{"id":1801,"date":"2018-07-31T15:33:17","date_gmt":"2018-07-31T14:33:17","guid":{"rendered":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/?p=1801"},"modified":"2019-01-30T14:04:01","modified_gmt":"2019-01-30T13:04:01","slug":"assaig-refals-criteris-dinclusio-i-exclusio","status":"publish","type":"post","link":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/","title":{"rendered":"Assaig REFALS, criteris d&#8217;inclusi\u00f3 i exclusi\u00f3"},"content":{"rendered":"<p>La Unitat Multidisciplinar de Motoneurona de l&#8217;Hospital de Bellvitge participa en l&#8217;assaig cl\u00ednic <a href=\"https:\/\/www.clinicaltrials.gov\/ct2\/show\/NCT03505021?term=NCT03505021&amp;cond=ALS&amp;rank=1\">REFALS<\/a>, que te com a a objectiu valorar els efectes del Levosimendan en l&#8217;ELA.<\/p>\n<p>Aquest medicament s&#8217;utilitza en pacients amb insufici\u00e8ncia card\u00edaca, en els quals millora la contractilitat del m\u00fascul card\u00edac. Un estudi inicial en pacients amb ELA va observar una millora en la capacitat respirat\u00f2ria, per la qual cosa s&#8217;ha posat en marxa aquest nou estudi en el qual s&#8217;inclouran 450 pacients a tot el m\u00f3n.<\/p>\n<p>T&#8217;indiquem els criteris d&#8217;inclusi\u00f3 i exclusi\u00f3 per participar en l&#8217;estudi.<\/p>\n<p><strong>Inclusi\u00f3<\/strong><\/p>\n<ul>\n<li>&gt; 18 anys<\/li>\n<li>Consentiment informat signat<\/li>\n<li>Diagn\u00f2stic d&#8217;ELA<\/li>\n<li>Capacitat d&#8217;empassar les c\u00e0psules de la medicaci\u00f3.<\/li>\n<li>Valors de capacitat respirat\u00f2ria entre el 60 i el 90% del valor te\u00f2ric.<\/li>\n<li>Mesos des de l&#8217;inici de s\u00edmptomes de la malaltia: entre 12 i 48 mesos.<\/li>\n<li>Dosi de riluzole estable en l&#8217;\u00faltim mes<\/li>\n<\/ul>\n<p><strong>Exclusi\u00f3<\/strong><\/p>\n<ul>\n<li>Pacients amb diagn\u00f2stic d&#8217;altres malalties neurodegeneratives (Alzheimer, Parkinson, dem\u00e8ncia ..).<\/li>\n<li>\u00das de qualsevol tipus de suport ventilatori (ventilaci\u00f3 no invasiva, BiPAP o fins i tot CPAP) en els darrers 3 mesos. \u00das de marcapassos diafragm\u00e0tic en els \u00faltims 3 mesos.<\/li>\n<li>Qualsevol tractament amb c\u00e8l\u00b7lules mare o ter\u00e0pia gen\u00e8tica com a tractament de l&#8217;ELA<\/li>\n<li>Administraci\u00f3 de Levosimendan en els \u00faltims 3 mesos previs a l&#8217;screening o al\u00b7l\u00e8rgia al Levosimendan.<\/li>\n<li>Qualsevol tractament amb Tirasemtiv o CK-2127107 (Reldesemtiv) en els darrers 3 mesos. Qualsevol \u00fas d&#8217;Edaravone en els \u00faltims 30 dies.<\/li>\n<li>\u00das de toxina botul\u00ednica en els \u00faltims 3 mesos.<\/li>\n<li>Malaltia respirat\u00f2ria o malaltia card\u00edaca (valvulopatia, miocardiopatia, ar\u00edtmies severes etc), Freq\u00fc\u00e8ncia card\u00edaca&gt; 100 batecs per min, Hipotensi\u00f3 (TA s &lt;90 mmHg), an\u00e8mia (Hb &lt;10 g \/ L), alteracions en el potassi, creatinina o funci\u00f3 hep\u00e0tica, infecci\u00f3 per HIV o qualsevol altra malaltia greu que pugui interferir en la participaci\u00f3 en l&#8217;estudi.<\/li>\n<\/ul>\n<p>Si ests interessat\/ada en participar o rebre m\u00e9s informaci\u00f3 contacta amb nosaltres al t. 638.680.789<\/p>\n<p>&nbsp;<\/p>\n<div class=\"sharedaddy sd-sharing-enabled\"><div class=\"robots-nocontent sd-block sd-social sd-social-icon sd-sharing\"><h3 class=\"sd-title\">Comparteix aix\u00f2:<\/h3><div class=\"sd-content\"><ul><li class=\"share-facebook\"><a rel=\"nofollow\" data-shared=\"sharing-facebook-1801\" class=\"share-facebook sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=facebook\" target=\"_blank\" title=\"Comparteix al Facebook\"><span><\/span><span class=\"sharing-screen-reader-text\">Comparteix al Facebook (Opens in new window)<\/span><\/a><\/li><li class=\"share-twitter\"><a rel=\"nofollow\" data-shared=\"sharing-twitter-1801\" class=\"share-twitter sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=twitter\" target=\"_blank\" title=\"Feu clic per compartir al Twitter\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per compartir al Twitter (Opens in new window)<\/span><\/a><\/li><li class=\"share-google-plus-1\"><a rel=\"nofollow\" data-shared=\"sharing-google-1801\" class=\"share-google-plus-1 sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=google-plus-1\" target=\"_blank\" title=\"Feu clic per compartir a Google+\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per compartir a Google+ (Opens in new window)<\/span><\/a><\/li><li class=\"share-email\"><a rel=\"nofollow\" data-shared=\"\" class=\"share-email sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=email\" target=\"_blank\" title=\"Feu clic per enviar un correu electr\u00f2nic a un amic\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per enviar un correu electr\u00f2nic a un amic (Opens in new window)<\/span><\/a><\/li><li class=\"share-print\"><a rel=\"nofollow\" data-shared=\"\" class=\"share-print sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/\" target=\"_blank\" title=\"Feu clic per imprimir\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per imprimir (Opens in new window)<\/span><\/a><\/li><li class=\"share-end\"><\/li><\/ul><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>La Unitat Multidisciplinar de Motoneurona de l&#8217;Hospital de Bellvitge participa en l&#8217;assaig cl\u00ednic REFALS, que te com a a objectiu valorar els efectes del Levosimendan en l&#8217;ELA. Aquest medicament s&#8217;utilitza en pacients amb insufici\u00e8ncia card\u00edaca, en els quals millora la &hellip; <a href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/\">Continua llegint <span class=\"meta-nav\">&rarr;<\/span><\/a><\/p>\n<div class=\"sharedaddy sd-sharing-enabled\"><div class=\"robots-nocontent sd-block sd-social sd-social-icon sd-sharing\"><h3 class=\"sd-title\">Comparteix aix\u00f2:<\/h3><div class=\"sd-content\"><ul><li class=\"share-facebook\"><a rel=\"nofollow\" data-shared=\"sharing-facebook-1801\" class=\"share-facebook sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=facebook\" target=\"_blank\" title=\"Comparteix al Facebook\"><span><\/span><span class=\"sharing-screen-reader-text\">Comparteix al Facebook (Opens in new window)<\/span><\/a><\/li><li class=\"share-twitter\"><a rel=\"nofollow\" data-shared=\"sharing-twitter-1801\" class=\"share-twitter sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=twitter\" target=\"_blank\" title=\"Feu clic per compartir al Twitter\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per compartir al Twitter (Opens in new window)<\/span><\/a><\/li><li class=\"share-google-plus-1\"><a rel=\"nofollow\" data-shared=\"sharing-google-1801\" class=\"share-google-plus-1 sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=google-plus-1\" target=\"_blank\" title=\"Feu clic per compartir a Google+\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per compartir a Google+ (Opens in new window)<\/span><\/a><\/li><li class=\"share-email\"><a rel=\"nofollow\" data-shared=\"\" class=\"share-email sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/?share=email\" target=\"_blank\" title=\"Feu clic per enviar un correu electr\u00f2nic a un amic\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per enviar un correu electr\u00f2nic a un amic (Opens in new window)<\/span><\/a><\/li><li class=\"share-print\"><a rel=\"nofollow\" data-shared=\"\" class=\"share-print sd-button share-icon no-text\" href=\"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/assaig-refals-criteris-dinclusio-i-exclusio\/\" target=\"_blank\" title=\"Feu clic per imprimir\"><span><\/span><span class=\"sharing-screen-reader-text\">Feu clic per imprimir (Opens in new window)<\/span><\/a><\/li><li class=\"share-end\"><\/li><\/ul><\/div><\/div><\/div>","protected":false},"author":10,"featured_media":0,"comment_status":"closed","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[102,83],"tags":[320],"_links":{"self":[{"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/posts\/1801"}],"collection":[{"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/users\/10"}],"replies":[{"embeddable":true,"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/comments?post=1801"}],"version-history":[{"count":3,"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/posts\/1801\/revisions"}],"predecessor-version":[{"id":1804,"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/posts\/1801\/revisions\/1804"}],"wp:attachment":[{"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/media?parent=1801"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/categories?post=1801"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/blogs.bellvitgehospital.cat\/aulaela\/wp-json\/wp\/v2\/tags?post=1801"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}