cometadata/datacite-titles-descriptions-related-identifiers huggingface dataset:
DOI: 10.6084/m9.figshare.4567999.v16
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.17633/rd.brunel.4565158
title: Analysis of the effect of intake plenum design on the scavenging process in a 2-Stroke Boosted Uniflow Scavenged Direct Injection Gasoline (BUSDIG) Engine

description: The data used in the following paper is archived here:Wang, X., Ma, J., and Zhao, H., "Analysis of the effect of intake plenum design on the scavenging process in a 2-Stroke Boosted Uniflow Scavenged Direct Injection Gasoline (BUSDIG) Engine" SAE Technical Paper 2017-01-1031.<br>The descriptions for each data are listed in "captions.txt".
DOI: 10.6084/m9.figshare.4565155
title: Myosin sequence analysis

description: These files contain the raw data to reproduce the results presented in the manuscript "Myosin repertoire expansion coincides with eukaryotic diversification in the Mesoproterozoic era". More related data is available for filtering and browsing at www.cymobase.org.
DOI: 10.6084/m9.figshare.4565161.v2
title: The effect of precrash velocity reduction on occupant response using a human body finite element model

description: <b>Objective</b>: The objective of this study is to use a validated finite element model of the human body and a certified model of an anthropomorphic test dummy (ATD) to evaluate the effect of simulated precrash braking on driver kinematics, restraint loads, body loads, and computed injury criteria in 4 commonly injured body regions. <b>Methods</b>: The Global Human Body Models Consortium (GHBMC) 50th percentile male occupant (M50-O) and the Humanetics Hybrid III 50th percentile models were gravity settled in the driver position of a generic interior equipped with an advanced 3-point belt and driver airbag. Fifteen simulations per model (30 total) were conducted, including 4 scenarios at 3 severity levels: median, severe, and the U.S. New Car Assessment Program (U.S.-NCAP) and 3 extra per model with high-intensity braking. The 4 scenarios were no precollision system (no PCS), forward collision warning (FCW), FCW with prebraking assist (FCW+PBA), and FCW and PBA with autonomous precrash braking (FCW + PBA + PB). The baseline ΔV was 17, 34, and 56.4 kph for median, severe, and U.S.-NCAP scenarios, respectively, and were based on crash reconstructions from NASS/CDS. Pulses were then developed based on the assumed precrash systems equipped. Restraint properties and the generic pulse used were based on literature. <b>Results</b>: In median crash severity cases, little to no risk (&lt;10% risk for Abbreviated injury Scale [AIS] 3+) was found for all injury measures for both models. In the severe set of cases, little to no risk for AIS 3+ injury was also found for all injury measures. In NCAP cases, highest risk was typically found with No PCS and lowest with FCW + PBA + PB. In the higher intensity braking cases (1.0–1.4 g), head injury criterion (HIC), brain injury criterion (BrIC), and chest deflection injury measures increased with increased braking intensity. All other measures for these cases tended to decrease. The ATD also predicted and trended similar to the human body models predictions for both the median, severe, and NCAP cases. Forward excursion for both models decreased across median, severe, and NCAP cases and diverged from each other in cases above 1.0 g of braking intensity. <b>Conclusions</b>: The addition of precrash systems simulated through reduced precrash speeds caused reductions in some injury criteria, whereas others (chest deflection, HIC, and BrIC) increased due to a modified occupant position. The human model and ATD models trended similarly in nearly all cases with greater risk indicated in the human model. These results suggest the need for integrated safety systems that have restraints that optimize the occupant's position during precrash braking and prior to impact.
DOI: 10.6084/m9.figshare.4565161.v1
title: The Effect of Pre-Crash Velocity Reduction on Occupant Response Using a Human Body Finite Element Model

description: <b>Objective</b>: The objective of this study is to use a validated finite element model of the human body and a certified model of an ATD to evaluate the effect of simulated pre-crash braking on driver kinematics, restraint loads, body loads and computed injury criteria in four commonly-injured body regions. <b>Methods</b>: The Global Human Body Models Consortium (GHBMC) 50th percentile male occupant (M50-O) and the Humanetics Hybrid-III 50<sup>th</sup> percentile models were gravity settled in the driver position of a generic interior equipped with an advanced three point belt and driver airbag. Fifteen simulations per model (30 total) were conducted, including four scenarios at three severity levels: median, severe, and US-NCAP and three extra per model with high intensity braking. The four scenarios were: No pre-collision system (No PCS), forward collision warning (FCW), FCW with pre-braking assist (FCW+PBA), and FCW and PBA with autonomous pre-crash braking (FCW+PBA+PB). The baseline ΔV was 17 kph, 34 kph and 56.4 kph for median, severe and US-NCAP scenarios, respectively, and were based on crash reconstructions from NASS/CDS. Pulses were then developed based on the assumed pre-crash systems equipped. Restraint properties and the generic pulse used were based on literature. <b>Results</b>: In median crash severity cases, little to no risk (&lt;10% risk for AIS 3+) was found for all injury measures for both models. In the severe set of cases, little to no risk for AIS 3+ injury was also found for all injury measures. In NCAP cases, highest risk was typically found with No PCS and lowest with FCW+PBA+PB. In the higher intensity braking cases (1.0 – 1.4 g) HIC, BrIC and chest deflection injury measures increased with increased braking intensity. All other measures for these cases tended to decrease. The ATD also predicted and trended similarly to the human body models predictions for both the median, severe and NCAP cases. Forward excursion for both models decreased across median, severe and NCAP cases and diverged from each other in cases above 1.0 g's of braking intensity. <b>Conclusions</b>: The addition of pre-crash systems simulated through reduced pre-crash speeds caused reductions in some injury criteria, while others (chest deflection, HIC, and BrIC) increased due to a modified occupant position. The human model and ATD models trended similar in nearly all cases with greater risk indicated in the human model. These results suggest the need for integrated safety systems that have restraints that optimize the occupant's position during pre-crash braking and prior to impact.
DOI: 10.17633/rd.brunel.4565158.v1
title: Analysis of the effect of intake plenum design on the scavenging process in a 2-Stroke Boosted Uniflow Scavenged Direct Injection Gasoline (BUSDIG) Engine

description: The data used in the following paper is archived here:Wang, X., Ma, J., and Zhao, H., "Analysis of the effect of intake plenum design on the scavenging process in a 2-Stroke Boosted Uniflow Scavenged Direct Injection Gasoline (BUSDIG) Engine" SAE Technical Paper 2017-01-1031.<br>The descriptions for each data are listed in "captions.txt".
DOI: 10.6084/m9.figshare.4565131
title: Supplementary Material for: Epidemiology of Amyotrophic Lateral Sclerosis and Effect of Riluzole on Disease Course

description: <b><i>Objectives:</i></b> To assess the epidemiology of ALS in Austria and to evaluate the long-term effect of riluzole treatment on survival. <b><i>Methods:</i></b> Hospital discharge and riluzole prescription databases were used to identify ALS cases from January 2008 to June 2012. Using the capture-recapture method we evaluated the incidence and prevalence of ALS and patients' survival in dependence of age, gender and riluzole treatment. <b><i>Results:</i></b> The corrected incidence and prevalence of ALS were 3.13/100,000 person-years (95% CI, 2.77 to 3.50) and 9.14/100,000 persons (95% CI, 8.53 to 9.79), respectively. Median survival from diagnosis was 676 days (95% CI, 591 to 761). A younger age at diagnosis was associated with a longer survival. Gender did not appear to affect survival time. Riluzole therapy was associated with a survival advantage only for the initial treatment period. The adjusted hazard ratio of mortality for using riluzole increased continually over time resulting in an apparent reversal of its beneficial effect after 6 months of therapy. <b><i>Conclusions:</i></b> We report incidence and prevalence estimates that are on the upper end of the wide range discussed in literature. Riluzole seems to exert a beneficial effect only in the first 6 months of therapy.
DOI: 10.6084/m9.figshare.4565155.v1
title: Myosin sequence analysis

description: These files contain the raw data to reproduce the results presented in the manuscript "Myosin repertoire expansion coincides with eukaryotic diversification in the Mesoproterozoic era". More related data is available for filtering and browsing at www.cymobase.org.
DOI: 10.6084/m9.figshare.4565104
title: Supplementary Material for: Clinical Relevance of Studies on the Accuracy of Visual Inspection for Detecting Caries Lesions: A Systematic Review

description: Although visual inspection is the most commonly used method for caries detection, and consequently the most investigated, studies have not been concerned about the clinical relevance of this procedure. Therefore, we conducted a systematic review in order to perform a critical evaluation considering the clinical relevance and methodological quality of studies on the accuracy of visual inspection for assessing caries lesions. Two independent reviewers searched several databases through July 2013 to identify papers/articles published in English. Other sources were checked to identify unpublished literature. The eligible studies were those which (1) assessed the accuracy of the visual method for detecting caries lesions on occlusal, approximal or smooth surfaces, in primary or permanent teeth, (2) used a reference standard, and (3) reported data about sample size and accuracy of the methods. Aspects related to clinical relevance and the methodological quality of the studies were evaluated. 96 of the 5,578 articles initially identified met the inclusion criteria. In general, most studies failed in considering some clinically relevant aspects: only 1 included study validated activity status of lesions, no study considered its prognosis, 79 studies did not consider a clinically relevant outcome, and only 1 evaluated a patient-centred outcome. Concerning methodological quality, the majority of the studies presented a high risk of bias in sample selection. In conclusion, studies on the accuracy of the visual method for caries detection should consider clinically relevant outcomes besides accuracy; moreover, they should be conducted with higher methodological quality, mainly regarding sample selection.
DOI: 10.6084/m9.figshare.4565131.v1
title: Supplementary Material for: Epidemiology of Amyotrophic Lateral Sclerosis and Effect of Riluzole on Disease Course

description: <b><i>Objectives:</i></b> To assess the epidemiology of ALS in Austria and to evaluate the long-term effect of riluzole treatment on survival. <b><i>Methods:</i></b> Hospital discharge and riluzole prescription databases were used to identify ALS cases from January 2008 to June 2012. Using the capture-recapture method we evaluated the incidence and prevalence of ALS and patients' survival in dependence of age, gender and riluzole treatment. <b><i>Results:</i></b> The corrected incidence and prevalence of ALS were 3.13/100,000 person-years (95% CI, 2.77 to 3.50) and 9.14/100,000 persons (95% CI, 8.53 to 9.79), respectively. Median survival from diagnosis was 676 days (95% CI, 591 to 761). A younger age at diagnosis was associated with a longer survival. Gender did not appear to affect survival time. Riluzole therapy was associated with a survival advantage only for the initial treatment period. The adjusted hazard ratio of mortality for using riluzole increased continually over time resulting in an apparent reversal of its beneficial effect after 6 months of therapy. <b><i>Conclusions:</i></b> We report incidence and prevalence estimates that are on the upper end of the wide range discussed in literature. Riluzole seems to exert a beneficial effect only in the first 6 months of therapy.
DOI: 10.6084/m9.figshare.4567999.v18
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4565104.v1
title: Supplementary Material for: Clinical Relevance of Studies on the Accuracy of Visual Inspection for Detecting Caries Lesions: A Systematic Review

description: Although visual inspection is the most commonly used method for caries detection, and consequently the most investigated, studies have not been concerned about the clinical relevance of this procedure. Therefore, we conducted a systematic review in order to perform a critical evaluation considering the clinical relevance and methodological quality of studies on the accuracy of visual inspection for assessing caries lesions. Two independent reviewers searched several databases through July 2013 to identify papers/articles published in English. Other sources were checked to identify unpublished literature. The eligible studies were those which (1) assessed the accuracy of the visual method for detecting caries lesions on occlusal, approximal or smooth surfaces, in primary or permanent teeth, (2) used a reference standard, and (3) reported data about sample size and accuracy of the methods. Aspects related to clinical relevance and the methodological quality of the studies were evaluated. 96 of the 5,578 articles initially identified met the inclusion criteria. In general, most studies failed in considering some clinically relevant aspects: only 1 included study validated activity status of lesions, no study considered its prognosis, 79 studies did not consider a clinically relevant outcome, and only 1 evaluated a patient-centred outcome. Concerning methodological quality, the majority of the studies presented a high risk of bias in sample selection. In conclusion, studies on the accuracy of the visual method for caries detection should consider clinically relevant outcomes besides accuracy; moreover, they should be conducted with higher methodological quality, mainly regarding sample selection.
DOI: 10.6084/m9.figshare.4565095
title: Myosin II activity is required for structural plasticity at the axon initial segment

description: All primary data for this study, including individual image files, Matlab scripts, and spreadsheets containing analysed data<br>
DOI: 10.6084/m9.figshare.4567999.v19
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this paper, an alternative TOST based on the effect size is demonstrated to maintain the desired type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the paper.
DOI: 10.6084/m9.figshare.4565095.v2
title: Myosin II activity is required for structural plasticity at the axon initial segment

description: All primary data for this study, including individual image files, Matlab scripts, and spreadsheets containing analysed data<br>
DOI: 10.6084/m9.figshare.4565095.v1
title: Myosin II activity is required for structural plasticity at the axon initial segment

description: All primary data for this study, including individual image files, Matlab scripts, and spreadsheets containing analysed data<br>
DOI: 10.6084/m9.figshare.4565038
title: Supplementary Material for: Molecular and Genetic Characterization of Depression: Overlap with Other Psychiatric Disorders and Aging

description: Genome-wide expression and genotyping technologies have uncovered the genetic bases of complex diseases at unprecedented rates. However, despite its heavy burden and high prevalence, the molecular characterization of major depressive disorder (MDD) has lagged behind. Transcriptome studies report multiple brain disturbances but are limited by small sample sizes. Genome-wide association studies (GWAS) report weak results but suggest an overlapping genetic risk with other neuropsychiatric disorders. We performed a systematic molecular characterization of altered brain function in MDD using meta-analysis of differential expression of 8 gene array studies across 3 corticolimbic brain regions in 101 subjects. The identified ‘metaA-MDD' genes suggest altered neurotrophic support, brain plasticity and neuronal signaling in MDD. Notably, metaA-MDD genes display a low connectivity and hubness in coexpression networks as well as a uniform genomic distribution, which is consistent with diffuse polygenic mechanisms. We have integrated these findings with results from over 1,800 published GWAS and show that genetic variations nearby metaA-MDD genes predict a greater risk for neuropsychiatric disorders, and notably for age-related phenotypes, but not for other medical illnesses (including those frequently co-occurring with depression) or body characteristics. Collectively, the intersection of unbiased investigations of gene function (transcriptome) and structure (GWAS) provides novel leads to investigate molecular mechanisms of MDD and suggests common biological pathways between depression, other neuropsychiatric diseases and brain aging.
DOI: 10.6084/m9.figshare.4565038.v1
title: Supplementary Material for: Molecular and Genetic Characterization of Depression: Overlap with Other Psychiatric Disorders and Aging

description: Genome-wide expression and genotyping technologies have uncovered the genetic bases of complex diseases at unprecedented rates. However, despite its heavy burden and high prevalence, the molecular characterization of major depressive disorder (MDD) has lagged behind. Transcriptome studies report multiple brain disturbances but are limited by small sample sizes. Genome-wide association studies (GWAS) report weak results but suggest an overlapping genetic risk with other neuropsychiatric disorders. We performed a systematic molecular characterization of altered brain function in MDD using meta-analysis of differential expression of 8 gene array studies across 3 corticolimbic brain regions in 101 subjects. The identified ‘metaA-MDD' genes suggest altered neurotrophic support, brain plasticity and neuronal signaling in MDD. Notably, metaA-MDD genes display a low connectivity and hubness in coexpression networks as well as a uniform genomic distribution, which is consistent with diffuse polygenic mechanisms. We have integrated these findings with results from over 1,800 published GWAS and show that genetic variations nearby metaA-MDD genes predict a greater risk for neuropsychiatric disorders, and notably for age-related phenotypes, but not for other medical illnesses (including those frequently co-occurring with depression) or body characteristics. Collectively, the intersection of unbiased investigations of gene function (transcriptome) and structure (GWAS) provides novel leads to investigate molecular mechanisms of MDD and suggests common biological pathways between depression, other neuropsychiatric diseases and brain aging.
DOI: 10.6084/m9.figshare.4564975
title: Nitrogen fertilization reduces wild berry production in boreal forests

description: Data and R code to reproduce results of our paper "Nitrogen fertilization reduces wild berry production in boreal forests".<br><br>Data on dwarf shrub (Vaccinium vitis-idaea & V. myrtillus) cover, fruit production, disease incidence and herbivory, for two years, from 30 experiment sites with fertilization and thinning treatments. <br>
DOI: 10.6084/m9.figshare.4567999.v20
title: Statistical Considerations in Demonstrating CMC Analytical Similarity for a Biosimilar Product

description: Demonstration of analytical similarity between a reference product and a biosimilar product is required as part of the biosimilarity approval process. A statistical two one-sided test (TOST) based on the difference of means proposed in the literature and recommended by the FDA for Tier 1 quality attributes is demonstrated to have a Type I error rate greater than the specified level, which cannot be corrected by increasing sample size. In this article, an alternative TOST based on the effect size is demonstrated to maintain the desired Type I error rate, and in some situations, provide greater power than the TOST based on the mean difference. Results are demonstrated both analytically and with computer simulations. An example with calculations is provided in the article. Supplementary materials for this article are avalilable online.
DOI: 10.6084/m9.figshare.4564975.v1
title: Nitrogen fertilization reduces wild berry production in boreal forests

description: Data and R code to reproduce results of our paper "Nitrogen fertilization reduces wild berry production in boreal forests".<br><br>Data on dwarf shrub (Vaccinium vitis-idaea & V. myrtillus) cover, fruit production, disease incidence and herbivory, for two years, from 30 experiment sites with fertilization and thinning treatments. <br>