bluuebunny/crossref_metadata_2025_split huggingface dataset:
Classification of Companion Diagnostics: A New Framework for Biomarker-Driven Patient Selection
Authors: Huber Cynthia , Friede Tim , Stingl Julia , Benda Norbert 
Published: November 2021

Abstract
Background
Modern personalized medicine strategies builds on therapy companion diagnostics to stratify patients into subgroups with differential benefit/risk. In general, stratification for drug response implies a treatment-by-subgroup interaction. This interaction is usually suggested by the drug’s mechanism of action and investigated in pharmacological research or in clinical studies. In these candidate genes or pathway approaches, either biological reasons for a differential benefit/risk or statistical interaction regarding a pharmacological or clinical endpoint or both may be given. For successful drug approval, demonstration of a positive benefit/risk balance in the intended patient population is required. This also applies to situations with biomarker-selected populations. However, further regulatory considerations relate to the usefulness and plausibility of the selected patients and benefit/risk extrapolations or alternative therapy options in biomarker-negative populations.

Methods
To facilitate the specification of regulatory requirements and support the design of clinical development programmes, a systematic classification of biomarker-drug pairs is needed, in particular with regard to the expected underlying molecular mechanism and the clinical evidence.

Results
A classification of five biomarker-drug categories is proposed related to increasing evidence on the biomarker’s predictive value in relation to a specific drug. We classified biomarkers into five ascending categories with increasing evidence on the predictive nature of the biomarker in relation to a specific drug according to the comparative pharmacological and clinical evidence.

Conclusions
The proposed classification will facilitate regulatory decision-making and support drug development with respect to biomarker-related subgrouping, both, during clinical programme and at the time of marketing authorization application, since the grade of evidence on the differential power of the biomarker can be considered as an indicator for the usefulness of a biomarker-related subgrouping.
Experimental approach to modeling of the plasticizing operation in the hot plate welding process
Authors: Wałęsa Krzysztof , Talaśka Krzysztof , Wilczyński Dominik , Górecki Jan , Wojtkowiak Dominik 
Published: November 2021

Abstract
The paper discusses the topic of butt welding of polyurethane drive belts by the hot plate method in the context of modeling the process of this technological operation. Based on the analysis of the butt welding process, a series of studies of the thermomechanical properties of the material from which the belt is made has been planned. The results will be used for mathematical modeling of the welding process, and in particular its most important phase: the plasticizing operation. On this basis, the study of the compression of cylindrical specimens taken from the belt has been performed at two different speeds. Their result is the relationship between the compressive stress σ
c and the modulus of longitudinal elasticity E
c at compression and: deformation ε
c, temperature value T, as well as the compressive velocity v
c. In the next step, dynamic viscosity η of the belt material was determined based on the results of dynamic thermomechanical analysis. The research work culminated in the attempts to plasticize the material on a hot plate, in conditions similar to the process of industrial welding. These studies were performed at different speeds v
pl, resulting in the correlation between the force required for plasticizing F
pl and the value of the speed of the belt end v
pl relative to the hot plate heated to a temperature T
p. The obtained results will be used to formulate a mathematical model of plasticizing the material, based on the selected mechanical deformation models.
Computational model of grid cells based on back‐propagation neural network
Authors: Li Baozhong , Liu Yanming , Lai Lei 
Published: November 2021

AbstractTo simulate the firing pattern of biological Grid cells (GCs), an efficient computational model based on back‐propagation neural network (BPNN), which allows for the generation of regular hexagonal grids, is described. For each GC, it is associated with the output of a learned BPNN. The firing characteristics of GCs can be controlled by the adjustment factors (AFs) flexibly. During the vehicle's space exploration, GCs can exhibit hexagonal firing patterns with different characteristics according to the settings of the AFs. Simulation results validate the proposed model's accuracy as they are in agreement with GCs' biological experimental electroencephalogram results. Meanwhile, the application of the three‐layer BPNN can greatly reduce the computational complexity, which lay a foundation for its application in realistic bio‐inspired autonomous navigation systems.
Finite‐control‐set model prediction current control of five‐phase permanent magnet synchronous motor based on eight‐switch fault‐tolerant inverter
Authors: Fu Changxin , Ma Xiao , Zhang Lixin 
Published: November 2021

AbstractThe existence of unbalanced voltage and current harmonics is one of the most pressing issues when the failure happens on the inverter, which will render the inverter less reliable or even failed. Therefore, an improved finite‐control‐set model predictive current control (FCS‐MPCC) is proposed for eight‐switch fault‐tolerant inverter (ESFTI)‐driven five‐phase permanent magnet synchronous motor (FPPMSM). First, the topological structure of the whole system and the mathematical model of FPPMSM are presented. Second, the unbalance voltage and the predictable current vector of the controlled system are analysed in terms of FCS‐MPCC. After that, the information of the corresponding control voltage vector is obtained by utilizing the deadbeat current control, which realizes the partial vector enumeration in the ideal voltage vector plane. Furthermore, the concept of two‐step forward prediction is integrated to induce the manipulated variables at next sampling time such that the time delay may be alleviated, whose corresponding minimum cost function is constructed by extra considering the fluctuation of the capacitor voltages. Finally, the comparative simulation studies between the traditional FCS‐MPCC and the proposed one are carried out to demonstrate the validity and effectiveness of the proposed method.
Application of a Proposed Algorithm to Cesarean Deliveries for Nonreassuring Fetal Heart Rate Tracing
Authors: Berger Dana Senderoff , Crosland Adam , Newman Rachel , Bosse Bradley , Makhoul Joshua , Chan Kenneth , Seet Emily L. 
Published: November 2021

Objectives The aim of the study is to evaluate how current management of Category II fetal heart rate tracings compares with that suggested by a published algorithm and whether these differences lead to disparate neonatal outcomes.
Study Design This is a retrospective observational study from the resident service at an academic-community tertiary care center from 2013 to 2018. We reviewed archived fetal heart rate tracings from patients with cesarean delivery performed for nonreassuring fetal heart rate tracing and interpreted tracings against the algorithm. We assigned tracings to one of three categories: Group A—consistent; Group B—inconsistent too early (algorithm permits the patient to labor longer); Group C—inconsistent too late (algorithm suggests performing the cesarean delivery sooner). Maternal demographics, features of labor, and neonatal outcomes were compared.
Results Of the 110 cases, 27 (24.5%) had a cesarean delivery performed in group A, 49 (44.5%) in group B, and 34 (30.9%) in group C. Baseline characteristics were similar. Of the 49 in group B, 46 (93.9%) violated the algorithm at the same branchpoint. In group C, cesarean deliveries would have been performed on average 244 minutes earlier had the algorithm been used. Neonatal outcomes were not significantly different among the groups, including 5-minute Apgar <7, pH <7.1, and NICU admit.
Conclusion Our retrospective application of the algorithm showed that 44.5% of patients who have cesarean delivery for nonreassuring fetal heart rate tracing may be able to labor longer and that violation at a common decision point on the algorithm (moderate variability or accelerations, but a lack of recurrent decelerations) is responsible for nearly all such cesarean deliveries. More studies are needed to evaluate if cesarean delivery rates for nonreassuring fetal heart rate tracing can be reduced without impacting neonatal outcomes using the algorithm.
Key Points
Optimizing Post-Cesarean Opioid Prescription Practices at Mayo Clinic: A Quality Improvement Initiative
Authors: Kim Sharon , King Amanda , Parikh Pavan , Sangtani Ajleeta , Shazly Sherif , Brodrick Ellen , Thompson Angela 
Published: November 2021

Objective Optimal prescriptions practices of opioids in the post-cesarean period remain controversial. The primary aim of this initiative was to minimize unused prescription narcotic medication, with a goal of ≤4 leftover pills of 5-mg oxycodone at postoperative day (POD) 14 without affecting pain or satisfaction measures.
Study Design This was a prospective longitudinal quality improvement (QI) initiative starting in 2017 utilizing the DMAIC methodology. The measurement phase consisted of validated surveys over 3 months, along with chart review to determine current institutional prescription practices and predictors of outpatient opioid use. Resulting recommendations were adopted, and 1 year later, all patients undergoing cesarean were surveyed for 3 months to determine the effectiveness of the intervention. The study was approved by the Department's QI Committee.
Results The response rate was 48%, with 50 of 101 patients completing surveys pre-intervention and 52 of 111 post-intervention. Pre-intervention, surplus medication was predicted (p <0.05) only by the quantity of the opioid prescription. In addition, patients who required ≤37.5 morphine milligram equivalents (MMEs) during the inpatient postoperative stay did not require outpatient narcotic prescriptions. Thereafter, a strategy of matching inpatient use to outpatient prescription 1:1 in a linear regression model (p <0.001, R
2 0.55) optimally matched patient needs up to 200 MME. In the post-intervention survey, mean (SD) prescription decreased from 17.6 (13.7) MME to 8.4 (8.3) MME (p <0.01); 39% compared with 16% of women were discharged without a prescription (p <0.01); and amongst all patients 82.7% compared with 59.6% (p <0.01) had ≤4 pills remaining without differences in patient satisfaction or pain perception.
Conclusion This initiative highlights a practical approach to QI utilizing industry techniques in health care. This approach resulted in significant reductions in over-prescription and unused medication, without impacting pain or satisfaction scores.
Key Points
Effect of Using Silver Nylon Dressings on Postoperative Pain after Cesarean Delivery
Authors: Connery Sheila , Tanner Jean Paul , Odibo Linda , Raitano Olivia , Nikolic-Dorschel Dusan , Louis Judette M. 
Published: November 2021

Objective Silver dressings have been associated with a decrease in postoperative pain in selected populations, but it is unknown if the benefit can be observed after cesarean deliveries. We sought to evaluate the impact of silver nylon dressings in reducing postoperative pain after cesarean delivery.
Study Design A secondary analysis of data from a blinded randomized clinical trial of women undergoing cesarean delivery scheduled and unscheduled at a single site was conducted. Women were recruited for participation from a single site and randomized to a silver nylon dressing or an identical-appearing gauze wound dressing. Wounds were evaluated in the outpatient clinic at 1 and 6 weeks after delivery and patient responded to the modified patient scar assessment scale. The primary outcome of this analysis was inpatient opioid and nonopioid analgesic dispensed. The secondary outcome was patient-reported pain at the 1- and 6-week postpartum visits. Data were analyzed using chi-square test, Student's t-test, Fisher's exact test, Wilcoxon–Mann–Whitney's test, and logistic regression where appropriate. A p-value of < 0.05 was considered significant.
Results Among the 649 participants, women allocated to the silver nylon dressing group, when compared with the gauze group, were similar in the amount of dispensed opioid and nonopioid analgesic medications (morphine equivalent milligrams of opioids dispensed [82.5 vs. 90 mg, p = 0.74], intravenous nonsteroidal anti-inflammatory drugs (NSAIDs) [120 vs. 120 mg, p = 0.55], and oral NSAIDs [4,800 vs. 5,600 mg in the gauze group, p = 0.65]). After adjusting for confounding variables, postoperative wound infection (adjusted odds ratio [aOR]: 11.70; 95% confidence interval [CI]: 4.51–30.31) at 1-week postoperative and again at 6-week postoperative (aOR: 5.59; 95% CI: 1.03–30.31) but not gauze dressing was associated with patient-reported postoperative pain.
Conclusion Among women undergoing cesarean delivery, silver nylon dressing was not associated with a reduction in postoperative pain.
Key Points
Intravenous versus Oral Iron for Iron-Deficiency Anemia in Pregnancy (IVIDA): A Randomized Controlled Trial
Authors: Lewkowitz Adam K. , Stout Molly J. , Cooke Emily , Deoni Seon C. , D'Sa Viren , Rouse Dwight J. , Carter Ebony B. , Tuuli Methodius G. 
Published: November 2021

Objective Iron-deficiency anemia (IDA) can have serious consequences for mothers and babies. Iron supplementation is recommended, but the administration route is controversial. We sought to conduct a randomized controlled trial (RCT) testing the effectiveness and safety of intravenous (IV) iron compared with oral iron on perinatal outcomes in pregnant women with IDA.
Study Design This open-label RCT randomized patients with IDA (hemoglobin [hgb] <10 g/dL and ferritin <30 ng/mL) at 24 to 34 weeks' to oral iron or single 1,000-mg dose of IV low-molecular weight iron dextran over one hour. The primary outcome was maternal anemia at delivery (hgb < 11 g/dL). Secondary outcomes were mild/moderate or severe adverse reactions, maternal hgb and ferritin at delivery, blood transfusion, gestational age at delivery, birth weight, neonatal hgb and ferritin, and composite neonatal morbidity. Analysis was as per protocol.
Results The trial was stopped early for logistical reasons, and the data analyzed as preliminary data to inform a larger, potentially externally funded, definitive trial. Of 55 patients approached, 38 consented. Of these, 15 were withdrawn: 5 received IV iron from their primary obstetrician after being randomized to oral iron and 10 declined to receive IV iron. Of the remaining 23 patients, who were included in the analytic population, 13 received oral iron and 10 received IV iron. The rate of maternal anemia at delivery (hgb < 11 g/dL) was high overall but significantly reduced with IV iron (40 vs. 85%, p = 0.039). Rates of maternal hgb < 10 g/dL were significantly lower in the IV iron group (10 vs. 54%, p = 0.029). There were no severe adverse reactions and similar rates of mild/moderate reactions between groups.
Conclusion IV iron reduces rates of anemia at the time of admission for delivery, supporting a larger RCT comparing IV versus oral iron for the treatment of IDA of pregnancy powered for definitive clinical outcomes. However, issues uncovered in this RCT suggest that patient, clinician, and systems-level barriers associated with different IDA treatment modalities must be considered prior to conducting a larger RCT. This study is registered with clinicaltrials.gov with identifier no.: NCT03438227.
Key Points
Association of Antenatal Corticosteroid Exposure and Infant Survival at 22 and 23 Weeks
Authors: Rossi Robert M. , DeFranco Emily A. , Hall Eric S. 
Published: November 2021

Objective In 2014, the leading obstetric societies published an executive summary of a joint workshop to establish obstetric interventions to be considered for periviable births. Antenatal corticosteroid administration between 220/7 and 226/7 weeks was not recommended given existing evidence. We sought to evaluate whether antenatal steroid exposure was associated with improved survival among resuscitated newborns delivered between 22 and 23 weeks of gestation.
Study Design We conducted a population-based cohort study of all resuscitated livebirths delivered between 220/7 and 236/7 weeks of gestation in the United States during 2009 to 2014 utilizing National Center for Health Statistics data. The primary outcome was rate of survival to 1 year of life (YOL) between infant cohorts based on antenatal steroid exposure. Multivariable logistic regression estimated the association of antenatal steroid exposure on survival outcomes.
Results In the United States between 2009 and 2014, there were 2,635 and 7,992 infants who received postnatal resuscitation after delivery between 220/7 to 226/7 and 230/7 to 236/7 weeks of gestation, respectively. Few infants born at 22 (15.9%) and 23 (26.0%) weeks of gestation received antenatal corticosteroids (ANCS). Among resuscitated neonates, survival to 1 YOL was 45.2 versus 27.8% (adjusted relative risk [aRR]: 1.6, 95% confidence interval [CI]: 1.2–2.1) and 57.9 versus 47.7% (aRR: 1.3, 95% CI: 1.1–1.5) for infants exposed to ANCS compared with those not exposed at 22 and 23 weeks of gestation, respectively. When stratified by 100 g birth weight category, ANCS were associated with survival among neonates weighing 500 to 599 g (aRR: 1.9, 95% CI: 1.3–2.9) and 600 to 699 g (aRR: 1.7, 95% CI: 1.1–2.6) at 22 weeks.
Conclusion Exposure to ANCS was associated with higher survival rates to 1 YOL among resuscitated infants born at 22 and 23 weeks. National guidelines recommending against ANCS utilization at 22 weeks should be re-evaluated given emerging evidence of benefit.
Key Points
Neonatal Outcomes of Premature Infants Born to Women with the Novel Coronavirus (SARS-CoV-2) Infection: A Case Control Study
Authors: Yasa Beril , Memur Seyma , Ozturk Dilek Y. , Bagci Onur , Uslu Sait I. , Cetinkaya Merih 
Published: November 2021

Objective Novel coronavirus disease 2019 (COVID-19) is a disease associated with atypical pneumonia caused by the severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2). The first cases of COVID-19 were reported in Wuhan at the end of 2019. Transmission usually occurs via infected droplets and close personal contact; the possibility of vertical transmission is still under debate. This retrospective study aimed to analyze clinical characteristics of premature infants born to mothers with symptomatic COVID-19 disease.
Study Design This case control study compared the clinical and laboratory data of 20 premature infants born to mothers infected with SARS-CoV-2 with sex and gestational age–matched historical controls.
Results The median gestational age and birth weight in both groups were similar. Respiratory distress developed in 11 (55.5%) infants in study group and 19 (47.5%) infants in control group. Mechanical ventilation and endotracheal surfactant administration rates were similar. Median duration of hospitalization was 8.5 (2–76) days in study group and 12 days in historical controls. Real-time reverse-transcription polymerase chain reaction tests (RT-PCR) of nasopharyngeal swab samples for SARS-CoV-2 were found to be negative twice, in the first 24 hours and later at 24 to 48 hours of life. No neutropenia or thrombocytopenia was detected in the study group. Patent ductus arteriosus, bronchopulmonary dysplasia, and necrotizing enterocolitis rates were similar between groups. No mortality was observed in both groups.
Conclusion To the best of our knowledge, this is one of the few studies evaluating the clinical outcomes of premature infants born to SARS-CoV-2 infected mothers. There was no evidence of vertical transmission of SARS-CoV-2 from symptomatic SARS-CoV-2-infected women to the neonate in our cohort. The neonatal outcomes also seem to be favorable with no mortality in preterm infants.
Key Points
Estimates of genetic parameters, principal components and cluster analysis for milk yield and body weight in Guzera cattle
Authors: Gama Manuela Pires Monteiro , Savegnago Rodrigo Pelicioni , Ventura Henrique Torres , Pereira Mariana Alencar , Freitas Luara Afonso , Paz Claudia Cristina Paro , El Faro Lenira 
Published: November 2021

Context The estimation of genetic parameters for traits related to the production of milk, beef or both may assist in defining the selection criteria and objectives of the breeding program, as well as in the identification and selection of genetically superior animals. Aims The objectives of this study were to estimate genetic parameters for body weight and 305-day milk yield of Guzera cattle and to perform cluster analysis on the basis of estimated breeding values for these traits, to identify groups of animals that could be selected for the production of beef, milk or dual purpose. Methods Body weights (N = 253 012) of males and females were ecorded at 120 days of age (BW120), at weaning (WW), at 365 days (BW365), at yearling stage (YW) and at 24 months (BW24), and 6237 complete lactations (MY305) of 4723 cows were used to estimate the genetic parameters. The bi-trait animal models included direct additive genetic, maternal permanent environmental and temporary random effects for body weights and additive genetic, permanent environmental and temporary environmental random effects for MY305. The fixed effects for all the traits were contemporary group and age of cow at calving. Key results The estimates of heritability ranged from 0.14 ± 0.01 for WW to 0.23 ± 0.01 for MY305. The genetic correlations between body weights at different ages and milk yield were positive and ranged from 0.27 ± 0.11 to 0.38 ± 0.19. Two principal components explained 86.74% of the total genetic variance among the traits. Conclusions Cluster analysis identified four different clusters and showed that the Guzera breed had bulls with different genetic patterns that permits genetic selection for beef, milk or dual purpose. Implications The genetic correlations of the present study suggest that selection to increase milk yield will lead to a slight genetic gain in the same direction for body weight at different ages, in contrast to reports from some other studies.