bluuebunny/crossref_metadata_2025_split huggingface dataset:
The Postnatal Resolution of Developmental Toxicity Induced by Pharmacological Diacylglycerol Acyltransferase 2 (DGAT2) Inhibition During Gestation in Rats
Authors: Catlin Natasha R , Bowman Christopher J , Campion Sarah N , Lewis Elise M , Nowland William S , Stethem Christine , Cappon Gregg D 
Published: July 2022

Abstract
Ervogastat (PF-06865571) is a small molecule diacylglycerol acyltransferase 2 (DGAT2) inhibitor being developed for the oral treatment of nonalcoholic steatohepatitis (NASH) with liver fibrosis. DGAT2 is a key enzyme in triglyceride synthesis in tissues and in regulating energy metabolism. Fertility and developmental toxicity studies with ervogastat were conducted in female rats and rabbits. There were no effects on female rat fertility or rabbit embryo-fetal development. Administration of ervogastat to pregnant rats during organogenesis reduced fetal weight and caused higher incidences of bent bones in fetuses that were shown to resolve by postnatal day 28 and were therefore considered to be transient variations secondary to developmental delay. Extended dosing in rats through the end of gestation and lactation (pre- and post-natal development study) caused impaired skin development, reduced offspring viability, and growth retardation. The spectrum of developmental effects in rats is consistent with the intended pharmacology (altered triglyceride metabolism) and the transient nature of the skeletal findings, along with the late gestational window of sensitivity for the effects on skin barrier development, reduce the concern for potential adverse developmental effects following unintended early gestational exposure to ervogastat in humans where treatment can be discontinued once pregnancy is determined.
17Theory on Theory
Authors: Carr Nicholas 
Published: July 2022

Abstract
This chapter reviews recent contributions to the meta-discourses of theory and criticism. Theory on theory is bound always to be a protean and polymorphous category, and the discussion here is structured by a division into five themes, even though the works reviewed frequently range across more than one of them. Section 1 notes the emergence of a distinctive move to reinsert teaching into discussions of literary studies. Section 2 surveys a range of publications that continue the long work of historicizing theory, particularly in the French vein that is almost synonymous with understandings of (high) theory as a period. Building on that glance backward, Section 3 considers a number of works that propose new approaches or methods for our field. These proposals, at least in part, emerge from a virtually universal sense of crisis in the humanities, which is examined in Section 4. Finally, Section 5 considers the positing of a transdisciplinary world turn that is said to go well beyond the humanities. In this year’s melange of continuing practices, revivals, and innovations, theory on theory is revealed to be a lively and stimulating voice in the cultural conversations of the past year.
Clinical Indicators of Surgical Outcomes After Laminoplasty for Patients With Cervical Ossification of the Posterior Longitudinal Ligament: A Prospective Multicenter Study
Authors: Nagoshi Narihito , Yoshii Toshitaka , Egawa Satoru , Sakai Kenichiro , Kusano Kazuo , Tsutsui Shunji , Hirai Takashi , Matsukura Yu , Wada Kanichiro , Katsumi Keiichi , Koda Masao , Kimura Atsushi , Furuya Takeo , Maki Satoshi , Nishida Norihiro , Nagamoto Yukitaka , Oshima Yasushi , Ando Kei , Nakashima Hiroaki , Takahata Masahiko , Mori Kanji , Nakajima Hideaki , Murata Kazuma , Miyagi Masayuki , Kaito Takashi , Yamada Kei , Banno Tomohiro , Kato Satoshi , Ohba Tetsuro , Inami Satoshi , Fujibayashi Shunsuke , Katoh Hiroyuki , Kanno Haruo , Watanabe Kota , Taneichi Hiroshi , Imagama Shiro , Kawaguchi Yoshiharu , Takeshita Katsushi , Nakamura Masaya , Matsumoto Morio , Yamazaki Masashi , Okawa Atsushi 
Published: July 2022

Study Design.
A prospective multicenter study.

Objective.
This study aims to evaluate patient-reported outcomes using the Japanese Orthopedic Association Cervical Myelopathy Evaluation Questionnaire (JOACMEQ) and clarify clinical factors that affect the therapeutic effects for patients with cervical ossification of the posterior longitudinal ligament (OPLL).

Summary of Background Data.
Although previous studies identified factors that affected the surgical outcomes, their assessment was mainly based on the Japanese Orthopedic Association score, which only includes neurological function. Investigating this pathology through multiple functions and quality of life (QOL) is pivotal to understanding the comprehensive clinical pictures of the cervical OPLL and its therapeutic outcomes.

Materials and Methods.
This study was performed by the Japanese Multicenter Research Organization for Ossification of the Spinal Ligament. A total of 478 patients with myelopathy caused by cervical OPLL from 28 institutions were prospectively registered from 2014 to 2017 and followed up for 2 years. Of the patients, 168 received laminoplasties and fully completed questionnaires. Demographic information, imaging findings, and clinical outcomes were collected. Patients were grouped according to effective or ineffective surgical outcomes as defined by the JOACMEQ using logistic regression analyses.

Results.
Laminoplasty resulted in functional improvement in the cervical spine and upper extremity around 40% of the patients, while QOL showed only 21.4% (P<0.01). Multivariable analyses revealed that younger age and a postoperative decrease in arm or hand pain were correlated with significantly improved function of the upper extremities. A reduction in lower limb pain favorably affected the postoperative lower extremity function. A postoperative reduction in upper extremity pain enhanced the QOL recovery.

Conclusions.
Surgeons should recognize the diversity of surgical outcomes after laminoplasty and understand the necessity of pain management even after the surgery to enhance bodily functions and QOL in patients with cervical OPLL.
Recovery Kinetics after Commonly Performed Minimally Invasive Spine Surgery Procedures
Authors: Shinn Daniel , Mok Jung Kee , Vaishnav Avani S. , Louie Philip K. , Sivaganesan Ahilan , Shahi Pratyush , Dalal Sidhant , Song Junho , Araghi Kasra , Melissaridou Dimitra , Sheha Evan D. , Sandhu Harvinder , Dowdell James , Iyer Sravisht , Qureshi Sheeraz A. 
Published: July 2022

Study Design.
Single-center, multi-surgeon, retrospective review.

Objective.
Evaluate the timing of return to commonly performed activities following minimally invasive spine surgery. Identify preoperative factors associated with these outcomes.

Summary of Background Data.
Studies have reported return to activities with open techniques, but the precise timing of when patients return to these activities after minimally invasive surgery remains uncertain.

Methods.
Patients who underwent either minimally invasive lumbar laminectomy (MI-L) or minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) were included. Patient reported outcome measures, return to drive, return to work and discontinuation of opioids data were reviewed. Regression was conducted to identify factors associated with return to driving by 15 days, return to work by 30 days, and for discontinuing opioids by 15 days. A composite group analysis was also performed for patients who returned to all three activities by 30 days.

Results.
In total, 123 MI-L patients and 107 MI-TLIF patients were included. 88.8% of MI-L patients and 96.4% of MI-TLIF patients returned to driving in 11 and 18.5 days, respectively. 91.9% of MI-L patients and 85.7% of MI-TLIF patients returned to work in 14 and 25 days. 88.7% of MI-L patients and 92.6% of MI-TLIF patients discontinued opioids in a median of 7 and 11 days. 96.2% of MI-L patients and 100% of MI-TLIF patients returned to all three activities, with a median of 27 and 31 days, respectively. Male gender (OR 3.57) and preoperative SF-12 PCS (OR 1.08) are associated with return to driving by 15 days. Male gender (OR 3.23) and preoperative SF-12 PCS (OR 1.07) are associated with return to work by 30 days. Preoperative VAS back was associated with decreased odds of discontinuing opioids by 15 days (OR 0.84).

Conclusion.
Most patients return to activity following MI-L and MI-TLIF. These findings serve as an important compass for preoperative counseling.
Minimally Invasive Lumbar Decompression Versus Minimally Invasive Transforaminal Lumbar Interbody Fusion for Treatment of Low-Grade Lumbar Degenerative Spondylolisthesis
Authors: Bovonratwet Patawut , Samuel Andre M. , Mok Jung Kee , Vaishnav Avani S. , Morse Kyle W. , Song Junho , Steinhaus Michael E. , Jordan Yusef J. , Gang Catherine H. , Qureshi Sheeraz A. 
Published: July 2022

Study Design.
Retrospective cohort comparison study.

Objective.
To compare perioperative outcomes, radiographic parameters, and patient reported outcome measures (PROMs) between minimally invasive unilateral laminotomy with bilateral decompression (MIS-ULBD) versus MIS transforaminal lumbar interbody fusion (MIS-TLIF) for treatment of low-grade lumbar degenerative spondylolisthesis.

Summary of Background Data.
While lumbar degenerative spondylolisthesis is a common condition, optimal surgical treatment remains controversial. Newer MIS techniques, which preserve bone, paraspinal musculature, and posterior midline stabilizers, are thought to reduce the risk of iatrogenic instability and may obviate the need for fusion. However, few comparative studies of MIS techniques for low-grade lumbar degenerative spondylolisthesis currently exist.

Methods.
Consecutive patients with low-grade (Meyerding grade I or II) lumbar degenerative spondylolisthesis treated with single-level MIS-ULBD or MIS-TLIF were identified retrospectively from a prospectively collected spine surgery registry from April 2017 – November 2021. Perioperative outcomes, radiographic data, and PROMs were assessed.

Results.
A total of 188 patients underwent either MIS-ULBD or MIS-TLIF (79 MIS-ULBD and 109 MIS-TLIF). Patients who underwent MIS-ULBD tended to be older, had higher Charlson Comorbidity Index, lower mean percentage back pain, higher percentage of L4/L5 pathology, shorter operative time, lower estimated blood loss, and lower postoperative pain (P<0.05). In both groups, there were statistically significant improvements at 1 year for five out of the six PROMs studied: Oswestry Disability Index (ODI), visual analog scale (VAS)-back pain, VAS-leg pain, Short Form 12 Physical Component Score (SF12-PCS), and Patient-Reported Outcomes Measurement Information System (PROMIS) (P<0.05). On multivariate analysis controlling for confounders, there were no associations between procedure type and achieving MCID at 1 year in any of the PROMs studied.

Conclusions.
The current study suggests that both MIS-ULBD and MIS-TLIF result in significant improvements in pain and physical function for patients with low-grade lumbar degenerative spondylolisthesis.

Level of Evidence.
3
Systematic Review of the “Pragmatism” of Pragmatic Critical Care Trials
Authors: Palakshappa Jessica A. , Gibbs Kevin W. , Lannan Margo T. , Cranford Anna R. , Taylor Stephanie P. 
Published: July 2022

OBJECTIVES:
To assess the pragmatism of published critical care randomized controlled trials self-described as pragmatic using a validated tool.

DATA SOURCES:
Medical Literature Analysis and Retrieval Online database and PubMed interface from inception to November 1, 2021.

STUDY SELECTION:
We performed a systematic search of randomized controlled trials evaluating interventions for critically ill adults that self-identified as pragmatic in title or abstract.

DATA EXTRACTION:
Reviewers independently performed study selection and data extraction in duplicate; discrepancies were resolved by consensus. Pragmatism was assessed independently in duplicate by trained reviewers using the Pragmatic-Explanatory Continuum Indicator Summary 2 (PRECIS-2), a validated tool designed to represent how explanatory/pragmatic a trial is on the pragmatic to explanatory continuum. Trials were scored in nine domains on a 5-point continuum (from 1 = very explanatory to 5 = very pragmatic). Discrepancies of greater than 2 points were adjudicated by consensus discussion.

DATA SYNTHESIS:
The search resulted in 284 studies; 56 met eligibility criteria. Forty-one of the trials had a discrepancy in at least one domain that required consensus discussion, most commonly in domains of eligibility and follow-up. Twelve studies (21.4%) were scored as “overall pragmatic,” defined as score of greater than 4 in five domains provided the scores in the remaining domains were three. The overall PRECIS-2 score of self-identified pragmatic studies increased from 1995 to 2021 suggesting increasing pragmatism over time. Pragmatic trials were more likely to have a waiver of informed consent (p = 0.05).

CONCLUSIONS:
The number and pragmatism of self-identified pragmatic trials have increased, particularly in the past decade. However, less than one-quarter of these trials that use the term pragmatic in title or abstract were retrospectively rated as pragmatic. Our results support the concept that trials are designed on a spectrum of pragmatic to explanatory. Advances in the design and reporting of critical care trials are needed to ensure their real-world applicability.
Awareness With Paralysis Among Critically Ill Emergency Department Patients: A Prospective Cohort Study*
Authors: Fuller Brian M. , Pappal Ryan D. , Mohr Nicholas M. , Roberts Brian W. , Faine Brett , Yeary Julianne , Sewatsky Thomas , Johnson Nicholas J. , Driver Brian E. , Ablordeppey Enyo , Drewry Anne M. , Wessman Brian T. , Yan Yan , Kollef Marin H. , Carpenter Christopher R. , Avidan Michael S. 
Published: July 2022

OBJECTIVES:
In mechanically ventilated patients, awareness with paralysis (AWP) can have devastating consequences, including post-traumatic stress disorder (PTSD), depression, and thoughts of suicide. Single-center data from the emergency department (ED) demonstrate an event rate for AWP factors higher than that reported from the operating room. However, there remains a lack of data on AWP among critically ill, mechanically ventilated patients. The objective was to assess the proportion of ED patients experiencing AWP and investigate modifiable variables associated with its occurrence.

DESIGN:
An a priori planned secondary analysis of a multicenter, prospective, before-and-after clinical trial.

SETTING:
The ED of three academic medical centers.

PATIENTS:
Mechanically ventilated adult patients that received neuromuscular blockers.

INTERVENTIONS:
None.

MEASUREMENTS AND MAIN RESULTS:
All data related to sedation and analgesia were collected. AWP was the primary outcome, assessed with the modified Brice questionnaire, and was independently adjudicated by three expert reviewers. Perceived threat, in the causal pathway for PTSD, was the secondary outcome. A total of 388 patients were studied. The proportion of patients experiencing AWP was 3.4% (n = 13), the majority of whom received rocuronium (n = 12/13; 92.3%). Among patients who received rocuronium, 5.5% (n = 12/230) experienced AWP, compared with 0.6% (n = 1/158) among patients who did not receive rocuronium in the ED (odds ratio, 8.64; 95% CI, 1.11–67.15). Patients experiencing AWP had a higher mean (sd) threat perception scale score, compared with patients without AWP (15.6 [5.8] vs 7.7 [6.0]; p < 0.01).

CONCLUSIONS:
AWP was present in a concerning proportion of mechanically ventilated ED patients, was associated with rocuronium exposure in the ED, and led to increased levels of perceived threat, placing patients at greater risk for PTSD. Studies that aim to further quantify AWP in this vulnerable population and eliminate its occurrence are urgently needed.
A Summary of Chinese Expert Consensus on Fetal Growth Restriction (An Update on the 2019 Version)
Authors:   Fetal Medicine Subgroup, Chinese Society of Perinatal Medicine, Chinese Medical Association; Maternal-Fetal Medicine Committee, Chinese Society of Obstetrics and Gynecology, Chinese Medical Association, Sun Luming , Hu Yali , Qi Hongbo 
Published: July 2022

Abstract
Fetal growth restriction (FGR) is a common complication of pregnancy associated with higher rates of perinatal mortality and morbidity, as well as a variety of long-term adverse outcomes. To standardize the clinical practice for the management of FGR in China, Fetal Medicine Subgroup, Chinese Society of Perinatal Medicine, Chinese Medical Association and Maternal-Fetal Medicine Committee, Chinese Society of Obstetrics and Gynecology,Chinese Medical Association organized an expert committee to provide official consensus-based recommendations on FGR. We evaluated the evidence provided by relevant high-quality literature, performed a three-round Delphi study and organized face-to-face meetings with experts from multidisciplinary backgrounds. The consensus includes the definition, prenatal screening, prevention, diagnosis, monitoring and management of FGR.
Histological evidence supporting the durability of successful radiofrequency renal denervation in a normotensive porcine model
Authors: Sharp Andrew S.P. , Tunev Stefan , Schlaich Markus , Lee David P. , Finn Aloke V. , Trudel Julie , Hettrick Douglas A. , Mahfoud Felix , Kandzari David E. 
Published: July 2022

Background:
Sustained blood pressure reductions after radiofrequency (RF) renal denervation (RDN) have been reported to 3 years in patients with uncontrolled hypertension. However, mechanistic data to support procedural durability are lacking. We aimed to quantify the long-term nerve anatomic and functional effects of RF RDN in a preclinical model.

Methods:
Bilateral RF RDN was performed in 20 normotensive swine. Renal tissue samples were obtained in the RDN-treated groups at 7 (n = 6), 28 (n = 6), and 180 days (n = 8) postprocedure for quantification of cortical norepinephrine (NE) levels and renal cortical axon density. Tissue fibrosis, necrosis and downstream nerve fiber atrophy (axonal loss) were also scored for each sample. Three additional untreated groups (n = 6, n = 6 and n = 8, respectively) served as control.

Results:
Pathologic nerve changes were characterized by necrosis in the ablated region at 7 days that partially resolved by 28 days and fully resolved at 180 days. Axonal loss was apparent within and downstream to the ablation regions and was evident at 7, 28 and 180 days in the main vessel and branch vessels. Consequently, renal cortical axon density and corresponding cortical NE levels were significantly reduced at 7 days in the RDN vs. control group and remained suppressed at 180 days.

Conclusions:
Reductions in renal NE, cortical axon density and downstream axonal loss caused by axonal destruction persisted through 180 days post-RDN in a normotensive swine model. These results suggest functional nerve regrowth after RF RDN is unlikely and support published clinical evidence that the procedure results in durable blood pressure reduction.
Immunoglobulin A (De Novo) Vasculitis After mRNA Moderna COVID-19 Vaccination
Authors: Aguilar-Aragon Javier Antonio , Mauro Anna Grace 
Published: July 2022

Abstract
Concurrent with the administration of vaccines for the novel coronavirus (COVID-19), there have been many reported adverse effects, and many of them anticipated as with any vaccine administration. This case report, however, focuses on a patient who, shortly after receiving the first dose of the Moderna COVID-19 vaccine, developed a pruritic maculopapular rash with typical distribution and clinical characteristics, along with high levels of immunoglobulin A (IgA), consistent with IgA vasculitis, formerly known as Henoch-Schonlein purpura. Although there are reported cases of IgA vasculitis after different vaccine administrations, to our knowledge, there are no reports of development of this condition after COVID-19 vaccination. The patient did not have any other triggering events or factors that could be attributed to the development of this pathology. This case describes the development of IgA vasculitis after the COVID-19 vaccination.
Outcomes for Malignant Pleural Effusions Because of Melanoma Treated With Indwelling Pleural Catheters
Authors: Masoudian Pourya , Kwok Chanel , Li Pen , Hosseini Sarah , Zhang Tinghua , Amjadi Kayvan 
Published: July 2022

Background:
Indwelling pleural catheters (IPCs) reduce dyspnea and improve quality of life in patients with malignant pleural effusions (MPEs). Data on outcomes of MPEs secondary to metastatic melanoma managed with IPCs are scarce. We aimed to evaluate outcomes of patients receiving IPCs for MPEs secondary to melanoma compared with other malignancies.

Methods:
We identified patients from our prospectively collected database of all patients who had an IPC insertion for MPEs at our tertiary care center for melanoma between May 2006 and November 2018 and for nonmelanoma between May 2006 and June 2013. Chart reviews were conducted to obtain patient demographics, catheter complications, time of IPC removal or death, x-ray imaging, and pleural fluid characteristics.

Results:
We identified 27 MPEs because of melanoma and 1114 because of nonmelanoma malignancies treated with IPC. The most frequent complication was pleural fluid loculation requiring fibrinolytics which was significantly higher in the melanoma (14.8%) compared with the nonmelanoma group (3.8%; P=0.02). Cumulative incidence functions for catheter removal (P=0.8) or death with catheter in situ (P=0.3) were not significant between melanoma and nonmelanoma groups in competing risk analysis. Baseline radiographic pleural effusion scores were similar, but became significantly higher (increased pleural opacity) in the melanoma group at time points following IPC insertion (P<0.05).

Conclusion:
MPEs because of melanoma had a higher rate of loculations requiring fibrinolytics and less radiographic improvement after IPC insertion suggesting this patient subgroup has a more complicated pleural space which may be less responsive to drainage.
Comparing the efficacy and safety of direct oral anticoagulants versus Vitamin K antagonists in patients with antiphospholipid syndrome: a systematic review and meta-analysis
Authors: Wu Xiaoling , Cao Shaobo , Yu Bo , He Tao 
Published: July 2022

Thromboprophylaxis is the cornerstone strategy for thrombotic antiphospholipid syndrome (APS). Data comparing direct oral anticoagulants (DOACs) to Vitamin K antagonists (VKAs) in the secondary prevention of thrombosis in APS patients remain contentious.
We aim to review and analyse literature on the efficacy and safety of DOACs compared with VKAs in treating patients with APS. A literature search was performed from inception to 31 December 2021. Subgroups were analysed based on the risk stratification of APS profiles and different DOAC types.
A total of nine studies with 1131 patients were included in the meta-analysis. High-risk APS patients (triple positive APS) who used DOACs displayed an increased risk of recurrent thrombosis [risk ratio = 3.65, 95% confidence interval (95% CI): 1.49–8.93; I
2 = 29%, P = 0.005] compared with those taking VKAs. Similar risk of recurrent thrombosis or major bleeding was noted in low-risk APS patients (single or double antibody-positive) upon administering DOACs or VKAs. The utilization of Rivaroxaban was associated with a high risk of recurrent thromboses (RR = 2.63; 95% CI: 1.56–4.42; I
2 = 0, P = 0.0003), particularly recurrent arterial thromboses (RR = 4.52; 95% CI: 1.99–10.29; I
2 = 0, P = 0.18) in overall APS patients. Comparisons of the rate of recurrent thrombosis events and major bleeding events when using dabigatran or apixaban versus VKAs yielded no statistical differences.
In the absence of contraindications, this meta-analysis suggests that VKAs remain the first-choice treatment for high-risk APS patients, with DOACs a more appropriate option for low-risk APS patients. Different DOACs may exhibit different levels of efficacy and safety for thromboprophylaxis in APS patients and require further exploration.