57 research outputs found
Développement des croisières maritimes en Chine : quelle adaptation de l'offre au marché chinois ?
Si le cœur historique de la mondialisation touristique est bien identifié comme étant l’Europe et les États-Unis, celle-ci a aujourd’hui largemedépassé ces espaces, repoussant sans cesse les frontières d’une pratique touristique, qui n’est plus réservée aux seules élites des pays riches anciennement industrialisés. Les mobilités récréatives se multiplient en effet en Asie, en Amérique latine, en Océanie et en Afrique, où se structurent de nouveaux foyers touristiques. Concernant des classes sociales de plus en plus élargies et mobilisant parfois des masses considérables comme en Chine ou en Inde, elles sont à l’origine de la production de lieux touristiques souvent inconnus en Europe. Elles s’accompagnent également de pratiques qui bousculent nos représentations, en suggérant l’existence d’autres modèles
culturels et manières de faire du tourisme. Cet ouvrage inédit, issu de tout récents travaux de recherche, donne à voir les pratiques de ces nouvelles populations touristiques à l’échelle de leurs propre pays comme à l’échelle régionale, à travers les mobilités qu’elles dessinent, les lieux qu’elles choisissent, en renversant une vision longtemps restée très européanocentrée du tourisme international. Il souhaite explorer ces nouvelles frontières du tourisme sous l’angle de la diversité des régions du monde étudiées et des filiations mobilitaires auxquelles ces pratiques se réfèrent, afin de mieux comprendre les dynamiques du tourisme à l’œuvre, dans des pays qui ne l’ont pas historiquement inventé, mais qui préfigurent peut-être celui de demain
A phase 3 multicenter, prospective, open-label efficacy and safety study of immune globulin (human) 10% caprylate/chromatography purified in patients with myasthenia gravis exacerbations
Background: Myasthenia gravis (MG) is an autoimmune disorder affecting neuromuscular transmission. Exacerbations may involve increasing bulbar weakness and/or sudden respiratory failure, both of which can be critically disabling. Management of MG exacerbations includes plasma exchange and intravenous immunoglobulin (IVIG); they are equally effective, but patients experience fewer side effects with IVIG. The objective of this study was to assess the efficacy and safety of immune globulin caprylate/chromatography purified (IGIV-C) in subjects with MG exacerbations. Methods: This prospective, open-label, non-controlled 28-day clinical trial was conducted in adults with MG Foundation of America class IVb or V status. Subjects received IGIV-C 2 g/kg over 2 consecutive days (1 g/kg/day) and were assessed for efficacy/safety on Days 7, 14, 21, and 28. The primary efficacy endpoint was the change from Baseline in quantitative MG (QMG) score to Day 14. Secondary endpoints of clinical response, Baseline to Day 14, included at least a 3-point decrease in QMG and MG Composite and a 2-point decrease in MG-activities of daily living (MG-ADL). Results: Forty-nine subjects enrolled. The change in QMG score at Day 14 was significant (p < 0.001) in the Evaluable (-6.4, n = 43) and Safety (-6.7, n = 49) populations. Among evaluable subjects, Day 14 response rates were 77, 86, and 88% for QMG, MG Composite, and MG-ADL, respectively. IGIV-C showed good tolerability with no serious adverse events. Conclusions: The results of this study show that IGIV-C was effective, safe, and well tolerated in the treatment of MG exacerbations
Hyperimmune immunoglobulin for hospitalised patients with COVID-19 (ITAC): a double-blind, placebo-controlled, phase 3, randomised trial
BACKGROUND:
Passive immunotherapy using hyperimmune intravenous immunoglobulin (hIVIG) to SARS-CoV-2, derived from recovered donors, is a potential rapidly available, specific therapy for an outbreak infection such as SARS-CoV-2. Findings from randomised clinical trials of hIVIG for the treatment of COVID-19 are limited.
METHODS:
In this international randomised, double-blind, placebo-controlled trial, hospitalised patients with COVID-19 who had been symptomatic for up to 12 days and did not have acute end-organ failure were randomly assigned (1:1) to receive either hIVIG or an equivalent volume of saline as placebo, in addition to remdesivir, when not contraindicated, and other standard clinical care. Randomisation was stratified by site pharmacy; schedules were prepared using a mass-weighted urn design. Infusions were prepared and masked by trial pharmacists; all other investigators, research staff, and trial participants were masked to group allocation. Follow-up was for 28 days. The primary outcome was measured at day 7 by a seven-category ordinal endpoint that considered pulmonary status and extrapulmonary complications and ranged from no limiting symptoms to death. Deaths and adverse events, including organ failure and serious infections, were used to define composite safety outcomes at days 7 and 28. Prespecified subgroup analyses were carried out for efficacy and safety outcomes by duration of symptoms, the presence of anti-spike neutralising antibodies, and other baseline factors. Analyses were done on a modified intention-to-treat (mITT) population, which included all randomly assigned participants who met eligibility criteria and received all or part of the assigned study product infusion. This study is registered with ClinicalTrials.gov, NCT04546581.
FINDINGS:
From Oct 8, 2020, to Feb 10, 2021, 593 participants (n=301 hIVIG, n=292 placebo) were enrolled at 63 sites in 11 countries; 579 patients were included in the mITT analysis. Compared with placebo, the hIVIG group did not have significantly greater odds of a more favourable outcome at day 7; the adjusted OR was 1·06 (95% CI 0·77–1·45; p=0·72). Infusions were well tolerated, although infusion reactions were more common in the hIVIG group (18·6% vs 9·5% for placebo; p=0·002). The percentage with the composite safety outcome at day 7 was similar for the hIVIG (24%) and placebo groups (25%; OR 0·98, 95% CI 0·66–1·46; p=0·91). The ORs for the day 7 ordinal outcome did not vary for subgroups considered, but there was evidence of heterogeneity of the treatment effect for the day 7 composite safety outcome: risk was greater for hIVIG compared with placebo for patients who were antibody positive (OR 2·21, 95% CI 1·14–4·29); for patients who were antibody negative, the OR was 0·51 (0·29–0·90; pinteraction=0·001).
INTERPRETATION:
When administered with standard of care including remdesivir, SARS-CoV-2 hIVIG did not demonstrate efficacy among patients hospitalised with COVID-19 without end-organ failure. The safety of hIVIG might vary by the presence of endogenous neutralising antibodies at entry.
FUNDING:
US National Institutes of Health
Thermosensitive coating dedicated to smart TPS for very high temperature - 850 °C to 1650°C
International audienceThis paper presents the recent development of a new thermosensitive coating and its associated reading device, which allows to determine thermal history in the 850°C- 1650°C temperature range, providing access to a new easy way to detect hot spot on smart Thermal Protection System with a much better thermal resolution than commercially available thermochromic paints. This technology is suitable to be rapidly integrated on re-usable launcher or vehicle parts as a paint on the thermostructural surfaces or inside small machined cavities. A new device dedicated to detection of overheated zones in the overall range of temperatures achieved in the whole Thermal Protection System (from CMCs to Metallics) is presented, thus promising a considerable reduction in the effort required for post-flight inspection
Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified
Kim Hanna, Maria Cristina Cruz, Elsa Mondou, Edward Corsi, Peter Vandeberg Grifols Bioscience Research Group, Grifols Inc, Research Triangle Park, NC, USA Background: Rabies immune globulin (RIG) and vaccination series are necessary for postexposure prophylaxis. A new formulation of RIG (human) purified by caprylate/chromatography (RIG-C) was evaluated. Trial registration: ClinicalTrials.gov identifier: NCT02139657.Materials and methods: This open-label, single-arm study in healthy subjects evaluated neutralizing rabies antibody concentrations produced from a single 20 IU/kg intramuscular (IM) dose of RIG-C as measured by rapid fluorescent focus inhibition test (50% neutralization endpoint) 1-hour postdose and on days 1, 2, 4, 6, 8, 10, 14, 18, and 21.Results: Twelve subjects were enrolled into the study. No discontinuations, serious adverse events (AEs), or treatment-emergent clinically significant changes in laboratory parameters were observed. All AEs resolved and were mild except 1 moderate AE of oropharyngeal pain. Injection site pain (4 subjects) was most commonly reported. RIG-C produced a rapid increase in neutralizing rabies antibody: mean value 0.113 IU/mL at 24 hours after IM injection, peak on day 4 (0.132 IU/mL), persisting through day 21 (0.116 IU/mL). The mean reciprocal titer was 11.5 by day 2; the peak value of 12.1 was achieved on day 4; and a mean value ≥10.6 was maintained through day 21.Conclusion: RIG-C was well tolerated and provided neutralizing rabies antibodies, which combined with vaccine series after rabies exposure, should result in effective prophylaxis per World Health Organization/Centers for Disease Control and Prevention guidelines. Keywords: rabies, rabies immune globulin, RIG-C, prophylaxis, rabies neutralizing antibody titers, GTI130
Continued efficacy and safety through 4 years of tenofovir disoproxil fumarate (tdf) treatment in hbeag-negative patients with chronic hepatitis b (study 102): Preliminary analysis
Bu çalışma, 29 Ekim-02 Kasım 2010 tarihleri arasında Boston[Amerika Birleşik Devletleri]’da düzenlenen 61. Annual Meeting of the American-Association-for-the-Study-of-Liver-Diseases’da bildiri olarak sunulmuştur.Amer Assoc Study Liver Di
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