bluuebunny/crossref_metadata_2025_split huggingface dataset:
Developing Drugs for Prevention of Chemotherapy-Induced Nausea and Vomiting: Draft Guidance from the FDA
Authors: Lyons Erica , Line Charles , Lee Jessica J. 
Published: July 2021

Abstract
The administration of preventative therapy for chemotherapy-induced nausea and vomiting (CINV) is an essential component of the treatment plan for many patients with cancer. In May 2021, the FDA issued a draft guidance for industry to facilitate the clinical development of drugs for the prevention of CINV in adults. FDA guidance has a vital role in the regulatory dialogue between the Agency and external stakeholders. Sharing the FDA's current recommended approach can expedite drug development and ultimately the availability of safe and effective therapies to patients in need. In addition, guidance documents may be leveraged to facilitate communication between regulatory agencies, the academic community, patient advocacy groups, and the pharmaceutical industry. The draft guidance for industry Chemotherapy-Induced Nausea and Vomiting: Developing Drugs for Prevention (May 2021) outlines the FDA's current recommendations regarding clinical development programs for drugs for the prevention of CINV and the required attributes of patients for enrollment, aspects of trial design, and efficacy assessments. This article provides an overview of the recommendations contained in the draft guidance.
Correlação entre o sistema sanguíneo ABO e portadores de gastrite
Authors: Trindade Leda Maria Delmondes Freitas , Barreto Íkaro Daniel de Carvalho , Guimarães Adriana de Oliveira , Castro Vinicius Leite de , Moreira Larissa Gonçalves , Santana Neto Durval José de 
Published: July 2021

Introdução: A infecção pelo Helicobacter pylori (HP) e fatores ambientais são importantes fatores de risco para gastrite. Estudos apontam correlação entre o sistema ABO e doenças gastrointestinais. Objetivos: caracterizar o perfil sociodemográfico de portadores de gastrite e HP e sua correlação com o sistema do grupo sanguíneo ABO. Materiais e métodos: Estudo prospectivo e descritivo, realizado em Aracaju, Sergipe, Brasil, de abril/2018 a maio/2019. Amostra constituída por 133 pacientes que realizaram endoscopia digestiva alta, análise histopatológica e tipagem sanguínea. Foram diagnosticados com gastrite 93 pacientes. Utilizou-se questionário sociodemográfico e clínico. Os dados foram analisados pelo RCore Team 2019 e submetidos a análises descritivas e inferenciais. Nível de significância 5%. Resultados: Idade média 53,7 anos (DP 17,4) sendo 48 (51,6%) do sexo masculino (p=0,018), 56 (65,9%) pardos, 45 (52,9%) casados e 33 (35,5%) tinham empregos fixos. Dos portadores de gastrite, 59 (63,4%) eram do tipo sanguíneo O. Dentre os tipos de gastrite, 31(33,4%) eram enantematosa leve e 16 (51,6%) desses eram do tipo O. Houve prevalência do tipo O em todos os graus de atividade inflamatória. Foi detectado H. pylori em 29 (31,2%) pacientes, sendo o fenótipo O mais prevalente nos graus moderado e severo da infecção. Conclusão: Os homens foram mais acometidos de gastrite, independente do tipo segundo a classificação de Sydney. O fenótipo sanguíneo O foi mais prevalente nos portadores de gastrite, naqueles que apresentaram atividade inflamatória à histologia e em portadores de H. pylori grau moderado e severo.
Digital Health Intervention in Acute Myocardial Infarction
Authors: Marvel Francoise A. , Spaulding Erin M. , Lee Matthias A. , Yang William E. , Demo Ryan , Ding Jie , Wang Jane , Xun Helen , Shah Lochan M. , Weng Daniel , Carter Jocelyn , Majmudar Maulik , Elgin Eric , Sheidy Julie , McLin Renee , Flowers Jennifer , Vilarino Valerie , Lumelsky David N. , Bhardwaj Vinayak , Padula William V. , Shan Rongzi , Huynh Pauline P. , Wongvibulsin Shannon , Leung Curtis , Allen Jerilyn K. , Martin Seth S. 
Published: July 2021

Background:
Thirty-day readmissions among patients with acute myocardial infarction (AMI) contribute to the US health care burden of preventable complications and costs. Digital health interventions (DHIs) may improve patient health care self-management and outcomes. We aimed to determine if patients with AMI using a DHI have lower 30-day unplanned all-cause readmissions than a historical control.

Methods:
This nonrandomized controlled trial with a historical control, conducted at 4 US hospitals from 2015 to 2019, included 1064 patients with AMI (DHI n=200, control n=864). The DHI integrated a smartphone application, smartwatch, and blood pressure monitor to support guideline-directed care during hospitalization and through 30-days post-discharge via (1) medication reminders, (2) vital sign and activity tracking, (3) education, and (4) outpatient care coordination. The Patient Activation Measure assessed patient knowledge, skills, and confidence for health care self-management. All-cause 30-day readmissions were measured through administrative databases. Propensity score–adjusted Cox proportional hazard models estimated hazard ratios of readmission for the DHI group relative to the control group.

Results:
Following propensity score adjustment, baseline characteristics were well-balanced between the DHI versus control patients (standardized differences <0.07), including a mean age of 59.3 versus 60.1 years, 30% versus 29% Women, 70% versus 70% White, 54% versus 54% with private insurance, 61% versus 60% patients with a non ST-elevation myocardial infarction, and 15% versus 15% with high comorbidity burden. DHI patients were predominantly in the highest levels of patient activation for health care self-management (mean score 71.7±16.6 at 30 days). The DHI group had fewer all-cause 30-day readmissions than the control group (6.5% versus 16.8%, respectively). Adjusting for hospital site and a propensity score inclusive of age, sex, race, AMI type, comorbidities, and 6 additional confounding factors, the DHI group had a 52% lower risk for all-cause 30-day readmissions (hazard ratio, 0.48 [95% CI, 0.26–0.88]). Similar results were obtained in a sensitivity analysis employing propensity matching.

Conclusions:
Our results suggest that in patients with AMI, the DHI may be associated with high patient activation for health care self-management and lower risk of all-cause unplanned 30-day readmissions.

Registration:

URL:
https://www.clinicaltrials.gov
; Unique identifier: NCT03760796.
“The Twofold Affection”: The Background to John Chrysostom’s Use of Φύσις and Χάρις
Authors: Dunkle Brian 
Published: July 2021

Abstract
John Chrysostom’s pairing of φύσις and χάρις, which tends to be read exclusively in light of the Pelagian controversies, reflects the influence of distinct models in early Christianity for conceptualizing the interaction between created nature(s) and the divine creator. The first, informed especially by Pauline categories, understands “nature” (φύσις; natura) to refer to an inborn relationship that stands in contrast to the adopted sonship qualified by “grace” (χάρις; gratia). The second, evident especially in Philo and Alexandrian theologians, takes nature as an individual essence, to which grace is superadded as a property. In the final portion of the essay I show evidence that Chrysostom tends to prioritize the property model over the filial model of nature and grace.
Antithesis and Paradox in the Epistle to Diognetus
Authors: Freeman Michelle 
Published: July 2021

Abstract
This paper examines the use of antithesis and paradox in the Epistle to Diognetus. The text employs these rhetorico-philosophical techniques in order to provoke interest in readers, whether pagan or Christian, and lure them toward deeper inquiry and understanding of the truths the author thinks Christianity teaches. That is, the anticipated effects of antithesis and paradox as classical rhetorical tools, as described by ancient rhetoricians and philosophers, promotes the overall protreptic goal of the text. The antitheses capture the audience’s attention, while the pervasive use of paradoxical language and reasoning guides it toward deeper inquiry about Christianity. Not only are Christian existence and God’s plan of salvation paradoxical, but the author’s very understanding of how to comprehend these paradoxes contradicts the expectations created by classical philosophical notions of paradox.
Anthrozoology, or
Authors: Emmrich Thomas 
Published: July 2021

Abstract
This essay looks at the relationship between the human and the animal with a particular focus on Ovid’s Metamorphoses. At the centre of the analysis is Ovid’s basic understanding of anthrozoology and his narrative about Lycaon. With continuous reference to the translations into English, German, French, Italian, and Spanish, this interpretation is concerned with the subtle linguistic phenomena that can only be derived from the Latin original text; and which, regardless of the obvious content of the metamorphosis, subvert the traditional distinction between human and animal. The anthropological difference is closely connected to the order of language, which has been considered a defining characteristic of the human being. It is therefore all the more remarkable that the plurality and convertibility of languages can be addressed in the light of Ovid’s anthrozoology. With this in mind, the essay concludes by discussing the concept of World Literature.
Impact of Assimilating GOES-R Geostationary Lightning Mapper Flash Extent Density Data on Severe Convection Forecasts in a Warn-on-Forecast System
Authors: Wang Yaping , Yussouf Nusrat , Mansell Edward R. , Matilla Brian C. , Kong Rong , Xue Ming , Chmielewski Vanna C. 
Published: July 2021

AbstractThe Geostationary Operational Environmental Satellite-R (GOES-R) Geostationary Lightning Mapper (GLM) instrument detects total lightning rate at high temporal and spatial resolution over the Americas and adjacent oceanic regions. The GLM observations provide detection and monitoring of deep electrified convection. This study explores the impact of assimilating the GLM-derived flash extent density (FED) on the analyses and short-term forecasts of two severe weather events into an experimental Warn-on-Forecast system (WoFS) using the ensemble Kalman filter data assimilation technique. Sensitivity experiments are conducted using two tornadic severe storm events: one with a line of individual supercells and the other one with both isolated cells and a severe convective line. The control experiment (CTRL) assimilates conventional surface observations and geostationary satellite cloud water path into WoFS. Additional experiments also assimilate either GLM FED or radar data (RAD), or a combination of both (RAD+GLM). It is found that assimilating GLM data in the absence of radar data into the WoFS improves the short-term forecast skill over CTRL in one case, while in the other case it degrades the forecast skill by generating weaker cold pools and overly suppressing convection, mainly owing to assimilating zero FED values in the trailing stratiform regions. Assimilating unexpectedly low FED values in some regions due to low GLM detection efficiency also accounts for the poorer forecasts. Although RAD provides superior forecasts over GLM, the combination RAD+GLM shows further gains in both cases. Additional observation operators should consider different storm types and GLM detection efficiency.
Similar frequency of atrial perforation between atrial and bicaval dual lumen veno-venous ECMO cannulas in a pediatric population
Authors: Ramaraj Akila , Jensen Guy , Rice-Townsend Samuel , DiGeronimo Robert , Yalon Larissa , Stark Rebecca 
Published: July 2021

Purpose: Complications associated with use of dual-lumen venovenous extracorporeal membrane oxygenation (VV-ECMO) cannulas are of concern in pediatric patients. While the risk of atrial perforation is believed to be higher with bicaval cannulas, direct comparison of complication rate between atrial and bicaval cannulas has not been conducted in this population. Methods: A retrospective review was conducted at a free-standing children’s hospital of all patients 0–18 years old, placed on VV-ECMO with a dual-lumen cannula from January 2009 to December 2018. Patients were grouped based on cannula type. Complications were assessed over the entire duration of the ECMO run. Logistic regression analyses were used to evaluate for an association between cannula type and risk of pericardial effusion or cannula-related complication requiring median sternotomy or pericardial drain placement. Results: During the study period 119 patients were placed on VVECMO using a dual-lumen cannula. Eighty-two patients (69%) were <2 years old, 19 (16%) were 2–10 years old, and 18 (15%) were 11–18 years old. Seventy-three were cannulated with an atrial cannula and 46 patients received a bicaval cannula. Pericardial effusions were seen in 30% and 24% of these patients respectively while severe complications were seen in 9.6% and 8.7% of patients respectively. Compared to patients treated with a bicaval cannula, those who received an atrial cannula had similar odds of effusions (OR: 1.41, 95% CI: 0.62–3.36) and severe complications (OR 0.89, 95% CI: 0.27–3.18). After adjusting for age, weight, cannula and circuit manipulations, and use of echocardiography, the OR of effusion was 1.91 (95% CI: 0.65–6.42), and the adjusted OR of severe complication was 0.69 (95% CI: 0.16–3.33). Conclusions: There were no significant differences in frequency of pericardial effusions or severe cannula-related complications between the treatment groups across all pediatric patients and within the subgroup of patients under 2 years of age.
Delayed diagnosis of critical congenital heart defects predicting risk factors and survival rate in newborns in Beijing: a retrospective study
Authors: Zhang Wen , Xu Hong-Yan , Zhang Yan-Chun , Liu Kai-Bo 
Published: July 2021

Objective To assess the prevalence and survival rate of newborns with a delayed diagnosis of critical congenital heart defects (CCHD) in Beijing. Methods This retrospective study analysed data from births between 2010 and 2017 from the Birth Defects Monitoring Network in Beijing. Newborns with CCHD were analysed according to seven categories. Statistical analyses were used to calculate the mortality rate within the first week (days 0–6) after live birth. Multivariate logistic regression analysis of survival was performed to analyse the potential risk factors for newborn mortality. Results A total of 1 773 935 perinatal newborns were screened in Beijing and 1851 newborns were diagnosed with CCHD, showing a prevalence of 10.43 per 10 000. Among the total 1851 CCHD patients, the majority (1692 of 1851; 91.41%) were identified through prenatal diagnosis, 104 of 1851 (5.62%) were diagnosed before obstetric discharge/transfer and 55 of 1851 (2.97%) were identified through delayed diagnosis. The prevalence of CCHD in newborns was 1.96 per 10 000 births. Multivariate logistic regression analysis of survival demonstrated that gestational age at delivery was the only risk factor for death within the first week after birth. Conclusions Within the first week after birth, gestational age was the only risk factor for death in newborns with CCHD.
Functional status in postural tachycardia syndrome
Authors: Rich Emily M , Vas Asha , Parsons Thomas D , Krone Ryan , Goodman Brent P 
Published: July 2021

Introduction Postural tachycardia syndrome is a form of orthostatic intolerance that often leads to functional impairment. Methods This survey explored functional status and impact of symptoms in adults ( n = 958) ages 18 to 60 (M = 32.63 ± 10.52 years, 96.7% female) with postural tachycardia syndrome. Results Individuals reported an average of 11 daily life activities impacted by postural tachycardia syndrome with high levels of self-perceived disability. Additionally, 93.4% reported some degree of cognitive impairment and falls occurred in 55.3% of participants annually. Despite frequent falls and functional impairment, participants infrequently (26.9%) utilized therapy services. Conclusion Individuals with postural tachycardia syndrome are at an increased risk of experiencing disability and often require assistance with daily activities. Further research is necessary to understand the potential role of therapy in improving function and quality of life.
Speech Outcome and Self-Reported Communicative Ability in Young Adults Born With Unilateral Cleft Lip and Palate: Comparing Long-Term Results After 2 Different Surgical Methods for Palatal Repair
Authors: Peterson Petra , Nyberg Jill , Persson Christina , Mark Hans , Lohmander Anette 
Published: July 2021

Objective: To compare speech outcome and self-reported speech and communicative ability (SOK) in young adults treated with one-stage (OS) or two-stage (TS) palatal repair. Furthermore, to compare with normative data on individuals without cleft lip and palate and to study the relationship between patients’ and experts’ judgments. Design: A cross-sectional group comparison study with long-term follow-up. Participants: Patients born with unilateral cleft lip and palate treated at 2 cleft centers; 17 with OS at 14 months and 25 with TS, soft palate repair at 7 months and hard palate repair at 6.2 years. Pharyngeal flap surgery was performed in 53% (OS) and 24% (TS) of patients. Main Outcome Measure(s): Speech characteristics were blindly assessed by speech and language pathologist from audio recordings, SOK at 19 years of age. Results: No group differences were found. Although the occurrence of nasality symptoms was low in both groups, only 60% (OS)/65% (TS) were assessed with competent velopharyngeal function (VPC). Articulation proficiency (percentage of consonants correct [PCC]) was 91%/97%, the /s/-sound specifically 87%/91%. Good intelligibility was found in 91%/87%. Patient opinion was in agreement with norms and significantly associated with intelligibility ( rs = 0.436, P < .01), PCC ( rs = −0.534, P < .01), and correct /s/ ( rs = −0.354, P < .05). Conclusions: No differences in speech outcome were related to operation method. The low prevalence of VPC was not clearly reflected in nasality symptoms. Patient opinion was related to articulation and intelligibility. A higher burden of care in terms of pharyngeal flap surgery was seen after the OS technique.
Eighty Percent Survival of Resurfacing Implants in the Knee After 10 Years: A Nationwide Cohort Study on 379 Procedures from the Danish Knee Arthroplasty Registry
Authors: Christensen Bjørn B. , El-Galaly Anders , Laursen Jens Ole , Lind Martin 
Published: July 2021

Objective Focal cartilage injuries are debilitating and difficult to treat. Biological cartilage repair procedures are used for patients younger than 40 years, and knee arthroplasties are generally reserved for patients older than 60 years. Resurfacing implants are well suited for patients in this treatment gap. The objective was to investigate the 10-year survival of resurfacing implants in the Danish Knee Arthroplasty Registry. Design In this retrospective cohort study, patients treated with resurfacing implants were followed longitudinally in the Danish Knee Arthroplasty Registry from 1997 to 2020. The primary endpoint was revision surgery. The survival of the resurfacing implants was analyzed by Kaplan-Meier method. Results A total of 379 resurfacing implant procedures were retrieved from the Danish Knee Arthroplasty Registry. The mean age and weight of patients were 50 years (SD = 11) and 84 kg (SD = 17), respectively. The indications for surgery were as follows: secondary osteoarthritis (42%), primary osteoarthritis (32%), and osteochondral lesions (20%). Within the follow-up period, 70 (19%) of the implants were revised to arthroplasties. The 1-, 5-, and 10-year revision-free survival estimation was 0.95 (95% CI 0.93-0.97), 0.84 (95% CI 0.80-0.88), and 0.80 (95% CI 0.75-0.84), respectively. The median time to revision was 2 years. Conclusion The 10-year revision-free survival rate for resurfacing implants was 80%. Based on the revision rates, this treatment offers a viable alternative to biological cartilage repair methods in patients aged 40 to 60 years with focal cartilage pathology. Improved patient selection could further improve the implant survival rate. Further studies are needed to investigate this treatment method.
‘I wish my body was stronger’: A qualitative study of attitudes and behaviours regarding treatment of hypertensive disorders of pregnancy
Authors: Helou Amyna , Stewart Kay , Ryan Kath , George Johnson 
Published: July 2021

Objectives: To investigate pregnant women’s attitudes and behaviours towards hypertensive disorders of pregnancy and their treatment. Methods: Face-to-face, in-depth interviews were undertaken with 27 pregnant women diagnosed with and being treated for hypertensive disorders of pregnancy to investigate attitudes and behaviours regarding the conditions and their treatment. Written consent was obtained individually from each participant, and the interviews ranged from 16 to 54 minutes. Data collection was continued until thematic saturation was reached. Thematic analysis was employed to interpret the data. Results: Four major themes emerged around beliefs and behaviours of pregnant women regarding treatment of their hypertension: understanding of hypertensive disorders of pregnancy and their implications, risks versus benefits of antihypertensive medication during pregnancy, trust in medical professionals and adherence to medication. The women’s level of understanding of hypertensive disorders of pregnancy and their implications determined whether they were able to make informed decisions about their treatment. Prior experiences and concern for preservation of the pregnancy played major roles in the perception of the risk/benefit balance of using antihypertensive medication during pregnancy. The degree of trust in the treating medical professionals varied according to the perception of their confidence and knowledge. Conclusions: Sound understanding of the condition, a positive risk/benefit balance regarding antihypertensive medication use during pregnancy, and trust in medical professionals contributed to adherence to medication. Good communication with healthcare professionals is important to achieve optimal treatment.
Ventilatory failure in a cat following radical chest wall resection for feline injection site sarcoma
Authors: Bilko Samantha J , Veytsman Stan , Amsellem Pierre M , Chow Rosalind S 
Published: July 2021

Case summary A 12-year-old spayed female domestic shorthair cat presented for chest wall resection and radiation therapy following incomplete surgical excision of a feline injection site sarcoma. A CT scan for surgical planning was performed under general anesthesia and showed extensive tumor infiltration of the soft tissues of the right thorax. The cat recovered uneventfully from this anesthetic event. Nineteen days later, the patient was reanesthetized for forequarter amputation plus radical chest wall resection, including ribs 3–8 and all associated soft tissues plus adjacent spinous processes. Postoperatively, the patient developed acute respiratory failure secondary to hypoventilation. The cat was mechanically ventilated for 12 h prior to being successfully weaned from the ventilator. However, the improvement was transient and mechanical ventilation was reinitiated 6 h later owing to respiratory fatigue. On the second day, the cat developed unexplained central nervous system signs and was euthanized. Relevance and novel information To our knowledge, this is the first case report to describe ventilatory failure secondary to radical chest wall resection in a cat. Hypoventilation with subsequent need for mechanical ventilation is a potential complication that should be considered during preoperative planning in patients requiring extensive chest wall resections.