38 results on '"Ticha V"'
Search Results
2. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study
- Author
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Kappos, L., Bar-Or, A., Cree, B. A. C., Fox, R. J., Giovannoni, G., Gold, R., Vermersch, P., Arnold, D. L., Arnould, S., Scherz, T., Wolf, C., Wallstrom, E., Dahlke, F., Achiron, A., Achtnichts, L., Agan, K., Akman-Demir, G., Allen, A. B., Antel, J. P., Antiguedad, A. R., Apperson, M., Applebee, A. M., Ayuso, G. I., Baba, M., Bajenaru, O., Balasa, R., Balci, B. P., Barnett, M., Bass, A., Becker, V. U., Bejinariu, M., Bergh, F. T., Bergmann, A., Bernitsas, E., Berthele, A., Bhan, V., Bischof, F., Bjork, R. J., Blevins, G., Boehringer, M., Boerner, T., Bonek, R., Bowen, J. D., Bowling, A., Boyko, A. N., Boz, C., Bracknies, V., Braune, S., Brescia Morra, V., Brochet, B., Brola, W., Brownstone, P. K., Brozman, M., Brunet, D., Buraga, I., Burnett, M., Buttmann, M., Butzkueven, H., Cahill, J., Calkwood, J. C., Camu, W., Cascione, M., Castelnovo, G., Centonze, D., Cerqueira, J., Chan, A., Cimprichova, A., Cohan, S., Comi, G., Conway, J., Cooper, J. A., Corboy, J., Correale, J., Costell, B., Cottrell, D. A., Coyle, P. K., Craner, M., Cui, L., Cunha, L., Czlonkowska, A., da Silva, A. M., de Sa, J., de Seze, J., Debouverie, M., Debruyne, J., Decoo, D., Defer, G., Derfuss, T., Deri, N. H., Dihenia, B., Dioszeghy, P., Donath, V., Dubois, B., Duddy, M., Duquette, P., Edan, G., Efendi, H., Elias, S., Emrich, P. J., Estruch, B. C., Evdoshenko, E. P., Faiss, J., Fedyanin, A. S., Feneberg, W., Fermont, J., Fernandez, O. F., Ferrer, F. C., Fink, K., Ford, H., Ford, C., Francia, A., Freedman, M., Frishberg, B., Galgani, S., Garmany, G. P., Gehring, K., Gitt, J., Gobbi, C., Goldstick, L. P., Gonzalez, R. A., Grandmaison, F., Grigoriadis, N., Grigorova, O., Grimaldi, L. M. E., Gross, J., Gross-Paju, K., Gudesblatt, M., Guillaume, D., Haas, J., Hancinova, V., Hancu, A., Hardiman, O., Harmjanz, A., Heidenreich, F. R., Hengstman, G. J. D., Herbert, J., Herring, M., Hodgkinson, S., Hoffmann, O. M., Hofmann, W. E., Honeycutt, W. D., Hua, L. H., Huang, D., Huang, Y., Hupperts, R., Imre, P., Jacobs, A. K., Jakab, G., Jasinska, E., Kaida, K., Kalnina, J., Kaprelyan, A., Karelis, G., Karussis, D., Katz, A., Khabirov, F. A., Khatri, B., Kimura, T., Kister, I., Kizlaitiene, R., Klimova, E., Koehler, J., Komatineni, A., Kornhuber, A., Kovacs, K., Koves, A., Kozubski, W., Krastev, G., Krupp, L. B., Kurca, E., Lassek, C., Laureys, G., Lee, L., Lensch, E., Leutmezer, F., Li, H., Linker, R. A., Linnebank, M., Liskova, P., Llanera, C., Lu, J., Lutterotti, A., Lycke, J., Macdonell, R., Maciejowski, M., Maeurer, M., Magzhanov, R. V., Maida, E. -M., Malciene, L., Mao-Draayer, Y., Marfia, G. A., Markowitz, C., Mastorodimos, V., Matyas, K., Meca-Lallana, J., Merino, J. A. G., Mihetiu, I. G., Milanov, I., Miller, A. E., Millers, A., Mirabella, M., Mizuno, M., Montalban, X., Montoya, L., Mori, M., Mueller, S., Nakahara, J., Nakatsuji, Y., Newsome, S., Nicholas, R., Nielsen, A. S., Nikfekr, E., Nocentini, U., Nohara, C., Nomura, K., Odinak, M. M., Olsson, T., van Oosten, B. W., Oreja-Guevara, C., Oschmann, P., Overell, J., Pachner, A., Panczel, G., Pandolfo, M., Papeix, C., Patrucco, L., Pelletier, J., Piedrabuena, R., Pless, M., Polzer, U., Pozsegovits, K., Rastenyte, D., Rauer, S., Reifschneider, G., Rey, R., Rizvi, S. A., Robertson, D., Rodriguez, J. M., Rog, D., Roshanisefat, H., Rowe, V., Rozsa, C., Rubin, S., Rusek, S., Sacca, F., Saida, T., Salgado, A. V., Sanchez, V. E. F., Sanders, K., Satori, M., Sazonov, D. V., Scarpini, E. A., Schlegel, E., Schluep, M., Schmidt, S., Scholz, E., Schrijver, H. M., Schwab, M., Schwartz, R., Scott, J., Selmaj, K., Shafer, S., Sharrack, B., Shchukin, I. A., Shimizu, Y., Shotekov, P., Siever, A., Sigel, K. -O., Silliman, S., Simo, M., Simu, M., Sinay, V., Siquier, A. E., Siva, A., Skoda, O., Solomon, A., Stangel, M., Stefoski, D., Steingo, B., Stolyarov, I. D., Stourac, P., Strassburger-Krogias, K., Strauss, E., Stuve, O., Tarnev, I., Tavernarakis, A., Tello, C. R., Terzi, M., Ticha, V., Ticmeanu, M., Tiel-Wilck, K., Toomsoo, T., Tubridy, N., Tullman, M. J., Tumani, H., Turcani, P., Turner, B., Uccelli, A., Urtaza, F. J. O., Vachova, M., Valikovics, A., Walter, S., Van Wijmeersch, B., Vanopdenbosch, L., Weber, J. R., Weiss, S., Weissert, R., West, T., Wiendl, H., Wiertlewski, S., Wildemann, B., Willekens, B., Visser, L. H., Vorobeychik, G., Xu, X., Yamamura, T., Yang, Y. N., Yelamos, S. M., Yeung, M., Zacharias, A., Zelkowitz, M., Zettl, U., Zhang, M., Zhou, H., Zieman, U., Ziemssen, T., Bergmann A., Haas J., Mirabella M. (ORCID:0000-0002-7783-114X), Terzi M., Kappos, L., Bar-Or, A., Cree, B. A. C., Fox, R. J., Giovannoni, G., Gold, R., Vermersch, P., Arnold, D. L., Arnould, S., Scherz, T., Wolf, C., Wallstrom, E., Dahlke, F., Achiron, A., Achtnichts, L., Agan, K., Akman-Demir, G., Allen, A. B., Antel, J. P., Antiguedad, A. R., Apperson, M., Applebee, A. M., Ayuso, G. I., Baba, M., Bajenaru, O., Balasa, R., Balci, B. P., Barnett, M., Bass, A., Becker, V. U., Bejinariu, M., Bergh, F. T., Bergmann, A., Bernitsas, E., Berthele, A., Bhan, V., Bischof, F., Bjork, R. J., Blevins, G., Boehringer, M., Boerner, T., Bonek, R., Bowen, J. D., Bowling, A., Boyko, A. N., Boz, C., Bracknies, V., Braune, S., Brescia Morra, V., Brochet, B., Brola, W., Brownstone, P. K., Brozman, M., Brunet, D., Buraga, I., Burnett, M., Buttmann, M., Butzkueven, H., Cahill, J., Calkwood, J. C., Camu, W., Cascione, M., Castelnovo, G., Centonze, D., Cerqueira, J., Chan, A., Cimprichova, A., Cohan, S., Comi, G., Conway, J., Cooper, J. A., Corboy, J., Correale, J., Costell, B., Cottrell, D. A., Coyle, P. K., Craner, M., Cui, L., Cunha, L., Czlonkowska, A., da Silva, A. M., de Sa, J., de Seze, J., Debouverie, M., Debruyne, J., Decoo, D., Defer, G., Derfuss, T., Deri, N. H., Dihenia, B., Dioszeghy, P., Donath, V., Dubois, B., Duddy, M., Duquette, P., Edan, G., Efendi, H., Elias, S., Emrich, P. J., Estruch, B. C., Evdoshenko, E. P., Faiss, J., Fedyanin, A. S., Feneberg, W., Fermont, J., Fernandez, O. F., Ferrer, F. C., Fink, K., Ford, H., Ford, C., Francia, A., Freedman, M., Frishberg, B., Galgani, S., Garmany, G. P., Gehring, K., Gitt, J., Gobbi, C., Goldstick, L. P., Gonzalez, R. A., Grandmaison, F., Grigoriadis, N., Grigorova, O., Grimaldi, L. M. E., Gross, J., Gross-Paju, K., Gudesblatt, M., Guillaume, D., Haas, J., Hancinova, V., Hancu, A., Hardiman, O., Harmjanz, A., Heidenreich, F. R., Hengstman, G. J. D., Herbert, J., Herring, M., Hodgkinson, S., Hoffmann, O. M., Hofmann, W. E., Honeycutt, W. D., Hua, L. H., Huang, D., Huang, Y., Hupperts, R., Imre, P., Jacobs, A. K., Jakab, G., Jasinska, E., Kaida, K., Kalnina, J., Kaprelyan, A., Karelis, G., Karussis, D., Katz, A., Khabirov, F. A., Khatri, B., Kimura, T., Kister, I., Kizlaitiene, R., Klimova, E., Koehler, J., Komatineni, A., Kornhuber, A., Kovacs, K., Koves, A., Kozubski, W., Krastev, G., Krupp, L. B., Kurca, E., Lassek, C., Laureys, G., Lee, L., Lensch, E., Leutmezer, F., Li, H., Linker, R. A., Linnebank, M., Liskova, P., Llanera, C., Lu, J., Lutterotti, A., Lycke, J., Macdonell, R., Maciejowski, M., Maeurer, M., Magzhanov, R. V., Maida, E. -M., Malciene, L., Mao-Draayer, Y., Marfia, G. A., Markowitz, C., Mastorodimos, V., Matyas, K., Meca-Lallana, J., Merino, J. A. G., Mihetiu, I. G., Milanov, I., Miller, A. E., Millers, A., Mirabella, M., Mizuno, M., Montalban, X., Montoya, L., Mori, M., Mueller, S., Nakahara, J., Nakatsuji, Y., Newsome, S., Nicholas, R., Nielsen, A. S., Nikfekr, E., Nocentini, U., Nohara, C., Nomura, K., Odinak, M. M., Olsson, T., van Oosten, B. W., Oreja-Guevara, C., Oschmann, P., Overell, J., Pachner, A., Panczel, G., Pandolfo, M., Papeix, C., Patrucco, L., Pelletier, J., Piedrabuena, R., Pless, M., Polzer, U., Pozsegovits, K., Rastenyte, D., Rauer, S., Reifschneider, G., Rey, R., Rizvi, S. A., Robertson, D., Rodriguez, J. M., Rog, D., Roshanisefat, H., Rowe, V., Rozsa, C., Rubin, S., Rusek, S., Sacca, F., Saida, T., Salgado, A. V., Sanchez, V. E. F., Sanders, K., Satori, M., Sazonov, D. V., Scarpini, E. A., Schlegel, E., Schluep, M., Schmidt, S., Scholz, E., Schrijver, H. M., Schwab, M., Schwartz, R., Scott, J., Selmaj, K., Shafer, S., Sharrack, B., Shchukin, I. A., Shimizu, Y., Shotekov, P., Siever, A., Sigel, K. -O., Silliman, S., Simo, M., Simu, M., Sinay, V., Siquier, A. E., Siva, A., Skoda, O., Solomon, A., Stangel, M., Stefoski, D., Steingo, B., Stolyarov, I. D., Stourac, P., Strassburger-Krogias, K., Strauss, E., Stuve, O., Tarnev, I., Tavernarakis, A., Tello, C. R., Terzi, M., Ticha, V., Ticmeanu, M., Tiel-Wilck, K., Toomsoo, T., Tubridy, N., Tullman, M. J., Tumani, H., Turcani, P., Turner, B., Uccelli, A., Urtaza, F. J. O., Vachova, M., Valikovics, A., Walter, S., Van Wijmeersch, B., Vanopdenbosch, L., Weber, J. R., Weiss, S., Weissert, R., West, T., Wiendl, H., Wiertlewski, S., Wildemann, B., Willekens, B., Visser, L. H., Vorobeychik, G., Xu, X., Yamamura, T., Yang, Y. N., Yelamos, S. M., Yeung, M., Zacharias, A., Zelkowitz, M., Zettl, U., Zhang, M., Zhou, H., Zieman, U., Ziemssen, T., Bergmann A., Haas J., Mirabella M. (ORCID:0000-0002-7783-114X), and Terzi M.
- Abstract
Background: No treatment has consistently shown efficacy in slowing disability progression in patients with secondary progressive multiple sclerosis (SPMS). We assessed the effect of siponimod, a selective sphingosine 1-phosphate (S1P) receptor1,5 modulator, on disability progression in patients with SPMS. Methods: This event-driven and exposure-driven, double-blind, phase 3 trial was done at 292 hospital clinics and specialised multiple sclerosis centres in 31 countries. Using interactive response technology to assign numbers linked to treatment arms, patients (age 18–60 years) with SPMS and an Expanded Disability Status Scale score of 3·0–6·5 were randomly assigned (2:1) to once daily oral siponimod 2 mg or placebo for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression (CDP) events. The primary endpoint was time to 3-month CDP. Efficacy was assessed for the full analysis set (ie, all randomly assigned and treated patients); safety was assessed for the safety set. This trial is registered with ClinicalTrials.gov, number NCT01665144. Findings: 1651 patients were randomly assigned between Feb 5, 2013, and June 2, 2015 (1105 to the siponimod group, and 546 to the placebo group). One patient did not sign the consent form, and five patients did not receive study drug, all of whom were in the siponimod group. 1645 patients were included in the analyses (1099 in the siponimod group and 546 in the placebo). At baseline, the mean time since first multiple sclerosis symptoms was 16·8 years (SD 8·3), and the mean time since conversion to SPMS was 3·8 years (SD 3·5); 1055 (64%) patients had not relapsed in the previous 2 years, and 918 (56%) of 1651 needed walking assistance. 903 (82%) patients receiving siponimod and 424 (78%) patients receiving placebo completed the study. 288 (26%) of 1096 patients receiving siponimod and 173 (32%) of 545 patients receiving placebo had 3-month CDP (hazard ratio 0·79, 95% CI 0·65–0·95; relative
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- 2018
3. Oral fingolimod in primary progressive multiple sclerosis (INFORMS): a phase 3, randomised, double-blind, placebo-controlled trial
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Lublin, F, Miller, D, Freedman, M, Cree, B, Wolinsky, J, Weiner, H, Lubetzki, C, Hartung, H, Montalban, X, Uitdehaag, B, Kappos, L, Easton, J, Kesselring, J, Weinshenker, B, Laupacis, A, Zarbin, M, Calandra, T, Temkin, N, Dimarco, J, Polman, C, Yousry, T, Hodgkinson, S, Barnett, M, King, J, Butzkueven, H, Macdonell, R, Taylor, B, D'Hooghe, M, Dubois, B, Seeldrayers, P, Mulleners, E, Willekens, B, Delvaux, V, Antel, J, Bhan, V, Devonshire, V, Grandmaison, F, O'Connor, P, Vorobeychik, G, Patry, D, Veloso, F, Duquette, P, Blevins, G, Jacques, F, Lee, L, Berger, J, Havrdova, E, Ticha, V, Kanovsky, P, Rektor, I, Minks, E, Pazdera, L, Vachova, M, Hradilek, P, Frederiksen, J, Petersen, T, Stenager, E, Kallela, M, Eralinna, J, Elovaara, I, Brochet, B, Pelletier, J, Camu, W, Wierstlewski, S, Edan, G, Vermersch, P, de Seze, J, Buttmann, M, Haas, J, Linker, R, Hohlfeld, R, Kieseier, B, Rauer, S, Baum, K, Faiss, J, Tiel Wilck, K, Ziemssen, T, Berthele, A, Maschke, M, Meuth, S, Sailer, M, Kastrup, O, Kleiter, I, Stangel, M, Jakab, G, Csiba, L, Csanyi, A, Imre, P, Rozsa, A, Sándor, P, Valikovics, A, Comi, G, Trojano, M, Lugaresi, A, Colle, A, Ghezzi, A, Mancardi, G, Capra, R, Perini, P, Scarpini, E, Centonze, D, Pozzilli, C, Patti, F, Grimaldi, L, Bertolotto, A, van Oosten, B, de Jong, B, Hupperts, R, van Dijl, R, Frequin, S, Hengstman, G, Selmaj, K, Czlonkowska, A, Kaminska, A, Stelmasiak, Z, Ramo, C, Ramio, L, Izquierdo, G, Arroyo, R, Casanova, B, Garcia Merino, J, Rodriguez Antigüedad, A, Brieva, L, Martinez Yelamos, S, Diaz Tejedor, E, Saiz Hinarejos, A, Olsson, T, Lycke, J, Linnebank, M, Schluep, M, Kamm, C, Gobbi, C, Bebek, N, Dokuz, E, Zorlu, Y, Karabudak, R, Terzi, M, Duddy, M, Lee, M, Nicholas, R, Silber, E, Sharrack, B, Chataway, J, Cottrell, D, Rog, D, Schmierer, K, Mitchell, G, Nelson, F, Saidha, S, Houtchens, M, Graves, D, Miller, A, Agius, M, Bowen, J, Rae Grant, A, Lynch, S, Reder, A, Cascione, M, Cohen, B, Coyle, P, Brook, S, Luzzio, C, Goldman, M, Conway, J, Khan, O, Parks, B, Steingo, B, Weinstock Guttman, B, Lathi, E, Bandari, D, Corboy, J, English, J, Picone, M, Goodman, A, Applebee, A, Gazda, S, Kisanuki, Y, Skeen, M, Wray, S, Moses, H, CHU Pitié-Salpêtrière [AP-HP], Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Klinische Neurowetenschappen, MUMC+: MA Med Staf Spec Neurologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Clinical sciences, Neuroprotection & Neuromodulation, Neurology, Amsterdam Neuroscience - Neuroinfection & -inflammation, Willekens, Barbara, and INFORMS study investigators
- Subjects
0301 basic medicine ,Male ,Clinical Trial, Phase III ,administration & dosage ,Placebo-controlled study ,Aucun ,Administration, Oral ,chemistry.chemical_compound ,0302 clinical medicine ,10. No inequality ,Medicine(all) ,education.field_of_study ,Research Support, Non-U.S. Gov't ,Orvostudományok ,General Medicine ,Middle Aged ,Multiple Sclerosis, Chronic Progressive ,Fingolimod ,3. Good health ,drug therapy ,Multicenter Study ,Treatment Outcome ,Randomized Controlled Trial ,Disease Progression ,Female ,Settore MED/26 - Neurologia ,Immunosuppressive Agents ,medicine.drug ,Adult ,medicine.medical_specialty ,Adolescent ,Population ,Klinikai orvostudományok ,Placebo ,03 medical and health sciences ,Young Adult ,Double-Blind Method ,Internal medicine ,Fingolimod Hydrochloride ,Journal Article ,medicine ,Humans ,education ,Aged ,Expanded Disability Status Scale ,Dose-Response Relationship, Drug ,business.industry ,Multiple sclerosis ,medicine.disease ,Surgery ,030104 developmental biology ,Siponimod ,chemistry ,Human medicine ,business ,030217 neurology & neurosurgery ,[SDV.MHEP]Life Sciences [q-bio]/Human health and pathology - Abstract
BACKGROUND: No treatments have been approved for primary progressive multiple sclerosis. Fingolimod, an oral sphingosine 1-phosphate receptor modulator, is effective in relapse-onset multiple sclerosis, but has not been assessed in primary progressive multiple sclerosis. We assessed the safety and efficacy of fingolimod in patients with primary progressive multiple sclerosis. METHODS: In INFORMS, a multicentre, double-blind, placebo-controlled parallel-group study, patients with primary progressive multiple sclerosis recruited across 148 centres in 18 countries were randomly allocated (1:1) with computer-generated blocks to receive oral fingolimod or placebo for at least 36 months and a maximum of 5 years. Patients were initially assigned to fingolimod 1·25 mg per day or placebo (cohort 1); however, after a protocol amendment on Nov 19, 2009, patients were switched in a masked manner to fingolimod 0·5 mg, whereas those on placebo continued on matching placebo. From then onwards, patients were assigned to receive fingolimod 0·5 mg/day or placebo (cohort 2). Key inclusion criteria were age 25-65 years, clinical diagnosis of primary progressive multiple sclerosis, 1 year or more of disease progression, and two of the following criteria: positive brain MRI; positive spinal cord MRI; or positive cerebrospinal fluid. Additional eligibility criteria included disease duration of 2-10 years and objective evidence of disability progression in the previous 2 years. Patients and study investigators were masked to group assignment. We used a novel primary composite endpoint based on change from baseline in Expanded Disability Status Scale (EDSS), 25' Timed-Walk Test, or Nine-Hole Peg Test to assess time to 3-month confirmed disability progression in study participants treated for at least 3 years. All randomised patients took at least one dose of study drug. The primary efficacy analysis included all patients in cohort 2 and those assigned to placebo in cohort 1. The safety analysis included all patients in cohorts 1 and 2. This study is registered with ClinicalTrials.gov, number NCT00731692. The study is now closed. FINDINGS: 970 patients were randomly assigned between Sept 3, 2008, and Aug 30, 2011 (147 to fingolimod 1·25 mg and 133 to placebo in cohort 1; 336 to fingolimod 0·5 mg and 354 to placebo in cohort 2). The efficacy analysis set (n=823) consisted of 336 patients randomly allocated to fingolimod 0·5 mg and 487 to placebo. Baseline characteristics were similar across groups and representative of a primary progressive multiple sclerosis population (48% women, mean age 48·5 years [SD 8·4], mean EDSS 4·67 [SD 1·03], 87% free of gadolinium-enhancing lesions). By end of study, 3-month confirmed disability progression had occurred in 232 and 338 patients in the fingolimod and placebo groups, respectively, resulting in Kaplan-Meier estimates of 77·2% (95% CI 71·87-82·51) of patients in the fingolimod group versus 80·3% (73·31-87·25) of patients in the placebo group (risk reduction 5·05%; hazard ratio 0·95, 95% CI 0·80-1·12; p=0·544). Safety results were generally consistent with those of studies of fingolimod in patients with relapse-onset multiple sclerosis. Lymphopenia occurred in 19 (6%) patients in the fingolimod group versus none in the placebo group, bradycardia in five (1%) versus one (
- Published
- 2016
- Full Text
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4. Lymphocyte count in peripheral blood is not associated with the level of clinical response to treatment with fingolimod [Meeting Abstract]
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Fragoso, Y. D., Alroughani, R., Barnett, M., Brooks, J. B., Butzkueven, H., Boz, C., Ticha, V., and Ondokuz Mayıs Üniversitesi
- Abstract
32nd Congress of the European-Committee-for-Treatment-and-Research-in-Multiple-Sclerosis (ECTRIMS) -- SEP 14-17, 2016 -- London, ENGLAND Havrdova, Eva Kubala/0000-0002-9543-4359; Lugaresi, Alessandra/0000-0003-2902-5589 WOS: 000383267201435 … European Comm Treatment & Res Multiple Sclerosis Biogen-IdecBiogen; Merck-SeronoMerck SeronoMerck & Company; NovartisNovartis; GenzymeGenzyme Corporation; BiogenBiogen; MerckMerck & Company; Oxford PharmaGenesis; Biogen IdecBiogen; Merck SeronoMerck SeronoMerck & Company; Almirall; BayerBayer AG; SanofiSanofi-Aventis; Teva; Fondazione Italiana Sclerosi MultiplaFondazione Italiana Sclerosi Multipla (FISM); Biogen IncBiogen; Bayer-ScheringBayer AG Michael Barnett has served on scientific advisory boards for Biogen-Idec, Novartis and Genzyme and has received conference travel support from Biogen-Idec and Novartis. His institution has received research support from Biogen-Idec, Merck-Serono and Novartis.; Helmut Butzkueven has received consulting fees from Genzyme, Biogen, Novartis, Merck and Oxford PharmaGenesis; and grant/ research support from Biogen, Novartis, Merck and Genzyme Cavit Boz has nothing to disclose; Franco Granella has served on scientific advisory boards for Biogen Idec, Novartis and Sanofi Aventis and has received funding for travel and speaker honoraria from Biogen Idec, Merck Serono, and Almirall; Alessandra Lugaresi has served as a Bayer, Biogen, Merck Serono, Novartis and Genzyme Advisory Board Member. She received travel grants and honoraria from Bayer, Biogen, Merck Serono, Novartis, Sanofi, Teva and Fondazione Italiana Sclerosi Multipla and research grants for her Institution from Bayer, Biogen, Merck Serono, Novartis, Sanofi, Teva and Fondazione Italiana Sclerosi Multipla.; Tim Spelman received compensation for serving on scientific advisory boards, honoraria for consultancy and funding for travel from Biogen Inc; speaker honoraria from Novartis.; Murat Terzi received travel grants from Merck Serono, Novartis, Bayer-Schering, Merck-Serono and Teva; has participated in clinical trials by Sanofi Aventis, Roche and Novartis.
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- 2016
5. GAVeCeLT* consensus statement on the correct use of totally implantable venous access devices for diagnostic radiology procedures
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Bonciarelli, G, Batacchi, S, Biffi, R, Buononato, M, Damascelli, B, Ghibaudo, F, Orsi, F, Pittiruti, Mauro, Scoppettuolo, Giancarlo, Verzè, A, Borasi, G, De Cicco, M, Dosio, R, Gazzo, P, Maso, R, Roman, A, Ticha, V, Venier, G, Blackburn, P, Goossens, Ga, Bowen Santolucito, J, Stas, M, Van Boxtel, T, Vesely, Tm, De Lutio, E., Pittiruti, Mauro (ORCID:0000-0003-4541-7566), Bonciarelli, G, Batacchi, S, Biffi, R, Buononato, M, Damascelli, B, Ghibaudo, F, Orsi, F, Pittiruti, Mauro, Scoppettuolo, Giancarlo, Verzè, A, Borasi, G, De Cicco, M, Dosio, R, Gazzo, P, Maso, R, Roman, A, Ticha, V, Venier, G, Blackburn, P, Goossens, Ga, Bowen Santolucito, J, Stas, M, Van Boxtel, T, Vesely, Tm, De Lutio, E., and Pittiruti, Mauro (ORCID:0000-0003-4541-7566)
- Abstract
The use of totally implantable venous access devices in radiology may be associated with complications such as occlusion of the system (because of the high density of some contrast), infection (if the port is not handled in aseptic conditions, using proper barrier protections), and mechanical complications due to the high-pressure administration of contrast by automatic injectors (so-called power injector), including extravasation of contrast media into the soft tissues, subintimal venous or myocardial injection, or serious damage to the device itself (breakage of the external connections, dislocation of the non-coring needle, or breakage of the catheter). The last problem - i.e., the damage of the device from a power injection - is not an unjustified fear, but a reality. A warning by the US Food and Drug Administration of July 2004 reports around 250 complications of this kind, referring to both port and central venous catheters and peripherally inserted central catheter systems, which occurred over a period of several years; in all cases, the damage occurred during the injection of contrast material by means of power injectors for computed tomography or magnetic resonance imaging procedures. Though the risk associated with the use of ports in radiodiagnostics is thus clear, it has been suggested that administration of the contrast material via the port may have some advantage in terms of image quality, increased comfort for the patient, and maybe more accurate reproducibility of the patient's own follow-up exams. This contention needs to be supported by evidence. Also, since many cancer patients who need frequent computed tomography studies already have totally implantable systems, it would seem reasonable to try to define how and when such systems may safely be used. The purpose of this consensus statement is to define recommendations based on the best available evidence, for the safe use of implantable ports in radiodiagnostics.
- Published
- 2011
6. Placement of port-a-cath through the right internal jugular vein under ultrasound guidance
- Author
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Capalbo, E., primary, Peli, M., additional, Lovisatti, M., additional, Cosentino, M., additional, Ticha, V., additional, Cariati, M., additional, and Cornalba, G., additional
- Published
- 2012
- Full Text
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7. Pulmonary Manifestations of Juvenile Laryngotracheal Papillomatosis: Case Report and Literature Review
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Skarda, J., primary, Ticha, V., additional, Tichy, M., additional, Perelman, M., additional, and Kopolovic, J., additional
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- 2009
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8. Randomized study of interferon beta-1a, low-dose azathioprine, and low-dose corticosteroids in multiple sclerosis
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Havrdova, E, primary, Zivadinov, R, additional, Krasensky, J, additional, Dwyer, MG, additional, Novakova, I, additional, Dolezal, O, additional, Ticha, V, additional, Dusek, L, additional, Houzvickova, E, additional, Cox, JL, additional, Bergsland, N, additional, Hussein, S, additional, Svobodnik, A, additional, Seidl, Z, additional, Vaneckova, M, additional, and Horakova, D, additional
- Published
- 2009
- Full Text
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9. Infection with Anaplasma phagocytophilum in a young dog: a case report
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Melter, O., primary, Stehlik, I., additional, Kinska, H., additional, Volfova, I., additional, Ticha, V., additional, and Hulinska, D., additional
- Published
- 2007
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10. Stereotactic breast biopsy: en bloc excision of microcalcifications with a large-bore cannula device.
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Damascelli, B, primary, Frigerio, L F, additional, Patelli, G, additional, Lanocita, R, additional, Viganotti, G, additional, Uslenghi, E, additional, Ticha, V, additional, Conti, A, additional, Bohm, S, additional, De Simone, T, additional, and Vespro, V, additional
- Published
- 1999
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11. Stereotactic excisional breast biopsy performed by interventional radiologists using the advanced breast biopsy instrumentation system.
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Damascelli, B, primary, Frigerio, L F, additional, Lanocita, R, additional, Patelli, G, additional, Viganotti, G, additional, Di Tolla, G, additional, Magnoni, S, additional, Ticha, V, additional, Galante, E, additional, Attili, A, additional, Saccozzi, R, additional, and Tomasich, G, additional
- Published
- 1998
- Full Text
- View/download PDF
12. Mitoxanthrone in the treatment of active multiple sclerosis (MS)
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Ticha, V., Havrdova, E., Novakova, I., and Horakova, D.
13. Interferon-beta or azathioprine as add-on therapy in patients with active multiple sclerosis
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Ticha, V., Kalincik, T., and Havrdova, E.
14. Efficacy results from a randomised, double-blind, placebo-controlled study of intramuscular interferon beta-1a, azathioprine, and corticosteroid combination therapy in patients with relapsing-remitting multiple sclerosis
- Author
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Havrdova, E., Zivadinov, R., Krasensky, J., Dwyer, M. G., Novakova, I., Dolezal, A., Ticha, V., Svobodnik, A., Seidl, Z., Houzvickova, E., and Horakova, D.
15. Interferon beta-1a in combination with azathioprine and low-dose steroids for relapsing-remitting multiple sclerosis: Preliminary clinical and MRI data from a two-year, double-blind, randomized, placebo-controlled study
- Author
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Havrdova, E., Horakova, D., Krasensky, J., Ticha, V., Novakova, I., Vaneckova, M., Dolezal, O., Seidl, Z., Meluzinova, E., and Pasekova, E.
16. Percutaneous implant of Denver peritone-ovenous shunt: A new opportunity for the interventional radiologist | L'impianto percutaneo dello shunt peritoneo-venoso di Denver: Una nuova opportunità per il radiologo interventista
- Author
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Spreafico, C., Patelli, G., Lanocita, R., Di Tolla, G., Alfonso Marchianò, Frigerio, L., Garbagnati, F., Ticha, V., and Damascelli, B.
17. MRI results from a randomised, double-blind, placebo controlled study of intramuscular interferon beta-1a, azathioprine, and corticosteroid combination therapy in patients with relapsing-remitting multiple sclerosis
- Author
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Zivadinov, R., Horakova, D., Dwyer, M. G., Dolezal, A., Krasensky, J., Bergsland, N., Cox, J. L., Novakova, I., Ticha, V., Balachandran, S., Svobodnik, A., Seidl, Z., Vaneckova, M., and Havrdova, E.
18. Differences between supratentorial. MR foci in the brain of patiens with neuropsychiatric lupus and multiple sclerosis
- Author
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Peterova, V., Dostal, C., Linkova, L., Seidl, Z., Olejarova, M., Havrdova, E., Zvarova, J., Zvara, K., Vitak, T., Ticha, V., and Danes, J.
19. Bone loss in multiple sclerosis patients treated with corticosteroids
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Stepan, Jj, Havrdova, E., Tyblova, M., Horakova, D., Ticha, V., Novakova, I., and Vit Zikan
20. Micturitional complaints in patients with multiple sclerosis
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Novakova, N., Libor Zamecnik, Havrdova, E., and Ticha, V.
21. Osteoporosis in multiple sclerosis patients: dependence on corticosteroid therapy and motor deficit
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Havrdova, E., Tyblova, M., Stepan, J., Horakova, D., Ticha, V., Novakova, I., Zelena, L., Vit Zikan, and Hlasenska, J.
22. Lysate of Parabacteroides distasonis prevents severe forms of experimental autoimmune encephalomyelitis by modulating the priming of T cell response.
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Jiraskova Zakostelska Z, Kraus M, Coufal S, Prochazkova P, Slavickova Z, Thon T, Hrncir T, Kreisinger J, Kostovcikova K, Kleinova P, Lizrova Preiningerova J, Pavelcova M, Ticha V, Kovarova I, Kubala Havrdova E, Tlaskalova-Hogenova H, and Kverka M
- Subjects
- Animals, Mice, Female, Bacteroidetes immunology, T-Lymphocytes immunology, T-Lymphocytes metabolism, Intestinal Mucosa immunology, Intestinal Mucosa microbiology, Intestinal Mucosa metabolism, Encephalomyelitis, Autoimmune, Experimental immunology, Encephalomyelitis, Autoimmune, Experimental prevention & control, Gastrointestinal Microbiome immunology, Mice, Inbred C57BL
- Abstract
The gut microbiota influences the reactivity of the immune system, and Parabacteroides distasonis has emerged as an anti-inflammatory commensal. Here, we investigated whether its lysate could prevent severe forms of neuroinflammation in experimental autoimmune encephalomyelitis (EAE) in mice and how this preventive strategy affects the gut microbiota and immune response. Lysate of anaerobically cultured P. distasonis (Pd lysate) was orally administered to C57BL/6 mice in four weekly doses. One week later, EAE was induced and disease severity was assessed three weeks after induction. Fecal microbiota changes in both vehicle- and Pd lysate-treated animals was analyzed by 16S V3-V4 amplicon sequencing and qPCR, antimicrobial peptide expression in the intestinal mucosa was measured by qPCR, and immune cell composition in the mesenteric and inguinal lymph nodes was measured by multicolor flow cytometry. Pd lysate significantly delayed the development of EAE and reduced its severity when administered prior to disease induction. EAE induction was the main factor in altering the gut microbiota, decreasing the abundance of lactobacilli and segmented filamentous bacteria. Pd lysate significantly increased the intestinal abundance of the genera Anaerostipes , Parabacteroides and Prevotella , and altered the expression of antimicrobial peptides in the intestinal mucosa. It significantly increased the frequency of regulatory T cells, induced an anti-inflammatory milieu in mesenteric lymph nodes, and reduced the activation of T cells at the priming site. Pd lysate prevents severe forms of EAE by triggering a T regulatory response and modulating T cell priming to autoantigens. Pd lysate could thus be a future modulator of neuroinflammation that increases the resistance to multiple sclerosis., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Jiraskova Zakostelska, Kraus, Coufal, Prochazkova, Slavickova, Thon, Hrncir, Kreisinger, Kostovcikova, Kleinova, Lizrova Preiningerova, Pavelcova, Ticha, Kovarova, Kubala Havrdova, Tlaskalova-Hogenova and Kverka.)
- Published
- 2024
- Full Text
- View/download PDF
23. Nurse training to enhance adherence counselling for HIV-tuberculosis coinfection in South Africa: Integrative review.
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Ticha V, Bimerew M, and Phetlhu RD
- Subjects
- Humans, South Africa, Coinfection, Nurses statistics & numerical data, Nurses psychology, Medication Adherence psychology, Assessment of Medication Adherence, HIV Infections complications, HIV Infections psychology, Tuberculosis complications, Counseling methods, Counseling standards, Counseling statistics & numerical data
- Abstract
Background: South Africa has seen strides in reducing HIV and tuberculosis (TB); however, adherence counselling for people living with HIV (PLHIV) coinfected with TB remains a challenge, particularly in specific sub-districts like Cape Town. Understanding the attributes of existing training programmes is crucial., Objectives: This study explored attributes of training programme development for nurses and other health professionals to enhance adherence counselling for PLHIV coinfected with TB in Cape Town., Method: An integrative literature review was conducted in five steps following PRISMA guidelines. Electronic searches encompassed multiple databases: COCHRANE, PsycINFO, PUBMED, ENMBASE, Science Direct, SCOPUS, SocINDEX, Academic Search Complete, Eric, SABINET, Health Resources and World Health Organization Global Health Library Regional Indexes. Inclusion criteria encompassed English language, peer-reviewed full-text studies on training programme development, qualitative and quantitative, published between January 2012 and May 2021. Exclusion criteria included non-English articles, conference proceedings and irrelevant studies. Thematic data analysis synthesised findings., Results: Three main themes emerged: participant identification, key programme content and programme implementation process, crucial for effective training programme development., Conclusion: Identifying participants, defining programme content and outlining implementation processes are pivotal in enhancing nurses' adherence counselling skills. This approach could stabilise patient treatment adherence, potentially reducing treatment default, loss to follow-up and mortality rates.Contribution: These findings lay the groundwork for developing effective training programmes aimed at improving adherence counselling among nurses.
- Published
- 2024
- Full Text
- View/download PDF
24. Professional Values of Undergraduate Students at a Nursing School in South Africa.
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Bimray P, Chipps J, and Ticha V
- Abstract
Background: Nursing schools play an important role in instilling nursing professional values in undergraduate nursing students and ensuring that they produce professional nurse graduates. Several studies in various countries have been conducted to describe the professional values held by nursing students, but this has not been explored in detail in South Africa., Aim: The purpose of this study was to describe the professional values held by undergraduate degree students at a nursing school in South Africa., Methods: A cross-sectional survey using a self-administered questionnaire was conducted. With a population of 1,233 undergraduate nursing students across four years in the degree programme at the nursing school, a sample of 294 was calculated as the representative (95% CI, 5% error, and 50% response distribution). The 26-item nurses professional values scale revision (NPVS-R) with five value dimensions was used to collect the data. Means, frequencies, and confidence intervals were used to describe the values and Mann-Whitney U tests and Kruskal-Wallis independent sample tests were used to compare the findings with the demographic characteristics., Results: A total number of 245 respondents completed the questionnaire (response rate of 83.3%). Overall, the nurse professional value score was high (113.1 ± 13.1). The values of trust (4.46 ± 0.61), justice (4.39 ± 0.57), and caring (4.38 ± 0.55) were rated significantly higher than those of professionalism (4.23 ± 0.64) and activism (4.22 ± 0.57). First- and final-year students had significantly higher professional value scores., Conclusion: The study results describe the professional values of undergraduate nursing students in the school and confirmed the importance of trust, justice, and caring as the key professional values in the South African setting. Clinical Relevance . Nursing education should embed and monitor nursing professional values in the curriculum. Instilling nursing professional values in undergraduate nurses during formal training programmes improves quality patient care and service delivery for clinical practice., Competing Interests: The authors declare that they have no conflicts of interest., (Copyright © 2023 Portia Bimray et al.)
- Published
- 2023
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- View/download PDF
25. Corrigendum to 'To be or not to be vaccinated: The risk of MS or NMOSD relapse after COVID-19 vaccination and infection'[Multiple sclerosis and related disorders vol. 65 (2022) 104014].
- Author
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Stastna D, Menkyova I, Drahota J, Hrnciarova T, Kubala Havrdova E, Vachova M, Andelova M, Kleinova P, Kovarova I, Krasulova E, Lizrova Preiningerova J, Novakova I, Novotna K, Novotna M, Nytrova P, Pavlickova J, Srpova B, Storey K, Ticha V, Tyblova M, Uher T, Vodehnalova K, and Horakova D
- Published
- 2023
- Full Text
- View/download PDF
26. To be or not to be vaccinated: The risk of MS or NMOSD relapse after COVID-19 vaccination and infection.
- Author
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Stastna D, Menkyova I, Drahota J, Hrnciarova T, Kubala Havrdova E, Vachova M, Andelova M, Kleinova P, Kovarova I, Krasulova E, Preiningerova JL, Novakova I, Novotna K, Novotna M, Nytrova P, Pavlickova J, Srpova B, Storey K, Ticha V, Tyblova M, Uher T, Vodehnalova K, and Horakova D
- Subjects
- BNT162 Vaccine, Czech Republic, Humans, Recurrence, Retrospective Studies, Vaccination adverse effects, COVID-19 prevention & control, COVID-19 Vaccines adverse effects, Multiple Sclerosis complications, Neuromyelitis Optica complications
- Abstract
Background: COVID-19 vaccination and infection are speculated to increase the activity of immune-mediated diseases, including multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD). The aim of this study was to evaluate a short-term risk of relapse after COVID-19 vaccination and COVID-19 infection in patients with these demyelinating disorders of the central nervous system and to determine disease exacerbation risk factors., Methods: Data in this retrospective, observational cohort study was collected via the Czech nationwide registry ReMuS from March 1, 2020, to October 30, 2021. We compared the proportion of patients with at least one clinical relapse in the 90 days following vaccination or infection to the 90-day intervals during the year before. For the evaluation of the risk factors of relapse, a comparison between groups with and without relapses after COVID-19 vaccination or infection was made., Results: We identified 1661 vaccinated (90.11% BNT162b2) patients with MS without a history of COVID-19 and 495 unvaccinated patients with MS who experienced COVID-19. A mild increase in the proportion of patients with at least one clinical relapse (-360 to -270 days: 4.46%; -270 to -180: 4.27%; -180 to -90: 3.85%; -90 to 0: 3.79% vs. 0 to +90 days: 5.30%) after vaccination in patients with MS was observed, as well as a rise in the proportion of patients with at least one clinical relapse after COVID-19. Lower age was associated with MS relapse after vaccination or infection. Although there were only 17 vaccinated and eight post-COVID-19 patients with NMOSD, the results were broadly consistent with those of patients with MS., Conclusion: There is a mild increase in the relapse incidence after the COVID-19 vaccination. The risks, however, need to be balanced against the risks of COVID-19 itself, also leading to the rise in relapse rate and particularly to morbidity and mortality., (Copyright © 2022 Elsevier B.V. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
27. Perceptions of nurses on TB with HIV adherence counselling skills in a health sub-district, Cape Town: A qualitative study.
- Author
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Ticha V, Bimerew M, and Phetlhu DR
- Abstract
Background: People living with HIV (PLHIV) co-infected with Tuberculosis (TB) account for one in three HIV-related deaths. Retention in care and adherence to medication remain key behaviours that PLHIV co-infected with TB must adopt to achieve better health outcomes. Nevertheless, TB with HIV adherence-counselling services provided by nurses designed to enhance these behaviours remain inadequate. Additionally, limited information is found in the literature on the perceptions of nurses regarding their TB with HIV adherence counselling skills pertaining to PLHIV co-infected with TB., Aim: To explore and describe the perceptions of nurses regarding their TB with HIV adherence counselling skills of PLHIV co-infected with TB., Setting: The study was conducted in a health sub-district of Cape Town., Method: An exploratory, descriptive qualitative design was followed. A total of 14 purposively sampled nurses were interviewed individually. Nurses caring for PLHIV co-infected with TB were included and nurses not offering care to PLHIV co-infected with TB were excluded. All interviews were audio recorded with the participants' permission followed by verbatim transcriptions. Thematic analysis was done using ATLASti.8 electronic software., Results: It was established that the varied roles of these nurses increased their workload. Nonetheless, despite the gap in their counselling skills, the majority still maintained work expertise, professionalism and empathy towards the patients. Additionally, there were perceived barriers impacting patients' attendance of their follow up appointments., Conclusion: Based on the findings of this study, there is a need to equip nurses caring for PLHIV co-infected with TB with adherence counselling skills to improve practice., Contribution: The findings were synthesised with results from an in-depth literature review to stand as the backbone for the development of a training programme for nurses to improve adherence counselling., Competing Interests: The authors declare that they have no financial or personal relationships that may have inappropriately influenced them in writing this article., (© 2022. The Authors.)
- Published
- 2022
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28. Multiple Sclerosis and Microbiome.
- Author
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Preiningerova JL, Jiraskova Zakostelska Z, Srinivasan A, Ticha V, Kovarova I, Kleinova P, Tlaskalova-Hogenova H, and Kubala Havrdova E
- Subjects
- Animals, Brain-Gut Axis, Humans, Mice, Gastrointestinal Microbiome, Microbiota, Multiple Sclerosis
- Abstract
The composition of microbiota and the gut-brain axis is increasingly considered a factor in the development of various pathological conditions. The etiology of multiple sclerosis (MS), a chronic autoimmune disease affecting the CNS, is complex and interactions within the gut-brain axis may be relevant in the development and the course of MS. In this article, we focus on the relationship between gut microbiota and the pathophysiology of MS. We review the contribution of germ-free mouse studies to our understanding of MS pathology and its implications for treatment strategies to modulate the microbiome in MS. This summary highlights the need for a better understanding of the role of the microbiota in patients' responses to disease-modifying drugs in MS and disease activity overall.
- Published
- 2022
- Full Text
- View/download PDF
29. Reflections on clinical practice whilst developing a portfolio of evidence: Perceptions of undergraduate nursing students in the Western Cape, South Africa.
- Author
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Ticha V and Fakude LP
- Subjects
- Education, Nursing, Baccalaureate, Evidence-Based Nursing methods, Focus Groups, Humans, Qualitative Research, South Africa, Perception, Students, Nursing psychology, Teaching standards
- Abstract
Background: In order to develop clinical judgement, nurses should be encouraged to become analytical and critical thinkers. Development of a portfolio of evidence (PoE) of reflection on clinical experiences is one of the strategies that can be used to enhance analytical and critical thinking amongst nursing students. Students' perceptions of the process are important in order to encourage their reflective practice. PoE compilation at a school of nursing at a university in the Western Cape includes evidence of students' clinical learning which they present in a portfolio. The students are expected to reflect on their clinical learning experiences and include these reflections in their portfolios., Objective: To describe the perceptions of fourth-year nursing students regarding reflective practice whilst compiling their PoEs., Method: A qualitative design was used to explore the perceptions of registered fourth-year nursing students with regard to their reflective practice whilst compiling their PoEs. Purposive sampling was used for selection of participants. Three focus group discussions were held, each consisting of six to eight participants. Data saturation was reached during the third meeting. Tesch's method of data analysis was used., Results: Findings revealed that reflection enabled the learners to gain experience and identify challenges related to the expected events and tasks carried out at the hospitals and in the classroom whilst developing their PoE., Conclusion: The compilation of a PoE was a good teaching and learning strategy, and the skills, experience and knowledge that the participants in this study acquired boosted their self-esteem, confidence and critical thinking. Reflection also assisted in self-directed learning.
- Published
- 2015
- Full Text
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30. Revaluation of breast cytology with pathologist on-site of lesions with suspicious sonographic features.
- Author
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Capalbo E, Sajadidehkordi F, Colombi C, Ticha V, Moretti A, Peli M, Cosentino M, Lovisatti M, Berti E, and Cariati M
- Subjects
- Adult, Aged, Aged, 80 and over, Female, Humans, Italy epidemiology, Middle Aged, Prevalence, Reproducibility of Results, Retrospective Studies, Risk Factors, Sensitivity and Specificity, Young Adult, Biopsy, Fine-Needle statistics & numerical data, Breast Neoplasms diagnosis, Breast Neoplasms epidemiology, Ultrasonography, Mammary statistics & numerical data
- Abstract
Objective: Evaluating correlation estimation between diagnostic ultrasound (U.S.) of breast lesions and fine needle aspiration cytology (FNAC), and the correlation between cytology and histology (I) of these lesions undergo surgery., Materials and Methods: In 2010 we performed 1589 ultrasound breast. We identified 210 suspicious lesions to be subjected to FNAC, which was performed with pathologist on site, and extemporaneous analysis of the sample to assess their appropriateness. We classified the lesions in 5 ultrasound (U) classes according to the criteria defined by Echographic BIRADS Lexicon. The results of cytology were classified in 5 classes (C) according to the guidelines of F.O.N.Ca.M. Then we evaluated the diagnostic correlation between U.S. and FNAC, and between FNAC and Histology., Results: The distribution of lesions in U classes was: 57U2, 55U3, 36U4 and 62U5. The diagnostic concordance between U and FNAC was 96.7%, with a sensitivity of 98%, specificity 93%, negative and positive predictive value respectively of 94.9% and 97.3%, and diagnostic accuracy of 96.6%. The 98 patients with C4-C5 lesions were subjected to surgery and the histology confirmed high-grade malignancy of lesions with a concordance of 99.7%., Conclusions: Having achieved high diagnostic concordance between U and FNAC, and then between FNAC and histology, we may say that the FNAC, less invasive and traumatic for the patient than needle biopsy (CB), may be still a valid method when performed with pathologist on-site to assess the adequacy of the sample taken., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)
- Published
- 2013
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31. Interferon-β or azathioprine as add-on therapies in patients with active multiple sclerosis.
- Author
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Ticha V, Kalincik T, and Havrdova E
- Subjects
- Adult, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Male, Middle Aged, Multiple Sclerosis blood, Multiple Sclerosis pathology, Retrospective Studies, Treatment Outcome, Azathioprine administration & dosage, Interferon-beta administration & dosage, Multiple Sclerosis drug therapy
- Abstract
Objectives: To evaluate safety and efficacy of add-on low-dose azathioprine or interferon (IFN)-beta in patients with active multiple sclerosis despite monotherapy., Methods: This retrospective observational study evaluated 5-year data from 85 patients with active multiple sclerosis despite monotherapy with either IFN-beta or azathioprine, who received add-on azathioprine or IFN-beta, respectively. In a subgroup of 23 patients, 10-year data were analysed. Clinical (relapse frequency, disability) and laboratory effects were compared preceding and following the addition of second drug and between the two treatment regimens. Potential serious adverse events were evaluated., Results: The add-on treatment triggered a drop in annualised relapse rate by approximately 1.5 points sustained over 5 and 10 years. No effect on disability was observed. Simultaneously, white blood cell and lymphocyte counts decreased, being below the physiological levels in 8-26% and 13-52% of patients at each time point, respectively. The drop in relapse rate was independent from the dosage of azathioprine or changes in lymphocyte count. Comparison between the two treatment regimens showed that, with the exception of lymphocyte count, these effects were triggered by the add-on of interferon but not azathioprine. The combination therapy was well tolerated; however, after 5 years on treatment a moderately increased incidence of cancer was observed., Conclusions: IFN-beta as add-on to azathioprine decreases relapse activity in active multiple sclerosis. In contrast, azathioprine add-on in patients with suboptimal response to IFN-beta does not improve the control over the disease activity.
- Published
- 2012
- Full Text
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32. GAVeCeLT* consensus statement on the correct use of totally implantable venous access devices for diagnostic radiology procedures.
- Author
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Bonciarelli G, Batacchi S, Biffi R, Buononato M, Damascelli B, Ghibaudo F, Orsi F, Pittiruti M, Scoppettuolo G, Verzè A, Borasi G, De Cicco M, Dosio R, Gazzo P, Maso R, Roman A, Ticha V, Venier G, Blackburn P, Goossens GA, Bowen Santolucito J, Stas M, Van Boxtel T, Vesely TM, and de Lutio E
- Subjects
- Catheterization, Central Venous adverse effects, Catheterization, Central Venous standards, Equipment Design, Equipment Failure, Humans, Injections, Magnetic Resonance Imaging, Interventional adverse effects, Magnetic Resonance Imaging, Interventional standards, Patient Safety, Predictive Value of Tests, Pressure, Radiography, Interventional adverse effects, Radiography, Interventional standards, Risk Assessment, Risk Factors, Catheterization, Central Venous instrumentation, Catheters, Indwelling adverse effects, Catheters, Indwelling standards, Contrast Media administration & dosage, Magnetic Resonance Imaging, Interventional instrumentation, Radiography, Interventional instrumentation
- Abstract
The use of totally implantable venous access devices in radiology may be associated with complications such as occlusion of the system (because of the high density of some contrast), infection (if the port is not handled in aseptic conditions, using proper barrier protections), and mechanical complications due to the high-pressure administration of contrast by automatic injectors (so-called power injector), including extravasation of contrast media into the soft tissues, subintimal venous or myocardial injection, or serious damage to the device itself (breakage of the external connections, dislocation of the non-coring needle, or breakage of the catheter). The last problem - i.e., the damage of the device from a power injection - is not an unjustified fear, but a reality. A warning by the US Food and Drug Administration of July 2004 reports around 250 complications of this kind, referring to both port and central venous catheters and peripherally inserted central catheter systems, which occurred over a period of several years; in all cases, the damage occurred during the injection of contrast material by means of power injectors for computed tomography or magnetic resonance imaging procedures. Though the risk associated with the use of ports in radiodiagnostics is thus clear, it has been suggested that administration of the contrast material via the port may have some advantage in terms of image quality, increased comfort for the patient, and maybe more accurate reproducibility of the patient's own follow-up exams. This contention needs to be supported by evidence. Also, since many cancer patients who need frequent computed tomography studies already have totally implantable systems, it would seem reasonable to try to define how and when such systems may safely be used. The purpose of this consensus statement is to define recommendations based on the best available evidence, for the safe use of implantable ports in radiodiagnostics.
- Published
- 2011
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33. Use of a retrievable vena cava filter with low-intensity anticoagulation for prevention of pulmonary embolism in patients with cancer: an observational study in 106 cases.
- Author
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Damascelli B, Ticha V, Patelli G, Lanocita R, Morosi C, Civelli E, Di Tolla G, Frigerio LF, Ciceri E, Garbagnati F, Spreafico C, Amadeo P, and Marchianò A
- Subjects
- Administration, Oral, Adolescent, Adult, Aged, Aged, 80 and over, Anticoagulants administration & dosage, Blood Coagulation drug effects, Combined Modality Therapy, Device Removal, Female, Humans, International Normalized Ratio, Italy, Male, Middle Aged, Phlebography methods, Prospective Studies, Pulmonary Embolism blood, Pulmonary Embolism diagnostic imaging, Pulmonary Embolism etiology, Recurrence, Time Factors, Tomography, X-Ray Computed, Treatment Outcome, Venous Thrombosis blood, Venous Thrombosis diagnostic imaging, Venous Thrombosis etiology, Young Adult, Anticoagulants therapeutic use, Neoplasms complications, Pulmonary Embolism prevention & control, Vena Cava Filters adverse effects, Venous Thrombosis drug therapy
- Abstract
Purpose: To evaluate a retrievable inferior vena cava (IVC) filter in combination with low-intensity oral anticoagulation for prevention of pulmonary embolism (PE) in patients with malignancy complicated by thromboembolic disease., Materials and Methods: From October 2005 to December 2009, 107 Bard G2 filters were placed in 106 patients. Forty-eight patients had deep vein thrombosis (DVT) alone, 53 had PE with DVT, and five had PE with no evidence of DVT. After an initial period of anticoagulation with heparin, low-intensity oral anticoagulant therapy to achieve a target International Normalized Ratio of 1.5-2.0 was instituted. Follow-up computed tomography to evaluate the pulmonary circulation, IVC, and lower limbs was performed at 3 and 6 months., Results: PE recurred in three of 58 patients (5.2%). None of the 48 patients with DVT alone developed PE, nor was there any recurrence of DVT. The filter was removed in 14 patients (13.2%). No complications occurred during the retrieval procedure. A total of 16 complications occurred in seven patients: one migration (0.9%); four cases of vena cava thrombosis (3.7%), three of which were associated with recurrent PE (2.8%); one filter fracture (0.9%); and one IVC penetration (0.9%). Filter tilting greater than 15° occurred in six patients (5.7%) and was associated with other complications in five (4.7%)., Conclusions: In patients with malignancies complicated by venous thromboembolic disease, an IVC filter together with low-intensity anticoagulation may be a possible treatment strategy for PE prophylaxis. Controlled studies are warranted., (Copyright © 2011 SIR. Published by Elsevier Inc. All rights reserved.)
- Published
- 2011
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34. Successful intra-arterial chemotherapy for extramammary Paget's disease of the axilla in a patient with Parkinson's disease.
- Author
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Damascelli B and Ticha V
- Subjects
- Angiography, Biopsy, Doxorubicin administration & dosage, Humans, Male, Middle Aged, Nanoparticles, Paclitaxel administration & dosage, Paget Disease, Extramammary blood supply, Paget Disease, Extramammary pathology, Skin pathology, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Axilla blood supply, Axilla pathology, Infusions, Intra-Arterial, Paget Disease, Extramammary complications, Paget Disease, Extramammary drug therapy, Parkinson Disease complications
- Abstract
Extramammary Paget's disease (EMPD) is a rare intraepithelial neoplasm occurring less frequently in men and even more rarely in the axilla. A 59-year-old man with severe Parkinson's disease presented with axillary EMPD. The neurological comorbidity made treatment of the EMPD problematical and prompted us to propose locoregional intra-arterial chemotherapy in single short sessions. Two innovative chemotherapeutic macrocomplexes were used: doxorubicin incorporated in large liposomes and the taxane paclitaxel incorporated in albumin nanoparticles. A therapeutic response was seen right from the first treatment and was macroscopically close to complete after four cycles. Five months after the end of treatment the patient had minimal visible disease and had enjoyed a distinct improvement in quality of life, with no noteworthy complications related to the intra-arterial chemotherapy with percutaneous transfemoral catheterization.
- Published
- 2011
- Full Text
- View/download PDF
35. Large renal artery aneurysm treated with Guglielmi detachable coils: procedural and 4-year follow-up results.
- Author
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Damascelli B, Bartorelli AL, Ticha V, Trabattoni D, and Lanocita R
- Subjects
- Adult, Aneurysm diagnosis, Aortography, Contrast Media, Female, Humans, Magnetic Resonance Angiography, Ultrasonography, Doppler, Color, Aneurysm therapy, Embolization, Therapeutic instrumentation, Renal Artery
- Abstract
A large aneurysm of the left renal artery was found incidentally during abdominal ultrasound in a 39-year-old woman with no medical or family history of cardiovascular disease. Vascular pathology with a dysplastic appearance was confirmed by magnetic resonance angiography and the patient was offered transcatheter embolization. Since the position and size of the neck of the aneurysm could not be determined at angiography, detachable platinum coils were used for occlusion. The procedure was performed without complications. During a 4-year follow-up no alterations of renal function, recanalization of the aneurysm, or perfusion defects in the rest of the left renal circulation were noted.
- Published
- 2008
- Full Text
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36. Oral lichenoid lesions and allergy to dental materials.
- Author
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Ditrichova D, Kapralova S, Tichy M, Ticha V, Dobesova J, Justova E, Eber M, and Pirek P
- Subjects
- Adult, Female, Humans, Hypersensitivity diagnosis, Lichen Planus, Oral chemically induced, Male, Middle Aged, Mouth Diseases diagnosis, Patch Tests, Allergens, Dental Materials adverse effects, Hypersensitivity etiology, Lichen Planus, Oral etiology, Mouth Diseases etiology
- Abstract
Background: Dental materials, oral hygiene products and food additives may cause contact allergic reactions in the mouth with varied clinical presentation. Oral lichenoid lesions (lichen planus-like lesions) can be induced by hypersensitivity to dental restorative metals, acrylates, flavorings and other substances., Aim: The aim of this study was to demonstrate contact allergy to dental materials in patients with oral lichenoid lesions using patch tests., Patients and Methods: Routine patch tests with two sets of allergens - "European Standard" and "Dental Screening" (Chemotechnique Diagnostics, Sweden) supplemented with pulverized amalgam, iridium, indium, menthol, sorbic acid and platinum were done on a set of 25 patients with lichenoid lesions located on the buccal mucosa, tongue and lips. Application and interpretation of the tests were conducted according to ICDRG (International Contact Dermatitis Research Group)., Results: 15 (60 %) patients showed sensitization to 1 or more allergens, with a total of 31 positive reactions. The greatest frequency of positive reactions was to dental metals, with a total of 27 positive reactions. The order of tested metals according to frequency of positive reactions was mercury (6/25/24 %), amalgam (6/25/24 %), nickel (4/25/16 %), palladium (4/25/16 %), cobalt (3/25/12 %), gold (2/25/8 %), chrome (1/25/4 %), indium (1/25/4 %). The clinical relevance of the results with regard to the material's presence in the mouth was demonstrated in 11 (44 %) patients. In 9 patients, replacement of the positively tested materials led to healing or to significant regression of mucosal changes., Conclusions: The results of the patch tests showed the possible contribution of contact sensitization in the pathogenesis of lichenoid manifestations in the oral cavity. Due to the premalignant character of these lesions, replacement of positively tested materials and follow up of these patients is advised.
- Published
- 2007
- Full Text
- View/download PDF
37. [Percutaneous implant of Denver peritoneovenous shunt: a new opportunity for the interventional radiologist].
- Author
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Spreafico C, Patelli G, Lanocita R, Di Tolla G, Marchianò A, Frigerio L, Garbagnati F, Ticha V, and Damascelli B
- Subjects
- Adult, Age Factors, Ascites etiology, Ascites therapy, Female, Follow-Up Studies, Humans, Liver Failure complications, Male, Middle Aged, Neoplasms complications, Sex Factors, Time Factors, Peritoneovenous Shunt instrumentation, Peritoneovenous Shunt methods, Radiology, Interventional
- Abstract
Purpose: The study is aimed at presenting our experience in the implant of Denver peritoneovenous shunts. Medical treatment-resistant ascites, either neoplastic or related to hepatic failure, is highly symptomatic and its treatment is indicated in order to improve patients' quality of life. One of the most efficient methods of treatment consists in implanting a peritoneovenous shunt. The availability of this device and its percutaneous implantation provide Interventional Radiologists with the possibility of expanding their repertoire., Material and Methods: Thirteen shunts were implanted in 12 patients, 10 with neoplastic ascites and 2 with hepatic failure-related ascites. In 1 patient a second device had to be implanted. All the procedures were performed in the Interventional Radiology Department, under local anesthesia and mild sedation. The central venous access was by the subclavian vein in 7 cases and the internal jugular vein in 6 cases. The puncture kit is consists of 2 needles, 1 for venous puncture and 1 for peritoneal puncture, 2 angiographic J-guide wires, 2 peel-away introducers, and a chamber containing the double valve-pump connected with both the venous and the peritoneal catheters. The whole device is placed subcutaneously thus allowing fluids to flow from the peritoneum to the vein either spontaneously, if intra-abdominal pressure exceeds 3cm of water, or by manual compression exerted on the pump itself., Results: All implants were successfully performed. One transient complication occurred consisting in a mild inflammatory reaction along the subcutaneous catheter route, which promptly solved by antibiotic therapy. So far a total of 1773 catheter/days have been accumulated. 7/10 of the neoplastic patients died from progressive disease after 915 catheter/days (median 120, range 30-180). In a cirrhotic patient the first shunt occluded after 430 days due to hemoperitoneum caused by hepatic biopsy: it was removed and a new one implanted. Five shunts are in now use, with a follow-up of 30, 48, 70, 120 and 160 days each., Discussion: The implanting technique was well tolerated by all patients and it could be performed under local anesthesia. The central vein puncture was easy for both accesses but the introducer diameter (12F) and the possibility of clavicle pinch-off induced us to use the internal jugular approach in the last six cases, which provided a reduced risk of pneumothorax and a better catheter track. In the patients with neoplastic ascites we observed neither disease dissemination nor changes in the patients' changed related to the shunt. Our results show that the implant of Denver venous-peritoneal shunts is a relatively easy procedure, which can be performed by Interventional Radiologists on a regular basis.
- Published
- 2001
38. Stereotactic breast biopsy: en bloc excision of microcalcifications with a large-bore cannula device.
- Author
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Damascelli B, Frigerio LF, Patelli G, Lanocita R, Viganotti G, Uslenghi E, Ticha V, Conti A, Bohm S, De Simone T, and Vespro V
- Subjects
- Biopsy methods, Breast pathology, Breast surgery, Catheterization instrumentation, Female, Humans, Middle Aged, Radiography, Interventional, Stereotaxic Techniques instrumentation, Biopsy instrumentation, Breast Diseases pathology, Breast Diseases surgery, Breast Neoplasms pathology, Breast Neoplasms surgery, Calcinosis pathology, Calcinosis surgery
- Abstract
Objective: Breast calcifications pose a significant diagnostic and procedural dilemma. We evaluated en bloc stereotactic excision of indeterminate and suggestive microcalcifications for histologic diagnosis using a large-bore cannula biopsy device., Materials and Methods: We retrospectively reviewed 61 groups of microcalcifications removed with a large-bore cannula biopsy device from 59 patients (age range, 35-72 years old). The cannula diameter was 20 mm in 47 cases, 15 mm in nine cases, and 10 mm in five cases. The median lesion diameter was 6.6 mm (range, 4-17 mm). The procedure was performed by radiologists in an outpatient setting, with patients undergoing local anesthesia. All patients with a diagnosis of malignancy underwent surgery., Results: In all instances, microcalcifications were removed in a single pass, in a single intact tissue specimen, through a maximum skin incision of 2 cm (0.8 inch). Twenty-five malignancies, 34 benign lesions, and two cases of lobular carcinoma in situ were identified. Sixteen malignancies were noninvasive and nine were invasive. No residual tumor was found at surgery in six of the 18 cases with involved margins and in five of the seven cases with uninvolved margins. One case of lobular carcinoma in situ with involvement of the margins additionally showed ductal carcinoma in situ at surgery., Conclusion: Mammographically identified microcalcifications are excised en bloc with the large-bore cannula biopsy device, providing a stereotactically localized tissue sample that is comparable with that obtained with open surgical biopsy and allows evaluation of the margins. This surgical radiologic procedure may represent a valid alternative, in selected patients, to conventional surgical biopsy after radiologic localization.
- Published
- 1999
- Full Text
- View/download PDF
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