50 research outputs found

    Raskaan liikenteen taukopaikat Uudenmaan ELY-keskuksen alueella : Kysynnän ja tarjonnan analyysi sekä mahdollisia yhteistoimintamalleja

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    Selvityksen tavoitteena oli tuottaa kokonaiskuva raskaan liikenteen taukopaikkojen nykytilanteesta, kehittämistarpeista, kysynnästä ja tarjonnasta Uudenmaan ELY-keskuksen alueella sekä kartoittaa esimerkkejä tauko- ja levähdysalueiden toimintamalleista Suomessa ja muualla. Tavoitteena oli tuottaa tietoa kehittämistoimenpiteiden suuntaamiselle ja eri sidosryhmien välisen yhteistoiminnan kehittämiselle. Selvitys toteutettiin kesäkuun ja joulukuun 2015 välisenä aikana. Hankkeessa toteutettiin taukopaikkojen raskaan liikenteen käyttäjälaskenta ja kapasiteetin inventointi elokuussa 2015. Laskenta suoritettiin sekä päivällä että yöllä. Inventoiduista valtion taukopaikoista on tehty myös levähdysaluekortit, joissa on esitetty taukopaikkojen ominaisuustietoja. Taukopaikkojen kysyntää arvioitiin lisäksi selvittämällä suurimmista kaupungeista etelän suuntaan lähtevien kuljetusten ajo- ja lepoaikojen perusteella määritellyt (4½ h ja 9 h) taukovyöhykkeet Uudenmaan ELY-keskuksen alueella. Taukopaikkojen kysynnän kehittymistä arvioitiin vertailemalla käyttäjälaskennan tuloksia aiemmin tehdyn käyttäjälaskennan tuloksiin. Kysynnän kehittymistä tulevaisuudessa arvioitiin Uudenmaan 4. vaihemaakuntakaavan kehityskuvavaihtoehtoa varten tehdyn liikenne-ennusteen perusteella. Kysynnän ja kehittämismahdollisuuksien (tauko- ja levähdysalueiden ominaisuudet) perusteella valittiin ne taukopaikat, joilla on eniten kehittämistarvetta ja -mahdollisuuksia. Nämä kehittämiskohteet priorisoitiin hankkeessa kehitetyllä priorisointimenetelmällä. Uusien taukopaikkojen likimääräinen tarve laskettiin taukopaikkojen kapasiteetin ja yön keskimääräisen käyttöasteen perusteella. Uusien alueiden tarvetta ja toteuttamismahdollisuuksia arvioitiin olemassa olevien suunnitelmien ja kysynnän perusteella. Raportin viimeisessä luvussa esitetään tutkimustuloksista pääteltyjä jatkotoimenpidetarpeita

    Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

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    Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1-3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.Peer reviewe

    Safety of alemtuzumab in a nationwide cohort of Finnish multiple sclerosis patients

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    Background Alemtuzumab is an effective disease-modifying therapy (DMT) for highly active multiple sclerosis (MS). However, safety concerns limit its use in clinical practice. Objectives To evaluate the safety of alemtuzumab in a nationwide cohort of Finnish MS patients. Methods In this retrospective case series study, we analyzed the data of all but two MS patients who had received alemtuzumab in Finland until 2019. Data were systematically collected from patient files. Results Altogether 121 patients were identified, most of whom had received previous DMTs (82.6%). Median follow-up time after treatment initiation was 30.3 months and exceeded 24 months in 78 patients. Infusion-associated reactions (IARs) were observed in 84.3%, 57.3%, and 57.1% of patients during alemtuzumab courses 1-3, respectively. Serious adverse events (SAEs) were observed in 32.2% of patients, serious IARs in 12.4% of patients, and SAEs other than IARs in 23.1% of patients. Autoimmune adverse events were observed in 30.6% of patients. One patient died of hemophagocytic lymphohistiocytosis, and one patient died of pneumonia. A previously unreported case of thrombotic thrombocytopenic purpura was documented. Conclusions SAEs were more frequent in the present cohort than in previous studies. Even though alemtuzumab is a highly effective therapy for MS, vigorous monitoring with a long enough follow-up time is advised.</p

    Safety, tolerability, and immunogenicity of V114 pneumococcal vaccine compared with PCV13 in a 2+1 regimen in healthy infants : A phase III study (PNEU-PED-EU-2)

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    Background: This phase III study evaluated safety, tolerability, and immunogenicity of V114 (15-valent pneumococcal conjugate vaccine) in healthy infants. V114 contains all 13 serotypes in PCV13 and additional serotypes 22F and 33F. Methods: Healthy infants were randomized to two primary doses and one toddler dose (2+1 regimen) of V114 or PCV13 at 3, 5, and 12 months of age; diphtheria, tetanus, pertussis (DTaP), inactivated poliovirus (IPV), Haemophilus influenzae type b (Hib), hepatitis B (HepB) vaccine was administered concomitantly. Adverse events (AEs) were collected on Days 1–14 following each vaccination. Serotype-specific anti-pneumococcal immunoglobulin G (IgG) was measured 30 days post-primary series, immediately prior to toddler dose, and 30 days post-toddler dose. Primary objectives included non-inferiority of V114 to PCV13 for 13 shared serotypes and superiority of V114 to PCV13 for serotypes 22F and 33F. Results: 1191 healthy infants were randomized to V114 (n = 595) or PCV13 (n = 596). Proportions of participants with solicited AEs and serious AEs were comparable between groups. V114 met non-inferiority criteria for 13 shared serotypes, based on difference in proportions with serotype-specific IgG ≥0.35 μg/mL (lower bound of two-sided 95% confidence interval [CI] >−10.0) and IgG geometric mean concentration (GMC) ratios (lower bound of two-sided 95% CI >0.5) at 30 days post-toddler dose. V114 met superiority criteria for serotypes 22F and 33F, based on response rates (lower bound of two-sided 95% CI >10.0) and IgG GMC ratios (lower bound of two-sided 95% CI >2.0) at 30 days post-toddler dose. Antibody responses to DTaP-IPV-Hib-HepB met non-inferiority criteria, based on antigen-specific response rates. Conclusion: A two-dose primary series plus toddler dose of V114 was well-tolerated in healthy infants. Compared with PCV13, V114 provided non-inferior immune responses to 13 shared serotypes and superior immune responses to additional serotypes 22F and 33F.publishedVersionPeer reviewe

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