-1712-0637], Apollo - University of Cambridge Repository, and Translational Immunology Groningen (TRIGR)

Subjects
Male, Receptor, Anaphylatoxin C5a/antagonists & inhibitors, Anaphylatoxin C5a, Anaphylatoxin C5a/antagonists & inhibitors, Nipecotic Acids, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculiti, Administration, Oral, Azathioprine, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, urologic and male genital diseases, Gastroenterology, C5a receptor, Cyclophosphamide/administration & dosage, Rituximab/administration & dosage, Immunosuppressive Agent, renal vasculitis, Prednisone/administration & dosage, 0302 clinical medicine, Glucocorticoid, immune system diseases, Prednisone, Recurrence, Medicine, 030212 general & internal medicine, skin and connective tissue diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis/drug therapy, Aniline Compounds, Remission Induction, General Medicine, Aniline Compound, Middle Aged, Administration, Combination, Rituximab, Drug Therapy, Combination, Female, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Cyclophosphamide, Double-Blind Method, Glucocorticoids, Humans, Immunosuppressive Agents, Receptor, Anaphylatoxin C5a, Vasculitis, Receptor, medicine.drug, Human, Azathioprine/administration & dosage, Oral, medicine.medical_specialty, Nipecotic Acid, ANCA-Associated Vasculitis, 03 medical and health sciences, Drug Therapy, Internal medicine, Aniline Compounds/adverse effects, cardiovascular diseases, Immunosuppressive Agents/administration & dosage, Anti-neutrophil cytoplasmic antibody, business.industry, Glucocorticoids/administration & dosage, medicine.disease, Nipecotic Acids/adverse effects, respiratory tract diseases, business
Abstract

BACKGROUND: The C5a receptor inhibitor avacopan is being studied for the treatment of antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.METHODS: In this randomized, controlled trial, we assigned patients with ANCA-associated vasculitis in a 1:1 ratio to receive oral avacopan at a dose of 30 mg twice daily or oral prednisone on a tapering schedule. All the patients received either cyclophosphamide (followed by azathioprine) or rituximab. The first primary end point was remission, defined as a Birmingham Vasculitis Activity Score (BVAS) of 0 (on a scale from 0 to 63, with higher scores indicating greater disease activity) at week 26 and no glucocorticoid use in the previous 4 weeks. The second primary end point was sustained remission, defined as remission at both weeks 26 and 52. Both end points were tested for noninferiority (by a margin of 20 percentage points) and for superiority.RESULTS: A total of 331 patients underwent randomization; 166 were assigned to receive avacopan, and 165 were assigned to receive prednisone. The mean BVAS at baseline was 16 in both groups. Remission at week 26 (the first primary end point) was observed in 120 of 166 patients (72.3%) receiving avacopan and in 115 of 164 patients (70.1%) receiving prednisone (estimated common difference, 3.4 percentage points; 95% confidence interval [CI], -6.0 to 12.8; PCONCLUSIONS: In this trial involving patients with ANCA-associated vasculitis, avacopan was noninferior but not superior to prednisone taper with respect to remission at week 26 and was superior to prednisone taper with respect to sustained remission at week 52. All the patients received cyclophosphamide or rituximab. The safety and clinical effects of avacopan beyond 52 weeks were not addressed in the trial. (Funded by ChemoCentryx; ADVOCATE ClinicalTrials.gov number, NCT02994927.).

Published
2021

15. Persistent Disease Activity in Patients With Long-Standing Glomerular Disease

Author

Gibson, K.L., Kidd, J.M., Canetta, P.A., Rizk, D.V., Marasa, M., Gharavi, A.G., Wenderfer, S.E., Hladunewich, M.A., Delbarba, E., Mu, X., Nachman, P.H., Julian, B.A., Hogan, J.J., Piva, S.E., Sanghani, N.S., CureGN Consortium, Kil, B.H., Chatterjee, D., Trachtman, H., Rheault, M.N., Bomback, A.S., and Laurin, L.-P.

Abstract

Introduction: Glomerular diseases are characterized by variable disease activity over many years. We aimed to analyze the relationship between clinical disease activity and duration of glomerular disease. Methods: Disease activity in adults with chronic minimal change disease, focal segmental glomerulosclerosis, membranous nephropathy, and IgA nephropathy (IgAN; first diagnostic biopsy >5 years before enrollment; Of Longstanding Disease [OLD] cohort, n = 256) followed at Columbia University Medical Center (CUMC), was compared with disease activity of an internal and external cohort of patients with first diagnostic biopsy

Published
2020
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16. Resolving Rivalries and Realigning Goals: Challenges of Clinical and Research Multiteam Systems

Author

Simon J. Craddock Lee, David E. Gerber, Mary Gill, Haskell Kirkpatrick, Laurin L. Priddy, Joan H. Schiller, Torsten Reimer, Erin L Williams, and Deidi Bergestuen

Subjects
Male, Clinical team, Care process, Lung Neoplasms, Attitude of Health Personnel, media_common.quotation_subject, education, Newly diagnosed, 03 medical and health sciences, 0302 clinical medicine, Nursing, Carcinoma, Non-Small-Cell Lung, Humans, Special Series: NCI-ASCO Teams, Medicine, 030212 general & internal medicine, Cooperative Behavior, Clinical care, Function (engineering), Randomized Controlled Trials as Topic, media_common, Patient Care Team, Oncology (nursing), business.industry, Health Policy, Middle Aged, Clinical trial, Regimen, Clinical research, Oncology, 030220 oncology & carcinogenesis, business
Abstract

This article describes the care processes for a 64-year-old man with newly diagnosed advanced non–small-cell lung cancer who was enrolled in a first-line clinical trial of a new immunotherapy regimen. The case highlights the concept of multiteam systems in cancer clinical research and clinical care. Because clinical research represents a highly dynamic entity—with studies frequently opening, closing, and undergoing modifications—concerted efforts of multiple teams are needed to respond to these changes while continuing to provide consistent, high-level care and timely, accurate clinical data. The case illustrates typical challenges of multiteam care processes. Compared with clinical tasks that are routinely performed by single teams, multiple-team care greatly increases the demands for communication, collaboration, cohesion, and coordination among team members. As the case illustrates, the described research team and clinical team are separated, resulting in suboptimal function. Individual team members interact predominantly with members of their own team. A considerable number of team members lack regular interaction with anyone outside their team. Accompanying this separation, the teams enact rivalries that impede collaboration. The teams have misaligned goals and competing priorities that create competition. Collective identity and cohesion across the two teams are low. Research team and clinical team members have limited knowledge of the roles and work of individuals outside their team. Recommendations to increase trust and collaboration are provided. Clinical providers and researchers may incorporate these themes into development and evaluation of multiteam systems, multidisciplinary teams, and cross-functional teams within their own institutions.

Published
2016
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17. Phase II trial of clinical activity and safety of ceritinib combined with stereotactic ablative radiotherapy (SABR) in lung adenocarcinoma patients

Author

Noah Sorrelle, Samantha Mannala, Hak Choy, Rolf A. Brekken, Puneeth Iyengar, Jessica Saltarski, Kenneth D. Westover, Jonathan E. Dowell, Sawsan Rashdan, Hong Zhu, Robert Timmerman, David E. Gerber, Kasia Harrah, Randall S. Hughes, Saad A. Khan, and Laurin L. Priddy

Subjects
Cancer Research, medicine.medical_specialty, Lung, Ceritinib, business.industry, medicine.medical_treatment, Cancer, medicine.disease, SABR volatility model, Radiation therapy, medicine.anatomical_structure, Oncology, Ablative case, medicine, Adenocarcinoma, In patient, Radiology, business, medicine.drug
Abstract

e21571 Background: ALK -targeting drugs and SABR are combined in patients with metastatic cancer, anecdotally yielding clinical benefit. However, the precise impact of the combination and the optimal time to introduce SABR remain unknown. Methods: This completed phase 2 study (NCT02513667) had a primary objective of doubling progression free survival (PFS) for ALK+ lung adenocarcinoma patients by consolidating all remaining disease with SABR, 8-10 weeks after ceritinib initiation. Patients who then progressed could receive repeat SABR as long as they then resumed ceritinib. Patients were divided into ALK-inhibitor naïve vs previously treated cohorts. Oligometastatic disease was NOT a requirement for study entry, CNS disease was permitted. Blood was serially analyzed for variation in 1. blood cfDNA detection of resistance mechanisms 2. flow cytometric analysis of white cell populations. Results: 14 patients were enrolled out of a planned 33; 7 female; 3 hispanic/latino; median age was 53 years (range 31-78); 5 patients had previously received crizotinib. 4 patients stopped ceritinib within 30 days due to toxicity, despite dose reductions or with-food administration. However, all patients still completed initial SABR consistent with protocol time-points. Patients predominantly had thoracic disease irradiated (11/14, 78%). Two patients had only brain metastases treated and 1 had bone only metastases treated. 4 had one fraction SBRT regimens (16-24 Gy per fraction) delivered to disease, 3 had three fraction SBRT regimens (9-11 Gy per fraction) delivered to disease, and 7 had five fraction SBRT or 15 fraction hypofractionated regimens (6 Gy per fraction or 3Gy per fraction, respectively) delivered to disease. Disease control in all irradiated areas was 100%. There was no significant grade 3 or higher toxicity associated with radiation. Broad variability in baseline and serial levels of circulating PMN-MDSC, VEGFR2, FoxP3+, CD56+CD16+ and various T-cell populations showed no clinical correlation. The trial terminated early due to increased use of alternative targeted therapies, thus the primary endpoint was not met. 8 patients had CR/PR/SD as best response. Including those who did not tolerate ceritinib, median PFS was 12 months, max of 31 months with 1 ongoing response. Conclusions: Consolidative SABR after ALK therapy is well tolerated, can be repeated and may prolong PFS compared to drug alone. Ceritinib toxicity meant higher rates of discontinuation but this did not prevent consolidative SABR in any patient. Clinical trial information: NCT02513667.

Published
2020
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18. Temporal Trends and Predictors for Cancer Clinical Trial Availability for Medically Underserved Populations

Author

Laurin L. Priddy, Jingsheng Yan, Ashley M. Lakoduk, David E. Gerber, and Xian Jin Xie

Subjects
Gerontology, Clinical Trials as Topic, Cancer Research, medicine.medical_specialty, Cancer clinical trial, Accrual, business.industry, Alternative medicine, Univariate, Logistic regression, Vulnerable Populations, United States, Clinical trial, Underserved Population, Editorial, Hospital system, Oncology, Neoplasms, medicine, Humans, business, Demography
Abstract

Background. Lack of access to available cancer clinical trials has been cited as a key factor limiting trial accrual, particularly among medically underserved populations. We examined the trends and factors in clinical trial availability within a major U.S. safety-net hospital system. Materials and Methods. We identified cancer clinical trials activated at the Harold C. Simmons Cancer from 1991 to 2014 and recorded the characteristics of the trials that were and were not activated at the Parkland Health and Hospital System satellite site. We used univariate and multivariate logistic regression to determine the association between trial characteristics and nonactivation status, and chi-square analysis to determine the association between the trial characteristics and the reasons for nonactivation. Results. A total of 773 trials were identified, of which 152 (20%) were not activated at Parkland. In multivariable analysis, nonactivation at Parkland was associated with trial year, sponsor, and phase. Compared with the 1991–2006 period, clinical trials in the 2007–2014 period were almost eightfold more likely not to be activated at Parkland. The most common reasons for nonactivation at Parkland were an inability to perform the study procedures (27%) and the startup costs (15%). Conclusion. Over time, in this single-center setting, a decreasing proportion of cancer clinical trials were available to underserved populations. Trial complexity and costs appeared to account for much of this trend. Efforts to overcome these barriers will be key to equitable access to clinical trials, efficient accrual, and the generalizability of the results. Implications for Practice: Despite numerous calls to increase and diversify cancer clinical trial accrual, the present study found that cancer clinical trial activation rates in a safety-net setting for medically underserved populations have decreased substantially in recent years. The principal reasons for study nonactivation were expenses and an inability to perform the study-related procedures, reflecting the increasing costs and complexity of cancer clinical trials. Future efforts need to focus on strategies to mitigate the increasing disparity in access to clinical research and cutting-edge therapies, which also threatens to hinder study accrual, completion rates, and generalizability.

Published
2015
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19. The role of regional organisations in international copyright law

Author

Correa Carranza, Laurin L-L., Correa Carranza, Laurin L-L., Correa Carranza, Laurin L-L., and Correa Carranza, Laurin L-L.

Abstract

This research will examine the role which regional organizations play for the implementation of the international copyright protection framework in their member states. This is done in order to gain an increased understanding of the impact that international and regional agreements have on national copyright legislation and its enforcement through national and regional courts. The issue of how copyright balance is reflected and implemented in these legal structures is of central importance to this research, since regional or national preferences can influence in which manner the creator’s or the user’s interests are represented in law. The theoretic concepts of constitutionalization (particularly in terms of institutionalization), embedded liberalism (as providing a theoretical link between social concerns and trade liberalization) as well as proportionality (in representation of the rights balancing done by courts) will be utilised in this research. The interconnected legal relationship of copyright will be examined utilizing the case studies of the European Union and the UK as well as the example of the Andean Community and Ecuador. In order to have an increased understanding of the difference in terms of implementation between being part of a regional union and not being a member state of such, the situation in Chile will also be part of this research and the comparative analysis. Chile is a case study which, through comparison with the legal and institutional framework of regional organizations, illustrates the situation of a country which is not part of a regional organization and entered into independent bilateral treaty obligations instead. These countries provide also a basis for considering the differences in preferences between developed and developing countries in the context of international and regional copyright protection. This can bridge the current gap in understanding of the particular effect that international and regional copyright legislation ha

Published
2015

20. The role of regional organisations in international copyright law

Author

Correa Carranza, Laurin L-L and Correa Carranza, Laurin L-L.

Abstract

This research will examine the role which regional organizations play for the implementation of the international copyright protection framework in their member states. This is done in order to gain an increased understanding of the impact that international and regional agreements have on national copyright legislation and its enforcement through national and regional courts. The issue of how copyright balance is reflected and implemented in these legal structures is of central importance to this research, since regional or national preferences can influence in which manner the creator’s or the user’s interests are represented in law. The theoretic concepts of constitutionalization (particularly in terms of institutionalization), embedded liberalism (as providing a theoretical link between social concerns and trade liberalization) as well as proportionality (in representation of the rights balancing done by courts) will be utilised in this research. The interconnected legal relationship of copyright will be examined utilizing the case studies of the European Union and the UK as well as the example of the Andean Community and Ecuador. In order to have an increased understanding of the difference in terms of implementation between being part of a regional union and not being a member state of such, the situation in Chile will also be part of this research and the comparative analysis. Chile is a case study which, through comparison with the legal and institutional framework of regional organizations, illustrates the situation of a country which is not part of a regional organization and entered into independent bilateral treaty obligations instead. These countries provide also a basis for considering the differences in preferences between developed and developing countries in the context of international and regional copyright protection. This can bridge the current gap in understanding of the particular effect that international and regional copyright legislation has on such countries. The conclusions and research findings of this research provide an insight into the importance that regional organizations have in shaping the legal framework of their members in accordance with a set of preferences in regards to copyright interests.

Published
2015
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34. Paul Theodore David

Author

Laurin L. Henry, Kenneth W. Thompson, and Ralph M. Goldman

Subjects
Sociology and Political Science, Political science, Religious studies, Law and economics
Published
1995
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42. THE AWKWARD INTERVAL.

Author

Henry, Laurin L.

Subjects
*ELECTIONS, *CONSTITUTIONS, *POLITICAL participation, UNITED States presidential elections
Abstract

Focuses on the ten week interval before an elected U.S. president can take the position of the former president. Disadvantages of the interval; Day specified by the constitution in which the decision of the election should be announced; Historical background on the problems faced by the U.S. elective system.

Published
1968

44. Treatment Patterns Among Adults and Children With Membranous Nephropathy in the Cure Glomerulonephropathy Network (CureGN)

Author

Al-Uzri, A., Rheault, M.N., Laurin, L.-P., Sanghani, N.S., Kogon, A.J., Wang, C.-S., Parsa, A., Hladunewich, M.A., Ashoor, I.F., Gibson, K.L., Matar, R.B., Selewski, D.T., Troost, J.P., Khalid, M., Guay-Woodford, L., Gillespie, B.W., Srivastava, T., Bomback, A.S., Gipson, D.S., O'Shaughnessy, M.M., and Vento, S.

Subjects
3. Good health
Abstract

Introduction: The 2012 Kidney Disease: Improving Global Outcomes (KDIGO) Clinical Practice Guidelines for Glomerulonephritis recommend that patients with membranous nephropathy (MN) at risk for progression receive immunosuppressive therapy (IST), usually after 6 months of observation. A cyclophosphamide (CYC) or calcineurin inhibitor (CNI)–based regimen is recommended as first-line IST. However, the extent to which KDIGO recommendations are adopted in practice remains largely unknown. Methods: We evaluated prescribing practice among patients with primary MN (diagnosed 2010–2018) enrolled in the Cure Glomerulonephropathy Network (CureGN) cohort study. We also evaluated the availability of testing for phospholipase A2 receptor (PLA2R) in the contemporary era. Results: Among 361 patients (324 adults and 37 children) with MN who were IST-naïve at biopsy and had at least 6 months of follow-up, 55% of adults and 58% of children initiated IST

50. The American Presidency.

Author

Henry, Laurin L.

Subjects
POLITICAL development, COGNITIVE development, PUBLIC administration, PRESIDENTS of the United States, PERIODICALS, SCHOLARS, CONFERENCES & conventions, UNITED States politics & government
Abstract

This article presents views of various American scholars on the American Presidency. The author reports that the generation since U.S. President Franklin Delano Roosevelt generally has thought of the presidency as responsive to progressive political forces, constituted to bring to the country a broad and enlightened vision of the national interest, and likely to be occupied by men of trustworthy instincts. The national tendency of people is to reconsider the values of decentralization, diversity, and dissent. In this perspective, writer Norton Long, in his article "Reflections on Presidential Power," describes the presidency as a product of distinctly American, not British, political development. Long suggests that the contemporary weakness is not necessarily in formal constitutional or party power but in "cognitive deficiencies" of the office and its incumbents. Author William Carey, in his article "Presidential Staffing in the Sixties and Seventies," presents an agenda of reforms to enable the President to be a better leader and teacher in the decade ahead.

Published
1969

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