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  • Oxford Journals (Oxford University Press)  (32)
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  • 1
    In: The American Historical Review, 2006, Vol. 111(5), pp.1467-1469
    Keywords: History & Archaeology;
    ISSN: 0002-8762
    E-ISSN: 1937-5239
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  • 2
    In: The American Historical Review, 1998, Vol. 103(5), pp.1634-1634
    Keywords: History & Archaeology;
    ISSN: 0002-8762
    E-ISSN: 1937-5239
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  • 3
    In: Human Reproduction, 2016, Vol. 31(8), pp.1703-1712
    Description: Abstract STUDY QUESTION Does administration of vilaprisan (VPR) to healthy women for 12 weeks reduce menstrual bleeding? SUMMARY ANSWER In this 12-week proof-of-concept phase 1 trial, most women (30/33, 90%) who received VPR at daily doses of 1–5 mg reported the absence of menstrual bleeding. WHAT IS KNOWN ALREADY Vilaprisan (BAY 1002670) is a novel, highly potent selective progesterone receptor modulator that markedly reduces the growth of human leiomyoma tissue in a preclinical model of uterine fibroids (UFs). STUDY DESIGN, SIZE, DURATION In this double-blind, parallel-group study, of the 163 healthy women enrolled 73 were randomized to daily VPR 0.1 mg (n = 12), 0.5 mg (n = 12), 1 mg (n = 13), 2 mg (n = 12), 5 mg (n = 12) or placebo tablets (n = 12) for 12 weeks. Participants were followed up until the start of the second menstrual bleeding after the end of treatment. Trial simulations were used to determine the minimum sample size required to estimate the non-bleeding rate (i.e. self-assessed bleeding intensity of ‘none’ or ‘spotting’) using Bayesian dose–response estimation with incorporated prior information. It was estimated that 48 participants in the per-protocol analysis population would be sufficient. PARTICIPANTS/MATERIALS, SETTING, METHODS Women aged 18–45 years who had been sterilized by tubal ligation were enrolled between November 2011 and May 2012. Participants kept a daily diary of bleeding intensity. Blood and urine samples were taken, and transvaginal ultrasound was performed before treatment, during treatment and follow-up. Endometrial biopsies were obtained during the pretreatment cycle, at the end of the treatment period and during the follow-up phase. The primary outcome was the estimated dose–response curve of the observed non-bleeding rate during Days 10–84 of treatment, excluding the endometrial biopsy day and 2 days after biopsy. Secondary outcomes included return of bleeding during follow-up, size of follicle-like structures and serum hormone levels. Safety assessments included adverse events (AEs), endometrial thickness and histology, laboratory parameters, vital signs and 12-lead electrocardiography. MAIN RESULTS AND THE ROLE OF CHANCE All 73 randomized participants received at least one dose of study medication and were included in safety analyses; six participants were excluded from the per-protocol analyses. A total of 69 completed the study. Observed non-bleeding rates increased with VPR dose: 0.1 mg (0%; 90% confidence interval [CI]: 0–23.8), 0.5 mg (27.3%; 90% CI: 7.9–56.4), 1 mg (80.0%; 90% CI: 49.3–96.3), 2 mg (100%; 90% CI: 77.9–100), 5 mg (90.9%; 90% CI: 63.6–99.5), compared with 0% (90% CI: 0–22.1) in the placebo group. Maximal non-bleeding rates were reached at doses of 2 mg and higher. Return of menstrual bleeding was observed in all women ≤52 days after VPR discontinuation. No treatment-emergent critical endometrial findings occurred. Follicular growth was not suppressed and minimum average estradiol levels remained above 40 pg/ml. No serious treatment-emergent AEs or study discontinuations due to AEs were reported. Clinically relevant changes in laboratory parameters or vital signs were not evident. LIMITATIONS, REASONS FOR CAUTION The results of this small proof-of-concept study will need to be confirmed in larger trials in patients with UFs to establish the potential therapeutic benefits and safety of VPR. WIDER IMPLICATIONS OF THE FINDINGS The high rates of non-bleeding (80–100% at VPR doses of 1–5 mg) support further evaluation of VPR in patients with UFs and heavy menstrual bleeding. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by Bayer Pharma AG. B.S., A.K., M.-H.S.M., C.S. and B.R. are employees of Bayer Pharma AG. B.S., A.K. and M.-H.S.M. are listed as inventors of an issued patent related to this work, and received payment for this from Bayer Pharma AG. D.B. is the founder of Biokinetic Europe Ltd, UK, which received funding for this study from Bayer Pharma AG. M.K. is an employee of Nuvisan GmbH, Germany, which received funding for this study from Bayer Pharma AG. TRIAL REGISTRATION NUMBER Clinicaltrials.gov identifier: NCT01816815. TRIAL REGISTRATION DATE 20 March 2013. DATE OF FIRST PATIENT'S ENROLMENT 28 November 2011.
    Keywords: Vilaprisan ; Clinical Trial, Phase 1 ; Selective Progesterone Receptor Modulator ; Uterine Fibroids ; Bleeding Pattern
    ISSN: 0268-1161
    E-ISSN: 1460-2350
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  • 4
    In: International Journal of Epidemiology, 2018, Vol. 47(1), pp.246-254
    Description: The theoretical conditions under which causal estimates can be derived from observational data are challenging to achieve in the real world. Applied examples can help elucidate the practical limitations of methods to estimate randomized-controlled trial effects from observational data. We used six methods with varying design and analytic features to compare the 5-year risk of incident myocardial infarction among statin users and non-users, and used non-cardiovascular mortality as a negative control outcome. Design features included restriction to a statin-eligible population and new users only; analytic features included multivariable adjustment and propensity score matching. We used data from 5294 participants in the Cardiovascular Health Study from 1989 to 2004. For non-cardiovascular mortality, most methods produced protective estimates with confidence intervals that crossed the null. The hazard ratio (HR) was 0.92, 95% confidence interval: 0.58, 1.46 using propensity score matching among eligible new users. For myocardial infarction, all estimates were strongly protective; the propensity score-matched analysis among eligible new users resulted in a HR of 0.55 (0.29, 1.05)-a much stronger association than observed in randomized controlled trials. In designs that compare active treatment with non-treated participants to evaluate effectiveness, methods to address bias in observational data may be limited in real-world settings by residual bias.
    Keywords: Bias ; Observational Studies ; Statins
    ISSN: 0300-5771
    E-ISSN: 1464-3685
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  • 5
    In: Journal of the American Medical Informatics Association, 2011, Vol. 18(6), pp.805-811
    Description: Objective We have reported that implementation of an electronic health record (EHR) based quality improvement system that included point-of-care electronic reminders accelerated improvement in performance for multiple measures of chronic disease care and preventive care during a 1-year period. This study examined whether providing pre-visit paper quality reminders could further improve performance, especially for physicians whose performance had not improved much during the first year. Design Time-series analysis at a large internal medicine practice using a commercial EHR. All patients eligible for each measure were included (range approximately 100–7500). Measurements The proportion of eligible patients in the practice who satisfied each of 15 quality measures after removing those with exceptions from the denominator. To analyze changes in performance for individual physicians, two composite measures were used: prescribing seven essential medications and completion of five preventive services. Results During the year after implementing pre-encounter reminders, performance continued to improve for eight measures, remained stable for four, and declined for three. Physicians with the worst performance at the start of the pre-encounter reminders showed little absolute improvement over the next year, and most remained below the median performance for physicians in the practice. Conclusions Paper pre-encounter reminders did not appear to improve performance beyond electronic point-of-care reminders in the EHR alone. Lagging performance is likely not due to providers' EHR workflow alone, and trying to step backwards and use paper reminders in addition to point-of-care reminders in the EHR may not be an effective strategy for engaging slow adopters.
    Keywords: Quality Improvement ; Computerized Clinical Decision Support ; Performance Measurement ; Audit And Feedback ; Chronic Disease Management ; Patient Engagement ; Personal Health Record ; Health Literacy ; Medical Informatics ; Infection Control ; Phenotyping ; Quality
    ISSN: 1067-5027
    E-ISSN: 1527-974X
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  • 6
    Language: English
    In: American journal of hypertension, June 2016, Vol.29(6), pp.780-1
    Keywords: Drug Prescriptions
    ISSN: 08957061
    E-ISSN: 1941-7225
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  • 7
    Language: English
    In: Monthly Notices of the Royal Astronomical Society, 11 October 2018, Vol.480(1), pp.245-250
    Description: The present articlereports on the first spatial intensity interferometry measurements on stars since the observations at Narrabri Observatory by Hanbury Brown et al. in the 1970's. Taking advantage of the progresses in recent years on photon-counting detectors and fast electronics, we were able to measure the zero-time delay intensity correlation \(g^{(2)}(\tau = 0, r)\) between the light collected by two 1-m optical telescopes separated by 15 m. Using two marginally resolved stars (\(\alpha\) Lyr and \(\beta\) Ori) with R magnitudes of 0.01 and 0.13 respectively, we demonstrate that 4-hour correlation exposures provide reliable visibilities, whilst a significant loss of contrast is found on alpha Aur, in agreement with its binary-star nature.
    Keywords: Sciences of the Universe ; Astrophysics ; Instrumentation and Methods for Astrophysic ; Meteorology & Climatology ; Astronomy & Astrophysics
    ISSN: 0035-8711
    E-ISSN: 1365-2966
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  • 8
    In: American Journal of Hypertension, 2016, Vol. 29(6), pp.780-781
    ISSN: 0895-7061
    E-ISSN: 1941-7225
    Source: Oxford University Press
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  • 9
    In: Military Medicine, 2019, Vol. 184(5-6), pp.e284-e289
    Description: INTRODUCTIONModern health systems have to respond to a wide variety of catastrophic scenarios, from natural disasters to terror attacks. It is reasonable to already start educational approaches for physicians in this field at medical school level. An approach combining civilian disaster medicine and military deployment medicine can be beneficial both for clinical strategies and in undergraduate teaching. MATERIALS AND METHODSA curricular 4-week teaching module on "deployment and disaster medicine," interdisciplinarily combining over 12 medical specialties, was launched in the summer semester of 2016 at a civilian medical school. The course was integrated into the undergraduate curriculum by learning spirals. Teaching formats encompassed a total of 72 hours of seminars, clinical case discussions, group work, e-Learning, and practical training. The students' gain in knowledge was analyzed with pre/post-multiple-choice tests and their attitude towards the offer was evaluated. RESULTSA total of 51 students participated in the module over three semesters. The evaluation revealed that the students were highly satisfied with the offer and felt motivated to increase their engagement with the topic. The students additionally valued the course as a good means of deepening the core curriculum. The pre/post-tests showed a significant gain in knowledge among the students (p 〈 0.001). CONCLUSIONSThe course presented received an overall highly positive feedback from the participating students. The experience of this approach suggests that the combination of civilian and military knowledge and expertise in deployment and disaster medicine may lead to the creation of effective interdisciplinary course concepts.
    Keywords: Disaster Medicine ; Deployment Medicine ; Education ; Undergraduate Students ; Medical School
    ISSN: 0026-4075
    E-ISSN: 1930-613X
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  • 10
    In: ICES Journal of Marine Science, 2011, Vol. 68(10), pp.2106-2113
    Description: Shephard, S., Gerritsen, H. D., Kaiser, M. J., Truszkowska, H. S., and Reid, D. G. 2011. Fishing and environment drive spatial heterogeneity in Celtic Sea fish community size structure. – ICES Journal of Marine Science, 68: 2106–2113. The Large Fish Indicator (LFI) is a univariate size-based indicator of fish community state that has been selected to support the OSPAR fish community Ecological Quality Objective (EcoQO). To operate this EcoQO, a survey-based LFI for each OSPAR region needs to be developed. However, fish communities in these regions are spatially heterogeneous, and there is evidence of within-region spatial variation in the LFI that could confound an overall indicator series. For Celtic Sea trawl-survey sites, spline correlograms indicate positive spatial autocorrelation at a similar range (∼40 km) for the LFI and for fishing effort (h year −1 ) from vessel monitoring systems. Statistical models reveal a strong negative effect on annual LFI by site of fishing effort within a radius of 40 km. There was a weak effect of fishing within 20 km and no effect at 10 km. LFI also varied significantly with substratum and with local fish community composition identified by a resemblance matrix derived from the survey data. Finally, there was a weak effect of survey year on LFI. Spatial stratification of LFI calculations may be necessary when developing size-based indicators for OSPAR or Marine Strategy Framework Directive regions.
    Keywords: Ecological Quality Objective ; Ecosystem Approach To Fisheries Management ; Large Fish Indicator ; Marine Protected Areas ; Vms
    ISSN: 1054-3139
    E-ISSN: 1095-9289
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