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425 results on '"van Geloven, Nan"'

102. A comparison of the beta-geometric model with landmarking for dynamic prediction of time to pregnancy

Author

Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, Child Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Eekelen, Rik, Putter, Hein, McLernon, David J, Eijkemans, Marinus J, van Geloven, Nan, Biostatistiek Onderzoek, Infection & Immunity, Circulatory Health, Child Health, JC onderzoeksprogramma Infectieziekten, JC onderzoeksprogramma Methodologie, van Eekelen, Rik, Putter, Hein, McLernon, David J, Eijkemans, Marinus J, and van Geloven, Nan

Published
2020

103. Progression of aortic root dilatation and aortic valve regurgitation after the arterial switch operation

Author

van der Palen, Roel L F, primary, van der Bom, Teun, additional, Dekker, Annika, additional, Tsonaka, Roula, additional, van Geloven, Nan, additional, Kuipers, Irene M, additional, Konings, Thelma C, additional, Rammeloo, Lukas A J, additional, Ten Harkel, Arend D J, additional, Jongbloed, Monique R M, additional, Koolbergen, Dave R, additional, Mulder, Barbara J M, additional, Hazekamp, Mark G, additional, and Blom, Nico A, additional

Published
2019
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104. Placebo Effect in the PATH Study of Subcutaneous Immunoglobulin in Chronic Inflammatory Demyelinating Polyneuropathy (S43.006)

Author

Lewis, Richard A., primary, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Sobue, Gen, additional, Mielke, Orell, additional, Lawo, John-Philip, additional, Durn, Billie L., additional, Cornblath, David R., additional, Merkies, Ingemar S. J., additional, and Van Schaik, Ivo N., additional

Published
2019
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105. Long-term Safety and Efficacy of Subcutaneous Immunoglobulin IgPro20 in CIDP: the PATH Extension Study. (S43.005)

Author

van Schaik, Ivo N., primary, Mielke, Orell, additional, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Praus, Micheala, additional, Durn, Billie L., additional, Cornblath, David R., additional, and Merkies, Ingemar S.J., additional

Published
2019
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106. Treatment Satisfaction and Work Productivity in a Clinical Study of IgPro20 Maintenance Treatment of CIDP (P5.2-078)

Author

Hartung, Hans-Peter, primary, Mallick, Rajiv, additional, Bril, Vera, additional, van Geloven, Nan, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Mielke, Orell, additional, Durn, Billie L., additional, Cornblath, David R., additional, Merkies, Ingemar S. J., additional, and van Schaik, Ivo N., additional

Published
2019
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107. Efficacy and safety of IVIG in CIDP : Combined data of the PRIMA and PATH studies

Author

Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, PRIMA Trial Investigators and the PATH Study Group, Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, and PRIMA Trial Investigators and the PATH Study Group

Published
2019

108. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy : Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

Mielke, Orell, Bril, Vera, Cornblath, David R, Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Merkies, Ingemar S J, Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N, PATH study group, Mielke, Orell, Bril, Vera, Cornblath, David R, Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Merkies, Ingemar S J, Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N, and PATH study group

Published
2019

109. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

ZL Neuromusculaire Ziekten Medisch, Brain, Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, PRIMA Trial Investigators and the PATH Study Group, ZL Neuromusculaire Ziekten Medisch, Brain, Merkies, Ingemar S J, van Schaik, Ivo N, Léger, Jean-Marc, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Durn, Billie L, Cornblath, David R, De Bleecker, Jan L, Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, and PRIMA Trial Investigators and the PATH Study Group

Published
2019

110. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre-randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

ZL Neuromusculaire Ziekten Medisch, Brain, Mielke, Orell, Bril, Vera, Cornblath, David R, Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Merkies, Ingemar S J, Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N, PATH study group, ZL Neuromusculaire Ziekten Medisch, Brain, Mielke, Orell, Bril, Vera, Cornblath, David R, Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Merkies, Ingemar S J, Sobue, Gen, Durn, Billie, Shebl, Amgad, van Schaik, Ivo N, and PATH study group

Published
2019

111. Long-term safety and efficacy of subcutaneous immunoglobulin IgPro20 in CIDP PATH extension study

Author

CSL Behring, van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., Merkies, Ingemar S. J., CSL Behring, van Schaik, Ivo N., Mielke, Orell, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Durn, Billie L., Cornblath, David R., and Merkies, Ingemar S. J.

Abstract

[Objective] To investigate the long-term safety and efficacy of weekly subcutaneous IgPro20 (Hizentra, CSL Behring) in chronic inflammatory demyelinating polyneuropathy (CIDP)., [Methods] In a 48-week open-label prospective extension study to the PATH study, patients were initially started on 0.2 g/kg or on 0.4 g/kg weekly and—if clinically stable—switched to 0.2 g/kg weekly after 24 weeks. Upon CIDP relapse on the 0.2 g/kg dose, 0.4 g/kg was (re)initiated. CIDP relapse was defined as a deterioration by at least 1 point in the total adjusted Inflammatory Neuropathy Cause and Treatment score., [Results] Eighty-two patients were enrolled. Sixty-two patients initially received 0.4 g/kg, 20 patients 0.2 g/kg weekly. Seventy-two received both doses during the study. Sixty-six patients (81%) completed the 48-week study duration. Overall relapse rates were 10% in 0.4 g/kg–treated patients and 48% in 0.2 g/kg–treated patients. After dose reduction from 0.4 to 0.2 g/kg, 51% (27/53) of patients relapsed, of whom 92% (24 of 26) improved after reinitiation of the 0.4 g/kg dose. Two-thirds of patients (19/28) who completed the PATH study without relapse remained relapse-free on the 0.2 g/kg dose after dose reduction in the extension study. Sixty-two patients had adverse events (AEs) (76%), of which most were mild or moderate with no related serious AEs., [Conclusions] Subcutaneous treatment with IgPro20 provided long-term benefit at both 0.4 and 0.2 g/kg weekly doses with lower relapse rates on the higher dose. Long-term dosing should be individualized to find the most appropriate dose in a given patient. Classification of evidence This study provides Class IV evidence that for patients with CIDP, long-term treatment with SCIG beyond 24 weeks is safe and efficacious.

Published
2019

112. Efficacy and safety of IVIG in CIDP: Combined data of the PRIMA and PATH studies

Author

CSL Behring, Merkies, Ingemar S. J., van Schaik, Ivo N., Léger, Jean-Marc, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, Mielke, Orell, CSL Behring, Merkies, Ingemar S. J., van Schaik, Ivo N., Léger, Jean-Marc, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Durn, Billie L., Cornblath, David R., De Bleecker, Jan L., Sommer, Claudia, Robberecht, Wim, Saarela, Mika, Kamienowski, Jerzy, Stelmasiak, Zbigniew, Tackenberg, Björn, and Mielke, Orell

Abstract

Intravenous immunoglobulin (IVIG) is a potential therapy for chronic inflammatory demyelinating polyneuropathy (CIDP). To investigate the efficacy and safety of the IVIG IgPro10 (Privigen) for treatment of CIDP, results from Privigen Impact on Mobility and Autonomy (PRIMA), a prospective, open‐label, single‐arm study of IVIG in immunoglobulin (Ig)‐naïve or IVIG pre‐treated subjects (NCT01184846, n = 28) and Polyneuropathy And Treatment with Hizentra (PATH), a double‐blind, randomized study including an open‐label, single‐arm IVIG phase in IVIG pre‐treated subjects (NCT01545076, IVIG restabilization phase n = 207) were analyzed separately and together (n = 235). Efficacy assessments included change in adjusted inflammatory neuropathy cause and treatment (INCAT) score, grip strength and Medical Research Council (MRC) sum score. Adverse drug reactions (ADRs) and ADRs/infusion were recorded. Adjusted INCAT response rate was 60.7% in all PRIMA subjects at Week 25 (76.9% in IVIG pre‐treated subjects) and 72.9% in PATH. In the pooled cohort (n = 235), INCAT response rate was 71.5%; median time to INCAT improvement was 4.3 weeks. No clear demographic differences were noticed between early (responding before Week 7, n = 148) and late responders (n = 21). In the pooled cohort, median change from baseline to last observation was −1.0 (interquartile range −2.0; 0.0) point for INCAT score; +8.0 (0.0; 20.0) kPa for maximum grip strength; +3.0 (1.0; 7.0) points for MRC sum score. In the pooled cohort, 271 ADRs were reported in 105 subjects (44.7%), a rate of 0.144 ADRs per infusion. This analysis confirms the efficacy and safety of IgPro10, a recently FDA‐approved IVIG for CIDP, in a population of mainly pre‐treated subjects with CIDP [Correction added on 14 March 2019 after first online publication: the INCAT response rate has been corrected.].

Published
2019

113. Restabilization treatment after intravenous immunoglobulin withdrawal in chronic inflammatory demyelinating polyneuropathy: Results from the pre‐randomization phase of the Polyneuropathy And Treatment with Hizentra study

Author

CSL Behring, Meridian HealthComms, Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie L., Shebl, Amgad, van Schaik, Ivo N., CSL Behring, Meridian HealthComms, Mielke, Orell, Bril, Vera, Cornblath, David R., Lawo, John-Philip, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A., Merkies, Ingemar S. J., Sobue, Gen, Durn, Billie L., Shebl, Amgad, and van Schaik, Ivo N.

Abstract

In patients with chronic inflammatory demyelinating polyneuropathy (CIDP), intravenous immunoglobulin (IVIG) is recommended to be periodically reduced to assess the need for ongoing therapy. However, little is known about the effectiveness of restabilization with IVIG in patients who worsen after IVIG withdrawal. In the Polyneuropathy And Treatment with Hizentra (PATH) study, the pre‐randomization period included sudden stopping of IVIG followed by 12 weeks of observation. Those deteriorating were then restabilized with IVIG. Of 245 subjects who stopped IVIG, 28 did not show signs of clinical deterioration within 12 weeks. Two hundred and seven received IVIG restabilization with an induction dose of 2 g/kg bodyweight (bw) IgPro10 (Privigen, CSL Behring, King of Prussia, Pennsylvania) and maintenance doses of 1 g/kg bw every 3 weeks for up to 13 weeks. Signs of clinical improvement were seen in almost all (n = 188; 91%) subjects. During IVIG restabilization, 35 subjects either did not show CIDP stability (n = 21, analyzed as n = 22 as an additional subject was randomized in error) or withdrew for other reasons (n = 14). Of the 22 subjects who did not achieve clinical stability, follow‐up information in 16 subjects after an additional 4 weeks was obtained. Nine subjects were reported to have improved, leaving a maximum of 27 subjects (13%) who either showed no signs of clinical improvement during the restabilization phase and 4 weeks post‐study or withdrew for other reasons. In conclusion, sudden IVIG withdrawal was effective in detecting ongoing immunoglobulin G dependency with a small risk for subjects not returning to their baseline 17 weeks after withdrawal.

Published
2019

115. Staken preventieve cardiovasculaire medicatie bij laagrisicopatiënten

Author

Luymes, Clare, primary, Poortvliet, Rosalinde, additional, van Geloven, Nan, additional, de Waal, Margot, additional, Drewes, Yvonne, additional, Blom, Jeanet, additional, Smidt, Nynke, additional, Assendelft, Willem, additional, van den Hout, Wilbert, additional, de Ruijter, Wouter, additional, and Numans, Mattijs, additional

Published
2018
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117. Accuracy of Pulse Oximetry Screening for Critical Congenital Heart Defects after Home Birth and Early Postnatal Discharge

Author

Narayen, Ilona C., primary, Blom, Nico A., additional, van Geloven, Nan, additional, Blankman, Ellen I.M., additional, van den Broek, Annique J.M., additional, Bruijn, Martijn, additional, Clur, Sally-Ann B., additional, van den Dungen, Frank A., additional, Havers, Hester M., additional, van Laerhoven, Henriëtte, additional, Mir, Shahryar E., additional, Muller, Moira A., additional, Polak, Odette M., additional, Rammeloo, Lukas A.J., additional, Ramnath, Gracita, additional, van der Schoor, Sophie R.D., additional, van Kaam, Anton H., additional, te Pas, Arjan B., additional, van den Akker, E.S.A., additional, van den Berg, E., additional, de Boer, M.A., additional, Bouwmeester, S., additional, van Dorp, M.C., additional, de Graaf, I.M., additional, Haak, M.C., additional, Hermsen, B.B.J., additional, Hummel, P., additional, Kok, B., additional, Medema, T.J., additional, Mérelle, M.E., additional, Mooren, G.C.A.H.C.N., additional, Onland, W., additional, Pernet, P.J., additional, von Rosenstiel, I.A., additional, Schrijver-Levie, N., additional, Six, S., additional, and Williams, J.M., additional

Published
2018
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118. Intravenous versus subcutaneous immunoglobulin – Authors' reply

Author

van Schaik, Ivo N, primary, Mielke, Orell, additional, Sabet, Arman, additional, George, Koshy, additional, Roberts, Leslie, additional, Carne, Ross, additional, Blum, Stefan, additional, Henderson, Robert, additional, Van Damme, Philip, additional, Demeestere, Jelle, additional, Larue, Sandrine, additional, Pinard D'Amour, Catherine-Andree, additional, Bril, Vera, additional, Breiner, Ari, additional, Kunc, Pavel, additional, Valis, Martin, additional, Sussova, Jana, additional, Kalous, Tomas, additional, Talab, Radomir, additional, Bednar, Michal, additional, Toomsoo, Toomas, additional, Rubanovits, Inna, additional, Gross-Paju, Katrin, additional, Sorro, Ulvi, additional, Saarela, Mika, additional, Auranen, Mari, additional, Pouget, Jean, additional, Attarian, Shahram, additional, Le Masson, Gwendal, additional, Wielanek-Bachelet, Anne-Cécile, additional, Desnuelle, Claude, additional, Delmont, Emilien, additional, Clavelou, Pierre, additional, Aufauvre, Dominique, additional, Schmidt, Jens, additional, Zschuentssch, Jana, additional, Sommer, Claudia, additional, Kramer, Daniela, additional, Hoffmann, Olaf, additional, Goerlitz, Carsten, additional, Haas, Judith, additional, Chatzopoulos, Marko, additional, Yoon, Min-Suk, additional, Gold, Ralf, additional, Berlit, Peter, additional, Jaspert-Grehl, Andrea, additional, Liebetanz, David, additional, Kutschenko, Anna, additional, Stangel, Martin, additional, Trebst, Corinna, additional, Baum, Petra, additional, Then Bergh, Florian, additional, Klehmet, Juliane, additional, Meisel, Andreas, additional, Klostermann, Fabian, additional, Oechtering, Johanna, additional, Lehmann, Helmar, additional, Schroeter, Michael, additional, Hagenacker, Tim, additional, Mueller, Daniel, additional, Sperfeld, Anne-Dorte, additional, Bethke, Florian, additional, Hartung, Hans-Peter, additional, Drory, Vivian, additional, Algom, Avi, additional, Yarnitsky, David, additional, Murinson, Beth Brianna, additional, Di Muzio, Antonio, additional, Ciccocioppo, Fausta, additional, Sorbi, Sandro, additional, Mata, Sabrina, additional, Schenone, Angelo, additional, Grandis, Marina, additional, Lauria, Giuseppe, additional, Cazzato, Daniele, additional, Antonini, Giovanni, additional, Morino, Stefania, additional, Cocito, Dario, additional, Zibetti, Maurizio, additional, Yokota, Takanori, additional, Ohkubo, Takuya, additional, Kanda, Takashi, additional, Kawai, Motoharu, additional, Kaida, Kenichi, additional, Onoue, Hiroyuki, additional, Kuwabara, Satoshi, additional, Mori, Masahiro, additional, Iijima, Masahiro, additional, Ohyama, Ken, additional, Sobue, Gen, additional, Baba, Masayuki, additional, Tomiyama, Masahiko, additional, Nishiyama, Kazutoshi, additional, Akutsu, Tsugio, additional, Yokoyama, Kazumasa, additional, Kanai, Kazuaki, additional, van Schaik, Ivo N., additional, Eftimov, Filip, additional, Notermans, Nicolette. C., additional, Visser, Nora. A., additional, Faber, Catharina, additional, Hoeijmakers, Janneke. G.J., additional, Merkies, Ingemar S.J., additional, van Geloven, Nan, additional, Rejdak, Konrad, additional, Chyrchel-Paszkiewicz, Urszula, additional, Casanovas Pons, Carlos, additional, Alberti Aguiló, María Antonia, additional, Gamez, Josep, additional, Figueras, María, additional, Marquez Infante, Celedonio, additional, Benitez Rivero, Sonia, additional, Lunn, Michael, additional, Morrow, Jasper, additional, Gosal, David, additional, Lavin, Timothy Myles, additional, Melamed, Isaac, additional, Testori, Alessandro, additional, Ajroud-Driss, Senda, additional, Menichella, Daniela, additional, Simpson, Ericka, additional, Chi-Ho Lai, Eugene, additional, Dimachkie, Mazen, additional, Barohn, Richard J., additional, Beydoun, Said, additional, Johl, Harpreet, additional, Lange, Dale, additional, Shtilbans, Alexander, additional, Muley, Suraj, additional, Ladha, Shafeeq, additional, Freimer, Miriam, additional, Kissel, John, additional, Latov, Norman, additional, Chin, Russell, additional, Ubogu, Eroboghene, additional, Mumfrey, Sandi, additional, Rao, T. Hermanth P., additional, MacDonald, Paul, additional, Sharma, Khema, additional, Gonzalez, Ginna, additional, Allen, Jeffrey, additional, Walk, David, additional, Hobson-Webb, Lisa, additional, Gable, Karissa, additional, Lewis, Richard A., additional, Cornblath, David R., additional, Lawo, John-Phillip, additional, Praus, Michaela, additional, and Durn, Billie L., additional

Published
2018
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119. Efficacy and Safety of Intravenous Immunoglobulin (IVIG) IgPro10 in Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): the PRIMA and PATH studies (P1.153)

Author

Mielke, Orell, primary, van Schaik, Ivo N., additional, Leger, Jean-Marc, additional, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Durn, Billie, additional, De Bleecker, Jan, additional, Cornblath, David R., additional, Sommer, Claudia, additional, Robberecht, Wim, additional, Saarela, Mika, additional, Kamienowski, Jerzy, additional, Stelmasiak, Zbigniew, additional, Tackenberg, Bjorn, additional, and Merkies, Ingemar S. J., additional

Published
2018
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120. Electrophysiological Testing in Patients with Chronic Inflammatory Demyelinating Polyneuropathy Treated with Subcutaneous Immunoglobulin: The PATH Study (P1.433)

Author

Bril, Vera, primary, van Schaik, Ivo N., additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A., additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Mielke, Orell, additional, Durn, Billie, additional, Cornblath, David R., additional, and Merkies, Ingemar S. J., additional

Published
2018
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121. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH) : a randomised, double-blind, placebo-controlled, phase 3 trial

Author

van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, PATH study group, van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, and PATH study group

Published
2018

122. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

ZL Neuromusculaire Ziekten Medisch, Brain, Opleiding Neurologie, van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, PATH study group, ZL Neuromusculaire Ziekten Medisch, Brain, Opleiding Neurologie, van Schaik, Ivo N, Bril, Vera, van Geloven, Nan, Hartung, Hans-Peter, Lewis, Richard A, Sobue, Gen, Lawo, John-Philip, Praus, Michaela, Mielke, Orell, Durn, Billie L, Cornblath, David R, Merkies, Ingemar S J, and PATH study group

Published
2018

123. Deprescribing preventive cardiovascular medication in patients with predicted low cardiovascular disease risk in general practice – the ECSTATIC study: a cluster randomised non-inferiority trial

Author

Luymes, Clare H., primary, Poortvliet, Rosalinde K. E., additional, van Geloven, Nan, additional, de Waal, Margot W. M., additional, Drewes, Yvonne M., additional, Blom, Jeanet W., additional, Smidt, Nynke, additional, Assendelft, Willem J. J., additional, van den Hout, Wilbert B., additional, de Ruijter, Wouter, additional, and Numans, Mattijs E., additional

Published
2018
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124. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (PATH): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

van Schaik, Ivo N, primary, Bril, Vera, additional, van Geloven, Nan, additional, Hartung, Hans-Peter, additional, Lewis, Richard A, additional, Sobue, Gen, additional, Lawo, John-Philip, additional, Praus, Michaela, additional, Mielke, Orell, additional, Durn, Billie L, additional, Cornblath, David R, additional, Merkies, Ingemar S J, additional, Sabet, A., additional, George, K., additional, Roberts, L., additional, Carne, R., additional, Blum, S., additional, Henderson, R., additional, Van Damme, P., additional, Demeestere, J., additional, Larue, S., additional, D'Amour, C., additional, Bril, V., additional, Breiner, A., additional, Kunc, P., additional, Valis, M., additional, Sussova, J., additional, Kalous, T., additional, Talab, R., additional, Bednar, M., additional, Toomsoo, T., additional, Rubanovits, I., additional, Gross-Paju, K., additional, Sorro, U., additional, Saarela, M., additional, Auranen, M., additional, Pouget, J., additional, Attarian, S., additional, Le Masson, G., additional, Wielanek-Bachelet, A., additional, Desnuelle, C., additional, Delmont, E., additional, Clavelou, P., additional, Aufauvre, D., additional, Schmidt, J., additional, Zschuentssch, J., additional, Sommer, C., additional, Kramer, D., additional, Hoffmann, O., additional, Goerlitz, C., additional, Haas, J., additional, Chatzopoulos, M., additional, Yoon, R., additional, Gold, R., additional, Berlit, P., additional, Jaspert-Grehl, A., additional, Liebetanz, D., additional, Kutschenko, A., additional, Stangel, M., additional, Trebst, C., additional, Baum, P., additional, Bergh, F., additional, Klehmet, J., additional, Meisel, A., additional, Klostermann, F., additional, Oechtering, J., additional, Lehmann, H., additional, Schroeter, M., additional, Hagenacker, T., additional, Mueller, D., additional, Sperfeld, A., additional, Bethke, F., additional, Drory, V., additional, Algom, A., additional, Yarnitsky, D., additional, Murinson, B., additional, Di Muzio, A., additional, Ciccocioppo, F., additional, Sorbi, S., additional, Mata, S., additional, Schenone, A., additional, Grandis, M., additional, Lauria, G., additional, Cazzato, D., additional, Antonini, G., additional, Morino, S., additional, Cocito, D., additional, Zibetti, M., additional, Yokota, T., additional, Ohkubo, T., additional, Kanda, T., additional, Kawai, M., additional, Kaida, K., additional, Onoue, H., additional, Kuwabara, S., additional, Mori, M., additional, Iijima, M., additional, Ohyama, K., additional, Baba, M., additional, Tomiyama, M., additional, Nishiyama, K., additional, Akutsu, T., additional, Yokoyama, K., additional, Kanai, K., additional, van Schaik, I.N., additional, Eftimov, F., additional, Notermans, N.C., additional, Visser, N., additional, Faber, C., additional, Hoeijmakers, J., additional, Rejdak, K., additional, Chyrchel-Paszkiewicz, U., additional, Casanovas Pons, C., additional, Alberti Aguiló, M., additional, Gamez, J., additional, Figueras, M., additional, Marquez Infante, C., additional, Benitez Rivero, S., additional, Lunn, M., additional, Morrow, J., additional, Gosal, D., additional, Lavin, T., additional, Melamed, I., additional, Testori, A., additional, Ajroud-Driss, S., additional, Menichella, D., additional, Simpson, E., additional, Chi-Ho Lai, E., additional, Dimachkie, M., additional, Barohn, R.J., additional, Beydoun, S., additional, Johl, H., additional, Lange, D., additional, Shtilbans, A., additional, Muley, S., additional, Ladha, S., additional, Freimer, M., additional, Kissel, J., additional, Latov, N., additional, Chin, R., additional, Ubogu, E., additional, Mumfrey, S., additional, Rao, T., additional, MacDonald, P., additional, Sharma, K., additional, Gonzalez, G., additional, Allen, J., additional, Walk, D., additional, Hobson-Webb, L., additional, and Gable, K., additional

Published
2018
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128. The Effect of Integration of Self-Management Web Platforms on Health Status in Chronic Obstructive Pulmonary Disease Management in Primary Care (e-Vita Study): Interrupted Time Series Design

Author

Talboom-Kamp, Esther PWA, primary, Verdijk, Noortje A, additional, Kasteleyn, Marise J, additional, Harmans, Lara M, additional, Talboom, Irvin JSH, additional, Looijmans-van den Akker, Ingrid, additional, van Geloven, Nan, additional, Numans, Mattijs E, additional, and Chavannes, Niels H, additional

Published
2017
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129. Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women

Author

Dreyer, Kim, primary, van Rijswijk, Joukje, additional, Mijatovic, Velja, additional, Goddijn, Mariëtte, additional, Verhoeve, Harold R., additional, van Rooij, Ilse A.J., additional, Hoek, Annemieke, additional, Bourdrez, Petra, additional, Nap, Annemiek W., additional, Rijnsaardt-Lukassen, Henrike G.M., additional, Timmerman, Catharina C.M., additional, Kaplan, Mesrure, additional, Hooker, Angelo B., additional, Gijsen, Anna P., additional, van Golde, Ron, additional, van Heteren, Cathelijne F., additional, Sluijmer, Alexander V., additional, de Bruin, Jan-Peter, additional, Smeenk, Jesper M.J., additional, de Boer, Jacoba A.M., additional, Scheenjes, Eduard, additional, Duijn, Annette E.J., additional, Mozes, Alexander, additional, Pelinck, Marie J., additional, Traas, Maaike A.F., additional, van Hooff, Machiel H.A., additional, van Unnik, Gijsbertus A., additional, de Koning, Cornelia H., additional, van Geloven, Nan, additional, Twisk, Jos W.R., additional, Hompes, Peter G.A., additional, and Mol, Ben W.J., additional

Published
2017
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131. Cortical development in fetuses with congenital heart defects using an automated brain-age prediction algorithm.

Author

Everwijn, Sheila M. P., Namburete, Ana I. L., Geloven, Nan, Jansen, Fenna A. R., Papageorghiou, Aris T., Noble, Alison J., Teunissen, Aalbertine K. K., Rozendaal, Lieke, Blom, Nico A., Lith, Jan M. M., Haak, Monique C., van Geloven, Nan, and van Lith, Jan M M

Subjects
CONGENITAL heart disease, FETAL development, FETAL brain, GESTATIONAL age, AGE distribution, EVALUATION research, THREE-dimensional imaging, RESEARCH funding, BRAIN, THIRD trimester of pregnancy, SECOND trimester of pregnancy, FETAL ultrasonic imaging, LONGITUDINAL method, FERRANS & Powers Quality of Life Index, CASE-control method, RESEARCH methodology, RESEARCH, COMPARATIVE studies, DISEASE complications
Abstract

Introduction: Congenital heart defects are associated with neurodevelopmental delay. It is hypothesized that fetuses affected by congenital heart defect have altered cerebral oxygen perfusion and are therefore prone to delay in cortical maturation. The aim of this study was to determine the difference in fetal brain age between consecutive congenital heart defect cases and controls in the second and third trimester using ultrasound.Material and Methods: Since 2014, we have included 90 isolated severe congenital heart defect cases in the Heart And Neurodevelopment (HAND)-study. Every 4 weeks, detailed neurosonography was performed in these fetuses, including the recording of a 3D volume of the fetal brain, from 20 weeks onwards. In all, 75 healthy fetuses underwent the same protocol to serve as a control group. The volumes were analyzed by automated age prediction software which determines gestational age by the assessment of cortical maturation.Results: In total, 477 volumes were analyzed using the age prediction software (199 volumes of 90 congenital heart defect cases; 278 volumes of 75 controls). Of these, 16 (3.2%) volume recordings were excluded because of imaging quality. The age distribution was 19-33 weeks. Mixed model analysis showed that the age predicted by brain maturation was 3 days delayed compared with the control group (P = .002).Conclusions: This study shows that fetuses with isolated cases of congenital heart defects show some delay in cortical maturation as compared with healthy control cases. The clinical relevance of this small difference is debatable. This finding was consistent throughout pregnancy and did not progress during the third trimester. [ABSTRACT FROM AUTHOR]

Published
2019
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133. Risk factors for primary sclerosing cholangitis

Author

MS MDL 1, Other research (not in main researchprogram), Cancer, Boonstra, Kirsten, de Vries, Elisabeth M G, van Geloven, Nan, van Erpecum, Karel J., Spanier, Marcel, Poen, Alexander C, van Nieuwkerk, Carin M, Witteman, Ben J, Tuynman, Hans A, Naber, Anton H, Kingma, Paul J, Beuers, Ulrich, Ponsioen, Cyriel Y, Epi PSC PBC Study Group, MS MDL 1, Other research (not in main researchprogram), Cancer, Boonstra, Kirsten, de Vries, Elisabeth M G, van Geloven, Nan, van Erpecum, Karel J., Spanier, Marcel, Poen, Alexander C, van Nieuwkerk, Carin M, Witteman, Ben J, Tuynman, Hans A, Naber, Anton H, Kingma, Paul J, Beuers, Ulrich, Ponsioen, Cyriel Y, and Epi PSC PBC Study Group

Published
2016

134. Intravenous versus subcutaneous immunoglobulin – Authors' reply

Author

Sabet, Arman, George, Koshy, Roberts, Leslie, Carne, Ross, Blum, Stefan, Henderson, Robert, Van Damme, Philip, Demeestere, Jelle, Larue, Sandrine, Pinard D'Amour, Catherine-Andree, Bril, Vera, Breiner, Ari, Kunc, Pavel, Valis, Martin, Sussova, Jana, Kalous, Tomas, Talab, Radomir, Bednar, Michal, Toomsoo, Toomas, Rubanovits, Inna, Gross-Paju, Katrin, Sorro, Ulvi, Saarela, Mika, Auranen, Mari, Pouget, Jean, Attarian, Shahram, Le Masson, Gwendal, Wielanek-Bachelet, Anne-Cécile, Desnuelle, Claude, Delmont, Emilien, Clavelou, Pierre, Aufauvre, Dominique, Schmidt, Jens, Zschuentssch, Jana, Sommer, Claudia, Kramer, Daniela, Hoffmann, Olaf, Goerlitz, Carsten, Haas, Judith, Chatzopoulos, Marko, Yoon, Min-Suk, Gold, Ralf, Berlit, Peter, Jaspert-Grehl, Andrea, Liebetanz, David, Kutschenko, Anna, Stangel, Martin, Trebst, Corinna, Baum, Petra, Then Bergh, Florian, Klehmet, Juliane, Meisel, Andreas, Klostermann, Fabian, Oechtering, Johanna, Lehmann, Helmar, Schroeter, Michael, Hagenacker, Tim, Mueller, Daniel, Sperfeld, Anne-Dorte, Bethke, Florian, Hartung, Hans-Peter, Drory, Vivian, Algom, Avi, Yarnitsky, David, Murinson, Beth Brianna, Di Muzio, Antonio, Ciccocioppo, Fausta, Sorbi, Sandro, Mata, Sabrina, Schenone, Angelo, Grandis, Marina, Lauria, Giuseppe, Cazzato, Daniele, Antonini, Giovanni, Morino, Stefania, Cocito, Dario, Zibetti, Maurizio, Yokota, Takanori, Ohkubo, Takuya, Kanda, Takashi, Kawai, Motoharu, Kaida, Kenichi, Onoue, Hiroyuki, Kuwabara, Satoshi, Mori, Masahiro, Iijima, Masahiro, Ohyama, Ken, Sobue, Gen, Baba, Masayuki, Tomiyama, Masahiko, Nishiyama, Kazutoshi, Akutsu, Tsugio, Yokoyama, Kazumasa, Kanai, Kazuaki, van Schaik, Ivo N., Eftimov, Filip, Notermans, Nicolette. C., Visser, Nora. A., Faber, Catharina, Hoeijmakers, Janneke. G.J., Merkies, Ingemar S.J., van Geloven, Nan, Rejdak, Konrad, Chyrchel-Paszkiewicz, Urszula, Casanovas Pons, Carlos, Alberti Aguiló, María Antonia, Gamez, Josep, Figueras, María, Marquez Infante, Celedonio, Benitez Rivero, Sonia, Lunn, Michael, Morrow, Jasper, Gosal, David, Lavin, Timothy Myles, Melamed, Isaac, Testori, Alessandro, Ajroud-Driss, Senda, Menichella, Daniela, Simpson, Ericka, Chi-Ho Lai, Eugene, Dimachkie, Mazen, Barohn, Richard J., Beydoun, Said, Johl, Harpreet, Lange, Dale, Shtilbans, Alexander, Muley, Suraj, Ladha, Shafeeq, Freimer, Miriam, Kissel, John, Latov, Norman, Chin, Russell, Ubogu, Eroboghene, Mumfrey, Sandi, Rao, T. Hermanth P., MacDonald, Paul, Sharma, Khema, Gonzalez, Ginna, Allen, Jeffrey, Walk, David, Hobson-Webb, Lisa, Gable, Karissa, Lewis, Richard A., Cornblath, David R., Lawo, John-Phillip, Praus, Michaela, Durn, Billie L., Mielke, Orell, and van Schaik, Ivo N

Published
2018
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135. Statistical modelling of unobserved medical data

Author

van Geloven, Nan, Zwinderman, A.H., Mol, B.W.J., Faculteit der Geneeskunde, Zwinderman, Koos H., Mol, Bernardus W. J., and Clinical Research Unit

Abstract

Het gebruik van nieuwe statistische methoden maakt het mogelijk meer informatie te halen uit onvolledige medische gegevens. Nan van Geloven toont dit in zes studies aan. In haar onderzoek optimaliseert Van Geloven onvolledige informatie door de oorzaken die leiden tot het ontbreken van gegevens grondig onder de loep te nemen. Ze maakt gebruik van specifieke statistische methoden die rekening houden met de kennis die voorhanden is over het ontbreken van de gegevens. Deze aanpak leidt tot nieuwe inzichten. Zo toont Van Geloven aan dat traditionele statistische methoden de kans op een zwangerschap overschatten door het gebruik van irreële aannames over het (niet geobserveerde) natuurlijke zwangerschapspotentieel in paren die starten met vruchtbaarheidsbehandelingen zoals IVF. Ook maakt ze met een statistisch model onderscheid tussen paren met verminderde en paren met afwezige kans op een zwangerschap. Dit onderscheid kan niet gemaakt worden met de conventionele analysemethoden. Verder maakt Van Geloven duidelijk dat de nauwkeurigheid van testen voor de doorgankelijkheid van eileiders beter geschat kan worden door deze testen gezamenlijk te evalueren. Ook toont ze aan dat het risicoprofiel van patiënten na een acuut coronair syndroom afneemt over de tijd. Er kan een nieuw analysemodel ontwikkeld worden voor virusdata afkomstig uit seriële verdunningsreeksen. Dit model kan processen verbeteren die virussen moeten verwijderen uit donorbloed en -plasma.

Published
2013

137. Local Depolarization Abnormalities Are the Dominant Pathophysiologic Mechanism for Type 1 Electrocardiogram in Brugada Syndrome A Study of Electrocardiograms, Vectorcardiograms, and Body Surface Potential Maps During Ajmaline Provocation

Author

Postema, Pieter G., van Dessel, Pascal F.H.M., Kors, Jan A., Linnenbank, Andre C., van Herpen, Gerard, Ritsema van Eck, Henk J., van Geloven, Nan, de Bakker, Jacques M.T., Wilde, Arthur A.M., Tan, Hanno L., Cardiology, Amsterdam Cardiovascular Sciences, and Other departments

Subjects
body surface potential mapping, electrocardiography, Brugada syndrome, vectorcardiography, sudden cardiac death
Abstract

Objectives We sought to obtain new insights into the pathophysiologic basis of Brugada syndrome (BrS) by studying changes in various electrocardiographic depolarization and/ or repolarization variables that occurred with the development of the signature type 1 BrS electrocardiogram (ECG) during ajmaline provocation testing. Background BrS is associated with sudden cardiac death. Its pathophysiologic basis, although unresolved, is believed to reside in abnormal cardiac depolarization or abnormal repolarization. Methods Ajmaline provocation was performed in 269 patients suspected of having BrS with simultaneous recording of ECGs, vectorcardiograms, and 62-lead body surface potential maps. Results A type 1 ECG was elicited in 91 patients (BrS patients), 162 patients had a negative test result (controls), and 16 patients had an abnormal test result. Depolarization abnormalities were more prominent in BrS patients and were mapped to the right ventricle (RV) by longer right precordial filtered QRS complex durations (142 +/- 23 ms vs. 125 +/- 14 ms, p

Published
2010

138. The Prognostic Value of Bleeding Academic Research Consortium (BARC)-Defined Bleeding Complications in ST-Segment Elevation Myocardial Infarction

Author

Kikkert, Wouter J., primary, van Geloven, Nan, additional, van der Laan, Mariet H., additional, Vis, Marije M., additional, Baan, Jan, additional, Koch, Karel T., additional, Peters, Ron J., additional, de Winter, Robbert J., additional, Piek, Jan J., additional, Tijssen, Jan G.P., additional, and Henriques, José P.S., additional

Published
2014
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139. Update on the Preventive Antibiotics in Stroke Study (PASS): a randomised controlled phase 3 clinical trial

Author

Westendorp, Willeke F, primary, Vermeij, Jan-Dirk, additional, van Geloven, Nan, additional, Dippel, Diederik WJ, additional, Dijkgraaf, Marcel GW, additional, van der Poll, Tom, additional, Prins, Jan M, additional, Spanjaard, Lodewijk, additional, Vermeij, Frederique H, additional, Nederkoorn, Paul J, additional, and van de Beek, Diederik, additional

Published
2014
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140. Season of sampling and season of birth influence serotonin metabolite levels in human cerebrospinal fluid.

Author

Luykx, Jurjen J, Luykx, Jurjen J, Bakker, Steven C, Lentjes, Eef, Boks, Marco PM, van Geloven, Nan, Eijkemans, Marinus JC, Janson, Esther, Strengman, Eric, de Lepper, Anne M, Westenberg, Herman, Klopper, Kai E, Hoorn, Hendrik J, Gelissen, Harry PMM, Jordan, Julian, Tolenaar, Noortje M, van Dongen, Eric PA, Michel, Bregt, Abramovic, Lucija, Horvath, Steve, Kappen, Teus, Bruins, Peter, Keijzers, Peter, Borgdorff, Paul, Ophoff, Roel A, Kahn, René S, Luykx, Jurjen J, Luykx, Jurjen J, Bakker, Steven C, Lentjes, Eef, Boks, Marco PM, van Geloven, Nan, Eijkemans, Marinus JC, Janson, Esther, Strengman, Eric, de Lepper, Anne M, Westenberg, Herman, Klopper, Kai E, Hoorn, Hendrik J, Gelissen, Harry PMM, Jordan, Julian, Tolenaar, Noortje M, van Dongen, Eric PA, Michel, Bregt, Abramovic, Lucija, Horvath, Steve, Kappen, Teus, Bruins, Peter, Keijzers, Peter, Borgdorff, Paul, Ophoff, Roel A, and Kahn, René S

Abstract

BackgroundAnimal studies have revealed seasonal patterns in cerebrospinal fluid (CSF) monoamine (MA) turnover. In humans, no study had systematically assessed seasonal patterns in CSF MA turnover in a large set of healthy adults.Methodology/principal findingsStandardized amounts of CSF were prospectively collected from 223 healthy individuals undergoing spinal anesthesia for minor surgical procedures. The metabolites of serotonin (5-hydroxyindoleacetic acid, 5-HIAA), dopamine (homovanillic acid, HVA) and norepinephrine (3-methoxy-4-hydroxyphenylglycol, MPHG) were measured using high performance liquid chromatography (HPLC). Concentration measurements by sampling and birth dates were modeled using a non-linear quantile cosine function and locally weighted scatterplot smoothing (LOESS, span = 0.75). The cosine model showed a unimodal season of sampling 5-HIAA zenith in April and a nadir in October (p-value of the amplitude of the cosine = 0.00050), with predicted maximum (PC(max)) and minimum (PC(min)) concentrations of 173 and 108 nmol/L, respectively, implying a 60% increase from trough to peak. Season of birth showed a unimodal 5-HIAA zenith in May and a nadir in November (p = 0.00339; PC(max) = 172 and PC(min) = 126). The non-parametric LOESS showed a similar pattern to the cosine in both season of sampling and season of birth models, validating the cosine model. A final model including both sampling and birth months demonstrated that both sampling and birth seasons were independent predictors of 5-HIAA concentrations.ConclusionIn subjects without mental illness, 5-HT turnover shows circannual variation by season of sampling as well as season of birth, with peaks in spring and troughs in fall.

Published
2012

141. Subcutaneous immunoglobulin for maintenance treatment in chronic inflammatory demyelinating polyneuropathy (The PATH Study): study protocol for a randomized controlled trial.

Author

van Schaik, Ivo N., van Geloven, Nan, Bril, Vera, Hartung, Hans-Peter, Lewis, Richard A., Sobue, Gen, Lawo, John-Philip, Mielke, Orell, Cornblath, David R., Merkies, Ingemar S. J., and PATH study group

Subjects
*IMMUNOGLOBULINS, *DEMYELINATION, *RANDOMIZED controlled trials, *TREATMENT effectiveness, *PLACEBOS, *CLINICAL trials, *COMPARATIVE studies, *FUNCTIONAL assessment, *EXPERIMENTAL design, *IMMUNOLOGICAL adjuvants, *INTRAVENOUS therapy, *RESEARCH methodology, *MEDICAL cooperation, *RESEARCH protocols, *PATIENT satisfaction, *GUILLAIN-Barre syndrome, *RESEARCH, *TIME, *DISEASE relapse, *EVALUATION research, *DISEASE remission, *BLIND experiment, *SUBCUTANEOUS infusions, *DIAGNOSIS
Abstract

Background: Subcutaneous administration of Ig (SCIg) has gained popularity as an alternative route of administration but has never been rigorously examined in chronic inflammatory demyelinating polyneuropathy (CIDP).Methods/design: The primary objective of the PATH study (Polyneuropathy and Treatment with Hizentra) is to determine the efficacy of two different doses of SCIg IgPro20 (0.2 g/kg bw or 0.4 g/kg bw) in a 24-week maintenance treatment of CIDP in comparison to placebo. The primary efficacy endpoint will be the proportion of patients who show CIDP relapse (1-point deterioration on the adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) disability score) or are withdrawn within 24 weeks after randomization for any reason. IVIg-dependent adult patients with definite or probable CIDP according to the European Federation of Neurological Societies/Peripheral Nerve Society who fulfil the inclusion and exclusion criteria will be eligible. Based on sample-size calculation and relapse assumptions in the three arms, a sample size of 58 is needed per arm (overall sample size will be 350, of which 174 will be randomized). All eligible patients will progress through three study periods: an IgG dependency period (≤12 weeks) to select those who are Ig dependent; an IVIg restabilization period (10 or 13 weeks), which will be performed using the 10 % IgPro10 product; and an SC treatment period (24 weeks, followed by a 1-week completion visit after last follow-up). Patients showing IVIg restabilization will be randomized to demonstrate the efficacy of SCIg IgPro20 maintenance treatment over placebo. After completing the study, subjects are eligible to enter a long-term, open-label, extension study of 1 year or return to their previous treatment. In case of CIDP relapse during the 24-week SC treatment period, IgPro10 rescue medication will be offered. Safety, tolerability, and patients' preference of Ig administration route will be examined.Discussion: The PATH trial, which started in March 2012, is expected to finish at the end of 2016. The results will increase knowledge about the efficacy, safety, and tolerability of SCIg in maintenance management of CIDP patients.Trial Registration: ClinicalTrials.gov, NCT01545076 . Registered on 1 March 2012. [ABSTRACT FROM AUTHOR]

Published
2016
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142. Allogeneic Serum Eye Drops: A Randomized Clinical Trial to Evaluate the Clinical Effectiveness of Two Drop Sizes.

Author

Vermeulen, Christie, van der Burg, Lars L. J., van Geloven, Nan, Eggink, Catharina A., Cheng, Yanny Y. Y., Nuijts, Rudy M. M. A., Wisse, Robert P. L., van Luijk, Chantal M., Nieuwendaal, Carla, Remeijer, Lies, van der Meer, Pieter F., de Korte, Dirk, and Klei, Thomas R. L.

Subjects
*EYE drops, *CLINICAL trials, *DRY eye syndromes
Abstract

Introduction: Allogeneic serum from blood donors is starting to be used to treat patients with dry eye disease (DED). However, the optimal dose is not known. We therefore aimed to evaluate the clinical efficaciousness and user-friendliness of micro-sized versus conventional-sized allogeneic serum eye drops (SEDs). Methods: In a randomized trial, patients with DED first receive micro-sized SEDs (7 µl/unit) for 1 month, followed by a 1-month washout, before receiving conventional-sized SEDs (50 µl/unit) for 1 month; or vice versa. The primary endpoint was the Ocular Surface Disease Index (OSDI) score. Secondary endpoints were tear break-up time (TBT), tear production (TP), and presence of corneal punctate lesions (CP). The user-friendliness of both application systems was also compared. A linear mixed model for cross-over design was applied to compare both treatments. Results: Forty-nine patients completed the trial. The mean OSDI score significantly improved from 52 ± 3 to 41 ± 3 for micro-sized SEDs, and from 54 ± 3 to 45 ± 3 for conventional-sized SEDs. Non-inferiority (margin = 6) of micro-sized SEDs was established. We demonstrate a significant improvement for TBT in case of conventional-sized SEDs and for CP in both treatment groups. TP trended towards an improvement in both treatment groups. The user-friendliness of the conventional drop system was significantly higher. Conclusions: For the first time, non-inferiority of micro-sized allogeneic SEDs was established. The beneficial effect of both SED volumes was similar as measured by the OSDI score. Although user-friendliness of the micro drop system was significantly lower, it is an attractive alternative as it saves valuable donor serum. Trial Registration: ClinicalTrials.gov (NCT03539159). [ABSTRACT FROM AUTHOR]

Published
2023
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145. Familial Evaluation in Catecholaminergic Polymorphic Ventricular Tachycardia

Author

van der Werf, Christian, primary, Nederend, Ineke, additional, Hofman, Nynke, additional, van Geloven, Nan, additional, Ebink, Corné, additional, Frohn-Mulder, Ingrid M.E., additional, Alings, A. Marco W., additional, Bosker, Hans A., additional, Bracke, Frank A., additional, van den Heuvel, Freek, additional, Waalewijn, Reinier A., additional, Bikker, Hennie, additional, van Tintelen, J. Peter, additional, Bhuiyan, Zahurul A., additional, van den Berg, Maarten P., additional, and Wilde, Arthur A.M., additional

Published
2012
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146. Season of Sampling and Season of Birth Influence Serotonin Metabolite Levels in Human Cerebrospinal Fluid

Author

Luykx, Jurjen J., primary, Bakker, Steven C., additional, Lentjes, Eef, additional, Boks, Marco P. M., additional, van Geloven, Nan, additional, Eijkemans, Marinus J. C., additional, Janson, Esther, additional, Strengman, Eric, additional, de Lepper, Anne M., additional, Westenberg, Herman, additional, Klopper, Kai E., additional, Hoorn, Hendrik J., additional, Gelissen, Harry P. M. M., additional, Jordan, Julian, additional, Tolenaar, Noortje M., additional, van Dongen, Eric P. A., additional, Michel, Bregt, additional, Abramovic, Lucija, additional, Horvath, Steve, additional, Kappen, Teus, additional, Bruins, Peter, additional, Keijzers, Peter, additional, Borgdorff, Paul, additional, Ophoff, Roel A., additional, and Kahn, René S., additional

Published
2012
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148. Lack of long‐term clinical benefit of thrombus aspiration during primary percutaneous coronary intervention with paclitaxel‐eluting stents or bare‐metal stents: Post‐hoc analysis of the PASSION‐trial

Author

Vink, Maarten A., primary, Dirksen, Maurits T., additional, Tijssen, Jan G.P., additional, Suttorp, Maarten J., additional, Patterson, Mark S., additional, van Geloven, Nan, additional, Ijsselmuiden, Alexander J., additional, Slagboom, Ton, additional, Kiemeneij, Ferdinand, additional, and Laarman, Gerrit J., additional

Published
2011
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149. Multiple Biomarkers at Admission Significantly Improve the Prediction of Mortality in Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-Segment Elevation Myocardial Infarction

Author

Damman, Peter, primary, Beijk, Marcel A.M., additional, Kuijt, Wichert J., additional, Verouden, Niels J.W., additional, van Geloven, Nan, additional, Henriques, José P.S., additional, Baan, Jan, additional, Vis, Marije M., additional, Meuwissen, Martijn, additional, van Straalen, Jan P., additional, Fischer, Johan, additional, Koch, Karel T., additional, Piek, Jan J., additional, Tijssen, Jan G.P., additional, and de Winter, Robbert J., additional

Published
2011
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