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- Villa, Luisa L., et al.
(author)
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Quadrivalent vaccine against human papillomavirus to prevent high-grade cervical lesions
- 2007
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In: New England Journal of Medicine. - 0028-4793 .- 1533-4406. ; 356:19, s. 1915-1927
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Journal article (peer-reviewed)abstract
- BACKGROUND: Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18. METHODS: In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18. RESULTS: Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31). CONCLUSIONS: In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group.
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- Hansson, B. A. M., et al.
(author)
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Characterisation of a liquid-xenon jet laser-plasma extreme-ultraviolet source
- 2004
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In: Review of Scientific Instruments. - : AIP Publishing. - 0034-6748 .- 1089-7623. ; 75:6, s. 2122-2129
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Journal article (peer-reviewed)abstract
- A liquid-xenon-jet laser-plasma source for extreme-ultraviolet (EUV) and soft-x-ray generation has been characterized. Being a source candidate for EUV lithography (EUVL), we especially focus on parameters important for the integration of the source in EUVL systems. The deep-ultraviolet (DUV) out-of-band radiation (=120–400 nm) was quantified, to within a factor of two, using a flying-circus tool together with a transmission-grating spectrograph resulting in a total DUV conversion efficiency (CE) of ~0.33%/2sr. The size and the shape of the xenon plasma was investigated using an in-band-only EUV microscope, based on a spherical Mo/Si multilayer mirror and a charge-coupled device detector. Scalability of the source size from 20–270 µm full width at half maximum was shown. The maximum repetition-rate sustainable by the liquid-xenon-jet target was simulated by a double-pulse experiment indicating feasibility of >17 kHz operation. The xenon-ion energy distribution from the plasma was determined in a time-of-flight experiment with a Faraday-cup detector showing the presence of multi-kilo-electron-volt ions. Sputtering of silicon witness plates exposed to the plasma was observed, while a xenon background of >1 mbar was shown to eliminate the sputtering. It is concluded that the source has potential to meet the requirements of future EUVL systems.
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- Irgens, I., et al.
(author)
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Spinal cord injury and development of pressure injury during acute rehabilitation in Norway: a national retrospective cross-sectional study
- 2020
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In: Spinal Cord. - : Springer Science and Business Media LLC. - 1362-4393 .- 1476-5624. ; 58, s. 1069-1079
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Journal article (peer-reviewed)abstract
- Study design A national, retrospective, cross-sectional study. Objectives To analyze the prevalence of pressure injury (PI), and characteristics associated with PI development in the hospitalized population of persons with a newly acquired spinal cord injury (SCI) between 2004 and 2014. Setting All three specialized Spinal Cord Units in Norway. Methods Demographic data related to prevalence and potential risk factors were retrieved from the electronic medical record (EMR). Statistical analyses were performed, using IBM SPSS Statistics, version 23. Results We identified 1012 individuals with a new SCI. Mean age at injury was 48 years (SD 19). The period prevalence of PI was 16% (95% CI = 0.14-0.19), and identified PI associations were complete SCI (OR = 0.1), being injured abroad (OR = 2.4), bowel (OR = 13), and bladder (OR = 9.2) dysfunction; comorbidities like diabetes mellitus 1 (OR = 7.9), diagnosed depression (OR = 3.8), ventilator support (OR = 3.0), drug abuse (OR = 3.0), and concurrent traumatic brain injury (OR = 1.7). Individuals in the age group of 15-29 years had higher odds of PI compared with middle-aged individuals (45-59 years). Conclusion PI is a serious complication after SCI. The association between depression or comorbidity and PI occurrence should be investigated more thoroughly. We recommend implementation of a simple follow-up program regarding observation and prevention of PI. Increased awareness of factors that could contribute to PI will help to focus on better prevention and early recognition of PI. This will contribute to more optimal rehabilitation.
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- Villa, L., et al.
(author)
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Effect of prophylactic human papillomavirus L1 virus-like-particle vaccine on risk of cervical intraepithelial neoplasia grade 2, grade 3, and adenocarcinoma in situ: a combined analysis of four randomised clinical trials
- 2007
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In: The Lancet. - 1474-547X. ; 369:9576, s. 1861-1868
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Journal article (peer-reviewed)abstract
- Background Cervical cancer and its obligate precursors, cervical intraepithelial neoplasia grades 2 and 3 (CIN2/3), and adenocarcinona in situ (AIS), are caused by oncogenic human papillomavirus (HPV). In this combined analysis of four clinical trials we assessed the effect of prophylactic HPV vaccination on these diseases. Methods 20 583 women aged 16-26 years were randomised to receive quadrivalent HPV6/11/16/18 vaccine (n=9087), its HPV16 vaccine component (n=1204), or placebo (n=10292). They underwent periodic Papanicolaou testing, with colposcopy or biopsy for detected abnormalities. The primary composite endpoint was the combined incidence of HPV16/18-related CIN2/3, AIS, or cervical cancer. These trials are registered at ClinicalTrials.gov, numbers NCT00365378, NCT00365716, NCT00092521, and NCT00092534. Findings Mean follow-up was 3.0 years (SD 0.66) after first dose. In women negative for HPV16 or HPV18 infection during the vaccination regimen (n=17129, per protocol), vaccine efficacy was 99% for the primary endpoint (95% Cl 93-100), meeting the statistical criterion for success. In an intention-to-treat analysis of all randomised women (including those who were HPV16/18 naive or HPV16/18-infected at day 1), efficacy was 44% (95% Cl 31-55); all but one case in vaccine recipients occurred in women infected with HPV16 or HPV18 before vaccination. In a second intention-to-treat analysis we noted an 18% reduction (95% CI 7-29) in the overall rate of CIN2/3 or AIS due to any HPV type. Interpretation Administration of HPV vaccine to HPV-naive women, and women who are already sexually active, could substantially reduce the incidence of HPV16/18-related cervical precancers and cervical cancer.
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