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排序方式: 共有196条查询结果,搜索用时 31 毫秒
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Nicola Disma Davinia Withington Mary Ellen McCann Rodney Wayne Hunt Sarah Jane Arnup Francesca Izzo Jurgen C. de Graaff Girolamo Mattioli Neil Morton Geoff Frawley Andrew Davidson Anne Lynn Peter Szmuk Joss John Thomas Philip Ragg Alessio Pini Prato 《Journal of pediatric surgery》2018,53(9):1643-1650
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Stanberry LR Simon JK Johnson C Robinson PL Morry J Flack MR Gracon S Myc A Hamouda T Baker JR 《Vaccine》2012,30(2):307-316
Background
Improving the systemic and mucosal immune response following intranasal vaccination could enhance disease protection against respiratory pathogens. We assessed the safety and immunogenicity of a novel nanoemulsion mucosal adjuvant W805EC combined with approved seasonal influenza antigens.Methods
This was a first-in-human Phase I study in 199 healthy adult volunteers randomized to receive a single intranasal administration of 5%, 10%, 15% or 20% W805EC, combined with 4 or 10 μg strain-specific Fluzone® HA, compared with intranasal PBS, intranasal Fluzone®, or 15 ug strain-specific intramuscular Fluzone®. Safety was evaluated by physical examination, laboratory parameters, symptom diaries, and adverse event reports. Serum HAI titers and nasal wash IgA were assessed at baseline as well as 28 and 60 days after vaccination.Results
W805EC adjuvant combined with seasonal influenza antigens was well tolerated without safety concerns or significant adverse events. The highest dose of 20% W805EC combined with 10 μg strain-specific HA elicited clinically meaningful systemic immunity based on increases in serum HAI GMT and ≥70% seroprotection for all 3 influenza strains, as well as a rise in antigen-specific IgA in nasal wash specimens.Conclusions
W805EC adjuvant was safe and well tolerated in healthy adult volunteers and elicited both systemic and mucosal immunity following a single intranasal vaccination. 相似文献4.
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《Vaccine》2015,33(32):3940-3946
BackgroundThis study aimed to investigate the dosage, immunogenicity and safety profile of a novel human papillomavirus (HPV) types 16 and 18 bivalent vaccine produced by E. coli.MethodsThis randomized, double-blinded, controlled phase 2 trial enrolled women aged 18–25 years in China. Totally 1600 eligible participants were randomized to receive 90 μg, 60 μg, or 30 μg of the recombinant HPV 16/18 bivalent vaccine or the control hepatitis B vaccine on a 0, 1 and 6 month schedule. The designated doses are the combined micrograms of HPV16 and 18 VLPs with dose ratio of 2:1. The immunogenicity of the vaccines was assessed by measuring anti-HPV 16 and 18 neutralizing antibodies and total IgG antibodies. Safety of the vaccine was assessed.ResultsAll but one of the seronegative participants who received 3 doses of the HPV vaccines seroconverted at month 7 for anti-HPV 16/18 neutralizing antibodies and IgG antibodies. For HPV 16, the geometric mean titers (GMTs) of the neutralizing antibodies were similar between the 60 μg (GMT = 10,548) and 90 μg (GMT = 12,505) HPV vaccine groups and were significantly higher than those in the 30 μg (GMT = 7596) group. For HPV 18, the GMTs of the neutralizing antibodies were similar among the 3 groups. The HPV vaccine was well tolerated. No vaccine-associated serious adverse events were identified.ConclusionThe prokaryotic-expressed HPV vaccine is safe and immunogenic in women aged 18–25 years. The 60 μg dosage formulation was selected for further investigation for efficacy.Clinical trials registration: NCT01356823. 相似文献
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Hélène Fontaine Marianne Maynard Cécile Bouix Maria Patrizia Carrieri Danielle Botta-Fridlund Louis D’Alteroche Filomena Conti Georges-Philippe Pageaux Vincent Leroy Sophie Métivier Rodolphe Anty François Durand Valérie Canva Antoine Vilotitch Pascal Lebray Laurent Alric Christophe Duvoux Ventzislava Petrov-Sanchez Elina Teicher 《Clinics and research in hepatology and gastroenterology》2017,41(1):56-65
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Emma Guttman-Yassky Patrick M. Brunner Avidan U. Neumann Saakshi Khattri Ana B. Pavel Kunal Malik Giselle K. Singer Danielle Baum Patricia Gilleaudeau Mary Sullivan-Whalen Sharon Rose Shelbi Jim On Xuan Li Judilyn Fuentes-Duculan Yeriel Estrada Sandra Garcet Claudia Traidl-Hoffmann James G. Krueger Mark G. Lebwohl 《Journal of the American Academy of Dermatology》2018,78(5):872-881.e6
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Kylie Kavanagh Soraya Sajadian Kurt A. Jenkins Martha D. Wilson J. Jeffery Carr Janice D. Wagner Lawrence L. Rudel 《Nutrition Research》2010
Industrially produced trans-fatty acids (TFAs) consumed in Western diets are incorporated into maternal and fetal tissues and are passed linearly to offspring via breast milk. We hypothesized that TFA exposure in utero and during lactation in infants would promote obesity and poor glycemic control as compared with unmodified fatty acids. We further hypothesized that in utero exposure alone may program for these outcomes in adulthood. To test this hypothesis, we fed female C57/BL6 mice identical Western diets that differed only in cis- or trans-isomers of C18:1 and then aimed to determine whether maternal transfer of TFAs through pregnancy and lactation alters growth, body composition, and glucose metabolism. Mice were unexposed, exposed during pregnancy, during lactation, or throughout pregnancy and lactation to TFA. Body weight and composition (by computed tomography) and glucose metabolism were assessed at weaning and adulthood. Trans-fatty acid exposure through breast milk caused significant early growth retardation (P < .001) and higher fasting glucose (P = .01), but insulin sensitivity was not different. Elevated plasma insulin-like growth factor-1 in mice consuming TFA-enriched milk (P = .02) may contribute to later catch-up growth and leanness and preserved peripheral insulin sensitivity observed in these mice. Mice exposed to TFA in utero underwent rapid early neonatal growth with TFA-free breast milk and had significantly impaired insulin sensitivity (P < .05) and greater abdominal fat (P = .01). We conclude that very early catch-up growth resulted in impaired peripheral insulin sensitivity in this model of diet-related fetal and neonatal programming. Trans-fatty acid surprisingly retarded growth and adiposity while still adversely affecting glucose metabolism. 相似文献
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