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2. Adherence to treatment of osteoporosis: a need for study

Author

Lekkerkerker, F., Kanis, J. A., Alsayed, N., Bouvenot, G., Burlet, N., Cahall, D., Chines, A., Delmas, P., Dreiser, R.-L., Ethgen, D., Hughes, N., Kaufman, J.-M., Korte, S., Kreutz, G., Laslop, A., Mitlak, B., Rabenda, V., Rizzoli, R., Santora, A., Schimmer, R., Tsouderos, Y., Viethel, P., and Reginster, J.-Y.

Published
2007
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4. The Use of Placebo-Controlled and Non-inferiority Trials for the Evaluation of New Drugs in the Treatment of Postmenopausal Osteoporosis

Author

Delmas, P.D., Calvo, G., Boers, M., Abadie, E., Avouac, B., Kahan, A., Kaufman, J.M., Laslop, A., Lekkerkerker, J.F., Nilsson, P., Van Zwieten-Boot, B., Kreutz, G., and Reginster, J.Y.

Subjects
Postmenopausal women -- Research, Clinical trials -- Research, Osteoporosis -- Research, Osteoporosis -- Care and treatment, Health
Abstract

Byline: P. D. Delmas (1), G. Calvo (2), M. Boers (3), E. Abadie (4), B. Avouac (5), A. Kahan (6), J. M. Kaufman (7), A. Laslop (8), J. F. Lekkerkerker (9), P. Nilsson (10), B. Van Zwieten-Boot (11), G. Kreutz (12), J. Y. Reginster (13) Keywords: Key words:Clinical trial -- Drug registration -- Osteoporosis -- Placebo Abstract: Registration of new agents for the treatment of postmenopausal osteoporosis has been based over the past few years on placebo-controlled phase III trials with the incidence of patients with new vertebral/nonvertebral fractures as the most usual primary endpoint. The use of a placebo in diseases where an active treatment is available has been a matter of debate following the update of the Declaration of Helsinki by the World Medical Association which questioned this trial design. Current regulatory recommendations within the European Union suggest that placebo-controlled trials are still the best option when assessing the efficacy and safety of new drugs intended for the treatment of postmenopausal osteoporosis. This suggestion seems to be in apparent contradiction with the current content of the Declaration of Helsinki. This paper addresses the ethics and feasibility of placebo-controlled trials in the treatment of postmenopausal osteoporosis, in the light of available therapeutic options, and discusses possible alternative approaches in those patients where placebo treatment could be deemed to be unethical. It is concluded that placebo-controlled trials remain the most efficient design to establish the efficacy and safety of a new agent for the treatment of postmenopausal osteoporosis. Such trials are feasible and ethically acceptable in patients with osteoporosis but without prevalent vertebral fractures. Conversely, in patients with prevalent vertebral fractures, placebo-controlled trials are ethically questionable and non-inferiority trials are more appropriate. A relative margin of non-inferiority of 20--30% is suggested, to be discussed on a case by case basis. Author Affiliation: (1) INSERM Research Unit 403 and Claude Bernard University of Lyon, France, FR (2) Department of Clinical Pharmacology, Santa Creu i Sant Pau Hospital, Autonomous University of Barcelona, Spain, ES (3) Department of Clinical Epidemiology &amp Biostatistics, VU University Medical Center, Amsterdam, The Netherlands, NL (4) Agence Francaise du MeA'dicament, Saint-Denis, France, FR (5) Service de Rhumatologie, Ho^pital Henri Mondor, CreA'teil, France, FR (6) UniversiteA' de Paris V, AP-HP, Ho^pital Cochin, Paris, France, FR (7) Department of Endocrinology and Unit for Osteoporosis and Metabolic Bone Diseases, Ghent University Hospital, Belgium, BE (8) Department of Pharmacology, University of Innsbruck, Austria, AT (9) Medicines Evaluation Board, The Hague, The Netherlands, NL (10) Medical Product Agency, Uppsala, Sweden, SE (11) Medicines Evaluation Board, The Hague, The Netherlands, NL (12) BfArM ARM, Bonn, Germany , DE (13) Department of Epidemiology and Public Health, University of Lie`ge and World Health Organization Collaborating Center for Public Health Aspects of Rheumatic Disease, Lie`ge, Belgium, BE Article note: Received: 25 October 2001 / Accepted: 13 November 2001

Published
2002

5. Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis

Author

Altman, R.D., M.D., Abadie, E., M.D., Avouac, B., M.D., Bouvenot, G., M.D., Branco, J., M.D., Bruyere, O., Ph.D., Calvo, G., M.D., Devogelaer, J.-P., M.D., Dreiser, R.L., M.D., Herrero-Beaumont, G., M.D., Kahan, A., M.D., Kreutz, G., M.D., Laslop, A., M.D., Lemmel, E.M., M.D., Menkes, C.J., M.D., Pavelka, K., M.D., Van De Putte, L., M.D., Vanhaelst, L., M.D., and Reginster, J.-Y., M.D.

Published
2005
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11. Music Interventions for Dementia and Depression in ELderly care (MIDDEL): protocol and statistical analysis plan for a multinational cluster-randomised trial

Author

Gold, C, Eickholt, J, Assmus, J, Stige, B, Wake, JD, Baker, FA, Tamplin, J, Clark, I, Lee, Y-EC, Jacobsen, SL, Ridder, HMO, Kreutz, G, Muthesius, D, Wosch, T, Ceccato, E, Raglio, A, Ruggeri, M, Vink, A, Zuidema, S, Odell-Miller, H, Orrell, M, Schneider, J, Kubiak, C, Romeo, R, Geretsegger, M, Gold, C, Eickholt, J, Assmus, J, Stige, B, Wake, JD, Baker, FA, Tamplin, J, Clark, I, Lee, Y-EC, Jacobsen, SL, Ridder, HMO, Kreutz, G, Muthesius, D, Wosch, T, Ceccato, E, Raglio, A, Ruggeri, M, Vink, A, Zuidema, S, Odell-Miller, H, Orrell, M, Schneider, J, Kubiak, C, Romeo, R, and Geretsegger, M

Abstract

INTRODUCTION: In older adults, dementia and depression are associated with individual distress and high societal costs. Music interventions such as group music therapy (GMT) and recreational choir singing (RCS) have shown promising effects, but their comparative effectiveness across clinical subgroups is unknown. This trial aims to determine effectiveness of GMT, RCS and their combination for care home residents and to examine heterogeneity of treatment effects across subgroups. METHODS AND ANALYSIS: This large, pragmatic, multinational cluster-randomised controlled trial with a 2×2 factorial design will compare the effects of GMT, RCS, both or neither, for care home residents aged 65 years or older with dementia and depressive symptoms. We will randomise 100 care home units with ≥1000 residents in total across eight countries. Each intervention will be offered for 6 months (3 months 2 times/week followed by 3 months 1 time/week), with extension allowed if locally available. The primary outcome will be the change in the Montgomery-Åsberg Depression Rating Scale score at 6 months. Secondary outcomes will include depressive symptoms, cognitive functioning, neuropsychiatric symptoms, psychotropic drug use, caregiver burden, quality of life, mortality and costs over at least 12 months. The study has 90% power to detect main effects and is also powered to determine interaction effects with gender, severity and socioeconomic status. ETHICS AND DISSEMINATION: Ethical approval has been obtained for one country and will be obtained for all countries. Results will be presented at national and international conferences and published in scientific journals. TRIAL REGISTRATION NUMBERS: NCT03496675; Pre-results, ACTRN12618000156280.

Published
2019

14. Erfordernisse einer Befunderstellung auf hoher Informationsebene im klinisch-pharmakologischen Routinelabor

Author

Nitz, M., Kreutz, G., Kewitz, H., Koller, S., editor, Reichertz, P. L., editor, Überla, K., editor, Anderson, J., editor, Goos, G., editor, Gremy, F., editor, Jesdinsky, H.-J., editor, Lange, H.-J., editor, Schneider, B., editor, Segmüller, G., editor, Wagner, G., editor, Köhler, C. O., editor, Tautu, P., editor, and Schlaefer, K., editor

Published
1984
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16. Klinische Pharmakologie

Author

Schwietzer, G., Distler, A., Reeck, S., Thiede, H. M., Philipp, T., Krämer, B., Hausen, M., Walz, G., Stankov, G., Welsch, M., Krämer, G., Mäurer, W., Kübler, W., Steinhauer, H. B., Schächtete, M., Günter, B., Rachel, M., Schollmeyer, P., Grützmacher, J., Schicht, R., Schlaeger, R., Sill, V., Klooker, P., Kreusser, W., Strein, K., Ritz, E., Müllerleile, U., Garbrecht, M., Hanrath, P., Bieber, K., Thier, W., Hossfeld, D. K., Nitsch, J., Manz, M., Steinbeck, G., Lüderitz, B., Schuster, C. J., Weil, M. H., Vincent, J. L., Kreutz, G., Schulz, R., Kewitz, H., Weiß, B., Donat, K., Ziegler, W. J., Londong, W., Londong, V., Cederberg, C., Steffen, H., Sonnenberg, A., Kurosinski, I., Gleiter, C., Antonin, K. H., Bieck, P., Hansen, W. E., Berti, S., Piper, C., Wallem, D., Brattig, N., Berg, P. A., Diao, G.-J., Brodde, O.-E., Bock, K. D., Rohm, N., Zerkowski, H.-R., Reidemeister, J. C., Krone, W., Carl, U., Müller-Wieland, D., Wilke, A., Greten, H., Legler, U. F., Benet, L. Z., Eggstein, M., Hildebrandt, R., Gundert-Remy, U., Laßmann, A., von Prittwitz, W., Lissner, R., Beckstein, P. B., Schoeppe, W., Rietbrock, N., Hoensch, H., Ohnhaus, E., André, M., Grüner, J., Kirch, W., Spahn, H., Hutt, H. J., Mutschler, E., Ohnhaus, E. E., Kuntz, H. D., Ferriferi, U., May, B., Epping, J., Kohler, S., Heusler, H., Richter, E., Klotz, U., Baughmann, R. A., Jr, Massoud, N., Williams, R. L., Ochs, H. R., Verburg-Ochs, B., Knüchel, M., Missmahl, M., Knauf, H., Wais, U., Schölmerich, J., Gerok, W., and Schlegel, Bernhard, editor

Published
1983
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19. EVIDENCE FOR LOCAL COMPENSATION OF BARYON NUMBER IN E+E- ANNIHILATION

Author

Althoff, M., Braunschweig, W., Wallraff, W., Cherney, M., Izen, J. M., Mermikides, M., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., Fischer, H. M., TASSO Collaboration, Hartmann, H., Jocksch, A., Knop, G., Köpke, L., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Kirschfink, F. J., Wollstadt, M., Eisenberg, Y., Gather, K., Hultschig, H., Joos, P., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Lübelsmeyer, K., Mättig, P., Mess, K. H., Notz, D., Nowak, R. J., Pyrlik, J., Riethmüller, R., Rushton, M., Schütte, W., Trines, D., Wolf, G., Martyn, H.-U., Xiao, Ch., Fohrmann, R., Hilger, E., Kracht, T., Krasemann, H. L., Leu, P., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Rimkus, J., Schmüser, P., Wiik, B. H., Beuselinck, R., Binnie, D. M., Campbell, A. J., Dornan, P. J., Foster, B., Garbutt, D. A., Jenkins, C., Jones, T. D., Rosskamp, P., Jones, W. G., McCardle, J., Sedgbeer, J. K., Thomas, J., Wan Abdullah, W. A. T., Bell, K. W., Bowler, M. G., Bull, P., Cashmore, R. J., Clarke, P. E. L., Sander, H. G., Devenish, R., Grossmann, P., Hawkes, C. M., Lloyd, S. L., Salmon, G. L., Wyatt, T. R., Youngman, C., Forden, G. E., Hart, J. C., Harvey, J., Schmitz, D., Hasell, D. K., Proudfoot, J., Saxon, D. H., Woodworth, P. L., Barreiro, F., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Siebke, H., Karshon, U., Mikenberg, G., Mir, R., Revel, D., Ronat, E., Shapira, A., Yekutieli, G., Baranko, G., Barklow, T., and Caldwell, A.

Subjects
Physics, Nuclear and High Energy Physics, Particle physics, Range (particle radiation), Annihilation, Proton, Electron–positron annihilation, Hadron, Nuclear Theory, Nuclear physics, Momentum, Antiproton, Physics::Accelerator Physics, ddc:530, High Energy Physics::Experiment, Baryon number, Nuclear Experiment
Abstract

Physics letters / B 139(1-2), 126 - 132 (1984). doi:10.1016/0370-2693(84)90047-9, Published by North-Holland Publ., Amsterdam

Published
2016
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20. Bose-Einstein correlations observed ine + e − annihilation at a centre of mass energy of 34 GeV

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Martyn, H. -U., Rosskamp, P., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Foster, B., Wood, A., Bernardi, E., Eskreys, A., Fohrmann, R., Gather, K., Hultschig, H., Joos, P., Karshon, U., Klima, B., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Notz, D., Revel, D., Shapira, A., Trines, D., Tymieniecka, T., Wolf, G., Zeuner, W., Hilger, E., Kracht, T., Krasemann, H. L., Lohrmann, E., Poelz, G., Pösnecker, K. -U., Binnie, D. M., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, W. G., Sedgbeer, J. K., Su, D., Thomas, J., Wan Abdullah, W. A. T., Barreiro, F., Labarga, L., Ros, E., Bowler, M. G., Bull, P., Cashmore, R. J., Dauncey, P., Devenish, R., Hawkes, C. M., Heath, G., Mellor, D. J., Ratoff, P., Lloyd, S. L., Forden, G. E., Hart, J. C., Hasell, D. K., Saxon, D. H., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Eisenberg, Y., Montag, A., Mikenberg, G., Mir, R., Ronat, E., Yekutieli, G., Baranko, G., Caldwell, A., Cherney, M., Hildebrandt, M., Izen, J. M., Mermikides, M., Ritz, S., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., and TASSO Collaboration

Published
1986
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21. Determination of α s in first and second order QCD frome + e − annihilation into hadrons

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Lübelsmeyer, K., Martyn, H. -U., Rosskamp, P., Sander, H. G., Schmitz, D., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Köpke, L., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Eskreys, A., Gather, K., Hultschig, H., Joos, P., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Notz, D., Nowak, R. J., Pyrlik, J., Rushton, M., Schütte, W., Trines, D., Tymieniecka, T., Wolf, G., Yekutieli, G., Xiao, Ch., Fohrmann, R., Hilger, E., Kracht, T., Krasemann, H. L., Leu, P., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Wiik, B. H., Beuselinck, R., Binnie, D. M., Dornan, P. J., Foster, B., Garbutt, D. A., Jenkins, C., Jones, T. D., Jones, W. G., McCardle, J., Sedgbeer, K. J., Thomas, J., Wan Abdullah, W. A. T., Bell, K. W., Bowler, M. G., Bull, P., Cashmore, R. J., Clarke, P. E. L., Devenish, R., Grossmann, P., Hawkes, C. M., Lloyd, S. L., Youngman, C., Forden, G. E., Hart, J. C., Harvey, J., Hasell, D. K., Saxon, D. H., Barreiro, F., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Eisenberg, Y., Karshon, U., Mikenberg, G., Mir, R., Revel, D., Ronat, E., Shapira, A., Winik, M., Baranko, G., Barklow, T., Caldwell, A., Cherney, M., Izen, J. M., Mermikides, M., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., and TASSO Collaboration

Published
1984
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22. The production and decay of Tau leptons ine + e − annihilation at PETRA energies

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Lübelsmeyer, K., Martyn, H. -U., Rosskamp, P., Schmitz, D., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Foster, B., Eskreys, A., Gather, K., Hildebrandt, M., Hultschig, H., Joos, P., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Notz, D., Nowak, R. J., Pyrlik, J., Ronat, E., Rushton, M., Schütte, W., Trines, D., Tymieniecka, T., Wolf, G., Yekutieli, G., Xiao, Ch., Fohrmann, R., Hilger, E., Kracht, T., Krasemann, H. L., Leu, P., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Wiik, B. H., Beuselinck, R., Binnie, D. M., Campbell, A. J., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, T. D., Jones, W. G., McCardle, J., Sedgbeer, J. K., Thomas, J., Wan Abdullah, W. A. T., Bell, K. W., Bowler, M. G., Bull, P., Cashmore, R. J., Clarke, P. E. L., Dauncey, P., Devenish, R., Grossmann, P., Hawkes, C. M., Lloyd, S. L., Mellor, D. J., Youngman, C., Forden, G. E., Hart, J. C., Harvey, J., Hasell, D. K., Saxon, D. H., Woodworth, P. L., Barreiro, F., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Eisenberg, Y., Karshon, U., Mikenberg, G., Mir, R., Revel, D., Shapira, A., Baranko, G., Caldwell, A., Cherney, M., Izen, J. M., Mermikides, M., Ritz, S., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., and TASSO Collaboration

Published
1985
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23. Upper limits on the production rate of the decuplet baryons Δ andΣ* ine + e − annihilation at 34.4 GeV

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Lübelsmeyer, K., Martyn, H. -U., Rosskamp, P., Sander, H. G., Schmitz, D., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Köpke, L., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Eskreys, A., Gather, K., Hultschig, H., Joos, P., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Mess, K. H., Notz, D., Nowak, R. J., Pyrlik, J., Riethmüller, R., Rushton, M., Scütte, W., Trines, D., Tymieniecka, T., Wolf, G., Xiao, Ch., Yekutieli, G., Fohrmann, R., Hilger, E., Kracht, T., Krasemann, H. L., Leu, P., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Schmüser, P., Wiik, B. H., Beuselinck, R., Binnie, D. M., Campbell, A. J., Dorman, P. J., Foster, B., Garbutt, D. A., Jenkins, C., Jones, T. D., Jones, W. G., McCardle, J., Sedgbeer, J. K., Thomas, J., Abdullah, W. A. T. Wan, Bell, K. W., Bowler, M. G., Bull, P., Cashmore, R. J., Clarke, P. E. L., Devenish, R., Grossmann, P., Hawkes, C. M., Lloyd, S. L., Youngman, C., Forden, G. E., Hart, J. C., Harvey, J., Hasell, D. K., Saxon, D. H., Woodworth, P. L., Barreiro, F., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Eisenberg, Y., Karshon, U., Mikenberg, G., Mir, R., Revel, D., Ronat, E., Shapira, A., Winik, M., Baranko, G., Caldwell, A., Cherney, M., Izen, J. M., Mermikides, M., Ritz, S., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., and TASSO Collaboration

Published
1984
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25. A detailed study of strange particle production ine + e − annihilation at high energy

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Lübelsmeyer, K., Martyn, H. -U., Rosskamp, P., Schmitz, D., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Joksch, A., Knop, G., Kolanoski, H., Kuck, H., Mertens, V., Wedemeyer, R., Foster, B., Eskreys, A., Gather, K., Hildebrandt, M., Hultschig, H., Joos, P., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Notz, D., Nowak, R. J., Pyrlik, J., Ronat, E., Rushton, M., Schütte, W., Trines, D., Tymieniecka, T., Wolf, G., Yekutieli, G., Xiao, Ch., Fohrmann, R., Hilger, E., Kracht, T., Krasemann, H. L., Leu, P., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Wiik, B. H., Beuselinck, R., Binnie, D. M., Campbell, A. J., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, T. D., Jones, W. G., McCardle, J., Sedgbeer, J. K., Thomas, J., Abdullah, W. A. T. Wan, Bell, K. W., Bowler, M. G., Bull, P., Cashmore, R. J., Clarke, P. E. L., Dauncey, P., Devenish, R., Grossmann, P., Hawkes, C. M., Lloyd, S. L., Mellor, D., Youngman, C., Forden, G. E., Hart, J. C., Harvey, J., Hasell, D. K., Saxon, D. H., Woodworth, P. L., Barreiro, F., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Eisenberg, Y., Karshon, U., Mikenberg, G., Mir, R., Revel, D., Shapira, A., Baranko, G., Caldwell, A., Cherney, M., Izen, J. M., Mermikides, M., Ritz, S., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., and TASSO Collaboration

Published
1985
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26. Photon pair production bye + e − annihilation and search for supersymmetric photinos at energies greater than 40 GeV

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Lübelsmeyer, K., Martyn, H. -U., Rosskamp, R., Schmitz, D., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Foster, B., Eskreys, A., Gather, K., Hultschig, H., Joos, P., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Notz, D., Nowak, R. J., Pyrlik, J., Rushton, M., Schütte, W., Trines, D., Tymieniecka, T., Wolf, G., Yekutieli, G., Xiao, Ch., Fohrmann, R., Hilger, E., Kracht, T., Krasemann, H. L., Leu, P., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Wiik, B. H., Beuselinck, R., Binnie, D. M., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, T. D., Jones, W. G., McCardle, J., Sedgbeer, J. K., Thomas, J., Wan Abdullah, W. A. T., Bell, K. W., Bowler, M. G., Bull, P., Cashmore, R. J., Clarke, P. E. L., Dauncey, P., Devenish, R., Grossmann, P., Hawkes, C. M., Lloyd, S. L., Mellor, D. J., Youngman, C., Forden, G. E., Hart, J. C., Harvey, J., Hasell, D. K., Saxon, D. H., Barreiro, F., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Eisenberg, Y., Karshon, U., Mikenberg, G., Mir, R., Revel, D., Ronat, E., Shapira, A., Winik, M., Baranko, G., Caldwell, A., Cherney, M., Izen, J. M., Mermikides, M., Ritz, S., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, Sau Lan, Zobernig, G., and TASSO Collaboration

Published
1984
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27. Particle correlation observed ine + e − annihilations into hadrons at c.m. Energies between 29 and 37 GeV

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Martyn, H. U., Rosskamp, R., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Foster, B., Wood, A., Bernardi, E., Eisenberg, Y., Eskreys, A., Fohrmann, R., Gather, K., Hultschig, H., Joos, P., Klima, B., Kötz, U., Kowalski, H., Lagage, A., Löhr, B., Lüke, D., Mättig, P., Mikenberg, G., Notz, D., Revel, D., Trines, D., Tymieniecka, T., Wolf, G., Zeuner, W., Hilger, E., Kracht, T., Krasemann, H. L., Lohrmann, E., Poelz, G., Pösnecker, K. U., Binnie, D. M., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, W. G., Sedgbeer, J. K., Su, D., Thomas, J., Wan Abdullah, W. A. T., Barreiro, F., Labarga, L., Ros, E., Bowler, M. G., Bull, P., Cashmore, R. J., Dauncey, P., Devenish, R., Hawkes, C. M., Heath, G., Mellor, D. J., Ratoff, P., Lloyd, S. L., Bell, K. W., Forden, G. E., Hart, J. C., Hasell, D. K., Saxon, D. H., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Karshon, U., Montag, A., Mir, R., Ronat, E., Yekutieli, G., Shapira, A., Baranka, G., Caldwell, A., Cherney, M., Hildebrandt, M., Izen, J. M., Mermikides, M., Ritz, S., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, S. L., Zobernig, G., and TASSO Collaboration

Published
1985
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28. A study of 3-jet events ine + e − annihilation into hadrons at 34.6 GeV c.m. energy

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Martyn, H. U., Rosskamp, R., Schmitz, D., siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, J., Knop, G., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Foster, B., Wood, A., Bernardi, E., Eisenberg, Y., Eskreys, A., Fohrmann, R., Gather, K., Hultschig, H., Joos, P., Karshon, U., Klima, B., Kötz, U., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Mikenberg, G., Notz, D., Pyrlik, J., Schütte, W., Trines, D., Tymieniecka, T., Wolf, G., Zeuner, W., Hilger, E., Kracht, T., Krasemann, H. L., Lohrmann, E., Pandoulas, D., Poelz, G., Pösnecker, K. U., Binnie, D. M., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, W. G., Sedgbeer, J. K., Su, D., Thomas, J., Wan Abdullan, W. A. T., Barreiro, F., Labarga, L., Ros, E., Bowler, M. G., Bull, P., Cashmore, R. J., Dauncey, P., Devenish, R., Hawkes, C. M., Heath, G., Mellor, D. J., Lloyd, S. L., Bell, K. W., Forden, G. E., Hart, J. C., Hasell, D. K., Saxon, D. H., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Montag, A., Mir, R., Revel, D., Ronat, E., Yekutieli, G., Shapira, A., Baranko, G., Caldwell, A., Cherney, M., Hildebrandt, M., Izen, J. M., Mermikides, M., Ritz, S., Rudolph, G., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, S. L., Zobernig, G., and TASSO Collaboration

Published
1985
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29. Search for two-photon production of resonances decaying intoK $$\bar K$$ π

Author

Althoff, M., Braunschweig, W., Kirschfink, F. J., Martyn, H. -U., Rosskamp, R., Siebke, H., Wallraff, W., Eisenmann, J., Fischer, H. M., Hartmann, H., Jocksch, A., Knop, G., Kolanoski, H., Kück, H., Mertens, V., Wedemeyer, R., Foster, B., Wood, A., Bernardi, E., Eisenberg, Y., Eskreys, A., Gather, K., Hultschig, H., Joos, P., Klima, B., Kowalski, H., Ladage, A., Löhr, B., Lüke, D., Mättig, P., Mikenberg, G., Notz, D., Revel, D., Trines, D., Tymieniecka, T., Walczak, R., Wolf, G., Zeuner, W., Hilger, E., Kracht, T., Krasemann, H. L., Lohrmann, E., Poelz, G., Pösnecker, K. U., Binnie, D. M., Dornan, P. J., Garbutt, D. A., Jenkins, C., Jones, W. G., Sedgbeer, J. K., Su, D., Thomas, J., Wan Abdullah, W. A. T., Barreiro, F., Labarga, L., Ros, E., Bowler, M. G., Bull, P., Cashmore, R. J., Dauncey, P., Devenish, R., Hawkes, C. M., Heath, G., Mellor, D. J., Lloyd, S. L., Bell, K. W., Forden, G. E., Hart, J. C., Hasell, D. K., Saxon, D. H., Brandt, S., Dittmar, M., Holder, M., Kreutz, G., Neumann, B., Duchovni, E., Karshon, U., Montag, A., Mir, R., Ronat, E., Yekutieli, G., Shapira, A., Baranko, G., Caldwell, A., Cherney, M., Hildebrandt, M., Izen, J. M., Mermikides, M., Ritz, S., Strom, D., Takashima, M., Venkataramania, H., Wicklund, E., Wu, S. L., Zobernig, G., and TASSO Collaboration

Published
1985
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30. Musik und Hirnplastizität

Author

Bernatzky, Günther, Kreutz, Gunter, Bernatzky, G ( Günther ), Kreutz, G ( Gunter ), Jäncke, Lutz; https://orcid.org/0000-0003-2110-9067, Bernatzky, Günther, Kreutz, Gunter, Bernatzky, G ( Günther ), Kreutz, G ( Gunter ), and Jäncke, Lutz; https://orcid.org/0000-0003-2110-9067

Abstract

Musizieren und Musikhören können vielfältige Anpassungen im menschlichen Gehirn auslösen. Diese Veränderungen äußern sich in größeren Volumina, einer größeren Dichte der grauen Substanz oder einer besseren anatomischen Verbindung in den Hirngebieten, welche an der Kontrolle des Musizierens und des Musikhörens beteiligt sind. Nicht nur anatomische Veränderungen können bei Musikern festgestellt werden, sondern auch veränderte neurophysiologische Aktivierungsmuster beim Hören und Generieren von Musik.

Published
2015

36. Recommendations for the registration of agents to be used in the prevention and treatment of glucocorticoid-induced osteoporosis: Updated recommendations from the group for the respect of ethics and excellence in science

Author

UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de rhumatologie, Abadie, EC, Devogelaer, JP, Ringe, JD, Ethgen, DJ, Bouvenot, GM, Kreutz, G, Laslop, A., Orloff, JJ, Vanderauwera, PM, Delmas, PD, Dere, WH, Branco, J, Altman, RD, Avouac, BP, Menkes, CJ, Vanhaelst, L., Mitlak, BH, Tsouderos, Y., Reginster, Jacques, UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de rhumatologie, Abadie, EC, Devogelaer, JP, Ringe, JD, Ethgen, DJ, Bouvenot, GM, Kreutz, G, Laslop, A., Orloff, JJ, Vanderauwera, PM, Delmas, PD, Dere, WH, Branco, J, Altman, RD, Avouac, BP, Menkes, CJ, Vanhaelst, L., Mitlak, BH, Tsouderos, Y., and Reginster, Jacques

Abstract

OBJECTIVES The Group for the Respect and Excellence in Science (GREES) has reviewed and updated their recommendations for clinical trials to evaluate the efficacy and safety of new chemical entities to be used in the treatment and prevention of glucocorticoid-induced osteoporosis (GIOP). METHODS Consensus discussion of the committee. RESULTS With the exception of steroid use posttransplantation, there is no need to differentiate between underlying diseases, Prevention and treatment for GIOP are dependent on exposure to glucocorticoids rather than T-scores as in postmenopausal osteoporosis (PMO). If fracture data are obtained for PMO, it need not be repeated for GIOP, relying instead on bone mineral density (BMD) trials of at least 1 year. GREES recommends several changes in the previous guidance for GIOP. The committee saw no need to repeat preclinical studies if those have been previously done to assure bone quality in PMO. Similarly, phase I and phase 11 trials, if careful dose selection has been done for PMO, should not be repeated. The "prevention" and "treatment" claims should remain. Since the most recent evidence suggests significant increase in fracture risk for daily doses of prednisone of 5 mg/day or equivalent, clinical trials should concentrate on patients receiving at least this daily dosage. The emergence of bisphosphonates as the reference treatment, together with the rapid bone loss and high fracture incidence in glucocorticoid users, necessitates recommending a noninferiority trial design with lumbar spine BMD as the primary endpoint after 1 year. CONCLUSIONS Registration of new chemical entities to be used in the management of GIOP should be granted, based on a 1-year noninferiority trial, using BMD as primary outcome and alendronate or risedronate as comparator. Demonstration of antifracture efficacy should have been previously demonstrated in PMO.

Published
2005

37. Total joint replacement of hip or knee as an outcome measure for structure modifying trials in osteoarthritis

Author

UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de rhumatologie, Altman, RD, Abadie, E., Avouac, B, Bouvenot, G, Branco, J, Bruyere, O., Calvo, G, Devogelaer, Jean-Pierre, Dreiser, RL, Herrero-Beaumont, G, Kahan, A, Kreutz, G, Laslop, A., Lemmel, EM, Menkes, CJ, Pavelka, K, Van De Putte, L, Vanhaelst, L., Reginster, Jacques, UCL - MD/MINT - Département de médecine interne, UCL - (SLuc) Service de rhumatologie, Altman, RD, Abadie, E., Avouac, B, Bouvenot, G, Branco, J, Bruyere, O., Calvo, G, Devogelaer, Jean-Pierre, Dreiser, RL, Herrero-Beaumont, G, Kahan, A, Kreutz, G, Laslop, A., Lemmel, EM, Menkes, CJ, Pavelka, K, Van De Putte, L, Vanhaelst, L., and Reginster, Jacques

Abstract

Objective: The Group for the Respect of Ethics and Excellence in Science (GREES) organized a working group to assess the value of time to joint surgery as a potential therapeutic failure outcome criterion for osteoarthritis (OA) of the hip or knee in the assessment of potential structure modifying agents. Methods: PubMed was searched for manuscripts from 1976 to 2004. Relevant studies were discussed at a 1-day meeting. Results: There are no accepted guidelines for 'time to' and 'indications for' joint replacement surgery. A limited number of trials have examined joint replacement surgery within the study population. Several parameters, particularly joint space narrowing (interbone distance), correlate with surgical intervention. However, at the level of the knee, none of the parameters have positive predictive value for joint replacement surgery better than 30%. In contrast, lack of significant joint space narrowing has a strong negative predictive value for joint replacement surgery (> 90%), that remains after controlling for OA pain severity. Conclusion: At this time, GREES cannot recommend time to joint surgery as a primary endpoint of failure for structure modifying trials of hip or knee OA-as the parameter has sensitivity but lacks specificity. In contrast, in existing trials, a lack of progression of joint space narrowing has predictive value of > 90% for not having surgery. GREES suggests utilizing joint space narrowing (e.g., > 0.3-0.7 mm) combined with a lack of clinically relevant improvement in symptoms (e.g., greater than or equal to 20-25%) for 'failure' of a secondary outcome in structure modifying trials of the hip and knee. (C) 2004 OsteoArthritis Research Society International. Published by Elsevier Ltd. All rights reserved.

Published
2005

41. Digitalis-Auslaßversuch bei Hämodialyse-Patienten

Author

Keller, F., primary, Schwarz, A., additional, Offermann, G., additional, Molzahn, M., additional, Distler, A., additional, Kreutz, G., additional, Weinmann, J., additional, Leitner, E.-R. von, additional, and Vöhringer, H.-F., additional

Published
2008
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42. Background for studies on the treatment of male osteoporosis: State of the art

Author

UCL - Autre, Kaufman, J.M., Fuchs, V., Kreutz, G., Nilsson, P., Pols, H., Ringe, J., Van Haelst, L., Reginster, J.Y., Johnell, O., Abadie, E., Adami, S., Audran, M., Avouac, B., Ben Sedrine, W., Calvo, G., Devogelaer, Jean-Pierre, UCL - Autre, Kaufman, J.M., Fuchs, V., Kreutz, G., Nilsson, P., Pols, H., Ringe, J., Van Haelst, L., Reginster, J.Y., Johnell, O., Abadie, E., Adami, S., Audran, M., Avouac, B., Ben Sedrine, W., Calvo, G., and Devogelaer, Jean-Pierre

Abstract

Male osteoporosis represents an important, although long underestimated, public health problem. Both in men and in women aging is accompanied by continuous bone loss and by an exponential increase in the incidence of osteoporotic fracture, with a female to male incidence ratio of about 2 to 3 to 1 in the elderly for hip and vertebral fractures. Morbidity after osteoporotic fractures appears to be more serious and mortality more common in men than in women. To date, no single treatment has been proved to be effective and safe in published prospective studies. The present report, based on a systematic search of the literature on male osteoporosis, summarises the state of the art on the clinical consequences of male osteoporosis and its risk factors, in relation to the present state of knowledge about female osteoporosis. This constitutes the background for the design of rational clinical development strategies for therapeutic interventions in male osteoporosis. From this review of the literature it is apparent that notwithstanding the existing sex differences in pathophysiology of osteoporosis and the difference in age-specific incidence of osteoporotic fractures, there are also important similarities between osteoporosis in women and men. The higher incidence of fracture in women than in men results from quantitative differences in risk factors rather than from different risk factors. Even though there are sex differences in bone geometry, incidence of fracture seems to be similar in men and women for a same absolute areal bone mineral density. However, the lack of data on the changes in fracture rates in men resulting from pharmacological intervention, leading to changes in bone mineral density or bone turnover, remains the main limitation for extrapolation of established treatment outcomes from women to men.

Published
2000

48. Recommendations for the registration of drugs used in the treatment of rheumatoid arthritis

Author

UCL, Lemmel, EM, Reid, DM, Nuki, G, Avouac, B, Bardin, T, Bouvenot, G, Cauwenberge, H, Cluzel, M, Devolgelaer, JP, Duff, GW, Emery, P., Ethgen, D, Kreutz, G, Menkes, CJ, Reidel, H, Serni, U, Van der Auwera, P, Veys, Emilie, White-Guay, B, Reginster, Jacques, UCL, Lemmel, EM, Reid, DM, Nuki, G, Avouac, B, Bardin, T, Bouvenot, G, Cauwenberge, H, Cluzel, M, Devolgelaer, JP, Duff, GW, Emery, P., Ethgen, D, Kreutz, G, Menkes, CJ, Reidel, H, Serni, U, Van der Auwera, P, Veys, Emilie, White-Guay, B, and Reginster, Jacques

Abstract

Rheumatoid arthritis (RA) is the commonest form of chronic inflammatory joint disease and a major target for symptom-modifying and disease-modifying drug therapy. New approaches to the treatment of RA using biological agents targeted to cellular receptors, cytokines and other mediators of inflammation, together with the availability of new methods of outcome assessment, make it timely to reconsider the classification of anti-rheumatic drugs and the requirements for the registration of new drug entities. Under the auspices of GREES (Group for the Respect of Ethics and Excellence in Science), a European Working Group of clinicians with experience in rheumatology, scientists and representatives from industry and national drug licensing authorities have formulated recommendations for the requirements for registration of anti-rheumatic drugs designed for symptom modification, structural modification and the suppression of inflammation, with particular emphasis placed on quality of life assessment by generic and disease-specific validated methods. This paper outlines the group's advice for pre clinical testing, and Phase I, Phase II and Phase III trials to allow licences to be granted for each indication, while recognizing that a single drug may have reason to be approved under several headings.

Published
1998

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